<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 0R 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) December 16, 1993
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CENTOCOR, INC.
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(Exact name of registrant as specified in its charter)
Pennsylvania 0-11103 23-2117202
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(State or other juris- (Commission file (IRS Employer
diction of incorporation) number) Identification No.)
200 Great Valley Parkway, Malvern, Pennsylvania 19355
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (215) 651-6000
-----------------------------
Not applicable
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
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On December 16, 1993, the Registrant entered into certain definitive
Agreements with The Wellcome Foundation Limited ("Wellcome") concerning the
development and marketing of certain of the Registrant's monoclonal antibody
based cancer therapeutic products, including Panorex(R).
Under the agreements, Wellcome paid $20 million to the Registrant in
exchange for two million newly issued shares of the Registrant's common stock,
which represents slightly less than five percent of the total outstanding shares
of common stock of the Registrant. In addition, upon entering into the
agreements, Wellcome paid $10 million to the Registrant, and may make certain
future payments up to $70 million based on milestones and possible acquisition
of certain manufacturing technologies.
Item 7. Financial Statements and Exhibits.
---------------------------------
Exhibits:
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10(a) Stock Purchase Agreement made as of December 16, 1993 by and
between the Registrant and Wellcome.
10(b) Supply, Distribution and Sales Agreement dated December 16,
1993 by and among the Registrant, Centocor B.V. ("CBV"),
Wellcome and Burroughs Wellcome Co. ("BW"). (The Registrant
has requested confidential treatment for portions of this
Agreement, which have been filed separately with the
Securities and Exchange Commission).
10(c) Clinical and Regulatory Development Agreement dated December
16, 1993 among the Registrant, CBV, Wellcome and BW. (The
Registrant has requested confidential treatment for portions
of this Agreement, which have been filed separately with the
Securities and Exchange Commission).
10(d) Manufacturing Technology Option Agreement dated as of
December 16, 1993 among the Registrant, CBV, Wellcome and
BW. (The Registrant has requested confidential treatment
for portions of this Agreement, which have been filed
separately with the Securities and Exchange Commission).
10(e) Centocor Technology License Agreement dated as of December
16, 1993 among the Registrant, CBV, Wellcome and BW. (The
Registrant has requested confidential treatment for portions
<PAGE>
of this Agreement, which have been filed separately with the
Securities and Exchange Commission).
10(f) Relicense Agreement dated as of December 16, 1993 among the
Registrant, CBV, Wellcome and BW.
10(g) Appendix A to the several Agreements dated December 16, 1993
among the Registrant, CBV, Wellcome and BW. - Glossary of
Terms (The Registrant has requested confidential treatment
for portions of this document, which have been filed
separately with the Securities and Exchange Commission)
<PAGE>
SIGNATURES
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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 hereunto duly authorized.
CENTOCOR, INC.
Registrant
Dated: January 21, 1994 By: /s/ George D. Hobbs
--------------------
George D. Hobbs, Vice President,
Corporate Counsel and
Secretary
24153.1
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THE WELLCOME FOUNDATION LIMITED
AND
CENTOCOR, INC.
____________________________________________________________
STOCK PURCHASE AGREEMENT
____________________________________________________________
The Wellcome Foundation Ltd
Legal Department
Unicorn House
P O Box 129
160 Euston Road
London NW1 2BP
England
Dated: As of December 16, 1993
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TABLE OF CONTENTS
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ARTICLE 1 - Definitions ................................................. 2
ARTICLE 2 - Purchase and Sale of Shares ................................. 6
2.1. Purchase and Sale ........................................... 6
2.2. The Closing ................................................. 7
ARTICLE 3 - Restrictions of Transferability ............................. 7
3.1. Transfers Generally ......................................... 7
3.2. Transfers of Restricted Securities Pursuant to Registration
Statements and Rule 144 ..................................... 8
3.3. Other Transfers ............................................. 8
3.4. Restrictive Legends ......................................... 8
3.5. Termination of Restrictions ................................. 9
ARTICLE 4 - Intentionally Omitted ....................................... 9
ARTICLE 5 - Representations of WELLCOME ................................. 9
5.1. Organization and Good Standing .............................. 9
5.2. Corporate Power and Authority; Enforceability ............... 10
5.3. Validity of Contemplated Transactions ....................... 10
5.4. Litigation; Compliance with Laws ............................ 10
5.5. Securities Act Representations .............................. 11
ARTICLE 6 - Representations and Warranties of CENTOCOR .................. 11
6.1. Organization and Good Standing .............................. 11
6.2. Corporate Power and Authority; Enforceability ............... 11
6.3. Validity of Contemplated Transactions ....................... 12
6.4. Litigation; Compliance with Laws ............................ 12
6.5. Capitalization; Ownership of CBV ............................ 12
6.6. Issuance of the Shares ...................................... 13
6.7. Other Securities and Financial Statement Matters ............ 13
6.8. Registration Rights ......................................... 14
</TABLE>
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<TABLE>
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<S> <C>
ARTICLE 7 - Miscellaneous ............................................... 14
7.1. Entire Agreement ............................................ 14
7.2. Amendments .................................................. 15
7.3. Headings .................................................... 15
7.4. Gender; Number .............................................. 15
7.5. Appendices; Exhibits and Schedules .......................... 15
7.6. Severability ................................................ 15
7.7. Notices ..................................................... 16
7.8. Waiver ...................................................... 17
7.9. Assignment .................................................. 17
7.10. Successors and Assigns ...................................... 18
7.11. Governing Law ............................................... 18
7.12. No Benefit to Others ........................................ 19
7.13. Continuing Obligation ....................................... 19
7.14. Counterparts ................................................ 19
</TABLE>
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<PAGE>
STOCK PURCHASE AGREEMENT
------------------------
THIS STOCK PURCHASE AGREEMENT (the "Agreement") is made as of the 16th
---------
day of December, 1993 by and between THE WELLCOME FOUNDATION LIMITED, a United
Kingdom corporation of Unicorn House, PO Box 129, 160 Euston Road, London NW1
2BP, England ("WELLCOME"), and CENTOCOR, INC., a Pennsylvania corporation of 200
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Great Valley Parkway, Malvern, Pennsylvania 19355-1307, USA ("CENTOCOR").
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W I T N E S S E T H:
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WHEREAS, WELLCOME and CENTOCOR desire to develop and pursue an alliance
relating to, among other things, the development, manufacture, sale and
distribution of anti-cancer therapies;
WHEREAS, in furtherance thereof, WELLCOME, CENTOCOR and CBV have entered
into the Alliance Agreement (as defined in Section 1.3 hereof) which
-----------
contemplates, among other things, that CENTOCOR shall issue and sell to WELLCOME
2,000,000 shares of CENTOCOR'S common stock, par value $.01 per share (the
"Common Stock"); and
------------
WHEREAS, CENTOCOR desires to issue, sell and deliver to WELLCOME, and
WELLCOME desires to subscribe for and purchase from CENTOCOR, 2,000,000 shares
of Common Stock (together with such securities which may be issued from time to
time, as a result of stock splits, stock dividends, recapitalizations,
reorganizations or similar events, the "Shares") on the terms and conditions set
------
forth in this Agreement;
<PAGE>
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the parties hereto,
intending to be legally bound hereby, do hereby agree as follows:
ARTICLE 1
Definitions
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1.1. "Affiliate" of a particular Person means any Person which, directly
---------
or indirectly, controls, is controlled by, or is under common control with such
particular Person. The term "control" (including, with correlative meaning, the
-------
terms "controlled by" and "under common control with"), as used with respect to
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any Person, means the possession, directly or indirectly, of the power to elect
forty percent (40%) or more of the board of directors, or to direct or cause the
direction of the management and policies of such Person, whether through the
ownership of voting securities, by contract or otherwise; provided, however,
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BURROUGHS WELLCOME INDIA LTD, WELLCOME PAKISTAN LTD, and BURROUGHS WELLCOME
INDONESIA LTD shall be considered to be Affiliates of WELLCOME.
1.2. "Agreement" has the meaning set forth in the heading hereof.
---------
1.3. "Alliance Agreement" means that certain agreement dated as of November
------------------
5, 1993 among WELLCOME, BURROUGHS WELLCOME CO., CENTOCOR and CENTOCOR B.V.
relating to, among other things, the development, manufacture, sale and
distribution of anti-cancer therapies.
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<PAGE>
1.4. "Business Day" means any day which is not a Saturday, Sunday or a day
------------
on which banks in the Commonwealth of Pennsylvania are authorized to close.
1.5. "CENTOCOR" has the meaning set forth in the heading hereof.
--------
1.6. "Closing" and "Closing Date" have the meanings set forth in Section
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2.1 and 2.2 hereof, respectively.
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1.7. "Common Stock" has the meaning set forth in the preambles hereof.
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1.8. "Court Order" means any judgment, decree, writ, injunction, order or
-----------
ruling of any Governmental Entity.
1.9. "Default" means (a) a breach of or default under any contract,
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agreement, document or instrument, (b) the occurrence of an event with which the
passage of time or the giving of notice or both would constitute a breach of or
default under any contract, agreement, document or instrument or (c) the
occurrence of an event that (with or without the passage of time or the giving
of notice or both) would give rise to a right of damages, specific performance,
termination, renegotiation or acceleration under any contract, agreement,
document or instrument.
1.10. "Derivative Securities" has the meaning assigned to such term under
---------------------
Rule 16a-1(c) promulgated by the SEC under the Exchange Act.
1.11. "Exchange Act" means the Securities Exchange Act of 1934, as amended,
------------
and the Regulations promulgated thereunder or with respect thereto, or any
successor or substitute Laws.
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<PAGE>
1.12. "Existing Derivative Securities" means the Derivative Securities listed
------------------------------
on Schedule 1.12 hereto.
-------------
1.13. "GAAP" means generally accepted accounting principles consistently
----
applied, as applied in the United States of America.
1.14. "Governmental Entity" means any nation or government, any state or
-------------------
other political subdivision thereof, and any entity exercising executive,
legislative, judicial, regulatory or administrative functions of or pertaining
to government.
1.15. "Hereof" and words of similar import refer to this Agreement in its
------
entirety and not to a particular article, section or paragraph, unless
specifically stated.
1.16. "Holder" means WELLCOME, together with any Affiliate of WELLCOME who
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is the record owner of any of the Shares.
1.17. "Known" or "to the knowledge" or "to the best knowledge" or words of
----- ---------------- ---------------------
similar import with respect to any Person mean the knowledge of any officer,
director or manager who reports to an officer of such Person or an Affiliate of
such Person, and the knowledge which such officer, director or manager would
have if he or she had made an inquiry, in a reasonably diligent manner, in
connection with the preparation, negotiation, execution and delivery of this
Agreement.
1.18. "Law" or "Regulation" means any applicable law, statute, rule,
--- ----------
ordinance, regulation, order, decree, edict or other requirement of any
Governmental Entity.
1.19. "Letter of Intent" means a certain letter agreement between WELLCOME
----------------
and CENTOCOR dated September 16, 1993.
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<PAGE>
1.20. "Lien" means any mortgage, lien, security interest, pledge, negative
----
pledge, encumbrance, assessment, title retention agreement, restriction or
restraint on transfer, defect of title, charge in the nature of a lien or
security interest, or option (whether consensual, statutory or otherwise).
1.21. "Litigation" means any action, lawsuit, arbitration, criminal
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prosecution, tax audit, administrative or other proceeding, or with respect to
any Governmental Entity, any investigation or inquiry.
1.22. "Permit" means any and all licenses, franchises, permits, easements,
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rights, consents, orders, approvals and other authorizations of or issued by any
Governmental Entity.
1.23. "Person" means an individual, a sole proprietorship, a corporation,
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a partnership, a joint venture, an association, a trust, or any other entity or
organization, including a Governmental Entity.
1.24. "Preferred Stock" means the authorized preferred stock of CENTOCOR, par
---------------
value $.01 per share.
1.25. "Purchase Price" has the meaning set forth in Section 2.1 hereof.
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1.26. "Regulation D" means Regulation D promulgated by the SEC under the
------------
Securities Act.
1.27. "Regulation S-X" means Regulation S-X promulgated by the SEC under
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the Securities Act.
1.28. "Registration Rights Agreement" means that certain agreement of even
-----------------------------
date herewith between WELLCOME and CENTOCOR
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<PAGE>
relating to, among other things, the registration of the Shares under the
Securities Act.
1.29. "Rule 144" means Rule 144 promulgated by the SEC under the Securities
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Act.
1.30. "Schedules" means the schedules referenced in and delivered pursuant
---------
hereto.
1.31. "SEC" means the United States Securities and Exchange Commission or
---
any successor Governmental Entity.
1.32. "SEC Reports" has the meaning set forth in Section 6.7 hereof.
----------- -----------
1.33. "Securities Act" means the Securities Act of 1933, as amended, and
--------------
the Regulations promulgated thereunder or with respect thereto, or any successor
or substitute Laws.
1.34. "Share Certificates" has the meaning set forth in Section 2.1 hereof.
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1.35. "Shares" has the meaning set forth in the heading hereof.
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1.36. "WELLCOME" has the meaning set forth in the heading hereof.
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ARTICLE 2
Purchase and Sale of Shares
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2.1. Purchase and Sale. At the closing referred to in Section 2.2 hereof
----------------- -----------
(the "Closing"), CENTOCOR shall issue, sell
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<PAGE>
and deliver the Shares to WELLCOME, and WELLCOME shall subscribe for and
purchase the Shares from CENTOCOR, all upon the terms and subject to the
conditions set forth herein. At the Closing, CENTOCOR will deliver to WELLCOME
duly authorized and executed certificates evidencing the Shares, all of which
will have been registered in the name of WELLCOME (the "Share Certificates"),
------------------
and WELLCOME will deliver to CENTOCOR the sum of Twenty Million United States
Dollars (US $20,000,000) (the "Purchase Price") by certified or official bank
--------------
check payable to the order of CENTOCOR or by wire transfer to CENTOCOR'S bank
account at CoreStates Bank, N.A. (Account #01157800; ABA #031-000-011).
2.2. The Closing. The Closing shall take place at the offices of Pepper,
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Hamilton & Scheetz, 3000 Two Logan Square, Eighteenth and Arch Streets,
Philadelphia, Pennsylvania 19103-2799, or such other place as the parties shall
mutually agree, simultaneously with the execution and delivery of this Agreement
(the "Closing Date"). The Closing shall be effective as of the close of
------------
business on the Closing Date. At the Closing, CENTOCOR shall deliver, or cause
to be delivered, to WELLCOME the Share Certificates referred to in Section 2.1
-----------
hereof against receipt from WELLCOME of the Purchase Price to be delivered in
accordance with Section 2.1 hereof.
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ARTICLE 3
Restrictions of Transferability
-------------------------------
3.1. Transfers Generally. The Shares shall be transferable only upon the
-------------------
conditions specified in this Section 3 and in the Registration Rights Agreement,
---------
which conditions are intended to insure compliance with the provisions of the
Securities Act with respect to the transfer of Restricted Securities (as defined
herein).
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<PAGE>
3.2. Transfers of Restricted Securities Pursuant to Registration Statements
----------------------------------------------------------------------
and Rule 144. The Shares may be offered or sold by the Holder thereof pursuant
- ------------
to (a) an effective registration statement under the Securities Act or (b) to
the extent applicable, Rule 144.
3.3. Other Transfers. A Holder may transfer any or all of the Shares,
---------------
without registration or without compliance with the provisions of Rule 144, so
long as it so notifies CENTOCOR and such notification is accompanied by an
opinion of counsel reasonably acceptable to CENTOCOR to the effect that such
transfer may be made without registration under the Securities Act of the Shares
sought to be transferred.
3.4. Restrictive Legends. Until otherwise permitted by Section 3.5 hereof,
------------------- -----------
each certificate representing any of the Shares shall bear a legend in
substantially the following form:
THE SALE, DISPOSITION OR OTHER TRANSFER OF THE SECURITIES REPRESENTED
BY THIS CERTIFICATE IS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED IN
THAT CERTAIN STOCK PURCHASE AGREEMENT DATED AS OF DECEMBER 16, 1993 BETWEEN
CENTOCOR, INC. AND THE WELLCOME FOUNDATION LIMITED, AS THE SAME MAY BE
AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND NO TRANSFER OF THE
SECURITIES REPRESENTED BY THIS CERTIFICATE SHALL BE VALID OR EFFECTIVE
UNTIL THE CONDITIONS TO ANY TRANSFER WHICH ARE SET FORTH IN SUCH AGREEMENT
HAVE BEEN SATISFIED. A COPY OF THE FORM OF SUCH AGREEMENT IS ON FILE AT
THE OFFICE OF THE SECRETARY OF CENTOCOR, INC. AND MAY BE INSPECTED DURING
NORMAL BUSINESS HOURS.
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN
REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, NOR HAVE ANY OF
THEM BEEN REGISTERED OR QUALIFIED UNDER THE SECURITIES OR BLUE SKY LAWS OF
ANY STATE. THE SECURITIES REPRESENTED BY THIS CERTIFICATE MAY NOT BE SOLD,
ASSIGNED, PLEDGED,
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<PAGE>
HYPOTHECATED, ENCUMBERED OR IN ANY OTHER MANNER TRANSFERRED OR DISPOSED OF,
EXCEPT IN COMPLIANCE WITH THE SECURITIES ACT OF 1933, AS AMENDED, THE RULES
AND REGULATIONS PROMULGATED THEREUNDER, AND APPLICABLE STATE SECURITIES OR
BLUE SKY LAWS AND REGULATIONS.
3.5. Termination of Restrictions. All restrictions imposed on the Shares
---------------------------
pursuant to this Section 3 shall cease and terminate automatically as to any
---------
particular Shares when such Shares (a) shall have been effectively registered
under the Securities Act and applicable state securities or blue sky laws and
sold by the Holder thereof in accordance with such registration, (b) shall have
been sold under and pursuant to Rule 144 or (c) shall be eligible to be sold
under and pursuant to subsection (k) of Rule 144.
ARTICLE 4
Intentionally Omitted
ARTICLE 5
Representations of WELLCOME
---------------------------
As a material inducement to CENTOCOR to enter into this Agreement and to
consummate the transactions contemplated hereby, WELLCOME hereby represents and
warrants to CENTOCOR as follows, which representations and warranties shall
survive the Closing and the issuance and delivery of the Shares:
5.1. Organization and Good Standing. WELLCOME is a corporation duly
------------------------------
organized and validly existing under the laws of the United Kingdom.
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<PAGE>
5.2. Corporate Power and Authority; Enforceability. WELLCOME has the
---------------------------------------------
requisite power and authority (corporate and otherwise) to execute, deliver and
perform this Agreement and to consummate the transactions contemplated hereby.
The execution, delivery and performance by WELLCOME of this Agreement and the
consummation by WELLCOME of the transactions contemplated hereby have been duly
authorized by all necessary action (corporate or otherwise) on its part. This
Agreement constitutes a legal, valid and binding obligation of WELLCOME,
enforceable in accordance with its terms.
5.3. Validity of Contemplated Transactions. The execution, delivery and
-------------------------------------
performance by WELLCOME of this Agreement and the consummation by it of the
transactions contemplated hereby do not (a) violate or contravene any provision
of WELLCOME'S charter or bylaws; (b) violate, breach, conflict with, constitute
a Default under, cause the acceleration of any payments pursuant to, or
otherwise impair the good standing, validity, or effectiveness of, any
agreement, contract, indenture, lease, license, or mortgage to which WELLCOME is
a party or by which WELLCOME is bound; (c) violate any provision of any Law,
Permit or Court Order applicable to WELLCOME; or (d) require any Permit or
Required Consent of any Governmental Entity to be obtained by WELLCOME which has
not been obtained.
5.4. Litigation; Compliance with Laws. There is no Litigation pending or,
--------------------------------
to WELLCOME'S knowledge, threatened against or related to WELLCOME, nor any
failure to comply with, violation of or any Default under, any Law, Permit or
Court Order applicable to WELLCOME, in each case which might have a material
adverse effect on the ability of WELLCOME to execute, deliver and perform this
Agreement or on the ability of WELLCOME to consummate the transactions
contemplated hereby.
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<PAGE>
5.5. Securities Act Representations. WELLCOME is an "accredited investor"
------------------------------
within the meaning of Regulation D. WELLCOME has such experience in financial
and business matters such that it is capable of evaluating the merits and risks
of purchasing the Shares. WELLCOME is purchasing the Shares for its own
account, with no present intention of transferring, distributing or reselling
the Shares, or any part thereof, all without prejudice, however, to the rights
of WELLCOME at any time, in accordance with this Agreement and the Registration
Rights Agreement, lawfully to sell or otherwise dispose of all or any part of
the Shares. WELLCOME has had an opportunity to discuss CENTOCOR'S business,
management and financial affairs with CENTOCOR'S management personnel.
ARTICLE 6
Representations and Warranties of CENTOCOR
------------------------------------------
As a material inducement to WELLCOME to enter into this Agreement and to
consummate the transactions contemplated hereby, CENTOCOR hereby represents and
warrants to WELLCOME as follows, which representations and warranties shall
survive the Closing and the issuance and delivery of the Shares:
6.1. Organization and Good Standing. CENTOCOR is a corporation duly
------------------------------
organized, validly existing, and in good standing under the laws of the
Commonwealth of Pennsylvania.
6.2. Corporate Power and Authority; Enforceability. CENTOCOR has the
---------------------------------------------
requisite power and authority (corporate and otherwise) to execute, deliver and
perform this Agreement and to consummate the transactions contemplated hereby.
The execution, delivery and performance by CENTOCOR of this Agreement and the
consummation by CENTOCOR of the transactions contemplated hereby,
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<PAGE>
have been duly authorized by all necessary action (corporate or otherwise) on
its part. This Agreement constitutes a legal, valid and binding obligation of
CENTOCOR, enforceable in accordance with its terms.
6.3. Validity of Contemplated Transactions. The execution, delivery and
-------------------------------------
performance by CENTOCOR of this Agreement, and the consummation by it of the
transactions contemplated hereby, do not (a) violate or contravene any provision
of CENTOCOR'S charter or bylaws; (b) violate, breach, conflict with, constitute
a Default under, cause the acceleration of any payments pursuant to, or
otherwise impair the good standing, validity, or effectiveness of, any
agreement, contract, indenture, lease, license, or mortgage to which CENTOCOR is
a party or by which CENTOCOR is bound; (c) subject any of CENTOCOR'S properties
or assets to any Lien or to any indenture, mortgage, contract, commitment, or
agreement (other than this Agreement) to which it is a party or by which
CENTOCOR or any of CENTOCOR'S properties or assets are bound; (d) violate any
provision of any Law, Permit or Court Order applicable to CENTOCOR; or (e)
require any Permit or Required Consent of any Governmental Entity to be obtained
by CENTOCOR which has not been obtained.
6.4. Litigation; Compliance with Laws. There is no Litigation pending or,
--------------------------------
to CENTOCOR'S knowledge, threatened against or related to CENTOCOR, nor any
failure to comply with, violation of or any Default under, any Law, Permit or
Court Order applicable to CENTOCOR, in each case which might have a material
adverse effect on the ability of CENTOCOR to execute, deliver and perform this
Agreement or on the ability of CENTOCOR to consummate the transactions
contemplated hereby.
6.5. Capitalization; Ownership of CBV. CENTOCOR'S total authorized capital
--------------------------------
stock consists of 100,000,000 shares of Common
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<PAGE>
Stock, of which 41,664,676 shares were issued and outstanding on November 30,
1993, all of which have been validly issued, and are fully paid and
non-assessable, and 10,000,000 shares of Preferred Stock, none of which shares
are presently issued. Since November 30, 1993, CENTOCOR has not issued any
shares of Common Stock other than shares of Common Stock issued pursuant to
Existing Derivative Securities. Except for the Existing Derivative Securities,
CENTOCOR does not have outstanding any Derivative Securities or any commitments
to issue any Derivative Securities. CBV is a direct wholly-owned subsidiary of
CENTOCOR.
6.6. Issuance of the Shares. The Shares, when issued and delivered to, and
----------------------
paid for by, WELLCOME pursuant to and in accordance with the terms of this
Agreement, (a) will have been validly issued, fully paid and non-assessable, (b)
will be free and clear of any Liens (other than Liens imposed by the Securities
Act), and (c) will have been issued without violation of any preemptive or other
right to purchase Common Stock. Neither CENTOCOR nor any Person acting on behalf
of CENTOCOR has offered or will offer the Shares, or any part thereof, or any
similar securities of issue and sale to, or has solicited or will solicit any
offer to acquire any of the same from, any Person so as to bring the issuance
and sale of the Shares within the provisions of the registration and prospectus
delivery requirements of the Securities Act.
6.7. Other Securities and Financial Statement Matters. CENTOCOR has duly
------------------------------------------------
filed in a timely manner (without any permitted extension) all reports and any
other applications and reports required to be filed by CENTOCOR with the SEC
under the Exchange Act (the "SEC Reports"). The SEC Reports (including, in each
-----------
case, without limiting the generality thereof, the audited and unaudited
financial statements of CENTOCOR included therein) when filed contained all
statements required to be stated therein in
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<PAGE>
accordance with the Exchange Act and did not contain any untrue statement of
material fact or omit to state a material fact necessary to make any of the
statements contained therein not misleading in light of the circumstances under
which they were made and otherwise complied in all material respects with the
applicable requirements of the Exchange Act. All of the shares of Common Stock
heretofore issued and sold by CENTOCOR were issued and sold in accordance with,
or were exempt from, the registration and prospectus delivery requirements of
the Securities Act. The consolidated financial statements included in the SEC
Reports comply as to form with the requirements of Regulation S-X and are
derived from the applicable books and records of CENTOCOR, have been prepared in
conformity with GAAP (as required by Regulation S-X) and present fairly the
financial condition, results of operations, changes in securityholders' equity
and cash flows of CENTOCOR on a consolidated basis, as at the close of business,
or for the period ended, on the date of each of such financial statements.
6.8. Registration Rights. Except as set forth on Schedule 6.8 hereto,
------------------- ------------
there is not in effect any agreement to which CENTOCOR is a party or by which it
is bound (including, without limitation, any such agreement among shareholders
of CENTOCOR) pursuant to which holders of securities of CENTOCOR have a right to
cause CENTOCOR to register such securities under the Securities Act other than
as contemplated by the Registration Rights Agreement.
ARTICLE 7
Miscellaneous
-------------
7.1. Entire Agreement. This Agreement, together with the other Alliance
----------------
Documents (as defined in the Alliance Agreement),
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<PAGE>
constitutes the entire understanding of the parties with respect to the subject
matter contained herein and supersedes any prior understandings and agreements
among them respecting such subject matter including, without limitation, the
Letter of Intent; provided, however, the Confidentiality Agreement dated May 12,
-------- -------
1993 between WELLCOME and CENTOCOR, as amended on August 11, 1993, shall
continue in full force and effect until the consummation of the transactions
contemplated by the Alliance Agreement, at which time such agreement shall
automatically terminate; provided further, the confidentiality agreement between
-------- -------
WELLCOME and CENTOCOR dated September 14, 1993 shall in all cases remain in full
force and effect in accordance with its terms.
7.2. Amendments. This Agreement may be amended and supplemented only by a
----------
written instrument duly executed by each of the parties.
7.3. Headings. The headings in this Agreement are for convenience of
--------
reference only and shall not affect its interpretation.
7.4. Gender; Number. Words of gender may be read as masculine, feminine,
--------------
or neuter, as required by context. Words of number may be read as singular or
plural, as required by context.
7.5. Appendices; Exhibits and Schedules. All appendices, exhibits and
----------------------------------
schedules referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.
7.6. Severability. If any provision of this Agreement or the application
------------
thereof to any Person or circumstance is held illegal, invalid or unenforceable,
such illegality, invalidity or
-15-
<PAGE>
unenforceability shall not affect any other provision hereof. This Agreement
shall, in such circumstances, be deemed modified to the extent necessary to
render enforceable the provisions hereof to the fullest extent permitted by Law.
7.7. Notices. All notices and other communications hereunder shall be in
-------
writing and shall be given to the Person either personally or by sending a copy
thereof by first class United States express mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, or by telecopier (with the
original sent by either of the foregoing manners), to such Person's address (or
to such Person's telecopier number). All notices shall be deemed to have been
given to the Person entitled thereto when received.
If to WELLCOME, to:
THE WELLCOME FOUNDATION LIMITED
Unicorn House, P.O. Box 129
129 Euston Road
London NW1 2BP
Attention: Company Secretary
Telecopy No.: 011-44-71-388-5462
with a copy to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
-16-
<PAGE>
If to CENTOCOR, to:
CENTOCOR, INC.
200 Great Valley Parkway
Malvern, Pennsylvania 19355-1307
Attention: Secretary
Telecopy No.: (215) 651-6100
with a copy to:
Duane, Morris & Heckscher
One Liberty Place
Philadelphia, Pennsylvania 19103
Attention: David C. Toner, Esquire
Telecopy No.: (215) 979-1020
Notice of any change in any such address shall also be given in the manner
set forth above. Whenever the giving of notice is required, the giving of such
notice may be waived by the party entitled to receive such notice.
7.8. Waiver. No provision of this Agreement may be waived except by a
------
written instrument signed by the party hereto sought to be bound. No failure or
delay by any party hereto in exercising any right or remedy hereunder or under
applicable Law will operate as a waiver thereof, and a waiver of a particular
right or remedy on one occasion will not be deemed a waiver of any other right
or remedy, or a waiver on any subsequent occasion (it being understood that
specific time frames for notice or actions to be taken shall be binding on the
parties).
7.9. Assignment. Neither party hereto may assign its rights or delegate
----------
any of its obligations hereunder without the
-17-
<PAGE>
prior written consent of the other party, except that, without such consent, (a)
WELLCOME may assign all or any part of its rights and obligations hereunder to
any Affiliate of WELLCOME, including but not limited to Burroughs Wellcome Co.,
a North Carolina corporation, so long as WELLCOME unconditionally guarantees the
obligations of such Affiliate, (b) WELLCOME may assign all of its rights and
delegate all of its duties under this Agreement to the transferee of all or
substantially all of the line of business of which this Agreement forms a part
or by way of merger or consolidation with another company and (c) CENTOCOR and
CBV may assign all of their rights and delegate all of their duties to a
transferee of all or substantially all their assets or by way of merger or
consolidation with another company. If any party shall assign its rights and
delegate its duties pursuant to clauses (b) or (c) of this Section 7.9, the
------------------ -----------
Person to whom such rights are assigned and duties are delegated shall assume
all of the obligations of the applicable party under this Agreement. The
guarantee by WELLCOME referenced in clause (a) of this Section 7.9 is a guaranty
---------- -----------
of payment and performance, and not of collection; and in case of a default by
an Affiliate of WELLCOME to which rights have been assigned or obligations
delegated pursuant to such clause (a), CENTOCOR and CBV shall have the right to
----------
proceed first against WELLCOME without the necessity to proceed against or join
such Affiliate.
7.10. Successors and Assigns. This Agreement shall bind, inure to the
----------------------
benefit of and be enforceable by the successors and permitted assigns of the
parties hereto.
7.11. Governing Law. This Agreement shall be construed and enforced in
-------------
accordance with the Laws of the Commonwealth of Pennsylvania without regard to
principles of conflicts of law applicable in such jurisdiction.
-18-
<PAGE>
7.12. No Benefit to Others. The representations, warranties, covenants
--------------------
and agreements contained in this Agreement are for the sole benefit of the
parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring, and are not intended to confer, any rights on any other
Person.
7.13. Continuing Obligation. Except as otherwise specifically provided
---------------------
herein, neither termination nor expiration of this Agreement shall relieve any
party hereto from any obligation under this Agreement which accrued, or arose
from facts and circumstances in existence, prior thereto.
7.14. Counterparts. This Agreement and any amendment or supplement hereto
------------
may be executed in any number of counterparts and any party hereto may execute
any such counterpart, each of which when executed and delivered shall be deemed
to be an original and all of which counterparts taken together shall constitute
but one and the same instrument. The execution of
-19-
<PAGE>
this Agreement and any such amendment or supplement by any party hereto will not
become effective until counterparts hereof have been executed by all the parties
hereto.
IN WITNESS WHEREOF, the parties have caused this Agreement to be duly
executed and delivered as of the date first above written by their duly
authorized representatives.
FOR AND ON BEHALF OF
THE WELLCOME FOUNDATION LIMITED
By: /s/ Trevor M. Jones
--------------------
Name: Trevor M. Jones
----------------
Title:Director/Research,Development
-----------------------------
& Medical
---------
CENTOCOR, INC.
By: /s/ Bobba Venkatadri
---------------------
Name: Bobba Venkatadri
-----------------
Title: Executive Vice-President
-------------------------
-20-
<PAGE>
SCHEDULE 6.8
------------
Under a certain Investment Agreement dated as of July 15, 1992 between
CENTOCOR and Eli Lilly & Company, CENTOCOR is obligated, under certain
circumstances, to register under the Securities Act 2,000,000 shares of CENTOCOR
Common Stock acquired by Eli Lilly & Company under such agreement.
-21-
<PAGE>
SCHEDULE 1.12
-------------
DERIVATIVE SECURITIES
---------------------
Shares Issuable Upon Exercise of Warrants Outstanding at September 30, 1993:
<TABLE>
<CAPTION>
================================================================================
SHARES EXERCISE EXERCISE ORIGINAL YEAR ISSUED
------ -------- -------- -------- -----------
ISSUABLE PRICE/SHARE PERIOD FINANCING
-------- ----------- ------ ---------
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
997,796 $21.495 Through CPII 1987
11/30/93
1,475,548 $ 19.33 Through CPIII 1988
2/28/95
882,242 $16.655 Through CPIII 1987
2/28/95
535,556 $ 10.83* Through CPIII 1988
2/28/96
5,441,600 $ 11.25 Through Tocor Inc. 1989
12/31/94
2,250,000 $ 64.50 1/1/94 through Tocor II, Inc. 1992
12/31/96
2,250,000 ** ** Tocor II, Inc. 1992
- ----------
13,832,742
==========
================================================================================
</TABLE>
* The exercise price increases by $2.50 per share for the last two years of the
exercise period.
* Warrants are callable by Centocor, Inc. The exercise price per share and
exercise period have not yet been established.
<PAGE>
<TABLE>
<S> <C>
Shares Issuable Upon Exercise of Options
Outstanding at September 30, 1993 5,801,668
Shares Reserved for Issuance at
September 30, 1993 in Connection With
Stock Option Plans 7,917,988
Shares Issuable Upon Vesting of
Restricted Stock Awards Outstanding at
September 30, 19993 329,842
Shares Reserved For Issuance at
September 30, 1993 in Connection With
Restricted Stock Award Plan 1,074,990
Shares Reserved For Issuance at
September 30, 1993 in connection with
the Company's Convertible Subordinated
Notes Due February 1, 2001 3,842,883
Shares Reserved For Issuance at
September 30, 1993 in connection with
the Company's Convertible Subordinated
Debentures Due 2001 2,049,181
</TABLE>
The number of shares of Centocor Common Stock outstanding at November 30, 1993
was 41,664,676
<PAGE>
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF
THIS AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE
AGREEMENT AT THE PLACES INDICATED BY DOUBLE ASTERISKS (**); AND HAVE BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
THE WELLCOME FOUNDATION LIMITED
AND
BURROUGHS WELLCOME CO.
AND
CENTOCOR, INC.
AND
CENTOCOR B.V.
-------------------------------------------------------------------------
SUPPLY, DISTRIBUTION AND SALES AGREEMENT
-------------------------------------------------------------------------
THE WELLCOME FOUNDATION LIMITED
Legal Department
Unicorn House
P O Box 129
160 Euston Road
London NW1 2BP
England
Dated As of December 16, 1993
<PAGE>
<TABLE>
<CAPTION>
TABLE OF CONTENTS
-----------------
PAGE
<S> <C> <C>
1. DEFINITIONS ..................................................... 3
2. JOINT AND SEVERAL LIABILITY; PERFORMANCE BY AFFILIATES .......... 3
3. APPOINTMENT AS DISTRIBUTOR ...................................... 5
4. OPTION FOR JAPAN, REPUBLIC OF KOREA, PEOPLE'S REPUBLIC OF CHINA
AND TAIWAN ....................................................... 9
5. PURCHASE AND SUPPLY OBLIGATIONS .................................. 10
6. FORECAST - ORDER AND DELIVERY PROCEDURES ......................... 12
7. PAYMENT TERMS FOR 17-1A PRODUCT .................................. 16
8. DELIVERY TERMS; INSPECTION UPON DELIVERY AND NON-CONFORMING
FINAL 17-1A PRODUCT/PRE FORMULATED BULK ANTIBODY ................. 25
9. QUALITY ASSURANCE AND QUALITY CONTROL OF FINAL 17-1A PRODUCT ..... 27
10. CENTOCOR'S AND CBV'S OBLIGATIONS AS MANUFACTURER ................. 30
11. LICENSE GRANT .................................................... 31
12. SUPPLY OF F&C TECHNICAL INFORMATION .............................. 32
13. FILLING AND CAPPING .............................................. 33
14. LICENSE AND USE OF TRADEMARKS AND HOUSE MARKS AND INDICIA ........ 35
15. INSURANCE ........................................................ 35
16. MARKETING ........................................................ 36
17. COUNTRY MARKETING PLANS .......................................... 37
18. PROMOTIONAL EFFORTS .............................................. 37
19. MARKETING AND PROMOTIONAL MATERIALS .............................. 38
20. ADVERSE REACTIONS, AGENCY COMMUNICATIONS AND PRODUCT RECALL ...... 40
21. REPRESENTATIONS AND WARRANTIES ................................... 42
</TABLE>
-i-
<PAGE>
<TABLE>
<S> <C> <C>
22. INDEMNIFICATION .................................................. 49
23. NON COMPETE ...................................................... 54
24. THIRD PARTY INFRINGEMENT ......................................... 55
25. ASSIGNMENT ....................................................... 57
26. TERMINATION AND EFFECTS OF TERMINATION ........................... 58
27. CONSEQUENCES OF TERMINATION ...................................... 61
28. CONFIDENTIALITY .................................................. 64
29. PUBLIC STATEMENTS ................................................ 66
30. MISCELLANEOUS .................................................... 66
</TABLE>
APPENDIX A -- GLOSSARY OF TERMS
SCHEDULE 5.3 -- WELLCOME'S STANDARD TERMS AND
CONDITIONS OF PURCHASE
SCHEDULE 8.3 -- 17-1A PRODUCT SPECIFICATION
SCHEDULE 12.1 -- TECHNICAL INFORMATION
RELATING TO F&C TECHNICAL
PROGRAM
SCHEDULE 20.2 -- ADVERSE REACTION PROCEDURES
-ii-
<PAGE>
SUPPLY, DISTRIBUTION AND SALES AGREEMENT
----------------------------------------
THIS SUPPLY, DISTRIBUTION AND SALES AGREEMENT (the "Agreement") is dated
---------
as of the 16th day of December, 1993 by and among THE WELLCOME FOUNDATION
LIMITED, a United Kingdom corporation of Unicorn House, PO Box 129, 160 Euston
Road, London NW1 2BP, England ("WELLCOME"), BURROUGHS WELLCOME CO., a North
--------
Carolina corporation of 3030 Cornwallis Road, Research Triangle Park, North
Carolina 27709 ("BW"), CENTOCOR, INC., a Pennsylvania corporation of 200 Great
--
Valley Parkway, Malvern, Pennsylvania 19355, USA ("CENTOCOR"), and CENTOCOR
--------
B.V., a Netherlands corporation of Einsteinweg 101, PO Box 251, 2300 AG Leiden,
the Netherlands ("CBV").
---
WITNESSETH:
WHEREAS, CENTOCOR and CBV are engaged in research and development with
respect to pharmaceutical products;
WHEREAS, CENTOCOR has undertaken certain research, clinical and
regulatory development of an anti-cancer pharmaceutical product containing a
murine monoclonal antibody that binds to the 17-1A antigen;
WHEREAS, CENTOCOR is willing to appoint WELLCOME, and WELLCOME is
willing to accept appointment as, the exclusive distributor of such
pharmaceutical product for the world, except certain countries in Asia, all in
accordance with this Agreement;
WHEREAS, as distributor, WELLCOME is to buy and CENTOCOR is to sell to
WELLCOME, such product, all as set forth in this Agreement;
<PAGE>
WHEREAS, for certain North American markets, the parties contemplate
that WELLCOME will buy and CENTOCOR will sell to WELLCOME fully purified,
pre-formulated product in bulk form which will require additional processing,
and such processing will be conducted at the BW facility located in Greenville,
North Carolina or another WELLCOME facility, all as more fully set forth in this
Agreement;
WHEREAS, CENTOCOR will supply to WELLCOME, in accordance with this
Agreement, the know-how and technical information necessary or appropriate for
the processing of fully purified, pre-formulated product in bulk form into
finished product;
WHEREAS, CENTOCOR is the proprietor of the trademark PANOREX in certain
countries and has entered into a Trademark Agreement of even date herewith with
WELLCOME allowing WELLCOME to use the trademark PANOREX in connection with the
product in accordance with terms and conditions therein contained; and
WHEREAS, WELLCOME is the proprietor of the Wellcome Indicia which will
be applied and used in connection with the product in accordance with the terms
and conditions hereof;
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the parties hereto,
intending to be legally bound hereby, do hereby agree as follows:
-2-
<PAGE>
1. DEFINITIONS
-----------
The terms defined in the Glossary attached as Appendix A hereto, when
----------
used in this Agreement, shall have the meanings set forth in such Glossary,
unless the context requires otherwise.
2. JOINT AND SEVERAL LIABILITY; PERFORMANCE BY AFFILIATES
------------------------------------------------------
2.1. Each obligation and liability of CENTOCOR under this Agreement shall
be an independent, joint and several obligation of CENTOCOR and CBV. Each of
CENTOCOR and CBV shall be fully liable for performance under this Agreement,
notwithstanding (a) the voluntary or involuntary liquidation, dissolution, sale
or other disposition of all, or substantially all of the assets, marshalling of
assets and liabilities, receivership, insolvency, bankruptcy, assignment for the
benefit of creditors, reorganization, arrangement, composition with creditors or
readjustment of, or other similar proceedings affecting CBV or CENTOCOR or any
contest of the validity of this Agreement in any such proceeding; or (b) any Law
or Court Order now or hereafter in effect in any jurisdiction which might in any
manner affect any of such terms or provisions or any of the rights of WELLCOME
or BW with respect thereto or which might cause or permit CBV or CENTOCOR to
invoke any defense to, or any alteration in the time, amount or manner of
performance of, any or all of their respective obligations under this Agreement,
except to the extent such Law or Court Order renders such obligations unlawful
or to the extent such Court Order constitutes a remedy for a breach by WELLCOME
or BW. The invalidity or unenforceability of this Agreement as to either of
CENTOCOR or CBV shall not render this Agreement invalid or unenforceable as to
the other. The invalidity or unenforceability of this Agreement in any
-3-
<PAGE>
jurisdiction shall not in itself render this Agreement invalid or unenforceable
in another jurisdiction. If any obligation hereunder of either CBV or CENTOCOR
is not performed by such party punctually, the other of CBV or CENTOCOR, as
applicable, will, without demand being made by WELLCOME, immediately perform
such obligation.
2.2. To the extent that BW has an obligation hereunder, either expressly
or by assignment by WELLCOME, WELLCOME hereby guarantees the full payment and
performance of such obligation. Each of WELLCOME and BW shall be fully liable
for performance of their obligations under this Agreement, notwithstanding (a)
the voluntary or involuntary liquidation, dissolution, sale or other disposition
of all or substantially all of the assets, marshalling of assets and
liabilities, receivership, insolvency, bankruptcy, assignment for the benefit of
creditors, reorganization, arrangement, composition with creditors or
readjustment of, or other similar proceedings affecting BW or WELLCOME or any
contest of the validity of this Agreement in any such proceeding; or (b) any Law
or Court Order now or hereafter in effect in any jurisdiction which might in any
manner affect any of such terms or provisions or any of the rights of CENTOCOR
with respect thereto or which might cause or permit BW or WELLCOME to invoke any
defense to, or any alteration in the time, amount or manner of performance of,
any or all of the respective obligations under this Agreement, except to the
extent such Law or Court Order renders such obligations unlawful or to the
extent such Court Order constitutes a remedy for a breach by CENTOCOR or CBV.
The invalidity or unenforceability of this Agreement as to either of WELLCOME or
BW shall not render the respective obligations of the other under this Agreement
invalid or unenforceable. The invalidity or unenforceability of this Agreement
in any jurisdiction shall not in itself render this Agreement invalid or
unenforceable in another jurisdiction. If
-4-
<PAGE>
any obligation hereunder of BW is not performed by it punctually, WELLCOME will,
without demand being made by CENTOCOR, immediately perform such obligation.
3. APPOINTMENT AS DISTRIBUTOR
--------------------------
3.1. CENTOCOR and CBV hereby appoint WELLCOME and its Affiliates as the
exclusive distributor for CENTOCOR and its Affiliates of the 17-1A Product in
the Territory and grant WELLCOME and its Affiliates the exclusive right to
promote, sell, market and distribute the 17-1A Product in the Territory subject
to the terms and conditions herein set forth.
3.2. WELLCOME hereby agrees to act in that capacity subject to the terms
and conditions herein set forth.
