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EXHIBIT 10.9
TUBERCULOSIS COLLABORATION
AND LICENSE AGREEMENT
BETWEEN
CORIXA CORPORATION
AND
SMITHKLINE ▇▇▇▇▇▇▇ BIOLOGICALS S.A.
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TABLE OF CONTENTS
1. Scope of Research Program; Other Activities 3
2. Product(s) 3
3. Territory 4
4. Option: Right of First Negotiation 4
5. Option and Research Program Term and Termination 5
6. License Payments 6
7. Royalties 7
8. Other Terms 9
9. Definitions 10
10. Joint Research Team 12
11. Equity 13
12. Inventions 13
13. Patents; Prosecution and Litigation 13
14. Confidentiality; Publicity; Publications 15
15. Governing Law; Arbitration 16
16. Miscellaneous 17
17. Notices 18
18. Assignment 18
19. Warranties and Representations 18
20. Term and ▇▇▇▇▇▇▇▇▇▇▇ ▇▇
▇▇. Rights and Duties Upon Termination 20
22. Indemnification 20
Schedule 1 22
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TUBERCULOSIS COLLABORATION AND LICENSE AGREEMENT
THIS TUBERCULOSIS COLLABORATION AND LICENSE AGREEMENT (together, with
the attachments hereto, the "Agreement ") is entered into the 6th day of
October, 1995 (the "Effective Date") by and between CORIXA CORPORATION, a
Delaware corporation with its principal place of business located at ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Corixa") and SmithKline
▇▇▇▇▇▇▇ Biologicals S.A., a Belgian corporation with its principal place of
business at ▇▇▇ ▇▇ ▇'▇▇▇▇▇▇▇▇ ▇▇, ▇-▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ("SB")
WITNESSETH:
WHEREAS, Corixa and SB desire to collaborate in the research and
development of antigens for the development of a vaccine product or products for
the prevention and/or treatment of tuberculosis and wish to memorialize their
agreement with respect to such collaboration in this Agreement;
WHEREAS, Corixa has agreed to license certain intellectual property
rights related to the subject matter of the collaboration subject to the terms
and conditions of this Agreement;
NOW, THEREFORE, for and in consideration of the mutual observance of
the covenants hereinafter set forth and other good and valuable consideration,
the receipt of which is hereby acknowledged, the parties hereto agree as
follows:
1. SCONE OF RESEARCH PROGRAM; OTHER ACTIVITIES. The parties will collaborate in
the discovery and development of antigens for use in vaccine(s) for the
prevention and/or treatment of mycobacterium tuberculosis hereinafter "Mtb").
The program of activities to be conducted by Corixa and SB during the term of
the Agreement is set forth in Schedule 1 (the "Research Program"). No material
deviation in the subject matter and scope of such Research Program shall be made
without the mutual and written agreement of both parties.
Except as set forth in Sections 4.b. and 5.c. respectively, during the
term of this Agreement, Corixa shall not enter into any commercial agreement
with a third party with respect to a collaboration regarding Mtb.
Notwithstanding the preceding sentence, Corixa may enter into research
agreements that provide for the in-licensing of intellectual property that may
be useful in the collaboration described in this Agreement; provided that any
such agreement shall provide that Corixa will own and/or control all
intellectual property rights related to Mtb arising from such agreement.
2. PRODUCT(S). The objective of the Research Program will be the development of
a Mtb vaccine consisting [***] and possibly consisting, in addition to [***] of
[***] (collectively, the "Product"). At SB's option, such combinations may
result in discrete versions of the Product, consisting of potentially different
mixtures of [***]. Also included in the Product and in the licenses granted
herein shall be [***].
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3. TERRITORY. The Territory is divided into two parts:
(a) Subterritory A includes all countries worldwide except Japan; and
(b) Subterritory B includes only Japan.
4. OPTION: RIGHT OF FIRST NEGOTIATION.
(a) SB will have an option, exercisable at any time during the Option
Term (as defined below) through written notice to Corixa to have
(i) an exclusive license under the Corixa Patents and Joint
Research Program Patents (each as defined in Section 9 below) and
under any Know-How (as defined in Section 9 below) to make, have
made, use, sell and have sold any and all Product(s) in any
formulation, configuration and/or combination in Subterritory A
for use as an in vivo administered vaccine for the prevention
and/or treatment of Mtb in humans and (ii) a co-exclusive (with
Corixa) license under the Corixa Patents and Joint Research
Program Patents (as defined in Section 9 below) and under any
Know-How (as defined in Section 9 below) to make, have made, use,
sell and have sold any and all Product(s) in any formulation,
configuration and/or combination in Subterritory B for use as an
in vivo administered vaccine for the prevention and/or treatment
of Mtb in humans (collectively, the "Option"). Upon exercise of
such Option and payment of the amount set forth in subparagraph 6
(b) (i), the licenses described in this subparagraph shall be in
full force and effect. Such licenses will include hill rights of
sublicense by SB. SB agrees it will exercise at least the same
level of diligence in the clinical development and
commercialization of Product within Subterritory A as it currently
uses, or in the past has used, with respect to its own
commercially successful products.
(b) During the Option Term (as it may be extended from time to time),
SB or any Affiliate (as defined in Section 9 below) shall have the
first right to negotiate for a license to diagnostic,
pharmaceutical and/or ex vivo prophylactic and/or therapeutic
vaccine applications of technology and/or patents owned and/or
controlled by Corixa in the field of Mtb at such time (including
Corixa Patents and Joint Research Program Patents) as follows.
