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EXHIBIT 10.19
7/23/97 LICENSE, DEVELOPMENT AND SUPPLY AGREEMENT
This License, Development and Supply Agreement (this "Agreement") is made
as of this _______ day of July, 1997 (the "Effective Date") by and between
Xxxxxx Laboratories, an Illinois corporation, together with its Affiliates (as
defined herein), having its principal place of business at 000 Xxxxxx Xxxx Xxxx,
Xxxxxx Xxxx, Xxxxxxxx 00000-0000 ("Abbott"), and Corixa Corporation, a Delaware
corporation, having its principal place of business at 0000 Xxxxxxxx Xxxxxx,
Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000 ("Corixa").
RECITALS
A. Corixa owns intellectual property rights relating to proprietary technology
useful in the diagnosis of tuberculosis.
X. Xxxxxx desires to acquire access to such technology and a non-exclusive
license under such intellectual property rights, and under any intellectual
property rights covering any improvements to such technology to make, have made,
use, import, offer to sell and sell diagnostic products which embody such
technology and are useful in the diagnosis of tuberculosis.
C. Corixa is willing to provide Abbott access to such technology and to xxxxx
Xxxxxx a license under such intellectual property rights in accordance with the
terms and conditions set forth in this Agreement.
D. Corixa is willing to supply to Xxxxxx, and Xxxxxx agrees to purchase from
Corixa under the conditions set forth in this Agreement, certain reagents for
Xxxxxx'x use in the manufacture of diagnostic products embodying such
intellectual property rights and technology.
NOW THEREFORE, in consideration of the premises and the mutual covenants
herein set forth, the receipt and sufficiency of which are hereby acknowledged,
the parties hereto agree as follows:
1. DEFINITIONS
In addition to the terms defined elsewhere in this Agreement, the
following words and phrases, whenever capitalized in this Agreement, shall have
the following meanings:
1.1 "Affiliate" shall mean, with respect to a party, any entity that
controls, is controlled by, or is under common control of a party. For this
purpose, control of an entity shall mean direct or indirect ownership of fifty
percent (50%) or more of the voting interest in, or a fifty percent (50%) or
greater interest in the equity of, such corporation or other business entity, or
the maximum percentage allowed by law in the country of the controlled entity.
1.2 "Calendar Quarter" shall mean respectively, the three consecutive
month periods of each calendar year: January, February, March; April, May, June;
July, August, September; and October, November and December.
1.3 "Combination Product" shall mean a Licensed Product that [***]
1.4 "Contract Year" shall mean a period of twelve (12) consecutive months
during the term of this Agreement, the first Contract Year shall commence on the
date Abbott submits a firm purchase order to Corixa pursuant to Article 9.
1.5 "FDA" shall mean the United States Food and Drug Administration or any
successor agency thereof.
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1.6 "Field" shall mean the in-vitro diagnostic detection and monitoring
of M. tuberculosis in humans. [***]
1.7 "First Commercial Sale" shall mean the date on which Abbott first
transfers title to Licensed Product in any country within the Territory to a
Third Party. The transfer of a reasonable amount of Licensed Product intended
for clinical use or for the primary purpose of evaluating customer acceptance
shall not be included in the calculation of the First Commercial Sale.
1.8 "Fully Burdened Manufacturing Cost" shall mean the cost of direct
labor, direct materials and manufacturing overhead incurred in the manufacture
of Materials, such calculation being based upon accepted GAAP.
1.9 "GAAP shall mean, as of any applicable date of determination,
generally accepted accounting principles consistently applied.
1.10 "GMP" shall mean the FDA's current good manufacturing practices, as
specified in 21 CFR Section 210 and the FDA's guidance documents, and all
successor regulations and guidance documents thereto.
1.11 "Licensed Know-How" shall mean any and all technical information,
processes, formulae, data, engineering, know-how and trade secrets, in each case
that is Confidential Information under Section 8 of this Agreement, that is
necessary to practice under the Licensed Patents in the Field. By way of
example, Licensed Know-How shall include with respect to Materials, chemical and
analytical methods and data, specifications and pharmacological and
toxicological methods and data.
1.12 "Licensed Patents" shall mean all:
(a) issued patents and patent applications identified in Exhibit A
attached hereto and as amended from time to time by the mutual
agreement of the parties, and all patents issuing from patent
applications identified in Exhibit A from time to time;
(b) all patents, patent applications and patents issuing from
patent applications that cover peptides and/or proteins which
are (i) discovered by Corixa within twelve months of the
Effective Date under Corixa's M. tuberculosis diagnostic
antigen discovery program and (ii) are not subject to any
rights of Third Parties;
(c) all patents, patent applications and patents issuing from
patent applications arising during the term of this Agreement
which claim the priority of the patents and patent
applications described in subparagraph (a) and (b) above,
including all extensions, renewals, re-examinations,
continuations, continuations-in-part, divisions, patents of
addition, reissues and foreign counterparts thereof in any
country in the world, in each case claiming such priority; and
(d) expressly excluding any patents (and patents issuing from
patent applications) of Corixa which obligates Corixa to pay
license, milestone, royalty or other fees to a third party.
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1.13 "Licensed Product" shall mean products which incorporate Materials or
are directly based on Licensed Patents or Licensed Know-How or which, but for
the license granted hereunder, the manufacture, sale or use of would infringe
one or more Valid Claims.
1.14 "Materials" shall mean the [***], including [***], listed on Exhibit
B, as amended from time to time by the mutual agreement of the parties.
1.15 "Net Sales" shall mean:
(a) the amount invoiced by Abbott or its Affiliates for the sale
or other disposition to Third Parties (or to Affiliates that
are end users of the Licensed Product) of all Licensed
Products, in the Territory, less the following deductions for
amounts actually incurred related to the sale or other
dispositions:
(i) commercially reasonable quantity, trade and cash
discounts or rebates, recalls, credits or allowances and
adjustments separately and actually credited to
customers for rejections and returns of Licensed
Product;
(ii) charges for freight, postage, transportation, import or
export taxes, excise taxes and other similar taxes,
insurance and other delivery costs not otherwise
charged to the customer; and
(iii) any tax or other government charges imposed on the
sale or use of Licensed Product (other than income
tax) levied on its sale, transportation or delivery
and borne by Abbott or its Affiliates.
(b) With respect to Combination Products, the gross invoiced price
of such Combination Products billed to customers by Abbott,
less: [***].
(c) In the event that a Licensed Product sold by Abbott or its
Affiliates is increased in price to include an amount to cover
the amortized cost of an instrument system and/or other
equipment supplied to a customer by Abbott under a Reagent
Agreement Plan, Reagent Rental Plan, or other successor or
similar plan (collectively referred to herein as "RAP"), the
Net Sales for such Licensed Product on which payments are made
pursuant to Article 4 shall be determined by reducing the
total Net Sales of such Licensed Product (including the total
of sale of the Licensed Product and instrument system RAP) by
the amount of the price increase attributable to RAP, using
Xxxxxx'x standard accounting procedures in accordance with
GAAP, provided the minimum amount attributable to the Net
Sales of the Licensed Product shall be no less than the per
unit current net selling price of the
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Licensed Product as sold alone to non-RAP customers.
(d) Net Sales shall not include [***] Licensed Product used in
[***].
(e) In the event that a Licensed Product is transferred by Abbott
or any of its Affiliates to an end user, except as provided in
(d) above, free of charge or at a price which is substantially
lower than the price that would be charged in an arms length
third party transaction, then the Net Sales of such Licensed
Product shall be determined using the average selling price of
such Licensed Product by Abbott and its Affiliates in arms
length Third Party transactions over the same time period or,
if no average selling price of such Licensed Product is
available as of such date, at a reasonable value (to be agreed
upon by the parties) based upon the average selling prices of
products available in the marketplace similar to such Licensed
Product.
1.16 "Specifications" means written specifications for the Materials that
will be developed pursuant to Section 10.1 and shall be attached hereto and made
a part hereof as Exhibit C.
1.17 "Territory" shall mean the entire world.
1.18 "Third Party" means a party other than Abbott, Corixa or their
Affiliates.
1.19 "Valid Claim" shall mean, with respect to each individual country in
the Territory, (i) a claim of an issued and unexpired patent included in the
Licensed Patents which claim has not been held invalid or unenforceable by a
final decision, unappealed or unappealable, of a court or agency of competent
jurisdiction or admitted to be invalid by Corixa or one of Corixa's licensors
[or (ii) a claim of a pending patent or patent application included in the
Licensed Patents, which claim has been pending less than five (5) years.]
