EXHIBIT 10.64
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CORIXA CORPORATION
AND
ZENYAKU KOGYO CO., LTD.
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DEVELOPMENT
AND
LICENSE AGREEMENT
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*Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 406 of the Securities Act of 1933, as amended.
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EXHIBITS
Exhibit A Corixa Patents
Exhibit B PVAC Specifications
Exhibit C Development and Commercialization Program
Exhibit D Other [*] Indications
Exhibit E Form of Supply Agreement
Exhibit F Corixa Third Party Agreements
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DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT (together with the attachments and
exhibits hereto, the "Agreement") is entered into as of August 16, 1999 (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 00000-0000, and Zenyaku
Kogyo Co., Ltd., a corporation organized and existing under the laws of Japan
and having its principal office at 0-00 Xxxxxx, 0-Xxxxx, Xxxxxx-Xx, Xxxxx
000-0000, Xxxxx.
RECITALS
WHEREAS, Corixa has scientific expertise, proprietary information and
biological materials related to the development of immune system modulating, or
immunomodulatory, materials;
WHEREAS, ZKC has expertise in developing and commercializing therapeutic
products;
WHEREAS, Corixa and ZKC desire to collaborate in the development of
immuno-modulatory products for the therapy of human psoriasis; and
WHEREAS, in connection with the collaboration, Corixa has agreed to license
to ZKC in Japan certain intellectual property rights related to the Licensed
Product, 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
4.1(c).
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 to the extent
of at least fifty percent (50%) of the equity (or such lesser percentage that is
the maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs of the entity
and any person, firm, partnership, corporation, or other entity actually
controlled by, controlling or under common control with a party to this
Agreement.
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1.3 "Commercial Launch" shall mean the [*] sale of the Licensed Product in
the Territory by ZKC or an Affiliate of ZKC.
1.4 "Development and Commercialization Program" shall have the meaning set
forth in Section 2.1.
1.5 "Collaboration" shall mean the joint collaboration of Corixa and ZKC
pursuant to the terms of this Agreement and the Development and
Commercialization Program.
1.6 "Corixa" shall mean Corixa Corporation and each of its Affiliates.
1.7 "Corixa Know-How" shall mean all technical information, materials and
know-how [*] relates to the Licensed Product and which Corixa has [*].
1.8 "Corixa Patents" shall mean (a) all patents and patent applications
that are identified on Exhibit A attached hereto and (b) all patents and patent
applications that cover inventions or discoveries that are made by Corixa [*]),
provided that any such [*] inventions or discoveries shall only be included in
Corixa Patents to the extent that Corixa has the right to grant licenses
thereunder on the terms and conditions of this Agreement, now or in the future
in connection with and as a result of [*] and that [*]. Included within the
definition of Corixa Patents are any [*]. Also included within the definition of
Corixa Patents are all patents and patent applications which [*] which are
developed by Corixa [*]), provided that any such [*] inventions or discoveries
shall only be included in Corixa Patents to the extent that Corixa has [*], in
connection with and as a result of the [*]. Corixa Patents shall specifically
not include either ZKC Patents or Joint Patents.
1.9 "Development Steering Committee" shall have the meaning set forth in
Section 3.1(a).
1.10 "IND" shall mean an Investigational New Drug application with an
appropriate regulatory authority.
1.11 "Joint Patents" shall mean all patents and patent applications that
cover Joint Inventions and that [*]. Included within the definition of Joint
Patents are any [*]. Also included within the definition of Joint Patents are
all patent and patent applications which cover Joint Inventions and which [*].
In no event shall Joint Patents be deemed to include Corixa Patents or ZKC
Patents.
1.12 "Joint Inventions" shall have the meaning set forth in Section 10.
1.13 "Licensed Field" shall mean therapy of psoriasis in humans.
1.14 "Licensed Product" shall mean Corixa's proprietary formulation of [*],
known as PVAC, as further specified in Exhibit B, and [*].
1.15 "Net Sales" shall mean the amount [*] by ZKC, or its Third Party
sublicensee(s), as applicable, for the sale or other disposition to a Third
Party of the Licensed Product, less the following deductions for amounts
actually incurred related to such sale or other disposition: (a)
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[*]; and (b) [*]. Additionally, "Net Sales" shall not include sales of Licensed
Product between either [*] or between [*], unless such [*], as the case may be,
are [*], nor shall "Net Sales" include the [*], provided that ZKC does not [*].
1.16 "Other [*] Indications" shall have the meaning set forth in Section
4.2.
1.17 "Territory" shall mean Japan.
1.18 "Third Party(ies)" shall mean any party other than a party to this
Agreement or an Affiliate.
1.19 "Valid Claim" shall mean a claim of an [*] or a claim of a [*], in
either case included in the Corixa Patents or the Joint Patents, that has not
been (a) [*], which [*] or was not [*] or (b) [*].
1.20 "ZKC" shall mean Zenyaku Kogyo Co., Ltd. and each of its Affiliates.
1.21 "ZKC Know-How" shall mean all technical information, materials and
know-how [*] relates to the Licensed Product and which [*].
1.22 "ZKC Patents" shall mean all patents and patent applications that (a)
cover patentable inventions or discoveries that are [*] by ZKC in connection
with and as a result of [*] and that [*] and (b) are now or become [*] and under
which ZKC has, now or in the future, the right to grant licenses in connection
with the use of the Licensed Products in the Licensed Field. Included with the
definition of ZKC Patents are any [*]. Also included within the definition of
ZKC Patents are all patents and patent applications which [*]. In no event shall
ZKC Patents be deemed to include either Corixa Patents or Joint Patents.
1.23 "Interpretive Rules" For purposes of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise requires:
(a) defined terms include the plural as well as the singular (and vice versa)
and the use of any gender shall be deemed to include the other gender; (b)
references to "Articles," "Sections" and other subdivisions and to "Schedules"
and "Exhibits" without reference to a document, are to designated Articles,
Sections and other subdivisions of, and to Schedules and Exhibits to, this
Agreement; (c) unless otherwise set forth herein, the use of the term
"including" means
"including but not limited to"; and (d) the words "herein," "hereof,"
"hereunder" and other words of similar import refer to this Agreement as a whole
and not to any particular provision.
2. DEVELOPMENT AND COMMERCIALIZATION PROGRAM.
2.1 Commencing on the Effective Date, the parties shall collaborate in the
development and commercialization of the Licensed Product in the Licensed Field.
The program of activities to be conducted by each of Corixa and ZKC during the
term of the Agreement is set forth on Exhibit C (the "Development and
Commercialization Program"), which shall be amended on an annual basis by mutual
agreement of the parties, effective upon each anniversary
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of the Effective Date. The Development and Commercialization Program shall
include a development plan setting forth the activities currently contemplated
by the parties to be performed in developing the Licensed Product, as well as a
description of each party's responsibilities in connection with the development
and commercialization of the Licensed Product. Anything herein to the contrary
notwithstanding, the timelines included in the development plan are [*] for the
development of Licensed Product and may be modified from time to time by the
Development Steering Committee. The parties agree that the end goal of the
Development and Commercialization Program shall be the expeditious clinical
development and regulatory approval of the Licensed Product as necessary for the
import, manufacture, marketing and/or sale thereof in the Territory in the
Licensed Field. No material deviation in the subject matter and scope of such
Development and Commercialization Program shall be made without the mutual
written agreement of both parties.
