EXHIBIT 10.2
*Certain confidential information contained in this document, marked by
brackets, has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
MANUFACTURING AND SUPPLY AGREEMENT
This MANUFACTURING AND SUPPLY AGREEMENT (the "Agreement") is entered
into as of October 26, 2001 (the "Signing Date") and made effective as of the
Effective Date (as defined below) between CORIXA CORPORATION, a Delaware
corporation, with its principal place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxx
000, Xxxxxxx, XX 00000, X.X.X. ("Corixa Corporation"), and AMERSHAM PLC, a
company incorporated under the laws of England, with its principal place of
business at Xxxxxxxx Xxxxx, Xxxxxx Xxxxxxxx, Xxxxxxxxxxxxxxx, Xxxxxxx XX0 0XX
("Amersham"). Both Corixa and Amersham are referred to individually as a "Party"
and collectively as the "Parties."
WHEREAS, Corixa and Amersham are parties to a development,
commercialization and license agreement of even date herewith wherein Corixa and
Amersham shall develop, and Corixa grants Amersham rights to commercialize,
Bexxar, Corixa's proprietary antibody product, in Europe for the treatment of
humans (the "License Agreement"); and
WHEREAS, in order to carry out the development and commercialization
goals expressed by the Parties in the License Agreement, Amersham desires to
obtain bulk and finished antibody for products from Corixa and Corixa is willing
to provide such antibody on the terms and conditions hereof; and
NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:
1. DEFINITIONS
The capitalized terms in this Agreement that are not defined below shall
have the meanings set forth in the License Agreement. The following terms shall
have the following meanings as used in this Agreement:
1.1 "AMERSHAM IODINE I 131 TOSITUMOMAB" shall mean any
Iodine I 131 Tositumomab that Amersham or its agent prepares from Tositumomab.
1.2 "BI PHARMA AGREEMENTS" shall mean the Supply Agreement
between Xxxxxxx and Boehringer Ingelheim Pharma KG dated November 3, 1998 and
the Contract Research and Development Agreement between Xxxxxxx and Xx. Xxxx
Xxxxxx GmbH dated October 22, 1997.
1.3 "CLINICAL TRIAL" shall mean a trial, conducted by a
Party or a licensee of a Party, in which a Product is administered to humans
with the goal of generating data (a) to support an application for Regulatory
Approval of such Product or (b) for purposes of marketing the Product.
1
1.4 "CONTROLLED" means, with respect to any gene, protein,
compound, material, Information or intellectual property right, that the Party
owns or has a license to such gene, protein, compound, material, Information or
intellectual property right and has the ability to grant to the other Party
access, a license or a sublicense (as applicable) to such gene, protein,
compound, material, Information or intellectual property right on the terms and
conditions set forth herein without violating the terms of any agreement or
other arrangements with any Third Party existing at the time such Party would be
first required hereunder to grant the other Party such access, license or
sublicense.
1.5 "CORIXA" shall mean Corixa Corporation and its
Affiliates.
1.6 "CORIXA INTELLECTUAL PROPERTY RIGHTS" shall mean all
Intellectual Property Rights in existence on the Effective Date that are
Controlled by Corixa during the term of this Agreement, including those Patents
set forth in Exhibit A (which Corixa may update from time to time).
1.7 "CORIXA IODINE I 131 TOSITUMOMAB" shall mean any Iodine
I 131 Tositumomab that Corixa provides to Amersham hereunder.
1.8 "CORIXA TERRITORY" shall mean all countries and
territories of the world except those in the Territory.
1.9 "DILIGENT EFFORTS" means the carrying out of obligations
or tasks in a sustained manner consistent with the efforts a Party devotes to a
product or a development or marketing project of similar market potential,
profit potential or strategic value resulting from its own efforts, based on
conditions then prevailing.
1.10 "EFFECTIVE DATE" shall mean the First Closing Date, as
such term is defined in the Stock Purchase Agreement.
1.11 "EUROPEAN FACILITY" shall have the meaning set forth in
Section 3.3(a).
1.12 "FULLY ALLOCATED COST" shall mean the direct and
indirect costs of Tositumomab provided by Corixa to Amersham or Corixa Iodine I
131 Tositumomab and shall be computed in accordance with United States generally
accepted accounting principles, consistently applied. To the extent that any
such costs arise from activities performed for Amersham as well as other Corixa
partners for the Product, the amounts allocated to Amersham shall be a fair, pro
rata allocation based upon the performance for Amersham relative to the
performance for other Corixa partners for the Product. Fully Allocated Cost
shall include without limitation:
(a) cost and expenses incurred by Corixa, including,
but not limited to, payments owed by Corixa to Third Parties (including Third
Party licensors such as Xxxx Xxxxxx and University of Michigan), for the
manufacture or supply to Amersham of such Tositumomab or Corixa Iodine I 131
Tositumomab, including, but not limited to, the transfer price for such
antibody, cancellation payments (limited to Amersham cancellations), payments
related to failed
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batches (to the extent not otherwise charged to Amersham pursuant to this
Agreement), readiness payments, and facilities charges owed to such Third
Parties, plus
(b) QA/QC Costs, plus
(c) If applicable, the cost of forward foreign
currency contracts to protect against risk of changes in foreign exchange rates,
provided that such costs are approved in advance by the Parties, plus
(d) Corixa's internal and external expenses,
including out-of-pocket expenses and employee expenses, if any, with respect to
freight and tariffs associated with transporting Tositumomab or Corixa Iodine I
131 Tositumomab from the source of manufacture to the end user, inclusive of
interim points of delivery, but excluding any such costs which are separately
invoiced to a customer, plus
(e) The cost of Corixa employees engaged in
Tositumomab or Corixa Iodine I 131 Tositumomab manufacturing-related activities,
including, without limitation, employees engaged in oversight of manufacture by
Third Parties, plus
(f) A reasonable allocation, with respect to such
Tositumomab or Corixa Iodine I 131 Tositumomab, of Corixa's: (i) indirect labor
(to the extent not previously included in (d) or (e)), (ii) administrative
costs, and (iii) facilities costs including electricity, water, sewer, waste
disposal, property taxes, and depreciation over the expected life of buildings
and equipment. Such allocations shall be in accordance with reasonable cost
accounting methods, consistently applied, of Corixa.
1.13 "GOOD CLINICAL PRACTICE" or "GCP" shall mean the then
current standards for clinical trials for pharmaceuticals, as set forth in (i)
the rules and regulations of the International Conference on Harmonization, and
(ii) any other applicable requirements for clinical trial activities under the
laws, rules or regulations of the Territory.
1.14 "GOOD LABORATORY PRACTICE" or "GLP" shall mean the then
current standards for laboratory activities for pharmaceuticals, as set forth in
the FD&C Act and applicable regulations and guidances promulgated thereunder,
including without limitation the Code of Federal Regulations, as amended from
time to time, and any other applicable requirements for laboratory activities
under the laws, rules or regulations of the Territory.
1.15 "GOOD MANUFACTURING PRACTICE" or "GMP" shall mean the
current standards for the manufacture of pharmaceuticals, as set forth in the
FD&C Act and applicable regulations and guidances promulgated thereunder,
including without limitation the Code of Federal Regulations, as amended from
time to time, and any other applicable manufacturing requirements under the
laws, rules or regulations of the Territory.
1.16 "INFORMATION" means information, results and data of any
type whatsoever, in any tangible or intangible form whatsoever, including
without limitation, databases, inventions, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill, experience,
test data including pharmacological, biological,
3
chemical, biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures, and patent and
other legal information or descriptions.
1.17 "INITIAL APPROVAL CLINICAL TRIALS" shall have the
meaning set forth in the License Agreement.
1.18 "INITIAL DEVELOPMENT PLAN" shall have the meaning set
forth in the License Agreement.
1.19 "INTELLECTUAL PROPERTY RIGHTS" shall mean all Patents,
copyrights, regulatory filings, Know-How, or any other intellectual property
other than trademarks, that are Controlled during the term of this Agreement by
a Party or jointly by the Parties and that relate to the development,
manufacture, importing, use, marketing and/or sale of the Product. The term
"Intellectual Property Rights" shall include any rights obtained by either Party
from a Third Party, subject to the terms and conditions of the agreements in
which such rights were conferred. The term "Intellectual Property Rights,"
however, shall not include Patents, copyrights, regulatory filings, know-how
and/or trade secrets, or any other intellectual property of either Party for the
manufacture or purification of monoclonal antibodies, whether developed prior to
or after the Effective Date.
1.20 "INVENTION" means any invention, development, result,
Know-How or other Information, and all intellectual property relating thereto,
made, discovered or developed (i) solely by a Party and its employees or agents
pursuant to work performed under the Agreement or (ii) jointly by the Parties
and their employees or agents pursuant to work performed under the Agreement.
1.21 "IODINE I 131 TOSITUMOMAB" shall mean any therapeutic,
prophylactic or palliative product containing or comprising the composition of
matter conjugated with 131Iodine that was one of the active agents tested in
Corixa's clinical trial with Protocol No. RIT-II-004 as referred to in that
Protocol as [*] anti CD20 murine monoclonal antibody.
1.22 "JOINT OTHER INVENTIONS" means any and all Other
Inventions made jointly by employees or agents of both Parties pursuant to work
conducted under the Agreement.
1.23 "KNOW-HOW" shall mean any technical information that is
secret and identified.
1.24 "NET SALES" shall mean gross amounts invoiced for sales
of the Product in the Territory by either Party, its Affiliates or sublicensees,
as appropriate, to Third Parties, less the following items: (i) trade, quantity
and cash discounts or rebates actually allowed and taken and any other
adjustments, including, without limitation, those granted on account of price
adjustments, billing errors, rejected goods, damaged goods and recall returns;
(ii) credits, rebates, charge-back and prime vendor rebates, fees,
reimbursements or similar payments granted or given to wholesalers and other
distributors, buying groups, health care insurance carriers, pharmacy benefit
management companies, health maintenance organizations or other institutions
* Confidential Treatment Requested
4
or health care organizations; (iii) any tax, tariff, customs duties, excise or
other duties or other governmental charge (other than an income tax) levied on
the sale, transportation or delivery of a Product and borne by the seller
thereof; (iv) payments or rebates paid in connection with sales of Products to
any governmental or regulatory authority in respect of any medical insurance
funded by a state or federal government; and (v) any charge for freight,
insurance or other transportation costs charged to the customer. For clarity,
Net Sales shall not include: sales of the Product by and between a Party and its
Affiliates (except where such Affiliates are end users).
