Exhibit 10.4
*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.
LICENSE AND SUPPLY AGREEMENT
This LICENSE AND SUPPLY AGREEMENT (the "Agreement") is entered into as
of May 27, 2003 (the "Effective Date") between CORIXA CORPORATION, a Delaware
corporation, with its principal place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxx
000, Xxxxxxx, XX 00000, X.X.X. and its subsidiary Xxxxxxx Pharmaceutical, Inc.
(referred to individually as "Corixa Corporation" and "Xxxxxxx Pharmaceutical",
respectively, and collectively as "Corixa"), and GLAXOSMITHKLINE INC., a
corporation amalgamated and continued under the laws of Canada, with its
principal place of business at 0000 Xxxxxxxxxxx Xxxx Xxxxx, Xxxxxxxxxxx,
Xxxxxxx, Xxxxxx X0X 0X0 ("GSK Canada"). Both Corixa and GSK Canada are referred
to individually as a "Party" and collectively as the "Parties."
WHEREAS, Corixa has rights to and is developing Bexxar therapy, a
therapeutic antibody product pending FDA approval; and
WHEREAS, GSK Canada possesses development, marketing and distribution
capability for therapeutic products in Canada; and
WHEREAS, Corixa Corporation and GSK Canada entered into a Conditional
Letter of Intent on February 17, 2003 (the "LOI") under which the Parties have
made preparations to register such product in Canada and which is terminated by
the signing of this Agreement; and
WHEREAS, GSK Canada desires to obtain rights to commercialize such
product in Canada for the treatment of humans, and Corixa is willing to grant
such rights on the terms and conditions hereof; and
WHEREAS, GSK Canada desires to obtain finished antibody for such
product 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 following terms shall have the following meanings as used in this
Agreement:
1.1 "AFFILIATE" means, with respect to a particular
Party, a person, corporation, partnership, or other entity that controls, is
controlled by or is under common control with such Party. For the purposes of
the definition in this Section 1.1, the word "control" (including, with
correlative meaning, the terms "controlled by" or "under the common control
with") means the actual power, either directly or indirectly through one or more
intermediaries, to direct or cause the direction of the management and policies
of such entity, whether by the ownership of at least fifty percent (50%) of the
voting stock of such entity, or by contract or otherwise.
1.2 "ANNUAL CLINICAL FTE RATE" shall mean the amount to
be paid by GSK Canada to Corixa for the services of one FTE. The Annual Clinical
FTE Rate will be US[*] per year for calendar year 2003. For each subsequent
calendar year, this rate will be adjusted by the percentage change in the
monthly Consumer Price Index for the immediately preceding December as compared
to the base month of December 2002. The index source will be the Consumer Price
Index published by the Bureau of Labor Statistics of the United States
Department of Labor and covering Seattle, Tacoma and Bremerton (all in the state
of Washington). Should indices covering all of the foregoing areas not be
available, then the national index will be used as the reference.
1.3 "ANNUAL NET SALES" shall mean, with respect to a
particular calendar year, the total Net Sales for such calendar year.
1.4 "BATCH CERTIFICATE" shall mean (a) a certificate
issued by the manufacturer of a lot or batch of a drug that is exported from the
country of manufacture under a mutual recognition agreement, which certificate
includes (i) a detailed description of such drug, (ii) analytical test methods
and results performed on such lot or batch, (iii) addresses of the buildings
where such lot or batch was manufactured, packaged, labeled and tested, (iv) a
master production document for such drug, and (v) certification that Good
Manufacturing Practices were followed; or (b) such other consistent, but more
detailed definition as provided in the Quality Policy Manual.
1.5 "BI PHARMA" SHALL MEAN Boehringer Ingelheim Pharma
KG.
1.6 "BI PHARMA AGREEMENTS" shall mean (a) the Supply
Agreement between Xxxxxxx Pharmaceutical and BI Pharma dated November 3, 1998,
as amended by (i) letter agreements dated July 17, 2001 and January 11, 2002 and
(ii) an amendment dated February 24, 2003, and (b) the Contract Research and
Development Agreement between Xxxxxxx Pharmaceutical and Xx. Xxxx Xxxxxx GmbH
dated October 22, 1997.
1.7 "BLA" shall mean a Biologics License Application, as
defined by the regulations promulgated under the FD&C Act and the United States
Public Health Services Act and any supplements thereunder, as amended from time
to time.
1.8 "BUSINESS DAY" OR "BUSINESS DAY" shall mean a day
other than Saturday, Sunday or any day on which banks located in the State of
Washington and/or Ontario are obligated to close. Whenever this Agreement refers
to a number of days, such number shall refer to calendar days unless Business
Days (or business days) are specified.
1.9 "CERTIFICATE OF ANALYSIS" shall mean (a) a
certificate issued by the manufacturer of a lot or batch of a drug, which
certificate (i) certifies that the lot was tested in accordance with Good
Manufacturing Practice and Good Laboratory Practice, (ii) includes the
analytical test results for such lot of drug, (iii) is in conformance with the
applicable NDS, and (iv) states whether such drug is manufactured in accordance
with the Specifications and cGMPs;
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2.
or (b) such other consistent, but more detailed definition as provided in the
Quality Policy Manual.
1.10 "CERTIFICATE OF MANUFACTURE" shall mean (a) a
certificate issued by a vendor to a distributor or importer, which certificate
(i) attests that a specific lot or batch of drug has been produced in accordance
with its master production documents, (ii) includes a detailed summary of
current batch documentation, with reference to respective dates of revision,
manufacture and packaging, and (iii) is signed and dated by the quality
assurance department of such vendor; or (b) such other consistent, but more
detailed definition as provided in the Quality Policy Manual.
1.11 "CLINICAL TRIAL" shall mean a trial, conducted by a
Party or a licensee of a Party, in which the Product is administered to humans
for one or more purposes, including, without limitation, with the goal of (a)
generating data to support an application for Regulatory Approval of the
Product, (b) familiarizing physicians with the use of the Product prior to
Initial Approval or (c) generating data in connection with, and familiarizing
physicians with, the use of the Product after Initial Approval.
1.12 "COLD COMPONENT" shall mean two 20ml vials of
Tositumomab and one 3ml vial of Tositumomab.
1.13 "CONFIDENTIAL INFORMATION" shall have the meaning
given such term in Section 9.1.
1.14 "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 Parties 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 (or in the case of Corixa,
with SB) existing at the time such Party would first be required hereunder to
grant the other Parties such access, license or sublicense.
1.15 "CORIXA INTELLECTUAL PROPERTY RIGHTS" shall mean,
subject to Section 7.3(f), (a) all Intellectual Property Rights 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) but excluding
any Intellectual Property Rights that Corixa obtains Control of as a result of a
merger or acquisition, and (b) all Intellectual Property Rights Controlled by
Corixa that are (i) licensed by Corixa after the Effective Date pursuant to
Section 2.6 or (ii) developed, after the Effective Date and during the term of
this Agreement, by Corixa or by one of Corixa's licensees for the Product in the
Corixa Territory.
1.16 "CORIXA POST-APPROVAL TRIAL" shall have the meaning
set forth in Section 3.9(b).
1.17 "CORIXA TERRITORY " shall mean all countries and
territories of the world except those in the Territory.
3.
1.18 "CROSS-TERRITORY CLINICAL TRIAL" shall mean a
Clinical Trial conducted in the Territory and in at least one country or
territory in the Corixa Territory.
1.19 "XXXX-XXXXXX AGREEMENTS" shall mean:
(a) Agreement between Xxxxxxx Corporation and
Xxxx-Xxxxxx Cancer Institute, Inc., dated April 1, 1994;
(b) Assignment Agreement among Xxxxxxx
Pharmaceutical, Xxxxxxx Corporation, Interwest Partners V, L.P. and Interwest
Investors V, dated February 24, 1995; and
(c) Agreement Regarding Sublicenses among
Xxxx-Xxxxxx Cancer Institute, Xxxxxxx Corporation and Xxxxxxx Pharmaceutical,
dated December 2, 1998.