1.20 Singular and Plural. Where the context herein requires, the singular
number shall be deemed to include the plural and vice versa.
2. LICENSE GRANT
2.1 License. Corixa hereby grants to Abbott a non-exclusive license,
without the right to sublicense, under Licensed Patents and Licensed Know-How to
use, make, have made, sell, offer to sell, import or otherwise distribute
Licensed Products within the Territory for use solely in the Field. Subject to
Section 12 hereof, Abbott shall have no right to make or have made any Materials
or other subject matter claimed in the Licensed Patents or a part of the
Licensed Know-How.
2.2 [Favored Terms. If, during the term of this Agreement, Corixa
grants another license in the Field for an identical antigen or antigens to
any Third Party under Licensed Patents and Licensed Know-How on overall terms
and conditions which are substantially more favorable to said Third Party with
respect to royalty and supply obligations than those contained herein, Corixa
shall notify Abbott promptly and provide Abbott with all relevant details of
such more favorable royalty and supply obligations. Abbott shall, by exercise
of notice within ten (10) days of receiving such information from Corixa, have
the benefit of such more favorable royalty and supply obligations commencing
upon the effective date of such other license.]
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3. MILESTONE AND ROYALTY PAYMENTS
3.1 License Fee. In consideration of the license granted to Abbott under
Article 2, Abbott shall pay to Corixa a [***] fee of [***] as soon as
practicable, but in no event later than thirty (30) days following the Effective
Date. Such fee shall be non-refundable and non-creditable against any payment
due hereunder, royalty or otherwise.
3.2 Milestone Payments.
(a) Abbott shall pay to Corixa [***] within thirty (30) days
following the earlier of (i) Xxxxxx'x initiation of clinical
trials of Licensed Product, or (ii) the first anniversary of
the Effective Date.
(b) Abbott shall pay to [***] within thirty (30) days following
the earlier of (i) the submission of a data package by Abbott
to a regulatory agency outside the U.S. seeking approval or
clearance to sell the first Licensed Product under this
Agreement outside the United States, or (ii) the first
anniversary of the date on which Abbott paid Corixa pursuant
to Section 3.2(a) above.
(c) Abbott shall pay to Corixa [***] within thirty (30) days
following the earlier of (i) the First Commercial Sale outside
the United States, or (ii) the first anniversary of the date
on which Abbott paid Corixa pursuant to Section 3.2(b) above.
(d) Abbott shall pay to Corixa [***] within thirty (30) days
following submission of a data package by Abbott to the FDA
seeking regulatory approval or clearance to sell the first
Licensed Product under this Agreement in the United States.
(e) Abbott shall pay to Corixa [***] within thirty (30) days
following the First Commercial Sale in the United States.
(f) Except with respect to Sections 3.2(d) and (e) above, Abbott
shall commit the same level of developmental and commercial
diligence towards achieving the above milestones as it would
toward any other leading internal project in the field of
rapid diagnostics.
Abbott shall receive a [***]
3.3 Royalties.
(a) Abbott shall pay to Corixa a royalty on Net Sales of each
Licensed Product in each country of the Territory. Such
royalty shall be calculated as follows: [***] of Net Sales in
countries with Valid Claims that cover the Licensed Product,
unless [***]
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for each [***] the [***] royalty rate payable to Corixa
hereunder shall [***]. The [***] royalty shall be paid on
Licensed Product covered by a Valid Claim on a country by
country basis. [***]
(b) The obligation to pay royalties to Corixa under this Section
3.3 is imposed only once with respect to the same unit of
Licensed Product regardless of the number of Valid Claims
pertaining thereto. Payments due under this Agreement shall be
deemed to accrue when Licensed Products are billed. The
royalty payable in countries with issued patents shall be paid
for the life time of the patents on a country-by-country
basis.
(c) No royalties shall be payable on sales of Licensed Product
among or between Abbott and its Affiliates, unless such
Affiliate in an end user of such Licensed Product.
4. ROYALTY REPORTS
4.1 Royalty Payment and Reports. The royalties payable pursuant to
Section 3.3 shall be paid within sixty (60) days after the last day of each
Calendar Quarter with respect to Net Sales occurring during such Calendar
Quarter. Each such payment shall be accompanied by a statement, in sufficient
detail describing the Licensed Products sold, the country of sale, the amount of
Licensed Product sold and the basis for calculating the accrued royalties. After
the First Commercial Sale, such statement shall be prepared whether or not
Abbott has recorded any sales in such Calendar Quarter. All information provided
by Abbott pursuant to this Section shall be deemed Confidential Information.
4.2 Calculation of Royalty. The calculation of the accrued royalties
payable hereunder shall be based on Net Sales converted to U.S. dollars using
standard conversion methodology, which is consistent with GAAP. The standard
conversion methodology for sales is based on monthly averages (the spot rate for
the end of the month immediately prior to that which payment is due plus the
spot rate for the month ending when payment is due divided by two), using
central bank fixing rates in countries where available and open market rates
otherwise.
4.3 Country Requirements. If any country restricts the amount payable on
account of Net Sales in such country, the amount due hereunder shall not exceed
the maximum amount payable, under applicable laws, regulations or administrative
rulings of such country. If any Net Sales are made in a currency as to which
conversion into U.S. Dollars is then blocked, Abbott shall make payment in such
local currency, to the extent permitted by U.S. and local law, to an account
designated by Corixa.
4.4 Payment of Applicable Taxes. If any taxes are imposed on any
payments accruing to Corixa under this Agreement, and are required to be
withheld by Abbott by the relevant taxing authority, such taxes shall be [***],
and when paid by Abbott to the proper taxing authority out of accrued royalties,
proof in evidence of such payment shall be secured and sent to Corixa together
with official or other appropriate evidence issued by the appropriate
governmental authority. All taxes levied on Corixa's income arising from this
Agreement shall be
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borne by Corixa. The parties shall take steps consistent with current commercial
practices to: (i) avoid or minimize any such withholding; and (ii) take
advantage of such double taxation avoidance agreements as may be available.
4.5 Records. Abbott shall keep full, complete and proper records and
accounts of Net Sales of the Licensed Products. Upon reasonable notice to
Abbott, Corixa shall have the right to have an independent certified public
accountant, selected by Corixa and acceptable to Abbott, audit Xxxxxx'x records
pertaining to the Licensed Product during normal business hours to verify the
amounts payable pursuant to this Agreement; provided, however that: (i) such
audit shall not take place more frequently than once a year, and (ii) shall not
cover such records for more than the preceding three (3) years. Such audit shall
be at Corixa's expense unless Abbott has paid Corixa less than [***] of the
amount determined to be due for a given time period, in which case such audit
shall be at Xxxxxx'x expense. Abbott shall preserve and maintain all such
records and accounts required for audit for a period of three (3) years after
the quarter to which such records and accounts apply.
5. DEVELOPMENT
5.1 Project Team. Upon execution of this Agreement, a group shall be
formed consisting of at least one technical representative from both Abbott and
Corixa (the "Project Team") for the purpose of ensuring (a) good communication
between Abbott and Corixa of technical information relative to the development
of Licensed Product, (b) smooth transfer of required Materials, and any [***]
shared between the parties, and (c) adequate support of the manufacturing
scaleup of the Materials. The Project Team shall interface at least [***] in a
mutually agreed format (e.g. in person, by telephone or video conference) during
the period beginning with the Effective Date of this Agreement and ending with
the First Commercial Sale.
5.2 Supply of Materials for Product Development. During the period
commencing with the Effective Date and terminating with clinical lot preparation
(the "Development Phase"), Corixa agrees to provide to Abbott, [***], reasonable
quantities of Materials to be used for development of Licensed Product. During
the period commencing upon the conclusion of the Development Phase and ending
with the First Commercial Sale (the "Clinical Phase"), Materials required for
use by Abbott will be provided by Corixa under the terms and conditions in
Section 9.2(a).
5.3 Exchange of [***]. During the Development Phase of the Licensed
Product, both parties agree to make available to the other, [***], reasonable
quantities of [***] to be used for the purpose of evaluating the performance of
the Licensed Product.
6. INTELLECTUAL PROPERTY
6.1 Disclosure of Inventions. Each party shall promptly disclose to the
other party all inventions, discoveries and improvements arising from the
development effort undertaken pursuant to this Agreement, whether or not
patentable, made or conceived in the Field (an "Invention").
