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EXHIBIT 10.20
OPTION AND LICENSE AGREEMENT
This Agreement is entered into by and between:
- CORIXA CORPORATION, a company duly organized and existing under the
laws of the State of Delaware, USA, having its principal place of
business at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000,
XXX,
represented by Xxxx XxXxxx, Executive Vice President and Chief
Operating Officer
(hereinafter referred to as "CORIXA")
and:
- PASTEUR MERIEUX SERUMS & VACCINS S.A., a societe anonyme existing and
organized in accordance with the laws of the Republic of France,
registered at the Registre du Commerce et des Societes in Lyon under
N(degrees) RCS B 349 505 370, with a capital of 1.698.859.000 French
Francs, whose registered head-office is located at 00, xxxxxx Xxxxxxx,
00000 Xxxx, Xxxxxx,
represented by Xx. Xxxx-Xxxxxxx XXXXXXXX, Chairman, President and
Chief Executive Officer,
(hereinafter referred to as "PMC")
WITNESSETH
WHEREAS, CORIXA has discovered and started to develop the adjuvant properties of
an antigenic protein of Leishmaniasis braziliensis which may be useful in the
formulation of vaccines with enhanced potency;
WHEREAS, CORIXA has generated and owns proprietary rights, including patent
rights and know-how, relating to LeIF and the use of LeIF as an immunoadjuvant;
WHEREAS, PMC is a leading vaccine company with worldwide research, development,
manufacturing and marketing capabilities;
WHEREAS, PMC is currently conducting several research and development programs
aiming at the creation of enhanced vaccines including research and development
of several candidate adjuvants of different chemical or biological definitions,
several vectors and several delivery systems;
WHEREAS, PMC wishes to acquire from CORIXA an option to a worldwide license
under CORIXA's patent rights and know-how related to LeIF for use in certain
fields;
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WHEREAS, CORIXA is willing to grant to PMC such an option to such a license in
order to allow PMC to evaluate LeIF in combination with certain of PMC's
proprietary vectors, drug delivery systems and antigens, subject to the terms of
and conditioned upon this Agreement;
NOW, THEREFORE, in consideration of the mutual covenants and obligations set
forth herein, the Parties hereto, intending to be legally bound, agree as
follows:
ARTICLE I - DEFINITIONS AND INTERPRETATION
1.1. DEFINITIONS: For the purposes of this Agreement the following
words and phrases shall have the following meanings:
(a) "AFFILIATE" means, with respect to a Party, any person,
corporation or business entity that directly, or indirectly through one or more
intermediaries, controls or is controlled by, or is under common control with, a
Party. For the purpose of this definition, control of a corporation or of
another business entity shall mean direct or indirect beneficial ownership of
fifty percent (50%) or more of the voting interests in, or a fifty percent
(50%) or greater interest in the equity of, such corporation or other business
entity;
(b) "AGREEMENT" means this agreement, all amendments and
supplements to this Agreement and all schedules to this Agreement, including the
following:
Schedule A - Existing Licensed Patents;
Schedule B - Authorized PMC Affiliates;
Schedule C - Material Specifications;
Exhibit 1 - Special Biological Materials Transfer Agreement
Exhibit 2 - Evaluation Plans
Exhibit 3 - Research Program.
(c) "CORIXA IMPROVEMENTS" means Improvements which are
conceived, developed or reduced to practice during the term of this Agreement
solely by employees or contractors acting on behalf of CORIXA or its Affiliates,
to the extent that CORIXA has now or hereafter shall have the right to grant
licenses, immunities or other rights thereon.
(d) "CORIXA RESEARCH PATENTS" has the meaning ascribed to it
in Section to it in Section 9.1. hereof;
(e) "CORIXA TECHNOLOGY" means the Licensed Patents, the
Material, the CORIXA Research Patents, the Licensed Know-How and the CORIXA
Improvements;
(f) "CALENDAR QUARTER" means any of the three-month periods
beginning January 1, April 1, July 1 and October 1 in any year;
(g) "COMBINATION PRODUCT" has the meaning ascribed to it in
Section 2.4. hereof;
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(h) "MATERIAL" or "LeIF" means CORIXA's proprietary antigen of
Leishmania, known as leishmanial eukaryotic initiation factor, either the
protein itself or its cDNA (except as otherwise specified herein), that is the
subject matter of the Licensed Patents;
(i) "IMPROVEMENTS" means all patentable or non-patentable
inventions, discoveries, technology and information of any type whatsoever,
including without limitation compositions, chemical compounds, biological
materials, whether or not derived from Material, methods, processes, technical
information, knowledge, experience and know-how which (i) utilize, incorporate,
derive from, are based on or could not be conceived, developed or reduced to
practice but for the use of the CORIXA Technology, (ii) which adds to the
knowledge of the Material, its properties in general or as an immunoadjuvant for
use in vaccines for active immunization or (iii) helps mastering or enhancing
processes for manufacturing Material (for instance, in terms of yield or purity)
or processes for formulating Material in combination with other molecules,
including but not limited to antigenic proteins; and which are conceived,
developed or reduced to practice as a result of and during the term of the
Agreement, solely or jointly by employees or others acting on behalf of CORIXA
or by employees or others acting on behalf of PMC.
(ii) "CONFIDENTIAL INFORMATION" has the meaning ascribed to it
in Section 8.1. of this Agreement;
(j) "DELIVERY DATE" means the date upon which CORIXA or a
CORIXA's Affiliates shall have delivered to PMC or an Authorized PMC Affiliate
that PMC shall designate, quantities of Material meeting Material Specifications
as described in Schedule C hereto sufficient to enable PMC and its Affiliates to
implement the Evaluation Plans during the Option Period and to evaluate PMC's
interest in exercising the Option;
(jj) "EVENT OF FORCE MAJEURE" has the meaning ascribed to it
in Article 16 of this Agreement;
(k) "EVALUATION PLANS" means the evaluation plans established
by PMC and agreed to and accepted by CORIXA with respect to each Field of Use
which describe evaluation works that shall be performed by PMC in each Field of
Use during the Option Period, and which are attached hereto as Exhibit 2;
(l) "FIELDS OF USE" means the use of LeIF as an adjuvant in
[***] vaccines for [***] immunization ([***]) against the following infectious
diseases: (i) Influenza, (ii) Acquired Immunodeficiency Syndrome ("AIDS"), (iii)
Malaria, (vi) Respiratory Syncitial Virus ("RSV") and (v) Mycobacterium
Tuberculosis; and "Field of Use" (singular) means any one of the foregoing, and
further provided that the [***];
(m) "FIRST COMMERCIAL SALE" means, in each country of the
Territory, the first commercial sale of a Product by PMC, its Affiliates or
Sublicensees to a Third-Party following, if required by law, approval of its
marketing and its pricing by the appropriate governmental agency for the country
in which the sale is to be made and, when such approval is not required by
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law, the first commercial sale in that country, in each case for use or
consumption of such Product in such country by the general public; for avoidance
of doubt, First Commercial Sale of a given Product cannot occur more than once
in any particular country of the Territory;
(n) "JOINT RESEARCH PATENTS" has the meaning ascribed to it
in Section 9.2.2 hereof;
(mm) "JOINT RESEARCH PATENTS" shall have the meaning assigned
to it in Section 9.2.2 hereof;
(n) "LICENSE" has the meaning ascribed to it in
Section 2.3.1. of this Agreement;
(nn) "LICENSED KNOW-HOW" means any and all technical
information, processes, formulae, data, engineering, technical and shop
drawings, inventions, shop-rights, chemical compounds, know-how and trade
secrets, in each case that is Confidential Information according to Article 8,
that is useful or necessary to make, have made, use or sell Products or to
practice under the Licensed Patents and/or the Joint Research Patents in the
Field of Use, which have been, or hereafter are, either developed by CORIXA or
its Affiliates, or the rights to which in the Field of Use have been acquired by
CORIXA or its Affiliates. In particular, but without prejudice to the generality
of the foregoing, Licensed Know-How shall include, with respect to Material,
chemical and analytical methods and data, Material specifications,
pharmacological and toxicological methods and data;
(o) "LICENSED PATENTS" means:
(i) any existing patents and patent applications
isted in Schedule A to this Agreement;
(ii) any future patents issued from any patent
applications referred to in Paragraph 1.1.(o).(i) above and any future patents
issued from a patent application filed in any country in the Territory which
corresponds to a patent or patent application identified in Paragraph
1.1.(o).(i) above;
(iii) any future patent issued, assigned or licensed
to CORIXA or its Affiliates or to any employee, contractor, subcontractor or
agent of the foregoing from a patent application filed in any country, useful or
necessary to make, have made, use or sell Products or to make, have made or use
Material;
(iv) any reissues, confirmations, renewals,
extensions (including but not limited to extensions referred to in Article 11
hereof), counterparts, divisions or continuations issued, assigned or licensed
to CORIXA or its Affiliates of or relating to the patents or patent applications
identified in Paragraph 1.1.(o).(i), (ii) and (iii) above; and
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(v) any continuations-in-part or patent-of-addition
issued, assigned or licensed to CORIXA or its Affiliates and of or relating to
the patents or patent applications identified in Paragraph 1.1.(o).(i), (ii) or
(iii) hereof;
(vi) any CORIXA Research Patents and CORIXA's
interest in Joint Research Patents;
For greater certainty, whenever used, "Licensed Patents"
include the inventions disclosed in and the subject matter of patent
applications;
(p) "MTA" means the Special Material Transfer Agreement
attached hereto as Exhibit 1;
(q) "NET SALES" means the gross amount received by PMC, its
Affiliates and Sublicensees from the sale or other disposition of Products to
Third-Parties, less the sum of the following deductions for amounts actually
incurred related to said sale or other disposition:
(i) normal, customary trade discounts (including
volume discounts), credits and rebates and allowances and adjustments for
rejections, recalls and returns;
(ii) cost of freight and insurance, sales, use,
excise, value-added and similar taxes and duties imposed on the sale and
included in the gross amount charged to customers, and government-mandated
vaccine insurance premium;
(r) "NOTICE OF DISPUTE" has the meaning ascribed to it in
Section 19.3.(a) of this Agreement;
(s) "OPERATIONAL DATE" is defined in Section 2.2.4. hereof;
(t) "OPTION" means, with respect to the Fields of Use, the
option granted by CORIXA to PMC pursuant to the provisions of Section 2.2.
hereof to obtain the licenses under Section 2.3. hereof;
(tt) "OPTION EXERCISE FEE" has the meaning ascribed to it in
Section 2.2.4. hereof;
(u) "OPTION FEE" has the meaning ascribed to it in
Section 2.2.2. hereof;
(uu) "OPTION PERIOD" means, with respect to each Field of Use,
the period commencing as of the Delivery Date and continuing until the date
referred to in the Evaluation Plan for such Field of Use, as such Option Period
may be extended pursuant to the provisions of Section 2.2.3. hereof, or
terminated earlier pursuant to the provisions of Article 14 below;
(v) "PARTIES" means PMC and CORIXA, and "Party" means any one
of them;
(vv) "PMC RESEARCH PATENTS" has the meaning ascribed to it in
Section 9.2.3.