1.20 "DEL" shall mean a Drug Establishment License, as
defined by regulations promulgated by Health Canada.
1.21 "DILIGENT EFFORTS" means the level of efforts
required to carry out obligations or tasks in a sustained manner consistent with
the efforts a major Canadian pharmaceutical corporation devotes to a high
priority therapeutic product of similar market potential, profit potential or
strategic value resulting from its own research and/or development efforts,
based on conditions then prevailing. Diligent Efforts requires that the Party:
(a) promptly assign responsibility for such obligations to specific employee(s)
who are held accountable for progress and monitor such progress on an on-going
basis, (b) set and consistently seek to achieve specific and meaningful
objectives for carrying out such obligations, and (c) consistently make and
implement decisions and allocate resources designed to advance progress with
respect to such objectives.
1.22 "DIN" shall mean a Drug Identification Number, as
defined by regulations promulgated by Health Canada.
1.23 "EXISTING SUPPLY AGREEMENTS" shall have the meaning
set forth in Section 4.1.
1.24 "FD&C ACT" shall mean the United States Federal Food,
Drug and Cosmetic Act, as amended.
1.25 "FDA" shall mean the United States Food and Drug
Administration or its successor.
1.26 "FIELD" shall mean the treatment, prevention or
palliation of any indication in humans. [*] shall [*] of [*].
1.27 "FIRST COMMERCIAL SALE" shall mean the first
commercial sale of the Product in the Territory after the Product has been
granted Regulatory Approval by Health Canada.
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4.
1.28 "FORCE MAJEURE" shall have the meaning set forth in
Section 13.7.
1.29 "FTE" means the equivalent of one person working full
time for or on behalf of Corixa for one 12-month period in a clinical or
regulatory capacity, which shall correspond to no less than 2000 hours per year.
1.30 "GOOD CLINICAL PRACTICE" OR "GCP" shall mean the then
current standards for clinical trials 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.
1.31 "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.
1.32 "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.
1.33 "GSK CANADA INTELLECTUAL PROPERTY RIGHTS" shall mean
all Intellectual Property Rights that are Controlled by GSK Canada during the
term of this Agreement and that disclose, claim or embody Inventions.
1.34 "HEALTH CANADA" means the federal Canadian regulatory
agency having jurisdiction over the manufacture, distribution, use and sale of
the Product in the Territory, and includes the Biologic and Genetic Therapies
Directorate of Health Canada or its successor.
1.35 "HOT COMPONENT" shall mean two 30ml vials of Iodine I
131 Tositumomab, one for dosimetric purposes and one for therapeutic purposes.
Based on Corixa's experiences to date, approximately [*] of patients require a
second therapeutic vial of Iodine I 131 Tositumomab. For such patients, a Hot
Component will consist of three 30ml vials of Iodine I 131 Tositumomab, one for
dosimetric purposes and two for therapeutic purposes.
1.36 "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, 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.
1.37 "INITIAL APPROVAL" shall mean the first approval of
an NDS for the Product by Health Canada.
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5.
1.38 "INITIAL ROYALTY PERIOD" shall mean the period
commencing upon the First Commercial Sale and ending at the later to occur of:
(a) the expiration of the last-to-expire Patent in the Territory within the
Corixa Intellectual Property Rights that claims the Product or its manufacture,
formulation or use, and (b) the end of the calendar year in which the tenth
(10th) anniversary of the First Commercial Sale occurs.
1.39 "INTELLECTUAL PROPERTY RIGHTS" shall mean all
Patents, copyrights, know-how, Information, or any other intellectual property
other than trademarks that relate to the development, manufacture, importing,
use, marketing, offer for sale and/or sale of the Product. The term
"Intellectual Property Rights" shall include any rights obtained by any Party
from a Third Party, including those obtained pursuant to Section 2.6, 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, know-how, Information, or any other intellectual property of any
Party for the [*], whether developed prior to or after the Effective Date.
1.40 "INVENTION" means any invention, development, result,
know-how or other Information, and all intellectual property relating thereto,
made, discovered or developed (a) solely by a Party and its employees, agents,
contractors (including clinical research organizations) or sublicensees pursuant
to work performed under the Agreement or (b) jointly by the Parties and their
employees, agents or sublicensees pursuant to work performed under the
Agreement.
1.41 "IODINE I 131 TOSITUMOMAB" shall mean a therapeutic,
prophylactic or palliative product that (a) contains or comprises the IgG(2a)
anti-CD20 murine monoclonal antibody conjugated with (131)Iodine that was one of
the active agents tested in Corixa's clinical trials with Protocol Nos.
RIT-II-004 and CP-97-012, (b) is supplied at [*] protein and activity
concentrations of (i) [*] mg/mL and [*] mCi/mL (at calibration), respectively,
for the dosimetric dosage form and (ii) [*] mg/mL and [*] mCi/mL (at
calibration), respectively, for the therapeutic dosage form, and (c) has been
formulated with [*] (or another formulation agreed upon in writing by the
Parties). Except as otherwise specified in this Agreement, Iodine I 131
Tositumomab shall mean only filled material.
1.42 "JOINT MARKETING COMMITTEE" and "JMC" shall have the
meanings given such terms in Section 3.2(a).
1.43 "JOINT OTHER INVENTIONS" means any and all Other
Inventions made jointly by employees or agents of Corixa and GSK Canada pursuant
to work conducted under the Agreement.
1.44 "LICENSED XXXX" shall mean a trademark that has been
registered or applied for in the Territory and is set forth on Exhibit C, which
may be updated by Corixa from time to time in accordance with Section 8.4(a) or
8.4(b).
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6.
1.45 "LICENSED PRODUCT" shall mean the Product when it is
promoted, offered for sale or sold under (a) the Licensed Marks "BEXXAR" and
"POWERED BY CORIXA" and (b) all other Licensed Marks agreed upon by the Parties.
1.46 "LICENSED SERVICES" shall mean all promotion,
advertising or other services that are (a) performed under (i) the Licensed Xxxx
"BEXXAR", (ii) if requested by Corixa for use with respect to such service, the
Licensed Xxxx "POWERED BY CORIXA", and (iii) all other Licensed Marks agreed
upon by the Parties with respect to such service, (b) related to the Product,
and (c) approved in writing by Corixa.
1.47 "LOI" shall have the meaning set forth in the
preamble to this Agreement.
1.48 "MARKETING PLAN" shall mean the plan (a) that
specifies the means by which GSK Canada or its sublicensee intends to
commercialize the Product in the Territory after it obtains Initial Approval,
including a detailed description of and estimated timeline for all marketing and
promotional activities and (b) that is prepared, reviewed and approved in
accordance with the procedures set forth in Section 3.5.
1.49 "MCKESSON" shall mean McKesson BioServices
Corporation.
1.50 "MCKESSON AGREEMENT" means the Pharmaceutical
Services Agreement between Xxxxxxx Pharmaceutical and McKesson, dated February
7, 2000.
1.51 "MICHIGAN AGREEMENT" shall mean (a) the
Commercialization Agreement between Xxxxxxx Corporation and the Regents of the
University of Michigan, dated November 1, 1994, (b) the Assignment of the
Commercialization Agreement among Xxxxxxx Pharmaceutical, Xxxxxxx Corporation
and the Regents of the University of Michigan, dated April 1, 1995, and (c) the
Amendment to Commercialization Agreement between Xxxxxxx Pharmaceutical and the
Regents of the University of Michigan, dated June 1, 1997.
1.52 "NDS" shall mean a New Drug Submission or a
Supplemental New Drug Submission, as defined by regulations promulgated by
Health Canada, or any other application for Regulatory Approval in the Territory
that is the equivalent of a BLA.
