EXHIBIT 10.1
*Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
EXECUTION COPY
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CORIXA CORPORATION
AND
KIRIN BREWERY COMPANY, LTD.
------------
LICENSE, DEVELOPMENT
AND
COMMERCIALIZATION
AGREEMENT
------------
TABLE OF CONTENTS
PAGE
1. DEFINITIONS.........................................................................1
2. SCOPE OF RESEARCH PROGRAM; CLINICAL DEVELOPMENT PROGRAM AND COMMERCIALIZATION
PROGRAM............................................................................11
2.1 Research Program............................................................11
2.2 Territory A Clinical Development Program....................................12
2.3 Territory B Clinical Development Program....................................13
2.4 Territory C Clinical Development............................................13
2.5 [*] Licensed Products.......................................................14
2.6 Freedom to Conduct Clinical Trials..........................................14
2.7 Commercialization Program...................................................14
3. DEVELOPMENT STEERING COMMITTEE; COMMERCIALIZATION STEERING COMMITTEE;
INFORMATION SHARING................................................................15
3.1 Development Steering Committee and Clinical Development Program.............15
3.2 Commercialization Steering Committee and Commercialization Program..........16
3.3 Information Sharing.........................................................17
4. LICENSE GRANTS.....................................................................19
4.1 License.....................................................................19
4.2 Additional Technology.......................................................22
4.3 Sublicenses of Third Party Rights to Kirin..................................24
4.4 Exploitation of Joint Inventions and Joint Patents..........................25
5. RESEARCH AND DEVELOPMENT FUNDING AND COSTS.........................................25
5.1 Lump-sum Research Funding...................................................25
5.2 Milestone Payments..........................................................25
5.3 Research Costs..............................................................26
5.4 Development Costs...........................................................26
5.5 Commercialization Costs.....................................................26
6. NET PROCEEDS SHARING AND ROYALTY PAYMENTS..........................................26
6.1 Net Proceeds................................................................26
6.2 Royalties and Transfer Prices for Licensed Products.........................27
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TABLE OF CONTENTS
(continued)
PAGE
6.3 Royalty Reduction for Non-Coverage of Licensed Products by Valid Claims.....30
6.4 Royalty Adjustment for Assignment or License of [*].........................30
6.5 Combination Products........................................................30
6.6 Royalty Term; Single Royalty; No Right of Offset............................31
6.7 Payments and Currency.......................................................31
6.8 Withholding Taxes...........................................................31
6.9 Currency Transfer Restrictions..............................................32
6.10 Payments Upon Termination...................................................32
7. REPORTS, PAYMENTS AND ACCOUNTING...................................................32
7.1 Payments and Reports........................................................32
7.2 Accounting..................................................................33
7.3 Confidentiality of Reports..................................................33
8. STANDARDS OF PERFORMANCE IN RESEARCH, DEVELOPMENT AND COMMERCIALIZATION............34
8.1 Diligence in Research, Development, and Commercialization...................34
8.2 Regulatory Matters and Compliance...........................................34
9. MANUFACTURING; SUPPLY..............................................................35
9.1 Materials...................................................................35
9.2 Delivery....................................................................35
9.3 Supply Agreement............................................................35
10. INVENTIONS AND IMPROVEMENTS........................................................36
10.1 Inventions..................................................................36
10.2 Improvements................................................................36
11. PATENTS; PROSECUTION AND LITIGATION................................................36
11.1 Filing, Prosecution and Maintenance.........................................36
11.2 Defense.....................................................................38
11.3 Enforcement.................................................................39
11.4 Recovery Sharing............................................................39
11.5 Interference Proceedings....................................................40
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TABLE OF CONTENTS
(continued)
PAGE
11.6 Status Updates..............................................................40
12. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS...........................................40
12.1 Disclosure of Inventions....................................................40
12.2 Safety......................................................................40
12.3 Confidential Information....................................................41
12.4 Permitted Disclosures.......................................................41
12.5 Bankruptcy Procedures.......................................................42
12.6 Press Release...............................................................42
12.7 Publicity...................................................................42
13. GOVERNING LAW; DISPUTE RESOLUTION..................................................42
13.1 Governing Law...............................................................42
13.2 Dispute Resolution..........................................................43
14. TRADEMARKS.........................................................................44
14.1 Trademark Ownership.........................................................44
14.2 Trademark Licenses..........................................................44
14.3 Trademark Use Requirements..................................................45
14.4 Infringement of Licensed Product Trademarks.................................45
15. MISCELLANEOUS......................................................................45
15.1 Force Majeure...............................................................45
15.2 Severability................................................................46
15.3 Entire Agreement............................................................46
15.4 Modification................................................................46
15.5 Waiver......................................................................46
15.6 Independent Contractors.....................................................46
15.7 Further Actions.............................................................46
15.8 Nature of Agreement.........................................................47
15.9 Counterparts................................................................47
15.10 Headings....................................................................47
15.11 No Right to Use Names.......................................................47
15.12 Notice Procedure and Effectiveness..........................................47
16. ASSIGNMENT.........................................................................48
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TABLE OF CONTENTS
(continued)
PAGE
17. WARRANTIES, REPRESENTATIONS AND COVENANTS; INSURANCE...............................48
17.1 Mutual Warranties, Representations and Covenants............................48
17.2 Corixa Warranties, Representations and Covenants............................49
00.0 Xxxxx Xxxxxxxxxxxxxx, Xxxxxxxx and Covenant.................................51
17.4 Disclaimer..................................................................51
17.5 Insurance...................................................................51
17.6 LIMITED LIABILITY...........................................................52
18. TERM AND TERMINATION...............................................................53
18.1 General.....................................................................53
18.2 Term........................................................................53
18.3 Termination for Breach......................................................53
18.4 Kirin Early Termination Option..............................................54
18.5 Termination For Scientific Reasons..........................................55
18.6 Kirin Right to Terminate....................................................57
18.7 Termination on Bankruptcy...................................................58
18.8 Other No-Fee Termination....................................................58
18.9 Termination By Mutual Agreement.............................................60
18.10 Suspension of Performance...................................................60
19. ADDITIONAL RIGHTS AND DUTIES UPON TERMINATION......................................60
19.1 Accrued Payments............................................................60
19.2 Inventory Sell-Off..........................................................61
19.3 Know-How....................................................................61
19.4 Joint Inventions and Joint Patents..........................................61
19.5 Licensed Trademarks.........................................................61
19.6 Confidential Information....................................................62
19.7 Cooperation.................................................................62
19.8 Survival....................................................................62
20. INDEMNIFICATION....................................................................63
20.1 Indemnification.............................................................63
20.2 Procedure...................................................................63
20.3 Cooperation.................................................................63
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TABLE OF CONTENTS
(continued)
PAGE
20.4 Settlement..................................................................63
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EXHIBITS
Exhibit A Corixa WT-1 Patents
Exhibit A-1 Corixa Adjuvants
Exhibit A-2 Corixa Adjuvant Patents
Exhibit A-3 Corixa [*] Patents
Exhibit B List of Third Party Agreements
Exhibit B-1 Copy of [*] Agreement
Exhibit C Supply Agreement Minimum Terms and
Conditions
Exhibit D Cost- and Revenue-Sharing Methodology
Exhibit E Third Party Agreement Royalties
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LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
This LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (together with
the attachments and exhibits hereto, the "Agreement") is entered into as of
November 27, 2002 (the "Effective 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 Kirin Brewery Company, Ltd., a corporation organized and
existing under the laws of Japan and having its principal office at 00-0
Xxxxxxxx 0-xxxxx, Xxxx-Xx, Xxxxx 000-0000, Xxxxx.
RECITALS
WHEREAS, Corixa has scientific expertise, proprietary information and
biological materials related to antigen discovery and vaccine development;
WHEREAS, Kirin has expertise in developing and commercializing
therapeutic products;
WHEREAS, Corixa and Kirin desire to collaborate in the development and
commercialization of vaccine products for the treatment of leukemia and other
cancers, which vaccines will contain certain protein, peptide or DNA antigens;
and
WHEREAS, Corixa has agreed to license to Kirin in certain territories
certain intellectual property rights related to the Collaboration (as defined
herein), 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 Technology" shall have the meaning set forth in Section
4.2(a).
1.2 "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, whether
directly or indirectly, to the extent of more than fifty percent (50%) of the
equity or other ownership interest (or such lesser percentage that is the
maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs of the entity,
or any person, firm, partnership, corporation, or other entity actually
controlled by, controlling or under common control with a party to this
Agreement, whether directly or indirectly.
1.3 "Asia" shall mean the countries of Afghanistan, Australia, Bahrain,
Bangladesh, Bhutan, Brunei, Burma (Myanmar), Cambodia, East Timor, India,
Indonesia, Iran, Iraq, Israel, Japan, Jordan, Kuwait, Laos, Lebanon, Malaysia,
Xxxxxxxx, Xxxxx, Xxx Xxxxxxx, Xxxxx Xxxxx, Xxxx, Xxxxxxxx, Papua New Guinea, the
People's Republic of China and its territories, possessions and protectorates
(including Hong Kong and Macao), Philippines, Qatar, Saudi Arabia, Singapore,
South Korea, South Yemen, Sri Lanka, Taiwan, Thailand, Turkey, United Arab
Emirates, Vietnam, and Yemen.
1.4 "Clinical Development Program" shall mean the Territory A Clinical
Development Program and the Territory B Clinical Development Program,
collectively.
1.5 "Collaboration" means the joint collaboration of Corixa and Kirin
pursuant to the terms of this Agreement, as described in the Research Program,
the Clinical Development Program, and the Commercialization Program.
1.6 "Combination Product" shall have the meaning set forth in Section
6.5.
1.7 "Commercialization Steering Committee" shall have the meaning set
forth in Section 3.2.
1.8 "Commercially Reasonable and Diligent Efforts" shall mean those
efforts and the deployment of resources consistent with the exercise of
reasonable and prudent scientific and business judgment, as applied to other
pharmaceutical products of similar potential, characteristics and market size by
the party in question, and in no event less than commensurate with those efforts
and resources prescribed by the Development Steering Committee for Territory B
(taking into account, as applicable, territorial differences, regulatory issues,
differences in timing and deadlines as set forth herein, and other reasonable
differences between Territory B and the territory in question).
1.9 "Corixa" shall mean Corixa Corporation and each of its Affiliates.
1.10 "Corixa Adjuvant" shall mean any adjuvant (a) that is developed,
owned or in-licensed by Corixa (solely or jointly with a Third Party) as of the
Effective Date and identified on Exhibit A-1 (together with any improvements,
enhancements or modifications thereto developed, owned or in-licensed by Corixa
(solely or jointly with a Third Party) as of the Effective Date or thereafter
during the Term); (b) as to which and to the extent that Corixa has the right to
license or sublicense to Kirin hereunder as of the Effective Date (or, as
applicable, as of the date such adjuvant identified on Exhibit A-1 (or an
improvement, enhancement or modification thereto) is first developed, owned or
in-licensed by Corixa) without payment of royalties or other fees on account of
such license or sublicense other than those fees or royalties allocated by the
parties in accordance with Section 4.2(a) or as otherwise agreed; and (c) that
is covered by one (1) or more Valid Claim(s) of any of the Corixa Adjuvant
Patents.
1.11 "Corixa Adjuvant Patents" shall mean: (a) all patents and patent
applications that are identified on Exhibit A-2 attached hereto; and (b) all
patents and patent applications anywhere in, covering or otherwise applicable to
activities occurring in Territory A or Territory B owned or in-licensed by
Corixa (solely or jointly with a Third Party) as to which and to the extent that
Corixa has the right to license or sublicense to Kirin hereunder without
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payment of royalties or other fees on account of such license or sublicense
other than those fees or royalties allocated by the parties in accordance with
Section 4.2(a) or as otherwise agreed, (i) that claim inventions or discoveries
that are made, conceived, developed, or reduced to practice solely by Corixa's
employees, agents and/or licensor(s) or jointly by Corixa's employees, agents
and/or licensor(s) with any Third Party, and (ii) that either (A) generically or
specifically claim all or any part of any adjuvant technology (including any
Corixa Adjuvant technology), any process required or useful for manufacturing
any such adjuvant technology, any intermediates used in any such process, or any
use of any such adjuvant technology, in all such cases that is developed, owned
or in-licensed by Corixa as of the Effective Date, or any improvements,
enhancements or modifications to the foregoing developed, owned or in-licensed
by Corixa as of the Effective Date or during the Term or (B) are necessary in
connection with the manufacture, use or sale of any such adjuvant technology or
other technology described in foregoing subsection (A). Included within this
definition of Corixa Adjuvant Patents are any patents issuing anywhere in the
world from any of the foregoing patent applications, and any continuations,
continuations-in-part (solely to the extent such continuation(s)-in-part
contains subject matter on which claims issuing obtain the benefit of a priority
date of any other patent application included herein), divisions, patents of
addition, reissues, renewals, registrations, confirmations, reexamination
certificates, revalidations, substitutions, extensions and/or foreign
counter-parts, anywhere in the world, of any of the foregoing patents or patent
applications. Corixa Adjuvant Patents shall specifically not include Corixa WT-1
Patents, Corixa [*] Patents, Kirin Patents, or Joint Patents.
1.12 "Corixa Know-How" shall mean all technical information, materials
and know-how, including, without limitation, all biological, chemical,
pharmacological, toxicological, clinical, assay, control and manufacturing data,
methods, processes, formulas, protocols, techniques, trade secrets, other
proprietary capabilities and any other data, information or manufacturing or
related technology relating to [*], Corixa Adjuvants or any Licensed Product and
that can reasonably be deemed to be useful for the development and/or
commercialization of any Licensed Product, and strains, samples, analytical
tools, libraries, clones, etc., thereof, in each case (a) to the extent the
foregoing is developed, owned or in-licensed by Corixa (solely or jointly with a
Third Party) as of the Effective Date or during the Term and (b) to the extent
to which Corixa has or obtains the right to license or sublicense a third party
as of the Effective Date or during the Term under the terms and conditions
hereof without payment of royalties or other fees on account of such license or
sublicense other than those fees or royalties allocated by the parties in
accordance with Section 4.2(a) or as otherwise agreed.
1.13 "Corixa [*] Patents" shall mean: (a) all patents and patent
applications that are identified on Exhibit A-3 attached hereto; and (b) all
patents and patent applications anywhere in, covering or otherwise applicable to
activities occurring in Territory A or Territory B owned or in-licensed by
Corixa (solely or jointly with a Third Party) as to which and to the extent that
Corixa has the right to license or sublicense to Kirin hereunder without payment
of royalties or other fees on account of such license or sublicense other than
those fees or royalties required under any Third Party Agreement, or allocated
by the parties in accordance with Section 4.2(a), or as otherwise agreed, (i)
that claim inventions or discoveries that are made, conceived, developed, or
reduced to practice solely by Corixa's employees, agents and/or licensor(s) or
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jointly by Corixa's employees, agents and/or licensor(s) with any Third Party,
and (ii) that either (A) generically or specifically claim all or any part of
any [*] technology (including any [*] technology), any process required or
useful for manufacturing any such [*] technology, any intermediates used in any
such process, or any use of any such [*] technology, in all such cases that is
developed, owned or in-licensed by Corixa as of the Effective Date, or any
improvements, enhancements or modifications to the foregoing developed, owned or
in-licensed by Corixa as of the Effective Date or during the Term or (B) are
necessary in connection with the manufacture, use or sale of any such [*]
technology or other technology described in foregoing subsection (A). Included
within this definition of Corixa [*] Patents are any patents issuing anywhere in
the world from any of the foregoing patent applications, and any continuations,
continuations-in-part (solely to the extent such continuation(s)-in-part
contains subject matter on which claims issuing obtain the benefit of a priority
date of any other patent application included herein), divisions, patents of
addition, reissues, renewals, registrations, confirmations, reexamination
certificates, revalidations, substitutions, extensions and/or foreign
counter-parts, anywhere in the world, of any of the foregoing patents or patent
applications. Corixa [*] Patents shall specifically not include Corixa WT-1
Patents, Corixa Adjuvant Patents, Kirin Patents, or Joint Patents.
1.14 "Corixa WT-1 Patents" shall mean: (a) all patents and patent
applications that are identified on Exhibit A attached hereto; and (b) all
patents and patent applications anywhere in, covering or otherwise applicable to
activities occurring in Territory A or Territory B owned or in-licensed by
Corixa (solely or jointly with a Third Party) in each case as of the Effective
Date or at any time during the Term, as to which and to the extent that Corixa
has the right to license to Kirin hereunder without payment of royalties or
other fees on account of such license or sublicense other than those fees or
royalties required under any Third Party Agreement, or allocated by the parties
in accordance with Section 4.2(a), or as otherwise agreed, (i) that claim
inventions or discoveries that are made, conceived, developed, or reduced to
practice solely by Corixa's employees, agents and/or licensor(s) or jointly by
Corixa's employees, agents and/or licensor(s) with any Third Party, and (ii)
that either (A) generically or specifically claim all or any part of the WT-1
Antigen or any Licensed Product, improvements, enhancements or modifications on
the WT-1 Antigen or any Licensed Product, any process required or useful for
manufacturing the WT-1 Antigen or any Licensed Product, intermediates used in
any such process, or any use of the WT-1 Antigen or any Licensed Product, or (B)
are necessary in connection with or that otherwise cover the manufacture, use or
sale of any WT-1 Antigen or Licensed Product. Included within this definition of
Corixa WT-1 Patents are any patents issuing anywhere in the world from any of
the foregoing patent applications, and any continuations, continuations-in-part
(solely to the extent such continuation(s)-in-part contains subject matter on
which claims issuing obtain the benefit of a priority date of any other patent
application included herein), divisions, patents of addition, reissues,
renewals, registrations, confirmations, reexamination certificates,
revalidations, substitutions, extensions and/or foreign counter-parts, anywhere
in the world, of any of the foregoing patents or patent applications. Corixa
WT-1 Patents shall specifically not include Corixa Adjuvant Patents, Corixa [*]
Patents, Kirin Patents, or Joint Patents.
1.15 "Costs" shall have the meaning set forth in Exhibit D.
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1.16 "Current Good Manufacturing Practices" or "cGMP" shall mean those
good manufacturing practices as set forth in the applicable provisions of 21
C.F.R. Sections 210 and 211 and/or any other similar applicable rules,
regulations or requirements governing comparable good manufacturing practices
issued by appropriate regulatory authorities of applicable jurisdiction(s).
1.17 "Development Period" shall mean the period commencing upon the
Effective Date and ending upon the last regulatory approval to occur in the U.S.
or Japan of all regulatory approvals for Licensed Products for which the parties
seek regulatory approval hereunder (for so long as such approvals are still
pending).
1.18 "Development Steering Committee" shall have the meaning set forth
in Section 3.1(a).
1.19 "Europe" shall mean the countries, territories, and republics (as
applicable) of Albania, Andorra, Austria, Belarus, Belgium, Bosnia-Herzegovina,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein,
Lithuania, Luxembourg, Macedonia, Malta, Moldova, Monaco, the Netherlands,
Norway, Poland, Portugal, Romania, San Marino, Slovakia, Slovenia, Spain,
Sweden, Switzerland, the United Kingdom, Ukraine, and Vatican City, and all
countries, territories and republics of the former Yugoslavia and former
republics of the Soviet Union that are not otherwise specifically set forth in
this Section.
1.20 "Ex Vivo Licensed Product" means any Licensed Product that is
administered through the use of [*] or [*] therapy.
1.21 "Fully Burdened Manufacturing Cost" shall mean with respect to
units of a particular Licensed Product: (a) the variable costs and fixed costs
properly and reasonably incurred by a party associated with the manufacture
(inclusive of finishing processes including filling, packaging, labeling and/or
other preparation), quality assurance, quality control and other testing,
storage and shipping of batches of such units of Licensed Product; or (b) if
such units or portions of Licensed Product are not manufactured by a party or an
Affiliate thereof, the reasonable amounts paid to the vendor plus out-of-pocket
costs directly associated with acquisition from such vendor; in either event in
accordance with GAAP or where applicable, GAAP Counterpart. For purposes of this
Section: (i) "variable costs" shall be deemed to be the cost of labor, raw
materials, supplies and other resources directly consumed in the manufacture,
quality assurance, quality control and other testing, storage and shipping of
batches of such Licensed Product; and (ii) "fixed costs" shall be deemed to be
the cost of facilities, utilities, insurance, facility and equipment
depreciation, and other fixed costs to the extent fairly and reasonably
attributable and allocable to the manufacture, quality assurance, quality
control and other testing, storage and shipping of batches of such Licensed
Product, but excluding any costs relating to excess facility capacity and idle
facility time. Fixed costs shall be allocated to a given Licensed Product based
upon the proportion of such costs attributable to the support of the
manufacturing, quality assurance, quality control and other testing, storage and
shipping processes for such Licensed Product. If a facility is used to
manufacture Licensed Product and
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products for other programs of either party or an Affiliate thereof, fixed costs
shall be allocated in proportion to the use of such facility for the manufacture
of Licensed Product and products for such other programs.
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 or other rulemaking bodies,
consistently applied.
1.23 "GAAP Counterpart" shall mean the accounting conventions, rules and
procedures governing accounting practices as established, and revised or
amended, by the applicable accounting standards organization or governmental or
regulatory authority(ies) of a country(ies) other than the United States,
consistently applied.
1.24 "[*] Claim" shall mean any issued patent issued on or claiming
priority from the [*] application [*] or any other issued patent issued on or
claiming priority from the patent application [*] (dated [*]), including
continuations, continuations-in-part (solely to the extent such
continuation(s)-in-part contains subject matter on which claims issuing obtain
the benefit of a priority date of any other patent application included in this
paragraph), divisions, patents of addition, reissues, renewals, registrations,
confirmations, reexamination certificates, confirmations, registrations,
revalidations, substitutions, extensions and/or foreign counterparts, anywhere
in the world, of any of the foregoing patents or patent applications.
1.25 "IND" shall mean an effective Notice of a Claimed Investigational
New Drug Exemption, as defined in Title 21 of the Code of Federal Regulations,
on file with the U.S. Food and Drug Administration (or any successor entity)
before the commencement of clinical trials of products in humans, or any
comparable filing in a foreign jurisdiction with a relevant regulatory agency or
other governmental entity.
1.26 "Joint Patents" shall mean all patents and patent applications that
cover Joint Inventions and which generically or specifically claim all or any
part of any Licensed Product, improvements on any Licensed Product, any process
required or useful for manufacturing any Licensed Product, intermediates used in
any such process, or any use of any Licensed Product. Included with this
definition of Joint Patents are any continuations, continuations-in-part (solely
to the extent such continuation(s)-in-part contains subject matter on which
claims issuing obtain the benefit of a priority date of any other patent
application included herein), divisions, patents of addition, reissues,
renewals, registrations, confirmations, reexamination certificates,
revalidations, substitutions, extensions and/or foreign counter-parts, anywhere
in the world, of any of the foregoing patents or patent applications. In no
event shall Joint Patents be deemed to include Corixa WT-1 Patents, Corixa
Adjuvant Patents, Corixa [*] Patents, or Kirin Patents.
1.27 "Joint Inventions" shall have the meaning set forth in Section 10.
1.28 "Kirin" shall mean Kirin Brewery Company, Ltd. and each of its
Affiliates.
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1.29 "Kirin Know-How" shall mean all technical information, materials
and know-how including, without limitation, all biological, chemical,
pharmacological, toxicological, clinical, assay, control and manufacturing data,
methods, processes, formulas, protocols, techniques, trade secrets, other
proprietary capabilities, and any other data, information, adjuvant technology
or manufacturing or related technology relating to adjuvants or any Licensed
Product that can reasonably be deemed to be useful for the development and/or
commercialization of any Licensed Product and strains, samples, analytical
tools, libraries, clones, etc., thereof, in each case (a) to the extent the
foregoing is developed, owned or in-licensed by Kirin (solely or jointly with a
Third Party) as of the Effective Date or during the Term and (b) to the extent
to which Kirin has or obtains the right to license or sublicense to a third
party as of the Effective Date or during the Term under the terms and conditions
hereof without payment of royalties or other fees on account of such license or
sublicense other than those fees or royalties allocated by the parties in
accordance with Section 4.2(a) or as otherwise agreed.
1.30 "Kirin Patents" shall mean all patents and patent applications
anywhere in, covering or otherwise applicable to activities occurring in
Territory A or Territory B owned or in-licensed by Kirin (solely or jointly with
a Third Party), in each case as of the Effective Date or at any time during the
Term, as to which and to the extent that Kirin has the right to license to
Corixa hereunder without payment of royalties or other fees on account of such
license or sublicense other than those fees or royalties allocated by the
parties in accordance with Section 4.2(a), or as otherwise agreed, (a) that
claim inventions or discoveries that are made, conceived, developed, or reduced
to practice solely by Kirin's employees, agents and/or licensor(s) or jointly by
Kirin's employees, agents and/or licensor(s) with any Third Party, and (b) that
either (i) generically or specifically claim all or any part of any Licensed
Product, improvements, enhancements or modifications on any Licensed Product,
any process required or useful for manufacturing any Licensed Product,
intermediates used in any such process, or any use of any Licensed Product, or
(ii) are necessary in connection with or that otherwise cover the manufacture,
use or sale of any Licensed Product. Included with the definition of Kirin
Patents are any patents issuing anywhere in the world from any of the foregoing
patent applications, and any continuations, continuations-in-part (solely to the
extent such continuation(s)-in-part contains subject matter on which claims
issuing obtain the benefit of a priority date of any other patent application
included herein), divisions, patents of addition, reissues, renewals,
registrations, confirmations, reexamination certificates, revalidations,
substitutions, extensions and/or foreign counter-parts, anywhere in the world,
of any of the foregoing patents or patent applications. In no event shall Kirin
Patents be deemed to include either Corixa WT-1 Patents, Corixa Adjuvant
Patents, Corixa [*] Patents, or Joint Patents.
1.31 "Licensed Field" shall mean the treatment or prevention of cancer
(including leukemia and MDS) in humans, whether by in vivo or ex vivo means, and
including through the use of [*] as Vaccines and the use of [*] therapy;
provided, however, that the Licensed Field shall specifically exclude (a) the
use of any Licensed Product as [*] and (b) the use of antigens as [*] or the use
of antigens as [*]; and further provided, however, that the Licensed Field shall
be deemed to include use of a WT-1 Small Molecule.
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1.32 "Licensed Product" shall mean any prophylactic and/or therapeutic cancer
Vaccine that includes a WT-1 Antigen or WT-1 Small Molecule. Except where
otherwise expressly specified to the contrary, "Licensed Product" shall include
an "Ex Vivo Licensed Product."
