EXHIBIT 10.16
*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.
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (together with the exhibits
hereto, this "Agreement") is made and entered into effective as of January 28,
2003, by and among Corixa Corporation, a Delaware corporation with its principal
place of business located at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx,
Xxxxxxxxxx 00000 ("Corixa") and SmithKline Xxxxxxx plc, a company established in
the United Kingdom with its registered office at 000 Xxxxx Xxxx Xxxx, Xxxxxxxxx,
Xxxxxxxxx XX0 0XX, Xxxxxx Xxxxxxx ("GSK"). Each of Corixa and GSK may be
referred to herein as a "Party" and together as the "Parties."
RECITALS
WHEREAS, Corixa and GSK are parties to that certain Multi-Field
Agreement (as defined herein) pursuant to which GSK has the right to research,
develop and commercialize immunotherapy products for use with specific diseases
or conditions affecting humans; and
WHEREAS, subject to the terms and conditions set forth herein,
including without limitation, certain rights and options retained by GSK, GSK
and Corixa desire that Corixa research, develop, and under certain
circumstances, commercialize, under this Agreement, Licensed Products (as
defined herein) in order to generate revenue for both Parties and in order to
validate intellectual property assets resulting from the Parties' collaborative
efforts under the Multi-Field Agreement (as defined herein).
NOW, THEREFORE, in consideration of the foregoing premises and other
good and valuable consideration the receipt and sufficiency of which is hereby
acknowledged, the Parties hereby agree as follows:
SECTION 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms
shall have the following meanings:
1.1. "AAA" shall have the meaning set forth in Section 12.6.
1.2. "AFFECTED PRODUCTS" shall have the meaning set forth in
Section 2.3.1.
1.3. "AFFECTED PRODUCT RIGHTS" shall have the meaning set forth in
Section 2.3.2.
1.4. "AFFECTED PRODUCT RIGHTS LICENSE" shall have the meaning set
forth in Section 2.3.2.
1
1.5. "AFFILIATE" shall mean any entity owned, 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 which 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 such entity. Notwithstanding the
foregoing, none of the Parties hereunder shall be "Affiliates" of any other
Party, or any of their respective Affiliates, for the purposes of this
Agreement.
1.6. "AMENDED MFA" shall mean the Multi-Field Agreement as amended
by Amendment No. 2 dated as of the Effective Date.
1.7. "ANTIBODY" shall mean an immunoglobulin capable of binding to
a specific Antigen and/or an immunoglobulin [*] capable of binding to a specific
Antigen and/or a [*] an immunoglobulin [*], which [*] is capable of binding to a
specific Antigen.
1.8. "[*] ANTIBODY" shall mean a [*] or [*] Antibody wherein the
[*] of such Antibody [*] a [*] and/or [*] immune response directed [*] such[*]
and solely against such variable region. For avoidance of doubt, in no case
shall the term [*] Antibody mean or include an Antibody that will bind to an
Antigen.
1.9. "ANTIGENS" shall mean (i) antigens and/or (ii) proteins and/or
(iii) other physical forms based on such antigens, such as [*] and/or [*] and/or
[*] and/or [*], including [*] but no other [*], except in the case of antigens
for [*] which may include [*] for [*] based on such antigens, in each case,
delivered in any form including, but not restricted to, [*] whether [*] or not.
1.10. "[*] ANTIGEN" shall mean the Antigen designated by Corixa as
[*] and entered into a database of Antigens maintained by Corixa on [*], the
full length amino acid and nucleic acid sequences for which are set forth on
Exhibit 1.10 hereto and any [*] or [*] of [*] which is capable of generating an
immune response against any [*] of any [*] which are set forth on Exhibit 1.10
hereto
1.11. "BIOLOGIC LICENSE APPLICATION" or "BLA" shall mean a Biologic
License Application filed with the FDA in accordance with applicable regulations
and requirements of the FDA in effect from time-to-time.
1.12. "BREACHING PARTY" shall have the meaning set forth in Section
9.2.
1.13. "BUY-BACK OPTION" shall have the meaning set forth in Section
2.3.2.
1.14. "CANCER FIELD" shall mean any and all forms of cancer in
humans.
1.15. "COLA" shall have the meaning set forth in Section 2.5.2.
-----------------------------------
* Confidential treatment requested.
2
1.16. "COLLABORATION STEERING COMMITTEE" or "CSC" shall have the
meaning set forth in Section 2.2, hereof.
1.17. "CO-PROMOTION FORM" shall have the meaning set forth in
Section 6.2.
1.18. "CONTROL" OR "CONTROLLED" shall mean, with respect to any
data, results, information, inventions, know-how, formulas, trade secrets,
techniques, methods, procedures, development, material or compositions of matter
of any type or kind, whether or not patentable, or any intellectual property
right, possession of the ability, whether by ownership or license, to assign,
grant a license, sublicense, immunities or other rights as provided for herein
to such item or under such right without violating the terms of any agreement or
other arrangement with any Third Party.
1.19. "CORIXA CO-PROMOTION OPTION" shall have the meaning set forth
in Section 6.1.
1.20. "CORIXA INVESTED FUNDS" shall have the meaning set forth in
Section 2.4.
1.21. "CORIXA PROGRAM INVENTIONS" shall mean any and all Inventions
that are invented (as determined under United States patent law) or first
produced, created, developed or discovered solely by Corixa or any of its
employees or agents (other than with GSK, its employees or agents) pursuant to
the activities under this Agreement during the Term hereof.
1.22. "CORIXA TAKEAWAY AGREEMENT" shall mean that certain agreement
entitled the "Corixa License Agreement" entered into by and between Corixa and
GSK as of the Effective Date.
1.23. "DEFAULT" shall have the meaning set forth in Section 9.2.
1.24. "DIAGNOSTIC PRODUCTS" shall mean products, containing one or
more Antigens, that are used solely for the purpose of detecting or monitoring
the presence or extent of a disease state in humans, but not including TDM Uses
(such uses are "Diagnostic Uses"). TDM Products shall not be included within the
definition of Diagnostic Products.
1.25. "DIAGNOSTIC USES" shall have the meaning set forth in Section
1.24.
1.26. "DISPUTE" shall have the meaning set forth in Section 12.6.
1.27. "EFFECTIVE DATE" shall mean the effective date of this
Agreement as set forth in the first paragraph hereof.
1.28. "FDA" shall mean the United States Food and Drug
Administration and any successor agency or authority thereto.
1.29. "FTE" shall mean a person or a number of persons that singly
or collectively work a minimum of forty (40) hours per week, as averaged over an
annual basis each month
3
based on the immediately preceding twelve (12) months, and as adjusted for
reasonable vacation, sick days and paid time off.
1.30. "GOOD LABORATORY PRACTICES" or "GLP" shall mean the current
good laboratory practices applicable to the development of the Licensed Products
as promulgated and amended from time-to-time by the United States Food and Drug
Administration.
1.31. "GSK ADJUVANTS" shall mean adjuvants that are supplied by GSK
to Corixa in connection with the performance of the Work Plan.
1.32. "GSK KNOW-HOW" shall mean all technical information, materials
and know-how that exists at the time of the Effective Date or is generated by
GSK during the Program Term and is Controlled, with the right to grant
sublicenses, by GSK, and that directly relates to and is reasonably useful for,
the research, development or commercialization of products in the Licensed
Product Fields and shall include, without limitation, all [*] and [*] data and
any [*] or [*]. In no event will the term "GSK Know-How" include the GSK
Licensed Know-How or any of it.
1.33. "GSK LICENSED KNOW-HOW" shall mean all technical information,
materials and know-how Controlled by GSK, with the right to grant sublicenses,
as a result of GSK's licenses from Corixa under the Multi-Field Agreement, and
that directly relates to, or is useful for, the research, development or
commercialization of products in the Licensed Product Fields and shall include,
without limitation, [*] and [*] data and any [*] or [*].
1.34. "GSK LICENSED PATENTS" shall mean the "Corixa Patents," the
"Joint R&D Program Patents" and "SPC," collectively, as such terms are defined
in the Multi-Field Agreement, including without limitation, the Patents set
forth on Exhibit 1.34.
1.35. "GSK PATENTS" shall mean all patents and patent applications
that are now or during the Program Term become Controlled by GSK (other than
jointly with, or under license from, Corixa) and/or under which GSK otherwise
has, now or in the future, the right to grant licenses or sublicenses, that
generically or specifically claim any Antigen and/or Adjuvant included in a
Licensed Product and/or all or part of a Licensed Product(s), a process for
manufacturing Licensed Product(s), intermediates used in such process or use of
Licensed Product, including without limitation, the Patents set forth on Exhibit
1.35 as may be amended from time to time by GSK. Included within the definition
of GSK Patents are any continuations, continuations-in-part, divisions, patents
of addition, reissues, renewals or extensions of the Patents described in this
Section 1.35. Also included in the definition of GSK Patents are any patent
applications that generically or specifically claim any improvements of Licensed
Product(s) or intermediates or manufacturing processes required or useful for
production of Licensed Product(s) that are developed by GSK during the Program
Term. In no event will the term "GSK Patents" include the GSK Licensed Patents
or any of them.
1.36. "GSK PROGRAM INVENTIONS" shall mean any and all Inventions
that are invented (as determined under United States patent law) or first
produced, created, developed or
-----------------------------------
* Confidential treatment requested.
4
discovered solely by GSK or any of its employees or agents (other than with
Corixa, its employees or agents) pursuant to the activities under this Agreement
during the Term hereof.
1.37. "INDEMNIFIED PARTY" shall have the meaning set forth in
Section 10.2.
1.38. "INDEMNIFYING PARTY" shall have the meaning set forth in
Section 10.2.
1.39. "INVENTION" means any and all inventions, whether or not
patentable, information, data, know-how, materials or technology, invented (as
determined under United States patent law) or first produced, created, developed
or discovered pursuant to the activities under this Agreement during the Term
hereof.
1.40. "JOINT PROGRAM INVENTIONS" shall mean any and all Inventions
that are invented (as determined under United States patent law) or first
produced, created, developed or discovered jointly by Corixa or any of its
employees or agents and GSK or any of its employees or agents pursuant to the
activities under this Agreement during the Term hereof.
1.41. "LICENSED [*] PRODUCTS" shall mean products consisting of [*]
Antigen in the form of [*], regardless of [*], and a [*] of [*] of a [*] that is
administered for the [*] purpose and effect of inducing a prophylactic or
therapeutic immune response specific to such Antigen(s) or one or more [*]
contained therein and possibly [*] or [*], at [*], [*] per [*] for the [*]
purpose and effect of maintaining a prophylactic or therapeutic immune response
specific to such Antigen(s) or one or more [*] contained therein.