6.2 Ownership of Joint Inventions. All Inventions jointly made or
conceived by employees or others acting on behalf of Abbott and Corixa during
the term of this Agreement (a "Joint Invention") shall be jointly owned by both
parties. All costs associated with (a) prosecuting and maintaining such patents
and patent applications, and (b) enforcing such patents against Third Party
infringers shall be shared equally by both parties. In the event that a Joint
Invention is solely related to or has greatest application to Licensed Know-How,
then the prosecution and maintenance of such patents and enforcement of such
patents against Third Party infringers shall be the responsibility of Corixa. In
the event a Joint Invention is solely related to or has greatest application to
Xxxxxx'x proprietary technology or know-how, then the prosecution and
maintenance
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of such patents and enforcement of such patents against Third Party
infringers shall be the responsibility of Abbott. Both parties shall be given
the opportunity to review and comment upon the other's patent applications
covering Joint Inventions and the parties shall mutually agree upon all such
filings. Each party shall keep the other party advised as to all material
developments with respect to all such patents and patent applications. Either
party may assign its interest under any Joint Invention to the other party and
have no further obligation for any prosecution, maintenance, enforcement, cost
and expenses of any patent application or patent covering such Joint Invention
except as to costs and expenses that have accrued prior to such assignment.
[***]
6.3 Corixa Sole Inventions. All inventions, discoveries and improvements
solely applicable to Licensed Know-How in the Field, whether or not patentable,
made or conceived solely by employees or others acting on behalf of Corixa
during the term of this Agreement ("Corixa Invention"), shall be (i) owned
solely by Corixa, (ii) promptly disclosed in writing to Abbott, (iii) considered
part of Licensed Know-How, and (iv) subject to the terms and conditions of this
Agreement. All costs associated with (a) prosecuting and maintaining such
patents and patent applications, and (b) enforcing such patents against third
party infringers shall be the responsibility of Corixa.
6.4 Abbott Sole Inventions. All improvements, developments,
modifications or derivatives of the Materials or other subject matter claimed in
the Licensed Patents or a part of the Licensed Know-How, whether or not
patentable, made or conceived solely by employees or others acting on behalf of
Abbott during the term of this Agreement ("Abbott Invention"), shall be owned
solely by Abbott. All costs associated with (a) prosecuting and maintaining such
patents and patent applications, and (b) enforcing such patents against third
party infringers shall be the responsibility of Abbott. If Abbott terminates
this Agreement pursuant to Section 13.3 or 13.5 and the rights to an Abbott
Invention are the only intellectual property rights preventing Corixa from
practicing in the Field, then Abbott shall xxxxx Corixa a royalty bearing
non-exclusive license on terms and conditions acceptable to the parties.
7. PATENT ENFORCEMENT
7.1 Notification of Third Party Infringement of Licensed Patents. If
during the term of this Agreement, either party becomes aware of a Third Party
infringement or threatened infringement (a "Third Party Infringement") of any
Licensed Patent in the Territory, or any misappropriation of Licensed Know-How,
the party having such knowledge shall promptly provide notice to the other
party, with all available details.
7.2 Corixa's Right to Restrain Infringement. Corixa shall have the
right, but not the obligation, to pursue in its name, at its own expense,
efforts to restrain a Third Party Infringement and to recover profits and
damages. Upon Corixa's request and at Corixa's expense, Abbott shall be joined
as a party plaintiff and shall cooperate in the pursuit thereof, as is
reasonably necessary. If Corixa decides to undertake such action, then Corixa
shall have the sole right to control prosecution, and may retain for its own
account any amounts recovered from Third Parties, but Corixa shall keep Abbott
informed on a regular basis as to the status of such proceeding.
7.3 Xxxxxx'x Right to Restrain Infringement. If Corixa fails to take
action within one hundred eighty (180) days after becoming aware of a Third
Party Infringement, then Abbott, at any time prior to Corixa thereafter taking
action, shall have the right, but not the obligation, to pursue the restraint of
such Third Party Infringement in its own name or in the name of Corixa as it
deems necessary or appropriate (at Xxxxxx'x expense), and Corixa hereby consents
and agrees to the use of its name in any such action. Corixa shall cooperate
with Abbott, at Xxxxxx'x expense, as is
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reasonably necessary in any such action brought by Abbott. If Abbott pursues
legal action, Xxxxxx shall have the sole right to control prosecution, and may
retain for its own account any amounts recovered from Third Parties, but Abbott
shall keep Corixa informed on a regular basis as to the status of such
proceeding.
7.4 Recovery of Litigation Expenses by Abbott. During the pendency of
any legal proceeding or appeal thereof undertaken by Abbott pursuant to Section
7.3, Abbott shall continue paying royalty to Corixa in accordance with the terms
of this Agreement, but shall be allowed to deposit in an interest-bearing escrow
account with a federally insured bank, [***] of such royalty, provided that
Abbott has first notified Corixa in writing prior to such action. In the event
that Abbott is successful in such legal proceeding or withdraws such action due
to settlement, Abbott shall be entitled to retain the full share of any
recovery, and the escrowed amount shall be released to Corixa. In the event that
Abbott is unsuccessful in such legal proceeding and Corixa fails to reimburse
Abbott for its reasonable expenses, including attorney fees, associated with
such legal proceeding within thirty (30) days following completion of the Third
Party Infringement action, the escrowed royalties shall be released to Abbott in
an amount equal to Xxxxxx'x reasonable litigation expenses, with any remaining
funds from the escrow account paid to Corixa.
7.5 Failure to Resolve Infringement. If within twelve (12) months of the
date of notice of Third Party Infringement in a country, neither Corixa nor
Abbott, for any reason, has effected termination of such infringement, or Corixa
has not granted a license to the infringing party in respect to the
infringement, and where the infringing sales equal or exceed [***] of Xxxxxx'x
total Net Sales of Licensed Product in such country, Xxxxxx'x royalty payment on
Net Sales of Licensed Product payable to Corixa in such country pursuant to this
Agreement shall be [***], which amount shall be deposited in an interest-bearing
escrow account with a federally insured bank. The funds deposited in such
account shall be released to Corixa upon the earlier of the execution of a
license with the alleged infringer or the issuance of an order in an action
against the alleged infringer or other termination of the infringement;
provided, however, that if within [***] after receiving notice of the Third
Party Infringement Corixa has neither instituted legal proceedings against nor
granted a license to the infringing party with respect to any such Third Party
Infringement, then Xxxxxx'x royalty rate on Net Sales of Licensed Product in
such country pursuant to this Agreement shall be [***] until such time as such
Third Party Infringement is terminated and all funds deposited in the escrow
account established pursuant to this Section 7.5 for such country shall be paid
to Abbott.
7.6 Shared Recovery in a Cooperative Legal Action. In the event Abbott
and Corixa agree to pursue a cooperative legal action related to a Third Party
Infringement and a monetary award is obtained in such action, such award shall
be applied in the following priority: (i) to reimburse Abbott and Corixa by
proportion and up to the extent of their actual out-of-pocket expenses
(including reasonable attorney fees) in prosecuting such action; (ii) to be
shared by proportion and up to the extent of any damages established to have
been suffered by either party, including but not limited to Xxxxxx'x lost
profits and Corixa's lost royalties; and (iii) the balance, if any, to be shared
equally between Abbott and Corixa.
7.7 Infringement of Third Party Patents. If any patent infringement or
similar action is brought in a country in the Territory against Abbott, or any
supplier, distributor, or customer of Abbott because of actual or anticipated
manufacture, use or sale of a Licensed Product or use of Licensed Know-How, then
Abbott shall promptly notify Corixa and send Corixa copies of all papers that
have been served. Corixa shall have the right, but not the obligation, to defend
any such action if and to the extent such claims of infringement, violation or
misappropriation are based in the making, using, importing, offering to sell
and/or selling of Materials or the practice of Licensed Patents or the use of
Licensed Know-How. If Corixa decides to undertake such action, then Corixa shall
have the sole right to control prosecution, and may retain for its own account
any amounts recovered from Third Parties, but Corixa shall keep Abbott informed
on a regular basis as
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to the status of such proceeding. Abbott shall at all times cooperate with
Corixa, and continue to pay Corixa any applicable royalties during the pendency
of such action and any appeals. Corixa agrees to reimburse Abbott for its
reasonable expenses and/or attorney's fees to the extent these expenses and fees
are related to the assistance provided to Corixa in defending such action or
claim.
