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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): October 28, 1998
CORIXA CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
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DELAWARE 0-22891 91-1654387
(State or Other Jurisdiction of (Commission (I.R.S. Employer
Incorporation or Organization) File Number) Identification Number)
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1124 COLUMBIA STREET, SUITE 200
SEATTLE, WA 98104
(206) 754-5711
(Address, Including Zip Code, and Telephone Number, Including Area Code,
of Registrant's Principal Executive Offices)
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This Current Report on Form 8-K is filed by Corixa Corporation, a Delaware
corporation (the "Company"), in connection with the matters described herein.
Item 5. Other Events
On October 28, 1998, the Company entered into a collaboration and license
agreement with SmithKline Beecham, which superseded and significantly expanded
the scope of Company's then-existing agreements with SB Manufacturing and SB
Biologicals. The Company granted SmithKline Beecham an exclusive worldwide
license to develop, manufacture and sell vaccine products and certain dendritic
cell therapy products that incorporate antigens discovered or in-licensed under
this corporate partnership; provided that with respect to tuberculosis, such
rights are co-exclusive with Corixa in Japan. Under the collaboration and
license agreement, SmithKline Beecham agreed to provide payment for work that is
performed under the Company's existing antigen discovery programs in
tuberculous, breast cancer and prostate cancer. In addition, SmithKline Beecham
agreed to provide payment for work that is performed in additional programs in
the following areas: (i) ovarian and colon carcinoma vaccine discovery and
development programs and (ii) vaccine discovery programs for two chronic
infectious pathogens, Chlamydia trachomatis, which causes sexually transmitted
diseases, and Chlamydia pneumoniae, which is associated with the development of
atherosclerosis. The discovery phase of the agreement also allows for the
selection of one additional disease field to be agreed upon at a future date.
The Company also granted SmithKline Beecham an exclusive worldwide license to
develop, manufacture and sell vaccine products resulting from the Company's
clinical program based on Her-2/neu for the treatment of breast and ovarian
cancer as well as the Company's preclinical program based on Mammoglobin, a
novel gene and protein associated with breast cancer. For certain of these
disease areas, the Company granted SmithKline Beecham certain license rights to
develop, manufacture and sell passive immune products such as T cell or antibody
therapeutics and therapeutic drug monitoring products.
SmithKline Beecham has committed to funding of $43.6 million for work
that is performed in such discovery programs during the next four years. The
Company and SmithKline Beecham may mutually agree to extend the research and
development programs beyond the initial four year term.
In addition, SmithKline Beecham agreed to purchase $2.5 million worth
of Corixa Common Stock at a premium to its fair market value, and Corixa has
the right to require SmithKline Beecham to purchase an additional $2.5 million
of Common Stock, at a premium in the future. The equity component combined with
the discovery program payment results in aggregate funding of $48.6 million
during the first four years of the agreement. Additionally, with respect to the
$5.0 million previously paid to the Company by SmithKline Beecham under the
prior option agreement, which covered the fields of ovarian and colon cancer,
SmithKline Beecham may elect to have Corixa repay such amount to SB on
September 1, 2003 or convert such amounts into the purchase of Corixa Common
Stock at a premium.
To the extent that certain clinical and commercial milestones in the
programs are achieved, the Company is entitled to receive payments which in the
aggregate could exceed $150 million. The individual amounts of such payments
vary depending on the milestones achieved and the types of product sold. The
Company is also entitled to receive future royalty payments on any product
sales, which royalties vary depending on the types of products sold.
The effectiveness of the agreement is subject to the expiration or early
termination of the requisite waiting period under the Hart Scott Rodino
Antitrust Improvements Act of 1976, as amended. The Company presently expects
this will occur in the fourth quarter of 1998, although there can be no
assurance that such events will occur within such time frame, or at all.
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Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(a) Exhibits.
10.1 Multi-Field Vaccine Discovery Collaboration and License Agreement
between Corixa Corporation and SmithKline Beecham, dated
September 1, 1998
99.1 Press Release, dated October 28, 1998
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: November 9, 1998
CORIXA CORPORATION
By: /s/ Michelle Burris
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Michelle Burris
Vice President and
Chief Financial Officer
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EXHIBIT INDEX
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Exhibit
No. Description Page
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10.1 Multi-Field Vaccine Discovery Collaboration and License Agreement between Corixa Corporation and
SmithKline Beecham, dated September 1, 1998
99.1 Press Release, dated October 28, 1998
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MULTI-FIELD VACCINE DISCOVERY
COLLABORATION AND LICENSE AGREEMENT
BETWEEN
CORIXA CORPORATION
AND
SMITHKLINE BEECHAM PLC
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TABLE OF CONTENTS
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1. DEFINITIONS........................................................................2
2. SCOPE OF R&D PROGRAM..............................................................17
3. R&D PROGRAM TERM AND TERMINATION..................................................19
4. COMMITTEES........................................................................21
(a) COLLABORATION STEERING COMMITTEE.........................................21
(b) R&D STEERING COMMITTEE...................................................23
5. LICENSE GRANTS AND OTHER GRANTS...................................................25
(a) ACTIVE IMMUNE RESPONSE PRODUCTS..........................................25
(b) PASSIVE IMMUNE THERAPY TRANSFER PRODUCTS.................................27
(c) [***]....................................................................32
(d) DIAGNOSTICS..............................................................32
(e) CORIXA PRE-CLINICAL AND CLINICAL DEVELOPMENT; ABILITY OF CORIXA TO
REQUEST ADDITIONAL RIGHTS; ABILITY OF SB TO REQUEST ADDITIONAL FORMATS...34
(f) ADDITIONAL TECHNOLOGY....................................................35
(g) CERTAIN RIGHTS OF FIRST REFUSAL; DETERMINATION OF OPEN FIELD.............37
(h) MAINTENANCE OF SB'S EXCLUSIVE RIGHTS; REVERSION OF CO-EXCLUSIVE RIGHTS
TO CORIXA................................................................41
6. PAYMENTS..........................................................................43
(a) UP-FRONT PAYMENTS........................................................43
(b) EQUITY...................................................................43
(c) TECHNOLOGY ACCESS FEES...................................................45
(d) [***]....................................................................45
(e) OTHER MILESTONES.........................................................46
(f) ADDITIONAL COSTS RELATING TO CLINICAL MATTERS............................49
7. ROYALTIES; SHARING OF PROCEEDS....................................................49
(a) VACCINE PRODUCT AND NEW DC THERAPY PRODUCT ROYALTIES FOR THE BC FIELD,
CP FIELD, OC FIELD AND CC FIELD..........................................49
(b) VACCINE PRODUCT AND NEW DC THERAPY PRODUCT ROYALTIES FOR THE TB FIELD,
CP FIELD AND CT FIELD....................................................51
(c) ROYALTIES FOR ACTIVE IMMUNE RESPONSE PRODUCTS INCORPORATING HER2/NEU
ANTIGEN(S) AND/OR MAMMAGLOBIN ANTIGEN(S).................................53
(d) ROYALTIES FOR EXISTING DC THERAPY PRODUCTS...............................56
(e) ROYALTIES FOR TDM PRODUCTS...............................................57
(f) ROYALTIES ON PRODUCTS COVERED BY SB PATENTS..............................58
(g) ROYALTIES FOR NEW T CELL-BASED PASSIVE IMMUNOTHERAPY PRODUCTS............58
(h) SHARING OF PROCEEDS......................................................59
(i) ROYALTY REPORTING AND OTHER ASPECTS......................................62
8. MANUFACTURING; SUPPLY.............................................................63
9. INVENTIONS........................................................................64
10. PATENTS; PROSECUTION AND LITIGATION..............................................65
11. CONFIDENTIALITY; PUBLICITY; PUBLICATIONS.........................................68
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12. GOVERNING LAW; ARBITRATION.......................................................70
13. MISCELLANEOUS....................................................................70
(a) TRADEMARKS...............................................................70
(b) FORCE MAJEURE............................................................70
(c) SEVERABILITY.............................................................71
(d) ENTIRE AGREEMENT.........................................................71
14. NOTICES..........................................................................71
15. ASSIGNMENT.......................................................................73
16. WARRANTIES AND REPRESENTATIONS...................................................73
17. TERM AND TERMINATION.............................................................74
18. RIGHTS AND DUTIES UPON TERMINATION...............................................77
19. INDEMNIFICATION..................................................................77
20. GOVERNMENTAL CONSENTS............................................................78
(a) HSR......................................................................78
(b) CLOSING CONDITION........................................................79
(c) TERMINATION..............................................................79
(d) EUROPEAN COMMISSION......................................................79
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LIST OF EXHIBITS
1(rr) Excluded Antibody(ies) (Identified Putative Therapeutic Cancer
Antibodies and Existing Obligations)
1(uu) Existing Corixa Antigens
1(vv) Existing Corixa Patents
1(aaa) Existing R&D Program Antigens
1(jjj) Her2/neu Antigens
1(dddd) Mammaglobin Antigens
1(bbbbb) R&D Programs
2(d) [***]
4(a)(i) Collaboration Steering Committee Members
4(b)(i) R&D Steering Committee Members
5(a)(v) T Cell and DC Technology Licensing Discussions
5(d)(i)-1 Committed or Partnered Diagnostics Technology (By Field)
5(d)(i)-2(A) Antigens Characterized For Diagnostic Use
5(d)(i)-2(B) Antigens to be Validated As Characterized For Diagnostic Use
6(b) Form of Stock Purchase Agreement
6(e) Milestone Payments
6(e)(i) Creditability of Milestones
6(f) Additional Costs Relating to Clinical Matters
7(a) Cancer Royalties
7(b) Infectious Disease Royalties
7(c) Her2/Neu and Mammaglobin Royalties
7(d) Existing DC Therapy Royalties
7(e)(i) Existing Corixa Royalty Obligations for Her2/neu and Mammaglobin
16(e) Corixa Third Party Agreements
17(d) Minimum Diligence Countries
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MULTI-FIELD VACCINE DISCOVERY
COLLABORATION AND LICENSE AGREEMENT
This MULTI-FIELD VACCINE DISCOVERY COLLABORATION AND LICENSE AGREEMENT
(together, with the Exhibits, hereto, the "Agreement") is entered into the first
day of September, 1998 (the "Effective Date") by and between Corixa Corporation,
a Delaware corporation with its principal place of business located at 1124
Columbia Street, Suite 200, Seattle, Washington 98104 ("Corixa") and SmithKline
Beecham plc, a company established in the United Kingdom with its registered
office at New Horizons Court, Brentford, Middlesex TW8 9EP, United Kingdom.
W I T N E S S E T H:
WHEREAS, (i) Corixa and SmithKline Beecham plc are parties to that
certain NonDisclosure Agreement dated January 6, 1995 (the "First NonDisclosure
Agreement"), (ii) Corixa and SmithKline Beecham Biologicals S.A. (an Affiliate
of SB) ("SB Bio") are parties to that certain Tuberculosis Collaboration and
License Agreement dated October 6, 1995 (the "Tb Agreement") and that certain
NonDisclosure Agreement dated August 10, 1995 (the "Second NonDisclosure
Agreement") and all applicable amendments to and extensions of the Tb Agreement,
and (iii) Corixa and SmithKline Beecham Biologicals Manufacturing S.A. ("SB Bio
Manufacturing") (an Affiliate of SB) are parties to that certain Option
Agreement dated as of March 1, 1997 (the "Option Agreement"), that certain
Breast Cancer Collaboration and License Agreement dated March 1, 1997 (the "BC
Agreement"), that certain Prostate Cancer Collaboration and License Agreement
dated March 1, 1997 (the "PC Agreement") and that certain Special Biologicals
Material Transfer Agreement dated March 1, 1997, and all applicable amendments
to and extensions of the foregoing documents;
WHEREAS, Corixa, SmithKline Beecham plc, SB Bio and SB Bio Manufacturing
each desire to continue and expand upon the collaborative relationship between
such parties on modified and more mutually favorable terms and conditions with a
view to extend the scope to the Fields set forth herein and to provide SB the
rights in the areas of Active Immune Response Induction, Passive Immune Transfer
and Diagnostics set forth herein, and in connection therewith, (i) Corixa and SB
Bio each desire to terminate the Tb Agreement in its entirety and accept the
rights and obligations pursuant to this Agreement in lieu of the rights and
obligations created under the Tb Agreement, (ii) Corixa and SB Bio Manufacturing
each desire to terminate the Option Agreement, the BC Agreement and the PC
Agreement in their entirety and accept the rights and obligations created
pursuant to this Agreement in lieu of the rights and obligations created under
the Option Agreement, the BC Agreement and the PC Agreement, and (iii) Corixa
and SB Bio Manufacturing each desire to terminate the Special Biologicals
Material Transfer Agreement dated March 1, 1997 in its entirety and accept the
rights and obligations created under that certain Amended and Restated Special
Biologicals Material Transfer Agreement between Corixa and SB Bio Manufacturing
dated October 28, 1998; and
WHEREAS, Corixa and SmithKline Beecham plc each desire that the First
NonDisclosure Agreement continue in full force and effect pursuant to the terms
thereof,
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and Corixa and SB Bio each desire that the Second NonDisclosure Agreement
continue in full force and effect pursuant to the terms thereof.
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) "6 Month Grace Period" shall have the meaning set forth in
Section 5(d)(iii).
(b) "18 Month Grace Period" shall have the meaning set forth in
Section 5(d)(ii).
(c) "AAA" shall have the meaning set forth in Section 12.
(d) "Active Immune Response Induction" shall mean the use of
Vaccines and/or DC Therapy [***].
(e) "Active Immune Response Products" shall mean any and all
Vaccine Products and/or DC Therapy Products, as the context requires, [***].
(f) "Additional Antigens" shall mean those Corixa Antigens and
R&D Program Antigens that are licensed by SB hereunder other than pursuant to
Section 5(f).
(g) "Additional Technology" shall have the meaning set forth in
Section 5(f)(i).
(h) "Adjuvant" shall mean a composition used [***] in conjunction
with (an) Active Immune Response Product(s) and/or (a) Passive Immune Transfer
Product(s).
(i) "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 Corixa or SB.
(j) "Antibody" shall mean [***] capable of binding to a specific
Antigen.
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(k) "Antibody-Based Passive Immunotherapy" shall mean the use of
(a) Corixa Antigen(s) and/or (an) R&D Program Antigen(s) and/or (an) Her2/neu
Antigen(s) and/or (a) Mammaglobin Antigen(s) as targets [***]
(l) "Antibody-Based Passive Immunotherapy Product(s)" shall mean
any product used for the purpose of Antibody-Based Passive Immunotherapy.
(m) "Antigen Tail Period" shall have the meaning set forth in
Subsection 5(g)(i).
(n) "Antigens" shall mean (i) antigens and/or (ii) proteins
and/or (iii) other physical forms based on such antigens, [***].
(o) "Available Antibody(ies)" shall mean [***].
(p) "BC Field" shall mean breast cancer in humans.
(q) "BLA" shall mean a Biologicals Label Application, as such
term is defined by the FDA, and any equivalent filing in a foreign jurisdiction.
(r) "Blocking Patents" shall mean [***].
(s) "Cancer Field" shall mean any and all forms of cancer in
humans.
(t) "Cancer Know-How Royalty" shall have the meaning set forth in
Subsection 7(a)(ii).
(u) "Cancer Patent Royalty" shall have the meaning set forth in
Subsection 7(a)(i).