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(w) "PMC IMPROVEMENTS" means Improvements which are conceived,
developed or reduced to practice during the term of this Agreement, either
during the performance of the Research Program or during subsequent development,
commercialization, marketing and manufacturing of Material and/or Products,
solely by employees or contractors acting on behalf of PMC or its Affiliates, to
the extent that PMC has now or hereafter shall have the right to grant licenses,
immunities or other rights thereon;
(ww) "PRODUCT" means any and all products used in the Field of
Use which utilize any or are based on any CORIXA Technology, PMC Improvements or
Joint Inventions, which means that the manufacture, sale or use of such Products
would have constituted a misappropriation of substantial Licensed Know-How,
Material or CORIXA Improvements and/or an infringement of the Licensed Patents
but for the licenses granted in this Agreement;
(x) "ROYALTY TERM" means, with respect to any Products in each
country in the Territory, the period of time equal to the longer of (a) [***]
from the date of First Commercial Sale of a Product in such country or (b) the
term for which a Valid Patent Claim in such country remains in effect and, but
for a license granted by this Agreement, would be infringed by the manufacture,
use or sale of such Product in the Field of Use in such country;
(xx) "SUBLICENSEES" means any person acting pursuant to a
sublicense granted to it by PMC or its Affiliates under the terms of this
Agreement;
(y) "TERRITORY" means all countries in the world;
(yy) "THIRD-PARTY" means any person other than PMC, CORIXA
and their respective Affiliates;
(z) "VALID PATENT CLAIM" means a claim of an issued and
unexpired patent or patent application included in Licensed Patents or those PMC
Research Patents having a subject matter on Improvement which has not been held
permanently revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise.
(zz) "AUTHORIZED PMC AFFILIATE" shall mean the Affiliates of
PMC that are listed on Schedule B, which may be amended from time to time by
mutual agreement of the parties.
1.2. CERTAIN RULES OF INTERPRETATION IN THIS AGREEMENT AND THE
SCHEDULES.
(a) An accounting term not otherwise defined has the meaning
assigned to it by, and every accounting matter will be determined in accordance
with, generally accepted accounting principles in the United States of America
(US Gaap);
(b) Unless otherwise specified, all references to monetary
amounts are to United States of America currency (US Dollars);
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(c) The descriptive headings of Articles and Sections are
inserted solely for convenience of reference and are not intended as complete or
accurate descriptions of the content of such Articles or Sections;
(d) The use of words in the singular or plural, or with a
particular gender, shall not limit the scope or exclude the application of any
provision of this Agreement to such person or persons or circumstances as the
context otherwise permits;
(e) Whenever a provision of this Agreement requires an
approval or consent by a Party to this Agreement and notification of such
approval or consent is not delivered within the applicable time limit, then,
unless otherwise specified, the Party whose approval or consent is required
shall be conclusively deemed to have withheld its approval or consent;
(f) Unless otherwise specified, time periods within or
following which any payment is to be made or act is to be done shall be
calculated by excluding the day on which the period commences and including the
day on which the period ends and by extending the period to the next business
day following if the last day of the period is not a business day in the
jurisdiction of the Party to make such payment or do such act; and
(g) Whenever any payment is to be made or action to be taken
under this Agreement is required to be made or taken on a day other than a
business day, such payment shall be made or action taken on the next business
day following such day in the jurisdiction of the Party to make such payment or
do such act.
ARTICLE 2 - OPTIONS AND LICENSES
2.1. RESEARCH LICENSE TO PMC.
2.1.1. Subject to the provisions of this Agreement, CORIXA
hereby grants to PMC and to Authorized PMC Affiliates, for the term of the
Option Period, a non-exclusive license in the Territory under the Corixa
Technology on the terms and conditions of the MTA and subject to Section 2.5 and
Article 8 hereof, solely for the purpose of conducting research and development
activities in the Fields of Use relating to the Material and/or Product and
evaluating PMC's interest to exercise the Option by implementing the Evaluation
Plans. The license granted to PMC under this Section 2.1 shall not include (i)
the right to use CORIXA Technology for any commercial purpose whatsoever, (ii)
the right to grant sublicenses thereto to any Affiliate or Third-Party, (iii)
the right to file a Product License Application in any country, or (iv) the
right to make, have made, use or sell a Product or Material for any purpose
other than the foregoing evaluation, including for any commercial purpose.
2.1.2. CORIXA agrees that promptly following the execution of
this Agreement, it shall make available to PMC and/or to Authorized PMC
Affiliates that PMC shall designate such Licensed Know-How (including, but not
limited to, non-published patent applications included in Licensed Patents) and
such quantities of Material as reasonably necessary to enable PMC to conduct its
research and development activities during the Option Period and to evaluate
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its interest in exercising the Option. All Material supplied by CORIXA to PMC
pursuant to this Section 2.1 shall meet the Material Specifications set forth in
Schedule C hereto, which specifications may be amended from time to time as the
Parties may agree in writing and set forth in a revised Schedule C.
2.2. OPTION GRANT.
2.2.1. Grant of the Option.
Subject to the provisions of this Agreement, CORIXA
hereby grants to PMC an Option with respect to the Fields of Use, during the
Option Period, to obtain the License set forth in Section 2.3 below. PMC may
exercise the Option at any time on or before the expiration of the Option Period
including any extension thereof; provided , however, that if PMC does not
exercise the Option in at least one (1) Field of Use on or before the later of
(a) July 1, 1997 or (b) six months following the date of PMC's receipt of a
quantity of Material meeting the specifications of Schedule C reasonably
sufficient to allow PMC to evaluate its interest in exercising the Option, this
Agreement shall terminate in accordance with Section 14.1.
2.2.2. Option Fee.
Upon execution and delivery of this Agreement by both
Parties, PMC shall pay to CORIXA a lump sum payment of [***] by wire transfer of
immediately available funds, which payment shall be nonrefundable and
non-creditable.
2.2.3. Extension of the Option Period.
Provided that PMC has exercised the Option in at
least one (1) Field of Use in accordance with Section 2.2.1 hereinabove, PMC
shall have the right to extend the Option Period for any other Field of Use for
one (1) additional period of [***] by providing written notice to CORIXA of
PMC's intention to extend the Option Period not less than thirty (30) days prior
to the expiration of the initial Option Period.
2.2.4. Exercise of the Option.
PMC may exercise the Option with respect to any Field
of Use on or before the expiration of the Option Period applicable to such Field
of Use or extension thereof (a) by providing written notice of exercise to
CORIXA not less than thirty (30) days prior to the expiration of the Option
Period or extension thereof, and (b) paying to CORIXA, a nonrefundable,
noncreditable Option Exercise Fee of:
(i) [***] with respect to the Influenza Field of
Use;
(ii) [***] with respect to the AIDS Field of Use;
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(iii) [***] with respect to the Malaria Field of Use;
(iv) [***] with respect to the RSV Field of Use;
(v) [***] with respect to the Tuberculosis Field of
Use.
The date upon which a first Option is exercised by
PMC pursuant to this Section 2.2.
is called the "Operational Date."
2.3. GRANT OF LICENSES TO PMC.
2.3.1. Grant.
If PMC exercises the Option for any Field of Use in
accordance with Section 2.2.4. above, and subject to and conditioned upon the
provisions of this Agreement, CORIXA automatically shall grant to PMC:
(i) a license to the CORIXA Technology in the
Territory, limited solely to the Field(s) of Use with respect to which the
Option has been so exercised, to make, have made, use and sell Products in such
Field(s) of Use; and
(ii) a license in the Territory, limited solely to
the Field(s) of Use with respect to which the Option has been so exercised, to
make, have made and use the Material under the Licensed Patents and by using the
CORIXA Technology solely in the relevant Field(s) of Use for the purpose of
manufacturing, or having manufactured, Products in accordance with Article 12
hereof (collectively, the "License").
2.3.2. Exclusivity.
Subject to and conditioned upon the provisions of
this Agreement, the rights, licenses and privileges granted pursuant to this
Article II in the Influenza Field of Use and the RSV Field of Use shall be
exclusive to PMC as far as any other Person in the world including CORIXA and
its Affiliates is concerned. Without limiting the generality of the foregoing,
CORIXA covenants that during the term of this Agreement, neither CORIXA nor its
Affiliates shall grant to any other person any right, license or privilege to
make, have made, use or sell Products, or to make, have made or use Material, or
to otherwise use or exploit CORIXA Technology, in the Influenza Field of Use and
the RSV Field of Use.
The licenses granted pursuant to Section 2.3.1.(i)
in the AIDS, Malaria and Tuberculosis Fields of Use, and the license granted
pursuant to Section 2.3.1.(ii), shall be non-exclusive.
For greater certainty, CORIXA has and retains all
rights in and to the CORIXA Technology outside the Fields of Use and PMC has no
rights in the CORIXA
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Technology outside the Fields of Use, and CORIXA retains the right to
manufacture the Material, without prejudice to PMC's right in this respect as
otherwise provided for in this Agreement.
2.3.3. Rights to Sublicense.
(i) PMC shall have the right, with CORIXA's
prior written consent (which consent shall not be unreasonably withheld), to
sublicense the rights granted to PMC pursuant to this Agreement in any Field of
Use to Third-Parties.
(ii) PMC shall have the right, without obtaining
the further consent of CORIXA, to sublicense in any Field of Use all or any
portion of the rights granted to PMC pursuant to this Agreement (i) to any or
all of its Affiliates, and (ii) to any person in any country of the Territory if
required to do so by any governmental authority having jurisdiction in such
country;
(iii) PMC agrees that all sublicenses granted by
PMC hereunder shall expressly bind Sublicensees to the terms of Article 8,
"Confidentiality." In the event PMC grants sublicenses, PMC shall pay royalties
to CORIXA as if Net Sales of the Sublicensees were Net Sales of PMC;
(iv) PMC shall pay to CORIXA [***] of all upfront
fees, license fees, milestone payments or any similar payments of any kind
received by PMC under any sublicenses granted by PMC to any Third-Party pursuant
hereto, whether in cash or non-cash consideration. If PMC receives non-cash
consideration (including any intellectual property rights) pursuant to any such
Third-Party sub-license, CORIXA shall be entitled to receive a cash payment
equal to [***] of the fair market value of such non-cash consideration, with
such fair market value determined by a New-York-based Third-Party appraiser with
significant background in evaluating the type of non-cash consideration at
issue. Such Third-Party appraiser shall be chosen by mutual agreement of the
Parties;
(v) PMC shall notify CORIXA of each sublicense
granted to Third-Parties and shall provide CORIXA with the name and address of
each Sublicensee and a description of the rights granted and the territory
covered by each sublicenses.