7.8 Failure of Corixa to Defend Third Party Patent Infringement. If
Corixa elects not to defend such infringement action after being notified by
Xxxxxx, Xxxxxx shall have the right to defend the action itself. If Xxxxxx does
undertake such defense, (a) Corixa shall cooperate with Xxxxxx and Xxxxxx shall
be entitled to select legal counsel of its choice and otherwise control all
aspects of the litigation, and (b) Xxxxxx shall be permitted to escrow [***] of
the royalties for Net Sales in the applicable country, which would otherwise be
payable to Corixa hereunder, during the pendency of any such suit or any appeal
taken from it, provided that no escrow offset will be made without prior
notification in writing to Corixa. Upon final decision in favor of Xxxxxx,
unappealed or unappealable, of an administrative agency or court of competent
jurisdiction, payment by Xxxxxx of said royalty amounts escrowed and back due,
shall then be made to Corixa within thirty (30) days of said final decision,
after deduction of the reasonable costs and expenses heretofore set forth in
this Section 7.8 and incurred by Xxxxxx. Upon final decision against Xxxxxx,
unappealed or unappealable, of any administrative agency or court of competent
jurisdiction, such that Xxxxxx must cease the making, using, offering to sell,
selling or importing of Licensed Product, then any amount held in escrow by
Xxxxxx shall be immediately released to Xxxxxx. In the event a final decision is
rendered against Xxxxxx and the escrowed amount is insufficient to reimburse
Xxxxxx for its reasonable costs and expenses, including reasonable attorney
fees, Corixa shall pay Xxxxxx an amount equal to such deficiency, provided such
amount payable by Corixa shall not exceed the royalties paid to Corixa for Net
Sales in the applicable country during the [***] prior to the
establishment of the escrow account by Xxxxxx in accordance with this Section
7.8. If Corixa's payment to Xxxxxx pursuant to the preceding sentence does not
reimburse Xxxxxx fully for its reasonable costs and expenses, [***].
7.9 Settlement of Legal Action. Any legal action undertaken by Corixa
pursuant to this Article 7, may be settled by Corixa without Xxxxxx'x consent,
provided that Xxxxxx is not bound by the terms of such settlement. Any legal
action that Xxxxxx undertakes pursuant to this Article 7 shall not be settled by
Xxxxxx without Corixa's prior written consent, which consent shall not be
unreasonably withheld.
8. CONFIDENTIALITY
It is contemplated that in the course of the performance of this Agreement
each party may, from time to time, disclose proprietary and confidential
information to the other ("Confidential Information"). Except to the extent
expressly authorized by this Agreement or otherwise agreed to in writing, during
the term of this Agreement and for a period of five (5) years following the
termination of this Agreement, the receiving party shall take such reasonable
measures to maintain such Confidential Information as confidential as it takes
to protect its own proprietary and confidential information, and shall not
publish or otherwise disclose such Confidential Information. The following
information shall not be considered Confidential Information:
(a) information which was already known to the receiving party, other
than under an obligation of confidentiality to the disclosing party,
at the time of disclosure by the other party; or
(b) information which was generally available to the public or otherwise
part of the public domain at the time of its disclosure to the
receiving party; or
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(c) information which becomes generally available to the public or
otherwise part of the public domain after its disclosure and other
than through any act or omission of the receiving party in breach of
this Agreement; or
(d) information which was disclosed to the receiving party, other than
under an obligation of confidentiality, by a third party who had no
obligation to the disclosing party not to disclose such information;
or
(e) information which was developed independently without reference to
Confidential Information received from the other party hereunder as
evidenced by the receiving party's own written records.
Confidential Information shall include all disclosures hereunder in
writing and identified as being "Confidential", or if disclosed orally, which
are reduced to writing within thirty (30) days of oral disclosure and clearly
identified as being "Confidential". In the event either party must disclose the
other party's Confidential Information in order to comply with applicable
governmental regulations or as otherwise required by law or judicial process,
such party shall give reasonable advance notice to the other party of such
proposed disclosure in order that the non-disclosing party may intercede and
oppose such process, and shall use its best efforts to secure confidential
treatment of such Confidential Information which is required to be disclosed.
9. PRODUCT SUPPLY
9.1 Purchase and Sale. Subject to the terms and conditions of this
Agreement, Corixa shall sell and supply to Xxxxxx, and Xxxxxx shall purchase
from Corixa or Corixa's designated Third Party manufacturer all of its
requirements of the Materials, in accordance with Section 9.2. In the event that
additional [***] not covered by Corixa's patents or patent applications are
required for improved Licensed Product performance, Xxxxxx shall be entitled to
purchase and/or license such materials from any Third Party. Upon one hundred
and eighty (180) days prior notice to Xxxxxx, Corixa may delegate the
performance of any or all of its obligations under Articles 9, 10, 11 and 12 of
this Agreement to a Third Party manufacturer (the "Third Party Manufacturer"),
but shall remain primarily liable to Xxxxxx for any failure to fully perform
such obligations.
9.2 Purchase Price, Price Adjustments and Payment.
(a) For Materials sold by Corixa and purchased by Xxxxxx pursuant
to this Agreement during the Clinical Phase, Xxxxxx shall pay
a purchase price equal to [***] of the Fully Burdened
Manufacturing Cost of such Materials calculated in accordance
with GAAP (the "Purchase Price"). The Purchase Price for each
antigen is set forth on Exhibit D. The parties may amend
Exhibit D by mutual written agreement as may be necessary to
reflect changes in the estimated cost of each antigen, which
Exhibit will be appended to this Agreement prior to the
Clinical Phase.
(b) For Materials sold by Corixa and purchased by Xxxxxx pursuant
to this Agreement, subsequent to the Clinical Phase, Xxxxxx
shall pay the Purchase Price, [***]. Corixa agrees to
diligently pursue efforts to reduce the overall cost of
Materials and will allow representatives of Xxxxxx to audit
Corixa's accounting records pertaining to the manufacture of
the Materials once per year.
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(c) The Purchase Price may be adjusted once each Contract Year by
written notice from Corixa to Xxxxxx at least ninety (90) days
prior to the anniversary date of the Contract Year. The
adjusted Purchase Price shall become effective for the
Materials ordered by and delivered to Xxxxxx during the
succeeding Contract Year provided that any such adjusted price
for that Contract Year shall not exceed the previous Contract
Year price by greater than [***], which last precedes the
effective date of the price adjustment.
(d) Corixa shall invoice Xxxxxx at the time of or after each
shipment of the Materials. Xxxxxx shall pay such invoice
within thirty (30) days from the date of receipt of the
invoice.
9.3 Forecast and Orders.
(a) Within thirty (30) days of the Effective Date (or a date
mutually agreed upon by the parties), Xxxxxx shall furnish to
Corixa a rolling quarterly forecast for the quantities of
Materials that Xxxxxx intends to order during the twelve (12)
month period, commencing no sooner than ninety (90) days from
the date of the forecast. Prior to the initiation of Clinical
Lots of Licensed Product, such forecast shall be used for
planning purposes only. Following initiation of Clinical Lots
of Licensed Product, the first [***] months of such forecast
shall constitute a binding commitment upon Xxxxxx to purchase
such quantities as evidenced by purchase orders received from
Xxxxxx in accordance with Section 9.3 (b). The balance of such
forecast shall merely represent reasonable estimates for
planning purposes only [***]. Xxxxxx shall update such
forecast quarterly.
(b) Xxxxxx shall place each purchase order with Corixa for
Materials to be delivered hereunder at least ninety (90) days
prior to the delivery date specified in each respective order.
Corixa hereby guarantees such ninety (90) day delivery from
the receipt of each purchase order and shall accept such firm
orders placed by Xxxxxx within ten (10) days of receipt for
that amount of Materials which varies no more than +/- [***]
of the then current estimate for the applicable period. For
orders of Materials that exceed [***] of the then current
estimate for the applicable period, Corixa shall use its
reasonable best efforts to meet the ninety (90) day delivery
date. If Corixa is unable to deliver on the specified date,
Corixa may decline to provide that amount of Materials which
exceeds [***] of the most current forecast underlying such
order, provided, that it is declined in writing and is
delivered to Xxxxxx within ten (10) days of Corixa's receipt
of the order. Corixa shall deliver against each such order in
accordance with Section 9.4. Xxxxxx shall be obligated to
purchase all Materials ordered and delivered by the delivery
date, provided, that such Materials is not otherwise rejected
pursuant to Section 11.1. The terms and conditions of this
Agreement shall control as to a particular order unless
otherwise agreed to in writing by the parties.