3.3. Notwithstanding the foregoing, and to the extent permitted by
applicable Law, if both (a) either (x) the Product Committee determines that it
is inadvisable for WELLCOME or its Affiliates to promote, use, sell, market or
distribute the 17-1A Product in any country in the Territory or (y) WELLCOME or
its Affiliates are prevented by any applicable Law from doing so, and (b)
CENTOCOR'S promotion, use, sale, marketing or distribution in such country does
not adversely affect WELLCOME'S promotion, use, sale, marketing or distribution
in any other country of the Territory, then, for so long as WELLCOME or its
Affiliates do not promote, use, sell, market or distribute the 17-1A Product in
a country described in clause (a) of this Section 3.3, CENTOCOR or its
---------- -----------
authorized agent may promote, use, sell, market or distribute the 17-1A Product
in such country; provided, however, neither CENTOCOR nor its authorized agent
-------- -------
may, without the express written consent of WELLCOME, use either the Panorex
Trademarks or the Wellcome House Marks or otherwise associate WELLCOME with
-5-
<PAGE>
such promotion, use, sale, marketing or distribution of the 17-1A Product.
3.4. To the extent permitted by applicable Law, and except with
WELLCOME'S express written consent to the contrary, if WELLCOME or any of its
Affiliates are no longer prevented by applicable Law from promoting, using,
selling, marketing or distributing the 17-1A Product in a country referenced in
Section 3.3(b) hereof or the Product Committee determines that it is no longer
- --------------
inadvisable for WELLCOME and its Affiliates to engage in promoting, using,
selling, marketing or distributing the 17-1A Product in a country in the
Territory, then WELLCOME may upon at least ninety (90) days' prior notice to
CENTOCOR commence sales of the 17-1A Product in such country. Immediately upon
WELLCOME'S commencing sales in such country, CENTOCOR shall cease all of its
efforts in such country with respect to the 17-1A Product, except that CENTOCOR
and its authorized agent may fulfill any outstanding orders then existing with
respect to such country.
3.5. Subject to the provisions with respect to early termination set
forth in Sections 26 and 27 hereof, this Agreement shall commence on the date
------------------
hereof and shall continue in full force and effect with respect to each country
in the Territory for a period of fifteen (15) years from First Commercial Sale
in such country. During the period commencing one (1) year prior to the
expiration of the aforementioned fifteen (15) year period with respect to any
country in the Territory (a "Country Expiration Date"), CENTOCOR and WELLCOME
-----------------------
shall negotiate in good faith with respect to the renewal of this Agreement with
respect to such country on terms and conditions mutually acceptable to the
parties; provided, however, nothing contained herein shall obligate either
-------- -------
CENTOCOR or WELLCOME to renew this Agreement. Prior to the date which is six
(6) months
-6-
<PAGE>
prior to a Country Expiration Date, neither CENTOCOR nor CBV, nor any of their
respective officers, directors, employees, shareholders, agents or Affiliates
shall solicit, initiate, furnish information relating to or participate in
negotiations with any Third Party with respect to the promotion, use, sale,
marketing, distribution or supply of the 17-1A Product or of any pharmaceutical
product containing the 17-1A Antibody with respect to the applicable country in
the Territory. Following the date which is six (6) months prior to a Country
Expiration Date, CENTOCOR shall have the right to negotiate with Third Parties
with respect to rights in the applicable country to promote, use, sell, market
and distribute the 17-1A Product.
3.6. If the parties hereto fail to renew this Agreement with respect to a
given country in the Territory as provided in Section 3.5 hereof, whether for
-----------
any reason or for no reason, then CENTOCOR shall pay to WELLCOME, in cash, with
respect to such country for which this Agreement was not renewed, a Termination
Fee. A "Termination Fee," with respect to a country, means an amount equal to
( ** )
-7-
<PAGE>
3.7. To assure appropriately the rights hereby granted to WELLCOME and
except to the extent required by applicable Law, during the term of this
Agreement, neither CENTOCOR nor its Affiliates shall (a) release or deliver, or
authorize the release or delivery of, or otherwise transfer or assign its rights
in, the Wistar Hybridoma, the Centocor Hybridoma or any cell line producing the
17-1A Antibody or a Derivative 17-1A Antibody to any Third Party; (b) grant any
rights to manufacture, have manufactured or sell, including the right to sell
for resale, any products incorporating the 17-1A Antibody or any Derivative
17-1A Antibody; or (c) assign or transfer the Centocor Technology or otherwise
grant to Third Parties the right to use the Centocor Technology to develop,
make, have made, use, market, promote or sell 17-1A Product or Derivative 17-1A
Product other than such rights as are granted to WELLCOME, as have been
previously granted to Ajinomoto or as are granted to another Permitted
Distributor in accordance with this Agreement. Nothing in this Section 3.7
-----------
shall limit the ability of CENTOCOR and CBV to assign their rights and delegate
their duties as provided in Section 25 hereof.
----------
3.8. If CENTOCOR or any of its Affiliates enters into an agreement with
another distributor with respect to 17-1A Product at any time at which pursuant
to this Agreement WELLCOME or any of its Affiliates is the exclusive distributor
of 17-1A Product in any country in the Territory, then CENTOCOR or its
Affiliates, as applicable, shall agree with such other distributor, to the
extent permitted by applicable Law, that (a) with respect to selling into any
country in which WELLCOME or any of its Affiliates is exclusive distributor,
such other distributor shall refrain, with respect to 17-1A Product, from
seeking customers, from establishing any branch, and from maintaining any
distribution depot, and (b) with respect to selling in any
-8-
<PAGE>
country in which WELLCOME or any of its Affiliates is exclusive distributor,
other than a member of the European Economic Community or such other country
that by applicable Law prohibits the restriction contained in this clause (b),
----------
such other distributor shall refrain from directly or indirectly selling 17-1A
Product.
4. OPTION FOR JAPAN, REPUBLIC OF KOREA, PEOPLE'S REPUBLIC OF CHINA AND TAIWAN
--------------------------------------------------------------------------
4.1. If at any time CENTOCOR shall terminate Ajinomoto as CENTOCOR'S
distributor of 17-1A Product in any country in the Ajinomoto Territory, or
modify the Ajinomoto Agreement so as to permit CENTOCOR to appoint another
distributor for the 17-1A Product on a non-exclusive basis for any country in
the Ajinomoto Territory or to appoint an exclusive distributor of the 17-1A
Product for a portion of such country, or the Ajinomoto Agreement shall expire
by its terms, CENTOCOR shall promptly give WELLCOME written notice of such
termination, modification or expiration. Thereupon, at WELLCOME'S exclusive
option to be exercised by written notice to CENTOCOR not later than ninety (90)
days after WELLCOME'S receipt of CENTOCOR'S notice, CENTOCOR and WELLCOME shall
negotiate in good faith the terms and conditions of a clinical and regulatory
development agreement and a supply, distribution and sale agreement for the
country or portion of a country with respect to which Ajinomoto's rights are no
longer exclusive (the "Former Ajinomoto Territory"). It is the intent of the
--------------------------
parties that such supply, distribution and sale agreement be on terms and
conditions similar to this Agreement, subject to such modifications as may be
necessary to reflect the special circumstances of the applicable country in the
Former Ajinomoto Territory and any subsisting or remaining rights of Ajinomoto
and further subject to the intent of the parties that the relative economic
benefits of the parties as a whole with respect to the
-9-
<PAGE>
Former Ajinomoto Territory be substantially equivalent to the relative economic
benefits of the parties as a whole with respect to the Territory. If WELLCOME
and CENTOCOR are unable to come to agreement within (**)
following WELLCOME'S exercise of the option to negotiate, unless such
period shall be extended by mutual consent of the parties hereto, then CENTOCOR
shall have the right to negotiate with Third Parties with respect to rights in
the applicable Former Ajinomoto Territory to promote, use, sell, market and
distribute the 17-1A Product, subject to the further provisions of this Section
-------
4.1. If CENTOCOR shall reach agreement in principle with any such Third Party as
- ---
to rights in the applicable Former Ajinomoto Territory, CENTOCOR shall first
offer such rights on the same terms and conditions to WELLCOME, and WELLCOME
shall have thirty (30) days to accept or reject such terms and conditions. If
within such period WELLCOME rejects such terms and conditions or fails to accept
such terms and conditions, then, for a period of one hundred eighty (180) days
from the earlier of WELLCOME'S rejection or the end of such period, CENTOCOR may
enter into an agreement on such terms and conditions with the applicable Third
Party.
4.2. Any distribution rights obtained pursuant to this Section 4 with
---------
respect to all or a portion of a country shall be for a period of fifteen (15)
years from the First Commercial Sale by WELLCOME or its Affiliates under such
distribution rights in such portion or all of the applicable country in the
Former Ajinomoto Territory.
5. PURCHASE AND SUPPLY OBLIGATIONS
-------------------------------
5.1. CENTOCOR shall supply WELLCOME with, and WELLCOME shall purchase
from CENTOCOR, the requirements of WELLCOME and its Affiliates of Salable 17-1A
Product for resale in each
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<PAGE>
country in the Territory for which Regulatory Approval has been issued, all in
accordance with the terms and conditions herein contained. All such Salable
17-1A Product shall meet applicable 17-1A Product Specification.
5.2. Pre Formulated Bulk Antibody shall be supplied only to the
Greenville Facility and only for purposes of Filling and Capping with the
resulting Final 17-1A Product being resold in (**) ; provided, however, in
-------- -------
the event that by reason of Force Majeure the Leiden Facility delivers
Inadequate Supplies of Final 17-1A Product for the Territory other than (**)
or in the event of mutual consent of the parties hereto, WELLCOME may
sell Final 17-1A Product that resulted from Filling and Capping at the
Greenville Facility in the Territory outside North America. "Force Majeure"
-------------
means a cause beyond the reasonable control and without the fault or negligence
of the applicable party, including, without limitation, act of God; Law; war;
insurrection or civil commotion; destruction of production facilities or
materials by earthquake, fire, flood or storm; labor disturbance; epidemic; or
failure of suppliers; public utilities or common carrier. "Inadequate Supplies"
-------------------
of Final 17-1A Product means Final 17-1A Product delivered by CENTOCOR such
that, in any (**) months, CENTOCOR has delivered in at least (**) of
those months less than (**) of the Final 17-1A Product it
is required to deliver in those months pursuant to Section 6.6 hereof (including
-----------
amounts which were required to be delivered in prior months pursuant to Section
-------
6.6 hereof and were not delivered). Nothing in this Section 5.2 releases
- --- -----------
CENTOCOR from its obligations to supply Salable 17-1A Product under Section 6.6
-----------
hereof.
5.3. All Firm Orders placed by WELLCOME for the supply of the Final 17-1A
Product and Pre Formulated Bulk Antibody shall be deemed to incorporate
Wellcome's Standard Terms and Conditions of
-11-
<PAGE>
Purchase in force at that time (copies of the current versions of which are
annexed hereto as Schedule 5.3 hereof) insofar as such terms and conditions are
------------
not varied by or inconsistent with this Agreement. In the event of
inconsistencies between the terms of this Agreement and Wellcome's Standard
Terms and Conditions of Purchase, the terms of this Agreement shall prevail.
5.4. WELLCOME shall from time to time place Firm Orders for the Salable
17-1A Product with CENTOCOR as provided in Section 6 hereof.
---------
5.5. CENTOCOR shall supply WELLCOME, at WELLCOME'S option, at any time
during the term of this Agreement, up to (**) stock of Final
17-1A Product and/or Pre Formulated Bulk Antibody based on the most recent
Requirements Forecasts as defined below and Launch Forecasts as defined below,
together with relevant material safety data sheets and instructions and all
relevant and necessary storage information.
5.6. In the event that WELLCOME elects to exercise its option under the
provisions of Section 5.5 hereof, WELLCOME shall inform CENTOCOR of its decision
-----------
in writing. CENTOCOR shall be obliged to provide the stock of Final 17-1A
Product and Pre Formulated Bulk Antibody, as applicable, within (**)
of receiving WELLCOME'S request for the same.
6. FORECAST - ORDER AND DELIVERY PROCEDURES
----------------------------------------
6.1. WELLCOME shall provide to CENTOCOR not later than thirty (30) days
prior to the commencement of each Quarter (such Quarter, the "Initial Quarter"
---------------
and the immediately succeeding quarter, the "Second Quarter") a forecast of
--------------
WELLCOME'S requirements for Salable 17-1A Product for each of the Initial
Quarter and the immediately succeeding three (3) quarters (a
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<PAGE>
"Requirements Forecast"). The Initial Quarter and Second Quarter forecasts
---------------------
shall not include requirements for any Launch Country. A "Launch Country" means
--------------
any country in the Territory until Launch has occurred in such country and
WELLCOME has notified CENTOCOR that such country is no longer to be treated as a
Launch Country.
6.1.1. Each Requirements Forecast shall differentiate between
requirements for Final 17-1A Product and Pre Formulated Bulk Antibody with
differentiation among the countries for which the Final 17-1A Product is to be
labeled and packaged. With respect to Pre Formulated Bulk Antibody, such
Requirements Forecasts, Launch Forecasts (as described below) and Firm Orders
shall specify the bulk vial equivalent to be delivered rather than the actual
quantity of Pre Formulated Bulk Antibody. In calculating such actual quantity,
Centocor shall take into account process yield as determined by the Product
Committee and batch specific and any other factors that would influence yield.
6.1.2. The quantity forecast for each of Final 17-1A Product and
Pre Formulated Bulk Antibody for the Initial Quarter in each Requirements
Forecast other than the first Requirements Forecast under this Section 6.1 shall
-----------
not be more than (**) above or below such quantity forecast for
the Second Quarter in the immediately preceding Requirements Forecast. Such
limits on variations in quantities of Final 17-1A Product shall not limit the
right of WELLCOME to vary its Firm Orders with respect to the countries for
which such quantities are to be labeled and packaged. There shall be no
restriction on the quantities shown in the forecasts for the Second Quarter and
subsequent quarters in each Requirements Forecast.
-13-
<PAGE>
6.2. When the Product Committee identifies a potential Launch in a
country in the Territory, but not earlier than one (1) year and not later than
six (6) months prior to such date, WELLCOME will begin providing to CENTOCOR
forecasts of WELLCOME'S requirements of 17-1A Product in such country (a "Launch
------
Forecast") for the twelve (12) month period beginning on the Launch and shall
- --------
continue such forecasts until the applicable country ceases to be a Launch
Country. The Launch Forecast shall be updated from time to time as WELLCOME
shall desire or the Product Committee shall request.
6.3. The Requirements Forecasts and Launch Forecasts shall not constitute
Firm Orders. To constitute a Firm Order, an order must be submitted in writing
on the Purchase Order form, be labeled as a Firm Order by WELLCOME or its
Affiliate, as applicable, and shall specify all necessary or appropriate
instructions with regard to the labeling and destination of the Final 17-1A
Product or Pre Formulated Bulk Antibody, as applicable.
6.4. WELLCOME shall submit Firm Orders for Salable 17-1A Product for
delivery during a Quarter equal to the quantities (but not necessarily for the
countries) forecast for such Quarter in the Requirements Forecast which reflects
such Quarter as the Initial Quarter.
6.5. With respect to a Launch Country, WELLCOME shall upon receipt of all
Regulatory Approvals with respect to such country, submit Firm Orders for
delivery in a Quarter of the lesser of the amounts set forth in the then most
recent Launch Forecast for such Quarter (pro rated if Regulatory Approval comes
after the beginning of such Quarter) or as agreed by the Product Committee. Once
a Launch Country is included in the forecast for the Initial
-14-
<PAGE>
Quarter of a Requirements Forecast, WELLCOME shall not be required to place Firm
Orders under this Section 6.5.
------------
6.6. CENTOCOR shall fulfill each Firm Order submitted pursuant to
Sections 6.4 or 6.5 hereof for Final 17-1A Product and Pre Formulated Bulk
- -------------------
Antibody specified in such Firm Order. Salable 17-1A Product ordered pursuant to
Section 6.4 hereof shall be delivered within four (4) weeks of CENTOCOR'S
- -----------
receipt of the applicable Firm Order. Salable 17-1A Product ordered pursuant to
Section 6.5 hereof shall be delivered within a period selected by the Product
- -----------
Committee but in no event later than ninety (90) days after CENTOCOR'S receipt
of the applicable Firm Order. Upon delivery to WELLCOME, all Final 17-1A
Product shall have at least (**) of its shelf life
remaining and Pre Formulated Bulk Antibody shall have such shelf life that upon
Filling and Capping, the shelf life remaining shall be (**)
for Final 17-1A Product. At CENTOCOR'S request, WELLCOME will accept Final
17-1A Product with a shelf life less than (**) , but in the
event such Final 17-1A Product is not sold due to the limited shelf life
remaining, CENTOCOR will refund the payment made by WELLCOME to CENTOCOR for
such stock.
6.7. CENTOCOR and CBV shall use commercially reasonable efforts to supply
to WELLCOME any requirements of WELLCOME in excess of those required to be
delivered under Section 6.6 hereof.
-----------
6.8. If there is a shortfall or anticipated shortage of Final 17-1A
Product and/or Pre Formulated Bulk Antibody and/or any other essential materials
used in the production of 17-1A Product and/or any delay in shipment or delivery
occasioned by CENTOCOR or its Affiliates, CENTOCOR hereby undertakes and agrees
(a) immediately to notify WELLCOME and its Affiliates as
-15-
<PAGE>
to the reason for the shortage of supply and to provide an indication of the
duration of the delay and (b) to use its best efforts to allocate to WELLCOME as
much Final 17-1A Product and Pre Formulated Bulk Antibody as is available as a
matter of priority in accordance with WELLCOME'S estimated requirements and Firm
Order(s) made under the terms hereof. CENTOCOR shall not grant an equal or
higher priority to any Third Party than to WELLCOME and its Affiliates with
respect to shipment of products from the Leiden Facility, except as may exist on
the date hereof. Nothing in this Section 6.8 releases CENTOCOR from its
-----------
obligations to supply Salable 17-1A Product under Section 6.6 hereof.
-----------
6.9. CENTOCOR shall use best efforts to make up all shortfalls in
delivery in accordance with a Firm Order as promptly as possible and shall
promptly supply Final 17-1A Product and Pre Formulated Bulk Antibody to WELLCOME
to meet such Firm Order.
6.10. WELLCOME shall in its forecasting and ordering maintain inventories
of Salable 17-1A Product in accordance with inventory management systems it uses
for other products of similar status and exposure in the marketplace.
7. PAYMENT TERMS FOR 17-1A PRODUCT
-------------------------------
7.1. PURCHASE PRICE
--------------
7.1.1. For all Final 17-1A Product delivered by CENTOCOR to
WELLCOME, WELLCOME shall pay as the Purchase Price to CENTOCOR:
(a) (**) of Net Sales by WELLCOME and its Affiliates
of such Final 17-1A Product on the
-16-
<PAGE>
(**) of Net Sales of such
Final 17-1A Product;
(b) (**) of Net Sales by WELLCOME and
its Affiliates of such Final 17-1A Product on the (**)
of Net Sales of such Final 17-1A Product; and
(c) (**) of Net Sales by WELLCOME and
its Affiliates of such Final 17-1A Product on Net Sales thereafter for the term
of this Agreement.
The appropriate Purchase Price level shall be measured from the date of First
Commercial Sale in the Territory, based on total Net Sales made in the initial
term and any renewal term of this Agreement.
7.1.2. For all Pre Formulated Bulk Antibody supplied to the
Greenville Facility, WELLCOME shall pay as the Purchase Price to CENTOCOR
(**) of Net Sales
by WELLCOME and its Affiliates of Final 17-1A Product resulting from the Filling
and Capping of such Pre Formulated Bulk Antibody.
7.1.3. Notwithstanding Section 7.1.2 hereof, if any Pre Formulated
-------------
Bulk Antibody supplied to the Greenville Facility shall be rendered unsalable by
reason of a failure of Filling and Capping, or if any such Pre Formulated Bulk
Antibody shall be deemed to be Unnecessary Waste, the Purchase Price thereof
shall be the lesser of the (**)
CENTOCOR'S cost shall mean direct labor, direct materials, variable burden and
fixed burden allocated to Pre Formulated Bulk
-17-
<PAGE>
Antibody. "Unnecessary Waste" means the difference between the yield of Final
-----------------
17-1A Product from Pre Formulated Bulk Antibody actually achieved in Filling and
Capping at the Greenville Facility and the feasible yield as determined by the
Product Committee. The Product Committee shall determine such feasible yield
taking into account actual yields at the Leiden Facility, special circumstances
at the Greenville Facility (including the length of time it has been conducting
Filling and Capping and variations in equipment) and the composition of specific
shipment of Pre Formulated Bulk Antibody.
7.1.4. (**)
Nothing in this Section 7.1.4 or in any negotiations or agreements entered into
-------------
pursuant to this Section 7.1.4 shall limit the indemnification obligations of
-------------
CENTOCOR and CBV under Section 22.1 hereof.
------------
-18-
<PAGE>
7.1.5. If the Centocor Hybridoma or the Wistar Hybridoma enters,
or is established already to be in, the public domain, in the Territory and, as
a result, a 17-1A Product or Derivative 17-1A Product competitive with the 17-1A
Product is marketed, sold or distributed hereunder by a Third Party in the
Territory, then the percentage applied to Net Sales under Sections 7.1.1 and
------------------
7.1.2 hereof shall be adjusted by multiplying such percentage by (**) .
- -----
7.2. INTERIM PAYMENTS
----------------
7.2.1. As further set forth in this Section 7.2, initial payments
-----------
will be made based on estimates of the Purchase Price ("Final 17-1A Product
-------------------
Interim Prices" and "Pre Formulated Bulk Antibody Interim Prices,"
- -------------- -------------------------------------------
respectively).
7.2.2. As interim payment of the Purchase Price, WELLCOME and its
Affiliates will pay the then current Final 17-1A Product Interim Price within
(**) after WELLCOME'S receipt of the invoice for Final 17-1A Product and
the then current Pre Formulated Bulk Antibody Interim Price within (**)
after WELLCOME'S receipt of the invoice for Pre Formulated Bulk Antibody shipped
pursuant to a Firm Order, provided that such Final 17-1A Product or Pre
Formulated Antibody has met the standards set forth in Section 21.4 hereof, and
------------
provided further that from and after payment of the Purchase Price for Final
17-1A Product delivered by CENTOCOR in an aggregate of (**) , payments
of the Final 17-1A Product Interim Price shall be due within (**) after
WELLCOME'S receipt of invoice. If the days outstanding for WELLCOME'S average
trade receivables (exclusive of bad debts) in the Territory on sales of Final
17-1A Product shipped as such by CENTOCOR at any time exceed (**) , then
the payment terms from WELLCOME to CENTOCOR
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<PAGE>
with respect to Final 17-1A Product shipped by CENTOCOR shall be adjusted by
adding to such terms (**) of the excess of the number of days such
average trade receivables are outstanding over (**) .
7.2.3. Based on WELLCOME'S proposed gross selling price and its
reasonable estimates of items that will be deducted therefrom to determine Net
Sales, WELLCOME will notify CENTOCOR of an initial Pre Formulated Bulk Antibody
Interim Price and an initial Final 17-1A Product Interim Price.
7.2.4. The initial Pre Formulated Bulk Antibody Interim Price
shall be based on an estimate of the
(**)
such estimate approved by the Product Committee.
7.2.5. The Final 17-1A Product Interim Price and the Pre
Formulated Bulk Antibody Interim Price (collectively, the "Interim Prices")
--------------
(**) as directed by the Product Committee
(**) .
7.3. ADJUSTMENTS TO PURCHASE PRICE
-----------------------------
7.3.1. On a basis not more frequently than monthly or less
frequently than quarterly, WELLCOME shall submit to CENTOCOR itemized
adjustments to the Purchase Price based on the deductions from gross sales price
that constitute adjustments to Net Sales and on variations in its actual gross
sales prices.
7.3.2. If WELLCOME holds for CENTOCOR pursuant to Section 8.6
-----------
hereof any inventory of 17-1A Product that is rendered unsalable by expiration
of its shelf life, a change in any Regulatory Approvals or recalls, market
withdrawals or
-20-
<PAGE>
corrections (except to the extent such recalls, market withdrawals or
corrections have been (a) solely the result of WELLCOME'S Filling and Capping at
the Greenville Facility but only other than in compliance with the 17-1A Product
Specification or such other written specifications as are issued by the Product
Committee or the CGMP Regulations, or (b) solely the result of WELLCOME'S
storage, physical handling or distribution of 17-1A Product but only other than
in compliance with the 17-1A Product Specification or CGMP Regulations), then
the Net Sales of such inventory shall be deemed (**) . The allocation of
costs other than payment of the Purchase Price with respect to 17-1A Product
that is subject to recalls, market withdrawals or corrections shall be governed
by Section 20.5 hereof.
------------
7.3.3. If any inventory of 17-1A Product is rendered unsalable by
reason of any casualty or event or circumstance for which an adjustment is not
made by reason of Sections 7.3.1 or 7.3.2 hereof, the Net Sales of such
-----------------------
inventory shall be deemed (**), provided that WELLCOME shall pay to CENTOCOR
for such inventory the lesser of
(**)
CENTOCOR'S cost shall mean direct labor, direct materials, variable
burden and fixed burden allocated to Final 17-1A Product or Pre Formulated Bulk
Antibody, as applicable.
7.3.4. If such adjustments result in reductions of the Purchase
Price from the applicable Interim Price, WELLCOME may apply such adjustments as
a credit against subsequent invoices. If such adjustments result in additional
amounts owing
-21-
<PAGE>
to CENTOCOR, WELLCOME shall pay such amounts to CENTOCOR within ten (10) days of
the submission of the applicable adjustment.
7.4. MANNER OF PAYMENT
-----------------
7.4.1. CENTOCOR shall direct all invoices for Salable 17-1A
Product, notwithstanding where delivery actually takes place, to WELLCOME at
Temple Hill, Dartford, Kent, UK for the attention of the accounts department or
such other offices as WELLCOME shall from time to time direct.
7.4.2. Payment of the Purchase Price shall be made by check drawn
(or by such other payment method as the parties may from time to time agree) in
Dollars, Pounds Sterling, Deutschmarks or such other currency as the parties may
mutually agree. Checks (or such other payment) will be delivered to the address
designated by CENTOCOR.
7.4.3. For purposes of making the calculations required to be made
in Dollars hereunder, for purposes of determining Currency Gains or Losses in
connection with the calculation of Net Sales, and for purposes of calculating
other amounts due hereunder, currencies shall be converted on the basis of
exchange rates calculated on WELLCOME'S normal basis taking exchange rates
published in the London Financial Times on the relevant day closest to the end
of the month in which the applicable event occurred.
7.4.4. In the event any tax or withholding is levied by any
foreign taxing authority in connection with the accrual or payment of any of the
Purchase Price, WELLCOME shall have the right to pay such tax or withholding to
the local taxing authorities on behalf of CENTOCOR and to deduct from the
amounts due to CENTOCOR the amounts paid for such taxes or withholding,
-22-
<PAGE>
provided that WELLCOME shall deliver to CENTOCOR evidence of payment. If the
Purchase Price in any country is higher than the maximum permitted by the Laws
of such country, the Purchase Price paid with respect to the Net Sales in such
country shall be reduced to the maximum rate permitted by Law.
7.5. RECORDS, REPORTS, AUDITS
------------------------
7.5.1. WELLCOME and its Affiliates shall maintain records of Net
Sales to enable the amounts due to CENTOCOR hereunder to be determined.
WELLCOME shall provide to CENTOCOR copies of WELLCOME'S monthly unit sales
distribution reports.
7.5.2. At least once each Quarter, WELLCOME shall furnish to
CENTOCOR a written statement for the preceding Quarter specifying:
(a) the quantities of Final 17-1A Product actually sold in
the countries in the Territory, including analysis of the number of units that
were shipped by CENTOCOR as Final 17-1A Product and as Pre Formulated Bulk
Antibody, and
(b) the Net Sales of 17-1A Product units sold in the
countries in the Territory, including analysis of Net Sales of units that were
shipped by CENTOCOR as Final 17-1A Product and as Pre Formulated Bulk Antibody.
7.5.3. CENTOCOR shall have the right upon prior notice to
WELLCOME, not more than once in each WELLCOME fiscal year nor more than once in
respect of any WELLCOME fiscal year, through an independent public accountant
selected by CENTOCOR and acceptable to WELLCOME, which acceptance shall not
unreasonably be refused, to have access during normal business hours to those
records of WELLCOME as may reasonably be necessary to verify the
-23-
<PAGE>
accuracy of the payments of the Purchase Price in respect of any fiscal year
ending not more than eighteen (18) months prior to the date of such notice.
Upon the expiration of eighteen (18) months following the end of any fiscal
year, the calculation of Purchase Price payable with respect to sales during
such fiscal year shall be binding and conclusive upon CENTOCOR, and WELLCOME and
its Affiliates shall be released from any liability or accountability with
respect to the Purchase Price for sales during such fiscal year. If such
independent public accountant's report shows any underpayment of the Purchase
Price, within thirty (30) days after WELLCOME'S receipt of such report, WELLCOME
shall remit or shall cause its Affiliate to remit to CENTOCOR (a) the amount of
such underpayment and (b) if such underpayment exceeds five percent (5%) of the
total Purchase Price owed for the fiscal year then being reviewed, the
reasonable and necessary fees and expenses of such independent accountant
performing the audit. Otherwise such fees and expenses shall be borne by
CENTOCOR. Any overpayment shall be fully creditable against the future Purchase
Price payable in subsequent payment periods.
7.5.4. All written statements provided by WELLCOME hereunder shall
be in the English language.
7.5.5. CENTOCOR agrees that all information which is the subject
matter of this Section 7 and which is subject to review under this Section 7 is
--------- ---------
strictly confidential and that CENTOCOR hereby undertakes and agrees that it
shall retain all such information in the strictest of confidence and shall cause
its accountant to retain all such information in the strictest of confidence.
-24-
<PAGE>
8. DELIVERY TERMS; INSPECTION UPON DELIVERY AND NON-CONFORMING FINAL 17-1A
-----------------------------------------------------------------------
PRODUCT/PRE FORMULATED BULK ANTIBODY
------------------------------------
8.1. CENTOCOR shall arrange for shipment CIF at facilities owned by
WELLCOME or an Affiliate of WELLCOME designated by WELLCOME (which such WELLCOME
facilities shall not exceed one (1) per country) in accordance with INCOTERMS
1990 of Salable 17-1A Product as directed in WELLCOME'S Firm Orders by a carrier
selected by CENTOCOR. WELLCOME shall pay freight and insurance in connection
with such shipment. WELLCOME will at its expense assist CENTOCOR in introducing
CENTOCOR to appropriate freight forwarders and others who will arrange shipments
on behalf of CENTOCOR.
8.2. Title to, and risk of loss of, the Salable 17-1A Product shall
remain with CENTOCOR until delivery to the destination specified in WELLCOME'S
Firm Orders, at which time WELLCOME shall assume title to and risk of loss of
the Salable 17-1A Product. WELLCOME shall promptly provide CENTOCOR with
confirmation of each delivery by telecopy, telex or other mutually acceptable
method.
8.3. Each shipment in addition to the quantities ordered shall include
such samples as may be reasonably necessary for testing for quality assurance
and verification. WELLCOME may, but is not obligated to, as soon as reasonably
practicable, but in any event not later than fifteen (15) Business Days
following receipt, inspect samples of all shipments of the 17-1A Product or Pre
Formulated Bulk Antibody, as the case may be, once received at the destination
specified in WELLCOME'S Firm Order to determine whether or not such shipments
conform with the 17-1A Product Specification.
-25-
<PAGE>
8.4. In the event that any sample of a shipment of the Final 17-1A
Product or Pre Formulated Bulk Antibody, as the case may be, is delivered to
WELLCOME by CENTOCOR hereunder and shall fail to conform with the Final 17-1A
Product Specification, WELLCOME shall notify CENTOCOR within ten (10) days of
WELLCOME'S confirming such nonconformity and shall specify the manner in which
the shipment fails to meet the Final 17-1A Product Specification.
8.5. If WELLCOME gives notice as contemplated by Section 8.4 hereof,
-----------
CENTOCOR shall promptly supply WELLCOME with replacement Final 17-1A Product or
Pre Formulated Bulk Antibody, as applicable. CENTOCOR shall ship to WELLCOME
such replacement Final 17-1A Product within (**) days, and Pre
Formulated Bulk Antibody within (**) days, of receiving notice
under Section 8.4 hereof.
-----------
8.6. WELLCOME shall hold the non-conforming 17-1A Product, together with
any returned, spoiled or out-of-date 17-1A Product, and any 17-1A Product that
is rendered unsalable by any change in Regulatory Approvals or recalls, market
withdrawals or corrections, all for CENTOCOR'S disposal thereof, and CENTOCOR
shall take possession of, and remove from WELLCOME'S facilities, such 17-1A
Product not later than thirty (30) days after receipt of WELLCOME'S notice
contemplated by Section 8.4 hereof or WELLCOME'S notice to CENTOCOR that it has
-----------
returned, spoiled, or out-of-date Final 17-1A Product of which CENTOCOR is to
dispose. CENTOCOR shall, promptly after such removal, dispose of such 17-1A
Product at its expense and in compliance with all Laws, including, but not
limited to, Environmental Laws.
-26-
<PAGE>
9. QUALITY ASSURANCE AND QUALITY CONTROL OF FINAL 17-1A PRODUCT
------------------------------------------------------------
9.1. CENTOCOR shall provide WELLCOME at regular intervals for the term of
this Agreement with all necessary material safety data and information
concerning the safe handling and storage of Salable 17-1A Product known to it
and warrants that at delivery such data and information will be accurate and
up-to-date.
9.2. CENTOCOR warrants that the shipment and transportation of Salable
17-1A Product shall comply with all Laws and relevant international codes and/or
regulations from time to time in force relating to the classification, packaging
and labeling of Salable 17-1A Product.
9.3. In addition to its own routine quality control and other tests
required by applicable Regulatory Authorities, CENTOCOR shall conduct, at
WELLCOME'S expense, such quality control and other tests for the Salable 17-1A
Product as required from time to time by written notice from WELLCOME to
CENTOCOR.
9.4. CENTOCOR shall, at its expense, supply to WELLCOME the protocol of
assay for all the tests performed on batches of Salable 17-1A Product made,
together with samples from each batch and each lot of Salable 17-1A Product.
WELLCOME, at its own expense, shall have the right to assay samples and to
perform such biological tests as WELLCOME deems necessary on samples from any
batch or lot of Salable 17-1A Product produced for WELLCOME hereunder.
9.5. For each batch or lot of Salable 17-1A Product produced for WELLCOME
hereunder, CENTOCOR shall furnish to WELLCOME on or before the date of each
shipment, along with any testing samples that may be requested by WELLCOME for
assay and microbiological testing purposes pursuant to Section 9.4 hereof,
-----------
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<PAGE>
a certificate that the batch or lot of Salable 17-1A Product, as applicable, of
which the submitted samples are representative, was manufactured, tested and
delivered in full compliance with all applicable Laws and a copy of CENTOCOR'S
certificate of analysis that all Salable 17-1A Product included in such shipment
complies in all respects with the applicable 17-1A Product Specification,
showing release of each such batch or lot. CENTOCOR shall be responsible for the
completion of all tests necessary to release Final 17-1A Product, whether
Filling and Capping occurs at the Leiden facility or the Greenville facility,
for sale in each country in the Territory for which Regulatory Approval has been
obtained. Where appropriate, CENTOCOR shall provide the services of a
"qualified person" within the meaning of the 2nd Council Directive of 20th May
1975 on the approximation of provisions laid down by law, regulation or
administrative action relating to proprietary medicinal products 75/319/EEC and
appropriate local legislation enacting such Directive or the equivalent person
under other applicable Law in connection with such release.
9.6. CENTOCOR shall conduct all necessary Stability Studies to validate
the lead times for shipment, the shelf life of inventory and the specifications
for shipping, storing and handling of Salable 17-1A Product.
9.7. Copies of CENTOCOR'S batch and production records as required to be
maintained by FDA and European equivalent regulations and guidelines, including
quality assurance data, pertaining to Final 17-1A Product and Pre Formulated
Bulk Antibody and the environment for the production of Salable 17-1A Product
(as required by FDA regulations and guidelines), shall be furnished to WELLCOME
within five (5) Business Days of the time of shipment of Salable 17-1A Product
hereunder.
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<PAGE>
9.8. In accordance with CENTOCOR'S normal safety and security procedures
in force from time to time and with reasonable advance notice, WELLCOME shall
have the right to send authorized representatives to facilities where Salable
17-1A Product is manufactured during each production run of Salable 17-1A
Product to audit any manufacturing, formulation and testing operations as
WELLCOME deems reasonably appropriate to confirm that production of each batch
of Salable 17-1A Product is in compliance with the CGMP Regulations, and at any
other time upon reasonable advance notice to CENTOCOR. Any such audit shall not
include any information that constitutes manufacturing technology or trade
secrets of CENTOCOR to which WELLCOME is not otherwise entitled. WELLCOME shall
have the right to send authorized representatives to facilities where Salable
17-1A Product is stored to inspect the stock and confirm the method and adequacy
of storage. Upon request of WELLCOME, CENTOCOR agrees to notify WELLCOME of the
next production run of Salable 17-1A Product. CENTOCOR agrees to cooperate with
WELLCOME'S authorized representatives conducting such audits. WELLCOME shall
from time to time identify the persons and timetable for such inspections.
9.9. If WELLCOME is required by a Regulatory Authority or Regulatory
Adjunct in any country of the Territory to have inspected or approved the site
of manufacturing 17-1A Product, CENTOCOR will permit officials of the applicable
Regulatory Authorities or appropriate Regulatory Adjunct to inspect the Leiden
Facility or such other CENTOCOR facility where 17-1A Product is manufactured and
will take all such action as such Regulatory Authorities or Regulatory Adjunct
may require.
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10. CENTOCOR'S AND CBV'S OBLIGATIONS AS MANUFACTURER
------------------------------------------------
10.1. CENTOCOR and CBV shall at all times comply with and shall
manufacture the Salable 17-1A Product in accordance with CGMP Regulations and in
compliance with all applicable Laws, including Environmental Laws.
10.2. CENTOCOR and CBV shall acquire all the necessary plant, equipment,
facilities and sufficiently and appropriately qualified personnel to enable them
to produce and package the Final 17-1A Product in accordance with the 17-1A
Product Specification, including, but not limited to, the provisions of Part III
of the 17-1A Product Specification, and in accordance with any and all relevant
local regulations where appropriate.
10.3. CENTOCOR and CBV undertake that the Leiden Facility and its
manufacturing environment where CENTOCOR and CBV will manufacture the 17-1A
Product and all the procedures used in manufacturing and processing, shall be in
accordance with CGMP Regulations and shall enable CENTOCOR and CBV to maintain
in good standing all applicable Permits.
10.4. CENTOCOR and CBV shall provide suitable storage facilities for the
Salable 17-1A Product.
10.5. CENTOCOR and CBV shall maintain ongoing Stability Studies throughout
the duration of this Agreement using Centocor Methodology and shall provide
WELLCOME with regular samples, specimens and full reports of the results of the
Stability Studies so as to ensure that the Salable 17-1A Product manufactured by
CENTOCOR and CBV is in accordance with the 17-1A Product Specification.
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<PAGE>
10.6. Capacity. CENTOCOR and CBV will at all relevant times own or
--------
lawfully control facilities and Intellectual Property, and have employees with
expertise necessary or appropriate to produce the 17-1A Product pursuant to
Regulatory Approvals in quantities sufficient to fulfill its obligations under
this Agreement without knowingly infringing the rights of any Third Party.
10.7. Manufacturing. CENTOCOR and CBV shall manufacture 17-1A Product in
-------------
accordance with the 17-1A Product Specification and, as manufactured in
accordance with the 17-1A Product Specification, the 17-1A Product will not
violate any applicable Laws including, without limitation, Environmental Laws.
10.8. Wistar License. CENTOCOR and CBV shall at all times during the term
--------------
of this Agreement maintain the Wistar License in full force and effect and pay
all royalties and other amounts due thereunder whether arising by virtue of the
transactions contemplated hereby or otherwise.
11. LICENSE GRANT
-------------
11.1. CENTOCOR and CBV hereby grant to WELLCOME an irrevocable,
non-transferable, non-assignable, royalty-free license freely to use and have
access to the F&C Technical Information with respect to the 17-1A Product.
11.2. CENTOCOR and CBV hereby agree not to grant any Third Party any
rights granted in this Section 11 and shall not transfer or assign such rights
----------
to any Third Party whatsoever except to the extent the F&C Technical Information
has applicability to products other than the 17-1A Product and other 17-1A
Antibodies.
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<PAGE>
12. SUPPLY OF F&C TECHNICAL INFORMATION
-----------------------------------
12.1. At such reasonable time after the date hereof as WELLCOME shall
designate, after consultation with the Product Committee, and from time to time
thereafter throughout the term of this Agreement, CENTOCOR and CBV shall supply
WELLCOME with the F&C Technical Information, including, but not limited to, the
Centocor Methodology, to enable Filling and Capping at the Greenville Facility
in accordance with the F&C Technical Program as amended from time to time by
mutual agreement of the parties hereto.
12.2. In connection with the transfer contemplated by Section 12.1 hereof,
------------
CENTOCOR and CBV will at the request of WELLCOME supply at the Greenville
Facility, the reasonable services of CENTOCOR'S and CBV'S suitable qualified
staff who are experts with hands-on knowledge and experience with Filling and
Capping at the Leiden Facility. Such services shall be without charge and shall
be to provide all necessary or appropriate support and assistance to WELLCOME in
the transfer of the F&C Technical Information, provided that CENTOCOR and CBV
shall be required to provide assistance and services with respect to the
transfer of the F&C Technical Information, including the Centocor Methodology,
to only one site.
12.3. If for any reason WELLCOME becomes, or is unable to complete Filling
and Capping using the Centocor Methodology and the F&C Technical Information or
WELLCOME in its sole discretion decides not to conduct such Filling and Capping
to meet North American demands, then WELLCOME shall be able to purchase Final
17-1A Product from CENTOCOR for North America.
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<PAGE>
12.4. If WELLCOME requires any further additional assistance to transfer
the F&C Technical Information not contemplated in the F&C Technical Program,
CENTOCOR will use all reasonable efforts to provide such assistance in a timely
manner.
13. FILLING AND CAPPING
-------------------
13.1. To the extent that WELLCOME conducts Filling and Capping at the
Greenville Facility, WELLCOME shall:
13.1.1. at all times comply with and shall conduct Filling and
Capping in accordance with CGMP Regulations and in compliance with all
applicable Laws, including Environmental Laws; provided, however, to the extent
-------- -------
that WELLCOME uses Centocor Methodology and such Centocor Methodology is not in
accordance with CGMP Regulations or in compliance with all applicable Laws,
WELLCOME shall have no liability under this Section 13.1.1;
---------------
13.1.2. acquire all the necessary plant, equipment, facilities and
sufficiently and appropriately qualified personnel to enable it to conduct
Filling and Capping, subject to CENTOCOR'S providing all necessary or
appropriate F&C Technical Information, in accordance with the 17-1A Product
Specification, and in accordance with any and all relevant local regulations
where appropriate; and
13.1.3. provide storage facilities for the Salable 17-1A Product in
accordance with the instructions of CENTOCOR.
13.2. To the extent that Filling and Capping is conducted at the
Greenville Facility,
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13.2.1. WELLCOME warrants that the shipment and transportation of
Final 17-1A Product resulting from such Filling and Capping shall comply with
all Laws and relevant international codes and/or regulations from time to time
in force relating to the classification, packaging and labeling of Final 17-1A
Product.
13.2.2. CENTOCOR, at its expense, shall have the right to assay
samples and to perform such biological tests as CENTOCOR deems necessary on
samples from any batch or lot of Final 17-1A Product resulting from Filling and
Capping at the Greenville Facility.
13.2.3. Copies of WELLCOME'S batch and production records as
required to be maintained by FDA and European equivalent regulations and
guidelines, including quality assurance data, pertaining to Salable 17-1A
Product and Pre Formulated Bulk Antibody and the environment for the Filling and
Capping of 17-1A Product (as required by FDA regulations and guidelines), shall
be furnished to CENTOCOR within five (5) Business Days of the time of shipment
of Final 17-1A Product resulting from Filling and Capping at the Greenville
Facility.
13.3. To the extent that Filling and Capping is conducted by WELLCOME,
WELLCOME shall be entitled to send to CBV samples of each lot or batch produced
by WELLCOME for purposes of testing for final release of such batch or lot, and
CENTOCOR and CBV shall at their expense conduct such tests and issue such
certificates of analysis and other relevant documentation as may be necessary or
appropriate to release such batch or lot for sale.
13.4. In accordance with WELLCOME'S normal safety and security procedures
in force from time to time and with
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<PAGE>
reasonable advance notice, CENTOCOR shall have the right to send its authorized
representatives to the Greenville Facility during the occurrence of the Filling
and Capping process with the express and limited purpose of confirming that the
Filling and Capping process is being performed in compliance with the Centocor
Methodology or such other specifications as the Product Committee shall from
time to time approve and in compliance with the CGMP Regulations and all
applicable Laws. Upon request of CENTOCOR, WELLCOME agrees to notify CENTOCOR
of the occurrence of the next Filling and Capping process and to cooperate with
CENTOCOR'S authorized representatives conducting such audits. CENTOCOR shall
from time to time identify the persons and timetable for such inspections.
14. LICENSE AND USE OF TRADEMARKS AND HOUSE MARKS AND INDICIA
---------------------------------------------------------
14.1. CENTOCOR shall grant WELLCOME a license to use the Centocor
Trademarks, and WELLCOME shall use the Centocor Trademarks, upon the terms and
conditions set out in the Trademark Agreement.
14.2. WELLCOME shall grant CENTOCOR a non-exclusive license to use the
Wellcome House Marks and Wellcome Indicia upon the terms and conditions set out
in the Wellcome House Mark License Agreement.