1.42. "LICENSED [*] PRODUCTS FIELD" shall mean the research,
development and commercialization of Licensed [*] Products for use in treating
cancer in humans. For the avoidance of doubt, the [*] Products Field shall not
include Diagnostic Uses or TDM Uses of Licensed [*] Products.
1.43. "LICENSED PRODUCTS" shall mean the Licensed [*] Products and
the Licensed [*] Products.
1.44. "LICENSED PRODUCTS FIELD" shall mean the Licensed Adenoviral
Products Field and the Licensed [*] Products Field.
1.45. "LICENSED [*] PRODUCTS" shall mean products designed to
generate an immune response to a [*] Antigen, which products consist of a [*]
Antigen in the form of [*] that is administered for the primary purpose and
effect of inducing a prophylactic or therapeutic immune response specific to [*]
Antigen or one or more [*] contained therein.
1.46. "LICENSED [*] PRODUCTS FIELD" shall mean the research,
development and commercialization of Licensed [*] Products for use in treating
cancer in humans. For the avoidance of doubt, the Licensed [*] Products Field
shall not include Diagnostic Uses or TDM Uses of Licensed [*] Products.
-----------------------------------
* Confidential treatment requested.
5
1.47. "LOSSES" shall have the meaning set forth in Section 10.1.
1.48. "MULTI-FIELD AGREEMENT" shall mean the Multi-Field Vaccine
Discovery Collaboration and License Agreement between the Parties dated
September 1, 1998, as amended by Amendment No. 1 dated May 25, 2000, as further
amended by that certain letter agreement by and between the Parties dated
November 30, 2000, and as further amended by those certain letter agreements by
and between the Parties dated: (i) January 21, 2000, (ii) September 1, 2000,
(iii) a further letter agreement dated September 1, 2000, (iv) November 30,
2000, (v) August 16, 2001, (vi) April 17, 2002, (vii) October 14, 2002 and
(viii) a further letter agreement dated October 14, 2002.
1.49. "NEW DRUG APPLICATION" or "NDA" shall mean a New Drug
Application filed with the FDA in accordance with applicable regulations and
requirements of the FDA in effect from time-to-time.
1.50. "[*] OPTION" shall have the meaning set forth in Section 2.4.3
1.51. "[*] OPTION NOTICE" shall have the meaning set forth in
Section 2.4.3
1.52. "NON-DEFAULTING PARTY" shall have the meaning set forth in
Section 9.2.
1.53. "[*] ANTIGEN" shall mean the Antigen designated by Corixa as
[*] and entered into a database of Antigens maintained by Corixa on [*], full
length amino acid and nucleic acid sequences for which are set forth on Exhibit
1.50 hereto.
1.54. "PARTIAL TERMINATION" shall have the meaning set forth in
Section 9.5.
1.55. "PATENT(S)" shall mean all patents and patent applications,
including, without limitation, any divisions, continuations, continuations-in-
part, reissues, renewals, extensions and SPCs, as well as any certificates of
invention or applications therefor.
1.56. "PATENT COMMITTEE" shall have the meaning set forth in Section
10 (b) of the Amended MFA.
1.57. "PHASE III CLINICAL TRIAL" shall mean any pivotal clinical
trial conducted with final process and final scale material and that is designed
(i) to provide statistically significant evidence of safety and efficacy of the
product under study and (ii) to be suitable for submission to the FDA as
'Pivotal Phase III Data' in support of an NDA or BLA for such product.
1.58. "PROGRAM" shall have the meaning set forth in
Section 2.1.
1.59. "PROGRAM TERM" shall have the meaning set forth in
Section 9.1.
1.60. "PROJECT COST" shall mean the actual costs and expenses
incurred by Corixa in performing, or having performed, the research and
development activities for a given Project as
-----------------------------------
* Confidential treatment requested.
6
set forth herein and in Section 2.4.2. Such costs and expenses shall include
amounts charged to Corixa by other entities for goods, including without
limitation, licenses or other rights to intellectual property or technology
Controlled by such other entities, as referred to in Section 2.5.2, which are
required or reasonably useful for the research and development activities of a
given Project, or services related to a particular Project and such portion of
any such amounts that are attributable to a given Project by application of
Corixa's cost accounting policies and practices and generally accepted
accounting practices consistently applied; [*]. Regarding the allocation of
costs across Projects, for example, the cost of acquiring a software program to
perform clinical study data management may be allocated across all Projects for
which such software was used. For avoidance of doubt, where an overhead or other
internal Corixa cost component has been included within an FTE rate, such
overhead or other internal Corixa cost component shall not be included
separately in the cost of such Project in order to avoid "double-counting" or
otherwise over-stating a particular Project's cost.
1.61. "PROJECTS" shall mean the two (2) research and development
projects set forth in the Work Plan. One of the Projects is intended to identify
and develop a Licensed [*] Product and the other Project is intended to identify
and develop a Licensed [*] Product.
1.62. "PROOF OF PRINCIPLE CLINICAL TRIALS" shall have the meaning
set forth in Section 3.1.
1.63. "PROOF OF PRINCIPLE OPTION" shall have the meaning set forth
in Section 3.1.2.
1.64. "PROOF OF PRINCIPLE OPTION LICENSE" shall have the meaning set
forth in Section 3.1.2.
1.65. "PROOF OF PRINCIPLE REPORT" shall have the meaning set forth
in Section 3.1.1.
1.66. "GSK MATERIALS" shall have the meaning set forth in Section
5.2.
1.67 "RELATED AGREEMENTS" shall mean the Corixa Takeaway Agreement
and the Amended MFA.
1.68. "RISK FEE" shall mean the additional fee described as a "Risk
Fee" in Exhibit 3.1.2, and payable by GSK in connection with the exercise of the
Proof of Principle Option, the Buy-Back Option and the [*] Option.
1.69. "SCIENTIFIC ADVISORY BOARD" shall have the meaning set forth
in Section 2.3.1.
1.70. "SPC" shall mean all Supplementary Protection Certificates for
medicinal products and their equivalents provided under the Council Regulation
(EEC) N# 1768/92 of June 18, 1992 or any other equivalent legislation.
-----------------------------------
* Confidential treatment requested.
7
1.71. "SUBLICENSEE" shall mean, with respect to specified
intellectual property rights, a person or entity to whom a license, sublicense,
immunities or other rights to any of such specified intellectual property rights
have been granted.
1.72. "TDM USES" shall have the meaning set forth in Section 1.75.
1.73. "TERM" shall have the meaning set forth in Section 9.1.
1.74. "THERAPEUTIC DRUG MONITORING PRODUCT(S)" or "TDM Product(S)"
shall mean the use of an Antigen(s) and/or Antibody in any format, provided that
in the case of use of [*] may be incorporated in TDM Products only for [*],
solely for the purpose of pre-screening human patients to determine therapeutic
eligibility for a Licensed Product that incorporates or is based on such
Antigen(s), or for monitoring human patients receiving such Licensed Product,
either during the clinical phase of development of such Licensed Product or
following commercialization thereof (such uses are "TDM Uses"). For further
clarification, a TDM Product can only be associated commercially with [*] or [*]
product administration and cannot be [*] or [*] purely as a diagnostic product
for use in [*] diagnosis, diagnosis of [*] or diagnosis of [*] with the [*] for
[*] with a product that is not the related [*], or for [*] to [*] other than
[*]. Further, a TDM Product shall not be commercialized in any country prior to
the [*] for [*] of the [*] in such country.
1.75. "THIRD PARTY" shall mean any person or entity other than
Corixa, GSK and their respective Affiliates.
1.76. "WORK PLAN" shall have the meaning set forth in Section 2.1.
SECTION 2
DEVELOPMENT AND COMMERCIALIZATION GENERALLY
2.1 DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES. The purpose of
this collaboration is to advance development of the Licensed Products as set
forth in this Agreement and the Work Plan to completion of Proof of Principle
Clinical Trials (the "Program"). The Program shall be conducted in accordance
with this Agreement and with the plan and budget attached hereto as Exhibit 2.1,
as amended from time-to-time in accordance herewith (the "Work Plan"). Corixa
shall use all reasonable efforts to undertake and complete the Work Plan in an
efficient manner and in accordance with high scientific standards.
2.2 ESTABLISHMENT OF COLLABORATION STEERING COMMITTEE. The Parties
hereby form a collaboration steering committee (the "Collaboration Steering
Committee" or "CSC"). The CSC is charged with considering and adopting or
rejecting changes to the Work Plan as required by the practice of good business
judgment and high scientific standards. The Parties agree that so long as this
Agreement and the Amended MFA are in effect, the CSC shall attempt to combine or
coordinate its meetings with the meetings of the "CSC" (as defined under the
Amended MFA) and further that either Party may appoint the same person or
persons to represent it on both of those committees.
-----------------------------------
* Confidential treatment requested.
8
2.2.1 COMPOSITION. The CSC shall be comprised of [*] named
representatives of Corixa and [*] named representatives of GSK. Each of
the representatives will have [*] vote on matters that come before the
CSC and is entitled to vote though proxy vote if he/she is unable to
attend in person. The initial named representatives to the CSC are as
follows:
Corixa Representatives GSK Representatives
[*]
Each Party may replace one (1) or more of its named representatives
from time-to-time with the consent of the other Party, which consent
shall not be unreasonably withheld. One (1) of the representatives of
[*] shall be the chairman of the CSC, and in such capacity, such
representative shall be responsible for setting the agenda for meetings
of the CSC, with input from the other members, and for conducting the
meetings of the CSC. Each Party shall be entitled to have further
representative(s) attending CSC meetings on an ad-hoc basis provided
that such Party informs the other at least five (5) working days prior
to the concerned CSC meeting and provided further that such additional
representative(s) shall have no vote on matters that come before the
CSC.
2.2.2 MEETINGS. The CSC shall meet not less than [*] times
per calendar year alternatively at Seattle, Washington USA and
Rixensart, Belgium or alternatively through video conferences as the
CSC may agree. Subject to the preceding sentence, the CSC shall meet on
such dates and at such times and places as agreed to by the members of
the CSC. Each Party shall be responsible for all of its own expenses
relating to attendance at or participation in CSC meetings. Within
thirty (30) days following each CSC meeting, the chairman shall cause
to be prepared and shall provide to the other Party a draft of
reasonably detailed written minutes describing all matters reviewed or
considered by the CSC and all determinations or decisions made and
actions taken by the CSC and a summary of the reasons therefor stated
by the members at the meeting. The minutes of any meeting of the CSC
shall be final upon approval by the members of the CSC at any
subsequent meeting. The minutes and the drafts of any minutes shall be
the confidential information of the Parties.
2.2.3 ACTIONS. For the transaction of business, a quorum
consisting of [*] of GSK's members and [*] of Corixa's members must be
present at a meeting. Decisions of the CSC, unless otherwise stated
herein, shall be made by [*] of the members, provided that a quorum is
present and that at least one (1) representative of each Party votes in
favor of such action.