2.2 On the Effective Date, ZKC agrees to diligently undertake, [*] as
determined by the Development Steering Committee or Commercialization Steering
Committee, as applicable. ZKC shall have the right, subject to the terms and
conditions of this Agreement, including, without limitation, Section 3 hereof,
to [*].
2.3 The parties acknowledge and agree that nothing in this Agreement shall
restrict in any manner [*], provided, however, Corixa shall not during the term
of this Agreement [*]. Notwithstanding the foregoing, Corixa shall provide ZKC
access to [*], and shall also use good faith efforts to cause any [*].
2.4 The parties acknowledge and agree that nothing in this Agreement shall
restrict in any manner [*], provided, however, ZKC shall not during the term of
this Agreement [*]. Notwithstanding the foregoing, ZKC shall provide Corixa
access to [*], and shall also use good faith efforts to cause any [*].
3. STEERING COMMITTEES.
3.1 (a) A Development Steering Committee (the "Development Steering
Committee") shall be established within thirty (30) days after the Effective
Date. During the period beginning on the Effective Date and ending on the
earlier of (i) the date on which all regulatory approvals have been obtained and
(ii) a date mutually agreed by the parties (the "Development Period"), the
Development Steering Committee shall consist of five (5) members, three (3)
individuals appointed by Corixa and two (2) individuals appointed by ZKC, and
shall be chaired by an individual from Corixa. During the Development Period,
the Development Steering Committee shall be responsible for, among other things,
regular coordination in the Territory of the [*] and [*] the [*]. In addition,
Corixa shall use good faith efforts to establish [*].
(b) Following the Development Period and until the expiration or earlier
termination of this Agreement, a Commercialization Steering Committee (the
"Commercialization Steering Committee") shall be established. The
Commercialization Committee shall consist of five (5) members, three (3)
individuals appointed by ZKC and two (2) individuals appointed by Corixa,
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and shall be chaired by an individual from ZKC. The Commercialization Steering
Committee shall be responsible for, among other things, [*] and such other [*].
3.2 To facilitate coordination during the Development Period, the parties
shall share all reports and data generated under the Development and
Commercialization Program with each other on a prompt and regular basis at
meetings of the Development Steering Committee, which shall be every six (6)
months during meetings to be held alternatively in Seattle, Washington and
Tokyo, Japan, or at such other location as may be determined by the Development
Steering Committee. ZKC shall provide Corixa with written reports in a format
agreed by Corixa and ZKC on the progress in the Territory of the Development and
Commercialization Program, including [*]. All such reports and data shall be in
sufficient detail to enable Corixa to determine ZKC's compliance with its
diligence obligations under Section 8.1, and all such reports, data and
information shall be subject to the confidentiality provisions of Section 12 of
this Agreement. In addition, Corixa shall provide ZKC written reports during the
course of the Development and Commercialization Program in a format to be agreed
by Corixa and ZKC which shall contain [*], and which shall be subject to the
confidentiality provisions of Section 12 of this Agreement. The Development
Steering Committee shall review the Development and Commercialization Program
annually, implement any mutually agreeable modifications and make
recommendations related to possible Development and Commercialization Program
extensions and/or expansions to the respective senior management teams of each
party. All actions by the Development Steering Committee shall require the
approval by [*], provided, however, that approval of any and all actions shall
require participation of [*].
3.3 Commencing at the end of the Development Period, the Commercialization
Steering Committee shall meet at least once every twelve (12) months at a
mutually agreed location to review and discuss the commercialization progress
and plans with respect to the Licensed Product in the Territory. In conjunction
with the foregoing meetings, ZKC shall provide Corixa with annual written
summary reports on the progress of commercialization, including [*]. All such
information shall be subject to the confidentiality provisions of Section 12 of
this Agreement. All actions by the Commercialization Steering Committee shall
require the approval by [*], provided, however, that approval of any and all
actions shall require participation of [*].
4. LICENSE GRANTS; RIGHTS OF FIRST NEGOTIATION
4.1 License.
(a) Subject to the terms and conditions of this Agreement, including,
without limitation, Section 5 hereof, Corixa hereby grants to ZKC an exclusive
license, [*] with regard to the Licensed Product and to [*] the Licensed Product
solely in the Licensed Field in the Territory. Corixa acknowledges that ZKC may,
in its sole discretion, [*] in the Territory and Corixa agrees that, if
requested by ZKC, it shall cooperate with ZKC to [*]
(b) Subject to the terms and conditions of this Agreement, ZKC hereby
grants to Corixa during the term of this Agreement a non-exclusive, [*] license
(except within the
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Xxxxxxxxx), [*] to practice under the [*], to the extent that ZKC has the right
to grant licenses thereunder on the terms and conditions of this Agreement.
(c) If during the period commencing on the Effective Date and ending
on the [*] of the Effective Date Corixa or ZKC believes that technology related
to the subject matter hereof is controlled by a Third Party ("Additional
Technology"), which technology may be valuable or necessary to the
commercialization of the Licensed Product hereunder, Corixa or ZKC as
appropriate shall present such Additional Technology, along with a written
report with respect thereto, to the Development Steering Committee. The
Development Steering Committee shall then determine whether licenses to, and/or
acquisitions of, such Additional Technology should be made, [*]. All [*] shall
be subject to approval of the Development Steering Committee, irrespective of
which party is [*]. [*]. Nothing set forth in this Section 4.1(c) shall limit
the ability of either party to procure technology for their own account or for
license to other parties, provided, however, that in the case of Additional
Technology [*].
(d) To the extent that ZKC does not [*], ZKC shall use good faith
efforts to [*].
(e) To the extent that Corixa does not [*], Corixa shall use good
faith efforts to [*].
4.2 Right of First Negotiation to Other [*] Indications. In the event that
Corixa from time to time during the period beginning on the Effective Date and
ending on [*], elects to undertake and completes, [*] (in each case as defined
in Exhibit D, the "Other [*] Indication(s)"), subject in the case of [*] to
Corixa having [*] in such Other [*] Indication(s) from [*], ZKC shall have a
first right of negotiation for an exclusive license to the Licensed Product in
the Territory for any or all of such Other [*] Indication(s) solely in
accordance with the process described in this Section 4.2. In connection with
each of the Other [*] Indications for which Corixa completes such [*], Corixa
shall notify ZKC promptly after it [*] related to such Other [*] Indication and
shall provide ZKC with a summary of relevant data available to Corixa with
respect to such Other [*] Indication. ZKC shall have one opportunity to exercise
its right of first negotiation in connection with such Other [*] Indication by
providing Corixa an [*] regarding the Licensed Product related to such Other [*]
Indication within [*] days of receipt of such notice from Corixa. Thereafter,
Corixa and ZKC shall have [*] days from Corixa's receipt of such [*] an
agreement covering a license for such Other [*] Indication. The terms of any
such license shall be [*], and shall reflect the [*]. In the event ZKC does not
provide such [*] within such [*] day period, Corixa shall be free to seek a
Third Party partner in the Territory for the Other [*] Indication, provided,
however, any agreement between Corixa and a Third Party partner in the Territory
for an Other [*] Indication shall [*].