15. INSURANCE
---------
15.1. CENTOCOR hereby agrees to maintain during the term of this Agreement
insurance with reputable and sound independent insurers at commercially
reasonable levels of coverage in relation to the type, scope and size of
business it conducts and to all its obligations herein contained and shall give
WELLCOME an opportunity from time to time to review the insurance policies
-35-
<PAGE>
so that WELLCOME may satisfy itself that such insurance policies are valid, that
the premiums are being paid regularly and that the policies are kept in full
force and effect. CENTOCOR shall, upon WELLCOME'S reasonable request from time
to time, produce evidence that all insurance premiums have been paid and kept up
to date and are kept in accordance with any local insurance laws or regulations
from time to time in force. CENTOCOR will at the request of WELLCOME name
WELLCOME and WELLCOME'S Affiliates as additional insureds as applicable on all
liability insurance policies, including, but not limited to, product liability,
products and clinicians, malicious product tampering and general liability
policies and will obtain for WELLCOME an endorsement that such insurance shall
not be cancelled without thirty (30) days' prior written notice to WELLCOME.
15.2. Prior to manufacturing Salable 17-1A Product for supply to WELLCOME,
CENTOCOR and CBV will increase their products liability coverage from
(**) to (**) or
such other level as the Product Committee may approve. The Product Committee
may determine to phase in the increase in insurance coverage in light of the
introduction of the 17-1A Product and other products of CENTOCOR.
16. MARKETING
---------
WELLCOME shall be responsible for the preparation, compilation and
completion of the Marketing Plan, which shall establish promotional strategy for
the promotion and sale of Final 17-1A Product in the Territory and which
WELLCOME shall update on an annual basis. The complete Marketing Plan shall be
provided from time to time (as appropriate) to the Product Committee for its
review. CENTOCOR, through the Product Committee, shall have the opportunity to
comment upon and provide
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<PAGE>
input with respect to the Marketing Plan. WELLCOME shall, from time to time,
advise the Product Committee on the coordination and implementation of the
Marketing Plan.
17. COUNTRY MARKETING PLANS
-----------------------
17.1. WELLCOME shall be responsible for the preparation, compilation and
completion of the Country Marketing Plans for each country in the Territory
provided that Regulatory Approval is obtained in such country.
17.2. The Country Marketing Plan shall establish the promotional
commercial strategy and tactics for the promotion and sale of Final 17-1A
Product in that country.
17.3. The completed Country Marketing Plan shall be provided from time to
time (as appropriate) to the Product Committee for its review. CENTOCOR,
through the Product Committee, shall have the opportunity to comment upon and
provide input with respect to the Marketing Plan. WELLCOME shall, from time to
time, advise the Product Committee on the coordination and implementation of the
applicable Country Marketing Plan.
18. PROMOTIONAL EFFORTS
-------------------
18.1. WELLCOME shall promote, sell and distribute Final 17-1A Product
using the Panorex Trademarks, the other Centocor Trademarks, Wellcome Indicia
and Wellcome House Marks throughout the term of this Agreement in the Territory
where Regulatory Approval has been obtained by CENTOCOR and where promotion,
sale and distribution in such country in the Territory is contemplated in the
Country Marketing Plans.
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<PAGE>
18.2. WELLCOME shall use the Marketing Plan and the Country Marketing
Plans as the basis for its promotional, sales and distribution efforts.
WELLCOME shall be authorized to vary such Plans from time to time as it deems
appropriate to further the goals of this Agreement, provided that it shall
report such variations to the Product Committee.
18.3. Except to the extent the Product Committee determines otherwise,
WELLCOME shall use the same or similar channels of distribution for the Final
17-1A Product that it uses for its own products of a similar nature. WELLCOME'S
level of effort in promoting Final 17-1A Product shall not be less than the
level of effort which WELLCOME uses for its own products which are of a similar
stature and at a similar stage of introduction into the market.
18.4. Such promotional activities shall be carried out through WELLCOME'S
sales force, which shall receive training and support and have skills and
resources commensurate with those of WELLCOME'S sales force for other products
which are of a similar nature as Final 17-1A Product and through such contract
or other sales force, if any, as WELLCOME may from time to time elect.
19. MARKETING AND PROMOTIONAL MATERIALS
-----------------------------------
19.1. WELLCOME shall have responsibility for the preparation of all
marketing and promotional materials, and, to assure compliance with all
applicable Laws, the License Holder shall have the right to approve, on an
expeditious basis, all such materials.
19.2. CENTOCOR shall have responsibility for filing all Trademark
applications, paying registration and renewal fees and for complying with any
other necessary and relevant formalities
-38-
<PAGE>
of whatever nature for the purposes of ensuring that the Panorex Trademarks and
the other Centocor Trademarks are available for use by WELLCOME and its
Affiliates as contemplated herein.
19.3. WELLCOME shall have responsibility for filing all registrations, for
paying registration and renewal fees and for complying with any other necessary
and relevant formalities of whatever nature for the purposes of ensuring that
the Wellcome House Marks are available for use by CENTOCOR and its Affiliates as
contemplated herein.
19.4. WELLCOME and its Affiliates (where appropriate in the circumstances)
will be presented and described, to the medical and paramedical communities and
to the trade as promoting and selling the Final 17-1A Product, and all written
information (including, but not limited to, journal advertisements, direct mail,
sales pieces and other promotional material) and, to the extent practicable, all
oral information, disseminated or presented, respectively, to such communities
and to the trade regarding the detailing and promoting of the 17-1A Product in
the Territory will state that WELLCOME and its Affiliates are promoting and
selling Final 17-1A Product under the Panorex Trademarks and the other Centocor
Trademarks.
19.5. Subject to the provisions of Section 19.6 hereof, neither WELLCOME
------------
nor CENTOCOR shall distribute or have distributed under any circumstances
whatsoever, any written information regarding the Final 17-1A Product which
bears the Panorex Trademarks or the other Centocor Trademarks, with respect to
WELLCOME, or the name of WELLCOME, Wellcome House Marks or any Wellcome Indicia,
with respect to CENTOCOR, without the prior written approval of the other party.
CENTOCOR'S review and approval shall be for purposes of determining compliance
with applicable Law.
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<PAGE>
19.6. CENTOCOR shall submit to WELLCOME, for approval prior to printing,
proofs of all printed packaging materials and package inserts and where
appropriate, English language translations of the same, and, for approval before
and after printing, proofs and examples of all literature and advertisements
concerning the Final 17-1A Product and, where appropriate, English language
translations of the same. WELLCOME will use reasonable endeavors to notify
CENTOCOR of WELLCOME'S approval or otherwise within thirty (30) days of such
submission. All literature and advertisements concerning the Final 17-1A Product
shall be in compliance with WELLCOME'S Group Approved Circular Text ("GACT") for
----
the Final 17-1A Product concerned, provided WELLCOME has made the GACT
Guidelines for the Final 17-1A Product available to CENTOCOR at appropriate
times.
19.7. CENTOCOR hereby grants WELLCOME a license to use free of charge any
and all materials subject to copyright developed by CENTOCOR or of which it is
the proprietor in connection with the packaging and other printed literature and
promotional material from time to time in connection with the promotion and sale
of the Final 17-1A Product.
19.8. To the extent permitted by any applicable Laws, WELLCOME shall give
the Centocor Trademarks and the Wellcome House Marks equal prominence on the
packaging of the Final 17-1A Product.
20. ADVERSE REACTIONS, AGENCY COMMUNICATIONS AND PRODUCT RECALL
-----------------------------------------------------------
20.1. During the term of this Agreement, each party shall within the time
periods prescribed from time to time by applicable Law, notify the other party
of all information coming
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<PAGE>
into its possession concerning Adverse Reactions (any reports arising therefrom,
the "Adverse Reaction Reports").
------------------------
20.2. The procedures to be followed in the event of an Adverse Reaction
are set out in Schedule 20.2 hereto, as amended from time to time by the Product
-------------
Committee.
20.3. The Product Committee shall determine from time to time which party
shall have responsibility for communications with various government agencies,
provided that the License Holder shall have responsibility for such
communications as are required of such party by virtue of its ownership of the
17-1A Product Permits.
20.4. During the term of this Agreement, each party shall provide the
other with copies of any communications (which are known to the party to exist
and which the party can obtain copies of) with any governmental agency
throughout the world concerning the 17-1A Product, including, but not limited
to, Adverse Reaction Reports, but excluding manufacturing data with respect to
the 17-1A Product that constitute trade secrets to which WELLCOME is not
otherwise entitled.
20.5. WELLCOME and CENTOCOR each shall notify the other promptly if any
batch or lot of Final 17-1A Product is alleged or proven to be the subject of a
recall, market withdrawal or correction, and the parties shall cooperate in the
handling and disposition of such recall, market withdrawal or correction;
provided, however, in the event of a disagreement as to any matters related to
- -------- -------
such recall, market withdrawal or correction, other than the determination of
who shall bear the costs as set forth in the immediately following sentence,
WELLCOME shall have final authority with respect to such matters. CENTOCOR
shall bear the cost of all recalls, market withdrawals or corrections
-41-
<PAGE>
of Final 17-1A Product unless such recall, market withdrawal or correction shall
have been (a) solely the result of WELLCOME'S Filling and Capping at the
Greenville Facility but only other than in compliance with the 17-1A Product
Specification or such other written specifications as are issued by the Product
Committee or the CGMP Regulations, or (b) solely the result of WELLCOME'S
storage, physical handling or distribution of 17-1A Product but only other than
in compliance with the 17-1A Product Specification or CGMP Regulations, in which
case, WELLCOME shall bear the cost of such recall, market withdrawal or
correction.
21. REPRESENTATIONS AND WARRANTIES
------------------------------
21.1. All Parties. WELLCOME and BW jointly and severally hereby represent
-----------
and warrant as to each of WELLCOME and BW; and CENTOCOR and CBV jointly and
severally hereby represent and warrant as to each of CENTOCOR and CBV:
21.1.1. Organization, Standing and Qualification. It is a
----------------------------------------
corporation duly organized, validly existing, and in good standing under the
laws of its jurisdiction of incorporation.
21.1.2. Power and Authority; Enforceability. It has the requisite
-----------------------------------
power and authority (corporate and otherwise) to execute, deliver and perform
this Agreement and to consummate the transactions contemplated hereby. The
execution, delivery and performance by it of this Agreement and the consummation
by it of the transactions contemplated hereby have been duly authorized by all
necessary action (corporate and otherwise) on its part. This Agreement
constitutes its legal, valid and binding obligation, enforceable in accordance
with its terms.
21.1.3. Validity of Contemplated Transactions. The execution,
-------------------------------------
delivery and performance by it of this Agreement and
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<PAGE>
the consummation by it of the transactions contemplated hereby do not (a)
violate or contravene any provision of its charter or bylaws; (b) violate,
breach, be in conflict with, constitute a Default under, cause the acceleration
of any payments pursuant to, or otherwise impair the good standing, validity, or
effectiveness of, any agreement, contract, indenture, lease, license, or
mortgage to which it is a party or by which it or any of its properties or
assets are bound; (c) subject any of its properties or assets to any Lien or to
any indenture, mortgage, contract, commitment, or agreement (other than this
Agreement) to which it is a party or by which it or any of its properties or
assets are bound; (d) violate any provision of any Law, Permit or Court Order
applicable to it or any of its properties or assets; or (e) other than filings
which have already been made, require any Permit or Required Consent of any
Governmental Entity to be obtained by it.
21.1.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to its knowledge, threatened against or related to it, nor any
failure to comply with, violation of or any Default under, any Law, Permit or
Court Order applicable to it, in each case which might have a material adverse
effect on the ability of it to execute, deliver and perform this Agreement or on
the ability of it to consummate the transactions contemplated hereby.
21.2. By CENTOCOR and CBV. CENTOCOR and CBV jointly and severally
-------------------
represent and warrant:
21.2.1. Intellectual Property. To the best of CENTOCOR'S
---------------------
knowledge, CENTOCOR and CBV own, possess or lawfully use pursuant to legal,
valid, binding and enforceable agreements all Intellectual Property necessary or
appropriate in connection with the development, production, testing and sale by
them of the
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<PAGE>
17-1A Product. The inception, development and reduction to practice of any
Intellectual Property in connection with the development, production, testing
and sale by them of the 17-1A Product has not constituted or involved the
misappropriation by CENTOCOR and its Affiliates or, to the best of its
knowledge, by Third Parties, of trade secrets or other rights of any other
Person (including, without limitation, any Governmental Entity). To the best of
CENTOCOR'S knowledge, in connection with the development, production, testing
and sale (including sale for resale) by them of the 17-1A Product, neither
CENTOCOR nor any of its Affiliates (and in connection with their resale of the
17-1A Product, neither WELLCOME nor any of its Affiliates) is or may be
infringing on or otherwise acting adversely to the rights of any Person under or
in respect of any of the Intellectual Property of such Person. To the best of
the knowledge of CENTOCOR and CBV, no Person is or may be infringing on or
otherwise acting adversely to the rights of CENTOCOR or any of its Affiliates
under or in respect of any of the Intellectual Property which is used in
connection with the development, production, testing and sale by them of the
17-1A Product.
21.2.2. Wistar License. CENTOCOR is party to the Wistar License,
--------------
which is valid, binding and enforceable, and, pursuant to such license, CENTOCOR
is the exclusive licensee of the Wistar Rights, has not sublicensed the Wistar
Rights to any Person other than Ajinomoto pursuant to the Ajinomoto Agreement,
and no Person other than CENTOCOR is entitled, either currently or during the
term of this Agreement, to license the Wistar Rights. CENTOCOR holds such
Wistar Rights free and clear of all Liens, claims and other encumbrances,
covenants, conditions or restrictions. There are no licenses, options, rights
of first refusal, conditional sales agreements or other arrangements, whether
oral or written, which affect any portion of or all such
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<PAGE>
Wistar Rights other than the rights granted to Ajinomoto pursuant to the
Ajinomoto Agreement.
21.2.3. Cell Line. The cell line from which CENTOCOR and CBV
---------
obtain the 17-1A Product is the Centocor Hybridoma. To the extent that such
cell line differs from the Wistar Hybridoma, CENTOCOR and CBV own all right,
title and interest in such cell line, free and clear of all Liens, claims and
other encumbrances, conditions, covenants or restrictions.
21.2.4. Conducted Clinical Trials. The Conducted Clinical Trials
-------------------------
were conducted solely and exclusively by those Persons named on Schedule 12.1 to
-------------
the Development Agreement, and CENTOCOR owns all data, information, and results
of the Conducted Clinical Trials free and clear of all Liens, claims and other
encumbrances, conditions, covenants or restrictions except applicable patient
confidentiality rights. There are no licenses, options, rights of first
refusal, conditional sales agreements or other arrangements, whether oral or
written, which affect any portion of or all the data, information, and results
of the Conducted Clinical Trials except publication rights of principal
investigators.
21.2.5. Capacity. CENTOCOR and CBV own or lawfully control
--------
facilities and Intellectual Property, and have employees with expertise,
necessary or appropriate to produce the 17-1A Product in accordance with
anticipated Regulatory Approvals and in quantities sufficient that they
anticipate will be sufficient to fulfill their obligations under this Agreement
without, to the best of CENTOCOR'S and CBV'S knowledge, infringing the rights of
any Third Party.
21.2.6. Veracity of Statements. No representation or warranty by
----------------------
it contained in this Agreement or in any
-45-
<PAGE>
certificate, schedule or other document or instrument furnished to it pursuant
hereto, contains or will contain any untrue statement of a material fact or
omits or will omit to state a material fact necessary to make it not misleading.
21.2.7. Insurance. The July, 1993 Schedule previously delivered to
---------
WELLCOME sets forth a complete and correct list of all policies of insurance
covering any of CENTOCOR and its Affiliates' assets or actions, specifying for
each policy the carrier, risks insured, the amounts of coverage, deductible,
premium rate, expiration date and any pending claims thereunder. All such
policies are outstanding and in full force and effect. Such policies include
without limitation policies covering products liability and recall, natural
disaster, directors and officers liability, clinicians liability, general
liability, automobile liability, workers compensation, employer liability,
fiduciary insurance, special risks, property casualty or loss, and fidelity
insurance.
21.2.8. The limits of CENTOCOR'S directors and officers coverage
is (**) and the limits of its product liability coverage is
(**) . The schedule referred to in Section 21.2.8
--------------
hereof provides a description of all material limitations on such coverages.
21.2.9. Trademark Warranties. CENTOCOR is the unencumbered sole
--------------------
legal and beneficial owner of the Panorex Trademarks and the other Centocor
Trademarks specified on Exhibits 1.2 and 1.3 of the Trademark Agreement and the
--------------------
Panorex Trademarks and the other Centocor Trademarks therein contained are all
readily available for use without restriction by WELLCOME and its Affiliates in
connection with the 17-1A Product under the terms of the Trademark Agreement
except that the "Centocor"
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<PAGE>
Trademark is not registered in Germany; all registration and renewal fees have
been paid on or before the date due therefore, and all other requirements of
whatever nature for the use and protection of the Panorex Trademarks and the
other Centocor Trademarks have been complied with; the Panorex Trademarks and
the other Centocor Trademarks have full force and effect and are not the subject
of and are not vulnerable to any proceedings for cancellation or rectification;
to the best of CENTOCOR'S knowledge there is and has been no infringement
whatsoever of the Panorex Trademarks and the other Centocor Trademarks by any
Third Party and the Panorex Trademarks and the other Centocor Trademarks do not
infringe the rights of any Third Party, whether registered or unregistered; no
license has been granted to any Third Party in any respect whatsoever of the
Panorex Trademarks and the other Centocor Trademarks and there are no
circumstances whatsoever which could entitle a Third Party to call for such a
license.
21.3. Warranties for Provision of CENTOCOR Staff/Employees to Assist in
-----------------------------------------------------------------
Provision of Technical Information and Know-How for Pre Formulated Bulk Antibody
- --------------------------------------------------------------------------------
and Technical Assistance.
- ------------------------
21.3.1. CENTOCOR and CBV hereby warrant that they have available
suitably qualified staff with all necessary or appropriate technical and
scientific expertise and knowledge in the post-purification process of Filling
and Capping as are necessary or appropriate to fulfill CENTOCOR'S obligations
under the F&C Technical Program.
21.3.2. CENTOCOR and CBV hereby warrant that the Centocor
Methodology is up-to-date, accurate and complete and contains all the relevant
information to enable WELLCOME to conduct and complete Filling and Capping.
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21.3.3. CENTOCOR and CBV hereby warrant that all the F&C Technical
Information is in CENTOCOR'S and/or CBV'S possession and control and contains
all the necessary information and know-how relevant and necessary to enable
WELLCOME to replicate the Filling and Capping process at the Greenville Facility
and that the same is free and clear from any and all encumbrances, that no Third
Parties have any prior claims, interests or rights attaching thereto and that
CENTOCOR and CBV are able to make the same freely available throughout the term
of this Agreement without any restrictions on WELLCOME.
21.4. 17-1A PRODUCT WARRANTIES
------------------------
21.4.1. Upon each delivery of Salable 17-1A Product, CENTOCOR shall
be deemed to have warranted that such Salable 17-1A Product:
21.4.1..1is manufactured and labelled in accordance with
all applicable Laws in the Territory;
21.4.1..2meets the 17-1A Product Specification subject to
such variances as may be required by the relevant Regulatory Authorities; and
21.4.1..3is labeled and packaged in accordance with the
labeling and packaging requirements set forth in the 17-1A Product
Specification.
21.4.2. Upon each delivery of Salable 17-1A Product, CENTOCOR shall
be deemed to have warranted that the Final 17-1A Product or Pre Formulated Bulk
Antibody, as applicable, is merchantable, salable pursuant to the applicable
Regulatory Approvals and is not adulterated or misbranded in any way whatsoever,
complies with any and all Laws, including but not
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limited to Environmental Laws and guidelines (whether or not with the force of
law) of applicable Regulatory Authorities or Regulatory Adjuncts, and is
transferred to WELLCOME, free and clear of Liens.
This warranty shall be a continuing warranty and shall be applicable to
all Salable 17-1A Product shipped or delivered by CENTOCOR to WELLCOME or its
Affiliates.
21.5. Survival. The representations and warranties contained herein shall
--------
survive execution and delivery of this Agreement.
22. INDEMNIFICATION
---------------
22.1. Subject to compliance by the applicable Indemnitee as defined below
with its obligations set forth in Sections 22.4 and 22.5 hereof, CENTOCOR and
----------------------
CBV shall defend, indemnify and hold WELLCOME, BW and their respective
Affiliates and the respective directors, officers, employees and agents of
WELLCOME, BW and their respective Affiliates, harmless from and against any and
all Losses arising out of, relating to or resulting from:
22.1.1. any product liability or similar claim relating to or
arising out of the Final 17-1A Product or Pre Formulated Bulk Antibody delivered
by CENTOCOR or its Affiliates to WELLCOME and/or its Affiliates except to the
extent any such claim (a) arises out of WELLCOME'S Filling and Capping at the
Greenville Facility but only other than in compliance with the 17-1A Product
Specification or such other written specifications as are issued by the Product
Committee or the CGMP Regulations, or (b) arises out of WELLCOME'S storage,
physical handling or distribution of 17-1A Product but only other than in
compliance with the 17-1A Product Specification or CGMP Regulations;
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22.1.2. any other claim relating to 17-1A Product to the extent
such Losses are caused by or arise out of the negligence, willful misconduct or
illegal acts of CENTOCOR, any of its Affiliates or any of their respective
directors, officers, employees or agents, including, but not limited to, any
such claim under any Environmental Laws and any claims for personal injury or
property damage;
22.1.3. the breach by CENTOCOR or CBV of any of their respective
representations, warranties and covenants contained within this Agreement;
22.1.4. the infringement of the rights of any Third Party by the
17-1A Product, or the development, manufacture, promotion, marketing,
distribution or sale or use thereof, or of any patent rights registered or at
application stage, Copyright, trademarks applied to Final 17-1A Product, trade
secrets, registered design rights, know-how or any other intellectual property
rights which are capable of subsisting, which apply to the 17-1A Product; and
22.1.5. any other claim, based on strict liability, relating to the
manufacturing, processing, distribution or other handling of the 17-1A Product
and associated by-products, returned products, wastes, or emissions including,
but not limited to, any such claim under any Environmental Laws and any claims
for personal injury or property damage, except any claim (a) arising out of
WELLCOME'S Filling and Capping at the Greenville Facility but only other than in
compliance with the 17-1A Product Specification or such other written
specifications as are issued by the Product Committee or the CGMP Regulations,
or (b) arising out of WELLCOME'S storage, physical handling or
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distribution of 17-1A Product but only other than in compliance with the 17-1A
Product Specification or CGMP Regulations.
22.2. Subject to compliance by the applicable Indemnitee as defined below
with its obligations set forth in Sections 22.4 and 22.5 hereof, WELLCOME and BW
----------------------
shall defend, indemnify and hold CENTOCOR, CBV and CENTOCOR'S Affiliates and
the respective directors, officers, employees and agents of CENTOCOR, CBV and
CENTOCOR'S Affiliates, harmless from and against any and all Losses arising out
of, relating to or resulting from:
22.2.1. any product liability or similar claim relating to or
arising out of the Final 17-1A Product that (a) is the result of WELLCOME'S
Filling and Capping at the Greenville Facility but only other than in compliance
with the 17-1A Product Specification or such other written specifications as are
issued by the Product Committee, or (b) is the result of WELLCOME'S storage,
physical handling or distribution of 17-1A Product but only other than in
compliance with the 17-1A Product Specification or CGMP Regulations;
22.2.2. the breach by WELLCOME or BW of any of their respective
representations, warranties and covenants contained in this Agreement;
22.2.3. any other claim relating to 17-1A Product to the extent
such Losses are caused by or arise out of the negligence, willful misconduct or
illegal acts of WELLCOME, BW, any of their respective Affiliates or any of their
respective directors, officers, employees or agents, including, but not limited
to, any such claim under any Environmental Laws and any claims for personal
injury or property damage; and
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22.2.4. any other claim, based on strict liability, relating to the
manufacturing, processing, distribution or other handling of the 17-1A Product
and associated by-products, returned products, wastes, or emissions including,
but not limited to, any such claim under any Environmental Laws and any claims
for personal injury or property damage, solely to the extent such claim (a)
arises out of WELLCOME'S Filling and Capping at the Greenville Facility but only
other than in compliance with the 17-1A Product Specification or such other
written specifications as are issued by the Product Committee or the CGMP
Regulations, or (b) arises out of WELLCOME'S storage, physical handling or
distribution of 17-1A Product but only other than in compliance with the 17-1A
Product Specification or CGMP Regulations.
22.3. An "Indemnitor" means CENTOCOR and CBV with respect to Section 22.1
---------- ------------
hereof and WELLCOME and BW with respect to Section 22.2 hereof. "Indemnitee"
------------ ----------
means any of WELLCOME, BW and their respective Affiliates and the respective
directors, officers, employees and agents of WELLCOME, BW and their respective
Affiliates with respect to Section 22.1 hereof and any of CENTOCOR, CBV and
------------
CENTOCOR'S Affiliates and the respective directors, officers, employees and
agents of CENTOCOR, CBV and CENTOCOR'S Affiliates with respect to Section 22.2
------------
hereof.
22.4. Notice. Promptly after receipt by an Indemnitee of written notice
------
of the commencement of any suit, audit, demand, judgment, action, investigation
or proceeding relating to a Loss (a "Third Party Action") or promptly after an
------------------
Indemnitee incurs a Loss or has knowledge of the existence of a Loss, such
Indemnitee will, if a claim with respect thereto is to be made against
Indemnitor due to Indemnitor's obligation to provide indemnification hereunder,
give Indemnitor written notice of such Loss or the commencement of such Third
Party Action; provided,
--------
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however, the failure to provide such notice within a reasonable period of time
- -------
shall not relieve Indemnitor of any of its obligations hereunder except to the
extent it is prejudiced by such failure.
22.5. Defense. The Indemnitor shall control the defense and settlement of
-------
a Third Party Action, except that the applicable Indemnitee may assume such
defense provided that the obligation of the Indemnitor to pay the attorneys'
fees of such Indemnitee shall cease upon such election. If the Indemnitor
defends such action, it shall not enter into any resolution or other compromise
of such action unless it (a) pays in cash or posts an adequate bond for the
payment of the amount of such resolution or other compromise and obtains a
complete release of the Indemnitee or (b) obtains the prior written consent of
the Indemnitee, which shall not be unreasonably withheld or delayed. If the
Indemnitee defends such action, such Indemnitee shall not enter into any
resolution or other compromise of such action unless such Indemnitee obtains the
consent of the Indemnitor, which shall not be unreasonably withheld or delayed.
The party defending the action shall keep the other parties informed on an
ongoing basis of the status of such Third Party Action and shall deliver to such
other parties copies of all documents relating to the Third Party Action as the
other parties may reasonably request. The party assuming such defense shall
receive from the others all necessary and reasonable cooperation in the defense
of a Third Party Action including, but not limited to, the services of employees
of such other parties who are familiar with the events or circumstances out of
which any such Third Party Action may have arisen.
22.6. The indemnifications contained in this Section 22 shall survive
----------
expiration or termination of this Agreement.
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23. NON COMPETE
-----------
23.1. During the period from the date hereof through the date which is
(**)
, neither WELLCOME nor its Affiliates shall
(**)
;
except that WELLCOME and its Affiliates may (**)
the 17-1A Product and any one (1) or more of the Cancer Products
(the "Excluded Products") and except as contemplated by Section 23.2 hereof.
-------- -------- ------------
23.2. If WELLCOME during the period referred to in Section 23.1 above
------------
(**) other than an Excluded Product, then
CENTOCOR may, by giving notice not later than
(**) by WELLCOME in such
country,
(**)
23.3.
(**)
23.4.
(**)
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<PAGE>
24. THIRD PARTY INFRINGEMENT
------------------------
24.1. "Infringement" for purposes of this Section 24 means any
------------ ----------
infringement or misappropriation by a Third Party of the Wistar Rights or any
Intellectual Property relating to or arising out of the Centocor Hybridoma or
the Wistar Hybridoma, but does not include infringement or misappropriation of
Trademarks other than the Panorex Trademarks and the other Centocor Trademarks.
24.2. In the event that any party hereto obtains knowledge of any
Infringement, such party shall inform the other parties promptly of such
Infringement and provide the other parties with any available evidence of such
Infringement.
24.3. CENTOCOR, at its own cost and expense, shall have the right but not
the obligation to prosecute any claim of Infringement. Where reasonably
necessary, WELLCOME shall, at its own expense, provide reasonable assistance to
CENTOCOR in the litigation of any such claim, including, without limitation,
permitting the use of its name in all suits and signing all necessary documents
if appropriate to the situation, and CENTOCOR shall keep WELLCOME informed of
the progress of such suits. WELLCOME may also, in its sole discretion, provide
CENTOCOR with written comments, recommendations and other information regarding
the prosecution of any claim of Infringement. If CENTOCOR does
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not commence action against an infringer within ninety (90) days after learning
of the Infringement, WELLCOME may commence action against the infringer.
24.4. Any recovery in any action brought in accordance with Section 24.3
------------
hereof shall be applied first to reimburse the party bringing the action for the
costs and expenses (including reasonable attorneys' fees) reasonably incurred by
such party in the course of such prosecution and then to reimburse the other
party for the costs and expenses (including reasonable attorneys' fees) incurred
by such party in the course of assisting such prosecution. The remainder of any
such recovery after reimbursement of such costs shall be (a) retained by
WELLCOME, in the case of WELLCOME bringing the action; or (b) divided equally
between WELLCOME and CENTOCOR, in the case of CENTOCOR bringing the action.
24.5. WELLCOME, at its own cost and expense, shall prosecute any claim of
infringement or misappropriation by a Third Party of the Wellcome Indicia.
Where reasonably necessary, CENTOCOR and CBV shall, at their own expense,
provide reasonable assistance to WELLCOME in the litigation of any such claim,
including, without limitation, permitting the use of their names in all suits
and signing all necessary documents, and WELLCOME shall keep them informed of
the progress of such suits. CENTOCOR and CBV may also, in their sole
discretion, provide WELLCOME with written comments, recommendations and other
information regarding the prosecution of any claim of infringement or
misappropriation of the Wellcome Indicia. Any recoveries under this Section
-------
24.5 shall be applied first to reimbursing WELLCOME for the cost of bringing the
- ----
suit and then to reimbursing CENTOCOR and CBV for providing the assistance
contemplated by this Section 24.5, in each case including their reasonable
-------------
attorneys' fees and other
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out-of-pocket costs. WELLCOME shall have the benefit of the balance.
24.6. Subject to the provisions of this Section 24 with respect to
----------
recoveries, if the party bringing the suit or proceeding loses such suit or
proceeding, then the party bringing the suit or proceeding shall be responsible
for all and any costs expenses, damages, and claims with respect to the Third
Party against whom the suit or proceeding or suit was brought.
24.7. If, subject to the provisions of this Section 24 with respect to
----------
recoveries, the other party is joined as party plaintiff and the suit or
proceeding is lost, then the party bringing the suit or proceedings shall
indemnify and continue to hold the other party harmless against all and any
costs, expenses, damages and claims including all attorneys' fees with respect
to the Third Party against whom the suit or proceeding was brought.
25. ASSIGNMENT
----------
No party hereto may assign any of its rights or delegate any of its
obligations hereunder without the prior written consent of the other parties,
except that, without such consent, (a) WELLCOME may assign all or any part of
its rights and obligations hereunder to an Affiliate of WELLCOME, including but
not limited to BW, so long as WELLCOME unconditionally guarantees the
obligations of such Affiliate; (b) WELLCOME and BW may assign all of their
rights and delegate all of their duties under this Agreement to a transferee of
all or substantially all of the line of business of which this Agreement forms a
part or by way of merger or consolidation with another company; and (c) CENTOCOR
and CBV may assign all of their rights and delegate all of their duties under
this Agreement to a transferee of all or
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substantially all their assets or by way of merger or consolidation with another
company, provided such transfer does not change the ownership or control of the
CENTOCOR business or stock. Without limiting the foregoing, all rights and
obligations with respect to the subject matter of this Agreement as to the
United States (including the shipment of, and payment of the Purchase Price for,
Pre Formulated Bulk Antibody) shall inure to the benefit of and be performed by
BW, subject to such further assignments as may be permitted by this Section 25
----------
and WELLCOME unconditionally guarantees BW'S performance of such obligations.
If any party shall assign its rights and delegate its duties pursuant to clauses
-------
(b) or (c) of this Section 25, the Person to whom such rights are assigned and
- ---------- ----------
duties are delegated shall assume all of the obligations of the applicable party
under this Agreement. The guarantee by WELLCOME referenced in clause (a) of
----------
this Section 25 is a guaranty of payment and performance, and not of collection;
----------
and in case of a default by an Affiliate of WELLCOME to which rights have been
assigned or obligations delegated pursuant to such clause (a), CENTOCOR and CBV
----------
shall have the right to proceed first against WELLCOME without the necessity to
proceed against or join such Affiliate.
26. TERMINATION AND EFFECTS OF TERMINATION
--------------------------------------
26.1. If any of the following (each, an "Event of Termination") shall
--------------------
have occurred, WELLCOME shall have the right to terminate this Agreement by
giving written notice to CENTOCOR not later than the date ninety (90) days
following the date on which CENTOCOR gives written notice to WELLCOME of the
existence of the applicable Event of Termination, such notice containing a
statement of the facts giving rise to such Event of Termination.
26.1.1. A Termination Event as defined in the Development Agreement
shall have occurred.
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26.1.2. A license shall have been granted to a Third Party in any
country in the Territory in, or a Governmental Entity in any country in the
Territory shall exercise rights to use, the Wistar Rights or the Centocor
Hybridoma.
26.1.3. In any (**) months,
CENTOCOR shall have delivered in at least (**) of those months less than
(**) of the Salable 17-1A Product it is required to deliver in
those months pursuant to Section 6.6 hereof (including amounts that were
-----------
required to be delivered in prior months pursuant to Section 6.6 hereof and were
-----------
not delivered).
26.1.4. CENTOCOR shall cease to own or otherwise lawfully control
the Leiden Facility to the extent necessary to produce the 17-1A Product
pursuant to Regulatory Approvals in quantities sufficient to fulfill its
obligations under this Agreement or the Development Agreement or such facilities
shall cease functioning for a period of ninety (90) days unless CENTOCOR shall
have promptly notified WELLCOME of the existence of any of the foregoing
conditions and ninety (90) days shall not have passed from the date of such
notice. During such ninety (90) days, CENTOCOR and WELLCOME shall consult on
whether alternative methods of producing the 17-1A Product may be utilized to
carry out the purposes of this Agreement.
26.1.5. CENTOCOR shall cease to, or not in fact, own or license
Intellectual Property sufficient to permit it to produce the 17-1A Product and
sell it pursuant to this Agreement without infringing the rights of Third
Parties unless CENTOCOR shall have promptly, after obtaining knowledge thereof,
notified WELLCOME of the existence of any of the foregoing conditions and ninety
(90) days shall not have passed from the date of such
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notice. During such ninety (90) days, CENTOCOR and WELLCOME shall consult on
whether sufficient Intellectual Property may be obtained to carry out the
purposes of this Agreement.
26.1.6. Any representation or warranty of CENTOCOR or CBV contained
herein or given in connection with this Agreement shall be untrue or incorrect
in any respect material to this Agreement as a whole.
26.1.7. CENTOCOR or Wistar shall have granted any rights (or
CENTOCOR shall otherwise cease or in fact not have the exclusive rights) to
manufacture, have manufactured, or sell, including selling for resale, any
products incorporating the 17-1A Antibody or any Derivative 17-1A Antibody other
than such rights as are granted to WELLCOME, have been previously granted to
Ajinomoto or are granted to another Permitted Distributor.
26.1.8. Regulatory Approval of the 17-1A Product in any country in
the Territory shall have been withdrawn because of safety questions or there
shall be reported adverse reactions that are fatal, life-threatening or severely
or permanently disabling or any Regulatory Authority shall require a "boxed
warning" under FDA practice or a warning of equivalent stature under the
practice of other Regulatory Authorities with respect to the 17-1A Product, and
in any case under this Section 26.1.8, WELLCOME shall determine in its
--------------
reasonable judgment that such withdrawal, reactions or warning substantially
impair the Target Program.
26.2. WELLCOME in its absolute discretion may terminate this Agreement in
its entirety at any time after five (5) years from the date of First Commercial
Sale in any of the countries in the Territory by giving at least one (1) year's
advance written notice in writing to CENTOCOR.
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26.3. Except as provided in Sections 26.1 and 26.2 hereof, if there shall
----------------------
be a material breach by a party hereto, the other party (CENTOCOR and CBV being
deemed one party for purposes of this Section 26.3 and WELLCOME and BW being
------------
deemed one party for purposes of this Section 26.3) shall give written notice to
------------
the breaching party to cure. Upon receipt of such notice, such breaching party
shall have ninety (90) days to respond by curing such default or by delivering
to the other party a certificate that such breach is not capable of being cured
within such ninety (90) days and that the breaching party is working diligently
to cure such breach. If the breaching party does not so respond or fails so to
work diligently, then the other party may terminate this Agreement.
27. CONSEQUENCES OF TERMINATION
---------------------------
27.1. Expiration or termination of this Agreement for any reason shall not
exempt any party from paying to the others any amounts due to such parties and
outstanding at the time of such expiration or termination. Except as expressly
stated otherwise herein, remedies hereunder are cumulative, and nothing in this
Agreement shall prevent any party, in the case of a breach, from not terminating
this Agreement and seeking to enforce its rights hereunder.
27.2. Upon expiration or termination of this Agreement:
27.2.1. All rights and licenses granted hereunder by any party
shall become null and void and will revert to CENTOCOR and CBV or WELLCOME and
BW, respectively, subject to Section 27.2.7 hereof and the terms and conditions
--------------
of the License.
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27.2.2. To the extent provided in the Trademark Agreement and any
other agreements in respect of Centocor Trademarks entered into by the parties
in connection therewith, such agreements shall immediately terminate, provided
that WELLCOME may sell Final 17-1A Product pursuant to Section 27.2.7 hereof
--------------
with the Panorex Trademarks and the other Centocor Trademarks affixed.
27.2.3. The Wellcome House Mark Agreement and any other agreement
in respect of Wellcome Indicia entered into by the parties in connection
therewith shall immediately terminate.
27.2.4. Stocks of the 17-1A Product with expired shelf life shall
be destroyed by CENTOCOR in accordance with Section 8.6 hereof and in accordance
-----------
with the Environmental Laws.
27.2.5. Subject to obtaining WELLCOME'S prior written consent,
CENTOCOR may either (a) repurchase all or any part of the 17-1A Product owned by
WELLCOME or its Affiliates (as appropriate in the circumstances) on the date of
expiration or termination of this Agreement or (b) request WELLCOME, and if
WELLCOME or its Affiliates in their sole discretion so choose, to transfer all
or any part of its respective stocks of the 17-1A Product on termination or
expiration of this Agreement to a nominated Third Party, subject to in both
instances the 17-1A Product being re-labeled without any reference to WELLCOME
or Wellcome Indicia if so directed by WELLCOME at CENTOCOR'S sole cost and
expense.
27.2.6. If pursuant to Section 27.2.5 hereof, CENTOCOR purchases
--------------
17-1A Product from WELLCOME or requests a transfer to a nominated Third Party,
the price shall be at cost procured by WELLCOME including any taxes and duties
thereon and the combination of the repurchase and transfer shall be of all
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17-1A Product which WELLCOME has in its inventory or which is in transportation
to WELLCOME at the time of expiration or termination of this Agreement.
27.2.7. WELLCOME and its Affiliates may, where appropriate, package
(including conducting Filling and Capping) and/or sell and distribute the 17-1A
Product, subject to any existing rights of the parties and continuing
observation by WELLCOME of its obligation to pay for such 17-1A Product
hereunder, which is in the possession of WELLCOME or its Affiliates or in
transit to WELLCOME or its Affiliates at the time of expiration or termination
of this Agreement, for a period of six (6) months after such expiration or
termination.
27.2.8. If such termination shall arise out of any action or
inaction that is an Event of Termination or a breach by CENTOCOR, CENTOCOR shall
immediately and forthwith cease to use the Panorex Trademarks and in any event
shall cease to use all Wellcome Indicia applied to the 17-1A Product on the
17-1A Product or make any references to WELLCOME or Wellcome Indicia and shall
destroy, if so directed by WELLCOME, all sales and promotion materials or return
the same to WELLCOME as WELLCOME shall direct, and subject to Section 27.2.7
--------------
hereof, WELLCOME shall cease to use the CENTOCOR Trademarks other than the
Panorex Trademarks.
27.2.9. CENTOCOR shall immediately cease to describe in any written
information (including but not limited to journals, advertisements, direct mail,
sales, sales, pieces and other promotional material) to the medical and
paramedical communities and to the trade and, to the extent practicable, all
oral information disseminated or presented respectively to such communities and
to the trade, WELLCOME and its Affiliates (where appropriate in the
circumstances) as promoting marketing, selling
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or distributing the 17-1A Product in connection with the Panorex Trademarks.
28. CONFIDENTIALITY
---------------
28.1. "Proprietary Information" for the purposes of this Section 28 means
----------------------- ----------
all inventions, discoveries, improvements and methods, business plans, marketing
techniques and plans, manufacturing and other plant designs, locations of
operations and any other information affecting the business operations of the
Disclosing Party and which is identified by the Disclosing Party at the time of
disclosure as being confidential or proprietary.
28.2. Except as expressly provided herein otherwise, each Receiving Party
shall, during the term of this Agreement including any renewals hereof, and for
a period of five (5) years following expiration or the termination hereof, but
in any event not for less than a period of ten (10) years from the date hereof,
maintain the confidentiality of all Proprietary Information disclosed by the
Disclosing Party hereunder and shall neither use the same except as expressly
authorized by this Agreement or any other Alliance Document, nor disclose the
same to any Third Party without the prior written consent of the Disclosing
Party. Nothing in this Section 28, however, shall be construed to require any
----------
party hereto to maintain the confidentiality and non-use of any information or
material that (a) at the time of disclosure, is already in the public domain;
(b) after disclosure, enters the public domain otherwise than by an act or
omission of the Receiving Party in violation of the terms of this Agreement; (c)
prior to disclosure under this Agreement was already in the possession of the
Receiving Party or its Affiliates, provided that such information or material
was not obtained, directly or indirectly, from the Disclosing Party
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under this Agreement or under any other obligation of confidentiality from the
Receiving Party to the Disclosing Party; (d) becomes known to the Receiving
Party from a Third Party, provided that such information or material was not
obtained, directly or indirectly, from the Disclosing Party on a confidential
basis; (e) is required in the reasonable judgment of the Receiving Party to be
disclosed to a Governmental Entity in furtherance of this Agreement or the
Alliance Agreement or pursuant to any Law, Permit or Court Order; or (f) results
from research or development by the Receiving Party or its Affiliate independent
of disclosures from the Disclosing Party. Disclosures made prior to the date of
this Agreement pursuant to that certain Confidentiality Agreement between
CENTOCOR and WELLCOME dated September 14, 1993 shall be governed by such
Confidentiality Agreement and to the extent not inconsistent therewith this
Section 28; other disclosures prior to the date of this Agreement of Proprietary
- ----------
Information shall be governed by the terms of this Section 28.
----------
28.3. Nothing in this Section 28 shall prevent any party hereto from
----------
disclosing its own information relating to its business, financial affairs,
products, research development, marketing and other commercial activities to any
Affiliate or any Third Party. In addition, notwithstanding the restrictions in
this Section 28 on confidentiality and use, any party hereto may disclose
----------
Proprietary Information which is disclosed to it hereunder to any of its
Affiliates which agrees to be bound by the terms of this Section 28 hereof.
----------
28.4. Nothing in this Section 28 shall prevent or restrict WELLCOME and
----------
its Affiliates from using and/or disclosing Proprietary Information received
from CENTOCOR and CBV where such use and/or disclosure is reasonably regarded by
WELLCOME or its Affiliates as necessary to enable WELLCOME to carry out its
obligations under the Target Program or the Post Target Program,
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provided that WELLCOME and its Affiliates shall take all reasonable steps to
ensure that disclosure of any such Proprietary Information is as limited as
possible and disclosed on a confidential basis.
29. PUBLIC STATEMENTS
-----------------
No party hereto, nor its representatives or employees, shall make any
disclosure, including any news release or other public statement, whether to the
press, stockholders, or otherwise, disclosing the terms of this Agreement or of
any amendment hereto, without the prior written approval of the other parties,
which approval shall not be unreasonably withheld or delayed; providing,
---------
however, nothing in this Section 29 shall be deemed to prevent any party hereto
- ------- ----------
from making such disclosures or statements which, in the opinion of counsel, are
legally required. In the event such disclosure or statement is required, the
disclosing party shall give prior notice to the other party of the proposed
disclosure or statement and the reason therefor. CENTOCOR acknowledges that it
shall file a Current Report on Form 8-K under the Exchange Act reporting the
transactions contemplated by the Alliance Agreement, including exhibits thereto,
subject to appropriate requests for confidential treatment.
30. MISCELLANEOUS
-------------
30.1. Entire Agreement. This Agreement and the other Alliance Agreements
----------------
constitute the entire understanding of the parties with respect to the subject
matter contained herein and supersede any prior understandings and agreements
among them respecting such subject matter including, without limitation, the
Letter of Intent dated September 16, 1993; provided, however, the
-------- -------
confidentiality agreement between WELLCOME and CENTOCOR dated
-66-
<PAGE>
September 14, 1993 shall in all cases remain in full force and effect in
accordance with its terms.
30.2. Amendments. This Agreement may be amended and supplemented only by
----------
a written instrument duly executed by each of the parties.
30.3. Headings. The headings in this Agreement are for convenience of
--------
reference only and shall not affect its interpretation.