From time to time as appropriate, Corixa shall give notice to SB
that its technology and/or patents are available for license,
which notice shall contain hill disclosure of information
available to Corixa with respect to such technology and/or patents
and terms upon which Corixa would be willing to enter into such a
license for such patents and/or technology. Thereafter, if within
[***] SB does not respond by agreeing to the terms proposed by
Corixa or with a comprehensive term sheet of a license agreement
for such technology and/or patents acceptable to Corixa, Corixa
shall have the right to present such technology and/or patents to
third parties with a view towards entering into a collaborative
agreement with such third parties with respect to such patents
and/or technology. In the event that SB does respond within the
aforementioned [***] period with agreement to the terms presented
by Corixa or with a comprehensive term sheet that is acceptable to
Corixa, SB shall enter into a written binding letter of intent
based on the terms set forth in such
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comprehensive term sheet within the [***] period immediately
following Corixa's notification of acceptance. In the event the
proposal contained in the term sheet presented by SB within the
[***] period is not acceptable to Corixa, Corixa shall inform SB
in writing and agrees that before entering into any arrangement
with a third party, Corixa will, within the [***] period following
the initiation [***], offer SB the right to match any terms
offered by such third party during such [***] period; provided
that SB must agree in writing to such terms within the [***]
described above or Corixa will be free to enter into an
arrangement with a third party. During the [***], Corixa shall
provide SB with periodic updates on material developments with
respect to the technology and/or patents provided to SB. In all
cases, after the [***], Corixa shall be free to enter
into an arrangement with a third party with respect to patents
and/or technology previously presented to SB.
(c) With the exception of the license, negotiation and/or first
refusal rights [***] applications set forth in this Agreement, all
rights to other applications of the Corixa Patents and/or
Know-How, including veterinary applications, remain with Corixa.
Ownership of Joint Research Program Patents shall be as set forth
in Section 12.
(d) In the event that a governmental agency in any country or
territory grants or compels Corixa to grant a license to any third
party for product(s) that compete(s) with Product, SB shall have
the benefit in such country or territory (and any other country
into which products that compete with Products are sold by such
third party compulsory licensee) of the terms granted to such
third party to the extent that such terms are more favorable to
the third party than those granted to SB under this Agreement.
5. OPTION AND RESEARCH PROGRAM TERM AND TERMINATION
(a) The Research Program will have an initial term of two (2) years,
effective 1 June, 1995 and ending 31 May, 1997.
(b) The Option term will be effective from 1 September, 1995 to 30
August, 1997 ("Option Term"). In the event SB exercises its
Option, SB shall have no obligation to renew the Research Program
beyond the second year, and any such renewal shall be at SB's
entire discretion. In the event both parties are agreed, the
Research Program and Option may be renewed on terms to be mutually
agreed at the time of renewal. However, in the event Corixa fails
to deliver, within the Option Term, [***] the Option Term shall be
automatically and without further consideration extended by the
shorter of three (3) months following [***], or one (1) year from
the end of the Option Term. If after such time Corixa has still
failed to [***] to SB, SB shall have a first right of refusal on
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terms at least as favorable as the Option herein contained of
three (3) years on any Mtb intellectual property rights owned
and/or controlled by Corixa for vaccine use in humans.
(c) At least six (6) months prior to the end of the initial Option
Term and provided Corixa has met the milestone [***] as set
forth in subparagraph 5.b, SB shall, if it so desires, provide
Corixa with a written notice of its intent to renew the Research
Program and extend its Option for a minimum of one (1) additional
year. In the event SB does not provide such notice, and provided
SB has not exercised its Option, Corixa shall be free to initiate
discussions and negotiations with other parties pertaining to
future rights to products and future research programs in the area
of Mtb, provided, however, that in the event Corixa agrees to
terms with respect to a research agreement in the area of Mtb with
a party other than SB prior to ninety (90) days before the end of
the Option Term, SB shall have a right of first refusal to extend
the Research Program and/or Option Term on the same or better
terms. Such right of refusal shall terminate at the end of the
Option Term. Notwithstanding anything to the contrary in this
Agreement including but not limited to the fact that Corixa may
have entered into discussions and has agreed to terms with a third
party as set forth above, the parties will maintain the right to
extend the Option and to continue the Research Program on terms
mutually acceptable to the parties, and SB will maintain its right
to exercise the Option, until the Option Term expires.
(d) Notwithstanding anything to the contrary in this Agreement, in the
event SB exercises its Option, to which it retains full right
until expiration of the Option Term, SB shall have the licenses
set forth in Section 4(a) and Corixa shall have no residual rights
to Corixa Patents, Joint Research Program Patents and/or Know-How
for use as an in vivo administered vaccine for the prevention
and/or treatment of Mtb in humans, other than specifically
mentioned in Section 4(a), 4(b) and 4(c).
6. LICENSE PAYMENTS. SB will make the following payments to Corixa under
the Agreement by wire transfer of immediately available funds:
(a) As a technology access fee, (i) [***] upon execution of the
Agreement; (ii) [***] on December 1, 1995; (iii) [***] on March 1,
1996; (iv) [***] on June 1, 1996; (v) [***] on September 1, 1996;
(vi) [***] on December 1, 1996; and (vii) [***] on March 1, 1997.