5. PAYMENTS.
ZKC shall make the following payments to Corixa under this Agreement in
U.S. Dollars by wire transfer of immediately available funds:
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5.1 Research and Development Funding. Research and development funding
payments in the following amounts on the dates set forth below:
PAYMENT DATE PAYMENT
AMOUNT (US$)
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[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
The payment amounts set forth above shall be guaranteed, non-refundable and
non-creditable and shall be paid directly to Corixa, provided, however, (1) in
the event that Corixa has not [*], ZKC's obligation to make the payment due
under Section 5.1 on [*] shall be [*] (2) in the event ZKC elects to terminate
this Agreement pursuant to Section 18.3 hereof, ZKC shall [*], provided,
however, that in the event such termination occurs after [*] due to [*], ZKC
shall [*] and (3) if ZKC shall elect to terminate this Agreement pursuant to
Section 18.4 hereof, ZKC shall (i) in the event such termination occurs pursuant
to Section 18.4(i), immediately [*] and (ii) in the event such termination
occurs pursuant to Section 18.4(ii), immediately [*]. In any of the
aforementioned instances, ZKC shall not be required to pay any amount that is
due on a date after the termination notice is dispatched under this Section 5.1.
5.2 License Fees.
(a) On September 16, 1999, ZKC shall pay to Corixa a licensing fee of [*].
(b) Beginning on [*], and on each [*] thereafter during the term of this
Agreement until Commercial Launch of the Licensed Product in the Territory, ZKC
shall pay Corixa a
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license maintenance fee equal to [*]. Subsequent to Commercial Launch of the
Licensed Product in the Territory, ZKC shall pay Corixa a minimum royalty equal
to [*] on each [*] thereafter, provided, however, that Corixa shall, [*]. For
purposes of clarification, in the event Commercial Launch occurs during the [*]
period following a payment made hereunder, the portion of that payment that
represents the pro rata portion of such [*] period that follows Commercial
Launch shall be [*]
5.3 Milestone Payments. In addition to the amounts payable pursuant to
Sections 5.1 and 5.2 above, ZKC also agrees to pay Corixa the following
milestone payments, to be made via wire transfer of immediately available funds,
within [*] days following (i) in the event such milestone is achieved [*], ZKC's
receipt of a written notice [*] and (ii) in the event such milestone is achieved
[*], achievement of such milestone:
[*] MILESTONES PAYMENT (US$)
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(i) [*]the Licensed Product in the Licensed Field [*]
[*].
(ii) [*] for the Licensed Product in the Licensed [*]
Field.
(iii) [*] the Licensed Product in the Licensed Field. [*]
(iv) [*] the Licensed Product in the Licensed Field. [*]
(v) [*] the Licensed Product in the Licensed Field. [*]
(vi) [*] the Licensed Product in the Licensed Field. [*]
[*] MILESTONES PAYMENT (US$)
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(i) [*] Licensed Product in the Licensed Field [*] [*]
(ii) [*] Licensed Product in the Licensed Field [*] [*]
(iii) [*] Licensed Product in the Licensed Field [*] [*]
6. LICENSE AND ROYALTY PAYMENTS.
6.1 Royalties for Licensed Product.
Royalties on annual Net Sales of Licensed Product in the Territory
shall be paid to Corixa by ZKC as follows:
[*] ROYALTY
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[*] [*]
[*] [*]
[*] [*]
[*] [*]
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The royalty rates under Section 6.1 are [*]
6.2 Royalty Term. Subject to Section 6.5 of this Agreement, Royalties shall
be earned and paid to Corixa until [*]. No royalties shall be payable on [*] or
[*], provided that such [*].
6.3 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 in accordance with Section 7.1. Net Sales
during a month shall be translated on a monthly basis from Japanese Yen to U.S.
Dollars by using [*].
6.4 Currency Transfer Restrictions. If payment or transfer of funds out of
the Territory shall be prohibited by law or regulation, the parties hereto shall
confer regarding the terms and conditions on which the Licensed Product shall be
sold in the Territory, including the possibility of payment of royalties to
Corixa in local currency to a bank account in the Territory or the renegotiation
of royalties for such sales, and in the absence of any other agreement by the
parties, such funds payable to Corixa shall be deposited in whatever currency is
allowable by ZKC in an accredited bank in that country that is acceptable to
Corixa.
6.5 Royalty Payments Upon Termination. Notwithstanding anything contained
herein to the contrary, if this Agreement is terminated in accordance with
Section 18, ZKC shall pay to Corixa all amounts payable pursuant to this Section
6 prior to the date on which such termination shall become effective, and shall
also pay Corixa royalty amounts earned thereafter as a result of sales of
residual inventory of the Licensed Product.
6.6 Withholding Tax. All payments made by ZKC under this Agreement shall be
made to Corixa with the deduction of withholding tax (if any) imposed upon such
payment. If requested by Corixa, ZKC shall cooperate with Corixa regarding [*].
7. REPORTS, PAYMENTS AND ACCOUNTING.
7.1 Payments and Reports.
(a) ZKC agrees to make written reports (in a format, if any,
reasonably specified by Corixa), and the payments set forth in Section 6 to
Corixa within [*] days after the close of each calendar quarter during the term
of this Agreement. These reports shall show for such calendar quarter sales by
ZKC, its Affiliates and sublicensees of Licensed Product, details of the [*].
Concurrently with the making of each such report, ZKC shall make payment to
Corixa of (i) amounts payable under Section 6 for the period covered by such
report and (ii) all other amounts accrued under this Agreement which have not
been previously reimbursed as required, unless otherwise provided hereunder.
[*].
(b) Corixa agrees to submit a [*] account to ZKC within [*] days after
the close of each calendar quarter for any costs or expenses incurred during
such calendar quarter related to patents and other expenses agreed to be paid or
reimbursed by ZKC. The costs and expenses of patent filings shall be as set
forth in Section 11.
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7.2 Termination Report. ZKC also agrees to make a written report (in a
format, if any, reasonably specified by Corixa) within [*] days after the date
on which ZKC, its Affiliates or sublicensees sell the last Licensed Product
stating in such report the same information required for quarterly reports
provided under Section 7.1 hereof.
7.3 Accounting. ZKC agrees to keep clear, accurate and complete records,
all in a format, if any, reasonably specified by Corixa, for a period of at
least [*] (or such longer period as may correspond to ZKC's internal records
retention policy) for each reporting period in which sales of Licensed Product
occur showing the manufacturing, if any, sales, use and other disposition
thereof in sufficient detail to determine amounts payable pursuant to Section 6
hereof. ZKC further agrees to permit its books and records to be examined from
time to time (but not more than once a year) by an independent accounting firm
selected and paid by Corixa and reasonably satisfactory to ZKC. Such examination
shall occur only on reasonable notice during regular business hours during the
term of this Agreement and for [*] thereafter, provided, however, that such
examination shall not (i) be of records for more than the prior [*], (ii) take
place more often than once a year and (iii) cover any records which date prior
to the date of the last examination, and provided further that such accountants
shall report to Corixa only as to the accuracy of the royalty statements and
payments. Copies of such reports shall be supplied to ZKC. In the event the
report demonstrates that ZKC has underpaid Corixa, ZKC shall pay the amount of
such underpayment immediately upon request of Corixa and to the extent such
underpayment is more than [*] of the royalty payments otherwise due for the
audited period, ZKC shall reimburse Corixa for the expense of the audit.
7.4 Confidentiality of Reports. Each party agrees that the information set
forth in (i) the reports required by Sections 7.1 and 7.2 and (ii) the records
subject to examination under Section 7.3, shall be subject to Section 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 obligations hereunder, and shall not be disclosed by the
receiving party or such accounting firm to any other person except for purposes
of enforcing this Agreement.
8. COMMERCIAL DEVELOPMENT.
8.1 Diligence by ZKC. ZKC will use [*] development program, and will use at
least the same level of diligence as ZKC currently uses or in the past has used
with respect to its own commercially successful products on which ZKC places or
has placed a priority, [*]. ZKC shall also use its commercially reasonable
efforts consistent with industry standards in the Territory to [*].