30.4. Gender; Number. Words of gender may be read as masculine, feminine,
--------------
or neuter, as required by context. Words of number may be read as singular or
plural, as required by context.
30.5. Appendices; Exhibits; and Schedules. All appendices, exhibits and
-----------------------------------
schedules referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.
30.6. Severability. It is the intention of the parties to comply with all
------------
applicable Laws, domestic or foreign, in connection with the performance of
their respective obligations hereunder. If any provision of this Agreement or
the application thereof to any Person or circumstance is held illegal, invalid,
or unenforceable, such illegality, invalidity, or unenforceability shall not
affect any other provision hereof. This Agreement shall, in such circumstances,
be deemed modified to the extent necessary to render enforceable the provisions
hereof to the fullest extent permitted by Law.
30.7. Remedies. Each of CENTOCOR and CBV on the one hand, and WELLCOME
--------
and BW on the other, stipulates that the remedies at law of the other in the
event of any Default or threatened
-67-
<PAGE>
Default in the performance of or compliance with any of the terms of this
Agreement are not and will not be adequate and that, to the fullest extent
permitted by Law, such terms may be specifically enforced by a decree for
specific performance of any agreement contained herein or by an injunction
against any violation of any terms hereof or otherwise.
30.8. Notices. All notices and other communications hereunder shall be in
-------
writing and shall be given to the Person either personally or by sending a copy
thereof by first class United States express mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, or by telecopier (with the
original sent by either of the foregoing manners), to such Person's address (or
to such Person's telecopier number). All notices shall be deemed to have been
given to the Person entitled thereto when received.
-68-
<PAGE>
If to WELLCOME, to:
THE WELLCOME FOUNDATION LIMITED
Unicorn House, P.O. Box 129
129 Euston Road
London NW1 2BP
Attention: Company Secretary
Telecopy No.: 011-44-71-388-5462
With a copy to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to BW, to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
-69-
<PAGE>
If to CENTOCOR or CBV, to:
CENTOCOR, INC.
200 Great Valley Parkway
Malvern, Pennsylvania 19355-1307
Attention: Corporate Secretary
Telecopy No.: (215) 651-6100
with a copy to:
Duane, Morris & Heckscher
One Liberty Place
Philadelphia, PA 19103
Attention: David C. Toner, Esquire
Telecopy No.: (215) 979-1020
Notice of any change in any such address shall also be given in the manner set
forth above. Whenever the giving of notice is required, the giving of such
notice may be waived by the Person entitled to receive such notice.
30.9. Waiver. No provision of this Agreement may be waived except by a
------
written instrument signed by the party hereto sought to be bound. No failure or
delay by any party hereto in exercising any right or remedy hereunder or under
applicable Law will operate as a waiver thereof, and a waiver of a particular
right or remedy on one (1) occasion will not be deemed a waiver of any other
right or remedy, or a waiver on any subsequent occasion (it being understood
that specific time frames for notice or actions to be taken shall be binding on
the parties).
30.10. Successors and Assigns. This Agreement shall bind, inure to the
----------------------
benefit of, and be enforceable by the successors and permitted assigns of the
parties hereto.
-70-
<PAGE>
30.11. Governing Law. This Agreement shall be construed and enforced in
-------------
accordance with the Laws of the Commonwealth of Pennsylvania without regard to
principles of conflicts of law applicable in such jurisdiction, and all sales of
the 17-1A Product contemplated hereby shall be governed by such Laws, except
that the parties hereto expressly exclude the application of the United Nations
Convention on Contracts for the International Sale of Goods.
30.12. No Benefit to Others. The representations, warranties, covenants
--------------------
and agreements contained in this Agreement are for the sole benefit of the
parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring, and are not intended to confer, any rights on any other
Person.
30.13. Independent Contractors. It is expressly understood and agreed that
-----------------------
the Centocor Group and the Wellcome Group are independent contractors; neither
the Centocor Group or any of its members, nor the Wellcome Group or any of its
members, shall be deemed the agent of the other group or of any of its members
for any purpose whatsoever, and neither the Centocor Group or any of its
members, nor the Wellcome Group or any of its members, shall have authority to
enter into any contract or agreement, assume any obligation or make any warranty
or representation for or on behalf of the other group or any of its members.
Nothing in this Agreement shall be deemed to create or constitute a partnership
or the relationship of employer and employee between the Wellcome Group or any
of its members on the one hand and the Centocor Group or any of its members on
the other.
30.14. Further Assurances. At the request of any party hereto, the other
------------------
parties hereto shall execute and deliver from
-71-
<PAGE>
time to time such further instruments and shall provide reasonable cooperation
in such proceedings or actions as shall be necessary or reasonably appropriate
to effectuate the purposes of this Agreement including, without limitation,
registering or recording the rights granted hereunder in appropriate offices of
particular Governmental Entities; provided, however, if any party hereto desires
-------- -------
to notify this Agreement under Article 85(3) of the Treaty of Rome establishing
the European Economic Community, such party shall give the other parties ninety
(90) days prior written notice of such notification and if during such period a
party shall reasonably object to such notification, the objecting party need not
cooperate in such notification and such notification shall not be implemented.
Except as otherwise provided in the Alliance Documents, the executions,
deliveries and cooperation of each party under this Section 30.14 shall be
-------------
without further consideration and at such party's expense.
30.15. Counterparts. This Agreement and any amendment or supplement hereto
------------
may be executed in any number of counterparts and any party hereto may execute
any such counterpart, each of which when executed and delivered shall be deemed
to be an original and all of which counterparts taken together shall constitute
but one and the same instrument. The execution of this Agreement and any such
amendment or supplement by any party hereto will not become effective until
counterparts hereof have been executed by all the parties hereto.
30.16. Savings Clause. Any restriction or information provision (as each
--------------
of these terms or expressions are defined in the RTPA) contained in this
Agreement or in any arrangement of which this Agreement forms part by virtue of
which this Agreement or any such arrangement is registrable under the RTPA shall
not take effect in the United Kingdom until the day after the day on
-72-
<PAGE>
which full particulars of this Agreement (and of any such arrangement) shall
have been duly furnished to the Office of Fair Trading under Section 24 of the
----------
RTPA.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the day and year first above written by their duly authorized
representatives.
FOR AND ON BEHALF OF
THE WELLCOME FOUNDATION LIMITED
By: /s/ Trevor M. Jones
------------------------------------
Name: Trevor M. Jones
----------------------------------
Title: Director-Research, Development &
---------------------------------
Medical
---------------------------------
BURROUGHS WELLCOME CO.
By: /s/ David W. Barry
------------------------------------
Name: David W. Barry
----------------------------------
Title: Vice President of Research,
---------------------------------
Development and Medical
---------------------------------
[EXECUTIONS CONTINUED]
-73-
<PAGE>
CENTOCOR, INC.
By: /s/ Bobba Venkatadri
------------------------------------
Name: Bobba Venkatadri
----------------------------------
Title: Executive Vice-President
---------------------------------
CENTOCOR B.V.
By: /s/ David P. Holveck
------------------------------------
Name: David P. Holveck
----------------------------------
Title: Managing Director
---------------------------------
-74-
<PAGE>
APPENDIX A
----------
GLOSSARY OF TERMS
-----------------
[See Appendix A to Alliance Agreement]
-75-
<PAGE>
SCHEDULE 5.3
------------
WELLCOME AND ITS AFFILIATES
STANDARD TERMS AND CONDITIONS OF PURCHASE
Four (4) Pages Attached.
<PAGE>
THE WELLCOME FOUNDATION LTD Purchase Order No.
WELLCOME DATE
- ---------------------------
Requistioner
[ ]
REQ NO. DATE
[ ]
Delivery Area
User Reference & Type
- ---------------------------
- ---------------------------
Order Number
Order Type
Raised By
Amended By
Progress Date
Invoice Instructions
- ---------------------------
- ---------------------------
Buyers Comment
Buying Category & GL Codes
Estimated Value & Indicator
- ---------------------------
- ---------------------------
Checked by Authorizing
Signature
Refer Purchase Queries to
- ---------------------------
- ---------------------------
Suppliers Code
- ---------------------------
Please execute the following Order subject to the terms and conditions detailed
overleaf
- -----------------------------------------------------
Delivery to be made to:
ADVICE NOTE quoting above order number must be sent
- -----------
the day goods are dispatched to the delivery address
stating time limit for notification of non-delivery
DELIVERY NOTE quoting above order number must
- ------------- ----
accompany the goods before
3:30 p.m. not Saturdays
Invoice to be sent to: -
Invoice must quote Wellcome Order No.
:-
- -----------------------------------------------------
The Wellcome Foundation Ltd Unicorn House PO Box 129 160 Easton Road London NW1
29P England No 194814 VAT No. GB 203 3017 31
<PAGE>
THE WELLCOME FOUNDATION LIMITED - CONDITIONS OF PURCHASE
1. DEFINITIONS
In these "Conditions" the following words shall, where the context so
admits, have the meanings respectively set against them:
The Order(s) The form of order contained on the reverse hereof
(including any subsequent amendments to the order(s))
duly completed and signed on behalf of the Wellcome
Foundation Limited
The Seller The company, firm or person to whom the order is
addressed
The Buyer The Wellcome Foundation Limited
The Goods The Goods or Services provided by the Seller, to the
Buyer, particulars whereof are set out in the Order
together with any Specification accompanying the Order
or referred to on the face thereof.
The Specification The Buyer's specific written requirements which
accompanies, is attached and or is set forth in the
Order (whichever is appropriate).
2. FORMATION OF CONTRACT
(a) Any contract made between the Seller and the Buyer for the sale and
purchase of the Goods shall consist of the Order together with all
documents expressly incorporated therewith and the acceptance of the
Order by the Seller, and shall be subject to these Conditions to the
exclusion of any other conditions which may be inconsistent and which
the Seller might seek to impose even though such conditions may be
submitted in a later document or purport to exclude or supersede any
conditions inconsistent with them. Unless otherwise agreed by the
Buyer no other terms or conditions shall be included or implied in the
contract nor shall any of these Conditions be varied or deleted.
(b) The Seller hereby acknowledges that these Conditions shall have
precedence over and shall supersede all representations, proposals,
prior agreements oral or written and all other communications between
the parties regardless of any other or additional terms or any printed
conditions appearing on any acceptance form or other document or
letter emanating from the Seller, and such conditions shall have no
effect whatsoever except insofar as they confirm the terms of the
Order.
(c) When the Order is placed by telephone on behalf of the Buyer it must
be subject to the quotation of the Buyer's order number and must be
subsequently confirmed by the Buyer in writing. The Order and written
confirmation must be signed by a duly authorized signatory of the
Buyer and must carry the Buyer's official order number. The Buyer
shall not be bound by Order if the Order does not expressly quote the
Buyer's official order number and notwithstanding this, is accepted by
the Seller.
3. THE SPECIFICATION
(a) Where the Order is placed subject to the Specification, the Seller
shall ensure that the Goods comply with the Specification. The Seller
shall not make any change of whatever nature to the Specification of
the Goods supplied under the Order without the prior written
acceptance of the Buyer
(b) The Seller shall ensure that no changes are made to the process of the
raw materials and/or the source of the raw materials from which the
Goods are made without prior written notification to the Buyer of what
those changes are.
4. DELIVERY
(a) The Goods shall be delivered to the Buyer within such period as is
stated for the delivery in the Order.
(b) If the Goods are not delivered within such period as aforesaid the
Buyer shall be entitled without prejudice to any of its other rights
under these Conditions to forthwith terminate the Order by notice in
writing given to the Seller.
(c) Upon consigning the Goods or any part thereof for delivery to the
Buyer the Seller shall forthwith give notice thereof to the Buyer.
5. PRICE AND PAYMENT
Unless otherwise agreed:
(a) The price of the Goods stated in the Order shall not be the subject of
increase without the consent of the Buyer and shall unless otherwise
agreed by the Buyer, be inclusive of the cost of packing and carriage
and of any duties, taxes (except as otherwise provided for under the
provisions of clause 12 hereof) tariffs or other impositions
chargeable or leviable on the Goods and of any other sums whatsoever
payable to any person in respect of the Goods.
(b) Subject to the Goods supplied hereunder, conforming to the
Specification (where relevant) payment will be made by the Buyer
normally through BACS Limited (Bankers Automated Clearing Services) or
SWIFT (Society for the World wide Interbank Financial
Telecommunications) into the Seller's designated bank account usually
between 49 and 56 days from invoice/tax point date.
(c) The Seller shall not be entitled to penalise the Buyer by forfeiting
discounts on prompt payment if the Seller fails to clearly indicate on
all correspondence the Buyer's purchase order number (through no fault
of the Buyer) which results in a delay to the payment under the
provisions hereof.
6. QUALITY OF MATERIALS
The materials used in manufacturing the Goods shall conform in all respects
to the particulars stated in the contract and if no such particulars are
stated, shall, subject to any contrary instructions given thereafter to the
Seller by the Buyer, be of the highest grade and quality obtainable.
7. HEALTH, SAFETY, TOXICITY AND ENVIRONMENTAL ISSUES
(a) Where EEC Directive 91 156 FCC applies the Seller will provide the
Buyer with a Safety Data Sheet in accordance with this Directive and
will be responsible for communicating any revisions of the Safety Data
Sheet to the Buyer.
(b) The Seller will ensure that the Safety Data Sheet will include but
shall not be limited to methods of disposal, precautions before and
after spillage and the occupation exposure limits.
(c) The Seller will be responsible for examining that the production and
supply of the Goods to the Buyer fully conforms with all Health, Safety
and Environmental legislation, such legislation shall include, but not
limited to statutes, Acts of Parliament, Regulations EEC legislation,
licensor, Approvals, Code of Practices and Guidance Notes as amended
from time to time.
(d) If the Goods (to which this clause applies) are rejected by the Buyer
then the Seller shall be responsible for collection and disposal of the
Goods within 21 days of notice of rejection by the Buyer.
8. INSPECTION AND TESTING
The Seller shall before delivery ensure whether by inspection or testing or
otherwise, that the Goods comply with these Conditions and/or the
Specification. Without limiting the obligations of the Seller as aforesaid
the Buyer may at any reasonable time during the performance of the contract
enter upon the premises of the Seller for the purpose of inspecting and
testing the Goods and the materials and the Seller shall afford to the
Buyer all reasonable facilities for such inspection and testing.
9. REJECTION OF FAULTY GOODS*
The Buyer shall not be deemed to have accepted the Goods until a reasonable
period after the date of delivery of the same. Payment for the Goods shall
not be deemed evidence of acceptance. Before the expiry of a reasonable
period of time after the date of delivery the Buyer shall be entitled to
reject such of the Goods as do not comply in all respects with these
Conditions and/or the Specification and shall upon rejection (with the
exception of the Goods in which the provision of Clause 7 hereof refers)
return such Goods to the Seller at the risk and expense of the Seller.
Upon notification of rejection as aforesaid, the Seller, as the Buyer may
require, shall forthwith either at its own expense deliver to the Buyer,
Goods complying in all respects with these Conditions or the Specification
in substitution for those rejected or Credit the Buyer in full for the
invoice value of the rejected Goods.
10. WARRANTY
Notwithstanding Clause 9, the Seller warrants that the Goods fit their
description, are of merchantable quality and are fit for their purpose,
comply with the Specification (where appropriate) and are free from defects
and faults of whatever nature for 12 months from delivery or commissioning,
whichever is the later, (unless otherwise set out in the Order ("the
Warranty Period")). If during the Warranty Period the Goods are found not
to comply with the above the Seller shall forthwith replace the Goods or
rectify such defect. The Seller shall bear all costs in this connection
(including carriage, packaging or any additional inspection or testing of
the replaced or repaired Goods). The Warranty Period shall be extended by a
further period of 12 months (unless otherwise agreed) from the date of
replacement or rectification.
11. SUB-CONTRACTING AND ASSIGNMENT
These Conditions shall be performed by the Seller or by its holding company
or subsidiary or by a subsidiary of its holding company and not by way
of subcontract to any other company, firm or person without the prior
consent in writing of the Buyer, save only for the supply of materials
or items not commonly made by the Seller. Copies in duplicate of any
sub-contract made in accordance with this provision, with the omission only
of any price stated therein, shall be delivered to the Buyer and no such
sub-contract shall in any way limit or otherwise affect the obligations of
the Seller under these Conditions.
The Seller shall not assign any contract or any rights hereunder in whole
or in part without the prior written consent of the Buyer.
12. PATENT RIGHTS ETC.
If the Goods, either by their sale, use or incorporation in other goods,
allegedly or otherwise infringes any design, trademark, copyright, letters
patent or any other intellectual property rights in the United Kingdom
or elsewhere, the Seller shall indemnify and hold the Buyer harmless from
and against all and any costs, claims, damages, expenses brought, made or
suffered by or against the Buyer.
13. TERMINATION AND CANCELLATION
13.1 Termination
Without prejudice to any of its other rights under these Conditions the
Buyer may by notice in writing to the Seller terminate these Conditions
forthwith if:
(a) the Seller shall commit any breach of these Conditions; or
(b) the Seller ceases to carry on business or permits any judgment
against it to remain unsatisfied for seven days; or
(c) being a Company the Seller has a petition presented or a meeting is
convened for the purpose of considering a resolution or other steps
are taken for its winding up or for the making of an administration
order (otherwise than for the purposes of a bona fide amalgamation or
reconstruction) or compounds with its creditors, or if it shall become
insolvent, or if a trustee receiver, administrative receiver or
similar officer is appointed in respect of all or any part of its
business or assets; or
(d) being an individual the Seller dies, or becomes bankrupt or insolvent,
or enters into any arrangements with creditors or takes or suffers any
similar action in consequence of debts.
13.2 Cancellation
The Buyer hereby reserves the right to cancel the whole or any part of
the Order without incurring any liability whatsoever to the Seller for
such cancellation provided that the Buyer gives to the Seller reasonable
prior written notice of its intention to so cancel.
14. NOTICES
Any notice or other document required to be served on the Seller shall be
delivered or posted to the Seller at its registered office being a company
or last known place of business or other address being an individual
or a firm and any notice or other document required to be served on the
Buyer shall be delivered or posted, in the case of an invoice or
statement to Buyer's Accounts Department and in any other case to the
Buyer's Buying Department as indicated on the order.
15. DRAWINGS COPYRIGHT AND OWNERSHIP
The Buyer retains copyright in and ownership of all plans, drawings,
specifications and patterns relating to the Goods delivered by the Buyer to
the Seller and the same shall remain the property of the Buyer and
forthwith upon the completion or termination (for whatever reason) of these
Conditions shall be returned to the Buyer. No such plans, drawings,
specifications, or patterns shall be shown nor its contents disclosed to
any other person without prior written agreement of the Buyer.
16. PASSING OF PROPERTY
The property and risk in the Goods shall remain in the Seller until the
Goods are delivered to the point specified by the Buyer.
17. MARKING OF MATERIALS
When required by the Buyer the Seller shall mark the materials ordered in
accordance with the reasonable instructions of the Buyer.
18. VALUE ADDED TAX (WHERE APPLICABLE)
Where it is agreed that Value Added Tax shall be paid by the Buyer, the
Seller shall show as a separate item in his invoice the amount of such
Value Added Tax.
19. USE OF NAME
It is a condition of the purchase of the Goods that the Seller shall
not, without the prior written consent of the Buyer issue or publish any
statement in writing indicating that the Seller has supplied goods to the
Buyer or is a supplier to the Buyer, whether regularly or intermittently or
otherwise of the Goods or any other goods but without prejudice to the
Buyer's rights with respect to the supply of Goods whether under these
Conditions or by virtue of a course of dealing with respect to the Goods or
similar goods.
20. INDEMNITY
The Seller shall defend, indemnify and continue to indemnify and hold the
Buyer harmless from and against all third party claims, demands, loss,
damage, liability (including without limitation liability for death or
personal injury attributable to the Goods) settlement amounts, costs and
expenses whatsoever (including reasonable legal fees and costs)
arising out of or resulting from the use and/or sale of the Goods or of any
product incorporating the Goods.
21. CONTRACTORS ON SITE
Under no circumstances should contractors work in or enter the Buyer's
premises without having first read the Buyer's Standard Preliminaries
document for Contractors (as amended from time to time), which must be
strictly adhered to. Copies of this document are available on request.
22. APPLICABLE LAW
This Order shall in all respects be construed in accordance with and be
governed by English Law. Nothing in these Conditions shall prejudice or
limit any condition or Warranty (express or implied) or right or remedy
to which the Buyer is entitled in relation to the material of the Goods
ordered by virtue of statute or Common Law and the parties agree to submit
or any dispute in relation to the Goods or the rights of the parties
hereunder in relation thereto to the jurisdiction of the English Courts.
<PAGE>
BURROUGHS WELLCOME DATE PURCHASE ORDER
WELLCOME CO.
3030 Cornwallis
INVOICE TO Road, Research
Triangle Park, NC THIS NUMBER MUST
27709 APPEAR ON ALL PACKAGES,
INVOICES AND
ACCOUNTS PAYABLE CORRESPONDENCE.
DEPARTMENT
P.O. BOX 13526 1.EACH CONTAINER MUST
RESEARCH TRIANGLE SHOW (A) YOUR COMPANY
PARK, NC 27709-3526 NAME (B) DESCRIPTION
OF CONTENTS (C) OUR
RESEARCH TRIANGLE ORDER NUMBER (D) OUR
PARK (919) 248-3000 ITEM NUMBER (E)
GREENVILLE - (919) QUANTITY.
758-3436 2.SEND BUYER
ACKNOWLEDGEMENT OF THIS
ORDER GIVING
SPECIFIC DELIVERY
INFORMATION.
3.RESEARCH TRIANGLE
PARK DELIVERIES
ACCEPTED FROM 8:15 TO
3:15 P.M.
4.GREENVILLE DELIVERIES
ACCEPTED FROM 7:30 A.M.
TO 3:00 P.M.
NO COD'S ACCEPTED.
- -------------------------------------------------------------------------------
VENDOR NUMBER TERMS F.O.B. FREIGHT TERMS
- -------------------------------------------------------------------------------
QUANTITY DESCRIPTION PRICE
- -------------------------------------------------------------------------------
TOTAL
- ------------------------------- -----------------------------
DIRECT ALL INQUIRIES TO BUYER DIRECTOR OF PURCHASING
<PAGE>
PURCHASE ORDER "TERMS AND CONDITIONS"
THIS ORDER IS PLACED SUBJECT TO THE FOLLOWING TERMS AND
CONDITIONS WHICH MAY NOT BE VARIED OR ADDED TO EXCEPT BY A
WRITING SIGNED BY BUYER'S PURCHASING AGENT
DELIVERY:
Title shall pass to Buyer on delivery of goods to its plant
at Greenville, N.C. or its establishment at Research
Triangle Park N.C. Notwithstanding any agreement to pay
freight express or other transportation charges, the risk of
loss or damage in transit shall be upon the Seller.
Delivery shall not be complete until goods have been actually received,
inspected and accepted by Buyer. Buyer shall have the privilege of return at
Seller's expense if goods are defective or not in compliance with Buyer's
specifications. Seller shall bear all risks after notice of rejection.
Buyer reserves the right to cancel this order or any part thereof if delivery is
not made within the time specified or within a reasonable time in case no time
is specified.
WARRANTY
Seller warrants the lawful ownership of the goods, the right to sell them, and
delivery, free of any security interest, lien or encumbrance. Seller further
warrants that the goods will conform to applicable drawings, specifications,
samples, models, descriptions, etc. and will be of good material and workmanship
and free from defects and shall in all respects be of merchantable quality and
fit and safe for the purpose intended.
Such warranties shall survive delivery and shall not be deemed waived either by
reason of Buyer's acceptance of the goods or by payment for them. Any deviation
from this order or the drawing, specifications, etc., furnished by Buyer or any
other exceptions or alterations must be approved in writing by Buyer's
Purchasing Agent.
CONTINGENCIES
No liability hereunder shall result to either party from delay in performance,
non performance, or non acceptance of deliveries caused by circumstances beyond
the control of the party affected, including, but not limited to, Acts of God,
fire, flood, war, labor trouble or voluntary compliance with governmental
regulations, directions or requests. Quantities so affected may be eliminated
from the order.
INVOICES
All invoices must carry the following clause in order to be passed for payment:
"We hereby guarantee that the articles listed herein are not adulterated or
misbranded within the meaning of the Federal Food, Drug and Cosmetic act of the
Federal Caustic Poison Act, as amended, and regulations thereunder; they contain
no substance which may not be introduced into interstate commerce under Sections
404 and 505 of the Federal Food, Drug and Cosmetic Act, where applicable they
have been registered under the Federal Insecticide, Fungicide and Rodenticide
Act and otherwise comply within. Any color additive is from a batch certified
in accordance with FDA regulations. We hereby certify that the goods listed
herein were produced in compliance with all applicable requirements of the Fair
Labor Standards Act, as amended.
Discounts will be taken according to terms, but from the date of delivery of the
goods to Buyer's plant.
PATENTS, TRADEMARKS AND COPYRIGHTS
Seller warrants that the use or sale of the goods delivered hereunder will not
infringe any patent, trademark or copyright; and shall indemnify and hold Buyer
harmless from and against all claims, liability, loss, damage or expense,
including counsel fees, arising from or by reason of any actual or claimed
infringement or any litigation based thereon.
SPECIAL AND CONSEQUENTIAL DAMAGES
By accepting this order, Seller acknowledges that the goods and/or services
covered by this order are intended for use by Buyer in connection with its
business of manufacturing, research, sale and distribution of human and
veterinary pharmaceutical, biological and diagnostic products and Seller
acknowledges that any defect in the goods and/or services covered by this order,
or any breach of warranty contained herein or any failure by Seller to perform
any of its obligations to Buyer may occasion special and/or consequential
damages to the Buyer.
INDEMNITY
Seller agrees to defend, indemnify, and save harmless the buyer from and
against all liability, loss, damage and expense of every kind, including
reasonable attorney's fees, resulting from or arising out of any breach
of warranty contained herein or any failure of Seller to properly
perform its obligations to Buyer created by and upon
Seller's acceptance of this purchase order.
WORK ON BUYER'S PREMISES
If Seller is required to make any delivery or to do any work on Buyer's
premises, Seller agrees to and will be subject to Buyer's factory and safety
regulations. Seller shall hold Buyer harmless and indemnify Buyer against all
loss or damage which may result from any act or omission of Seller, its
employees, agents or subcontractors. Seller shall furnish satisfactory
certificates of insurance covering Workmen's Compensation for all of its
employees engaged in work on Buyer's premises, and public liability insurance
and property damage insurance. Seller for itself and its agents, servants and
employees covenants to maintain in strictest confidence any trade secret or
confidential information of Buyer's which Seller or its agents, servants or
employees acquire arising out of the work or being upon the premises.
TERMINATION FOR BANKRUPTCY
The voluntary or involuntary bankruptcy or receivership of the insolvency of
either party hereto shall permit the other party to terminate this agreement
forthwith upon notice.
GOVERNMENT CONTRACT:
If Buyer advises Seller that any of the goods are subject to use by Buyer to
satisfy contracts with the United States Government, Seller covenants to comply
with the Equal Opportunity, Walsh Healy Public Contracts, Contract Work Hours,
Standards, Buy-American, Renegotiation, and other applicable federal, state and
local laws.
VARIATION
No variation in any of the terms, conditions or specifications of this order,
and no different or additional terms contained in any of Seller's documents,
irrespective of the wording of Seller's acceptance or trade custom will be
binding upon Buyer unless agreed to in writing and signed by Buyer's Purchasing
Agent. No other representative of Buyer is authorized to change any of these
terms and conditions.
NO WAIVER
Failure to insist upon strict compliance with any of the terms, conditions,
and/or representations of this order shall not be deemed a waiver of compliance,
nor shall any waiver or relinquishment of any right at any one time or more
times be deemed a waiver or relinquishment at any other time or times absent
written notice to such effect by Buyer's Purchasing Agent.
INSPECTION
Upon reasonable notice, buyer shall have the right of access to and inspection
of areas of Seller's plant in which the goods are manufactured and may further
inspect and test the goods at Sellers' plant or at point of destination.
REMEDIES
No remedy herein provided shall be deemed exclusive of any other remedy allowed
by law.
ASSIGNMENT
Seller may not assign or delegate its rights or obligations under this order
without the expressed written agreement of Buyer.
APPLICABLE LAWS
Seller warrants that its performance and the goods under this order shall be in
compliance with all applicable Federal, State, and local laws.
LAW GOVERNING
This order is to be governed by and construed in accordance with the laws of
North Carolina.
<PAGE>
SCHEDULE 8.3
------------
(**)
<PAGE>
SCHEDULE 12.1
-------------
TECHNICAL INFORMATION RELATING
TO F&C TECHNICAL PROGRAM
(**)
<PAGE>
SCHEDULE 20.2
-------------
Adverse Reaction Reporting
--------------------------
1. Each party shall use its best endeavors to obtain and record written medical
confirmation and relevant details of all suspected or alleged Adverse Reactions
to the 17-1A Product and shall ensure by means of a written log that all such
cases and the dossiers of information relating to them are uniquely identified
and retrievable.
2. Each party shall comply with all legal and regulatory requirements in the
applicable country in the Territory concerning the reporting of Adverse
Reactions to the 17-1A Product and shall send copies of all such reports to the
other party and as otherwise required by applicable Law.
3. Each party shall inform such persons of the other party in writing as are
identified from time to time by the Product Committee of all serious Adverse
Reactions to the 17-1A Product as soon as possible and at the latest within
fifteen (15) days of a party receiving notice thereof. Serious Adverse
Reactions are those that are fatal, life-threatening or severely or permanently
disabling for any reason.
4. Each party shall provide to the other party every Quarter a report containing
clinical details of all those Adverse Reactions to the 17-1A Product for which
information is deemed to have been completed during the relevant period.
5. Each party shall respond as soon as is reasonably practicable to requests
from the other party for further information on any Adverse Reaction reported
under points 3 or 4 above.
6. Each party shall provide to the other party every six (6) months a report
summarizing:
(i) complaints received from users of the 17-1A Product; and
(ii) toxicological or other information which becomes available to such
party and which is relevant to the use, indications and
contra-indications or safety of the 17-1A Product.
7. Each party, to the extent it has any, shall notify the other party of any
revision of clinical recommendations and precautions relevant to the 17-1A
Product.
<PAGE>
8. Each party, to the extent it has any, shall make available to the other party
on reasonable request a summary of clinical information (excluding detail
identifying patient or reporter) concerning worldwide spontaneous Adverse
Reaction reports to the other party which are relevant to the 17-1A Product.
<PAGE>
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF
THIS AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE
AGREEMENT AT THE PLACES INDICATED BY DOUBLE ASTERISKS (**); AND HAVE BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
THE WELLCOME FOUNDATION LIMITED
AND
BURROUGHS WELLCOME CO.
AND
CENTOCOR, INC.
and
CENTOCOR B.V.
------------------------------------------------------------------------------
CLINICAL AND REGULATORY DEVELOPMENT AGREEMENT
------------------------------------------------------------------------------
THE WELLCOME FOUNDATION LIMITED
Legal Department
Unicorn House
P O Box 129
160 Euston Road
London NW1 2BP
England
Dated: As of December 16, 1993
<PAGE>
TABLE OF CONTENTS
-----------------
<TABLE>
<CAPTION>
Page
----
<S> <C> <C>
1. DEFINITIONS........................................................... 2
2. CLINICAL AND REGULATORY DEVELOPMENT PROGRAM GENERALLY................. 2
3. APPOINTMENT OF COORDINATORS........................................... 3
4. ESTABLISHMENT OF PRODUCT COMMITTEE.................................... 3
5. ESTABLISHMENT OF OVERSIGHT COMMITTEE.................................. 5
6. STANDARDS............................................................. 6
7. THE TARGET PROGRAM.................................................... 6
8. CONSIDERATION......................................................... 10
9. TERMINATION........................................................... 12
10. POST TARGET DEVELOPMENT............................................... 14
11. APPROVALS TO SELL 17-1A PRODUCT....................................... 14
12. COOPERATION WITH RESPECT TO CLINICAL TRIALS........................... 15
13. PUBLIC STATEMENTS..................................................... 17
14. ADVERSE REACTIONS..................................................... 17
15. CONFIDENTIALITY....................................................... 18
16. OTHER ANTIBODIES...................................................... 20
17. JOINT AND SEVERAL LIABILITY........................................... 20
18. REPRESENTATIONS AND WARRANTIES........................................ 22
19. INDEMNIFICATION WITH RESPECT TO TARGET PROGRAM AND POST
TARGET PROGRAM........................................................ 26
20. MISCELLANEOUS......................................................... 28
</TABLE>
-i-
<PAGE>
CLINICAL AND REGULATORY DEVELOPMENT
-----------------------------------
AGREEMENT
---------
THIS CLINICAL AND REGULATORY DEVELOPMENT AGREEMENT (the "Agreement") is
---------
dated as of the 16th day of December, 1993 by and among THE WELLCOME FOUNDATION
LIMITED, a United Kingdom corporation of Unicorn House, PO Box 129, 160 Euston
Road, London NW1 2BP, England ("WELLCOME"), BURROUGHS WELLCOME CO., a North
--------
Carolina corporation of 3030 Cornwallis Road, Research Triangle Park, North
Carolina 27709 ("BW"), CENTOCOR, INC., a Pennsylvania corporation of 200 Great
--
Valley Parkway, Malvern, Pennsylvania 19355, USA ("CENTOCOR"), and CENTOCOR
--------
B.V., a Netherlands corporation of Einsteinweg 101, PO Box 251, 2300 AG Leiden,
the Netherlands ("CBV").
---
WITNESSETH:
WHEREAS, CENTOCOR is engaged in research and development of
pharmaceutical products and CENTOCOR and CBV, a wholly owned subsidiary of
CENTOCOR, own rights in a murine monoclonal antibody that binds to the 17-1A
antigen and own and operate a plant in Leiden, the Netherlands, that produces a
pharmaceutical product containing such antibody;
WHEREAS, CENTOCOR has undertaken certain research and development of
such product;
WHEREAS, CENTOCOR has entered into an anti-cancer alliance with
WELLCOME, a part of which is the distribution by WELLCOME of such product in a
territory consisting of the world except certain countries in Asia;
<PAGE>
WHEREAS, in order for such product to be manufactured, used, distributed
and sold in such territory it will be necessary for substantial additional
clinical and regulatory work to be undertaken; and
WHEREAS, CENTOCOR and WELLCOME have agreed to the extent set out herein
to collaborate in the clinical and regulatory development, testing and
commercialization of such product;
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for such other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
parties hereto, intending to be legally bound hereby, agree as follows:
1. DEFINITIONS
-----------
The terms defined in the Glossary attached as Appendix A hereto, when
----------
used in this Agreement, shall have the meanings set forth in such Glossary,
unless the context requires otherwise.
2. CLINICAL AND REGULATORY DEVELOPMENT PROGRAM GENERALLY
-----------------------------------------------------
2.1. As more fully described in this Agreement, CENTOCOR and WELLCOME
shall employ the Product and Oversight Committees to coordinate the clinical and
regulatory development of the 17-1A Product. Such Committees shall also have
such responsibilities as are set forth in the Supply Agreement.
2.2. As more fully described in this Agreement, CENTOCOR shall be
principally responsible for the Target Program.
2.3. As more fully described in this Agreement, WELLCOME shall be
principally responsible for the Post Target Program.
-2-
<PAGE>
3. APPOINTMENT OF COORDINATORS
---------------------------
3.1. As soon as possible after the date hereof, WELLCOME and CENTOCOR
shall each appoint an authorized representative (a "Coordinator"). Each such
party shall provide notice to the other as to the name of the individual so
appointed. Each such party may replace its Coordinator at any time for any
reason by providing written notice to the other party.
3.2. Each Coordinator shall be responsible for communications, other
than legal notices, among the parties with respect to the subject matter of this
Agreement.
4. ESTABLISHMENT OF PRODUCT COMMITTEE
----------------------------------
4.1. The Coordinators shall establish the Product Committee consisting
of representatives of WELLCOME and CENTOCOR.
4.2. The Product Committee will consist of at least three (3) persons
from each of CENTOCOR and WELLCOME, such persons having significant
responsibility for the development and marketing of the 17-1A Product. The
Product Committee will meet from time to time at mutually agreeable times via
teleconference or at mutually agreeable locations, but no less than once every
two (2) months during the term hereof. The Coordinators shall set the agenda
for each meeting, and each Coordinator shall determine which regular members of
the Product Committee and other representatives of the Coordinator's party shall
attend in light of the agenda. The Product Committee shall act only upon the
unanimous consent of both CENTOCOR and WELLCOME. Each party shall bear its own
costs incurred in connection with participation in the Product Committee.
-3-
<PAGE>
4.3. The Product Committee will have jurisdiction over the clinical and
regulatory development of the 17-1A Product in or with respect to the countries
in the Territory and such matters as specified in this Agreement and the Supply
Agreement, subject to the further terms of this Agreement and the Supply
Agreement; provided, however, each party shall have responsibility (subject to
-------- -------
review by and coordination with the Product Committee) for such actions as are
legally required of it by virtue of its ownership of a Permit with respect to
the 17-1A Product; provided further, the cost of fulfilling such responsibility
----------------
shall be as further set forth in this Agreement and the Supply Agreement.
4.4. The Product Committee shall determine Clinical Trial program
strategies and plans, milestones, and timetables, protocol design, selection of
contract research organizations and investigators and in general shall supervise
the Clinical Trials, the Target Program and, subject to Section 10.1 hereof, the
------------
Post Target Program.
4.5. The Product Committee shall determine the priority among countries
within the Territory with respect to the seeking of Regulatory Approval for
Targeted Indications.
4.6. In setting the priority among countries in which Regulatory
Approval for Targeted Indications will be sought, the Product Committee will
include Germany as its highest priority and will also include the United States
among the higher priority countries and will seek CPMP approval at the earliest
possible time. The Product Committee will give the following countries priority
with the goal that Regulatory Approval for Targeted Indications be obtained
therein not later than two (2) years after the later of Regulatory Approval for
Targeted Indications by the FDA or all approvals for commercial sale for
Targeted Indications by the CPMP: France, Italy, Spain, the United Kingdom,
Canada, Australia, South Africa, Austria, Belgium,
-4-
<PAGE>
Denmark, Finland, Greece, Ireland, Luxembourg, the Netherlands, Norway,
Portugal, Sweden and Switzerland. The Product Committee will designate
priorities, if any, for such other countries as it may determine from time to
time.
4.7. If, pursuant to the Supply Agreement, WELLCOME receives and
exercises the option to become the exclusive distributor of the 17-1A Product in
any of Japan, the Republic of Korea, Taiwan, the People's Republic of China, or
a combination thereof, the Product Committee will also give such one (1) or more
additional countries priorities with the goal that Regulatory Approval for the
Targeted Indications be obtained at the earliest possible time.
4.8. If at any time following a good faith discussion of an issue, the
Coordinator for either WELLCOME or CENTOCOR determines that the Product
Committee is unable to resolve an issue on an expeditious basis, such issue
shall immediately be referred to the Oversight Committee.
5. ESTABLISHMENT OF OVERSIGHT COMMITTEE
------------------------------------
5.1. As soon as possible after the date hereof, WELLCOME and CENTOCOR
shall establish an Oversight Committee consisting of two (2) senior executives
of each of CENTOCOR and WELLCOME. If the Committee were formed on the date of
the Alliance Agreement it would have consisted of Trevor M. Jones and David W.
Barry for WELLCOME and Hubert J.P. Schoemaker and David P. Holveck for
CENTOCOR. Each of CENTOCOR and WELLCOME shall name and may replace its
representatives on the Oversight Committee, provided that the representatives of
a party shall have statures within the applicable party comparable to the
statures of the individuals named above.
-5-
<PAGE>
5.2. The Oversight Committee, at the request of the Coordinator for
either WELLCOME or CENTOCOR, will meet at mutually agreeable times and
locations. The Oversight Committee shall act only by unanimous consent of all
its members. A member of the Oversight Committee may give a proxy to the other
member of the Oversight Committee from the same party.
5.3. The Oversight Committee shall regularly review the status of the
clinical and regulatory development and marketing of the 17-1A Product and
resolve any questions referred to it by either Coordinator as provided in
Section 4.8 hereof. Such resolution by the Oversight Committee shall be binding
- -----------
on the parties and, where action of the Product Committee is contemplated
hereunder, shall be deemed action of the Product Committee.
6. STANDARDS
---------
Each party agrees to carry out as expeditiously as possible its
duties and obligations with respect to the Target Program and the Post Target
Program in accordance with good clinical research practices, WELLCOME'S and
CENTOCOR'S internal standards and the requirements for Regulatory Approval in
the Territory.
7. THE TARGET PROGRAM
------------------
7.1. With respect to each country in the Territory designated by the
Product Committee, CENTOCOR shall conduct the Target Program, at its sole
expense, risk and responsibility (subject to the express indemnities provided by
WELLCOME to CENTOCOR) in accordance with this Section 7.1 and subject to review
-----------
and supervision by the Product Committee. The Product Committee shall designate
for the Target Program all of the countries identified in Section 4.6 hereof
-----------
and, if applicable,
-6-
<PAGE>
Section 4.7 hereof, and such other countries as the Product Committee from time
- -----------
to time deems appropriate.
7.1.1. Prior to submitting portions of the Target Program to the
Product Committee, CENTOCOR shall consult with WELLCOME in connection with the
design of the Target Program, including, but not limited to, Clinical Trial
program strategies and plans, milestones and timetables, protocol design and
selecting and monitoring contract research organizations and investigators.
Design of the Target Program, all Clinical Trials and the appointment of all
contract research organizations and principal investigators for the Target
Program and the Post Target Program shall be subject to the prior approval of
the Product Committee. The Clinical Trials in the Target Program shall be
designed with a goal of optimizing the commercial success and market potential
of the 17-1A Product in addition to meeting minimum regulatory requirements.
The parties currently anticipate that such Clinical Trials will involve over
(**) patients in the United States and Europe, and have an
aggregate cost of between
(**) .
7.1.2. CENTOCOR shall provide all Clinical Trial Materials for the
Target Program.
7.1.3. CENTOCOR shall conduct all Clinical Trials. All investigators
shall enter into and comply with clinical trial agreements which are
satisfactory both in form and substance to the Product Committee.
7.1.4. CENTOCOR shall take all necessary steps with all due speed and
due diligence and in accordance with the timetables established by the Product
Committee (a) toward obtaining Regulatory Approval for the Targeted Indications
in each country in the Territory referred to in Section 4.6 hereof
-----------
-7-
<PAGE>
and, if applicable, Section 4.7 hereof, and such other countries as the Product
-----------
Committee shall designate from time to time and (b) thereafter to maintain such
Regulatory Approvals.
7.1.5. With respect to the PLA Submission, CENTOCOR shall apply (a)
with respect to 17-1A Product that is produced as Final 17-1A Product in the
Leiden Facility and (b) with respect to 17-1A Product that is fully purified in
the Leiden Facility, is transported as Pre Formulated Bulk Antibody to the
Greenville Facility and is then prepared by WELLCOME as Final 17-1A Product.
7.1.6. CENTOCOR shall provide to WELLCOME regular progress reports on
Clinical Trials of the 17-1A Product, at such reasonable intervals as WELLCOME
shall request and shall promptly provide WELLCOME with copies of all
correspondence to and from all Regulatory Authorities and Regulatory Adjuncts
pertaining to the 17-1A Product and promptly report to WELLCOME all other
discussions with Regulatory Authorities and Regulatory Adjuncts that may be
material to the prospects, timing or scope of the approval, licensing, marketing
or sale of the 17-1A Product. To the extent practicable, CENTOCOR shall provide
WELLCOME with reasonable prior notice and an opportunity to attend all meetings
with Regulatory Authorities with respect to the 17-1A Product.
7.1.7. CENTOCOR shall provide all necessary, relevant and appropriate
preclinical and manufacturing data for regulatory submissions. CENTOCOR shall
further take such actions as determined by the Product Committee and shall use
best efforts to meet the timelines for issuance of Regulatory Approvals as
established by the Product Committee. CENTOCOR makes no representation to
WELLCOME that Regulatory Approvals will be obtained.
-8-
<PAGE>
7.1.8. WELLCOME shall have the right but not the obligation to observe
and review the Clinical Trials and the Target Program as more fully set forth in
Section 12 hereof.
- ----------
7.1.9. WELLCOME shall have the right but not the obligation, through
the Product Committee, to review, comment upon and provide input with respect to
the preparation of the annual reports, investigators' brochures, final medical
reports, all documents forming a part of the PLA Submission, all applications to
any Regulatory Authority or Regulatory Adjunct, protocols and safety reports.
7.1.10. WELLCOME shall be responsible for obtaining any necessary
licenses, registrations, permits and approvals to act as a contract filler of
the 17-1A Product at the Greenville Facility.
7.2. CENTOCOR shall have the right to redact materials provided to
WELLCOME pursuant to Section 7.1 hereof and to exclude WELLCOME from meetings
-----------
with Regulatory Authorities or Regulatory Adjuncts contemplated by Section 7.1
-----------
hereof only to the extent necessary to protect CENTOCOR'S trade secrets to the
extent WELLCOME has not obtained physical access to such trade secrets pursuant
to other agreements.
7.3. If any Clinical Trials or other studies are required to maintain a
Regulatory Approval for a Targeted Indication or are a condition to a Regulatory
Approval for a Targeted Indication, the satisfactory completion of such Clinical
Trials or other studies shall be deemed a part of the Target Program.
7.4. If any Regulatory Approval for a Targeted Indication shall
subsequently be rescinded, suspended or materially limited in any respect, the
steps necessary to remove such rescission,
-9-
<PAGE>
suspension or limitation shall be deemed part of the Target Program.