(b) In the event SB exercises the Option to the license under Section
4(a) above SB agrees to pay Corixa the following fees:
(i) as a condition of such exercise, the sum of [***] via wire
transfer of immediately available ▇▇▇▇▇; and
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(ii) subsequent one-time milestone payments, made via wire
transfer of immediately available funds, based upon
completion of the following with respect to the first
Product:
A) start Phase 1 clinical trials : [***]
US dollars)
B) end Phase 1 clinical trials : [***]
US dollars)
C) end Phase 2 clinical trials : [***]
US dollars)
D) end Phase 3 clinical trials : [***] US dollars)
E) Regulatory Approval in at : [***] US dollars)
least one (1) major country
of Europe (being UK, France,
Germany, Italy or Spain)
F) Regulatory Approval in USA : [***]
Regulatory approval milestones will be creditable against future
royalties, provided royalties are not reduced by more than [***]
in any given year. Any uncredited portion will be carried forward
for credit in subsequent years.
(c) In the event SB wishes to extend the Research Program and the
Option Term, the following technology access fees are foreseen,
which will be increased or decreased by mutual agreement of the
parties based upon the scope of work to be conducted:
i) For the [***] year [***] US dollars)
ii) For the [***] year [***] US dollars)
7. ROYALTIES. SB will pay Corixa a royalty on Net Sales of Products as
follows:
(a) Subject to subparagraph (b) below, on annual Net Sales of Products
sold in countries where current claims of any Corixa Patent and/or
Joint Research Program Patent are issued or pending for no longer
than [***], SB shall pay a royalty on annual Net Sales of
each Product. Such royalty shall increase for Net Sales above
certain levels and shall be payable as follows: (i) on the portion
of annual Net Sales of a given Product up to the [***], SB shall
pay a royalty of [***] per annum; (ii) on the portion of annual
Net Sales of a given Product between [***], SB shall pay a royalty
of [***] per annum and (iii) on the portion of annual Net Sales of
a given Product over [***], SB shall pay a royalty of [***] per
annum (the "Patent Royalty").
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(b) Provided SB has actually received and uses Know-How from Corixa in
any Product, which Know-How is Secret, Substantial and has been
Identified by Corixa, the percentage royalty rates specified in
subparagraph 7(a) above will be paid but reduced [***] for any
Product sold into a country where, (x) a patent application for a
Corixa Patent and/or a Joint Research Program Patent with claims
covering the Product has been pending and no patent with claims
covering such Product has issued for a period of more than
[***] or (y) no patent application with claims covering such
Product has been filed in the country of sale (the "Know-How
Royalty"). Royalties under this subparagraph 7(b) shall expire, on
a country-by-country basis, [***] after first launch of a Product
in any such country. For purposes of this Agreement, the terms
"Corixa Patents," "Joint Research Program Patents," "SB Patents",
"Know-How", "Secret", "Substantial" and "Identified" shall have
the meaning as ascribed to such terms in Section 9, below.
(c) Except for additional Mtb antigens, which shall be treated as set
forth in Section 9(a)(ii) hereof, and/or third party(ies) blocking
patents covering antigens licensed hereunder which are covered in
Section 7(d) hereof, SB and Corixa shall [***], which may include
but shall not be limited to royalties payable for adjuvants and
other technology included in the Product. Corixa's contribution to
such share shall be through a reduction in the patent royalty
payable to Corixa by SB, provided however that there shall in no
event be a reduction in the royalty rate payable to Corixa greater
than [***] (i.e. reducing the rate from [***] on the portion of
all sales of a given Product up to annual Net Sales of [***] on
the portion of all sales of a given Product for annual Net Sales
of between [***], and [***] on the portion of all sales of given
Product for annual Net Sales exceeding [***]. For the Know-How
Royalty, the royalty rates, as set forth in subparagraph 7(b)
shall apply on the rates as reduced according to this subparagraph
7(c), provided SB has royalty obligations towards third party(ies)
on its sales in those countries.
(d) In the event of an issued third party blocking patent covering
antigens licensed hereunder, royalty obligations to the third
party will be [***] provided that in no event shall royalties paid
to Corixa be reduced to more than [***] of the otherwise payable
royalty.
(e) SB shall provide a royalty report and, if applicable, a royalty
payment to Corixa every six (6) months. The report and payment
relating to Net Sales shall be provided within sixty (60) days
after June 30 and December 31 of each calendar year and shall
include all Net Sales of Products or Combination Products (as
defined in Paragraph 9 below) by SB and its Affiliates, licensees
or sublicensees. SB shall keep, and require any Affiliate,
licensee and sublicensee to keep, for a period not less than five
(5) years, complete and accurate records of all Net Sales of each
Product and Combination Product. Corixa shall have the right, at
Corixa's sole expense, through a certified public accountant
reasonably acceptable to SB,
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and following reasonable notice, to examine such records during
regular business hours during the life of the SB obligation to pay
royalties on Product and Combination Product; provided, however,
that such examination shall not (i) be of records for more than
the prior two (2) years, (ii) take place more often than once a
year, and (iii) cover any records which date prior to the date of
the last examination, and provided further that such accountants
shall report to Corixa only as to the accuracy of the royalty
statements and payments. Copies of such reports shall be supplied
to SB. In the event the report demonstrates that SB has underpaid
royalties, SB shall pay such royalties immediately upon request of
Corixa. If SB has overpaid royalties, SB may deduct such
over-payments from future royalties owed to Corixa.