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(v) "CC Field" shall mean colorectal cancer in humans.
(w) "Clinical Development" shall mean the clinical development of
a Product starting for the purpose of this Agreement from the time SB or Corixa,
as the context requires, files an IND.
(x) "Clinical R&D" shall mean the clinical development of a
Viable Clinical Development Candidate [***].
(y) "COLA" shall have the meaning set forth in Section 3(b).
(z) "Collaboration Steering Committee" shall have the meaning set
forth in Section 4(a)(i).
(aa) "Competitive DC Therapy/Her2/neu Product" shall mean, solely
with respect to the Her2/neu-Mammaglobin Field, (i) a product for use in DC
Therapy that would otherwise infringe Existing Corixa Patents or Joint R&D
Program Patents in the Her2/neu-Mammaglobin Field, or (ii) [***].
(bb) "Competitive Existing DC Therapy Product" shall mean, solely
with respect to products incorporating Existing Corixa Antigens and/or Existing
R&D Program Antigens developed solely pursuant to the Existing R&D Programs, (i)
a product for use in DC Therapy that would otherwise infringe Existing Corixa
Patents, or (ii) any other product for use in DC Therapy comprised of at least
one (1) or more Existing Corixa Antigen(s) and/or Existing R&D Program
Antigen(s), [***].
(cc) "Competitive Her2/neu Product" shall mean (i) a Vaccine
product that incorporates only Her2/neu Antigen(s), which Vaccine product would
otherwise infringe Existing Corixa Patents, or [***].
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(dd) "Competitive Product" shall mean a Product that would
otherwise infringe Corixa Patents or Joint R&D Program Patents, excluding,
however, Competitive DC Therapy/Her2/neu Products, Competitive Existing DC
Therapy Products and Competitive Her2/neu Products.
(ee) "Corixa" shall mean Corixa Corporation and its Affiliates.
(ff) "Corixa Antigens" shall mean Existing Corixa Antigens and
New Corixa Antigens. As used herein, Corixa Antigens shall not include R&D
Program Antigens or SB Antigens.
(gg) "Corixa Call Date" shall have the meaning set forth in
Subsection 6(b)(i)(B).
(hh) "Corixa Patents" shall mean Existing Corixa Patents and New
Corixa Patents.
(ii) "Corixa Third Party Agreements" shall have the meaning set
forth in Section 16(e).
(jj) "CP Field" shall mean infection by Chlamydia pneumoniae in
humans.
(kk) "CT Field" shall mean infection by Chlamydia trachomatis in
humans.
(ll) "Damages" shall have the meaning set forth in Section 19(a).
(mm) "DC Therapy" shall mean [***].
(nn) "DC Therapy Product(s)" shall mean any Existing DC Therapy
Product(s) and/or New DC Therapy Product(s).
(oo) "Diagnostic(s)" shall mean [***].
(pp) "Dissemination" shall have the meaning set forth in Section
11(g).
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(qq) "Effective Date" shall have the meaning set forth in the
first paragraph of this Agreement.
(rr) "Excluded Antibody(ies)" shall mean any and all
Antibody(ies) capable of binding to a specific Existing Corixa Antigen and/or a
specific Existing R&D Program Antigen and/or an Her2/neu Antigen and/or a
Mammaglobin Antigen, which Antigen (each of which is identified on Exhibit 1(rr)
attached hereto, [***].
(ss) "Exclusive TDM Format" shall mean a Format for use in TDM
chosen by SB for the exclusive use of SB and/or SB's Affiliates and/or SB's
sublicensee(s) through written notification by SB to Corixa as provided in
Section 5(d).
(tt) "Execution Date" shall mean the date that the last party
executes this Agreement, as set forth on the signature page hereto.
(uu) "Existing Corixa Antigens" shall mean those Antigens
discovered by Corixa in the BC Field, PC Field or Tb Field prior to the
Effective Date [***].
(vv) "Existing Corixa Patents" shall mean (A) all patents and
patent applications that are identified on Exhibits 1(vv), 1(jjj) and 1(dddd)
attached hereto and [***].
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(ww) "Existing DC Therapy Know-How Royalty" shall have the
meaning set forth in Subsection 7(d)(ii).
(xx) "Existing DC Therapy Patent Royalty" shall have the meaning
set forth in Subsection 7(d)(i).
(yy) "Existing DC Therapy Product" shall mean a Product that is
used for DC Therapy and is comprised of at least one (1) Existing Corixa
Antigen(s) and/or Existing R&D Program Antigen(s) and/or Her2/neu Antigen(s)
and/or Mammaglobin Antigen(s).
(zz) "Existing Microsphere Licenses" shall have the meaning set
forth in Section 7(c)(vii)(A).
(aaa) "Existing R&D Program Antigens" shall mean Antigens that
were jointly discovered by Corixa and SB prior to the Effective Date [***] as
such Existing R&D Program Antigens are identified on Exhibit 1(aaa) attached
hereto.
(bbb) "Existing R&D Programs" shall mean the research programs as
set forth in the Tb Agreement, PC Agreement and BC Agreement prior to the
Effective Date.
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(ccc) "Existing T Cell-Based Passive Immunotherapy" shall mean
[***].
(ddd) "Existing T Cell-Based Passive Immunotherapy Product" shall
mean any product used for the purpose of Existing T Cell-Based Passive
Immunotherapy.
(eee) "FDA" means the United States Food and Drug Administration
(or its foreign equivalent).
(fff) "Field(s)" shall mean the Tb Field, the BC Field, the PC
Field, the Her2/neu-Mammaglobin Field, the OC Field, the CC Field, the CT Field,
the CP Field and the Open Field, either on an individual basis or in the
aggregate, as the context requires.
(ggg) "First Tranche" shall have the meaning set forth in Section
6(b)(i)(A).
(hhh) "Format" shall mean [***].
(iii) "FTE" shall mean [***].
(jjj) "Her2/neu Antigen(s)" shall mean those Antigens that are
covered by the Corixa Patents identified on Exhibit 1(jjj) attached hereto[***].
(kkk) "Her2/neu DC Therapy Know-How Royalty" shall have the
meaning set forth in Subsection 7(c)(iv).
(lll) "Her2/neu DC Therapy Patent Royalty" shall have the meaning
set forth in Subsection 7(c)(ii).
(mmm) "Her2/neu-Mammaglobin Field" shall mean the use of Products
that contain one (1) or more Her2/neu Antigens and/or Mammaglobin Antigens.
(nnn) "Her2/neu Patient Eligibility Profile" shall have the
meaning set forth in Subsection 6(e)(v).
(ooo) "Her2 Terms" shall have the meaning set forth in Section
5(g)(ii)(B).
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(ppp) "Her2/neu Vaccine Know-How Royalty" shall have the meaning
set forth in Subsection 7(c)(iii).
(qqq) "Her2/neu Vaccine Patent Royalty" shall have the meaning
set forth in Subsection 7(c)(i).
(rrr) "HSR" shall have the meaning set forth in Section 20(a).
(sss) "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.
(ttt) "IND" shall mean an Investigational New Drug application,
as defined by the FDA, and any equivalent filing in a foreign jurisdiction.
(uuu) "Indemnified Party" shall have the meaning set forth in
Section 19(b).
(vvv) "Indemnifying Party" shall have the meaning set forth in
Section 19(b).
(www) "Infectious Disease Know-How Royalty" shall have the
meaning set forth in Subsection 7(b)(ii).
(xxx) "Infectious Disease Patent Royalty" shall have the meaning
set forth in Subsection 7(b)(i).
(yyy) "Intended Clinical Delay" with respect to a particular
Field shall mean [***].
(zzz) "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
"Sections," "Subsections" and other subdivisions and to "Exhibits" without
reference to a document are to designated Sections, Subsections and other
subdivisions of, and to Exhibits to, this Agreement; (c) unless otherwise set
forth herein, the use of the term "including" means "including but not limited
to"; and (d) the words "herein," "hereof," "hereunder" and other words of
similar import refer to this Agreement as a whole and not to any particular
provision.
(aaaa) "Joint Inventions" shall have the meaning set forth in
Section 9.
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(bbbb) "Joint R&D Program Patents" shall mean all patents and
patent applications which cover Joint Inventions [***].
(cccc) "Know-How" shall mean all technical information, materials
and know-how owned and/or controlled, with the right to grant sublicenses, by
Corixa now and/or during the R&D Program Term as may be extended and, subject in
all cases to SB's exercise of the right of first refusal set forth in Section
5(g)(i) below, during a period of two (2) years thereafter, which directly
relates to Product [***].
(dddd) "Mammaglobin Antigens" shall mean those Antigens that are
covered by the Corixa Patents identified on Exhibit 1(dddd) attached hereto
and/or that are or have been in-licensed by Corixa prior to the Effective Date.
(eeee) "Mammaglobin Patient Eligibility Profile" shall have the
meaning set forth in Subsection 6(e)(v).
(ffff) "Mammaglobin Product" shall have the meaning set forth in
Section 6(e)(v).
(gggg) "Minimum Diligence Period" shall have the meaning set
forth in Section 17(d).
(hhhh) "Net Sales."
(i) For purposes of this Agreement, Net Sales shall be
defined to mean [***].
(ii) [***].
(iii) [***].
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(iiii) "New Corixa Antigens" shall mean (i) those Antigens
discovered solely by Corixa in the Field during the R&D Program Term as may be
extended, in connection with and as a result of the R&D Programs under this
Agreement and/or (ii) [***].
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(jjjj) "New Corixa Patents" shall mean all patents and patent
applications that cover patentable inventions or discoveries that arise in
connection with and as a result of any R&D Program which are made solely by
Corixa [***].
(kkkk) "New DC Therapy Product" shall mean a Product that is used
for DC Therapy and is comprised of at least one (1) New Corixa Antigen(s) and/or
New R&D Program Antigen(s).
(llll) "New Field [***] Grace Period" shall have the meaning
set forth in Section 5(d)(iv).
(mmmm) "New R&D Program Antigens" shall mean Antigens jointly
discovered by Corixa and SB in the Field during the R&D Program Term as may be
extended, in connection with and as a result of the conduct of the R&D Programs.
(nnnn) "New T Cell-Based Passive Immunotherapy" shall mean the
[***].
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(oooo) "New T Cell-Based Passive Immunotherapy Product" shall
mean any product used for the purpose of New T Cell-Based Passive Immunotherapy.
(pppp) "OC Field" shall mean ovarian cancer in humans.
(qqqq) "Open Field" shall mean any single disease field [***].
(rrrr) "Passive Immune Transfer" shall mean Antibody-Based
Passive Immunotherapy and T Cell-Based Passive Immunotherapy.
(ssss) "Passive Immune Transfer Product(s)" shall mean (i)
Antibody-Based Passive Immunotherapy Product(s) and/or (ii) T Cell-Based Passive
Immunotherapy Product(s), as the context requires.
(tttt) [***].
(uuuu) "PC Field" shall mean prostate cancer in humans.
(vvvv) "Priority Date" shall mean for the purposes of Section 7
hereof [***].
(wwww) "Product" shall mean any Active Immune Response Product,
Passive Immune Transfer Product and/or TDM Product, either on an individual
basis or in the aggregate, as the context requires.
(xxxx) "Product Information" shall have the meaning set forth in
Section 16 (c).
(yyyy) "R&D Program Antigens" shall mean the Existing R&D Program
Antigens and the New R&D Program Antigens.
(zzzz) "R&D Program Exhibit(s)" shall have the meaning set forth
in Section 2(a).
(aaaaa) "R&D Program Term" shall have the meaning set forth in
Section 3(a).
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(bbbbb) "R&D Program(s)" shall mean the programs for Antigen
discovery directed to the Tb Field, the BC Field, the PC Field, the OC Field,
the CC Field, the CT Field, the CP Field, the Her2/neu-Mammaglobin Field and the
Open Field, respectively, each as set forth in the R&D Program Exhibits.
(ccccc) "R&D Steering Committee" shall have the meaning set forth
in Section 4(b)(i).
(ddddd) "Research and Development Payments and Equity
Investments" shall mean [***].
(eeeee) "Royalty Certificate" shall have the meaning set forth in
Section 7(i)(ii).
(fffff) "Royalty Factors" shall have the meaning set forth in
Section 7(i)(ii).
(ggggg) "SB" shall mean SmithKline Beecham plc and its
Affiliates.
(hhhhh) "SB Bio" shall mean SmithKline Beecham Biologicals S.A.
(iiiii) "SB Bio Manufacturing" shall mean SmithKline Beecham
Biologicals Manufacturing S.A.
(jjjjj) "SB Adjuvants" shall mean [***].
(kkkkk) "SB Antigens" shall mean Antigens discovered and/or
in-licensed by SB other than from Corixa pursuant to this Agreement (whether
before, on or after the Effective Date) that are determined by SB using
commercially reasonable judgment to enhance the performance of a particular
Product.
(lllll) "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 [***].
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(mmmmm) "Second Tranche" shall have the meaning set forth in
Subsection 6(b)(i)(B).
(nnnnn) "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 the Know-How 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 Corixa's business.
(ooooo) "SPC" shall mean all Supplementary Protection
Certificates for medicinal products and their equivalents provided under the
Council Regulation (EEC) N# 1768/92 of June 18, 1992 or any other equivalent
foreign legislation.
(ppppp) "Stock Purchase Agreement" shall have the meaning set
forth in Subsection 6(b)(i).
(qqqqq) "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.
(rrrrr) "T Cell-Based Passive Immunotherapy" shall mean the
[***].
(sssss) "T Cell-Based Passive Immunotherapy Product(s)" shall
mean New T Cell-Based Passive Immunotherapy Product(s) and/or Existing T
Cell-Based Passive Immunotherapy Product(s).
(ttttt) "Tb Field" shall mean infection by Mycobacterium
tuberculosis in humans.
(uuuuu) "TDM Net Sales."
(i) For purposes of this Agreement, TDM Net Sales shall be
defined to mean [***].
(ii) [***].
(iii) [***].
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(vvvvv) "TDM Product" shall mean a Diagnostic product comprised
of at least one (1) or more Corixa Antigen(s) and/or R&D Program Antigen(s)
and/or Her2/neu Antigen(s) and/or Mammaglobin Antigen(s) for use in TDM. In
addition to Corixa Antigen(s) and/or R&D Program Antigen(s) and/or Her2/neu
Antigen(s) and/or Mammaglobin Antigen(s), a TDM Product may also include SB
Antigen(s).
(wwwww) "Territory" shall mean all the countries of the world.
(xxxxx) "Therapeutic Drug Monitoring" (or "TDM") shall mean
[***].
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(yyyyy) "Two Major Countries" shall have the meaning set forth in
Exhibit 6(e), Section 1(v).
(zzzzz) "UW Agreement" shall have the meaning set forth in
Section 7(c)(vii).
(aaaaaa) "Third Party(ies)" shall mean any party other than
Corixa or SB or an Affiliate.
(bbbbbb) "Vaccine Product" shall mean any product for Vaccine use
that is comprised of at least one (1) or more Corixa Antigen(s) and/or R&D
Program Antigen(s) and/or Her2/neu Antigen(s) and/or Mammaglobin Antigen(s). In
addition to Corixa Antigen(s) and/or R&D Program Antigen(s) and/or Her2/neu
Antigen(s) and/or Mammaglobin Antigen(s), Vaccine Product may also include SB
Antigen(s).
(cccccc) "Vaccine(s)" shall mean [***].
