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EXHIBIT 10.14
PROSTATE CANCER COLLABORATION AND
LICENSE AGREEMENT
BETWEEN
CORIXA CORPORATION
AND
SMITHKLINE XXXXXXX BIOLOGICALS MANUFACTURING S.A.
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TABLE OF CONTENTS
1. DEFINITIONS 3
2. SCOPE OF RESEARCH PROGRAM 8
3. RESEARCH PROGRAM TERM AND TERMINATION 8
4. LICENSE GRANT 9
5. LICENSE PAYMENTS 10
6. ROYALTIES 12
7. OTHER TERMS 15
8. JOINT RESEARCH TEAM 15
9. INVENTIONS 16
10. PATENTS; PROSECUTION AND LITIGATION 16
11. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS 18
12. GOVERNING LAW; ARBITRATION 20
13. MISCELLANEOUS 21
14. NOTICES 22
15. ASSIGNMENT 22
16. WARRANTIES AND REPRESENTATIONS 23
17. TERM AND XXXXXXXXXXX 00
00. RIGHTS AND DUTIES UPON TERMINATION 25
19. INDEMNIFICATION 25
EXHIBIT A 27
EXHIBIT B 28
EXHIBIT C 30
EXHIBIT D 31
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PROSTATE CANCER COLLABORATION AND LICENSE AGREEMENT
This PROSTATE CANCER COLLABORATION AND LICENSE AGREEMENT (together, with the
attachments hereto, the "Agreement") is entered into the ______ day of March,
1997 (the "Effective Date") by and between 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
Biologicals Manufacturing S.A., a Belgian corporation with its principal place
of business at Xxx xx x'Xxxxxxxx 00, X-0000 Xxxxxxxxx, Xxxxxxx ("SB").
W I T N E S S E T H:
WHEREAS, Corixa and SB desire to collaborate in the research and
development of antigens for the development of Vaccine product(s) for the
prevention and/or treatment of any form of prostate cancer 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. DEFINITIONS
(a) "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.
(b) "Antigens" shall mean [***]
(c) "PC" shall mean prostate cancer.
(d) "PC Field" shall mean any and all in vivo administered
prophylactic and/or therapeutic prostate cancer Vaccines for
use in humans.
(e) "Blocking Patents" shall mean any patents and/or patent
applications owned and/or controlled by Third Parties having
claims which would be infringed by SB making, having made,
using, having used, offering for sale, selling or having sold
all or part of
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Product and which would prevent SB from using the intellectual
property rights granted to SB by Corixa hereunder.
(f) "Competition" shall mean a product which would otherwise
infringe Corixa Patents or Joint Research Program Patents.
(g) "Corixa" shall mean Corixa Corporation and its Affiliates.
(h) "Corixa Antigens" shall mean (i) those Antigens identified on
Exhibit A attached hereto and/or (ii) those Antigens solely
discovered by Corixa during the Research Program Term as may
be extended in connection with and as a result of the Research
Program and/or (iii) those Antigens discovered by Corixa as a
result of research directed to PC during the Research Program
Term as may be extended but not in connection with and not as
a result of the Research Program and, subject to SB's exercize
of the option set forth in Paragraph 4(d) below, during a
period of [***] after the Research Program Term as may
be extended and/or (iv) subject to SB's compliance with the
terms and conditions of Paragraph 4(c) below, those Antigens
in the PC Field licensed-in or otherwise acquired by Corixa
during the Research Program Term as may be extended and,
subject to Paragraph 4(d) below, during a period of [***]
thereafter. As used herein, Corixa Antigens shall not
include Research Program Antigens nor SB Antigens.
(i) "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 Research Program Term as may be extended
and, subject to Paragraph 4(d) below, during a period of
[***] thereafter and/or 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(s), a
process for manufacturing Product(s), intermediates used in
such process or a use of Product and any and all
technology(ies) generated solely by Corixa in connection with
Corixa's performance under this Agreement during the Research
Program Term as may be extended and, subject to Paragraph 4(d)
below, during a period of [***] thereafter. 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
Research Program Term as may be extended and, subject to
Paragraph 4(d) below, during a period of [***]
thereafter. Corixa Patents shall specifically not include SB
Patents. Corixa Patents in existence as of the Effective Date
are set forth on Exhibit B attached hereto. Exhibit B also
sets forth a list of patents owned and/or controlled by
Corixa which are specifically excluded from the scope of
Corixa Patents and shall not be considered Corixa Patents for
the purpose of this Agreement and to which SB shall have no
rights except as separately agreed by the parties in a written
separate agreement.