2.3.4. Subcontracting.
Notwithstanding anything herein provided for to the
contrary, PMC shall be allowed to (i) sub-contract in whole or in part Product
development to Third-Parties, (ii) appoint sales agents and distributors to
market Product and (iii) sub-contract manufacturing of Product with
Third-Parties or with CORIXA, or CORIXA's Affiliates.
2.4. COMBINATION PRODUCTS.
The License shall not include a license to make, have made,
use or sell any Product as part of a Combination Product (as defined below).
However, in the event that PMC
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wishes to sell such Combination Product, the Parties shall at such time
negotiate in good faith the terms upon which a license with respect to
Combination Products might be granted by CORIXA to PMC. Such terms would
include, at a minimum [***] provided it is scientifically established that
Material acts effectively as an adjuvant stimulating and/or enhancing the immune
response with respect to the infectious agent(s) other than those listed in the
definition of the Field of Use for which the concerned Combination Product(s)
claim(s) an active immunization effect. "Combination Product" shall mean a
product that combines a Product and another vaccine for active immunization
against an infectious disease that does not fall under the definition of Field
of Use.
2.5. PROCEDURES FOR PROVISION OF KNOW-HOW AND MATERIALS.
2.5.1. Disclosure of Technology.
From time to time during the term of this Agreement,
CORIXA shall disclose or cause its Affiliates to disclose to PMC such CORIXA
Technology as reasonably necessary to enable PMC to evaluate, develop,
manufacture and commercialize Products and to manufacture, have manufactured or
use Material in the Fields of Use on the terms and subject to the conditions of
this Agreement. In addition, during the term of this Agreement, CORIXA shall,
upon PMC's reasonable request and with adequate notice to CORIXA, make available
to PMC at PMC's or its Authorized Affiliates' manufacturing facilities or the
facility of a Third-Party manufacturer who shall have contracted with PMC to
manufacture Products or Material, CORIXA's or CORIXA Affiliate's personnel to
provide technical assistance to PMC's personnel, or PMC's Authorized Affiliates'
personnel or Third-Party manufacturer's personnel.
PMC shall pay or have paid by its concerned
Affiliates all reasonable and necessary out-of-pocket expenses incurred by
CORIXA or its Affiliates in connection with such technical assistance.
The technical assistance to be rendered by CORIXA and
its Affiliates hereunder may include, upon reasonable request by PMC,
demonstration of manufacturing Know-How at a CORIXA's or a CORIXA Affiliate's
facility and disclosure of any and all sources of raw material and list and
specifications of equipment and machinery used in the production of Material
according to the Licensed Know-How.
2.5.2. Communication among Parties.
Each of PMC and CORIXA shall appoint a specific
individual who shall be available and shall act as a liaison person to
facilitate the day-to-day communications among the Parties. The names of the
liaison persons who shall act on behalf of each of the Parties shall be provided
by each of the Parties to the other immediately following the execution of this
Agreement. Each of PMC and CORIXA agrees to notify the other in accordance with
the terms of Section 19.1. of this Agreement in the event of a change in liaison
person.
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2.5.3. Identification of Know-How.
The Parties agree that all know-how and Materials to
be transferred to PMC pursuant to this Agreement shall be so transferred in the
case of written know-how memoranda marked confidential and, in the case of
Materials, by clearly marked containers. CORIXA shall clearly designate such
know-how and Materials that are Confidential Information. PMC shall designate an
individual who shall be responsible for receiving the know-how and Materials
from CORIXA and/or its Affiliates and the Parties agree that know-how (where
written) and Materials shall in all cases (except where the Parties agree
otherwise) be sent solely to the attention of such individual.
Upon receipt of Know-How and/or Materials, the
designated individual shall, on behalf of PMC, send an acknowledgment to CORIXA
and/or its Affiliates confirming receipt of the Know-How and/or Materials. The
Parties agree that they shall in good faith work together to establish and
maintain a system to record the transmission of Know-How and/or Materials under
this Agreement and make all commercially reasonable efforts to ensure such
system is followed.
2.5.4. Confidentiality.
All written Know-How transferred pursuant to this
Agreement shall be deemed to be "Confidential Information" in accordance with
Section 8.1.
2.5.5. Supply of Material.
CORIXA hereby warrants that any and all quantities of
Material to be supplied pursuant to this Section 2 by CORIXA or its Affiliates
to PMC (except such Material delivered by CORIXA to PMC pursuant to Section
2.1.2.) hereof shall be manufactured in accordance with current Good
Manufacturing Practices (cGMP) as in force in the country where such Material
shall be manufactured or as in force in the country where such Material shall be
used (if more stringent than cGMP applicable in the country of manufacture), and
shall meet Material Specifications as set forth in Schedule C hereto.
ARTICLE 3 - DEVELOPMENT AND COMMERCIALIZATION.
3.1. DEVELOPMENT AND COMMERCIALIZATION EFFORTS.
PMC shall develop, commercialize and market Products using
efforts at least comparable to the resources PMC invests in its internally
developed priority projects. Without limiting the foregoing, PMC (i) shall
conduct such preclinical and clinical trials as are necessary or desirable to
obtain all regulatory approvals to develop and commercialize such Products as
and where PMC determines are commercially feasible, (ii) shall diligently
develop and obtain necessary approval to market such Products (including, as the
case may be, pricing approval), and (iii) shall commence marketing and market
such Product in each country in which PMC has received all applicable regulatory
approvals therefor. PMC shall comply with all applicable good
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laboratory, clinical and manufacturing practices in the development and
commercialization of such Products, and shall cause its Affiliates and
subcontractors to do the same.
PMC shall be solely responsible for funding all costs of the
development and commercialization of each such Product. PMC shall keep CORIXA
informed in a timely manner as to the progress of the development of Products.
3.2. REVERSION OF RIGHTS TO CORIXA.
3.2.1. Failure to meet Milestones.
(a) PMC's rights hereunder shall automatically
become non-exclusive on a field-by-field basis in the Influenza Field of Use and
the RSV Field of Use in the event PMC shall not have achieved the milestone set
forth in Section 4.4.2.(ii) with respect to the Influenza Field of Use or the
milestone set forth in Section 4.4.4.(ii) with respect to the RSV Field of Use,
in the case of the Influenza Field of Use on the [***] anniversary of the
date of delivery of the first clinical lot of Material delivered by CORIXA to
PMC pursuant to Article 12 hereof, and in the case of the RSV Field of Use, on
the [***] anniversary of the commencement date of the first Phase I
clinical trial for a Product in the RSV Field of Use.
(b) PMC's rights hereunder shall terminate on a
field-by-field basis in whichever of the AIDS Field of Use, the Malaria Field of
Use and the Tuberculosis Field of Use PMC shall not have initiated Phase III
clinical trials on the [***] anniversary of the commencement date of the
first Phase I clinical trial for a Product in the relevant Field of Use.
(c) PMC's rights hereunder shall terminate on a
field-by-field basis effective [***] in whichever of the Influenza
Field of Use, the AIDS Field of Use, the Malaria Field of Use and the RSV Field
of Use in the event PMC shall not have commercialized at least one (1) Product
in each Field of Use on or before [***].
(d) PMC's rights hereunder shall terminate in
the Tuberculosis Field of Use effective [***] in the event PMC shall
not have commercialized at least one (1) Product in the Tuberculosis Field of
Use on or before [***].
(e) If within [***] year following PMC's
commencement of pivotal clinical efficacy trials for elderly people in the
Influenza Field of Use (the "Elderly Flu Trials"), PMC has not commenced pivotal
clinical efficacy trials for LeIF as a vaccine adjuvant in at least one (1)
additional representative population, PMC's rights hereunder in the Influenza
Field of Use shall be limited to use in elderly people; provided, however, that
if the data received from the Elderly Flu Trials is, in Corixa's reasonable
judgement, sufficient to file a PLA with respect to such additional
representative population, PMC's rights will not be so limited.
(f) If within [***] year following PMC's
commencement of pivotal clinical efficacy trials for infants in the RSV Field of
Use (the "Infant Flu Trials"), PMC has not commenced pivotal clinical efficacy
trials for LeIF as a vaccine adjuvant in at least one (1) additional
representative population, PMC's rights hereunder in the RSV Field of Use shall
be
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limited to use in infants; provided, however, that if the data received from
the Infant Flu Trials is, in Corixa's reasonable judgement, sufficient to file a
PLA with respect to such additional representative population, PMC's rights will
not be so limited.
3.2.3. Force Majeure.
If PMC's failure to satisfy a milestone under
Section 3.2.1. above, is due to one or more of the causes specified in Article
16, "Force Majeure," below, the applicable period specified in Section 3.2.1.
above shall be extended for such time as one or more causes specified in Article
16 below continues to exist.
3.2.4. [***]
ARTICLE 4 - ROYALTIES AND MILESTONES.
4.1. ROYALTIES PAYABLE BY PMC.
In consideration for the License granted to PMC herein, during
the Royalty Term, PMC shall pay to CORIXA royalties on Net Sales of Products but
for the License granted hereunder would infringe one or more Valid Patent
Claims. Such royalties shall be established at the following rates:
(a) with respect to the Influenza Field of Use
and the RSV Field of Use, [***], and
(b) with respect to the AIDS Field of Use, the
Malaria Field of Use and the Tuberculosis Field of Use, [***],
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provided, however, that in the event CORIXA transfers Licensed Know-How related
to the manufacture of LeIF to PMC or its Affiliates under Article 12 hereof, the
foregoing royalty rates shall be [***] and [***], respectively.
With respect to all countries in which no Valid Patent Claim
exists, the above mentioned royalty rates shall be reduced by [***], except that
in any country in which a Third-Party is commercializing a product that, if sold
in a country in which a Valid Patent Claim exists would infringe such Valid
Patent Claim, the above-mentioned royalty rates shall be reduced by [***].
4.2. THIRD-PARTY ROYALTIES.
If PMC, its Affiliates or Sublicensees is required to pay
royalties to any Third-Party in order to exercise its rights hereunder to make,
have made, use or sell Products or to make, have made or use Material, then the
royalty rates hereinabove mentioned shall be reduced by the royalty payable by
PMC to such Third-Party, provided, however, that in no event shall the royalty
rate applicable pursuant to this Section 4.2 be less than [***],
except in the event CORIXA transfers Licensed Know-How related to the
manufacture of LeIF to PMC or its Affiliates, in which case the foregoing
minimum royalties shall be [***].
4.3. SINGLE ROYALTY: NON-ROYALTY SALES.
It is understood that in no event shall more than one royalty
be payable under Sections 4.1. and 4.2. with respect to a particular unit of
Product. No royalty shall be payable under this Article 4 with respect to sales
of Products among PMC and its Authorized Affiliates, or among Sublicensees and
their Affiliates, or among PMC and its Sublicensees, but a royalty shall be due
upon the subsequent sale of the Product to a Third-Party. [***].