1.33 "[*]" shall mean any [*] (a) that is developed, owned or
in-licensed by Corixa (solely or jointly with a Third Party) as of the Effective
Date (together with any improvements, enhancements or modifications thereto
developed, owned or in-licensed by Corixa (solely or jointly with a Third Party)
as of the Effective Date or during the Term); (b) as to which and to the extent
that Corixa has the right to license or sublicense to Kirin hereunder as of the
Effective Date (or, as applicable, as of the date such now existing [*] (or an
improvement, enhancement or modification thereto) is first developed, owned or
in-licensed by Corixa) without payment of royalties or other fees on account of
such license or sublicense other than those fees or royalties required under any
Third Party Agreement, or allocated by the parties in accordance with Section
4.2(a), or as otherwise agreed; and (c) that is covered by one (1) or more Valid
Claim(s) of any of the Corixa [*] Patents.
1.34 "MDS" shall mean myelodysplastic syndrome.
1.35 "Net Proceeds" shall have the meaning set forth in Exhibit D.
1.36 "Net Sales" shall mean the gross amount received by Corixa, Kirin,
an Affiliate of either Corixa or Kirin, or any of their respective Third Party
sublicensee(s), as applicable, for the sale, transfer or other disposition to a
Third Party of a Licensed Product (other than to a Third Party sublicensee that
is not the end-user of the Licensed Product) in Territory A and Territory B,
however such amounts are characterized (including any such amounts that are
labeled as, but that are not actually bona fide, fees, royalties or milestone
payments, where such amounts are instead actually received as consideration for
sales of Licensed Products), less the following deductions for amounts actually
incurred related to such sale, transfer, or other disposition and, where
applicable, included in the gross invoiced amount (in accordance with GAAP or,
where applicable, GAAP Counterpart): (a) normal, customary trade discounts
(including volume discounts), credits, chargebacks, reductions, and rebates, and
allowances and adjustments for rejections, recalls, outdated products, returns,
or bad debt, in each event whether voluntary or required; (b) commissions paid
or allowed to distributors and agents who are independent Third Parties (and not
Affiliates of either party); (c) freight, shipping, insurance, sales, use,
excise, value-added and similar customs, taxes, tariffs or duties imposed on
such sale, transfer, or other disposition; (d) credits or allowances given or
made for wastage replacement, Medicare/Medicaid rebates (other than as described
in the following subsection), indigent patient and similar programs, to the
extent actually deducted from the gross amount invoiced; and (e) amounts repaid
or credits taken by reason of rejections, defects or returns or because of
retroactive price reductions or due to recalls or government laws or regulations
requiring rebates. Net Sales calculated as described above shall be adjusted for
Combination Products, as applicable. Net Sales shall not include amounts for any
Licensed Product furnished to a Third Party for which payment is not intended to
be received, such as Licensed Products used in
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clinical trials or Licensed Products distributed as promotional or free goods,
provided that the amounts of such Licensed Products so made available are
reasonable for the intended purpose.
1.37 "North America" shall mean the United States, Canada, and Mexico,
and their respective territories, commonwealths and possessions.
1.38 "Operational Task Forces" shall have the meaning set forth in
Section 3.1(c).
1.39 "Research and Development Field" shall mean the treatment or
prevention of leukemia (including MDS) in humans initially. "Research and
Development Field" will automatically be deemed modified to include additional
cancer types, if any, that are covered from time to time by the Research Program
and/or the Clinical Development Program or that either party reasonably requests
during the Research Program Term to be included in this definition to the extent
such request does not expand the Research and Development Field to be broader in
scope than the development of Licensed Products within the Licensed Field.
1.40 "Research Program" shall have the meaning set forth in Section
2.1(a).
1.41 "Research Program Term" shall have the meaning set forth in Section
2.1(a).
1.42 "Rest of World" shall mean worldwide, except for Territories A, B
and C.
1.43 "Serious Adverse Drug Experience" shall have the meaning set forth
in 21 CFR Section 312.32(a).
1.44 "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.
1.45 "[*] Claim" shall mean any issued patent issued on or claiming
priority from the [*] application [*] or any other issued patent issued on or
claiming priority from the patent application [*] (dated [*]) or any issued
patent issued on or claiming priority from the [*], including continuations,
continuations-in-part (solely to the extent such continuation(s)-in-part
contains subject matter on which claims issuing obtain the benefit of a priority
date of any other patent application included in this Section 1.45), divisions,
patents of addition, reissues, renewals, registrations, confirmations,
reexamination certificates, confirmations, registrations, revalidations,
substitutions, extensions and/or foreign counterparts, anywhere in the world, of
any of the foregoing patents or patent applications.
1.46 "Supply Agreement" shall have the meaning set forth in Section 9.3.
1.47 "Territory A" shall mean Asia.
1.48 "Territory A Clinical Development Program" shall have the meaning
set forth in Section 2.2.
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1.49 "Territory B" shall mean North America.
1.50 "Territory B Clinical Development Program" shall have the meaning
set forth in Section 2.3.
1.51 "Territory B Commercialization Program" shall have the meaning set
forth in Section 2.7.
1.52 "Territory C" shall mean Europe.
1.53 "Third Party(ies)" shall mean any party other than a party to this
Agreement or an Affiliate of either such party.
1.54 "Vaccine" shall mean the administration or application of (an)
antigen(s) in any formulation or configuration, whether through in vivo
(including injection) or ex vivo (including [*] such as [*] or [*]) means, for
the primary purpose and effect of eliciting a prophylactic and/or therapeutic
immune response directed directly or indirectly to such antigen or one (1) or
more epitopes contained therein. "Vaccine" shall not include (a) the use of any
Licensed Product as [*] and (b) the use of antigens as [*] or the use of
antigens as [*]; provided, however, that "Vaccine" shall include a WT-1 Small
Molecule.
1.55 "Valid Claim" shall mean, with respect to each country in the
applicable territory, (i) a claim of an issued, unexpired patent included in the
Corixa WT-1 Patents or the Joint Patents, or, if the applicable Licensed Product
incorporates a Corixa Adjuvant or [*], the Corixa Adjuvant Patents and the
Corixa [*] Patents, which patent has not been (a) held invalid or unenforceable
by a final decision of a court or governmental agency of competent jurisdiction,
which decision is unappealable or was not appealed within the time allowed
therefor, or (b) admitted in writing to be invalid or unenforceable by the
holder(s), whether by means of reissue, disclaimer or otherwise or (ii) a
pending claim of a patent application that has been pending for less than [*]
years from the priority date.
1.56 "WT-1 Antigen(s)" shall mean the antigen(s) collectively defined by
the patents listed in Exhibit A, and any protein and/or other physical form of,
based on or derived from such antigens (and any epitopes or improvements
thereof), such as peptides and/or nucleic acids(s) (DNA, RNA) delivered in any
form (including recombinant vectors).
1.57 "WT-1 Small Molecule" shall mean any small molecule that is [*].
1.58 "WT-1 Claims" shall mean all Valid Claims of all Corixa WT-1
Patents that claim the WT-1 Antigen and/or the manufacture, use, or sale
thereof.
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 references to designated Articles, Sections and other subdivisions
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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 "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 AND COMMERCIALIZATION
PROGRAM.
2.1 Research Program.
(a) The "Research Program Term" shall mean the period commencing
on the Effective Date and ending on the preparation of the first IND for a
clinical trial of any Licensed Product in the United States. During the Research
Program Term, the parties shall collaborate in the research and development of
Licensed Products in the Research and Development Field in accordance with a
program of activities and associated timelines and responsibilities to be
jointly determined by Kirin and Corixa and approved by the Development Steering
Committee within forty-five (45) days after the Effective Date, which program
shall be amended on an annual basis by mutual agreement of the parties,
effective upon each anniversary of the Effective Date (such program, as may be
amended from time to time in accordance with the preceding, the "Research
Program"). The parties shall each be responsible for conducting those activities
assigned to such party in the Research Program. The parties agree that the end
goal of the Research Program shall be the expeditious pre-clinical development
of Licensed Product(s) in the Research and Development Field. No material
deviation in the subject matter and scope of such Research Program, including
the Research and Development Field, shall be made without the mutual written
agreement of both parties. The Research Program shall specify each of Corixa's
and Kirin's responsibilities. The Research Program shall specify that Corixa's
responsibilities during the Research Program Term include all pre-clinical
testing of the Licensed Products, formulation and quality control of the
Licensed Products, and supply of all samples of Licensed Products required for
both parties' performance of the Research Program at Fully Burdened
Manufacturing Cost in accordance with Article 9, provided that Kirin shall have
the opportunity to consult with Corixa with respect to such testing,
formulation, quality control and supply.
(b) The parties [*], in accordance with Section 5.3, all Costs
directly attributable to Research Program activities performed in Territory B, a
budget for which (broken down by party) shall be included in the Research
Program and shall be amended on an annual basis by mutual agreement of the
parties, effective upon each anniversary of the Effective Date; provided that
neither party shall be obligated to pay for any such Costs incurred by the other
party to the extent such Costs exceed by more than [*] of both (i) the projected
Costs for such party set forth in such budget and (ii) the amount of any
additional Costs expressly authorized by the Development Steering Committee. To
the extent the Research Program includes any activities required to be performed
solely for Territory A, the Costs of such activities will be [*]. The parties do
not currently anticipate that the budget for any given year during the Research
Program will be less than the budget for the prior year, except as circumstances
may otherwise reasonably require.
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(c) The parties shall consider the use of [*] and [*] in the
Licensed Products for the purpose of improving the regulatory prospects or
commercial success of such Licensed Products and, accordingly, agree to pursue
reasonable and mutually agreed upon research and testing thereof in connection
with the Research Program. In the event that such research and testing indicates
reasonably positive results, the parties agree to consult with each other
regarding inclusion of one or both such technologies in Licensed Products,
subject to Kirin's exercise of the option in Section 4.1(d)(i). In the event
that use of [*] does not indicate a reasonable chance of improving the
regulatory or commercial prospects of such Licensed Products, the parties shall
consider using one or more of the [*] technologies proposed by [*] for use in
the Licensed Products and to pursue reasonable and mutually agreed upon research
and testing thereof in connection with the Research Program. Furthermore, as and
if applicable and reasonably appropriate due to the failures of either of the
foregoing technologies, the parties shall consider using one or more [*] or [*]
technologies of [*] for use in the Licensed Products and, if applicable, pursue
reasonable and mutually agreed upon research and testing thereof in connection
with the Research Program in accordance with Section 4.2.
(d) Upon and in accordance with the reasonable request of Kirin,
Corixa agrees to provide reasonable quantities of Licensed Product samples,
including the WT-1 Antigen, for certain limited pre-clinical testing by Kirin
with regards to certain Japanese regulatory requirements at Fully Burdened
Manufacturing Cost in accordance with Section 9.
2.2 Territory A Clinical Development Program. [*]. Kirin shall have
the right, subject to its obligation to provide Corixa with the reports
specified in Section 3.3, to determine the clinical development and
commercialization plan for all Licensed Product(s) within Territory A, which
plan shall cover the period commencing on the preparation of an IND, or its
foreign equivalent, for a clinical trial(s) of any Licensed Product in Territory
A and ending on the regulatory approval of all Licensed Product(s) in Japan for
which regulatory approval was sought by Kirin hereunder (such plan, hereinafter,
the "Territory A Clinical Development Program" with respect to such Licensed
Product(s) in such territory). The parties agree that the end goal of the
Territory A Clinical Development Program will be the expeditious clinical
development and regulatory approval of a Licensed Product for subsequent
commercialization in Territory A. The parties further agree that each type of
Licensed Product developed and commercialized in Territory A shall be of the
same formulation (i.e. [*], [*] and/or [*] formulation) as such type of Licensed
Product developed and commercialized in Territory B, unless additional or
different Licensed Products are approved for Territory A by the Development
Steering Committee or the Commercialization Steering Committee and except as
otherwise required by applicable regulatory authorities. Corixa agrees to
provide Kirin with reasonable assistance in connection with Kirin's efforts
under the Territory A Clinical Development Program, including by providing Kirin
with rights and access to all pre-clinical and clinical data and other
applicable information from or relating to the Territory B Clinical Development
Program or Territory C (subject to Section 2.4); provided that (a) Corixa shall
not
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be required to incur significant costs or dedicate significant resources in
providing such assistance unless Kirin agrees to reimburse Corixa for such costs
and (b) Kirin shall not be permitted to share such pre-clinical and clinical
data and other applicable information generated under or in connection with
Territory C development activities (except data and information which is from
the Territory B Clinical Development Program) with any third party (including
sublicensees) that conducts clinical development or commercialization of
Licensed Products in Territory A on Kirin's behalf or in conjunction with which
Kirin conducts clinical development or commercialization of Licensed Products in
Territory A (each a "Kirin Partner") unless such Kirin Partner has agreed in
advance in writing to provide, or as applicable to permit Kirin to provide (in
which event Kirin shall provide), or Kirin otherwise has the right to provide
(in which event Kirin shall provide), Corixa with rights and access to all of
such Kirin Partner's pre-clinical and clinical data and other applicable
information (other than financial information) relating to such clinical
development and commercialization activities (and Kirin shall make reasonable
efforts to persuade such Kirin Partner to so cooperate).
2.3 Territory B Clinical Development Program. Kirin and Corixa shall
each undertake, using efforts required by Section 8.1(b), and [*] the Costs
directly attributable to, clinical development of Licensed Product(s) within
Territory B. Kirin and Corixa shall jointly determine the clinical development
plan for such Licensed Product(s) within Territory B, which plan shall cover the
period commencing on the expiration of the Research Program Term (or earlier to
the extent required to prepare or plan for the IND) and ending on the earlier of
regulatory approval of any Licensed Product(s) in the United States or the
European Union (such plan, hereinafter, the "Territory B Clinical Development
Program" with respect to such Licensed Product(s) in such territory). The
parties agree that the end goal of the Territory B Clinical Development Program
will be the expeditious clinical development and regulatory approval of Licensed
Product(s) for subsequent commercialization in Territory B. In particular, the
Territory B Clinical Development Program shall include, if available, the [*]
for [*] in [*] for the Licensed Products and shall focus first on clinical
trials in the United States under an IND filed in the United States before
undertaking clinical trials in other countries, unless the Development Steering
Committee recommends a different course of action. Furthermore, the Territory B
Clinical Development Program shall set forth the responsibilities of each party
thereunder, the budget (broken down by party) for all activities thereunder and
the targeted timelines for completion of the activities thereunder. The parties
[*], in accordance with Section 5.4, all Costs directly attributable to the
performance of the Territory B Clinical Development Program; provided that
neither party shall be obligated to pay for any such Costs incurred by the other
party to the extent such Costs exceed by more than [*] both (a) the projected
Costs for such party set forth in such budget and (b) the amount of any
additional Costs expressly authorized by the Development Steering Committee.
Kirin agrees to provide Corixa with reasonable assistance in connection with
Corixa's efforts under the Territory B Clinical Development Program, including
by providing Corixa with rights and access to all pre-clinical and clinical data
and other applicable information from or relating to the Territory A Clinical
Development Program; provided that Kirin shall not be required to incur
significant costs or dedicate significant resources in providing such assistance
unless Corixa agrees to reimburse Kirin [*] of such costs.
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2.4 Territory C Clinical Development. Corixa has the exclusive right,
but not the obligation, itself, with a third party or to authorize a third
party, to undertake clinical development and commercialization of Licensed
Products within Territory C. Subject to the prior written approval of a Corixa
Partner (defined below), if necessary, Corixa agrees to provide Kirin with
rights and access to all pre-clinical and clinical data and other applicable
information (other than financial information) relating to Corixa's clinical
development and commercialization of Licensed Products within Territory C, for
Kirin's use in Territory A and Territory B, provided that Corixa shall not be
required to incur significant costs or dedicate significant resources in
providing such information unless Kirin [*] Corixa for such costs. Kirin agrees
to provide Corixa with rights and access to all pre-clinical and clinical data
and other applicable information relating to the Territory A Clinical
Development Program for Corixa's use in Territory C; provided that (a) Kirin
shall not be required to incur significant costs or dedicate significant
resources in providing such information unless Corixa agrees to reimburse Kirin
for such costs and (b) Corixa shall not be permitted to share such pre-clinical
and clinical data and other applicable information with any third party
(including sublicensees) that conducts clinical development or commercialization
of Licensed Products in Territory C on Corixa's behalf or in conjunction with
which Corixa conducts clinical development and commercialization of Licensed
Products in Territory C (each, a "Corixa Partner") unless such Corixa Partner
has agreed in advance in writing to provide, or as applicable to permit Corixa
to provide (in which event Corixa shall provide), or Corixa otherwise has the
right to provide (in which event Corixa shall provide), Kirin with rights and
access to all of such Corixa Partner's pre-clinical and clinical data and other
applicable information (other than financial information) relating to such
clinical development and commercialization activities (and Corixa shall make
reasonable efforts to persuade such Corixa Partner to so cooperate). Kirin
acknowledges that Corixa shall be permitted to use pre-clinical and clinical
data and other applicable information relating to the Territory B Clinical
Development Program for Corixa's activities in Territory C.
2.5 [*] Licensed Products. Within thirty (30) days after the Development
Steering Committee makes the determination that [*] formulations of Licensed
Product (i.e. [*], [*] and [*] Licensed Product formulations) are not suitable
for further development based on the results of pre-clinical or clinical tests
or trials of such formulations, the Development Steering Committee shall make an
additional determination as to whether the development of [*] Licensed Products
is appropriate and should be undertaken in accordance with the terms and
conditions of this Agreement (provided that the Development Steering Committee
shall also be permitted to consider and make a decision regarding the foregoing
additional determination at any time during the Development Period at its
discretion). Notwithstanding the foregoing, any decision to proceed with the
development of [*] Licensed Product hereunder shall be subject to the
independent written approval of each party, which approval shall be subject to
each such party's sole discretion. In the event that the Development Steering
Committee determines and the parties agree, in accordance with the foregoing
sentence, that the development of [*] Licensed Products is appropriate and
should be undertaken, then the parties shall proceed with the development and
commercialization of [*] Licensed Products in accordance with the terms and
conditions of this Agreement.
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2.6 Freedom to Conduct Clinical Trials. The parties acknowledge and
agree that nothing in this Agreement shall restrict in any manner either party's
ability to conduct clinical trials of any nature not involving any Licensed
Product, whether within or outside the Research and Development Field, on behalf
of such party or its partners, at such party's or its partner(s)' sole cost and
expense.
2.7 Commercialization Program. Subject to the following sentence, Kirin
and Corixa shall jointly determine the commercialization plan for Licensed
Product(s) for Territory B, which plan shall cover the period commencing on
regulatory approval of a Licensed Product in the first country within Territory
B for a given Licensed Product (such plan, hereinafter, the "Territory B
Commercialization Program" with respect to such Licensed Product(s)). Under the
Territory B Commercialization Program, Corixa and Kirin shall have joint
responsibility for the marketing and commercialization of Licensed Products in
Territory B. The Territory B Commercialization Program shall describe, among
other things, each party's respective [*] responsibilities and activities
(including those performed by sublicensees and subcontractors) [*], [*] and [*],
and Licensed Product [*] and [*] plans (including examples of planned Licensed
Product [*]). The Commercialization Steering Committee shall review the
Territory B Commercialization Program annually, and implement agreed-upon
necessary modifications, if any. In light of Kirin's diligence obligation under
Section 8.1, Kirin shall have the sole authority to determine the plan and
budget for, and conduct, the marketing and commercialization of Licensed
Products in Territory A. As between Corixa and Kirin, Corixa alone shall have
the right and sole authority to conduct the marketing and commercialization of
Licensed Products in Territory C.
3. DEVELOPMENT STEERING COMMITTEE; COMMERCIALIZATION STEERING COMMITTEE;
INFORMATION SHARING.
3.1 Development Steering Committee and Clinical Development Program.
(a) Establishment and General Responsibilities of the Development
Steering Committee. A Development Steering Committee (the "Development Steering
Committee") shall be established within thirty (30) days after the Effective
Date of this Agreement. During the Development Period, the Development Steering
Committee shall consist of [*] members, [*] individuals appointed by Kirin and
[*] individuals appointed by Corixa, in each event identified through written
notice to the other party in accordance with this Agreement. Any member of the
Development Steering Committee may designate a substitute to attend and perform
the functions of that member at any meeting of the Development Steering
Committee. The Development Steering Committee shall be responsible for review
and adoption of annual budgets for the Research Program and annual budgets for
the Territory B Clinical Development Program, coordination of the supply of
preclinical and clinical grade test materials, the monitoring and oversight of
the Research Program and the Clinical Development Program, and the monitoring of
the research and clinical development activities of Kirin in Territory A,
provided that, in light of Kirin's diligence obligation under Section 8.1, Kirin
shall retain sole and exclusive control over the activities to be undertaken
pursuant to the Territory A Clinical Development Program, including the budgets
therefor.
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(b) Meetings. Meetings of the Development Steering Committee
shall be held, at a minimum, every six (6) months (or more frequently as agreed
by the Development Steering Committee) during the Development Period, and will
be held alternatively in Seattle, Washington (such meetings to be chaired by an
individual from Corixa) and Tokyo, Japan (such meetings to be chaired by an
individual from Kirin), or at such other location as may be determined by the
Development Steering Committee, including, if applicable, by telephone. If a
meeting of the Development Steering Committee is necessary either to resolve any
dispute(s) as provided below or to make any decision(s) or determination(s)
specified or required under this Agreement, then either party may call a special
meeting of the Development Steering Committee to address such dispute, decision
or determination upon thirty (30) days prior written notice to the other party.
A quorum of the Development Steering Committee shall require the attendance of
all [*] members. A final copy of the minutes of each meeting, clearly describing
any formal actions taken by the Development Steering Committee, shall be
approved and signed by a representative from each party within thirty (30) days
after the meeting. Any modifications to the Research Program or any Clinical
Development Program (including the work, budget and timeline therefor) formally
approved at any Development Steering Committee meeting shall be included in or
attached to the minutes for such meeting. The Development Steering Committee
will operate by [*] consent, with each party having [*]. In the event that any
issue comes before the Development Steering Committee that requires action,
approval or resolution and the Development Steering Committee is unable to reach
agreement on a mutually acceptable action, approval or resolution after a
reasonable period of time (not to exceed sixty (60) days from the date either
party first requests the Development Steering Committee to reach a final
decision on such action, approval or resolution), then the issue shall be
resolved by the parties in accordance with the dispute resolution procedures set
forth in Section 13.2. The parties agree that in making decisions, the
Development Steering Committee shall take into consideration the maximum
commercial potential of Licensed Products.
(c) Operational Task Forces. The Development Steering Committee
shall have authority to establish and oversee up to five (5) Operational Task
Forces, one in each of the following subject areas of operation: production;
manufacturing; clinical strategy; pre-clinical development; and
legal/patent/regulatory (collectively, "Operational Task Forces"). Each of the
Operational Task Forces shall consist of [*] members, [*] individuals appointed
by Kirin and [*] individuals appointed by Corixa. Any member of an Operational
Task Force may designate a substitute to attend and perform the functions of
that member at any meeting of the Operational Task Force, provided that the
Development Steering Committee is notified in writing in advance of any such
substitution. Individuals serving on either the Development Steering Committee
or one of the Operational Task Forces may be appointed to and serve on
additional Operational Task Forces. The responsibilities, frequency and location
of meetings for each of the Operational Task Forces shall be determined by the
Development Steering Committee.
3.2 Commercialization Steering Committee and Commercialization Program.
(a) Establishment and General Responsibilities of
Commercialization Steering Committee. After the initial commercial launch of a
given Licensed Product in a given country within Territory B, the Development
Steering Committee shall no longer have authority with
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respect to such Licensed Product. Instead, to facilitate coordination subsequent
to the regulatory approval of such Licensed Product, a Commercialization
Steering Committee (the "Commercialization Steering Committee") shall be
established within a reasonable time prior to regulatory approval of the first
Licensed Product in the first country granting such approval. The
Commercialization Steering Committee shall consist of [*] members, [*]
individuals appointed by Kirin and [*] individuals appointed by Corixa, in each
event as identified through written notice to the other party in accordance with
this Agreement. Any member of the Commercialization Steering Committee may
designate a substitute to attend and perform the functions of that member at any
meeting of the Commercialization Steering Committee. The Commercialization
Steering Committee shall be responsible for those matters that are reasonably
proper and appropriate for joint consideration by Corixa and Kirin relating to
commercialization of the Licensed Products in the Licensed Field within
Territory B, including, when appropriate, the review and adoption of annual
budgets for the Commercialization Program; monitoring the progress of Kirin's
commercialization activities in Territory A; marketing of Licensed Products;
post-launch clinical studies; expansion of indications/additional regulatory
approvals to be sought in connection with Licensed Products; coordination of
reimbursement procedures and training; regulatory matters; technical support;
Licensed Product positioning; Licensed Product life cycle management; Licensed
Product marketing and advertising; and such other related and ancillary
activities relating to the commercialization of the Licensed Products in the
Licensed Field. Notwithstanding the foregoing, in light of Kirin's diligence
obligation under Section 8.1, Kirin shall retain sole and exclusive control over
the commercialization activities to be undertaken in Territory A.
(b) Meetings. Meetings of the Commercialization Steering
Committee shall be held, at a minimum, every six (6) months (or more frequently
as agreed by the Commercialization Steering Committee) beginning reasonably
prior to the regulatory approval of the first Licensed Product in the first
country and continuing for so long as any Licensed Products continue to be
marketed and sold hereunder in Territory B, and will be held alternatively in
Seattle, Washington (such meetings to be chaired by an individual from Corixa)
and Tokyo, Japan (such meetings to be chaired by an individual from Kirin), or
at such other location as may be determined by the Commercialization Steering
Committee, including by telephone. If a meeting of the Commercialization
Steering Committee is necessary either to resolve any dispute(s) as provided
below or to make any decision(s) or determination(s) specified or required under
this Agreement, then either party may call a special meeting of the
Commercialization Steering Committee to address such dispute, decision or
determination upon thirty (30) days prior written notice to the other party. A
quorum of the Commercialization Steering Committee shall require the attendance
of [*] members. A final copy of the minutes of each meeting, clearly describing
any formal actions taken by the Commercialization Steering Committee, shall be
approved and signed by a representative from each party within thirty (30) days
after the meeting. Any modifications to the Territory B Commercialization
Program (including the work, budget and timeline therefor) formally approved at
any Commercialization Steering Committee meeting shall be included in or
attached to the minutes for such meeting. The Commercialization Steering
Committee will operate by [*] consent, with each party having [*]. In the event
that any issue comes before the Commercialization Steering Committee that
requires action, approval or resolution and the Commercialization Steering
Committee is unable
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to reach agreement on a mutually acceptable action, approval or resolution after
a reasonable period of time (not to exceed sixty (60) days from the date either
party first requests the Commercialization Steering Committee to reach a final
decision on such action, approval or resolution), then the issue shall be
resolved by the parties in accordance with the dispute resolution procedures set
forth in Section 13.2. 3.3 Information Sharing.