1.25 "NORDION AGREEMENTS" shall mean (a) the Supply Agreement
between Xxxxxxx Pharmaceutical, Inc. and MDS Nordion Inc. dated August 31, 1998;
(b) the Supply Agreement for I-131 between Xxxxxxx Pharmaceutical, Inc. and MDS
Nordion, Inc. dated September 13, 2000; (c) the Development Agreement between
Xxxxxxx Pharmaceutical, Inc. and MDS Nordion, Inc. dated November 13, 1995; and
(d) the Facilities Agreement between Xxxxxxx Pharmaceutical, Inc. and MDS
Nordion, Inc. dated August 31, 1998.
1.26 "OTHER INVENTION" means any Invention that is not a
Product Invention.
1.27 "PATENT" means (i) unexpired letters patent (including
inventor's certificates) that have not been held invalid or unenforceable by a
court of competent jurisdiction from which no appeal can be taken or has been
taken within the required time period, including without limitation any
substitution, extension, registration, confirmation, reissue, re-examination,
renewal or any like filing thereof and (ii) pending applications for letters
patent, including without limitation any continuation, division or
continuation-in-part thereof and any provisional applications.
1.28 "PRODUCT" shall mean (a) Iodine I 131 Tositumomab as
defined in Section 1.21 or (b) any therapeutic, prophylactic or palliative
product containing or comprising Tositumomab as defined in Section 1.37 for use
in connection with a Iodine I 131 Tositumomab, in any formulation or mode of
administration.
1.29 "PRODUCT INVENTION" means any Invention that pertains
solely to or the sole use of which is limited to, the Product or its
development, manufacture or use.
1.30 "QA/QC COSTS" shall mean Corixa's internal and external
costs of quality assurance and quality control work performed by or on behalf of
Corixa related to Product release and Product testing of Tositumomab and Corixa
Iodine I 131 Tositumomab, but only to the extent that such quality assurance and
quality control work is required by the FDA or other relevant regulatory
authorities. QA/QC Costs shall include a reasonable allocation of Corixa's
facility overhead, and shall include any allocation of the costs of establishing
or validating a facility or any costs of excess capacity directly related to
Tositumomab.
1.31 "SOLE OTHER INVENTIONS" means any and all Other
Inventions made, discovered or developed solely by a Party and its employees or
agents pursuant to work performed under the Agreement.
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1.32 "SPECIFICATIONS" shall mean the requirements and
standards pertaining to Tositumomab or Iodine I 131 Tositumomab (depending upon
context) and consistent with filings made for Regulatory Approval and all
relevant written agreements between Corixa and a Third Party with respect to
manufacture or supply of Tositumomab, Iodine I 131 Tositumomab or Product, which
specifications are set forth in the BLA identified by Biologics License
Application Submission Tracking Number 125011, provided that such specifications
may be modified in writing by the Parties from time to time as follows: any
modifications to the Specifications shall be reasonably acceptable to both
Parties or required for approval of the Product in the Territory and shall be
reasonably consistent with respect to products manufactured by or on behalf of
Corixa for use in markets in the Corixa Territory. The Specifications shall be
release or stability specifications, as applicable, and each reference to
Specifications shall mean the type of such Specifications appropriate to the
context.
1.33 "STOCK PURCHASE AGREEMENT" shall mean that certain Stock
Purchase Agreement entered into between Corixa Corporation and Nycomed, Inc. as
of the Signing Date.
1.34 "TERRITORY" shall mean the countries and territories of
Europe set forth on Exhibit B of the License Agreement.
1.35 "THERAPY" shall mean two doses of Tositumomab and two
doses of Corixa Iodine I 131 Tositumomab (one for dosimetric purposes and one
for therapeutic purposes, including "top-off" vials) for administration to a
single patient, unless otherwise adjusted by mutual agreement of the Parties.
1.36 "THIRD PARTY" means any entity other than (i) Corixa,
(ii) Amersham or (iii) an Affiliate of either of them.
1.37 "TOSITUMOMAB" shall mean the composition of matter that
(i) has not been conjugated with 131Iodine or any other isotope, molecule,
compound or moiety and (ii) was administered to patients in Corixa's clinical
trial with Protocol No. RIT-II-004 as referred to in that Protocol as [*] anti
CD20 murine monoclonal antibody. Except as otherwise specified in this
Agreement, Tositumomab shall mean both bulk and filled material.
1.38 "TRANSFER PRICE" shall have the meaning set forth in
Section 4.1(a).
2. GENERAL UNDERSTANDING. Pursuant to the BI Pharma Agreements and
the Nordion Agreements, Corixa has the ability to have Tositumomab and Corixa
Iodine I 131 Tositumomab manufactured and supplied to it and its licensees.
Under this Agreement, Corixa will provide certain amounts of Tositumomab and
Corixa Iodine I 131 Tositumomab for use in the Initial Approval Clinical Trials
and to Amersham for Amersham's use in the Territory in accordance with the
License Agreement. Amersham acknowledges and understands that Corixa's ability
to supply Tositumomab and Corixa Iodine I 131 Tositumomab to Amersham under this
Agreement is limited by the BI Pharma Agreements, the Nordion Agreements and
Corixa's agreements with other suppliers and other licensees, including Glaxo
SmithKline.
* Confidential Treatment Requested
6
Amersham hereby agrees to be legally bound by and to comply with all applicable
(as a result of this Agreement) provisions of the BI Pharma Agreements and the
Nordion Agreements. Corixa shall consult with Amersham before entering into a
new supply agreement during the term of this Agreement to replace or supplement
the BI Pharma Agreements.
3. MANUFACTURING AND SUPPLY OF ANTIBODY.
3.1 TOSITUMOMAB.
(a) OVERVIEW. Except as set forth in Sections 3.1(e)
and 3.11, and subject to availability of Tositumomab and Amersham's compliance
with the terms and conditions of this Agreement and the License Agreement,
Corixa shall use commercially reasonable efforts to have manufactured and supply
to Amersham all of its requirements in the Territory for Tositumomab in
accordance with the BI Pharma Agreements and the volume allocation methodology
set forth in Section 3.11. Amersham shall pay for such Tositumomab as set forth
in Article 4. Except as set forth in Section 3.1(e), Amersham shall obtain from
Corixa all of Amersham's requirements for Tositumomab in the Territory, whether
for development or commercial sale.
(b) FORECASTS AND ORDERING.
(i) Corixa has already submitted to BI
Pharma the forecast shown in Exhibit A for the supply of Tositumomab to
Amersham, including the supply of Tositumomab designated for use in an Initial
Approval Clinical Trial, for the period from the Effective Date until December
31, 2003 (the "Corixa Forecast"). Within thirty (30) days after the approval by
the JDC of the Initial Development Plan, and no later than the tenth (10th) day
of the second month of each calendar quarter thereafter, Amersham shall furnish
to Corixa a written rolling three (3) year forecast of its anticipated purchase
of bulk Product (including Tositumomab to be used in the manufacture of Corixa
Iodine I 131 Tositumomab or Amersham Iodine I 131 Tositumomab) or filled and
finished Product for the Territory which shall be consistent with the terms and
conditions of the BI Pharma Agreements (the "Amersham Forecast"). Each Amersham
Forecast shall cover a three (3) year forecast period starting the first (1st)
day of the second calendar quarter after the quarter in which Amersham provided
such Amersham Forecast to Corixa. The Amersham Forecast shall be submitted to
Corixa in the format specified in writing by Corixa. Unless the JDC agrees
otherwise, Amersham shall include in the Amersham Forecasts and shall
specifically identify within the Amersham Forecasts, those quantities of
Tositumomab intended for use in an Initial Approval Clinical Trial in the
Territory, as decided by the JDC or Corixa pursuant to Section 4.6 of the
License Agreement.
(ii) Subject to subsection (iii) below,
Amersham shall be obligated to purchase from Corixa those portions of the
Amersham Forecasts that are binding in accordance with the criteria set forth in
Appendix 2B of the BI Pharma Agreement. Amersham shall pay Corixa, in accordance
with the terms of Article 4 of this Agreement, for all such quantities of
Tositumomab.
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(iii) Corixa shall be obligated, for the
period from the Effective Date until the end of an Initial Approval Clinical
Trial, to pay for all Tositumomab designated for use in an Initial Approval
Clinical Trial in the Territory, to the extent that such Tositumomab is
manufactured pursuant to a binding portion of the Corixa Forecast or an Amersham
Forecast. All amounts paid by Corixa pursuant to this subsection 3.1(b)(iii)
shall be included in the Development Budget for the Initial Approval Clinical
Trials and shall be Initial Approval Trials Costs for the Initial Approval
Clinical Trials and subject to the terms and conditions of the License
Agreement, including but not limited to Section 5.2(a)(iii) thereof.
(iv) In the event that Corixa is informed by
BI Pharma that BI Pharma, pursuant to Section 3.1.2 of the BI Pharma supply
agreement, will not be able to supply enough Tositumomab to satisfy Amersham's
projected requirements for Tositumomab during a particular period, Corixa shall
inform Amersham of such projected shortfall and Section 3.1(e) shall apply.
(c) DELIVERY; SHIPMENT; TITLE. It is anticipated
that BI Pharma will manufacture Tositumomab twice a year. Tositumomab will be
delivered to Amersham FOB at the manufacturing facility of BI Pharma or an
alternate Corixa supplier. "FOB" shall be construed in accordance with INCOTERMS
2000 of the International Chamber of Commerce. Amersham shall be the importer of
record for all Tositumomab delivered hereunder. Title to individual shipments of
Tositumomab that are not designated for use in an Initial Approval Clinical
Trial shall pass to Amersham upon Amersham's payment of that portion of the
Transfer Price set forth in Section 4.1(a)(i). Amersham shall bear the
responsibility for all expenses related to the delivery of Tositumomab from BI
Pharma to Amersham's storage facility.
(d) VIAL LABELING; STORAGE. Amersham shall vial
label, store and distribute Tositumomab in accordance with (i) Corixa's and BI
Pharma's Specifications for vial labeling and storage and (ii) all applicable
laws, rules and regulations. It shall be Amersham's sole responsibility to
establish and maintain a site for such activities. Distribution of Tositumomab
hereunder shall be in accordance with Section 3.4.
(e) CORIXA INABILITY TO SUPPLY. If Corixa is unable
to supply any Tositumomab to Amersham due to BI Pharma's inability to supply as
set forth in Section 3.1.2 of the BI Pharma Agreement, Corixa shall have the
right to establish a second source of Tositumomab and Amersham shall remain
obligated to obtain all Tositumomab from Corixa. If by ninety (90) days after
the date of the most recent delivery of Tositumomab to Amersham, Corixa has not
established a second source, then Corixa shall provide Amersham with a written
description of its plan to establish such a second source within the next ninety
(90) days. If Corixa does not successfully establish a second source of
Tositumomab within one hundred eighty (180) days following the date of the most
recent delivery of Tositumomab to Amersham, then Corixa shall grant to Amersham
the license set forth in Section 2.1(c) of the License Agreement and Amersham
will thereafter have the right to supply such antibody itself at its expense.