7.5. Subject to the express indemnities provided to CENTOCOR by
WELLCOME, CENTOCOR shall bear all costs and expenses of the Target Program.
Subject to the express indemnities provided to WELLCOME by CENTOCOR, WELLCOME'S
costs and expenses in connection with the Target Program shall not be paid by
CENTOCOR, except to the extent CENTOCOR shall have requested that WELLCOME
perform services other than in the ordinary course of participating on the
Product Committee. If CENTOCOR shall request such services, CENTOCOR shall pay
WELLCOME'S fees and expenses in connection therewith.
8. CONSIDERATION
-------------
8.1. In consideration for CENTOCOR'S collaboration in connection with
the Target Program and the benefit thereof to WELLCOME, WELLCOME will make the
following payments to CENTOCOR:
8.1.1. (**) upon receipt of Regulatory
Approval of the 17-1A Product for the Targeted Indications in each of Germany,
France, Italy, Spain and the United Kingdom, being an aggregate maximum under
this Section 8.1.1 of (**) ;
-------------
8.1.2. (**) upon receipt of Regulatory
Approval of the 17-1A Product for the Targeted Indications in each of the
following countries: Austria, Belgium, Denmark, Finland, Greece, Ireland,
Luxembourg, the Netherlands, Norway, Portugal, Sweden and Switzerland; provided,
--------
however, the aggregate maximum of payments under this Section 8.1.2 shall not
- ------- -------------
exceed (**) ;
-10-
<PAGE>
8.1.3. (**) upon submission by CENTOCOR
to the FDA of a PLA Submission for 17-1A Product for the Targeted Indications as
contemplated by Section 7.1.5 hereof, which PLA Application is accepted for
-------------
review by the FDA; and
8.1.4. (**) upon Regulatory Approval
for the United States of the 17-1A Product for the Targeted Indications.
8.2. It shall be a condition of each payment due hereunder that the
Chief Financial Officer of CENTOCOR and of CBV or such other executive officer
of CENTOCOR and CBV as is reasonably acceptable to WELLCOME deliver a
certificate to WELLCOME certifying that (a) the Regulatory Approval for the
Targeted Indications in the applicable country has been obtained and remains in
full force and effect; (b) the Regulatory Approval for the Targeted Indications
in each other country for which a payment under this Section 8 hereof has been
---------
made has not been rescinded, suspended or materially limited, which rescission,
suspension or limitation has not been terminated; and (c) CENTOCOR and CBV agree
that they continue to be bound by the terms of and will fully perform this
Agreement and the Supply Agreement and have no right to terminate this Agreement
and the Supply Agreement or their performances thereunder except in accordance
with the terms of this Agreement and the Supply Agreement, as applicable.
8.3. Each payment hereunder shall be made in immediately available
United States funds wired to CENTOCOR at such location in the United States as
CENTOCOR may designate in writing not later than three (3) Business Days prior
to the time such payment is due.
-11-
<PAGE>
8.4. If any Regulatory Approval for a Targeted Indication for which a
payment has been made under this Section 8 is rescinded by the applicable
---------
Regulatory Authority within (**) years of the date such Regulatory Approval
is issued, CENTOCOR shall promptly pay to WELLCOME an amount equal to
(**) of the payment made by WELLCOME to CENTOCOR with respect to such
Regulatory Approval. If subsequent to such rescission and during the term of
this Agreement such Regulatory Approval is again issued, WELLCOME shall pay to
CENTOCOR the amount so paid by CENTOCOR to WELLCOME.
8.5. Notwithstanding the foregoing, if a Termination Event as defined
in Section 9 hereof shall have occurred and be continuing, the obligation of
---------
WELLCOME to pay under this Section 8 shall be suspended and upon an exercise of
---------
the right to terminate pursuant to Section 9.3 hereof, the obligation to make
-----------
any such suspended payment or any payment under this Section 8 subsequent to
---------
such termination shall terminate.
9. TERMINATION
-----------
9.1. This Agreement shall terminate upon the termination of the Supply
Agreement.
9.2. The following events or circumstances shall constitute
"Termination Events":
------------------
9.2.1. An Event of Termination as defined in the Supply Agreement
shall have occurred.
9.2.2. Any representation or warranty of CENTOCOR or CBV
contained herein or given in connection with this Agreement shall be untrue or
incorrect in any respect material to this Agreement as a whole.
-12-
<PAGE>
9.2.3. Clinical Trials shall have been terminated in any country
referenced in Sections 4.6 or 4.7 hereof because of toxicity or lack of efficacy
-------------------
for the Targeted Indications.
9.3. If a Termination Event shall have occurred and be continuing,
WELLCOME shall have the option to terminate its and BW'S obligations under this
Agreement with respect to suspended payments and any payments not yet due
hereunder by giving written notice to CENTOCOR not later than the date ninety
(90) days following the date on which CENTOCOR gives written notice to WELLCOME
of the existence of the applicable Termination Event, such notice containing a
statement of the facts giving rise to such Termination Event. WELLCOME'S
remedies under this Agreement shall be cumulative. If CENTOCOR shall terminate
its performance under this Agreement or the Supply Agreement other than by
reason of a material default under, or voluntary termination of, this Agreement
or the Supply Agreement by WELLCOME, WELLCOME shall continue to have exclusive
rights to the Clinical Information and the rights hereunder of CENTOCOR to such
Clinical Information shall terminate.
9.4. Except as otherwise provided in this Section 9, if there shall be
---------
a material breach by a party hereto, the other party (CENTOCOR and CBV being
deemed one party for purposes of this Section 9.4 and WELLCOME and BW being
-----------
deemed one party for purposes of this Section 9.4) shall give written notice to
-----------
the breaching party to cure. Upon receipt of such notice, such breaching party
shall have ninety (90) days to respond by curing such default or by delivering
to the other party a certificate that such breach is not capable of being cured
within such ninety (90) days and that the breaching party is working diligently
to cure such breach. If the breaching party does not so respond or fails so to
work diligently, then the other party may terminate this Agreement.
-13-
<PAGE>
10. POST TARGET DEVELOPMENT
-----------------------
10.1. Upon completion of the Target Program with respect to a country
in the Territory, WELLCOME at its sole option shall have the right but not the
obligation to have conducted at its expense the Post Target Program with respect
to such country.
10.2. The Post Target Program shall be conducted at the direction of
the Product Committee and at WELLCOME'S sole expense, risk and responsibility,
subject to the express indemnities provided by CENTOCOR to WELLCOME.
10.3. CENTOCOR shall provide, and WELLCOME shall pay for, Clinical
Trial Materials for the Post Target Program. The price shall be at cost and
shall be due sixty (60) days after invoice. CENTOCOR shall file in a timely,
efficient and orderly manner all submissions to Regulatory Authorities and
Regulatory Adjuncts in connection with the Post Target Program as WELLCOME shall
reasonably request from time to time. WELLCOME shall reimburse CENTOCOR for any
application fees paid by CENTOCOR in connection with any such submissions.
10.4. The Post Target Program shall include (subject to Section 10.1
------------
hereof) Clinical Trials and other studies to expand the market for and remove
restrictions on the use of the 17-1A Product, but shall not include Clinical
Trials or other studies necessary to maintain Regulatory Approval for the
Targeted Indications.
11. APPROVALS TO SELL 17-1A PRODUCT
-------------------------------
WELLCOME shall be responsible, at its sole cost and expense, for
obtaining and maintaining any licenses, registrations, permits and approvals
necessary for WELLCOME as
-14-
<PAGE>
distributor to sell 17-1A Product in the Territory; provided, however, nothing
-------- --------
in this Section 11 shall limit the obligations of CENTOCOR under Section 7
---------- ---------
hereof to obtain any and all necessary or appropriate licenses, registrations,
permits and approvals for the manufacture, sale by manufacturer or use of the
17-1A Product, it being understood that the licenses, registrations, permits and
approvals contemplated by this Section 11 are solely those required by local law
----------
for the distributor of a finished product the use of which for the applicable
indications is fully approved and licensed. WELLCOME shall use its commercially
reasonable efforts to obtain and maintain all such licenses, registrations,
permits and approvals contemplated by this Section 11 in those countries in
----------
which Regulatory Approval is obtained and in which sale is contemplated by the
Country Marketing Plans.
12. COOPERATION WITH RESPECT TO CLINICAL TRIALS
-------------------------------------------
12.1. CENTOCOR shall make available to WELLCOME, to the extent
permitted by applicable Law, all information received or held by CENTOCOR or any
contract research organization or any investigator with respect to any Conducted
Clinical Trial or any Clinical Trial contemplated by this Agreement, including,
but not limited to, case report forms, data bases, analyses and reports, whether
oral or written, from investigators or contract research organizations.
12.2. CENTOCOR shall cause any agreement or release entered into or
obtained, on or after November 5, 1993, with or from any patient, investigator
or contract research organization with respect to Clinical Trials to provide
that any information released to CENTOCOR may also be released to WELLCOME.
12.3. With a view to enabling WELLCOME to support CENTOCOR'S conduct of
the Target Program and the Post Target
-15-
<PAGE>
Program by providing WELLCOME with information with respect to the Clinical
Trials and facilitating WELLCOME'S contribution of its expertise to the process,
WELLCOME shall have the right but not the obligation to observe all aspects of
the Clinical Trials, including, but not limited to, the activities of contract
research organizations and investigators. Such observation shall be conducted
on reasonable prior notice to CENTOCOR and shall be conducted in such a manner
as not to disrupt or interfere with the work of the contract research
organizations and investigators. Any communications between WELLCOME and
investigators or the contract research organizations shall make clear that
WELLCOME is an observer only and any and all instructions are to be made by
CENTOCOR. If CENTOCOR so elects, its representatives may accompany WELLCOME'S
representatives during such observations. The observations by WELLCOME may, but
are not required to, include audits of the Clinical Trials with respect to good
clinical research practices, CENTOCOR'S and WELLCOME'S internal standards and
the requirements of applicable Regulatory Authorities. CENTOCOR shall authorize
and direct all of its and CBV'S employees, contract research organizations and
investigators to furnish to WELLCOME, to the extent permitted by applicable Law,
all information with respect to Clinical Trials as WELLCOME may from time to
time request.
12.4. CENTOCOR shall take such steps and provide such information as
may be necessary or appropriate to permit WELLCOME to cross file an
Investigational New Drug Application or similar submission with the FDA and
other Regulatory Authorities; provided, however, subject to the other Alliance
-------- -------
Agreements, nothing in this Section 12.4 shall require CENTOCOR to divulge to
------------
WELLCOME any of CENTOCOR'S trade secrets.
-16-
<PAGE>
13. PUBLIC STATEMENTS
-----------------
13.1. No party hereto, nor its representatives or employees, shall make
any disclosure, including any news release or other public statement, whether to
the press, stockholders, or otherwise, disclosing the terms of this Agreement or
of any amendment hereto, without the prior written approval of the other
parties, which approval shall not be unreasonably withheld or delayed, providing
that nothing in this Section 13 shall be deemed to prevent any party hereto from
----------
making such disclosures or statements which, in the opinion of counsel, are
legally required. In the event such disclosure or statement is required, the
disclosing party shall give prior notice to the other party of the proposed
disclosure or statement and the reason therefor. CENTOCOR acknowledges that it
shall file a Current Report on Form 8-K under the Exchange Act reporting the
transactions contemplated by the Alliance Agreement, including exhibits thereto,
subject to appropriate requests for confidential treatment.
13.2. Notwithstanding Section 13.1 hereof, nothing herein shall
------------
prohibit the publication by principal investigators of scientific papers with
respect to their research to the extent permitted by their clinical trial
agreements, provided that to the extent permitted by such agreements, each party
hereto shall have the opportunity to review and comment upon such papers prior
to publication and shall have reasonable advance notice of the time of such
publication.
14. ADVERSE REACTIONS
-----------------
During the term of this Agreement each party shall immediately report to
the other parties any information coming into the first party's possession
concerning Adverse Reactions
-17-
<PAGE>
arising out of any Clinical Trials and shall take all steps required by
applicable Law with respect to such Adverse Reactions.
15. CONFIDENTIALITY
---------------
15.1. "Proprietary Information" for the purposes of this Section 15
----------------------- ----------
means all inventions, discoveries, improvements and methods, business plans,
marketing techniques and plans, manufacturing and other plant designs, locations
of operations and any other information affecting the business operations of the
Disclosing Party and which is identified by the Disclosing Party at the time of
disclosure as being confidential or proprietary.
15.2. Except as expressly provided herein otherwise, each Receiving
Party shall, during the term of this Agreement including any renewals hereof,
and for a period of five (5) years following expiration or the termination
hereof, but in any event not for less than a period of ten (10) years from the
date hereof, maintain the confidentiality of all Proprietary Information
disclosed by the Disclosing Party hereunder and shall neither use the same
except as expressly authorized by this Agreement or any other Alliance Document,
nor disclose the same to any Third Party without the prior written consent of
the Disclosing Party. Nothing in this Section 15, however, shall be construed
----------
to require any party hereto to maintain the confidentiality and non-use of any
information or material that (a) at the time of disclosure, is already in the
public domain; (b) after disclosure, enters the public domain otherwise than by
an act or omission of the Receiving Party in violation of the terms of this
Agreement; (c) prior to disclosure under this Agreement was already in the
possession of the Receiving Party or its Affiliates, provided that such
information or material was not obtained, directly or indirectly, from the
Disclosing Party
-18-
<PAGE>
under this Agreement or under any other obligation of confidentiality from the
Receiving Party to the Disclosing Party; (d) becomes known to the Receiving
Party from a Third Party, provided that such information or material was not
obtained, directly or indirectly, from the other party on a confidential basis;
(e) is required in the reasonable judgment of the Receiving Party to be
disclosed to a Governmental Entity in furtherance of this Agreement or the
Alliance Agreement or pursuant to any Law, Permit, or Court Order; or (f)
results from research or development by the Receiving Party or its Affiliate
independent of disclosures from the Disclosing Party. Disclosures made prior to
the date of this Agreement pursuant to that certain Confidentiality Agreement
between CENTOCOR and WELLCOME dated September 14, 1993 shall be governed by such
Confidentiality Agreement and to the extent not inconsistent therewith this
Section 15; other disclosures prior to the date of this Agreement of
- ----------
Proprietary Information shall be governed by the terms of this Section 15.
----------
15.3. Nothing in this Section 15 shall prevent any party hereto from
----------
disclosing its own information relating to its business, financial affairs,
products, research development, marketing and other commercial activities to any
Affiliate or any Third Party. In addition, notwithstanding the restrictions in
this Section 15 on confidentiality and use, any party hereto may disclose
----------
Proprietary Information which is disclosed to it hereunder to any of its
Affiliates which agrees to be bound by the terms of this Section 15.
----------
15.4. Nothing in this Section 15 shall prevent or restrict WELLCOME and
----------
its Affiliates from using and/or disclosing Proprietary Information received
from CENTOCOR or CBV where such use and/or disclosure is reasonably regarded by
WELLCOME or its Affiliates as necessary to enable WELLCOME to carry out its
obligations under the Target Program or the Post Target Program,
-19-
<PAGE>
provided that WELLCOME and its Affiliates shall take all reasonable steps to
ensure that disclosure of any such Proprietary Information is as limited as
possible and disclosed on a confidential basis.
16. OTHER ANTIBODIES
----------------
16.1. During the term of this Agreement and the Supply Agreement,
CENTOCOR shall not develop, conduct clinical trials or seek regulatory approval
or license out rights to any Third Party with respect to, marketing, selling or
distributing any Derivative 17-1A Antibody or any product derived therefrom or
from the 17-1A Antibody except with, and pursuant to an agreement with,
WELLCOME.
16.2. If the Product Committee determines that it is not scientifically
or commercially feasible to continue the Target Program with the 17-1A Product,
or a Termination Event occurs, WELLCOME may, but is under no obligation to,
substitute under this Agreement for the 17-1A Product another product that is or
contains a Derivative 17-1A Antibody.
17. JOINT AND SEVERAL LIABILITY
---------------------------
17.1. Each obligation and liability of CENTOCOR under this Agreement
shall be an independent, joint and several obligation of CENTOCOR and CBV. Each
of CENTOCOR and CBV shall be fully liable for performance under this Agreement
notwithstanding (a) the voluntary or involuntary liquidation, dissolution, sale
or other disposition of all, or substantially all of the assets, marshalling of
assets and liabilities, receivership, insolvency, bankruptcy, assignment for the
benefit of creditors, reorganization, arrangement, composition with creditors or
readjustment of, or other similar proceedings affecting CBV or CENTOCOR or any
contest of the validity of this Agreement in any
-20-
<PAGE>
such proceeding; or (b) any Law or Court Order now or hereafter in effect in any
jurisdiction which might in any manner affect any of such terms or provisions or
any of the rights of WELLCOME or BW with respect thereto or which might cause or
permit CBV or CENTOCOR to invoke any defense to, or any alteration in the time,
amount or manner of performance of any or all of their respective obligations
under this Agreement except to the extent such Law or Court Order renders such
obligations unlawful or to the extent such Court Order constitutes a remedy for
a breach by WELLCOME or BW. The invalidity or unenforceability of this
Agreement as to either of CENTOCOR or CBV shall not render this Agreement
invalid or unenforceable as to the other. The invalidity or unenforceability of
this Agreement in any jurisdiction shall not in itself render this Agreement
unenforceable in another jurisdiction. If any obligation hereunder of either
CBV or CENTOCOR is not performed by such party punctually, the other of CBV or
CENTOCOR, as applicable, will, without demand being made by WELLCOME,
immediately perform such obligation.
17.2. To the extent that BW has an obligation hereunder, either
expressly or by assignment by WELLCOME, WELLCOME hereby guarantees the full
payment and performance of such obligation. Each of WELLCOME and BW shall be
fully liable for performance of their obligations under this Agreement
notwithstanding (a) the voluntary or involuntary liquidation, dissolution, sale
or other disposition of all, or substantially all of the assets, marshalling of
assets and liabilities, receivership, insolvency, bankruptcy, assignment for the
benefit of creditors, reorganization, arrangement, composition with creditors or
readjustment of, or other similar proceedings affecting BW or WELLCOME or any
contest of the validity of this Agreement in any such proceeding; or (b) any Law
or Court Order now or hereafter in effect in any jurisdiction which might in any
manner affect any of such terms or provisions or any of the rights of CENTOCOR
with respect thereto or which might cause or permit BW or
-21-
<PAGE>
WELLCOME to invoke any defense to, or any alteration in the time, amount or
manner of performance of any or except to the extent such Law or Court Order
renders such obligations unlawful or to the extent such Court Order constitutes
a remedy for a breach by CENTOCOR or CBV. The invalidity or unenforceability of
this Agreement as to either of WELLCOME or BW shall not render the respective
obligations of the other under this Agreement invalid or unenforceable. The
invalidity or unenforceability of this Agreement in any jurisdiction shall not
in itself render this Agreement unenforceable in another jurisdiction. If any
obligation hereunder of BW is not performed by it punctually, WELLCOME will,
without demand being made by CENTOCOR, immediately perform such obligation.
18. REPRESENTATIONS AND WARRANTIES
------------------------------
18.1. All Parties. WELLCOME and BW hereby represent and warrant
-----------
jointly and severally as to each of WELLCOME and BW; and CENTOCOR and CBV hereby
jointly and severally represent and warrant as to each of CENTOCOR and CBV:
18.1.1. Organization, Standing and Qualification. It is a
----------------------------------------
corporation duly organized, validly existing, and in good standing under the
laws of its jurisdiction of incorporation.
18.1.2. Power and Authority; Enforceability. It has the
-----------------------------------
requisite power and authority (corporate and otherwise) to execute, deliver and
perform this Agreement and to consummate the transactions contemplated hereby.
The execution, delivery and performance by it of this Agreement and the
consummation by it of the transactions contemplated hereby have been duly
authorized by all necessary action (corporate and otherwise) on its part. This
Agreement constitutes its legal, valid and binding obligation enforceable in
accordance with its terms, except as such enforcement may be limited by
applicable
-22-
<PAGE>
bankruptcy, insolvency, moratorium or similar laws affecting the enforcement of
creditors' rights generally.
18.1.3. Validity of Contemplated Transactions. The execution,
-------------------------------------
delivery and performance by it of this Agreement and the consummation by it of
the transactions contemplated hereby do not (a) violate or contravene any
provision of its charter or bylaws; (b) violate, breach, conflict with,
constitute a Default under, cause the acceleration of any payments pursuant to,
or otherwise impair the good standing, validity, or effectiveness of any
agreement, contract, indenture, lease, license, or mortgage to which it is a
party or by which it or any of its properties or assets are bound; (c) subject
any of its properties or assets to any Lien or to any indenture, mortgage,
contract, commitment, or agreement (other than this Agreement) to which it is a
party or by which it or any of its properties or assets are bound; (d) violate
any provision of any Law, Permit or Court Order applicable to it or any of its
properties or assets; or (e) other than filings which have already been made,
require any Permit or Required Consent of any Governmental Entity to be obtained
by it.
18.1.4. Litigation; Compliance with Laws. There is no
--------------------------------
Litigation pending or, to its knowledge, threatened against or related to it,
nor any failure to comply with, violation of or any Default under, any Law,
Permit or Court Order applicable to it, in each case which might have a material
adverse effect on the ability of it to execute, deliver and perform this
Agreement or on the ability of it to consummate the transactions contemplated
hereby.
18.2. By CENTOCOR and CBV. CENTOCOR and CBV represent and warrant that
-------------------
with respect to each of them:
18.2.1. Intellectual Property. To the best of CENTOCOR'S
---------------------
knowledge, CENTOCOR and CBV own, possess or lawfully
-23-
<PAGE>
use pursuant to legal, valid, binding and enforceable agreements all
Intellectual Property necessary or appropriate in connection with the
development, production, testing and sale by them of the 17-1A Product. The
inception, development and reduction to practice of any of the Intellectual
Property in connection with the development, production, testing and sale by
them of the 17-1A Product has not constituted or involved the misappropriation
by CENTOCOR or its Affiliates or, to the best of its knowledge, by Third
Parties, of trade secrets or other rights of any other Person (including,
without limitation, any Governmental Entity). In connection with the
development, production, testing and sale (including sale for resale) by them of
the 17-1A Product, neither CENTOCOR nor any of its Affiliates (and in connection
with their resale of the 17-1A Product, neither WELLCOME nor any of its
Affiliates), to the best of CENTOCOR'S knowledge, is or may be infringing on or
otherwise acting adversely to the rights of any Person under or in respect of
any of the Intellectual Property of such Person. To the best of CENTOCOR'S and
CBV'S knowledge, no Person is or may be infringing on or otherwise acting
adversely to the rights of CENTOCOR or any of its Affiliates under or in respect
of any of the Intellectual Property which is used in connection with the
development, production, testing and sale by them of the 17-1A Product.
18.2.2. Wistar License. CENTOCOR is party to the Wistar
--------------
License, which is valid, binding and enforceable, and, pursuant to such license,
is the exclusive licensee of the Wistar Rights, has not sublicensed the Wistar
Rights to any Person excluding Ajinomoto pursuant to the Ajinomoto Agreement,
and no Person other than CENTOCOR is entitled, either currently or during the
term of the Supply Agreement, to license the Wistar Rights. CENTOCOR holds such
Wistar Rights free and clear of all Liens, claims and other encumbrances,
covenants, conditions, or restrictions. There are no licenses, options, rights
of first refusal, conditional sales agreements or other arrangements,
-24-
<PAGE>
whether oral or written, which affect any portion of or all such Wistar Rights
other than the rights granted to Ajinomoto pursuant to the Ajinomoto Agreement.
18.2.3. Cell Line. The cell line from which CENTOCOR and CBV
---------
obtain the 17-1A Antibody is the Centocor Hybridoma. To the extent that such
cell line differs from the Wistar Hybridoma, CENTOCOR and CBV own all right,
title and interest in such cell line, free and clear of all Liens, claims and
other encumbrances, conditions, covenants or restrictions.
18.2.4. Conducted Clinical Trials. The Conducted Clinical
-------------------------
Trials were conducted solely and exclusively by the Persons identified on
Schedule 12.1 hereto, and CENTOCOR owns all data, information, and results of
- -------------
the Conducted Clinical Trials free and clear of all Liens, claims and other
encumbrances, conditions, covenants or restrictions except applicable patient
confidentiality rights. There are no licenses, options, rights of first
refusal, conditional sales agreements or other arrangements, whether oral or
written, which affect any portion of or all the data, information, and results
of the Conducted Clinical Trials.
18.2.5. Capacity. CENTOCOR and CBV own or lawfully control
--------
facilities and Intellectual Property, and have employees with expertise,
necessary or appropriate to produce the 17-1A Product pursuant to Regulatory
Approvals in quantities sufficient to fulfill their obligations under this
Agreement and the Supply Agreement without, to the best of CENTOCOR'S and CBV'S
knowledge, infringing the rights of any Third Party.
18.2.6. Veracity of Statements. No representation or warranty
----------------------
by it contained in this Agreement or in any certificate, schedule or other
document or instrument furnished to it pursuant hereto, contains or will contain
any untrue
-25-
<PAGE>
statement of a material fact or omits or will omit to state a material fact
necessary to make it not misleading.
18.3. The representations and warranties contained herein shall survive
execution and delivery of this Agreement.
19. INDEMNIFICATION WITH RESPECT TO TARGET PROGRAM AND POST TARGET PROGRAM.
----------------------------------------------------------------------
19.1. By CENTOCOR and CBV. Subject to compliance by the applicable
-------------------
Indemnitee as defined below with its obligations set forth in Sections 19.4 and
-----------------
19.5 hereof, CENTOCOR and CBV shall defend, indemnify and hold WELLCOME, BW and
- ----
their respective Affiliates and the respective directors, officers, employees
and agents of WELLCOME, BW and their respective Affiliates, harmless from and
against any and all Losses arising out of, relating to or resulting from:
19.1.1. the Target Program, including, but not limited to,
patient claims in connection with the Target Program; except to the extent such
Losses arise out of the negligence or willful misconduct of WELLCOME or any of
its Affiliates in connection with the Target Program; and
19.1.2. the Post Target Program to the extent such Losses arise
out of the negligence or willful misconduct of CENTOCOR or any of its Affiliates
in connection with the Post Target Program.
19.2. By WELLCOME and BW. Subject to compliance by the applicable
-------------------
Indemnitee as defined below with its obligations set forth in Sections 19.4 and
-----------------
19.5 hereof, WELLCOME and BW shall defend, indemnify and hold CENTOCOR, CBV and
- ----
CENTOCOR'S Affiliates and the respective directors, officers, employees and
agents of CENTOCOR, CBV and the CENTOCOR'S Affiliates, harmless
-26-
<PAGE>
from and against any and all Losses arising out of, relating to or resulting
from the Post Target Program to the extent such Losses arise out of the
negligence or willful misconduct of WELLCOME, BW or any of their respective
Affiliates in connection with the Post Target Program.
19.3. "Indemnitor" means CENTOCOR and CBV with respect to Section 19.1
---------- ------------
hereof and WELLCOME and BW with respect to Section 19.2 hereof. "Indemnitee"
------------ ----------
means any of WELLCOME, BW and their respective Affiliates and the respective
directors, officers, employees and agents of WELLCOME, BW and their respective
Affiliates with respect to Section 19.1 hereof and any of CENTOCOR, CBV and
------------
CENTOCOR'S Affiliates and the respective directors, officers, employees and
agents of CENTOCOR, CBV and CENTOCOR'S Affiliates with respect to Section 19.2
------------
hereof.
19.4. Notice. Promptly after receipt by an Indemnitee of written
------
notice of the commencement of any suit, audit, demand, judgment, action,
investigation or proceeding relating to a Loss (a "Third Party Action") or
------------------
promptly after an Indemnitee incurs a Loss or has knowledge of the existence of
a Loss, such Indemnitee will, if a claim with respect thereto is to be made
against Indemnitor due to Indemnitor's obligation to provide indemnification
hereunder, give Indemnitor written notice of such Loss or the commencement of
such Third Party Action; provided, however, the failure to provide such notice
-------- -------
within a reasonable period of time shall not relieve Indemnitor of any of its
obligations hereunder except to the extent it is prejudiced by such failure.
19.5. Defense. The Indemnitor shall control the defense and settlement
-------
of a Third Party Action, except that (a) the applicable Indemnitee may assume
such defense provided that the obligation of the Indemnitor to pay the
attorneys' fees of such Indemnitee shall cease upon such election and (b) upon
the
-27-
<PAGE>
applicable Indemnitee determining that its interests are divergent from
those of the Indemnitor, the Indemnitee may assume such defense and the
Indemnitor shall remain liable for the attorneys' fees of such Indemnitee. If
the Indemnitor defends such action, it shall not enter into any resolution or
other compromise of such action unless it (x) pays in cash or posts an adequate
bond for the payment of the amount of such resolution or other compromise and
obtains a complete release of the Indemnitee or (y) obtains the prior written
consent of the Indemnitee, which shall not be unreasonably withheld or delayed.
If the Indemnitee defends such action, such Indemnitee shall not enter into any
resolution or other compromise of such action unless such Indemnitee obtains the
consent of the Indemnitor, which shall not be unreasonably withheld or delayed.
The party defending the action shall keep the other parties informed on an
ongoing basis of the status of such Third Party Action and shall deliver to such
other parties copies of all documents relating to the Third Party Action as the
other party may reasonably request. The party assuming such defense shall
receive from the others all necessary and reasonable cooperation in the defense
of a Third Party Action including, but not limited to, the services of employees
of such other parties who are familiar with the events or circumstances out of
which any such Third Party Action may have arisen.
19.6. The indemnifications contained in this Section 19 shall survive
----------
termination of this Agreement.
20. MISCELLANEOUS
-------------
20.1. Entire Agreement. This Agreement and the other Alliance
----------------
Agreements constitute the entire understanding of the parties with respect to
the subject matter contained herein and supersede any prior understandings and
agreements among them respecting such subject matter including, without
limitation, the
-28-
<PAGE>
Letter of Intent between CENTOCOR and WELLCOME dated September 16, 1993;
provided, however, the confidentiality agreement between WELLCOME and CENTOCOR
- -------- -------
dated September 14, 1993 shall in all cases remain in full force and effect in
accordance with its terms.
20.2. Amendments. This Agreement may be amended and supplemented
----------
only by a written instrument duly executed by each of the parties.
20.3. Headings. The headings in this Agreement are for convenience of
--------
reference only and shall not affect its interpretation.
20.4. Gender; Number. Words of gender may be read as masculine,
--------------
feminine, or neuter, as required by context. Words of number may be read as
singular or plural, as required by context.
20.5. Appendices; Exhibits; and Schedules. All appendices, exhibits
-----------------------------------
and schedules referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.
20.6. Severability. If any provision of this Agreement or the
------------
application thereof to any Person or circumstance is held illegal, invalid, or
unenforceable, such illegality, invalidity, or unenforceability shall not affect
any other provision hereof. This Agreement shall, in such circumstances, be
deemed modified to the extent necessary to render enforceable the provisions
hereof to the fullest extent permitted by Law.
20.7. Remedies. Each of CENTOCOR and CBV on the one hand, and WELLCOME
--------
and BW on the other, stipulates that the remedies at Law of the other in the
event of any default or threatened default in the performance of or compliance
with any of the terms
-29-
<PAGE>
of this Agreement are not and will not be adequate and that, to the fullest
extent permitted by Law, such terms may be specifically enforced by a decree for
specific performance of any agreement contained herein or by an injunction
against any violation of any terms hereof or otherwise.
20.8. Notices. All notices and other communications hereunder shall be
-------
in writing and shall be given to the Person either personally or by sending a
copy thereof by first class United States express mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, or by telecopier (with the
original sent by either of the foregoing manners), to such Person's address (or
to such Person's telecopier number). All notices shall be deemed to have been
given to the person entitled thereto when received.
If to WELLCOME or BW, to:
THE WELLCOME FOUNDATION LIMITED
Unicorn House, P.O. Box 129
129 Euston Road
London NW1 2BP
Attention: Company Secretary
Telecopy No.: 011-44-71-388-5462
and
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
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<PAGE>
If to CENTOCOR or CBV, to:
CENTOCOR, INC.
200 Great Valley Parkway
Malvern, Pennsylvania 19355-1307
Attention: Corporate Secretary
Telecopy No.: (215) 651-6100
with a copy to:
Duane, Morris & Heckscher
One Liberty Place
Philadelphia, PA 19103
Attention: David C. Toner, Esquire
Telecopy No.: (215) 979-1020
Notice of any change in any such address shall also be given in the manner set
forth above. Whenever the giving of notice is required, the giving of such
notice may be waived by the Person entitled to receive such notice.
20.9. Waiver. No provision of this Agreement may be waived except by a
------
written instrument signed by the party hereto sought to be bound. No failure or
delay by any party hereto in exercising any right or remedy hereunder or under
applicable Law will operate as a waiver thereof, and a waiver of a particular
right or remedy on one (1) occasion will not be deemed a waiver of any other
right or remedy, or a waiver on any subsequent occasion (it being understood
that specific time frames for notice or actions to be taken shall be binding on
the parties).
20.10. Assignment. No party hereto may assign its rights or delegate
----------
any of its obligations hereunder without the prior written consent of the other
parties, except that, without such consent, (a) WELLCOME may assign all or any
part of its rights
-31-
<PAGE>
and obligations hereunder to an Affiliate of WELLCOME, including but not limited
to BW, so long as WELLCOME unconditionally guarantees the obligations of such
Affiliate; (b) WELLCOME and BW may assign all of their rights and delegate all
of their duties under this Agreement to the transferee of all or substantially
all of the line of business of which this Agreement forms a part or by way of
merger or consolidation with another company; and (c) CENTOCOR and CBV may
assign all of their rights and delegate all of their duties to a transferee of
all or substantially all their assets or by way of merger or consolidation with
another company. Without limiting the foregoing, all rights and obligations
with respect to the subject matter of this Agreement as to the United States
(including the payment of the amounts contemplated by Sections 8.1.3 and 8.1.4
------------------------
hereof) shall inure to the benefit of and be performed by BW, subject to such
further assignments as may be permitted by this Section 20.10. If any party
-------------
shall assign its rights and delegate its duties pursuant to clauses (b) or (c)
------------------
of this Section 20.10, the Person to whom such rights are assigned and duties
-------------
are delegated shall assume all of the obligations of the applicable party under
this Agreement. The guarantee by WELLCOME referenced in clause (a) of this
----------
Section 20.10 is a guaranty of payment and performance, and not of collection;
- -------------
and in case of a default by an Affiliate of WELLCOME to which rights have been
assigned or obligations delegated pursuant to such clause (a), CENTOCOR and CBV
----------
shall have the right to proceed first against WELLCOME without the necessity to
proceed against or join such Affiliate.
20.11. Successors and Assigns. This Agreement shall bind, inure to the
----------------------
benefit of, and be enforceable by the successors and permitted assigns of the
parties hereto.
20.12. Governing Law. This Agreement shall be construed and enforced in
-------------
accordance with the Laws of the Commonwealth of
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<PAGE>
Pennsylvania without regard to principles of conflicts of law applicable in such
jurisdiction.
20.13. No Benefit to Others. The representations, warranties, covenants
--------------------
and agreements contained in this Agreement are for the sole benefit of the
parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring, and are not intended to confer, any rights on any other
Person.
20.14. Independent Contractors. It is expressly understood and agreed
-----------------------
that the Centocor Group and the Wellcome Group are independent contractors;
neither the Centocor Group or any of its members, nor the Wellcome Group or any
of its members, shall be deemed the agent of the other group or of any of such
group's members for any purpose whatsoever, and neither the Centocor Group or
any of its members, nor the Wellcome Group or any of its members, shall have
authority to enter into any contract or agreement, assume any obligation or make
any warranty or representation for or on behalf of the other group or any of its
members. Nothing in this Agreement shall be deemed to create or constitute a
partnership or the relationship of employer and employee between the Wellcome
Group or any of its members on the one hand and the Centocor Group or any of its
members on the other.
20.15. Further Assurances. At the request of any party hereto, the
------------------
other parties hereto shall execute and deliver from time to time such further
instruments and shall provide reasonable cooperation in such proceedings or
actions as shall be necessary or reasonably appropriate to effectuate the
purposes of this Agreement including, without limitation, registering or
recording the rights granted hereunder in appropriate offices of particular
Governmental Entities; provided, however, that if any party hereto desires to
-------- -------
notify this Agreement under Article 85(3)
-33-
<PAGE>
of the Treaty of Rome establishing the European Economic Community, such party
shall give the other parties ninety (90) days prior written notice of such
notification and if during such period a party shall reasonably object to such
notification, the objecting party need not cooperate in such notification and
such notification shall not be implemented. Except as otherwise provided in the
Alliance Documents, the executions, deliveries and cooperation of each party
under this Section 20.15 shall be without further consideration and at such
-------------
party's expense.
20.16. Counterparts. This Agreement and any amendment or supplement
------------
hereto may be executed in any number of counterparts and any party hereto may
execute any such counterpart, each of which when executed and delivered shall be
deemed to be an original and all of which counterparts taken together shall
constitute but one and the same instrument. The execution of this Agreement and
any such amendment or supplement by any party hereto will not become effective
until counterparts hereof have been executed by all the parties hereto.
20.17. Savings Clause. Any restriction or information provision (as
--------------
each of these terms or expressions are defined in the RTPA) contained in this
Agreement or in any arrangement of which this Agreement forms part by virtue of
which this Agreement or any such arrangement is registrable under the RTPA shall
not take effect in the United Kingdom until the day after the day on
-34-
<PAGE>
which full particulars of this Agreement (and of any such arrangement) shall
have been duly furnished to the Office of Fair Trading under Section 24 of the
----------
RTPA.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed as of the day and year first above written by their duly authorized
representatives.
FOR AND ON BEHALF OF
THE WELLCOME FOUNDATION LIMITED
Signed: /s/ Trevor M. Jones
------------------------------
Name: Trevor M. Jones
--------------------------------
Title: Director/Research, Development
-------------------------------
& Medical
-------------------------------
BURROUGHS WELLCOME CO.
Signed: /s/ David W. Barry
------------------------------
Name: David W. Barry
--------------------------------
Title: Vice President of Research
-------------------------------
Development and Medical
-------------------------------
CENTOCOR, INC.
Signed: /s/ Bobba Venkatadri
------------------------------
Name: Bobba Venkatadri
--------------------------------
Title: Executive Vice President
-------------------------------
[EXECUTIONS CONTINUED]
-35-
<PAGE>
CENTOCOR B.V.
Signed: /s/ David P. Holveck
------------------------------
Name: David P. Holveck
--------------------------------
Title: Managing Director
-------------------------------
-36-
<PAGE>
APPENDIX A
----------
GLOSSARY OF TERMS
-----------------
[See Appendix A to Alliance Agreement]
-37-
<PAGE>
SCHEDULE 12.1
CONDUCTED CLINICAL TRIALS
(**)
<PAGE>
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THIS
AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE AGREEMENT AT
THE PLACES INDICATED BY DOUBLE ASTERISKS (**); AND HAVE BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
THE WELLCOME FOUNDATION LIMITED
AND
BURROUGHS WELLCOME CO.
AND
CENTOCOR, INC.
AND
CENTOCOR B.V.
- --------------------------------------------------------------------------------
MANUFACTURING TECHNOLOGY OPTION AGREEMENT
- --------------------------------------------------------------------------------
The Wellcome Foundation Ltd
Legal Department
Unicorn House
P O Box 129
160 Euston Road
London NW1 2BP
England
Dated: As of December 16, 1993
<PAGE>
TABLE OF CONTENTS
-----------------
<TABLE>
<CAPTION>
Page
----
<S> <C> <C>
1. DEFINITIONS ........................................................... 2
2. OPTION AND RELATED TERMS .............................................. 2
3. SCOPE OF LICENSE ...................................................... 3
4. TRANSFER OF MANUFACTURING TECHNOLOGY .................................. 3
5. PAYMENTS .............................................................. 5
6. OWNERSHIP OF TECHNOLOGY ............................................... 10
7. REPRESENTATIONS AND WARRANTIES ........................................ 10
8. INDEMNIFICATION ....................................................... 15
9. INFRINGEMENT .......................................................... 17
10. TERM AND TERMINATION .................................................. 17
11. MISCELLANEOUS ......................................................... 18
</TABLE>
-i-
<PAGE>
MANUFACTURING TECHNOLOGY OPTION AGREEMENT
THIS MANUFACTURING TECHNOLOGY OPTION AGREEMENT (the "Agreement") is dated
---------
as of the 16th day of December, 1993 by and among CENTOCOR, INC., a Pennsylvania
corporation of 200 Great Valley Parkway, Malvern, Pennsylvania 19355-1307, USA
("CENTOCOR"), CENTOCOR B.V., a Netherlands corporation headquartered at
--------
Einsteinweg 101, PO Box 251, 2300 AG Leiden, the Netherlands ("CBV"), THE
---
WELLCOME FOUNDATION LIMITED, a United Kingdom corporation of Unicorn House, PO
Box 129, 160 Euston Road, London NW1 2BP, England ("WFL"), and BURROUGHS
---
WELLCOME CO., a North Carolina corporation of 3030 Cornwallis Road, Research
Triangle Park, NC 27709-4498, USA (individually, "BW," and collectively with
--
WFL, "WELLCOME").
--------
W I T N E S S E T H:
--------------------
WHEREAS, WELLCOME, CENTOCOR and CBV have entered into an Anti-Cancer
Alliance Agreement dated as of November 5, 1993 (the "Alliance Agreement") which
------------------
governs the parties' collaboration in the development, manufacture, marketing,
sale and distribution of products for the treatment of cancers;
WHEREAS, among other things, the Alliance Agreement contemplates that WFL,
CENTOCOR and CBV will enter into a Cancer Products Option Agreement of even date
herewith granting WFL the option to obtain from CENTOCOR and CBV a sublicense or
an assignment of the right to manufacture one (1) or more Cancer Products (as
defined in Appendix A hereto, each such license or assignment to be referred to
----------
herein as a "Cancer Product License");
----------------------
WHEREAS, CENTOCOR and CBV own and continue to develop certain Manufacturing
Technology (as defined in Appendix A hereto and more specifically described in
----------
Schedule 1 hereto) relating to
- ----------
-1-
<PAGE>
the fermentation, downstream processing and formulation of Biological Products
(as defined in Appendix A hereto); and
----------
WHEREAS, the parties contemplate that WELLCOME and/or its Affiliates may
desire to use the Manufacturing Technology in the production of Cancer Products
in accordance with one (1) or more Cancer Product Licenses, and/or the
manufacture of other Biological Products;
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for such other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
parties hereto, intending to be legally bound hereby, do hereby agree as
follows:
1. DEFINITIONS
-----------
Capitalized terms not otherwise defined herein shall have the meanings set
forth in Appendix A hereto.
----------
2. OPTION AND RELATED TERMS
------------------------
2.1. CENTOCOR and CBV hereby grant to WELLCOME an irrevocable option to
obtain from them a nonexclusive, worldwide license, in and under the
Manufacturing IP, to use the Manufacturing Technology to produce Biological
Products in accordance with the terms set forth herein. WELLCOME may exercise
the option granted herein by written notice provided to CENTOCOR at any time on
or before May 31, 1994. Except as the parties may mutually agree, failure by
WELLCOME to exercise such option within the period specified by this Section 2.1
-----------
shall render this Agreement of no further force or effect.
2.2. For so long as the option provided for in this Section 2 shall be
---------
exercisable and, thereafter if the option
-2-
<PAGE>
provided for in this Section 2 shall have been exercised, CENTOCOR or CBV shall
---------
take all such steps as may be necessary or proper, including the payment of any
minimum royalties, research payments or other moneys that may come due under any
agreements granting CENTOCOR or CBV rights to the Manufacturing Technology, to
preserve, renew or revalidate such agreements, or the rights thereunder, to
prevent their becoming void, expired, terminated, cancelled, or withdrawn.
3. SCOPE OF LICENSE
----------------
Effective on the date on which CENTOCOR timely receives WELLCOME'S notice
exercising the option granted by Section 2 hereof (the "License Date"), CENTOCOR
--------- ------------
and CBV shall be deemed, subject to the terms set forth in this Agreement, to
have granted WELLCOME a nonexclusive, worldwide right and license under the
Manufacturing IP, including the technology described in Schedule 1 hereto but
----------
excluding the technology rights granted to CENTOCOR or CBV under the agreements
listed in Schedule 3 hereto, to use the Manufacturing Technology to develop,
----------
make, have made, market, use and sell (a) Cancer Products to the extent each
such Cancer Product is the subject of a valid Cancer Product License; and/or (b)
other Biological Products. Such right and license shall not include a right to
sublicense to any party other than a WELLCOME Affiliate without CENTOCOR'S prior
written consent.
4. TRANSFER OF MANUFACTURING TECHNOLOGY
------------------------------------
4.1. Within one (1) month after the License Date (or such other period as
the parties mutually agree), CENTOCOR and CBV shall begin transferring to
WELLCOME the Manufacturing Technology requested in writing by WELLCOME in
accordance with the transfer program outlined in Schedule 4.1 hereto (the
------------
"Transfer Program"), as modified from time to time by mutual agreement of the
- -----------------
parties. In addition, CENTOCOR and CBV from time to time will provide such
-3-
<PAGE>
additional technical assistance and Know-how as is reasonably requested by
WELLCOME to permit WELLCOME to use the Manufacturing Technology to manufacture
Biological Products in accordance with the license granted by Section 3 hereof.
---------
Such technical assistance shall include, without limitation, appropriately
qualified CENTOCOR and CBV personnel being present at WELLCOME'S facilities upon
WELLCOME'S request to assist in the installation, qualification and validation
of the Manufacturing Technology and the availability of technical support
following such installation, qualification and validation until the date on
which WELLCOME'S payment is due under Section 5.1.2 hereof.