(j) "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
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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.
(k) "Joint Inventions" shall have the meaning set forth in Section
(l) "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 Term as may be extended. 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 cover Joint
Inventions and which generically or specifically claim any
improvements on Product or intermediates or manufacturing
processes required or useful for production of Product. In no
event shall Joint Research Program Patents be deemed to
include Corixa Patents or SB Patents.
(m) "Joint Research Team" shall have the meaning set forth in
Paragraph 8(a).
(n) "Know-How" shall mean all technical information, materials and
know-how owned and/or controlled by Corixa now and/or during
the term of the Research Program Term as may be extended and,
subject to SB's exercize of the option set forth in Paragraph
4(d) below, during a period of two (2) years thereafter, which
directly relates to Product and shall include, without
limitation, all chemical, pharmacological, toxicological,
clinical, assay, control and manufacturing data and any other
information relating to Products and useful for the
development and commercialization of Products and strains,
samples, analytical tools, libraries, clones, etc.
(o) "Licensed Field" shall mean any and all in vivo administered
[***] cancer Vaccines for use [***] and shall [***] adoptive
immunotherapy.
(p) "Milestone" shall mean the technical milestone set forth in
Exhibit C attached hereto, the satisfaction of which shall be
reasonably determined by the Joint Research Team within ten
(10) days of submission of the relevant information and data
by Corixa to the Joint Research Team.
(q) "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 from sales of Product
less (i) normal customary trade discounts allowed and
taken; (ii) rebates to wholesalers; (iii) returns;
(iv) amounts for including insurance; (v) shipping
charges to purchasers if invoiced separately; (vi)
taxes (not including any income taxes), and duties
levied on sales;
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transportation(vii) deduction allowed for
government-mandated vaccine insurance premiums, such
as the National Childhood Vaccine Injury Act in the
U.S.; (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) In determining royalty payments hereunder, Net Sales
of Product shall be multiplied by [***].
(iii) In the event of a product incorporating a Product and
one or more non-prostate cancer Vaccines (a
"Combination Product"), Net Sales shall exclude [***].
(r) "Product" shall mean any product comprised at least of one (1)
or more Corixa Antigens and/or Research Program Antigens,
including any combination thereof. In addition to Corixa
Antigens and/or Research Program Antigens Product may also
include SB Antigen(s).
(s) "Research Program" shall have the meaning set forth in
Paragraph 2(a).
(t) "Research Program Antigens" shall mean Antigens discovered by
Corixa and SB during the Research Program Term, as may be
extended, in connection with and as a result of the conduct of
the Research Program.
(u) "Research Program Term" shall have the meaning set forth in
Paragraph 3(a).
(v) "SB" shall mean SmithKline Xxxxxxx Biologicals Manufacturing
S.A. and its Affiliates.
(w) "SB Antigens" shall mean Antigens discovered and/or
in-licensed by SB and related physical forms based on such
Antigens including peptides, proteins and nucleic acids other
than Research Program Antigens.
(x) "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) and/or under which SB
otherwise has, now or in the future, the right to grant
licenses, which generically or specifically claim any Antigen
and/or adjuvant included in Product. Included with the
definition of SB Patents are any continuations,
continuations-in-part, divisions, patents of
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addition, reissues, renewals or extensions thereof. In no
event shall SB Patents be deemed to include either Corixa
Patents or Joint Research Program Patents.
(y) "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.
(z) "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.
(aa) "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;
(bb) "Territory" shall mean all the countries of the world.
(cc) "Third Party(ies) shall mean any party other than a party to
this Agreement or an Affiliate.
(dd) "Vaccines" shall mean the administration of [***] any
formulation or configuration, for the primary purpose and
effect of eliciting a [***] or [***] immune response directed
directly or indirectly to such [***] contained therein.
[***]
"Interpretive Rules". For purposes of this Agreement, except as
otherwise expressly provided herein or unless the context otherwise
requires : (a) defined terms include the plural as well as the singular
and the use of any gender shall be deemed to include the other gender;
(b) references to "Articles", "Sections" and other subdivisions and to
"Schedules" and "Exhibits" without reference to a document, are to
designated Articles, Sections and other subdivisions of, and to
Schedules and Exhibits to, this Agreement; (c) the use of the term
"including" means "including but not limited to"; and (d) the words
"herein", "hereof", "hereunder" and other words of similar import refer
to this Agreement as a whole and not to any particular provision.
