1
EXHIBIT 10.03
CORIXA CORPORATION
AND
JAPAN TOBACCO INC.
LICENSE
AND
COLLABORATIVE RESEARCH
AGREEMENT
2
TABLE OF CONTENTS
1. DEFINITIONS............................................................................1
2. SCOPE OF RESEARCH PROGRAM; CLINICAL DEVELOPMENT PROGRAM................................5
3. RESEARCH PROGRAM TERM AND TERMINATION..................................................5
4. STEERING COMMITTEES....................................................................6
5. LICENSE GRANTS; OPTION; RIGHTS OF FIRST REFUSAL........................................7
6. PAYMENTS...............................................................................8
7. ROYALTY PAYMENTS.......................................................................9
8. REPORTS, PAYMENTS AND ACCOUNTING......................................................10
9. COMMERCIAL DEVELOPMENT................................................................12
10. MANUFACTURING; SUPPLY.................................................................12
11. INVENTIONS............................................................................13
12. PATENTS; PROSECUTION AND LITIGATION...................................................13
13. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS..............................................14
14. GOVERNING LAW; ARBITRATION............................................................15
15. MISCELLANEOUS.........................................................................15
16. NOTICES...............................................................................16
17. ASSIGNMENT............................................................................17
18. WARRANTIES, REPRESENTATIONS AND COVENANTS.............................................17
19. TERM AND TERMINATION..................................................................19
20. RIGHTS AND DUTIES UPON TERMINATION....................................................19
21. INDEMNIFICATION.......................................................................20
22. GOVERNMENTAL CONSENT..................................................................21
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EXHIBITS
Exhibit A Corixa Patents
Exhibit A-1 Corixa Adjuvant Patents
Exhibit A-2 Microsphere Patents
Exhibit B Research Program
Exhibit C List of Third Party Agreements
Exhibit D Form of Supply Agreement
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LICENSE AND COLLABORATIVE RESEARCH AGREEMENT
This LICENSE AND COLLABORATIVE RESEARCH AGREEMENT (together with the
attachments and exhibits hereto, the "Agreement") is entered into as of June 15,
1999 (the "Execution Date") by and between Corixa Corporation, a corporation
organized and existing under the laws of the State of Delaware and having its
principal office at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxxx, and
Japan Tobacco Inc., a corporation organized and existing under the laws of Japan
and having its principal office at 0-0-0 Xxxxxxxxx, Xxxxxx-xx, Xxxxx 000-0000,
Xxxxx.
RECITALS
WHEREAS, Corixa has scientific expertise, proprietary information and
biological materials related to antigen discovery and vaccine development;
WHEREAS, JT has expertise in developing and commercializing therapeutic
products;
WHEREAS, Corixa and JT desire to collaborate in the development of
vaccine products for the treatment of lung cancer, which vaccines will contain
certain [***]* antigens [***]*; and
WHEREAS, Corixa has agreed to license to JT in certain territories
certain intellectual property rights related to the Collaboration, including
discoveries to be made during the Collaboration, subject to the terms and
conditions of this Agreement.
NOW, THEREFORE, for and in consideration of the mutual observance of the
covenants hereinafter set forth and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
1. DEFINITIONS.
All references to particular Exhibits, Articles and Sections shall mean
the Exhibits to, and Articles and Sections of, this Agreement, unless otherwise
specified. References to this "Agreement" include the Exhibits. For the purposes
of this Agreement, the following words and phrases shall have the following
meanings:
1.1 "Additional Lung Cancer License Agreement" shall have the
meaning set forth in Section 5.3.
1.2 "Additional Technology" shall have the meaning set forth in
Section 5.1(f).
1.3 "Affiliate" of an entity means, for so long as one of the
following relationships is maintained, any corporation or other business entity
owned by, owning, or under common ownership with a party to this Agreement to
the extent of at least fifty percent (50%) of the equity (or such lesser
percentage that is the maximum allowed to be owned by a foreign corporation in a
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particular jurisdiction) having the power to vote on or direct the affairs of
the entity and any person, firm, partnership, corporation, or other entity
actually controlled by, controlling or under common control with a party to this
Agreement. Notwithstanding the foregoing, the government of Japan shall not be
considered an Affiliate of JT for purposes of this Agreement.
1.4 "Antibody" shall mean [***]*.
1.5 "Antigen(s)" shall mean any antigen [***]* covered by one (1) or
more claim(s) of any of the Corixa Patents and/or the Joint Research Patents.
1.6 "Asia" shall mean [***]*
1.7 "Clinical Development Program" shall have the meaning set forth
in Section 2.3.
1.8 "Co-Development Committee" shall have the meaning set forth in
Section 9.2.
1.9 "Collaboration" means the joint collaboration of Corixa and JT
pursuant to the terms of this Agreement, the Research Program and the Clinical
Development Program.
1.10 "Completion" shall have the meaning set forth in Section 6.3.
1.11 "Corixa" shall mean Corixa Corporation and each of its
Affiliates.
1.12 "Corixa Adjuvant" shall mean the protein Leishmania Elongation
Initiation Factor, known as LeIF, [***]* covered by one (1) or more of claim(s)
of any of the Corixa Patents that are identified on Exhibit A-1, as may be
amended from time to time.
1.13 "Corixa Patents" shall mean (a) all [***]*. Corixa Patents shall
specifically not include either JT Patents or Joint Research Program Patents.
1.14 "Development Steering Committee" shall have the meaning set
forth in Section 4.1(b).
1.15 "Development Period" shall mean the period commencing upon the
end of the Research Program Term and ending upon [***]*.
1.16 "Effective Date" shall have the meaning set forth in Section
22.2.
1.17 "Europe" shall mean [***]*.
1.18 "European Partner" shall have the meaning set forth in Section
5.3.
1.19 "FTE" shall mean [***]* for individual Corixa scientific
employees assigned to perform the Research Program, or its equivalent if a given
employee is assigned on a part-time basis and therefore multiple employees are
added to provide a single FTE.
1.20 "FTE Rate" shall have the meaning set forth in Section 2.1.
1.21 "Fully Burdened Manufacturing Cost" shall mean [***]*.
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1.22 "GAAP" or "U.S. generally accepted accounting principles" shall
mean the conventions, rules and procedures governing accounting practices as
established, and revised or amended, by the U.S. Financial Accounting Standards
Board or the U.S. Securities and Exchange Commission.
1.23 [***]*
1.24 "IND" shall have the meaning set forth in Section 4.1(a).
1.25 "Joint Research Program Patents" shall mean all [***]*. In no
event shall Joint Research Program Patents be deemed to include Corixa Patents
or JT Patents.
1.26 "Joint Inventions" shall have the meaning set forth in Section
11.
1.27 "JT" shall mean Japan Tobacco Inc. and each of its Affiliates.
1.28 "JT Patents" shall mean [***]*. In no event shall JT Patents be
deemed to include either Corixa Patents or Joint Research Program Patents.
1.29 "Know-How" shall mean all [***]*.
1.30 "Licensed Antibody Product" shall mean any [***]*. For purposes
of clarity, "Licensed Antibody Product" shall refer to and mean Licensed Corixa
Antibody Product and/or Licensed JT Antibody Product, as the case may be.
1.31 "Licensed Corixa Antibody Product" shall mean any Licensed
Antibody Product that [***]*.
1.32 "Licensed Field" shall mean [***]*.
1.33 "Licensed JT Antibody Product" shall mean any Licensed Antibody
Product that [***]*.
1.34 "Licensed Product" shall mean any and all Licensed Antibody
Products and Licensed Vaccine Products.
1.35 "Licensed Vaccine Product" shall mean any [***]*.
1.36 "Microspheres" shall mean the encapsulated antigen delivery
system [***]* covered by one (1) or more claim(s) of any of the Corixa Patents
that are identified on Exhibit A-2.
1.37 "Net Sales" shall mean the amount [***]* to a Third Party of a
Licensed Product, less the following deductions for amounts actually incurred
related to such sale or other disposition: [***]*.
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1.38 "North America" shall mean [***]*.
1.39 "Patent Steering Committee" shall have the meaning set forth in
Section 4.1(c).
1.40 "Research Field" shall mean lung cancer in humans.
1.41 "Research Steering Committee Period" shall have the meaning set
forth in Section 4.1(a).
1.42 "Research Program" shall have the meaning set forth in Section
2.1.
1.43 "Research Program Term" shall have the meaning set forth in
Section 3.1.
1.44 "Research Steering Committee" shall have the meaning set forth
in Section 4.1.
1.45 "Rest of World" shall mean worldwide, except for [***]*.
1.46 "Selected Antigen(s)" shall have the meaning set forth in
Section 3.3.
1.47 "SPC" shall mean all Supplementary Protection Certificates for
any medicinal Licensed Product and its equivalents provided under the Council
Regulation (EEC) N# 1768/92 of June 18, 1992 or any succeeding regulation
thereto.
1.48 "Territory A" shall mean Asia, North America and Rest of World.