(f) In addition to, and simultaneous with, the royalty reports set
described in Section 7(e) above, SB's Senior Vice President and
General Manager shall deliver to Corixa a certificate (the
"Royalty Certificate") stating that during the previous six (6)
month period, the following factors (the "Royalty Factors") have
equaled in the aggregate no more than [***] of total sales of
Product during such six (6) month period: (i) normal customary
trade discounts allowed and taken; (ii) rebates to wholesalers;
(iii) any deductions allowed for government-mandated vaccine
insurance premiums, such as the National Childhood Vaccine Injury
Act in the US; and (iv) any deduction, at standard cost, for
special administration devices and the packaging and filling
thereof, such as pre-filled syringes. In the event the Royalty
Factors exceed [***] in any six (6) month period, SB may deduct
such greater percentage for such six (6) month period only, but
shall provide Corixa with a written explanation setting forth the
reasons for such excess and shall provide Corixa with a
certificate that will state that the pricing of all Products sold
by SB and/or its Affiliates has been on an "arms length" basis and
not set so as to subsidize sales of other products sold by SB
and/or its Affiliates. In the event of a disagreement with respect
to size of the Royalty Factors in any given six (6) month period,
the CEO of Corixa and the Senior Vice President and General
Manager of SB shall first attempt to resolve such disagreement
through good faith negotiation. In the event such resolution is
not achieved, the disagreement shall finally be resolved through
arbitration pursuant to Section 15 hereof.
(g) Royalties shall be paid by SB in US dollars with currency
conversions calculated based upon the applicable closing exchange
rates quoted by the Foreign exchange desk of the General de
Banque, Brussels, Belgium on the last business day of the
applicable six (6) month period.
8. OTHER TERMS.
(a) MARKETING RIGHTS. Upon receipt of regulatory approval in the
Territory, SB shall use its reasonable commercial efforts to
launch and market the Product. Under the license granted herein,
SB may select sublicensees to maximize market penetration. Corixa
may review product marketing plans prior to launch and annually,
provided arrangements for such reviews are made in advance, but SB
will have the right to
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make all final determinations with respect to any differences of
opinion that arise as part of such review.
(b) MANUFACTURING. Corixa will provide reasonable quantities of
preclinical test material for SB as required through the course of
the Research Program at no additional charge to SB. These
materials will include sufficient quantities of [***]. It is
anticipated that SB will provide for later stage (clinical) and
commercial requirements.
(c) PRODUCT DEVELOPMENT. SB shall have responsibility for, and control
of, the development and commercialization of each Product arising
from this Agreement, including process development, delivery
system and formulation development, preclinical studies, clinical
studies, sales and marketing; provided however, that in no event
shall this paragraph be deemed to limit in any way SB's diligence
obligations with respect to development and commercialization of
Product set forth in Section 4(a) hereof.
9. DEFINITIONS.
(a) NET SALES.
(i) For purposes of this Agreement, Net Sales shall be defined
to mean the aggregate amounts invoiced by SB or its
Affiliates, licensees or sublicensees to non-Affiliate third
parties, less (i) normal customary trade discounts allowed
and taken; (ii) rebates to wholesalers; (iii) returns; (iv)
amounts for transportation including insurance; (v) shipping
charges to purchasers if invoiced separately; (vi) taxes
(not including any income taxes), and duties levied on
sales; (vii) deduction allowed for government-mandated
vaccine insurance premiums, such as the National Childhood
Vaccine Injury Act in the US; (viii) a deduction, at
standard cost, for special administration devices and the
packaging and filling thereof such as pre-filled syringes;
provided, in no event shall the total of items (iii) through
(vi) exceed [***] of Net Sales. Any commercial use of a
Product by SB (including its Affiliates, licensees and sub
licensees) shall be considered a sale hereunder for
accounting and royalty purposes.
(ii) [***]
(iii) [***]
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(b) KNOW-HOW shall mean all technical information, materials and
know-how owned and/or controlled by Corixa now and/or during the
longer of the Option Term or the term of the Research Program, as
may be extended from time to time, which relates to Product and
shall include, without limitation, all chemical, pharmacological,
toxicological, clinical, assay, control and manufacturing data
and any other information relating to Product and useful for the
development and commercialization of Product.
(c) SECRET shall mean that the Know-How as a body or in the precise
configuration and assembly of its components is not generally
known or easily accessible, so that part of its value consists in
the lead-time SB gains when it is communicated to it; Know-How is
not limited to the narrow sense that each individual component of
the Know-How should be totally unknown or unobtainable outside the
Corixa's business.
(d) SUBSTANTIAL shall mean that the Know-How includes information
which is of importance for the whole or a significant part of (i)
a manufacturing process or (ii) a product or service, or (iii) for
the development thereof and excludes information which is trivial.
Such Know-How must thus be useful, i.e., can reasonably be
expected at the date of conclusion of the Agreement to be capable
of improving the competitive position of SB, for example by
helping SB to enter a new market or giving SB an advantage in
competition with other manufacturers or providers of services who
do not have access to the licensed Secret Know-How or other
comparable Secret know-how;
(e) IDENTIFIED shall mean that the Know-How is described or recorded
in such a manner as to make it possible to verify that it fulfills
the criteria of secrecy and substantiality and to ensure that SB
is not unduly restricted in its exploitation of its own
technology. To be identified the Know-How can either be set out in
this Agreement or in a separate document or recorded in any other
appropriate form at the latest when the Know-How is transferred or
shortly thereafter, provided that the separate document or other
record can be made available if the need arises.
(f) 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 a party to this Agreement.