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2. SCOPE OF RESEARCH PROGRAM
(a) During the Research Program Term, the parties will collaborate
in the discovery and development of Antigens for use in
Vaccine(s) for the prevention and/or treatment of PC and any
other tumor type in the Licensed Field to the extent those
Antigens are useful for such tumor types. The program of
activities to be conducted by Corixa and SB during the term of
the Agreement is set forth in Exhibit D (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.
(b) During the Research Program Term and for a period of [***]
thereafter, Corixa shall not enter into any commercial
agreement with a Third Party with respect to a collaboration
regarding the PC Field without the prior written consent of
SB. Subject to provisions of Paragraph 4(c), 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 Research Program, provided
that any such agreement shall provide that Corixa will own
and/or control all intellectual property rights related to the
Licensed Field arising from such agreement and that Corixa
Antigens arising from the use of it shall automatically fall
within the scope of the rights and licences granted to SB by
Corixa hereunder.
(c) The objective of the Research Program will be the development
of Product(s). At SB's option, Corixa Antigens and/or
Research Program Antigens shall be combined with SB Antigens
and/or adjuvants of SB, and such combinations may result in
discrete versions of the Product(s), consisting of potentially
different mixtures of Antigens and/or adjuvants and/or Corixa
Antigens and/or Research Program Antigens and/or SB Antigens.
3. RESEARCH PROGRAM TERM AND TERMINATION.
(a) The Research Program will be effective from January 1, 1997 to
December 31, 1998 (the "Research Program Term") and shall be
renewable for up to [***] additional one (1) year periods.
SB shall have no obligation to renew the Research Program
beyond December 31, 1998, and any such renewal shall be at
SB's entire discretion. Corixa undertakes to : (i) use all
reasonable efforts to materially perform all activities set
forth in the Research Program; (ii) use all reasonable
efforts to achieve the Research Program's objective; and (iii)
use all reasonable efforts to achieve the Milestone within the
initial Research Program Term.
(b) At least four and a half (4 1/2) months prior to the end of
the initial Research Program Term and provided Corixa has met
the Milestone, SB shall have the option, exercisable by giving
Corixa written notice of its intent, to renew the Research
Program for a minimum of one (1) additional year and the
parties shall agree upon the terms and conditions including
the financial elements regarding such renewal, which at a
minimum shall be as set forth in Paragraph 5 (c) below.
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The parties shall at the same time agree upon the scope of the
Research Program during such extended Research Program Term.
Thereafter, or in the event Corixa has not met the Milestone,
SB shall notify Corixa of its intention to renew the Research
Program at least two (2) months before the termination of each
affected Research Program Term, as renewed from time to time.
4. LICENSE GRANT
(a) Subject to the terms and conditions of this Agreement,
including, without limitation, the license payments and
royalty provisions in Sections 5 and 6 below, Corixa hereby
grants to SB an exclusive license, with the right to grant
sublicenses, under Corixa Patents, Joint Research Program
Patents, Know-How and any SPC to make, have made, use, have
used, sell, offer for sale, have sold, keep and import any and
all Products in the Licensed Field in the Territory, in any
formulation, configuration, combination and/or with any
delivery system. For purpose of clarity, the foregoing
license shall include rights of SB to Corixa Antigens and/or
Research Program Antigens in and outside the PC Field but in
the Licensed Field; any commercial use of such Corixa Antigens
and/or Research Program Antigens shall be subject to the
royalties set forth in Section 6 in the same manner as
royalties are paid on Products thereunder.
(b) 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 Product
are sold by such Third Party compulsory licensee) of the terms
granted to such Third Party to the extent that such terms are
more favourable to the Third Party than those granted to SB
under this Agreement.
(c) During the Research Program Term, if Corixa or SB believes
that technology related to the subject matter of the Research
Program that is controlled by a Third Party including GenQuest
Inc., which may include new Antigens, adjuvants and/or
Blocking Patents ("Additional Technology") would be valuable
or necessary to the Research Program in the Licensed Field
hereunder, Corixa or SB as appropriate shall present such
Additional Technology, along with a written report with
respect thereto to the Joint Research Team. The Joint
Research Team shall then determine, except for Blocking
Patents which shall be at SB's sole discretion subject to
other provisions contained herein, whether licenses to, and/or
acquisitions of, such Additional Technology should be made,
the party that shall approach and negotiate with any Third
Party(ies) and the terms of any agreement(s) with any Third
Parties, including, without limitation, payments for sponsored
research. No such Third Party license and/or acquisition
shall be effective with respect to SB unless and until SB has
specifically agreed in writing to abide by the applicable
terms and conditions of any such license and/or acquisition,
and to make such payments and/or royalties as are mutually
agreed to by the parties and provided further that the access
to and acquisition of any Blocking Patents shall be decided by
SB at its entire discretion, provided however that if Corixa
disagrees on the acquisition by SB of a Blocking Patent, the
matter shall be submitted for resolution to the CEO of Corixa
and the Senior Vice President and General Manager of SB. In
case of persistent disagreement, the matter shall be submitted
to arbitration pursuant to Section 12 below. In any event, the
parties
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shall behave reasonably and adopt a standard of reasonableness
in their assessment of the matter. Notwithstanding the
foregoing, this Paragraph 4(c) shall not be deemed to preclude
either party from acquiring Additional Technology.