1.49 "Territory B" shall mean [***]* China and its territories,
possessions and protectorates, [***]*.
1.50 "Third Party(ies)" shall mean any party other than a party to
this Agreement or an Affiliate.
1.51 "Vaccine" shall mean the administration of (an) antigen(s)
[***]*.
1.52 "Valid Claim" shall mean, with respect to each country in the
territory, a claim of [***]*.
1.53 Interpretive Rules. For purposes of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise requires:
(a) defined terms include the plural as well as the singular (and vice versa)
and the use of any gender shall be deemed to include the other gender; (b)
references to "Articles," "Sections" and other subdivisions and to "Schedules"
and "Exhibits" without reference to a document, are to designated Articles,
Sections and other subdivisions of, and to Schedules and Exhibits to, this
Agreement; (c) unless otherwise set forth herein, the use of the term
"including" means "including but not limited to"; and (d) the words
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"herein," "hereof," "hereunder" and other words of similar import refer to this
Agreement as a whole and not to any particular provision.
2. SCOPE OF RESEARCH PROGRAM; CLINICAL DEVELOPMENT PROGRAM.
2.1 During the Research Program Term, the parties shall collaborate
in the development of [***]*. The program of activities to be conducted by
Corixa during the term of the Agreement is set forth on Exhibit B (the "Research
Program"), [***]*. Corixa and JT agree that during the first and second years of
the initial Research Program Term [***]*. During the third year of the initial
Research Program Term, Corixa and JT agree that [***]*.
2.2 In the event JT desires during the Research Program Term as may
be extended to [***]*.
2.3 Subsequent to [***]* (hereinafter the "Clinical Development
Program" with respect to such Licensed Product(s)). The parties agree that the
end goal of the Clinical Development Program is [***]*.
2.4 During the Research Program Term as may be extended, [***]*.
2.5 The parties acknowledge and agree that nothing in this Agreement
shall restrict in any manner Corixa's ability to [***]*.
3. RESEARCH PROGRAM TERM AND TERMINATION.
3.1 The initial period of time during which the Research Program
shall be performed shall commence on the Effective Date and terminate on the
[***]* anniversary of the Effective Date, subject to extension as set forth in
Section 3.2 (the "Research Program Term"); provided, however, that the Research
Program Term shall terminate upon any termination of this Agreement in
accordance with Sections 19.3(b), 19.6 or 19.7.
3.2 Upon the mutual written agreement of the parties, the Research
Program Term shall be extended for one or more additional period(s) beyond the
termination date of its initial term or any subsequent extension period,
provided the such agreement is reached no later than [***]* prior to the
expiration of such initial term or subsequent extension period. In the event of
such a mutually agreed extension, the parties shall [***]*. With respect to any
such extension of the Research Program Term pursuant to this Section 3.2, Corixa
and JT shall [***]*.
3.3 Prior to the termination of the Research Program Term, JT shall
have the right to notify Corixa in writing of [***]*.
4. STEERING COMMITTEES.
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4.1 (a) A Research Steering Committee (the "Research Steering
Committee") shall be established within [***]* after the full execution of this
Agreement. During the period beginning on the Effective Date and ending on
[***]* (the "Research Steering Committee Period"), the Research Steering
Committee shall consist of [***]*. During the Research Steering Committee
Period, the Research Steering Committee shall be responsible for [***]*.
(b) Following the Research Steering Committee Period and
until [***]* (the "Development Steering Committee") shall be established. The
Development Steering Committee shall consist of [***]*. The Development Steering
Committee shall be responsible for [***]*.
(c) Additionally, a Patent Steering Committee (the "Patent
Steering Committee") shall be established within [***]* after the full execution
of this Agreement. The Patent Steering Committee shall operate during the term
of this Agreement and shall be responsible for all patent-related activities
pursuant to this Agreement. The Patent Steering Committee shall consist of
[***]*.
4.2 To facilitate coordination during the Research Steering
Committee Period, the parties shall share [***]*. Corixa shall provide JT with
[***]* on the progress of the Research Program and, [***]*. All such [***]*
shall be subject to the confidentiality provisions of Section 13 of this
Agreement. The Research Steering Committee shall review the Research Program
[***]*. All actions by the Research Steering Committee shall require [***]*.
4.3 The Development Steering Committee shall meet [***]*. To
facilitate coordination during and subsequent to the Development Period, the
parties shall [***]*. JT shall provide Corixa with [***]* on the progress of the
Clinical Development Program, including [***]*. All such [***]* shall be, [***]*
subject to the confidentiality provisions of Section 13 of this Agreement.
Additionally, [***]*. All actions by the Development Steering Committee shall
require the [***]*.
4.4 After [***]*, the Development Steering Committee shall [***]*.
In conjunction with the foregoing meetings, JT shall provide Corixa with [***]*
commercialization, including [***]*. All such information shall be subject to
the confidentiality provisions of Section 13 of this Agreement. [***]*
4.5 The Patent Steering Committee shall meet regularly [***]*. To
facilitate the coordination and monitoring of patent-related activities
hereunder, the Patent Steering Committee shall [***]*. The Patent Steering
Committee shall [***]*. All such [***]* shall be subject to the confidentiality
provisions of Section 13 of this Agreement. All actions by the Patent Steering
Committee shall require [***]*, provided that all such actions shall be subject
to the procedures and responsibilities set forth in Section 12. [***]*.
5. LICENSE GRANTS; [***]* .
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5.1 License.
(a) Subject to the terms and conditions of this Agreement,
including, without limitation, Section 3.3 and the payments set forth in Section
6 hereof, Corixa hereby grants to JT an exclusive license, [***]* Licensed
Vaccine Products and Licensed Corixa Antibody Products solely in the Licensed
Field in Territory A.
(b) Subject to the terms and conditions of this Agreement,
including, without limitation, Section 3.3, Section 5.3 and the payments set
forth in Section 6 hereof, Corixa hereby grants to JT a co-exclusive license
[***]* Licensed Vaccine Products and Licensed Corixa Antibody Products solely in
the Licensed Field in Territory B.
(c) Subject to the terms and conditions of this Agreement,
including, without limitation, Section 3.3 and the payments set forth in Section
6 hereof, Corixa hereby grants to JT (i) a worldwide co-exclusive license [***]*
Licensed JT Antibody Products solely for use in the Licensed Field and (ii)
[***]*.
(d) Subject to the terms and conditions of this Agreement,
Corixa hereby grants to JT a [***]* non-exclusive license, [***]*, to use Corixa
Adjuvant and Microspheres solely for research purposes for evaluation [***]*. JT
may [***]* confidential information under Section 13 hereof. [***]*. Subject to
the terms and conditions of this Agreement, including, without limitation, the
payments set forth in Section 6 hereof, Corixa hereby grants to JT a
non-exclusive option, [***]* to obtain a non-exclusive license, [***]*
Microspheres or Corixa Adjuvant in the Licensed Field in Territory A and B,
[***]*.
(e) In the event that Corixa and JT shall have mutually
agreed to the terms and conditions of [***]*.
(f) During the Research Program Term, [***]*.
(g) [***]*
(h) [***]*
5.2 Sublicenses of Third Party Rights to JT. JT understands and
agrees that in the event it exercises the option to license Microspheres granted
to it under Section 5.1(d) of this Agreement, such license shall include
sublicenses by Corixa under agreements between Corixa and certain Third Parties.
Exhibit C includes a list of agreements pursuant to which Third Party rights
related to Microspheres are licensed to Corixa as of the Effective Date. JT
understands and agrees that such sublicenses or licenses may in some respects be
more restrictive than the terms and conditions of this Agreement or may require
payments in addition to those set forth herein and agrees to abide by all
applicable terms and conditions of such agreements.
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5.3 [***]*
5.4 [***]*
5.5 [***]*
5.6 [***]*
6. PAYMENTS.
Subject to Section 7.8, JT shall make the following payments to Corixa
under this Agreement in U.S. Dollars by wire transfer of immediately available
funds:
6.1 [***]* Funding. In addition to the [***]* funding set forth in
Section 6.2, the [***]* amount of [***]* for [***]*. The full amount of this
[***]* funding shall be [***]* paid directly to Corixa.
6.2 [***]* Funding. [***]* payments in the following amounts and
[***]* dates set forth below, it being acknowledged and agreed each such payment
shall be [***]*:
-------------------------------------- ---------------------
PAYMENT AMOUNT
PAYMENT DATE (U.S.$)
-------------------------------------- ---------------------
[***]* [***]*
-------------------------------------- ---------------------
The payment amounts set forth in the above table shall be [***]* paid
directly to Corixa. The Research Program and corresponding payments, may be
extended or expanded as set forth in Section 2.2 and Section 3.2 above. [***]*
6.3 Milestone Payments. In addition to the amounts payable pursuant
to Sections 6.1 and 6.2 above, JT also agrees to pay Corixa the following
milestone payments, to be made via wire transfer of immediately available funds,
[***]*:
-------------------------------------------------- -------------------------
MILESTONE PAYMENT (U.S.$)
-------------------------------------------------- -------------------------
[***]* [***]*
-------------------------------------------------- -------------------------
For purposes of the above milestones [***]*.