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(g) CORIXA PATENTS shall mean all patents and patent applications
(including those arising from the Research Program) which are now
or become owned and/or controlled by Corixa during the longer of
the Option Term or the term of the-Research Program, as may be
extended from time to time, under which Corixa otherwise has, now
or in the future, the right to grant licenses, which generically
or specifically claim all or part of Product, a process for
manufacturing Product, intermediates used in such process or a use
of Product and any and all technology(ies) generated solely by
Corixa during the Research Program. Included with the definition
of Corixa Patents are any continuations, continuations-in-part,
divisions, patents of addition, reissues, renewals or extensions
thereof. Also included within the definition of Corixa Patents are
any patent applications which generically or specifically claim
any improvements on Product or intermediates or manufacturing
processes required or useful for production of Product which are
developed by Corixa, or which Corixa otherwise has the right to
grant licenses, now or in the future during the longer of the
Option Term or the term of the Research Program, as may be
extended from time to time. In no event shall Corixa Patents be
deemed to include SB Patents.
(h) JOINT RESEARCH PROGRAM PATENTS shall mean all patents and patent
applications which cover Joint Inventions and which generically or
specifically claim Product, a process for manufacturing Product,
and intermediates used in such process or a use of Product and any
and all technology(ies) generated during the Research Program.
Included with the definition of Joint Research Program Patents are
any continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals or extensions thereof. Also included
within the definition of Joint Research Program Patents are any
patent applications which generically or specifically claim any
improvements on Product or intermediates or manufacturing
processes required or useful for production of Product which are
developed jointly by Corixa and SB during the longer of the Option
Term or the term of the Research Program, as may extended from
time to time. In no event shall Joint Research Program Patents be
deemed to include SB Patents.
(i) SB PATENTS shall mean all patents and patent applications which
are now or become owned and/or controlled by SB (other than
jointly with Corixa), which SB otherwise has, now or in the
future, the right to grant licenses, which generically or
specifically claim an antigen or adjuvant included in Product.
Included with the definition of SB Patents are any continuations,
continuations-in-part, divisions, patents of addition, reissues,
renewals or extensions thereof. In no event shall SB Patents be
deemed to include either Corixa Patents or Joint Research Program
Patents.
10. JOINT RESEARCH TEAM.
(a) A Joint Research Team will be established within thirty (30) days
after the full execution of this Agreement, responsible for
regular coordination and monitoring of the research activities.
The team will consist of at least two (2) individuals from each of
SB and Corixa. To facilitate such coordination, the parties will
share all research data generated in this collaboration with each
other on a prompt and regular basis, which shall be at a minimum,
every three (3) months. The data
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generated shall be subject to the confidentiality provisions of
Paragraph 14 of this Agreement. The Joint Research Team will
review the Research Program annually, implement any mutually
agreeable modifications and make recommendations related to
possible Research Program or Option extensions to the respective
senior management teams of each company. In the event that the
members of the Joint Research Team are unable to agree on a
particular course of action, any such disagreement shall be
resolved in good faith by the CEO of Corixa and the Senior Vice
President and General Manager of SB, respectively.
(b) From the amounts specified in subparagraph 6(a) Corixa shall
reinvest US [***] in the performance of the Research Program. In
the event the amounts specified have not been dedicated fully to
the Research Program, the Joint Research Team will decide how
these amounts shall be allocated by Corixa to a further usage of
the Research Program. On an annual basis, Corixa shall provide to
the Joint Research Team a report in reasonable detail setting
forth the use of funds provided by SB to Corixa under Section 6(a)
of this Agreement.
11. EQUITY. Simultaneous with execution of this Agreement, Corixa will
enter into good faith negotiations with SR One for the purchase by SR One of up
to two million, five hundred thousand dollars ($2,500,000.00) of Corixa's Series
B Preferred Stock.
12. INVENTIONS. Patentable inventions or discoveries which arise from the
Research Program and which are made by an employee or agent of Corixa, solely or
jointly other than with an employee or agent of SB, shall be owned by Corixa.
Patentable inventions or discoveries which arise from the Research Program and
which are made jointly by employees or agents of Corixa and SB shall be jointly
owned by Corixa and SB and treated as joint inventions under the US laws
applicable to joint inventions (collectively, "Joint Inventions"). Patentable
inventions or discoveries which arise from the Research Program and which are
made by an employee or agent of SB, solely or jointly other than with an
employee or agent of Corixa, shall be owned by SB. Except as otherwise set forth
in this Agreement, SB and Corixa shall retain their respective unrestricted
rights to make, have made, use and sell all such inventions and discoveries
which are owned solely by them. In the event this Agreement is terminated as a
result of an uncured breach by SB under Section 20(c) hereof, without further
action on the part of either party, Corixa will receive a non-royalty-bearing
and exclusive license to all Joint Research Program Patents and Joint Inventions
in the Mtb field and Know-How associated therewith; such license shall in no
event include SB Patents. In such event, SB agrees to take all steps necessary
to effectuate such license to Corixa.
13. PATENTS; PROSECUTION AND LITIGATION.
(a) Corixa shall have the right to prosecute and maintain all Corixa
Patents and Joint Research Program Patents and shall do so in a
timely manner. Corixa shall disclose to SB the complete texts of
all patents and patent applications filed by Corixa which relate
to any Product (including Corixa Patents) as well as all
information received concerning the institution or possible
institution of any interference, opposition, re-examination,
reissue, revocation, nullification or any official proceeding
involving any patent licensed herein anywhere in the
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Subterritory A. SB shall have the right to review all such pending
applications and other proceedings and make recommendations to
Corixa concerning them and their conduct. Corixa agrees to keep SB
promptly and fully informed of the course of patent prosecution or
other proceedings including by providing SB with copies of
substantive communications, search reports and third party
observations submitted to or received from patent offices
throughout Subterritory A. Corixa shall provide such patent
consultation to SB at no cost to SB. SB shall hold all information
disclosed to it under this section as confidential.