2.3 WORK PLAN. The Program shall be conducted by Corixa
in accordance with the Work Plan. The Work Plan shall include a budget for the
expenses to be incurred in connection with each Project. The Parties acknowledge
that the Work Plan includes certain activities that were undertaken by Corixa
beginning on June 15, 2002. The Parties agree that despite the fact that such
activities were undertaken prior to the Effective Date, such activities, that
shall be
-----------------------------------
* Confidential treatment requested.
9
listed and included in Exhibit 2.3 with a detail of the related costs, are
hereby deemed to have been undertaken and performed as part of the Work Plan for
all purposes hereunder. Either Party may propose amendments to the Work Plan
based on the most reliable and current information available at the time,
provided that no amendments to the Work Plan may be made without the approval of
the CSC, subject to the following. The Work Plan, including trial design and
budget pursuant to Section 2.4.1 below, shall be reviewed and agreed upon
annually by the CSC provided the Work Plan can also be modified by the CSC
throughout the year. Corixa shall send to GSK on a [*] basis progress reports on
the work, including clinical studies, performed under the Work Plan. Such
reports shall be in written form and shall be sent to GSK at least [*] before
the next planned meeting of the CSC.
2.3.1 DISPUTES; SCIENTIFIC ADVISORY BOARD. In the event the
CSC is unable to agree upon the adoption of an amendment to the Work
Plan proposed by one of the Parties, or in the event there is a
disagreement between the Parties as to whether any Project under the
Work Plan should be terminated for reason of technical infeasibility,
such dispute shall be resolved by an independent scientific advisory
board (the "Scientific Advisory Board"). The Scientific Advisory Board
shall be composed of [*] appointed by Corixa, [*] appointed by GSK and
a third member appointed by the agreement of [*] members. In order to
be eligible for appointment to the Scientific Advisory Board, a person
must be independent in all respects from both Corixa and GSK. The
Parties shall identify their respective appointees within [*] following
notice by one Party to the other of a dispute as to a proposed
amendment to the Work Plan or the termination of a Project for
technical infeasibility. The first [*] members so appointed will have
an additional [*] days to choose the [*]. Corixa and GSK shall share
equally any cost involved in the engagement and services of such [*]
The Scientific Advisory Board shall evaluate the disputed proposed
amendment to the Work Plan or termination and shall determine whether,
in light of all circumstances, including without limitation, scientific
and technical feasibility and, subject to Corixa's obligation to
provide the Corixa Invested Funds, resource availability, (i) such
amendment would increase or decrease the likelihood of one or both
Licensed Products advancing to completion of Proof of Principle
Clinical Trials or whether (ii) such Project should indeed be
terminated for technical infeasibility. Notwithstanding the foregoing,
the Parties may, by agreement, identify a more specific or relevant
standard for the Scientific Advisory Board to consider in resolving a
particular dispute. The Scientific Advisory Board shall make its
determination as soon as reasonably possible, but no later than thirty
(30) days after referral of the dispute to the Scientific Advisory
Board by the Parties. Decisions of the Scientific Advisory Board shall
be made by [*] vote of the members and shall be announced, with such
reasoning as the Scientific Advisory Board, in its sole discretion,
shall determine to be appropriate, in a document delivered on the same
date to both Parties. In the event that the Scientific Advisory Board
makes a decision concerning a disputed amendment to the Work Plan,
which decision is counter to the position advocated by GSK, and such
decision will result in the Program, as it relates to the Licensed [*]
Products and/or the Licensed [*] Products, being conducted in a manner
which is materially different than the manner set forth in the Work
Plan as it existed
-----------------------------------
* Confidential treatment requested.
10
immediately before such dispute arose, then GSK may exercise the
Buy-Back Option relating to such Licensed Products (the "Affected
Products") as set forth in Section 2.3.2.
2.3.2 BUY-BACK OPTION. Subject to the terms and conditions
set forth herein, GSK shall have the option (the "Buy-Back Option") to
license back from Corixa the intellectual property rights licensed to
Corixa hereunder, to research, develop and commercialize the Affected
Products within the applicable Licensed Products Field (the "Affected
Product Rights"). The Buy-Back Option shall be exercisable by GSK
giving written notice of its desire to exercise such option within [*]
days of receipt by GSK of the notice of the decision of the Scientific
Advisory Board that created the Affected Products. The terms of any
license granted to GSK upon exercise of the Buy-Back Option (the
"Buy-Back Option License") shall be in accordance with the terms set
forth in this Section 2.3.2 and the terms set forth on Exhibit 2.3.2.
In addition, upon exercise of the Buy-Back Option, GSK shall
automatically have the rights provided in Section 3.2 of the Corixa
Takeaway Agreement related to the development and commercialization of
TDM Products for use in association with the Affected Products as if
such Affected Products were "Proof of Principle Products" for purposes
of Section 3.2 of the Corixa Takeaway Agreement.
2.4 FUNDING COMMITMENT. Corixa shall be responsible for providing
the resources and funding necessary to perform the work under the Work Plan,
pursuant to the terms herein, subject to Section 2.4.3, up to a maximum of
sixteen million dollars ($16,000,000) for each of the two Projects (the "Corixa
Invested Funds"). The Parties acknowledge that the Corixa Invested Funds will be
used to fund Project Costs, all as further set forth in the Work Plan and
budgets described in Section 2.4.2.
2.4.1 BUDGETS. The Work Plan includes the initial budget
for the Program. The initial budget shall be reviewed on an annual
basis by the CSC or whenever material changes are made to the Work
Plan. The budget shall include the projected cost, on a
Project-by-Project basis, of progressing both Projects through to
completion of a Proof of Principle Clinical Trial.
2.4.2 DEVELOPMENT EXPENDITURES. The cost of obtaining or
performing the following goods, services and activities shall be deemed
to be included within the Project Cost for the Project to which such
costs relate: (a) [*], (b) [*], including without limitation[*], and
[*] (c) [*] [*], including without limitation, [*] and [*], (d) [*],
(e) [*] and [*], and (f) [*] the [*] described in [*] of the Amended
MFA and [*]. Materials supplied by Corixa for use in Proof of Principle
Clinical Trials shall be accounted for at [*]. Services supplied by
Corixa employees, if any, shall be accounted for on an FTE basis with
the reimbursement rate for each FTE being fixed at an annual rate of
[*], such rate being subject to increase once per year beginning in
2003, to reflect any increase in the cost-of-living Consumer Price
Index for the geographic region where the applicable FTE is located
("COLA") with such increase being given effect as of the start of the
following calendar year to which such rate applies. The foregoing FTE
rate includes the
-----------------------------------
* Confidential treatment requested.
11
cost of [*] (such as [*] and [*]) but excludes the [*] and [*] provided
by [*] and the [*] of [*].
2.4.3 EFFECT OF RESOURCE LIMITATIONS ON WORK PLAN. Corixa
shall not be obligated to commence or undertake any new activity under
the Work Plan as in existence on the Effective Date or as amended from
time to time thereafter, including without limitation any new clinical
trial, if there are not sufficient remaining Corixa Invested Funds
available to complete such new activity. Under such circumstances, the
CSC shall meet to determine how to modify the Work Plan to maximize the
benefits from the remaining Corixa Invested Funds in light of the
purposes of the Program including by allocating resources remaining
unspent for a Project to the other Project, within the limit of the
Corixa Invested Funds and up to a maximum of [*] which represents [*]
of the Corixa Invested Funds for each Project. In addition when Corixa
has spent [*] of the Corixa Invested Funds for any particular Project
for which Proof of Principle Clinical Trials have not been yet
achieved, Corixa shall inform GSK and GSK shall have the option to
buy-back that Project and acquire world-wide development, manufacturing
and commercialization rights with respect to the Licensed Products in
connection with that Project under the conditions described in Exhibit
2.4.3 attached hereto (the "[*] Option"). More specifically, within [*]
of Corixa determining that [*] of the Corixa Invested Funds have been
spent for a particular Project, Corixa will provide written notice of
such determination to GSK, which notice shall include a summary of the
Project to which the [*] Option pertains (the [*] Option Notice"). The
[*] Option shall commence upon receipt by GSK of the [*] Option Notice
and shall terminate [*] days thereafter. The terms of any license
granted to GSK upon exercise of the [*] Option (the "[*] Option
License") shall be in accordance with the terms set forth on Exhibit
2.4.3. In addition, upon exercise of the [*] Option, GSK shall
automatically have the rights provided in Section 3.2 of the Corixa
Takeaway Agreement related to the development and commercialization of
TDM Products for use in association with the Project as if the products
under development as part of such Project were "Proof of Principle
Products" for purposes of Section 3.2 of the Corixa Takeaway Agreement.
GSK shall exercise the [*] Option by giving written notice to Corixa of
its desire to exercise such rights within [*] days of receipt of the
[*] Option Notice. Corixa shall have the co-promotion rights described
in Section 6.1 to Licensed Product that GSK licenses through the
exercise of the [*] Option. In the event GSK does not exercise the [*]
Option for any available Project, Corixa and/or GSK may seek additional
financing to fund the research and development of Project(s) which have
been developed under the Work Plan but which have not achieved Proof of
Principle Clinical Trial prior to the expiration or termination of the
Program Term. If funding is obtained, then Corixa will continue to
develop such Project(s) through completion of the Proof of Principle
Clinical Trial, including generation of the Proof of Principle Report
therefor, provided that neither Corixa nor GSK shall be obligated to
provide any of the additional funding required or to encumber any of
their assets to obtain additional funding.
-----------------------------------
* Confidential treatment requested.
12
2.5 CONTRACT SERVICES; THIRD PARTY TECHNOLOGY. Corixa shall enter
into such contract service agreements as it reasonably determines to be
necessary or convenient in the exercise of sound business judgment and in light
of the goals set forth in the Work Plan.
2.5.1 INTELLECTUAL PROPERTY MATTERS. Corixa will make
reasonable efforts to ensure that any service agreements it enters into
shall provide: (a) for the assignment or conveyance of ownership of
intellectual property rights in all inventions conceived or reduced to
practice in the performance of such contracted services to Corixa
including transferability to GSK if and when GSK exercises its Proof of
Principle Option, Buy-Back Option or [*] Option and (b) that the other
party to such agreement shall maintain, and cause it employees and
consultants to maintain, records in sufficient detail and in a good
scientific manner appropriate for obtaining and maintaining
intellectual property rights and protections, including, without
limitation, patent rights.
2.5.2 THIRD PARTY TECHNOLOGY. Corixa may obtain such
licenses or other rights to intellectual property or technology
Controlled by Third Parties, as are required or reasonably useful for
the research and development activities to be performed hereunder.