(a) Data Sharing During Research Program. To facilitate
coordination during the Research Program, the parties shall share all results,
data and information generated under or in connection with the Research Program
with each other on a prompt and regular basis (not to exceed monthly but at
least quarterly), including at meetings of the Development Steering Committee.
Each party shall provide the other party with written quarterly reports on its
respective progress with respect to the Research Program, upon a party's written
request and with at least seven (7) days prior notice, the other party shall (i)
provide access to results, data and information generated by such other party
under or in connection with the Research Program within Territory B and (ii)
make reasonably available appropriate personnel to discuss such results, data
and information. All such reports and data shall be in sufficient detail to
enable the Development Steering Committee to determine the furnishing party's
compliance with its diligence obligations under Sections 8.1(a) and 8.1(b) and
shall be subject to the confidentiality provisions of Article 12 of this
Agreement. The Development Steering Committee shall (i) monitor the progress of
Kirin's activities in Territory A annually; and (ii) review the Research Program
annually, implement any mutually agreeable modifications, make recommendations
related to possible Research Program extensions and/or expansions to the
respective senior management teams of each party, and attach a copy of any such
modified Research Program as an additional schedule to this Agreement. Kirin
acknowledges that subject to Section 2.4, Corixa shall have the right to use
results, data and information received under this Section 3.3(a) in Corixa's
activities within Territory C, and Corixa acknowledges that, subject to Section
2.2, Kirin shall have the right to use results, data and information received
under this Section 3.3(a) in Kirin's activities within Territory A.
(b) Data Sharing During Clinical Development Program. To
facilitate coordination during the Development Period, the parties shall share
all results, data and information generated under or in connection with the
Clinical Development Program and all other relevant information related to
Licensed Product development with each other on a prompt and regular basis. Each
party shall provide the other party with written quarterly summary reports on
the progress of the Clinical Development Program, including clinical and
regulatory progress, clinical development (including utilization of pre-clinical
and clinical grade test materials), and contemplated commercial launch of
Licensed Products, in a format to be agreed upon by Corixa and Kirin. In
addition, upon a party's written request and with at least seven (7) days prior
notice, the other party shall (i) provide access to results, data and
information generated by such other party under or in connection with the
Clinical Development Program and (ii) make reasonably available appropriate
personnel to discuss such results, data and information. All such reports and
data shall be in sufficient detail to enable the Development Steering Committee
to determine each party's compliance with its respective diligence obligations
under Sections 8.1(b) and 8.1(c), and all such reports, data and information
shall be subject to the confidentiality provisions of Article 12 of this
Agreement. Additionally, upon
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Kirin's written request and with at least seven (7) days prior notice, Corixa
shall provide Kirin with access to all clinical data related to Corixa Adjuvants
and [*] to the extent Corixa has access to and the right to share such data. The
Development Steering Committee shall review the Clinical Development Program
annually, implement agreed-upon necessary modifications, if any, and attach a
copy of such modified Clinical Development Program as an additional schedule to
this Agreement. Kirin acknowledges that subject to Section 2.4, Corixa shall
have the right to use results, data and information received under this Section
3.3(b) in Corixa's activities within Territory C, and Corixa acknowledges that,
subject to Section 2.2, Kirin shall have the right to use results, data and
information received under this Section 3.3(b) in Kirin's activities within
Territory A.
(c) Data Sharing During Commercialization. To facilitate
coordination during the commercialization of Licensed Products, the parties
shall share with each other on a prompt and regular basis all material
information it has regarding the safety and efficacy of Licensed Products,
material regulatory events, adverse drug events, and similar information. Each
party shall provide the other party with written summary reports (on a quarterly
basis during the first two (2) years after commercial launch of a Licensed
Product and annually thereafter) on the progress of the Territory B
Commercialization Program (including the status of all activities to be
performed thereunder) and the progress of Kirin's commercialization activities
in Territory A. All such reports and data shall be in sufficient detail to
enable the Commercialization Steering Committee to determine each party's
compliance with its respective diligence obligations under Sections 8.1(b) and
8.1(c), and all such reports, data and information shall be subject to the
confidentiality provisions of Article 12 of this Agreement. The
Commercialization Steering Committee shall (i) monitor the progress of Kirin's
activities in Territory A annually; and (ii) review the Territory B
Commercialization Program annually and implement agreed-upon necessary
modifications, if any. Kirin acknowledges that subject to Section 2.4, Corixa
shall have the right to use results, data and information received under this
Section 3.3(c) in Corixa's activities within Territory C, and Corixa
acknowledges that, subject to Section 2.2, Kirin shall have the right to use
results, data and information received under this Section 3.3(c) in Kirin's
activities within Territory A.
(d) Rights to Data. Each party shall have full rights to utilize
and, subject to Article 12, disclose any results, data or information provided
to it by the other party under Section 2.4 or this Section 3.3 for all purposes
relating to performing its obligations or exercising its rights hereunder,
including Corixa's use of such data in Corixa's activities in Territory C
(subject to Section 2.4).
4. LICENSE GRANTS.
4.1 License.
(a) (i) Corixa License to Kirin in Territory A. Subject to the
terms and conditions of this Agreement, including, without limitation, the
payments set forth in Articles 5 and 6 hereof, Corixa hereby grants to Kirin an
exclusive (even as to Corixa) license, with the right to grant sublicenses
solely in accordance with subsection 4.1(a)(ii), under the Corixa WT-1
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Patents, the Joint Patents, the Corixa Know-How, and any SPC, to research,
develop, make and have made (subject to Section 4.1(f) below), use, have used,
sell, offer for sale, have sold, import, and otherwise dispose of any and all
Licensed Products solely in the Licensed Field in Territory A.
(ii) Sublicense Rights. Kirin shall have the right to
sublicense the licenses granted under subsection 4.1(a)(i), provided that Kirin
discloses to Corixa the identity of the sublicensee and, subject to
confidentiality restrictions imposed by third parties, all details regarding the
sublicense agreement with such sublicensee requested by Corixa.
(b) (i) Corixa License to Kirin Outside Territory A. Subject to
the terms and conditions of this Agreement, including, without limitation, the
payments set forth in Articles 5 and 6 hereof, Corixa hereby grants to Kirin a
co-exclusive license (with Corixa), with the right to grant sublicenses solely
in accordance with subsection 4.1(b)(ii), under the Corixa WT-1 Patents, the
Joint Patents, the Corixa Know-How, and any SPC to research, develop, make and
have made (subject to Section 4.1(f) below), use, have used, sell, offer for
sale, have sold, import, and otherwise dispose of any and all Licensed Products
solely in the Licensed Field within Territory B. The license rights granted in
this Section 4.1(b) shall be limited to the research, development and
commercialization of Licensed Product(s) undertaken by Corixa and/or Kirin
(and/or their respective permitted sublicensees) in connection with the joint
Collaboration hereunder in accordance with this Agreement.
(ii) Sublicense Rights. Kirin shall have the right to
sublicense the licenses granted under Section 4.1(b)(i); provided such
sublicense has been approved by the Commercialization Steering Committee.
Similarly, Corixa agrees that it shall not license any of the co-exclusive
rights retained under Section 4.1(b)(i) without the approval of the
Commercialization Steering Committee.
(c) (i) Kirin License to Corixa in Territory B. Subject to the
terms and conditions of this Agreement, including, without limitation, the
payments set forth in Articles 5 and 6 hereof, Kirin hereby grants to Corixa a
co-exclusive license (with Kirin), with the right to grant sublicenses solely in
accordance with Section 4.1(c)(ii), under the Kirin Patents, the Joint Patents,
Kirin Know-How and any SPC to research, develop, make, have made, use, have
used, sell, offer for sale, have sold, import, and otherwise dispose of any and
all Licensed Products solely in the Licensed Field within Territory B. The
license rights granted in this Section 4.1(c) shall be limited to the research,
development and commercialization of Licensed Product(s) undertaken by or for
Corixa and/or Kirin (and/or their respective permitted sublicensees) in
accordance with this Agreement.
(ii) Sublicense Rights. Corixa shall have the right to
sublicense the licenses granted under Section 4.1(c)(i) subject to the approval
of the Commercialization Steering Committee.
(d) (i) Corixa License to Adjuvants and [*]. Subject to the terms
and conditions of this Agreement, including, without limitation, the payments
set forth in Articles 5
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and 6 hereof, Corixa hereby grants to Kirin a non-exclusive license, under the
Corixa Adjuvant Patents and Corixa [*] Patents, to use Corixa Adjuvants and [*]
solely for research and development purposes in connection with the evaluation
of Corixa Adjuvants and [*] for determining interest in further development and
commercialization hereunder, and not for any other commercial use. Subject to
the terms and conditions of this Agreement, including, without limitation, the
payments set forth in Articles 5 and 6 hereof, Corixa hereby grants to Kirin a
non-exclusive option, exercisable by Kirin, for no additional royalty, payment,
or other cost or expense, upon written notice to Corixa at any time during the
Research Program Term, to obtain a non-exclusive license under the Corixa
Adjuvant Patents and Corixa [*] Patents to research, develop, make and have made
(subject to Section 4.1(f) below), use, have used, sell, offer for sale, have
sold, import, and otherwise dispose of [*] and Corixa Adjuvants in the Licensed
Field throughout the world (excluding Territory C), but solely to the extent
that such [*] or Corixa Adjuvants are incorporated in or bundled with a Licensed
Product(s). Such license shall be effective upon receipt by Corixa of written
notice of Kirin's exercise of the foregoing option.
(ii) Sublicense Rights. Kirin shall have the right to
sublicense the licenses granted under Section 4.1(d)(i) to any third party,
provided that, (A) with respect to sublicenses in Territory A, Kirin discloses
to Corixa the identity of the sublicensee and, subject to confidentiality
restrictions imposed by third parties, the details regarding the sublicense
agreement with such sublicensee requested by Corixa and such sublicensee has
agreed in writing to license to Corixa all such intellectual property of such
sublicensee developed in connection with the sublicense and necessary to the
manufacture, use and sale of Licensed Products, which license shall be
equivalent in scope to the licenses granted to Corixa hereunder, and (B) with
respect to sublicenses within Territory B, each such sublicense shall be subject
to the approval of the Commercialization Steering Committee.
(e) Subcontractors. Notwithstanding anything herein to the
contrary, and without limiting any other provision hereof, each party shall have
the right to enter into subcontracts with Third Parties ("Subcontractors") for
services in support of research, development and commercialization of or
otherwise in connection with Licensed Product(s), such as manufacturing or
clinical trial management, provided that such party shall ensure that any such
service agreements it enters into that is reasonably likely to result in the
creation of any intellectual property shall provide: (i) for the assignment, or
license (with the right to sublicense) sufficient to grant the rights granted
hereunder, of or under intellectual property rights in all inventions conceived
or reduced to practice by such Subcontractors in the performance of such
contracted services, which inventions relate to WT-1 Antigen, Corixa Adjuvant or
[*] technology or are otherwise necessary for the manufacture, use or sale of
the Licensed Products; and (ii) that the Subcontractor shall agree to maintain,
and cause it employees and consultants to maintain, records in sufficient detail
appropriate for obtaining and maintaining intellectual property rights and
protections, including, without limitation, patent rights, in such inventions.
(f) Agreement Not to Exercise Manufacturing Rights.
Notwithstanding the licenses granted to Kirin pursuant to Sections 4.1(a), (b)
and (d), Kirin agrees not to exercise (or sublicense) its "make" or "have made"
rights granted by Corixa thereunder (i) unless Corixa terminates this Agreement
in accordance with Section 18.5 or (ii) except as provided in the
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Supply Agreement. In the event Kirin exercises such rights, Corixa shall
reasonably cooperate in transferring the necessary Corixa Know-How to Kirin or
its designee as reasonably necessary to enable Kirin or its designee to
manufacture Licensed Products.
(g) Territory C. Kirin acknowledges that Corixa retains the
exclusive right, but not an obligation, with the right to grant licenses to
third parties, under the Corixa WT-1 Patents, the Joint Patents, and the Corixa
Know-How, and any SPC to research, develop, make, have made, use, have used,
sell, offer for sale, have sold, import, and otherwise dispose of any Licensed
Products in Territory C. Subject to the terms and conditions of this Agreement,
Kirin (i) hereby grants to Corixa a royalty-free, exclusive license, with the
right to grant sublicenses, under the Kirin Patents, the Joint Patents, Kirin
Know-How, and any SPC, but excluding any Kirin adjuvant technology and any Kirin
[*] technology, to research, develop, make, have made, use, have used, sell,
offer for sale, have sold, import and otherwise dispose of any and all Licensed
Products solely in the Licensed Field within Territory C; and (ii) if applicable
to a Licensed Product, shall grant to Corixa a royalty-bearing, exclusive
license, with the right to grant sublicenses, under Kirin's adjuvant technology
and [*] technology, to research, develop, make, have made, use, have used, sell,
offer for sale, have sold, import and otherwise dispose of any and all such
Licensed Products solely in the Licensed Field within Territory C subject to a
reasonable royalty to be negotiated in good faith between the parties. Corixa
shall not be permitted to license, sublicense or otherwise provide any rights,
intellectual property or materials related to any Kirin Patents or Kirin
Know-How to any Corixa Partner (as defined in Section 2.4) unless such Corixa
Partner has agreed in advance in writing to license to Kirin all Corixa Partner
intellectual property developed in connection with such sublicense and necessary
for the use, sale or manufacture of the Licensed Products, which license shall
be equivalent in scope to the other licenses to Kirin hereunder (and Corixa
shall make reasonable efforts to persuade such Corixa Partner to so cooperate).
Except as set forth in this Section 4.1(g), Kirin shall not be entitled to any
royalties or other compensation relating to Corixa's exercise of its rights
under this Section 4.1(g) or other activities within Territory C.
4.2 Additional Technology.
(a) Additional Technology Licenses. Throughout the Term of this
Agreement, if Corixa or Kirin believes that any technology or intellectual
property rights related to the subject matter of the Research Program or the
Clinical Development Program is held or otherwise controlled by a Third Party,
which technology or intellectual property rights may include, but are not
limited to, new antigens, adjuvants, [*], other delivery technology(ies) and/or
any patents covering the manufacture, use or sale of Licensed Products
("Additional Technology") and may be valuable or necessary to the Research
Program or the Clinical Development Program in the Licensed Field or otherwise
to the commercialization of Licensed Products hereunder in Territory A or
Territory B, Corixa or Kirin as appropriate shall present such Additional
Technology, along with a written report with respect thereto, to the Development
Steering Committee (or, if such sublicense is initially proposed after the
Development Period, the Commercialization Steering Committee), which committee
shall then determine whether licenses to, and/or acquisitions of, such
Additional Technology should be made or obtained, or, if applicable, whether a
sublicense to such Additional Technology should
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be granted hereunder. If the Development Steering Committee (or, as applicable,
the Commercialization Steering Committee) determines that rights to the
Additional Technology shall be obtained, the Development Steering Committee (or,
as applicable, the Commercialization Steering Committee) shall appoint one or
more individuals from Corixa and/or Kirin as may be appropriate under the
circumstances (such individuals, collectively, the "Negotiating Team") to
approach and negotiate with any applicable Third Party(ies) for necessary
licenses or other right in or to such Additional Technology, provided that the
execution of any agreement for a license or other rights in or to the Additional
Technology shall require the advance written approval of the Development
Steering Committee (or, if applicable, the Commercialization Steering
Committee). All costs and expenses to be incurred in connection with obtaining
(or sublicensing, if applicable) such rights and licenses shall be subject to
the approval of the Development Steering Committee (or, if applicable, the
Commercialization Steering Committee), and all such approved costs and expenses
shall be [*] by Corixa and Kirin, including upfront fees, milestone payments and
running royalties. Nothing set forth in this Section shall limit the ability of
either party to license-in or otherwise procure technology for its own account
or for purposes of licensing such technology to Third Parties; provided,
however, that in the case of Additional Technology the parties shall first have
presented such Additional Technology to the applicable committee as set forth
above and determined that such Additional Technology shall not be acquired for
the benefit of the Research Program or the Clinical Development Program in the
Licensed Field or the commercialization of Licensed Products hereunder.
(b) [*], if during the Term of this Agreement: (i) either Corixa
and Kirin jointly [*] or (ii) the Development Steering Committee determines that
[*] (provided that the Development Steering Committee shall be required to meet,
consider and make a decision regarding the foregoing upon the request of either
party at any time after either party becomes aware [*] and subsequently after
[*]; then Corixa shall [*]; provided that in the event [*], Corixa shall use
best efforts, including [*] notwithstanding any other provision of this
Agreement, Kirin shall not be required to [*]. Kirin shall provide such
assistance and cooperation to Corixa's efforts under this Section 4.2(b) to [*]
as reasonably requested by Corixa, provided that [*]. Corixa shall [*].
(c) Covenant Regarding Excluded Technology. Each party agrees
that it will not include or incorporate (or cause to be included or
incorporated) into any Licensed Product any technology or intellectual property
that is not already included in the technology and/or intellectual property
licensed under this Agreement, without first notifying the other party of its
intent to include or incorporate (or cause to be included or incorporated) such
technology or intellectual property into the applicable Licensed Product, and
thereafter proceeding under Section 4.2(a) above as if such technology or
intellectual property were Additional Technology.
(d) [*]. Immediately upon this Agreement becoming effective in
accordance with Section 5.1, Kirin and Corixa shall [*] on reasonable terms and
conditions [*] not to be unreasonably withheld. The parties shall reasonably
cooperate with each other in [*]. Kirin and Corixa shall share [*] (including
the limits specified thereon), but all other fees, costs [*] with
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respect thereto as of the Effective Date. Without limiting Kirin's obligations
to share certain costs as expressly provided above, Corixa shall [*].
4.3 Sublicenses of Third Party Rights to Kirin. Kirin understands that
the rights granted hereunder include certain rights sublicensed to it by Corixa
pursuant to the [*] Agreement between Corixa and [*] the [*] License Agreement
[*] and Corixa, [*] and the License Agreement between [*] and Corixa, dated [*].
Kirin further understands that in the event it exercises the option to license
[*] granted to it under Section 4.1(d) of this Agreement, such license shall
include sublicenses granted by Corixa under agreements between Corixa and
certain Third Parties in effect as of the Effective Date (such agreements,
collectively with the [*] Agreement, the [*] Agreement and the [*] Agreement,
the "Third Party Agreements"). Exhibit B includes a complete list of agreements
pursuant to which the foregoing Third Party rights are licensed to Corixa as of
the Effective Date. Kirin understands that such sublicenses or licenses may in
some respects be more restrictive than the terms and conditions of this
Agreement, but that such restrictions do not narrow the scope of the licenses
granted to Kirin hereunder or otherwise materially affect the ability of the
parties to fully develop and commercialize Licensed Product(s) as contemplated
in this Agreement. Kirin shall reimburse Corixa [*] of all amounts Corixa pays
during the term of this Agreement in running royalties under the Third Party
Agreements and the [*] in connection with Licensed Products sold in Territory B
or Kirin's exercise of rights granted hereunder in Territory B up to but not
exceeding the maximum rates set forth in Exhibit E hereto (with Kirin's
corresponding reimbursement obligations limited to one-half of the royalty
amounts resulting from application of such maximum rates), and such royalty
payments shall be treated as Commercialization Costs directly attributable to
Territory B for purposes of Section 5.5 of this Agreement. All other fees,
costs, royalties and other payments (including, without limitation, running
royalties in excess of the amounts set forth in Exhibit E or in Territories
outside Territory B and milestone payments) required to be paid under or in
connection with any such license shall be borne [*], and notwithstanding any
other provision of this Agreement, [*]. In addition, (i) in the event of any
termination of the [*] Agreement, Corixa will promptly (but in no event later
than five (5) days after such termination) notify Kirin of such termination and
will reasonably cooperate with Kirin in allowing Kirin's sublicense(s) under the
[*] Agreement to survive such termination in accordance with the terms of the
[*] Agreement; and (ii) provided that Kirin has exercised the option to license
[*] granted to it under Section 4.1(d) of this Agreement, in the event of any
termination of the License Agreement between [*] and Corixa, dated [*] (the "[*]
Agreement") (a copy of which has been attached hereto as Exhibit B-1 pursuant to
Section 2.4(b) of such [*] Agreement), Corixa will promptly (but in no event
later than five (5) days after such termination) notify Kirin of such
termination.
4.4 Exploitation of Joint Inventions and Joint Patents. Corixa and Kirin
shall each have the right to exploit, including but not limited to by means of
licensing to Third Party(ies), the Joint Inventions and Joint Patents for any
purpose (a) outside of the Licensed Field anywhere in the world during the Term,
(b) both outside and within the Licensed Field outside of Territories A and B
during the Term, and (c) both outside and within the Licensed Field anywhere in
the world following expiration or termination of this Agreement subject to
Sections 18.5(b), 18.5(c) and 18.8. Neither Party shall have any obligation to
obtain the other
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party's consent to any aspect of such exploitation, to account to the other
party in any manner in connection therewith, or to make any payment to the other
party in connection therewith.
5. RESEARCH AND DEVELOPMENT FUNDING AND COSTS.
Kirin shall make the following payments to Corixa under this Agreement
in U.S. Dollars by wire transfer of immediately available funds:
5.1 Lump-sum Research Funding. In addition to the research funding set
forth in Section 5.3, the lump-sum amount of U.S. $3,000,000 shall be due and
payable by Kirin within thirty (30) days after execution of this Agreement
("Initial Installment"). This Agreement shall become effective upon the date of
Corixa's receipt of full payment of the Initial Installment. Except for Kirin's
obligation to pay the Initial Installment, neither party shall incur any
obligation to the other party hereunder prior to Corixa's receipt of the Initial
Installment. If Kirin fails to pay the Initial Installment when due, Corixa
shall have the right to terminate this Agreement on immediate notice, in
addition to other remedies available under this Agreement or at law. The full
amount of this research funding shall be guaranteed, non-refundable and
non-creditable and shall be paid directly to Corixa. The Initial Installment is
not to be credited against Kirin's obligation to share Costs under Section 5.3.
Corixa agrees to use the Initial Installment to meet Corixa's own obligations to
fund one-half of the pre-clinical development under the Research Program in
Territory B.
5.2 Milestone Payments. In addition to the research funding set forth in
Section 5.1 and Section 5.3, the one-time milestone payments set forth below
shall be payable to Corixa within thirty (30) days after the later of (i) the
occurrence of the applicable milestone event (of which Corixa shall promptly
notify Kirin) and (ii) Kirin's receipt of Corixa's invoice for such payment:
(a) [*] upon the [*];
(b) [*] upon completion [*]; and
(c) [*] upon successful completion of [*].
The full amount of each milestone payment set forth in this Section 5.2 shall be
guaranteed, non-refundable and non-creditable and shall be paid directly to
Corixa.
5.3 Research Costs. Those Costs (as defined in Exhibit D) directly
attributable to Kirin's performance of the Research Program in Territory A shall
be borne solely by Kirin. Subject to the budget limits set forth in Section
2.1(b) and the Research Program, Kirin shall reimburse Corixa [*] of those Costs
directly attributable to Corixa's performance of the Research Program in
Territory B and Corixa shall reimburse Kirin [*] of those Costs directly
attributable to Kirin's performance of the Research Program in Territory B in
accordance with Section 2.2 of Exhibit D.
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5.4 Development Costs. Those Costs (as defined in Exhibit D) directly
attributable to Kirin's performance of the Territory A Clinical Development
Program in Territory A shall be borne solely by Kirin. Subject to the budget
limits set forth in Section 2.3, Kirin shall reimburse Corixa [*] of those Costs
directly attributable to Corixa's performance of the Territory B Clinical
Development Program in Territory B and Corixa shall reimburse Kirin [*] of those
Costs directly attributable to Kirin's performance of the Territory B Clinical
Development Program in Territory B in accordance with Section 2.3 of Exhibit D.
5.5 Commercialization Costs. Those Commercialization Costs directly
attributable to Kirin's commercialization activities in Territory A shall be
borne solely by Kirin. Each party shall reimburse the other party [*] of those
Commercialization Costs directly attributable to either party's performance of
the Territory B Commercialization Program in Territory B (that is, Corixa shall
be responsible for [*] of such Commercialization Costs, and Kirin shall be
responsible for [*] of such Commercialization Costs) in accordance with Section
2.4 of Exhibit D.
6. NET PROCEEDS SHARING AND ROYALTY PAYMENTS.
6.1 Net Proceeds. Corixa and Kirin shall [*] in all Net Proceeds in
accordance with Section 2.5 of Exhibit D.
6.2 Royalties and Transfer Prices for Licensed Products. Subject to the
terms and conditions of this Article 6, Kirin shall pay Corixa royalties and
transfer prices on Net Sales by Kirin or Third Party Kirin sublicensees in
Territory A, on a Licensed Product-by-Licensed Product and country-by-country
basis, as follows:
(a) Licensed Products Other Than Ex Vivo Licensed Products.
i) Royalties for Licensed Products Other Than Ex Vivo
Licensed Products. For Licensed Products that are not Ex Vivo Licensed Products,
Kirin shall pay to Corixa the following royalties:
(A) For Licensed Products that incorporate WT-1
Antigen(s) but do not incorporate either [*] or Corixa Adjuvant(s), Kirin shall
pay to Corixa royalties on annual Net Sales by Kirin or Third Party Kirin
sublicensees in Territory A on a Licensed Product-by-Licensed Product and
country-by-country basis equal to [*] of such Net Sales.
(B) For Licensed Products that incorporate WT-1
Antigen(s) and Corixa Adjuvant(s) but do not incorporate [*], Kirin shall pay to
Corixa royalties on annual Net Sales by Kirin or Third Party Kirin sublicensees
in Territory A on a Licensed Product-by-Licensed Product and country-by-country
basis equal to [*] of such Net Sales.
(C) For Licensed Products that incorporate WT-1
Antigen(s) and [*] but do not incorporate any Corixa Adjuvants, Kirin shall pay
to Corixa royalties on annual Net Sales by Kirin or Third Party Kirin
sublicensees in Territory A on a Licensed Product-by-Licensed Product and
country-by-country basis equal to [*] of such Net Sales.