-------------
4.2. Without limiting the obligations imposed by Section 4.1 hereof, the
-----------
parties agree that CENTOCOR and CBV shall, as soon as practicable after the
License Date or, to the extent the Manufacturing Technology includes information
coming into existence after the License Date, promptly after such information
comes into existence:
4.2.1. Deliver to WELLCOME copies of such Manufacturing Technology
as may be in written or other tangible form;
4.2.2. Reduce to written or other tangible form such
additional Manufacturing Technology that can be reduced to written or other
tangible form, and transfer the same to WELLCOME; and
4.2.3. Provide personal demonstrations of any remaining
Manufacturing Technology.
4.3. As soon as practicable after the License Date, WELLCOME
and CENTOCOR shall each appoint an authorized representative (a "Coordinator").
-----------
Each such party shall provide notice to the other as to the name of the
individual appointed by
-4-
<PAGE>
it as a Coordinator. Each such party may replace its Coordinator at any time
for any reason by providing written notice to the other party. Each Coordinator
shall be responsible for communications, other than legal notices, among the
parties with respect to the subject matter of this Agreement.
4.4. The Coordinators shall establish a committee (the "Technology
----------
Transfer Committee") consisting of representatives of WELLCOME and CENTOCOR.
- ------------------
The Technology Transfer Committee will meet from time to time, at mutually
agreeable times and locations, to review the progress of, and proposed changes
to, the Transfer Program and such additional matters as either party may
consider appropriate or necessary concerning the subject matter of this
Agreement.
5. PAYMENTS
--------
5.1. License Fees: In exchange for the license granted pursuant to
------------
Section 3 hereof, WELLCOME agrees to make the following payments to CENTOCOR:
- ---------
5.1.1. A one-time payment of (**)
within ten (10) days of the License Date;
5.1.2. A one-time payment of
(**) on September 30, 1994 if, prior to that date, CENTOCOR and CBV
(a) have provided to WELLCOME all of the deliverables listed in Schedule 4.1
------------
hereto and requested in writing by WELLCOME, and (b) have granted WELLCOME
reasonable access to the Leiden Facility and the personnel working at the
Leiden Facility, in each case in furtherance of the Transfer Program;
5.1.3. A one-time payment of (**)
for the first time WELLCOME, or a WELLCOME
-5-
<PAGE>
Affiliate, makes use of the process described in Part II of Schedule 1 hereto
----------
(such process being referred to herein as a "Key Manufacturing Stage") to
-----------------------
produce Clinical Trial Material, which Clinical Trial Material meets applicable
industry standards and the requirements imposed by Law, for a Biological
Product; and
5.1.4. A one-time payment of
(**) upon the First Commercial Sale in any country of the first
Biological Product produced by WELLCOME or a WELLCOME Affiliate using a Key
Manufacturing Stage.
Nothing in this Agreement shall be construed to require WELLCOME to utilize the
Manufacturing Technology in any manner except as it shall so determine in its
sole and absolute discretion, subject, however, to the limitations imposed upon
that use by this Agreement.
5.2. Royalties. In addition to the license fees specified in Section 5.1
--------- -----------
hereof, WELLCOME shall make the following royalty payments as applicable:
5.2.1. If and to the extent WELLCOME employs a Key Manufacturing
Stage in the manufacture of any Cancer Product, WELLCOME shall pay CENTOCOR a
royalty equal to (**) of Net Sales of such Cancer Product to Third
Parties during the period of time equal to fifteen (15) years from and after the
First Commercial Sale of such Cancer Product in any country, or for such shorter
period of time as may be prescribed by applicable Law (the "Payment Period").
--------------
Such royalty shall be in addition to, and not subject to set off against, any
royalty payable to CENTOCOR under any Cancer Product License. At the end of the
Payment Period, WELLCOME and its Affiliates shall have a fully paid-up, royalty
free licence to use the Manufacturing Technology with respect to such Cancer
Product.
-6-
<PAGE>
5.2.2. Subject to the provisions of Section 5.2.3 hereof, if and
-------------
to the extent WELLCOME employs a Key Manufacturing Stage in the manufacture of
any Biological Product other than a Cancer Product, the 17-1A Product or a
Derivative 17-1A Product, WELLCOME, until December 31, 2011 or for such shorter
period of time as may be prescribed by applicable Law, shall pay to CENTOCOR a
royalty of (**) on the Net Sales of such Biological Product to
Third Parties.
5.2.3. If and to the extent WFL or BW, by mutual agreement of the
parties hereto, employs a Key Manufacturing Stage in the manufacture of the
17-1A Product, WFL or BW, as applicable, shall pay such royalties as the parties
may establish.
5.3. Limitation on Royalties.
-----------------------
5.3.1. Notwithstanding any of the requirements of Section 5.2
-----------
hereof, WELLCOME shall not be required to pay any royalty (a) for the use of a
Key Manufacturing Stage if WELLCOME, in accordance with the terms of Section
-------
11.16 hereof, does not owe a duty of confidentiality with respect to such Key
- -----
Manufacturing Stage taken as a whole; (b) for use of a Key Manufacturing Stage
pursuant to any other Alliance Document or any rights granted therein to
WELLCOME; (c) on any Biological Product (i) made or used for Clinical Trials,
tests or development purposes or distributed as samples, or (ii) sold among
WELLCOME and its Affiliates. In addition, WELLCOME shall be required to pay no
more than one (1) royalty to CENTOCOR and CBV collectively on any sale of a
Biological Product irrespective of the extent to which a Key Manufacturing Stage
is employed by WELLCOME.
-7-
<PAGE>
5.3.2. In addition, notwithstanding the requirements of Section
-------
5.2 hereof, WELLCOME'S obligation to pay royalties under this Agreement shall
- ---
expire not later than the twentieth (20th) anniversary of the date hereof, at
the end of which period, WELLCOME and its Affiliates shall have a fully paid-up,
royalty free licence to use the Manufacturing Technology.
5.4. Manner of Payment
-----------------
5.4.1. Within sixty (60) days of the end of each Quarter, WELLCOME
shall pay to CENTOCOR the royalties accruing in respect of such Quarter pursuant
to this Section 5. Payment of royalties shall be made by check drawn (or by
---------
such other payment method as the parties may from time to time agree) in
Dollars, Pounds Sterling, Deutschmarks or such other currency as the parties may
mutually agree. Checks (or such other payment) will be delivered to the address
designated by CENTOCOR.
5.4.2. For purposes of calculating amounts due hereunder,
currencies shall be converted on the basis of exchange rates calculated on
WELLCOME'S normal basis taking exchange rates published in the London Financial
Times on the last Business Day of the Quarter in respect of which the royalty
payment is made.
5.4.3. In the event any tax or withholding is levied by any
foreign taxing authority in connection with the accrual or payment of any of
royalties, WELLCOME shall have the right to pay such tax or withholding to the
local taxing authorities on behalf of CENTOCOR and to deduct from the amounts
due to CENTOCOR the amounts paid for such taxes or withholding, provided that
WELLCOME shall deliver to CENTOCOR evidence of payment. If royalties in any
country are higher than the maximum permitted by the Laws of such country,
royalties paid with
-8-
<PAGE>
respect to the Net Sales in such country shall be reduced to the maximum rate
permitted by Law.
5.5. Records, Reports, Audits
------------------------
5.5.1. WELLCOME and its Affiliates shall maintain records of Net
Sales to enable the amounts due to CENTOCOR hereunder to be determined.
5.5.2. At least once each Quarter, WELLCOME shall furnish to
CENTOCOR a written statement for the preceding Quarter specifying the quantities
of Cancer Products or other Biological Products sold during the applicable
Quarter pursuant to the license granted hereunder and the aggregate Net Sales
for such Quarter.
5.5.3. CENTOCOR shall have the right upon prior notice to
WELLCOME, not more than once in each WELLCOME fiscal year nor more than once in
respect of any WELLCOME fiscal year, through an independent public accountant,
selected by CENTOCOR and acceptable to WELLCOME, which acceptance shall not
unreasonably be refused, to have access during normal business hours to those
records of WELLCOME as may reasonably be necessary to verify the accuracy of the
payments of royalties in respect of any fiscal year ending not more than
eighteen (18) months prior to the date of such notice. Upon the expiration of
eighteen (18) months following the end of any fiscal year, the calculation of
royalties payable with respect to sales during such fiscal year shall be binding
and conclusive upon CENTOCOR and CBV, and WELLCOME and its Affiliates shall be
released from any liability or accountability with respect to royalties for
sales during such fiscal year. If such independent public accountant's report
shows any underpayment of royalties, within thirty (30) days after WELLCOME'S
receipt of such report, WELLCOME shall remit or shall cause its Affiliate to
remit to CENTOCOR (a) the amount of
-9-
<PAGE>
such underpayment and (b) if such underpayment exceeds five percent (5%) of the
total royalties owed for the fiscal year then being reviewed, the reasonable and
necessary fees and expenses of such independent accountant performing the
audit. Otherwise such fees and expenses shall be borne by CENTOCOR. Any
overpayment shall be fully creditable against future royalties payable in
subsequent payment periods.
5.5.4. All written statements provided by WELLCOME hereunder shall
be in the English language.
5.5.5. CENTOCOR agrees that all information which is the subject
matter of this Section 5.5 and which is subject to review under this Section 5.5
----------- -----------
is strictly confidential and that CENTOCOR hereby undertakes and agrees that it
shall retain all such information in the strictest of confidence and shall cause
its accountant to retain all such information in the strictest of confidence.
6. OWNERSHIP OF TECHNOLOGY
-----------------------
Notwithstanding any other provision of this Agreement:
6.1. The Manufacturing Technology and all Improvements created by CENTOCOR
or CBV shall be the sole and exclusive property of CENTOCOR or CBV, as
applicable; and
6.2. All Improvements created by WELLCOME shall be the sole and exclusive
property of WELLCOME.
7. REPRESENTATIONS AND WARRANTIES
------------------------------
7.1. Representations and Warranties of WFL and BW. As a material
--------------------------------------------
inducement to CENTOCOR and CBV to enter into this Agreement and to consummate
the transactions contemplated hereby,
-10-
<PAGE>
WFL and BW hereby, jointly and severally, represent and warrant to CENTOCOR and
CBV as follows, which representations and warranties shall survive the execution
and delivery of this Agreement:
7.1.1. Organization and Good Standing. Each of WFL and BW is a
------------------------------
corporation duly organized and validly existing under the Laws of their
respective jurisdictions of incorporation with the requisite power and authority
(corporate or otherwise) to carry on their businesses as presently being
conducted and as proposed to be conducted pursuant to the Alliance Agreement,
and to own and operate their properties and assets.
7.1.2. Corporate Power and Authority; Enforceability. Each of WFL
---------------------------------------------
and BW has the requisite power and authority (corporate and otherwise) to
execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby. The execution, delivery and performance by WFL and BW of
this Agreement and the consummation by WFL and BW of the transactions
contemplated hereby have been duly authorized by all necessary actions
(corporate or otherwise) on their parts. This Agreement constitutes a legal,
valid and binding obligation of WFL and BW, enforceable in accordance with its
terms.
7.1.3. Validity of Contemplated Transactions. The execution,
-------------------------------------
delivery and performance by WFL and BW of this Agreement, and the consummation
by them of the transactions contemplated hereby, do not (a) violate or
contravene any provision of WFL'S or BW'S charter or bylaws; (b) violate,
breach, conflict with, constitute a Default under, cause the acceleration of any
payments pursuant to, or otherwise impair the good standing, validity, or
effectiveness of any agreement, contract, indenture, lease, license, or mortgage
to which WFL or BW is a party or by which WFL or BW is bound; (c) violate any
provision of any Law, Permit or Court Order applicable to WFL or
-11-
<PAGE>
BW; or (d) require any Permit or Required Consent of any Governmental Entity
to be obtained by WFL and BW which has not been obtained.
7.1.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to WFL'S or BW'S knowledge, threatened against or related to WFL or
BW, nor any failure to comply with, violation of or any Default under, any Law,
Permit or Court Order applicable to WFL or BW, in each case which might have a
material adverse effect on the ability of WFL or BW to execute, deliver and
perform this Agreement or on the ability of WFL or BW to consummate the
transactions contemplated hereby.
7.2. Representations and Warranties of CENTOCOR and CBV. As a material
--------------------------------------------------
inducement to WELLCOME to enter into this Agreement and to consummate the
transactions contemplated hereby, CENTOCOR and CBV hereby, jointly and
severally, represent and warrant to WELLCOME as follows, which representations
and warranties shall survive the execution and delivery of this Agreement:
7.2.1. Organization and Good Standing. Each of CENTOCOR and CBV
------------------------------
is a corporation duly organized, validly existing, and in good standing under
the Laws of their respective jurisdictions of incorporation with the requisite
power and authority (corporate or otherwise) to carry on their businesses as
presently being conducted and as proposed to be conducted pursuant to the
Alliance Agreement, and to own and operate their properties and assets.
7.2.2. Corporate Power and Authority; Enforceability. Each of
---------------------------------------------
CENTOCOR and CBV has the requisite power and authority (corporate and otherwise)
to execute, deliver and perform this Agreement and to consummate the
transactions contemplated hereby. The execution, delivery and performance by
CENTOCOR and CBV of this Agreement and the consummation by
-12-
<PAGE>
CENTOCOR and CBV of the transactions contemplated hereby, have been duly
authorized by all necessary actions (corporate or otherwise) on their part.
This Agreement constitutes a legal, valid and binding obligation of each of
CENTOCOR and CBV, enforceable in accordance with its terms.
7.2.3. Validity of Contemplated Transactions. The execution,
-------------------------------------
delivery and performance by CENTOCOR and CBV of this Agreement, and the
consummation by CENTOCOR and CBV of the transactions contemplated hereby, do not
(a) violate or contravene any provision of CENTOCOR'S or CBV'S charter or
bylaws; (b) violate, breach, conflict with, constitute a Default under, cause
the acceleration of any payments pursuant to, or otherwise impair the good
standing, validity, or effectiveness of any agreement, contract, indenture,
lease, license, or mortgage to which CENTOCOR or CBV is a party or by which
CENTOCOR or CBV is bound; (c) subject any of CENTOCOR'S or CBV'S properties or
assets to any Lien or to any indenture, mortgage, contract, commitment, or
agreement (other than this Agreement) to which CENTOCOR or CBV is a party or by
which CENTOCOR or CBV or any of CENTOCOR'S of CBV'S properties or assets are
bound; (d) violate any provision of any Law, Permit or Court Order applicable to
CENTOCOR or CBV; or (e) require any Permit or Required Consent of any
Governmental Entity to be obtained by CENTOCOR or CBV which has not been
obtained.
7.2.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to CENTOCOR'S or CBV'S knowledge, threatened against or related to
CENTOCOR or CBV, nor any failure to comply with, violation of or any Default
under, any Law, Permit or Court Order applicable to CENTOCOR or CBV, in each
case which might have a material adverse effect on the ability of CENTOCOR or
CBV to execute, deliver and perform this Agreement or on the ability of CENTOCOR
or CBV to consummate the transactions contemplated hereby.
-13-
<PAGE>
7.2.5 Intellectual Property Warranties.
--------------------------------
(a) CENTOCOR and CBV, collectively have sufficient right,
title and interest in the Manufacturing Technology to grant the rights and
perform the obligations contemplated by this Agreement.
(b) Neither CENTOCOR nor CBV has any knowledge of any
facts or circumstances which give rise to, or form the basis of, any claim of
invalidity, unenforceability or lack of priority of any of CENTOCOR'S or CBV'S
rights in the Manufacturing Technology.
(c) To the knowledge of CENTOCOR and CBV, the inception,
development and reduction to practice of the Manufacturing Technology has not
constituted or involved, and does not constitute or involve, the
misappropriation of trade secrets or other rights of any other Person
(including, without limitation, any Governmental Entity).
(d) There is no interference action or other Litigation
pending or threatened before the United States Patent and Trademark Office or
any other Governmental Entity in any jurisdiction with regard to any Patent
forming a part of the Manufacturing Technology.
(e) To CENTOCOR'S and CBV'S knowledge, the use of the
Manufacturing Technology in the development, manufacture, use, marketing and
sale of 17-1A Product by CENTOCOR and its Affiliates has not infringed any
Intellectual Property rights of any Third Party.
-14-
<PAGE>
8. INDEMNIFICATION
---------------
8.1. Subject to compliance by the applicable Indemnitee as defined below
with its obligations set forth in Sections 8.4 and 8.5 hereof, CENTOCOR and CBV
--------------------
shall defend, indemnify and hold WELLCOME and its Affiliates and the respective
directors, officers, employees and agents of WELLCOME and its Affiliates,
harmless from and against any and all Losses arising out of, relating to or
resulting from the breach by CENTOCOR and CBV of any of their representations,
warranties and covenants contained within this Agreement.
8.2. Subject to compliance by the applicable Indemnitee as defined below
with its obligations set forth in Sections 8.4 and 8.5 hereof, WELLCOME shall
--------------------
defend, indemnify and hold CENTOCOR, CBV and their Affiliates and the respective
directors, officers, employees and agents of CENTOCOR and CBV and their
Affiliates, harmless from and against any and all Losses arising out of,
relating to or resulting from the breach by WELLCOME of any of its
representations, warranties and covenants contained in this Agreement.
8.3. "Indemnitor" means CENTOCOR and CBV with respect to Section 8.1
---------- -----------
hereof and WELLCOME with respect to Section 8.2 hereof. "Indemnitee" means any
----------- ----------
of WELLCOME and its Affiliates and the respective directors, officers, employees
and agents of WELLCOME and its Affiliates with respect to Section 8.1 hereof and
-----------
any of CENTOCOR, CBV and their Affiliates and the respective directors,
officers, employees and agents of CENTOCOR, CBV and their Affiliates with
respect to Section 8.2 hereof.
-----------
8.4. Notice. Promptly after receipt by an Indemnitee of written notice
------
of the commencement of any suit, audit, demand, judgment, action, investigation
or proceeding relating to a Loss
-15-
<PAGE>
(a "Third Party Action") or promptly after an Indemnitee incurs a Loss or has
------------------
knowledge of the existence of a Loss, such Indemnitee will, if a claim with
respect thereto is to be made against Indemnitor due to Indemnitor's obligation
to provide indemnification hereunder, give Indemnitor written notice of such
Loss or the commencement of such Third Party Action; provided, however, the
-------- -------
failure to provide such notice within a reasonable period of time shall not
relieve Indemnitor of any of its obligations hereunder except to the extent it
is prejudiced by such failure.
8.5. Defense. Indemnitor shall control the defense and settlement of a
-------
Third Party Action, except that the applicable Indemnitee may assume such
defense provided that the obligation of Indemnitor to pay the attorneys' fees of
such Indemnitee shall cease upon such election. Indemnitor shall not enter into
any resolution or other compromise of such action unless it (a) pays in cash or
posts an adequate bond for the payment of the amount of such resolution or other
compromise and obtains a complete release of the Indemnitee or (b) obtains the
prior written consent of the Indemnitee, which shall not be unreasonably
withheld or delayed. If the Indemnitee defends such action, such Indemnitee
shall not enter into any resolution or other compromise of such action unless
such Indemnitee obtains the consent of Indemnitor, which shall not be
unreasonably withheld or delayed. The party defending the action shall keep the
other parties informed on an ongoing basis of the status of such Third Party
Action and shall deliver to such other parties copies of all documents relating
to the Third Party Action as the other parties may reasonably request. The
party assuming such defense shall receive from the other parties all necessary
and reasonable cooperation in the defense of a Third Party Action including, but
not limited to, the services of employees of such other parties who are familiar
with the events or circumstances out of which any such Third Party Action may
have arisen.
-16-
<PAGE>
8.6. The indemnifications contained in this Section 8 shall survive
---------
expiration or termination of this Agreement.
9. INFRINGEMENT
------------
In the event that any party hereto obtains knowledge of any infringement or
misappropriation by a Third Party of the Manufacturing Technology (an
"Infringement"), such party shall inform the other parties promptly of such
- -------------
Infringement and provide the other parties with any available evidence of such
Infringement or misappropriation. CENTOCOR shall have the option, but not the
obligation, to prosecute at its own expense any claim of Infringement of the
Manufacturing IP, and shall be entitled to retain any recoveries therefrom.
10. TERM AND TERMINATION
--------------------
10.1. The license granted by this Agreement shall take effect on the
License Date, and shall be perpetual unless terminated in accordance with its
terms.
10.2. CENTOCOR and CBV may give notice in writing to WELLCOME terminating
this Agreement within sixty (60) days if WELLCOME is in material breach of its
obligations hereunder and fails to remedy such breach within sixty (60) days of
receiving notice in writing requiring such remedy. WELLCOME may give notice in
writing to CENTOCOR and CBV terminating this Agreement within sixty (60) days if
CENTOCOR or CBV is in material breach of its obligations hereunder and fails to
remedy such breach within sixty (60) days of receiving notice in writing
requiring such remedy. No such termination, however, shall release any of the
parties from any obligations hereunder incurred prior to such termination.
-17-
<PAGE>
10.3. WELLCOME reserves the right to terminate this Agreement at any time
for any reason provided that reasonable prior written notice is given to
CENTOCOR.
11. MISCELLANEOUS
-------------
11.1. Entire Agreement. This Agreement and the other Alliance Documents
----------------
constitute the entire understanding of the parties with respect to the subject
matter contained herein and supersede any prior understandings and agreements
among them respecting such subject matter including, without limitation, the
Letter of Intent between CENTOCOR and WFL dated September 16, 1993; provided,
--------
however, the confidentiality agreement between WFL and CENTOCOR and dated
- -------
September 14, 1993 shall in all cases remain in full force and effect in
accordance with its terms.
11.2. Amendments. This Agreement may be amended and supplemented only by
----------
a written instrument duly executed by each of the parties.
11.3. Headings. The headings in this Agreement are for convenience of
--------
reference only and shall not affect its interpretation.
11.4. Gender; Number. Words of gender may be read as masculine, feminine,
--------------
or neuter, as required by context. Words of number may be read as singular or
plural, as required by context.
11.5. Appendices; Exhibits; and Schedules. All appendices, exhibits and
-----------------------------------
schedules referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.
11.6. Severability. If any provision of this Agreement or the application
------------
thereof to any Person or circumstance is held
-18-
<PAGE>
illegal, invalid, or unenforceable, such illegality, invalidity, or
unenforceability shall not affect any other provision hereof. This Agreement
shall, in such circumstances, be deemed modified to the extent necessary to
render enforceable the provisions hereof to the fullest extent permitted by Law.
11.7. Remedies. Each of CENTOCOR and CBV on the one hand, and WFL and BW
--------
on the other, stipulates that the remedies at Law of the other in the event of
any Default or threatened Default in the performance of or compliance with any
of the terms of this Agreement are not and will not be adequate and that, to the
fullest extent permitted by Law, such terms may be specifically enforced by a
decree for specific performance of any agreement contained herein or by an
injunction against any violation of any terms hereof or otherwise.
11.8. Joint and Several Liability. CENTOCOR and CBV shall be jointly and
---------------------------
severally responsible and liable for all of their respective obligations to
WELLCOME arising under this Agreement. WFL and BW shall be jointly and severally
liable for all of their respective obligations to CENTOCOR or CBV arising under
this Agreement.
11.9. Notices. All notices and other communications hereunder shall be in
-------
writing and shall be given to the Person either personally or by sending a copy
thereof by first class United States express mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, or by telecopier (with the
original sent by either of the foregoing manners), to such Person's address (or
to such Person's telecopier number). All notices shall be deemed to have been
given to the Person entitled thereto when received.
-19-
<PAGE>
If to WFL, to:
THE WELLCOME FOUNDATION LIMITED
Unicorn House, P.O. Box 129
129 Euston Road
London NW1 2BP
Attention: Company Secretary
Telecopy No.: 011-44-71-388-5462
With a copy to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to BW, to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to CENTOCOR or CBV, to:
CENTOCOR, INC.
200 Great Valley Parkway
Malvern, Pennsylvania 19355-1307
Attention: Corporate Secretary
Telecopy No.: (215) 651-6100
-20-
<PAGE>
with a copy to:
Duane, Morris & Heckscher
One Liberty Place
Philadelphia, PA 19103
Attention: David C. Toner, Esquire
Telecopy No.: (215) 979-1020
Notice of any change in any such address shall also be given in the manner set
forth above. Whenever the giving of notice is required, the giving of such
notice may be waived by the Person entitled to receive such notice.
11.10. Waiver. No provision of this Agreement may be waived except by a
------
written instrument signed by the party hereto sought to be bound. No failure or
delay by any party hereto in exercising any right or remedy hereunder or under
applicable Law will operate as a waiver thereof, and a waiver of a particular
right or remedy on one (1) occasion will not be deemed a waiver of any other
right or remedy, or a waiver on any subsequent occasion (it being understood
that specific time frames for notice or actions to be taken shall be binding on
the parties).
11.11. Assignment. No party hereto may assign its rights or delegate any
----------
of its obligations hereunder without the prior written consent of the other
parties, except that, without such consent, (a) WFL may assign all or any part
of its rights and obligations hereunder to an Affiliate of WFL, including but
not limited to BW, so long as WFL unconditionally guarantees the obligations of
such Affiliate; (b) WFL and BW may assign all of their rights and delegate all
of their duties under this Agreement to a transferee of all or substantially all
of the line of business of which this Agreement forms a part or by way of merger
or consolidation with another company; and (c) CENTOCOR and CBV may assign all
of their rights and delegate all of their
-21-
<PAGE>
duties under this Agreement to a transferee of all or substantially all their
assets or by way of merger or consolidation with another company. Without
limiting the foregoing, all rights and obligations with respect to the subject
matter of this Agreement as to the United States shall inure to the benefit of
and be performed by BW, subject to such further assignments as may be permitted
by this Section 11.11. If any party shall assign its rights and delegate its
-------------
duties pursuant to clauses (b) or (c) of this Section 11.11, the Person to whom
------------------ -------------
such rights are assigned and duties are delegated shall assume all of the
obligations of the applicable party under this Agreement. The guarantee by
WELLCOME referenced in clause (a) of this Section 11.11 is a guaranty of payment
---------- -------------
and performance, and not of collection; and in case of a default by an Affiliate
of WELLCOME to which rights have been assigned or obligations delegated pursuant
to such clause (a), CENTOCOR and CBV shall have the right to proceed first
----------
against WELLCOME without the necessity to proceed against or join such
Affiliate.
11.12. Successors and Assigns. This Agreement shall bind, inure to the
----------------------
benefit of, and be enforceable by the successors and permitted assigns of the
parties hereto.
11.13. Governing Law. This Agreement shall be construed and enforced in
-------------
accordance with the Laws of the Commonwealth of Pennsylvania without regard to
principles of conflicts of law applicable in such jurisdiction.
11.14. No Benefit to Others. The representations, warranties, covenants
--------------------
and agreements contained in this Agreement are for the sole benefit of the
parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring, and are not intended to confer, any rights on any other
Person.
-22-
<PAGE>
11.15. Independent Contractors. It is expressly understood and agreed that
-----------------------
the Centocor Group and the Wellcome Group are independent contractors; neither
the Centocor Group or any of its members, nor the Wellcome Group or any of its
members, shall be deemed the agent of the other group or of any of its members
for any purpose whatsoever, and neither the Centocor Group or any of its
members, nor the Wellcome Group or any of its members, shall have authority to
enter into any contract or agreement, assume any obligation or make any warranty
or representation for or on behalf of the other group or any of its members.
Nothing in this Agreement shall be deemed to create or constitute a partnership
or the relationship of employer and employee between the Wellcome Group or any
of its members on the one hand and the Centocor Group or any of its members on
the other.
11.16. Confidentiality.
---------------
11.16.1. "Proprietary Information" for the purposes of this
-----------------------
Section 11.16 means (a) the Manufacturing Technology transferred or otherwise
- -------------
disclosed by CENTOCOR or its Affiliates to WELLCOME pursuant to this Agreement;
and (b) any Know-how or other technical, financial or business information of
WELLCOME or its Affiliates that is disclosed orally or in writing by WELLCOME or
its Affiliates to CENTOCOR or its Affiliates in the course of performing this
Agreement, or obtained by CENTOCOR or CBV in the course of transferring the
Manufacturing Technology in accordance with this Agreement.
11.16.2. Except as expressly provided herein otherwise, each
Receiving Party shall, during the term of this Agreement including any renewals
thereof, and for a period of five (5) years following expiration or the
termination hereof, but in any event not for less than a period of ten (10)
years from the date hereof, maintain the confidentiality of all Proprietary
Information disclosed by the Disclosing Party
-23-
<PAGE>
hereunder and shall neither use the same except as expressly authorized by this
Agreement, the Alliance Agreement or any other Alliance Document, nor disclose
the same to any Third Party that is not an Affiliate of the Receiving Party
without the prior written consent of the Disclosing Party. Nothing in this
Section 11.16, however, shall be construed to require any party hereto to
- -------------
maintain the confidentiality and non-use of any information or material that (a)
at the time of disclosure, is already in the public domain; (b) after
disclosure, enters the public domain otherwise than by an act or omission of the
Receiving Party in violation of the terms of this Agreement; (c) prior to
disclosure under this Agreement was already in the possession of the Receiving
Party or its Affiliates, provided that such information or material was not
obtained, directly or indirectly, from the Disclosing Party; (d) becomes known
to the Receiving Party from a Third Party, provided that such information or
material was not obtained, directly or indirectly, from the Disclosing Party on
a confidential basis; (e) is required in the reasonable judgment of the
Receiving Party to be disclosed to a Governmental Entity in furtherance of this
Agreement or the Alliance Agreement or pursuant to any Law, Governmental Entity,
or Court Order; or (f) results from research or development by the Receiving
Party or its Affiliates independent of disclosures from the Disclosing Party.
Disclosures of Proprietary Information made prior to the date hereof shall be
governed by this Section 11.16.
-------------
11.16.3. Nothing in this Section 11.16 shall prevent any party
-------------
hereto from disclosing its own information relating to its business, financial
affairs, products, research development, marketing and other commercial
activities to any Affiliate or any Third Party. In addition, notwithstanding
the restrictions in this Section 11.16 on confidentiality and use, any party
-------------
hereto may disclose Proprietary Information which is disclosed to it hereunder
to any of its Affiliates which agrees to be bound by the terms of this Section
-------
11.16.
- -----
-24-
<PAGE>
11.17. Continuing Obligation. Except as otherwise specifically provided
---------------------
herein, neither termination nor expiration of this Agreement shall relieve any
party from any obligation under this Agreement which accrued or arose from facts
and circumstances in existence prior thereto.
11.18. Covenant Not to Sue. CENTOCOR and CBV agree that during the term of
-------------------
this Agreement neither they nor their Affiliates will assert or cause to be
asserted against WELLCOME, its Affiliates or sublicensees any Intellectual
Property rights relating to the manufacture of Biological Products not licensed
hereunder that are or may be infringed by reason of the exercise by WELLCOME,
its Affiliates or its sublicensees of the license granted hereunder for which a
royalty is paid to CENTOCOR under Section 5.2 hereof; provided, however, nothing
----------- -------- -------
herein shall prohibit CENTOCOR, CBV or their Affiliates from instituting any
suit they are obligated to institute pursuant to the terms of a license
agreement with a Third Party pursuant to which a license to such Intellectual
Property has been granted.
11.19. Counterparts. This Agreement and any amendment or supplement hereto
------------
may be executed in any number of counterparts and any party hereto may execute
any such counterpart, each of which when executed and delivered shall be deemed
to be an original and all of which counterparts taken together shall constitute
but one and the same instrument. The execution of this Agreement and any such
amendment or supplement by any party hereto will not become effective until
counterparts hereof have been executed by all the parties hereto.
11.20. Savings Clause. Any restriction or information provision (as each
--------------
of these terms or expressions are defined in the RTPA) contained in this
Agreement or in any arrangement of which this Agreement forms part by virtue of
which this
-25-
<PAGE>
Agreement or any such arrangement is registrable under the RTPA shall not take
effect in the United Kingdom until the day after the day on which full
particulars of this Agreement (and of any such arrangement) shall have been duly
furnished to the Office of Fair Trading under Section 24 of the RTPA.
----------
11.21. Further Assurances. At the request of any party hereto, the other
------------------
parties hereto shall execute and deliver from time to time such further
instruments and shall provide reasonable cooperation in such proceedings or
actions as shall be necessary or reasonably appropriate to effectuate the
purposes of this Agreement including, without limitation, registering or
recording the rights granted hereunder; provided, however, if any party hereto
-------- -------
desires to notify this Agreement under Article 85(3) of the Treaty of Rome
establishing the European Economic Community, such party shall give the other
parties ninety (90) days prior written notice of such notification and if during
such period a party shall reasonably object to such notification, the objecting
party need not cooperate in such notification and such notification shall not be
implemented. Except as otherwise provided in the Alliance Documents, the
executions, deliveries and cooperation of each party under this section shall be
without further consideration and at such party's expense.
IN WITNESS WHEREOF, the parties hereto have duly caused this Agreement to
be executed as of the day and year first above written by their duly authorized
representatives.
FOR AND ON BEHALF OF
THE WELLCOME FOUNDATION LIMITED
By: /s/ Trevor M. Jones
------------------------------------
Name: Trevor M. Jones
----------------------------------
Title: Director/Research, Development
---------------------------------
& Medical
---------------------------------
[EXECUTIONS CONTINUED]
-26-
<PAGE>
BURROUGHS WELLCOME CO.
By: /s/ David W. Barry
------------------------------------
Name: David W. Barry
----------------------------------
Title: Vice President of Research,
---------------------------------
Development and Medical
---------------------------------
CENTOCOR, INC.
By: /s/ Bobba Venkatadri
------------------------------------
Name: Bobba Venkatadri
----------------------------------
Title: Executive Vice-President
---------------------------------
CENTOCOR B.V.
By: /s/ David P. Holveck
------------------------------------
Name: David P. Holveck
----------------------------------
Title: Managing Director
---------------------------------
-27-
<PAGE>
APPENDIX A
----------
GLOSSARY OF TERMS
-----------------
[See Appendix A to Alliance Agreement]
-28-
<PAGE>
SCHEDULE 1
(**)
-1-
<PAGE>
SCHEDULE 3
EXCLUDED AGREEMENTS
1. "Research and License Agreement" between New York Blood Center and
Centocor, Inc. dated as of March 1, 1986, as amended in June 1987 and on August
24, 1988
-2-
<PAGE>
SCHEDULE 4.1
Transfer Program
----------------
The Transfer Program shall include, but shall not be limited to, the following:
(**)
-1-
<PAGE>
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF
THIS AGREEMENT. THOSE PORTIONS HAVE BEEN OMITTED FROM THIS COPY OF THE
AGREEMENT AT THE PLACES INDICATED BY DOUBLE ASTERISKS (**); AND HAVE BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
THE WELLCOME FOUNDATION LIMITED
AND
BURROUGHS WELLCOME CO.
and
CENTOCOR, INC.
AND
CENTOCOR B.V.
________________________________________________________________________________
CENTOCOR TECHNOLOGY LICENSE AGREEMENT
________________________________________________________________________________
The Wellcome Foundation Ltd
Legal Department
Unicorn House
P O Box 129
160 Euston Road
London NW1 2BP
England
Dated: As of December 16, 1993
<PAGE>
TABLE OF CONTENTS
-----------------
<TABLE>
<CAPTION>
Page
----
<C> <S> <C>
1. DEFINITIONS.......................................................... 2
2. GRANT OF LICENSE..................................................... 2
3. TRANSFER OF CENTOCOR TECHNOLOGY...................................... 3
3.1. Escrow Agreement.......................................... 3
3.2. Delivery.................................................. 4
3.3. Release from Escrow....................................... 4
3.4. Other Antibodies.......................................... 4
4. PAYMENTS............................................................. 5
5. OWNERSHIP OF TECHNOLOGY.............................................. 5
6. REPRESENTATIONS AND WARRANTIES....................................... 5
6.1. Representations and Warranties of WFL and BW................... 5
6.1.1. Organization and Good Standing.......................... 6
6.1.2. Corporate Power and Authority;
Enforceability.......................................... 6
6.1.3. Validity of Contemplated
Transactions............................................ 6
6.1.4. Litigation; Compliance with Laws........................ 7
6.2. Representations and Warranties of CENTOCOR and
CBV............................................................ 7
6.2.1. Organization and Good Standing.......................... 7
6.2.2. Corporate Power and Authority;
Enforceability.......................................... 7
6.2.3. Validity of Contemplated Transactions................... 8
6.2.4. Litigation; Compliance with Laws........................ 8
6.2.5. Intellectual Property Warranties........................ 9
7. INDEMNIFICATION...................................................... 10
8. INFRINGEMENT......................................................... 12
9. TERM AND TERMINATION................................................. 13
</TABLE>
<PAGE>
<TABLE>
<C> <S> <C>
10. MISCELLANEOUS......................................................... 15
10.1. Entire Agreement............................................... 15
10.2. Amendments..................................................... 15
10.3. Headings....................................................... 15
10.4. Gender; Number................................................. 15
10.5. Appendices; Exhibits; and Schedules............................ 15
10.6. Severability................................................... 15
10.7. Remedies....................................................... 16
10.8. Joint and Several Liability.................................... 16
10.9. Notices........................................................ 16
10.10. Waiver......................................................... 18
10.11. Assignment..................................................... 18
10.12. Successors and Assigns......................................... 19
10.13. Governing Law.................................................. 19
10.14. No Benefit to Others........................................... 19
10.15. Independent Contractors........................................ 19
10.16. Confidentiality................................................ 20
10.17. Continuing Obligation.......................................... 21
10.18. Covenant Not to Sue............................................ 21
10.19. Counterparts................................................... 22
10.20. Savings Clause................................................. 22
</TABLE>
ii
<PAGE>
CENTOCOR TECHNOLOGY LICENSE AGREEMENT
THIS CENTOCOR TECHNOLOGY LICENSE AGREEMENT (the "Agreement") is dated as of
---------
the 16th day of December, 1993 by and among CENTOCOR, INC., a Pennsylvania
corporation of 200 Great Valley Parkway, Malvern, Pennsylvania 19355-1307, USA
("CENTOCOR"), CENTOCOR B.V., a Netherlands corporation of Einsteinweg 101, PO
--------
Box 251, 2300 AG Leiden, the Netherlands ("CBV"), THE WELLCOME FOUNDATION
---
LIMITED, a United Kingdom corporation of Unicorn House, PO Box 129, 160 Euston
Road, London NW1 2BP, England ("WFL"), and BURROUGHS WELLCOME CO., a North
---
Carolina corporation of 3030 Cornwallis Road, Research Triangle Park, NC
27709-4498, USA ("BW" and, collectively with WFL, "WELLCOME").
-- --------
W I T N E S S E T H:
--------------------
WHEREAS, WELLCOME, CENTOCOR and CBV have entered into an Anti-Cancer
Alliance Agreement dated as of November 5, 1993 (the "Alliance Agreement") which
------------------
governs the parties' collaboration in the development, manufacture, marketing,
sale and distribution of products for the treatment of cancers;
WHEREAS, the Alliance Agreement contemplates that WFL, CENTOCOR, CBV and
The Wistar Institute of Anatomy and Biology ("Wistar") will enter into a
------
Novation and Cell Line Release Agreement of even date herewith (the "Novation")
--------
authorizing WFL and WFL'S Affiliates (as defined in Appendix A hereto), at WFL'S
----------
option, to qualify a manufacturing facility to produce 17-1A Products (as
defined in Appendix A hereto) and Derivative 17-1A Products (as defined in
----------
Appendix A hereto) for the commercial market; and
- ----------
WHEREAS, the Alliance Agreement further contemplates that WELLCOME,
CENTOCOR and CBV will enter into an agreement on the
1
<PAGE>
terms set forth herein granting WELLCOME a license to use the Centocor
Technology (as defined in Appendix A hereto) under certain limited circumstances
----------
to support its production of 17-1A Product and Derivative 17-1A Products for the
commercial market;
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for such other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
parties hereto, intending to be legally bound hereby, do hereby agree as
follows:
1. DEFINITIONS
-----------
Capitalized terms not otherwise defined herein shall have the meanings set
forth in Appendix A hereto.
----------
2. GRANT OF LICENSE
----------------
2.1. Subject to the terms and conditions of this Agreement, CENTOCOR and
CBV, under their respective Intellectual Property rights, including the Patents
listed in Schedule 2.1 hereto (but excluding the rights granted to CENTOCOR or
------------
CBV under the agreements listed in Schedule 2.2 hereto), hereby grant WELLCOME a
------------
worldwide, fully paid-up right and license, including the right to sublicense,
to use the Centocor Technology in the Field to develop, make, have made, use,
market, promote and sell 17-1A Product and Derivative 17-1A Products. In
addition, to the extent applicable Law precludes CENTOCOR or CBV from granting
WELLCOME a license with respect to Improvements to the Centocor Technology,
CENTOCOR and CBV hereby grant WELLCOME an option to obtain a worldwide, fully
paid-up right and license to use the Centocor Technology in the Field to
develop, make, have made, use, market, promote and sell 17-1A Product and
Derivative 17-1A Products, such license to be on the same terms and conditions
as set forth herein. The license and option granted by this Section
-------
2
<PAGE>
2 shall be (a) exclusive of all other parties, including without limitation
- -
CENTOCOR, CBV and their respective Affiliates, for so long as such license
remains in effect or for such shorter period as may be prescribed by applicable
Law; and (b) assignable by WELLCOME to WELLCOME Affiliates or to Third Parties
solely for use within the Field. "Field" means the development, manufacture,
-----
use, marketing and sale of 17-1A Product and Derivative 17-1A Products.
2.2. To assure appropriately the rights hereby granted to WELLCOME and
except to the extent required by applicable Law, during the term of this
Agreement, neither CENTOCOR nor its Affiliates shall (a) release or deliver, or
authorize the release or delivery of, or otherwise transfer or assign its rights
in, the Wistar Hybridoma or the Centocor Hybridoma, or any cell line producing
the 17-1A Antibody or a Derivative 17-1A Antibody, to any Third Party; (b) grant
any rights to manufacture, have manufactured or sell, including the right to
sell for resale, any products incorporating the 17-1A Antibody or any Derivative
17-1A Antibody; or (c) assign or transfer the Centocor Technology or otherwise
grant to Third Parties the right to use the Centocor Technology to develop,
make, have made, use, market, promote or sell 17-1A Product or Derivative 17-1A
Product other than such rights as are granted to WELLCOME, as have been
previously granted to Ajinomoto or as are granted to another Permitted
Distributor in accordance with this Agreement. Nothing in this Section 2.2
-----------
shall limit the ability of CENTOCOR and CBV to assign their rights and delegate
their duties as provided in Section 10.11(c) hereof.
----------------
3. TRANSFER OF CENTOCOR TECHNOLOGY
-------------------------------
3.1. Escrow Agreement. Upon the execution of this Agreement, CENTOCOR,
----------------
CBV and WELLCOME shall execute an escrow agreement substantially in the form
attached as
3
<PAGE>
Exhibit 3.1 hereto (the "Escrow Agreement") appointing an escrow agent (the
- ----------- ----------------
"Escrow Agent") to receive the materials to be delivered by CENTOCOR and CBV
- -------------
pursuant to Section 3.2 hereof (such materials, the "Escrow Materials").
----------- ----------------
3.2. Delivery. Subject to the terms and conditions of this Agreement,
--------
CENTOCOR or CBV (a) on or before the date hereof shall have delivered to the
Escrow Agent copies of the Centocor Technology described in Schedule 3.2 hereto
------------
to the extent any of such Centocor Technology is in written or other tangible
form prior to the date hereof (the "Initial Deposit"); and (b) at regular
---------------
intervals no less frequent than once every six (6) months, deliver to the Escrow
Agent copies of such additional Centocor Technology that is described in
Schedule 3.2 hereto and that is reduced to written or other tangible form after
- ------------
the date hereof.
3.3. Release from Escrow. The parties agree that WELLCOME, at any time
-------------------
after the license granted pursuant to Section 2 hereof becomes perpetual in
---------
accordance with Section 9.1 hereof, shall be entitled in accordance with the
-----------
procedures set forth in the Escrow Agreement to obtain release of the Escrow
Materials or so much thereof as WELLCOME specifies to the Escrow Agent in
writing.
3.4. Other Antibodies. During the term of this Agreement, neither
----------------
CENTOCOR nor its Affiliates shall use the Centocor Technology to develop,
conduct clinical trials or seek regulatory approval of, or license out rights to
any Third Party with respect to marketing, sale or distribution of, any
Derivative 17-1A Antibody or any product derived therefrom or from the 17-1A
Antibody except with, and pursuant to an agreement with, WELLCOME.
4
<PAGE>
4. PAYMENTS
--------
In exchange for the license granted pursuant to Section 2 hereof, WELLCOME
---------
agrees to pay a one-time, irrevocable, non-refundable license fee of
(**) such amount to be due and payable on the date hereof, provided
that CENTOCOR and CBV shall have completed the Initial Deposit in accordance
with Section 3.2 hereof. With respect to such license fee, (**)
-----------
is for rights in the United States, and (**)
is for rights outside of the United States.
5. OWNERSHIP OF TECHNOLOGY
-----------------------
Notwithstanding any other provision of this Agreement:
5.1. The Centocor Technology and all Improvements created by CENTOCOR or
CBV shall at all times be the sole and exclusive property of CENTOCOR or CBV, as
applicable, it being understood that such rights of ownership shall not impair
the ability of WELLCOME to have access to the Escrow Materials in accordance
with the terms of this Agreement and the Escrow Agreement.