1.53 "NET SALES" shall mean the gross amounts invoiced for
sales of the Product in the Territory by GSK Canada or its Affiliates or
sublicensees, as appropriate, to Third Parties, less the following items: (a)
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; (b) 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 or
health care organizations; (c) any Tax levied on the sale, transportation or
delivery of the Product and borne by the seller thereof; (d) payments or rebates
paid in connection with sales of the Product to any governmental or regulatory
authority in respect of any medical insurance funded by a state, provincial or
federal government; and (e) any charge for freight, insurance or other
transportation costs charged to the customer. For clarity, Net Sales
7.
shall not include sales of the Product by and between GSK Canada and its
Affiliates or sublicensees (except where such Affiliates or sublicensees are end
users).
1.54 "NORDION" shall mean MDS Nordion, a division of MDS
(Canada) Inc.
1.55 "NORDION AGREEMENTS" shall mean (a) the Bexxar Supply
Agreement between MDS (Canada) Inc., through its division, Nordion, and Xxxxxxx
Pharmaceutical and Corixa Corporation expected to be dated in June, 2003; and
(b) the Supply Agreement for I-131 between Xxxxxxx Pharmaceutical and Nordion
dated September 13, 2000.
1.56 "OTHER INVENTION" means any Invention that is not a
Product Invention.
1.57 "PACKAGED BULK DRUG SUBSTANCE" shall mean bulk
Tositumomab that is used solely in the manufacture of Iodine I 131 Tositumomab.
1.58 "PATENT" means (a) 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 (b) pending applications
for letters patent, including without limitation any continuation, division or
continuation-in-part thereof and any provisional applications.
1.59 "POTENTIAL LICENSED XXXX" shall mean a trademark that
has not been registered or applied for in the Territory and is set forth on
Exhibit D.
1.60 "PRODUCT" shall mean Tositumomab and Iodine I 131
Tositumomab, either (a) together or (b) individually for use in connection with
each other.
1.61 "PRODUCT INVENTION" means any Invention that pertains
to the Product or its development, manufacture, formulation or use.
1.62 "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 the Cold
Component and Hot Component determined in accordance with this Section 1.62, but
only to the extent that such quality assurance and quality control work is
required by FDA, Health Canada or other relevant regulatory authorities. QA/QC
Costs shall be computed consistent with Article 1.71 of the SB Agreement, and
shall include a reasonable allocation of Corixa's facility overhead, but shall
exclude any allocation of the costs of establishing or validating a facility or
any costs of excess capacity.
1.63 "QUALIFYING CLINICAL TRIAL" shall mean [*] in the [*]
on [*].
1.64 "QUALITY POLICY MANUAL" shall have the meaning set
forth in Section 4.11.
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8.
1.65 "REGULATORY APPROVAL" means any and all approvals
(including supplements, amendments, label expansions, pre- and post-approvals,
pricing and reimbursement approvals), licenses, registrations or authorizations
of any national, regional, state, provincial or local regulatory agency,
department, bureau, commission, council or other governmental entity, that are
necessary for the manufacture, distribution, use or sale of a product in a
regulatory jurisdiction.
1.66 "SB" shall mean SmithKline Xxxxxxx Corporation.
1.67 "SB AGREEMENT" shall mean the Collaboration Agreement
between Xxxxxxx Pharmaceutical and SB dated October 23, 1998, as amended by
letter agreements dated April 20, 2000, February 12, 2001, and October 18, 2001.
1.68 "SCHEDULED BATCH COMPLETION DATE" shall have the
meaning set forth in the Nordion Agreements. Corixa shall promptly inform GSK
Canada, in the same manner in which it informs SB, of any planned deviations
from the normal practice of [*] being the Scheduled Batch Completion Date for
therapeutic Iodine I 131 Tositumomab and [*] being the Scheduled Batch
Completion Date for diagnostic Iodine I 131 Tositumomab.
1.69 "SOLE OTHER INVENTIONS" means any and all Other
Inventions made, discovered or developed solely by one Party's employees,
agents, contractors (including clinical research organizations) or sublicensees
pursuant to work performed under the Agreement.
1.70 "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 for the
Product and all relevant written agreements between Corixa and a Third Party or
SB with respect to manufacture or supply of Tositumomab, Iodine I 131
Tositumomab or the Product, which specifications have been agreed upon by the
Parties in writing prior to the Effective Date, as may be modified from time to
time in accordance with the procedures set forth in the Quality Policy Manual.
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.
1.71 "STANDARD COST OF GOODS" shall mean the cost of Cold
Component, Hot Component, or Therapy and shall be computed using, unless
otherwise provided, United States generally accepted accounting principles.
Standard Cost of Goods shall include, without limitation, the following:
(a) payments made by Corixa to Third Parties in
respect to such Cold Component, Hot Component or Therapy, including, but not
limited to, the transfer price for such Cold Component, Hot Component or
Therapy, costs of conjugating Tositumomab with (131)Iodine, cancellation
payments, readiness payments and facilities charges owed to such Third Parties,
plus
(b) QA/QC Costs, plus
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9.
(c) 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 out-of-pocket costs of freight and
tariffs associated with transporting such Cold Component, Hot Component or
Therapy from the source of manufacture to the end user (or, in the case of Cold
Component, to GSK Canada's storage facility in Canada), inclusive of interim
points of delivery, but excluding (i) any such costs which are separately
invoiced to a customer, and (ii) the personnel expenses involved in the
management of supply chain logistics other than Corixa's cost of [*] FTE's in
materials management, but excluding
(e) depreciation, indirect costs other than
those specifically included, inventory holding costs other than those paid
directly to third parties, and the costs of inventory write-offs.
Standard Cost of Goods will be computed annually in accordance with the methods
described in Exhibit B unless Corixa and SB agree upon new methods for computing
"Cost of Goods" pursuant to the SB Agreement, in which case it shall be computed
in accordance with such new methods.
1.72 "TAXES" shall mean any present or future sales or
use, value added, ad valorem or similar amounts (including in particular Goods
and Services Tax, Harmonized Sales Tax and Quebec Sales Tax), stamp or other
taxes, customs, duties, levies, imposts, deductions, charges, fees,
withholdings, liabilities, restrictions or conditions of any nature whatsoever
now or hereafter imposed, levied, collected, assessed or withheld by any
jurisdiction, by any political subdivision thereof or therein or by any other
government or taxing authority of any kind, but excluding any tax payable on any
income or gain.
1.73 "TERRITORY" shall mean the country of Canada and all
provinces and territories thereof.
1.74 "THERAPY" shall mean two Cold Components and one Hot
Component for administration to a single patient, unless otherwise adjusted by
mutual agreement of the Parties.
1.75 "THIRD PARTY" means any entity other than (a) Corixa,
(b) GSK Canada or (c) an Affiliate of either of them.
1.76 "THIRD PARTY ROYALTIES" means all payments owed to
Third Parties as a result of agreements entered into by Corixa pursuant to
Section 2.6, including all agreements granting Corixa licenses to intellectual
property rights that the Parties were aware of on the Effective Date, but
excluding any agreements entered into by Corixa pursuant to Section 2.6 that
pertain to intellectual property rights that Corixa had actual knowledge on the
Effective Date would be infringed by the sale of the Product in the Territory by
GSK Canada or its sublicensee but which knowledge Corixa did not disclose to GSK
Canada.
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1.77 "TOSITUMOMAB" shall mean a therapeutic, prophylactic
or palliative product that (a) contains or comprises the IgG(2a) anti-CD20
murine monoclonal antibody that (i) was administered to patients in Corixa's
clinical trials with Protocol Nos. RIT-II-004 and CP-97-012 and (ii) has not
been conjugated with (131)Iodine or any other isotope, molecule, compound or
moiety, (b) is supplied as [*] mg/mL in [*]-mg and [*]-mg single-use vials and
(c) has been formulated with [*] and [*] (or another formulation agreed upon in
writing by the Parties). Except as otherwise specified in this Agreement,
Tositumomab shall mean only filled material.
2. LICENSES AND EXCLUSIVITY
2.1 LICENSES TO GSK CANADA
(a) PATENTS AND KNOW-HOW. Subject to the terms
and conditions of this Agreement, Corixa hereby grants GSK Canada an exclusive,
royalty-bearing license, under all Corixa Intellectual Property Rights (i) to
develop the Product in the Field in the Territory, (ii) to use and import the
Product in the Field in the Territory and (iii) to keep, offer for sale and sell
the Product in the Field in the Territory.