4.4. MILESTONE PAYMENTS.
As additional consideration for the licenses, rights and
privileges granted to it hereunder, PMC shall pay to CORIXA the following
milestone payments to CORIXA within thirty (30) days of the first occurrence of
each event set forth below with respect to Products, whether such events are
achieved by PMC, its Affiliates or Sublicensees :
4.4.1. In the AIDS Field of Use:
(i) Upon completion of the first Phase I
clinical trial, [***];
(ii) Upon initiation of the first Phase III
clinical trial, [***];
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(iii) Upon receipt of the first regulatory
approval in either [***].
4.4.2. In the Influenza Field of Use:
(i) Upon completion of the first Phase I
clinical trial [***];
(ii) Upon initiation of the first Phase III
clinical [***];
(iii) Upon receipt of the first regulatory
approval for use [***].
4.4.3. In the Malaria Field of Use:
(i) Upon completion of the first Phase I
clinical trial, [***];
(ii) Upon initiation of the first Phase III
clinical trial, [***];
(iii) Upon receipt of the first regulatory
approval in either [***].
4.4.4. In the RSV Field of Use:
(i) Upon completion of the first Phase I
clinical trial in [***];
(ii) Upon initiation of the first Phase III
clinical trial in [***];
(iii) Upon receipt of the first regulatory
approval for use [***].
4.4.5. In the Tuberculosis Field of Use:
(i) Upon completion of the first Phase I
clinical trial, [***];
(ii) Upon initiation of the first Phase III
clinical trial, [***];
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(iii) Upon receipt of the first regulatory
approval in either [***].
4.4.6. The milestone payments set forth above shall each be
payable [***]. Payments of milestone by PMC to CORIXA shall be made net of
applicable withholding tax, if any.
ARTICLE 5 - ROYALTY REPORTS AND ACCOUNTING.
5.1. REPORTS, EXCHANGE RATES.
During the term of this Agreement following the First
Commercial Sale and during the Royalty Term, PMC shall furnish to CORIXA, with
respect to each Calendar Quarter, a written report showing on a consolidated
basis in reasonably specific detail, on a country-by-country basis, (a) the
gross sales of Products sold by PMC, its Affiliates and its Sublicensees in the
Territory during the corresponding Calendar Quarter and the calculation of Net
Sales from such gross sales; (b) the royalties payable in US dollars, if any,
which shall have accrued hereunder based upon Net Sales of Products (c) the
withholding taxes, if any, required by law to be deducted in respect of such
royalties; (d) the date of the First Commercial Sales of Product having occurred
in each country in the Territory during the corresponding Calendar Quarter; and
(e) the exchange rates used in determining the royalty amount expressed in US
dollars.
With respect to sales (if any) of Products invoiced in US
dollars, the gross sales, Net Sales, and royalties payable shall be expressed in
US dollars. With respect to sales of Products invoiced in a currency other than
US dollars, the gross sales, Net Sales and royalties payable shall be expressed
in the currency of the invoice issued by the Party making the sale together with
the US dollars equivalent of the royalty payable, calculated using the rate of
exchange published in the Wall Street Journal for the last business day of the
applicable Calendar Quarter.
Reports shall be due on the forty-fifth (45th) day following
the close of each Calendar Quarter. PMC shall keep complete and accurate records
in sufficient detail to properly reflect all gross sales and Net Sales and to
enable the royalties payable hereunder to be determined.
5.2. AUDITS.
5.2.1. Upon the written request of CORIXA and not more than
once in each calendar year, PMC shall permit an independent certified public
accounting firm of internationally recognized standing, selected by CORIXA and
reasonably acceptable to PMC, at CORIXA's expense, to have access during normal
business hours to such of the records of PMC and its Affiliates as may be
reasonably necessary to verify the accuracy of the royalty reports hereunder for
any year ending not more than [***] prior to the date of such
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request. The accounting firm shall disclose to CORIXA only whether the records
are correct or not and the specific details concerning any discrepancies. No
other information shall be shared.
5.2.2. If such accounting firm concludes that additional
royalties were owed during such period, PMC shall pay the additional royalties
within thirty (30) days of the date CORIXA delivers to PMC such accounting
firm's written report so concluding. The fees charged by such accounting firm
shall be paid by CORIXA; provided, however if the audit discloses that the
royalties payable by PMC for the audited period are more than [***] of the
royalties actually paid for such period, then PMC shall pay the reasonable
fees and expenses charged by such accounting firm.
5.2.3. PMC shall include in each permitted sublicense granted
by it pursuant to the Agreement a provision requiring its Affiliates and
Sublicensees to make reports to PMC, to keep and maintain records of sales made
pursuant to such sublicense and to grant access to such records by CORIXA's
independent accountant to the same extent required with respect to PMC's records
under this Agreement.
5.2.4. Upon the expiration of [***] following the end of any
calendar year, the calculation of royalties payable with respect to such year
shall be binding and conclusive upon CORIXA, and PMC, its Affiliates and
Sublicensees shall be released from any liability or accountability with respect
to royalties for such year.
5.3. CONFIDENTIAL FINANCIAL INFORMATION.
CORIXA shall treat all financial information subject to review
under this Article 5 or under any sublicense agreement as Confidential
Information, and shall cause its accounting firm to retain all such financial
information in confidence.
ARTICLE 6 - PAYMENTS. LATE PAYMENTS.
6.1. PAYMENT TERMS.
Royalties shown to have accrued by each royalty report
provided for under Article 5 of this Agreement shall be due on the date such
royalty report is due. Payment of royalties in whole or in part may be made in
advance of such due date. Past due payments shall accrue interest at a rate of
[***] per annum, unless occurring as a result of an Event of Force Majeure.
6.2. PAYMENT METHOD.
All payments by PMC to CORIXA under this Agreement shall be
paid in US dollars, and all such payments shall be made by bank wire transfer in
immediately available funds to the following bank account
Account No. [***]
----------------------------------------
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Bank: [***]
----------------------------------------
ABA Code [***]
----------------------------------------
6.3. EXCHANGE CONTROL.
If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country in the Territory
where Product is sold, payment shall be made through such lawful means or method
as the Parties reasonably shall determine.
6.4. WITHHOLDING TAXES.
Except as otherwise provided below, all amounts owing from PMC
to CORIXA under this Agreement are gross amounts. PMC shall be entitled to
deduct the amount of any withholding taxes payable or required to be withheld by
PMC, its Affiliates or Sublicensees, to the extent PMC, its Affiliates or
Sublicensees pay to the appropriate governmental authority on behalf of CORIXA
such taxes. PMC shall use commercially reasonable efforts to minimize any such
taxes, levies or charges required to be withheld on behalf of CORIXA by PMC, its
Affiliates or Sublicensees. PMC promptly shall deliver to CORIXA proof of
payment of all such taxes, levies and other charges, together with copies of all
communications from or with such governmental authority with respect thereto.
ARTICLE 7 - RESEARCH PROGRAM.
7.1. OBJECT.
Pursuant to a mutually agreed upon research program which
shall be definitely established by the Research Committee referred to in Section
7.2. hereinafter on terms substantially in accordance with the draft research
program attached hereto as Exhibit 3 (the "Research Program"), and subject to
the condition precedent that PMC shall have exercised at least one (1) Option in
accordance with Section 2.2. hereof, CORIXA agrees to conduct research works
described therein and PMC agrees to support and fund such Research Program in
accordance with the terms and conditions set forth here below.
7.2. OVERSIGHT OF THE RESEARCH PROGRAM.
7.2.1. Oversight. The Research Program shall be overseen
and monitored by the Research Committee as described herein (the "Committee").
7.2.2. Membership. Fifteen (15) days after the Operational
Date, CORIXA and PMC shall each appoint two (2) persons (or such other number of
persons as the Parties may determine) to serve on the Committee. Such
representatives shall be qualified, by reason of background and experience, to
assess the scientific progress of the Research Program. Each Party
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shall have the right to change its representation on the Committee upon written
notice sent to the other.
7.2.3. Co-Chair. The Committee shall be co-chaired by one
representative of each Party.
7.2.4. Responsibilities. The Committee shall have
authority to:
(i) review and approve the draft Research
Program prepared by CORIXA and establish the definitive Research Program;
(ii) make recommendations regarding the
performance of the Research Program and the conduct of research works pursuant
thereto, and monitor performance thereunder;
(iii) modify the Research Program as it
determines, for each twelve (12) month period during the term thereof;
(iv) review any and all proposed publication or
communication relating to the Research Program and the results therefrom;
(v) review any and all proposed filing of patent
application in connection with the Research Program.
7.2.5. Meetings. The Committee shall meet not less than two
(2) times a year during the term of the Research Program, at such dates and
times as agreed to by the Parties. Meetings in person shall normally take place
at CORIXA's premises or such other place as may be mutually agreed upon.
Meetings may be held by telecommunication means. At such meetings, the Committee
shall discuss the Research Program and the status of performance by CORIXA under
the Program, evaluate the results thereof and set priorities therefor. All
decisions made or actions taken by the Committee shall be made unanimously by
its members with the CORIXA members and PMC members having one vote each. The
Committee shall prepare written minutes of each meeting and a written record of
all decisions whether made at a formal meeting or not. Such minutes shall
incorporate semi-annual research reports prepared for the Parties by CORIXA. Any
disagreement among members of the Committee shall first be resolved within the
Committee with any resolution targeting the efficient achievement of the stated
objectives of the Research Program.
In the event that the Committee members maintain
their disagreement, either Party may ask for resolution in accordance with
Section 19.3 hereof
7.3. THE PRINCIPAL INVESTIGATOR.
7.3.1. Principal Investigator. The Principal Investigator of
the Research Program shall be Dr. Xxxxxx Xxxx, an employee of CORIXA (the
"Principal Investigator"). CORIXA shall consult with PMC regarding any
replacement of the Principal Investigator, provided,
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however, that CORIXA shall have the right to make, and shall make, the final
determination regarding any such replacement. The Principal Investigator shall
be at)pointed as a member of the Committee, and may be designated by CORIXA to
act on behalf of CORIXA as co-chair on such Committee.
7.3.2. Duties. The Principal Investigator shall direct the
Research Program and coordinate the efforts of other researchers involved in the
performance of such Program. The Principal Investigator shall sit with the
Committee as provided in Section 7.2. hereof, shall perform the duties set forth
hereunder and shall be afforded the opportunity to actively participate in all
Committee deliberations. The Principal Investigator shall provide reasonably
detailed status reports of the Research Program to the Committee at six-month
intervals, as well as at the earliest practicable time whenever, in the
Principal Investigator's judgment, an invention is created or reduced to
practice. The Principal Investigator shall devote such time and efforts as may
be required to fulfill his duties hereunder and to ensure the successful
administration and coordination of the Research Program.