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(D) For Licensed Products that incorporate WT-1
Antigen(s), Corixa Adjuvant(s) and [*], Kirin shall pay to Corixa royalties on
annual Net Sales by Kirin or Third Party Kirin sublicensees in Territory A on a
Licensed Product-by-Licensed Product and country-by-country basis equal to [*]
of such Net Sales.
ii) Transfer Prices for Licensed Products Other Than Ex
Vivo Licensed Products. In addition to the royalties under Section 6.2(a)(i),
for Licensed Products (other than Ex Vivo Licensed Products) supplied to Kirin
under the Supply Agreement, Kirin shall pay to Corixa the following transfer
prices:
(A) Japan. Kirin shall pay to Corixa a transfer
price for Licensed Products (other than Ex Vivo Licensed Products) supplied
under the Supply Agreement for sale by Kirin or Third Party Kirin sublicensees
in Japan equal to [*] of Net Sales of Licensed Products as calculated in
accordance with Section 7.1.
(B) Territory A (Excluding Japan). Kirin shall pay
to Corixa a transfer price for Licensed Products (other than Ex Vivo Licensed
Products) supplied under the Supply Agreement for sale by Kirin or Third Party
Kirin sublicensees in Territory A (excluding Japan) equal to the following: (A)
if the WT-1 Antigen or component thereof included within the applicable Licensed
Product was produced by means of a [*], [*] of the Fully Burdened Manufacturing
Costs for such Licensed Product; or (B) if the WT-1 Antigen or component thereof
included within the applicable Licensed Product was [*], [*] of the Fully
Burdened Manufacturing Costs for such Licensed Products.
iii) Additional Terms and Conditions Concerning Royalties
and Transfer Prices for Licensed Products Other Than Ex Vivo Licensed Products.
(A) In the event that the total transfer prices
paid by Kirin under this Section 6.2(a) during any given calendar quarter for
Licensed Products (other than Ex Vivo Licensed Products) sold, transferred or
otherwise disposed of in Japan is less than the Fully Burdened Manufacturing
Costs for such Licensed Products sold, transferred or otherwise disposed of in
Japan during such period, then such total shall be deemed to equal such Fully
Burdened Manufacturing Costs and Kirin shall make a supplemental payment of the
difference to Corixa.
(B) In the event that the total royalties and
transfer prices paid by Kirin under this Section 6.2(a) during any given
calendar quarter for Licensed Products (other than Ex Vivo Licensed Products)
sold, transferred or otherwise disposed of in Territory A (excluding Japan)
exceed [*] of Net Sales of such Licensed Products, then the parties shall meet
within thirty (30) days of the end of such calendar quarter to negotiate in good
faith an adjustment to the royalties and transfer prices paid by Kirin for the
sale, transfer and other disposition of Licensed Products (other than Ex Vivo
Licensed Products) in Territory A (excluding Japan) to address such concerns.
(b) Ex Vivo Licensed Products.
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i) Royalties for Ex Vivo Licensed Products. Corixa and
Kirin shall [*] in all Net Proceeds in accordance with Exhibit D. For Ex Vivo
Licensed Products disposed of in Territory A, Kirin shall pay to Corixa the
following royalties:
(A) For all periods of time during which any other
Licensed Product that is not an Ex Vivo Licensed Product ("non-Ex Vivo Licensed
Product") is sold in Japan, Kirin shall pay to Corixa royalties on sales by
Kirin or Third Party Kirin sublicensees of Ex Vivo Licensed Products in
Territory A, on an Ex Vivo Licensed Product-by-Ex Vivo Licensed Product and
country-by-country basis, equal to the greater of (1) [*] of an amount equal to:
(x) the total number of units of all Ex Vivo Licensed Products sold during the
applicable royalty period in Japan, multiplied by (y) the weighted average sales
price per unit (minus applicable discounts set forth in the definition of Net
Sales in Section 1.35) for all non-Ex Vivo Licensed Products sold during such
period in Japan or (2) [*] of Net Sales of such Ex Vivo Licensed Products (such
greater value of foregoing subsections (1) and (2), the "Adjusted Ex Vivo
Royalty");
(B) Subject to the adjustment provided for in
Section 6.2(b)(i)(D) below, for that period of time during which no non-Ex Vivo
Licensed Product is sold in Japan but at least one non-Ex Vivo Licensed Product
is sold in any other country, Kirin shall pay to Corixa royalties on sales by
Kirin or Third Party Kirin sublicensees of Ex Vivo Licensed Products in
Territory A, on an Ex Vivo Licensed Product-by-Ex Vivo Licensed Product and
country-by-country basis, equal to the greater of (1) [*] of an amount equal to:
(x) the total number of units of all Ex Vivo Licensed Products sold during the
applicable royalty period, multiplied by (y) the weighted average sales price
per unit (minus applicable discounts set forth in the definition of Net Sales in
Section 1.35) for all non-Ex Vivo Licensed Products sold during such period in
all countries outside of Japan and (2) [*] of Net Sales of such Ex Vivo Licensed
Products (such greater value of foregoing subsections (1) and (2), the "Interim
Ex Vivo Royalty"); and
(C) Subject to the adjustment provided for in
Section 6.2(b)(i)(D) below, for that period of time during which no non-Ex Vivo
Licensed Product has yet been sold in any country and continuing until Section
6.2(b)(i)(A) or Section 6.2(b)(i)(B) applies, Kirin shall pay to Corixa
royalties on Net Sales by Kirin or Third Party Kirin sublicensees of Ex Vivo
Licensed Products in Territory A, on an Ex Vivo Licensed Product-by-Ex Vivo
Licensed Product and country-by-country basis, equal to [*] of such Net Sales
(the "Base Ex Vivo Royalty").
(D) Adjustments. The Base Ex Vivo Royalty and the
Interim Ex Vivo Royalty are subject to retroactive adjustments as follows: (1)
When a non-Ex Vivo Licensed Product is sold for the first time in any country
but is not sold in Japan (the "Interim Trigger"), all sales of Ex Vivo Licensed
Products made during the twenty-four (24) months prior to the occurrence of the
Interim Trigger shall be subject to retroactive adjustment to apply the Interim
Ex Vivo Royalty that prevails during the second calendar quarter following the
occurrence of the Interim Trigger. (2) When a non-Ex Vivo Licensed Product is
sold for the first time in Japan (the "Full Trigger"), all sales of Ex Vivo
Licensed Products made during the twenty-four (24) months prior to the
occurrence of the Full Trigger shall be subject to retroactive adjustment to
apply the Adjusted Ex Vivo Royalty that prevails during the second calendar
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quarter following the occurrence of the Full Trigger. The parties acknowledge
that the same sales may be subject to two royalty adjustments (e.g., upon the
occurrence of the Interim Trigger and again upon the occurrence of the Full
Trigger). Kirin shall, within one-hundred eighty (180) days following the
occurrence of an Interim Trigger or a Full Trigger, as the case may be, provide
Corixa with written notice calculating the amount of adjustment due hereunder
(provided that Corixa shall provide Kirin with prompt written notice of any sale
of a non-Ex Vivo Licensed Product in any country in Territory C and, if
necessary, pricing information related thereto, so that Kirin may comply with
the foregoing). With respect to each trigger, Kirin shall make the applicable
adjustment payments due hereunder in four (4) equal semi-annual installments,
with the first payment to be made within thirty (30) days of Kirin's providing
written notice under this Section 6.2(b)(i)(D). In addition to the adjustment
payment, Kirin shall also be required to pay an additional amount as interest,
calculated from the period of the sales made to the date of payment, as follows:
the lesser of [*] per annum or the maximum rate permitted under applicable law.
ii) Transfer Prices for Ex Vivo Licensed Products. Kirin
shall pay to Corixa a transfer price for the applicable portion of the Ex Vivo
Licensed Products supplied under the Supply Agreement for sale by Kirin or Third
Party Kirin sublicensees in Territory A equal to the following: (A) if the WT-1
Antigen or component thereof included within the applicable Ex Vivo Licensed
Product was produced by means of a [*], [*] of the Fully Burdened Manufacturing
Costs for the applicable portion of such Ex Vivo Licensed Product; or (B) if the
WT-1 Antigen or component thereof included within the applicable Ex Vivo
Licensed Product was produced by a means [*], [*] of the Fully Burdened
Manufacturing Costs for the applicable portion of such Ex Vivo Licensed Product.
6.3 Royalty Reduction for Non-Coverage of Licensed Products by Valid
Claims. On a country-by-country basis, to the extent that any Licensed Product
sold or otherwise distributed by Kirin or its Third Party sublicensee(s) is not
covered by at least one (1) WT-1 Claim in the country in which such Licensed
Product is sold or otherwise distributed, (a) for Licensed Products other than
Ex Vivo Licensed Products, the applicable royalty percentage on Net Sales of
such Licensed Products otherwise owed under Section 6.2 shall be reduced by [*]
(i.e. if the original royalty to be paid by Kirin was [*] of Net Sales, such
royalty shall be reduced to [*] of Net Sales), and (b) for Ex Vivo Licensed
Products, the applicable royalty on Net Sales of such Licensed Products
otherwise owed under Section 6.2 shall be reduced by [*] (i.e. if the original
royalty to be paid by Kirin was [*] of Net Sales, such royalty shall be reduced
to [*] of Net Sales); in each event, provided that in the event a Licensed
Product is subject to a reduced royalty under this Section 6.3 and such Licensed
Product is later covered by at least one (1) WT-1 Claim in the country in which
such Licensed Product is sold or otherwise distributed, such Licensed Product
shall then bear the full royalty applicable in accordance with Section 6.2, but
only for so long as such Licensed Product is so covered and no payments shall be
owed retroactively with respect to the period of non-coverage.
6.4 Royalty Adjustment for Assignment or License of [*]. In the event
that [*] or any assignee, licensee or sublicensee of his right, title or
interest in, to or under any of the [*] (as defined in Section 17.2(m), below)
licenses or exercises any rights under such [*] in any country
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in Territory A, and [*] or such party, as applicable, or any of their respective
licensees or sublicensees, makes or sells any Licensed Product(s) in such
country in connection therewith, then, for Licensed Products other than Ex Vivo
Licensed Products the applicable royalty percentage on Net Sales of all Licensed
Products in such country otherwise owed by Kirin under Section 6.2 shall
thereafter be reduced by [*] (i.e. if the original royalty to be paid by Kirin
was [*] of Net Sales, such royalty shall be reduced to [*] of Net Sales), and
for Ex Vivo Licensed Products, the applicable royalty on Net Sales of such
Licensed Products otherwise owed under Section 6.2 shall be reduced by [*] (i.e.
if the original royalty to be paid by Kirin was [*] of Net Sales, such royalty
shall be reduced to [*] of Net Sales). Such reduction shall last only for so
long as such manufacture or sale activity continues.
6.5 Combination Products. In the event a Licensed Product is sold in the
form of a combination product containing one (1) or more separate products (such
as a delivery device or diagnostic kit that could reasonably be sold separately
and has economic value on its own) which are not Licensed Products (each, a
"Combination Product"), Net Sales for such Combination Product will be
calculated by multiplying actual Net Sales of such Combination Product by the
fraction A/(A + B), where A is the average sales price of the Licensed Product
when sold separately in finished form, and B is the average sales price of all
other products in the combination when sold separately in finished form. If, on
a country-by-country basis, the other product(s) in the Combination Product is
sold separately in finished form in such country but the Licensed Product is not
sold separately in finished form in such country, Net Sales shall be calculated
by multiplying actual Net Sales of such Combination Product by the fraction one
(1) minus (C/(C+D)) where C is the average sales price of the other product(s)
in the Combination Product and D is the difference between the average sales
price of the Combination Product and the average sales price of the other
product(s).
6.6 Royalty Term; Single Royalty; No Right of Offset. Royalties payable
by Kirin on a given Licensed Product shall be paid to Corixa until the last
Valid Claim in Territory A under the Corixa WT-1 Patents, the Joint Patents and,
if the Licensed Product incorporates a Corixa Adjuvant and/or a [*], the
applicable Corixa Adjuvant Patents and/or the Corixa [*] Patents, covering the
applicable Licensed Product, expires (or is held invalid or unenforceable or
admitted in writing to be invalid or unenforceable by the holder, as described
in Section 1.54). No royalties shall be payable on Net Sales in Territory A of
Licensed Products between Kirin and any Affiliate or Third Party sublicensee of
Kirin, unless such Affiliate or Third Party sublicensee is an end user of such
Licensed Products. Notwithstanding any other provision of this Agreement, only
one (1) applicable royalty payment shall be due on the sale of each Licensed
Product in Territory A. Except as otherwise provided herein, Kirin shall have no
right to offset any other payments or amounts against any of the royalties
payable under this Agreement.
6.7 Payments and 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. All amounts payable to Kirin under this Agreement shall be payable in
United States Dollars, by wire transfer of immediately available funds to a bank
account designated by Kirin, at Kirin's option. Monthly Net Sales amounts shall
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be translated to U.S. Dollars by using an average rate of exchange, which
average shall be computed by (a) adding the rate of exchange quoted under
Foreign Exchange in the Wall Street Journal as of the end of the then-current
month to such rate as of the end of the immediately prior month and (b) dividing
such sum by two (2).
6.8 Withholding Taxes. Each party shall be entitled to deduct from
amounts otherwise due and payable hereunder (including any royalties or other
amounts due under Article 6 and any amounts due and payable under Sections 5.1
and 5.2) any withholding taxes, value-added taxes, sales taxes or any other
taxes, levies or charges with respect to amounts payable hereunder (other than
United States taxes and/or taxes imposed on or measured by such party's net
income), including any taxes that are required to be withheld by the paying
party on behalf of the receiving party, to the extent such taxes, levies and
changes are levied against the paying party by governmental authorities. Each
party shall use commercially reasonable efforts to minimize any such taxes,
levies or charges required to be withheld on behalf of the receiving party by
the paying party. Upon the receiving party's request, the paying party promptly
shall deliver to the receiving party proof of payment of all such taxes, levies
and other charges. Each paying party shall reasonably cooperate with the
receiving party (at the receiving party's expense) regarding the
characterization of payments so that the receiving party may take advantage of
any and all benefits under any applicable treaty and/or in efforts required by
the receiving party to receive any reimbursement or refund of amounts so paid or
withheld.
6.9 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 or Net Proceeds to Kirin in local currency to a bank
account in such country, and in the absence of any other agreement by the
parties, such funds payable to a party shall be deposited in whatever currency
is allowable by the other party in an accredited bank in that country that is
reasonably acceptable to the payee party.
6.10 Payments Upon Termination. If this Agreement is terminated in
accordance with Article 18 in some or all of the countries in Territory A or
Territory B, each party shall pay the other party all amounts accrued and
payable to the other party pursuant to this Article 6 prior to the date of such
termination and any amounts earned thereafter as a result of sales of residual
inventory of Licensed Products. In addition, each party shall continue to pay to
the other party all amounts payable hereunder with respect to Licensed Products,
if any, with respect to which this Agreement has not been terminated.
7. REPORTS, PAYMENTS AND ACCOUNTING.
7.1 Payments and Reports.
(a) Except to the extent otherwise set forth in, and otherwise in
accordance with Exhibit D, each party agrees to make written reports (consistent
with GAAP or, where applicable, GAAP Counterpart, and in a format, if any,
specified by the Development Steering Committee, or as applicable, the
Commercialization Steering Committee) with respect to any payments or
reimbursements for the preceding calendar quarter to the other party within
sixty (60) days after the close of such calendar quarter during the Term of this
Agreement.
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Notwithstanding anything contained in this Agreement to the contrary, the
transfer prices payable to Corixa under Article 6 shall be due within sixty (60)
days after the close of the calendar quarter in which the Licensed Products were
delivered. For transfer prices to be calculated as a function of Net Sales, as
applied to such Licensed Products, the value assigned to Net Sales shall be the
average Net Sales for the applicable Licensed Product for the applicable
territory (Japan or Territory A) during the previous calendar quarter, as
calculated on a per-unit basis (i.e. the average per-unit Net Sales for Licensed
Products for the applicable territory during such calendar quarter, multiplied
by the total number of Licensed Product units supplied under the Supply
Agreement for sale in such territory during such calendar quarter) and confirmed
by the Commercialization Steering Committee. Following commercial launch of the
first Licensed Product, these reports shall show for such calendar quarter sales
by such party, its Affiliates and sublicensees of Licensed Products, details of
the quantities of each type of Licensed Product sold in each country and the
country of manufacture (if different), gross revenues from sales, trade
discounts allowed and taken, Net Sales, Net Proceeds (detailing all transactions
generating Net Proceeds), and all payments or reimbursements due to the other
party pursuant to this Agreement. Except to the extent otherwise set forth in
Exhibit D, concurrently with the making of each such report, Corixa shall make
payment to Kirin of amounts payable to Kirin under Article 6, and Kirin shall
make payment to Corixa of any amounts payable under Article 6, for the calendar
quarter covered by such report.
(b) All late payments under this Agreement shall bear interest
from the date due until paid at the lesser of [*] per annum or the maximum rate
permitted under applicable law.
7.2 Accounting. Each party agrees to keep clear, accurate and complete
books and records, all in a format, if any, specified by the Development
Steering Committee in accordance with GAAP (or, where applicable, GAAP
Counterpart) and otherwise in accordance with Exhibit D, for a period of at
least three (3) years (or such longer period as may correspond to such party's
internal records retention policy) for each reporting period in which sales
occur, Net Proceeds are obtained or Costs are incurred. Such books and records
shall contain such detail as is reasonably sufficient to enable amounts payable
pursuant to Articles 5 and 6, including the Costs and other expenses
reimbursable hereunder, to be determined. During the Term of this Agreement and
for three (3) years thereafter, each party agrees to permit such books and
records to be examined, at the other party's expense, by an independent
third-party accounting firm mutually agreeable to the parties (acting
reasonably) and bound to confidentiality restrictions at least equivalent in
scope to and at least as restrictive as those set forth in Article 12, on at
least ten (10) days prior written notice, during such party's normal business
hours and no more than once during any consecutive twelve (12) month period, in
a manner that does not unreasonably interfere with such party's normal business
activities. Notwithstanding anything to the contrary contained in this
Agreement, such audit may include a review of any sublicense agreements entered
into by either Kirin or Corixa with a Third Party. Such audit shall only be
conducted for the purpose of confirming the audited party's compliance with its
payment or reimbursement obligations hereunder or to obtain payment or financial
information required for Corixa to comply with its obligations under the Third
Party Agreements, and shall only include records for the three (3) years prior
to the date of such audit. In connection with any such audit, the auditor shall
be permitted to report to the auditing party only as to the accuracy of the
audited party's
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statements and compliance with its payment obligations hereunder (provided that
the auditor shall be required to provide such report to the audited party
simultaneously). In the event that any audit under this Section 7.2 demonstrates
that either party has underpaid the other party, the underpaying party shall pay
to the auditing party the amount of such underpayment immediately upon request,
and to the extent such underpayment is more than [*] of the amount otherwise
required to be paid during the audited payment period, shall reimburse the
auditing party for the expense of the audit. If one party has overpaid the
other, such party may, at its sole discretion, choose to deduct such
overpayments from future amounts owed to the other party.
7.3 Confidentiality of Reports. Each party agrees that the information
set forth in (a) the reports required by Sections 7.1, and (b) the records
subject to audit under Section 7.2, shall be subject to the confidentiality
restrictions set forth in Article 12 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 payment
obligations hereunder; and shall not be disclosed by the receiving party or such
accounting firm to any other person.
8. STANDARDS OF PERFORMANCE IN RESEARCH, DEVELOPMENT AND COMMERCIALIZATION.
8.1 Diligence in Research, Development, and Commercialization.
(a) Each of Corixa and Kirin will use Commercially Reasonable and
Diligent Efforts to conduct the research and related activities assigned to them
under and in accordance with the Research Program within Territory B and, with
respect to Kirin only, within Territory A.
(b) Each of Corixa and Kirin will use Commercially Reasonable and
Diligent Efforts in proceeding with: (i) the development (including clinical
development), testing and, where applicable, manufacturing of Licensed Products
within Territory B; (ii) filing for and pursuing regulatory approvals of
Licensed Products in all applicable countries within Territory B; and (iii) the
subsequent marketing and commercialization of Licensed Products within
Territory B.
(c) Kirin will use Commercially Reasonable and Diligent Efforts
in proceeding with: (i) the development (including clinical development),
testing and, where applicable, manufacturing of Licensed Products within
Territory A; (ii) filing for and pursuing regulatory approvals of Licensed
Products in all applicable countries within Territory A; and (iii) the
subsequent marketing and commercialization of Licensed Products within
Territory A.
8.2 Regulatory Matters and Compliance.
(a) Each party, in performing its activities hereunder, shall
comply with all applicable national, federal, state and local laws, rules and
regulations directed to such activities, including where applicable, cGMP and
good clinical practices.
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(b) Kirin shall be solely responsible for filing for and
obtaining regulatory approval for Licensed Products in Territory A and Kirin
shall solely own all such filings and regulatory approvals. Both parties shall
be jointly responsible, in accordance with the Territory B Clinical Development
Program, for filing for and obtaining regulatory approval of Licensed Products
in Territory B and both parties shall jointly own such filings and approvals;
provided, however, unless otherwise agreed by the parties Corixa shall be the
named holder of such filings and approvals. Within Territory B and Territory A,
each party shall notify the other of any oral or written communications to or
from regulatory authorities on matters relating to Licensed Products and shall
provide the other party, upon request, with copies of any such written
communications reasonably promptly after such request.
(c) Each party hereby grants to the other party full rights of
reference to any regulatory filings or approvals for Licensed Products, and any
clinical data contained therein. Each party agrees to execute such documents as
may be reasonably necessary to accomplish such rights of reference.
9. MANUFACTURING; SUPPLY.
9.1 Materials. Subject to Section 4.1(f), Corixa shall provide
reasonable quantities of preclinical and clinical grade test materials to Kirin
as required or requested by Kirin through the course of the performance of the
Research Program and Clinical Development Program. These materials shall include
sufficient quantities of Licensed Products and, as applicable [*] and [*], as
required or requested by Kirin. Without limitation, such materials shall include
Corixa Adjuvants and [*], provided that Kirin shall use such Corixa Adjuvants
and [*] solely in accordance with the licenses granted hereunder. Any materials
manufactured or supplied by Corixa for Kirin under this Section for use under
the Clinical Development Program shall comply with cGMP and all other relevant
specifications and requirements therefore, including any such requirements
arising out of applicable regulations or regulatory filings or actions. Kirin
shall use all materials provided to Kirin by Corixa hereunder or under the
Supply Agreement in compliance with all applicable federal, state or local laws
and regulations. Materials, including Licensed Product, provided by Corixa to
Kirin under this Section 9.1 for use in Territory A shall be reimbursed by Kirin
at Corixa's Fully Burdened Manufacturing Costs therefor. The costs of all other
materials shall be accounted for in accordance with Article 5. All materials not
rejected by Kirin within sixty (60) days of delivery shall be deemed to be
accepted. Materials properly rejected by Kirin shall be replaced promptly by
Corixa at Corixa's sole expense.
9.2 Delivery. All materials delivered to Kirin pursuant to Section 9.1
above shall be C.I.F. Narita Airport and shall be subject to testing and
acceptance by Kirin. Kirin shall use its reasonable efforts to assist Corixa in
arranging any desired insurance (in amounts that Kirin shall determine) and
transportation, via air freight unless otherwise specified in writing by Kirin,
to any destinations specified in writing from time to time by Kirin. All
customs, duties, costs, taxes, insurance premiums, and other expenses relating
to such transportation and delivery shall be at Corixa's expense (and shall be
included in Fully Burdened Manufacturing Costs hereunder).
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9.3 Supply Agreement. Subject to Kirin's right to manufacture and have
manufactured Licensed Products in certain circumstances set forth more
specifically in Exhibit C, Corixa shall have the right to, and Corixa shall,
manufacture and supply 100% of Kirin's requirements of Licensed Products in both
Territory A and Territory B (provided that notwithstanding the foregoing, in the
case of Ex Vivo Licensed Products, the foregoing shall apply only to the
applicable portion of the Ex Vivo Licensed Product (i.e. the WT-1 antigen)
actually supplied, rather than to the entire Ex Vivo Licensed Product). Prior to
the initiation of Phase III clinical trials (or similar pivotal studies) for the
first Licensed Product, Corixa and Kirin shall negotiate and enter into a
manufacturing and supply agreement (the "Supply Agreement") which shall be
subject to Section 4.1(f) and which shall contain the minimum terms and
conditions set forth in Exhibit C and such other reasonable terms and conditions
as the parties may mutually agree upon.
10. INVENTIONS AND IMPROVEMENTS.
10.1 Inventions. Patentable inventions or discoveries that arise in
connection with performance of the Research Program or the Clinical Development
Program and that are made, conceived, developed, or reduced to practice by an
employee or agent of Corixa, whether solely or jointly other than with an
employee or agent of Kirin, shall be owned by Corixa (collectively, the "Corixa
Inventions"). Patentable inventions or discoveries that arise in connection with
performance of the Research Program or the Clinical Development Program and that
are made, conceived, developed, or reduced to practice by an employee or agent
of Kirin, whether solely or jointly other than with an employee or agent of
Corixa, shall be owned by Kirin (collectively, the "Kirin Inventions").
Patentable inventions, discoveries or technology(ies) that arise in connection
with performance of the Research Program or the Clinical Development Program and
that are made, conceived, developed, or reduced to practice jointly by at least
one employee or agent of Corixa and at least one employee or agent of Kirin
shall be jointly owned by Corixa and Kirin (collectively, "Joint Inventions").
For purposes of the foregoing, inventorship shall be determined in accordance
with U.S. law. Subject to the terms and conditions of this Agreement (including
the licenses granted hereunder), Kirin and Corixa shall each retain their
respective unrestricted rights to make, have made, use, sell, have sold, and
import, respectively, the Kirin Inventions and the Corixa Inventions. Kirin and
Corixa shall each have those licenses under the Joint Inventions and Joint
Patents as set forth in Article 4, and the right to exploit Joint Inventions and
Joint Patents as set forth in Section 4.4.
10.2 Improvements. Notwithstanding the foregoing Section 10.1: (a) in
the event that the use by Kirin, in connection with the activities under this
Agreement, of the WT-1 Antigen, Corixa Adjuvants or [*] provided to Kirin by
Corixa results, during the Term, in an invention or discovery that constitutes a
new use, improvement or enhancement of such WT-1 Antigen, Corixa Adjuvant(s) or
[*], Kirin shall promptly give Corixa written notice of such new use,
improvement or enhancement, and Kirin shall license such invention or discovery
to Corixa on a worldwide, irrevocable, fully-paid basis, which license shall be
exclusive (even as to Kirin, except that Kirin reserves and retains the rights
to such invention or discovery in connection with the exercise of its rights or
performance of its obligations hereunder) with respect to such invention or
discovery that constitutes a new use, improvement or enhancement of the Corixa
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Adjuvants or [*] and non-exclusive with respect to such invention or discovery
that constitutes a new use, improvement or enhancement of the WT-1 Antigen; and
(b) in the event that the use of the Kirin adjuvants or [*] technology by Corixa
(if applicable) results, during the Term, in an invention or discovery that
constitutes a new use, improvement or enhancement thereof, Corixa shall promptly
give Kirin written notice of such new use, improvement or enhancement, and
Corixa shall license such invention or discovery to Kirin on a non-exclusive,
worldwide, fully-paid basis.