(b) In the event Corixa intends to abandon any patent or any part of a
patent (including Corixa Patents) covered by this Agreement, it
shall notify SB and SB shall have the right to assume
responsibility for any such patent or part of patent.
(c) In the event of the initiation of any suit by a third party
against Corixa, SB or the Affiliates of either for patent
infringement involving the manufacture, use, sale, distribution or
marketing of any Product anywhere in Subterritory A, the party
sued shall promptly notify the other party in writing. SB shall
have the right but not the obligation to defend such suit at its
own expense. Corixa and SB shall assist one another and cooperate
in any such litigation at the other's request without expense to
the requesting party.
(d) In the event that Corixa or SB becomes aware of actual or
threatened infringement of a patent anywhere in Subterritory A,
that party shall promptly notify the other party in writing. SB
shall have the first right but not the obligation to bring, at its
own expense, an infringement action against any third party and to
use Corixa's name in connection therewith. If SB does not commence
a particular infringement action within ninety (90) days, Corixa,
after notifying SB in writing, shall be entitled to bring such
infringement action at its own expense. The party conducting such
action shall have full control over its conduct, including
settlement thereof. In any event, Corixa and SB shall assist one
another and cooperate in any such litigation at the other's
request without expense to the requesting party.
(e) Corixa and SB shall recover their respective actual out-of-pocket
expenses, or equitable proportions thereof, associated with any
litigation or settlement thereof from any recovery made by any
party. In the event SB takes responsibility for such actions, it
shall bear [***] and Corixa shall bear the remaining [***]
provided that Corixa's remaining share of the expenses do not
exceed [***] of royalties owed to Corixa by SB. Any excess amount
shall be shared between SB and Corixa, with SB receiving [***] and
Corixa receiving [***] of such excess. In the event Corixa takes
responsibility for such actions, Corixa will undertake all actions
at its own entire expense, and recover [***].
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(f) The parties shall keep one another informed of the status of their
respective activities regarding any litigation or settlement
thereof concerning any Product.
(g) DISCLAIMER OF WARRANTIES. CORIXA MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED OTHER THAN THOSE CONTAINED IN
SECTION 19 BELOW, WITH RESPECT TO THE CORIXA PATENTS, THE RESEARCH
PROGRAM PATENTS OR KNOW-HOW, AND ANY PRODUCTS RELATED THERETO
INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
14. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS.
(a) During the term of this Agreement, Corixa shall promptly disclose
to SB and/or supply SB in a timely fashion with all Know-How and
all inventions related to Mtb arising from the Research Program.
In addition, each party will provide the other party with all
information which is necessary or useful for obtaining the goals
of the Research Program. Corixa shall also provide SB with
quarterly reports on the progress of the Research Program.
(b) During the term of this Agreement, each party shall promptly
inform the other party of any information that it obtains or
develops regarding the utility and safety of any Product(s) and
shall promptly report to the other party any confirmed information
of serious or unexpected reactions or side effects related to the
utilization or medical administration of Product(s).
(c) During the term of this Agreement and for five (5) years
thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, Corixa and SB shall not
use or reveal or disclose to any third party any confidential
information received from the other party or otherwise developed
by either party in the performance of activities in furtherance of
this Agreement without first obtaining the written consent of the
disclosing party, except as may be otherwise provided herein, or
as may be required for purposes of investigating, developing,
manufacturing or marketing any Product or for securing essential
or desirable authorizations, privileges or rights from
governmental agencies, or is required to be disclosed to a
governmental agency, or is necessary to file or prosecute patent
applications concerning any Product or to carry out any litigation
concerning any Product. This confidentiality obligation shall not
apply to such information which is or becomes a matter of public
knowledge, or is already in the possession of the receiving party,
or is disclosed to the receiving party by a third party having the
right to do so, or is subsequently and independently developed by
employees of the receiving party or Affiliates thereof who had no
knowledge of the confidential information disclosed. The parties
shall take reasonable measures to assure that no unauthorized use
or disclosure is made by others to whom access to such information
is granted.
(d) Nothing herein shall be construed as preventing SB from disclosing
any information received from Corixa to an Affiliate, sublicensee
or distributor, provided such Affiliate, sublicensee or
distributor has undertaken in writing a similar obligation of
confidentiality with respect to the confidential information, with
Corixa stated as a third party beneficiary thereof.
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(e) All confidential information disclosed by one party to the other
shall remain the intellectual property of the disclosing party. In
the event that a court or other legal or administrative tribunal,
directly or through an appointed master, trustee or receiver,
assumes partial or complete control over the assets of a party to
this Agreement based on the insolvency or bankruptcy of such
party, the bankrupt or insolvent party shall promptly notify the
court or other tribunal (1) that confidentiality of the other
party's confidential information received from the other party
under this Agreement remains the property of the other party and
(2) 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 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.
(f) The parties to this Agreement may disclose the nature of the
intended Agreement in a press release following signature,
provided, however, that the terms of the Agreement are not
disclosed by either party. The wording of any press release must
be agreed to by both parties in advance of its release, provided
that such agreement is not unreasonably withheld by either party.
(g) Neither party will publish or provide disclosure of information or
inventions arising from the Research Program (a "Dissemination")
without at least sixty (60) days prior written notice of such
planned publication or disclosure. In the event any such
Dissemination is determined by the other party to be detrimental
to its intellectual property position, the disseminating party
will delay such publication for a period sufficient to allow the
other party to take the steps necessary to protect such
intellectual property, including the filing of any patent
applications, and/or deletion of its confidential information.