7.4. CONDUCT OF RESEARCH PROGRAM.
The Research Program shall be conducted by CORIXA at CORIXA's
laboratories. CORIXA shall use all reasonable efforts to complete research works
in accordance with the said Program. Any research work performed by CORIXA
pursuant hereto shall be in compliance with current Good Laboratory Practices
(cGLP) as applicable in the United States of America.
7.5. FINANCIAL CONDITIONS.
7.5.1. Support Commitment. In consideration of the work
performed by CORIXA pursuant to and in accordance with the Research Program, PMC
shall pay to CORIXA a research fee of [***] (the "Commitment"). The Commitment
shall be inclusive of all costs incurred by CORIXA implementing the Research
Program.
7.5.2. Payments Schedule. Support payments shall be made by
PMC to CORIXA in four (4) quarterly payments of [***] in advance with the first
payment to be made within fifteen (15) days of the Operational Date, and the
other payments payable on the first day of each of the three (3) subsequent
Calendar Quarters, followed by four (4) other quarterly payments of [***]
payable on the first day of each of the following four (4) subsequent Calendar
Quarters.
7.5.3. No Conflict With Research Program. CORIXA agrees that
the Program funds provided by PMC shall be applied to the Research Program and
may not, without PMC prior written approval, be used in support of any other
research at CORIXA.
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7.5.4. Title to Equipment. CORIXA shall retain title to any
equipment purchased with funds provided by PMC under this Agreement, if such
purchase is mutually agreed upon as part of the Research Program budget.
7.6. TERM OF THE RESEARCH PROGRAM.
7.6.1. The term of the Research Program shall be [***]
as from the fifteenth day after the Operational Date, unless terminated earlier
upon termination of this Agreement in accordance with Article 14 hereof.
7.7. CONFIDENTIALITY. In order to facilitate the Research Program,
either Party may disclose confidential or proprietary information owned or
controlled by it to the other. It is hereby understood and agreed that such
information shall be deemed "Confidential Information" as defined in Article 8
and treated as such.
7.8. RESULTS OF THE RESEARCH PROGRAM.
7.8.1. All rights and title to the results of the Research
Program (the "Results"), whether patentable or not, which shall belong to
CORIXA, or jointly to CORIXA and PMC according to Section 9.1. hereof
(including but not limited to CORIXA Research Patents and Joint Research
Patents), shall be licensed to PMC subject to the terms and conditions of this
Agreement including, but not limited to, the limitation to the Fields of Use, at
no additional cost to PMC.
7.8.2. The Results shall be deemed Confidential Information
and shall not be disclosed by either Party to any Third-Party unless permitted
in accordance with Section 8 hereof Notwithstanding the foregoing, CORIXA shall
have the right to disclose Results to Third-Parties subject to confidentiality,
non-disclosure and restriction of use obligations with respect to such Results
as provided in Article 8 hereof, and without prejudice to the License granted to
PMC pursuant hereto, and provided further that such disclosure does not
jeopardize the ability of any Party to apply for patent in accordance with this
Agreement with respect to said Results.
7.8.3. All rights and titles to the Results, whether
patentable or not, including but not limited to, all PMC Inventions, Joint
Inventions and PMC Improvement, which shall belong to PMC, or jointly to PMC and
CORIXA in accordance with Section 9.1 hereof, shall be licensed by PMC to CORIXA
on a worldwide, non-exclusive basis for exploitation by CORIXA in any field of
use except the [***] Field of Use and the [***] Field of Use, subject to all
terms and conditions of this Agreement and without prejudice to the License
granted to PMC pursuant hereto. The financial conditions of such a license shall
be negotiated in good faith in a timely manner by the Parties, and shall not
include a right for CORIXA to grant sub-licenses to Third-Parties except with
the prior approval in writing of PMC.
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ARTICLE 8 - CONFIDENTIALITY.
8.1. NON-DISCLOSURE OBLIGATIONS.
Except as otherwise provided in this Article 8, during the
term of this Agreement and for a period of ten (10) years thereafter, each Party
shall maintain in confidence, and use only for purposes as expressly authorized
and contemplated by this Agreement, all information and data supplied by the
other Party under this Agreement marked or otherwise identified as
"Confidential," including but not limited to Licensed Know-How, Results, and
Improvements. For purposes of this Article 8, information and data described
above shall be hereinafter referred to as "Confidential Information."
8.2. PERMITTED DISCLOSURES.
To the extent it is reasonably necessary or appropriate to
fulfill its obligations or exercise its rights under this Agreement, (a) a Party
may disclose Confidential Information it is otherwise obligated under this
Article 8 not to disclose, to its Affiliates, Sublicensees, consultants, outside
contractors and clinical investigators, on a need-to-know basis, provided that
such Persons agree to keep the Confidential Information confidential and not use
the Confidential Information for the same time period and to the same extent as
such Party is required; and
(b) a Party may disclose such Confidential Information to
government or other regulatory authorities to the extent that such disclosure is
required by applicable law, regulation or court order, or is reasonably
necessary to obtain patents, copyrights or authorizations to conduct clinical
trials with, and to commercially market Product, provided that the disclosing
Party shall provide written notice to the other Party and sufficient opportunity
to object to such disclosure or to request confidential treatment thereof. The
obligation not to disclose or use Confidential Information shall not apply to
any part of such Confidential Information (including Licensed Know-How) that (i)
is or becomes patented, published or otherwise part of the public domain or
publicly available other than by acts of the Party obligated not to disclose
such Confidential Information, or of its Affiliates or Sublicensees in
contravention of the Agreement; (ii) is disclosed to the receiving Party or its
Affiliates or Sublicensees by a Third Party, provided such Confidential
Information was not obtained by such Third-Party directly or indirectly from the
other Party under this Agreement on a confidential basis; (iii) prior to
disclosure under the Agreement, was already in the possession of the receiving
Party or its Affiliates or Sublicensees, provided such Confidential Information
was not obtained directly or indirectly from the other Party under the Agreement
as can be evidenced by the receiving Party by documentation, or (iv) is
disclosed in a press release agreed to by both Parties hereto, which agreement
shall not be unreasonably withheld.
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8.3. TERMS OF THE AGREEMENT.
PMC and CORIXA shall not disclose any terms or conditions of
this Agreement to any Third-Party without the prior consent of the other Party,
except (a) to Persons with whom PMC or CORIXA has entered into or proposes to
enter into a business relationship, provided that such Persons shall enter into
the required confidentiality agreement, or (b) as required by applicable laws,
regulations or a court order, provided that the disclosing Party shall provide
written notice to the other Party and sufficient opportunity to object to such
disclosure or to request confidential treatment thereof.
8.4. PRESS RELEASES AND OTHER DISCLOSURES TO THIRD-PARTIES.
Neither CORIXA nor PMC will, without the prior written consent
of the other, issue any press release or make any other public announcement or
furnish any statement to any Person (other than either Parties' respective
Affiliates) concerning the existence of this Agreement and the transactions
contemplated by this Agreement, except for (i) general statement referring to
the existence of this Agreement, specifying the Fields of Use and identity of
the Parties but no other details,(ii) disclosures made in compliance with
sections 8.2. and 8.3. hereof, (iii) attorneys, consultants, and accountants
retained to represent them in connection with the transactions contemplated
hereby and (iv) occasional, brief comments by the respective officers of PMC and
CORIXA consistent with such guidelines for public statements as may be mutually
agreed by PMC and CORIXA made in connection with routine interviews with
analysts or members of the financial press.
In addition, either Party (after consultation with counsel) in
its own right may make such further announcements and disclosures, if any, as
may be required by applicable law, in which case the Party making the
announcement or disclosure will use its best efforts to give advance notice to,
and discuss such announcement or disclosure with, the other Party.
8.5. PUBLICATIONS.
Each Party shall have the right to publish or present the
Results and announce scientific progress of the Research Program, provided such
publication, presentation or announcement (and any revisions thereof, a
"Publication") is submitted to the other Party through the Committee at least
sixty (60) days prior to submitting it to any Third-Party (including any editing
person). The other Party shall have sixty (60) days after receipt of the draft
Publication to review and comment on such draft. Upon notice within such sixty
(60) day period by the other Party that such Party reasonably believes the
Publication would amount to the public disclosure of such Party's Confidential
Information and/or of a patentable invention upon which a patent application
should be filed prior to any such disclosure, submission of the concerned
Publication to Third-Parties shall be delayed for a ninety (90) day period from
the date of said notice, or for such longer period which may appear necessary
for appropriately deleting Confidential Information from the proposed
Publication and/or drafting and filing a patent application covering such
invention. In addition, each Party shall duty take into account comments made by
the other Party on any Publication and shall accept to have employees or others
acting on behalf
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of the other Party be mentioned as co-authors on any Publication describing
Results to which such persons will have contributed.
ARTICLE 9 - INVENTIONS AND PATENTS.
9.1. OWNERSHIP OF INVENTIONS.
The entire right and title to technology (including but not
limited to Improvements), whether or not patentable, and any patent applications
or patents based thereon, either resulting from the Research Program or which
relate to the Material, made, conceived or reduced to practice during the term
of this Agreement (a) by employees or others acting solely on behalf of CORIXA
or its Affiliates, shall be owned solely by CORIXA (including any CORIXA
Improvements and those CORIXA's patents and patent applications which fall under
the definition of Results, herein referred to as "CORIXA Research Patents"), (b)
by employees or others acting solely on behalf of PMC or its Affiliates, shall
be owned solely by PMC (a "PMC Invention"), and (c) jointly by employees or
others acting both on behalf of PMC and CORIXA, shall be jointly owned on an
equal basis by PMC and CORIXA (a "Joint Invention"). Each Party promptly shall
disclose to the other Party the making, conception or reduction to practice of
any such new technology by employees or others acting on behalf of such Party.
CORIXA and PMC each hereby represents that all employees and
other persons acting on its behalf in performing its obligations under this
Agreement shall be obligated under a binding written agreement to assign to it,
or as it shall direct, all Improvements conceived or reduced to practice by such
employees or other Persons.
9.2. PATENT PROSECUTION AND MAINTENANCE.
9.2.1 CORIXA shall be responsible at its sole expense for and
shall control the preparation, filing, prosecution, grant and maintenance of all
Licensed Patents (including CORIXA Research Patents) and all patents and patent
applications having as a subject matter an Improvement. CORIXA shall prepare,
file, prosecute and maintain such Licensed Patents in good faith consistent with
its customary patent policy and its reasonable business judgment, and shall
consider in good faith the interests of PMC in so doing.
9.2.2 Subject to Section 9.2.1, PMC shall be responsible for
and shall control the preparation, filing, prosecution, grant and maintenance,
of any patents and patent applications having as subject matter a Joint
Invention (the "Joint Research Patents"). PMC shall prepare, file, prosecute and
maintain such patent rights in good faith consistent with its customary patent
policy and its reasonable business judgment, and shall consider in good faith
the interests of CORIXA in so doing. PMC and CORIXA shall share all patent costs
in connection therewith on an equal basis.