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3.2 CORIXA IODINE I 131 TOSITUMOMAB.
(a) OVERVIEW. Except as set forth in Section 3.11
and subject to Amersham's compliance with the terms and conditions of this
Agreement, Corixa shall use commercially reasonable efforts to provide Corixa
Iodine I 131 Tositumomab to Amersham until the earlier of: (i) the first date
that Amersham is able to manufacture Amersham Iodine I 131 Tositumomab in
sufficient quantities to fulfill its requirements for Iodine I 131 Tositumomab,
(ii) December 31, 2003, or (iii) Nordion's last date of production in 2003 for
Corixa Iodine I 131 Tositumomab. In no event will Corixa be obligated to supply
Corixa Iodine I 131 Tositumomab to Amersham after December 31, 2003. Corixa will
supply Corixa Iodine I 131 Tositumomab to Amersham in accordance with the
Nordion Agreements and the volume allocation methodology set forth in Section
3.11. Amersham acknowledges that such supply may be subject to delays or
interruptions due to suspended production during periods of Nordion's scheduled
maintenance of its facilities in accordance with Section 5.3 of the Nordion
Supply Agreement dated August 31, 1998. Amersham shall pay for Corixa Iodine I
131 Tositumomab as set forth in Article 4.
(b) ANTICIPATED NUMBER OF THERAPIES. Corixa
anticipates being able to provide the number of Therapies set forth below in the
Territory in the specified calendar years:
Calendar Year Maximum Number of Therapies
------------- ---------------------------
2001 [*]
2002 [*]
2003 [*]
The foregoing estimates are based on assumptions that: (i) the demand
for Corixa Iodine I 131 Tositumomab in the Territory will be spread evenly
throughout each calendar year and (ii) the percentage of patients requiring a
second vial of Corixa Iodine I 131 Tositumomab will not exceed [*]%. Amersham
acknowledges that if one or both of these assumptions is not correct, then
Corixa's ability to provide the anticipated number of Therapies will be
adversely affected and the number of available Therapies will be adjusted
accordingly.
If Corixa becomes able to supply more than the specified number of
Therapies in calendar year 2001, 2002 or 2003, then the Parties will mutually
agree whether Corixa will provide additional Therapies in the Territory.
Notwithstanding the foregoing, Amersham acknowledges and agrees that Corixa may
be unable to meet the anticipated Therapy requirement for the Territory for a
specified week or a specified year even if the amounts of Corixa I 131
Tositumomab ordered by Amersham are in weekly amounts balanced over the
applicable calendar year.
(c) FORECASTS AND ORDERING.
(i) Within thirty (30) days after the
approval of the Initial Development Plan, Amersham shall provide Corixa with its
projected requirements for Corixa
* Confidential Treatment Requested
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Iodine I 131 Tositumomab through December 31, 2003 in accordance with the
Amersham Forecast mechanism set forth in Section 3.1(b). Unless the JDC agrees
otherwise, Amersham shall include in all of its forecasts and firm orders and
specifically identify within such forecasts and firm orders, those quantities of
Corixa Iodine I 131 Tositumomab intended for use in an Initial Approval Clinical
Trial in the Territory, as decided by the JDC or Corixa pursuant to Section 4.6
of the License Agreement. Amersham shall update such forecast for its entire
projected requirements of Corixa Iodine I 131 Tositumomab quarterly. Such
forecasts shall be consistent with the quantities of Corixa I 131 Tositumomab
set forth in Section 3.2(b).
(ii) On the Effective Date and on the first
day of each month thereafter, Amersham will submit a rolling two (2) month
forecast to Corixa for Corixa I 131 Tositumomab in the Territory (the "Corixa I
131 Tositumomab Forecast"). The Corixa I 131 Tositumomab Forecast shall be
consistent with (A) the forecasting and ordering mechanisms required under the
Nordion Agreements and (B) the quantities of Corixa I 131 Tositumomab set forth
in Section 3.2(b). Each Corixa I 131 Tositumomab Forecast shall cover, in weekly
amounts, the two (2) months that follow the month in which such forecast was
submitted to Corixa.
(iii) Every Monday during the period that
Corixa is supplying Corixa Iodine I 131 Tositumomab to Amersham, Amersham shall
place a firm order for all Corixa Iodine I 131 Tositumomab that it wishes to
receive, including for so long as applicable the Corixa Iodine I 131 Tositumomab
designated for use in an Initial Approval Clinical Trial, during the week that
is two weeks after the week of such firm order. Such firm order shall be
consistent with the quantities of Corixa I 131 Tositumomab set forth in Section
3.2(b) and shall be considered binding on Amersham. Subject to the next
sentence, Amersham shall pay for all Corixa Iodine I 131 Tositumomab delivered
pursuant to such a firm order in accordance with Article 4. Corixa shall pay for
all Corixa Iodine I 131 Tositumomab delivered pursuant to such a firm order that
is designated in such firm order for use in an Initial Approval Clinical Trial
in the Territory. Any shortfalls of Corixa I 131 Tositumomab shall be handled as
set forth in Section 3.11.
(d) DELIVERY; SHIPMENT. The Corixa Iodine I 131
Tositumomab will be delivered to Amersham FOB Nordion's facility. "FOB" shall be
construed in accordance with INCOTERMS 2000 of the International Chamber of
Commerce. Amersham shall be the importer of record for all Corixa Iodine I 131
Tositumomab delivered hereunder. Title to individual shipments of Corixa Iodine
I 131 Tositumomab that are not designated for use in an Initial Approval
Clinical Trial shall pass to Amersham upon Amersham's payment of that portion of
the Transfer Price set forth in Section 4.1(a)(i). Subject to the next sentence,
Amersham shall also bear the responsibility for all expenses related to the
delivery of Amersham's portion of Tositumomab to Nordion's facility (which will
be coordinated by Corixa) and the subsequent delivery of Corixa Iodine I 131
Tositumomab from Nordion's facility to Initial Approval Clinical Trial sites,
Subsequent Clinical Trial sites and Amersham's customers in the Territory.
Corixa shall bear the foregoing costs for all Corixa Iodine I 131 Tositumomab
that is designated for use in an Initial Approval Clinical Trial. Distribution
of Corixa Iodine I 131 Tositumomab for use in an Initial Approval Clinical Trial
shall be in accordance with Section 3.4.
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(e) INITIAL APPROVAL TRIAL COSTS. All amounts paid
by Corixa pursuant to subsection 3.1(c) and 3.2(d) shall be included in the
Development Budget for the Initial Approval Clinical Trials and shall be Initial
Approval Trials Costs for the Initial Approval Clinical Trials and subject to
the terms and conditions of the License Agreement, including but not limited to
Section 5.2(a)(iii) thereof.
3.3 AMERSHAM IODINE I 131 TOSITUMOMAB.
(a) No later than December 31, 2003 or the later
date agreed in writing by the Parties (such date shall take into account the
date upon which the Parties expect Initial Approval for the Product in the
Territory and any delays in establishing the radiolabeling facility that are
attributable to regulatory agencies and are beyond Amersham's control), Amersham
shall establish a radiolabeling facility that, in accordance with all applicable
laws and regulations, converts Tositumomab to Amersham Iodine I 131 Tositumomab
and supplies all of Amersham's requirements for Iodine I 131 Tositumomab for
development and commercial sale in the Territory (the "European Facility").
Amersham may begin supplying Amersham Iodine I 131 Tositumomab at any time prior
to December 31, [*] or such agreed date.
(b) Within sixty (60) days after the Effective Date,
Amersham shall provide Corixa with a timetable for the establishment of the
European Facility and a copy of Amersham's full plan (rather than a summary
thereof) for the manufacture of Amersham Iodine I 131 Tositumomab, which plan
shall include the milestones and timelines set forth on Exhibit B hereto.
Amersham shall update such timetable and plan semi-annually, provided that any
updates or modifications to the milestones and timelines set forth on Exhibit B
shall require Corixa's prior written consent. Corixa may comment on the initial
and updated timetables and plans. Amersham's failure to provide the first
timetable and the first plan within ninety (90) days after the Effective Date
shall constitute a material breach of this Agreement. Amersham shall be
responsible for all capital and other expenses related to the establishment of
the European Facility and its operation.
(c) At the request of Amersham, during the period
commencing on the Effective Date and ending three (3) years after the date
determined in accordance with Section 3.3(a), Corixa shall provide reasonable
assistance, within Corixa's area of expertise, to help Amersham establish and
operate the European Facility. Provision of such assistance shall include, but
not be limited to, supply of any Corixa know-how which Amersham may require to
the extent such Corixa know-how can be provided to Amersham under applicable
agreements with Third Parties. In the event that Amersham requests that Corixa
perform work, including providing consultation services, under this Section
3.3(c), Amersham shall reimburse Corixa for all out-of-pocket expenses and
personnel expenses (at the applicable FTE Rate) incurred by Corixa with respect
to such performance within thirty (30) days of receipt of an invoice from
Corixa.
(d) In the event that based on Amersham's progress
against the milestones and timelines set forth on Exhibit B (as may be amended
in accordance with
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Section 3.3(b)), Corixa makes a good faith determination that the European
Facility is not reasonably likely to be completed and available to manufacture
and supply Amersham's requirements of Iodine I 131 Tositumomab for development
and commercial sale in the Territory by the later of December 31, [*] or the
date agreed in writing pursuant to Section 3.3(a), Corixa may give notice to
Amersham that Corixa intends to (i) terminate this Agreement and the License
Agreement or (ii) adjust the licenses granted by Corixa under the License
Agreement to become non-exclusive. Amersham hereby acknowledges that if Corixa
proceeds under subsection (ii), (1) the License Agreement shall otherwise remain
in full force and effect in accordance with its terms, including, but not
limited to, all payment terms, and (2) Corixa shall retain the right to
terminate this Agreement pursuant to Section 7.2 on account of Amersham's
material breach of this Agreement, including (without limitation) the
obligations set forth in Sections 3.3(a) and 3.3(b).
(e) Delivery of Tositumomab to the European Facility
for radiolabeling will be the responsibility of Amersham. Amersham shall be
responsible for all shipping, manufacturing and supply expenses associated with
the conversion of Tositumomab to Amersham Iodine I 131 Tositumomab.
(f) Amersham shall establish and maintain a site for
the vial labeling, storage, allocating and distribution of Amersham Iodine I 131
Tositumomab in accordance with Corixa's and BI Pharma's Specifications and
applicable legal and regulatory requirements in the Territory for vial labeling
and storage.