11. PATENTS; PROSECUTION AND LITIGATION.
11.1 Filing, Prosecution and Maintenance.
(a) Filing, Prosecution and Maintenance. Corixa shall have the
first right to file, prosecute and maintain all Corixa WT-1 Patents, Corixa
Adjuvant Patents, Corixa [*] Patents and Joint Patents as provided in this
Section 11.1(a) and shall do so in a timely manner, provided that in any
jurisdiction where joint filing and/or prosecution is required regarding a Joint
Patent, Kirin shall reasonably and promptly cooperate with Corixa regarding the
filing and/or prosecution of such Joint Patent. Corixa shall promptly disclose
in writing to Kirin (a) the complete texts of all patents and patent
applications filed by Corixa (and any related filings) that relate to any
Licensed Product (including Corixa WT-1 Patents and all Joint Patents) prior to
filing so that Kirin has a reasonable opportunity to comment and consult with
Corixa on such filings, as well as (b) all information received concerning the
institution or possible institution of any interference, opposition,
re-examination, reissue, revocation, nullification or any official proceeding
involving any patent or patent application licensed herein. Kirin shall have the
right to review all such applications, patents, filings and other proceedings
and make recommendations to Corixa concerning them and their conduct. Corixa
agrees to give due consideration to Kirin's recommendations and to keep Kirin
promptly and fully informed of the course of patent prosecution, maintenance or
other proceedings including by providing Kirin with copies of substantive
communications, notices, actions, search reports and Third Party observations
submitted to or received from patent offices. Corixa shall provide such patent
consultation, filings and information to Kirin at no cost to Kirin. Kirin shall
hold all information disclosed to it under this Section as Corixa's Confidential
Information under Article 12, provided that such information relating to Joint
Patents shall be the Confidential Information of both parties. Subject to
Section 11.1(b), Kirin shall reimburse Corixa for all reasonable, direct, and
documented out-of-pocket costs incurred by Corixa after the Effective Date in
connection with the filing, prosecution and maintenance of Corixa WT-1 Patents
and the Joint Patents with respect to Territory A, plus one-half of all
reasonable, direct, and documented out-of-pocket costs incurred by Corixa after
the Effective Date in connection with the filing, prosecution and maintenance of
Corixa WT-1 Patents and the Joint Patents with respect to Territory B. Corixa
shall be responsible for all costs incurred by Corixa in connection with the
filing, prosecution and maintenance of the Corixa Adjuvant Patents and the
Corixa [*] Patents. Kirin shall designate the countries in Territory A in which
Kirin wants Corixa to make national filings of Corixa WT-1 Patents or Joint
Patents based on Corixa's PCT filings, to the extent such PCT filings exist as
of the Effective Date, and Corixa shall make filings in such countries, and
shall
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duly prosecute and maintain such filings, in a timely manner, and Corixa may
file Corixa WT-1 Patents or Joint Patents in other countries in Territory A at
its discretion.
(b) Kirin Right to Relinquish Certain Patent Rights. Kirin shall,
at any time during or after the Term of this Agreement, have the right to notify
Corixa that Kirin wishes to relinquish its rights to any one or more Joint
Patent(s) or Corixa WT-1 Patent(s) in a particular country(ies). Effective upon
such notice, Kirin shall thereafter, notwithstanding the foregoing Section
11.1(a), have no obligation to reimburse Corixa for any costs incurred in
connection with the filing, prosecution and/or maintenance of such relinquished
Joint Patent(s) or Corixa WT-1 Patent(s) in such country(ies). In such event,
Kirin's license rights under Section 4.1(a) and 4.1(b) to such Joint Patent or
Corixa WT-1 Patent in the specified country(ies) shall automatically terminate,
and Kirin's right to share in royalties attributable to any Valid Claims of such
Joint Patent or Corixa WT-1 Patent in the specified country(ies) shall
automatically terminate. In addition, in the event Kirin elects to relinquish
any Joint Patent rights in a particular country(ies), Kirin shall, effective
upon such notice, grant to Corixa an exclusive (subject to the following
proviso), fully paid, sublicensable license under all Kirin's rights in such
Joint Patent in the specified country(ies) to research, develop, make and have
made, use, have used, sell, offer for sale, have sold, import, and otherwise
dispose of any and all Licensed Products solely in the Licensed Field in the
specified country(ies); provided that Kirin shall retain the right to exercise
(but not sublicense to Third Parties) all rights to such Joint Patent solely for
internal research purposes and not for commercial manufacture or sale. In the
event that Kirin has notified Corixa pursuant to this Section 11.1(b) that Kirin
wishes to relinquish its rights to all Joint Patent(s) and all Corixa WT-1
Patent(s) in either or both of Territory A or Territory B, Kirin shall be
required to pay the termination option fee set forth in Section 18.4 that would
otherwise be applicable to such Territory. Corixa acknowledges that Kirin's
relinquishment of its rights in any given Joint Patent(s) or Corixa WT-1
Patent(s) shall not affect Kirin's rights in, to or under any other Joint
Patent(s) or Corixa WT-1 Patent(s) hereunder.
(c) Kirin Step-In Rights on Corixa Abandonment in Territory B.
Within Territory B, in the event Corixa desires to abandon any patent or patent
application or any part thereof included within the Corixa WT-1 Patents and
Joint Patents, elects not to prosecute or maintain any such patent or patent
application (or part thereof), or refuses to file a given patent application
with respect to an invention relating to the WT-1 Antigen, which patent
application, if filed, would be deemed a Corixa WT-1 Patent hereunder (each such
patent application, a "WT-1 Application"), Corixa shall provide Kirin with
reasonable prior written notice of such desired abandonment, election or
refusal, and Kirin shall have the right, at its own expense, to prepare, file,
prosecute and maintain such patent or patent application or part thereof in any
or all of such applicable country(ies). In the event Kirin exercises this right
with respect to any Corixa WT-1 Patent(s), Joint Patent(s), Joint Invention(s)
or WT-1 Application(s) for any country(ies), effective upon such exercise
notice, such country(ies) shall thereafter be deemed part of Territory A for
purposes of this Agreement (for example, in such country(ies), Kirin will have
those exclusive rights under Corixa's technology that are granted in Section
4.1(a) as opposed to those rights granted under Section 4.1(b)), provided that
Corixa shall retain the right to exercise (but not sublicense to Third Parties)
all rights to such Joint Patents, Corixa WT-1 Patents or WT-1 Applications
outside the Licensed Field solely for internal research purposes and not for
commercial manufacture or sale.
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11.2 Defense. In the event of the initiation of any suit by a Third
Party against Corixa, Kirin or any of their Affiliates for patent infringement
involving the manufacture, use, sale, distribution or marketing of any Licensed
Product(s), the party sued shall promptly notify the other party in writing.
Corixa shall have the first right but not the obligation to defend any such suit
at its own expense, subject to a reasonable obligation to consult with Kirin on
issues, if any, related to the other party's patents. Notwithstanding the
foregoing, Kirin shall have the right but not the obligation to participate in
the defense at its own expense, and shall be free to take such action in
defending itself as it deems necessary in its sole discretion. If Corixa fails
to defend such action within a reasonable time after written notice provided in
accordance with the first sentence of this Section 11.2, then Kirin shall have
the full right but not the obligation to defend such action in its own name and
to solely control all aspects of such defense. In any event, Corixa and Kirin
shall reasonably assist one another and reasonably cooperate in any such
litigation at the other's request, provided that the cooperating party shall be
entitled to reimbursement of its reasonable, direct, out-of-pocket costs
incurred in connection therewith. Without limiting the foregoing, the parties
shall reasonably cooperate regarding issues of validity or enforceability of
Corixa WT-1 Patents, Corixa Adjuvant Patents, and Corixa [*] Patents. Neither
Corixa nor Kirin may enter into any settlement with respect to such suit without
the written consent of the other party to the extent such settlement would
materially adversely affect the other party's ability to make, use or sell
Licensed Products in accordance with this Agreement or the other party's rights
or obligations hereunder.
11.3 Enforcement. In the event that Corixa or Kirin becomes aware of
actual or threatened infringement of any Corixa WT-1 Patent, Corixa Adjuvant
Patent, Corixa [*] Patent, Kirin Patents or Joint Patent, that party shall
promptly notify the other party in writing. Subject to the following sentence,
in connection with any such actual or threatened infringement, Corixa shall have
the first right but not the obligation to bring an infringement action against
any such Third Party infringer, provided that Corixa shall not name or join (or
seek to name or join) Kirin in any such suit without first obtaining Kirin's
prior written consent (which consent will not be unreasonably withheld if
inclusion of Kirin is required for initiation of such action). Notwithstanding
the foregoing, in connection with any such actual or threatened infringement
primarily in Territory A where such actual or threatened infringement includes
the manufacture, use or sale in Territory A of any product in the Licensed Field
or any product which is otherwise competitive with any Licensed Product(s),
Kirin shall have the first right but not the obligation to bring an infringement
action against any such Third Party infringer and, only if required to bring
suit, Corixa will agree to be a named party thereto. If the party ("Responding
Party") having the first right to respond to such actual or alleged infringement
does not respond to or commence a particular infringement action within ninety
(90) days following, as applicable, such notification from the other party or
the date upon which the Responding Party becomes aware of such actual or
threatened infringement, the other party, after notifying the Responding Party
in writing, shall be entitled to respond to or bring such infringement action at
its own expense. The party conducting such action shall have full control over
its conduct, provided that neither Corixa nor Kirin may enter into any
settlement with respect to infringement relating to this Collaboration without
the written consent of the other party. In any event, Corixa and Kirin shall
reasonably assist one another and reasonably cooperate in any such litigation at
the other's reasonable
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request, provided that the cooperating party shall be entitled to reimbursement
of its reasonable, direct, actual, out-of-pocket costs incurred in connection
therewith.
11.4 Recovery Sharing. If either party recovers monetary damages from a
Third Party in connection with any action (including any settlement) described
in Section 11.3, such damages shall be applied in the following manner: First,
Corixa and Kirin shall each recover their respective out-of-pocket expenses, or
pro-rata proportions thereof, incurred by them in connection with such
litigation or settlement (except to the extent such expenses have already been
reimbursed by the other party in accordance with Section 11.3). Then, any
monetary recovery in an amount in excess of such expenses shall be shared
between Corixa and Kirin equally, provided that with respect to any such excess
recovery made by Kirin and attributable to infringement in Territory A
("Territory A Excess"), in lieu of an equal share, Corixa shall be entitled to
receive a percentage of the Territory A Excess that approximates the applicable
royalty amount that would have been applicable to the sale of infringing
products were they Licensed Products hereunder. For purposes of this Section
11.4, "out-of-pocket expenses" shall mean all actual, out-of-pocket costs and
expenses of legal work performed and court costs related to a particular action,
including all attorneys' fees and related expenses and all court fees, and all
other actual, out-of-pocket expenses that a party incurs in connection with such
action, including reasonable travel-related expenses.
11.5 Interference Proceedings. In the event of the declaration of any
interference proceeding by the United States patent authorities with respect to
Corixa WT-1 Patents or Joint Patents, Corixa shall promptly notify Kirin in
writing. Corixa shall have the right to represent and manage Corixa's and
Kirin's interests in such proceeding. Corixa and Kirin shall reasonably assist
one another and reasonably cooperate in any such proceeding. The costs and
expenses of participating in all such interference proceedings shall be
allocated as follows: (i) if such proceeding is brought with respect to one or
more [*] or [*] or any Corixa Adjuvant Patents or Corixa [*] Patents, Corixa
will bear all the costs and expenses associated with such proceeding, and (ii)
if such proceeding is brought with respect to Joint Patents or Corixa WT-1
Patents that cover a Licensed Product, but not in connection with one or more
[*] or [*] or the Corixa patents listed in the preceding subsection (i), Corixa
and Kirin shall share the costs and expenses associated with such proceeding
equally.
11.6 Status Updates. The parties shall keep one another informed of the
status of their respective activities regarding any litigation or settlement
thereof concerning any Licensed Product or concerning the patent(s) and
intellectual property rights licensed to the other party hereunder.
12. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS.
12.1 Disclosure of Inventions. During the Term of this Agreement, Corixa
shall promptly disclose to Kirin and/or supply Kirin in a timely fashion with
all Corixa WT-1 Patents, Joint Patents and all relevant patent applications
filed and/or controlled by Corixa in Territory A and Territory B related to the
Licensed Product(s) or arising from the performance of the Research Program and
the Clinical Development Program (except to the extent that Corixa is
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prohibited from doing so by any agreements in existence between Corixa and a
third party(ies) as of the Effective Date). During the Term of this Agreement,
Kirin shall promptly disclose to Corixa and/or supply to Corixa in a timely
fashion with all Kirin Patents, Joint Patents and all relevant patent
applications filed and/or controlled by Kirin related to the Licensed Product or
arising from the performance of the Research Program and the Clinical
Development Program (except to the extent that Kirin is prohibited from doing so
by any agreements in existence between Kirin and a third party(ies) as of the
Effective Date). In addition, each party shall provide the other party with all
its information that is reasonably necessary or useful for achieving the goals
of the Research Program and the Clinical Development Program. Upon the
reasonably specific request of either party that the other party provide such
requesting party with documented Corixa Know-How or Kirin Know-How (as
applicable) that may be reasonably necessary for the requesting party to
exercise its rights or perform its obligations hereunder, such other party shall
comply with such request, provided that neither party shall be required to incur
significant costs or dedicate significant resources in providing such materials
unless the requesting party agrees to reimburse such other party therefor.
12.2 Safety. During the Term of this Agreement, each party shall
promptly inform the other party of any information that it obtains or develops
regarding the utility or safety of any Licensed Product and shall promptly
report to the other party any confirmed information of any Serious Adverse Drug
Experience or other serious, adverse, or unexpected reactions or side effects
related to the utilization or medical administration of any Licensed Product.
Each party shall cause any Affiliate or Third Party that performs research on or
development of the Licensed Product on behalf of such party to comply with this
disclosure obligation.
12.3 Confidential Information. During the Term of this Agreement and for
five (5) years thereafter, neither Corixa nor Kirin shall use or reveal or
disclose to any Third Party any Confidential Information of the other party
(including of such other party's Affiliates) without first obtaining the written
consent of the disclosing party, except as may be otherwise provided herein. No
Confidential Information of a disclosing party may be used by the receiving
party for any purpose other than the purposes expressly permitted by this
Agreement or for the purpose of exercising the receiving party's rights and
obligations under this Agreement. Each party shall, at minimum, take reasonable
measures and exert a reasonable degree of care to assure that no unauthorized
use or disclosure is made by any person to whom access to the other party's
Confidential Information is granted. Each party shall promptly notify the other
party in writing upon discovery of any unauthorized use or disclosure of the
other party's Confidential Information, and shall describe the facts and
circumstances of such use or disclosure. The nonuse and nondisclosure
obligations set forth in this Article 12 shall not apply to such Confidential
Information which is or becomes a matter of public knowledge through no fault of
the receiving party, or is already in the possession of the receiving party as
of the time of such disclosure by the disclosing 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.
"Confidential Information" shall mean any and all proprietary or confidential
information or materials of a party (or its Affiliates) disclosed to or obtained
by the other party or otherwise developed by either party in the performance of
activities in furtherance of this Agreement, without the need to xxxx as
"proprietary" or "confidential," which information or materials are
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disclosed or developed under circumstances reasonably indicating that they are
proprietary or confidential.
12.4 Permitted Disclosures. Notwithstanding anything in Section 12.3 to
the contrary, the receiving party may, subject to the provisions of this
Agreement, disclose Confidential Information received from the disclosing party
to: (a) those of its directors, officers, employees, agents, consultants and
clinical investigators that have a need to know such Confidential Information to
achieve the purposes of this Agreement, provided that such receiving party shall
ensure that its directors, officers, employees, agents, consultants or clinical
investigators to whom disclosure is to be made are bound by obligations of
confidentiality, nondisclosure, and nonuse at least equivalent in scope to and
at least as restrictive as those set forth in this Article 12; (b) any Affiliate
or permitted sublicensee or distributor to the extent necessary to exercise its
rights or fulfill its obligations hereunder, provided such Affiliate or
permitted sublicensee or distributor is bound in writing by obligations of
confidentiality, nondisclosure, and nonuse at least equivalent in scope to and
at least as restrictive as those set forth in this Article 12; and (c) a Third
Party who is a financial advisor of such party, provided such Third Party is
bound in writing by obligations of confidentiality, nondisclosure, and nonuse at
least equivalent in scope to and at least as restrictive as those set forth in
this Article 12. In addition, it shall not be a breach of this Article 12 for
either party to disclose Confidential Information to the extent required to be
disclosed: (i) in order to comply with applicable laws or regulations; (ii) as
necessary to file or prosecute patent applications concerning any Licensed
Product; or (iii) to carry out litigation against a Third Party concerning any
Licensed Product, provided that in each event the receiving party discloses only
that portion of Confidential Information required or necessary to be disclosed,
and provides reasonable notice to the disclosing party to allow the disclosing
party to object to or seek protection for the disclosure.
12.5 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 (a) that Confidential Information
received from the other party under this Agreement remains the property of such
other party and (b) of the confidentiality and nonuse 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 Confidential Information
in confidence in accordance with the terms of this Agreement.
12.6 Press Release. The parties to this Agreement may each disclose the
nature and general terms of this Agreement in a press release following
signature, provided that the disclosing party has obtained the prior written
approval of the other party (not to be unreasonably withheld or delayed) of the
content of such press release. Notwithstanding the foregoing, each party shall
have the right to issue press releases immediately and without prior consent of
the other party, solely to the extent such press releases disclose any
information required to be disclosed at such time by the rules and regulations
of the Securities and Exchange Commission
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or similar federal, state or foreign authorities, as determined in good faith by
legal counsel to the disclosing party.
12.7 Publicity. Neither party shall publish or publicly disclose any
discoveries or inventions arising from the performance of the Research Program
or the Clinical Development Program (a "Dissemination") without at least sixty
(60) days prior written notice of such planned publication or disclosure sent to
the 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, but in no event
greater than an additional ninety (90) days, 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, either party shall have the right to
make a Dissemination immediately and without prior consent of the other party if
and only to the extent such disclosure is required by the rules and regulations
of the Securities and Exchange Commission or similar federal, state or foreign
authority, as determined in good faith by such party, provided that the
disclosing party provides the other party with notice of the nature and content
of such proposed disclosure and seeks confidential treatment for such
information the other party reasonably requests be retained as confidential.
13. GOVERNING LAW; DISPUTE RESOLUTION.
13.1 Governing Law. This Agreement shall be governed by the laws of the
State of Washington, USA, as such laws would be applied to agreements entered
into and to be performed entirely in Washington as if both parties were
Washington residents (without reference to its conflicts of laws principles).
13.2 Dispute Resolution.
(a) Informal Resolution. The parties agree to follow the
procedures set forth in this Section 13.2 to resolve any dispute, controversy or
claim arising out of or in relation to this Agreement or the breach, termination
or invalidity thereof (each, a "Dispute"), including Disputes with respect to
the Collaboration, Development Steering Committee and/or the Commercialization
Steering Committee. Prior to engaging in any formal dispute resolution with
respect to any Dispute, the Chief Executive Officer of Corixa Corporation and
the president of the pharmaceutical division of Kirin, or their respective
designees, shall, if either party provides written notice to the other party
requesting resolution of such Dispute ("Resolution Notice"), attempt to resolve
such Dispute through good faith negotiations. If any Dispute cannot be settled
by agreement of the parties pursuant to the preceding sentence within sixty (60)
days of receipt of the Resolution Notice, then either party may, by written
notice to the other requesting resolution by arbitration ("Arbitration Notice"),
invoke the dispute resolution provisions of Section 13.2(b).
(b) Arbitration. In the event that the dispute resolution
provisions of Section 13.2(a) do not result in a mutually agreed resolution of
the Dispute, then the parties agree to submit to confidential arbitration, which
shall be commenced as soon as practicable following the receipt by one party of
the other party's Arbitration Notice. Any arbitration proceeding relating to the
Agreement shall be presided over by a single independent arbitrator experienced
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in the biopharmaceutical industry and having relevant and significant experience
relating to the subject matter of the dispute, who shall be agreed to by the
parties, provided that if the parties are unable to agree on an arbitrator, then
each party shall name one (1) such arbitrator (whose sole role shall be to
select an impartial arbitrator) and the two (2) arbitrators will together
designate an impartial, independent arbitrator experienced in the
biopharmaceutical industry to preside over the arbitration proceeding. Each of
the parties agrees to use its reasonable best efforts to cause the arbitrator to
be selected by the thirtieth (30th) day after the receipt of the Arbitration
Notice. The arbitration shall be held in the City of San Francisco in the State
of California in accordance with the rules of the American Arbitration
Association then in force (as modified herein), and shall be held on an
expedited basis and in confidence. The language of arbitration shall be English.
The arbitrator shall not have the power to award exemplary or punitive damages.
Each party agrees that the final determination/decision of the arbitrator
presiding over the proceeding shall be binding on it. Notwithstanding the
foregoing or anything in this Section 13.2, the parties may apply to any court
of competent jurisdiction for preliminary or interim equitable relief, including
such relief for: (a) breach of confidentiality restrictions; (b) infringement;
or (c) compelling the commencement of the dispute resolution provisions in
accordance with Section 13.2, without breach of this arbitration provision. The
prevailing party in any dispute related hereto, whether in a court of law or in
arbitration, shall have its reasonable costs and expenses related to such
dispute reimbursed by the non-prevailing party; provided, however, that if the
arbitrator rules in favor of one party on some issues and the other party on
other issues, the arbitrator shall allocate such costs and expenses between the
parties in a manner that bears a reasonable relationship to the outcome of the
arbitration. Except for claims for injunctive or other equitable relief, which
may be brought in any court of competent jurisdiction, any claim or controversy
arising out of or related to this Agreement or any breach hereof shall be
submitted to a state or federal court of general jurisdiction in the City of San
Francisco in the State of California, USA for any action or proceeding arising
from or relating to this Agreement or relating to any arbitration in which the
parties are participants. Each of the parties irrevocably agrees to submit to
the personal jurisdiction and venue of the state and federal courts located in
the City of San Francisco in the State of California, USA.
(c) Notwithstanding any other provision of this Agreement, in the event
that the Development Steering Committee acting pursuant to Section 4.2(b)(ii)
fails to determine that a given Licensed Product cannot be made, used or sold
[*], then either party may compel arbitration in accordance with Section 13.2(b)
(subject to an abbreviated consultation under 13.2(a)) to determine whether such
Licensed Product cannot be made, used or sold [*]; provided that any such
arbitration shall be (i) conducted promptly after a thirty (30) days (rather
than a sixty (60) day) period of consultation as provided under Section 13.2(a)
and (ii) presided over by a single independent arbitrator who is a neutral
patent attorney selected by mutual agreement of the parties, with relevant
experience in patent litigation and who has competence in the biopharmaceutical
industry. In the event that such arbitrator determines that such Licensed
product cannot be made, used or sold [*], then the Development Steering
Committee shall be deemed to have made the same determination for purposes of
triggering Corixa's corresponding obligations under Section 4.2(b) hereof.
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14. TRADEMARKS.
14.1 Trademark Ownership. All Licensed Products to be sold in Territory
A shall be sold under trademarks selected by Kirin (the "Territory A
Trademarks"), and all Licensed Products to be sold in Territory B shall be sold
under trademarks selected by the Commercialization Steering Committee (the
"Territory B Trademarks," and collectively with the Territory A Trademarks, the
"Licensed Product Trademarks"). All Territory A Trademarks shall be owned solely
by Kirin, and all Territory B Trademarks shall be owned solely by Corixa;
provided, however, that any trademarks identifying Corixa Adjuvants or [*] shall
be owned by Corixa worldwide. As between the parties hereto, Kirin shall
reimburse Corixa one-half of all costs incurred by Corixa after the Effective
Date in connection with the registration and maintenance of Territory B
Trademarks.
14.2 Trademark Licenses. In order to enable each party to perform its
obligations as set forth in this Agreement, (a) Kirin hereby grants to Corixa a
non-assignable, non-exclusive, royalty-free, fully paid-up right and license to
use the Territory A Trademarks outside Territory A (including in Territory C,
provided that Corixa shall not be permitted to license or sublicense the use of
any Territory A Trademarks to any Corixa Partner (as defined in Section 2.4)
unless such Corixa Partner has agreed in advance, in writing, to license to
Kirin such trademarks used or to be used in connection with Licensed Products in
Territory C upon Kirin's request (which license shall be equivalent in scope to
the licenses granted to Kirin hereunder in the Territory B Trademarks)), and (b)
Corixa hereby grants to Kirin a non-assignable, non-exclusive, royalty-free,
fully paid-up right and license to use the Territory B Trademarks, in each event
solely in connection with the preparation and use of Licensed Product
promotional materials, labeling of Licensed Products, marketing of Licensed
Products, compliance with such parties' obligations under the Territory B
Commercialization Program, and as necessary in connection with regulatory
correspondence relating to Licensed Products.
14.3 Trademark Use Requirements. In marketing Licensed Products outside
Territory A, Kirin and Corixa shall each comply with mutually agreed trademark
usage policies applicable to the Territory B Trademarks, as determined by the
Commercialization Steering Committee and as may be amended from time to time.
Corixa agrees to comply with Kirin's trademark usage policies applicable to
Territory A Trademarks, as amended from time to time. Each party agrees to
provide samples of use of the other party's Licensed Product Trademarks as
reasonably requested by the other party from time to time for the purposes of
the other party's review and quality control of the manner in which its
trademarks are used therein. The reviewing party shall notify the other party
within ten (10) business days after delivery of such samples, whether the
reviewing party approves or disapproves of the manner of such use and, in the
case of disapproval, the specific reasons therefor and an acceptable alternative
(in which case the other party shall make commercially reasonable efforts to
remedy or discontinue such use). In the event the reviewing party fails to so
notify the other party within such ten (10) business day period, the reviewing
party shall be deemed to have approved of the manner of such use. Any goodwill
arising from use by a party of the other party's Licensed Product Trademarks
shall accrue to the benefit of the other party.