Corixa will give notice to GSK prior to obtaining rights to
intellectual property or technology from a Third Party (including a
description of such intellectual property or technology) and will
consider in good faith any information about such rights or technology
as is promptly provided by GSK.
2.6 ADVERSE EVENTS. During the Term, Corixa and GSK each agree to
promptly inform the other of any information that it obtains or develops
regarding the safety of any substance which, under the Work Plan, is to be used
in the manufacture or development of, or is to be incorporated in, a Licensed
Product, and each shall promptly report to the other any confirmed information
of serious or unexpected reactions or side effects related to the utilization or
administration to humans of any such substance. Corixa, in close consultation
with GSK, shall be responsible for reporting adverse events arising from the use
of Licensed Products to the FDA and other regulatory authorities; provided
however, that GSK shall have such obligation for Licensed Products for which GSK
acquires research, development and commercialization rights through the exercise
of its Buy-Back Option, the Proof of Principle Option, the [*] Option or
otherwise.
SECTION 3
GSK PROOF OF PRINCIPLE OPTION
3.1 PROOF OF PRINCIPLE CLINICAL TRIALS. Completion of a Proof of
Principle Clinical Trial for a Licensed Product shall trigger GSK's option to
acquire certain rights as set forth in this Section 3. A Proof of Principle
Clinical Trial for a Licensed Product shall be deemed to have been completed
when the following items have been accomplished with respect to such Licensed
Product: (a) [*] and (b) the achievement of [*] (such trials are "Proof of
Principle Clinical Trials").
-----------------------------------
* Confidential treatment requested.
13
3.1.1 COMPLETION OF PROOF OF PRINCIPLE CLINICAL TRIALS.
Upon completion of each Proof of Principle Clinical Trial, Corixa shall
prepare a final, written study report containing the full, complete and
final data and conclusions with respect to such data (the "Proof of
Principle Report"). Corixa shall deliver a copy of each Proof of
Principle Report to the CSC and to GSK.
3.1.2 GSK'S PROOF OF PRINCIPLE OPTION. Subject to the terms
and conditions set forth herein, GSK shall have an option to acquire an
exclusive (even as to Corixa), royalty-bearing, worldwide license or
sublicense, as applicable, with the right to grant further sublicenses,
under all of: (a) the intellectual property rights licensed by GSK to
Corixa under Section 4.1 hereof and (b) Corixa's right, title and
interest in and to any and all Corixa Program Inventions or Joint
Program Inventions, to research, develop, make, have made, use, have
used, sell, offer for sale, have sold, keep and import the Licensed
Products described in the Proof of Principle Report within the
applicable Licensed Product Field (the "Proof of Principle Option").
Each Proof of Principle Option shall commence upon receipt by GSK of
the Proof of Principle Report for a Licensed Product. The terms of any
license granted to GSK upon exercise of the Proof of Principle Option
(the "Proof of Principle Option License") shall be in accordance with
the terms set forth in this Section 3.1.2 and the terms set forth on
Exhibit 3.1.2. Upon exercise of the Proof of Principle Option, GSK
shall automatically have the rights provided in Section 3.2 of the
Corixa Takeaway Agreement related to the development and
commercialization of TDM Products for use in association with the
Licensed Products described in the Proof of Principle Report. GSK shall
exercise the Proof of Principle Option if at all, by giving written
notice to Corixa of its desire to exercise such option within [*] days
of receipt of the Proof of Principle Report to which the option
relates. Such notice shall make specific reference to the Proof of
Principle Report to which it is responsive. Corixa shall have certain
co-promotion rights to the Product Fields that GSK licenses through the
exercise of the Proof of Principle Option as set forth in Section 6.1.
3.1.3 FAILURE TO EXERCISE PROOF OF PRINCIPLE OPTION. In the
event GSK does not exercise its Proof of Principal Option, Corixa shall
retain the right to research, develop and commercialize the Licensed
Products as set forth in Section 4.1.
SECTION 4
LICENSE GRANTS TO CORIXA
4.1 LICENSE GRANT TO CORIXA BY GSK. Subject to the terms and
conditions set forth herein, including without limitation, certain rights of GSK
as set forth in Section 2.3.2, Section 2.4.3 and Section 3.1.2, GSK hereby
grants to Corixa, for the Term, an exclusive (even as to GSK), royalty-bearing,
worldwide license or sublicense, as applicable, with the right to grant further
sublicenses, under all of GSK's right, title and interest in and to the GSK
Licensed Patents, GSK Licensed Know-How, GSK Patents, GSK Know-How, GSK Program
Inventions and Joint Program Inventions to research, develop make, have made,
use, have used, sell, offer
-----------------------------------
* Confidential treatment requested.
14
for sale, have sold, keep and import solely the following: (a) Licensed [*]
Products for use in the Licensed [*] Products Field and (b) Licensed [*]
Products for use in the Licensed [*] Products Field.
4.2 OTHER INTELLECTUAL PROPERTY RIGHTS. If Corixa desires to
obtain a non-exclusive license to any intellectual property rights Controlled by
GSK not specifically granted herein, then Corixa may request such a license and
GSK shall, subject to such rights being legally available for licensing to
Corixa, duly consider such request in good faith. At any time prior to such a
request from Corixa, or if no agreement is reached within a reasonable period of
time not to exceed [*] after such a request, GSK shall be free to out-license or
otherwise convey or encumber such rights free from the obligations set forth in
this Section 4.2. For the avoidance of doubt, this right of negotiation shall
only apply to intellectual property rights that could enable or assist Corixa to
research, develop, make, have made, use, have used, sell, offer for sale, have
sold, keep and import Licensed Products in the Licensed Products Field in
accordance with Section 4.1.
4.3 PAYMENT TERMS. In consideration of the grant of rights granted
under Section 4.1 hereunder, Corixa agrees to pay royalties and milestones to
GSK in accordance with the terms and conditions of Sections 6 and 7 of the
Multi-Field Agreement; provided, however, that in the event Corixa out-licenses
rights with respect to a particular Licensed Product, then Corixa shall pay to
GSK [*] of the net proceeds as contemplated by Section 7(h) of the Multi-Field
Agreement. Subject to the limitation set forth in the preceding sentence, for
purposes of payments by Corixa to GSK pursuant to this Section 4.3, all terms
and conditions applicable to Vaccine Products under Sections 6 and 7 of the
Multi-Field Agreement shall apply to Licensed Products and are hereby
incorporated by reference into this Section 4.3, including without limitation,
the definitions of the capitalized terms used in Sections 6 and 7. Milestones
and royalties on Net Sales of such Licensed Product payable by Corixa to GSK
shall be determined as if Corixa were GSK and GSK were Corixa for purposes of
Sections 6 and 7 of the Multi-Field Agreement.
4.3.1 WITHHOLDING TAXES. Each Party shall be entitled to
deduct from amounts otherwise due and payable hereunder (including any
royalties or other amounts due under Sections 6 and 7 of the
Multi-Field Agreement and any amounts due and payable under this
Section 4.3) 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
-----------------------------------
* Confidential treatment requested.
15
and/or in efforts required by the receiving party to receive any
reimbursement or refund of amounts so paid or withheld.
4.4 CORIXA TAKEAWAY AGREEMENT. In the event that Corixa completes
the research and development work set forth in the Work Plan, the Parties rights
in and to certain intellectual property rights that are subject to the license
granted to Corixa under Section 2.1 of the Corixa Takeaway Agreement shall
automatically convert as set forth in the Corixa Takeaway Agreement.
Notwithstanding the foregoing, in the event the CSC terminates the research and
development work under the Work Plan because of technical infeasibility, safety
concerns or such other reasons as they shall determine to be appropriate, other
than for Corixa's material breach, but subject to the Buy-Back Option and the
[*] Option in the event they are applicable under the circumstances, for
purposes of this Section 4.4, the research and development work set forth in the
Work Plan shall be deemed to be completed and the conversion of rights set forth
in the Corixa Takeaway Agreement shall automatically occur.
SECTION 5
TECHNOLOGY TRANSFER
5.1 TECHNOLOGY TRANSFER. Promptly following the Effective Date,
GSK shall begin the process of making available to Corixa the technology claimed
or covered by the intellectual property rights licensed by GSK to Corixa under
Section 4.1 hereof.
5.2 [*] AND [*] SUPPLY. GSK hereby agrees to supply to Corixa [*]
and the [*] that are identified in the Work Plan (collectively, the "GSK
Materials") as set forth in the Work Plan and this Section 5.2. GSK shall supply
the GSK Materials in sufficient quantities to enable Corixa to conduct the
activities under the Work Plan, including without limitation, (i) [*], (ii) [*]
and (iii) [*]. Such supply shall be pursuant to GSK's form of material transfer
agreement as modified to indemnify Corixa, Corixa's Affiliates and Corixa's
contract service providers in connection with the use of the GSK Materials but
only with respect to the use of the GSK Materials under the Work Plan and not
for any other use. The GSK Materials shall meet reasonable specifications as
agreed by GSK and Corixa. The GSK Materials shall be supplied in a form and
condition appropriate to enable Corixa to file an investigational new drug
application as required to initiate clinical trials for the Licensed Product and
shall be accompanied by such documentation as may be reasonably necessary to
enable Corixa to support such an application. In the event GSK does not exercise
its Proof of Principle Option, Buy-Back Option or [*] Option, as applicable, GSK
shall enter into good faith negotiations with respect to the supply of GSK
Materials required by Corixa or its Sublicensee(s) for further clinical trials
on a commercially reasonable fee basis. GSK agrees to either (i) enter into good
faith negotiations for a supply agreement for commercial quantities of the GSK
Materials with Corixa, its Sublicensee, or their Affiliates, under commercially
reasonable terms that would include supply at [*] taking into account any supply
and licensing terms and conditions that are applicable to GSK if any of such GSK
Materials are manufactured by a Third Party supplier or are licensed from a
Third Party or (ii) enter into good faith negotiations with a Third Party
contract manufacturer identified by Corixa to grant such Third Party a
sublicense to manufacture GSK Materials on terms to be
-----------------------------------
* Confidential treatment requested.
16
negotiated in good faith, taking into account any supply and licensing terms and
conditions that are applicable to GSK if any of such GSK Materials are
manufactured by a Third Party supplier or are licensed from a Third Party. In
addition, if any GSK Adjuvant supplied by GSK for use under the Work Plan is [*]
such [*] shall be supplied to Corixa at [*]
SECTION 6
CORIXA CO-PROMOTION OPTION
6.1 CORIXA U.S. CO-PROMOTION RIGHTS.
6.1.1 Corixa shall have the option to become GSK's
co-promotion partner in the United States with respect to any Licensed
Product for which GSK exercises its Proof of Principle Option, on the
terms and conditions set forth in Exhibit 6.1 (Paragraph 6.1.1)
("Corixa Co-Promotion Option").