(g) At the request of Corixa, Amersham shall
negotiate in good faith a supply agreement with Corixa pursuant to which
Amersham would supply Amersham Iodine I 131 Tositumomab to Corixa for
development or commercialization in the Corixa Territory.
3.4 DISTRIBUTION. Distribution of Tositumomab, Iodine I 131
Tositumomab and Product in the Territory shall be handled exclusively by
Amersham and shall be in accordance with applicable law and regulations,
including regulations promulgated by nuclear regulatory agencies. Except as set
forth below, the expenses related to such distribution shall be solely the
responsibility of Amersham. Notwithstanding the foregoing, Corixa may elect to
itself or through a Third Party designee distribute some or all of the
Tositumomab, Iodine I 131 Tositumomab and Product in the Territory in connection
with an Initial Approval Clinical Trial. Corixa, or Amersham at Corixa's
request, shall coordinate product release, customs clearance and delivery of
Tositumomab, Iodine I 131 Tositumomab and Product to Initial Approval Clinical
Trial sites in the Territory. Amersham shall coordinate product release, customs
clearance and delivery of Tositumomab, Iodine I 131 Tositumomab and Product to
all Subsequent Clinical Trial sites and customer sites in the Territory. All
expenses related to the distribution of the Tositumomab, Iodine I 131
Tositumomab and Product designated for use in the Initial Approval Clinical
Trials shall be solely the responsibility of Corixa. All amounts paid by Corixa
pursuant to this Section 3.4 shall be included in the Development Budget for the
Initial Approval Clinical Trials and shall be Initial Approval Trials Costs for
the Initial Approval Clinical Trials and subject to the terms and conditions of
the License Agreement, including but not limited to Section 5.2(a)(iii) thereof.
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3.5 CUSTOMER ORDERS. Amersham shall establish and maintain
infrastructure to collect and collate customer orders for Tositumomab or Iodine
I 131 Tositumomab and Product and to transfer information regarding such
customer orders to Corixa's order fulfillment system.
3.6 ENHANCEMENTS. Upon mutual agreement of the Parties to
effect one or more Product enhancements in the manufacturing process (including
without limitation the [*] at BI Pharma and [*] Iodine-131), the Parties shall
cooperate to effect such enhancements. Amersham shall bear all expenses
(including, without limitation, the cost of any studies, Clinical Trials and
changes in Product manufacturing) for enhancements that are only applicable to
the Territory. Amersham shall bear [*] percent ([*]%) of all world-wide expenses
(including, without limitation, the cost of any studies, Clinical Trials and
changes in Product manufacturing) for enhancements that are applicable
throughout the world, provided Amersham has access to such enhancements and has
agreed to participate in such enhancement process. Each Party (the "Auditing
Party") shall have the right, upon prior written notice to the other Party (the
"Audited Party") and at the Auditing Party's cost, to have the certified public
accountants of the Auditing Party's choice, bound by confidentiality and
reasonably acceptable to the Audited Party, audit Audited Party's books and
records to verify the Audited Party's calculations of expenses for enhancements
for which the Auditing Party is obligated to pay a percentage of the world-wide
expenses therefor. Each Party may exercise this right no more than once per
contract year. If Amersham elects not to participate in the development of a
particular Product enhancement, then in the event that such Product enhancement
would otherwise reduce the Fully Allocated Cost, Amersham nonetheless shall pay
a Fully Allocated Cost that does not include such a reduction.
3.7 MANUFACTURING REGULATORY COMPLIANCE. Any manufacture of
Tositumomab and Iodine I 131 Tositumomab for development purposes or commercial
sale in the Territory shall be performed in full compliance with GCP, GLP and
GMP and all applicable United States laws and regulations (including regulations
promulgated by the Nuclear Regulatory Commission or any successor thereto).
Amersham will notify Corixa of any regulatory requirements for manufacture of
Tositumomab and/or Iodine I 131 Tositumomab for sale in the Territory with which
it wishes Third Party manufacturers of Tositumomab and/or Corixa Iodine I 131
Tositumomab to comply. To the extent Corixa can cause such manufacturers to
comply with such regulatory requirements, Corixa will do so. To the extent
permitted by applicable laws, Amersham or its designee shall serve as the point
of contact with the foreign equivalents of the FDA in the Territory and any
other applicable governmental entity in the Territory concerning the manufacture
and supply of Tositumomab and Iodine I 131 Tositumomab, but may, as appropriate,
request the assistance of Corixa with respect to communications with such
governmental entities. Amersham shall reimburse Corixa for all out-of-pocket and
FTE expenses incurred in connection with providing such assistance.
3.8 REGULATORY COMPLIANCE. Amersham shall be responsible for
establishing and maintaining infrastructure to ensure that Tositumomab or Iodine
I 131 Tositumomab and Product comply with applicable drug regulations in the
Territory.
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3.9 QUALITY CONTROL; TESTING. Any Party responsible for the
manufacture of Tositumomab or Iodine I 131 Tositumomab shall maintain a quality
control and testing program consistent with GMP, as required by the FDA and/or
any other governmental entity whether in the United States or part of another
applicable foreign jurisdiction, with respect to the manufacture by or on behalf
of either Party hereunder; provided that regarding such requirements in the
Territory, Corixa shall be obligated to comply only with requirements of the EU
itself and not of individual countries or territories within the Territory to
the extent such requirements may differ from those of the EU. Corixa shall be
entitled to audit the quality control program for the manufacture of Tositumomab
and Iodine I 131 Tositumomab that is manufactured by Amersham. Each Party shall
bear its own expenses for such audits.
3.10 NON-COMPLIANCE WITH SPECIFICATIONS. Corixa shall provide
to Amersham copies of all analysis certificates and data that Corixa receives
from the Third Party manufacturer with respect to Tositumomab or Corixa Iodine I
131 Tositumomab ordered by Amersham hereunder. In the event that Amersham wishes
to avail itself of the defective product procedures set forth in Section 5.9 of
the BI Pharma Agreement or Section 6.4 of the Nordion Supply Agreement dated
August 31, 1998, it shall provide all relevant information to Corixa, in the
case of Tositumomab, not more than 15 days after receipt of shipment by
Amersham, and, in the case of Corixa I 131 Tositumomab, not more than 5 days
after receipt of shipment of Amersham. Corixa shall use commercially reasonable
efforts to perform the relevant activity in accordance with Section 5.9 of the
BI Pharma Agreement or Section 6.4 of the Nordion Supply Agreement dated August
31, 1998, as applicable. The Parties shall work together, at the [*] expense of
[*], to use commercially reasonable efforts to enable Amersham to avail itself
of such procedures.
3.11 ALLOCATION IN THE EVENT OF PRODUCT SHORTAGES.
(a) ALLOCATION OF IODINE I 131 TOSITUMOMAB. In the
event of shortages in a batch of Iodine I 131 Tositumomab such that either (i)
Corixa is unable to supply to Amersham from such batch the amount of Corixa
Iodine I 131 Tositumomab estimated to be supplied by Corixa to Amersham per
batch in accordance with Section 3.2(b), or (ii) there is insufficient material
to supply to Corixa from such batch Corixa's pending order for Iodine I 131
Tositumomab for use in the Corixa Territory, then any Iodine I 131 Tositumomab
material produced by Nordion, Kanata, from the facility in existence as of the
Effective Date, shall be allocated as follows: [*] percent ([*]%) of the
manufactured vials in each batch shall be allocated to the Territory and [*]
percent ([*]%) of the manufactured vials in each batch shall be allocated for
use by Corixa in the Corixa Territory (rounded to the nearest whole vial on
weekly basis). If after the Effective Date, Corixa, alone or together with one
or more of Corixa's partners in the Corixa Territory, funds further expansion
[*] for production of Iodine I 131 Tositumomab, this expanded capacity shall not
be available to Amersham unless Amersham funds an appropriate part of the costs
of the additional capacity. If such funding is provided by Amersham,
apportionment of available Iodine I 131 Tositumomab for use in the Territory
shall be limited to the equivalent percentage of the funding contribution made
by Amersham. Shortages of Iodine I 131 Tositumomab which arise from shortages of
Tositumomab rather than a capacity constraint
* Confidential Treatment Requested
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in connection with radiolabeling shall not be allocated in accordance with this
Section 3.11(a), but rather the available Tositumomab shall be radiolabeled for
use in the Territory or Corixa Territory in accordance with the allocation by
territory set forth in Section 3.11(b), unless the Parties then agree
differently.
(b) ALLOCATION OF TOSITUMOMAB. Corixa shall place
orders for Tositumomab for use in the Territory following consultation with
Amersham and in accordance with the Forecast for the Territory and as agreed
upon by the Parties. Corixa shall place orders for use in the Corixa Territory
in its own discretion. Any orders placed with BI Pharma or any other vendor of
Tositumomab which is a supplier for use both inside and outside of Territory (a
"Vendor") shall be a "Vested Order" for purposes of this Section 3.11(b), if it
is a firm order which has been accepted by the Vendor and is scheduled for
delivery within twenty-four (24) months after the date of such order.
(i) VESTED ORDERS. To the extent that a
Vendor is able to deliver Tositumomab material in accordance with Vested Orders,
such material shall be purchased by, and the benefits and risks of ownership
shall belong to, the party which was responsible for such portion of the Vested
Order. For clarity, Amersham shall purchase that portion of the Vested Order
that corresponds to Amersham's estimation of its total requirements of Product
contained in Amersham's Forecast corresponding to the same twenty four (24)
month period as the Vested Order. Thus, Vested Orders which had been placed for
the purpose of supply in the Territory shall be allocated solely to the
Territory for use by Amersham and Vested Orders which had been placed for the
purposes of supply outside of the Territory shall be allocated solely to Corixa
for use outside of the Territory, in each case except by the mutual written
agreement of the parties.
(ii) SHORTAGE OF TOSITUMOMAB. Subject to the
terms and conditions of Section 3.1(e), in the event of shortages of
Tositumomab, the following rules shall apply:
(1) If Corixa seeks to place a
Vested Order for Tositumomab and is advised by a Vendor that such Vendor will
not accept the full amount of such order, whether such order is for purposes of
supply in the Territory or elsewhere in the world, then Corixa shall consult
with Amersham regarding the allocation of available supply. Unless the Parties
otherwise agree, all future Vested Orders shall be allocated [*]% to the
Territory and [*]% for use outside of the Territory so long as such conditions
of supply shortage prevail, with each lot being allocated in such pro rata
manner. In the event that, over the course of the 12 month period following such
Vendor's refusal to accept the full amount of such order, such Vendor also
refuses to accept the full amount of each and every subsequent order which
Corixa attempts to place as a Vested Order, the Parties shall meet to discuss a
plan for remedying such shortage of Tositumomab.