(d) Corixa hereby grants SB an option during a [***] period
from the end of the Research Program to acquire an exclusive
license under any Corixa Patents filed by Corixa and/or
Know-How developed by Corixa during said [***] period
and/or which are owned and/or controlled by Corixa and/or
under which Corixa otherwise has the right to grant licenses
for use in the PC Field during a period of [***] after
the Research Program Term as may be extended. License terms
and conditions with respect to licensing-in such Corixa
Patents and/or Know-How shall be negotiated in good faith
between the parties taking into account the value of such
Corixa Patents and/or Know-How and their contribution to the
successful development of Product in the PC Field, but shall
in no event have the effect of rendering the terms of this
Agreement less favourable to Corixa than those currently
agreed upon.
5. LICENSE PAYMENTS. SB will make the following payments to Corixa under
this Agreement by wire transfer of immediately available funds:
(a) Technology access fees in the following amounts :
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PAYMENT DATE PAYMENT AMOUNT (U.S.$)
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Execution of this Agreement [***]
April 1, 1997 [***]
July 1, 1997 [***]
October 1, 1997 [***]
January 1, 1998 [***]
April 1, 1998 [***]
July 1, 1998 [***]
October 1, 1998 [***]
Second anniversary of this Agreement [***] (the "Milestone
Payment")
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Notwithstanding the foregoing, SB will only be obligated to
make the Milestone Payment on [***] of this Agreement if the
following conditions are satisfied or waived (the "Milestone
Payment Conditions") : (i) Corixa has achieved the Milestone
(as determined by the Joint Research Team) and (ii) the
Research Program has not been terminated effective on or before
the date the Milestone Payment is due. If SB is not obligated
to make the Milestone Payment on the [***] of this Agreement,
then the Milestone Payment shall be delayed and shall become
due and payable on the [***] of this Agreement provided the
Milestone Payment Conditions have been satisfied or waived, or
if not satisfied or waived, then on the [***] of this Agreement
provided that the Milestone Payment Conditions have by then
been satisfied or waived, or if not satisfied or waived, then
on the [***] of this Agreement provided that the Milestone
Payment Conditions have by then been satisfied or waived. If
SB is not obligated to make the Milestone Payment on or
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before the [***] of this Agreement and if SB extends the
Research Program Term beyond the [***] of this Agreement, then
SB shall pay Corixa a one time non-refundable payment of U.S. $
[***] on the [***] hereof only, which shall be fully creditable
against the Milestone Payment to the extent the latter becomes
due and payable on the [***] of this Agreement.
Notwithstanding the foregoing, if the Milestone Payment
Conditions are not satisfied or waived on or before the [***]
of this Agreement, the balance of the Milestone Payment shall
be forever waived and discharged by Corixa.
(b) In addition to the technology access fees payable pursuant to
Paragraph 5(a) above, SB also agrees to pay Corixa the
following one-time milestone payments, to be made via wire
transfer of immediately available funds in U.S.$, within ten
(10) days of receipt of notice from SB to Corixa of
achievement of each of the following milestones with respect
to the first Product to meet such milestone :
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MILESTONE PAYMENT (U.S.$)
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(i) Approval of IND $ [***]
(ii) Start of Phase II clinical trials $ [***]
(iii) Start of Phase III clinical trials $ [***]
(iv) Submission for regulatory $ [***]
approval in U.S.
(v) Regulatory approval in at least $ [***]
[***]
(vi) Regulatory approval in U.S. $ [***]
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the milestones payments set forth in Subparagraphs 5(b)(iv),
(v) and (vi) above are fully creditable against future
royalties payable pursuant to Section 6, provided such
royalties will not be 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 beyond
the second anniversary of this Agreement, the parties estimate
that the following additional technology access fees would be
required, which fees in Subparagraph 5(c)(ii) below are
subject to increase or decrease by mutual agreement of the
parties based upon the scope of work to be conducted:
i) For the [***] year : $ [***] U.S. dollars) per
quarter;
ii) For the [***] years: a minimum of [***]
of the third year funding level.