(dddddd) "Viable Clinical Development Candidate" means any Active
Immune Response Product or Passive Immune Transfer Product that [***].
2. SCOPE OF R&D PROGRAM.
(a) During the R&D Program Term, as may be extended, the parties
shall collaborate in [***].
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(b) [***].
(c) [***].
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(d) [***]
3. R&D PROGRAM TERM AND TERMINATION.
(a) The initial R&D Program term shall be effective from
September 1, 1998 to August 31, 2002 (the "R&D Program Term") and shall be
renewable for additional two (2) year periods [***].
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(b) [***].
(c) [***].
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(d) [***]
(e) [***]
4. COMMITTEES.
(a) Collaboration Steering Committee.
(i) Creation of Collaboration Steering Committee. The
parties hereby create a Collaboration Steering Committee (the "Collaboration
Steering Committee") which shall consist of [***]. If any member of the
Collaboration Steering Committee dies, resigns, or becomes incapacitated, the
party which designated such member shall designate his or her successor (whose
term shall commence immediately), and any party may withdraw the designation of
any of its members of the Collaboration Steering Committee and designate a
replacement (whose term shall commence immediately) at any time by giving notice
of the withdrawal and replacement to
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the other party. A party's successor or replacement member of the Collaboration
Steering Committee shall be subject to the other party's consent, which shall
not be unreasonably withheld. The members of the Collaboration Steering
Committee as of the Execution Date are set forth on Exhibit 4(a)(i) hereto.
[***].
(ii) Meetings of the Collaboration Steering Committee.
Regular meetings of the Collaboration Steering Committee shall be held [***] or
at such other dates as the parties may deem appropriate or as may be required in
accordance with actions and/or decisions required to be taken pursuant to the
provisions of this Agreement, at such times and places (or telephonically) as
the members of the Collaboration Steering Committee shall agree from time to
time. Special meetings of the Collaboration Steering Committee may be called by
either party on fifteen (15) days' written notice to the other party unless
notice is waived by the parties. All nontelephonic meetings shall alternate
between the offices of Corixa and SB unless the parties otherwise agree. In the
event a Collaboration Steering Committee member is unable to attend a meeting of
the Collaboration Steering Committee, such Collaboration Steering Committee
member shall designate an alternate member reasonably acceptable to the other
members who shall serve solely for that Collaboration Steering Committee
meeting.
(iii) Decisions of the Collaboration Steering Committee.
Unless otherwise specifically designated as a responsibility of the R&D Steering
Committee pursuant to Section 4(b), all decisions regarding [***] shall be made
by the Collaboration Steering Committee acting in accordance with this Agreement
or by agents duly authorized in writing by the Collaboration Steering Committee
provided a quorum shall be present at the meeting of the Collaborative Steering
Committee. Each party is responsible for ensuring that at least two (2) of such
party's three (3) representative members (or their permitted designees) are
present at each meeting of the Collaboration Steering Committee in person or by
telephone. A quorum of the Collaboration Steering Committee shall be present at
any meeting of the Collaboration Steering Committee if [***] on behalf of
Corixa, and [***] on behalf of SB (or other representative(s) on behalf of
either party as provided for hereunder) are present at such meeting in person or
by telephone. If a quorum exists at any meeting, decision shall be taken by
[***].
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Unless otherwise specifically stated to the contrary herein, no individual
party shall purport to act on behalf of the other party unless and then only
to the extent authorized in writing to do so by the Collaboration Steering
Committee.
(iv) Responsibility of Collaboration Steering Committee.
The Collaboration Steering Committee, in accordance with the terms of Subsection
4(a)(iii) above, shall be responsible for [***].
(v) Collaboration Steering Committee Reports. Within ten
(10) days following each meeting of the Collaboration Steering Committee held
pursuant to Subsection 4(a)(ii), the secretary of the Collaboration Steering
Committee shall prepare and send to the members of the Collaboration Steering
Committee a detailed written report of actions and decisions taken at the
meeting in such form and containing such detail as shall be determined by the
Collaboration Steering Committee.
(b) R&D Steering Committee.
(i) An R&D Steering Committee shall be established, at the
latest, within thirty (30) days after the Execution Date (the "R&D Steering
Committee"). The R&D Steering Committee shall be responsible for [***].
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The R&D Steering Committee shall consist of two (2) subcommittees, one related
to the infectious disease R&D Programs and one related to the cancer R&D
Programs. Each subcommittee shall consist of [***] from SB Bio and [***] from
Corixa; provided, however, that each party shall have the right to have up to
[***] of the members serving on one of the foregoing subcommittees also be such
party's members of the other subcommittee, and each such subcommittee shall be
chaired by an individual from SB Bio. If any member of the R&D Steering
Committee dies, resigns, or becomes incapacitated, the party which designated
such member shall designate his or her successor (whose term shall commence
immediately), and any party may withdraw the designation of any of its members
of the R&D Steering Committee and designate a replacement (whose term shall
commence immediately) at any time by giving notice of the withdrawal and
replacement to the other party. A party's successor or replacement member of the
R&D Steering Committee shall be subject to the other party's consent, which
shall not be unreasonably withheld. The members of the R&D Steering Committee as
of the Execution Date are set forth on Exhibit 4(b)(i) hereto. [***].
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(ii) To facilitate coordination, (A) the parties shall
[***] meetings of the R&D Steering Committee to be held alternatively at
Seattle, Washington USA and Rixensart, Belgium. Corixa shall provide SB with
[***]. The data generated shall be subject to the confidentiality provisions of
Section 11 of this Agreement. In addition, SB shall provide, [***]. The
subcommittees of the R&D Steering Committee shall review each applicable R&D
Program in the Field annually, implement any mutually agreeable modifications
and make recommendations related to possible R&D Program extensions to the
respective senior management teams of each party. [***].
5. LICENSE GRANTS AND OTHER GRANTS.
(a) Active Immune Response Products.
(i) Subject to the terms and conditions of this Agreement,
including, without limitation, the payments and royalty provisions set forth in
Sections 6 and 7 hereof, Corixa hereby grants to SB an exclusive license, with
the right to grant sublicenses, under Corixa Patents, Joint R&D Program Patents,
Know-How and any SPC,
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to [***] any and all Active Immune Response Products [***] the BC Field, the PC
Field, the Her2/neu-Mammaglobin Field, the OC Field and the CC Field in the
Territory, [***]. For the avoidance of doubt, the foregoing license is subject
to modification or termination in accordance with Sections 3(c), 3(d), 5(h),
17(c), 17(d) and 17(h) of this Agreement.
(ii) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB an exclusive
license, with the right to grant sublicenses, under Corixa Patents, Joint R&D
Program Patents, Know-How and any SPC, [***] and any and all Active Immune
Response Products [***] the CP Field and the CT Field in the Territory [***].
For the avoidance of doubt, the foregoing license is subject to modification or
termination in accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and
17(h) of this Agreement.
(iii) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB an exclusive
license, with the right to grant sublicenses, under Corixa Patents, Joint R&D
Program Patents, Know-How and any SPC, to [***] and any and all Active Immune
Response Products [***] the Tb Field in the Territory, excluding Japan [***].
For the avoidance of doubt, the foregoing license is subject to modification or
termination in accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and
17(h) of this Agreement.
(iv) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB a co-exclusive
license [***] with the right to sublicense [***], under Corixa Patents, Joint
R&D Program Patents, Know-How and any SPC, to [***] any and all Active Immune
Response Products [***] the Tb Field in Japan, [***]. For the avoidance of
doubt, the foregoing license is subject to modification or termination in
accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and 17(h) of this
Agreement.
(v) Notwithstanding the terms and conditions of
Subsections 5(a)(i)-(iii) above, SB's license to Existing DC Therapy Products
shall be co-exclusive
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[***] with the right to sublicense [***], only with respect to [***].
(b) Passive Immune Therapy Transfer Products.
(i) T Cell-Based Passive Immunotherapy Products.
(A) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB a co-exclusive
license [***] with the right to sublicense [***], under Existing Corixa Patents,
Joint R&D Program Patents, Know-How and any SPC, [***] in the Territory any and
all Existing T Cell-Based Passive Immunotherapy Products for which, as of the
Execution Date, Corixa has [***] and an exclusive license, with the right to
grant sublicenses, under Existing Corixa Patents, Joint R&D Program Patents,
Know-How and any SPC, [***] in the Territory any and all other Existing T
Cell-Based Passive Immunotherapy Products [***] the BC Field, the PC Field, and
the Her2/neu Mammaglobin Field [***]. For the avoidance of doubt, the foregoing
licenses are subject to modification or termination in accordance with Sections
3(c), 3(d), 5(g)(ii), 5(h), 17(c), 17(d) and 17(h) of this Agreement.
(B) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB a co-exclusive
license [***] with the right to sublicense to [***] under Existing Corixa
Patents, Joint R&D Program Patents, Know-How and any SPC, [***] in the Tb Field
in the Territory any and all Existing T Cell-Based Passive Immunotherapy
Products for which, as of the Execution Date, Corixa has [***], and an
exclusive license, with the right to grant sublicenses, under Existing Corixa
Patents, Joint R&D Program Patents, Know How and any SPC, [***] in the Tb Field
in the Territory any and all other Existing T Cell-Based Passive Immunotherapy
Products [***] to the Tb Field [***]. For the avoidance of doubt, the foregoing
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licenses are subject to modification or termination in accordance with Sections
3(c), 3(d), 5(g)(ii), 5(h), 17(c), 17(d) and 17(h) of this Agreement.
(C) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB an exclusive
license, with the right to grant sublicenses, under Corixa Patents, Joint R&D
Program Patents, Know-How and any SPC, [***] any and all New T Cell-Based
Passive Immunotherapy Products [***] the BC Field, the PC Field, the CC Field
and the OC Field in the Territory, [***]. For the avoidance of doubt, the
foregoing license is subject to modification or termination in accordance with
Sections 3(c), 3(d), 5(h), 17(c), 17(d) and 17(h) of this Agreement.
(D) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB an exclusive
license, with the right to grant sublicenses, under Corixa Patents, Joint R&D
Program Patents, Know-How and any SPC, [***] any and all New T Cell-Based
Passive Immunotherapy Products [***] the CT Field and the CP Field in the
Territory,[***]. For the avoidance of doubt, the foregoing license is subject to
modification or termination in accordance with Sections 3(c), 3(d), 5(h), 17(c),
17(d) and 17(h) of this Agreement.
(E) Subject to the terms and conditions of this
Agreement, including, without limitation, the payments and royalty provisions
set forth in Sections 6 and 7 hereof, Corixa hereby grants to SB an exclusive
license, with the right to grant sublicenses, under Corixa Patents, Joint R&D
Program Patents, Know-How and any SPC, [***] any and all New T Cell-Based
Passive Immunotherapy Products [***] the Tb Field in the Territory, [***]. For
the avoidance of doubt, the foregoing license is subject to modification or
termination in accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and 17(h)
of this Agreement.
(ii) Antibody-Based Passive Immunotherapy.
(A) Grant. Subject to all of the terms of this
Agreement, Corixa hereby grants to SB [***].
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(B) Notice of Antigens for Antibody Development.
[***].
(C) SB Development of Antibodies.[***].
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(D) Corixa Development of Antibodies. [***].
(E) Notice of Available Antibodies. [***].
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(F) No SB Maintenance of License in Connection with
Available Antibodies Developed without SB Funding. [***].
(G) Limitation on Corixa Development of Available
Antibodies. [***]
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(H) Unavailability of Excluded Antibodies. The
parties acknowledge and agree that certain Excluded Antibodies indicated on
Exhibit 1(rr) hereto are not currently available for license to SB because of
Corixa's pre-existing commitments to Third Parties [***]. Corixa will promptly
notify the R&D Steering Committee when any such Excluded Antibody becomes an
Available Antibody.
(c) [***]
(d) Diagnostics.
(i) [***]
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(ii) [***]
(iii) [***]
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(iv) [***]
(v) Subject to the foregoing Subsections 5(d)(i) - (iv)
and to the terms and conditions of this Agreement, including, without
limitation, the payments and royalty provisions set forth in Sections 6 and 7
hereof, Corixa hereby grants to SB an exclusive license, with the right to grant
sublicenses, under Corixa Patents, Joint R&D Patents, Know-How and any SPC,
[***] TDM Products in the applicable Exclusive TDM Formats as set forth in
Subsections 5(d)(i)-(iv) in the applicable Field in the Territory. [***]. For
the avoidance of doubt, the foregoing license is subject to modification or
termination in accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and 17(h)
of this Agreement. [***].
(e) Corixa Pre-Clinical and Clinical Development; Ability of
Corixa to Request Additional Rights; Ability of SB to Request Additional
Formats.
(i) Notwithstanding anything else set forth in this
Agreement, Corixa shall retain a right to conduct at its sole expense any and
all pre-clinical and clinical research and development activities solely for
non-commercial purposes with respect to
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any T Cell-Based Passive Immunotherapy Products in any Field that Corixa deems
appropriate and to make and/or have made any materials necessary to conduct such
activities. Any such pre-clinical or clinical efforts shall be initiated only
after Corixa informs the R&D Steering Committee of its intent to begin such
efforts. [***].
(ii) [***]
(iii) SB may from time to time during the term of this
Agreement request the right to obtain a license to additional Format(s) other
than the applicable Exclusive TDM Formats to the extent such additional
Format(s) are available on an exclusive, co-exclusive or non-exclusive basis,
and Corixa shall consider such requests in good faith, provided that Corixa
shall have no obligation to agree to any such request.
(f) Additional Technology.
(i) During the R&D Program Term, if Corixa or SB believes
that technology related to the subject matter of the R&D Program that is
controlled by a Third Party (which may include Antigens, Adjuvants, delivery
technology and/or Blocking Patents) ("Additional Technology") would be valuable
or necessary to any R&D Program in the Field hereunder, Corixa or SB, as
appropriate, shall present such Additional Technology, along with a written
report with respect thereto, to the R&D Steering Committee. [***].
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Notwithstanding the foregoing, this Subsection 5(f)(i) shall not be deemed to
preclude either party from licensing and/or acquiring Additional Technology.
(ii) Potentially useful Additional Technology and
technology that is owned and/or controlled by a Third Party shall be a regular
topic of discussion at meetings of the R&D Steering Committee.
(iii) [***].
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(g) Certain Rights of First Refusal; Determination of Open Field.
(i) After Termination of the Applicable R&D Program.
Subject to all of the terms of this Agreement, Corixa hereby grants SB a right
of first refusal, solely in connection with Active Immune Response Products and
Passive Immune Transfer Products, exercisable during the period beginning on the
date on which the R&D Program for a particular Field is terminated as a result
of the occurrence of any of the events set forth in Subsections 3(c)(i)-(iii)
above and ending [***] (for purposes of this Section 5(g)(i) the "Antigen Tail
Period"), to acquire an exclusive license to any Antigens discovered or
in-licensed by Corixa in such particular Field during such Antigen Tail Period,
if and only if SB has previously pursued, or during such Antigen Tail Period is
actively pursuing, or is in an Intended Clinical Delay regarding, Clinical R&D
or commercialization of an Active Immune Response Product or Passive Immune
Transfer Product, as the case may be, in such Field. SB's right under this
Subsection 5(g)(i) shall extend to TDM Product(s), provided TDM Product rights
are directly related to an Active Immune Response Product(s) or Passive Immune
Transfer Product(s); provided, however, that if such TDM Product is not directly
related to an Active Immune Response Product(s) or Passive Immune Transfer
Product(s), SB shall have the right under this Subsection 5(g)(i) to license
such TDM Product solely on a nonexclusive basis. From time to time during the
Antigen Tail Period as appropriate, Corixa shall give prompt notice to the R&D
Steering Committee (or to SB in case all R&D Programs have been terminated) if
it has discovered or in-licensed any such Antigen(s), which notice shall include
full disclosure of the information available to Corixa with respect to such
Antigen(s). [***].