(b) TRADEMARKS. Subject to the terms and
conditions of this Agreement (including without limitation Article 8), Corixa
hereby grants GSK Canada an exclusive, royalty-bearing license, to use the
Licensed Marks in the Territory upon, or in relation to, the Product and the
Licensed Services.
(c) SUBLICENSING. GSK Canada may grant
sublicenses of the licenses set forth in Sections 2.1(a) and 2.1(b), except for
the license in Section 2.1(a)(i) (which license may not be sublicensed under any
conditions), if the following conditions are met:
(i) Initial Approval has already been
obtained;
(ii) GSK Canada provides Corixa with a
copy of the written sublicense agreement prior to execution and obtains Corixa's
written consent, which shall not be unreasonably withheld or delayed, to execute
such sublicense agreement;
(iii) GSK Canada may only grant a
sublicense of the licenses set forth in Section 2.1(a)(ii) and (iii) in
conjunction with the grant, to such sublicensee, of a sublicense of the license
set forth in Section 2.1(b);
(iv) GSK Canada may only grant a
sublicense of the license set forth in Section 2.1(b) in conjunction with the
grant, to such sublicensee, of a sublicense of the licenses set forth in Section
2.1(a)(ii) and (iii); and
(v) the written agreement contractually
obligates the sublicensee to abide by the applicable provisions of this
Agreement as if such sublicensee were GSK Canada and lists Corixa as a
third-party beneficiary of such sublicense agreement.
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11.
All sublicenses granted pursuant to this Section 2.1(c) shall terminate upon the
termination of this Agreement.
2.2 NEGATIVE COVENANT. GSK Canada covenants that it shall
not, nor shall it cause any Affiliate or sublicensee to, (a) knowingly use or
practice directly or indirectly, any Corixa Intellectual Property Rights or
Licensed Marks for any other purposes other than those expressly permitted by
this Agreement or (b) develop, use, import, keep, offer for sale or sell the
Product in any manner outside the scope of the licenses set forth in Section
2.1(a).
2.3 LICENSES TO CORIXA.
(a) MANUFACTURING. Subject to the terms and
conditions of this Agreement, GSK Canada hereby grants to Corixa a worldwide,
exclusive, royalty-free license (with the right to sublicense), under GSK Canada
Intellectual Property Rights, to make and have made Tositumomab, Iodine I 131
Tositumomab, the Product and products containing a IgG(2a) anti-CD20 murine
monoclonal antibody (whether or not it has been conjugated with (131)Iodine or
any other isotope, molecule, compound or moiety).
(b) COMMERCIALIZATION. Subject to the terms and
conditions of this Agreement, GSK Canada hereby grants to Corixa an exclusive,
royalty-free license (with the right to sublicense), under GSK Canada
Intellectual Property Rights, to develop, use, sell, offer for sale, and import,
solely in the Corixa Territory, Tositumomab, Iodine I 131 Tositumomab, the
Product and products containing a IgG(2a) anti-CD20 murine monoclonal antibody
(whether or not it has been conjugated with (131)Iodine or any other isotope,
molecule, compound or moiety).
2.4 NEGATIVE COVENANT. Corixa covenants that it shall
not, nor shall it cause or permit any Affiliate or sublicensee to, knowingly use
or practice directly or indirectly, any GSK Canada Intellectual Property Rights
for any other purposes other than those expressly permitted by this Agreement.
2.5 EXISTING THIRD PARTY LICENSES. GSK Canada
acknowledges and agrees to be bound by all provisions of the Xxxx-Xxxxxx
Agreements and Michigan Agreements and all amendments thereto (including,
without limitation, those provisions regarding royalty payments (as described in
greater detail in Section 6.4), insurance and indemnification), to the extent
that such provisions are applicable to activities performed in or for the
benefit of the Territory pursuant to this Agreement. The Parties agree that the
foregoing does not require GSK Canada to fulfill obligations arising under the
Xxxx-Xxxxxx Agreements and Michigan Agreements as a result of the activities,
for the benefit of the Corixa Territory, of Corixa or Corixa's other licensees,
or to be responsible or liable for any failure or breach by Corixa of any of its
obligations under any of those agreements, unless such failure or breach was due
to GSK Canada's action or inaction. Corixa shall provide GSK Canada with each
proposed amendment of the Xxxx-Xxxxxx Agreements or Michigan Agreements, and GSK
Canada shall have reasonable opportunity to comment on such proposed amendment
before it becomes effective.
2.6 NEW THIRD PARTY LICENSES.
(a) In the event that the Parties agree that one
or more licenses under intellectual property held by a Third Party are necessary
or desirable in order to assure that the
12.
activities contemplated by this Agreement do not infringe the intellectual
property rights of such Third Party, then Corixa shall use commercially
reasonable efforts to obtain such license(s) from such Third Party, with the
right to grant sublicense(s) to GSK Canada of the scope set forth in Section
2.1(a).
(b) If the payments owed under a license
described in Section 2.6(a) would be Third Party Royalties, then prior to
entering into the license agreement, Corixa shall obtain GSK Canada's consent to
the economic terms of such license, provided that such consent shall not be
unreasonably withheld or delayed. By giving such consent, GSK Canada
acknowledges and agrees to be bound by all provisions of such license agreement
(including, without limitation, those provisions regarding royalty payments (as
described in greater detail in Section 6.5), insurance and indemnification), to
the extent that such provisions are applicable to activities performed in or for
the benefit of the Territory pursuant to this Agreement. The Parties agree that
the foregoing does not require GSK Canada to fulfill obligations arising under
such license agreement as a result of the activities, for the benefit of the
Corixa Territory, of Corixa or Corixa's other licensees, or to be responsible or
liable for any failure or breach by Corixa of any of its obligations under any
of those agreements, unless such failure or breach was due to GSK Canada's
action or inaction. Allocation between the Parties of the amounts payable to
such Third Party on account of such license agreement shall be as set forth in
Section 6.5.
(c) If the payments owed under a license
described in Section 2.6(a) would not be Third Party Royalties, then Corixa need
not obtain GSK Canada's consent before entering into the license, and Corixa
shall be responsible for all payments owed under the license, provided that GSK
Canada timely and accurately provides all information requested by Corixa to
calculate and substantiate the amount of such payments.
2.7 EXCLUSIVITY. If GSK Canada or its Affiliate or
sublicensee files an NDS or other application for Regulatory Approval in the
Territory, to market an antibody directed at CD20 (other than the Product and
whether or not such antibody is conjugated to any isotope, molecule, compound or
moiety) for the same indication for which GSK Canada plans to seek, is seeking
or has received Regulatory Approval in the Territory for the Product, GSK Canada
shall immediately notify Corixa. Corixa may at any time thereafter, upon six
months prior written notice to GSK Canada, terminate this Agreement or convert
the licenses contained in Section 2.1 to nonexclusive. If GSK Canada fails to
notify Corixa immediately after the filing of such an NDS, Corixa may
nevertheless terminate this Agreement or convert the licenses contained in
Section 2.1 to nonexclusive, but the length of the prior notice period shall be
decreased by the amount of time of GSK Canada's delay in providing notification
to Corixa of such NDS filing.
2.8 RIGHT OF FIRST NEGOTIATION. If Corixa or any
Affiliate of Corixa that Corixa controls (as such term is defined in Section
1.1) develops a therapeutic antibody directed at CD20 (other than the Product
and whether or not such antibody is conjugated to any isotope, molecule,
compound or moiety) for the same indication for which GSK Canada plans to seek,
is seeking or has received Regulatory Approval in the Territory for the Product
and Corixa has the ability to grant a license to GSK Canada to develop and
market such antibody in the Territory for such indication, then Corixa shall, at
any time prior to the earlier of (a) Corixa's filing an NDS or other application
for Regulatory Approval in the Territory, to market such antibody for such
indication or (b) Corixa's granting to a Third Party a license to develop and
market in the
13.