6.1.2 Corixa Co-Promotion Option shall also extend on the
terms and conditions set forth in Exhibit 6.1 (Paragraph 6.1.2) to (a)
the first product developed by GSK that is composed of [*] Antigen or
[*] Antigen and no other Antigen and to (b) any replacement product
composed of [*] Antigen or [*] Antigen and no other Antigen, provided
the regulatory filing of such product related to the [*] or [*] Antigen
portion of such product is based on efficacy data generated as part of
the Work Plan and/or as part of Phase III Clinical Trial(s) co-funded
by Corixa, provided that no additional Phase III Clinical Trial(s) are
necessary for the new product approval, in case GSK decides to exercise
its Proof of Principle Option with respect to Licensed [*] Products or
Licensed [*] Products as the case may be but does not wish to pursue
further the development and/or commercialization of the concerned
Licensed [*] Products or Licensed [*] Products as the case may be.
6.1.3 Corixa Co-Promotion Option shall also extend on the
terms and conditions set forth in Exhibit 6.1 (Paragraph 6.1.3) to the
first product developed by GSK that is composed of [*] Antigen or [*]
Antigen and no other Antigen (and to any replacement product composed
of [*] Antigen or [*] Antigen and no other Antigen provided the
regulatory filing of such product related to the [*] or [*] Antigen
portion of such product is based on efficacy data generated as part of
the Work Plan and/or as part of Phase III Clinical Trial(s) co-funded
by Corixa, provided that no additional Phase III Clinical Trial(s) are
necessary for the new product approval, in case GSK decides to exercise
its Proof of Principle Option with respect to Licensed [*] Products or
Licensed [*] Products as the case may be and pursues in parallel the
development and/or commercialization of the concerned Licensed [*]
Products or Licensed [*] Products as the case may be and of that first
product developed by GSK that is composed of [*] Antigen or [*]
Antigen, as applicable.
6.1.4 Every [*] months after GSK commences a Phase III
Clinical Trial for the applicable product, GSK shall provide a written
report to Corixa detailing GSK's efforts
-----------------------------------
* Confidential treatment requested.
17
to develop any products that are subject to the Corixa Co-Promotion
Option. In addition to the foregoing notice, GSK shall provide Corixa
with not less than [*] days prior written notice (i) before initiating
a Phase III Clinical Trial of any Licensed Product that is subject to
the Corixa Co-Promotion Option or (ii) following the exercise of its
Proof of Principle Option, before initiating a Phase III Clinical Trial
of any GSK product that is subject to the Corixa Co-Promotion Option.
6.1.5 Corixa shall have the further option to become GSK's
co-promotion partner in the United States with respect to any Licensed
Product for which GSK exercises its [*] Option, on the terms set forth
in Exhibit 6.1 (Paragraph 6.1.1) (the "Corixa [*] Option"), subject to
a possible reduction in the amount of Corixa's percentage profit share
as follows. If GSK exercises its [*] Option, GSK will be responsible,
among other things, for the cost required to bring such Licensed
Product to completion of the Proof of Principle Clinical Trial (such
costs are the "Actual Additional GSK Funding"). If Corixa exercises the
[*] Option for such a Licensed Product, Corixa's percentage profit
share will be reduced by the same percentage as the Actual Additional
GSK Funding represents of the total Project Costs incurred by Corixa
for such Licensed Product as of the time GSK exercised the [*] Option
("Corixa's Actual Project Costs"). However, if Corixa commits to GSK in
writing, within [*] following GSK's exercise of the [*] Option for such
Licensed Product, to reimburse GSK for the amount of the Actual
Additional GSK Funding (regardless of the outcome of the Proof of
Principal Clinical Trial) plus an additional [*] of such Actual
Additional GSK Funding, and such Actual Additional GSK Funding is equal
to or less than [*] of Corixa's Actual Project Costs for such Licensed
Product, then no such reduction in Corixa's percentage profit share
shall be implemented. In the event that the Actual Additional GSK
Funding exceeds [*] of Corixa's Actual Project Costs for such Licensed
Product, then Corixa shall not be obligated to reimburse such amounts
despite its prior commitment to do so and Corixa's percentage profit
share will be reduced by the same percentage as the Actual Additional
GSK Funding represents of Corixa's Actual Project Costs.
6.2 CO-PROMOTION AGREEMENT. If Corixa desires to exercise the
Corixa Co-Promotion Option, it may do so by providing written notice to GSK of
such desire at any time prior to the [*] for the Licensed Product or product in
respect of which Corixa desires to exercise such option but no less than [*]
prior to said [*] initiation. Corixa and GSK shall negotiate the terms of a form
co-promotion agreement to be attached hereto as Exhibit 6.2 within [*] months of
the Effective Date (the "Co-Promotion Form"). In the event Corixa provides
timely notice to GSK of its desire to exercise the Corixa Co-Promotion Option,
Corixa and GSK shall thereafter negotiate in good faith towards a co-promotion
agreement to be substantially in the form attached hereto as Exhibit 6.2 with
such additions as are required to complete the Co-Promotion Form based on the
facts at hand (for example, by inserting the Licensed Product name and other
factual information that is not available at this time). GSK and Corixa may
agree to such modifications of the Co-Promotion Form as they shall mutually
determine to be appropriate and acceptable, but if either GSK or Corixa insists
on modifications beyond those that are required to bring the agreement, or the
performance of GSK or Corixa as defined by the agreement, into compliance with
applicable laws and industry practice, then such insistence shall be deemed to
-----------------------------------
* Confidential treatment requested.
18
be a breach of this Section 6.2. If Corixa fails to timely notify GSK of its
desire to exercise the Corixa Co-Promotion Option with respect to a particular
Licensed Product or product, then the Corixa Co-Promotion Option with respect to
such Licensed Product or product shall lapse.
6.3 NO SUBLICENSE OF RIGHTS. Corixa shall have no right to
sublicense the Corixa Co-Promotion Option except as set forth herein. If Corixa
exercises the Corixa Co-Promotion Option, Corixa shall have the right to: (a)
engage one or more contract sales organizations other than major competitors of
GSK and (b) may assign its rights under a co-promotion agreement to its
successor in the event of a change-of-control of Corixa but only for a
then-marketed product and with respect to any not yet-marketed product, upon
such a change-of-control, the Corixa Co-Promotion Option shall otherwise
terminate.
6.4 OTHER AMOUNTS PAYABLE. For the avoidance of doubt, if Corixa
elects to exercise its Co-Promotion Option with respect to a Licensed Product,
it shall still be entitled to receive the upfront fee and milestone payments
(post Proof of Principle Clinical Trial) which are otherwise due hereunder in
addition to a share of the profits as detailed on Exhibit 6.1 and, if Corixa
elects not to exercise its Co-Promotion Option with respect to a Licensed
Product, Corixa shall be entitled to receive such upfront fee, milestone
payments (post Proof of Principle Clinical Trial) and royalties as are otherwise
provided hereunder, including without limitation, as provided under Section
2.4.3 and Section 3.1.2 and the related Exhibits.
SECTION 7
INTELLECTUAL PROPERTY MATTERS
7.1 INTELLECTUAL PROPERTY MATTERS. The filing, prosecution,
maintenance and enforcement of the intellectual property rights that are subject
to this Agreement shall be governed by Section 10 of the Amended MFA.
7.2 DISCLOSURE OF INVENTIONS. Corixa shall provide the Patent
Committee written disclosure of all Corixa Program Inventions and Joint Program
Inventions, and GSK shall provide the Patent Committee written disclosure of all
GSK Program Inventions and Joint Program Inventions, in each case prior to
filing patent applications covering such inventions in order that the Parties
may determine inventorship.
SECTION 8
CONFIDENTIALITY AND NONDISCLOSURE
8.1 CONFIDENTIALITY. During the Term and for five (5) years
thereafter, irrespective of any termination earlier than the expiration of the
Term, Corixa and GSK shall not use or reveal or disclose to any Third Party any
confidential information received from any other Party or otherwise developed by
any other Party in the performance of activities in furtherance of this
Agreement without first obtaining the written consent of the disclosing Party,
except as may be otherwise provided herein, or as may be required for purposes
of investigating, developing, manufacturing or marketing products within the
Licensed Products Field or for securing essential
19
or desirable authorizations, privileges or rights from governmental agencies, or
as required to be disclosed to a governmental agency, including without
limitation, the FDA or the Securities and Exchange Commission, or to carry out
any litigation concerning products within the Licensed Products Field; provided,
however, that in each such instance, the disclosing Party shall use reasonable
efforts to provide notice to the other Party prior to the first disclosure of
any particular item of confidential information and shall use reasonable efforts
to obtain confidential treatment of such confidential information by the person
or entity to which it is disclosed. This confidentiality obligation shall not
apply to such information which is or becomes a matter of public knowledge, or
is already in the possession of the receiving Party, or is disclosed to the
receiving Party by a Third Party having the right to do so, or is subsequently
and independently developed by employees of the receiving Party 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.
8.2 CORIXA PERMITTED DISCLOSURES. Nothing herein shall be
construed as preventing Corixa from disclosing any information received from GSK
to: (i) an Affiliate of Corixa, (ii) a Sublicensee or distributor solely in
connection with the exercise of Corixa's rights under this Agreement, or (iii) a
Third Party in connection with a potential investment, loan, merger or
acquisition transaction with Corixa; provided, however, that such Affiliate,
Sublicensee, distributor or Third Party has undertaken in writing a similar
obligation of confidentiality with respect to the confidential information, with
GSK named as a third party beneficiary thereof.
8.3 REQUIRED DISCLOSURES. All confidential information disclosed
by one Party to any other Party shall remain the property of the disclosing
Party. In the event that a court or other legal or administrative tribunal,
directly or through an appointed master, trustee or receiver, assumes partial or
complete control over the assets of a Party to this Agreement based on the
insolvency or bankruptcy of such Party, the bankrupt or insolvent Party shall
promptly notify the court or other tribunal (i) that confidential information
received from the other Party under this Agreement remains the property of the
other Party and (ii) of the confidentiality obligations under this Agreement. In
addition, the bankrupt or insolvent Party shall, to the extent permitted by law,
take all steps necessary or desirable to maintain the confidentiality of any
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.
8.4 PRESS RELEASE. The Parties to this Agreement may disclose the
nature of this Agreement in joint or individual press releases following
signature; provided, however, that the releasing Party shall obtain the prior
consent of the other Party on the text of such press release, such consent not
to be unreasonably withheld. In the event that either Party reasonably
determines that it is required by the applicable laws of any jurisdiction, or
the rules of any stock exchange on which its securities are listed or traded, to
publicly disclose information concerning this Agreement or the rights and
obligations of the Parties hereunder, including without limitation, the
circumstances under which money or other consideration may become payable
hereunder and the amount(s) of such payment(s), then such Party shall provide
the other Party with a reasonable opportunity to review the text of such
disclosure and the disclosing Party shall use reasonable best efforts to
implement the reasonable comments provided by the other Party while still
complying with such laws or rules.