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All Antigens licensed by SB under this Subsection 5(g)(i) shall be subject to
Section 5(h) hereof. For the avoidance of doubt, the right of first refusal set
forth in this Subsection 5(g)(i) is subject to modification or termination in
accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and 17(h) of this
Agreement.
(ii) Existing T Cell-Based Passive Immunotherapy
Product(s).
(A) Subject to all of the terms of this Agreement
as well as the availability of Existing Antigens (as listed on Exhibits 1(uu),
1(aaa), 1(jjj) and 1(dddd)), Corixa hereby grants to SB a right of first
refusal, exercisable during the R&D Program Term as may be extended, to convert
the co-exclusive licenses set forth in Section 5(b)(i) above to an exclusive
license on the following terms. [***].
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In any event, SB shall retain at least the co-exclusive license as set forth in
Subsection 5(b)(i). For the avoidance of doubt, the right of first refusal set
forth in this Subsection 5(g)(ii)(A) is subject to modification or termination
in accordance with Sections 3(c), 3(d), 5(h), 17(c), 17(d) and 17(h) of this
Agreement.
(B) With respect to any Existing T Cell-Based
Passive Immunotherapy Product not exclusively licensed to SB or a Third Party
pursuant to Subsection 5(b)(i)(A) or (B) or Subsection 5(g)(ii)(A) above, Corixa
shall have the right to proceed at any time with clinical development thereof.
In the event Corixa later determines during the term of this Agreement to
license or sublicense such Existing T Cell-Based Passive Immunotherapy Product
for which Corixa has proceeded with clinical development, SB shall have the
right of first refusal described in Subsection 5(g)(ii)(A) above, [***] In the
event SB does not elect to obtain an exclusive license pursuant to such right of
first refusal, Corixa shall then be free to license on a co-exclusive basis only
such Existing T Cell-Based Passive Immunotherapy Product to a Third Party [***].
Additionally, if SB does not exclusively license such Existing T Cell-Based
Passive Immunotherapy Product, SB shall nonetheless have access to all of
Corixa's data related thereto solely for use in SB's research, development and
commercialization activities directed to Products under this Agreement and SB
shall retain at least the co-exclusive license to any Existing T Cell-Based
Passive Immunotherapy Product as set forth in Subsection 5(b)(i). For the
avoidance of doubt, the right of first refusal set forth in this Subsection
5(g)(ii)(B) is subject to modification or termination in accordance with
Sections 3(c), 3(d), 5(h), 17(c) and 17(d) or this Agreement.
(C) For the avoidance of doubt, the provision of
Subsections 5(g)(ii)(A) and (B) above shall only apply to Existing T Cell-Based
Immunotherapy Products, and subject to Section 3(c), 3(d), 5(h), 17(c), 17(d)
and 17(h), SB shall have an exclusive license for all New T Cell-Based
Immunotherapy Products.
(iii) Diagnostic Products. Subject to all of the terms of
this Agreement, during the R&D Program Term as may be extended and any Intended
Clinical Delay, Corixa shall grant SB a right of first refusal with respect to
all Diagnostics (other than TDM Products) comprised of at least one (1) Corixa
Antigen(s) and/or R&D Program Antigen(s), excluding those Diagnostics that
Corixa has [***].
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From time to time as appropriate, Corixa shall give notice to the R&D Steering
Committee that Corixa Antigens or R&D Program Antigens are available for license
as Diagnostics (other than TDM Products), which notice shall include full
disclosure of the information available to Corixa with respect to the use of any
such Antigens as Diagnostics (other than TDM Products). [***]. If SB does not
exercise its right of first refusal or the parties have not entered into a
license agreement within the applicable ninety (90) day periods set forth above,
Corixa shall be free to out-license such Corixa Antigens or R&D Antigens for
Diagnostics, exclusively, co-exclusively or non-exclusively, outside the
Exclusive TDM Format designated by SB pursuant to Subsections 5(d)(i)-(iv) above
for a particular Antigen and/or a particular Field, as applicable, subject to
sharing of proceeds as set forth in Subsection 7(h)(ii). For the avoidance of
doubt, the right of first refusal set forth in this Subsection 5(g)(iii) is
subject to modification or termination in accordance with Sections 3(c), 3(d),
5(h), 17(c), 17(d) and 17(h) of this Agreement.
(iv) Open Field Determination. In addition to the Tb Field, the
BC Field, the PC Field, the Her2/neu-Mammaglobin Field, the OC Field, the CC,
the CT Field and the CP Field, the parties intend that the collaboration set
forth in this Agreement encompass an Open Field that is undetermined as of the
Execution Date. The parties shall jointly determine which disease field shall
constitute the Open Field to be included in the R&D Program as follows. [***].
In the event the parties are unable to agree in good faith on the specifics of
such R&D Program plan and financial terms within ninety (90) days after SB
initially proposes a given Open Field, the parties agree that such field shall
no longer be considered for collaboration between the parties pursuant to this
Agreement. In such event, SB will have the right to propose another Open Field,
which proposal shall be subject to the same procedure set forth above in this
Subsection. The parties agree that subject to Subsection 5(g)(v) below, the
financial terms relating to any agreed upon Open Field shall be equivalent to
those for the BC Field if the agreed upon Open Field is in the Cancer Field or
equivalent to the Tb Field in the event the agreed
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upon Open Field is an infectious disease except that no up-front payments shall
be due for the Open Field irrespective of whether such Field is in the Cancer
Field or an infectious disease or neither in the Cancer Field nor an infectious
disease. For a proposed Open Field outside of the Cancer Field or infectious
diseases, the parties agree to negotiate financial terms in good faith [***].
Once the parties have agreed on the designated Open Field, the basic structure
of all provisions set forth in this Agreement for other similar Fields,
including license grants as per this Section 5, rights of first refusal, payment
provisions, etc., will also apply to the Open Field. [***]. Notwithstanding the
foregoing, the parties agree that Corixa may, in its sole discretion on the
basis of scientific judgment, reject any Open Field proposed by SB. Upon mutual
determination of the Open Field, as set forth above, the parties shall amend
this Agreement to reflect such additional financial terms and licenses as
appropriate.
(v) [***].
(h) Maintenance of SB's Exclusive Rights; Reversion of
Co-Exclusive Rights to Corixa.
(i) For the avoidance of doubt, if SB or any SB
sublicensee begins Clinical R&D with a particular Active Immune Response Product
or Passive Immune Transfer Product prior to the lapse of the applicable Intended
Clinical Delay in any particular Field, subject to Corixa's right to terminate
this Agreement as provided for in Section 17 hereof, all rights and licenses
granted to SB pursuant to Section 5 with respect to that particular Field shall
be valid in accordance with the terms of this Agreement for so long as SB or its
sublicensee is engaged in Clinical R&D, further clinical
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development or the commercialization of at least one (1) Active Immune Response
Product or Passive Immune Transfer Product in that Field.
(ii) Notwithstanding the terms of other Subsections in
this Section 5(h), in the event SB begins Clinical R&D with a particular Active
Immune Response Product or Passive Immune Transfer Product prior to the lapse of
the applicable Intended Clinical Delay in any particular Field and later
terminates such Clinical R&D and at the time of such termination SB has not
begun Clinical R&D with any other Active Immune Response Product or Passive
Immune Transfer Product in such Field, then all of SB's exclusive licenses and
rights of refusal to negotiate exclusive licenses granted under Section 5 with
respect to all Active Immune Response Products and Passive Immune Transfer
Products in such Field shall become co-exclusive licenses [***], and rights of
first refusal to negotiate co-exclusive licenses, respectively, subject to the
applicable sharing of proceeds set forth in Section 7(h), effective as follows:
(A) immediately [***] or (B) after two (2) years following such termination
[***].
(iii) [***].
(iv) [***].
(v) [***].
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6. PAYMENTS.
SB shall make the following payments to Corixa under this Agreement by
wire transfer of immediately available funds, each of which shall be
non-refundable and non-creditable, except as otherwise set forth below:
(a) Up-front Payments.
(i) Up-front license fees of U.S.[***], payable as
follows: [***].
(ii) [***]
(b) Equity.
(i) SB shall purchase shares of Common Stock of Corixa,
pursuant to the terms and conditions of a Common Stock Purchase Agreement of
even
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<PAGE> 48
date herewith and all Exhibits thereto and attached hereto as Exhibit 6(b) (the
"Stock Purchase Agreement") on the following dates and in the following amounts:
(A) On the first business day following the date of
the expiration or early termination of the waiting period applicable to this
Agreement under HSR as provided in Section 20 below, the number of shares of
Common Stock of Corixa equal to (A) U.S.$2,500,000.00 divided by (B) the average
per share closing price of Corixa Common Stock on the Nasdaq National Market as
reported in the Wall Street Journal for [***], multiplied by [***] (the "First
Tranche"). The payment amount for the First Tranche shall be guaranteed and
non-refundable and shall be paid directly to Corixa.
(B) On the date designated by Corixa that is on or
after the first anniversary of the Execution Date but on or before the third
anniversary of the Execution Date (the "Corixa Call Date"), the number of shares
of Common Stock of Corixa equal to (A) U.S.$2,500,000.00 divided by (B) the
average per share closing price of Corixa Common Stock on the Nasdaq National
Market as reported in the Wall Street Journal for [***] (the "Second Tranche").
The payment amount for the Second Tranche shall be guaranteed and non-refundable
and shall be paid directly to Corixa, provided that Corixa designates a Corixa
Call Date as set forth in the Stock Purchase Agreement.
(C) The existing credit line of [***] resulting
from the Option Agreement shall be [***].
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(c) Technology Access Fees.
Technology access fees in the following amounts and on the
following schedule:
<TABLE>
<CAPTION>
----------------------------------------------------------------
PAYMENT DATE PAYMENT AMOUNT (U.S.$)
----------------------------------------------------------------
<S> <C>
January 1, 1999 [***]
----------------------------------------------------------------
January 1, 2000 [***]
----------------------------------------------------------------
January 1, 2001 [***]
----------------------------------------------------------------
January 1, 2002 [***]
----------------------------------------------------------------
</TABLE>
In the event of any extension of the R&D Program Term, the amounts set
forth in the table above shall be increased on an annual basis to reflect any
increase[***].
(d) [***]
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(e) Other Milestones.
(i) For the sake of clarity, with respect to the making of
milestone payments to Corixa by SB under this Agreement (other than payments for
[***]), the following principles shall apply:
(A) In the event SB has begun to pay the applicable
milestones in a particular Field for the development and/or commercialization of
a Vaccine Product, a DC therapy Product, a T Cell-Based Passive Immunotherapy
Product or an Antibody-Based Passive Immunotherapy Product, if SB notifies
Corixa in writing that it has terminated the development and/or
commercialization of such Product and SB begins development of or has been
developing a replacement Product for the applicable Field (which replacement
Product is one of the three other types of Product set forth above), then
milestones payments already made on the abandoned Product in the applicable
Field will not also be paid on the replacement Product in such particular Field;
(B) In the event SB is developing more than one (1)
type of Product (a Vaccine Product, a DC therapy Product, a T Cell-Based Passive
Immunotherapy Product or an Antibody-Based Passive Immunotherapy Product) in a
particular Field, and such additional Product(s) is (are) not intended by SB to
be a replacement Product in such Field, then applicable milestone payments shall
be payable for each type of Product in such particular Field. To further clarify
by way of example
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but not limitation, if SB is developing a Vaccine Product, a DC Therapy Product
and a T Cell-Based Passive Immunotherapy Product in the BC Field, then milestone
payments shall be payable on all three of such Products;
(C) In the event SB is developing more than one (1)
Product of a particular type (more than one (1) Vaccine Product or more than one
(1) DC Therapy Product or more than one (1) T Cell-Based Passive Immunotherapy
Product or more than one (1) Antibody-Based Passive Immunotherapy Product) in a
particular Field, then applicable milestone payments shall be payable on only
the first Product of such Product type that meets the applicable milestone in
the particular Field (unless such milestone is expressly applicable to a second
Product). To further clarify by way of example but not limitation, if SB is
developing two (2) Vaccine Products in the BC Field, then milestone payments
shall be payable on only the first of such Vaccine Products to meet the
applicable milestone (unless such milestone is expressly applicable to a second
Product);
(D) Milestone payments shall not be applicable to
TDM Products or Diagnostics;
(E) The milestone payments set forth in Exhibit
6(e) hereto shall be creditable as set forth in Exhibit 6(e)(i) hereto against
certain future royalties payable pursuant to Section 7; provided, however,
notwithstanding anything to the contrary in this Agreement, 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; and
(F) To the extent milestones are payable on a
particular Product, the milestones shall be as follows:
(I) The milestones and corresponding payment
amounts set forth on Exhibit 6(e), Sections 1 through 9 shall apply to all
Vaccine Products, New DC Therapy Products and Passive Immune Transfer Products.
(II) The milestone payments and
corresponding payment amounts set forth on Exhibit 6(e), Section 10 shall apply
to all Existing DC Therapy Products.
(ii) In addition to the technology access fees payable
pursuant to Section 6(c) and the [***] payable pursuant to Section 6(d), SB also
agrees to pay Corixa the one-time milestone payments set forth on Exhibit 6(e),
made via wire transfer of immediately available funds in U.S. Dollars, within
fifteen (15) days of receipt of notice from Corixa or SB, as appropriate, of
achievement of each of the milestones in the applicable Field set forth on such
Exhibit 6(e), provided that with respect to the Her2/neu-Mammaglobin Field, the
milestone payments shall distinguish between Products containing [***] and
Products
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containing [***] as set forth on Exhibit 6(e), Sections 6 and 7.
(iii) In the event a Competitive DC Therapy/Her2/neu
Product has received regulatory approval and is available for commercial sale in
any of [***] at the time the corresponding applicable milestone payment for a DC
Therapy Product developed by SB that incorporates Her2/neu Antigen(s) becomes
due and payable in accordance with the terms hereof, then SB shall pay only
[***] of such milestone payment to Corixa. In the event Corixa receives a
corresponding milestone payment(s) for such Competitive DC Therapy/Her2/neu
Product from a Third Party, Corixa shall pay SB [***] of the amount of such
milestone payment(s) actually received by Corixa.
(iv) In the event a Competitive Existing DC Therapy
Product has received regulatory approval and is available for commercial sale in
any of [***] at the time the corresponding applicable milestone payment for an
Existing DC Therapy Product developed by SB that does not incorporate Her2/neu
Antigen(s) becomes due and payable in accordance with the terms hereof, then SB
shall pay only [***] of such milestone payment to Corixa. In the event Corixa
receives a corresponding milestone payment(s) for such Competitive Existing DC
Therapy Product from a Third Party, Corixa shall pay SB [***] of the amount of
such milestone payment(s) actually received by Corixa.
(v) [***].