Territory such antibody for such indication, offer GSK Canada the opportunity to
consider whether it wishes to acquire a license to develop and market in the
Territory such antibody for such indication as follows: Corixa shall provide to
GSK Canada under confidentiality such information and data as Corixa reasonably
determines is sufficient to enable GSK Canada to evaluate whether it wishes to
acquire such a license. GSK Canada shall have [*] days following receipt of such
information in which to inform Corixa in writing that it is interested in
acquiring such a license. Thereafter, the Parties shall negotiate in good faith
for [*] days on the terms of a license agreement. If GSK Canada fails to notify
Corixa of its interest or the Parties fail to execute a written license
agreement within the applicable period, then GSK Canada shall have no rights
with respect to such antibody, and Corixa shall have unrestricted rights
(without compensation to GSK Canada) to develop and market such antibody in the
Territory for any indication and to grant a Third Party a license to do so. The
right of first negotiation under this Section 2.8 shall expire upon the earlier
of (i) the end of the Initial Royalty Period and (ii) termination of this
Agreement.
2.9 CONVERSION TO DISTRIBUTORSHIP. If at any time during
the term of this Agreement, the Parties agree or GSK Canada decides and notifies
Corixa in writing that GSK Canada does not need any of the licenses granted by
Corixa in Section 2.1(a) to develop, use, import, offer for sale or sell the
Product in the Field in the Territory, this Agreement shall automatically
convert to an exclusive distribution agreement for the Territory in the Field.
GSK Canada shall nevertheless remain obligated to make all payments specified in
this Agreement, including without limitation the royalty payments set forth in
Sections 6.3, 6.4 and 6.5.
3. REGISTRATION AND MARKETING
3.1 OVERVIEW. GSK Canada shall be responsible for
carrying out all registration and marketing activities for the Product in the
Territory and for bearing all costs associated with such activities. As set
forth in greater detail in Section 3.10(b), Corixa shall provide, at GSK
Canada's expense, reasonable assistance to GSK Canada (a) in connection with
obtaining Initial Approval for the Product in the Territory, and (b) subject to
the availability of Corixa FTEs, in connection with any regulatory filings or
Regulatory Approvals for the Product in the Territory determined by GSK Canada
to be necessary or desirable following the obtaining of Initial Approval.
3.2 JOINT MARKETING COMMITTEE (JMC)
(a) PURPOSE; FORMATION. Within thirty (30) days
after the Effective Date, the Parties will appoint their respective
representatives to a committee to oversee, coordinate and provide strategic
direction to the commercialization of the Product for and in the Territory and
to approve the plans, budgets and resource allocations for such activities (the
"Joint Marketing Committee" or "JMC"). The JMC may discuss regulatory matters as
they come up from time to time.
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(b) MEMBERSHIP. Corixa and GSK Canada shall each
initially appoint two (2) representatives to the JMC. GSK Canada's initial JMC
representatives shall be [*] and [*]; Corixa's initial JMC representatives shall
be [*] and [*]. The JMC may change its size from time to time by mutual consent
of its members; provided that the JMC shall at all times consist of an equal
number of representatives of each of Corixa and GSK Canada. Corixa and GSK
Canada may each replace its JMC representatives at any time upon written notice
to the other Party. At least one (1) of each Party's representatives on the JMC
will have the title of Vice-President (or a comparable position) or above for
such Party. The JMC may invite nonmembers to participate in the discussions and
meetings of the JMC, provided that such participants shall have no voting
authority at the JMC.
(c) CHAIRPERSON. GSK Canada shall name, from
among its JMC representatives, a chairperson of the JMC. The chairperson shall
be responsible for administering JMC meetings but shall have no additional
powers or rights beyond those held by the other representatives on the JMC. The
chairperson will be responsible for preparing minutes of JMC meetings, which
shall be circulated for review and approval by all members within thirty (30)
days after each meeting.
(d) DECISION-MAKING. The JMC shall act by
unanimous vote, with each Party having one (1) vote. The Parties shall engage in
good faith discussions to reach agreement on all issues presented. If the JMC
becomes deadlocked on an issue, then [*] shall be the decision maker on all
issues relating to [*], and [*] or [*], and any Party may refer the matter for
dispute resolution pursuant to Section 13.1 by written notice to the other
Parties if the issue is related to any other subject. Notwithstanding the
foregoing, (i) [*] shall not have the authority to make any deadlock-ending
decisions with respect to [*], and (ii) if the JMC becomes deadlocked on any
issue that affects [*] shall not be the decision maker with respect to such
issue and either Corixa or GSK Canada may refer the matter for dispute
resolution pursuant to Section 13.1 by written notice to the other Party.
(e) MEETINGS. The JMC shall meet at least once
per calendar quarter throughout the term of this Agreement, unless the Parties
mutually agree in writing to a different frequency or to disband the JMC. Any
member of the JMC may call a special meeting of the JMC from time to time to
address issues in connection with which a decision or review is reasonably
required prior to the next regularly scheduled JMC meeting. The JMC will meet at
locations alternately selected by Corixa and by GSK Canada. The JMC may meet by
video or audio conference. Meetings of the JMC will be effective only if a
representative of each Party is present or participating. Each Party shall bear
all expenses it incurs in regard to participating in JMC meetings, including all
travel and living expenses.
(f) SPECIFIC RESPONSIBILITIES OF THE JMC. In
addition to its general responsibility to oversee, monitor, review, coordinate
and provide strategic direction to the commercialization of the Product for and
in the Territory, the JMC shall in particular:
(i) review, coordinate and approve all
plans for marketing activities with respect to the Product in or for the
Territory;
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(ii) facilitate the flow of information
between the Parties with respect to such activities for the Product in the
Territory;
(iii) oversee the activities of GSK
Canada in marketing, selling and distributing the Product in the Territory,
including pre-launch and post-launch activities;
(iv) review and comment on the Marketing
Plan and all updates thereto, as provided in Section 3.5;
(v) monitor GSK Canada's compliance
with the Marketing Plan; and
(vi) perform any other functions set
forth for the JMC in this Agreement.
(g) LIMITED AUTHORITY. The JMC shall have no
authority to amend this Agreement.
3.3 SUBTEAMS FROM SB AGREEMENT. The Joint Finance Subteam
and the Joint Manufacture and Supply Chain Subteam established by SB and Corixa
pursuant to the SB Agreement may periodically provide information to the JMC to
help it coordinate the activities of the Parties and SB and optimize the
implementation of this Agreement. Such subteams shall not have any
decision-making authority with respect to this Agreement.
3.4 DILIGENCE.
(a) GENERAL REQUIREMENT. GSK Canada shall use
Diligent Efforts to: (i) obtain Regulatory Approval of the Product in the
Territory, (ii) obtain reimbursement, promote, market and sell the Product in
the Territory, and (iii) carry out the tasks set forth in the Marketing Plan at
the times specified therein.
(b) SPECIFIC ACTIONS. In partial fulfillment of
the diligence obligations set forth in Section 3.4(a), GSK Canada shall perform
the following actions by the dates specified herein, subject to Section 3.4(c):
(i) [*] by [*];
(ii) [*]; and
(iii) [*]
(c) The Parties acknowledge and agree that,
while failure to perform the actions set forth in Section 3.4(b) by the
specified dates shall constitute a material breach of the diligence obligations
set forth in Section 3.4(a), performance of such actions by such dates shall not
be sufficient to fulfill such diligence obligations in their entirety. If GSK
Canada fails to perform one or more actions set forth in Section 3.4(b) by the
date(s) specified therefor in
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Section 3.4(b), Corixa may terminate this Agreement pursuant to Section 10.3
unless (i) such failure was due to a Force Majeure event, in which case GSK
Canada shall be entitled to an extension of time equal to the duration of such
Force Majeure event; or (ii) such failure was due to Corixa's (1) failure to
review and approve the plans and protocols in respect of the Clinical Trial in a
timely manner pursuant to Section 3.7(a) or (2) material breach of its
obligations under Section 3.10(b), in which case GSK Canada shall be entitled to
an extension of time equal to the delay attributable to such failure or breach.