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6. ROYALTIES. SB will pay Corixa a royalty on Net Sales of Products as
follows:
(a) Subject to Paragraphs 6(d) and 6(e) 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 are pending for up to [***] from the date of first filing
anywhere in the world (the priority date) or if pending after
such [***] period, then not until such time as issued, if ever,
SB shall pay royalties on annual Net Sales of Product (the
"Patent Royalty") payable on each portion of annual Net Sales
of Product as follows :
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Net Sales Patent in Minimum Royalty
Country of Sale
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[***] [***] [***]
[***] [***] [***]
[***] [***] [***]
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(b) To the extent the royalties set forth in Paragraph 6 (a) are
not applicable to a Product, then 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 below will be
payable 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 covering
such Product has been filed in the country of sale (the
"Know-How Royalty"), as adjusted based on the existence of
Competition in the respective country, as follows :
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Net Sales No Patent - No Patent - Minimum
No Competition Royalty
Competition
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[***] [***] [***] [***]
[***] [***] [***] [***]
[***] [***] [***] [***]
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(c) Royalties under Paragraph 6 (a) shall be payable on a
country-by-country basis for the life of any valid granted
Corixa Patent and/or Joint Research Program Patent which has
not been successfully opposed by a Third Party or revoked on a
country-by- country basis. Royalties under Paragraph 6(b) shall
expire on a country-by-country basis [***] after first launch
of the first Product in any such country.
(d) Except for Antigens licensed hereunder that are covered by
Blocking Patent which are covered in Paragraph 6(e) below, SB
and Corixa shall share [***] any and all Third Party royalties
payable on Additional Technology or for
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technology that is owned and/or controlled by a Third Party and
which is licensed to SB, incorporated into the Product(s),
which may include but shall not be limited to, royalties
payable for adjuvants such as, by way of an example only, [***]
adjuvants and other technology useful or necessary for the
Product. Corixa's contribution to such share shall be through
[***]. For the Know-How Royalty, the royalty rates, as set
forth in Paragraph 6(b) shall apply on the rates as reduced
according to this Paragraph 6(d), provided SB has royalty
obligations towards Third Party(ies) on its sales in those
countries. In the case both 6(d) and 6(e) apply, reductions in
accordance with 6(d) shall apply first.
(e) In the event of a Blocking Patent covering Corixa Antigens
and/or Research Program Antigens licensed hereunder, royalty
obligations to the Third Party will be [***].
(f) From the first launch of Product anywhere in the Territory 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 Product by SB and its
Affiliates, licensees or sublicensees. SB shall keep, and
require any Affiliate, licensee and sublicensee to keep, for a
period of not less than five (5) years, complete and accurate
records of all Net Sales of Product. Corixa shall have the
right, at Corixa's sole expense except as hereinafter
provided, through a certified public accountant reasonably
acceptable to SB, and following reasonable notice, to examine
such records during regular business hours during the life of
the SB obligation to pay royalties on 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 and to the extent such under payment is more than
[***] for the audited period, shall reimburse Corixa for the
expense of the audit. If SB has overpaid royalties, SB may
deduct such over-payments from future royalties owed to Corixa.
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(g) In addition to, and simultaneous with, the royalty reports set
described in Paragraph 6(f) 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 equalled 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 U.S.; 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 12 hereof.
(h) Royalties shall be paid by SB in U.S. dollars with currency
conversions calculated based upon the applicable closing
exchange rates quoted by the Foreign exchange desk of the
Generale de Banque, Brussels, Belgium on the last business day
of the applicable six (6) month period.
(i) [***]
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7. 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 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.
8. 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 as well as patent related activities (the "Joint
Research Team"). The Joint Research 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 during quarterly meetings to be held
alternatively at Seattle and Rixensart. In addition, Corixa
shall provide SB with written monthly reports on the progress
of the Research Program. The data generated shall be subject
to the confidentiality provisions of Section 11 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 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 together,
respectively. In case the disagreement relates to the
appropriateness of filing a patent application on any
invention arising out of the Research Program, each party
hereto shall be given an opportunity to file for applications
in its own right and in its own name and shall bear the
expenses thereof.
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(b) From the amounts specified in Paragraph 5(a) Corixa shall
allocate U.S. $[***] U.S. dollars) to the performance of the
Research Program for the [***]. 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 Paragraph 5(a) of
this Agreement.