15. GOVERNING LAW; ARBITRATION. This Agreement will be governed by the laws
of the State of Washington, USA. Any dispute, controversy or claim arising out
of or in relation to this Agreement or the breach, termination or invalidity
thereof, that cannot be settled amicably by agreement of the parties hereto,
shall be finally settled by arbitration in accordance with the arbitration rules
of the American Arbitration Association ("AAA"), then in force, by one or more
arbitrators appointed in accordance with said rules; provided, however, that
arbitration proceedings may not be instituted until the party alleging breach of
this Agreement by the other party has given the other party not less than sixty
(60) days notice to remedy any alleged breach and the other party has failed to
do so. The place of arbitration shall be Seattle, Washington, USA if arbitration
is initiated by SB and New York, New York if initiated by Corixa. The award
rendered shall be final and binding upon both parties. The judgment rendered by
the arbitrator shall include costs of arbitration, reasonable attorneys' fees
and reasonable costs for any expert and other witnesses. The arbitration in such
proceeding may expressly consider the amounts paid pursuant to Sections 6(a) and
6(b) hereof in considering any claim of damages. Nothing in this Agreement shall
be deemed as preventing either party from seeking injunctive relief (or any
other provisional remedy) from any court having jurisdiction over the parties
and the subject matter of the dispute as necessary to protect either party's
name, proprietary information, trade secrets, know-how or any other proprietary
rights. Judgment upon the award may be entered in any court
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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.
16. MISCELLANEOUS.
(a) TRADEMARK. SB shall be responsible for the selection, and SB shall
be responsible for registration and maintenance, of all trademarks
which are employed in connection with any Product or Combination
Product and SB shall own and/or control any such trademarks;
provided that prior to selection of such trademarks, SB shall
provide Corixa an opportunity to review and comment on any such
trademark.
(b) FORCE MAJEURE. If the performance of any part of this Agreement by
either party, or of any obligation under this Agreement, is
prevented, restricted, interfered with or delayed by reason of any
cause beyond the reasonable control of the party liable to
perform, unless conclusive evidence to the contrary is provided;
the party so affected shall, upon giving written notice to the
other party, be excused from such performance to the extent of
such prevention, restriction, interference or delay, provided that
the affected party shall use its reasonable best efforts to avoid
or remove such causes of nonperformance and shall continue
performance with the utmost dispatch whenever such causes are
removed. When such circumstances arise, the parties shall discuss
what, if any, modification of the terms of this Agreement may be
required in order to arrive at an equitable solution.
(c) SEVERABILITY.
(i) 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;
(ii) If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then
such terms or provisions shall be deemed inoperative to the
extent that they may conflict therewith and shall be deemed
to be modified to conform with such statute or rule of law.
(d) ENTIRE AGREEMENT. This Agreement, entered into a of the date
written above, constitutes the entire agreement between the
parties relating to the subject matter hereof and supersedes all
previous writings and understandings except that the Non
Disclosure Agreements between the parties dated 17 February 1995
and 10 August 1995 remain in full force and effect. No terms or
provisions of this Agreement shall be varied or modified by any
prior or subsequent statement, conduct or act of either of the
parties, except that the parties may mutually amend this Agreement
by written instruments specifically referring to and executed in
the same manner as this Agreement.
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17. NOTICES.
(a) Any notice required or permitted under this Agreement shall be
sent by registered air mail, postage pre-paid, international cable
or telex to the following addresses of the parties:
If to Corixa:
Corixa Corporation
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: President and Chief Executive Officer
If to SB:
SmithKline ▇▇▇▇▇▇▇ Biologicals ▇.▇.
▇▇▇ ▇▇ ▇'▇▇▇▇▇▇▇▇ ▇▇
▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
Attention: Senior Vice President, General Manager
(b) Any notice required or permitted to be given concerning this
Agreement shall be effective upon receipt by the party to whom it
is addressed.
18. ASSIGNMENT. This Agreement and the licenses herein granted shall be
binding upon and inure to the benefit of the successors in interest of the
respective parties. Neither this Agreement nor any interest hereunder shall be
assignable by either party without the written consent of the other provided,
however, that either party may assign this Agreement and all patents related to
this Agreement to an Affiliate or to any corporation or other entity with which
it may merge or consolidate, and/or to any corporation or other entity to which
it may transfer all or substantially all of its assets, without obtaining the
consent of the other party; provided that the consent of the non-transferring
party shall be required for any transfer of all or substantially all assets that
materially alters the rights of such non-transferring party under this Section.
19. WARRANTIES AND REPRESENTATIONS.
(a) Each party warrants that it has the right to enter into this
Agreement.
(b) Nothing in this Agreement shall be construed as a warranty that
patents covered by this Agreement are valid or enforceable or that
their exercise will not infringe any patent rights of third
parties.
(c) Corixa acknowledges that in entering into this Agreement, SB has
relied or will rely upon information supplied by Corixa, by
Corixa's agents and/or representatives to SB pursuant to
confidentiality agreements between the parties and pursuant to
Section 14 hereof (all of such information being hereinafter
referred to collectively as "Product Information") and Corixa
warrants and represents that such Product Information has been
accurate in all material respects.
(d) The parties warrant to one another that neither of them has any
present knowledge of the existence of any pre-clinical or clinical
data or information covering any
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Product which suggests that there may exist toxicity, safety
and/or efficacy concerns which may materially impair the utility
and/or safety of Product.