(2) If a Vendor is unable to deliver
the full amount of a Vested Order, either because the amount delivered is less
than the amount ordered or because
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some or all of the delivery is not accepted for any reason, including, without
limitation, non-compliance with Specifications, then the available Tositumomab
in each calendar year in which a shortage of supply prevails shall be allocated
as between the Territory and the rest of the world pro rata on the basis of the
aggregate Vested Orders for delivery in that calendar year that had been placed
for use in the Territory and in the rest of the world. If the shortfall or
failure occurs in a batch which is part of a manufacturing campaign, then the
acceptable material manufactured as part of that campaign, and all future
deliveries in that calendar year, shall be allocated between the Territory and
the rest of the world so as to make the aggregate allocation of material on a
year-to-date basis equal, as nearly as practicable, to such pro rata allocation.
(Such allocation on a campaign basis could require that material already
received as part of the same campaign for use in one territory be redesignated
for use in a different territory, if such redesignation is necessary in order to
achieve the specified pro rata allocation. However, material received as part of
previous campaigns shall not be redesignated except by mutual consent.) As used
herein, a "manufacturing campaign" shall refer to two or more batches
manufactured in the same manufacturing plant in temporal proximity to each
other. The allocation rule set forth in this Section 3.11(b)(ii)(2) shall
restart for each calendar year, without any carryover of shortfalls realized for
a particular territory in the prior calendar year.
(iii) In the event either Party desires to
reduce the size of a Vested Order previously placed, the percentage by which
such Vested Order may be reduced under the contract with the Vendor shall be
applied equally to the Territory and to the rest of the world unless the Parties
otherwise agree. By way of example, if the supply agreement permits a reduction
in Vested Orders of up to 25% for orders with delivery dates at a specified time
period in the future, and the Parties desire to reduce the Vested Order for that
time period in the Territory by 35% and the rest of the world by 10%, then the
reduction for the Territory shall be limited to 25% while the order for the rest
of the world is reduced by the full 10%. In that case, by mutual agreement, any
further reduction which would have been available for the order for the rest of
the world may be reallocated to permit a further reduction in the Vested Order
for the Territory.
(iv) If under the contract with the Vendor,
Corixa is obligated to take quantities of Tositumomab produced in excess of the
amount specified in the original Vested Order (e.g., as a result of the inherent
uncertainty of the quantity of material produced in each batch or due to minimum
batch sizes), then at Corixa's option any excess quantities which Corixa is
obligated to purchase shall be allocated as between the Territory and the rest
of the world pro rata on the basis of the aggregate Vested Orders for delivery
to each territory in that calendar year.
(v) The purpose of the foregoing allocation
rules is to permit the Parties jointly (with respect to the Territory) and
Corixa independently (with respect to the rest of the world) to make their
respective long-term purchase decisions for Tositumomab, with the benefits and
risks of such purchase decisions to be allocated to the Parties jointly, or
Corixa independently, as the case may be.
(c) ALLOCATION OF TERRITORY SUPPLIES IN FAVOR OF
INITIAL APPROVAL CLINICAL TRIAL. In the event of Product Shortages giving rise
to allocation under this Section
16
3.11, all quantities of Tositumomab and Iodine I 131 Tositumomab allocated to
the Territory in accordance with this Section 3.11 shall be first allocated to
supply the requirements of an Initial Approval Clinical Trial in the Territory.
After such requirements have been met, Amersham shall decide, in its sole
discretion, how the remainder of the Tositumomab and Iodine I 131 Tositumomab
allocated to the Territory is used.
4. ECONOMICS.
4.1 TRANSFER PRICE.
(a) Subject to the next sentence and Section 4.1(b),
Amersham shall pay Corixa for the Tositumomab Corixa provides to Amersham and
the Corixa Iodine I 131 Tositumomab, a transfer price equal to the sum of (i)
Fully Allocated Costs for such Tositumomab or Corixa Iodine I 131 Tositumomab,
as applicable, and (ii) [*] percent ([*]%) of Net Sales for any Product
containing or comprising such Tositumomab (even if such Tositumomab is
radiolabeled by or on behalf of Amersham) or such Corixa Iodine I 131
Tositumomab (the "Transfer Price"). For clinical trial supplies of Tositumomab
and Corixa Iodine I 131 Tositumomab, the Transfer Price paid by Amersham shall
exclude that part of the Transfer Price described in (ii) above. Corixa shall
pay for all such clinical supplies that are designated for use in an Initial
Approval Clinical Trial. Amersham acknowledges that the Fully Allocated Costs
for Tositumomab and Corixa Iodine I 131 Tositumomab may vary depending on, among
other factors, the then current price paid to BI Pharma by Corixa for
Tositumomab and the then current price paid to Nordion by Corixa for Corixa
Iodine I 131 Tositumomab. Amersham shall pay the amount set forth in (i) within
30 days after the date of Corixa's invoice therefor. It is anticipated that
Corixa will send Amersham semi-annual invoices for Tositumomab (except for
Tositumomab designated for use in an Initial Approval Clinical Trial) and
monthly invoices for Corixa Iodine I 131 Tositumomab (except for Corixa Iodine I
131 Tositumomab designated for use in an Initial Approval Clinical Trial). The
amount set forth in (ii) shall be paid in accordance with Section 4.4.
(b) The percentage of Net Sales owed by Amersham
pursuant to Section 4.1(a)(ii) shall be reduced to the applicable percentage
shown below in a particular country of the Territory during such time as one of
the following circumstances is then in effect in such country:
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PERCENTAGE
CIRCUMSTANCE OF NET SALES
------------ ------------
(i) there is on sale in such country an [*] that is marketed by [*]%
[*] or a distributor or licensee of Corixa (other than [*])
(ii) there is on sale in such country a [*] of [*] that is marketed [*]%
by [*] which does not [*] in such country [*]
(iii) there is on sale in such country a [*] of [*] that is marketed [*]%
by [*] which [*] in such country [*]
(iv) there is on sale in such country an [*] that is marketed by [*]%
[*] which [*] in such country from [*] was required to [*] by law,
regulation or governmental agency
(c) In the event that more than one circumstance set
forth in Section 4.1(b) occurs simultaneously in a particular country,
Amersham's percentage of Net Sales shall be the [*] percentage applicable to any
of the circumstances. Multiple such simultaneous circumstances shall [*] on the
percentage of Net Sales paid by Amersham.
4.2 FULLY ALLOCATED COST AUDIT. Amersham shall have the
right, upon prior written notice to Corixa and at Amersham's cost, to have the
certified public accountants of Amersham's choice, bound by confidentiality and
reasonably acceptable to Corixa, audit Corixa's books and records to verify
Corixa's calculations of Fully Allocated Cost. Amersham may exercise this right
no more than once per contract year.
4.3 QUARTERLY ACCOUNTING FOR TOSITUMOMAB STORED BY NORDION.
Some of the Tositumomab manufactured hereunder may be shipped to Nordion so that
Nordion can use such Tositumomab for the manufacture of Corixa Iodine I 131
Tositumomab. Under normal circumstances, Amersham shall ordinarily pay the
Transfer Price for such Tositumomab after it is made into Corixa Iodine I 131
Tositumomab. Thus, the Transfer Price will include both the Fully Allocated
Costs of manufacturing the Tositumomab and the Fully Allocated Cost of making
Corixa Iodine I 131 Tositumomab from such Tositumomab. Corixa reserves the right
to perform a quarterly assessment of the amount of Amersham-earmarked
Tositumomab being stored by Nordion and the length of time that such Tositumomab
has been stored by Nordion. For all such Tositumomab that Nordion has stored for
more than 6 months, Corixa reserves the right to invoice Amersham for the Fully
Allocated Cost of such Tositumomab. Amersham shall pay such invoice within 30
days. If any such Tositumomab is subsequently converted into Corixa Iodine I 131
Tositumomab, Corixa's invoice for the Fully Allocated Cost of such Corixa Iodine
I 131 Tositumomab shall include a credit for the amount already paid by
Amersham.
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4.4 QUARTERLY PAYMENTS AND PAYMENT REPORTS. All payments due
under Section 4.1(a)(ii) shall be made to Corixa or its designee quarterly
within 30 days following the end of each calendar quarter for which payments are
due. Each such payment shall be accompanied by a statement stating the number,
description, and aggregate Net Sales, by country, of each Product sold during
the relevant calendar quarter.
4.5 PAYMENT METHOD. All payments due under this Agreement to
Corixa shall be made by bank wire transfer in immediately available funds to an
account designated by Corixa. All payments hereunder shall be made in U.S.
dollars and shall be noncreditable and nonrefundable.
4.6 TAXES. Corixa shall pay any and all taxes levied on
account of all payments it receives under this Agreement. If laws or regulations
require that taxes be withheld, Amersham will (i) deduct those taxes from the
remittable payment, (ii) pay the taxes to the proper taxing authority, and (iii)
send evidence of the obligation together with proof of tax payment to Corixa
within 60 days following that tax payment.
4.7 BLOCKED CURRENCY. In each country in the Territory where
the local currency is blocked and cannot be removed from the country, royalties
accrued in that country shall be paid to Corixa in the country in local currency
by deposit in a local bank designated by Corixa, unless the Parties otherwise
agree.
4.8 SUBLICENSES. In the event Amersham grants licenses or
sublicenses to others to sell Products which are subject to payments under
Section 4.1, such licenses or sublicenses shall include an obligation for the
licensee or sublicensee to account for and report its sales of Products on the
same basis as if such sales were Net Sales by Amersham, and Amersham shall pay
to Corixa, with respect to such sales, payments as if such sales of the licensee
or sublicensee were Net Sales of Amersham.
4.9 FOREIGN EXCHANGE. Payments due on sales of the Product
shall be calculated and paid by Amersham in United States Dollars. Sales will be
converted into U.S. Dollars from locally billed currency on a monthly basis
using the exchange rates for the last trading day of the month as published by
Reuters. Royalties will be calculated on a quarterly calendar basis and payments
shall be due thirty (30) days after the completion of the quarter.
4.10 RECORDS; INSPECTION. Amersham shall keep complete, true
and accurate books of account and records for the purpose of determining the
payments to be made under this Agreement. Such books and records shall be kept
for at least three years following the end of the calendar quarter to which they
pertain. Such records will open for inspection during such three year period by
independent accountants, solely for the purpose of verifying payment statements
hereunder. Such inspections shall be made no more than once each calendar year,
at reasonable time and on reasonable notice. Inspections conducted under this
Section 4.10 shall be at the expense of Corixa, unless a variation or error
producing an increase exceeding [*]% of the royalty amount stated for any period
covered by the inspection is established in the course of
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such inspection, whereupon all costs relating to the inspection for such period
and any unpaid amounts (plus interest) that are discovered will be paid promptly
by Amersham.