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14.4 Infringement of Licensed Product Trademarks. Each party shall
notify the other party promptly upon learning of any actual, alleged or
threatened infringement of a Licensed Product Trademark, or of any unfair trade
practices, trade dress imitation, passing off of counterfeit goods, or like
offenses in respect of any Licensed Product Trademark. The party who owns such
Licensed Party Trademark pursuant hereto shall have the right to take
responsibility for defending and enforcing a Licensed Product Trademark in its
respective assigned territory; provided, that if Corixa fails to take responsive
action within a reasonable period of time to defend or enforce a Territory B
Trademark and the Kirin reasonably believes such action is necessary to protect
Kirin's material financial interests in the applicable territory, the parties
shall confer in good faith regarding the defense of the Licensed Product
Trademark and, if Corixa still declines or fails to take responsive action,
Kirin may take steps to protect, defend, maintain or enforce the Licensed
Product Trademark for use by the parties in the territory in connection with the
applicable Licensed Product. The parties shall cooperate in good faith with
respect to all Licensed Product Trademark enforcement actions hereunder outside
Territory A, and each party shall notify the other party promptly of all
substantive developments with respect to such Licensed Product Trademark
enforcement actions, including, but not limited to, all material filings, court
papers and other related documents.
15. MISCELLANEOUS.
15.1 Force Majeure. If the performance of any part of this Agreement, or
of any obligation under this Agreement (other than failure to pay), by either
party is prevented, restricted, interfered with or delayed by reason of any
government action, war, fire, explosion, flood, strike, lockout, embargo, act of
God, or any other cause beyond the reasonable control of the party responsible
or 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
commercially reasonable efforts to avoid or remove such causes of nonperformance
and shall continue performance with the utmost dispatch whenever such causes are
removed. Each party agrees to give the other party prompt written notice of the
occurrence of any such condition or cause, the nature thereof, and the extent to
which the affected party expects to be unable to perform its obligations
hereunder or any part hereof, and to give the other party prompt written notice
when it is again fully able to perform hereunder.
15.2 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.
15.3 Entire Agreement. This Agreement including all Exhibits hereto
constitutes the entire agreement between the parties relating to the subject
matter hereof and supersedes all previous and contemporaneous writings and
understandings, whether written or oral, including
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the Confidential Information and Non-Disclosure Agreement dated as of May 9,
2001, as amended on July 30, 2001 (provided that confidential information
exchanged between the parties under that agreement shall be deemed Confidential
Information hereunder and shall be subject to the terms of Article 12).
15.4 Modification. No subsequent alteration, amendment, change or
addition to this Agreement shall be binding upon the parties hereto unless
reduced to writing and signed by the respective authorized officers of both
parties.
15.5 Waiver. Except as specifically provided for herein, the waiver from
time to time by either of the parties of a breach of or a default under any
provision of this Agreement or of any of such party's rights hereunder shall not
be effective unless in writing, and no such waiver or such party's failure to
exercise any remedy shall operate or be construed as a continuing waiver of same
or of any other of such party's rights or remedies provided in this Agreement.
15.6 Independent Contractors. The relationship between the parties
established by this Agreement is that of independent contractors, and nothing
contained herein shall or shall be construed to: (a) give either party the power
to direct or control the day-to-day activities of the other party; (b)
constitute either party as the legal representative or agent of the other party,
or constitute the parties as partners or joint venturers; or (c) allow either
party to bind the other party or to create or assume any liability or obligation
of any kind, express or implied, against or in the name of or on behalf of the
other party for any purpose whatsoever, except as expressly set forth in this
Agreement.
15.7 Further Actions. Each party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other commercially
reasonable acts, as may be reasonably necessary or appropriate in order to carry
out the purposes and intent of this Agreement.
15.8 Nature of Agreement. The rights and licenses granted under this
Agreement are, for purposes of Section 365(n) of the U.S. Bankruptcy Code (the
"Bankruptcy Code"), licenses of "intellectual property" within the scope of
Section 101 of the Bankruptcy Code. The parties agree that each party, as a
licensee of such rights and licenses, shall retain and may fully exercise all of
its rights and elections under the Bankruptcy Code. The parties further agree
that, in the event of the commencement of a bankruptcy or insolvency proceeding
by or against a party, the other party shall be entitled to a complete duplicate
of (and complete access to) any such intellectual property and embodiments
thereof solely to exercise the rights under this Agreement. If not already in
the other party's possession, such other party shall have the right to immediate
delivery of such intellectual property and embodiments upon written request.
15.9 Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
15.10 Headings. All headings are for reference purposes only and shall
not in any way affect the meaning or interpretation of this Agreement.
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15.11 No Right to Use Names. Except as expressly provided otherwise
herein, neither party has the right, express or implied, under this Agreement to
use in any manner the name of the other party or any other trade name or
trademark of the other party or any of its Affiliates.
15.12 Notice Procedure and Effectiveness. Any notice required or
permitted under this Agreement shall be in writing and be deemed given if
delivered (a) personally, (b) by facsimile transmission (receipt verified), (c)
by registered or certified mail (return receipt requested), postage prepaid, or
(d) sent by express courier service (receipt verified), to the following
addresses of the parties (or at such other address for a party as shall be
specified by like notice; provided, that notices of a change of address shall be
effective only upon receipt thereof):
IF TO CORIXA:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Chief Operating Officer
with a copy to General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
WITH A COPY TO:
Xxxxxx Xxxxxxxxxx & Xxxxxxxxx LLP
0000 Xxxxx Xxxx
Xxxxx Xxxx, XX 00000
Attention: Xxxxx X. Xxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
IF TO KIRIN:
Kirin Brewery Company, Limited
Pharmaceutical Division
00-0, Xxxxxxxx 0-Xxxxx
Xxxxxxx-xx, Xxxxx 000-0000, Xxxxx
Attention: Vice President, Licensing Department,
Pharmaceutical Division
Telephone: (00)0000-0000
Facsimile: (00)0000-0000
WITH A COPY TO:
Xxxxxxxx & Xxxxxxxx LLP
000 Xxxxxx Xxxxxx
Xxx Xxxxxxxxx, XX 00000
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Attention: Xxxxxxxx X. Xxxxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Any notice required or permitted to be given pursuant to this Agreement shall be
effective upon receipt by Corixa or Kirin, as the case may be.
16. ASSIGNMENT.
Neither this Agreement nor any rights or interests hereunder shall be
assignable by either party without the prior written consent of the other party;
provided, however, that either party may assign this Agreement, and its rights
and interests hereunder, without the consent of the other party: (a) to any of
such assigning party's Affiliates, if such Affiliate has the financial and other
resources to perform and assume all the obligations of the assigning party under
this Agreement; or (b) to any Third Party that acquires all or substantially all
of the assets of such assigning party or, in the case of Kirin, of Kirin's
pharmaceuticals business, or that is the surviving person in a merger or
consolidation with such surviving party; in each event, provided that: (i) such
assigning party shall promptly notify the other party of such assignment; (ii)
such Affiliate or Third Party (as applicable) shall assume and agree in writing
to be bound by all of the obligations of the assigning party hereunder; and
(iii) no rights granted hereunder to the non-assigning party are diminished by
such assignment. Subject to the foregoing, 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 and permitted assigns of the respective
parties. Any assignment or transfer in violation of this Article 16 shall be
null and void.
17. WARRANTIES, REPRESENTATIONS AND COVENANTS; INSURANCE.
17.1 Mutual Warranties, Representations and Covenants. Each party hereby
warrants, represents and covenants to the other party as follows:
(a) Such party: (i) is a corporation duly organized, validly
existing and in good standing under the laws of the jurisdiction in which it is
incorporated or organized; (ii) has the corporate power and authority and the
legal right to enter into this Agreement and to perform its obligations
hereunder; and (iii) has taken all necessary corporate action on its part to
authorize the execution and delivery of this Agreement and the performance of
its obligations hereunder.
(b) This Agreement is a legal and valid obligation binding upon
such party and enforceable in accordance with its terms, and the execution,
delivery and performance of this Agreement by such party does not conflict with
any material agreement, instrument or understanding, oral or written, to which
it is a party or by which it is bound, nor violate any law or regulation of any
court, governmental body or administrative or other agency having jurisdiction
over it.
(c) All material consents, approvals and authorizations of all
governmental authorities and other persons required to be obtained by such party
in connection with the execution and delivery and performance of this Agreement
have been and shall be obtained.
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(d) Such party has not, and during the Term will not, grant any
rights related to Licensed Products to any Third Party that would conflict with
or be inconsistent with the rights granted to the other party hereunder.
17.2 Corixa Warranties, Representations and Covenants. Corixa hereby
warrants, represents and covenants to Kirin as follows:
(a) Corixa: (i) has the right to grant the licenses and/or
sublicenses granted hereunder under the Corixa WT-1 Patents, Corixa Adjuvant
Patents, Corixa [*] Patents, and Corixa Know-How as provided herein; (ii) has
not granted, and during the Term hereof will not grant, to any Third Party or
Corixa Affiliate any rights that conflict with or materially and adversely
affect the rights granted by Corixa hereunder.
(b) Corixa shall not enter into any agreement or understanding,
or any amendment or modification of or to either of the foregoing, that will
limit the rights granted to Kirin hereunder.
(c) As of the Effective Date, except as has been disclosed to
Kirin, Corixa neither has received nor do the senior managers of Corixa (and
Corixa's in-house Senior Patent Counsel) have actual knowledge of any claims by
any Third Parties to an ownership interest in any of the Corixa WT-1 Patents,
Corixa Adjuvant Patents, Corixa [*] Patents, or Corixa Know-How that are
licensed to Kirin under this Agreement (other than to the extent rights in such
patents or know-how have been in-licensed by Corixa from Third Parties).
(d) Corixa has disclosed to Kirin all patents and patent
applications of which Corixa is aware as of the Effective Date that cover the
WT-1 Antigen and/or the manufacture, use or sale thereof.
(e) To the actual knowledge of Corixa senior management (and
Corixa's in-house Senior Patent Counsel), except as has been disclosed to Kirin,
(i) Exhibits A, A-2, and A-3 set forth a complete list of all patents and patent
applications that are owned or in-licensed by Corixa or as to which Corixa has
the right to license any rights to third parties as of the Effective Date and
(ii) as of the Effective Date, taking into account the fact that the actual
formulation, composition, mechanism of action, delivery and methods of
manufacture of the Licensed Product to be developed under this Agreement are
unknown, there are no other valid patents held by a Third Party and covering the
WT-1 Antigen that will prevent the parties from developing, manufacturing and
selling the WT-1 Antigen.
(f) (i) Exhibit A sets forth a complete list of all patents and
patent applications covering or otherwise relating to the WT-1 Antigen that are
owned (solely or jointly) or controlled by Corixa or as to which Corixa has the
right to license any rights to third parties as of the Effective Date; (ii)
Exhibit A-2 sets forth a complete list of all patents and patent applications
covering or otherwise relating to adjuvant technology that are owned (solely or
jointly) or controlled by Corixa or as to which Corixa has the right to license
any rights to third parties as of the Effective Date; and (iii) Exhibit A-3 sets
forth a complete list of all patents and patent applications covering or
otherwise relating to [*] technology that are owned (solely or
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jointly) or controlled by Corixa or as to which Corixa has the right to license
any rights to third parties as of the Effective Date.
(g) To the actual knowledge of senior managers of Corixa and
Corixa's in-house Senior Patent Counsel), as of the Effective Date, taking into
account the fact that the actual formulation, composition, mechanism of action,
delivery and methods of manufacture of the Licensed Product to be developed
under this Agreement are unknown, the manufacture, use, sale or other
commercialization of any Licensed Product, solely to the extent such Licensed
Product is covered by one or more Corixa WT-1 Patents, Corixa Adjuvant Patents,
and/or Corixa [*] Patents, would not infringe any issued patent of any Third
Party.
(h) As of the Effective Date, Corixa has not admitted in writing
that any claim of an issued, unexpired patent included within the Corixa WT-1
Patents, Corixa Adjuvant Patents, or Corixa [*] Patents is invalid or
unenforceable by the holder thereof by reissue, disclaimer or otherwise;
(i) As of the Effective Date, except as disclosed prior to the
Effective Date to Kirin, no patent or patent application within the Corixa WT-1
Patents, Corixa Adjuvant Patents, or Corixa [*] Patents is involved in or, to
the actual knowledge of senior managers of Corixa (and Corixa's in-house Senior
Patent Counsel) is threatened to be involved in, any interference, reissue,
re-examination or opposition, and there are no claims, judgments or settlements,
either actual or, to the actual knowledge of senior managers of Corixa,
threatened, relating to the Corixa WT-1 Patents, Corixa Adjuvant Patents, Corixa
[*] Patents.
(j) Exhibit B sets forth all of the agreements entered into by
Corixa with Third Parties as of the Effective Date pursuant to which Corixa has
acquired intellectual property or intellectual property rights included in the
Corixa WT-1 Patents, Corixa Adjuvant Patents, Corixa [*] Patents.
(k) (i) Each of the Third Party Agreements is valid, binding and
enforceable, and to the best of Corixa's knowledge, no party to any such
agreement is in default in complying with any provision thereof and no condition
or event or facts exist which, with notice or lapse of time or both, would
constitute a default thereunder; (ii) Corixa will comply with all terms of each
of the Third Party Agreements, and will be responsible for making all payments
due under such Third Party Agreements; (iii) Corixa will notify Kirin promptly
if Corixa receives any notice or written communication threatening or stating
that a Third Party Agreement licensor intends to terminate its respective Third
Party Agreement or modify, assign or amend such Third Party Agreement in any way
that adversely affects this Agreement or Kirin's rights hereunder; (iv) Corixa
will not terminate, amend or assign, nor by act or omission permit the
termination, amendment or assignment of, any Third Party Agreement without the
prior written consent of Kirin in the event such termination, amendment or
assignment would adversely affect Kirin's rights hereunder; and (v) Corixa will
provide Kirin with copies of all communications regarding any alleged or actual
breach of any Third Party Agreement.
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(l) During the term of this Agreement, Corixa shall not consent
to any assignment, license or sublicense by [*] of all or any part of his right,
title or interest in, to or under the [*] to any Third Party. For purposes of
this Agreement, "[*]" shall mean: (i) the [*] any foreign counterpart
applications to the [*] anywhere in the world, and any other patent applications
claiming priority back to the [*]; (ii) all patents issuing anywhere in the
world from any of the foregoing patent applications; and (iii) any
continuations, continuations-in-part (solely to the extent such
continuation(s)-in-part contains subject matter on which claims issuing obtain
the benefit of a priority date of any other patent application included herein),
divisions, patents of addition, reissues, renewals, registrations,
confirmations, reexamination certificates, revalidations, substitutions,
extensions and/or foreign counter-parts, anywhere in the world, of any of the
foregoing patents or patent applications.
17.3 Kirin Representation, Warranty and Covenant. Kirin hereby warrants,
represents and covenants to Corixa that Kirin: (i) has the right to grant the
licenses and/or sublicenses granted hereunder under the Kirin Patents and Kirin
Know-How as provided herein; (ii) has not granted, and during the Term hereof
will not grant, to any Third Party or Kirin Affiliate any rights that conflict
with or materially and adversely affect the rights granted by Kirin hereunder;
and (iii) shall not enter into any agreement or understanding, or any amendment
or modification of or to either of the foregoing, that will limit the rights
granted to Corixa hereunder.
17.4 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, NEITHER
KIRIN NOR CORIXA MAKES ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS,
IMPLIED, OR STATUTORY WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT,
INCLUDING BUT NOT LIMITED TO, THE WT-1 ANTIGENS, CORIXA ADJUVANTS, [*], CORIXA
WT-1 PATENTS, CORIXA ADJUVANT PATENTS, CORIXA [*] PATENTS, THE JOINT PATENTS,
THE KIRIN PATENTS, THE CORIXA KNOW-HOW, OR THE KIRIN KNOW-HOW, OR ANY LICENSED
PRODUCTS, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF NONINFRINGEMENT,
PATENTABILITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
17.5 Insurance. Each party (the "Insured Party") shall maintain in full
force and effect liability insurance coverage with terms comparable to that
maintained by other similarly situated biomedical companies engaged in clinical
evaluations and in no case with less than the following minimum coverages.
(a) Insured Party shall at its sole cost and expense, procure and
maintain with one or more insurance carriers with a rating of "A" or higher,
comprehensive general liability insurance in amounts not less than $[*] per
incident and $[*] annual aggregate and shall name the parties entitled to
receive indemnity by Insured Party under Article 20 of this Agreement as
additional insureds. Such comprehensive general liability insurance shall
provide: (i) product liability coverage, once clinical trials commence and (ii)
broad form contractual liability coverage for Insured Party's indemnification
obligations under Article 20 of this Agreement. At such time as a Licensed
Product is being commercially distributed or sold (other than for the purpose of
obtaining regulatory approval) by Insured Party or by an Affiliate, sublicensee
or
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agent of Insured Party, the foregoing insurance limits will be increased as a
function of its (or their) increasing annual Net Sales levels of such Licensed
Products as follows:
Annual Net Sales Insurance Limit
** US$[*] US$[*]
*** US$[*] and ** US$[*] US$[*]
*** US$[*] and ** US$[*] US$[*]
*** US$[*] and ** US$[*] US$[*]
*** US$[*] US$[*]
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** less than
*** greater than or equal to
(b) Insured Party shall provide the other party with written
evidence of such insurance upon request of such other party. Insured Party shall
provide the other party with written notice at least thirty (30) days prior to
the cancellation, non-renewal or material change in coverage of such insurance.
(c) Insured Party shall maintain such comprehensive general
liability insurance during the period that the Licensed Product is being
commercially distributed or sold by Insured Party or by an Affiliate,
sublicensee or agent of Insured Party, and for an additional period of ten (10)
years thereafter. The minimum amounts of insurance coverage required under this
Section 17.5 shall not be construed to create a limit of Insured Party's
liability with respect to its indemnification obligation under Article 20 or
under any other provision of this Agreement.
17.6 LIMITED LIABILITY. NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT
OR OTHERWISE, NEITHER CORIXA NOR KIRIN WILL BE LIABLE TO THE OTHER PARTY OR ANY
OF THE OTHER PARTY'S AFFILIATES WITH RESPECT TO ANY SUBJECT MATTER OF THIS
AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR
CONSEQUENTIAL DAMAGES INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES (INCLUDING
LOST PROFITS), EVEN IF SUCH FIRST PARTY OR ITS AFFILIATES HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH LOSS, DAMAGE, OR COST.
18. TERM AND TERMINATION.
18.1 General. This Agreement may not be terminated by either party
except in accordance with this Article 18.
18.2 Term. Unless otherwise terminated in accordance with this
Agreement, this Agreement shall expire upon the later of (a) the expiration,
lapse or invalidation (or other loss of enforceability, including admission in
writing by the holder as invalid or unenforceable) of the last Valid Claim of a
Corixa WT-1 Patent or Joint Patent, or, if applicable to a Licensed Product,
Corixa Adjuvant Patent and/or Corixa [*] Patent, issued in any country, or (b)
the tenth (10th)
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anniversary following commercial market launch of the last Licensed Product(s),
if any, that is launched (the period between the Effective Date and the later of
the foregoing, or if applicable, any earlier termination in accordance with this
Agreement, the "Term").
18.3 Termination for Breach.
(a) Termination. If either party materially breaches any material
provision of this Agreement and if such breach is not cured within forty-five
(45) days (the "Cure Period") after receiving written notice from the other
party specifying such breach, the non-breaching party shall have the right to
terminate this Agreement by giving written notice thereof to the party in
breach, which termination shall go into effect immediately unless the allegedly
breaching party has commenced dispute resolution proceedings pursuant to Section
13.2 (in which event, such termination shall not be effective unless there has
been a final mutually agreed resolution by the parties or final decision of the
arbitrator finding that termination is justified). In addition, Corixa shall
have the right to terminate this Agreement if Kirin initiates any action to
challenge the enforceability or invalidity of any claim of any Corixa WT-1
Patent, Corixa Adjuvant Patent, Corixa [*] Patent or Joint Patent, and Kirin
shall have the right to terminate this Agreement if Corixa initiates any action
to challenge the enforceability or invalidity of any claim of any Kirin Patent
or Joint Patent.
(b) Effect of Termination for Breach. If this Agreement is
terminated for material breach by reason of either party's breach in accordance
with this Section 18.3, then without further action on the part of either party:
i) if Kirin is the terminating party, unless Kirin is also
in material breach hereunder, Kirin may, at Kirin's sole discretion, elect to
waive any claim for damages against Corixa and either (A) if the termination due
to Corixa's breach occurred on or before the eighteenth (18th) month following
the Effective Date, Kirin may elect to receive a termination fee from Corixa in
the amount of [*] and in such event Corixa agrees to pay such amount to Kirin
within thirty (30) days after receiving notice of Kirin's election thereof, or
(B) in lieu of receiving such termination fee from Corixa, and regardless of the
date of termination due to Corixa's breach, Kirin may elect to retain for what
would have otherwise been the remainder of the Term the rights and licenses
granted to Kirin under this Agreement and continue to pay royalties to Corixa as
and when they would be due hereunder; provided, however, that (1) if Kirin makes
the election set forth in Section 18.3(b)(i)(A) or 18.3(b)(i)(B), such election
shall be deemed Kirin's sole remedy for Corixa's material breach of this
Agreement, (2) if Kirin makes the election set forth in Section 18.3(b)(i)(B),
any and all royalties on Net Sales and Net Proceeds due from Kirin accruing
after the effective date of such termination shall be reduced by [*], and (3)
Corixa shall have no further obligations hereunder after the effective date of
such termination except for those obligations that had accrued prior to the date
of such termination and those obligations that survive such termination pursuant
to Section 19.8. For the avoidance of doubt, if Kirin does not make any of the
elections set forth in this Section 18.3(b)(i) and Kirin chooses to terminate
this Agreement pursuant to Section 18.3(a), Kirin shall retain all other rights
and remedies it may have at law, in equity or otherwise with respect to any
breach by Corixa of this Agreement;
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ii) unless Kirin makes the election described in Section
18.3(b)(i)(B) above by written notice to Corixa on or before the date the
termination becomes effective, all licenses granted under this Agreement,
including licenses to Corixa WT-1 Patents, Corixa Adjuvant Patents, Corixa [*]
Patents, Joint Patents, Corixa Know-How, Kirin Know-How, Kirin Patents, clinical
data related to the Collaboration, and any Licensed Product Trademarks, shall
terminate; and
iii) notwithstanding any other provision of this
Agreement, if Kirin is the terminating party under this Section 18.3, Kirin
shall not be required to pay any termination option fee (as described in Section
18.4(a)) to Corixa.
(c) Deduction of Costs. The parties acknowledge and agree that in
the event that both of the following conditions are satisfied: (1) the
occurrence of a material breach of this Agreement by either party which is not
cured within the time period permitted and (2) the breaching party does not have
the financial resources to meet its obligations under the Agreement; then the
other party who has not breached the Agreement shall not be required to
terminate this Agreement, shall be permitted to pursue any rights and/or
remedies that it may have at law, in equity or otherwise, and shall be entitled:
(i) to pay any reasonable costs the payment of which otherwise would have been
the responsibility of the breaching party hereunder but which, in connection
with such breach, are not being paid; and (ii) to deduct any such paid costs,
including interest thereon calculated pursuant to Section 7.1(b), from any
royalty payments otherwise owed to the breaching party.
18.4 Kirin Early Termination Option.
(a) Termination. Kirin shall have the option at any time in its
sole discretion to terminate this entire Agreement, or at any time to terminate
the rights and obligations of Kirin and Corixa with respect to each of Territory
A or Territory B, or both territories; provided, however, that in order to
exercise this early termination option pursuant to this Section 18.4, Kirin
shall (i) provide Corixa with no less than sixty (60) days prior written notice
of such termination and (ii) pay a termination option fee within such sixty (60)
day period calculated as follows: If Kirin elects to terminate this Agreement in
accordance with this Section 18.4(a) with respect to Territory A, Kirin shall
pay to Corixa a termination option fee in the amount of [*]; and if Kirin elects
to terminate this Agreement in accordance with this Section 18.4(a) with respect
to Territory B, Kirin shall pay to Corixa a termination option fee in the amount
of [*]. These termination option fees are cumulative, such that if Kirin
terminates this entire Agreement with respect to both territories (i.e.,
Territory A and Territory B) in accordance with this Section 18.4(a), Kirin
shall pay to Corixa a termination option fee equal to the amount of [*]. Kirin
and Corixa acknowledge that the amounts for the termination option fees set
forth in this Section 18.4(a) are negotiated option fees, are intended to fairly
reflect the value to Kirin of the option to terminate certain of its obligations
under this Agreement and are not to be considered a penalty.
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(b) Effect of Kirin's Exercise of Early Termination Option. In
the event Kirin terminates this Agreement pursuant to this Section 18.4, whether
in its entirety or with respect to Territory A only, or Territory B only, then
without further action on the part of either party:
i) all licenses granted under this Agreement with respect
to the affected territory(ies), including licenses to Corixa WT-1 Patents,
Corixa Adjuvant Patents, Corixa [*] Patents, Joint Patents, Corixa Know-How,
Kirin Know-How, Kirin Patents, clinical data related to the Collaboration, and
any Licensed Product Trademarks, shall terminate;
ii) in the event (A) Corixa wishes to obtain a license
within the affected territory(ies) to any Kirin Patents, Kirin Know-How, or
Territory A Trademarks (if applicable), or Kirin's interest in any Joint Patents
and Joint Inventions, or (B) Corixa wishes to obtain access to and/or the right
to use clinical data owned or controlled by Kirin related to Licensed Product(s)
within the Territory A, Kirin shall, for a period of thirty (30) days, negotiate
the terms of such license with Corixa in good faith (provided that Kirin shall
be under no obligation to enter into any such license); and
iii) in the event that Kirin has terminated this Agreement
pursuant to this Section 18.4 with respect to Territory B only (and not with
respect to Territory A), Kirin shall retain its rights hereunder to use in
Territory A any pre-clinical and clinical data and other applicable information
from or relating to Territory B and Territory C (as applicable) research,
development and commercialization activities.
18.5 Termination For Scientific Reasons.
(a) Option Notice. At any time during the period that commences
with the initiation of a preclinical tests and ends upon the commercial launch
of the first Licensed Product developed hereunder, either party shall have the
option to terminate its obligations under this Agreement if either (i) all three
(3) formulations of Licensed Product (i.e. [*], [*], and [*] Licensed Product
formulations) are determined by the Development Steering Committee to not be
suitable for further development based on the results of pre-clinical tests or
clinical trials of such formulations (provided that the Development Steering
Committee shall be required to consider and make a decision regarding the
foregoing within thirty (30) days after the reasonable request of either party)
or (ii) the administration of any Licensed Product in any human clinical trial
results in a Serious Adverse Drug Experience; provided, however, that in order
to exercise this option pursuant to this Section 18.5 the terminating party
shall (A) provide the other party with no less than sixty (60) days prior
written notice of such termination and (B) provide the other party a detailed
disclosure of the basis for its decision.