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(vi) In connection with the milestone payments set forth
on Exhibit 6(e), Sections 8(ix) and 8(x) and Exhibit 6(e), Sections 9 (viii) and
9(ix), respectively, if the milestone sales levels are both reached in the same
year, computed on a 12 month, non-calendar basis, then only the highest
corresponding payment will be due for that year.
(f) Additional Costs Relating to Clinical Matters. With respect
to pre-clinical and clinical costs incurred by Corixa in the development of
Products pursuant to this Agreement, including and limited to [***] which
studies and costs have been agreed upon in writing by SB, SB agrees that such
amounts are not covered by the payments described in Sections 6(a)-(e) above or
Section 7 below and SB agrees that SB will reimburse Corixa for all such costs
that are approved in writing by SB prior to occurrence. For the R&D Programs
directed to the Her2/neu-Mammaglobin Field and the Tb Field, such costs that SB
has approved as of the Execution Date are set forth on Exhibit 6(f).
7. ROYALTIES; SHARING OF PROCEEDS.
(a) Vaccine Product and New DC Therapy Product Royalties for the
BC Field, PC Field, OC Field and CC Field.
(i) Subject to Subsections 7(a)(iii) and (iv) below, on
annual Net Sales of Vaccine Product(s) and New DC Therapy Product(s),
respectively, developed pursuant to the R&D Programs directed to the BC Field,
the PC Field, the OC Field and the CC Field sold in countries where current
claims of any Corixa Patent and/or Joint R&D Program Patent (A) are [***], SB
shall pay royalties on annual Net Sales of such Vaccine Product(s) and New DC
Therapy Product(s) (the "Cancer Patent Royalty"), payable on each portion of
annual Net Sales of such Vaccine Product(s) and New DC Therapy Product(s) as set
forth on Exhibit 7(a), Section 1 hereto; provided, however, in the case of
[***], the Cancer Patent Royalty shall be as set forth on Exhibit 7(a), Section
2.
(ii) To the extent a Cancer Patent Royalty is not
applicable to a particular Vaccine Product or New DC Therapy Product, as the
case may be, then provided SB has [***] Know-How from Corixa in such Vaccine
Product or New DC Therapy Product, as applicable, which Know-How [***], the
percentage royalty rates specified in Exhibit 7(a), Section 1 will be payable
for any such Vaccine Product or New DC Therapy Product, as applicable, sold into
a country where [***]
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(the "Cancer Know-How Royalty"); provided, however, in the case of [***], the
Cancer Know-How Royalty shall be as set forth on Exhibit 7(a), Section 2, and in
each case such royalties shall be as adjusted based on the existence of a
Competitive Product in the respective country, as set forth on Exhibit 7(a),
Sections 1 and 2.
(iii) Except for Antigens licensed hereunder developed
pursuant to the R&D Programs directed to the BC Field, the PC Field, the CC
Field and the OC Field that are covered by a Blocking Patent (which are covered
in Subsection 7(a)(iv) below), SB and Corixa shall share [***] Third Party
royalties payable on Additional Technology or for technology that is owned
and/or controlled by a Third Party and which is licensed to SB, provided that
such Additional Technology or SB technology is incorporated into Vaccine
Product(s) or New DC Therapy Product(s), as applicable, that are developed
pursuant to the R&D Programs directed to the BC Field, the PC Field, the CC
Field or the OC Field, [***]. Corixa's contribution to such share shall be
[***]. With respect to the Cancer Know-How Royalty, the royalty rates, as set
forth on Exhibit 7(a), Section 1 or Section 2, as applicable, shall apply on the
rates as reduced according to this Subsection 7(a)(iii), provided SB has royalty
obligations toward Third Party(ies) on its sales in those countries. In the case
both Subsections (iii) and (iv) apply, reduction in accordance with Subsection
7(a)(iii) shall apply first.
(iv) In the event of a Blocking Patent covering Corixa
Antigens and/or R&D Program Antigens licensed to SB hereunder and developed
pursuant to the R&D Programs directed to the BC Field, the PC Field, the CC
Field or the OC Field, royalty obligations to the Third Party will be shared
[***].
(v) The parties recognize that Vaccine Products in the BC
Field, the PC Field, the OC Field or the CC Field can be marketed in two
different ways:
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[***]. In the latter case, the Net Sales of Vaccine Product shall consist of
[***], and the royalty due shall be either the Cancer Patent Royalty or the
Cancer Know-How Royalty as detailed on Exhibit 7(a), Section 2. In case [***],
then Net Sales shall be computed on [***] and relevant royalties computed
accordingly. [***].
(b) Vaccine Product and New DC Therapy Product Royalties for the
Tb Field, CP Field and CT Field.
(i) Subject to Subsections 7(b)(iii) and (iv) below, on
annual Net Sales of Vaccine Product(s) and New DC Therapy Product(s),
respectively, developed pursuant to the R&D Programs directed to the Tb Field,
the CP Field and the CT Field sold in countries where current claims of any
Corixa Patent and/or Joint R&D Program Patent (A) are [***] SB shall pay
royalties on annual Net Sales of such Vaccine Product(s) and New DC Therapy
Product(s) (the "Infectious Disease Patent Royalty"), payable on each portion of
annual Net Sales of such Vaccine Product(s) and New DC Therapy Product(s) as set
forth on Exhibit 7(b), Sections 1 and 2 hereto.
(ii) To the extent an Infectious Disease Patent Royalty is
not applicable to a particular Vaccine Product or New DC Therapy Product, as the
case may be, then provided that SB has [***] Know-How from Corixa in such
Vaccine Product or New DC Therapy Product, as applicable, which Know-How [***],
the Infectious Disease Patent Royalty rates specified in Exhibit 7(b), Sections
1 and 2 will be paid but reduced by [***] for any such Vaccine Product or New DC
Therapy Product, as applicable, sold into a country where [***]
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(the "Infectious Disease Know-How Royalty").
(iii) Except for Antigens licensed hereunder developed
pursuant to the R&D Programs directed to the Tb Field, the CT Field and the CP
Field that are covered by a Blocking Patent (which are covered under Subsection
7(b)(iv) below), SB and Corixa shall share [***] Third Party royalties payable
on Additional Technology or for technology that is owned and/or controlled by a
Third Party and which is licensed to SB, provided that such Additional
Technology or SB technology is incorporated into Vaccine Product(s) or New DC
Therapy Product(s), as applicable, that are developed pursuant to the R&D
Programs directed to the Tb Field, the CT Field or the CP Field, which royalties
may include but shall not be limited [***]. Corixa's contribution to such share
shall be [***]. For the Infectious Disease Know-How Royalty, the royalty rates,
as set forth on Exhibit 7(b), Sections 1 and 2, shall apply on the rates as
reduced according to this Subsection 7(b)(iii), provided such reduction is
applicable solely to the extent SB has royalty obligations to Third Party(ies)
on its sales in those countries.
(iv) In the event of an issued Blocking Patent covering
Corixa Antigens licensed to SB hereunder and developed pursuant to the R&D
Programs directed to the Tb Field, the CT Field or the CP Field, [***].
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(c) Royalties for Active Immune Response Products incorporating
Her2/neu Antigen(s) and/or Mammaglobin Antigen(s).
(i) Subject to Subsection 7(c)(vii) below, on annual Net
Sales of Vaccine Product(s) developed pursuant to the R&D Program directed to
the Her2/neu-Mammaglobin Field sold in countries where current claims of any
Corixa Patent and/or Joint R&D Program Patent covering a Her2/neu Antigen(s) (A)
are [***], SB shall pay royalties on annual Net Sales of such Vaccine Product(s)
(the "Her2/neu Vaccine Patent Royalty"), as adjusted based on the incorporation
of Additional Antigens in such Vaccine Product(s), payable on each portion of
annual Net Sales of such Vaccine Product(s) as set forth on Exhibit 7(c),
Section 1 hereto.
(ii) Subject to Subsection 7(c)(vii) below, on annual Net
Sales of DC Therapy Product(s) developed pursuant to the R&D Program directed to
the Her2/neu-Mammaglobin Field sold in countries where current claims of any
Corixa Patent and/or Joint R&D Program Patent covering (an) Her2/neu Antigen(s)
(A) are [***], SB shall pay royalties on annual Net Sales of such Product(s)
(the "Her2/neu DC Therapy Patent Royalty"), as adjusted based on the
incorporation of Additional Antigens in such DC Therapy Product(s), payable on
each portion of annual Net Sales of such DC Therapy Product(s) as set forth on
Exhibit 7(c), Section 2 hereto.
(iii) To the extent a Her2/neu Vaccine Patent Royalty is
not applicable to a particular Vaccine Product Her2/neu Antigen(s), then
provided SB has [***] Know-How from Corixa in such Vaccine Product, which
Know-How [***], the percentage royalty rates specified in Exhibit 7(c), Section
3 will be payable for any such Vaccine Product sold into a country where [***]
(the "Her2/neu Vaccine Know-How Royalty"), as adjusted based on the
incorporation of Additional Antigens in such Vaccine Product(s) and/or the
existence of a Competitive Her2/neu Product in the respective country.
(iv) To the extent a Her2/neu DC Therapy Patent Royalty is
not applicable to a particular DC Therapy Product, then provided SB has [***]
Know-How from Corixa in such DC Therapy Product, which Know-How [***],
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the percentage royalty rates specified in Exhibit 7(c), Section 4 will be
payable for any such DC Therapy Product sold into a country where [***] (the
"Her2/neu DC Therapy Know-How Royalty"), as adjusted based on the incorporation
of Additional Antigens in such DC Therapy Product(s) and/or the existence of a
Competitive DC Therapy/Her2/neu Product in the respective country.
(v) (A) In the event a Competitive DC Therapy/Her2/neu
Product is available for commercial sale in any country at the time the
corresponding Her2/neu DC Therapy Patent Royalty applicable to such country
becomes due and payable in accordance with the terms of Subsection 7(c)(ii),
then SB shall pay only [***] of such Her2/neu DC Therapy Patent Royalty to
Corixa. In the event Corixa receives corresponding patent royalties from a Third
Party for net sales of such Competitive DC Therapy/Her2/neu Product in such
country, Corixa shall pay SB [***] of the amount of such royalties actually
received by Corixa, provided that such royalties are on the net sales of such
Competitive DC Therapy/Her2/neu Product sold in a country where [***].
(B) In the event a Competitive DC Therapy/Her2/neu
Product that incorporates Antigens other than Additional Antigens is available
for commercial sale in any country at the time the corresponding Her2/neu DC
Therapy Patent Royalty applicable to such country becomes due and payable in
accordance with the terms of Subsection 7(c)(ii), then SB shall pay only [***]
of such Her2/neu DC Therapy Patent Royalty to Corixa. In the event Corixa
receives corresponding patent royalties from a Third Party for net sales of such
Competitive DC Therapy/Her2/neu Product in such country, Corixa shall pay SB
[***] of the amount of such royalties actually received by Corixa, provided that
such royalties are on the net sales of such Competitive DC Therapy/Her2/neu
Product sold in a country where [***].
(vi) The royalties set forth on Exhibit 7(c), Sections 1-4
with respect to a Vaccine Product or DC Therapy Product that incorporates (an)
Her2/neu Antigen(s) and/or (a) Mammaglobin Antigen(s) as well as an Additional
Antigen(s) are intended to replace the royalties that would otherwise be payable
by SB to Corixa on Net Sales of Vaccine Products or DC Therapy Products that
incorporate either (A) only Her2/neu Antigen(s) and/or Mammaglobin Antigen(s) or
(B) only Additional Antigens.
(vii) Except for [***],
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SB and Corixa shall share [***] Third Party royalties payable on Additional
Technology and/or Blocking Patents or for technology that is owned and/or
controlled by a Third Party and which is licensed to Corixa or SB after the
Effective Date and is incorporated into Active Immune Response Product(s) that
incorporate (an) Her2/neu Antigen(s) by SB, which may include but shall not be
limited to, [***] Corixa's contribution to such share shall be [***] provided,
however, that notwithstanding anything herein to the contrary, in no event shall
the royalties otherwise payable by SB to Corixa on Net Sales of such Active
Immune Response Product under this Section 7(c) be reduced below [***].
(viii) In connection with any Vaccine Product that
contains (an) Her2/neu Antigen(s) and (a) Mammaglobin Antigen(s), whether or not
such Vaccine
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Product also contains (an) Additional Antigen(s), SB shall pay to Corixa, except
as expressly set forth below, [***] on Net Sales applicable to such Vaccine
Product. Notwithstanding the foregoing, in the event SB determines [***].
(ix) In connection with any DC Therapy Product that
contains an Her2/neu Antigen(s) and (a) Mammaglobin Antigen(s), whether or not
such DC Therapy Product also contains (an) Additional Antigen(s), SB shall pay
to Corixa, except as expressly set forth below, [***] on Net Sales applicable to
such DC Therapy Product. Notwithstanding the foregoing, in the event SB
determines [***].
(d) Royalties for Existing DC Therapy Products. Excluding DC
Therapy Products that incorporate either (an) Her2/neu Antigen(s) and/or (a)
Mammaglobin Antigen(s), which are subject to Section 7(c) above, SB shall pay
Corixa the following royalties for Existing DC Therapy Products:
(i) Subject to Section 7(d)(iii) below, on annual Net
Sales of Existing DC Therapy Product(s) developed pursuant to the R&D Programs
directed to the BC Field, the PC Field and the Tb Field sold in countries where
current claims of any Corixa Patent and/or Joint R&D Program Patent (A) are
[***],
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SB shall pay royalties on annual Net Sales of Existing DC Therapy Product(s)
(the "Existing DC Therapy Patent Royalty") payable on each portion of annual Net
Sales of Existing DC Therapy Product(s) in each applicable Field as set forth on
Exhibit 7(d), Sections 1 and 2 hereto.
(ii) To the extent an Existing DC Therapy Patent Royalty
is not applicable to a particular Existing DC Therapy Product, then provided SB
has [***] Know-How from Corixa in such Existing DC Therapy Product, which
Know-How [***] the percentage royalty rates specified in Exhibit 7(d), Sections
1 and 2 will be payable for any such Existing DC Therapy Product sold into a
country where [***] (the "Existing DC Therapy Know-How Royalty"), as adjusted
solely in the BC Field and the PC Field based on the existence of a Competitive
Existing DC Therapy Product in the respective country.
(iii) In the event a Competitive Existing DC Therapy
Product developed pursuant to the R&D Programs directed to the BC Field, the PC
Field or the Tb Field is [***] at the time the corresponding Existing DC Therapy
Patent Royalty applicable to such country becomes due and payable in accordance
with the terms of Subsection 7(d)(i), then SB shall pay only [***] of such
Existing DC Therapy Patent Royalty to Corixa. In the event Corixa receives
corresponding patent royalties from a Third Party for net sales of such
Competitive Existing DC Therapy Product in such country, Corixa shall pay SB
[***] of the amount of such royalties actually received by Corixa, provided that
such royalties are on the net sales of such Competitive Existing DC Therapy
Product sold in a country where current claims of any patent covering such
Competitive Existing DC Therapy Product are [***].
(e) Royalties for TDM Products.