9.4 Delivery. Delivery terms shall be F.O.B. Corixa's manufacturing
facility in Seattle, Washington, or other facility as designated by the Third
Party Manufacturer. Corixa shall ship Materials under appropriate storage
conditions in accordance with Xxxxxx'x purchase order form.
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In all other respects, the obligations and rights of the parties shall be
governed by the terms and conditions of this Agreement. None of the general
terms and conditions set forth on any such purchase order form shall be
applicable, and none of the general terms or conditions set forth in any
acknowledgement form used by Corixa shall be applicable.
9.5 Safety Stock. After the First Commercial Sale, Corixa shall maintain
a fresh safety stock of Materials, equivalent to the forecasted purchases for
the most recent [***] month period, to be exclusively available to Xxxxxx.
Deliveries by Corixa to Xxxxxx may be taken from Corixa's inventory identified
as safety stock. Corixa's safety stock shall be rotated with its regular
inventory of Materials to maintain a reasonable shelf life. Corixa shall keep
Xxxxxx reasonably informed of the level of inventory identified as the safety
stock. In the event of termination of this Agreement, Xxxxxx will be obligated
to purchase the unsold portion of such safety stock from Corixa, to the extent
the quantity on termination is equal to or less than the most recent [***] month
forecast.
10. PRODUCT MANUFACTURE
10.1 Incoming Specifications. The parties will in good faith cooperate
with one another to develop the Specifications, which shall be acceptable to
both parties. The Specifications shall be agreed upon in writing and shall be
incorporated into this Agreement as Exhibit C, as amended from time to time by
the mutual agreement of the parties. The parties may from time to time amend the
Specifications by mutual written agreement without the necessity of amending
this Agreement. Such amended Specifications shall then be deemed the
Specifications as defined in Section 1.16. The Specifications shall be
considered Confidential Information for the purposes of Article 8.
10.2 Manufacturing Process.
(a) Except for Materials manufactured for use in the Development
Phase, Corixa or the Third Party Manufacturer, as the case may
be, shall manufacture the Materials in accordance with GMP, as
required by the United States Food and Drug and Cosmetic Act
(the "Act"), together with all pertinent rules and regulations
of the FDA, the Specifications, and all other applicable
national, state and local laws, regulations, and guidelines.
(b) In the event that a regulatory submission or country
registration requires the disclosure of information regarding
the manufacturing process used in connection with the
Materials to be supplied under this Agreement, Corixa shall
promptly disclose all such information to the appropriate
governmental authority. Such information shall be considered
Confidential Information pursuant to Article 8. Corixa shall
not modify the processes nor change the materials used in the
manufacturing process without the prior written approval of
Xxxxxx.
10.3 Testing of Materials. Corixa shall test or cause to be tested each
batch of Materials manufactured pursuant to this Agreement before delivery to
Xxxxxx. Each test shall set forth the Specifications, the items tested and test
results in a certificate of analysis for each batch delivered. Corixa shall send
or cause to be sent such certificates to Xxxxxx along with delivery of
Materials. Xxxxxx is entitled to rely on such certificates for all purposes of
this Agreement. Nothing in this Agreement shall be construed to require Xxxxxx
to perform any incoming testing, analytical or otherwise, on any Material
received from Corixa. The information in such certificates shall be true in all
material respects. Nothing in this Agreement shall be construed to require
Xxxxxx'x verification of the test results used to complete such certificates.
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10.4 Certification. Corixa or its designated third party manufacturer
shall use commercially reasonable efforts to become an Xxxxxx approved vendor
within twelve (12) months following the Effective Date.
10.5 Cease Manufacture. Corixa or the Third Party Manufacturer may elect
to cease supply of Materials to Xxxxxx upon at least twelve months advance
notice to Xxxxxx. Such notice shall include all necessary information to enable
Xxxxxx or any Third Party designated by Xxxxxx to manufacture the Materials in
accordance with the Specifications.
11. QUALITY ASSURANCE AND INSPECTION
11.1 Rejected Goods/Shortages.
(a) Xxxxxx shall notify Corixa in writing of any claim relating to
Materials which do not conform to the Specifications or any
shortage in quantity of any shipment of Materials within
thirty (30) days of receipt of such shipment. In the event of
such rejection or shortage, Corixa shall replace the Materials
or make up the shortage within thirty (30) days of receiving
such notice, at no additional cost to Xxxxxx, and shall make
arrangements with Xxxxxx for the return or destruction of any
rejected Materials, such return shipping charges or costs of
destruction to be paid by Corixa.
(b) In the event of a conflict regarding any nonconforming
Materials which Corixa and Xxxxxx are unable to resolve, a
sample of such Materials, together with mutually agreed upon
questions, shall be submitted by Xxxxxx to an independent
laboratory reasonably acceptable to both parties for testing
against the Specifications and the test results obtained by
such laboratory shall be final and binding upon the parties.
The fees and expenses of such laboratory testing shall be
borne entirely by the party against whom such laboratory's
findings are made. In the event the test results indicate that
the Material in question does not conform to the
Specifications, Corixa shall replace such Material with
conforming Material at no additional cost to Xxxxxx within
thirty (30) days after receipt of such results, provided that
Corixa has sufficient conforming Material in its inventory to
do so. If sufficient conforming Material is not available,
Corixa shall use its best efforts to replace the nonconforming
Material with conforming Material at no additional cost to
Xxxxxx as soon as possible, but in no event shall the
replacement time exceed one hundred twenty (120) days.
11.2 Regulatory.
(a) Each party shall keep the other informed of any formal or
informal inquiry by any regulatory agency of any state or
national government or supranational authority relating to
either Materials or Licensed Product used or sold hereunder.
(c) Upon reasonable prior notice, but not less than five (5)
working days, Corixa shall permit representatives of any
regulatory agency having jurisdiction over the manufacture
and/or marketing of the Materials or of any diagnostic assay
or other product in which the Materials is incorporated, to
inspect its facilities in conjunction with the manufacture,
testing, packaging, storage, handling and shipping of the
Materials. Further, Corixa shall advise Xxxxxx immediately if
Corixa receives notice of an impending inspection or if an
authorized agent of the FDA or other governmental
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agency visits any of Corixa's manufacturing facilities
concerning the Materials. Corixa shall furnish to Xxxxxx any
report including any FDA Form 483 notices (or comparable
notices of other agencies), regulatory letters or similar
documents received from such agency and the application of
such report to the Materials, if any, within seven (7) days of
Corixa's receipt of such report.
11.3 Inspection by Xxxxxx. Notwithstanding Corixa's obligation to provide
the certificate set forth in Section 9.9, Corixa shall permit Xxxxxx upon
reasonable prior notice, but not less than five (5) working days, and during
regular business hours, but no more often than once in each contract year,
access to (i) those areas of Corixa's manufacturing facilities where the
Material is manufactured, tested, packaged, stored, handled and shipped, and
(ii) the manufacturing records for the Materials manufactured for Xxxxxx.
11.4 Recall; MDR; Field Correction. Should any defect or governmental
action relating to the Licensed Product result in (a) the recall, destruction or
withholding from market of the Licensed Product ("Recall"); (b) the issuance of
a Medical Device Report within the meaning of the Act on Licensed Product
("MDR"); or (c) the institution of a field correction of any Licensed Product
("Field Correction"), then Corixa shall reasonably cooperate, at Xxxxxx'x
reasonable request, in the resolution of such recall, MDR or Field Correction.
Xxxxxx shall handle notification of customers and returns of Licensed Product
from customers and all FDA communications and requests regarding any Recalls,
MDRs or Field Corrections.
11.5 Customer Complaints. In the event that Corixa or Xxxxxx receives any
customer complaint regarding a Licensed Product, then that party shall promptly
inform the other concerning the details of any such complaint. The complaint
shall then be evaluated and investigated by Xxxxxx at Xxxxxx'x own cost. Corixa
shall assist Xxxxxx in follow-up correction of product complaints, at Xxxxxx'x
reasonable request. The cost of any follow-up correction shall be borne by
Corixa up to the extent such complaint is related to the manufacturing of the
Materials by Corixa, or some other cause or event attributable to Corixa, and
shall be borne by Xxxxxx up to the extent such complaint is related to a cause
or event attributable to Xxxxxx.
12. FAILURE TO SUPPLY
12.1 Failure. In the event that Corixa is unable, or notifies Xxxxxx that
it is unable, for any reason (including an event of force majeure) to supply
quantities of Materials in accordance with Section 9.3 for a period of
[***], Xxxxxx may at its discretion (a) require Corixa to supply the
undelivered Materials at a future date agreed upon by the parties; or (b)
manufacture or have manufactured by a Third Party designated by Xxxxxx that
quantity of the Materials required by Xxxxxx which Corixa is unable to supply.