Corixa shall be presumed to have fulfilled its obligations under Sections 3.7(a)
and 3.10(b), if Corixa provides or has provided, pursuant to and in accordance
with the terms of this Agreement and/or the LOI, [*] or more to GSK Canada for
assistance in matters specified therein. For the purposes of Section 3.4(b)(ii),
a Force Majeure event shall include delays in obtaining Initial Approval due to
Health Canada's action or inaction, provided that such delays are outside of GSK
Canada's control and not attributable to GSK Canada's action or inaction
(including, without limitation, (A) delay or errors in filing of documents
necessary to obtain Initial Approval, (B) delay or errors in responding to
inquiries or requests from Health Canada, or (C) insufficiency of data or
responses provided to Health Canada). For the purposes of Section 3.4(b)(iii), a
Force Majeure event shall include supply Product limitations outside of GSK
Canada's control but shall not include supply limitations arising from GSK
Canada's failure to forecast or order sufficient amounts of Product.
3.5 MARKETING PLAN. GSK Canada shall submit a proposed
Marketing Plan to the JMC by the later of (a) [*] and (b) [*] after filing the
NDS for the Product in the Territory. Prior to such submission, GSK Canada shall
use reasonable efforts to keep the JMC informed of its marketing plans for the
Product in the Territory. The JMC may suggest revisions to the Marketing Plan or
any updated Marketing Plan and GSK Canada shall consider in good faith the JMC's
proposed revisions to such Marketing Plan and incorporate those that are
commercially reasonable. GSK Canada shall update the Marketing Plan each time it
obtains a new Regulatory Approval for the Product in the Territory and no less
often than once a year.
3.6 TRANSFER OF PRE-EXISTING DATA. All preclinical and
clinical data relating to the Product that were provided to GSK Canada pursuant
to the LOI are the Confidential Information of Corixa, and GSK Canada may use
such data solely for the purpose of obtaining Regulatory Approval of or
marketing the Product in the Territory. Corixa shall also make reasonable
efforts to arrange for GSK Canada to have a right of cross reference on all
regulatory filings in the Corixa Territory, made prior to the Effective Date and
by Corixa, that include data from a Clinical Trial initiated prior to the
Effective Date, provided that Corixa shall not be obligated to make any payments
to its licensees or corporate partners in the Corixa Territory to fulfill such
obligation. If such efforts are successful, GSK Canada shall have the right to
use, solely for the purpose of obtaining Regulatory Approval of or marketing the
Product in the Territory, any data generated or created in relation to or as a
result of such regulatory filings.
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3.7 CLINICAL TRIALS SOLELY IN THE TERRITORY.
(a) RESPONSIBILITIES.
(i) GSK CANADA. GSK Canada shall be
responsible for planning, deciding whether or not to perform, and performing all
Clinical Trials conducted solely in the Territory that are initiated after the
Effective Date and shall bear all expenses associated with such activities. GSK
Canada shall conduct such Clinical Trials in accordance with GCP and any other
applicable requirements for clinical trial activities under the laws, rules or
regulations of the Territory.
(ii) QUALIFYING CLINICAL TRIAL.
(1) As of the Effective Date,
GSK Canada is considering conducting a Qualifying Clinical Trial. Subject to
Section 3.9(b), if GSK Canada plans or conducts a Qualifying Clinical Trial at a
time when Corixa [*] planning or conducting the Corixa Post-Approval Trial, GSK
Canada shall ensure that the [*]. The Parties shall [*], via the JMC, to [*]
with the understanding that Corixa [*], with respect to issues concerning the
Corixa Post-Approval Trial. If Corixa performs training on behalf of GSK Canada
with respect to a Qualifying Clinical Trial, then GSK Canada shall reimburse
Corixa, within thirty (30) day of Corixa's invoice, for all out-of-pocket and
personnel expenses (which personnel expenses shall be calculated at the Annual
Clinical FTE Rate) incurred in connection with providing such training.
(2) At least forty-five (45)
days before the planned start date of a Qualifying Clinical Trial, GSK Canada
shall submit to Corixa the concept protocol, protocol timelines and proposed
clinical sites for such Clinical Trial that GSK Canada circulates internally in
accordance with its then current approval requirements for a clinical trial.
Such concept protocol shall include the following sections: rationale,
objective(s), endpoint(s), study design, dose rationale, study population, study
assessments and procedures, data analysis and statistical considerations, and
data management. Corixa shall review such concept protocol within fifteen (15)
days. GSK Canada shall also submit to Corixa the full protocol for such
Qualifying Clinical Trial. Corixa shall review such full protocol within fifteen
(15) days. GSK Canada shall not initiate any Qualifying Clinical Trial before it
receives Corixa's written approval which shall not be unreasonably withheld or
delayed, of the concept protocol as well as the full protocol for such
Qualifying Clinical Trial. GSK Canada shall not be required to reimburse Corixa
for expenses Corixa incurs in connection with its review of the concept protocol
and full protocol pursuant to this Section 3.7(a)(ii)(2).
(iii) OTHER CLINICAL TRIALS. With respect
to each Clinical Trial to be conducted solely in the Territory and that is not a
Qualifying Clinical Trial, GSK Canada shall submit the protocols for such
Clinical Trial at least sixty (60) days before GSK Canada intends to initiate
such Clinical Trial. Corixa shall review such protocols in a timely manner. GSK
Canada shall not initiate such Clinical Trial before it receives Corixa's
written approval, which shall not be unreasonably withheld or delayed, of such
protocols for such Clinical Trial.
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GSK Canada shall not be required to reimburse Corixa for expenses Corixa incurs
in connection with its review of such Clinical Trial protocols for approval
purposes.
(iv) ADVICE FROM CORIXA. GSK Canada may
seek Corixa's advice and assistance regarding the conduct of Clinical Trials
solely in the Territory, including the transfer of any necessary documents and
information. Corixa shall provide in a timely manner, and, subject to Corixa's
reasonable availability, in no event later than 15 business days from the date
of Corixa's receipt of such request, all such advice and assistance that is
reasonably requested by GSK Canada for provision in such timeframe, and GSK
Canada shall reimburse Corixa, within thirty (30) day of Corixa's invoice, for
all out-of-pocket and personnel expenses (which personnel expenses shall be
calculated at the Annual Clinical FTE Rate) incurred in connection with
providing such advice and assistance, including advice and assistance provided
at GSK Canada's request following Corixa's rejection of Clinical Trial protocols
submitted by GSK Canada for Corixa's approval.
(b) ACCESS TO DATA. Within thirty (30) days
after the beginning of each calendar quarter during the term of this Agreement,
GSK Canada shall provide Corixa with copies of all analyzed data in GSK Canada's
possession at such time that were analyzed during the preceding calendar quarter
and were generated or analyzed (i) as a result of any Clinical Trial conducted
by GSK Canada solely in the Territory or (ii) in relation to or as a result of a
regulatory filing for the Product in the Territory. Corixa may publish or
otherwise publicly disclose such data only after the primary analysis and
underlying data have been reviewed and released by GSK Canada. Subject to the
foregoing and the nondisclosure obligations of Section 9.1, Corixa may
nevertheless use such data at any time for any purpose relating to the Product
in the Corixa Territory. GSK Canada shall arrange for Corixa to have a right of
cross reference on all regulatory filings in the Territory made by or on behalf
of GSK Canada that include data from any Clinical Trial conducted by GSK Canada
solely in the Territory.