(b) Effect of Kirin's Exercise of Option. If Kirin elects to
exercise its right under this Section 18.5, Corixa shall notify Kirin, within
thirty (30) days after receipt of Kirin's written notice under Section 18.5(a),
that either (i) Corixa agrees to terminate this Agreement or (ii) Corixa intends
to continue development of any Licensed Product(s). If Corixa agrees to
terminate this Agreement, or if Corixa fails to notify Kirin otherwise within
such thirty (30) day period, then this Agreement and all licenses granted under
this Agreement, including licenses to
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Corixa WT-1 Patents, Corixa Adjuvant Patents, Corixa [*] Patents, Joint Patents,
Corixa Know-How, Kirin Know-How, Kirin Patents, and any Licensed Product
Trademarks, shall terminate. If Corixa notifies Kirin of its intent to continue
development of any Licensed Product(s) in accordance with the first sentence of
this Section 18.5(b), then, upon Kirin's receipt of such notice: (A) Kirin shall
thereafter be relieved of all its obligations to conduct or share in the cost of
research, development and commercialization activities hereunder and all other
obligations under this Agreement (other than those obligations that accrued
prior to such termination and those obligations that survive such termination
pursuant to Section 19.8); (B) Kirin shall thereafter have no right to share in
Net Sales or Net Proceeds generated by Corixa's activities (except as provided
in clause (D) below); (C) the licenses granted to Corixa in accordance with
Section 4.1(c) shall thereafter be deemed exclusive (even as to Kirin, provided
that Kirin shall retain such rights solely for internal research purposes and
not for commercial manufacture or sale) to Corixa; and (D) the other licenses
granted to Corixa in Section 4 shall remain in effect provided that Corixa's
continuing rights to Kirin adjuvant technology and any Kirin [*] technology
shall be subject to reasonable and customary license terms and conditions
consistent with this Agreement and a reasonable royalty that Corixa shall be
required to pay to Kirin on all Net Sales of Licensed Products hereunder
incorporating or made using such Kirin adjuvant technology and/or any Kirin [*]
technology (such license terms and conditions and such royalty to be negotiated
in good faith by the parties); provided, however, that thereafter, if Corixa
initiates Phase III clinical trials with such Licensed Product(s) within ten
(10) years after the effective date of termination by Kirin under this Section
18.5, then Kirin shall be required pay to Corixa a termination option fee equal
to the amount of [*]. Notwithstanding anything to the contrary contained in this
Agreement, Corixa's license to Kirin adjuvant and Kirin [*] technology shall be
non-exclusive.
(c) Effect of Corixa's Exercise of Option. If Corixa elects to
exercise its right under this Section 18.5, Kirin shall notify Corixa, within
thirty (30) days after receipt of Corixa's written notice under Section 18.5(a),
that either (i) Kirin agrees to terminate this Agreement or (ii) Kirin intents
to continue development of any Licensed Product(s). If Kirin agrees to terminate
this Agreement, or if Kirin fails to notify Corixa otherwise within such thirty
(30) day period, then this Agreement and all licenses granted under this
Agreement, including licenses to Corixa WT-1 Patents, Corixa Adjuvant Patents,
Corixa [*] Patents, Joint Patents, Corixa Know-How, Kirin Know-How, Kirin
Patents, and any Licensed Product Trademarks, shall terminate. If Kirin notifies
Corixa of its intent to continue development of any Licensed Product(s) in
accordance with the first sentence of this Section 18.5(c), then, upon Corixa's
receipt of such notice: (A) Corixa shall thereafter be relieved of all its
obligations to conduct or share in the cost of research, development and
commercialization activities hereunder and all other obligations under this
Agreement (other than those obligations that accrued prior to such termination
and those obligations that survive such termination pursuant to Section 19.8);
(B) the licenses granted to Kirin in accordance with Section 4.1(b) shall be
deemed exclusive (even as to Corixa, provided that Corixa shall retain such
rights solely for internal research purposes and not for commercial manufacture
or sale) to Kirin; and (C) the other licenses granted to Kirin in Section 4
shall remain in effect, subject to reasonable and customary license terms and
conditions consistent with this Agreement and a reasonable royalty that Kirin
shall be required to pay to
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Corixa on all Net Sales of Licensed Products hereunder (such license terms and
conditions and such royalty to be negotiated in good faith by the parties).
18.6 Kirin Right to Terminate.
(a) Termination on [*]. If at any time during the Term, (i)
Corixa breaches Section 4.2(b) hereof and fails to cure such breach; (ii) the
Development Steering Committee determines that a Licensed Product cannot be
made, used, or sold [*] and either (A) the Development Steering Committee also
determines that there is no reasonable strategy for [*] or (B) subsequent
efforts to [*] are unsuccessful after nine (9) months after such determination
by the Development Steering Committee that a Licensed Product cannot be made,
used, or sold [*] (provided that the Development Steering Committee shall be
required to meet and to make either of the foregoing determinations upon the
request of either party following the [*]); or (iii) any lawsuit is filed
against Kirin, its Affiliates or sublicensees, or a legal complaint sufficient
to be filed is officially delivered to Kirin, its Affiliates or sublicensees but
has not been filed in a court of law, in each case alleging that the
development, manufacture, use or sale of Licensed Products [*] (an "[*] Claim"),
which [*] Claim is not resolved by Corixa to the reasonable satisfaction of
Kirin or dismissed in a final ruling not subject to appeal within one hundred
eighty (180) days after such [*] Claim is brought or (iv) Corixa fails to timely
defend Kirin from any [*] Claim or to timely indemnify Kirin from Damages
arising out of or relating to such [*] Claim in accordance with Section 4.2(b)
of this Agreement, then Kirin shall have the right to terminate this Agreement,
either in its entirety or solely with respect to those territories or countries
in which Corixa's acts or omissions have materially affected Kirin's rights to
research, develop, and/or commercialize Licensed Products in such territories or
countries, by giving written notice of such termination to Corixa, which
termination shall go into effect sixty (60) days following delivery of such
notice (unless Corixa has cured the circumstance in subsection (i), (ii), (iii)
or (iv), as applicable, to Kirin's reasonable satisfaction within such sixty
(60) day period).
(b) Termination for Lack of [*]. If a [*] is not obtained in
accordance with Section 4.2(d) within [*], and the parties are [*], and if
senior management of Kirin has made a good faith determination [*], then Kirin
shall have the right to terminate this Agreement by giving written notice of
such termination to Corixa within twenty four (24) months of the Effective Date,
which termination shall go into effect sixty (60) days following delivery of
such notice (unless Corixa has cured the circumstance in Section 4.2(d), within
such sixty (60) day period).
(c) Effect of Kirin's Exercise of Termination Right on [*]. In
the event Kirin terminates this Agreement pursuant to this Section 18.6 (whether
18.6(a) or 18.6(b)), then without further action on the part of either party:
i) all licenses granted under this Agreement, including
licenses to Corixa WT-1 Patents, Corixa Adjuvant Patents, Corixa [*] Patents,
Joint Patents, Corixa Know-How, Kirin Know-How, Kirin Patents, clinical data
related to the Collaboration, and any Licensed Product Trademarks, shall
terminate in those countries and/or territories with respect to which Kirin
terminated this Agreement pursuant to Section 18.6(a); and
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ii) notwithstanding any other provision of this Agreement,
if Kirin terminates this Agreement under this Section 18.6, Kirin shall not be
required to pay any termination option fee (as described in Section 18.4(a)) to
Corixa.
18.7 Termination on Bankruptcy.
(a) Termination. Either party (the "Terminating Party") may
terminate this Agreement by giving written notice to the other party (which
termination shall go into effect upon such notice) if, at any time, the other
party (the "Bankrupt Party"): (i) 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;
(ii) shall petition for or acquiesces in the arrangement or appointment of any
receiver, trustee or similar officer to liquidate or conserve its business or
any substantial part of its assets; (iii) shall commence under the laws of any
jurisdiction any proceeding involving its insolvency, bankruptcy, reorganization
for the relief of financially distressed debtors, adjustment of debt,
dissolution, liquidation or any other similar proceeding; (iv) shall become a
party to any proceeding or action of the type described above in (ii) or (iii),
and such proceeding or action remains undismissed or unstayed for a period of
more than sixty (60) days; (v) shall fail generally to pay its debts as they
become due, as set forth in 11 U.S.C. Section 303(h)(1), or such Bankrupt
Party's debts are greater than all of such Bankrupt Party's property, as set
forth in Section 11 U.S.C. Section 101(32)(A) (as such statutes are interpreted
by relevant case law of the United States); (vi) shall cease to do business in
the normal course for a period of ninety (90) days or more; (vii) shall have
wound up or liquidated its business; or (viii) shall make an assignment for the
benefit of creditors.
(b) Effect of Termination on Bankruptcy. If this Agreement is
terminated by either party in accordance with this Section 18.7, then without
further action on the part of either party:
i) all licenses granted under this Agreement, including
licenses to Corixa WT-1 Patents, Corixa Adjuvant Patents, Corixa [*] Patents,
Joint Patents, Corixa Know-How, Kirin Know-How, Kirin Patents, clinical data
related to the Collaboration, and any Licensed Product Trademarks, shall
terminate; and
ii) notwithstanding any other provision of this Agreement,
if Kirin terminates this Agreement under this Section 18.7, Kirin shall not be
required to pay any termination option fee (as described in Section 18.4(a)) to
Corixa.
18.8 Other No-Fee Termination.
(a) Termination. Either party shall have the right to terminate
this Agreement by giving written notice of such termination to the other party
(which termination shall go into effect immediately) upon any of the following
occurrences: (i) if, by the date that is ten (10) years after the Effective Date
hereof, no Licensed Product developed hereunder has successfully completed Phase
III Clinical Trials; (ii) if, by the date that is twelve (12) years after the
Effective Date hereof, no regulatory approval has been obtained for a Licensed
Product in either Japan or
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the United States; (iii) if a patent owned or controlled by a Third Party
renders the parties hereto unable to or otherwise blocks the manufacture, use,
sale, or import of all Licensed Product(s) that are in active development and/or
are currently being sold by either Party in the United States or Japan and,
after reasonable efforts are exerted by the parties, (A) a license on reasonable
terms under such Third Party patent that would permit the manufacture, use, sale
and import of at least one such Licensed Product in both the United States and
Japan has not been obtained, (B) such Third Party patent has not been
invalidated or abandoned, (C) in the event that litigation is initiated against
Kirin, Corixa or their respective Affiliates in which it is claimed or alleged
that the development, manufacture, use, sale or import of a Licensed Product in
connection with either party's exercise of its rights or performance of its
obligations hereunder, infringes such Third Party patent(s), no reasonable
defense exists to such litigation, and (D) no reasonable strategies remain
reasonably available to the parties for invalidating such Third Party patent; or
(iv) one (1) or more force majeure events (as described in Section 15.1) delay
Corixa's research and/or development efforts or development schedule by at least
eighteen (18) continuous months. In addition, Kirin shall have the right to
terminate this Agreement by giving thirty (30) days prior written notice of such
termination to Corixa in the event that Corixa has done one of the following and
the offending activity has not been cured within such thirty (30) day period:
Corixa terminates any Third Party Agreement, or breaches any Third Party
Agreement, which breach results in (i) the Third Party who is party to such
Third Party Agreement instituting any claim, suit, or proceeding against Kirin
or (ii) the material diminishment of Kirin's rights under this Agreement.
(b) Effect of Either Party's No-Fee Termination. In the event
either party terminates this Agreement pursuant to this Section 18.8, then
without further action on the part of either party:
i) all licenses granted to the terminating party under
this Agreement, whether in the Corixa WT-1 Patents, Corixa Adjuvant Patents,
Corixa [*] Patents, Joint Patents, Corixa Know-How, Kirin Know-How, Kirin
Patents, clinical data related to the Collaboration, or any Licensed Product
Trademarks, shall terminate;
ii) (A) the terminating party shall thereafter be relieved
of all of its obligations to conduct or share in the cost of research,
development and commercialization activities hereunder and all other obligations
under this Agreement (other than those obligations that accrued prior to such
termination and those obligations that survive such termination pursuant to
Section 19.8); (B) the terminating party shall not be entitled to share in any
Net Proceeds or Net Sales generated by the other party after such termination;
(C) the co-exclusive licenses granted to the non-terminating party in accordance
with Section 4.1 shall be deemed exclusive (even as to the terminating party,
provided that the terminating party shall retain such rights solely for internal
research purposes and not for commercial manufacture or sale) to such
non-terminating party; and (D) the rights granted to the non-terminating party
under Section 4 shall remain in effect; and
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iii) notwithstanding any other provision of this
Agreement, if Kirin terminates this Agreement under this Section 18.8, Kirin
shall not be required to pay any termination option fee (as described in Section
18.4(a)) to Corixa.
18.9 Termination By Mutual Agreement. The parties shall have the right
to terminate this Agreement at any time and for any reason upon their mutual
written agreement; provided that in the event of such termination,
notwithstanding any other provision of this Agreement, Kirin shall not be
required to pay any termination option fee (as described in Section 18.4(a)) to
Corixa, unless otherwise agreed in writing.
18.10 Suspension of Performance. In the event that (a) any bona fide
claim or allegation is made in a letter or other communication (which letter or
communication would, if delivered in the United States, trigger the right to
file a declaratory action) claiming or alleging that Kirin, its Affiliates or
sublicensees, or their respective successors or assigns, has or have [*] or [*],
and (b) Kirin reasonably believes that it is necessary for Kirin to suspend
certain of its activities under this Agreement in order to avoid [*] or [*],
then: (i) Kirin will promptly notify the Development Steering Committee
concerning such letter or communication; (ii) the Development Steering Committee
will meet within fourteen (14) days of such notice to determine, among other
issues, whether Kirin shall be permitted to suspend performance of those of its
activities hereunder that could otherwise be deemed to [*] or [*] ("[*]
Activities"); and (iii) during such fourteen (14) day period, Kirin may suspend
performance of those [*] Activities the suspension of which would not materially
adversely impact the continued development of Licensed Products hereunder (and
such suspension shall not be deemed a breach of this Agreement). In the event
that the Development Steering Committee: (A) determines, in accordance with the
foregoing sentence, that Kirin may suspend its performance of the [*]
Activities, then Kirin shall be permitted to suspend its performance of the [*]
Activities (and such suspension shall not be deemed a breach of this Agreement)
for a reasonable period of time under the circumstances as determined by the
Development Steering Committee; (B) determines, in accordance with the foregoing
sentence, that Kirin may not suspend its performance of the [*] Activities, then
Kirin shall not be permitted to continue suspending its performance of the [*]
Activities; or (C) is unable to reach a determination as to whether Kirin may
suspend its performance of the [*] Activities, then Kirin shall be permitted to
suspend its performance of the [*] Activities until the issue is resolved in
accordance with the dispute resolution procedures set forth in Section 13.2 (and
such suspension shall not be deemed a breach of this Agreement).
19. ADDITIONAL RIGHTS AND DUTIES UPON TERMINATION.
19.1 Accrued Payments. Upon termination of this Agreement, each party
shall pay all sums which are then due hereunder, which, in each case, shall
include all payments then due under Articles 2 ("Scope of Research Program;
Clinical Development Program and Commercialization Program"), 5 ("Research and
Development Funding and Costs"), 6 ("Net Proceeds Sharing and Royalty
Payments"), and 11 ("Patents; Prosecution and Litigation"), and Sections 4.2(b)
("[*]") and 4.3 ("Sublicenses of Third Party Rights to Kirin").
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19.2 Inventory Sell-Off. Upon termination of this Agreement, each party
shall notify the other party of the amount of Licensed Product(s) such party and
its Affiliates, sublicensees and distributors then have on hand in Territory A
and/or Territory B, as applicable, the sale of which would, but for the
termination, be subject to a royalty payment or Net Proceeds sharing, and such
party and its Affiliates, sublicensees and distributors shall thereupon be
permitted to sell that amount of Licensed Product(s) as well as any Licensed
Product(s) for which manufacture has already begun, provided that such party
shall pay to the other party the amounts payable thereon at the time herein
provided for.
19.3 Know-How. Upon any (a) expiration or (b) termination of this
Agreement after which a party is granted or retains a license under Article 18
of this Agreement to continue the research, development, manufacture,
commercialization, sale or other exploitation of any Licensed Product(s)
(including after the expiration of all Valid Claims covering a given Licensed
Product), the licenses granted to such party hereunder in such of the other
party's know-how (i.e. with respect to Corixa, in the Kirin Know-How, or with
respect to Kirin, in the Corixa Know-How) that existed as of the effective date
of termination, shall remain in effect (on a non-exclusive, royalty free, fully
paid-up basis) for so long as such party's right to research, develop,
manufacture, commercialize, sell, and/or otherwise exploit such Licensed
Product(s) remains in effect.
19.4 Joint Inventions and Joint Patents. In the event this Agreement
either expires or is terminated in its entirety, Corixa and Kirin shall, subject
to Sections 18.5(b) and (c) and Section 18.8, each have the right to exploit,
including but not limited to by means of licensing to Third Party(ies), the
Joint Inventions and Joint Patents for any purpose in any field, and neither
party shall have any obligation to obtain the other party's consent to any
aspect of such permitted exploitation, to account to the other party in any
manner in connection therewith, or to make any payment to the other party in
connection therewith. Upon any termination of this Agreement with respect to a
given country(ies) or territory(ies) pursuant to Section 18.4, Corixa and Kirin
shall each have the right to exploit, including but not limited to by means of
licensing to Third Party(ies), the Joint Inventions and Joint Patents for any
purpose in any field in such country(ies) or territory(ies), and neither party
shall have any obligation to obtain the other party's consent to any aspect of
such permitted exploitation, to account to the other party in any manner in
connection therewith, or to make any payment to the other party in connection
therewith, provided that the parties agree to cooperate with each other with
respect to any patent prosecution and maintenance activities related to such
Joint Patents and Joint Inventions as set forth in Section 11.1 hereof.
19.5 Licensed Trademarks. Except as otherwise provided in Article 18,
each party's licenses in the other party's Licensed Trademarks shall expire, on
a trademark-by-trademark basis, upon the expiration or termination of this
Agreement; provided, however, that each party (to the extent permitted under
this Agreement to sell Licensed Products after expiration or termination of this
Agreement): (a) shall thereafter have a reasonable period, not to exceed twelve
(12) months following such expiration or termination, within which to use the
existing inventory of such Licensed Product promotional materials and labeling
containing any Licensed Product Trademarks; and (b) may continue to use such
Licensed Product Trademarks solely as necessary in connection with regulatory
correspondence relating to Licensed Products.
-61-
19.6 Confidential Information. Upon any termination or expiration of
this Agreement, any and all Confidential Information of a party ("Disclosing
Party") possessed in tangible form by the other party, its Affiliates or
sublicensees or its or any of their officers, directors, employees, agents,
consultants or clinical investigators ("Receiving Party") shall, upon written
request of the Disclosing Party, be immediately returned to the Disclosing Party
(or destroyed if so requested) and not retained by the Receiving Party, its
Affiliates or sublicensees or any of their officers, directors, employees,
agents, consultants or clinical investigators, provided that, in the event
(pursuant to Article 18 or 19) any rights or licenses survive or are granted
upon the termination of this Agreement, the party retaining or receiving such
rights and/or licenses, as applicable, shall be entitled to retain any
Confidential Information of the other party that is reasonably required to
exercise such rights and licenses for so long as such rights and licenses
survive. Notwithstanding the foregoing, each party may retain one (1) copy of
any Confidential Information in an appropriately secure location for
record-keeping purposes.
19.7 Cooperation. If either party ("Licensed Party") shall receive or be
granted any rights or licenses from the other party ("Licensing Party") in
accordance with the provisions of Article 18, the Licensing Party shall
reasonably promptly provide to the Licensed Party (or any Affiliate designated
by the Licensed Party) such manufacturing know-how and access to regulatory
filings as is reasonably sufficient to allow the Licensed Party to exercise the
rights or licensed granted thereunder. The Licensing Party shall further provide
reasonable assistance and cooperation required by the Licensed Party with
respect to such transfer so as to permit the Licensed Party to begin to exercise
such rights as soon as reasonably possible to minimize any disruption in the
continuity of supply or marketing of Licensed Products.
19.8 Survival. 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, (a) the following Articles and Sections shall
survive any expiration or termination of this Agreement (whether such
termination is of the entire Agreement or with respect to a given specific
territory(ies)): 1 ("Definitions"), 2.6 ("Freedom to Conduct Clinical Trials"),
3.3(d) ("Rights to Data"), 4.2(b) ("[*]"), 4.2(d) ("[*]"), 4.3 ("Sublicenses of
Third Party Rights to Kirin"), 4.4 ("Exploitation of Joint Inventions and Joint
Patents"), 5 ("Research and Development Funding and Costs"), 6.7 ("Payments and
Currency"), 6.8 ("Withholding Taxes"), 6.10 ("Payments Upon Termination"), 7.1
("Payments and Reports") (for Sections 5, 6.1, 6.2, 6.7, 6.8, 6.10 and 7.1, only
with respect to applicable payments accruing prior to termination or expressly
provided to be made after termination hereunder); 7.2 ("Accounting") (in
accordance with its terms), 7.3 ("Confidentiality of Reports"), 10.1
("Inventions"), 12.3 ("Confidential Information") (in accordance with its
terms), 12.4 ("Permitted Disclosures"), 12.5 ("Bankruptcy Procedures"), 12.7
("Publicity"), 13 ("Governing Law; Dispute Resolution"), 14.2 ("Trademark
Licenses"), 14.3 ("Trademark Use Requirements"), 14.4 ("Infringement of Licensed
Product Trademarks"), 15 ("Miscellaneous"), 16 ("Assignment"), 17.4
("Disclaimer"), 17.6 ("Limited Liability"), 18 ("Term and Termination"), 19
("Additional Rights and Duties Upon Termination"), and 20 ("Indemnification");
and (b) only in the event Kirin retains any licenses or rights to Corixa WT-1
Patents, Corixa Adjuvant Patents or Corixa [*] Patents following termination or
expiration in accordance with Section 18.3, Section 18.5 or Section 18.8,
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Section 11 ("Patents; Prosecution and Litigation") shall survive termination or
expiration of this Agreement solely with respect to such patents.
20. INDEMNIFICATION.
20.1 Indemnification. Subject to Section 20.2 hereof, from and after the
Effective Date, each of the parties hereto (each, the "Indemnifying Party")
shall defend, indemnify and hold harmless the other party (the "Indemnified
Party") and its Affiliates, successors and assigns, and their respective
officers, directors, shareholders and employees from and against all losses,
damage, liability and expense including reasonable attorney's fees ("Damages")
arising out of any third party claim, suit or demand arising out of or resulting
from: (a) any breach or violation of any covenant or agreement made by such
Indemnifying Party hereunder (unless such breach or violation has been waived in
writing by the Indemnifying Party); (b) any breach of any of the representations
or warranties made by such Indemnifying Party hereunder; or (c) the gross
negligence or willful misconduct of the Indemnifying Party; provided, however,
that the foregoing subsection (c) shall not apply to the extent such Damages are
attributable to the gross negligence or willful misconduct of the Indemnified
Party.
20.2 Procedure. If either Indemnified Party receives any written claim
which it believes is the subject of indemnity hereunder by the Indemnifying
Party, the Indemnified Party shall, as soon as reasonably practicable after
forming such belief, give notice thereof to the Indemnifying Party, including
the 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 under this Section 20.2 shall not release the Indemnifying
Party from any liability to the Indemnified Party other than any liabilities
directly attributable to such failure. 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, at the sole
cost and expense of the Indemnifying Party; provided that 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 cost and expense of
the Indemnifying Party. If the Indemnifying Party 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.
20.3 Cooperation. The party not assuming the defense of any claim
subject to indemnification under this Article 20 shall render all reasonable
assistance to the party assuming such defense, provided that all costs of such
assistance shall be borne solely by the Indemnifying Party.
20.4 Settlement. No claim that is subject to indemnification under this
Article 20 shall be settled or otherwise compromised other than by the party
defending such claim, and then only with the prior written consent of the other
party, which shall not be withheld unless the settlement or compromise either
(a) imposes on the Indemnified Party any liability or obligation which cannot be
assumed and performed in full by the Indemnifying Party, or (b) materially
adversely affects the Indemnified Party.
[Signature page follows]
-63-
IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement
to be executed by its duly authorized officer as of the Effective Date first
written above.
CORIXA CORPORATION KIRIN BREWERY COMPANY, LTD.
By: /s/ XXXXXX XXXXXX By: /s/ XXXXXXXXX XXXXX
------------------------------------ ----------------------------------
Xxxxxx Xxxxxx Xxxxxxxxx Xxxxx
Chairman and Chief Executive Officer President, Pharmaceutical Division
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EXHIBIT A TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
CORIXA WT-1 PATENTS
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
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[*] US [*] Abandoned
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[*] US [*] Abandoned
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[*] US [*] [*] ISSUED
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[*] US [*] [*] ISSUED
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[*] US [*] Published
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[*] US [*] [*] ISSUED
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[*] US [*] Pending
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[*] WO [*] Converted
------------------------------------------------------------------------------
[*] CA [*] Pending
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[*] CH [*] [*] Granted
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[*] DE [*] [*] Granted
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[*] EP [*] [*] ISSUED
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[*] FR [*] [*] Granted
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[*] GB [*] [*] Granted
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[*] IT [*] [*] Granted
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[*] JP [*] Pending
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[*] US [*] Pending
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[*] US [*] Pending
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* Confidential Treatment Requested.
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[*] US [*] Pending
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[*] US [*] Pending
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[*] US [*] Pending
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[*] US [*] Pending
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[*] US [*] Pending
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[*] US [*] Pending
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[*] US [*] Pending
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[*] US Unfiled
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[*] WO [*] [*] Converted
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[*] AR [*] Pending
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[*] AU [*] Pending
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[*] BR [*] Pending
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[*] CA [*] Pending
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[*] CN [*] Published
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[*] CO [*] Pending
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[*] CZ [*] Pending
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[*] EP [*] Published
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[*] HK [*] Pending
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[*] HU [*] Pending
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[*] IL [*] Pending
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[*] JP [*] Pending
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[*] KR [*] Pending
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* Confidential Treatment Requested.
-2-
------------------------------------------------------------------------------
[*] MX [*] Pending
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[*] MY [*] Pending
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[*] NO [*] Pending
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[*] NZ [*] Pending
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[*] PH [*] Pending
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[*] PK [*] Pending
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[*] PL [*] Pending
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[*] RU [*] Pending
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[*] SA [*] Pending
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[*] TR [*] Pending
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[*] TW [*] Pending
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[*] VE [*] Pending
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[*] ZA [*] Pending
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[*] WO [*] [*] Published
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] [*] Converted
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[*] AU [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
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[*] EP [*] Pending
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[*] JP [*] Pending
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[*] NZ [*] Pending
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* Confidential Treatment Requested.