4.11 LATE PAYMENT PENALTY. Any payment due under this Article
4 that is not paid by fourteen (14) days after the payment's due date shall
accrue interest, which must be paid by the Party with the payment obligation to
the recipient Party, on a daily basis at a rate equal to two (2) percent above
the then-applicable reference rate of CitiBank, N.A. San Francisco, California
(or the maximum amount permitted by law, if less), from the date first owed
until paid.
5. INTELLECTUAL PROPERTY.
5.1 OWNERSHIP. Corixa shall own the entire right, title and
interest in and to any and all Product Inventions, and Patents covering such
Product Inventions. Each Party shall own the entire right, title and interest in
and to any and all of its Sole Other Inventions, and Patents covering such Sole
Other Inventions. Amersham and Corixa shall each own an undivided one-half
interest in and to any and all Joint Other Inventions and Patents and other
intellectual property rights claiming or covering or arising from such Joint
Other Inventions (the "Joint Other Patents"), with inventorship to be determined
under the patent laws of the United States. Amersham and Corixa, as joint
owners, shall each have the right to practice and to grant licenses under such
Joint Other Patents without a duty of accounting, except as otherwise provided
in this Agreement. Amersham hereby covenants that it will not license any Joint
Other Patents it Controls for use in conjunction with an anti-CD20 antibody
product.
5.2 DISCLOSURE. Amersham shall submit a written report to
Corixa within 60 days of the end of each quarter describing any Product
Invention arising during the prior quarter. The Parties shall mutually decide
whether to file a patent application for a Joint Other Invention, as discussed
in Section 5.3.
5.3 PATENT PROSECUTION AND MAINTENANCE; ABANDONMENT.
(a) Each Party shall retain control over and bear
all expenses associated with the filing, prosecution and maintenance of all
Patents claiming its Sole Other Inventions.
(b) Corixa shall retain control over and bear all
expenses associated with the filing, prosecution and maintenance of all Patents
claiming Product Inventions.
(c) The Parties' rights and obligations with respect
to the filing, prosecution and maintenance of Joint Other Patents shall be
decided on a case-by-case basis.
5.4 ENFORCEMENT OF PATENT RIGHTS.
(a) If either Party becomes aware of any Third Party
activity in the Territory that infringes an issued Patent in the Corixa
Intellectual Property Rights or an issued Patent claiming a Product Invention,
then that Party shall give prompt written notice to the other Party within
thirty (30) days after having knowledge of such infringement. Corixa shall have
the
20
primary right, but not the obligation, to institute, prosecute or control any
action or proceeding with respect to such infringement by counsel of its own
choice.
(b) If Corixa enforces a Patent that is part of the
Corixa Intellectual Property Rights or covers a Product Invention made by
Amersham, then (i) Amersham shall have the right (at its own expense) to
participate in such action and to be represented by counsel of its own choice,
and (ii) Amersham shall, at the request and expense of Corixa, be joined as a
party to the suit. Any damages or monetary award recovered shall be applied to
reimburse the reasonable costs and expenses of the Parties in connection with
such litigation and the balance shall be divided between Corixa and Amersham in
accordance with the percentage to which each such entity funded the suit.
(c) If Corixa fails to bring an action or proceeding
to enforce a Patent that is part of the Corixa Intellectual Property Rights or
covers a Product Invention made by Amersham within a period of sixty (60) days
after such notice, then Amersham shall have the right, but not the obligation,
to bring and control any such action by counsel of its own choice, and Corixa
shall have the right to participate in such action and to be represented, at its
own expense, by counsel of its own choice. Any damages or monetary award
recovered shall be applied to reimburse the reasonable costs and expenses of the
Parties in connection with such litigation and the balance shall be divided
between Corixa and Amersham in accordance with the percentage to which each such
entity funded the suit.
5.5 DEFENSE OF THIRD PARTY CLAIMS.
(a) If a claim is brought by a Third Party that any
activity related to the Agreement or a Product infringes the intellectual
property rights of such Third Party, each Party will give prompt written notice
to the other Party of such claim. If the Third Party claim arises from Corixa's
activities under the Agreement, Corixa shall control and bear the expense of its
own defense and, except as set forth in Section 5.5(b), Corixa shall defend,
indemnify and hold harmless Amersham, which shall include costs or judgments
whether for money or equitable relief, and reasonable legal expenses and
reasonable attorney's fees. Corixa shall not enter into a settlement agreement
with such Third Party without the written consent of Amersham, which shall not
be unreasonably withheld. If the Third Party claim arises from Amersham's
activities under the Agreement or from a Product, Amersham shall control and
bear the expense of its own defense and Amersham shall defend, indemnify and
hold harmless Corixa, which shall include costs or judgments whether for money
or equitable relief, and reasonable legal expenses and reasonable attorney's
fees. Amersham shall not enter into a settlement agreement with such Third Party
without the written consent of Corixa, which shall not be unreasonably withheld.
(b) Except as set forth in Section 5.5(a), each
Party shall be responsible for its own defense of such Third Party claims, at
its own expense and without indemnification by the other Party. In any event,
neither Party shall be required to conduct any work under this Agreement which
it believes may infringe Third Party rights. In the event the Third Party claim
arises from the manufacture, sale or use of a Product by Amersham or its
21
licensee, the indemnity obligations of Amersham under Section 5.5(a) shall
apply, and Corixa shall not have any indemnity obligation to Amersham in respect
of such claims.
5.6 TRADEMARKS. Amersham shall be responsible for the
acquisition and maintenance of trademarks for the Product in the Territory.
Amersham is not licensed to use any trademark Controlled by Corixa.
6. CONFIDENTIALITY.
6.1 NONDISCLOSURE OF CONFIDENTIAL INFORMATION. All
Information disclosed by one Party to the other Party pursuant to this Agreement
shall be "Confidential Information." The Parties agree that during the term of
this Agreement, and for a period of five years after this Agreement expires or
terminates, a Party receiving Confidential Information of the other Party will
(i) maintain in confidence such Confidential Information to the same extent such
Party maintains its own proprietary industrial information of similar kind and
value (but at a minimum each Party shall use commercially reasonable efforts),
(ii) not disclose such Confidential Information to any Third Party without prior
written consent of the other Party, except for disclosures made in confidence to
any Third Party manufacturer of Tositumomab or Iodine I 131 Tositumomab, and
(iii) not use such Confidential Information for any purpose except those
permitted by this Agreement.
6.2 EXCEPTIONS. The obligations in Section 6.1 shall not
apply with respect to any portion of the Confidential Information that the
receiving Party can show by competent written proof:
(a) Is publicly disclosed by the disclosing Party,
either before or after it is disclosed to the receiving Party hereunder; or
(b) Was known to the receiving Party, without
obligation to keep it confidential, prior to disclosure by the disclosing Party;
or
(c) Is subsequently disclosed to the receiving Party
by a Third Party lawfully in possession thereof and without obligation to keep
it confidential; or
(d) Has been published by a Third Party; or
Has been independently developed by the receiving Party without the aid,
application or use of Confidential Information.
6.3 AUTHORIZED DISCLOSURE. A Party may disclose the
Confidential Information belonging to the other Party to the extent such
disclosure is reasonably necessary in the following instances:
(a) Filing or prosecuting Patents relating to Sole
Inventions, Joint Inventions or Products;
(b) Regulatory filings;
22
(c) Prosecuting or defending litigation;
(d) Complying with applicable governmental
regulations; and
(e) Disclosure, in connection with the performance
of this Agreement, to Affiliates, sublicensees, research collaborators,
employees, consultants, or agents, each of whom prior to disclosure must be
bound by similar obligations of confidentiality and non-use at least equivalent
in scope to those set forth in this Article 6.
In addition, Corixa shall have the right to disclose Confidential
Information under in connection with discussing potential business transactions
involving the Product outside of the Territory provided that Corixa and the
party to which Corixa is disclosing the Confidential Information are parties to
a written confidentiality agreement.
The Parties acknowledge that the terms of this Agreement shall be
treated as Confidential Information of both Parties. Such terms may be disclosed
by a Party to investment bankers, investors, and potential investors, each of
whom prior to disclosure must be bound by similar obligations of confidentiality
and non-use at least equivalent in scope to those set forth in this Article 6.
In addition, a copy of this Agreement may be filed by Corixa with the Securities
and Exchange Commission. In connection with any such filing, Corixa shall
endeavor to obtain confidential treatment of economic and trade secret
information.
In any event, the Parties agree to take all reasonable action to avoid
disclosure of Confidential Information except as permitted hereunder.
6.4 TERMINATION OF PRIOR AGREEMENTS. This Agreement
supersedes all mutual non-disclosure agreements entered into by the Parties
prior to the Effective Date. All Information exchanged between the Parties under
those earlier agreements shall be deemed Confidential Information and shall be
subject to the terms of this Article 6.
6.5 PUBLICITY. The Parties shall agree on the language of
the public announcement of the execution of this Agreement prior to the release
thereof. Any other publication, news release or other public announcement
relating to this Agreement or to the performance hereunder, shall first be
reviewed and approved by both Parties; provided, however, that any disclosure
which is required by law as advised by the disclosing Party's counsel may be
made without the prior consent of the other Party, although the other Party
shall be given prompt notice of any such legally required disclosure and to the
extent practicable shall provide the other Party an opportunity to comment on
the proposed disclosure. The Parties shall agree on language relating to this
Agreement which either Party may use without the repeated approval of the other
Party.
6.6 PUBLICATIONS. Amersham shall not publish or present the
results of Clinical Trials carried out in the Territory under this Agreement
without the opportunity for prior review by Corixa. Subject to Section 6.3,
Amersham agrees to provide Corixa the opportunity to review any proposed
abstracts, manuscripts or presentations (including verbal presentations) which
relate to any Product at least 30 days prior to its intended submission for
publication and
23
agrees, upon request, not to submit any such abstract or manuscript for
publication until Corixa is given a reasonable period of time to secure patent
protection for any material in such publication which it believes to be
patentable. Both Parties understand that a reasonable commercial strategy may
require delay of publication of information or filing of patent applications.
The Parties agree to review and consider delay of publication and filing of
patent applications under certain circumstances. Neither Party shall have the
right to publish or present Confidential Information of the other Party which is
subject to Section 6.1. Nothing contained in this Section 6.6 shall prohibit the
inclusion of information necessary for a patent application, except for
Confidential Information of the nonfiling Party, provided the nonfiling Party is
given a reasonable opportunity to review the information to be included prior to
submission of such patent application.