6.4 [***]*
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7. ROYALTY PAYMENTS.
7.1 Royalties for Licensed Vaccine Products.
[***]*
7.2 Royalties for Licensed Antibody Products.
[***]*
7.3 Royalties for [***]*.
(a) For Licensed Vaccine Products that [***]*.
(b) For Licensed Vaccine Products that [***]*.
(c) For Licensed Vaccine Products that [***]*.
7.4 [***]*
7.5 [***]*
7.6 Royalty Term; [***]*. Royalties shall be earned and paid to
Corixa until [***]*.
7.7 Currency. All amounts payable to Corixa under this Agreement
shall be payable in United States Dollars, by wire transfer of immediately
available funds to a bank account designated by Corixa, at Corixa's option.
Monthly sales amounts shall be translated from Japanese Yen to U.S. Dollars by
using an average rate of exchange. This average shall be computed using the rate
of exchange quoted under Foreign Exchange in the Wall Street Journal as of the
end of the current month plus the rate as of the end of the prior month and
dividing by two (2). With respect to sales made by sublicensees (either
Affiliates or Third Parties) of Japan Tobacco Inc., sales amounts will be
converted from any foreign currencies to Japanese Yen using average rates of
exchange published by the Bank of Tokyo-Mitsubishi in accordance with JT's
standard methodology, consistently applied.
7.8 Withholding Taxes. If any law or regulation in any country
requires the withholding by JT or its sublicensees of any taxes due on payments
to be remitted to Corixa under this Agreement, such taxes shall be deducted from
the amounts paid to Corixa. If the taxes are deducted from the amounts paid to
Corixa, then JT or sublicensees shall furnish Corixa the originals of all
official receipts for such taxes and such other evidence of such taxes and
payment thereof as may be reasonably requested by Corixa and shall provide any
reasonable assistance or cooperation which may be requested by Corixa in
connection with any efforts by Corixa to obtain a credit for such taxes.
7.9 Currency Transfer Restrictions. If in any country payment or
transfer of funds out of such country is prohibited by law or regulation, the
parties hereto shall confer regarding the terms and conditions on which Licensed
Products shall be sold in such countries, including the possibility of payment
of royalties to Corixa in local currency to a bank account in such country or
the renegotiation of royalties for such sales, and in the absence of any other
agreement by the
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parties, such funds payable to Corixa shall be deposited in whatever currency is
allowable by JT in an accredited bank in that country that is acceptable to
Corixa.
7.10 Royalty Payments Upon Termination. If this Agreement is
terminated in accordance with Section 19 with respect to all or some of the
Licensed Products, JT shall continue to pay Corixa all amounts earned pursuant
to this Section 7 prior to the date of termination and any amounts earned
thereafter as a result of sales of residual inventory of Licensed Products. In
addition, JT shall continue to pay to Corixa all amounts payable hereunder with
respect to Licensed Products, if any, with respect to which this Agreement is
not terminated.
8. REPORTS, PAYMENTS AND ACCOUNTING.
8.1 Payments and Reports.
(a) JT agrees to make written reports (consistent with GAAP
and/or its Japanese equivalent [***]* and payments to Corixa within [***]* after
the close of each calendar quarter during the term of this Agreement. These
reports shall show for such calendar quarter sales by Japan Tobacco Inc., its
Affiliates and sublicensees of Licensed Vaccine Products, Licensed Corixa
Antibody Products and Licensed JT Antibody Products, [***]*, Net Sales and the
royalties due to Corixa thereon pursuant to Article 7. Concurrently with the
making of each such report, JT shall make payment to Corixa of (i) amounts
payable for the period covered by such report and/or (ii) payment of all accrued
amounts incurred by Corixa as costs and expenses for which statements of account
have been submitted by Corixa and which have not been previously reimbursed
under this Agreement.
(b) Corixa agrees to submit a detailed statement of account
to JT within [***]* after the close of each calendar quarter (consistent with
GAAP [***]*, for any costs or expenses incurred related to patents and other
agreed upon expenses during such calendar quarter and not previously reimbursed.
The costs and expenses of patent filings shall be as set forth in Section 12. In
addition, [***]* the Effective Date, JT shall reimburse Corixa for costs and
expenses incurred to date for filings in Territory A and B in the amount of
[***]*.
8.2 Termination Report. For each Licensed Product, JT also agrees to
make a written report to Corixa within ninety (90) days after the date on which
Japan Tobacco Inc., its Affiliates or sublicensees last sell that Licensed
Product stating in such report the same information required for quarterly
reports of sales of all such Licensed Products made, sold or otherwise disposed
of which were not previously reported to Corixa.
8.3 Accounting. JT agrees to keep clear, accurate and complete
records, all [***]* accordance with GAAP and/or its Japanese equivalent, for a
period of at least three (3) years (or such longer period as may correspond to
JT's internal records retention policy) for each reporting period in which sales
occur showing the manufacturing, sales, use and other disposition of Licensed
Products in sufficient detail to enable amounts payable pursuant to Section 7,
and the
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costs and expenses reimbursable hereunder to be determined, and further agrees
to permit its books and records to be examined by an independent accounting firm
selected by Corixa and reasonably satisfactory to JT, and that is bound in
confidence to disclose only evidence of noncompliance, from time-to-time to the
extent necessary, but not more than once a year. Corixa shall have the right, at
Corixa's sole expense except as hereinafter provided, through a certified public
accountant reasonably acceptable to JT, and following reasonable notice, to
examine such records during regular business hours during the life of JT's
payment obligations to Corixa under this Agreement and for three (3) years
thereafter; provided, however, that such examination shall not (i) be of records
for more than the prior three (3) years, (ii) take place more often than once a
year, and (iii) cover any records which date prior to the date of the last
examination, and provided further that such accountants shall report to Corixa
only as to the accuracy of the royalty statements and payments. Copies of such
reports shall be supplied to JT. In the event the report demonstrates that JT
has underpaid Corixa, JT shall pay the amount of such underpayment immediately
upon request of Corixa and to the extent such underpayment is more than [***]*
for the audited period, shall reimburse Corixa for the expense of the audit. If
JT has overpaid Corixa, JT may deduct such overpayments from future amounts owed
to Corixa .
8.4 Confidentiality of Reports. Each party agrees that the
information set forth in (a) the reports required by Sections 8.1 and 8.2, and
(b) the records subject to examination under Section 8.3, shall be subject to
Section 13 hereof and maintained in confidence by the receiving party and any
independent accounting firm selected by such party, shall not be used by such
party or such accounting firm for any purpose other than verification of the
performance by the other party of its obligations hereunder, and shall not be
disclosed by the receiving party or such accounting firm to any other person
except for purposes of enforcing this Agreement.
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9. COMMERCIAL DEVELOPMENT.
9.1 Diligence in Research and Commercial Development.
(a) Corixa will [***]*.
(b) JT will [***]*.
9.2 [***]*
10. MANUFACTURING; SUPPLY.
10.1 Materials. Corixa shall provide reasonable quantities of [***]*
for JT as required through the course of the performance of the Research Program
[***]*. In addition, for non-commercial research and evaluation purposes only,
such materials shall include Corixa Adjuvant and Microspheres. [***]* terms set
forth in a Supply Agreement in the form attached hereto as Exhibit D (the
"Supply Agreement"). Any materials manufactured by Corixa for JT hereunder in
accordance with "Good Manufacturing Practices," [***]* upon the terms and
subject to the conditions of the Supply Agreement. JT shall use all materials
provided to JT by Corixa hereunder or under the Supply Agreement in compliance
with all applicable federal, state or local laws and regulations.
10.2 Delivery. Subject to modification by the Research Steering
Committee, all materials delivered to JT pursuant to Section 10.1 above shall
[***]*. Corixa shall [***]*. All customs, duties, costs, taxes, insurance
premiums, and other expenses relating to such transportation and delivery, shall
be at JT's expense.
10.3 [***]*
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11. INVENTIONS.
Patentable inventions or discoveries that arise from the performance of
the Research Program or the Clinical Development Program [***]*. Patentable
inventions, discoveries or technology(ies) that arise from the performance of
the Research Program or the Clinical Development Program [***]*. Patentable
inventions or discoveries which arise from the performance of the Research
Program or the Clinical Development Program [***]*.
12. PATENTS; PROSECUTION AND LITIGATION.
12.1 Corixa shall have the right [***]* to prosecute and maintain all
Corixa Patents and Joint Research Program Patents as provided in this Section 12
[***]*. Corixa shall [***]*. JT shall have the right [***]*. Corixa agrees to
keep JT [***]*. JT shall hold all information disclosed to it under this Section
as confidential information under Section 13. For the avoidance of doubt, as
previously set forth in Section 8.1(b) hereof, JT shall reimburse Corixa for all
reasonable and documented costs incurred by Corixa prior to the Effective Date
in connection with the filing, prosecution and maintenance of the Corixa Patents
in the amount of [***]*, payable [***]* the Effective Date. Corixa shall [***]*.