(i) With respect to TDM Products, (i) if SB has an
exclusive license to a particular TDM Product, SB shall pay to Corixa a [***]
royalty on annual TDM Net Sales of such TDM Product, with a minimum royalty on
annual TDM Net Sales of [***]
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and (ii) if SB has either a co-exclusive or non-exclusive license to a
particular TDM Product, SB shall pay to Corixa a [***] on TDM Net Sales of such
TDM Product; provided, however, that such co-exclusive or non-exclusive royalty
shall not [***] with respect to all TDM Products that incorporate either (an)
Her2/neu Antigen(s) or (a) Mammaglobin Antigen(s), whether licensed to SB
exclusively, co-exclusively or non-exclusively, SB shall pay the applicable
royalty rate pursuant to Corixa's pre-existing in-license agreements as listed
on Exhibit 7(e)(i) plus [***].
(ii) The royalty payable to Corixa for TDM Product(s) set
forth in Subsection 7(e)(i) above shall not [***].
(f) Royalties on Products Covered by SB Patents.
In the event any Product sold by SB, its licensees or its
sublicenses is covered by (an) SB Patent(s) in the country of sale, [***], SB
shall pay in connection with such sales of Product [***] set forth in Section 7
with respect to such Product.
(g) Royalties for T Cell-Based Passive Immunotherapy Products. In
connection with all New T Cell-Based Passive Immunotherapy Products and Existing
T Cell-Based Passive Immunotherapy Products for which SB maintains a
co-exclusive license and does not obtain an exclusive license pursuant to
Subsection 5(g)(ii)(A), the following shall apply:
(i) [***]
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(ii) In the event SB commercializes such a T Cell-Based
Passive Immunotherapy Product in a particular Field and Subsection 7(g)(i) does
not apply, then SB shall pay a royalty on Net Sales of such T Cell-Based Passive
Immunotherapy Product equal to the royalty rate applicable to [***] in the
applicable Field in accordance with Section 7(a), (b) or (c), as applicable.
(h) Sharing of Proceeds.
(i) Vaccine Products and New DC Therapy Response Products.
(A) In the event rights to a particular Field have
reverted to Corixa pursuant to [***] and Corixa out-licenses rights to Corixa
Antigen(s) and/or R&D Program Antigen(s) in such Field to a Third Party for the
research, development and/or commercialization of Vaccine Products and/or New DC
Products in such Field, Corixa shall pay to SB a percentage of [***] in
connection with such Third-Party license as follows:
[***]
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(B) In the event Corixa obtains a co-exclusive
license pursuant to Subsection 5(h)(ii) which license covers a particular Corixa
Antigen and/or R&D Program Antigen and/or Her2/neu Antigen and/or Mammaglobin
Antigen or, solely with respect to the Her2/neu-Mammaglobin Field, in the event
Corixa obtains such co-exclusive license and SB has [***] Corixa shall pay to SB
[***]
(ii) Diagnostics. With respect to all licenses granted by
Corixa hereunder to Third Parties as allowed under the terms and conditions of
Sections 5(d) and 5(g)(iii) for the use of Corixa Antigen(s) and/or R&D Program
Antigen(s) in Diagnostic products, Corixa shall pay to SB [***] provided,
however, that Corixa shall have no such payment obligation in connection with
[***].
(iii) Existing T Cell-Based Passive Immunotherapy
Products. If SB does not exercise its right of first refusal pursuant to
Subsection 5(g)(ii)(A) hereof to exclusively license an Existing T Cell-Based
Passive Immunotherapy Product, then provided that SB has [***], in addition to
retaining co-exclusive rights, SB shall be entitled to receive [***].
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(iv) New T Cell-Based Passive Immunotherapy Products.
(A) In the event rights to a particular Field have
reverted to Corixa pursuant to [***] and Corixa out-licenses rights to Corixa
Antigen(s) and/or R&D Program Antigen(s) in such Field to a Third Party for the
research, development and/or commercialization of New T Cell-Based Passive
Immunotherapy Products in such Field, Corixa shall pay to SB [***].
(B) In the event Corixa obtains a co-exclusive
license pursuant to Subsection 5(h)(ii) which license covers a particular Corixa
Antigen and/or R&D Program Antigen and/or Her2/neu Antigen and/or Mammaglobin
Antigen or, solely with respect to the Her2/neu-Mammaglobin Field, in the event
Corixa obtains such co-exclusive license and SB has [***], Corixa shall pay to
SB [***].
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(v) Antibody-Based Passive Immunotherapy Products. If SB
does not elect to maintain its license to an Available Antibody that was
developed by Corixa without SB's funding pursuant to Subsection 5(b)(ii)(E),
then provided that SB has [***], SB shall be entitled to receive [***].
(vi) No Sharing of Proceeds in the Tb Field in Japan.
Notwithstanding anything to the contrary in this Section 7(h), SB shall not be
entitled to receive any portion of any net proceeds received by Corixa in
connection with any license related to the sale of Active Immune Response
Products and/or New T Cell Therapy Products in the Tb Field in Japan.
(i) Royalty Reporting and Other Aspects.
(i) Reporting. From the first launch of any Product
anywhere in the Territory, SB shall provide a royalty report and, if applicable,
a royalty payment to Corixa every [***]. The report and payment relating to Net
Sales and/or TDM Net Sales applicable to such Product shall be provided within
[***] after [***] of each calendar year and shall include all Net Sales and/or
TDM Net Sales applicable to such Product by SB or its licensees or sublicensees.
SB shall keep, and require any licensee and sublicensee to keep, for a period of
not less than [***], complete and accurate records of all Net Sales and/or TDM
Net Sales applicable to such 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 SB's
obligation to pay royalties on such Product; provided, however, that such
examination shall not (i) be of records for more than the prior [***], (ii) take
place more often than once a year, and (iii) cover any records which date prior
to the date of the last examination, and provided further, that such accountants
shall report to Corixa only as to the accuracy of the royalty statements and
payments. Copies of such reports shall be supplied to SB. In the event the
report demonstrates that SB has underpaid royalties, SB shall pay such royalties
immediately
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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.
(ii) Royalty Certificate. In addition to, and simultaneous
with, the royalty reports set described in Subsection 7(i)(i) above, SB Bio's
President and General Manager shall deliver to Corixa a certificate (the
"Royalty Certificate") stating that during the previous [***] period, the
following factors (the "Royalty Factors") have equaled in the aggregate no more
than [***] of total sales of each Product other than TDM Products during such
[***] period: (i) normal customary trade and cash discounts allowed and taken;
(ii) rebates to wholesalers; (iii) any deductions allowed and actually incurred
in direct connection with such Product for government-mandated Vaccine insurance
premiums, such as the National Childhood Vaccine Injury Act in the U.S.; and
(iv) any deduction, at full 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 [***] period, SB may deduct such greater
percentage for such [***] 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 each Product sold by SB
has been on an "arms length" basis and not set so as to subsidize sales of other
products sold by SB and/or its licensees or sublicensees. In the event of a
disagreement with respect to size of the Royalty Factors in any given [***]
period, the Chief Executive Officer of Corixa and the President and General
Manager of SB Bio 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. With respect to TDM Products, the Royalty Certificate shall take into
account the Royalty Factors described in (i), (ii) and (iii) above in this
Subsection to apply the [***] aggregate figure.
(iii) Currency. 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 Barclay's Bank, London, UK
on the last business day of the applicable six (6) month period.
(iv) Expiration of Royalty Obligation. Royalties under
Subsections 7(a)(i), 7(b)(i), 7(c)(i), 7(c)(ii), 7(c)(v) and 7(d)(i) shall be
payable [***] for the life of any valid granted Corixa Patent and/or Joint R&D
Program Patent which has not been successfully opposed by a Third Party or
revoked [***]. Royalties under Sections 7(a)(ii), 7(b)(ii), 7(c)(iii), 7(c)(iv)
and 7(d)(ii) shall expire [***] after first launch of the first Product in the
applicable country.
8. MANUFACTURING; SUPPLY.
(a) Corixa will provide reasonable quantities of preclinical and
clinical
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grade test material for SB as required through the course of the R&D Programs at
no additional charge to SB. These materials will include sufficient quantities
of [***]. Additionally, with respect to [***] related thereto, at SB's request
Corixa will provide SB with up to [***] of those [***] and up to [***] of all
other [***]. Corixa shall disclose its manufacturing Know-How with respect to
such materials to SB at no additional charge, and SB shall be permitted to
manufacture such materials solely in connection with SB's licenses hereunder.
Notwithstanding the first sentence of this Subsection, if the provision of such
materials under this Section 8(a) exceeds [***], then Corixa shall not be
required to provide materials to SB other than at a price and on the terms set
forth in a supply agreement to be negotiated by Corixa and SB.
(b) SB shall have the right to manufacture all clinical materials
required for the sale of Product pursuant to this Agreement and Corixa shall
transfer to SB all Corixa biological materials and Know-How necessary to such
manufacture. Nonetheless, if SB so desires at its sole discretion, commercial
grade (i.e., GMP) materials may be provided to SB by Corixa or a Third Party
supplier at the price and on the terms set forth in a supply agreement to be
negotiated by SB and Corixa or such Third Party supplier in good faith [***].
Additionally, in the event SB manufactures a particular Antigen hereunder and
such Antigen is also used by a Third Party for DC Therapy, Diagnostics and/or
Passive Immune Transfer, such Third Party shall not have the right to any SB
technology, including SB Patents and SB Antigens; provided, however, in its
discretion SB may elect to supply such Third Party with such Antigen or such SB
technology pursuant to a separate agreement between SB and such Third Party.
9. INVENTIONS.
Patentable inventions or discoveries which arise from the R&D
Program as a result of activities conducted during the R&D Program Term as may
be extended 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 R&D 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 R&D 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
and subject to the rights and licenses granted by Corixa to SB hereunder, SB and
Corixa
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shall retain their respective unrestricted rights to make, have made, use, have
used, and sell and have sold all such inventions and discoveries which are owned
solely by them.
10. PATENTS; PROSECUTION AND LITIGATION.
(a) (i) Subject to Subsection 10(a)(ii), Corixa shall have the
right and the obligation to prosecute and maintain all Corixa Patents and Joint
R&D Program Patents and shall do so in a timely manner. Corixa shall disclose to
SB the complete texts of all patents and draft patent applications to be filed
by Corixa which relate to any Product (including Corixa Patents and Joint R&D
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 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 10 as confidential in accordance with Section
11 hereof. Corixa agrees that it will use prudent scientific and legal judgment
in determining the number and types of patent applications filed by Corixa
pursuant to this Agreement. 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 (to the
extent such costs have not already been reimbursed pursuant to the Tb Agreement,
the BC Agreement and/or the PC Agreement) 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
R&D Program Patents up to an amount of U.S.[***] per year for each individual
Field, provided that if Corixa incurs less than U.S.[***] of such costs during
any given year for a particular Field, then subject to the last two sentences of
this Subsection 10(a)(i), Corixa shall be allowed to apply the remaining amount
for such Field to costs incurred during such year for any other Field(s) to the
extent Corixa incurred over U.S.[***] of any costs for such other Field(s) in
such year. Any costs incurred by Corixa in connection with the filing,
prosecution and maintenance of Corixa Patents and/or Joint R&D Program Patents
in any particular Field in excess of said U.S.[***] shall be reimbursed by SB to
Corixa only if they have been specifically approved and authorized prior to
expenditure by the R&D Steering Committee, in its reasonable discretion, and if
they are reasonable and documented. In determining whether to approve such
additional expenses, the R&D Steering Committee shall apply reasonable
standards, taking into consideration the norms of the biotechnology industry in
general.
(ii) Notwithstanding Subsection 10(a)(i) hereof, beginning
upon the earlier of [***], SB shall have
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the right and the obligation at SB's expense to prosecute and maintain all
Corixa Patents and Joint R&D Program Patents related to such Field and
shall do so in a timely manner; provided, however, if SB subsequently
terminates all Clinical R&D and commercialization in such Field, SB's right and
obligation under this Subsection 10(a)(ii) shall terminate with respect to such
Field and Corixa shall assume the prosecution and maintenance of all Corixa
Patents and Joint R&D Program Patents related to such Field in accordance with
Subsection 10(a)(i). SB shall disclose to Corixa the complete texts of all
patents and draft patent applications to be filed by SB which relate to any
Product related to such Field (including Corixa Patents and Joint R&D 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. Corixa shall have the right to
review all such pending applications and other proceedings and make
recommendations to SB concerning them and their conduct. SB agrees to keep
Corixa promptly and fully informed of the course of patent prosecution or other
proceedings, including by providing Corixa with copies of substantive
communications, search reports and Third Party observations submitted to or
received from patent offices throughout the Territory. SB shall provide such
patent consultation to Corixa at no cost to Corixa. Corixa shall hold all
information disclosed to it under this Section 10 as confidential in accordance
with Section 11 hereof.
(b) (i) Subject to Subsection 10(b)(ii), 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.
(ii) Solely in the event that SB is prosecuting and
maintaining patents in accordance with Subsection 10(a)(ii) above, then, in the
event SB intends to finally abandon any patent or any part of a patent
(including Corixa Patents) covered by this Agreement and related to the
particular Field, it shall notify Corixa and Corixa 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 or SB 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) (i) Subject to Subsections 10(d)(ii) and 10(f) below, 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
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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 R&D
Program Patents. If SB elects not to conduct and defend such action directed
against Joint R&D Program Patents, Corixa shall have the right to do it at
Corixa's own expense. No settlement of any Third Party claim which restricts the
scope or affects the enforceability of any Joint R&D Program Patent may be
entered into by either Corixa or SB without the other party's prior written
consent, which consent shall not be unreasonably withheld. Corixa and SB shall
assist one another and cooperate in any such action at the other's request
without expense to the requesting party.
(ii) Solely in the event that SB is prosecuting and
maintaining patents in accordance with Subsection 10(a)(ii) above, then 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, SB shall have,
at its own expense, the control over the conduct and defense of such action in
case it is directed against Corixa Patents or SB Patents and the first right to
control, at its own expense, the conduct and defense of any such action directed
against Joint R&D Program Patents. If SB elects not to conduct and defend such
action directed against the Corixa Patents or Joint R&D Program Patents, Corixa
shall have the right to do it at Corixa's own expense. SB shall not enter into
any settlement of any Third Party claim which restricts the scope or affects the
enforceability of any Corixa Patent without Corixa's prior written consent,
which consent shall not be unreasonably withheld. Additionally, no settlement of
any Third Party claim which restricts the scope or affects the enforceability of
any Joint R&D Program Patent may be entered into by either Corixa or SB without
the other party's prior written consent, which consent shall not be unreasonably
withheld. Corixa and SB shall assist one another and cooperate in any such
action at the other's request without expense to the requesting party.
(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 contemplated by Section 10(c), (d) or (e) above 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
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[***] of such excess. In the event Corixa takes responsibility for such
actions, Corixa will undertake all actions at its own entire expense and
recover one hundred percent (100%) 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 any Product.
(h) In the event any matter governed by Sections 10(c), (d), (e)
and/or (f) shall apply to rights co-exclusively licensed by Corixa and SB, the
parties shall discuss regularly and in good faith the appropriate management of
such matter(s) prior to proceeding. The parties shall agree on matters
including, but not limited to, whether control of any action shall rest with
only one party or be managed cooperatively, how related expenses shall be shared
and how related damages or recoveries shall be shared.