If Xxxxxx determines to manufacture or have manufactured by a Third Party such
Materials, Corixa will give Xxxxxx and/or any such Third Party all necessary
information and cooperation to enable Xxxxxx or such Third Party to manufacture
the Materials in accordance with the Specifications.
12.2 Supply Resumption. Corixa will have [***] from the original delivery
date of the Materials to Xxxxxx in which to resume supply of the Materials to
Xxxxxx; provided, however, such [***] limitation shall not apply to a failure by
Corixa to supply that results from a force majeure event pursuant to Section
16.6. At the time that Corixa resumes supply of the Materials, Xxxxxx will cease
manufacture of the Materials or have the Third Party cease such manufacture in a
reasonable time and manner, and shall purchase Materials exclusively from
Corixa.
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13. TERM / TERMINATION
13.1 Term and Expiration. The initial term of this Agreement shall expire
on the date on which the last patent expires for the Licensed Patents. This
Agreement may be terminated at any time upon the written mutual agreement of the
parties. This Agreement shall be automatically extended for additional one (1)
year terms until such time as either party provides the other with a written
notice of termination at least ninety (90) days prior to any such automatic
annual extension.
13.2 Termination With Cause. Upon any material breach of this Agreement
by either party, the non-breaching party may terminate this Agreement upon
ninety (90) days written notice to the breaching party. The notice shall become
effective at the end of the ninety (90) day period unless the breaching party
shall cure such breach within such period.
13.3 Acquisition of Corixa. If a Third Party acquires in one transaction
or as a result of a series of transactions at least 50% of the common stock or
equity of Corixa, whether through sale or merger, Corixa shall promptly notify
Xxxxxx of such acquisition or merger (the "Notification Date"). Within
forty-five (45) days of the Notification Date, Xxxxxx shall provide written
notification to Corixa of Xxxxxx'x election of either one of the following two
options: (i) that Xxxxxx shall permit such Third Party to assume the terms of
this Agreement in the place of Corixa; or (ii) that Xxxxxx has elected to
terminate this Agreement effective upon Corixa's receipt of Xxxxxx'x notice.
13.4 Termination for Insolvency. Either party may terminate this
Agreement upon written notice to the other in the event of (a) insolvency of the
other party, or the appointment of a receiver by the other party for all or any
substantial part of its properties, provided that such receiver is not
discharged within sixty (60) days of its appointment; (b) the adjudication of
the other party as a bankrupt; (c) the admission by the other party in writing
of its inability to pay its debts as they become due; (d) the execution by the
other party of an assignment for the benefit of its creditors; or (e) the filing
by the other party of a petition to be adjudged as a bankrupt, or a petition or
answer admitting the material allegations of a petition filed against the other
party in any bankruptcy proceeding, or the acts of the other party to any other
judicial proceeding intended to effect a discharge of the debts of the other
party, in whole or in part.
13.5 Termination by Xxxxxx. Xxxxxx may terminate this Agreement upon
sixty (60) days written notice to Corixa if (a) Xxxxxx fails to achieve any of
the milestones set forth in Section 3.2, (b) Xxxxxx'x marketing plans and
projections for the Licensed Product materially change subsequent to the
Effective Date, or (c) Corixa settles any legal action pursuant to Section 7.9
without obtaining Xxxxxx'x prior consent.
13.6 Termination of Supply. Xxxxxx may terminate this Agreement upon
sixty (60) days written notice to Corixa following Xxxxxx'x receipt of notice
from Corixa or the Third Party Manufacturer given pursuant to Section 10.5.
13.7 Consequences of Expiration or Early Termination. Upon the expiration
or early termination of this Agreement:
(a) Each party shall return or destroy, and certify to such
destruction of, all Confidential Information of the other
party, except that each party may maintain one (1) copy for
archival purposes solely to confirm compliance with the
provisions of Article 8;
(b) Xxxxxx shall purchase the safety stock inventory held by
Corixa in accordance with Section 9.5 upon early termination
by Xxxxxx for any reason, except for breach or failure to
supply by Corixa or termination due
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to a force majeure event of Corixa, provided that Xxxxxx may,
but is not obligated to, purchase the safety stock upon
expiration or any early termination of this Agreement by
Corixa for any reason; and
(c) Xxxxxx may dispose of, by sale or otherwise, any remaining
inventory of Materials, including safety stock, and Licensed
Product that Xxxxxx may have in its possession on the date of
expiration or early termination of this Agreement, and Xxxxxx
shall pay to Corixa any royalties due on the Net Sales of such
Licensed Product in the Territory.
13.8 Inclusive Remedy. Except as otherwise provided in this Agreement,
each party shall have the rights and remedies set forth herein in addition to
any other remedies which it may have under applicable statutory or common law.
Each party shall have the sole discretion to determine which of its rights and
remedies, if any, it shall pursue and such party shall not be required to
exhaust any of its other rights or remedies before pursuing any one of the
rights and remedies set forth in this Agreement.
13.9 Survival. Expiration or early termination of this Agreement shall
not relieve either party of its obligations incurred prior to expiration or
early termination. The obligations under Sections 11.4, 11.5, 16.2, 16.3, 16.8
and 16.9, and Articles 8, 14 and 15, shall survive expiration or early
termination of this Agreement or of any extensions thereof for a period of ten
(10) years. All licenses hereunder shall survive in accordance with their terms.
14. REPRESENTATIONS AND WARRANTIES
14.1 By Corixa. Corixa represents and warrants to Xxxxxx that:
(a) as of the Effective Date, it has the full right to enter into
and perform Corixa's obligations under this Agreement and to
grant the license described in Article 2 and to supply the
Materials;
(b) as of the Effective Date, it is not a party to, and to the
best of its knowledge none of its assets are subject to, any
agreements, assignments or encumbrances currently in force
that are inconsistent with the provisions of this Agreement;
(c) as of the Effective Date and to the best of its knowledge,
without having undertaken any special investigation, the
manufacture, use, sale, offer to sell or importing of
Materials in the Territory does not infringe or violate any
patent, trademark, or copyright or any other intellectual
property or proprietary rights of any Third Party;
(d) as of the Effective Date and to the best of its knowledge,
there are no pending actions, either actual or threatened,
relating to Licensed Know-How or Licensed Patents;
(e) as of the Effective Date, the execution, delivery, and
performance of this Agreement does not conflict with, violate,
or breach any agreement to which Corixa is a party;
(f) no Materials delivered by Corixa under this Agreement will be
adulterated or misbranded within the meaning of the Act, or
within the meaning of any other applicable law in which the
definitions of adulteration or misbranding are substantially
the same as those contained in the Act, as such laws are
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constituted and effective at the time of such shipment or
delivery, or as an article which may not, under the provisions
of Section 404 or 505 of the Act, be introduced into
interstate commerce;
(g) except for the Materials manufactured for the Development
Phase, all Materials supplied by it to Xxxxxx under this
Agreement shall conform to the Specifications and be
manufactured in accordance with GMP; and
(h) it shall not, with respect to any present or future patent or
patent application which it owns or under which it has the
right to grant licenses of the scope of the licenses granted
in this Agreement, or which it shall own or under which it
shall have the right to grant licenses of the scope of the
licenses granted in this Agreement, assert against Abbott, or
its vendees, any claims for infringement based on the
manufacture, use, offer to sell, import or sale of Licensed
Products made, used or sold by Abbott in accordance with and
during the term of this Agreement.
14.2 By Xxxxxx. Xxxxxx represents and warrants to Corixa that Abbott has
the full right to enter into and perform Xxxxxx'x obligations under this
Agreement and that the execution, delivery and performance of this Agreement
does not conflict with, violate, or breach any agreement to which Abbott is a
party.
14.3 Extent of Warranties. EXCEPT AS SPECIFICALLY PROVIDED IN THIS
AGREEMENT, CORIXA MAKES NO WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED,
INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
15. INDEMNIFICATION
15.1 Indemnification by Corixa. In addition to Corixa's indemnity
obligations set forth in Article 7, Corixa shall defend, indemnify and hold
Abbott harmless against any liability, damage, loss, cost or expense, including
legal fees ("Liability"), arising out of or resulting from: (i) Corixa's breach
of any representation or warranty set forth in Section 14.1; (ii) Corixa's
default in the performance of its obligations under this Agreement and failure
or inability to cure such default in accordance with Section 13.2; and (iii) any
third person claims or suits made or brought against Abbott to the extent such
Liability arises out of or relates to Corixa's negligence or willful misconduct
with regard to Corixa's manufacture of the Materials.