JT shall [***]*. All expenses reimbursed by JT pursuant to this Section shall be
obligations that are separate and apart from other payment obligations described
in this Agreement and shall be invoiced and paid separately, with no right of
offset.
12.2 [***]*
12.3 In the event of the initiation of any suit by a Third Party
against Corixa Corporation, [***]*.
12.4 In the event that Corixa or JT becomes aware of actual or
threatened infringement of a patent covered by this Agreement with respect to
Licensed Products anywhere in Territory A or Territory B, that party shall
promptly notify the other party in writing. [***]* In any event, Corixa and JT
shall assist one another and cooperate in any such litigation at the other's
request without expense to the requesting party.
12.5 Corixa and JT shall recover their respective actual
out-of-pocket expenses, or equitable proportions thereof, associated with any
litigation or settlement thereof from any recovery made by any party. [***]*
12.6 [***]*
12.7 The parties shall keep one another informed of the status of
their respective activities regarding any litigation or settlement thereof
concerning any Licensed Product.
12.8 CORIXA MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR
IMPLIED, OTHER THAN THOSE EXPRESSLY SET FORTH IN SECTION 18 BELOW,
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WITH RESPECT TO THE ANTIGENS, ANTIBODIES, CORIXA ADJUVANT, MICROSPHERES, CORIXA
PATENTS, THE JOINT RESEARCH PROGRAM PATENTS OR KNOW-HOW AND ANY LICENSED
PRODUCTS RELATED THERETO, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF
NONINFRINGEMENT, PATENTABILITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
13. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS.
13.1 Disclosure of Inventions. During the term of this Agreement,
Corixa shall [***]*. During the term of this Agreement, JT shall [***]*. In
addition, each party shall provide the other party with [***]*.
13.2 Safety. [***]*
13.3 Confidential Information. During the term of this Agreement and
for [***]* thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, Corixa and JT shall not use or reveal
or disclose to any Third Party any confidential information received from the
other party or otherwise developed by either party in the performance of
activities in furtherance of this Agreement without first obtaining the written
consent of the disclosing party, [***]*. This confidentiality obligation shall
not apply to such information which is or becomes a matter of public knowledge,
or is already in the possession of the receiving party, or is disclosed to the
receiving party by a Third Party having the right to do so, or is subsequently
and independently developed by employees of the receiving party or Affiliates
thereof who had no knowledge of the confidential information disclosed. The
parties shall take reasonable measures to assure that no unauthorized use or
disclosure is made by others to whom access to such information is granted.
13.4 Permitted Disclosures.
[***]*
13.5 Bankruptcy Procedures. All confidential information disclosed by
one party to the other shall remain the intellectual property of the disclosing
party. In the event that a court or other legal or administrative tribunal,
directly or through an appointed master, trustee or receiver, assumes partial or
complete control over the assets of a party to this Agreement based on the
insolvency or bankruptcy of such party, the bankrupt or insolvent party shall
promptly notify the court or other tribunal (i) that confidential information
received from the other party under this Agreement remains the property of the
other party and (ii) of the confidentiality obligations under this Agreement. In
addition, the bankrupt or insolvent party shall, to the extent permitted by law,
take all steps necessary or desirable to maintain the confidentiality of the
other party's confidential information and to insure that the court, other
tribunal or appointee maintains such information in confidence in accordance
with the terms of this Agreement.
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13.6 Press Release. The parties to this Agreement may disclose the
nature and general terms of the Agreement in a press release following signature
after due consultation with the other party. The wording of any press release
must be agreed to by both parties in advance of its release; provided that such
agreement is not unreasonably withheld by either party. Notwithstanding the
foregoing, each party shall have the right to issue press releases immediately
and without prior consent of the other that disclose any information required by
the rules and regulations of the Securities and Exchange Commission or similar
federal, state or foreign authorities, as determined in good faith by the
disclosing party.
13.7 Publicity. Neither party shall publish or provide public
disclosure of information or inventions arising from the performance of the
Research Program or the Clinical Development Program (a "Dissemination") without
[***]* such planned publication or disclosure sent to the other party. In the
event any such Dissemination is determined by the other party to be [***]*, the
disseminating party shall delay such publication for a period sufficient, but in
no event greater than [***]*, to allow the other party to take the steps
necessary to protect such intellectual property, including the filing of any
patent applications and/or deletion of the other party's confidential
information. Notwithstanding the foregoing, Corixa shall have the right to
disclose information immediately and without prior consent of JT if such
disclosure is required by the rules and regulations of the Securities and
Exchange Commission or similar federal or state authority, as determined in good
faith by Corixa.
14. GOVERNING LAW; ARBITRATION.
This Agreement shall be governed by the laws of [***]*. Judgment upon
the award may be entered in any court having jurisdiction, or application may be
made to such court for judicial acceptance of the award and/or an order of
enforcement as the case may be.
15. MISCELLANEOUS.
15.1 Trademarks. [***]*
15.2 Force Majeure. If the performance of any part of this Agreement
by either party, or of any obligation under this Agreement, is prevented,
restricted, interfered with or delayed by reason of any cause beyond the
reasonable control of the party liable to perform, unless conclusive evidence to
the contrary is provided, the party so affected shall, upon giving written
notice to the other party, be excused from such performance to the extent of
such prevention, restriction, interference or delay, provided that the affected
party shall use its reasonable best efforts to avoid or remove such causes of
nonperformance and shall continue performance with the utmost dispatch whenever
such causes are removed. When such circumstances arise, the parties shall
discuss what, if any, modification of the terms of this Agreement may be
required in order to arrive at an equitable solution.
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15.3 Severability.
(a) In the event any portion of this Agreement shall be held
illegal, void or ineffective, the remaining portions hereof shall remain in full
force and effect.
(b) If any of the terms or provisions of this Agreement are
in conflict with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may conflict
therewith and shall be deemed to be modified to conform with such statute or
rule of law.
15.4 Entire Agreement. This Agreement and all Exhibits hereto,
entered into as of the date first written above, constitutes the entire
agreement between the parties relating to the subject matter hereof and
supersedes all previous writings and understandings except that the Confidential
Information and Non Disclosure Agreement dated [***]*, shall remain in full
force and effect. No terms or provisions of this Agreement shall be varied or
modified by any prior or subsequent statement, conduct or act of either of the
parties, except that the parties may mutually amend this Agreement by written
instruments specifically referring to and executed in the same manner as this
Agreement.
16. NOTICES.
16.1 Any notice required or permitted under this Agreement shall be
deemed given if delivered (i) personally, (ii) by facsimile transmission
(receipt verified), (iii) by registered or certified mail (return receipt
requested), postage prepaid, or (iv) sent by express courier service (receipt
verified), to the following addresses of the parties:
IF TO CORIXA:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Chief Operating Officer
with a copy to Director of Legal Affairs
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
WITH A COPY TO:
Venture Law Group
0000 Xxxxxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
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IF TO JT:
Japan Tobacco Inc.
0-0-0, Xxxxxxxxx
Xxxxxx-xx, Xxxxx 000-0000 Xxxxx
Attention: Vice President, Pharmaceutical
Business Development
Telephone: x00-0-0000-0000
Facsimile: x00-0-0000-0000
WITH A COPY TO:
Xxxxxxx, Xxxxxx and Xxxxx LLP
000 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Attention: Xxxx X. Xxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
16.2 Any notice required or permitted to be given pursuant to this
Agreement shall be effective upon receipt by Corixa or JT, as the case may be.
17. ASSIGNMENT.
Neither this Agreement nor any interest hereunder shall be assignable by
either party without the written consent of the other; [***]*. Transfer in
contravention of this Section 17 shall be considered a material breach of this
Agreement pursuant to Section 19.6 below. Subject to other provisions of this
Section 17, all rights and obligations under this Agreement and the licenses
herein granted shall be binding upon and inure to the benefit of the successors
in interest of the respective parties. Any assignment in violation of the
foregoing shall be null and void.
18. WARRANTIES, REPRESENTATIONS AND COVENANTS.
18.1 Each party warrants that it has the right to enter into this
Agreement, and that this Agreement is a legal and valid obligation binding upon
such party and enforceable in accordance with its terms.
18.2 Nothing in this Agreement shall be construed as a warranty that
patents covered by this Agreement are valid or enforceable or, except as set
forth in Section 18.3, that their exercise will not infringe any patent rights
of third parties.
18.3 [***]*
18.4 Corixa warrants [***]*.
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18.5 [***]*
18.6 JT acknowledges that the licenses granted to JT herein include
sublicenses under technology that has been licensed by Corixa from certain Third
Parties (the "Corixa Third Party Agreements"), and JT warrants and represents
that it shall comply with all applicable terms and conditions of such Corixa
Third Party Agreements.