(i) CORIXA MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR
IMPLIED, OTHER THAN THOSE CONTAINED IN SECTION 16 BELOW, INCLUDING WITH RESPECT
TO THE CORIXA PATENTS, THE JOINT R&D PROGRAM PATENTS OR KNOW-HOW AND ANY
ANTIGENS, ANTIBODIES, OR PRODUCTS RELATED THERETO, INCLUDING WITHOUT LIMITATION
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
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
including, but not limited to, manufacturing Know-How, all Corixa Patents and
all relevant patent applications filed and/or controlled by Corixa, all Corixa
Antigen(s) and all inventions related to the Field arising from the R&D Program
as may be extended. In addition, each party will provide the other party with
all information which is reasonably necessary or useful for achieving the goals
of the R&D 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
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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 as required
to be disclosed to a governmental agency, or as 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 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 SB sublicensee or
distributor solely in connection with the exercise of SB's rights under this
Agreement, provided 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 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 joint press release following signature; provided,
however, that the terms of, or subject matter covered by, the Agreement
(including without limitation payment amounts and financial terms) shall not be
disclosed by either party without the prior consent of the other party, which
consent shall not be unreasonably withheld, except that the disease targets
under the R&D Program may be disclosed. 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 R&D Program (a "Dissemination")
without at least sixty (60) days prior written notice of such planned
publication or disclosure sent to
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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 reasonable period sufficient to allow
the other party to take the steps necessary to protect such intellectual
property position, including the filing of any patent applications and/or
deletion of the other party's 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 hereof 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, 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 Sections
6 or 7, 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 6 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.
13. MISCELLANEOUS.
(a) Trademarks. SB shall be responsible for the selection,
registration and maintenance of all trademarks which are employed in connection
with Products and SB shall own and/or control any such trademarks, provided
that, prior to the use 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
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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 provided that such conformity is in accordance with the intent of
the parties.
(d) Entire Agreement. This Agreement, the Stock Purchase
Agreement, the Standstill Agreement of even date herewith between Corixa and SB,
and the three (3) side letters of even date herewith between the parties
constitute the entire agreement between the parties relating to the subject
matter hereof and supersede all previous writings and understandings except that
the First NonDisclosure Agreement, the Second NonDisclosure Agreement and the
Amended and Restated Special Biological Materials Transfer Agreement of even
date herewith covering Corixa's proprietary LeIF and microsphere technology,
each as may be amended from time to time, 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.
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:
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If to Corixa:
Corixa Corporation
1124 Columbia Street, Suite 200
Seattle, WA 98104
Attention: Chief Operating Officer
cc: Corporate Counsel
Telephone: (206) 754-5711
Telecopy: (206) 754-5715
with a copy to:
Venture Law Group
4750 Carillon Point
Kirkland, WA 98033
Attention: William W. Ericson
Telephone: (425) 739-8700
Telecopy: (425) 739-8750
If to SB:
SmithKline Beecham plc
New Horizons Court
Brentford, Middlesex
TW8 9EP
United Kingdom
Attention: Senior Vice President
General Counsel
Corporate Secretary
Telephone: 44-181-975-2030
Telecopy: 44-181-975-2040
with a copy to:
SmithKline Beecham Biologicals
Manufacturing S.A.
Rue de l'Institut 89
1330 Rixensart, Belgium
Attention: 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.
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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 further, however, 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 breach of this
Agreement pursuant to Section 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. Corixa warrants that it owns and/or controls the entire right, title
and interest in Existing Corixa Patents and Existing R&D Program Patents [***].
Corixa warrants (i) that Exhibits 1(jjj) and 1(dddd) set forth all patents and
patent applications that have been in-licensed by Corixa pursuant to the Corixa
Third Party Agreements that cover Her2/neu Antigens and Mammaglobin Antigens,
respectively, and (ii) that Exhibit 1(vv) includes a complete list of patents
and patent applications owned by Corixa as of the Effective Date that are
necessary or useful for the rights and licenses granted by Corixa hereunder,
[***]. In the event that additional patents and/or patent applications owned by
Corixa and filed prior to the Effective Date are necessary or useful for the
rights and licenses granted by Corixa hereunder, [***], such patents and/or
patent applications will be included automatically in Exhibit 1(vv) and shall be
considered to be Existing Corixa Patents.
(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. Except to the extent known by or disclosed to SB
as of the Execution Date, Corixa represents that Corixa has no present and
actual knowledge from which it can be inferred that Existing Corixa Patents
and/or Existing R&D Program Patents are invalid or that their exercise would
infringe 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) 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 Product
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which suggests that there may exist toxicity, safety and/or efficacy concerns
which may materially impair the utility and/or safety of such Product.
(e) SB acknowledges that the licenses granted to SB herein
include sublicenses under technology that has been licensed by Corixa from
certain Third Parties (the "Corixa Third Party Agreements"), which Corixa Third
Party Agreements are set forth on Exhibit 16(e) attached hereto, and SB warrants
and represents that it will comply with all applicable terms and conditions of
such Corixa Third Party Agreements; provided, however, SB shall not have any
obligation to pay any license fees or royalty or milestone payments under such
Corixa Third Party Agreements except as expressly provided for in this
Agreement, and provided further, that if as a result of complying with the
applicable terms and conditions of (a) Corixa Third Party Agreement(s) SB would
be in breach of this Agreement, then Corixa in its sole discretion shall
determine whether the responsibility of such compliance will be borne by Corixa
and/or SB, and such compliance shall not be deemed to cause a breach of this
Agreement by either party.
17. TERM AND TERMINATION.
(a) This Agreement may not be terminated by either party except
in accordance with this Section 17.
(b) 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 R&D Program Patent issued in any country or [***] years after
first commercial sale of a Product in the last country in which a Product is
commercially launched. Expiration of this Agreement under this Section 17(b)
shall not preclude SB from continuing to market Product and to use Know-How
without any further royalty payments.
(c) (i) 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 6 or 7, 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.
(ii) In the event this Agreement is terminated by either
party as a result of an uncured material breach by the other party under
Section 17(c)(i), then without further action on the part of either party, the
non-breaching party will receive an exclusive license to [***]. If Corixa
terminates this Agreement under Section 17(c)(i) for uncured material breach
by SB, the license described in the preceding sentence shall be [***], and if
SB terminates this Agreement under Section 17(c)(i) for uncured material
breach by Corixa, such
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license shall be [***]. Additionally, if Corixa terminates this Agreement under
Section 17(c)(i) for uncured material breach by SB, then all other aspects of
the contractual relationship created by this Agreement, other than [***], shall
terminate forthwith, including [***]. If SB terminates this Agreement under
Section 17(c)(i) for uncured breach by Corixa, then all other aspects of the
contractual relationship created by this Agreement, other than [***], shall
terminate forthwith, while [***]. In such event, the breaching party agrees to
take all steps necessary to effectuate such license(s) granted to the other
party in accordance with this Section 17(c)(ii).
(iii) In the event of termination of this Agreement by SB
under Section 17(c)(i) for Corixa's uncured material breach, the following shall
apply:
(A) [***]
(B) SB's milestone and royalty obligations under
this Agreement shall be modified as follows: [***]
(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, [***].
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SB shall be entitled to withdraw the Product(s) from the market at any time for
medical or safety reasons.
(e) [***].
(f) 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 or 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 within 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.
(g) 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 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.
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'
(h) SB may terminate this Agreement at any time, on or after the
fourth anniversary of this Agreement by giving [***] prior written notice to
Corixa.
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
hereunder which are then due in accordance with the terms of this Agreement,
which, in each case, shall include all applicable payments under Sections 6 and
7 as may be modified pursuant to Subsection 17(c)(iii)(B) except 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, sublicensees and distributors
then have on hand, the sale of which would, but for the termination, be subject
to royalty, and SB and its subsidiaries, 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
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 (as defined
in Paragraph 19(b)) in this Agreement, unless waived in writing by the
Indemnified Party (as defined in Paragraph 19(b)); (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 (in each case an "Indemnified Party")
receives any written claim which it believes is the subject of indemnity
hereunder by either Corixa or SB, 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
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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.
20. GOVERNMENTAL CONSENTS.
(a) HSR. As promptly as practicable after the execution of this
Agreement, and from time to time during the term hereof as may be required,
Corixa and SB each shall, at its own expense, execute and file, or join in the
execution and filing, of all applications and documents that may be required
under the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended
("HSR"), in connection with this Agreement and the transactions contemplated
hereby; provided, however, that SB agrees to pay the applicable U.S. $45,000.00
fee associated with the filing of such applications and documents. Corixa and SB
each shall use all reasonable commercial efforts to take such action as may be
required to cause the expiration or early termination of the notice periods
under HSR as promptly as possible after the execution of this Agreement and to
resolve such objections, if any, as may be asserted with respect to the
transactions contemplated by this Agreement under HSR; provided, however,
notwithstanding the foregoing, neither party shall be required to make any
material change or amendment to this Agreement as a result of such objections
unless such change or amendment is agreed to by the other party in advance. In
connection therewith, if any administrative or judicial action or proceeding is
instituted (or threatened to be instituted) challenging any transaction
contemplated by this Agreement or the transactions contemplated hereby as
violative of HSR, Corixa and SB shall, if by mutual agreement Corixa and SB
decide that such action is in their respective best interests, cooperate and use
all reasonable commercial efforts to contest and resist any such action or
proceeding and to have vacated, lifted, reversed, or overturned any decree,
judgment, injunction or other order, whether temporary, preliminary or
permanent, that is in effect and that prohibits, prevents, or restricts
consummation and/or effectiveness of the Agreement or the transactions
contemplated hereby. The parties hereto will consult and cooperate with one
another, and consider in good faith the views of one another, in connection with
any analyses, appearances, presentations, memoranda, briefs, arguments, opinions
and proposals made or submitted by or on behalf of any party hereto in
connection with proceedings under or relating to HSR.
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(b) Closing Condition. The respective obligations of Corixa and
SB to effect this Agreement and the transactions contemplated hereby shall be
subject to the expiration or early termination of the waiting period applicable
to this Agreement under HSR. Corixa and SB each hereby agree that the foregoing
sentence represents the only condition to the effectiveness of this Agreement
and the transactions contemplated hereby and once such condition has been
satisfied, this Agreement will be in full force and effect.
(c) Termination. In the event that the condition set forth in
Section 20(b) above has not been satisfied by April 30, 1999 either Corixa or SB
may terminate this Agreement by providing a written notice to the other party in
the manner provided in Section 14 hereof.
(d) European Commission. In the event the European Commission
requires any material change or amendment to this Agreement, or any such
material change or amendment is required under the European law, in the opinion
of counsel to both parties, this Agreement shall be amended in a manner such
that the Agreement is acceptable to the European Commission and/or complies with
European law and which does not adversely affect the expected compensation to
Corixa and/or other material rights and/or obligations of Corixa or SB under
this Agreement. In the event that the required changes adversely affect the
expected compensation to Corixa and/or other material rights and/or obligations
of Corixa or SB under this Agreement, the parties shall in good faith discuss
the situation and negotiate an appropriate amendment to this Agreement. If a
mutually acceptable amendment is not effected within one hundred and twenty
(120) days, Corixa or SB shall have the right to terminate this Agreement. If
either Party desires to notify this Agreement to the European Commission, both
Parties shall collaborate to affect such filing in accordance with the
cooperative efforts set forth in Section 20(a) above.
[Signature Page Follows]
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IN WITNESS WHEREOF, each of the parties hereto has caused this Agreement
to be executed by its duly authorized officer as of the date first written
above.
Agreed to and accepted by: Agreed to and accepted by:
CORIXA CORPORATION SMITHKLINE BEECHAM PLC
/s/ Steven Gillis /s/ Jean Stephenne
- ----------------------------------- ------------------------------------
Steven Gillis Jean Stephenne
President and CEO Attorney-in-Fact
Execution Date: October 28, 1998 Execution Date: October 28, 1998
Agreed to and accepted by: Agreed to and accepted by:
SMITHKLINE BEECHAM SMITHKLINE BEECHAM
BIOLOGICALS S.A. BIOLOGICALS MANUFACTURING S.A.
/s/ Jean Stephenne /s/ Jean Stephenne
- ----------------------------------- ------------------------------------
Jean Stephenne Jean Stephenne
President and General Manager President and General Manager
Execution Date: October 28, 1998 Execution Date: October 28, 1998
SIGNATURE PAGE TO MULTI-FIELD VACCINE
DISCOVERY COLLABORATION AND LICENSE AGREEMENT
<PAGE> 85
EXHIBIT 1(rr) TO COLLABORATION AND LICENSE AGREEMENT
EXCLUDED ANTIBODY(IES)
(IDENTIFIED PUTATIVE THERAPEUTIC CANCER
ANTIBODIES AND EXISTING OBLIGATIONS)
[***]
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EXHIBIT 1(uu) TO COLLABORATION AND LICENSE AGREEMENT
EXISTING CORIXA ANTIGENS
To be finalized by the R&D Steering Committee on or before December 31,
1998.
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EXHIBIT 1(vv) TO COLLABORATION AND LICENSE AGREEMENT
EXISTING CORIXA PATENTS
[***]
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EXHIBIT 1(VV) CONTINUED
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EXHIBIT 1(VV) CONTINUED
[***]
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EXHIBIT 1(VV) CONTINUED
[***]
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EXHIBIT 1(VV) CONTINUED
[***]
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EXHIBIT 1(VV) CONTINUED
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EXHIBIT 1(VV) CONTINUED
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EXHIBIT 1(VV) CONTINUED
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EXHIBIT 1(aaa) TO COLLABORATION AND LICENSE AGREEMENT
EXISTING R&D PROGRAM ANTIGENS
[***]
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EXHIBIT 1(jjj) TO COLLABORATION AND LICENSE AGREEMENT
HER2/NEU ANTIGENS
Antigens covered by the following patents and patent applications:
[***]
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EXHIBIT 1(dddd) TO COLLABORATION AND LICENSE AGREEMENT
MAMMAGLOBIN ANTIGENS
Antigens covered by the following patents and patent applications:
[***]
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EXHIBIT 1(DDDD) CONTINUED
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EXHIBIT 1(bbbbb) TO COLLABORATION AND LICENSE AGREEMENT
R&D PROGRAMS
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EXHIBIT 2(d) TO COLLABORATION AND LICENSE AGREEMENT
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EXHIBIT 4(a)(i) TO COLLABORATION AND LICENSE AGREEMENT
COLLABORATION STEERING COMMITTEE
[***]
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EXHIBIT 4(b)(i) TO COLLABORATION AND LICENSE AGREEMENT
R&D STEERING COMMITTEE
Infectious Disease Fields Subcommittee
[***]
Cancer Fields Subcommittee
[***]
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EXHIBIT 5(a)(v) TO COLLABORATION AND LICENSE AGREEMENT
T CELL AND DC TECHNOLOGY LICENSING DISCUSSIONS
[***]
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EXHIBIT 5(d)(i)-1 TO COLLABORATION AND LICENSE AGREEMENT
COMMITTED OR PARTNERED DIAGNOSTICS TECHNOLOGY (By Field)
[***]
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ANTIGENS CHARACTERIZED FOR DIAGNOSTIC USE
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EXHIBIT 5(D)(I)-2(A) CONTINUED
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EXHIBIT 5(d)(i)-2(B) TO COLLABORATION AND LICENSE AGREEMENT
ANTIGENS TO BE VALIDATED AS CHARACTERIZED FOR DIAGNOSTIC USE
To be finalized and validated by the R&D Steering Committee.