8.2 Diligence by Corixa. Corixa undertakes to use [*] the Development and
Commercialization Program, and will use at least the same level of diligence as
Corixa currently uses or in the past has used with respect to its own
commercially successful products on which Corixa has placed a priority.
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9. SUPPLY; DISTRIBUTION OF SAMPLE PRODUCT.
9.1 Corixa shall provide ZKC with Licensed Product pursuant to the terms
and conditions of a Supply Agreement in the form attached hereto as Exhibit E
(the "Supply Agreement") and in compliance with all applicable foreign, federal,
state or local laws and regulations. ZKC shall use all materials provided to ZKC
by Corixa hereunder or under the Supply Agreement in compliance with all
applicable foreign, federal, state or local laws and regulations.
9.2 ZKC may only transfer Licensed Product to a Third Party in the
Territory [*], as applicable, and according to the following.
(a) Prior to Commercial Launch, ZKC may request that Corixa transfer [*] in
connection with the performance of the Development and Commercialization
Program. In the event that the Development Steering Committee determines that
such transfer is [*]. ZKC shall present such [*]. In the event that such [*].
ZKC shall thereafter [*]. Corixa shall cooperate with ZKC [*]; provided,
however, that Corixa shall have the [*].
(b) Prior to Commercial Launch, ZKC may transfer Licensed Product [*]
reasonable amounts.
(c) Following [*] commercial sales in the Territory, ZKC may transfer
reasonable amounts [*]
10. INVENTIONS.
Inventions, discoveries and technology(ies) related to the Licensed Product
that arise from the performance of the Development and Commercialization Program
and that are made by Corixa [*] shall be owned by Corixa. Inventions,
discoveries and technology(ies) which are made jointly by [*] shall be jointly
owned by Corixa and ZKC and treated as joint inventions (collectively, "Joint
Inventions"). Inventions, discoveries and technology(ies) which arise from the
performance of the Development and Commercialization Program and that are made
by [*], shall be owned by ZKC (collectively, "ZKC Inventions"). Except as
otherwise set forth in this Agreement, [*].
11. PATENTS; PROSECUTION AND LITIGATION.
11.1 Corixa shall have the [*] to prosecute and maintain all Corixa Patents
and Joint Patents as provided in this Section 11 and shall do so in a timely
manner. Corixa shall disclose [*] to ZKC the complete texts of all Corixa
Patents and Joint Patents as well as all information received concerning the
institution or possible institution of any [*] involving any patent licensed
herein. Corixa agrees to keep ZKC [*] informed of the course of patent
prosecution or other proceedings including by providing ZKC with copies of [*]
submitted to or received from patent offices. ZKC shall have the right to review
all such [*] and make recommendations to Corixa concerning them and their
conduct in the Territory. ZKC shall hold all information disclosed to it under
this Section 11 as confidential information under Section 12. ZKC shall
reimburse
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Corixa for all [*] costs for the filing, prosecution and maintenance of the
Corixa Patents and Joint Patents in the Licensed Field in the Territory that [*]
and [*] costs for the filing, prosecution and maintenance of the Corixa Patents
and Joint Patents in the Licensed Field incurred by Corixa during the term of
this Agreement in the Territory that [*]. The amount payable by ZKC on the
Effective Date for such prior costs shall be [*]. All expenses to be paid or
reimbursed by ZKC pursuant to this Section shall be obligations that are
separate and apart from other payment obligations described in this Agreement
and shall be invoiced and paid separately. In the event Corixa [*]), Corixa
shall [*]. In addition, in the event Corixa [*], Corixa shall [*].
11.2 In the event Corixa finally abandons any patent or any part of a
patent (including Corixa Patents) covered by this Agreement, it shall notify ZKC
and ZKC shall have the right [*] to assume all rights to any such patent or part
thereof in the Territory, provided, however, ZKC's rights under this Section
11.2 shall in all respects be subject to [*] of such abandoned patent or part of
a patent.
11.3 In the event of the initiation of any suit by a Third Party against
Corixa Corporation, Zenyaku Kogyo Co., Ltd. or any Affiliate of either for
patent infringement with respect to Corixa Patents, Joint Patents or ZKC Patents
in the License Field and involving the manufacture, use, sale, distribution or
marketing of the Licensed Product in the License Field in the Territory, the
party sued shall promptly notify the other party in writing. Corixa [*]with
respect to the Corixa Patents, or ZKC with respect to the ZKC Patents, that are
the subject of such suit, shall [*] defend such suit at its own expense. ZKC
shall assist and cooperate with Corixa [*], and Corixa [*], as applicable, shall
assist and cooperate with ZKC, as applicable, in any such litigation at Corixa's
[*], or ZKC's request and expense, as applicable. Neither Corixa [*] may enter
into any settlement with respect to such suit without ZKC's written consent, [*]
and ZKC shall not enter into any settlement with respect to such suit without
Corixa's [*] consent, [*].
11.4 (a) In the event that Corixa or ZKC becomes aware of actual or
threatened infringement of a patent covered by this Agreement with respect to
the Licensed Product in the Licensed Field in the Territory, that party shall
promptly notify the other party in writing. In connection with any such actual
or threatened infringement in the Territory, Corixa [*] with respect to the
Corixa Patents or the Joint Patents, or ZKC with respect to the ZKC Patents,
that are the subject of such actual or threatened infringement shall have [*]
bring an infringement action against any alleged infringer [*]. The party
conducting such action shall have full control over its conduct, provided that
it may not enter into any settlement related to infringement in the Territory
without ZKC's written consent [*]. ZKC shall assist and cooperate with Corixa
[*], in any such action at Corixa's [*]. In the event that ZKC [*] with respect
to the ZKC Patents that are the subject of such actual or threatened
infringement bring an infringement action against any alleged infringer, Corixa
shall assist and cooperate with ZKC [*], as applicable, in any such action at
ZKC's [*]. The party conducting such action shall have full control over its
conduct, provided that it may not enter into any settlement related to
infringement in the Territory without Corixa's prior written consent, [*].
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(b) In the event that Corixa or ZKC becomes aware of actual or
threatened infringement of a patent covered by this Agreement with respect to
the Licensed Product in the Licensed Field outside the Territory, that party
shall promptly notify the other party in writing. In connection with any such
actual or threatened infringement outside the Territory, ZKC [*] with respect to
the ZKC Patents, that are the subject of such actual or threatened infringement
shall [*] bring an infringement action against any alleged infringer [*]. The
party conducting such action shall have full control over its conduct, provided
that it may not enter into any settlement related to infringement in the
Territory without Corixa's written consent [*]. Corixa shall assist and
cooperate with ZKC [*], in any such action at ZKC's [*]. Notwithstanding the
foregoing, in the event such actual or threatened infringement of any ZKC
Patent(s) is [*] bring an infringement action against the alleged infringer [*].
[*] shall have full control over conduct of such action, provided that it may
not enter into any settlement related to such infringement without ZKC's written
consent, [*]. ZKC shall assist and cooperate with [*], in any such action at
[*].
11.5 Any recovery by Corixa [*] with respect to the Corixa Patents or the
Joint Patents that are the subject of an action pursuant to Section 11.3 or
Section 11.4, in an amount in excess of expenses and related to an action
involving activities in the Territory shall be [*], provided, however, that in
the event [*], and provided further that any recovery by ZKC with respect to the
ZKC Patents that are the subject of an action pursuant to Section 11.3 or
Section 11.4, in an amount in excess of expenses and related to an action
involving activities in the Territory shall be [*], provided, however, that in
the event [*].