18.7 Commencing at the time of JT's initial clinical testing of a
Licensed Product, JT shall maintain Licensed Product liability insurance with
respect to its development, manufacture and sale of the Licensed Products at
commercially reasonable and appropriate levels. JT currently maintains, with
respect to clinical development-related activities, insurance coverage in an
amount equal to [***]*, over a period of [***]*, for each product in
development. JT shall maintain such insurance for so long as it continues to
develop, manufacture or sell any Licensed Product, and thereafter for so long as
JT maintains insurance for itself covering such manufacture or sales. JT's
general liability insurance shall name Corixa as an additional insured.
18.8 LIMITED LIABILITY. NOTWITHSTANDING ANYTHING ELSE IN THIS
AGREEMENT OR OTHERWISE, NEITHER CORIXA NOR JT WILL BE LIABLE WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR (i) ANY INCIDENTAL OR
CONSEQUENTIAL DAMAGES OR LOST PROFITS OR (ii) COST OF PROCUREMENT OF SUBSTITUTE
GOODS, TECHNOLOGY OR SERVICES. NEITHER CORIXA NOR JT SHALL HAVE ANY LIABILITY
FOR ANY FAILURE OR DELAY DUE TO MATTERS BEYOND THEIR RESPECTIVE REASONABLE
CONTROL.
19. TERM AND TERMINATION.
19.1 This Agreement may not be terminated by either party except in
accordance with this Section 19.
19.2 Unless otherwise terminated, this Agreement shall expire upon
[***]*.
19.3 [***]*
19.4 [***]*
19.5 [***]*
19.6 If either party materially breaches any material provision of this
Agreement and if such breach is not cured within [***]* (or in the case of
non-payment pursuant to Section 6 or 7, [***]*) after receiving written
notice from the other party with respect to such breach, the non-breaching party
shall have the right to terminate this Agreement by giving written notice to the
party in breach, provided that such notice of termination is given [***]*.
In the event that [***]*.
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19.7 Either party may terminate this Agreement if, at any time, the
other party shall file in any court or agency pursuant to any statute or
regulation of the United States or of any individual state or foreign country, a
petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver of trustee of the party or of its assets,
or if the other party proposes a written agreement of composition or extension
of its debts, or if the other party shall be served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition shall not be
dismissed with sixty (60) days after the filing thereof, or if the other party
shall propose or be a party to any dissolution or liquidation, or if the other
party shall make an assignment for the benefit of creditors.
19.8 Notwithstanding the bankruptcy of Corixa, or the impairment of
performance by Corixa of its obligations under this Agreement as a result of
bankruptcy or insolvency of Corixa, JT shall [***]*.
20. RIGHTS AND DUTIES UPON TERMINATION.
20.1 Upon termination of this Agreement, Corixa shall have the right
to retain any sums already paid by JT hereunder, and JT shall pay all sums
accrued hereunder which are then due, which, in each case, shall include all
payments under Sections 6 and 7 except to the extent [***]*.
20.2 Upon termination of this Agreement, JT shall notify Corixa of
the amount of Licensed Product(s) JT and its Affiliates, sublicensees and
distributors then have on hand, the sale of which would, but for the
termination, be subject to royalty, and JT and its Affiliates, sublicensees and
distributors shall [***]*.
20.3 Expiration or early termination of this Agreement shall not
relieve either party of its obligations incurred prior to such expiration or
early termination. In addition, Sections 1, , 7.10, 8.2, 8.3, 8.4, 11, 12.3,
12.5, 12.7, 12.8, 13.3, 13.4, 13.5, 13.6, 13.7, 14, 15, 16, 18.7 (for so long as
JT continues the sale of Licensed Products and thereafter for so long as JT
maintains insurance for itself covering such sales), 19.3, 19.4, 19.5, 19.6, 20
and 21 shall survive any expiration or early termination of this Agreement. In
addition, in the event this Agreement is terminated pursuant to Section 19.6,
Sections 5 and 8.1(a) and all reporting obligations of JT under this Agreement
shall survive as provided in Section 19.6. Further, Section 12.1 shall survive
any expiration or termination of this Agreement solely with respect to the
payment and reimbursement of any patent-related costs and expenses that were
incurred prior to such termination or expiration.
21. INDEMNIFICATION.
21.1 Subject to Section 21.2 hereof, from and after the Effective
Date, except as otherwise herein specifically provided, each of the parties
hereto shall defend, indemnify and hold
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harmless the other party and its Affiliates, successors and assigns, and their
respective officers, directors, shareholders, partners and employees from and
against all [***]*.
21.2 If either JT or Corixa, or any Affiliate of JT or Corixa (in
each case an "Indemnified Party"), receives any written claim which it believes
is the subject of indemnity hereunder by either Corixa or JT, as the case may be
(in each case an "Indemnifying Party"), the Indemnified Party shall, as soon as
reasonably practicable after forming such belief, give notice thereof to the
Indemnifying Party, including full particulars of such claim to the extent known
to the Indemnified Party; provided, however, that the failure to give timely
notice to the Indemnifying Party as contemplated hereby shall not release the
Indemnifying Party from any liability to the Indemnified Party. The Indemnifying
Party shall have the right, by prompt notice to the Indemnified Party, to assume
the defense of such claim with counsel reasonably satisfactory to the
Indemnified Party, and at the cost of the Indemnifying Party. If the
Indemnifying Party does not so assume the defense of such claim, the Indemnified
Party may assume such defense with counsel of its choice at the sole expense of
the Indemnifying Party. If the Indemnifying Party so assumes such defense, the
Indemnified Party may participate therein through counsel of its choice, but the
cost of such counsel shall be borne solely by the Indemnified Party.
21.3 The party not assuming the defense of any such claim shall
render all reasonable assistance to the party assuming such defense, and all
out-of-pocket costs of such assistance shall be borne solely by the Indemnifying
Party.
21.4 No such claim shall be settled other than by the party defending
the same, and then only with the consent of the other party, which shall not be
unreasonably withheld; provided, however, that the Indemnified Party shall have
no obligation to consent to any settlement of any such claim which imposes on
the Indemnified Party any liability or obligation which cannot be assumed and
performed in full by the Indemnifying Party.
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22. GOVERNMENTAL CONSENT.
22.1 HSR Act. As promptly as practicable after the execution of this
Agreement, and from time to time during the term hereof as may be required,
Corixa and JT each shall execute and file, or join in the execution and filing,
of all applications and documents that may be required under the Xxxx-Xxxxx
Xxxxxx Antitrust Improvements Act of 1976, as amended (the "HSR Act"), in
connection with this Agreement and the transactions contemplated hereby;
provided, however, that JT shall pay all applicable filing fees associated with
the filing of such applications, and documents. Corixa and JT each shall use
their best commercial efforts to take such action as may be required to cause
the expiration or early termination of the notice periods under the HSR Act as
promptly as possible after the execution of this Agreement and to resolve such
objections, if any, as may be asserted with respect to the transactions
contemplated by this Agreement under the HSR Act; provided, however,
notwithstanding the foregoing, neither party shall agree to any change or
amendment to this Agreement unless such change or amendment is agreed to by the
other party in advance. In connection therewith, if any administrative or
judicial action or proceeding is instituted (or threatened to be instituted)
challenging any transaction contemplated by this Agreement or the transactions
contemplated hereby as violative of the HSR Act, Corixa and JT shall cooperate
and use best commercial efforts to contest and resist any such action or
proceeding and to have vacated, lifted, reversed, or overturned any decree,
judgment, injunction or other order, whether temporary, preliminary or
permanent, that is in effect and that prohibits, prevents, or restricts
consummation and/or effectiveness of the Agreement or the transactions
contemplated hereby, unless by mutual agreement Corixa and JT decide that such
action is not in their respective best interests. The parties hereto will
consult and cooperate with one another, and consider in good faith the views of
one another, in connection with any analyses, appearances, presentations,
memoranda, briefs, arguments, opinions and proposals made or submitted by or on
behalf of any party hereto in connection with proceedings under or relating to
the HSR Act. Notwithstanding the foregoing, neither Corixa nor JT will have any
obligation to litigate or contest any administrative or judicial action or
proceeding or any decree, judgment, injunction or other order beyond the first
anniversary of the Execution Date.
22.2 Closing Condition. The respective obligations of Corixa and JT
to effect this Agreement and the transactions contemplated hereby shall be
subject to the expiration or early termination of the waiting period applicable
to this Agreement under the HSR Act. Corixa and JT each hereby agree that the
foregoing sentence represents the only condition to the effectiveness of this
Agreement and the transactions contemplated herein and upon the date such
condition has been satisfied (the "Effective Date"), this Agreement will be in
full force and effect.
[Signature page follows]
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IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement
to be executed by its duly authorized officer as of the date first written
above.
CORIXA CORPORATION JAPAN TOBACCO INC.