9. 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 U.S. 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 by either party as a result
of an uncured breach by the other party under Paragraph 17(c) hereof,
without further action on the part of either party, the non-breaching
party will receive an exclusive license to all Joint Research Program
Patents and Joint Inventions in the Licensed Field and Know-How
associated therewith provided, however, that in the case this
Agreement is terminated by Corixa for uncured breach by SB, such
license shall in no event include SB Patents, and provided further
that if the non-breaching party is Corixa, such licence shall be
non-royalty bearing and if the non-breaching party is SB, such licence
shall be royalty bearing as per the present contract but all other
aspects of the contractual relationship other than survival clauses,
including Research Program and Technology Access Fees, shall terminate
forthwith while the licenses and rights granted to SB shall be
maintained. In such event, the breaching party agrees to take all
steps necessary to effectuate such license to the other party in
accordance with this Section 9.
10. PATENTS; PROSECUTION AND LITIGATION.
(a) Corixa shall have the right and the obligation 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 and Joint Research Program 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 Territory. SB shall have the right to review
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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 the Territory. 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. SB shall reimburse Corixa for all reasonable
and documented costs incurred by Corixa prior to the Effective
Date in connection with the filing, prosecution and maintenance
of the Corixa Patents and for all reasonable and documented
costs incurred by Corixa during the term of this Agreement in
connection with the filing, prosecution and maintenance of the
Corixa Patents and/or the Joint Research Program Patents up to
an amount of [***] per year to the extent same are not already
reimbursed by SB to Corixa pursuant to the Breast Cancer
Collaboration and Licence Agreement of even date herewith. Any
such costs incurred by Corixa in connection with the filing,
prosecution and maintenance of Corixa Patents and/or Joint
Research Program Patents in excess of said [***] shall be
reimbursed by SB to Corixa only if they have been specifically
approved and authorized by the Joint Research Team, in its
reasonable discretion, and if they are reasonable and
documented. In determining whether to approve such additional
expenses, the Joint Research Team shall apply reasonable
standards taking into consideration the norms of the biotech
industry in general.
(b) In the event Corixa intends to finally 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
at its own expense 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 Product anywhere in the
Territory, 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) Subject to subparagraph (f) herebelow, in the event of any
threat or initiation of any legal action by a Third Party
challenging the validity of any patent covered by this
Agreement, Corixa shall have, at its own expense, the control
over the conduct and defense of such action in case it is
directed against Corixa Patents and SB shall have, at its own
expense, the control over the conduct and defense of any such
action directed against SB Patents and the first right to
control, at its own expense, the conduct and defense of any
such action directed against Joint Research Program Patents.
If SB elects not to conduct and defend such action directed
against Joint Research Program Patents, Corixa shall have the
right to do it at its own expense.
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(e) In the event that Corixa or SB becomes aware of actual or
threatened infringement of a patent covered by this Agreement
with respect to Products anywhere in the Territory, that party
shall promptly notify the other party in writing. SB shall
have the first right but not the obligation to bring 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, provided that in the case Corixa is leading the
action it may not enter into any settlement without SB's
consent. 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.
(f) 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 [***] of the
expenses other than out-of-pocket expenses 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 [***]of any excess.
(g) The parties shall keep one another informed of the status of
their respective activities regarding any litigation or
settlement thereof concerning Product.
(h) DISCLAIMER OF WARRANTIES. CORIXA MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED OTHER THAN THOSE CONTAINED IN
SECTION 16 BELOW, WITH RESPECT TO THE CORIXA PATENTS, THE
JOINT RESEARCH PROGRAM PATENTS OR KNOW-HOW, AND ANY PRODUCTS
RELATED THERETO INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
(i) In the event [***] establishes a research and license agreement
with a Third Party, and such partnership includes the
reimbursement of patent expenses by such Third Party to [***],
reasonable patent expenses directly related to any patents
shared between [***] and Corixa pursuant to the Research
Program shall be equally shared between SB and the Third Party,
subject to provision to SB of reasonable documentation
supporting such expenses.
11. 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
documented Know-How, all Corixa Patents
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and all relevant patent applications filed and/or controlled
by Corixa, all Corixa Antigens and all inventions related to
the Licensed Field arising from the Research Program as may be
extended and during a period of [***] thereafter. In
addition, each party will provide the other party with all
information which is reasonably necessary or useful for
achieving the goals 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 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.