11.6 The parties shall keep one another informed of the status of their
respective activities regarding any litigation or settlement thereof concerning
the Licensed Product.
11.7 TO THE EXTENT PERMITTED BY APPLICABLE LAW, CORIXA MAKES NO
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OTHER THAN THOSE EXPRESSLY
SET FORTH IN SECTION 17 BELOW, WITH RESPECT TO THE CORIXA PATENTS, THE JOINT
PATENTS OR CORIXA KNOW-HOW AND THE LICENSED PRODUCT RELATED THERETO, INCLUDING
WITHOUT LIMITATION ANY WARRANTY OF NONINFRINGEMENT, PATENTABILITY,
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
11.8 ZKC MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, OTHER
THAN THOSE EXPRESSLY SET FORTH IN SECTION 17 BELOW.
12. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS.
12.1 Disclosure of Inventions. During the term of this Agreement, Corixa
shall promptly disclose, and shall [*] disclose, to ZKC and/or supply ZKC in a
timely fashion with all [*], all [*] and all [*] filed and/or controlled by
Corixa [*] and all inventions controlled by Corixa [*] related to the Licensed
Product in the Licensed Field arising from the performance of the Development
and Commercialization Program. During the term of this Agreement, ZKC shall [*]
disclose to Corixa and/or supply Corixa in a timely fashion with all [*] owned
or
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controlled by ZKC related to the Licensed Product in the Licensed Field, all [*]
and all [*] filed and/or controlled by ZKC in the Territory, and all inventions
controlled by ZKC related to the Licensed Product in the Licensed Field arising
from the performance of Development and Commercialization Program. In addition,
each party shall provide the other party with all information [*] Development
and Commercialization Program. All such reports shall comply with all applicable
requirements of appropriate regulatory agencies in any country which is or is
anticipated to be a significant market for such Licensed Product.
12.2 Adverse Drug Events. The parties recognize that each may be required
to submit information and file reports to various governmental agencies on
compounds under clinical investigation, compounds proposed for marketing, or
marketed drugs. In this regard, information must be submitted at the time of
initial filing for investigational use in humans and at the time of a request
for market approval of a new drug. In addition, supplemental information must be
provided on compounds at periodic intervals and adverse drug experiences must be
reported at more frequent intervals depending on the severity of the experience.
Consequently, each party agrees to:
(a) provide to the other party for initial and/or periodic submission to
government agencies significant information on the Licensed Product from
preclinical laboratory, animal toxicology and pharmacology studies, as well as
adverse drug experience reports from clinical trials and commercial experiences
with the Licensed Product;
(b) in connection with investigational use of the Licensed Product, report
to the other party within five (5) business days of the initial receipt of a
report of any unexpected Grade 3 or 4 adverse event or serious adverse event
with the Licensed Product or concurrently with the reporting of such experience
to a regulatory agency, if sooner than five (5) business days, or sooner if
required for any party to comply with regulatory requirements; and
(c) in connection with commercial use of the Licensed Product, report to
the other party within five (5) business days of the initial receipt of a report
of any adverse experience with the Licensed Product that is serious and
unexpected or sooner if required for any party to comply with regulatory
requirements. Serious adverse experiences mean any experience that suggests a
significant hazard, contraindication side-effect or precaution, or any
experience that is fatal or life-threatening, is permanently disabling, requires
or prolongs inpatient hospitalization, or is a congenital anomaly, cancer or
overdose. An unexpected adverse experience is one not identified in nature,
specificity, severity or frequency in the current investigator brochure or the
United States labeling for the Licensed Product. Each party also agrees that if
it contracts with a third party for research to be performed by such third party
on the Licensed Product, that party agrees to require such third party to report
to the contracting party the information set forth in subparagraphs (a), (b) and
(c) above, and such contracting party shall provide this information to the
other party.
12.3 Confidential Information. During the term of this Agreement and for
five (5) years thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, Corixa and ZKC shall not use or reveal
or disclose to any Third Party any
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proprietary or confidential information received from the other party or
otherwise developed by either party in the performance of activities in
furtherance of this Agreement that by its nature or content, or the context of
disclosure, might reasonably be expected to be confidential ("Confidential
Information"), without first obtaining the written consent of the disclosing
party, except as may be otherwise provided herein, or as may be required for
purposes of investigating, developing, manufacturing, selling or marketing the
Licensed Product or for securing essential or desirable authorizations,
privileges or rights from governmental agencies, or is required to be disclosed
to a governmental agency, or is necessary to file or prosecute patent
applications concerning the Licensed Product or to carry out any litigation
concerning the Licensed Product or is otherwise required by applicable law
and/or regulations. This confidentiality obligation shall not apply to such
Confidential Information which is or becomes a matter of public knowledge, or is
already in the possession of the receiving party, or is disclosed to the
receiving party by a Third Party having the right to do so, or is subsequently
and independently developed by employees of the receiving party or Affiliates
thereof who had no knowledge of the confidential information disclosed. The
parties shall take reasonable measures to assure that no unauthorized use or
disclosure is made by others to whom access to such information is granted.
12.4 Permitted Disclosures. Nothing herein shall be construed as preventing
ZKC from disclosing any information received from Corixa to any ZKC Affiliate,
or sublicensee or distributor of ZKC, provided such Affiliate is bound by
similar confidentiality obligations and such sublicensee or distributor has
undertaken in writing a similar obligation of confidentiality with respect to
the confidential information, with Corixa stated as a third-party beneficiary
thereof. In addition, notwithstanding anything herein to the contrary, Corixa
shall have the right to disclose [*].
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 or any other similar insolvency event with respect
to such party, the bankrupt or insolvent party shall promptly notify the court
or other tribunal (i) that confidential information received from the other
party under this Agreement remains the property of the other party and (ii) of
the confidentiality obligations under this Agreement. In addition, the bankrupt
or insolvent party shall, to the extent permitted by law, take all steps
necessary or desirable to maintain the confidentiality of the other party's
confidential information and to insure that the court, other tribunal or
appointee maintains such information in confidence in accordance with the terms
of this Agreement.
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12.6 Publicity.
(a) The parties to this Agreement may disclose the nature and general terms
of the Agreement in a press release following signature after due consultation
with the other party. The wording of any press release must be agreed by both
parties in advance of its release; provided that such agreement is not
unreasonably withheld by either party. Notwithstanding the foregoing, each party
shall have the right to issue press releases immediately and without prior
consent of the other that disclose any information required by the rules and
regulations of the Securities and Exchange Commission or similar federal, state
or foreign authorities, as determined in good faith by the disclosing party.
(b) Neither party shall publish or provide public disclosure of information
or inventions arising from the performance of the Development and
Commercialization Program (a "Dissemination") without at least [*] 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 [*] 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, Corixa shall have the right to
disclose information immediately and without prior consent of ZKC if such
disclosure is required by the rules and regulations of the Securities and
Exchange Commission or similar federal or state authority, as determined in good
faith by Corixa, and ZKC shall have the right to disclose information
immediately and without prior consent of Corixa if such disclosure is required
by the rules and regulations of regulatory authorities in Japan, as determined
in good faith by ZKC.