By: By:
-------------------------------- -------------------------------------
Xxxx XxXxxx
President and Name:
Chief Operating Officer -----------------------------------
Title:
----------------------------------
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EXHIBIT A TO COLLABORATION AGREEMENT
Corixa Patents
[***]*
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27
EXHIBIT A-1 TO COLLABORATION AGREEMENT
Corixa Adjuvant Patents
[***]*
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28
EXHIBIT A-2 TO COLLABORATION AGREEMENT
Microsphere Patents
[***]*
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29
EXHIBIT B TO COLLABORATION AGREEMENT
RESEARCH PROGRAM
[***]*
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30
EXHIBIT C TO COLLABORATION AGREEMENT
LIST OF THIRD PARTY AGREEMENTS
1. Licensing Agreement, effective as of [***]* between Corixa and [***]* a
copy of which is attached to this Exhibit C and incorporated herein by
reference. Pursuant to the terms of the foregoing, the parties hereto
acknowledge that Corixa's license thereunder shall remain exclusive for the life
of the last to expire issued patent licensed to Corixa thereunder.
2. License Agreement, made and entered into as of [***]*, by and among
[***]* and Corixa.
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EXHIBIT D TO COLLABORATION AGREEMENT
FORM OF SUPPLY AGREEMENT
This Supply Agreement (this "Agreement") is made as of _______, 1999
(the "Effective Date") by and between Japan Tobacco Inc., a Japanese corporation
("JT") and Corixa Corporation, a Delaware corporation ("Corixa").
RECITALS
A. JT and Corixa have entered into a License and Collaborative Research
Agreement dated as of _________ __, 1999 (the "Collaboration Agreement"),
pursuant to which Corixa licensed to JT certain of its intellectual property
rights related to the development of vaccine products for the treatment of lung
cancer.
B. In connection with, and in accordance with the terms and conditions
of Section 10.1 of the Collaboration Agreement, Corixa is willing to supply to
JT, and JT agrees to purchase from Corixa upon the terms and subject to the
conditions set forth in this Agreement, [***]* (as such terms are defined
in the Collaboration Agreement).
NOW THEREFORE, in consideration of the premises and the mutual covenants
herein set forth, the receipt and sufficiency of which are hereby acknowledged,
the parties hereto agree as follows:
1. DEFINITIONS.
Capitalized terms used herein shall have the respective meanings set
forth in the Collaboration Agreement unless otherwise defined herein.
1.1 "Commercialization Materials" shall mean those Materials that
are required by governmental law or regulation to be manufactured in accordance
with Good Manufacturing Practices.
1.2 "FDA" shall mean the U.S. Food and Drug Administration or any
successor agency thereof.
1.3 "Fully Burdened Manufacturing Cost" shall mean [***]*.
1.4 "Materials" shall mean [***]*, set forth on Exhibit A
attached hereto, as amended from time to time upon mutual agreement of the
parties, as well as [***]*.
1.5 "Specifications" means written specifications related to the
manufacture of the Materials that will be developed pursuant to Section 3.1 and
shall be attached hereto and made a part hereof as Exhibit B.
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32
1.6 Singular and Plural. Where the context hereto requires, the
singular number shall be deemed to include the plural and vice versa.
2. PRODUCT SUPPLY.
2.1 Purchase and Sale. Upon the terms and subject to the
conditions of this Agreement, JT shall [***]* purchase from Corixa, for
itself, its Affiliate, and sublicensees, the Materials in accordance with this
Section 2, and Corixa shall sell and supply to JT such Materials. The parties
agree that Corixa shall have the right in connection with the supply of
Materials hereunder to contract with respect to manufacture of the Materials
with such third parties as Corixa deems advisable; provided, however, that
Corixa shall remain fully responsible for all of its obligations hereunder.
2.2 Purchase Price, Price Adjustments and Payment.
(a) For Materials supplied by Corixa to JT pursuant to
this Agreement, JT shall pay a purchase price equal to [***]* (the "Purchase
Price"). Corixa agrees to [***]* and will allow representatives of JT to audit
Corixa's accounting records pertaining to the manufacture of the Materials
[***]* per year. JT agrees that all information relating to such account by
records shall be treated as confidential information under Section 13 of the
Collaboration Agreement.
(b) Corixa shall invoice JT [***]* each shipment of the
Materials. JT shall pay such invoice within [***]* from the date of receipt of
the invoice.
2.3 Forecast and Orders.
(a) Within [***]* of the Effective Date (or such other
date as may be agreed upon by the parties), and at least every [***]*
thereafter, JT shall furnish to Corixa a rolling [***]* forecast for the
quantities of Materials that JT intends to order during the [***]* period
commencing [***]* from the date of such forecast. [***]*. Following [***]*, the
first [***]* of such forecast shall constitute a binding commitment upon JT to
purchase such quantities as evidenced by purchase orders received from JT in
accordance with Section 2.3(b). The balance of such forecast shall merely
represent reasonable good faith estimates for planning purposes only and shall
not obligate JT to purchase any such amounts.
(b) JT shall place each purchase order with Corixa for
Materials to be delivered hereunder at least [***]* prior to the delivery date
specified in each respective order. Corixa hereby [***]* from the receipt of
each firm purchase order and shall accept such firm purchase orders placed by JT
within [***]* of receipt for that amount of Materials which is [***]* the then
current forecast for the applicable period. For orders of Materials that exceed
[***]*. Corixa shall have no obligation to supply that amount of Materials which
exceeds [***]* of the most current forecast underlying such order, provided that
[***]* of Corixa's receipt of the order. Corixa shall deliver against each firm
purchase order accepted by Corixa in accordance with this Section 2.3. JT shall
be obligated to purchase all Materials ordered and delivered by the
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33
delivery date, unless such Materials are rejected pursuant to Section 4.1. In
the event any purchase order submitted by JT contains term(s) or condition(s)
that conflicts with any term or condition set forth in this Agreement, this
Agreement shall control, unless otherwise agreed to in writing by the parties.
2.4 Delivery. Delivery terms shall be F.O.B. Corixa's
manufacturing facility in Seattle, Washington, or such other facility as may be
designated by Corixa. Corixa shall [***]* assist JT in arranging any
desired insurance (in amounts that JT shall determine) and transportation, via
air freight unless otherwise specified in writing, to any destinations specified
in writing from time to time by JT. All customs, duties, costs, taxes, insurance
premiums, and other expenses relating to such transportation and delivery, shall
be at JT's sole expense. Corixa shall ship Materials under appropriate storage
conditions [***]*). Any cost of compliance with such storage conditions
shall be added to the calculation of Fully Burdened Manufacturing Cost.
2.5 Safety Stock. After [***]*, Corixa shall maintain a
fresh safety stock of Materials, equivalent to the forecasted purchases for the
most recent [***]* period, to be exclusively available to JT. Deliveries by
Corixa to JT may be taken from Corixa's inventory identified as safety stock.
Corixa's safety stock shall be rotated with its regular inventory of Materials
to maintain a reasonable shelf-life. Corixa shall keep JT reasonably informed of
the level of inventory identified as the safety stock. In the event of any
termination of this Agreement, JT will be obligated to purchase the unsold
portion of such safety stock from Corixa, to the extent the quantity on
termination is equal to or less than the most recent [***]* forecast
provided by JT.
2.6 Payment Instructions.
All payments due hereunder shall be made in U.S. dollars by wire
transfer of immediately available funds to the following account:
Account No. 0000000
Bank: Commerce Bank of Washington
ABA Code: 000000000
or to such other account as Corixa may designate from time to time.
2.7 Past Due Amounts. Any past due payments under this Agreement
shall accrue interest until paid at [***]* per annum, or the maximum rate
permitted by law, whichever is less.
2.8 Foreign Currency. Currency conversions to U.S. Dollars, if
any, shall be calculated using an average rate of exchange, which rate of
exchange shall be computed by adding the rate of exchange quoted under Foreign
Exchange in The Wall Street Journal as of the end of the current month to the
rate as of the end of the prior month and dividing by 2.
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3. PRODUCT MANUFACTURE.
3.1 Incoming Specifications. The parties will in good faith
cooperate with one another to develop the Specifications, which shall be
acceptable to both parties. The Specifications shall be agreed upon in writing
and shall be attached hereto and incorporated into this Agreement as Exhibit B,
and may be amended from time to time by mutual written agreement of the parties.
The Specifications shall be considered confidential information pursuant to
Section 13 of the Collaboration Agreement and for the purposes of Section 10
hereof.
3.2 Manufacturing Process.
(a) During the term of the Collaboration Agreement, Corixa
shall manufacture the Commercialization Materials in accordance in all material
respects with "Good Manufacturing Practices" and the Specifications.
(b) Corixa shall not materially modify the processes or
materials used in the manufacturing process without the prior approval of JT.
3.3 Testing of Materials. Corixa shall test or cause to be tested
each batch of Materials manufactured pursuant to this Agreement before delivery
to JT. Each test shall set forth the Specifications, the items tested and test
results in a certificate of analysis for each batch delivered. Corixa shall send
or cause to be sent such certificates to JT along with delivery of Materials.