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EXHIBIT 6(b) TO COLLABORATION AND LICENSE AGREEMENT
FORM OF STOCK PURCHASE AGREEMENT
[omitted in its entirety]
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EXHIBIT 6(e) TO COLLABORATION AND LICENSE AGREEMENT
MILESTONE PAYMENTS
SB agrees to pay Corixa the one-time milestone payments set forth
below in this Exhibit 6(e), to be made via wire transfer of immediately
available funds in U.S. Dollars, within fifteen (15) days of receipt of notice
from SB or Corixa, as appropriate, of achievement of each of the following
milestones in each applicable Field (or, with respect to the
Her2/neu-Mammaglobin Field, in the separate sub-Fields of Her2/neu and
Mammaglobin, as set forth below). For avoidance of doubt the provisions of
Section 6(e) of the Agreement apply.
SECTION 1 -- TB FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
SECTION 2 -- BC FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
SECTION 3 -- PC FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
SECTION 4 -- CC FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
SECTION 5 -- OC FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
SECTION 6 -- HER2/NEU
For avoidance of doubt, the following milestones are applicable to
Products that contain Her2/neu Antigen(s) but not Mammaglobin Antigen(s).
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
Section 6 Continued
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EXHIBIT 6(E) CONTINUED
SECTION 7 -- MAMMAGLOBIN
For avoidance of doubt, the following milestones are applicable to
Products that contain Her2/neu Antigen(s) and Mammaglobin Antigen(s).
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
SECTION 8 -- CP FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
Section 8 Continued
[***]
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EXHIBIT 6(E) CONTINUED
SECTION 9 -- CT FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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<PAGE> 120
EXHIBIT 6(E) CONTINUED
SECTION 10 -- EXISTING DC THERAPY PRODUCTS
SECTION 10(A) -- IN THE BC FIELD
----------------------------------------------------
MILESTONE PAYMENT (U.S.$)
----------------------------------------------------
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EXHIBIT 6(E) CONTINUED
Section 10(A) Continued
[***]
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EXHIBIT 6(E) CONTINUED
SECTION 10(B) -- IN THE PC FIELD
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MILESTONE PAYMENT (U.S.$)
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EXHIBIT 6(E) CONTINUED
Section 10(B) Continued
[***]
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EXHIBIT 6(E) CONTINUED
SECTION 10(C) -- IN THE TB FIELD
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MILESTONE PAYMENT (U.S.$)
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EXHIBIT 6(E) CONTINUED
Section 10(C) Continued
[***]
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<PAGE> 126
EXHIBIT 6(E) CONTINUED
SECTION 10(D) -- IN HER2/NEU
[***]
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EXHIBIT 6(E) CONTINUED
Section 10(D) Continued
[***]
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EXHIBIT 6(E) CONTINUED
SECTION 10(E) -- IN MAMMAGLOBIN
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MILESTONE PAYMENT (U.S.$)
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EXHIBIT 6(e)(i) TO COLLABORATION AND LICENSE AGREEMENT
CREDITABILITY OF MILESTONES
[***]
Any milestone not referenced by subsection number in the above table is
not creditable.
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EXHIBIT 6(f) TO COLLABORATION AND LICENSE AGREEMENT
ADDITIONAL COSTS RELATING TO CLINICAL MATTERS
Her2/neu-Mammaglobin Field:
[***]
Tb Field:
[***]
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EXHIBIT 7(a) TO COLLABORATION AND LICENSE AGREEMENT
CANCER ROYALTIES
SECTION 1 -- BC FIELD, PC FIELD, OC FIELD AND CC FIELD
Vaccine Product and New DC Therapy Product Patent Royalty:
[***]
Vaccine Product and New DC Product Know-How Royalty:
[***]
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EXHIBIT 7(a) TO COLLABORATION AND LICENSE AGREEMENT
CANCER ROYALTIES
SECTION 2
In the event of vial-based treatment for the BC Field, the PC Field, the
OC Field or the CC Field, solely in connection with Vaccine Products, the
following royalties shall apply:
Vaccine Product Patent Royalty:
[***]
Vaccine Product Know-How Royalty:
[***]
Notwithstanding anything to the contrary in Subsection 7(a) of
the Agreement, the royalties set forth on this Exhibit 7(a), Section 2, shall
not apply to Net Sales of New DC Therapy Products developed pursuant to the R&D
Programs directed to the BC Field, the PC Field, the OC Field or the CC Field.
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EXHIBIT 7(b) TO COLLABORATION AND LICENSE AGREEMENT
INFECTIOUS DISEASE ROYALTIES
SECTION 1 -- TB FIELD
Vaccine Product and New DC Therapy Product Patent Royalty:
[***]
Vaccine Product and New DC Therapy Product Know-How Royalty:
See Subsection 7(b)(ii).
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EXHIBIT 7(B) CONTINUED
SECTION 2 -- CP FIELD AND CT FIELD
Vaccine Product and New DC Therapy Product Patent Royalty:
[***]
Vaccine Product and New DC Therapy Product Know-How Royalty:
See Subsection 7(b)(ii).
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<PAGE> 135
EXHIBIT 7(c) TO COLLABORATION AND LICENSE AGREEMENT
HER2/NEU AND MAMMAGLOBIN ROYALTIES
SECTION 1 -- VACCINE PRODUCT PATENT ROYALTIES
Her2/neu Antigen(s)
[***]
Her2/neu Antigen(s) and Additional Antigens
[***]
Mammaglobin Royalties: [***]
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<PAGE> 136
EXHIBIT 7(c) TO COLLABORATION AND LICENSE AGREEMENT
HER2/NEU AND MAMMAGLOBIN ROYALTIES
SECTION 2 -- DC THERAPY PRODUCT PATENT ROYALTIES
Her2/neu Antigen(s)
[***]
Her2/neu Antigen(s) and Additional Antigen(s)
[***]
Mammaglobin Royalties: [***]
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EXHIBIT 7(c) TO COLLABORATION AND LICENSE AGREEMENT
HER2/NEU AND MAMMAGLOBIN ROYALTIES
SECTION 3 -- VACCINE PRODUCT KNOW-HOW ROYALTIES
Her2/neu Antigen(s)
[***]
Her2/neu Antigen(s) and Additional Antigen(s)
[***]
Mammaglobin Royalties: [***]
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EXHIBIT 7(c) TO COLLABORATION AND LICENSE AGREEMENT
HER2/NEU AND MAMMAGLOBIN ROYALTIES
SECTION 4 -- DC THERAPY PRODUCT KNOW-HOW ROYALTIES
Her2/neu Antigen(s)
[***]
Her2/neu and Additional Antigen(s)
[***]
Mammaglobin Royalties: [***]
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EXHIBIT 7(d) TO COLLABORATION AND LICENSE AGREEMENT
EXISTING DC THERAPY ROYALTIES
SECTION 1 - TB FIELD:
Existing DC Therapy Patent Royalty:
[***]
Existing DC Therapy Know-How Royalty:
[***]
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<PAGE> 140
EXHIBIT 7(d) TO COLLABORATION AND LICENSE AGREEMENT
EXISTING DC THERAPY ROYALTIES
SECTION 2 - BC FIELD, PC FIELD:
Existing DC Therapy Patent Royalty:
[***]
Existing DC Therapy Know-How Royalty:
[***]
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<PAGE> 141
EXHIBIT 7(e)(i) TO COLLABORATION AND LICENSE AGREEMENT
EXISTING CORIXA ROYALTY OBLIGATIONS FOR HER2/NEU AND MAMMAGLOBIN
Her2/neu:
[***]
Mammaglobin:
[***]
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<PAGE> 142
EXHIBIT 16(e) TO COLLABORATION AND LICENSE AGREEMENT
CORIXA THIRD PARTY AGREEMENTS
1. Amended and Restated Exclusive License Agreement between The University of
Washington and Corixa Corporation, effective April 1, 1997.
2. License Agreement, between Washington University and Corixa Corporation,
dated August 20, 1996.
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EXHIBIT 17(d) TO COLLABORATION AND LICENSE AGREEMENT
MINIMUM DILIGENCE COUNTRIES
[***]
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<PAGE> 1
EXHIBIT 99.1
CORIXA AND SMITHKLINE BEECHAM BIOLOGICALS SIGN STRATEGIC PARTNERSHIP
Agreement is a Major Expansion, Adding Five New Vaccine Programs to Existing
Discovery Efforts
October 28, 1998 - Corixa Corporation, Seattle, USA (Nasdaq : CRXA) and
SmithKline Beecham Plc (SB), London, (London Stock Exchange : SB)/SmithKline
Beecham, Philadelphia (NYSE: SBH) today announced that they have entered into a
strategic partnership. The new partnership is a major expansion of Corixa's
current collaboration and licensing agreements with SB's vaccine division, SB
Biologicals S.A (SB Bio). The new agreement retains the existing programs
between Corixa and SB Bio, namely antigen discovery in tuberculosis, breast
cancer and prostate cancer and adds programs in ovarian and colon carcinoma
vaccine discovery and development. In addition to these programs, the new
agreement will add discovery efforts aimed at the development of vaccines for
two chronic infectious pathogens, Chlamydia trachomatis, which causes sexually
transmitted disease and Chlamydia pneumoniae, which has recently been associated
with the development of atherosclerosis. Finally, the discovery phase of the
agreement allows for the selection of one additional field to be agreed upon at
a future time.
"This partnership is by far our biggest collaboration to date, both in terms of
its scope and financial commitment", stated Steven Gillis, Ph.D., President and
CEO of Corixa. "What began as a small antigen discovery effort aimed at
identifying novel tuberculosis antigens has led to a relationship which could
result in a number of products for the prevention or treatment of a variety of
life-threatening diseases. We firmly believe that the breadth of this new
agreement with SB speaks well of Corixa's antigen discovery technology, know-how
and early stage development capabilities. The long-term nature of this new
relationship will enable us to continue to add new vaccine and immunotherapeutic
discovery programs, even as we undertake the additional obligations under this
new agreement."
In addition to the four-year collaboration program, SB has licensed rights to
Corixa's Her-2/neu vaccine for breast and ovarian cancer which is currently in
Phase I clinical trials, as well as Corixa's novel breast cancer antigen known
as mammaglobin. With the exception of tuberculosis vaccine rights, in which
Corixa and SB have co-exclusive rights in Japan, all other vaccine rights are
worldwide and exclusive to SB. SB has also retained option rights to
non-exclusively license Corixa's adjuvant LeiF, as well as to use Corixa's
patented microsphere technology for vaccine delivery.
"We believe that Corixa's abilities represent state-of-the-art antigen discovery
technology and know-how, as evidenced by the results to date in our
tuberculosis, breast and prostate cancer collaborations," said Jean Stephenne,
President and General Manager of SB. "In reviewing our mid-to-long-term program
options, Corixa's technology and proven capabilities were complementary to our
own, and they demonstrated a willingness to pursue collaboration in areas that
matched our disease priorities. In addition, by in-licensing Corixa's Her-2/neu
vaccine for worldwide development, we are adding a clinical stage program which,
from the recent data presented at the American Society of Clinical Oncology, we
believe holds promise as an important new cancer therapeutic," he added. "This
is the largest collaboration we have at SB Bio, and was accomplished as a result
of the strong working relationship we have built over the past three years and
the vision that both our companies share toward the development of pharmaccines,
or therapeutic vaccines."
According to the terms of the agreement, SB has committed to funding of
approximately $49 million during the next four years. Included in this, SB will
pay $2.5 million to purchase shares of Corixa's common stock at a premium to its
market value, and Corixa may require SB to purchase an additional $2.5 million,
at a premium to market value, at a later date. In addition, product milestones
payable upon successful clinical development and successful commercialization
for all of the programs could exceed $150 million, excluding future royalty
obligations which vary depending on the types of the product sold. This figure
also excludes milestones and royalties on possible non-vaccine products
potentially available to SB under the programs, such as monoclonal
antibody-based therapeutics. Further financial details have not
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been disclosed by either company. The effectiveness of the new agreement is
subject to the expiration or early termination of the required waiting period
under Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended, which is
currently anticipated to occur in the fourth quarter of 1998.
"Because SB understands our desire to partner discrete applications of our
technology, the means for Corixa to pursue complementary non-vaccine
partnerships for antigen discoveries made under our collaborative program have
been incorporated into the new agreement," stated Dr. Gillis. "This structure
provides SB with a return on its investment in the event it wishes to forego
commercialization of such non-vaccine products. As a result, we believe the
collaboration will be a win for Corixa, its shareholders and SB."
The two companies foresee potential opportunities to use the antigen discoveries
made under this agreement outside vaccine development, and the new collaboration
provides certain limited rights to the parties to antigens discovered under the
programs for purposes of therapeutic drug monitoring. In accordance with the
agreement, SB and Corixa will share in proceeds resulting from certain
subsequent third party license arrangements generated from diagnostic and
passive immunotherapy products (such as monoclonal antibodies). The two
companies have been collaborating since October 1995, when Corixa and SB
established an antigen discovery program in the field of tuberculosis. The
companies broadened their collaborative efforts in March 1997, when SB committed
to a multi-year vaccine research effort for breast and prostate cancers, and
obtained an option on two additional cancers.
About Corixa
Corixa Corporation (Nasdaq : CRXA) is a research-based biotechnology company
committed to saving lives and preventing diseases by understanding and directing
the immune system. Corixa applies its advanced immunological expertise and
proprietary technology platforms to rapidly discover and optimize vaccines and
other antigen-based products. The company partners with innovative developers
and marketers of pharmaceuticals and diagnostic products to make its solutions
available to patients around the world. Corixa was founded in 1994 and is
headquartered in Seattle, Washington. For more information about the company,
please visit its Website at www.corixa.com.
About SmithKline Beecham Biologicals
SB, one of the world's leading healthcare companies, discovers, develops,
manufactures, and markets human pharmaceuticals, health-related consumer
products and clinical laboratory testing services.
SB Bio is located in Rixensart, Belgium, and is the center of all SB's
activities in the field of vaccine research, development and production. SB Bio
employs over 500 research scientists who are devoted to discovering and
developing cost-effective and more convenient combination vaccine products to
prevent infections which cause serious medical problems worldwide. SmithKline
Beecham's expertise in immunology and vaccinology is being used to develop a
number of therapeutic vaccines (Pharmaccines) for the treatment of some chronic
infectious diseases and cancers. SB Bio produces well over 700 million doses of
vaccines per year. Every second, over 20 doses of SB Bio vaccines are
distributed around the world.
Forward-Looking Statements
Except for the historical information presented, the matters discussed in this
press release are forward-looking statements that are subject to certain risks
and uncertainties that could cause actual results to differ materially from any
future results, performance or achievements expressed or implied by such
statements. Such risks and uncertainties include possible delays or failure by
Corixa or SB to develop and/or commercialize any technology covered by the new
collaborative agreement between the parties, possible risks related to adverse
clinical results as products including any of such technology move into clinical
trials, impact of alternative technological advances and competition in the
collaborative relationship between the parties, inherent risks in early stage
development of such technology, the potential dilutive effect of equity
purchases by SB to other Corixa shareholders; and other risks detailed from time
to time in
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Corixa's public disclosure filings with the U.S. Securities and Exchange
Commission (SEC), including the Annual Report on Form 10-K for the fiscal year
ended December 31, 1997, the Form 10-Q for the first and second quarters ended
March 31, 1998, and June 30, 1998, respectively, and in the Company's
Registration Statement on Form S-4, as amended and filed on August 5, 1998.
Copies of Corixa's public disclosure filings with the SEC are available from its
investor relations department.
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