13. GOVERNING LAW; ARBITRATION.
This Agreement shall be governed by the laws of the State of Washington,
without regard to conflicts of law principles. Prior to engaging in any formal
dispute resolution with respect to any dispute, controversy or claim arising out
of or in relation to this Agreement or the breach, termination or invalidity
thereof (each, a "Dispute"), the most senior executive officer having the right
to represent the respective parties shall attempt for a period of not less than
sixty (60) days to resolve such Dispute. Any Dispute that cannot be settled
amicably by agreement of the parties pursuant to the preceding sentence, shall
be finally settled by arbitration in accordance with the arbitration rules of
the American Arbitration Association ("AAA"), then in force, by one or more
arbitrators appointed in accordance with said rules, provided that the appointed
arbitrators shall have appropriate experience in the biopharmaceutical industry.
The language of the arbitration shall be in English, and the place of
arbitration shall be [*]. The award rendered shall be final and binding upon
both parties. The judgment rendered by the arbitrator(s) shall include costs of
arbitration, reasonable attorneys' fees and reasonable costs for any expert and
other witnesses. The arbitrators in such proceeding may expressly consider the
amounts paid or payable pursuant to this Agreement in considering any claim of
damages. Nothing in this Agreement shall be deemed as preventing either party
from seeking injunctive relief (or any other provisional remedy) from any court
having jurisdiction over the parties and the subject matter of the dispute
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as necessary to protect either party's name, proprietary information, trade
secrets, know-how or any other proprietary rights. Judgment upon the award may
be entered in any court having jurisdiction, or application may be made to such
court for judicial acceptance of the award and/or an order of enforcement as the
case may be.
14. MISCELLANEOUS.
14.1 Trademarks. Corixa shall be responsible for the selection,
registration and maintenance of all trademarks which are employed in connection
with the Licensed Product in the Territory and Corixa shall own and/or control
any such trademarks and shall use commercially reasonable efforts to ensure that
such trademarks and use thereof by ZKC in the Territory does not infringe any
rights of Third Parties, provided that prior to selection of such trademarks,
Corixa shall provide ZKC an opportunity to review and comment on any such
trademark together with the results of Corixa's non-infringement searches and
analysis related to such trademark and Corixa shall, in good faith and a
commercially reasonable manner, take ZKC's comments into consideration in
Corixa's selection of such trademarks.
14.2 Force Majeure. If the performance of any part of this Agreement by
either party, or of any obligation under this Agreement, is prevented,
restricted, interfered with or delayed by reason of any cause beyond the
reasonable control of the party liable to perform, unless conclusive evidence to
the contrary is provided, the party so affected shall, upon giving written
notice to the other party, be excused from such performance to the extent of
such prevention, restriction, interference or delay, provided that the affected
party shall use its reasonable best efforts to avoid or remove such causes of
nonperformance and shall continue performance with the utmost dispatch whenever
such causes are removed. When such circumstances arise, the parties shall
discuss what, if any, modification of the terms of this Agreement may be
required in order to arrive at an equitable solution.
14.3 Severability.
(a) In the event any portion of this Agreement shall be held illegal,
void or ineffective, the remaining portions hereof shall remain in full force
and effect.
(b) If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may conflict
therewith and shall be deemed to be modified to conform with such statute or
rule of law.
14.4 Entire Agreement. This Agreement and all Exhibits hereto, entered into
as of the date first written above, constitutes the entire agreement between the
parties relating to the subject matter hereof and supersedes all previous
writings and understandings except that the Confidential Information and Non
Disclosure Agreement dated as of January 18, 1998, as amended December 18, 1998,
shall remain in full force and effect. No terms or provisions of this Agreement
shall be varied or modified by any prior or subsequent statement, conduct or act
of either of the parties, except that the parties may mutually amend this
Agreement by written instruments specifically referring to and executed in the
same manner as this Agreement.
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15. NOTICES.
15.1 Any notice required or permitted under this Agreement shall be deemed
given if delivered (i) personally, (ii) by facsimile transmission (receipt
verified), (iii) by registered or certified mail (return receipt requested),
postage prepaid, or (iv) sent by express courier service (receipt verified), to
the following addresses of the parties:
IF TO CORIXA:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000-0000
Attention: Chief Operating Officer
with a copy to Director of Legal Affairs
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
WITH A COPY TO:
Venture Law Group
0000 Xxxxxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxxxx X. Xxxxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
IF TO ZKC:
Zenyaku Kogyo Co., Ltd.
0-00 Xxxxxx, 0-Xxxxx
Xxxxxx-Xx, Xxxxx 000-0000 Xxxxx
Attention: Product Development Department
Telephone: 000-0000-0000
Facsimile: 000-0000-0000
15.2 Any notice required or permitted to be given pursuant to this
Agreement shall be effective upon receipt by Corixa or ZKC, as the case may be.
16. ASSIGNMENT.
Neither this Agreement nor any interest hereunder shall be assignable by
either party without the written consent of the other, provided, however, that
either party may assign this Agreement and all patents related to this Agreement
to any of such party's Affiliates or to any corporation or other entity with
which such party may merge or consolidate, and/or to any corporation or other
entity to which such party may transfer all or substantially all of such party's
assets, without obtaining the consent of other party. Transfer in contravention
of this Section 16 shall be considered a material breach of this Agreement
pursuant to Section 18.5 below. Subject to other provisions of this Section 16,
all rights and obligations under this Agreement and the licenses herein granted
shall be binding upon and inure to the benefit of the successors in interest of
the respective parties. Any assignment in violation of the foregoing shall be
null and void.
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17. WARRANTIES, REPRESENTATIONS AND COVENANTS.
17.1 Each party warrants that it has the right to enter into this
Agreement, and that this Agreement is a legal and valid obligation binding upon
such party and enforceable in accordance with its terms.
17.2 Based on [*], Corixa warrants that [*] (i) Corixa Patents [*], (ii)
Corixa [*] terms and conditions of this Agreement [*], (iii) no [*], (iv) the
Licensed Product, [*] and (v) there are [*].
17.3 ZKC acknowledges that the licenses granted to ZKC herein [*].
Notwithstanding anything herein to the contrary, the foregoing covenant shall
not be deemed to have the effect of limiting Corixa's representation and
warranty set forth in Section 17.2.
17.4 LIMITED LIABILITY.
IN NO EVENT WILL EITHER PARTY HERETO BE LIABLE FOR ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR INDIRECT DAMAGES SUFFERED BY THE OTHER PARTY ARISING IN
ANY WAY OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE PARTY HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH DAMAGE.
18. TERM AND TERMINATION.
18.1 This Agreement may not be terminated by either party except in
accordance with this Section 18.
18.2 Unless otherwise terminated, this Agreement shall expire upon the
later of (i) the [*] anniversary of the Effective Date and (ii) the expiration,
lapse or invalidation of the last to expire of the Corixa Patents and the Joint
Patents in the Territory. [*].
18.3 If on the later of the [*] anniversary of the Effective Date and the
date that is [*]after the date Corixa delivers to ZKC the data analysis of
Corixa's US Phase II clinical study, both Corixa and ZKC shall have determined
not to conduct a future Phase III clinical trial in respect of the Licensed
Product, this Agreement may be terminated by the mutual consent of the parties,
in which event without further action on the part of either party, (i) all
rights and licenses granted to ZKC pursuant to this Agreement with respect to
the Licensed Product, including, without limitation, rights and licenses granted
to ZKC to all Corixa Patents, Joint Patents and Corixa Know-How, shall revert to
Corixa and ZKC shall retain no license rights therein, (ii) Corixa shall have an
[*], under all of [*] rights, title and interest in the [*] and, [*], all [*]
related to the Licensed Products in the Licensed Field to the extent that [*],
(iii) subject to Corixa's [*], Corixa shall have an [*], under all of [*]
Patents to the extent that [*], and (iv) each party shall [*]not covered by the
[*]except as provided for by applicable law, provided that the parties agree to
[*]. In the event either party wants to [*], the parties agree to negotiate [*].