15.2 Indemnification by Xxxxxx. Xxxxxx shall defend, indemnify and hold
Corixa harmless against any Liability arising out of or resulting from: (i)
Xxxxxx'x breach of its representations set forth in Section 14.2; (ii) Xxxxxx'x
default in the performance of its obligations under this Agreement and failure
or inability to cure such default in accordance with Section 13.2; and (iii) any
third person claims or suits made or brought against Corixa to the extent such
Liability arises out of or relates to Xxxxxx'x negligence or willful misconduct
with regard to Xxxxxx'x sale or promotion of any Licensed Product.
15.3 Conditions of Indemnification. The agreement of indemnity set forth
in Section 15.1 and 15.2 above is conditioned upon the indemnified party's
obligation to: (i) advise the indemnifying party of any claim or suit, in
writing, within ninety (90) days after the indemnified party has received notice
of such claim or suit, and (ii) assist the indemnifying party and its
representatives in the investigation and defense of any claim and/or suit for
which indemnification is provided. This agreement of indemnity shall not be
valid as to any settlement of a claim or suit or offer of settlement or
compromise without the prior written approval of the indemnifying party.
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15.4 Insurance. During the term of this Agreement, Corixa shall, at its
sole cost and expense, obtain and keep in force a policy of comprehensive
general liability insurance with bodily injury, death and property damage limits
of [***] per occurrence and One Million US Dollars (US$1,000,000) per
occurrence and Three Million US Dollars (US$3,000,000) in the aggregate,
including product liability coverage and such additional provisions or coverages
as Abbott may reasonably require. Upon the Effective Date, Corixa shall furnish
a certificate of insurance, in form acceptable to Abbott, evidencing the
insurance required hereunder and providing for at least thirty (30) days prior
written notice to Abbott of any cancellation, termination or change of such
insurance coverage.
15.5 No Consequential Damages. NOTWITHSTANDING ANY OTHER PROVISION OF
THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO THE
SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR (A) ANY CONSEQUENTIAL,
INCIDENTAL, SPECIAL OR INDIRECT DAMAGES WHATSOEVER, OR (B) THE COST OF
PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES.
16. MISCELLANEOUS
16.1 Notices. All notices, requests or other communications required or
permitted to be given under this Agreement to any party shall be in writing and
shall be deemed to have been sufficiently given when delivered by personal
service or sent by registered mail, telex or facsimile, to the recipient
addressed as follows:
(a) If to Abbott: with a copy to:
Xxxxxx Laboratories Xxxxxx Laboratories
Director, Technology Acquisition Legal Department - International
Diagnostic Division Dept. 323, AP6D-2
Dept. 9RK-AP6C 000 Xxxxxx Xxxx Xxxx
000 Xxxxxx Xxxx Xxxx Xxxxxx Xxxx, XX 00000
Xxxxxx Xxxx, XX 00000 Facsimile: (000) 000-0000
Facsimile: (000) 000-0000
(b) If to Corixa: with a copy to:
Corixa Venture Law Group
0000 Xxxxxxxx Xxxxxx 0000 Xxxxxxxx Xxxxx
Xxxxx 000 Xxxxxxxx, XX 00000
Xxxxxxx, Xxxxxxxxxx 00000 Facsimile: (000) 000-0000
Facsimile: (000) 000-0000
Attn: Xxxxxxx X. Xxxxxxx
Attn: Chief Operating Officer
All such communications shall be deemed to be effective on the day on
which personally served, or, if sent by registered mail, on the fourth day
following the date presented to the postal authorities for delivery to the other
party (the cancellation date stamped on the envelope being evidence of the date
of such delivery), or if by telex or facsimile, on the telex or facsimile date.
Either party may give to the other written notice of change of address, in which
event any communication shall thereafter be given to such party as above
provided at such changed address.
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16.2 Publication. If Corixa shall desire to present at symposia, national
or regional professional meetings, or to publish in journals or other
publications any non-Confidential Information derived from or in anyway related
to its activities under this Agreement, Corixa shall first provide Abbott with
copies of the proposed presentation or publication materials at least ninety
(90) days in advance of the presentation or publication date. Within sixty (60)
days after its receipt of such information, Abbott shall advise Corixa whether
Abbott consents to the disclosure of the submitted information. If Abbott does
not provide its written consent thereto, Corixa shall modify the proposed
presentation or publication to Xxxxxx'x satisfaction or cancel its plans for
publications. Upon receipt of Xxxxxx'x written consent to the proposed
publication or presentation material, as modified to the extent required under
the terms of this Section, Corixa may proceed with the proposed presentation or
publication.
16.3 Assignment. This Agreement shall be binding upon and inure to the
benefit of the parties hereto and their successors and assigns. Notwithstanding
the foregoing, neither party hereto shall have the right to assign any of its
rights or obligations under this Agreement without the prior written consent of
the other party; provided, however, that either party may assign its rights and
obligations under this Agreement in connection with the sale of all or
substantially all of its assets. This Agreement shall survive the merger of
either party with or into another party and no consent shall be required
hereunder; provided, however, that in the event of the sale of all or
substantially all of a party's assets, no intellectual property rights of the
acquiring Third Party shall be included in the Licensed Patents or the Licensed
Know-How.
16.4 Waivers. Any waiver by either of the parties hereto of any rights
arising from a breach of any covenants or conditions of this Agreement shall not
be construed as a continuing waiver of other breaches of the same nature or
other covenants or conditions of this Agreement.
16.5 No Agency, Etc. This Agreement is not intended to create, nor should
it be construed as creating, an agency, joint venture, partnership or
employer-employee relationship between Abbott and Corixa. Each party shall act
solely as an independent contractor and shall have no right to act for or to
sign the name of or bind the other party in any way or to make quotations or to
write letters under the name of the other party or to represent that the party
is in any way responsible for any acts or omissions of such party.
16.6 Force Majeure. Abbott and Corixa shall not be liable for loss,
damage, detention or delay resulting from any cause whatsoever beyond its
reasonable control or resulting from a force majeure, including, without
limitation, fire, flood, strike, lockout, civil or military authority,
insurrection, war, embargo, container or transportation shortage or delay of
suppliers due to such causes, and delivery dates shall be extended to the extent
of any delays resulting from the foregoing or similar causes. The party so
affected shall give prompt notice to the other party of such cause, and shall
take whatever reasonable steps are necessary to relieve the effect of such cause
as rapidly as reasonably possible. The party giving such notice shall thereupon
be excused from such of its obligations hereunder as it is thereby disabled from
performing for so long as it is so disabled and for thirty (30) days thereafter,
whichever is longer; provided, however, that such affected party commences and
continues to take reasonable and diligent actions to cure such cause.
16.7 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Washington.
16.8 Public Announcements. The parties agree to consult with each other
before issuing any press release or making any public statement with respect to
this Agreement or any other transaction contemplated herein and, except as may
be required by applicable law or any listing agreement with any national
securities exchange, shall not issue any such press release or make any such
public statement prior to obtaining the written consent of the other party.
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16.9 Disputes and Alternative Dispute Resolution. Any dispute or claim
arising out of or in connection with this Agreement (unless otherwise set forth
herein) shall be resolved as follows: (i) for a period of thirty (30) days after
a dispute arises the respective appropriate officers of the parties shall
negotiate in good faith in an effort to resolve the dispute, and (ii) if the
dispute has not been resolved at the close of such thirty (30) day period, the
matter will be finally settled by Alternative Dispute Resolution ("ADR") in
accordance with the provisions set forth herein and attached hereto as Exhibit
E.
16.10 Severability. If any provision of this Agreement is finally held to
be invalid, illegal or unenforceable by a court or agency of competent
jurisdiction, that provision shall be severed or shall be modified by the
parties so as to be legally enforceable (and to the extent modified, it shall be
modified so as to reflect, to the extent possible, the intent of the parties)
and the validity, legality and enforceability of the remaining provisions shall
not be affected or impaired in any way.
16.11 Amendments. Except as otherwise expressly provided herein, neither
this Agreement nor any provision hereof may be amended or waived except by a
written instrument signed by the party against whom enforcement of the amendment
or waiver is sought.
16.12 Headings. The headings of the paragraphs and subparagraphs of this
Agreement have been added for the convenience of the parties and shall not be
deemed a part hereof.