4. QUALITY ASSURANCE AND INSPECTION.
4.1 Rejected Goods/Shortages.
(a) JT shall notify Corixa in writing of any claim that
any Materials do not conform to the Specifications or any shortage in quantity
of any shipment of Materials within [***]* of receipt of such shipment. Upon
confirming any such nonconformance or shortage, Corixa shall [***]* of receiving
such notice, [***]* and shall make arrangements with JT for the return or
destruction of any rejected Materials, with any reasonable return shipping
charges or costs of destruction to be paid by Corixa.
(b) In the event of a conflict regarding any nonconforming
Materials which Corixa and JT are unable to resolve, a sample of such Materials,
together with mutually agreed upon questions, shall be submitted by JT to an
independent laboratory reasonably acceptable to both parties for testing against
the Specifications, and the test results obtained by such laboratory shall be
final and binding upon the parties. The test results shall be considered
confidential information pursuant to Section 13 of the Collaboration Agreement
and for purposes of Section 10 hereof. The fees and expenses of such laboratory
testing shall be borne entirely by the party against whom such laboratory's
findings are made. In the event the test results indicate that the Materials in
question do not conform to the Specifications, Corixa shall [***]*. If [***]*,
Corixa shall [***]* replace the nonconforming Materials with conforming
Materials at no
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additional cost to JT as soon as possible, but in no event shall the replacement
time exceed [***]*.
4.2 Regulatory.
(a) In the event that regulatory certification is required
by the applicable regulatory authority in Territory A or Territory B for
Materials, Corixa will [***]* certification is met, [***]*.
(b) Each party shall keep the other informed of any formal
or informal inquiry by any regulatory agency of any state or national government
or supranational authority relating to Materials used or sold hereunder.
(c) Upon reasonable prior notice of at least [***]*,
Corixa shall permit representatives of any regulatory agency having jurisdiction
over the manufacture and/or marketing of the Materials or of any diagnostic
assay or other product in which the Materials are incorporated, to inspect its
facilities in conjunction with the manufacture, testing, packaging, storage,
handling and shipping of the Materials. Further, Corixa shall advise JT
immediately if Corixa receives notice of an impending inspection or if an
authorized agent of the FDA or other governmental agency visits any of Corixa's
manufacturing facilities concerning the Materials. [***]*.
4.3 Inspection by JT. Notwithstanding Corixa's obligation to
provide the certificate set forth in Section 3.3, Corixa shall permit JT upon
reasonable prior notice, but not less than [***]*, and during regular
business hours, but no more often than once per year, access to (a) those areas
of Corixa's manufacturing facilities where the Materials are manufactured,
tested, packaged, stored, handled and shipped, and (b) the manufacturing records
for the Materials manufactured for JT.
5. FAILURE TO SUPPLY.
5.1 Failure. In the event that Corixa is unable, or notifies JT
that it is unable, for any reason (including an event of force majeure) to
supply quantities of Materials in accordance with Section 2.3 for a period of
[***]* beyond the delivery date for such Materials, JT may at its
discretion (a) require Corixa to supply the undelivered Materials at a future
date agreed upon by the parties; or (b) manufacture or have manufactured by a
Third Party designated by JT that quantity of the Materials required by JT which
Corixa is unable to supply. If JT determines to manufacture or have manufactured
by a Third Party such Materials, Corixa will give JT and/or any such Third Party
all reasonably necessary information and cooperation to enable JT or such Third
Party to manufacture the Materials in accordance with the Specifications.
5.2 Supply Resumption. Corixa will have [***]* from the
original delivery date of any Materials in which Corixa fails to supply to JT,
as set forth in Section 5.1, in which to resume supply of the Materials to JT;
provided, however, such [***]* limitation shall not apply to a failure by
Corixa to supply that results from a force majeure event as set forth in Section
12.7.
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At the time that Corixa resumes supply of the Materials, JT will cease
manufacture of the Materials or have the Third Party cease such manufacture in a
reasonable time and manner, and shall purchase Materials from Corixa upon the
terms and subject to the conditions of this Agreement. [***]*
6. TERM/TERMINATION.
6.1 Term and Expiration. The initial term of this Agreement shall
expire upon the expiration or termination of the Collaboration Agreement, unless
extended or earlier terminated by mutual agreement of the parties.
6.2 Termination With Cause. Upon any material breach of this
Agreement by either party, the non-breaching party may terminate this Agreement
upon [***]* written notice to the breaching party. The notice shall become
effective at the end of such [***]* period unless the breaching party shall
have cured such breach within such period.
6.3 Termination for Insolvency. Either party may terminate this
Agreement upon written notice to the other in the event of (a) insolvency of the
other party, or the appointment of a receiver by the other party for all or any
substantial part of its properties, provided that such receiver is not
discharged within sixty (60) days of its appointment, (b) the adjudication of
the other party as a bankrupt, (c) the admission by the other party in writing
of its inability to pay its debts as they become due, (d) the execution by the
other party of an assignment for the benefit of its creditors or (e) the filing
by the other party of a petition to be adjudged as a bankrupt, or a petition or
answer admitting the material allegations of a petition filed against the other
party in any bankruptcy proceeding, or the acts of the other party to any other
judicial proceeding intended to effect a discharge of the debts of the other
party, in whole or in part.
6.4 Termination of Supply. [***]*.
6.5 Consequences of Expiration or Early Termination. Upon the
expiration or termination of this Agreement:
(a) Each party shall return or destroy, and certify to
such destruction of, all confidential information of the other party provided or
obtained pursuant to this Agreement, except that each party may maintain one (1)
copy for archival purposes solely to confirm compliance with the provisions of
Section 10 hereof;
(b) JT shall purchase the safety stock inventory held by
Corixa in accordance with Section 2.5; and
(c) [***]*
6.6 Inclusive Remedy. Except as otherwise provided in this
Agreement, each party shall have the rights and remedies set forth herein in
addition to any other remedies which it may have under applicable statutory or
common law. Each party shall have the sole discretion to
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determine which of its rights and remedies, if any, it shall pursue and such
party shall not be required to exhaust any of its other rights or remedies
before pursuing any one of the rights and remedies set forth in this Agreement.
6.7 Survival. Expiration or early termination of this Agreement
shall not relieve either party of its obligations incurred prior to expiration
or early termination. The obligations under Sections 4, 6.5, 6.6, 6.7 and 7-12
shall survive any expiration or termination of this Agreement. Further, JT shall
make all payments as are required for the final quarter of the effectiveness of
this Agreement.
7. REPRESENTATIONS AND WARRANTIES.
7.1 By Corixa. Corixa represents and warrants to JT that:
(a) it has full right to enter into and perform Corixa's
obligations under this Agreement and to supply the Materials; and
(b) the execution, delivery, and performance of this
Agreement does not conflict with, violate or breach any agreement to which
Corixa is a party.
7.2 By JT. JT represents and warrants to Corixa that
(a) it has the full right to enter into and perform JT's
obligations under this Agreement; and
(b) the execution, delivery and performance of this
Agreement does not conflict with, violate or breach any agreement to which JT is
a party.
7.3 Extent of Warranties. EXCEPT AS SPECIFICALLY PROVIDED IN THIS
AGREEMENT, THE MATERIALS ARE SUPPLIED "AS IS" AND CORIXA HEREBY DISCLAIMS ANY
AND ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND WITH REGARD TO THE MATERIALS,
WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR USE, AND
ANY OTHER STATUTORY WARRANTIES OR ANY WARRANTY OF PATENTABILITY OR
NONINFRINGEMENT.
8. INDEMNIFICATION.
8.1 Damages. Subject to Paragraph 8.2 hereof, from and after the
Effective Date, except as otherwise herein specifically provided, each of the
parties hereto shall defend, indemnify and hold harmless the other party and its
Affiliates, successors and assigns, and their respective officers, directors,
shareholders, partners and employees from and against all losses, damage,
liability and expense including legal fees but excluding punitive or
consequential damages
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(including lost profits) ("Damages") incurred thereby or caused thereto arising
out of or relating to (a) [***]*.
8.2 Notice of Claim. If either JT or Corixa, or any Affiliate of
JT or Corixa (in each case an "Indemnified Party"), receives any written claim
which it believes is the subject of indemnity hereunder by either Corixa or JT,
as the case may be (in each case an "Indemnifying Party"), the Indemnified Party
shall, as soon as reasonably practicable after forming such belief, give notice
thereof to the Indemnifying Party, including full particulars of such claim to
the extent known to the Indemnified Party; provided, however, that the failure
to give timely notice to the Indemnifying Party as contemplated hereby shall not
release the Indemnifying Party from any liability to the Indemnified Party. The
Indemnifying Party shall have the right, by prompt notice to the Indemnified
Party, to assume the defense of such claim with counsel reasonably satisfactory
to the Indemnified Party, and at the cost of the Indemnifying Party. If the
Indemnifying Party does not so assume the defense of such claim, the Indemnified
Party may assume such defense with counsel of its choice at the sole expense of
the Indemnifying Party. If the Indemnifying Party so assumes such defense, the
Indemnified Party may participate therein through counsel of its choice, but the
cost of such counsel shall be borne solely by the Indemnified Party.