(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 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 Product or to carry out any litigation
concerning 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
is bound by similar confidentiality obligations and such
sublicensee or distributor has undertaken in writing a similar
obligation of confidentiality with respect to the confidential
information, with Corixa stated as a Third Party beneficiary
thereof.
(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 (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
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permitted by law, take all steps necessary or desirable to
maintain the confidentiality of the other party's confidential
information and to insure that the court, other tribunal or
appointee maintains such information in confidence in
accordance with the terms of this Agreement.
(f) The parties to this Agreement may disclose the nature of the
intended Agreement in a press release following signature,
provided, however, except for the disease target under the
Research Program, 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 public 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 sent
to the other party. In the event any such Dissemination is
determined by the other party to be detrimental to its
intellectual property position, the disseminating party 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.
12. 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 that the appointed arbitrators shall have
appropriate experience in the biopharmaceutical industry; provided
further, however, that arbitration proceedings may not be instituted
until the party alleging breach of this Agreement by the other party
has given the other party not less than sixty (60) days notice (or in
the case of non-payment pursuant to Section 5 or 6 then fourteen (14)
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, USA if initiated by Corixa. The award rendered shall be final
and binding upon both parties. The judgment rendered by the
arbitrator(s) shall include costs of arbitration, reasonable
attorneys' fees and reasonable costs for any expert and other
witnesses. The arbitration in such proceeding may expressly consider
the amounts paid pursuant to Section 5 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 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.
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13. 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 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 as of the date
first written above, constitutes the entire agreement between
the parties relating to the subject matter hereof and
supersedes all previous writings and understandings except
that the Non Disclosure Agreements dated 17 February 1995 and
10 August 1995, the Tuberculosis collaboration and Licence
Agreement dated October 6, 1995 between Corixa Corporation and
SmithKline Xxxxxxx Biologicals S.A., the Breast Cancer
Collaboration and License Agreement of even date herewith and
the Option Agreement of even date herewith 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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14. NOTICES.
(a) Any notice required or permitted under this Agreement shall be
deemed given if delivered (i) personally, (ii) by facsimile
transmission (receipt verified), (iii) by registered or
certified mail (return receipt requested), postage prepaid, or
(iv) sent by express courier service (receipt verified), to
the following addresses of the parties :
If to Corixa:
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Chief Operating Officer
Telephone : (000) 000-0000
Telecopy : (000) 000-0000
with a copy to : Venture Law Group
0000 Xxxxxxxx Xxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention : Xxxxxxx X. Xxxxxxx
Telephone : (000) 000-0000
Telecopy : (000) 000-0000
If to SB:
SmithKline Xxxxxxx Biologicals
Manufacturing x.x.
Xxx xx x'Xxxxxxxx 00
0000 Xxxxxxxxx, Xxxxxxx
Attention: Senior Vice President,
General Manager
Telephone : 32-2-656 8250
Telecopy : 32-2-656 8025
(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.
15. ASSIGNMENT.
Neither this Agreement nor any interest hereunder shall be assignable
by either party without the written consent of the other provided,
however, that either party may assign this Agreement and all patents
related to this Agreement to 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 SB shall be required for any
assignment, whether by way of transfer of all or substantially all
assets of Corixa or by merger or consolidation, that materially alters
the rights of SB under this Agreement. Transfer in contravention of
this Section 15 shall be considered a material
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breach of this Agreement pursuant to Paragraph 17 (c) below. Subject
to other provisions of this Section 15, 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.
16. 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 the commercialization of any product
covered by such patents 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 11 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) [***]
(e) 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 Product which suggests
that there may exist toxicity, safety and/or efficacy concerns
which may materially impair the utility and/or safety of
Product.
17. TERM AND TERMINATION.
(a) Unless otherwise terminated this Agreement shall expire upon
the later of (i) expiration, lapse or invalidation of the last
to expire Corixa Patent or Joint Research Program Patent issued
in any country or (ii) [***] after first commercial sale of a
Product in the last country in which a Product is commercially
launched. 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.
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(b) If this Agreement is terminated by Corixa for breach by SB
under Paragraph 17(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 9, revert to Corixa and SB shall retain
no rights therein. All payments set forth in Subparagraphs
5(a) (i) through (ix) will be guaranteed and non-refundable.
Failure by Corixa to conduct the Research Program materially
as detailed in Exhibit D shall be considered a breach of
Agreement and be subject to Paragraph 17(c) below and any
amount previously paid by SB may be submitted for
consideration in arbitration pursuant to Section 12.