7. TERM AND TERMINATION.
7.1 TERM. This Agreement shall become effective on the
Effective Date and shall remain in effect until the sooner to occur of (a) the
expiration or termination for any reason by the Parties of the License
Agreement, (b) Corixa's inability to supply Amersham's Product needs in the
Territory pursuant to terms and conditions hereunder, (c) termination by Corixa
due to Amersham's failure to establish a European Facility in accordance with
Section 3.3(d) herein, or (d) termination of this Agreement by a Party for
material breach pursuant to Section 7.2 below, including, without limitation,
Amersham's failure to comply with the terms and conditions of the BI Pharma
Agreements and Nordion Agreements applicable to Amersham.
7.2 TERMINATION FOR MATERIAL BREACH.
(a) If either Party believes that the other is in
material breach of this Agreement (including without limitation any material
breach of a representation or warranty made in this Agreement), then the
non-breaching Party may deliver notice of such breach to the other Party. In
such notice the non-breaching Party shall identify the actions or conduct that
such Party would consider to be an acceptable cure of such breach. The allegedly
breaching Party shall have sixty (60) days to either cure such breach or, if
cure cannot be reasonably effected within such sixty (60) day period, to deliver
to the other Party a plan for curing such breach which is reasonably sufficient
to effect a cure. Such a plan shall set forth a program for achieving cure as
rapidly as practicable. Following delivery of such plan, the breaching Party
shall use Diligent Efforts to carry out the plan and cure the breach. In the
event of breach for failure to meet any payment obligations under this
Agreement, the breaching Party shall have fifteen (15) days to cure such breach
for nonpayment. For the avoidance of any doubt, any failure on the part of
Nycomed, Inc. to fulfill its obligations set forth in the Stock Purchase
Agreement shall be a material breach of this Agreement.
(b) If the Party receiving notice of breach fails to
cure such breach within the 60-day period, or the Party providing the notice
reasonably determines that the proposed corrective plan or the actions being
taken to carry it out is not commercially practicable, the Party originally
delivering the notice may terminate this Agreement upon thirty (30) days advance
written notice. If Corixa is the breaching Party, Amersham may elect to not
terminate this Agreement as provided herein. If the non-breaching Party elects
not to terminate
24
this Agreement under circumstances in which such non-breaching Party believes it
is entitled to a temporary restraining order against the breaching Party, it may
seek such a temporary restraining order. After the issuance of any temporary
restraining order granted hereunder, any disputes concerning the appropriateness
of such temporary restraining order shall be resolved in accordance with Section
10.1 and, if arbitration results, the arbitrator shall have the right to grant
the Party subject to such temporary restraining order any redress that might
have been available to such Party if the matter had remained under the
jurisdiction of the courts.
(c) If a Party gives notice of termination under
this Section 7.2 and the other Party disputes whether such notice was proper,
then the issue of whether this Agreement has been terminated shall be resolved
in accordance with Section 10.1. If as a result of such dispute resolution
process it is determined that the notice of termination was proper, then such
termination shall be deemed to have been effective 30 days following the date of
the notice of termination. If as a result of such dispute resolution process it
is determined that the notice of termination was improper, then no termination
shall have occurred and this Agreement shall have remained in effect.
7.3 EFFECT OF TERMINATION; SURVIVAL.
(a) In the event of termination of this Agreement
for any reason, the following provisions of this Agreement shall survive:
Sections 4.10, 4.11, 5.1, 5.3, 6.1, 6.2, 6.3 and 7.3, and Articles 1, 9 and 10.
(b) In any event, termination of this Agreement
shall not relieve the Parties of any liability which accrued hereunder prior to
the effective date of such termination nor preclude either Party from pursuing
all rights and remedies it may have hereunder or at law or in equity with
respect to any breach of this Agreement nor prejudice either Party's right to
obtain performance of any obligation.
(c) In the event of termination of this Agreement as
a result of Amersham's termination of the License Agreement pursuant to Section
11.4(a) of the License Agreement, Corixa may, at its sole discretion, purchase
from Amersham some or all of the Tositumomab and Corixa Iodine I 131 Tositumomab
that Amersham purchased for commercial use and for which Amersham paid Corixa in
full prior to the effective date of such termination. Corixa shall pay Amersham
any mutually agreed purchase price for such Tositumomab and Corixa Iodine I 131
Tositumomab, provided such price does not exceed the price originally paid by
Amersham to Corixa. Amersham shall destroy all Tositumomab and Corixa Iodine I
131 Tositumomab not purchased by Corixa within sixty (60) days of such
termination.
8. REPRESENTATIONS AND COVENANTS.
8.1 MUTUAL AUTHORITY. Corixa and Amersham each represents
and warrants to the other that (i) it has the authority and right to enter into
and perform this Agreement and (ii) its execution, delivery and performance of
this Agreement will not conflict in any material fashion with the terms of any
other agreement to which it is or becomes a party or by which it is or becomes
bound.
25
8.2 PERFORMANCE BY AFFILIATES. The Parties recognize that
each may perform some or all of its obligations under this Agreement through
Affiliates, provided, however, that each Party shall remain responsible and be
guarantor of the performance by its Affiliates and shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such
performance.
9. INDEMNIFICATION AND LIMITATION OF LIABILITY.
9.1 INDEMNIFICATION.
(a) Amersham hereby agrees to defend and hold
harmless Corixa and its agents and employees from and against any and all suits,
claims, actions, demands, liabilities, expenses and/or loss, including
reasonable legal expenses and reasonable attorneys' fees ("Losses") resulting
directly or indirectly from (i) manufacture, use or storage by Amersham or its
sublicensee or agent of Tositumomab, Iodine I 131 Tositumomab or Product or (ii)
sale of Product in the Territory, except to the extent such Losses result from
an activity as to which Corixa is obliged to indemnify Amersham pursuant to
Section 9.1(b).
(b) Corixa hereby agrees to defend and hold harmless
Amersham and its agents and employees from and against any and all suits,
claims, actions, demands, liabilities, expenses and/or loss, including
reasonable legal expenses and reasonable attorneys' fees ("Losses") resulting
directly or indirectly from (i) the failure of Tositumomab provided to Amersham
by Corixa or Corixa Iodine I 131 Tositumomab to comply with the relevant
Specifications or (ii) the failure of Corixa to comply with GMP during its
manufacture of Tositumomab or Corixa Iodine I 131 Tositumomab, except to the
extent such Losses result from an activity as to which Amersham is obliged to
indemnify Corixa pursuant to Section 9.1(a).
(c) In the event that a Party (the "Indemnified
Party") is seeking indemnification under Section 9.1(a) or (b), the Indemnified
Party shall inform the other Party (the "Indemnifying Party") of a claim as soon
as reasonably practicable after the Indemnified Party receives notice of the
claim, shall permit the Indemnifying Party to assume direction and control of
the defense of the claim (including the right to settle the claim solely for
monetary consideration), and shall cooperate as requested by the Indemnifying
Party (at the expense of the Indemnifying Party) in the defense of the claim.
9.2 LIMITATION OF LIABILITY. EXCEPT AS SPECIFICALLY PROVIDED
IN SECTION 9.1, IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS,
EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT,
INCIDENTAL, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON A
CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER
TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT. For clarification, the
foregoing sentence shall not be interpreted to limit or to expand the express
rights specifically granted in the sections of this Agreement.
26
10. MISCELLANEOUS.
10.1 DISPUTE RESOLUTION. In the event of any controversy or
claim arising out of, relating to or in connection with any provision of this
Agreement, the Parties shall try to settle their differences amicably between
themselves first, by referring the disputed matter to the respective heads of
Research and Development of each Party and, if not resolved by the Research and
Development heads, by referring the disputed matter to the respective Chief
Executive Officers of each Party. Either Party may initiate such informal
dispute resolution by sending written notice of the dispute to the other Party,
and, within 20 days after such notice, such representatives of the Parties shall
meet for attempted resolution by good faith negotiations. If such personnel are
unable to resolve a dispute within 30 days of their first meeting of such
negotiations, except as provided in Section 10.3, either Party may seek to have
such dispute resolved by binding arbitration with a single arbitrator under the
commercial rules of the American Arbitration Association. The Parties hereby
consent to conduct such binding arbitration procedures in English in the city of
New York, New York.
10.2 GOVERNING LAW. Resolution of all disputes arising out of
or related to this Agreement or the performance, enforcement, breach or
termination of this Agreement and any remedies relating thereto, shall be
governed by and construed under the substantive laws of the State of Delaware,
as applied to agreements executed and performed entirely in the State of
Delaware by residents of the State of Delaware, without regard to conflicts of
law rules.
10.3 PATENTS AND TRADEMARKS. Any dispute, controversy or
claim relating to the scope, validity, enforceability or infringement of any
Patent rights covering the manufacture, use or sale of any Product or of any
trademark rights related to any Product shall be submitted to a court of
competent jurisdiction in the territory in which such Patent or trademark rights
were granted or arose.
10.4 ENTIRE AGREEMENT; AMENDMENT. This Agreement sets forth
the complete, final and exclusive agreement and all the covenants, promises,
agreements, warranties, representations, conditions and understandings between
the Parties hereto and supersedes and terminates all prior agreements and
understandings between the Parties. There are no covenants, promises,
agreements, warranties, representations, conditions or understandings, either
oral or written, between the Parties other than as are set forth herein and
therein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties unless reduced to writing and signed
by an authorized officer of each Party.
10.5 EXPORT CONTROL. This Agreement is made subject to any
restrictions concerning the export of products or technical information from the
United States of America or other countries which may be imposed upon or related
to Corixa or Amersham from time to time. Each Party agrees that it will not
export, directly or indirectly, any technical information acquired from the
other Party under this Agreement or any products using such technical
information to a location or in a manner that at the time of export requires an
export license or other governmental approval, without first obtaining the
written consent to do so from the appropriate agency or other governmental
entity.
27
10.6 FORCE MAJEURE. Both Parties shall be excused from the
performance of their obligations under this Agreement to the extent that such
performance is prevented by force majeure and the nonperforming Party promptly
provides notice of the prevention to the other Party. Such excuse shall be
continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition. For
purposes of this Agreement, force majeure shall include conditions beyond the
control of the Parties, including without limitation, an act of God, voluntary
or involuntary compliance with any regulation, law or order of any government,
war, civil commotion, labor strike or lock-out, epidemic, failure or default of
public utilities or common carriers, destruction of production facilities or
materials by fire, earthquake, storm or like catastrophe; provided, however, the
payment of invoices due and owing hereunder shall not be delayed by the payer
because of a force majeure affecting the payer.