20
SECTION 9
TERM AND TERMINATION
9.1 PROGRAM TERM AND TERM. Unless earlier terminated in accordance
with the terms hereof, the Program term shall commence on the Effective Date and
shall expire upon the first to occur of the following events: (a) all work to be
performed under the Work Plan has been completed, (b) the CSC has determined to
terminate the Program, for example due to technical infeasibility or safety
concerns, but not due to a dispute between the Parties, or (c) the Corixa
Invested Funds are fully expended (the "Program Term"). Subject to the last
sentence of Section 9.4.1 below, unless earlier terminated in accordance with
the terms hereof, the Term shall commence upon the Effective Date and shall
expire upon the expiration of the last GSK Patent and GSK Licensed Patent
licensed by GSK to Corixa hereunder at which point, subject to the surviving
terms and conditions as set forth in Section 9.7 and subject to Corixa's
obligations to make the payments called for under Section 4.3 if still
applicable, all of the rights and obligations hereunder shall terminate and the
license granted under Section 4.1 hereof shall automatically convert to an
irrevocable, fully-paid and perpetual license (the "Term"). If the Term is
terminated in accordance with this Section 9 prior to the expiration of the
Program Term, then the Program Term shall terminate simultaneously with the
termination of the Term, subject to Corixa's obligations to make the payments
called for under Section 4.3,.
9.2 CERTAIN RIGHTS UPON A MATERIAL BREACH. Failure by a Party (the
"Breaching Party") to comply with any of its material obligations contained
herein (a "Default") shall entitle the other Party (the "Non-Defaulting Party")
to take the actions provided for in this Section 9. Upon a Default, the
Non-Defaulting Party shall give notice to the Breaching Party specifying the
nature of the Default, demanding that it cure such Default, and stating its
intention to exercise its rights under Section 9.2 or Section 9.3, if such
Default is not cured. If such Default is not cured within [*] days after the
receipt of such notice, then: (a) if the Non-Defaulting Party is GSK, GSK shall
be entitled, in addition to any rights GSK may have at law or equity, to
terminate this Agreement, in which case all rights and licenses granted to
Corixa hereunder shall terminate and GSK shall have no obligations whatsoever to
Corixa with respect to the Licensed Products covered by such terminated rights
and licenses (other than the obligations which survive termination of this
Agreement under Section 9.8 to the extent applicable), and (b) if the
Non-Defaulting party is Corixa, Corixa shall be entitled, in addition to any
other rights Corixa may have at law or in equity, to exercise its rights under
Section 9.5; provided, however, that in both cases, such rights shall be stayed
if either (i) the breach is susceptible to cure but not within such [*] day
period, in which case, the exercise of such rights shall be stayed so long as
the Breaching Party uses best reasonable efforts to cure such breach, or (ii)
the Breaching Party shall have initiated dispute resolution in accordance with
Section 12.6 with respect to the alleged Default during such [*] day period.
9.3 RIGHTS IN BANKRUPTCY. All rights and licenses granted under or
pursuant to this Agreement are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
"intellectual property" as defined under Section 101 of the U.S. Bankruptcy
Code. GSK may terminate this Agreement if, at any time, Corixa shall file in any
court or agency pursuant to any statute or regulation of the United States or of
any individual
-----------------------------------
* Confidential treatment requested.
21
state or foreign country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a receiver or
trustee or Corixa or of its assets, or if Corixa proposes a written agreement of
composition or extension of its debts, or if Corixa shall be served with an
involuntary petition against it filed in any insolvency proceeding, and such
petition shall not be dismissed within [*] days after the filing thereof, or if
Corixa shall propose or be a party to any dissolution or liquidation, or if
Corixa shall make an assignment for the benefit of creditors. Notwithstanding
the bankruptcy of Corixa, or the impairment of performance by Corixa of its
obligations under this Agreement as a result of bankruptcy or insolvency of
Corixa, GSK shall be entitled to retain the rights and licenses granted herein.
9.4 CERTAIN CONSEQUENCES OF TERMINATION. Following are certain
consequences of the termination of this Agreement under Section 9. This Section
9.4 does not set forth all consequences of a termination of this Agreement that
may arise pursuant to the exercise of the Parties of their respective rights and
remedies arising hereunder or otherwise arising under law or equity. All such
other rights and remedies shall be cumulative and are not waived or limited by
the occurrence of the following consequences of termination.
9.4.1 RIGHTS UPON FAILURE OF CORIXA TO PERFORM THE WORK
UNDER THE WORK PLAN. In the event Corixa fails to perform the research
and development work set forth in the Work Plan, such failure shall be
a Default under this Agreement and, subject to the notice and cure
provisions set forth in Section 9.2, GSK shall be entitled to terminate
the Agreement. If GSK chooses to terminate this Agreement, then upon
such a termination: (i) all rights and licenses granted hereunder shall
terminate and shall revert to GSK free of any obligations to Corixa
(other than the obligations which survive termination of this Agreement
under Section 9.8 to the extent applicable) and (ii) Corixa shall be
deemed to be in material breach of the Corixa Takeaway Agreement with
the consequences set forth in Section 9.2.1 of the Corixa Takeaway
Agreement. Notwithstanding the foregoing, in the event the CSC
terminates the research and development work under the Work Plan
because of technical infeasibility, safety concerns or such other
reasons as they shall determine to be appropriate, then Corixa's
failure to complete such research and development work shall not
constitute a breach of this Agreement and Corixa shall not be in
Default hereunder or under the Corixa Takeaway Agreement by virtue of
such failure and GSK shall have the right to buy back the terminated
Project(s) on the terms and conditions set forth on Exhibit 2.3.2, as
if the products under development, or which could have been developed,
in connection with such terminated Project(s), were "Affected Products"
as of the date the CSC terminated such Project(s). Likewise if the
Corixa Invested Funds allocated to a Project are spent, and GSK did not
exercise the [*] Option for such Project, and Corixa failed to reach
Proof of Principle Clinical Trials with respect to such Project, then
GSK shall have the right to buy back the terminated Project on the
terms and conditions set forth on Exhibit 2.3.2 as if the products
under development, or which could have been developed, in connection
with such terminated Project, were "Affected Products" as of the date
that the Corixa Invested Funds allocated to such Project are spent;
provided, however, that GSK shall not be obligated to pay
-----------------------------------
* Confidential treatment requested.
22
Corixa any Risk Fee in case GSK buys-back the terminated Project under
the circumstances described in this Section 9.4.1.
9.5 DEFAULT BY GSK. The Parties acknowledge that, in the event
that GSK commits a Default under this Agreement, Corixa's remedies should
include the right to continue to make, use and sell Licensed Products, subject
to the obligation to pay royalties to GSK, and that GSK should forfeit certain
of the options and rights granted to it hereunder because of such Default.
Therefore, upon Default by GSK, subject to the notice and cure provisions set
forth in Section 9.2 hereof, Corixa shall have the option of terminating this
Agreement or opting for a partial termination with the effects set forth herein
(a "Partial Termination"). Corixa shall exercise such option by providing notice
to GSK. Pursuant to a Partial Termination, the Program Term shall immediately
terminate, all rights, licenses and options granted to GSK hereunder, including
without limitation, the [*] Option, the Proof of Principle Option and the
Buy-Back Option, shall automatically terminate and Corixa's rights with respect
to the research, development and commercialization of Licensed Products shall
continue subject only to its obligations to make the payments called for under
Section 4.3
9.6 CERTAIN CONSEQUENCES OF TERMINATION OF THE PROGRAM TERM.
Except as otherwise provided in Section 9.5 hereof, upon the expiration or
termination of the Program Term, any Proof of Principle Option that is then in
effect with respect to a particular Licensed Product shall continue, subject to
the limitations applicable to such right, until it is exercised or rejected by
GSK or it expires. For the avoidance of doubt, a Proof of Principle Option shall
be "in effect" for the purposes of the foregoing sentence if a report or a
notice from Corixa to GSK has been sent notifying GSK of the availability of
such option, or such report or notice should have been sent under the terms and
conditions of this Agreement, and such option has not been rejected by GSK or
expired, and no license has yet resulted. The Program Term shall be deemed to be
extended until the last of such Proof of Principle Options has been exercised or
rejected by GSK, or expires, in each case in accordance with the terms of such
Proof of Principle Option.
9.7 FAILURE TO DEVELOP. In the event GSK exercises the Proof of
Principle Option with respect to a Licensed Product comprising either [*]
Antigen or [*] Antigen and GSK has not, within [*] following the date of such
exercise, commenced a Phase III Clinical Trial: (a) for such Licensed Product,
or (b) for any other product comprising the same Antigen and to which Corixa's
Co-Promotion Option may then apply pursuant to Section 6.1, in either case other
than for reasons outside of GSK's reasonable control, then all rights, licenses
and options granted to GSK with regard to such Licensed Product shall
automatically terminate and Corixa's rights with respect to the research,
development and commercialization of such Licensed Product shall continue
subject only to its obligations to make the payments called for under Section
4.3.
9.8 ACCRUED RIGHTS; SURVIVING OBLIGATIONS. Termination of this
Agreement for any reason shall be without prejudice to any rights that shall
have accrued to the benefit of a Party prior to or on account of such
termination. All remedies provided hereunder or elsewhere are cumulative.
Sections 7, 8, 9, 10, 11, 12.4 and 12.8 of this Agreement shall survive the
termination of this Agreement for any reason and, Section 1 hereof shall survive
such termination to the extent any terms defined therein are used in such other
surviving provisions.
-----------------------------------
* Confidential treatment requested.
23
SECTION 10
INDEMNITY AND INSURANCE
10.1 INDEMNIFICATION. Subject to Section 5.2 above and Section 10.2
below, 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 successors and assigns, and their
respective officers, directors, shareholders, partners and employees from and
against all losses, damage, liability and expense including legal fees (but
excluding punitive or consequential damages and lost profits) ("Losses")
incurred thereby or caused thereto arising out of or relating to (i) any breach
or violation of, or failure to properly perform, any covenant or agreement made
by such Indemnifying Party (as defined in Section 10.2) in this Agreement,
unless waived in writing by the Indemnified Party (as defined in Section 10.2);
(ii) any breach of any of the representations or warranties made by such
Indemnifying Party in this Agreement; (iii) the manufacture, marketing,
distribution or sale of products that are sold by or offered for sale on behalf
of, the Indemnifying Party, its Affiliates or sublicensees; or (iv) the gross
negligence or willful misconduct of the Indemnifying Party.