16.13 Counterparts. This Agreement may be executed in any number of
counterparts, all of which together shall constitute a single Agreement.
16.14 Final Agreement. This Agreement is the sole understanding and
agreement of the parties hereto with respect to the subject matter hereof and
supersedes all other such prior agreements and understandings.
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be
executed by its duly authorized representative.
XXXXXX LABORATORIES CORIXA
By: /s/ XXX X. XXXXXXXX By: /s/ XXXX XxXXXX 7/24/97
------------------------------ -----------------------
Xxx X. Xxxxxxx Xxxx XxXxxx
Vice President Chief Operating Officer
Diagnostic Assays & Operations
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SCHEDULE OF EXHIBITS
Exhibit A - Attach list of issued patents and patent applications
Exhibit B - Attach list of Materials
Exhibit C - Attach Specifications
Exhibit D - Attach Price Schedule of Individual Antigens that are
Materials
Exhibit E - Attach Alternative Dispute Resolution Procedure
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EXHIBIT A
ISSUED PATENTS AND PATENT APPLICATIONS
U.S. Xxx. App. No. [***], entitled [***], filed [***].
U.S. Xxx. App. No. [***], entitled [***], filed [***].
U.S. Xxx. App. No. [***], entitled [***], filed [***].
U.S. Xxx. App. No. [***], entitled [***], filed [***].
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EXHIBIT B
MATERIALS
[***]
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EXHIBIT C
SPECIFICATIONS
[***]
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EXHIBIT D
[TO FOLLOW]
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EXHIBIT E
Alternative Dispute Resolution
The parties recognize that a bona fide dispute as to certain matters may arise
from time to time during the term of this Agreement which relates to either
party's rights and/or obligations. To have such a dispute resolved by this
Alternative Dispute Resolution ("ADR") provision, a party first must send
written notice of the dispute to the other party for attempted resolution by
good faith negotiations between their respective presidents (or their
equivalents) of the affected subsidiaries, divisions, or business units within
twenty-eight (28) days after such notice is received (all references to "days"
in this ADR provision are to calendar days).
If the matter has not been resolved within twenty-eight (28) days of the other
party's receipt of the notice of dispute, or if the parties fail to meet or
conduct such good faith negotiations by such twenty-eight (28) days, either
party may initiate an ADR proceeding as provided herein. The parties each shall
have the right to be represented by counsel in such a proceeding.
1. To begin an ADR proceeding, a party shall provide written notice to the
other party of the issues to be resolved by ADR. Within fourteen (14) days
after its receipt of such notice, the other party may, by written notice to
the party initiating the ADR, add additional issues to be resolved within
the same ADR.
2. Within twenty-eight (28) days following receipt of the original ADR notice,
the parties shall select a mutually acceptable neutral to preside in the
resolution of any disputes in this ADR proceeding. If the parties are unable
to agree on a mutually acceptable neutral within such period, either party
may request the President of the CPR Institute for Dispute Resolution
("CPR"), 000 Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, to select
a neutral pursuant to the following procedures:
(a) The CPR shall submit to the parties a list of not less than five (5)
candidates within fourteen (14) days after receipt of the request, along
with a Curriculum Vitae for each candidate. No candidate shall be an
employee, director, or shareholder of either party or any of their
subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each candidate of
any circumstances likely to affect his or her impartiality.
(c) Each party shall number the candidates in order of preference (with the
number one (1) signifying the greatest preference) and shall deliver the
list to the CPR within seven (7) days following receipt of the list of
candidates. If a party believes a conflict of interest exists regarding
any of the candidates, that party shall provide a written explanation of
the conflict to the CPR along with its list showing its order of
preference for the candidates. Any party failing to return a list of
preferences on time
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shall be deemed to have no order of preference.
(d) If the parties collectively have identified fewer than three (3)
candidates deemed to have conflicts, the CPR immediately shall
designate as the neutral the candidate for whom the parties
collectively have indicated the greatest preference. If a tie should
result between two candidates, the CPR may designate either candidate.
If the parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review the
explanations regarding conflicts and, in its sole discretion, may
either (i) immediately designate as the neutral the candidate for whom
the parties collectively have
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indicated the greatest preference, or
(ii) issue a new list of not less than five (5) candidates, in which
case the procedures set forth in subparagraphs 2(a) - 2(d) shall be
repeated until the neutral is selected.
3. No earlier than twenty-eight (28) days or later than fifty-six (56) days
after selection, the neutral shall select the date(s) on which to hold a
hearing to resolve each of the issues identified by the parties and shall
notify the parties of such dates in writing as promptly as possible. The ADR
proceeding shall take place at a location agreed upon by the parties. If the
parties cannot agree, the neutral shall designate a location other than the
principal place of business of either party or any of their subsidiaries or
affiliates.
4. At least seven (7) days prior to the hearing date(s) selected by the
neutral, each party shall submit the following to the other party and the
neutral:
(a) a copy of all exhibits on which such party intends to rely in any oral
or written presentation to the neutral;
(b) a list of any witnesses such party intends to call at the hearing, and a
short summary of the anticipated testimony of each witness;
(c) a proposed ruling on each issue to be resolved, together with a request
for a specific damage award or other remedy for each issue. The proposed
rulings and remedies shall not contain any recitation of the facts or
any legal arguments and shall not exceed one (1) page per issue.
(d) one (1) brief in support of such party's proposed rulings and remedies,
provided that the brief shall not exceed twenty (20) pages. This page
limitation shall apply regardless of the number of issues raised in the
ADR proceeding.
Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery
shall be required or permitted by any means, including depositions,
interrogatories, requests for admissions, or production of documents.
5. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing time to
present its case. The neutral shall determine whether each party has had
the five (5) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make an opening
statement, to present regular and rebuttal testimony, documents or other
evidence, to cross-examine witnesses, and to make a closing argument.
Cross-examination of witnesses shall occur immediately after their
direct testimony, and cross-examination time shall be charged against
the party conducting the cross-examination.
(c) The party initiating the ADR shall begin the hearing and, if it chooses
to make an opening statement, shall address not only issues it raised
but also any issues raised by the responding party. The responding
party, if it chooses to make an opening statement, also shall address
all issues raised in the ADR. Thereafter, the presentation of regular
and rebuttal testimony and documents, other evidence, and closing
arguments shall proceed in the same sequence.
(d) Except when testifying, witnesses shall be excluded from the hearing
until closing
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arguments.
(e) Settlement negotiations, including any statements made therein, shall
not be admissible under any circumstances. Affidavits prepared for
purposes of the ADR hearing also shall not be admissible. As to all
other matters, the admissability of any evidence shall be in accordance
with the Federal Rules of Civil Procedure.
6. Within seven (7) days following completion of the hearing, each party may
submit to the other party and the neutral a post-hearing brief in support of
its proposed rulings and remedies, provided that such brief shall not
contain or discuss any new evidence and shall not exceed ten (10) pages.
This page limitation shall apply regardless of the number of issues raised
in the ADR proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14) days
following completion of the hearing. Such ruling shall adopt in its entirety
the proposed ruling and remedy of one of the parties on each disputed issue
but may adopt one party's proposed rulings and remedies on some issues and
the other party's proposed rulings and remedies on other issues. The neutral
shall not issue any written opinion or otherwise explain the basis of the
ruling.
8. The neutral shall be paid a reasonable fee plus expenses. These fees and
expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all expert witness fees and expenses), the fees
and expenses of a court reporter, and any expenses for a hearing room, shall
be paid as follows:
(a) If the neutral rules in favor of one party on all disputed issues in the
ADR, the losing party shall pay 100% of such fees and expenses.
(b) If the neutral rules in favor of one party on some issues and the other
party on other issues, the neutral shall issue with the rulings a
written determination as to how such fees and expenses shall be
allocated between the parties. The neutral shall allocate fees and
expenses in a way that bears a reasonable relationship to the outcome of
the ADR, with the party prevailing on more issues, or on issues of
greater value or gravity, recovering a relatively larger share of its
legal fees and expenses.
9. The rulings of the neutral and the allocation of fees and expenses shall be
binding, non-reviewable, and non-appealable, and may be entered as a final
judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence of
the dispute, any settlement negotiations, the ADR hearing, any submissions
(including exhibits, testimony, proposed rulings, and briefs), and the
rulings shall be deemed Confidential Information. The neutral shall have the
authority to impose sanctions for unauthorized disclosure of Confidential
Information.
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