In addition, ZKC hereby agrees that in the event of any such termination, unless
Corixa shall otherwise [*] or ZKC
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shall obtain any right to the Licensed Products, ZKC will (a) [*] and (b) [*]
pursuant to this Section 18.3. Following termination pursuant to this Section
18.3, Corixa shall be responsible for any and all [*] pursuant to this Section
18.3.
18.4 ZKC may terminate this Agreement at its option, [*], by providing
written notice at any time (i) during the [*] following the [*] anniversary of
the Effective Date and (ii) during the [*] period that ends [*] following the
[*] anniversary of the Effective Date, solely in the event that ZKC determines
in good faith for bona fide scientific or clinical reasons, not to proceed with
development of the Licensed Product. In addition, ZKC may terminate this
Agreement at its option, [*] upon [*] prior written notice at any time after
Commercial Launch of the Licensed Product in the Territory, in the event (x) ZKC
determines [*] the unprofitability of the Licensed Product in the Territory
during a period of [*] or (y) ZKC receives a governmental order to stop selling
Licensed Product. In the event ZKC terminates this Agreement pursuant to this
Section 18.4, then (i) all rights and licenses granted to ZKC pursuant to this
Agreement with respect to the Licensed Product, including, without limitation,
rights and licenses granted to ZKC to all Corixa Patents, Joint Patents and
Corixa Know-How, shall revert to Corixa and ZKC shall retain no license rights
therein, (ii) Corixa shall have an [*], under all of [*] rights, title and
interest in the [*] and, [*], all [*] related to the Licensed Products in the
Licensed Field to the extent that [*], and [*], (iii) subject to Corixa's
payment of all [*], Corixa shall have an [*], under all of [*] Patents to the
extent that [*], and (iv) each party shall [*] not covered by the [*], except as
provided for by applicable law, provided that the parties agree to [*]. In the
event either party wants to [*], the parties agree to [*]. In addition, ZKC
hereby agrees that in the event of any such termination, unless Corixa shall
otherwise [*] or ZKC shall obtain any right to the Licensed Products, ZKC will
(a) [*] and (b) [*] pursuant to this Section 18.4. Following termination
pursuant to this Section 18.4, Corixa shall be responsible for any and all [*]
pursuant to this Section 18.4.
18.5
(a) If either party is in material breach of any material provision of this
Agreement and if such breach is not cured within [*] days [*] after receiving
written notice from the other party with respect to such breach, the
non-breaching party shall have the right to terminate this Agreement by giving
written notice to the party in breach. The parties agree and acknowledge that
any breach by ZKC or Corixa of Section 8 shall be deemed to be a material breach
of a material provision of this Agreement. ZKC shall also have the right to
terminate this Agreement by giving written notice to Corixa in the event of
Corixa's material breach of the Supply Agreement due to Corixa's failure to
supply Materials for ZKC's clinical trials or commercial use, provided that such
termination shall not be effective if Corixa has cured such material breach
within the [*] day cure period provided in Section 6.2 of the Supply Agreement.
(b) In the event ZKC terminates this Agreement pursuant to this Section
18.5 as a result of Corixa's uncured material breach, then if (x) ZKC determines
to continue to use and/or sell the Licensed Products in the Territory, (i) all
rights and licenses granted to ZKC pursuant to Section 4.1(a) of this Agreement
with respect to the Corixa Patents shall remain in effect and ZKC shall continue
to have the obligation to pay royalties in accordance with Section 5 with
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respect to Licensed Product thereafter commercialized provided, however, that
the applicable royalty rate(s) set forth in Section 5 shall thereafter be [*],
(ii) all rights and licenses granted to ZKC pursuant to Section 4.1(a) of this
Agreement with respect to the Joint Patents shall remain in effect, provided,
however, that solely to the extent that any Licensed Products that are
thereafter commercialized are covered by [*], the sale of such Licensed Products
shall be [*] (iii) subject to maintenance on their terms and conditions of all
[*], all rights and licenses granted to Corixa pursuant to Section 4.1(b) shall
revert to ZKC and (iv) each party shall [*] not covered by the [*], except as
provided for by applicable law, provided that the parties agree to [*] and, (y)
ZKC determines not to continue to use or sell the Licensed Products in the
Territory, (i) ZKC shall be [*], (ii) all rights and licenses granted to ZKC
pursuant to this Agreement with respect to the Licensed Product, including,
without limitation, rights and licenses granted to ZKC to all Corixa Patents,
Joint Patents and Corixa Know-How, shall revert to Corixa and ZKC shall retain
no license rights therein, (iii) subject to maintenance on their terms and
conditions of all [*], all rights and licenses granted to Corixa pursuant to
Section 4.1(b) shall revert to ZKC and (iv) each party shall [*] not covered by
the [*], except as provided for by applicable law, provided that the parties
agree to [*]. In the event either party wants to [*], the parties agree to [*].
(c) In the event Corixa terminates this Agreement pursuant to this Section
18.5 as a result of ZKC's uncured material breach, then (i) all rights and
licenses granted to ZKC pursuant to this Agreement with respect to the Licensed
Product, including, without limitation, rights and licenses granted to ZKC to
all Corixa Patents, Joint Patents and Corixa Know-How, shall revert to Corixa
and ZKC shall retain no license rights therein, (ii) Corixa shall have an [*],
under all of [*] rights, title and interest in the [*] and, [*], all [*] related
to the Licensed Products in the Licensed Field to the extent that [*], and [*],
(iii) subject to Corixa's [*], Corixa shall have an [*], under all of [*] to the
extent that [*], and (iv) each party shall [*] not covered by the [*], except as
provided for by applicable law, provided that the parties agree to [*]. In the
event either party wants to [*], the parties agree to [*]. In addition, ZKC
hereby agrees that in the event of any such termination, unless Corixa shall
otherwise [*] or ZKC shall obtain any right to the Licensed Products, ZKC will
(a) [*] and (b) [*] pursuant to this Section 18.5. Following termination
pursuant to this Section 18.5, Corixa shall be responsible for any and all [*]
pursuant to this Section 18.5.
18.6
(a) Either party may terminate this Agreement if, at any time, the other
party shall file in any court or agency pursuant to any statute or regulation of
the United States or of any individual state or foreign country, a petition in
bankruptcy or insolvency or for reorganization or for an arrangement or for the
appointment of a receiver of trustee of the party or of its assets or for any
other similar proceedings, or if the other party proposes a written agreement of
composition or extension of its debts, or if the other party shall be served
with an involuntary petition against it, filed in any of such insolvency
proceeding, and such petition shall not be dismissed with [*] days after the
filing thereof, or if the other party shall propose or be a party to any
dissolution or liquidation, or if the other party shall make an assignment for
the benefit of creditors, or if the other party's license, registration,
approval or the like granted by any official or governmental agency is
rescinded, canceled or suspended.