-3-
EXHIBIT A-1 TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
CORIXA ADJUVANTS
[*]
----------
* Confidential Treatment Requested.
EXHIBIT A-2 TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
CORIXA ADJUVANT PATENTS
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Pending
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] WO [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] WO [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] WO [*] Published
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Pending
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Pending
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Pending
------------------------------------------------------------------------------
[*] US [*] [*] Expired
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] AU [*] [*] Expired
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] DK [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IL [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] Pending
------------------------------------------------------------------------------
[*] NO [*] [*] Granted
------------------------------------------------------------------------------
[*] NZ [*] [*] Expired
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-2-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] SE [*] [*] Granted
------------------------------------------------------------------------------
[*] ZA [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IL [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] [*] Granted
------------------------------------------------------------------------------
[*] NZ [*] [*] Granted
------------------------------------------------------------------------------
[*] ZA [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] AU [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-3-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] NZ [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] Published
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-4-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] Abandoned
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] Pending
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-5-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Published
------------------------------------------------------------------------------
[*] AR [*] Pending
------------------------------------------------------------------------------
[*] AU [*] Pending
------------------------------------------------------------------------------
[*] BR [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
------------------------------------------------------------------------------
[*] CN [*] Pending
------------------------------------------------------------------------------
[*] CO [*] Pending
------------------------------------------------------------------------------
[*] EP [*] Pending
------------------------------------------------------------------------------
[*] GC [*] Pending
------------------------------------------------------------------------------
[*] JP [*] Pending
------------------------------------------------------------------------------
[*] MX [*] Pending
------------------------------------------------------------------------------
[*] MY [*] Pending
------------------------------------------------------------------------------
[*] NO [*] Pending
------------------------------------------------------------------------------
[*] NZ [*] Pending
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-6-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] PH [*] Pending
------------------------------------------------------------------------------
[*] PK [*] Pending
------------------------------------------------------------------------------
[*] TW [*] Pending
------------------------------------------------------------------------------
[*] VE [*] Pending
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Pending
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] Published
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
[*] AU [*] [*] Granted
------------------------------------------------------------------------------
[*] AU [*] Pending
------------------------------------------------------------------------------
[*] AU [*] Pending
------------------------------------------------------------------------------
[*] BR [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
------------------------------------------------------------------------------
[*] CN [*] Pending
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-7-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] EP [*] Pending
------------------------------------------------------------------------------
[*] HK [*] Pending
------------------------------------------------------------------------------
[*] HU [*] Pending
------------------------------------------------------------------------------
[*] IL [*] Pending
------------------------------------------------------------------------------
[*] JP [*] Published
------------------------------------------------------------------------------
[*] KR [*] Pending
------------------------------------------------------------------------------
[*] MX [*] Pending
------------------------------------------------------------------------------
[*] NO [*] Pending
------------------------------------------------------------------------------
[*] NZ [*] Pending
------------------------------------------------------------------------------
[*] PL [*] Pending
------------------------------------------------------------------------------
[*] SG [*] [*] Granted
------------------------------------------------------------------------------
[*] TR [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
[*] AP [*] Pending
------------------------------------------------------------------------------
[*] AU [*] [*] ISSUED
------------------------------------------------------------------------------
[*] BR [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
------------------------------------------------------------------------------
[*] CN [*] Pending
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-8-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] EP [*] Published
------------------------------------------------------------------------------
[*] HK [*] Pending
------------------------------------------------------------------------------
[*] HU [*] Published
------------------------------------------------------------------------------
[*] ID [*] Published
------------------------------------------------------------------------------
[*] IL [*] Pending
------------------------------------------------------------------------------
[*] JP [*] Pending
------------------------------------------------------------------------------
[*] KP [*] [*] Granted
------------------------------------------------------------------------------
[*] KR [*] Pending
------------------------------------------------------------------------------
[*] MX [*] Pending
------------------------------------------------------------------------------
[*] NZ [*] Pending
------------------------------------------------------------------------------
[*] OA [*] [*] Granted
------------------------------------------------------------------------------
[*] PL [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
[*] AU [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
------------------------------------------------------------------------------
[*] EP [*] Published
------------------------------------------------------------------------------
[*] JP [*] Pending
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-9-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] AU [*] Pending
------------------------------------------------------------------------------
[*] BR [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
------------------------------------------------------------------------------
[*] CN [*] Pending
------------------------------------------------------------------------------
[*] EP [*] Published
------------------------------------------------------------------------------
[*] HK [*] Pending
------------------------------------------------------------------------------
[*] HU [*] Published
------------------------------------------------------------------------------
[*] IN [*] Pending
------------------------------------------------------------------------------
[*] JP [*] Pending
------------------------------------------------------------------------------
[*] KR [*] Pending
------------------------------------------------------------------------------
[*] MX [*] Pending
------------------------------------------------------------------------------
[*] NO [*] Pending
------------------------------------------------------------------------------
[*] NZ [*] Pending
------------------------------------------------------------------------------
[*] SG [*] Pending
------------------------------------------------------------------------------
[*] ZA [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-00-
XXXXXXX X-0 TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
CORIXA [*] PATENTS
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] US [*] Converted
------------------------------------------------------------------------------
[*] US [*] Published
------------------------------------------------------------------------------
[*] WO [*] Published
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] AU [*] [*] Granted
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] DK [*] [*] Granted
------------------------------------------------------------------------------
[*] EP [*] [*] Granted
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] GR [*] [*] Granted
------------------------------------------------------------------------------
[*] IE [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] Pending
------------------------------------------------------------------------------
[*] LI [*] [*] Granted
------------------------------------------------------------------------------
[*] LU [*] [*] Granted
------------------------------------------------------------------------------
[*] MC [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] [*] Granted
------------------------------------------------------------------------------
[*] PT [*] [*] Granted
------------------------------------------------------------------------------
[*] SE [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-2-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] US [*] Pending
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] AU [*] [*] Pending
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] CN [*] [*] Granted
------------------------------------------------------------------------------
[*] CN [*] Pending
------------------------------------------------------------------------------
[*] EP [*] Pending
------------------------------------------------------------------------------
[*] IE [*] [*] Granted
------------------------------------------------------------------------------
[*] IL [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] KR [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-3-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] NZ [*] [*] Granted
------------------------------------------------------------------------------
[*] SG [*] ISSUED
------------------------------------------------------------------------------
[*] TW [*] [*] Granted
------------------------------------------------------------------------------
[*] ZA [*] [*] Granted
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] EP [*] [*] Granted
------------------------------------------------------------------------------
[*] EP [*] Pending
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] IE [*] [*] ISSUED
------------------------------------------------------------------------------
[*] IE [*] Pending
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] LU [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] [*] Granted
------------------------------------------------------------------------------
[*] SE [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-4-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] TW [*] [*] ISSUED
------------------------------------------------------------------------------
[*] CN [*] Allowed
------------------------------------------------------------------------------
[*] CN [*] Pending
------------------------------------------------------------------------------
[*] IE [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] RU [*] Published
------------------------------------------------------------------------------
[*] US [*] Abandoned
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
[*] CA [*] [*] Granted
------------------------------------------------------------------------------
[*] CH [*] Abandoned
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] DK [*] [*] Granted
------------------------------------------------------------------------------
[*] EP [*] [*] Converted
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FI [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] GR [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-5-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] HK [*] [*] Granted
------------------------------------------------------------------------------
[*] IE [*] [*] Granted
------------------------------------------------------------------------------
[*] IL [*] [*] Granted
------------------------------------------------------------------------------
[*] IN [*] [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] [*] Granted
------------------------------------------------------------------------------
[*] KR [*] [*] Granted
------------------------------------------------------------------------------
[*] LU [*] [*] Granted
------------------------------------------------------------------------------
[*] MX [*] [*] Granted
------------------------------------------------------------------------------
[*] NL [*] [*] Granted
------------------------------------------------------------------------------
[*] NO [*] [*] Granted
------------------------------------------------------------------------------
[*] NZ [*] [*] Granted
------------------------------------------------------------------------------
[*] SE [*] [*] Granted
------------------------------------------------------------------------------
[*] SG [*] [*] Granted
------------------------------------------------------------------------------
[*] TW [*] [*] Granted
------------------------------------------------------------------------------
[*] ZA [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] AT [*] [*] Granted
------------------------------------------------------------------------------
[*] AU [*] Granted
------------------------------------------------------------------------------
[*] BE [*] [*] Granted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-6-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] BR [*] Abandoned
------------------------------------------------------------------------------
[*] CA [*] [*] ISSUED
------------------------------------------------------------------------------
[*] CH [*] [*] Granted
------------------------------------------------------------------------------
[*] DE [*] [*] Granted
------------------------------------------------------------------------------
[*] EP [*] [*] Granted
------------------------------------------------------------------------------
[*] ES [*] [*] Granted
------------------------------------------------------------------------------
[*] FR [*] [*] Granted
------------------------------------------------------------------------------
[*] GB [*] [*] Granted
------------------------------------------------------------------------------
[*] GR [*] [*] Granted
------------------------------------------------------------------------------
[*] IL [*] Granted
------------------------------------------------------------------------------
[*] IT [*] [*] Granted
------------------------------------------------------------------------------
[*] JP [*] Abandoned
------------------------------------------------------------------------------
[*] LU [*] [*] Granted
------------------------------------------------------------------------------
[*] MX [*] Granted
------------------------------------------------------------------------------
[*] NL [*] [*] Granted
------------------------------------------------------------------------------
[*] NZ [*] Granted
------------------------------------------------------------------------------
[*] PH [*] Granted
------------------------------------------------------------------------------
[*] SE [*] [*] Granted
------------------------------------------------------------------------------
[*] US [*] [*] ISSUED
------------------------------------------------------------------------------
[*] WO [*] Converted
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-7-
------------------------------------------------------------------------------
APP. NO./FILING PATENT NO./ISSUE
CASE NUMBER COUNTRY DATE DATE STATUS
------------------------------------------------------------------------------
------------------------------------------------------------------------------
[*] AU [*] Pending
------------------------------------------------------------------------------
[*] CA [*] Pending
------------------------------------------------------------------------------
[*] EP [*] Pending
------------------------------------------------------------------------------
[*] HK [*] Pending
------------------------------------------------------------------------------
----------
* Confidential Treatment Requested.
-8-
EXHIBIT B TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
LIST OF THIRD PARTY AGREEMENTS
1. License Agreement, made and entered into as of [*], by and among [*]
and Corixa.
2. [*] License Agreement, made and entered into as of [*], between [*]
and Corixa.
3. License Agreement, made and entered into as of [*], between [*] and
Corixa.
4. Exclusive License Agreement, made and entered into as of [*], between
[*] and Corixa.
5. License Agreement, made and entered into as of [*], between [*] and
Corixa.
----------
* Confidential Treatment Requested.
EXHIBIT B-1 TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
COPY OF [*] AGREEMENT
[*]
----------
* Confidential Treatment Requested.
EXHIBIT C TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
MINIMUM TERMS AND CONDITIONS OF
SUPPLY AGREEMENT
The Supply Agreement, as defined in Section 9.3 of the License, Development and
Commercialization Agreement (the "LDC Agreement"), shall contain the following
minimum terms and conditions and such other reasonable terms and conditions as
the parties may mutually agree upon (capitalized terms in this Exhibit C shall
have the meanings given thereto in the LDC Agreement):
1. Term. The term of the Supply Agreement shall commence upon signing
and end upon the expiration or termination of the LDC Agreement.
2. Suspension and Termination. Upon either party's material breach of a
material provision of the Supply Agreement the non-breaching party may either
(a) suspend performance under the Supply Agreement upon thirty (30) days prior
written notice detailing the breach unless the breaching party cures such breach
within such thirty (30) day period (and any such suspension shall continue until
the breaching party has cured such breach, at which time the Supply Agreement
shall resume); or (b) the non-breaching party may terminate the Supply Agreement
following ninety (90) days prior written notice detailing the breach unless the
breaching party cured such breach within such ninety (90) day period.
3. Supply. Corixa shall, and shall have the right to, manufacture and
supply 100% of Kirin's requirements of Licensed Products (including Corixa
Adjuvants and [*] for such Licensed Products, if applicable) in both Territory A
and Territory B (provided that notwithstanding the foregoing, in the case of Ex
Vivo Licensed Products, the foregoing shall apply only to the applicable portion
of the Ex Vivo Licensed Product (i.e. the WT-1 antigen) actually supplied,
rather than to the entire Ex Vivo Licensed Product). Corixa shall manufacture
all Licensed Products in accordance with cGMP applicable to the jurisdiction in
which such Licensed Products are manufactured, and with other applicable
specifications determined by the Development Steering Committee and, as
applicable, the Commercialization Steering Committee, as determined by mutual
agreement of the parties or as reasonably required to comply with applicable
law. Corixa shall manufacture all Licensed Products in a manner such that such
Licensed Products shall have at least a [*] year shelf-life. Corixa may elect to
discontinue supplying Kirin by providing Kirin no less than one hundred eighty
(180) days prior written notice of such election, in which case Kirin may
exercise its make and have made rights pursuant to Section 4.1(f) of the LDC
Agreement (and Corixa will promptly and fully cooperate with Kirin in ensuring a
smooth transition to Kirin's exercise of such rights).
4. QA/QC and Packaging. Corixa shall, in consultation with Kirin and in
accordance with any applicable directions of the Development Steering Committee
and, as applicable, Commercialization Steering Committee, develop, validate and
implement suitable manufacturing and packaging processes for Licensed Products,
appropriate quality control and
----------
* Confidential Treatment Requested.
quality assurance processes and procedures, and lot release testing for the
Licensed Products. Corixa shall fully disclose such quality control, quality
assurance and lot release processes, procedures and testing methods to Kirin.
5. Delivery. Delivery of Licensed Products shall be made in accordance
with reasonable time schedules (including reasonable ordering and fulfillment
procedures) and in sufficient quantities to meet Kirin's requirements of
Licensed Product. All deliveries to Kirin shall be C.I.F. Narita Airport and
shall be subject to testing and acceptance by Kirin. All deliveries not rejected
within sixty (60) days of delivery shall be deemed to be accepted by Kirin.
Materials properly rejected by Kirin shall be replaced promptly by Corixa at
Corixa's sole expense. Kirin shall use its reasonable efforts to assist Corixa
in arranging any desired insurance (in amounts that Kirin shall determine) and
transportation, via air freight unless otherwise specified in writing by Kirin,
to any destinations specified in writing from time to time by Kirin. All
customs, duties, costs, taxes, insurance premiums, and other expenses relating
to such transportation and delivery shall be at Corixa's expense (and shall be
included in Fully Burdened Manufacturing Costs under this Agreement). The Supply
Agreement will provide for reasonable acceptance procedures, procedures for
returns and supply of replacement goods and final quality assurance and lot
release testing procedures.
6. Transfer Prices. With respect to Licensed Products supplied to Kirin
for disposition in Territory A, Kirin shall pay Corixa the amounts specified in
Section 6.2 of the LDC Agreement. With respect to Licensed Products supplied to
Kirin under the Supply Agreement for disposition in Territory B, Kirin shall pay
Corixa one-half of Corixa's Fully Burdened Manufacturing Cost.
7. Packaging. Subject to paragraph 8 of this Exhibit C below, Corixa
shall be responsible for primary packaging of Licensed Products in accordance
with mutually agreed upon specifications, provided that Kirin shall be
responsible for secondary packaging of Licensed Products to be sold in Territory
A (secondary packaging to include, without limitation, packaging and labeling of
the trade carton or shipment package containing the Licensed Product, labeling
of the Licensed Products themselves, and corresponding printed components) in
accordance with specifications determined by Kirin in its sole discretion.
8. Local Regulatory Requirements. In the event the applicable laws
or regulations of the jurisdiction in which the Licensed Products are to be sold
require that portions of the manufacturing process for Licensed Products take
place in such jurisdiction (for example, filling, formulation, or labeling),
Corixa and Kirin shall reasonably accommodate such requirements and provide each
other with such reasonable assistance as may be necessary to comply with such
requirements.
9. Kirin's Manufacturing Rights. In the event: (a) Corixa elects to
discontinue supplying Kirin in accordance with Section 3 of this Exhibit C
above, (b) Corixa breaches the Supply Agreement which breach affects the
availability, quantity or quality of Licensed Products, and Corixa fails to cure
such breach within sixty (60) days of Kirin's written notice thereof (provided
that the occurrence of the third of three breaches of a similar nature within
any consecutive twelve (12) month period shall not be deemed curable hereunder);
(c) Corixa fails materially to meet any of its manufacture and supply
commitments for Licensed Products (in
-2-
terms of availability, quantity or quality of Licensed Products and including
the failure to supply Kirin's requirements for Licensed Products) to Kirin under
the Supply Agreement (regardless of the cause of such failure and
notwithstanding the absence of any breach by Corixa) for a continuous period of
nine (9) months or a non-continuous period of twelve (12) months over any two
(2) year period; (d) any of the events triggering a right of Kirin to terminate
under Section 18.7 ("Termination on Bankruptcy") occurs with respect to Corixa;
or (e) Kirin elects to continue the development and/or commercialization of the
Licensed Product(s) in accordance with Section 18.5(c) or Section 18.8 following
termination of the LDC Agreement, then Kirin shall thereafter have no further
obligation under Section 4.1(f) of the LDC Agreement to forebear exercising, and
Kirin shall thereupon have the right to exercise, its "make" and "have made"
rights with respect to the Licensed Products. If Kirin exercises this right, it
shall provide Corixa with written notice thereof and Corixa shall reasonably
cooperate in transferring the necessary Corixa Know-How to Kirin, and provide
Kirin with reasonable technical assistance, all as reasonably necessary to
enable Kirin to manufacture Licensed Products; provided that Kirin shall
reimburse Corixa all out-of-pocket costs incurred in connection with such
transfer and assistance (except in the event that Corixa has elected in
accordance with Section 3 of this Exhibit C above to discontinue supplying
Kirin, in which event Corixa will itself be responsible for all such
out-of-pocket costs).
10. Other. The Supply Agreement will include other provisions
customarily found in agreements for products of a similar nature, including,
without limitation representations and warranties, rejection, recall and
inspection of Licensed Products, facility audits and inspections, performance
and quality standards, insurance, indemnification and compliance with
governmental laws, rules and regulations in the manufacture and supply of
Licensed Products.
-3-
EXHIBIT D TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
COST AND REVENUE SHARING
1. Definitions.
1.1 "Commercialization Costs" shall mean those Costs directly
attributable to either Party's performance of the Territory B Commercialization
Program (or, as applicable Kirin's performance of its commercialization
activities in Territory A), but in any event limited to such Costs that are
reasonably and fairly allocable to marketing and sales of Licensed Products,
management of sublicensee relationships, manufacture and supply of Licensed
Products (to the extent not already addressed hereunder) and regulatory
compliance.
1.2 "Costs" shall mean those variable costs and fixed costs (as defined
below in this Section) properly and reasonably incurred by the parties in
connection with their performance of, as applicable, the Research Program, the
Territory A and Territory B Clinical Development Programs, the Territory B
Commercialization Program, and Kirin's commercialization activities in Territory
A (each a "Program"). For purposes of this Section: (i) "variable costs" shall
be deemed to be the cost of labor, raw materials, supplies and other resources
directly consumed in the execution of the applicable Program and amounts paid to
permitted contractors and sublicensees to the extent reasonably and fairly
attributable to the performance of the applicable Program; and (ii) "fixed
costs" shall be deemed to be the cost of facilities, utilities, insurance,
facility and equipment depreciation and other fixed costs directly related to,
or otherwise reasonably and fairly allocable to, the execution of the applicable
Program. All cost determinations made under this Section shall be made in
accordance with GAAP or GAAP Counterpart (as applicable), consistently applied.
In any event, Costs shall exclude all costs otherwise reimbursed or otherwise
paid by one Party to the other pursuant to this Agreement and, for the avoidance
or doubt, shall also exclude any unreimbursed remainder portion of costs where
the other portion of such costs was reimbursed pursuant to this Agreement (that
is, for example, if Kirin already reimbursed Corixa for one half of Corixa's
Fully Burdened Manufacturing Costs for Licensed Products hereunder, Corixa must
exclude the remaining unreimbursed half of such amount from its incurred Costs
to be further shared between the parties under Article 5).
1.3 "Net Proceeds" shall mean the fair market value of all compensation
or consideration received by Corixa or Kirin in connection with: (a) any license
and/or sublicense to a Third Party in Territory B of any rights in, to or under
a Licensed Product (including Ex Vivo Licensed Products) or the Corixa WT-1
Patents, Corixa Adjuvant Patents, Corixa [*] Patents, or Joint Patents,
including license fees, technology access fees, royalties and milestone
payments; and (b) Net Sales (as defined in Section 1.35) of Licensed Products
(including Ex Vivo Licensed Products) in Territory B. Net Proceeds shall not
include any compensation received by Corixa or Kirin: (i) for any materials
supplied hereunder or under the Supply Agreement by Corixa to Kirin for sale in
Territory A; (ii) for any proceeds received in connection with any litigation or
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settlement arising from or related to this Agreement or Licensed Product(s) or
any other subject matter hereof; (iii) for bona fide research and development
services relating to the Licensed Product(s) but solely to the extent provided
at actual cost; (iv) from a Third Party in exchange for issuance of the
licensing party's securities (including options to purchase the licensing
party's securities), provided no such amounts are fairly attributable to
anything in subsection (a) or (b) above; or (v) which amounts are already shared
by the parties in accordance with the Agreement.
2. Allocation and Reconciliation of Costs.
2.1 Allocation of Research, Development and Commercialization Costs.
Kirin shall reimburse Corixa [*] of those Costs and Commercialization Costs
directly attributable to Corixa's performance of the Research Program in
Territory B, the Territory B Clinical Development Program and the Territory B
Commercialization Program; and Corixa shall reimburse Kirin [*] of those Costs
and Commercialization Costs directly attributable to Kirin's performance of the
Research Program in Territory B, the Territory B Clinical Development Program
and the Territory B Commercialization Program.
2.2 Reconciliation of Research Costs. Within forty-five (45) days
following the end of the first calendar quarter in which Costs are incurred by
either party pursuant to the Research Program taking place in Territory B and
each subsequent calendar quarter during the Term until the quarter after such
Research Program ends or is terminated, each party shall provide to the other a
statement of the Costs incurred by such party directly attributable to such
party's performance of the Research Program taking place in Territory B. Within
thirty (30) days of the date when Cost statements are to be provided, the party
incurring the lower amount of Costs for such quarter shall pay to the other an
amount equal to one half of the difference between the two incurred Cost amounts
for each party for such quarter, so that, as a result of such payment, each
party bears [*] of such shared Costs. A report specifying how each payment was
calculated shall also be submitted with each payment to the non-paying party.
2.3 Reconciliation of Development Costs. Within forty-five (45) days
following the end of the first calendar quarter in which Costs are incurred by
either party pursuant to the Territory B Clinical Development Program, and each
subsequent calendar quarter during the Term until the quarter after the
Territory B Clinical Development Program ends or is terminated, each party shall
provide to the other a statement of the Costs incurred by such party directly
attributable to such party's performance of the Territory B Clinical Development
Program. Within thirty (30) days of the date when Cost statements are to be
provided, the party incurring the lower amount of Costs for such quarter shall
pay to the other an amount equal to one half of the difference between the two
incurred Cost amounts for each party for such quarter, so that, as a result of
such payment, each party bears [*] of such shared Costs. A report specifying how
each payment was calculated shall also be submitted with each payment to the
non-paying party.
2.4 Reconciliation of Shared Commercialization Costs. Within forty-five
(45) days following the end of the first calendar quarter in which
Commercialization Costs are incurred by either party pursuant to the Territory B
Commercialization
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Program, and each subsequent calendar quarter during the Term until the quarter
after the Territory B Commercialization Program ends or is terminated, each
party shall provide to the other a statement of the Commercialization Costs
incurred by such party directly attributable to such party's performance of the
Territory B Commercialization Program. Within thirty (30) days of the date when
Commercialization Cost statements are to be provided, the party incurring the
lower amount of Commercialization Costs for such quarter shall pay to the other
an amount equal to one half of the difference between the two incurred
Commercialization Cost amounts for each party for such quarter, so that, as a
result of such payment, each party bears [*] of such shared Commercialization
Costs. A report specifying how each payment was calculated shall also be
submitted with each payment to the non-paying party.
2.5 Net Proceeds Reconciliation. Within forty-five (45) days following
the end of the first calendar quarter during which Net Proceeds are earned by
either party, and each subsequent calendar quarter during the Term, each party
shall provide to the other a statement of the Net Proceeds received by such
party during such quarter. Within thirty (30) days of the date when Net Proceeds
statements are to be provided, the party receiving the higher amount of Net
Proceeds for such quarter shall pay to the other an amount equal to one half of
the difference between the two Net Proceeds amounts for each party for such
quarter, so that, as a result of such payment, each party receives [*] of such
Net Proceeds. A report specifying how each payment was calculated shall also be
submitted with each payment to the non-paying party.
2.6 Adjustment for Assignment or License of [*] Patent in Certain
Countries. In the event that [*] or any assignee, licensee or sublicensee of his
right, title or interest in, to or under any of the [*] licenses or exercises
any rights under such [*] in any country in Territory B, and [*] or such party,
as applicable, or any of their respective licensees or sublicensees, makes or
sells any Licensed Product(s) in such country in connection therewith, then Net
Proceeds required to be paid to Corixa hereunder shall thereafter be reduced by
an amount equal to the lost profits attributable to the sale of any such
Licensed Product(s) in Territory B. For purposes of this Section 2.6, lost
profits shall be the average per unit profit during the immediately preceding
three calendar quarters calculated as follows: total Net Proceeds earned for all
Licensed Products sold in Territory B by the parties during the immediately
preceding three calendar quarters, minus all Costs incurred by the parties in
Territory B during such immediately preceding three calendar quarters. Such per
unit profit average shall then be multiplied by the number of units of the
competitive Licensed Product(s) actually sold by such third party in Territory B
to arrive at the lost profit amount. Such adjustment shall be calculated at the
end of each quarter during which such manufacture or sale activity continues.
2.7 Mechanisms for Net Payment. If the parties mutually agree, they may
institute a procedure for netting out all the payments to be made by each party
hereunder after the end of each quarter so that only one net payment needs to be
made (including, for example, by having the parties exchange reports of Costs
incurred and Net Proceeds earned and then using the reports to calculate one net
reconciliation payment to be paid by the applicable party).
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EXHIBIT E TO LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
THIRD PARTY AGREEMENT ROYALTIES
Maximum Royalty Rate
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[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
Exhibit E does not include royalties under the [*] license [*]
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