3.8 CLINICAL TRIALS SOLELY IN THE CORIXA TERRITORY.
Corixa shall provide written notice to GSK Canada regarding the existence of any
Clinical Trial that is initiated after the Effective Date and conducted solely
in the Corixa Territory. In the event that GSK Canada desires to participate
financially in such a Clinical Trial that is being conducted solely by Corixa,
then Corixa shall in good faith attempt to permit GSK Canada to do so on
commercially reasonable terms. In the event that GSK Canada desires to
participate financially in such a Clinical Trial that is being conducted, in
whole or in part, by another licensee of Corixa, then Corixa shall in good faith
attempt to permit GSK Canada to do so on the terms that Corixa is subject to,
with respect to the Territory, as a result of its agreements with such licensee.
In the event that GSK Canada requires the data from any such Clinical Trial to
assist in obtaining the Initial Approval for the Product in the Territory, GSK
Canada shall provide written notice of such desire to Corixa and Corixa shall
make reasonable efforts to arrange for GSK Canada to have a right of cross
reference on all regulatory filings in the Corixa Territory made by Corixa that
include data from such Clinical Trial, provided that Corixa shall not be
obligated to make any payments to its licensees or corporate partners in the
Corixa Territory or to breach any confidentiality obligations to such licensees
or corporate partners, to fulfill such obligation. Such reasonable efforts shall
include, where applicable, requesting permission from such licensee or corporate
partner in the Corixa Territory to grant such right of cross reference.
19.
3.9 CROSS-TERRITORY CLINICAL TRIALS.
(a) If either Corixa or GSK Canada desires to
conduct a Cross-Territory Clinical Trial, the Parties shall discuss this
possibility. GSK Canada acknowledges that Corixa cannot conduct a Clinical Trial
in the United States without the consent of SB or a Clinical Trial in Europe
without the consent of Amersham PLC. Subject to Section 3.9(b), in the event
that the Parties do not agree, neither Corixa nor GSK Canada shall have the
right to conduct a Clinical Trial in each other's Territory. If the Parties
agree to carry out a Cross-Territory Clinical Trial, the Parties shall give
first consideration to using in such Cross-Territory Clinical Trial sites in the
Territory that are identified by GSK Canada as long as such sites reasonably
meet Corixa's standards for Clinical Trial sites. However, GSK Canada
acknowledges that Corixa does not have sole control over the selection of sites
for any Cross-Territory Clinical Trial that involves a country in the Corixa
Territory in which Corixa has a licensee or corporate partner.
(b) (i) As of the Effective Date, [*] and
[*] are [*] pursuant to the [*] that [*] shall [*] with a copy of the [*] that
are, as of the Effective Date, [*]. Unless [*] otherwise and GSK Canada agrees,
(1) [*] will [*] for [*] and (2) [*] will [*], subject to Section 3.9(b)(iv).
(ii) Corixa acknowledges GSK Canada's
[*] the planned Corixa Post-Approval Trial, including the [*], the planned [*],
and GSK Canada's [*] Qualifying Clinical Trial referred to in Section 3.7(a)(ii)
and [*], for purposes of Section 3.9(a) hereof, GSK Canada agrees to [*] which
are authorized by the [*] established pursuant to the [*] or which, with the
authorization of the [*], are made by Corixa pursuant to discussions with the
FDA. Subject to Section 3.9(b)(i), during the [*], Corixa shall [*].
(iii) Corixa Regulatory and GSK Canada
Regulatory representatives shall discuss with Health Canada the requirements of
[*] The Parties shall agree on the optimal process in respect of the filing and
communications with [*] in accordance with such requirements relating to the [*]
At the request of either Party, GSK Canada or Corixa shall provide reasonable
assistance to the other Party with respect to [*], which may include the
requirement to [*].
(iv) In the event that as a result of
the conduct of the [*], the Clinical Development Department of GSK Canada
determines that [*] in effect on the Effective Date for the [*] and the
associated tasks required to [*]. Notwithstanding the foregoing, except as
required by the [*] arising from or related to the [*] unless the Parties first
agree in writing upon [*].
(v) The Parties acknowledge that,
notwithstanding the foregoing, it is possible that GSK Canada may be performing
the Qualifying Clinical Trial [*] In such case, both Parties shall operate
through the JMC to define the optimal processes intended to [*]
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3.10 REGULATORY FILINGS IN THE TERRITORY.
(a) GSK CANADA'S RESPONSIBILITIES. GSK Canada
shall at its own expense prepare, file and prosecute in its name all relevant
regulatory filings for Products in the Territory. GSK Canada shall also be the
holder of the NDSs, DINs, DELs and other applicable regulatory filings and
approval documents for the Product in the Territory, and will at its own
expense, be responsible for all administrative matters necessary to compile and
submit the NDSs and other applicable regulatory filings for the Product in the
Territory. GSK Canada shall also be responsible for maintaining the NDSs, DINs,
DELs and other applicable regulatory filings and approval documents and will
bear the registration renewal fees for the NDSs, DINs, DELs and other applicable
regulatory filings and approval documents of the Product in the Territory. GSK
Canada will keep Corixa informed of its regulatory activities regarding the
Product in the Territory on an ongoing and timely basis not less than once each
calendar quarter, unless no regulatory activities were conducted in the quarter.
In addition, GSK Canada shall provide Corixa with drafts of all regulatory
filings, including NDSs and other applicable regulatory filings, at least 60
days before they are filed except for: (i) the NDS prepared pursuant to the LOI,
which GSK Canada shall provide to Corixa in installments as soon as practically
possible and with a reasonable time to review, and (ii) any regulatory filing
that is in response to an inquiry from Health Canada and for which the response
deadline is less than 90 days after such inquiry, in which case GSK Canada shall
provide the draft regulatory filing to Corixa a reasonable time in advance of
filing. Corixa shall have the right to comment thereon, provided that it does so
within the response deadline, and GSK Canada shall revise the draft before
filing to implement all reasonable Corixa comments.
(b) CORIXA'S RESPONSIBILITIES. In order to
assist GSK Canada's performance of the obligations set forth in Section 3.10(a),
Corixa shall, in a diligent and timely manner, provide up to [*], including FTEs
provided pursuant to the LOI, to:
(i) review with GSK Canada the BLA for
the Product in the United States;
(ii) advise GSK Canada regarding its
strategy and action plan for obtaining Initial Approval;
(iii) review and provide GSK Canada with
comments upon all draft regulatory filings provided by GSK Canada in accordance
with Section 3.10(a);
(iv) participate in the preparation of
timely responses to questions posed by Health Canada regarding regulatory
filings for the Product in the Territory; and
(v) subject to the availability of
Corixa FTEs, provide any additional advice and assistance reasonably requested
by GSK Canada regarding obtaining Regulatory Approval for the Product in the
Territory or making any regulatory filing with respect to the Product in the
Territory.
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The foregoing obligations shall be waived to the extent that Corixa performed
them pursuant to the LOI. If a greater number of FTEs is required to complete
the tasks described above, then Corixa shall use reasonable efforts to provide
them. GSK Canada shall reimburse Corixa for all reasonable out-of-pocket and
personnel expenses (which personnel expenses shall be calculated at the Annual
Clinical FTE Rate) incurred in connection with providing services described in
this Section 3.10(b) within thirty (30) days of receipt of an invoice from
Corixa. Corixa shall provide such invoices on a monthly basis (if there is a
payment due).
(c) COMMUNICATIONS WITH REGULATORY AUTHORITIES.
From and after the Effective Date, Corixa shall promptly, and in any event,
within 30 days of receipt or mailing, as the case may be, provide to GSK Canada
copies of all (i) material correspondence, including a copy of the Annual Report
to the FDA, between Corixa and the FDA or any other applicable regulatory
authority relating to the Product in the United States, and (ii) material
regulatory correspondence regarding regulatory warning letters, the withdrawal
or possible withdrawal of the Product in the United States, or otherwise bearing
on or relating to the safety and efficacy of the Product in the United States.