9.2.3 Subject to Section 9.2.1, PMC shall be responsible at
its sole expense for and shall control the preparation, filing, prosecution,
grant and maintenance of any patents and patent applications having as subject
matter an invention which is part of Results and which
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ownership is attributed to PMC in accordance with Section 9.1 hereof (the "PMC
Research Patents"). PMC shall prepare, file, prosecute and maintain PMC Research
Patents in food faith consistent with its customary patent policy and its
reasonable business judgment, and shill consider in good faith the interests of
CORIXA in so doing.
9.2.4 The Parties shill at all times fully cooperate in order
to smoothly implement the foregoing provisions.
9.3. ENFORCEMENT OF LICENSED PATENTS.
CORIXA shall have the right, at its sole expense, to determine
the appropriate course of action to enforce the Licensed Patents or otherwise
xxxxx the infringement thereof, to take (or refrain from taking) appropriate
action to enforce the Licensed Patents, to control any litigation or other
enforcement action and to enter into, or permit, the settlement of any such
litigation or other enforcement action with respect to the Licensed Patents, and
in good faith shall consider the interests of PMC in so doing.
All monies recovered upon the final judgment or settlement of
any such suit to enforce any Licensed Patents shall be retained by CORIXA.
Notwithstanding the foregoing, PMC and CORIXA shall fully cooperate with each
other in any action to enforce the Licensed Patents.
9.4. UNABATED INFRINGEMENT.
If there exists a substantial and continuing infringement of
the Licensed Patents in any country, and CORIXA has failed to take appropriate
action to xxxxx such substantial and continuing infringement within sixty (60)
days after receipt of written notice from PMC thereof, then PMC shall have the
right to reduce by [***] the royalties payable to CORIXA under Sections 4. 1.
and 4.2. above in such country until such time as such substantial and
continuing infringement has been abated.
ARTICLE 10 - INFRINGEMENT ACTIONS BY THIRD-PARTIES.
If PMC, CORIXA or their respective Affiliates, or PMC's Sublicensees,
is sued by a Third-Party for infringement of a Third-Party's patent because of
the manufacture, use or sale of Product or manufacture or use of Material, the
Party which has been sued shall promptly notify the other Party in writing of
the institution of such suit. CORIXA shall have the right, in its sole
discretion, to control the defense of such suit at its own expense, in which
event PMC shall have the right to be represented by advisory counsel of its own
selection, at its own expense, and shall cooperate fully in the defense of such
suit and furnish to CORIXA all evidence and assistance in its control. If CORIXA
does not elect within thirty (30) days after receipt of such notice to so
control the defense of such suit, PMC may undertake such control at its own
expense, and CORIXA shall then have the right to be represented by advisory
counsel of its own selection and at its own expense, and CORIXA shall cooperate
fully in the defense of such suit and furnish to PMC all evidence and assistance
in CORIXA's control. The Party controlling the suit may not
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settle the suit or otherwise consent to an adverse judgment in such suit that
diminishes the rights or interests of the non-controlling Party without the
express written consent of the non-controlling Party. Any judgments, awards,
settlements or damages payable with respect to legal proceedings covered by this
Article 10 shall be paid by the Party which controls the litigation.
ARTICLE 11 - NOTIFICATION OF PATENT TERM RESTORATION - PATENT EXTENSIONS.
CORIXA shall notify PMC of (a) the issuance of each U.S. patent
included within the Licensed Patents, giving the date of issue and patent number
for each such patent, and (b) each notice pertaining to any patent included
within the Licensed Patents which it receives as patent owner pursuant to the
United Sates Drug Price Competition and Patent Term Restoration Act of 1984
(hereinafter called the "Act"), including notices pursuant to SectionSection101
and 103 of the Act from persons who have filed an abbreviated new drug
application ("ANDA").
Such notices shall be given promptly, but in any event within five (5)
business days of each such patent's date of issue or receipt of each such notice
pursuant to the Act, whichever is applicable. CORIXA shall notify the other
Party of each filing for patent term restoration under the Act, any allegations
of failure to show due diligence and all awards of patent term restoration
(extensions) with respect to the Licensed Patents. Likewise, CORIXA or PMC, as
the case may be, shall inform the other Party of patent extensions and periods
of data exclusivity in the rest of the world regarding any Product and more
generally the Parties shall diligently cooperate with respect to any procedures
for patent and period of data exclusivity extensions, such as but not limited to
Supplementary Protection Certificates, the above mentioned Patent Term
Restoration and corresponding GATT regulations.
ARTICLE 12 - SUPPLY CONDITIONS.
12.1. THE SUPPLY AGREEMENT. CORIXA has stated to PMC its current
intention to establish itself or to appoint a third party contractor as a
manufacturer of the Material. Provided CORIXA can reasonably demonstrate that it
shall be able to timely manufacture LeIF under current Good Manufacturing
Practice at reasonable cost in sufficient quantities, PMC shall purchase from
CORIXA PMC's requirements for LeIF for use in the manufacture of Products under
the terms and conditions of a supply agreement (the "Supply Agreement"), which
agreement shall be negotiated in good faith in a timely fashion by the Parties
hereto so as to become effective at least six months before PMC's expected First
Commercial Sale of Products. The Parties agree to negotiate in good faith in a
timely fashion the detailed terms and conditions of the Supply Agreement which
shall include at a minimum the following terms and conditions set forth in this
Article 12, as well as such other terms and conditions as may be agreed upon by
the Parties.
12.2. LEIF REQUIREMENTS. The Supply Agreement shall provide that CORIXA
shall manufacture or have manufactured and PMC shall purchase from CORIXA, PMC's
entire requirements of LeIF (clinical lots as well as commercial lots) for
Products and that PMC shall
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purchase such LeIF for its own use in manufacturing Products only and shall not
be permitted to sell or re-sell LeIF to any Third-Party.
12.3. SPECIFICATIONS. The Supply Agreement shall provide for
(i) specifications that CORIXA shall be obligated to comply with; (11) quality
control criteria and procedures; and (iii) PMC's reasonable acceptance criteria
for the LeIF.
12.4. FORECASTS AND ORDERS. The Supply Agreement shall provide for the
establishment of reasonable rolling forecasts and placement of orders which
shall take into account, among other factors, the seasonal nature of PMC's flu
vaccination campaigns and CORIXA's need to rationally plan its manufacturing of
LeIF consistent with its other manufacturing obligations.
12.5. PRICE. The price of Material shall be negotiated in good faith by
the Parties and set forth in the Supply Agreement, but in no event shall such
price be for less than CORIXA's fully burdened cost of manufacturing (calculated
in accordance with Generally Accepted Accounting Practices in the USA) plus
[***].
12.6. BACK-UP INVENTORIES. Pursuant to the Supply Agreement, CORIXA
shall agree to supply, and PMC shall agree to maintain inventory of LeIF in its
own facility sufficient to meet its needs for at least one complete, global
annual flu campaign, plus a reasonable quantity of Material for use in the other
Fields of Use.
12.7. WARRANTIES. Pursuant to the Supply Agreement, CORIXA shall
warrant that (i) LeIF at the time of delivery shall meet the specifications
referred to in Article 12.3.; (ii) LeIF shall be manufactured in accordance with
the principles of current Good Manufacturing Practices (cGMP) in effect in the
country where it is manufactured or in compliance in all material respects with
the principles of the current Good Manufacturing Practices in effect in any
other country where Products are manufactured and/or sold (if more stringent
than cGMP first referred above) and any relevant establishment and product
licenses issued by any Agency. PMC shall inform CORIXA of the countries in which
Product is to be licensed to be sold and of any and all Agency(ies) responsible
in such countries. Upon request, PMC shall provide CORIXA with information
regarding the regulatory requirements in each such country; (iii) none of the
LeIF delivered to PMC shall be adulterated or misbranded within the meaning of
the United States Food, Drug and Cosmetics Act (the "Act"); (iv) none of the
LeIF is an article which may not, under the provisions of Article 404 or 505 of
the Act, be introduced into interstate commerce, and (v) the LeIF at the time of
delivery shall be pharmaceutically acceptable in terms of consistency and
validation. CORIXA SHALL DISCLAIM ANY OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS.
12.8. QUALITY AUDIT. Pursuant to the Supply Agreement, CORIXA shall
permit PMC, upon reasonable notice and at reasonable times, at PMC's expense, to
audit in cooperation with CORIXA's personnel production, packaging, quality
control and forwarding facilities of CORIXA and any of its significant suppliers
as they relate to CORIXA's manufacturing responsibilities under the Supply
Agreement.
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12.9. ADVERSE EVENTS REPORTING. Under the Supply Agreement, the
Parties shall establish a procedure for monitoring and reporting adverse drug
experiences, consistent with Article 13 hereof
12.10. ASSURANCE OF SUPPLY. Under the terms of the Supply Agreement,
PMC and CORIXA shall cooperate to anticipate PMC's reasonable long-term
requirements for LeIF, and CORIXA shall take reasonable measures to assure that
PMC's reasonable requirements can be met, which measures may include the
qualification of more than one manufacturing facility (including one such
facility to be operated by PMC or an Affiliate of PMC, in which case CORIXA
shall transfer Material manufacturing Know-how in accordance with Section 12.11
hereinafter) and/or maintenance of safety stocks of LeIF as provided for in
Article 12.6. hereof.
12.11. TRANSFER OF MANUFACTURING TECHNOLOGY.
Failure to Supply. Under the terms of the Supply Agreement,
upon CORIXA's first failure (the "First Failure", as defined below), CORIXA
shall complete the transfer of the manufacturing technology relating to the
Material by diligently rendering technical assistance to PMC so that PMC is able
to manufacture or have manufactured the LeIF, but only for use in the production
of Products. In such event, CORIXA shall promptly disclose to PMC, at any time
upon first request in writing by PMC, all information and current Know-How not
yet disclosed pursuant to this Agreement that is reasonably necessary for PMC to
manufacture or have manufactured LeIF. Such disclosure and supporting technical
assistance shall be made at PMC's costs and expenses, and CORIXA shall invoice
to PMC its reasonable out-of-pocket expenses as incurred in connection with such
transfer. There shall be no additional fees or payments (other than additional
royalties as provided for in accordance with Article 4 hereof) due to final
completion of the manufacturing technology transfer. After the first occasion
only of any such failure, the Parties agree that CORIXA shall have the right to
resume manufacture for PMC as the sole supplier of LeIF to PMC under the terms
and conditions of the Supply Agreement at such time as CORIXA demonstrates to
PMC's reasonable satisfaction that it can supply PMC's requirement for LeIF. For
the purpose of this Section 12.1 1, "First Failure" shall mean the first time
CORIXA fails to supply at least ninety percent (90%) of the amount of LeIF
being subject to a PMC's firm order placed by PMC with CORIXA pursuant to and in
accordance with the Supply Agreement.