(c) If either party materially breaches the material provisions of
this Agreement and if such breach is not cured within sixty
(60) days (or in the case of non-payment pursuant to Sections
5 or 6, then fourteen (14) 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) SB agrees it will exercise at least the same level of diligence
in the clinical development and commercialization of Product
within the Territory 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 country upon ninety (90) 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 [***] 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. In that event the licence granted
hereunder to SB with respect to said country of the Territory
shall revert back to Corixa. Such Minimum Diligence Period may
be reduced below [***] 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 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
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insolvency of Corixa, SB shall be entitled to retain the rights
and licenses granted herein, without any further 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.
(g) SB may terminate this Agreement at any time, on or after the
second anniversary of this Agreement by giving six (6) months
prior written notice to Corixa. In the event SB terminates
this Agreement effective as of the second anniversary of this
Agreement, the Milestone Payment provided for in Paragraph
5(a) shall not be due regardless of whether or not the
Milestone has been achieved. Thereafter, even if the
Milestone has been achieved, SB may still elect to terminate
this Agreement in which case SB shall be relieved of the
obligation to make the Milestone Payment.
18. 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
Paragraph 5(a) except to the extent the Milestone Payment has
not become due and payable pursuant to the terms of Paragraphs
5(a) and/or 17(g) and to the extent such payments may be
considered and reviewed by the arbitrator(s) pursuant to
Section 12 hereof.
(b) Upon termination of this Agreement, SB shall notify Corixa of
the amount of Product(s) 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
sublicensees and distributors shall thereupon be permitted to
sell that amount of Product(s), provided that SB shall pay the
royalty thereon at the time herein provided for.
19. INDEMNIFICATION.
(a) Subject to Paragraph 19(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 and expense including
legal fees but excluding punitive or consequential damages
(including lost profits) ("Damages") incurred thereby or
caused thereto arising out of or relating to (i) any 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
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indemnity hereunder by either SB 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.
(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 XXXXXXX
BIOLOGICALS
MANUFACTURING S.A.
/s/ XXXXXX XXXXXX /s/ JEAN STEPHENNE
----------------- ------------------
Xxxxxx Xxxxxx Jean Stephenne
President and CEO Senior Vice President and
General Manager
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EXHIBIT A TO PROSTATE CANCER COLLABORATION AND LICENSE AGREEMENT
CORIXA ANTIGENS
The antigens disclosed in the following patent applications:
PATENT NO./APP. NO. COUNTRY FILING/ISSUE DATE
App. No. [***] [***] Filed [***]
PCT/US[***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
To be filed [***]
_____________________
[***]
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28
EXHIBIT B TO PROSTATE CANCER COLLABORATION AND LICENSE AGREEMENT
CORIXA PATENTS
PATENT NO./APP. NO. COUNTRY FILING/ISSUE DATE
App. No. [***] [***] Filed [***]
PCT/US [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
To be filed(10) [***]
The following patents, patent applications, invention disclosures, patent
applications thereon and patents issuing on any of the foregoing, including all
continuations, continuations-in-part, divisionals, additions, substitutions,
reissues, renewals and extensions of any of the foregoing, and including all
foreign counterparts of any of the foregoing, are by this listing below
excluded from Corixa Patents:
PATENT NO./APP. NO. COUNTRY FILING/ISSUE DATE
[***]
App. No. [***] Filed [***]
[***] Not yet filed
[***]
Xxx. No. [***] [***] Issued [***]
App. No. [***] [***] Filed [***]
[***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
[***]
Ser. No. [***] [***] Filed [***]
[***]
App. No. [***] [***] Filed [***]
____________________
[***]
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29
PATENT NO./APP. NO. COUNTRY FILING/ISSUE DATE
[***]
App. No. [***] [***] Filed [***]
[***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
App. No. [***] [***] Filed [***]
Invention Disclosure(11) Not yet filed
Invention Disclosure(12) Not yet filed
____________________
[***]
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EXHIBIT C
PROSTATE CANCER ANTIGEN DISCOVERY
Milestone:
[***]
-30-
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EXHIBIT D
SECTION I: WORKPLAN -- PROSTATE CANCER VACCINE ANTIGEN DISCOVERY
[***]
-31-
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EXHIBIT D: SECTION I (CON'T):
[***]
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EXHIBIT D: SECTION I (CON'T):
[***]
-33-
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[***]
-34-
35
[***]
-35-
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[***]
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EXHIBIT D
SECTION III: STREAMLINED WORKPLAN -- PROSTATE CANCER ANTIGEN DISCOVERY
[***]
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EXHIBIT D: SECTION III (CON'T):
[***]
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