5.2. All Improvements created by WELLCOME shall be the sole and exclusive
property of WELLCOME.
6. REPRESENTATIONS AND WARRANTIES
------------------------------
6.1. Representations and Warranties of WFL and BW. As a material
--------------------------------------------
inducement to CENTOCOR and CBV to enter into this Agreement and to consummate
the transactions contemplated hereby, WFL and BW hereby, jointly and severally,
represent and warrant to CENTOCOR and CBV as follows, which representations and
5
<PAGE>
warranties shall survive the execution and delivery of this Agreement:
6.1.1. Organization and Good Standing. Each of WFL and BW is a
------------------------------
corporation duly organized and validly existing under the Laws of its respective
jurisdiction of incorporation with the requisite power and authority (corporate
or otherwise) to carry on its business as presently being conducted and as
proposed to be conducted pursuant to the Alliance Agreement, and to own and
operate its properties and assets.
6.1.2. Corporate Power and Authority; Enforceability. Each of WFL
---------------------------------------------
and BW has the requisite power and authority (corporate and otherwise) to
execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby. The execution, delivery and performance by WFL and BW of
this Agreement and the consummation by WFL and BW of the transactions
contemplated hereby have been duly authorized by all necessary action (corporate
or otherwise) on the part of WFL and BW. This Agreement constitutes a legal,
valid and binding obligation of WFL and BW, enforceable in accordance with its
terms.
6.1.3. Validity of Contemplated Transactions. The execution,
-------------------------------------
delivery and performance by WFL and BW of this Agreement, and the consummation
by WFL and BW of the transactions contemplated hereby, do not (a) violate or
contravene any provision of WFL'S or BW'S charter or bylaws; (b) violate,
breach, conflict with, constitute a Default under, cause the acceleration of any
payments pursuant to, or otherwise impair the good standing, validity, or
effectiveness of any agreement, contract, indenture, lease, license, or mortgage
to which WFL or BW is a party or by which WFL or BW is bound; (c) violate any
provision of any Law, Permit or Court Order applicable to WFL or BW; or (d)
require any Permit or Required Consent of any
6
<PAGE>
Governmental Entity to be obtained by WFL and BW which has not been obtained.
6.1.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to WFL'S or BW'S knowledge, threatened against or related to WFL or
BW, nor any failure to comply with, violation of or any Default under, any Law,
Permit or Court Order applicable to WFL or BW, in each case which might have a
material adverse effect on the ability of WFL or BW to execute, deliver and
perform this Agreement or on the ability of WFL or BW to consummate the
transactions contemplated hereby.
6.2. Representations and Warranties of CENTOCOR and CBV. As a material
--------------------------------------------------
inducement to WELLCOME to enter into this Agreement and to consummate the
transactions contemplated hereby, CENTOCOR and CBV hereby, jointly and
severally, represent and warrant to WELLCOME as follows, which representations
and warranties shall survive the execution and delivery of this Agreement:
6.2.1. Organization and Good Standing. Each of CENTOCOR and CBV
------------------------------
is a corporation duly organized, validly existing, and in good standing under
the Laws of the jurisdiction of its incorporation with the requisite power and
authority (corporate or otherwise) to carry on its business as presently being
conducted and as proposed to be conducted pursuant to the Alliance Agreement,
and to own and operate its properties and assets.
6.2.2. Corporate Power and Authority; Enforceability. Each of
---------------------------------------------
CENTOCOR and CBV has the requisite power and authority (corporate and otherwise)
to execute, deliver and perform this Agreement and to consummate the
transactions contemplated hereby. The execution, delivery and performance by
CENTOCOR and CBV of this Agreement and the consummation by CENTOCOR and CBV of
the transactions contemplated hereby have
7
<PAGE>
been duly authorized by all necessary action (corporate or otherwise) on the
part or CENTOCOR and CBV. This Agreement constitutes a legal, valid and binding
obligation of each of CENTOCOR and CBV, enforceable in accordance with its
terms.
6.2.3. Validity of Contemplated Transactions. The execution, delivery
-------------------------------------
and performance by CENTOCOR and CBV of this Agreement, and the consummation by
CENTOCOR and CBV of the transactions contemplated hereby, do not (a) violate or
contravene any provision of CENTOCOR'S or CBV'S charter or bylaws; (b) violate,
breach, conflict with, constitute a Default under, cause the acceleration of any
payments pursuant to, or otherwise impair the good standing, validity, or
effectiveness of any agreement, contract, indenture, lease, license, or mortgage
to which CENTOCOR or CBV is a party or by which CENTOCOR or CBV is bound; (c)
subject any of CENTOCOR'S or CBV'S properties or assets to any Lien or to any
indenture, mortgage, contract, commitment, or agreement (other than this
Agreement) to which CENTOCOR or CBV is a party or by which CENTOCOR or CBV or
any of CENTOCOR'S of CBV'S properties or assets are bound; (d) violate any
provision of any Law, Permit or Court Order applicable to CENTOCOR or CBV; or
(e) require any Permit or Required Consent of any Governmental Entity to be
obtained by CENTOCOR or CBV which has not been obtained.
6.2.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to CENTOCOR'S or CBV'S knowledge, threatened against or related to
CENTOCOR or CBV, nor any failure to comply with, violation of or any Default
under, any Law, Permit or Court Order applicable to CENTOCOR or CBV, in each
case which might have a material adverse effect on the ability of CENTOCOR or
CBV to execute, deliver and perform this Agreement or on the ability of CENTOCOR
or CBV to consummate the transactions contemplated hereby.
8
<PAGE>
6.2.5. Intellectual Property Warranties.
--------------------------------
(a) CENTOCOR and CBV collectively have sufficient right,
title and interest in the Centocor Technology to grant the rights and perform
the obligations contemplated by this Agreement.
(b) To the knowledge of CENTOCOR and CBV, there is no
Third Party using or infringing all or any portion of the Centocor Technology in
derogation of the rights granted to WELLCOME in this Agreement.
(c) To the knowledge of CENTOCOR and CBV, there are no
facts or circumstances which give rise to, or form the basis of, any claim of
invalidity, unenforceability or lack of priority of any of CENTOCOR'S or CBV'S
rights in the Centocor Technology.
(d) To the knowledge of CENTOCOR and CBV, the inception,
development and reduction to practice of the Centocor Technology has not
constituted or involved, and does not constitute or involve, the
misappropriation of trade secrets or other rights of any other Person
(including, without limitation, any Governmental Entity).
(e) There is no interference action or other Litigation
pending or threatened before the United States Patent and Trademark Office or
any other Governmental Entity in any jurisdiction in regard to any Patent
forming a part of the Centocor Technology.
(f) The use of the Centocor Technology in the development,
manufacture, use, marketing and sale of the 17-1A Products by WELLCOME as
contemplated by this Agreement will not infringe any Intellectual Property
rights of any Third Party.
9
<PAGE>
(g) Schedule 2.1 hereto contains a true and complete list
------------
of the Patents owned by CENTOCOR and CBV, or in which CENTOCOR or CBV has rights
assignable or sublicensable to WELLCOME as contemplated herein, useful in the
development, manufacture, use, marketing, distribution or sale of 17-1A
Products.
(h) None of the Know-how included in the Centocor
Technology has been disclosed by CENTOCOR or CBV to any Third Party except (a)
pursuant to suitable confidentiality agreements; (b) in Patents; (c) in filings
made with appropriate Regulatory Authorities; or (d) otherwise required by Law.
7. INDEMNIFICATION
---------------
7.1. Subject to compliance by the applicable Indemnitee (as defined
below) with its obligations set forth in Sections 7.4 and 7.5 hereof, CENTOCOR
--------------------
and CBV shall defend, indemnify and hold WELLCOME and its Affiliates and the
respective directors, officers, employees and agents of WELLCOME and its
Affiliates, harmless from and against any and all Losses arising out of,
relating to or resulting from the breach by CENTOCOR or CBV of any of their
representations, warranties and covenants contained within this Agreement.
7.2. Subject to compliance by the applicable Indemnitee (as defined
below) with its obligations set forth in Sections 7.4 and 7.5 hereof, WELLCOME
--------------------
shall defend, indemnify and hold CENTOCOR, CBV and their Affiliates and the
respective directors, officers, employees and agents of CENTOCOR and CBV and
their Affiliates, harmless from and against any and all Losses arising out of,
relating to or resulting from the breach by WELLCOME of any of its
representations, warranties and covenants contained in this Agreement.
10
<PAGE>
7.3. "Indemnitor" means CENTOCOR and CBV with respect to Section 7.1
---------- -----------
hereof and WELLCOME with respect to Section 7.2 hereof. "Indemnitee" means any
----------- ----------
of WELLCOME and its Affiliates and the respective directors, officers, employees
and agents of WELLCOME and its Affiliates with respect to Section 7.1 hereof and
-----------
any of CENTOCOR, CBV and their Affiliates and the respective directors,
officers, employees and agents of CENTOCOR, CBV and their Affiliates with
respect to Section 7.2 hereof.
-----------
7.4. Notice. Promptly after receipt by an Indemnitee of written notice
------
of the commencement of any suit, audit, demand, judgment, action, investigation
or proceeding relating to a Loss (a "Third Party Action") or promptly after an
------------------
Indemnitee incurs a Loss or has knowledge of the existence of a Loss, such
Indemnitee will, if a claim with respect thereto is to be made against
Indemnitor due to Indemnitor's obligation to provide indemnification hereunder,
give Indemnitor written notice of such Loss or the commencement of such Third
Party Action; provided, however, the failure to provide such notice within a
-------- -------
reasonable period of time shall not relieve Indemnitor of any of its obligations
hereunder except to the extent it is prejudiced by such failure.
7.5. Defense. Indemnitor shall control the defense and settlement of a
-------
Third Party Action, except that the applicable Indemnitee may assume such
defense provided that the obligation of Indemnitor to pay the attorneys' fees of
such Indemnitee shall cease upon such election. If Indemnitor defends such
action, it shall not enter into any resolution or other compromise of such
action unless it (a) pays in cash or posts an adequate bond for the payment of
the amount of such resolution or other compromise and obtains a complete release
of the Indemnitee or (b) obtains the prior written consent of the Indemnitee,
which shall not be unreasonably withheld or delayed. If the Indemnitee defends
such
11
<PAGE>
action, such Indemnitee shall not enter into any resolution or other compromise
of such action unless such Indemnitee obtains the consent of Indemnitor, which
shall not be unreasonably withheld or delayed. The party defending the action
shall keep the other parties informed on an ongoing basis of the status of such
Third Party Action and shall deliver to such other parties copies of all
documents relating to the Third Party Action as the other parties may reasonably
request. The party assuming such defense shall receive from the other parties
all necessary and reasonable cooperation in the defense of a Third Party Action
including, but not limited to, the services of employees of such other parties
who are familiar with the events or circumstances out of which any such Third
Party Action may have arisen.
7.6. The indemnifications contained in this Section 7 shall survive
---------
expiration or termination of this Agreement.
8. INFRINGEMENT
------------
In the event that any party hereto obtains knowledge of any infringement or
misappropriation by a Third Party of the Intellectual Property rights relating
to the Centocor Technology (an "Infringement"), such party shall inform the
------------
other parties promptly of such Infringement and provide the other parties with
any available evidence of such Infringement or misappropriation. WELLCOME shall
have the right but not the obligation to prosecute at its own cost and expense
any claim of Infringement of the Intellectual Property rights relating to the
Centocor Technology. If WELLCOME does not commence action against an infringer
within ninety (90) days after learning of the Infringement, CENTOCOR or CBV may
commence action against the infringer. At the reasonable request of the party
filing suit, the other parties, at their own expense, will provide reasonable
assistance, including, without limitation, permitting the use of their
respective names in all
12
<PAGE>
suits and signing all necessary documents if appropriate to the situation. Any
recovery in any action brought in accordance with this section shall be applied
first to costs incurred by the party bringing suit, and then to the costs of the
party or parties providing assistance as contemplated by this Section 8, with
---------
the remainder to be retained by the party bringing the action.
9. TERM AND TERMINATION
--------------------
9.1. Subject to the provisions of this Section 9, the license granted by
---------
this Agreement shall take effect on the date hereof, and shall continue until
the expiration of the Supply Agreement, including all renewals and extensions
thereof, or for such shorter period as may be prescribed by applicable Law.
Notwithstanding the foregoing, the license granted by this Agreement shall
continue in full force and effect as an irrevocable license, which license shall
continue in perpetuity or such shorter period as may be prescribed by applicable
Law, upon the occurrence of any of the following events:
9.1.1. WELLCOME terminates the Supply Agreement pursuant to
Sections 26.1.2, 26.1.3, 26.1.4, 26.1.6, 26.1.7 or 26.3 thereof;
- -------------------------------------------------------
9.1.2. WELLCOME terminates (a) the Development Agreement pursuant
to Sections 9.2.2 or 9.4 thereof and (b) the Supply Agreement pursuant to
---------------------
Section 26.1.1 thereof;
- --------------
9.1.3. CENTOCOR terminates the Supply Agreement other than
pursuant to Section 26.3 thereof; or
------------
9.1.4. CENTOCOR terminates the Development Agreement other than
pursuant to Section 9.4 thereof.
-----------
13
<PAGE>
9.2. CENTOCOR or CBV, prior to the date on which the license granted
hereunder becomes perpetual pursuant to Section 9.1 hereof, may give notice in
-----------
writing to WELLCOME terminating this Agreement within sixty (60) days if
WELLCOME is in material breach of its obligations hereunder and fails to remedy
such breach within such sixty (60) day period. WELLCOME may give notice in
writing to CENTOCOR terminating this Agreement within sixty (60) days if
CENTOCOR or CBV is in material breach of its obligations hereunder and fails to
remedy such breach within such sixty (60) day period. No such termination,
however, shall release any of the parties from any obligations hereunder
incurred prior to such termination.
9.2.1. If any of the following events occurs prior to the date on
which the license granted hereunder becomes perpetual pursuant to Section 9.1
-----------
hereof, CENTOCOR and CBV shall entitled, by written notice to take effect
immediately, to terminate the license granted by this Agreement:
9.2.2. WELLCOME terminates the Supply Agreement pursuant to
Sections 26.1.5, 26.1.8 or 26.2 thereof; or
- -------------------------------
9.2.3. CENTOCOR terminates the Supply Agreement pursuant to
Section 26.3 thereof.
- ------------
9.3. WELLCOME reserves the right to terminate this Agreement at any time
for any reason provided that reasonable prior written notice is given to
CENTOCOR.
9.4. Upon termination of this Agreement by CENTOCOR or the expiration of
this Agreement in accordance with the terms hereof, other than for breach by
CENTOCOR or CBV, WELLCOME shall instruct the Escrow Agent to return the Escrow
Materials to CENTOCOR.
14
<PAGE>
10. MISCELLANEOUS
-------------
10.1. Entire Agreement. This Agreement and the other Alliance Documents
----------------
constitute the entire understanding of the parties with respect to the subject
matter contained herein and supersede any prior understandings and agreements
among them respecting such subject matter including, without limitation, the
Letter of Intent between CENTOCOR and WELLCOME dated September 16, 1993;
provided, however, the confidentiality agreement between WELLCOME and CENTOCOR
- -------- -------
dated September 14, 1993 shall in all cases remain in full force and effect in
accordance with its terms.
10.2. Amendments. This Agreement may be amended and supplemented only by
----------
a written instrument duly executed by each of the parties.
10.3. Headings. The headings in this Agreement are for convenience of
--------
reference only and shall not affect its interpretation.
10.4. Gender; Number. Words of gender may be read as masculine, feminine,
--------------
or neuter, as required by context. Words of number may be read as singular or
plural, as required by context.
10.5. Appendices; Exhibits; and Schedules. All appendices, exhibits and
-----------------------------------
schedules referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.
10.6. Severability. If any provision of this Agreement or the application
------------
thereof to any Person or circumstance is held illegal, invalid, or
unenforceable, such illegality, invalidity, or unenforceability shall not affect
any other provision hereof.
15
<PAGE>
This Agreement shall, in such circumstances, be deemed modified to the extent
necessary to render enforceable the provisions hereof to the fullest extent
permitted by Law.
10.7. Remedies. Each of CENTOCOR and CBV on the one hand, and WELLCOME
--------
and BW on the other, stipulates that the remedies at law of the other in the
event of any Default or threatened Default in the performance of or compliance
with any of the terms of this Agreement are not and will not be adequate and
that, to the fullest extent permitted by Law, such terms may be specifically
enforced by a decree for specific performance of any agreement contained herein
or by an injunction against any violation of any terms hereof or otherwise.
10.8. Joint and Several Liability. CENTOCOR and CBV shall be jointly and
---------------------------
severally responsible and liable for all of their respective obligations to
WELLCOME arising under this Agreement. WFL and BW shall be jointly and severally
liable for all of their respective obligations to CENTOCOR or CBV arising under
this Agreement.
10.9. Notices. All notices and other communications hereunder shall be in
-------
writing and shall be given to the Person either personally or by sending a copy
thereof by first class United States express mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, or by telecopier (with the
original sent by either of the foregoing manners), to such Person's address (or
to such Person's telecopier number). All notices shall be deemed to have been
given to the Person entitled thereto when received.
16
<PAGE>
If to WELLCOME, to:
THE WELLCOME FOUNDATION LIMITED
Unicorn House, P.O. Box 129
129 Euston Road
London NW1 2BP
Attention: Company Secretary
Telecopy No.: 011-44-71-388-5462
With a copy to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to BW, to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to CENTOCOR or CBV, to:
CENTOCOR, INC.
200 Great Valley Parkway
Malvern, Pennsylvania 19355-1307
Attention: Corporate Secretary
Telecopy No.: (215) 651-6100
17
<PAGE>
with a copy to:
Duane, Morris & Heckscher
One Liberty Place
Philadelphia, PA 19103
Attention: David C. Toner, Esquire
Telecopy No.: (215) 979-1020
Notice of any change in any such address shall also be given in the manner set
forth above. Whenever the giving of notice is required, the giving of such
notice may be waived by the Person entitled to receive such notice.
10.10. Waiver. No provision of this Agreement may be waived except by a
------
written instrument signed by the party hereto sought to be bound. No failure or
delay by any party hereto in exercising any right or remedy hereunder or under
applicable Law will operate as a waiver thereof, and a waiver of a particular
right or remedy on one occasion will not be deemed a waiver of any other right
or remedy, or a waiver on any subsequent occasion (it being understood that
specific time frames for notice or actions to be taken shall be binding on the
parties).
10.11. Assignment. No party hereto may assign its rights or delegate any
----------
of its obligations hereunder without the prior written consent of the other
parties, except that, without such consent, (a) WELLCOME may assign all or any
part of its rights and obligations hereunder to an Affiliate of WELLCOME,
including but not limited to BW, so long as WELLCOME unconditionally guarantees
the obligations of such Affiliate; (b) WELLCOME may assign all of its rights and
delegate all of its duties under this Agreement to the transferee of all or
substantially all of the line of business of which this Agreement forms a part
or by way of merger or consolidation with another company; and (c) CENTOCOR and
CBV may assign all of their rights and delegate all
18
<PAGE>
of their duties to a transferee of all or substantially all their assets or by
way of merger or consolidation with another company. Without limiting the
foregoing, all rights and obligations with respect to the subject matter of this
Agreement as to the United States shall inure to the benefit of and be performed
by BW, subject to such further assignments as may be permitted by this Section
-------
10.11. If any party shall assign its rights and delegate its duties pursuant to
- -----
clauses (b) or (c) of this Section 10.11, the Person to whom such rights are
- ------------------ -------------
assigned and duties are delegated shall assume all of the obligations of the
applicable party under this Agreement. The guarantee by WELLCOME referenced in
clause (a) of this Section 10.11 is a guaranty of payment and performance, and
- ---------- -------------
not of collection; and in case of a default by an Affiliate of WELLCOME to which
rights have been assigned or obligations delegated pursuant to such clause (a),
----------
CENTOCOR and CBV shall have the right to proceed first against WELLCOME without
the necessity to proceed against or join such Affiliate.
10.12. Successors and Assigns. This Agreement shall bind, inure to the
----------------------
benefit of, and be enforceable by the successors and permitted assigns of the
parties hereto.
10.13. Governing Law. This Agreement shall be construed and enforced in
-------------
accordance with the Laws of the Commonwealth of Pennsylvania without regard to
principles of conflicts of law applicable in such jurisdiction.
10.14. No Benefit to Others. The representations, warranties, covenants
--------------------
and agreements contained in this Agreement are for the sole benefit of the
parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring, and are not intended to confer, any rights on any other
Person.
19
<PAGE>
10.15. Independent Contractors. It is expressly understood and agreed that
-----------------------
the Centocor Group and the Wellcome Group are independent contractors; neither
the Centocor Group or any of its members, nor the Wellcome Group or any of its
members, shall be deemed the agent of the other group or of any of its members
for any purpose whatsoever, and neither the Centocor Group or any of its
members, nor the Wellcome Group or any of its members, shall have authority to
enter into any contract or agreement, assume any obligation or make any warranty
or representation for or on behalf of the other group or any of its members.
Nothing in this Agreement shall be deemed to create or constitute a partnership
or the relationship of employer and employee between the Wellcome Group or any
of its members on the one hand and the Centocor Group or any of its members on
the other.
10.16. Confidentiality.
---------------
10.16.1. "Proprietary Information" for the purposes of this Section
----------------------- -------
10.16 means all of the Escrow Materials, with respect to which each party shall
- -----
be considered the Disclosing Party and Receiving Party for the purposes of this
Section 10.16.
- -------------
10.16.2. Except as expressly provided herein otherwise, each
Receiving Party shall, during the term of this Agreement including any renewals
thereof, and for a period of five (5) years following expiration or the
termination hereof, but in any event not for less than a period of ten (10)
years, maintain the confidentiality of all Proprietary Information disclosed by
the Disclosing Party hereunder and shall neither use the same except as
expressly authorized by this Agreement, the Alliance Agreement or any other
Alliance Document, nor disclose the same to any Third Party that is not an
Affiliate of the Receiving Party without the prior written consent of the
Disclosing Party. Nothing in this Section 10.16, however, shall be construed to
-------------
require any party hereto to maintain the
20
<PAGE>
confidentiality and non-use of any information or material that (a) at the time
of disclosure, is already in the public domain; (b) after disclosure, enters the
public domain otherwise than by an act or omission of the Receiving Party in
violation of the terms of this Agreement; (c) prior to disclosure under this
Agreement was already in the possession of the Receiving Party or its
Affiliates, provided that such information or material was not obtained,
directly or indirectly, from the Disclosing Party; (d) becomes known to the
Receiving Party from a Third Party, provided that such information or material
was not obtained, directly or indirectly, from the Disclosing Party on a
confidential basis; (e) is required in the reasonable judgment of the Receiving
Party to be disclosed to a Governmental Entity in furtherance of this Agreement
or the Alliance Agreement or pursuant to any Law, Governmental Entity, or Court
Order; or (f) results from research or development by the Receiving Party or its
Affiliates independent of disclosures from the Disclosing Party. Disclosures of
Proprietary Information made prior to the date hereof shall be governed by the
terms of this Section 10.16.
-------------
10.16.3. Nothing in this Section 10.16 shall prevent any party
-------------
hereto from disclosing its own information relating to its business, financial
affairs, products, research development, marketing and other commercial
activities to any Affiliate or any Third Party. In addition, notwithstanding
the restrictions in this Section 10.16 on confidentiality and use, any party
-------------
hereto may disclose Proprietary Information which is disclosed to it hereunder
to any of its Affiliates which agrees to be bound by the terms of this Section
-------
10.16.
- -----
10.17. Continuing Obligation. Except as otherwise specifically provided
---------------------
herein, neither termination nor expiration of this Agreement shall relieve any
party from any obligation under this Agreement which accrued or arose from facts
and circumstances in existence prior thereto.
21
<PAGE>
10.18. Covenant Not to Sue. CENTOCOR and CBV agree that during the term of
-------------------
this Agreement, neither they nor their Affiliates will assert or cause to be
asserted against WELLCOME, its Affiliates or its sublicensees, any Intellectual
Property rights not licensed hereunder that are or may be infringed by reason of
the exercise by WELLCOME, its Affiliates or its sublicensees of the license
granted hereunder; provided, however, nothing herein shall prohibit CENTOCOR,
-------- -------
CBV or their Affiliates from instituting any suit they are obligated to
institute pursuant to the terms of a license agreement with a Third Party
pursuant to which a license to such Intellectual Property has been granted.
10.19. Counterparts. This Agreement and any amendment or supplement hereto
------------
may be executed in any number of counterparts and any party hereto may execute
any such counterpart, each of which when executed and delivered shall be deemed
to be an original and all of which counterparts taken together shall constitute
but one and the same instrument. The execution of this Agreement and any such
amendment or supplement by any party hereto will not become effective until
counterparts hereof have been executed by all the parties hereto.
10.20. Savings Clause. Any restriction or information provision (as each
--------------
of these terms or expressions are defined in the RTPA) contained in this
Agreement or in any arrangement of which this Agreement forms part by virtue of
which this Agreement or any such arrangement is registrable under the RTPA shall
not take effect in the United Kingdom until the day after the day on which full
particulars of this Agreement (and of any such arrangement) shall have been duly
furnished to the Office of Fair Trading under Section 24 of the RTPA.
----------
22
<PAGE>
10.21. Further Assurances. At the request of any party hereto, the other
------------------
parties hereto shall execute and deliver from time to time such further
instruments and shall provide reasonable cooperation in such proceedings or
actions as shall be necessary or reasonably appropriate to effectuate the
purposes of this Agreement including, without limitation, registering or
recording the rights granted hereunder; provided, however, if any party hereto
-------- -------
desires to notify this Agreement under Article 85(3) of the Treaty of Rome
establishing the European Economic Community, such party shall give the other
parties ninety (90) days prior written notice of such notification and if during
such period a party shall reasonably object to such notification, the objecting
party need not cooperate in such notification and such notification shall not be
implemented. Except as otherwise provided in the Alliance Documents, the
executions, deliveries and cooperation of each party under this Section 10.21
-------------
shall be without further consideration and at such party's expense.
IN WITNESS WHEREOF, the parties hereto have duly caused this Agreement to
be executed as of the day and year first above written by their duly authorized
representatives.
FOR AND ON BEHALF OF
THE WELLCOME FOUNDATION LIMITED
By: /s/ Trevor M. Jones
------------------------------------
Name: Trevor M. Jones
----------------------------------
Title: Director/Research, Development
---------------------------------
& Medical
---------------------------------
BURROUGHS WELLCOME CO.
By: /s/ David W. Barry
------------------------------------
Name: David W. Barry
----------------------------------
Title: Vice President of Research,
---------------------------------
Development and Medical
---------------------------------
[EXECUTIONS CONTINUED]
23
<PAGE>
CENTOCOR, INC.
By: /s/ Bobba Venkatadri
------------------------------------
Name: Bobba Venkatadri
----------------------------------
Title: Executive Vice-President
---------------------------------
CENTOCOR B.V.
By: /s/ David P. Holveck
------------------------------------
Name: David P. Holveck
----------------------------------
Title: Managing Director
---------------------------------
24
<PAGE>
APPENDIX A
----------
GLOSSARY OF TERMS
-----------------
[See Appendix A to Alliance Agreement]
25
<PAGE>
SCHEDULE 2.1
------------
17-1A PATENT RIGHTS
-------------------
<TABLE>
<CAPTION>
- --------------------------------------------------------------------------------
Patent Application
Docket Country Title No. No.
------ ------- ----- ------ -----------
- --------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
(**)
CTR87-25 USA Immunoreactive 4,978,745 89 90 05201
EPO Heterochain Antibodies 0389554 583,830-4
(**)
CTR88-48A USA Radiotheropeutic 5,130,166 89 91 2700.5
- --------------------------------------------------------------------------------
</TABLE>
<PAGE>
SCHEDULE 2.2
EXCLUDED AGREEMENTS
1. "RESEARCH AND LICENSE AGREEMENT" BETWEEN NEW YORK BLOOD CENTER AND
CENTOCOR, INC. DATED AS OF MARCH 1, 1986, AS AMENDED ON JUNE 1987 AND
AUGUST 24, 1988
<PAGE>
SCHEDULE 3.1
------------
ESCROW AGREEMENT
----------------
[See Exhibit K to the Alliance Agreement]
<PAGE>
SCHEDULE 3.2
------------
ESCROW MATERIALS
----------------
(**)
<PAGE>
THE WELLCOME FOUNDATION LIMITED
AND
BURROUGHS WELLCOME CO.
and
CENTOCOR, INC.
AND
CENTOCOR B.V.
- --------------------------------------------------------------------------------
RELICENSE AGREEMENT
- --------------------------------------------------------------------------------
The Wellcome Foundation Ltd
Legal Department
Unicorn House
P O Box 129
160 Euston Road
London NW1 2BP
England
Dated: As of December 16, 1993
<PAGE>
TABLE OF CONTENTS
-----------------
<TABLE>
<CAPTION>
Page
----
<S> <C>
1. DEFINITIONS ........................................................... 2
2. GRANT OF LICENSE ...................................................... 2
3. TERM; TERMINATION ..................................................... 3
4. REPRESENTATIONS AND WARRANTIES ........................................ 4
5. PROPRIETARY RIGHTS; WARRANTY DISCLAIMER ............................... 8
6. INFRINGEMENT .......................................................... 8
7. INDEMNIFICATION ....................................................... 9
8. MISCELLANEOUS ......................................................... 11
</TABLE>
-i-
<PAGE>
RELICENSE AGREEMENT
THIS RELICENSE AGREEMENT (the "Agreement") is dated as of the 16th day
---------
of December, 1993 by and among CENTOCOR, INC., a Pennsylvania corporation of 200
Great Valley Parkway, Malvern, Pennsylvania 19355-1307, USA ("CENTOCOR"),
--------
CENTOCOR B.V., a Netherlands corporation of Einsteinweg 101, PO Box 251, 2300 AG
LEIDEN, the Netherlands ("CBV"), THE WELLCOME FOUNDATION LIMITED, a United
---
Kingdom corporation of Unicorn House, PO Box 129, 160 Euston Road, London NW1
2BP, England ("WFL"), and BURROUGHS WELLCOME CO., a North Carolina corporation
---
of 3030 Cornwallis Road, Research Triangle Park, NC 27709-4498, USA ("BW" and,
--
collectively with WFL, "WELLCOME").
--------
W I T N E S S E T H:
--------------------
WHEREAS, WELLCOME, CENTOCOR and CBV have entered into an Anti-Cancer
Alliance Agreement dated as of November 5, 1993 (the "Alliance Agreement") which
------------------
governs the parties' collaboration in the development, manufacture, marketing,
sale and distribution of products for the treatment of cancers;
WHEREAS, as contemplated by the Alliance Agreement, a Centocor Technology
License Agreement of even date herewith by and among CENTOCOR, CBV and WELLCOME
(the "License Agreement") grants WELLCOME the exclusive worldwide right and
-----------------
license under the Intellectual Property rights of CENTOCOR and CBV to use the
Centocor Technology (as defined in Appendix A hereto) to develop, make, have
----------
made, use, market, promote, distribute and sell 17-1A Product and Derivative
17-1A Products; and
-1-
<PAGE>
WHEREAS, WELLCOME desires to grant back to CENTOCOR and CBV a license to
use the Centocor Technology solely on the terms and conditions set forth below;
NOW THEREFORE, in consideration of the premises and the mutual covenants
and agreements herein contained, and for such other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
parties hereto, intending to be legally bound hereby, do hereby agree as
follows:
1. DEFINITIONS
-----------
Capitalized terms not otherwise defined herein shall have the meanings set
forth in Appendix A hereto.
----------
2. GRANT OF LICENSE
----------------
In consideration for the covenants and agreements set forth in the other
Alliance Documents, and subject to the terms and conditions set forth in this
Agreement and the limitations expressly imposed by the License Agreement,
WELLCOME hereby grants CENTOCOR and CBV an exclusive (including, without
limitation, as to WELLCOME and its Affiliates) worldwide, royalty-free license,
with the right to sublicense, under all of WELLCOME'S rights in the Centocor
Technology pursuant to the License Agreement, to develop, use, make and sell
17-1A Product solely (a) for Clinical Trials conducted in accordance with the
Development Agreement; (b) for delivery to or at the instruction of WELLCOME in
accordance with the Supply Agreement; and (c) for delivery to or at the
instruction of a Permitted Distributor in such Permitted Distributor's territory
as authorized by the Supply Agreement.
-2-
<PAGE>
3. TERM; TERMINATION
-----------------
3.1. The license granted by this Agreement shall take effect on the date
hereof and shall be perpetual unless terminated in accordance with the terms of
this Section 3.
---------
3.2. CENTOCOR may give notice in writing to WELLCOME terminating this
Agreement within sixty (60) days if WELLCOME is in material breach of its
obligations hereunder and fails to remedy such breach within such sixty (60) day
period. WELLCOME may give notice in writing to CENTOCOR terminating this
Agreement within sixty (60) days if CENTOCOR or CBV is in material breach of its
obligations hereunder and fails to remedy such breach within such sixty (60) day
period. No such termination, however, shall release any of the parties from any
obligations hereunder incurred prior to such termination.
3.3. In addition to the provisions of Section 3.2 hereof, WELLCOME reserves
-----------
the right to terminate this Agreement by written notice to take effect
immediately upon the occurrence of any of the following events:
3.3.1. WELLCOME terminates the Supply Agreement pursuant to Sections
--------
26.1.2, 26.1.3, 26.1.4, 26.1.6, 26.1.7 or 26.3 thereof;
- ----------------------------------------------
3.3.2. WELLCOME terminates (a) the Development Agreement pursuant to
Sections 9.2.2 or 9.4 thereof and (b) the Supply Agreement pursuant to Section
- --------------------- --- -------
26.1.1 thereof;
- ------
-3-
<PAGE>
3.3.3. CENTOCOR terminates the Supply Agreement other than pursuant
to Section 26.3 thereof;
------------
3.3.4. CENTOCOR terminates the Development Agreement other than
pursuant to Section 9.4 thereof; or
-----------
3.3.5. The License Agreement expires or is terminated for any cause
or for no cause;
provided, however, termination pursuant to this Section 3.3 shall not affect
- -------- ------- -----------
CENTOCOR'S and CBV'S license under this Agreement to develop, make and sell
17-1A Product, in each case solely for delivery to or at the instruction of
Ajinomoto or its successor in the Ajinomoto Territory (excluding the Former
Ajinomoto Territory, as defined in Section 4.1 of the Supply Agreement, to the
-----------
extent Ajinomoto's successor in such Former Ajinomoto Territory is WELLCOME or a
WELLCOME Affiliate).
4. REPRESENTATIONS AND WARRANTIES
------------------------------
4.1. Representations and Warranties of CENTOCOR and CBV. As a material
--------------------------------------------------
inducement to WELLCOME to enter into this Agreement and to consummate the
transactions contemplated hereby, CENTOCOR and CBV hereby represent and warrant
to WELLCOME as follows, which representations and warranties shall survive the
execution and delivery of this Agreement:
4.1.1. Organization and Good Standing. Each of CENTOCOR and CBV is a
------------------------------
corporation duly organized, validly existing, and in good standing under the
Laws of the jurisdiction of its incorporation with the requisite power and
authority (corporate or otherwise) to carry on its business as presently
-4-
<PAGE>
being conducted and as proposed to be conducted pursuant to the Alliance
Agreement, and to own and operate its properties and assets.
4.1.2. Corporate Power and Authority; Enforceability. Each of CENTOCOR
---------------------------------------------
and CBV has the requisite power and authority (corporate and otherwise) to
execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby. The execution, delivery and performance by CENTOCOR and
CBV of this Agreement and the consummation by CENTOCOR and CBV of the
transactions contemplated hereby have been duly authorized by all necessary
action (corporate or otherwise) on the part or CENTOCOR and CBV. This Agreement
constitutes a legal, valid and binding obligation of each of CENTOCOR and CBV,
enforceable in accordance with its terms.
4.1.3. Validity of Contemplated Transactions. The execution, delivery
-------------------------------------
and performance by CENTOCOR and CBV of this Agreement, and the consummation by
CENTOCOR and CBV of the transactions contemplated hereby, do not (a) violate or
contravene any provision of CENTOCOR'S or CBV'S charter or bylaws; (b) violate,
breach, conflict with, constitute a Default under, cause the acceleration of any
payments pursuant to, or otherwise impair the good standing, validity, or
effectiveness of, any agreement, contract, indenture, lease, license, or
mortgage to which CENTOCOR or CBV is a party or by which CENTOCOR or CBV is
bound; (c) subject any of CENTOCOR'S or CBV'S properties or assets to any Lien
or to any indenture, mortgage, contract, commitment, or agreement (other than
this Agreement) to which CENTOCOR or CBV is a party or by which CENTOCOR or CBV
or any of CENTOCOR'S of CBV'S properties or assets are bound; (d) violate any
provision of any Law, Permit or Court Order
-5-
<PAGE>
applicable to CENTOCOR or CBV; or (e) require any Permit or Required Consent of
any Governmental Entity to be obtained by CENTOCOR or CBV which has not been
obtained.
4.1.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to CENTOCOR'S or CBV'S knowledge, threatened against or related to
CENTOCOR or CBV, nor any failure to comply with, violation of or any Default
under, any Law, Permit or Court Order applicable to CENTOCOR or CBV, in each
case which might have a material adverse effect on the ability of CENTOCOR or
CBV to execute, deliver and perform this Agreement or on the ability of CENTOCOR
or CBV to consummate the transactions contemplated hereby.
4.2. Representations and Warranties of WFL and BW. As a material
--------------------------------------------
inducement to CENTOCOR and CBV to enter into this Agreement and to consummate
the transactions contemplated hereby, WFL and BW hereby jointly and severally
represent and warrant to CENTOCOR and CBV as follows, which representations and
warranties shall survive the execution and delivery of this Agreement:
4.2.1. Organization and Good Standing. Each of WFL and BW is a
------------------------------
corporation duly organized and validly existing under the Laws of the
jurisdiction of its incorporation, with the requisite power and authority
(corporate or otherwise) to carry on its business as presently being conducted
and as proposed to be conducted pursuant to the Alliance Agreement, and to own
and operate its properties and assets.
4.2.2. Corporate Power and Authority; Enforceability. Each of WFL and
---------------------------------------------
BW has the requisite power and authority (corporate and otherwise) to execute,
deliver and
-6-
<PAGE>
perform this Agreement and to consummate the transactions contemplated hereby.
The execution, delivery and performance by WFL and BW of this Agreement and the
consummation by WFL and BW of the transactions contemplated hereby have been
duly authorized by all necessary action (corporate or otherwise) on the part of
WFL and BW. This Agreement constitutes a legal, valid and binding obligation of
WFL and BW, enforceable in accordance with its terms.
4.2.3. Validity of Contemplated Transactions. The execution, delivery
-------------------------------------
and performance by WFL and BW of this Agreement, and the consummation by WFL and
BW of the transactions contemplated hereby, do not (a) violate or contravene any
provision of WFL'S or BW'S charter or bylaws; (b) violate, breach, conflict
with, constitute a Default under, cause the acceleration of any payments
pursuant to, or otherwise impair the good standing, validity, or effectiveness
of, any agreement, contract, indenture, lease, license, or mortgage to which WFL
or BW is a party or by which WFL or BW is bound; (c) violate any provision of
any Law, Permit or Court Order applicable to WFL or BW; or (d) require any
Permit or Required Consent of any Governmental Entity to be obtained by WFL and
BW which has not been obtained.
4.2.4. Litigation; Compliance with Laws. There is no Litigation
--------------------------------
pending or, to WFL'S or BW'S knowledge, threatened against or related to WFL or
BW, nor any failure to comply with, violation of or any Default under, any Law,
Permit or Court Order applicable to WFL or BW, in each case which might have a
material adverse effect on the ability of WFL or BW to execute, deliver and
perform this Agreement or on the ability of WFL or BW to consummate the
transactions contemplated hereby.
-7-
<PAGE>
5. PROPRIETARY RIGHTS; WARRANTY DISCLAIMER
---------------------------------------
5.1. WELLCOME agrees that, for so long as this Agreement is in effect, it
shall take no action that materially impairs its ability to grant and continue
the license contemplated by this Agreement; provided, however, nothing herein
-------- -------
shall require WELLCOME to maintain the License Agreement in effect.
5.2. Except as provided in Section 5.1 hereof, WELLCOME makes no
-----------
representation or warranty with respect to the Centocor Technology. WITHOUT
LIMITING THE FOREGOING, WELLCOME EXPRESSLY DISCLAIMS ANY REPRESENTATION OR
WARRANTY CONCERNING WELLCOME'S TITLE TO, OR RIGHT TO GRANT LICENSES OR
SUBLICENSES IN THE CENTOCOR TECHNOLOGY, ANY IMPLIED WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE, AND ANY IMPLIED WARRANTY OF MERCHANTABILITY.
6. INFRINGEMENT
------------
6.1. In the event that any party hereto obtains knowledge of any
infringement or misappropriation by a Third Party of the Intellectual Property
rights relating to the Centocor Technology (an "Infringement"), such party shall
------------
inform the other parties promptly of such Infringement and provide the other
parties with any available evidence of such Infringement or misappropriation.
CENTOCOR and CBV shall have the right but not the obligation to prosecute at
their own cost and expense any claim of Infringement of the Intellectual
Property rights relating to the Centocor Technology. If both CENTOCOR and CBV
fail to commence any action against an infringer within ninety (90) days after
either obtains knowledge of the infringement, WELLCOME may commence action
against the infringer. At the reasonable request of the
-8-
<PAGE>
party filing suit, the other parties, at their own expense, will provide
reasonable assistance, including, without limitation, permitting the use of
their respective names in all suits and signing all necessary documents if
appropriate to the situation. Any recovery in any action brought in accordance
with this section shall be applied first to costs incurred by the party bringing
suit, and then to the costs of the party or parties providing assistance as
contemplated by this Section 6, with the remainder to be retained by the party
---------
bringing the suit.
6.2. WELLCOME agrees that, so long as this Agreement remains in effect, it
shall not exercise its right under Section 8 of the License Agreement to bring
---------
suit for Infringement (as defined therein).
7. INDEMNIFICATION
---------------
7.1. Subject to compliance by the applicable Indemnitee (as defined
below) with its obligations set forth in Sections 7.4 and 7.5 hereof, CENTOCOR
--------------------
and CBV shall defend, indemnify and hold WELLCOME and its Affiliates and the
respective directors, officers, employees and agents of WELLCOME and its
Affiliates, harmless from and against any and all Losses arising out of,
relating to or resulting from the breach by CENTOCOR and CBV of any of their
representations, warranties and covenants contained within this Agreement.
7.2. Subject to compliance by the applicable Indemnitee (as defined below)
with its obligations set forth in Sections 7.4 and 7.5 hereof, WELLCOME shall
--------------------
defend, indemnify and hold CENTOCOR, CBV and their Affiliates and the respective
directors, officers, employees and agents of CENTOCOR and CBV and their
-9-
<PAGE>
Affiliates, harmless from and against any and all Losses arising out of,
relating to or resulting from the breach by WELLCOME of any of its
representations, warranties and covenants contained in this Agreement.
7.3. "Indemnitor" means CENTOCOR and CBV with respect to Section 7.1 hereof
---------- -----------
and WELLCOME with respect to Section 7.2 hereof. "Indemnitee" means any of
----------- ----------
WELLCOME and its Affiliates and the respective directors, officers, employees
and agents of WELLCOME and its Affiliates with respect to Section 7.1 hereof and
-----------
any of CENTOCOR, CBV and their Affiliates and the respective directors,
officers, employees and agents of CENTOCOR, CBV and their Affiliates with
respect to Section 7.2 hereof.
-----------
7.4. Notice. Promptly after receipt by an Indemnitee of written notice of
------
the commencement of any suit, audit, demand, judgment, action, investigation or
proceeding relating to a Loss (a "Third Party Action"), or promptly after an
------------------
Indemnitee incurs a Loss or has knowledge of the existence of a Loss, such
Indemnitee will, if a claim with respect thereto is to be made against
Indemnitor due to Indemnitor's obligation to provide indemnification hereunder,
give Indemnitor written notice of such Loss or the commencement of such Third
Party Action; provided, however, the failure to provide such notice within a
-------- -------
reasonable period of time shall not relieve Indemnitor of any of its obligations
hereunder except to the extent it is prejudiced by such failure.
7.5. Defense. The Indemnitor shall control the defense and settlement of a
-------
Third Party Action, except that the applicable Indemnitee may assume such
defense provided that the obligation of the Indemnitor to pay the attorneys'
fees of such
-10-
<PAGE>
Indemnitee shall cease upon such election. If the Indemnitor defends such
action, it shall not enter into any resolution or other compromise of such
action unless (a) it pays in cash or posts an adequate bond for the payment of
the amount of such resolution or other compromise and obtains a complete release
of the Indemnitee or (b) obtains the prior written consent of the Indemnitee,
which shall not be unreasonably withheld or delayed. If the Indemnitee defends
such action, such Indemnitee shall not enter into any resolution or other
compromise of such action unless such Indemnitee obtains the consent of the
Indemnitor, which shall not be unreasonably withheld or delayed. The party
defending the action shall keep the other parties informed on an ongoing basis
of the status of such Third Party Action and shall deliver to such other parties
copies of all documents relating to the Third Party Action as the other parties
may reasonably request. The party assuming such defense shall receive from the
others all necessary and reasonable cooperation in the defense of a Third Party
Action including, but not limited to, the services of employees of such other
parties who are familiar with the events or circumstances out of which any such
Third Party Action may have arisen.
7.6. The indemnifications contained in this Section 7 shall survive
---------
expiration or termination of this Agreement.