12.12. OTHER TRANSFER EVENTS. The completion of the transfer of the
manufacturing technology shall also be implemented in case of CORIXA's
bankruptcy or termination of the Supply Agreement for CORIXA's material breach
thereof in accordance with its terms.
ARTICLE 13 - ADVERSE EXPERIENCE REPORTING.
During the term of the Agreement, each Party shall notify the other
immediately of any information (howsoever obtained and from whatever source)
concerning any unexpected side effect, injury, toxicity or sensitivity reaction,
or any unexpected incidence, and the severity thereof, associated with the
clinical uses, studies, investigations, tests and marketing of a Product or
Material. For purposes of this Article 13, "unexpected" shall mean (x) for a
nonmarketed
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Product, an experience that is not identified in nature, severity or
frequency in the current clinical investigator's confidential information
brochure, and (y) for a marketed Product, an experience which is not listed in
the current labeling for such Product, and includes an event that may be
symptomatically and pathophysiologically related to an event listed in the
labelling but differs from the event because of increased frequency or greater
severity or specificity. Each Party further shall immediately notify the other
of any information received regarding any threatened or pending action by an
agency which may affect the safety and efficacy claims of a Product. Upon
receipt of any such information, the Parties shall consult with each other in an
effort to arrive at a mutually acceptable procedure for taking appropriate
action; provided, however, that nothing contained herein shall be construed as
restricting either Party's right to make a timely report of such matter to any
government agency or take other action that it deems to be appropriate or
required by applicable law or regulation.
ARTICLE 14 - TERM AND TERMINATION.
14.1. AUTOMATIC TERMINATION.
Unless terminated earlier pursuant to this Article 14 or in
accordance with Article 16 hereof, the Agreement shall automatically terminate
effective February 1, 1997 unless on or before March 31, 1997 PMC exercises at
least one (1) Option under Section 2.2.4 hereof. Any termination of the Research
Program shall also terminate this Agreement as a whole.
14.2. EXPIRATION.
Unless terminated earlier pursuant to this Article 14, or in
accordance with Section 3.2.1 or Article 16 hereof, the Agreement shall expire
on the expiration of PMC's obligations to pay royalties hereunder.
14.3. TERMINATION BY PMC.
PMC shall have the right, at any time prior to the Operational
Date and after expiry of the Research Program term, in its sole discretion, to
terminate this Agreement as a whole, either forthwith upon written notice to
CORIXA if such notice is sent before the end of the Option Period, or by giving
not less than three (3) months prior written notice to CORIXA of such
termination, provided such notice is sent at the earliest three (3) months
before the end of the Research Program or at any time thereafter, and any such
termination shall not give rise to any indemnification or compensation
whatsoever.
14.4. DISCONTINUANCE OF DEVELOPMENT EFFORTS BY PMC.
PMC shall promptly give CORIXA notice in writing if PMC ceases
to authorize and/or expend financial resources towards satisfaction of its
obligations under this Agreement with respect to any particular Field of Use,
whereupon the License with respect to such Field of Use shall automatically
terminate, and such termination shall not give rise to any indemnification or
compensation whatsoever.
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14.5. TERMINATION FOR CAUSE.
Either Party may terminate this Agreement for material breach
by the other Party (the "Breaching Party") of any material provision of the
Agreement, if the Breaching Party has not cured such breach within ninety (90)
days after written notice thereof; provided, however, that neither party shall
be deemed to be in material breach of this Agreement for purposes of a
termination hereunder during any period in which a good faith dispute between
the parties exists regarding performance of breach of its obligations hereunder,
and provided further, however, that in the event PMC fails to timely pay CORIXA
the royalty payments and milestone payments as set forth in Section 6.1 hereof
or the Option Exercise Fee(s) set forth in Section 2.2.4 hereof, PMC shall have
only fifteen (15) days to cure such material breach.
14.6. EFFECT OF EXPIRATION AND TERMINATION.
14.6.1 Expiration or termination of the Agreement shall not
relieve the Parties of any obligation accruing prior to such expiration or
termination. The provisions of Sections 3.2, 4.1, 4.3, 4.4, 7.7, 7.8, 14.6.2 and
14.6.3 and Articles 6, 8, 9, 10, 11, 15, and 19shall survive the expiration or
termination of the Agreement.
14.6.2 In the event of termination of this Agreement pursuant
to Section 14.5 due to PMC's uncured material breach of a material provision
hereof, PMC shall automatically grant CORIXA a royalty-free, perpetual,
worldwide, exclusive license to Joint Inventions, Joint Research Patents and PMC
Research Patents in the field of enhanced immunomodulation and to all Licensed
Know-How related thereto. Such license shall be effective upon termination of
this Agreement, and PMC shall then take all steps necessary to effectuate the
said license to CORIXA.
14.6.3 In the event of termination of this Agreement pursuant
to Section 14.5 due to CORIXA's uncured material breach of a material provision
hereof, CORIXA shall automatically grant PMC a royalty-free, perpetual,
worldwide, license to Joint Inventions, Joint Research Patents and CORIXA
Research Patents in the Fields of Use.
ARTICLE 15 - INDEMNITY.
15.1. DIRECT INDEMNITY.
15.1.1. Each Party shall indemnify and hold harmless, and
hereby forever releases and discharges the other Party from and against all
claims, demands, liabilities, damages and expenses, including attorneys' fees
and costs (collectively, the "Liabilities") arising out of the breach of any
material provision of this Agreement by the indemnifying Party, except to the
extent such Liabilities resulted from the gross negligence, recklessness or
willful misconduct of the other Party.
15.1.2. PMC shall indemnify and hold harmless, and hereby
forever releases and discharges CORIXA from and against all Liabilities suffered
or incurred arising out of any
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Third-Party claims for personal injury, death or disability or any product
recall to the extent caused by (a) any failure to test for or provide adequate
warnings of adverse side effects to the extent such failure arises out of acts
or omissions in connection with the preclinical or clinical testing of any
Product, (b) any manufacturing defect in any Product, or (c) any other act or
omission (without regard to culpable conduct) of PMC in connection with its
activities thereof contemplated by this Agreement; except in each case to the
extent such Liabilities resulted from the gross negligence, recklessness or
willful misconduct by CORIXA.
15.2. PROCEDURE.
A Party (the "Indemnitee") that intends to claim
indemnification under this Article 15 shall promptly notify the other Party (the
"Indemnitor") of any Liability or action in respect of which the Indemnitee
intends to claim such indemnification, and the Indemnitor shall have the right
to participate in, and, to the extent the Indemnitor so desires, jointly with
any other Indemnitor similarly noticed, to assume the defense thereof with
counsel selected by the Indemnitor; provided, however, that the Indemnitee shall
have the right to retain its own counsel, with the fees and expenses to be paid
by the Indemnitor, if representation of such Indemnitee by the counsel retained
by the Indemnitor would be inappropriate due to actual or potential differing
interests between such Indemnitee and any other Party represented by such
counsel in such proceedings. The indemnity obligations under this Article 15
shall not apply to amounts paid in settlement of any loss, claim, damage,
liability or action if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld unreasonably. The Indemnitee,
its Affiliates, employees and agents, shall cooperate fully with the Indemnitor
and its legal representatives in the investigation of any action, claim or
liability covered by this indemnification.
ARTICLE 16 - FORCE MAJEURE.
No Party (or any of its Affiliates) shall be held liable or responsible
to the other Party (or any of its Affiliates) nor be deemed to have defaulted
under or breached the Agreement for failure or delay in fulfilling or performing
any term of the Agreement when such failure or delay is caused by or results
from causes beyond the reasonable control of the affected Party (or any of its
Affiliates) including but not limited to fire, floods, embargoes, war, acts of
war (whether war be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, acts of God or acts, omissions or
delays in acting by any governmental authority or the other Party (collectively,
"Events of Force Majeure"); provided, however, that the affected Party shall
exert all reasonable efforts to eliminate, cure or overcome any such Event of
Force Majeure and to resume performance of its covenants with all possible
speed; and provided, further, that nothing contained herein shall require any
Party to settle on terms unsatisfactory to such Party any strike, lockout or
other labor difficulty, any investigation or proceeding by any governmental
authority or any litigation by any Third-Party. Notwithstanding the foregoing,
to the extent that an Event of Force Majeure continues for a period in excess of
six (6) months, the affected Party shall promptly notify in writing the other
Party of such Event of Force Majeure and within four (4) months of the other
Party's receipt of such notice, the Parties agree to negotiate in good faith
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either (i) to resolve the Event of Force Majeure, if possible, (ii) to extend by
mutual agreement the time period to resolve, eliminate, cure or overcome such
Event of Force Majeure, (iii) to amend this Agreement to the extent reasonably
possible, or (iv) to terminate this Agreement.
ARTICLE 17 - ASSIGNMENT.
This Agreement may not be assigned or otherwise transferred, nor,
except as expressly provided hereunder, may any right or obligations hereunder
be assigned or transferred to any Third-Party by either Party without the
consent of the other Party; provided, however, that either Party may, without
such consent, assign this Agreement and its rights and obligations hereunder to
any of its Affiliates or in connection with the transfer or sale of all or
substantially all of its business, or in the event of its merger or
consolidation or change in control or similar transaction. Any permitted
assignee shall assume all obligations of its assignor under this Agreement.
ARTICLE 18 - SEVERABILITY.
Each Party hereby agrees that it does not intend to violate any public
policy, statutory or common laws, rules, regulations, treaty or decision of any
government agency or executive body thereof of any country or community or
association of countries. Should one or more provisions of this Agreement be or
become invalid, the Parties hereto shall substitute, by mutual consent, valid
provisions for such invalid provisions which valid provisions in their economic
effect are sufficiently similar to the invalid provisions that it can be
reasonably assumed that the Parties would have entered into this Agreement with
such provisions.
In case such provisions cannot be agreed upon, the invalidity of one or
several provisions of this Agreement shall not affect the validity of this
Agreement as a whole, unless the invalid provisions are of such essential
importance to this Agreement that it is to be reasonably assumed that the
Parties would not have entered into this Agreement without the invalid
provisions.
ARTICLE 19 - MISCELLANEOUS.
19.1. NOTICES.
Any consent, notice or report required or permitted to be
given or made under this Agreement by one of the Parties hereto to the other
shall be in writing, delivered personally or by facsimile (and promptly
confirmed by personal delivery, first class air mail or courier), first class
air mail or courier, postage prepaid (where applicable), addressed to such other
Party at its address indicated below, or to such other address as the addressee
shall have last furnished in writing to the address or in accordance with this
Section 19.1 and (except as otherwise provided in this Agreement) shall be
effective upon receipt by the addressee.
If to CORIXA:
CORIXA CORPORATION
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1124 Columbia Street, Suite 464
Seattle, Washington XX 00000, XXX
Attention: Chief Operating Officer
With copy to Corporate Attorney
If to PMC:
PASTEUR MERIEUX Serums & Vaccins S.A.