8.3 Assistance; Costs. The party not assuming the defense of any
such claim shall render any reasonable assistance that may be requested by the
party assuming such defense, and all out-of-pocket costs of such assistance
shall be borne solely by the Indemnifying Party.
8.4 Settlement. No such claim shall be settled other than by the
party defending the same, and then only with the consent of the other party,
which shall not be unreasonably withheld; provided, however, that the
Indemnified Party shall have no obligation to consent to any settlement of any
such claim which imposes on the Indemnified Party any liability or obligation
which cannot be assumed and performed in full by the Indemnifying Party.
9. LIMITATION OF LIABILITY.
IN NO EVENT WILL EITHER PARTY HERETO BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES SUFFERED BY THE OTHER PARTY
ARISING IN ANY WAY OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE PARTY HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGE. IN NO EVENT SHALL THE LIABILITY OF CORIXA TO JT
UNDER ANY PROVISION OF THIS AGREEMENT EXCEED THE AMOUNTS ACTUALLY RECEIVED BY
CORIXA FROM JT HEREUNDER.
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39
10. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS.
10.1 Confidential Information. During the term of this Agreement
and for [***]* thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, Corixa and JT shall not use or reveal
or disclose to any Third Party any confidential information received from the
other party or otherwise developed by either party in the performance of
activities in furtherance of this Agreement without first obtaining the written
consent of the disclosing party, except as may be otherwise provided herein, or
as may be required [***]*. This confidentiality obligation shall not apply
to such information which is or becomes a matter of public knowledge, or is
already in the possession of the receiving party, or is disclosed to the
receiving party by a Third Party having the right to do so, or is subsequently
and independently developed by employees of the receiving party or Affiliates
thereof who had no knowledge of the confidential information disclosed. The
parties shall take reasonable measures to assure that no unauthorized use or
disclosure is made by others to whom access to such information is granted.
10.2 Permitted Disclosure. Nothing herein shall be construed as
preventing JT from disclosing any information received from Corixa to
[***]*.
10.3 Intellectual Property; Bankruptcy. All confidential
information disclosed by one party to the other shall remain the intellectual
property of the disclosing party. In the event that a court or other legal or
administrative tribunal, directly or through an appointed master, trustee or
receiver, assumes partial or complete control over the assets of a party to this
Agreement based on the insolvency or bankruptcy of such party, the bankrupt or
insolvent party shall promptly notify the court or other tribunal (a) that
confidential information received from the other party under this Agreement
remains the property of the other party and (b) of the confidentiality
obligations under this Agreement. In addition, the bankrupt or insolvent party
shall, to the extent permitted by law, take all steps necessary or desirable to
maintain the confidentiality of the other party's confidential information and
to ensure that the court, other tribunal or appointee maintains such information
in confidence in accordance with the terms of this Agreement.
10.4 Press Release. The parties to this Agreement may disclose
the nature and general terms of the Agreement in a press release following the
Effective Date with the prior approval of such release by the other party, which
approval shall not be unreasonably withheld. Notwithstanding the foregoing,
Corixa shall have the right to issue press releases or other announcements
immediately and without prior consent of JT that disclose any information
required by the rules and regulations of the Securities and Exchange Commission
or similar federal or state authority, as determined in good faith by Corixa.
10.5 Publicity. Neither party shall publish or provide public
disclosure of information or inventions arising from the Research Program or the
Clinical Development Program, or the manufacture of Materials pursuant to this
Agreement (a "Dissemination") without at least [***]* prior written notice
of such planned publication or disclosure sent to the
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40
other party. In the event any such Dissemination is determined by the other
party to be detrimental to its intellectual property position, the disseminating
party shall delay such publication for a period sufficient to allow the other
party to take the steps necessary to protect such intellectual property,
including the filing of any patent applications and/or deletion of the other
party's confidential information. Notwithstanding the foregoing, Corixa shall
have the right to issue disclose information immediately and without prior
consent of JT to the extent that such disclosure is required by the rules and
regulations of the Securities and Exchange Commission or similar federal or
state authority, as determined in good faith by Corixa.
11. GOVERNING LAW; ARBITRATION.
This Agreement shall be governed by the laws of the [***]*.
Prior to engaging in any formal dispute resolution with respect to any dispute,
controversy or claim arising out of or in relation to this Agreement or the
breach, termination or invalidity thereof (each, a "Dispute"), the Chief
Executive Officers of the respective parties shall attempt for a period not less
than sixty (60) days to resolve such Dispute. Any dispute, controversy or claim
arising out of or in relation to this Agreement or the breach, termination or
invalidity thereof, that cannot be settled amicably by agreement of the parties
pursuant to the preceding sentence, shall be finally settled by arbitration in
New York City, New York, USA, in accordance with the arbitration rules of the
American Arbitration Association ("AAA"), then in force, by one or more
arbitrators appointed in accordance with said rules, provided that the appointed
arbitrators shall have appropriate experience in the biopharmaceutical industry;
provided, however, that arbitration proceedings may not be instituted until the
party alleging breach of this Agreement by the other party has given the other
party not less than sixty (60) days notice (or, in the event of any alleged
failure to make payments due hereunder, not less than fourteen (14) days notice)
to remedy any alleged breach and the other party has failed to do so. The award
rendered shall be final and binding upon both parties. The judgment rendered by
the arbitrator(s) shall include costs of arbitration, reasonable attorneys' fees
and reasonable costs for any expert and other witnesses. Nothing in this
Agreement shall be deemed as preventing either party from seeking injunctive
relief (or any other provisional remedy) from any court having jurisdiction over
the parties and the subject matter of the dispute as necessary to protect either
party's name, proprietary information, trade secrets, know-how or any other
proprietary rights. Judgment upon the award may be entered in any court having
jurisdiction, or application may be made to such court for judicial acceptance
of the award and/or an order of enforcement as the case may be.
12. GENERAL PROVISIONS.
12.1 Independent Contractors. Corixa and JT shall be independent
contractors and shall not be deemed to be partners, joint venturers or each
other's agents, and neither party shall have the right to act on behalf of the
other except as is expressly set forth in this Agreement.
12.2 Entire Agreement. This Agreement, including all appendices
hereto, together with the Collaboration Agreement, including all appendices
thereto, sets forth the entire agreement and understanding between the parties
and supersedes all previous agreements,
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promises, representations, understandings, and negotiations, whether written or
oral between the parties with respect to the subject matter hereof. There shall
be no amendments or modifications to this Agreement, except by a written
document signed by both parties.
12.3 Assignment. Neither party may assign its rights or delegate
its duties under this Agreement without the prior written consent of the other
party, which consent shall not be unreasonably withheld, [***]*.
12.4 Unenforceable Provisions. If any provision of this Agreement
is finally held to be invalid, illegal or unenforceable by a court of competent
jurisdiction, the validity, legality and enforceability of the remaining
provisions shall not be affected or impaired in any way.
12.5 Waiver. Any delay in enforcing a party's rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of a party's right to the future enforcement of its rights
under this Agreement.
12.6 Notices. Any notice required or permitted by this Agreement
to be given to either party shall be in writing and shall be deemed given when
delivered personally, by confirmed telecopy to a fax number designated in
writing by the party to whom notice is given, or by registered, recorded or
certified mail, return receipt requested, and addressed to the party to whom
such notice is directed, at:
If to Corixa:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Chief Operating Officer
With a copy to: Director of Legal Affairs
Facsimile: (000) 000-0000
with a copy to:
Venture Law Group
0000 Xxxxxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxxxx
Facsimile: (000) 000-0000
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If to JT:
Japan Tobacco Inc.
------------------------------
------------------------------
------------------------------
Facsimile:
--------------------
with a copy to:
------------------------------
------------------------------
------------------------------
Facsimile:
--------------------
or at such other address or telecopy number as such party to whom notice is
directed may designate to the other party in writing.
12.7 Force Majeure. If the performance of this Agreement or any
obligations hereunder is prevented, restricted or interfered with by reason of
fire or other casualty or accident, strikes or labor disputes, war or other
violence, any law, order, proclamation, ordinance, demand or requirement of any
government agency, or any other act or condition beyond the control of the
parties hereto, the party so affected, upon giving prompt notice to the other
party shall be excused from such performance (other than the obligation to pay
money) during such prevention, restriction or interference.
12.8 Counterparts. This Agreement may be signed in counterparts,
each of which shall be deemed an original and all of which together shall
constitute one instrument.
[Signature page follows.]
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
CORIXA CORPORATION
By:______________________________________
Name:____________________________________
Title:___________________________________
JAPAN TOBACCO INC.
By:______________________________________
Name:____________________________________
Title:___________________________________
44
EXHIBIT A
Materials
45
EXHIBIT B
Specifications