20. TERM AND TERMINATION.
(a) In the event SB does not exercise its Option by the end of the
Option Term, the Agreement will be terminated, except for the
provisions of Sections 12, 14,15, 21(a) and 22. If this agreement
is terminated by Corixa for breach by SB under Section 20(c)
hereof, all rights to all intellectual property arising from the
Research Program, including but not limited to Corixa Patents,
Joint Research Program Patents and Know-How, but excluding SB
Patents, shall, subject to the provisions of Section 12, revert to
Corixa and SB shall retain no rights therein. All payments set
forth in Paragraphs 6.(a) and 6.(b) will be guaranteed and
non-refundable. Failure by Corixa to conduct the Research Program
as detailed in Schedule 1 shall be considered a breach of
Agreement and be subject to sub-paragraph 20(c) below and any
amount previously paid by SB may be submitted for consideration in
arbitration pursuant to Section 15.
(b) Unless otherwise terminated, in the event the Option is exercised
by SB, this Agreement shall expire upon the expiration, lapse or
invalidation of the last remaining Corixa Patent or Joint Research
Program Patent licensed to SB by Corixa hereunder. Expiration of
this Agreement under this provision shall not preclude SB from
continuing to market Product and to use Know-How without any
further royalty payments.
(c) If either party materially breaches the material provisions of
this Agreement and if such breach is not cured within sixty (60)
days after receiving written notice from the other party with
respect to such breach, the non-breaching party shall have the
right to terminate this Agreement by giving written notice to the
party in breach provided the notice of termination is given within
six (6) months of the breach and prior to cure thereof.
(d) As set forth in Section 4(a) above, SB agrees it will exercise at
least the same level of diligence in the clinical development and
commercialization of Product within Subterritory A as it currently
uses, or in the past has used, with respect to its own
commercially successful products. However, prior to marketing
Product in any given country, SB may terminate its development
efforts and the license granted hereunder with respect to that
Product and country upon one hundred eighty (180) days notice if
in SB's reasonable judgment sales in such country would not be
commercially viable. Thereafter, after beginning Product marketing
efforts in any particular country, and continuing such efforts for
three (3) or more years (the "Minimum Diligence Period"), SB may
terminate sales efforts with respect to any single country by
giving Corixa at least six (6) months prior written notice
thereof. Such Minimum Diligence Period may be reduced below three
(3) years by mutual agreement of the parties.
(e) Either party may terminate this Agreement if, at any time, the
other party shall file in any court or agency pursuant to any
statute or regulation of the United States or
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of any individual state or foreign country, a petition in
bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver of trustee of the
party or of its assets, or if the other party proposes a written
agreement of composition or extension of its debts, or if the
other party shall be served with an involuntary petition against
it, filed in any insolvency proceeding, and such petition shall
not be dismissed with sixty (60) days after the filing thereof, or
if the other party shall propose or be a party to any dissolution
or liquidation, or if the other party shall make an assignment for
the benefit of creditors.
(f) 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, SB shall be entitled
to retain the rights and licenses granted herein, without any
farther obligations to Corixa, subject to Corixa's right to
terminate this Agreement for reasons other than bankruptcy or
insolvency as expressly provided in this Agreement.
21. RIGHTS AND DUTIES UPON TERMINATION.
(a) Upon termination of this Agreement, Corixa shall have the right to
retain any sums already paid by SB hereunder, and SB shall pay all
sums accrued hereunder which are then due, which, in each case,
shall include all payments under 6(a) except to the extent such
payments may be considered and reviewed by the arbitrator pursuant
to Section 15 hereof.
(b) Upon termination of this Agreement, SB shall notify Corixa of the
amount of any Product SB and its subsidiaries and distributors
then have on hand, the sale of which would, but for the
termination, be subject to royalty, and SB and its sublicensces
and distributors shall thereupon be permitted to sell that amount
of any Product, provided that SB shall pay the royalty thereon at
the time herein provided for.
22. INDEMNIFICATION.
(a) Subject to Section 22(b) hereof, from and after the Effective
Date, except as otherwise herein specifically provided, each of
the parties hereto shall defend, indemnify and hold harmless the
other party and its Affiliates, successors and assigns, and their
respective officers, directors, shareholders, partners and
employees from and against all losses, damage, liability arid
expense including legal fees but excluding punitive or
consequential damages (including lost profits) ("Damages")
incurred thereby or caused thereto arising out of or relating to
(i) any breach or violation of, or failure to properly perform,
any covenant or agreement made by such indemnifying party in this
Agreement, unless waived in writing by the indemnified party; (ii)
any breach of any of the representations or warranties made by
such indemnifying party in this Agreement; or (iii) the gross
negligence or willful misconduct of the indemnifying party.
(b) If either SB or Corixa, or any Affiliate of SB or Corixa (in each
case an "Indemnified Party"), receives any written claim which it
believes is the subject of indemnity hereunder by either SB or
Corixa, as the case may be (in each case an
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"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.
(c) 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.
(d) 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.
IN WITNESS WHEREOF, each of the parties hereto has caused this
Agreement to be executed by its duly authorized officer as of the date first
written above.
Agreed to and accepted by: Agreed to and accepted by:
CORIXA CORPORATION SMITHKLINE ▇▇▇▇▇▇▇ BIOLOGICALS S.A.
/s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇ /s/ JEAN STEPHENNE
------------------------------- -----------------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇ Jean Stephenne
President and CEO Senior Vice President and General Manager
attachment: Schedule 1
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SCHEDULE 1
[***]
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