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(b) In the event ZKC terminates this Agreement pursuant to this Section
18.6, then, subject to all bankruptcy laws and regulations applicable to
licensing arrangements, then if (x) ZKC determines to continue to use and/or
sell the Licensed Products in the Territory, (i) all rights and licenses granted
to ZKC pursuant to Section 4.1(a) of this Agreement with respect to the Corixa
Patents shall remain in effect and ZKC shall continue to have the obligation to
pay royalties in accordance with Section 5 with respect to Licensed Product
thereafter commercialized provided, however, that the applicable royalty rate(s)
set forth in Section 5 shall thereafter be [*], (ii) all rights and licenses
granted to ZKC pursuant to Section 4.1(a) of this Agreement with respect to the
Joint Patents shall remain in effect, provided, however, that solely to the
extent that any Licensed Products that are thereafter commercialized are covered
[*], the sale of such Licensed Products shall be [*] (iii) subject to
maintenance on their terms and conditions of all [*], all rights and licenses
granted to Corixa pursuant to Section 4.1(b) shall revert to ZKC, and (iv) each
party shall [*]not covered by the [*], except as provided for by applicable law,
provided that the parties agree to [*] and, (y) ZKC determines not to continue
to use or sell the Licensed Products in the Territory, (i) ZKC shall be [*],
(ii) all rights and licenses granted to ZKC pursuant to this Agreement with
respect to the Licensed Product, including, without limitation, rights and
licenses granted to ZKC to all Corixa Patents, Joint Patents and Corixa
Know-How, shall revert to Corixa and ZKC shall retain no license rights therein,
(iii) subject to maintenance on their terms and conditions of all [*], all
rights and licenses granted to Corixa pursuant to Section 4.1(b) shall revert to
ZKC, and (iv) each party shall [*] not covered by the [*], except as provided
for by applicable law, provided that the parties agree to [*]. In the event
either party wants to [*], the parties agree to [*].
(c) In the event Corixa terminates this Agreement pursuant to this Section
18.6 then, subject to all bankruptcy laws and regulations applicable to
licensing arrangements, then (i) all rights and licenses granted to ZKC pursuant
to this Agreement with respect to the Licensed Product, including, without
limitation, rights and licenses granted to ZKC to all Corixa Patents, Joint
Patents and Corixa Know-How, shall revert to Corixa and ZKC shall retain no
license rights therein, (ii) Corixa shall have an [*], under all of [*] rights,
title and interest in [*], all [*] related to the Licensed Products in the
Licensed Field to the extent that [*], and [*], (iii) subject to Corixa's [*],
Corixa shall have an [*], under all of [*] to the extent that [*], and [*], and
(iv) each party shall [*] not covered by [*], except as provided for by
applicable law, provided that the parties agree to [*]. In the event either
party wants to [*], the parties agree to [*]. In addition, ZKC hereby agrees
that in the event of any such termination, unless Corixa shall otherwise [*] or
ZKC shall obtain any right to the Licensed Products, ZKC will (a) [*] and (b)
[*] pursuant to this Section 18.6. Following termination pursuant to this
Section 18.6, Corixa shall be responsible for any and all [*] pursuant to this
Section 18.6.
18.7 The termination of this Agreement pursuant to Section 18.5 or 18.6
does not release the Indemnifying Party (as defined in Section 20.2) from any
obligation of indemnity under Section 20.1.
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19. RIGHTS AND DUTIES UPON TERMINATION.
19.1 Upon termination of this Agreement, Corixa shall have the right to
retain any sums already paid by ZKC hereunder, and ZKC shall pay all sums
accrued hereunder which are due as of the date of termination. For the avoidance
of doubt, as of the date of termination ZKC shall not be liable for any sums
that would have been due and payable under this Agreement after the date of
termination, except for those provided under this Agreement.
19.2 Upon termination of this Agreement, ZKC shall notify Corixa of the
amount of Licensed Product ZKC and its Affiliates, sublicensees and distributors
then have on hand, the sale of which would be subject to royalty, and ZKC and
its Affiliates, sublicensees and distributors shall thereupon be permitted at
Corixa's sole discretion, the right to sell that amount of Licensed Product,
provided that ZKC shall pay to Corixa the amounts payable thereon at the time
herein provided for.
19.3 Expiration or early termination of this Agreement shall not relieve
either party of its obligations incurred prior to such expiration or early
termination. In addition, Sections 1, 7, 11.3, 11.5 through 11.8, 12.3 through
12.6, 14 through 16, 17.4, 18.3, 18.4, 19 and 20, shall survive any expiration
or early termination of this Agreement.
20. INDEMNIFICATION.
20.1 Subject to Section 20.2 hereof, from and after the Effective Date,
except as otherwise herein specifically provided, each of the parties hereto
shall defend, indemnify and hold harmless the other party and its Affiliates,
successors and assigns, sublicensees and their respective officers, directors,
shareholders, partners and employees from and against all losses, damage,
liability and expense including legal fees but excluding punitive or
consequential damages (including lost profits) ("Damages") incurred thereby or
caused thereto arising out of or relating to (i) any [*]; (ii) any [*]; or (iii)
the [*] of the Indemnifying Party; provided, however, that this subsection (iii)
shall not apply to the extent such Damages are attributable to the [*] of the
Indemnified Party.
20.2 If either ZKC or Corixa, or any Affiliate of ZKC or Corixa (in each
case an "Indemnified Party"), receives any written claim which it believes is
the subject of indemnity hereunder by either Corixa or ZKC, as the case may be
(in each case an "Indemnifying Party"), the Indemnified Party shall, as soon as
reasonably practicable after forming such belief, give notice thereof to the
Indemnifying Party, including full particulars of such claim to the extent known
to the Indemnified Party; provided, however, that the failure to give timely
notice to the Indemnifying Party as contemplated hereby shall not release the
Indemnifying Party from any liability to the Indemnified Party other than any
liabilities caused by 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, and at the cost
of the Indemnifying Party. If the Indemnifying Party does not so assume the
defense of such claim, the Indemnified Party may assume such defense with
counsel of its choice at the sole expense of the Indemnifying Party. If the
Indemnifying Party so assumes such defense, the
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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 The party not assuming the defense of any such claim shall render all
reasonable assistance to the party assuming such defense, and all out-of-pocket
costs of such assistance shall be borne solely by the Indemnifying Party.
20.4 No such claim shall be settled other than by the party defending the
same, and then only with the consent of the other party, which shall not be
unreasonably withheld; provided, however, that the Indemnified Party shall have
no obligation to consent to any settlement of any such claim which imposes on
the Indemnified Party any liability or obligation which cannot be assumed and
performed in full by the Indemnifying Party.
[Signature page follows]
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IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement to
be executed by its duly authorized officer as of the date first written above.
CORIXA CORPORATION ZENYAKU KOGYO CO., LTD.
By: /s/ Xxxx XxXxxx By: /s/ Xxxxxxxx Xxxxxxxxx
---------------------------------- -------------------------------------
Xxxx XxXxxx Xxxxxxxx Xxxxxxxxx
President and Chief Operating Officer President and Representative Director
SIGNATURE PAGE TO THE ZENYAKU DEVELOPMENT AND LICENSE AGREEMENT
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EXHIBIT A
PATENT EXHIBIT
CORIXA PATENTS
COUNTRY APPLICATION NO. FILING DATE PATENT NO. ISSUE DATE
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[*] [*] [*] [*] [*]
[*] [*] [*]
[*] [*] [*]
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EXHIBIT B
PVAC SPECIFICATIONS
[*]
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EXHIBIT C
DEVELOPMENT AND COMMERCIALIZATION PROGRAM
PROJECT ROLES AND RESPONSIBILITIES:
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
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EXHIBIT D
OTHER [*] INDICATIONS
[*]
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