10.2 INDEMNIFICATION PROCEDURE. If either Corixa or GSK (in each
case an "Indemnified Party") receives any written claim which it believes is the
subject of indemnity hereunder by either GSK or Corixa, as the case may be (in
each case an "Indemnifying Party") the Indemnified Party shall, as soon as
reasonably practicable after forming such belief, give notice thereof to the
Indemnifying Party, including full particulars of such claim to the extent known
to the Indemnified Party; provided, however, that the failure to give timely
notice to the Indemnifying Party as contemplated hereby shall not release the
Indemnifying Party from any liability to the Indemnified Party. The Indemnifying
Party shall have the right, by prompt notice to the Indemnified Party, to assume
the defense of such claim with counsel reasonably satisfactory to the
Indemnified Party, and at the cost of the Indemnifying Party. If the
Indemnifying Party does not so assume the defense of such claim, the Indemnified
Party may assume such defense with counsel of its choice at the sole expense of
the Indemnifying Party. If the Indemnifying Party so assumes such defense, the
Indemnified Party may participate therein through counsel of its choice, but the
cost of such counsel shall be borne solely by the Indemnified Party.
10.3 ASSISTANCE. 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.
10.4 SETTLEMENT. No such claim shall be settled other than by the
Party defending the same, and then only with the consent of the other Party,
which shall not be unreasonably withheld; provided, however, that the
Indemnified Party shall have no obligation to consent to any settlement of any
such claim which imposes on the Indemnified Party any liability or obligation
which cannot be assumed and performed in full by the Indemnifying Party.
24
10.5 INSURANCE. Each 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/or
the sale of a drug product, as applicable. Each Party shall maintain such
liability insurance so long as it, its Sublicensees or their Affiliates are
engaged in the sale of a Licensed Product and for an additional period of [*]
years thereafter. The amounts of insurance coverage required under this Section
10.5 shall not be construed to create a limit of the insured Party's liability
with respect to its indemnification obligation under Section 10 or under any
other provision of this Agreement.
10.6 LIMITATION ON DAMAGES. IN NO EVENT SHALL EITHER PARTY OR ANY
OF THEIR AFFILIATES BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES OF ANY OTHER PARTY, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT,
STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (A) THE MANUFACTURE, USE OR SALE
OF ANY PRODUCT DEVELOPED OR MARKETED HEREUNDER OR (B) ANY BREACH OF OR FAILURE
TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT EXCEPT TO THE EXTENT REQUIRED
FOR AN INDEMNIFYING PARTY TO PROVIDE INDEMNITY TO AN INDEMNIFIED PARTY AGAINST
SUCH DAMAGES IN THE EVENT SUCH DAMAGES ARE SUCCESSFULLY ASSERTED AGAINST AN
INDEMNIFIED PARTY BY A THIRD PARTY.
SECTION 11
REPRESENTATIONS, WARRANTIES AND COVENANTS
11.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party hereby
represents, warrants and covenants to the other Parties as of the Effective Date
as follows:
(a) Such Party has the power, authority and the legal right to
enter into this Agreement and to perform its obligations hereunder, and has
taken all necessary action on its part required to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder. The
Agreement has been duly executed and delivered on behalf of such Party and
constitutes a legal, valid, binding obligation of such Party and is enforceable
against it in accordance with its terms subject to the effects of bankruptcy,
insolvency, or other laws of general application affecting the enforcement of
creditor rights and judicial principles affecting the availability of specific
performance and general principles of equity, whether enforceability is
considered a proceeding at law or equity.
(b) Such Party is not aware of any pending or threatened
litigation (and has not received any communication) that alleges that such
Party's activities related to this Agreement have violated, or that by
conducting the activities as contemplated herein such Party would violate, any
of the intellectual property rights of any other person.
(c) The execution and delivery of this Agreement and the
performance of such Party's obligations hereunder do not conflict with or
violate any requirement of applicable law or
-----------------------------------
* Confidential treatment requested.
25
regulation or any provision of articles of incorporation, bylaws or limited
partnership agreement of such Party, as applicable, in any material way, and do
not conflict with, violate, or breach or constitute a default or require any
consent under, any contractual obligation or court or administrative order by
which such Party is bound.
(d) Such Party is a corporation duly organized and in good
standing under the laws of its jurisdiction of incorporation, and has full power
and authority and the legal right to own and operate its property and assets and
to carry on its business as it is now being conducted and as it is contemplated
to be conducted by this Agreement.
(e) EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES
DISCLAIM ALL WARRANTIES WHATSOEVER, EITHER EXPRESS OR IMPLIED, INCLUDING
WARRANTIES AS TO THE MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.
SECTION 12
MISCELLANEOUS
12.1 FORCE MAJEURE. If the performance of any part of this
Agreement by any 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.
12.2 ASSIGNMENT. Except as otherwise provided in Section 6.3,
without the prior written consent of the other Party, neither Party shall sell,
transfer, assign, delegate, pledge, or otherwise dispose of, whether
voluntarily, involuntarily, by operation of law or otherwise, this Agreement or
any of its rights or duties hereunder; provided, however, that either Party may
assign this Agreement, without the consent of the others, to the purchaser of
all or substantially all of its assets, or to its successor or acquirer in the
event of a merger, consolidation or change of control, or to any of its
Affiliates.
12.3 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
26
statute or rule of law provided that such conformity is in accordance with the
intent of the Parties.
12.4 GOVERNING LAW. This Agreement shall be governed by and
construed in accordance with the laws of the State of Washington, without
reference to the rules of conflict of laws thereof.
12.5 NOTICES. All notices or other communications that are required
or permitted hereunder shall be in writing and delivered personally, sent by
telecopier (and promptly confirmed by personal delivery, registered or certified
mail or overnight courier), sent by nationally-recognized overnight courier or
sent by registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:
IF TO CORIXA, TO:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attn: Chairman and Chief Executive Officer
with a copy to:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attn: General Counsel
IF TO GSK, TO:
SmithKline Xxxxxxx plc
000 Xxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxx
XX0 0XX
Xxxxxx Xxxxxxx
Attn.: General Counsel
with a copy to:
GlaxoSmithKline Biologicals, X.X.
xxx xx x'Xxxxxxxx 00
0000 Xxxxxxxxx
Xxxxxxx
Attn: Senior Vice-President, Business and New Product
Development
or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such
communication shall be deemed to have
27
been given: (i) when delivered, if personally delivered or sent by telecopier on
a business day, (ii) on the business day after dispatch, if sent by
nationally-recognized overnight courier, and (iii) on the third business day
following the date of mailing, if sent by registered mail. It is understood and
agreed that this Section 12.5 is not intended to govern the day-to-day business
communications necessary between the Parties in performing their duties, in due
course, under the terms of this Agreement.
12.6 DISPUTE RESOLUTION.
(a) 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 hereof (each, a
"Dispute"), the Chief Executive Officers of the Parties or their single
designees, shall attempt over a period of not less than sixty (60) days to
resolve such Dispute. Such attempt may at the request of a Party include a
thirty (30) day period of mediation by a Third Party whose selection is agreed
upon by the Parties. In the event of mediation, the Parties in dispute shall
bear equally the costs associated with the mediation.
(b) Any dispute, controversy or claim arising out of or in
relation to this Agreement or the breach, termination or invalidity hereof that
cannot be settled amicably by agreement of the Parties or through mediation
pursuant to Section 12.6(a) shall be finally settled by arbitration in
accordance with the arbitration rules of the American Arbitration Association
("AAA") then in force. The place of arbitration shall be New York City, New
York. The arbitrator's award rendered shall be final and binding upon the
Parties. Judgment upon the award may be entered in any court having
jurisdiction, or application may be made to such court for judicial acceptance
of the award and/or an order of enforcement as the case may be.
12.7 ENTIRE AGREEMENT; MODIFICATIONS. This Agreement and the
Related Agreements set forth and constitute the entire agreement and
understanding between the Parties with respect to the subject matter hereof and
thereof and all prior agreements, understanding, promises and representations,
whether written or oral, with respect thereto are superseded hereby. Each Party
confirms that it is not relying on any representations or warranties made by any
other Party except as specifically set forth herein. No amendment, modification,
release or discharge hereof shall be binding upon the Parties unless in writing
and duly executed by authorized representatives of both Parties.
12.8 HEADINGS. The headings used in this Agreement are intended for
convenience only and shall not be considered part of the written understanding
between the Parties and shall not affect the construction of this Agreement.
12.9 EQUITABLE RELIEF. Notwithstanding anything herein to the
contrary, nothing in this Agreement shall preclude a Party from seeking interim
or provisional relief, in the form of a temporary restraining order, preliminary
injunction or other interim equitable relief concerning a dispute prior to or
during an arbitration pursuant to Section 12.6 necessary to protect the
interests of such Party.
28
12.10 WAIVER. The waiver by a Party hereto of any right hereunder or
the failure to perform or a breach by the any other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.
12.11 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.
12.12 NO BENEFIT TO THIRD PARTIES. The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties hereto and their successors and permitted assigns, and they shall
not be construed as conferring any rights on any Third Parties.
12.13 FURTHER ASSURANCE. Each Party shall duly execute and deliver,
or cause to be duly executed and delivered, such further instruments and do and
cause to be done such further acts and things, including, without limitation,
the filing of such assignments, agreements, documents and instruments, as may be
necessary or as the other Party may reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes hereof,
or to better assure and confirm unto such other Party its rights and remedies
under this Agreement.
12.14 CONSTRUCTION. Except where the context otherwise requires,
wherever used, the singular shall include the plural, the plural the singular,
the use of any gender shall be applicable to all genders and the word "or" is
used in the inclusive sense. The captions of this Agreement are for convenience
of reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement. The Parties have participated equally in the formation of this
Agreement; the language of this Agreement shall not be presumptively construed
against either Party.
29
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the date first above
written.
CORIXA CORPORATION
By: /s/ XXXXXX XXXXXX
_____________________________
Name: Xxxxxx Xxxxxx
_____________________________
Title: CEO
_____________________________
SMITHKLINE XXXXXXX PLC
By: /s/ JEAN STEPHENNE
_____________________________
Name: Jean Stephenne
_____________________________
Title: Attorney
_____________________________
30
EXHIBIT 1.10
[*]
[*]
[*]
[*]
-----------------------------------
* Confidential treatment requested.
31
EXHIBIT 1.34
GSK LICENSED PATENTS
[*] APPLICATIONS
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
32
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
33
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
34
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
35
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
36
EXHIBIT 1.34 CONTINUED
[*] APPLICATIONS
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
37
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
38
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
-----------------------------------
* Confidential treatment requested.