8. MISCELLANEOUS
-------------
8.1. Entire Agreement. This Agreement and the other Alliance Documents
----------------
constitute the entire understanding of the parties with respect to the subject
matter contained herein and supersede any prior understandings and agreements
among them respecting such subject matter including, without limitation, the
-11-
<PAGE>
Letter of Intent between CENTOCOR and WFL dated September 16, 1993; provided,
--------
however, the confidentiality agreement between WFL and CENTOCOR dated September
- -------
14, 1993 shall in all cases remain in full force and effect in accordance with
its terms.
8.2. Amendments. This Agreement may be amended and supplemented only by a
----------
written instrument duly executed by each of the parties.
8.3. Headings. The headings in this Agreement are for convenience of
--------
reference only and shall not affect its interpretation.
8.4. Gender; Number. Words of gender may be read as masculine, feminine,
--------------
or neuter, as required by context. Words of number may be read as singular or
plural, as required by context.
8.5. Appendices; Exhibits; and Schedules. All appendices, exhibits and
-----------------------------------
schedules referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.
8.6. Severability. If any provision of this Agreement or the application
------------
thereof to any Person or circumstance is held illegal, invalid, or
unenforceable, such illegality, invalidity, or unenforceability shall not affect
any other provision hereof. This Agreement shall, in such circumstances, be
deemed modified to the extent necessary to render enforceable the provisions
hereof to the fullest extent permitted by Law.
8.7. Remedies. Each of CENTOCOR and CBV on the one hand, and WFL and BW on
--------
the other, stipulates that the remedies at law
-12-
<PAGE>
of the other in the event of any default or threatened default in the
performance of or compliance with any of the terms of this Agreement are not and
will not be adequate and that, to the fullest extent permitted by Law, such
terms may be specifically enforced by a decree for specific performance of any
agreement contained herein or by an injunction against any violation of any
terms hereof or otherwise.
8.8. Joint and Several Liability. CENTOCOR and CBV shall be jointly and
---------------------------
severally responsible and liable for all of their respective obligations to
WELLCOME arising under this Agreement. WFL and BW shall be jointly and severally
liable for all of their respective obligations to CENTOCOR or CBV arising under
this Agreement.
8.9. Notices. All notices and other communications hereunder shall be in
-------
writing and shall be given to the Person either personally or by sending a copy
thereof by first class United States express mail, postage prepaid and
return-receipt requested, or by a nationally-recognized courier service
guaranteeing next-day delivery, charges prepaid, or by telecopier (with the
original sent by either of the foregoing manners), to such Person's address (or
to such Person's telecopier number). All notices shall be deemed to have been
given to the Person entitled thereto when received.
-13-
<PAGE>
If to WFL, to:
THE WELLCOME FOUNDATION LIMITED
Unicorn House, P.O. Box 129
129 Euston Road
London NW1 2BP
Attention: Company Secretary
Telecopy No.: 011-44-71-388-5462
With a copy to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to BW, to:
BURROUGHS WELLCOME CO.
3030 Cornwallis Road
Research Triangle Park, NC 27709
Attention: Secretary
Telecopy No.: (919) 315-0478
If to CENTOCOR or CBV, to:
CENTOCOR, INC.
200 Great Valley Parkway
Malvern, Pennsylvania 19355-1307
Attention: Corporate Secretary
Telecopy No.: (215) 651-6100
-14-
<PAGE>
with a copy to:
Duane, Morris & Heckscher
One Liberty Place
Philadelphia, PA 19103
Attention: David C. Toner, Esquire
Telecopy No.: (215) 979-1020
Notice of any change in any such address shall also be given in the manner set
forth above. Whenever the giving of notice is required, the giving of such
notice may be waived by the Person entitled to receive such notice.
8.10. Waiver. No provision of this Agreement may be waived except by a
------
written instrument signed by the party hereto sought to be bound. No failure or
delay by any party hereto in exercising any right or remedy hereunder or under
applicable Law will operate as a waiver thereof, and a waiver of a particular
right or remedy on one occasion will not be deemed a waiver of any other right
or remedy, or a waiver on any subsequent occasion (it being understood that
specific time frames for notice or actions to be taken shall be binding on the
parties).
8.11. Assignment. No party hereto may assign its rights or delegate any
----------
of its obligations hereunder without the prior written consent of the other
parties, except that, without such consent, (a) WFL may assign all or any part
of its rights and obligations hereunder to an Affiliate of WFL, including but
not limited to BW, so long as WFL unconditionally guarantees the obligations of
such Affiliate; (b) WFL and BW may assign all of their rights and delegate all
of their duties under this
-15-
<PAGE>
Agreement to the transferee of all or substantially all of the line of business
of which this Agreement forms a part or by way of merger or consolidation with
another company; and (c) CENTOCOR and CBV may assign all of their rights and
delegate all of their duties under this Agreement to a transferee of all or
substantially all their assets or by way of merger or consolidation with another
company. Without limiting the foregoing, all rights and obligations with
respect to the subject matter of this Agreement as to the United States shall
inure to the benefit of and be performed by BW, subject to such further
assignments as may be permitted by this Section 8.11. If any party shall assign
------------
its rights and delegate its duties pursuant to clauses (b) or (c) of this
------------------
Section 8.11, the Person to whom such rights are assigned and duties are
- ------------
delegated shall assume all of the obligations of the applicable party under this
Agreement. The guarantee by WELLCOME referenced in clause (a) of this Section
---------- -------
8.11 is a guaranty of payment and performance, and not of collection; and in
- ----
case of a default by an Affiliate of WELLCOME to which rights have been assigned
or obligations delegated pursuant to such clause (a), CENTOCOR and CBV shall
----------
have the right to proceed first against WELLCOME without the necessity to
proceed against or join such Affiliate.
8.12. Successors and Assigns. This Agreement shall bind, inure to the
----------------------
benefit of, and be enforceable by the successors and permitted assigns of the
parties hereto.
8.13. Governing Law. This Agreement shall be construed and enforced in
-------------
accordance with the Laws of the Commonwealth of Pennsylvania without regard to
principles of conflicts of law applicable in such jurisdiction.
-16-
<PAGE>
8.14. No Benefit to Others. The representations, warranties, covenants
--------------------
and agreements contained in this Agreement are for the sole benefit of the
parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring, and are not intended to confer, any rights on any other
Person.
8.15. Further Assurances. At the request of any party hereto, the other
------------------
parties hereto shall execute and deliver from time to time such further
instruments and shall provide reasonable cooperation in such proceedings or
actions as shall be necessary or reasonably appropriate to effectuate the
purposes of this Agreement including, without limitation, registering or
recording the rights granted hereunder; provided, however, if any party hereto
-------- -------
desires to notify this Agreement under Article 85(3) of the Treaty of Rome
establishing the European Economic Community, such party shall give the other
parties ninety (90) days prior written notice of such notification and if during
such period a party shall reasonably object to such notification, the objecting
party need not cooperate in such notification and such notification shall not be
implemented. Except as otherwise provided in the Alliance Documents, the
executions, deliveries and cooperation of each party under this Section 8.15
------------
shall be without further consideration and at such party's expense.
8.16. Confidentiality.
---------------
8.16.1. "Proprietary Information," for the purposes of this Section
----------------------- -------
8.16, means the Centocor Technology provided by WELLCOME to CENTOCOR or CBV in
- ----
accordance with this Agreement.
-17-
<PAGE>
8.16.2. Except as expressly provided herein otherwise, each
Receiving Party shall, during the term of this Agreement including any renewals
thereof, and for a period of five (5) years following expiration or the
termination hereof, but in any event not for less than a period of ten (10)
years, maintain the confidentiality of all Proprietary Information disclosed by
the Disclosing Party hereunder and shall neither use the same except as
expressly authorized by this Agreement, the Alliance Agreement or any other
Alliance Document, nor disclose the same to any Third Party that is not an
Affiliate of the Receiving Party without the prior written consent of the
Disclosing Party. Nothing in this Section 8.16, however, shall be construed to
------------
require any party hereto to maintain the confidentiality and non-use of any
information or material that (a) at the time of disclosure, is already in the
public domain; (b) after disclosure, enters the public domain otherwise than by
an act or omission of the Receiving Party in violation of the terms of this
Agreement; (c) prior to disclosure under this Agreement was already in the
possession of the Receiving Party or its Affiliates, provided that such
information or material was not obtained, directly or indirectly, from the
Disclosing Party; (d) becomes known to the Receiving Party from a Third Party,
provided that such information or material was not obtained, directly or
indirectly, from the Disclosing Party on a confidential basis; (e) is required
in the reasonable judgment of the Receiving Party to be disclosed to a
Governmental Entity in furtherance of this Agreement or the Alliance Agreement
or pursuant to any Law, Governmental Entity, or Court Order; or (f) results from
research or development by the Receiving Party or its Affiliates independent of
disclosures from the Disclosing Party. Disclosures of Proprietary Information
made prior to the
-18-
<PAGE>
date hereof shall be governed by the terms of this Section 8.16.
------------
8.16.3. Nothing in this Section 8.16 shall prevent any party hereto
------------
from disclosing its own information relating to its business, financial affairs,
products, research development, marketing and other commercial activities to any
Affiliate or any Third Party. In addition, notwithstanding the restrictions in
this Section 8.16 on confidentiality and use, any party hereto may disclose
------------
Proprietary Information which is disclosed to it hereunder to any of its
Affiliates which agrees to be bound by the terms of this Section 8.16.
------------
8.17. Continuing Obligation. Except as otherwise specifically provided
---------------------
herein, neither termination nor expiration of this Agreement shall relieve any
party from any obligation under this Agreement which accrued or arose from facts
and circumstances in existence prior thereto.
8.18. Covenant Not to Sue. WELLCOME agrees that during the term of this
-------------------
Agreement it will not assert or cause to be asserted against CENTOCOR, its
Affiliates or its sublicensees, any Intellectual Property rights not licensed
hereunder that are or may be infringed by reason of the exercise by CENTOCOR,
its Affiliates or its sublicensees of the license granted hereunder; provided,
--------
however, nothing herein shall prohibit WELLCOME from instituting any suit which
- -------
it is obligated to institute pursuant to the terms of a license agreement with a
Third Party pursuant to which a license to such Intellectual Property has been
granted.
8.19. Counterparts. This Agreement and any amendment or supplement hereto
------------
may be executed in any number of counterparts
-19-
<PAGE>
and any party hereto may execute any such counterpart, each of which when
executed and delivered shall be deemed to be an original and all of which
counterparts taken together shall constitute but one and the same instrument.
The execution of this Agreement and any such amendment or supplement by any
party hereto will not become effective until counterparts hereof have been
executed by all the parties hereto.
8.20. Savings Clause. Any restriction or information provision (as each
--------------
of these terms or expressions are defined in the RTPA) contained in this
Agreement or in any arrangement of which this Agreement forms part by virtue of
which this Agreement or any such arrangement is registrable under the RTPA shall
not take effect in the United Kingdom until the day after the day on which full
particulars of this Agreement (and of any such arrangement) shall have been duly
furnished to the Office of Fair Trading under Section 24 of the RTPA.
----------
8.21. Independent Contractors. It is expressly understood and agreed that
-----------------------
the Centocor Group and the Wellcome Group are independent contractors; neither
the Centocor Group or any of its members, nor the Wellcome Group or any of its
members, shall be deemed the agent of the other group or of any of its members
for any purpose whatsoever, and neither the Centocor Group or any of its
members, nor the Wellcome Group or any of its members, shall have authority to
enter into any contract or agreement, assume any obligation or make any warranty
or representation for or on behalf of the other group or any of its members.
Nothing in this Agreement shall be deemed to create or constitute a partnership
-20-
<PAGE>
or the relationship of employer and employee between the Wellcome Group or any
of its members on the one hand and the Centocor Group or any of its members on
the other.
IN WITNESS WHEREOF, the parties hereto have cause this Agreement to be
executed as of the day and year first above written by their duly authorized
representatives.
FOR AND ON BEHALF OF
THE WELLCOME FOUNDATION LIMITED
By: /s/ Trevor M. Jones
------------------------------------
Name: Trevor M. Jones
----------------------------------
Title: Director/Research, Development &
---------------------------------
Medical
---------------------------------
BURROUGHS WELLCOME CO.
By: /s/ David W. Barry
------------------------------------
Name: David W. Barry
----------------------------------
Title: Vice President of Research,
---------------------------------
Development and Medical
---------------------------------
[EXECUTIONS CONTINUED]
-21-
<PAGE>
CENTOCOR, INC.
By: /s/ Bobba Venkatadri
------------------------------------
Name: Bobba Venkatadri
----------------------------------
Title: Executive Vice-President
---------------------------------
CENTOCOR B.V.
By: /s/ David P. Holveck
------------------------------------
Name: David P. Holveck
----------------------------------
Title: Managing Director
---------------------------------
-22-
<PAGE>
APPENDIX A
----------
GLOSSARY OF TERMS
-----------------
[See Appendix A to Alliance Agreement]
<PAGE>
THE REGISTRANT HAS REQUESTED CONFIDENTIAL TREATMENT FOR CERTAIN PORTIONS OF THE
ATTACHED DOCUMENT. "APPENDIX A: GLOSSARY OF TERMS." THOSE PORTIONS HAVE BEEN
OMITTED FROM THIS COPY OF THE DOCUMENT AT THE PLACES INDICATED BY DOUBLE
ASTERISKS (**); AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
<PAGE>
APPENDIX A
----------
GLOSSARY OF TERMS
-----------------
1. 17-1A ANTIBODY" means an unconjugated murine monoclonal antibody that
--------------
is produced by the Centocor Hybridoma, binds to an epitope of the 17-1A Antigen
and has the characteristics more fully set forth in Herlyn et. al., Proc. Natl.
------- -----------
Acad. Sci., 76(3) 1438-1442, March 1979.
- -----------------
2. "17-1A ANTIGEN" means the 37 kilodalton cell surface glycoprotein
-------------
containing two asparagine-linked (N. Linked) carbohydrate chains and expressed
on colorectal tissue.
3. "17-1A PRODUCT" means a pharmaceutical product that includes as its
-------------
active ingredient the 17-1A Antibody.
4. "17-1A PRODUCT SPECIFICATION" means the specification for the Pre
---------------------------
Formulated Bulk Antibody and the Final 17-1A Product set out in Schedule 8.3 of
------------
the Supply Agreement as such specification may be modified from time to time by
the Product Committee or as such specification may be modified as required by
applicable Regulatory Authorities.
5. "ADVERSE REACTIONS" means side effects, injury, toxicity or sensitivity
-----------------
reactions including unexpected increased incidence and severity thereof
associated with commercial or clinical uses, studies, investigations or tests
with the 17-1A Product or the 17-1A Antibody inside or outside the Territory.
6. "AFFILIATE" of a particular Person means any other Person which,
---------
directly or indirectly, controls, is controlled by, or is under common control
with such particular Person. The term
<PAGE>
"control" (including, with correlative meaning, the terms "controlled by" and
------- -------------
"under common control with"), as used with respect to any Person, means the
-------------------------
possession, directly or indirectly, of the power to elect forty percent (40%) or
more of the board of directors, or to direct or cause the direction of the
management and policies of such Person, whether through the ownership of voting
securities, by contract or otherwise; provided, however, BURROUGHS WELLCOME
-------- -------
INDIA LTD, WELLCOME PAKISTAN LTD, and BURROUGHS WELLCOME INDONESIA LTD shall be
considered to be Affiliates of WELLCOME.
7. "AJINOMOTO" means Ajinomoto Co., Inc., a Japanese corporation.
---------
8. "AJINOMOTO AGREEMENT" means the distribution agreement by and between
-------------------
CENTOCOR and Ajinomoto dated as of March 31, 1987.
9. "AJINOMOTO TERRITORY" means Japan, the Republic of Korea, the People's
-------------------
Republic of China and Taiwan.
10. "ALLIANCE AGREEMENT" means that certain Anti-Cancer Alliance Agreement
------------------
dated as of November 5, 1993 among WELLCOME, BW, CENTOCOR and CBV.
11. "ALLIANCE DOCUMENTS" means, collectively, the Alliance Agreement, the
------------------
Supply Agreement, the Development Agreement, the Manufacturing Technology
Option, the Cancer Products Agreement, the Novation, the License, the Relicense,
the Escrow Agreement, the Wellcome House Mark Agreement, the Trademark
Agreement, the Stock Purchase Agreement, the Registration Rights Agreement and
the Hybridoma Letter.
-2-
<PAGE>
12. "APHIS" means the United States Animal and Plant Health Inspection
-----
Service or any successor entity.
13. "BANKRUPTCY CODE" means the United States Bankruptcy Code of 1978, as
---------------
amended or supplemented from time to time, or any successor or substitute Laws.
14. "BIOLOGICAL PRODUCT" means a polypeptide or protein for therapeutic
------------------
use or otherwise and including, without limitation, Cancer Antibodies, the 17-1A
Antibody and the Derivative 17-1A Antibodies.
15. "BUSINESS DAY" means any day which is not a Saturday, Sunday, or a day
------------
on which banks in the Commonwealth of Pennsylvania or the United Kingdom are
authorized to close.
16. "BW" means Burroughs Wellcome Co., a North Carolina corporation and a
--
wholly-owned subsidiary of WFL.
17. "CANCER ANTIBODY" means a monoclonal antibody produced from a Cancer
---------------
Product Cell Line, or from a cell line derived from a Cancer Product Cell Line,
including, without limitation, a chimeric, murine or humanized antibody, and any
fragments thereof, whether or not conjugated, directly or indirectly, to
radionuclide, toxin, drugs, enzymes or otherwise.
18. "CANCER PRODUCT" means a pharmaceutical product containing as an
--------------
active ingredient a Cancer Antibody.
19. "CANCER PRODUCT AGREEMENT" means the Cancer Product Option Agreement
------------------------
among CENTOCOR, CBV and WELLCOME.
-3-
<PAGE>
20. "CANCER PRODUCT CELL LINE" means a cell line of CENTOCOR or cell line
------------------------
licensed to CENTOCOR under a Cancer Product Contract that has the designation
(**).
21. "CANCER PRODUCT CONTRACT" means an agreement by which a Licensor has
-----------------------
granted CENTOCOR or CBV rights to enable CENTOCOR or CBV to use Licensor IP in
the development, manufacture, production, marketing and/or sale of a Cancer
Product.
22. "CANCER PRODUCT INFORMATION" with respect to any Cancer Product
--------------------------
Contract, means technical data, information and Know-how, including information
concerning the derivation and properties of the applicable Cancer Product Cell
Line and the sequence and properties of the applicable Cancer Antibody, that
have been reduced to writing and that are owned by CENTOCOR or its Affiliates,
or in which CENTOCOR or its Affiliates have rights assignable or sublicensable
to WELLCOME.
23. "CANCER PRODUCT IP" means any Intellectual Property of CENTOCOR or its
-----------------
Affiliates, or Intellectual Property to which CENTOCOR or its Affiliates have
rights assignable or sublicensable to WELLCOME, necessary or useful to develop,
make, have made, use, market, sell or otherwise dispose of Cancer Products,
together with the related Licensor IP including, without limitation,
improvements to or trade secrets embodied in a Cancer Product Cell Line, but
excluding any Trademarks and any Manufacturing IP.
24. "CBV" means Centocor B.V., a Netherlands corporation and a
---
wholly-owned subsidiary of CENTOCOR.
-4-
<PAGE>
25. "CENTOCOR" means Centocor, Inc., a Pennsylvania corporation.
--------
26. "CENTOCOR GROUP" means CENTOCOR, CBV and their respective Affiliates.
--------------
27. "CENTOCOR HYBRIDOMA" means the hybridoma cell line known as (**) .
------------------
28. "CENTOCOR METHODOLOGY" means the methods, assays and analytical
--------------------
procedures, equipment specifications, manufacturing instructions, standard
operating instructions and procedures, process operating procedures and
techniques currently used by CENTOCOR and CBV in Filling and Capping.
29. "CENTOCOR TECHNOLOGY" means all Know-how and other Intellectual
-------------------
Property, together with all Improvements, owned by CENTOCOR or its Affiliates,
or licensed to CENTOCOR or its Affiliates with the right of sublicense, relating
to the development, manufacture, use, marketing and sale of the 17-1A Product or
Derivative 17-1A Products, including, without limitation, the Manufacturing
Technology and information and materials described in Schedule 3.2 attached to
------------
the License; provided, however, Centocor Technology shall in no event include
-------- -------
any Know-how or other Intellectual Property licensed by CENTOCOR under the
Wistar License or under any other rights the sublicense of which would give rise
to an obligation on the part of CENTOCOR or its Affiliates to pay additional
royalties to any Third Party.
30. "CENTOCOR TRADEMARKS" means the Panorex Trademarks and such other
-------------------
Trademarks as CENTOCOR may use from time to time, or as may be applied for or
registered by CENTOCOR, in countries in the Territory in connection with the
manufacture, use, packaging,
-5-
<PAGE>
promotion, marketing, sale and distribution of the 17-1A Product including, but
not limited to, those Trademarks set forth on Exhibits 1.2 and 1.3 to the
--------------------
Trademark Agreement.
31. "CGMP REGULATIONS" means those manufacturing practice regulations set
----------------
forth in Current Good Manufacturing Practices for Finished Pharmaceuticals, 21
C.F.R. (S) 211, as the same may be amended from time to time.
32. "CLINICAL INFORMATION" means the information made available by
--------------------
CENTOCOR to WELLCOME pursuant to Section 12 of the Development Agreement.
----------
33. "CLINICAL TRIAL MATERIAL" means material prepared for use or used in
-----------------------
Clinical Trials of the safety and efficacy of the 17-1A Product or such other
Biological Product (as the context requires).
34. "CLINICAL TRIALS" means trials involving administration of the 17-1A
---------------
Product or such other Biological Product (as the context requires) to humans to
obtain statistically meaningful results.
35. "CONDUCTED CLINICAL TRIALS" means those Clinical Trials conducted by
-------------------------
or on behalf of CENTOCOR and described on Schedule 12.1 to the Development
-------------
Agreement.
36. "COPYRIGHTS" means registered copyrights, copyright applications and
----------
unregistered copyrights.
37. "COUNTRY MARKETING PLANS" means the marketing plans developed from
-----------------------
time to time for countries in the Territory in accordance with the provisions of
the Supply Agreement.
-6-
<PAGE>
38. "COURT ORDER" means any judgment, decree, writ, injunction, order or
-----------
ruling of any Governmental Entity.
39. "CPMP" means the Committee for Proprietary Medicinal Products of the
----
European Community.
40. "CURRENCY GAIN OR LOSS" means, if the price paid to WELLCOME is in a
---------------------
currency (the "Customer Currency") different from the currency in which the
-----------------
Interim Price is paid to CENTOCOR (the "Wellcome Currency"), the adjustment to
-----------------
Net Sales will be made to reflect the difference between:
(a) the exchange rate between the Customer Currency and the Wellcome
Currency prevailing at the time of payment of the Interim Price, and
(b) the exchange rate between the Customer Currency and the Wellcome
Currency prevailing at the time of the applicable sale.
If the value of the Customer Currency in the Wellcome Currency is less at the
time described in clause (b), then, at the time described in clause (a), the Net
---------- ----------
Sales will be reduced. If the value of the Customer Currency in the Wellcome
Currency is more at the time described in clause (b) then, at the time described
----------
in clause (a), the Net Sales will be increased.
----------
41. "DATE OF REGULATORY APPROVAL" means the date of issuance of Regulatory
---------------------------
Approval for Targeted Indications in the applicable country, with respect to the
17-1A Product, or of other Regulatory Approval with respect to any other
Biological Product.
42. "DEFAULT" means (a) a breach of or default under any contract,
-------
agreement, document or instrument; (b) the occurrence of an event with which the
passage of time or the giving of
-7-
<PAGE>
notice or both would constitute a breach of or default under any contract,
agreement, document or instrument; or (c) the occurrence of an event that (with
or without the passage of time or the giving of notice or both) would give rise
to a right of damages, specific performance, termination, renegotiation or
acceleration under any contract, agreement, document or instrument.
43. "DERIVATIVE 17-1A ANTIBODY" means a monoclonal antibody, whether
-------------------------
murine, chimerized, humanized or otherwise, including, but not limited to,
fragments of any of the foregoing, that is expressed from the DNA which encodes
the 17-1A Antibody in whole or in part, but shall not include the 17-1A
Antibody.
44. "DERIVATIVE 17-1A PRODUCT" means a pharmaceutical product containing
------------------------
as its active ingredient Derivative 17-1A Antibody.
45. "DEVELOPMENT AGREEMENT" means the Clinical and Regulatory Development
---------------------
Agreement by and among WELLCOME, BW, CENTOCOR and CBV.
46. "DISCLOSING PARTY" means a party who discloses Proprietary Information
----------------
to a Receiving Party.
47. "DOLLARS" or "$" means United States Dollars.
------- -
48. "ENVIRONMENTAL LAWS" means all Laws and Regulations of any
------------------
Governmental Entity relating to pollution, safety or protection of human health
or the environment (including, without limitation, ambient air, surface water,
groundwater, land surface or subsurface strata), including, without limitation,
the Comprehensive Environmental Response, Compensation, and Liability
-8-
<PAGE>
Act, 42 U.S.C.A. (S)(S) 9601 et seq., the Resource Conservation and Recovery
-- ---
Act, 42 U.S.C.A. (S)(S) 6901 et seq., the Clean Water Act, 33 U.S.C.A. (S)(S)
-- ---
1251 et seq., the Clean Air Act 42 U.S.C.A. (S)(S)7401 et seq., the Occupational
-- ---
Safety and Health Act, 29 U.S.C.A. (S)(S)651 et seq., Atomic Energy Act of 1954,
-- ---
42 U.S.C.A. (S)(S) 3011 et seq., The Environmental Protection Act, The
-- ---
Environmental Protection General Provisions Act, Decree Environmental Impact
Assessment, Air Pollution Act, The Surface Water Pollution Act, The Waste Act
and Chemical Waste Act, The Soil Pollution Act, The Soil Clean-up Act, The
Nuisance Act, The Environmentally Hazardous Substance Act and any other foreign,
state and local counterparts to each of the foregoing, and other Laws and
Regulations relating to Materials of Environmental Concern or otherwise relating
to the manufacture, possession, distribution, use, treatment, storage, disposal,
transport or handling of, or emissions, spills, leaks, discharges, releases or
threatened releases of, Materials of Environmental Concern. "MATERIALS OF
------------
ENVIRONMENTAL CONCERN" means (a) hazardous or toxic wastes, substances or
- ---------------------
materials; (b) contaminants, solid wastes, petroleum, asbestos, polychlorinated
biphenyls or any other substance regulated by any Environmental Law; and (c)
material that is a source, special nuclear or by-product material, as defined by
the Atomic Energy Act of 1954, 42 U.S.C.A. (S)(S) 3011 et seq., and the
Regulations promulgated with respect thereto.
49. "ESCROW AGREEMENT" means one or more escrow agreements by and among
----------------
one or more of CBV, CENTOCOR, WELLCOME, BW and an Escrow Agent.
-9-
<PAGE>
50. "ESCROW MATERIALS" means the documents deposited by CENTOCOR and its
----------------
Affiliates with an Escrow Agent in accordance with an Escrow Agreement.
51. "EXCHANGE ACT" means the Securities Exchange Act of 1934, as amended,
------------
and the Regulations promulgated thereunder or with respect thereto, or any
successor or substitute Laws.
52. "F&C TECHNICAL INFORMATION" means any technical data, formulations,
-------------------------
formulae, methods, materials, assays, assay methods and materials, information,
design, including specifications, of all pertinent equipment, facilities, and
utility services, knowledge and experience with respect to any and all of the
processes of handling of frozen concentrate of the Pre Formulated Bulk Antibody,
thawing the Pre Formulated Bulk Antibody for quality control and for production,
the reconstitution, dilution and final formulation thereof, and filling into
vials, including, but not limited to, any and all samples, techniques,
processes, instructions, directions, laboratory scale-up data, instrumentation
and any and all necessary safety data, handling instructions, and instructions,
whether or not currently employed by CENTOCOR and CBV at the Leiden Facility,
necessary or appropriate for Filling and Capping and the assistance which
WELLCOME and BW require to enable complete and successful replication at the
Greenville Facility of Filling and Capping such that Final 17-1A Product, which
meets in all respects the Final 17-1A Product Specification, is produced at the
Greenville Facility from Pre Formulated Bulk Antibody.
53. "F&C TECHNICAL PROGRAM" means the program set forth in Schedule 12.1
--------------------- -------------
of the Supply Agreement which will provide for the transfer of the F&C Technical
Information.
-10-
<PAGE>
54. "FDA" means the United States Food and Drug Administration or any
---
successor agency.
55. "FILLING AND CAPPING" means the process of producing Final 17-1A
-------------------
Product from Pre Formulated Bulk Antibody.
56. "FINAL 17-1A PRODUCT" means 17-1A Product which has been put into
-------------------
vials and packaged into boxes and is duly labeled in accordance with the 17-1A
Product Specification, using the Centocor Trademarks, the Wellcome Indicia and
the Wellcome House Marks.
57. "FIRM ORDER" means an order by WELLCOME or any WELLCOME Affiliate in
----------
writing on its purchase order form, which, if in compliance with Section 6 of
---------
the Supply Agreement, shall on receipt thereof by CENTOCOR constitute a binding
order for Salable 17-1A Product.
58. "FIRST COMMERCIAL SALE" means the date on which Final 17-1A Product
---------------------
(or other Biological Products, as applicable) is delivered to a Third Party
pursuant to a binding agreement of sale (which may consist of an invoice
acknowledging a purchase order) in the applicable country in the Territory
following the Date of Regulatory Approval in such country or, if no such
approval is required, following the date on which the Product Committee (in the
case of Final 17-1A Product) or WELLCOME (in the case of other Biological
Products) determines to launch the 17-1A Product (or such other Biological
Products, as applicable) in such country.
59. "FISCAL YEAR" means, with respect to any party, the period which
-----------
constitutes such party's accounting period for annual reports.
-11-
<PAGE>
60. "GAAP" means generally accepted accounting principles as practiced in
----
the United States.
61. "GOVERNMENTAL ENTITY" means any nation or government, any state or
-------------------
other political subdivision thereof, any Person and any combination of any of
the foregoing exercising executive, legislative, judicial, regulatory or
administrative functions of or pertaining to government, and any Affiliate of
any of the foregoing.
62. "GREENVILLE FACILITY" means the BW facility at Greenville, North
-------------------
Carolina, or such other WELLCOME facility as may be designated by WELLCOME from
time to time.
63. "HEREOF" and words of similar import as used in any Alliance Document
------
means the applicable Alliance Document in its entirety and not any particular
article, section or paragraph of such Alliance Document unless so specifically
stated.
64. "HYBRIDOMA LETTER" means the letter agreement among WELLCOME, CENTOCOR
----------------
and CBV relating to the delivery of the Centocor Hybridoma.
65. "IMPROVEMENTS," with respect to a technology, means those
------------
modifications to such technology which confer an improvement to the design,
technology, process or product as measured by its cost, quality, reliability or
acceptability to Regulatory Authorities.
66. "INTELLECTUAL PROPERTY" means, collectively, all Copyrights, Patents,
---------------------
Trademarks, tradenames, registrations and applications for any of the foregoing,
trade secrets, Know-how,
-12-
<PAGE>
technology, formulae, processes, research, technical and other data, and other
similar intangible assets, cell line and other tangible materials embodying any
of the foregoing.
67. "KNOW-HOW" means all technical directions, raw materials lists,
--------
intermediate and final product specifications, analytical know-how, show-how,
formulae, procedures, designs, protocols, manufacturing instructions, validation
reports, standards, other directions in any form and similar intellectual
property rights.
68. "KNOWN" or "TO THE KNOWLEDGE" or "TO THE BEST KNOWLEDGE" or words of
----- ---------------- ---------------------
similar import with respect to any Person means the knowledge of any officer,
director or manager who reports to an officer of such Person or an Affiliate of
such Person, and the knowledge which such an officer, director or manager would
have if he or she had performed an inquiry in connection with this Agreement in
a reasonably diligent manner.
69. "LABELED INDICATIONS" means indications that are on a package insert
-------------------
as usages approved by the applicable Regulatory Authority.
70. "LAUNCH" means the date of First Commercial Sale by WELLCOME in the
------
applicable country in the Territory.
71. "LAW" or "REGULATION" means any applicable law, statute, ordinance,
--- ----------
governmental regulation, order, decree, edict, directive, guidance or other
requirement of any Governmental Entity, including, without limitation,
Environmental Laws and those covering health, transportation, bribery,
recordkeeping, zoning, employment, tax, anti-discrimination, antitrust, wage and
hour, and price and wage control matters.
-13-
<PAGE>
72. "LEIDEN FACILITY" means the (a) CBV facility at Einsteinweg 101, P.O.
---------------
Box 251, 2300 AG Leiden, the Netherlands, at which CBV produces the 17-1A
Product (the "Original Leiden Facility") or (b) such other facility of CENTOCOR
------------------------
or CBV at which the 17-1A Product is produced such that any such 17-1A Product
(x) has the same Regulatory Approvals as 17-1A Product produced at the Original
Leiden Facility and any successor thereto and (y) will have the same benefit of
any future Regulatory Approvals as does 17-1A Product produced at the Original
Leiden Facility or any successor thereto, it being the intent of the parties
that any transfer of production of 17-1A Product from the Original Leiden
Facility to any other Leiden Facility shall be permitted only to the extent that
such transfer does not interfere with, or delay or increase the cost to,
WELLCOME and its Affiliates of the Target Program, any Post Target Program,
Filling and Capping at the Greenville Facility or the promotion, marketing, sale
and distribution of Final 17-1A Product in the Territory.
73. "LICENSE" means the Centocor Technology License Agreement by and among
-------
CENTOCOR, CBV, WELLCOME and BW.
74. "LICENSE HOLDER" means, with respect to a particular country, the
--------------
Person (a) in whose name Regulatory Approvals have been issued and (b) who bears
responsibility to Regulatory Authorities with respect to such Regulatory
Approvals.
75. "LICENSOR" with respect to each Cancer Product Contract means the
--------
party granting CENTOCOR rights under the Cancer Product Contract with respect to
the applicable Cancer Antibody and/or Cancer Product, or any party to whom
Licensor has assigned or might in the future assign its rights under such Cancer
Product Contract.
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<PAGE>
76. "LICENSOR IP" with respect to a Cancer Product means the Cancer
-----------
Product Cell Line and other Intellectual Property to which Licensor granted
CENTOCOR a license under the applicable Cancer Product Contract.
77. "LIEN" means any mortgage, lien, security interest, pledge, negative
----
pledge, encumbrance, assessment, title retention agreement, restriction or
restraint on transfer, defect of title, charge in the nature of a lien or
security interest, or option (whether consensual, statutory or otherwise).
78. "LITIGATION" means any action, lawsuit, arbitration, criminal
----------
prosecution, tax audit, administrative or other proceeding or, with respect to
any Governmental Entity, any investigation or inquiry.
79. "LOSS" means any and all damages, losses, obligations, deficiencies,
----
liabilities, claims, Liens, penalties, fines, costs and expenses, including
reasonable attorneys', accountants', experts' and other consultants' fees and
disbursements.
80. "MANUFACTURING IP" means any Intellectual Property of CENTOCOR or its
----------------
Affiliates, or to which CENTOCOR or its Affiliates have rights assignable or
sublicensable to WELLCOME or its Affiliates, applicable to the Manufacturing
Technology.
81. "MANUFACTURING TECHNOLOGY" means the processes and technologies
------------------------
described in Schedule 1 to the Manufacturing Technology Option, together with
----------
any Improvements thereto reduced to practice by CENTOCOR or CBV on or before
December 1, 1995.
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<PAGE>
82. "MANUFACTURING TECHNOLOGY OPTION" means the Manufacturing Technology
-------------------------------
Option Agreement by and among CENTOCOR, CBV, WELLCOME and BW.
83. "MARKETING PLANS" means the marketing plans developed from time to
---------------
time for the overall marketing strategy for the Final 17-1A Product in
accordance with the provisions of the Supply Agreement.
84. "NET SALES" of any product means
---------
(**)
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<PAGE>
85. "NORTH AMERICA" means the United States and Canada.
-------------
86. "NOVATION" means the Novation and Cell Line Release Agreement among
--------
WELLCOME, WISTAR, CENTOCOR and CBV.
87. "OVERSIGHT COMMITTEE" means the Oversight Committee established under
-------------------
the provisions of the Development Agreement.
88. "PANOREX TRADEMARKS" means the Panorex Trademark as set forth on
------------------
Exhibit 1.3 of the Trademark Agreement and any other CENTOCOR Trademark used
- -----------
currently or in the future in conjunction solely with the 17-1A Product and with
no other products or services manufactured, provided, marketed or sold by
CENTOCOR or its Affiliates or licensees.
89. "PATENTS" means all letters patent and pending applications for
-------
patents of the United States and all countries foreign thereto, including
regional patents, certificates of invention and utility models, rights of
license or otherwise to or under letters patent, certificates of invention and
utility models which have been opened for public inspection and all reissues,
divisions, continuations, continuations-in-part, extensions (including, without
limitation, any extensions thereof under the United States Patent Term
Restoration Act or otherwise), substitutions, renewals, confirmations,
supplementary
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<PAGE>
protection certificates, registrations, revalidations or additions of any of the
foregoing, as applicable.
90. "PERMITTED DISTRIBUTOR" means (a) Ajinomoto pursuant to the Ajinomoto
---------------------
Agreement in the Ajinomoto Territory, (b) a successor or successors to Ajinomoto
in the Former Ajinomoto Territory (as permitted by Section 4.1 of the Supply
-----------
Agreement), or (c) CENTOCOR or such other party that is distributing the 17-1A
Product in a country in the Territory pursuant to the authority granted in
Section 3.3 of the Supply Agreement.
- -----------
91. "PERMITS" means any and all licenses, franchises, permits, easements,
-------
rights, consents, orders, approvals and other authorizations of or issued by any
Governmental Entity.
92. "PERSON" means an individual, sole proprietorship, corporation,
------
partnership, joint venture, association, trust, or any other entity or
organization, including, without limitation, a Governmental Entity.
93. "PLA SUBMISSION" means the final Product License Application and
--------------
Establishment License Application required for Regulatory Approval in the United
States, including all necessary environmental impact statements.
94. "POST TARGET PROGRAM" means, as more fully set forth in Section 10 of
------------------- ----------
the Development Agreement, a clinical and regulatory development program for a
country with respect to the 17-1A Product, subsequent to obtaining Regulatory
Approval of the Targeted Indications in such country.
95. "PRE FORMULATED BULK ANTIBODY" means 17-1A Antibody which has been
----------------------------
purified and which requires for processing into
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<PAGE>
Final 17-1A Product only thawing, diluting, final formulation, filling, capping,
labeling the primary container and completing all secondary packaging.
96. "PRODUCT COMMITTEE" means the Product Committee established under the
-----------------
provisions of the Development Agreement.
97. "PURCHASE PRICE" means the purchase price paid for 17-1A Product
--------------
calculated in accordance with Section 7 of the Supply Agreement.
---------
98. "QUARTER" means a three-month period beginning on the first day of
-------
March, June, September, or December, or, upon written notice by WELLCOME, such
other three-month periods as may correspond to WELLCOME'S fiscal quarters.
99. "RECEIVING PARTY" means a party who receives Proprietary Information
---------------
from a Disclosing Party.
100. "REGISTRATION RIGHTS AGREEMENT" means the Registration Rights
-----------------------------
Agreement by and between WELLCOME and CENTOCOR.
101. "REGULATORY ADJUNCT" means any governmental or quasi-governmental body
------------------
or any independent private body, including, but not limited to, FDA Advisory
Committees, Institutional Review Boards ("IRBs") and the Data Safety and
----
Monitoring Board ("DSMB"), which in the ordinary course, takes part in, comments
----
upon or reviews clinical or regulatory development of a pharmaceutical or
Biological Product.
102. "REGULATORY APPROVAL" for a country in the Territory means all
-------------------
necessary or appropriate approvals, licenses, permits, registrations and
authorizations of the applicable Regulatory
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<PAGE>
Authority with respect to the production and release of the 17-1A Product (or
such other Biological Product as the context requires) for sale in such country
and the marketing, promotion, importation, commercial sale and distribution of
the 17-1A Product (or such other Biological Product as the context requires) in
such country, including, but not limited to, any pricing or reimbursement scheme
approvals.
103. "REGULATORY AUTHORITY" for a country in the Territory means the
--------------------
relevant, competent, governmental health authority or authorities and governing
body or bodies in such country (including, but not limited to, the FDA, USDA,
and APHIS) having jurisdiction with respect to the clinical development,
promotion, marketing, sale or distribution of a monoclonal antibody product with
therapeutic indications.
104. "RELICENSE" means the Relicense Agreement among WELLCOME, BW, CENTOCOR
---------
and CBV.
105. "REQUIRED CONSENTS" means any and all licenses, waivers, consents,
-----------------
approvals or notifications of or from any Governmental Entity, including the
expiration of any periods of time under statutory or regulatory notice
provisions without action on the part of any Governmental Entity, and any and
all approvals, consents or waivers from other parties to assignments, leases,
licenses, sublicenses, franchises, permits, indentures, contracts and other
instruments necessary or appropriate to consummate the transactions as
contemplated hereby and by any schedule or exhibit hereto.
106. "RTPA" means the Restrictive Trade Practices Act 1976 of the United
----
Kingdom.
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<PAGE>
107. "SALABLE 17-1A PRODUCT" means Final 17-1A Product and Pre Formulated
---------------------
Bulk Antibody.
108. "STABILITY STUDIES" means studies to determine the degradation or rate
-----------------
of degradation of a pharmaceutical product over a defined period in a defined
environment.
109. "STOCK PURCHASE AGREEMENT" means the Stock Purchase Agreement by and
------------------------
between CENTOCOR and WELLCOME.
110. "SUBSIDIARIES" means, with respect to a Person, any corporation or
------------
other entity in which fifty percent (50%) or more of the equity interests are
owned by such Person.
111. "SUPPLY AGREEMENT" means the Supply, Distribution and Sales Agreement
----------------
by and among WELLCOME, BW, CENTOCOR and CBV.
112. "TARGET PROGRAM" means, as more fully set forth in Section 7 of the
-------------- ---------
Development Agreement, a clinical and regulatory development program for the
17-1A Product, which program shall conclude with respect to a country upon
obtaining Regulatory Approval for the Targeted Indications in such country,
except as provided in the Supply Agreement.
113. "TARGETED INDICATIONS" means Labeled Indications for use as adjuvant
--------------------
therapy for colon or colorectal carcinoma in humans, in accordance with the
classifications of the applicable Regulatory Authority, or such other Labeled
Indications as the Product Committee may, from time to time, determine.
114. "TERRITORY" means the entire world excluding Japan, the Republic of
---------
Korea, the People's Republic of China and Taiwan.
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<PAGE>
115. "THIRD PARTY" means a Person other than WELLCOME, BW, CENTOCOR, CBV
-----------
and their respective Affiliates, as the context requires.
116. "TRADEMARK AGREEMENT" means the Trademark Agreement by and among
-------------------
CENTOCOR, BW and WELLCOME relating to the Centocor Trademarks.
117. "TRADEMARKS" means registered trademarks, registered service marks,
----------
trademark and service mark applications and unregistered trademarks and service
marks.
118. "USDA" means the United States Department of Agriculture or any
----
successor entity.
119. "UNITED STATES" means the United States of America, its territories
-------------
and possessions.
120. "WELLCOME" means either (a) WFL or (b) WFL and BW, as the context of a
--------
particular Alliance Document requires.
121. "WELLCOME GROUP" means WFL, BW and their respective Affiliates.
--------------
122. "WELLCOME HOUSE MARK" means the WELLCOME Trademark attached to the
-------------------
Wellcome House Mark Agreement as Exhibit 1.2 thereof.
-----------
123. "WELLCOME HOUSE MARK AGREEMENT" means the Wellcome House Mark
-----------------------------
Agreement by and among CENTOCOR, CBV and WELLCOME.
124. "WELLCOME INDICIA" means all the indications applied to the Final
----------------
17-1A Product or promotional materials which state a
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<PAGE>
connection between the 17-1A Product and WELLCOME, Indicia selected by WELLCOME
which is applied to the Final 17-1A Product label, the Wellcome House Mark and
the WELLCOME Trademarks set out in Exhibit 1.3 to the Wellcome House Mark
-----------
Agreement.
125. "WELLCOME PURCHASE ORDER" means the purchase order sent by WELLCOME or
-----------------------
its Affiliates when it places a Firm Order from time to time for supply by
CENTOCOR of Salable 17-1A Product.
126. "WELLCOME'S STANDARD TERMS AND CONDITIONS OF PURCHASE" means the
----------------------------------------------------
purchase terms set out in Schedule 5.3 to the Supply Agreement as may be
------------
modified from time to time.
127. "WFL" means The Wellcome Foundation Limited, a United Kingdom
---
corporation.
128. "WISTAR" means the Wistar Institute of Anatomy and Biology, a
------
Pennsylvania not-for-profit corporation.
129. "WISTAR HYBRIDOMA" means the hybridoma cell line delivered to CENTOCOR
----------------
under the Wistar License, from which was derived the Centocor Hybridoma.
130. "WISTAR IP" means the Intellectual Property licensed by WISTAR to
---------
CENTOCOR under the Wistar License.
131. "WISTAR LICENSE" means the Basic Patent and Cell Line License
--------------
Agreement dated September 6, 1988 by and between WISTAR and CENTOCOR.
132. "WISTAR RIGHTS" means the Intellectual Property rights relating to the
-------------
17-1A Product granted to CENTOCOR pursuant to the Wistar License.
-23-