00, xxxxxx Xxxxxxx
00000 Xxxx, Xxxxxx
Attention: Corporate Vice-President, Secretary and General Counsel
Legal Department
19.2. APPLICABLE LAW.
The Agreement shall be governed by and construed in accordance
with the laws of the State of Washington, without regard to the conflict of law
principles thereof.
19.3. DISPUTE RESOLUTION.
The Parties agree that if any dispute or disagreement arises
between PMC on the one hand and CORIXA on the other in respect of this
Agreement, they shall follow the following procedure in an attempt to resolve
the dispute or disagreement.
(a) The Party claiming that such a dispute exists shall give
notice in writing ("Notice of Dispute") to the other Party of the nature of the
dispute;
(b) Within fourteen (14) business days of receipt of a Notice
of Dispute, a nominee or nominees of PMC and a nominee or nominees of CORIXA
shall meet in person and exchange written summaries reflecting, in reasonable
detail, the nature and extent of the dispute, and at this meeting they shall use
their reasonable endeavors to resolve the dispute;
(c) If, within a further period of fourteen (14) business
days, the dispute has not been resolved, the President of CORIXA and the
Directeur General or, if there is no Directeur General, the President Directeur
General, of PMC shall meet at a mutually agreed upon time and location for the
purpose of resolving such dispute;
(d) If, within a further period of thirty (30) business days,
the dispute has not been resolved or if, for any reason, the required meeting
has not been held, then the Parties agree that any dispute shall be referred to
an arbitrator appointed by agreement of CORIXA and PMC or, if no such agreement
is reached within thirty (30) business days after a Party commences the
arbitration, then by a panel of three arbitrators, with each of PMC and CORIXA
to select one arbitrator and those two arbitrators to select the third. If all
three arbitrators have not been selected within sixty (60) business days after a
Party commences the arbitration, then the Parties agree to abide by the
selection of the remaining arbitrator to be named by a representative of the
International Chamber of Commerce. The Parties agree that the Rules of the
International
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Chamber of Commerce shall govern such arbitration and that any decision of the
arbitrators shall be final and binding and shall be enforceable in any court of
competent jurisdiction worldwide (regardless of whether one of the Parties fails
or refuses to participate in the arbitration). The Parties agree that all
arbitrations shall be conducted in the English language and that the exclusive
venue of all arbitrations shall be in Zurich, Switzerland. The Party determined
by the arbitrators to be the Party substantially prevailing in the arbitration
shall be entitled to recover its legal and consultants' fees and other costs
reasonably incurred in connection with the arbitration (as determined by the
arbitrators) and
(e) in the event of a dispute regarding any payments owing
under this Agreement, all undisputed amounts shall be paid promptly when due and
the balance, if any, promptly after resolution of the dispute.
19.4. ENTIRE AGREEMENT.
This Agreement contains the entire understanding of the
Parties with respect to the subject matter hereof. All express or implied
agreements and understandings, either oral or written, heretofore made are
expressly superseded by this Agreement. This Agreement may be amended, or any
term hereof modified, only by a written instrument duly executed by both Parties
hereto.
19.5. INDEPENDENT CONTRACTORS.
CORIXA and PMC each acknowledge that they shall be independent
contractors and that the relationship between the two Parties shall not
constitute a partnership, joint venture or agency. Neither CORIXA nor PMC shall
have the authority to make any statements, representations or commitments of any
kind, or to take any action, which shall be binding on the other Party, without
the prior consent of the other Party to do so.
19.6. AFFILIATES.
Each Party shall cause its respective Affiliates to comply
fully with the provisions of this Agreement to the extent such provisions
specifically relate to, or are intended to specifically relate to, such
Affiliates, as though such Affiliates were expressly named as joint obligors
hereunder.
19.7. WAIVER.
The waiver by either Party hereto of any right hereunder or
the failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.
19.8. COUNTERPART.
This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
For CORIXA CORPORATION
Date: December 23, 1996
Place: Seattle
By: /s/ Xxxx XxXxxx
---------------------------------
Name:
Title :
PASTEUR MERIEUX SERUMS & VACCINS S.A.
Date: December 23, 1996
Place: Lyon
By: /s/ Xxxx-Xxxxxxx Xxxxxxxx
-------------------------------
Name: Xxxx-Xxxxxxx XXXXXXXX
Title: Chairman, President and Chief Executive Officer
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SCHEDULE A
Existing Licensed Patents
38
PCT App. No. [***], filed [***], entitled, [***].
U.S. Xxx. App. No. [***], filed [***], entitled, [***].
U.S. Xxx. App. No. [***], filed [***], entitled, [***].
U.S. Xxx. App. No. [***], filed [***], entitled, [***].
U.S. Xxx. App. No. [***], filed [***], entitled, [***].
PCT App. No. [***], filed [***], entitled, [***].
39
SCHEDULE B
AUTHORIZED PMC AFFILIATES
1. Connaught Laboratories, Limited, Willowdale, Ontario, Canada
2. Connaught Laboratories, Inc., Swiftwater, Pennsylvania, USA
3. Virogenetics Corporation, Troy, New York, USA
40
SCHEDULE C
[***]
41
Exhibit 1
Special Material Transfer Agreement
Pasteur Merieux Connaught Group ("PMC") desires to receive from Corixa
Corporation ("Corixa") certain Biological Materials. These Biological Materials
are considered by Corixa to be highly valuable, confidential and proprietary
products of Corixa research. Accordingly, Corixa and PMC, intending to be
legally bound by the following terms and conditions, agree that:
1. Definitions. "Biological Materials" means all materials related
to LeIF transferred by Corixa to PMC hereunder, any replicates, progeny and
derivatives of the Biological Materials, and any mixtures or combinations of
Biological Materials and other substances. "Proposed Use" shall mean the
evaluation of the Biological Materials for determining interest in further
development and commercialization by Chiron.
2. Title to Biological Materials. Corixa shall retain all title
and interest in and to the Biological Materials. PMC shall not imply or
represent to any person that it is the owner of the Biological Materials.
3. Delivery of Biological Materials. Corixa shall deliver the
Biological Materials from time to time, as discussed between PMC and Corixa in
advance, provided the requested amounts are considered fair and reasonable.
4. Use of Biological Materials. As of the date of this Agreement,
Corixa grants to PMC a non-exclusive license to use the Biological Materials
for the Proposed Use for research purposes and not for any commercial use. PMC
shall not use the Biological Materials in humans or in contact with any cells
or other materials to be infused into humans. PMC shall use the Biological
Materials in compliance with all applicable federal, state and local laws and
regulations. PMC shall not transfer the Biological Materials or any information
related to those materials to any person who is not under the immediate and
direct supervision of PMC, nor use the Biological Materials in research that is
subject to consulting or licensing obligations to another corporation or
government agency. No other license shall be granted or implied.
5. Reports: Publicity. As often as mutually agreed between PMC and
Corixa but at least once per month, PMC shall provide a written report
summarizing the results of the Proposed Use of the Biological Materials. No
publication of results by PMC may be made unless it is with the express,
written permission of Corixa. Neither party shall disclose the existence of
this Agreement to any third party or use the name of the other party in any
publicity or advertising without prior written approval of the other party.
6. Inventions. All rights and title to patents or patent
applications of or related to the Biological Materials are exclusively
Corixa's. In the event that use of the Biological Materials results in an
invention or discovery involving a new use, improvement or enhancement of the
Biological Materials, whether patentable or not ("Invention"), PMC shall
disclose the Invention to Corixa. PMC shall cooperate with Corixa in seeking
patent coverage for the Invention and in
42
assigning all right and title to the Invention to Corixa. Corixa shall be
responsible for all costs of obtaining patent coverage.
7. No Conflicts. Both parties warrant and represent that they have
the right to enter into this Agreement and that the terms of this Agreement are
not inconsistent with other contractual obligations they may have or with the
policies of any institution with which they are associated.
8. Disclaimer. THE BIOLOGICAL MATERIALS ARE PROVIDED TO PMC
WITHOUT WARRANTY OF MERCHANTABILITY OF FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER WARRANTY, EXPRESS OR IMPLIED. CORIXA SHALL NOT BE LIABLE FOR ANY USE OF
THE BIOLOGICAL MATERIALS BY PMC, OR FOR ANY LOSS, CLAIM, DAMAGE OR LIABILITY,
OF ANY KIND OR NATURE, WHICH MAY ARISE FROM OR IN CONNECTION WITH THIS
AGREEMENT OR FROM THE USE, HANDLING OR STORAGE OF THE BIOLOGICAL MATERIALS. No
indemnification for any loss, claim, damage or liability is intended or shall
be provided by any party under this Agreement.
9. Term and Termination. This Agreement shall be effective as of
15 February, 1996 and shall terminate nine (9) months thereafter. This
Agreement may be terminated earlier at any time by either party upon ten (10)
days' written notice. All unused Biological materials shall be returned to
Corixa or destroyed, at the sole option of Corixa, within ten (10) days
following termination of this Agreement. Termination shall not affect any
rights of any party under paragraphs 5, 6 or 8 above.
10. Assignability. The rights and obligations of the investigator
and the institution under this Agreement shall not be assignable without the
prior written consent of Corixa.
11. Applicable Law. This Agreement and the rights of the parties
shall be determined in accordance with the laws of the State of Washington. In
the event of actual or threatened disclosure or transfer of the Biological
Materials by PMC to a third party without the prior written consent of Corixa,
Corixa is likely to suffer irreparable harm, and shall be entitled to specific
performance of the obligations of PMC under this Agreement, without bond, as
well as all necessary injunctive relief against unauthorized disclosure or
transfer.
12. Amendments; Other. No modification of this Agreement shall be
effective unless the modification is in writing and executed by both parties.
This Agreement is to be executed in duplicate. One fully executed copy is to be
retained by PMC in care of ___________________________________________________.
The second fully executed copy is to be retained by Corixa at 0000 Xxxxxxxx
Xx., Xxx. 000, Xxxxxxx, XX 00000.
13. Entire Understanding. This Agreement, including the Research
Proposal attached as an appendix, constitutes the entire understanding of the
parties hereto with respect to the matters herein contained.
-2-
43
The signatures of the authorized officers of each party are required
below to make the Agreement effective.
CORIXA CORPORATION PMC
------------------------ ------------------------
Xxxx XxXxxx Name: __________________
Chief Operating Officer Title:__________________
Date:____________, 1996 Date:____________, 1996
-3-
44
EXHIBIT 2
EVALUATION PLANS
45
LeiF Evaluation Plan
TARGETS TO BE EVALUATED DURATION OF EVALUATION
-------------- --------------- ----------------------
Flu [***] [***]
[***] [***]
AIDS [***] [***]
[***] [***]
Malaria [***] [***]
[***] [***]
RSV [***] [***]
[***] [***]
Tuberculosis [***] [***]
46
EXHIBIT 3
RESEARCH PROGRAM
[intentionally omitted]