10.7 NOTICES. Any notice required or permitted to be given
under this Agreement shall be in writing, shall specifically refer to this
Agreement and shall be deemed to have been sufficiently given for all purposes
if mailed by first class certified or registered mail, postage prepaid, express
delivery service or personally delivered. Unless otherwise specified in writing,
the mailing addresses of the Parties shall be as described below.
For Corixa: Senior VP, and Chief Operating Officer
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
With a copy to: General Counsel
Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
With a copy to: Cooley Godward LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxx X. Xxxxx, Esq.
For Amersham: Group Secretary
Amersham PLC
Amersham Place
Little Chalfont
Buckinghamshire
ENGLAND HP7 9NA
With a copy to: General Counsel
Amersham Health, Inc.
000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
28
10.8 CONSENTS NOT UNREASONABLY WITHHELD OR DELAYED. Whenever
provision is made in this Agreement for either Party to secure the consent or
approval of the other, that consent or approval shall not unreasonably be
withheld or delayed, and whenever in this Agreement provisions are made for one
Party to object to or disapprove a matter, such objection or disapproval shall
not unreasonably be exercised.
10.9 MAINTENANCE OF RECORDS. Each Party shall keep and
maintain all records required by law or regulation with respect to Products and
shall make copies of such records available to the other Party upon request.
10.10 UNITED STATES DOLLARS. References in this Agreement to
"Dollars" or "$" shall mean the legal tender of the United States of America.
10.11 NO STRICT CONSTRUCTION. This Agreement has been prepared
jointly and shall not be strictly construed against either Party.
10.12 ENGLISH. This Agreement has been prepared in English and
shall be interpreted solely in English.
10.13 ASSIGNMENT. Neither Party may assign or transfer this
Agreement or any rights or obligations hereunder without the prior written
consent of the other, except a Party may make such an assignment without the
other Party's consent to an Affiliate or to a successor to substantially all of
the business of such Party, whether in a merger, sale of stock, sale of assets
or other transaction. Any permitted successor or assignee of rights and/or
obligations hereunder shall, in writing to the other Party, expressly assume
performance of such rights and/or obligations. Any permitted assignment shall be
binding on the successors of the assigning Party. Any assignment or attempted
assignment by either Party in violation of the terms of this Section 10.13 shall
be null and void and of no legal effect.
10.14 HARDSHIP. If, during the term of the Agreement,
performance of the Agreement should lead to unreasonable hardship for one or
other Party taking the interests of both Parties into account both Parties shall
endeavor to agree in good faith to amend the Agreement in the light of the
change in circumstances.
10.15 ELECTRONIC DATA INTERCHANGE. If both Parties elect to
facilitate business activities hereunder by electronically sending and receiving
data in agreed formats (also referred to as Electronic Data Interchange or
"EDI") in substitution for conventional paper-based documents, the terms and
conditions of this Agreement shall apply to such EDI activities.
10.16 COUNTERPARTS. 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.
10.17 FURTHER ACTIONS. Each Party agrees to execute,
acknowledge and deliver such further instruments, and to do all such other acts,
as may be necessary or appropriate in order to carry out the purposes and intent
of this Agreement.
29
10.18 SEVERABILITY. If any one or more of the provisions of
this Agreement is held to be invalid or unenforceable by any court of competent
jurisdiction from which no appeal can be or is taken, the provision shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof. The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement may be realized. If the Parties, after making good faith effort, are
unable to effectively replace an invalid or unenforceable provision pursuant to
this Section 10.18, and a Party is suffering or reasonably expects to suffer
significant economic harm as a result of the invalidity or unenforceability of
an original provision of this Agreement, such Party shall have the right to
terminate this Agreement upon six months prior written notice to the other
Party. Such termination shall be in accordance with the provisions of Section
7.3 of this Agreement.
10.19 AMBIGUITIES. Ambiguities, if any, in this Agreement
shall not be construed against any Party, irrespective of which Party may be
deemed to have authored the ambiguous provision.
10.20 HEADINGS. The headings for each article and section in
this Agreement have been inserted for convenience of reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular article or section.
10.21 NO WAIVER. Any delay in enforcing a Party's rights under
this Agreement or any waiver as to a particular default or other matter shall
not constitute a waiver of such Party's rights to the future enforcement of its
rights under this Agreement, excepting only as to an express written and signed
waiver as to a particular matter for a particular period of time.
IN WITNESS WHEREOF, the Parties have executed this Agreement in
duplicate originals by their proper officers as of the date and year first above
written.
AMERSHAM PLC CORIXA CORPORATION
By: By:
----------------------------------------- -------------------------------------------
Name: Name: Xxxxxx Xxxxxx
--------------------------------------- -----------------------------------------
Title: Title: Chairman and Chief Executive Officer
-------------------------------------- ----------------------------------------
Date: Date:
--------------------------------------- -----------------------------------------
30
EXHIBIT A
CORIXA FORECAST
CALENDAR YEAR AMOUNT
------------- ---------
2001 [*] grams
2002 [*] grams
2003 [*] grams
* Confidential Treatment Requested
A-1
EXHIBIT B
EUROPEAN FACILITY
MILESTONES AND TIMELINES
MILESTONE TIMELINE
---------- ---------
Development of [*] for [*]. Within [*] days following the Effective Date
Completion of [*], ready for submission for [*]. June 30, [*]
Commencement of [*]. Beginning June 30, [*]
Purchase of all [*] required for [*] of Product. December 30, [*]
Validation of [*] and submission of validation Completed by September 30, [*]
documents to regulatory agencies as required.
* Confidential Treatment Requested
B-1
1. Definitions..........................................................................1
1.1 "Amersham Iodine I 131 Tositumomab"...........................................1
1.2 "BI Pharma Agreements"........................................................1
1.3 "Clinical Trial"..............................................................1
1.4 "Controlled"..................................................................1
1.5 "Corixa"......................................................................2
1.6 "Corixa Intellectual Property Rights".........................................2
1.7 "Corixa Iodine I 131 Tositumomab".............................................2
1.8 "Corixa Territory"............................................................2
1.9 "Diligent Efforts"............................................................2
1.10 "Effective Date"..............................................................2
1.11 "European Facility"...........................................................2
1.12 "Fully Allocated Cost"........................................................2
1.13 "Good Clinical Practice"......................................................3
1.14 "Good Laboratory Practice"....................................................3
1.15 "Good Manufacturing Practice".................................................3
1.16 "Information".................................................................3
1.17 "Initial Approval Clinical Trials"............................................3
1.18 "Initial Development Plan"....................................................4
1.19 "Intellectual Property Rights"................................................4
1.20 "Invention"...................................................................4
1.21 "Iodine I 131 Tositumomab"....................................................4
1.22 "Joint Other Inventions"......................................................4
1.23 "Know-How"....................................................................4
1.24 "Net Sales"...................................................................4
1.25 "Nordion Agreements"..........................................................5
1.26 "Other Invention".............................................................5
1.27 "Patent"......................................................................5
1.28 "Product".....................................................................5
1.29 "Product Invention"...........................................................5
1.30 "QA/QC Costs".................................................................5
1.31 "Sole Other Inventions".......................................................5
1.32 "Specifications"..............................................................5
1.33 "Stock Purchase Agreement"....................................................6
1.34 "Territory"...................................................................6
1.35 "Therapy".....................................................................6
1.36 "Third Party".................................................................6
1.37 "Tositumomab".................................................................6
1.38 "Transfer Price"..............................................................6
2. General Understanding................................................................6
3. Manufacturing And Supply Of Antibody.................................................6
3.1 Tositumomab...................................................................6
3.2 Corixa Iodine I 131 Tositumomab...............................................8
3.3 Amersham Iodine I 131 Tositumomab............................................10
3.4 Distribution.................................................................12
3.5 Customer Orders..............................................................12
3.6 Enhancements.................................................................12
3.7 Manufacturing Regulatory Compliance..........................................13
3.8 Regulatory Compliance........................................................13
3.9 Quality Control; Testing.....................................................13
3.10 Non-Compliance with Specifications...........................................13
3.11 Allocation in the Event of Product Shortages.................................13
4. Economics...........................................................................16
4.1 Transfer Price...............................................................16
4.2 Fully Allocated Cost Audit...................................................17
4.3 Quarterly Accounting for Tositumomab Stored by Nordion.......................17
4.4 Quarterly Payments and Payment Reports.......................................18
4.5 Payment Method...............................................................18
4.6 Taxes........................................................................18
4.7 Blocked Currency.............................................................18
4.8 Sublicenses..................................................................18
4.9 Foreign Exchange.............................................................18
4.10 Records; Inspection..........................................................18
4.11 Late Payment Penalty.........................................................19
5. Intellectual Property...............................................................19
5.1 Ownership....................................................................19
5.2 Disclosure...................................................................19
5.3 Patent Prosecution and Maintenance; Abandonment..............................19
5.4 Enforcement of Patent Rights.................................................19
5.5 Defense of Third Party Claims................................................20
5.6 Trademarks...................................................................21
6. Confidentiality.....................................................................21
6.1 Nondisclosure of Confidential Information....................................21
6.2 Exceptions...................................................................21
6.3 Authorized Disclosure........................................................21
6.4 Termination of Prior Agreements..............................................22
6.5 Publicity....................................................................22
6.6 Publications.................................................................22
7. Term And Termination................................................................23
7.1 Term.........................................................................23
7.2 Termination for Material Breach..............................................23
7.3 Effect of Termination; Survival..............................................24
8. Representations And Covenants.......................................................24
8.1 Mutual Authority.............................................................24
8.2 Performance by Affiliates....................................................24
9. Indemnification And Limitation Of Liability.........................................25
9.1 Indemnification..............................................................25
9.2 Limitation of Liability......................................................25
10. Miscellaneous.......................................................................25
10.1 Dispute Resolution...........................................................25
10.2 Governing Law................................................................26
10.3 Patents and Trademarks.......................................................26
10.4 Entire Agreement; Amendment..................................................26
10.5 Export Control...............................................................26
10.6 Force Majeure................................................................26
10.7 Notices......................................................................27
10.8 Consents Not Unreasonably Withheld or Delayed................................27
10.9 Maintenance of Records.......................................................27
10.10 United States Dollars........................................................28
10.11 No Strict Construction.......................................................28
10.12 English......................................................................28
10.13 Assignment...................................................................28
10.14 Hardship.....................................................................28
10.15 Electronic Data Interchange..................................................28
10.16 Counterparts.................................................................28
10.17 Further Actions..............................................................28
10.18 Severability.................................................................28
10.19 Ambiguities..................................................................29
10.20 Headings.....................................................................29
10.21 No Waiver....................................................................29