39
EXHIBIT 1.35
GSK PATENTS
[*] APPLICATIONS
----------------------------------------------------------------------------------------------------------------
CASE NUMBER COUNTRY APP. NO./FILING DATE PATENT NO./ISSUE DATE STATUS
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] [*] [*] [*]
----------------------------------------------------------------------------------------------------------------
[*] APPLICATIONS
None
-----------------------------------
* Confidential treatment requested.
EXHIBIT 1.50
[*]
[*]
----------------------------------
* Confidential treatment requested.
2
EXHIBIT 2.1
WORK PLAN
[Current Work Plan attached.]
[*]
------------------------
* Confidential treatment requested
EXHIBIT 2.3
Project costs from 6/15/02 through 11/30/02
[*]
FTEs [*]
[*]:
FTEs [*]
Out of Pocket costs [*]
-----------------------------------
* Confidential treatment requested.
EXHIBIT 2.3.2
AFFECTED PRODUCT RIGHTS LICENSE TERMS
(a) GENERAL ECONOMIC TERMS
UPFRONT FEE: Calculated as: the Project Cost for such Project multiplied by 1.25
(Corixa cost of capital) plus a Risk Fee equal to $3million multiplied by a
fraction in which the numerator is [*]and the denominator is [*].
MILESTONES: as per the Amended MFA * (post the development stage of the Project
at time of GSK license from Corixa).
ROYALTIES: as per the Amended MFA (as set forth in "(b)" below).
(b) INCORPORATION OF AMENDED MFA PAYMENT TERMS: Subject to the terms and
conditions of this Agreement, royalty and milestone payments due pursuant to
Section 2.3.2 hereof shall be made in accordance with the terms and conditions
of Sections 6 and 7 of the Amended MFA as provided in this Exhibit 2.3.2.
Accordingly, all terms and conditions applicable to Vaccine Products under
Sections 6 and 7 of the Amended MFA shall apply for purposes of this Exhibit
2.3.2 to Licensed Products and are hereby incorporated by reference into this
Exhibit 2.3.2, including without limitation, the definitions of the capitalized
terms used in Sections 6 and 7.
In the event a Licensed Product is covered by one (1) or more claims of a patent
covering a Corixa Program Invention ("New Corixa Patent") and is no longer
covered by any claims of a Licensed Patent such that royalties for the sale of
such Licensed Product would no longer be due under the Amended MFA, unless GSK
notifies Corixa in writing that it is discontinuing its license to such New
Corixa Patent, GSK shall be required to continue to pay Corixa royalties as per
the Amended MFA only in the case that [*] In the event a New Corixa Patent does
[*] unless GSK notifies Corixa in writing that it is discontinuing its license
to such New Corixa Patent, GSK and Corixa shall negotiate in good faith a
reasonable royalty rate that reflects the [*], provided that such royalty rate
shall never exceed the royalty rate under the Amended MFA .
(c) MANUFACTURING: In all cases where GSK exercises its Proof of Principle
Option, GSK shall be designated the manufacturer for all products that are the
subject of such Proof of Principle Option, unless otherwise agreed by GSK and
only to the extent that CRXA can grant such rights. As in the case of provision
of [*], Corixa shall use its reasonable commercial efforts to ensure
transferability of Third Party rights involved in such manufacture.
-----------------------------------
* Confidential treatment requested.
EXHIBIT 2.4.3
GSK OPTION UPON [*] OF THE CORIXA INVESTED FUNDS HAVING BEEN SPENT
(a) UPFRONT FEE: Calculated as: the Project Cost for such Project
multiplied by 1.25 (Corixa cost of capital) plus $[*] ("Risk Fee").
MILESTONES: as per the Amended MFA* (post the Proof of Principle Clinical Trial)
EX US ROYALTIES: as per the Amended MFA *
US ROYALTIES: To be replaced by and addressed in the applicable co-promotion
agreement.
(b) INCORPORATION OF AMENDED MFA PAYMENT TERMS: Subject to the terms and
conditions of this Agreement, royalty and milestone payments due pursuant to
Section 3.1.2 hereof shall be made in accordance with the terms and conditions
of Sections 6 and 7 of the Amended MFA as provided in this Exhibit 2.4.3.
Accordingly, all terms and conditions applicable to Vaccine Products under
Sections 6 and 7 of the Amended MFA shall apply for purposes of this Exhibit
2.4.3 to Licensed Products and are hereby incorporated by reference into this
Exhibit 2.4.3, including without limitation, the definitions of the capitalized
terms used in Sections 6 and 7.
In the event a Licensed Product is covered by one (1) or more claims of a patent
covering a Corixa Program Invention ("New Corixa Patent") and is no longer
covered by any claims of a Licensed Patent such that royalties for the sale of
such Licensed Product would no longer be due under the Amended MFA, unless GSK
notifies Corixa in writing that it is discontinuing its license to such New
Corixa Patent, GSK shall be required to continue to pay Corixa royalties as per
the Amended MFA only in the case that the [*] In the event a New Corixa Patent
does not [*] unless GSK notifies Corixa in writing that it is discontinuing its
license to such New Corixa Patent, GSK and Corixa shall negotiate in good faith
a reasonable royalty rate that reflects the [*], provided that such royalty rate
shall never exceed the royalty rate under the Amended MFA.
(c) MANUFACTURING: In all cases where GSK exercises its Proof of Principle
Option, GSK shall be designated the manufacturer for all products that are the
subject of such Proof of Principle Option, unless otherwise agreed by GSK and
only to the extent that CRXA can grant such rights. As in the case of provision
of [*], Corixa shall use its reasonable commercial efforts to ensure
transferability of Third Party rights involved in such manufacture.
-----------------------------------
* Confidential treatment requested.
EXHIBIT 3.1.2
PROOF OF PRINCIPLE OPTION LICENSE TERMS
(a) UPFRONT FEE: Calculated as: the Project Cost for such Project
multiplied by 1.25 (Corixa cost of capital) plus $3MM ("Risk Fee").
e.g. If costs incurred equal $10MM:
$10MM * 1.25 = $12.5MM
+$3MM = $15.5MM
Total to Corixa = $15.5MM
MILESTONES: as per the Amended MFA * (post the Proof of Principle Clinical
Trial)
EX US ROYALTIES: as per the Amended MFA *
US ROYALTIES: To be replaced by and addressed in the applicable co-promotion
agreement.
(b) INCORPORATION OF MULTI-FIELD AGREEMENT PAYMENT TERMS: Subject to the terms
and conditions of this Agreement, royalty and milestone payments due pursuant to
Section 3.1.2 hereof shall be made in accordance with the terms and conditions
of Sections 6 and 7 of the Multi-Field Agreement as provided in this Exhibit
3.1.2. Accordingly, all terms and conditions applicable to Vaccine Products
under Sections 6 and 7 of the Multi-Field Agreement shall apply for purposes of
this Exhibit 3.1.2 to Licensed Products and are hereby incorporated by reference
into this Exhibit 3.1.2, including without limitation, the definitions of the
capitalized terms used in Sections 6 and 7.
In the event a Licensed Product is covered by one (1) or more claims of
a patent covering a Corixa Program Invention ("New Corixa Patent") and is no
longer covered by any claims of a Licensed Patent such that royalties for the
sale of such Licensed Product would no longer be due under the Amended MFA,
unless GSK notifies Corixa in writing that it is discontinuing its license to
such New Corixa Patent, GSK shall be required to continue to pay Corixa
royalties as per the Amended MFA only in the case that [*]. In the event a New
Corixa Patent does [*], unless GSK notifies Corixa in writing that it is
discontinuing its license to such New Corixa Patent, GSK and Corixa shall
negotiate in good faith a reasonable royalty rate that reflects the [*] provided
that such royalty rate shall never exceed the royalty rate under the Amended
MFA.
(c) MANUFACTURING: In all cases where GSK exercises its Proof of Principle
Option, GSK shall be designated the manufacturer for all products that are the
subject of such Proof of Principle Option, unless otherwise agreed by GSK and
only to the extent that CRXA can grant such rights. As in the case of provision
of [*], Corixa shall use its reasonable commercial efforts to ensure
transferability of Third Party rights involved in such manufacture.
-----------------------------------
* Confidential treatment requested.
EXHIBIT 6.1
TERMS OF CO-PROMOTION AGREEMENT BETWEEN GSK AND CORIXA
The Corixa Co-Promotion Option shall be defined as the right to sell,
with a Corixa sales team, as a [*] product in [*] in the US, any product for
which Corixa exercises such option. GSK shall be the [*] [*] and all sales shall
be [*]. "Profits" (Net Sales less the [*] allocable to such Net Sales, less
costs of [*] including associated [*], less [*] GSK on such Net Sales) shall
either be split [*] GSK/Corixa or,
6.1.1 In the case of development by GSK of Licensed Products as
described in Section 6.1.1, Profits shall be split based on [*] that Corixa
agrees to [*] If Corixa agrees to [*] of [*], Profits shall be shared [*]
Corixa/GSK, if Corixa agrees to [*] of [*], Profits shall be shared 1[*] and if
Corixa agrees to [*] of [*], Profits shall be shared [*] provided that in no
case shall payment (other than payment to Corixa, if applicable, for [*] to
Corixa be less than [*] GSK and Corixa to agree the percentage of [*], prior to
the initiation of Phase III Clinical Trial, to a maximum of [*]
6.1.2 In the case of development by GSK of a GSK product as described
in Section 6.1.2, Profits shall be split based on [*] that Corixa agrees to [*].
If Corixa agrees to [*] of [*], Profits shall be shared [*] Corixa/GSK, and if
Corixa agrees to [*] of [*], Profits shall be shared [*] provided that in no
case shall payment (other than payment to Corixa, if applicable, for [*] to
Corixa be less than [*] GSK and Corixa to agree the percentage of [*], prior to
the initiation of Phase III Clinical Trial, to a maximum of [*]
6.1.3 In the case of development by GSK of a GSK product and a Licensed
Product as described in Section 6.1.3, Corixa may elect to exercise its
Co-Promotion Option for either the GSK product, the Licensed Product or both. In
such cases, Profits shall be split based on [*] that Corixa agrees to [*]
provided that Corixa shall not have the right to co-fund the development of a
GSK product that has already [*] at the time Corixa exercises its Co-Promotion
Option. If Corixa agrees to [*] Corixa may [*] of such [*]. If Corixa agrees to
[*] Profits shall be shared [*] Corixa/GSK, if Corixa agrees to [*], Profits
shall be shared [*] and if Corixa agrees to [*] of [*], Profits shall be shared
[*] If Corixa agrees to [*] for both the GSK product and the Licensed Product,
Corixa may [*] of such [*]. If Corixa [*] Profits shall be shared [*] Corixa/GSK
and if Corixa [*] Profits shall be shared [*] Corixa/GSK. Notwithstanding the
foregoing, in no case shall payment (other than payment to Corixa[*] to [*].
-----------------------------------
* Confidential treatment requested.