3.11 REPORTING. GSK Canada shall prepare and provide to
Corixa written reports within thirty (30) days following the end of each
calendar quarter summarizing the work done by GSK Canada and its sublicensees
pursuant to this Agreement, including with respect to obtaining Regulatory
Approval of the Product in the Territory (which shall be done only by GSK
Canada) and under the Marketing Plan (which shall be done by GSK Canada and/or
its sublicensee), as applicable. Between such reports, GSK Canada shall keep
Corixa reasonably informed of material developments relating to the activities
performed by GSK Canada and its sublicensees hereunder, especially as to the
Regulatory Approval of the Product in the Territory. In addition, GSK Canada
shall inform Corixa in writing and in advance of implementation, of any
decisions that GSK Canada ought reasonably to be expected to know that may
significantly impact any part of the Corixa Territory for the Product.
3.12 RECORDS. GSK Canada and its sublicensees shall
maintain complete and accurate records of all work conducted under this
Agreement and all results, data and developments made pursuant to its efforts
under this Agreement. Such records shall fully and properly reflect all work
done and results achieved in the performance of this Agreement in sufficient
detail and in good scientific manner appropriate for patent and regulatory
purposes. Corixa shall have the right to review and copy, at Corixa's expense,
such records at reasonable times to the extent necessary for Corixa to monitor
GSK Canada's and its sublicensees' performance of its obligations under this
Agreement.
3.13 PRICING. GSK Canada shall be responsible for [*]
approval for the Product with the Patented Medicines Prices Review Board (the
"PMPRB"), in accordance with PMPRB guidelines. GSK Canada shall keep Corixa
informed regarding its pricing strategy and discussions with the PMPRB. At the
request of GSK Canada, Corixa shall reasonably provide GSK Canada with pricing
information in Corixa's possession or otherwise readily available to Corixa that
is required by the PMPRB with respect to the Product in one or more countries of
the Corixa Territory. After obtaining pricing approval from the PMPRB, the JMC
shall determine,
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and revise from time to time if necessary, the price at which GSK Canada will
sell the Product in the Territory.
3.14 REIMBURSEMENT. GSK Canada shall be responsible for
obtaining reimbursements in the Territory from public and private payors.
3.15 COMPLIANCE. GSK Canada shall comply with all
applicable laws, statutes, regulations, orders and health registration laws of
any government entity in the Territory and with all other governmental and
administrative requirements, policies and rules relating to the development,
regulatory registration, importation, storage, distribution and marketing of the
Product in the Territory.
4. MANUFACTURING AND SUPPLY OF THERAPIES.
4.1 GENERAL UNDERSTANDING.
(a) EXISTING SUPPLY AGREEMENTS. Pursuant to the
BI Pharma Agreements, McKesson Agreement, and Nordion Agreements (the "Existing
Supply Agreements"), Corixa has the ability to have Tositumomab and Iodine I 131
Tositumomab manufactured, stored and supplied to it and its licensees. Under
this Agreement, Corixa will provide Therapies to GSK Canada for GSK Canada's use
in the Territory in accordance with the terms of this Agreement. GSK Canada
acknowledges and understands that Corixa's ability to supply Therapies to GSK
Canada under this Agreement is limited by the BI Pharma Agreements, the McKesson
Agreement, and the Nordion Agreements and Corixa's agreements with other
suppliers and other licensees, including SB and Amersham PLC. Except to the
extent that Section 4.3, 4.5 or 4.7 specifically requires GSK Canada to deal
directly with Corixa rather than BI Pharma, Nordion or McKesson, GSK Canada
hereby agrees to comply with all provisions of the Existing Supply Agreements
(including any amendments thereof entered into in accordance with Section
4.1(b)) and all other agreements with Corixa suppliers as may exist in the
future (and are entered into in accordance with Section 4.1(b)), to the extent
that such provisions are applicable to Products intended for use in the
Territory. The Parties agree that the foregoing does not require GSK Canada to
fulfill obligations arising under such agreements as a result of the
manufacture, storage or distribution of Products intended for use in the Corixa
Territory.
(b) NEW SUPPLY AGREEMENTS. Corixa shall notify
GSK Canada in writing prior to entering, during the term of this Agreement, into
any new supply agreement(s) relevant to the manufacture, storage or distribution
of Products intended for use in the Territory or amending any Existing Supply
Agreement in a manner that alters the manufacture, storage or distribution of
Products intended for use in the Territory. Corixa shall provide GSK Canada with
a reasonable time, after such notification, to review and comment upon any such
supply agreement(s) or amendment(s), and Corixa shall make reasonable efforts to
implement all reasonable GSK Canada comments, provided that such comments do not
benefit GSK Canada at the expense of Corixa or any of Corixa's licensees or
corporate partners in the Corixa Territory. Following the execution of any such
new supply agreement(s) or amendment(s) of any Existing Supply Agreement, the
Parties shall amend this Agreement as necessary to make it consistent with the
applicable terms of such supply agreement(s) or amendment(s). GSK Canada may
terminate this Agreement, pursuant to Section 10.5(a), if it is materially
adversely affected by the
23.
terms of any such new supply agreement(s) or amendment(s) or the corresponding
amendment of this Agreement.
(c) [*] AGREEMENTS. During that portion of the
term of this Agreement that the SB Agreement remains in force, Corixa and SB
shall include GSK Canada in discussions regarding [*] for the United States (and
possibly Canada) from [*] For clarity, the previous sentence does not confer
upon GSK Canada [*]
4.2 REQUIREMENTS CONTRACT. Except as set forth in
Sections 4.3(e), 4.3(f) and 4.16, and subject to GSK Canada's compliance with
the forecasting and ordering obligations for Tositumomab and Iodine I 131
Tositumomab outlined in Sections 4.3(b), 4.3(c) and 4.3(d) and GSK Canada's
compliance with the material terms and conditions of this Agreement, Corixa
shall have manufactured and supply to GSK Canada all of its requirements in the
Territory for Therapies in accordance with the Existing Supply Agreements.
Corixa shall not be considered in breach of the foregoing obligation in the
event that there are delays or interruptions in the manufacture or supply of
Therapies or portions thereof, that are attributable to Third Parties. GSK
Canada shall pay for such Therapies and any excess Tositumomab and Packaged Bulk
Drug Substance ordered by it as set forth in Sections 6.7 and 6.8, respectively.
GSK Canada shall obtain from Corixa all of GSK Canada's requirements for
Therapies in the Territory, whether for development, marketing or commercial
sale. GSK Canada acknowledges that the supply of Therapies may be subject to
delays or interruptions due to suspended production during periods of scheduled
maintenance of Nordion facilities in accordance with Section 4.6 of the Bexxar
Supply Agreement expected to be dated in June, 2003. Corixa shall notify GSK
Canada regarding the dates of such scheduled maintenance promptly after Corixa
receives such information from Nordion.
4.3 FORECASTS AND ORDERING.
(a) ANTICIPATED NUMBER OF THERAPIES. Corixa
anticipates being able to provide GSK Canada with up to the number of Therapies
set forth below in the specified calendar years:
Calendar Year Maximum Number of Therapies
------------- ---------------------------
2003 [*]
2004 [*]
2005 [*]
The foregoing estimates are based on the assumption that the percentage of
patients requiring a second vial of Iodine I 131 Tositumomab will not exceed [*]
If Corixa becomes able to supply more than the specified number of Therapies in
any one or more of the calendar years 2003, 2004 or 2005, then Corixa will
provide to GSK Canada whatever number of additional Therapies the Parties agree
upon. If the Parties fail to agree, then Corixa will provide to GSK Canada [*]
of the additional Therapies. GSK Canada shall include
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such Corixa additional Therapies in the forecasts it supplies pursuant to
Sections 4.3(b), 4.3(c) and 4.3(d).
(b) SUPPLY FROM BI PHARMA.
(i) No later than the [*] day of the
[*] month of each [*], GSK Canada shall furnish to Corixa, directly or via SB, a
written rolling [*] forecast of GSK Canada's anticipated purchases of Therapies
for the Territory which shall be consistent with the terms and conditions of the
BI Pharma Agreements (the "BI Pharma Forecast"). The BI Pharma Forecast may be
part of the forecast for the same time period that SB provides to Corixa
pursuant to the SB Agreement, provided that such forecast is received by Corixa
by the date specified in the previous sentence and further provided that the
Therapies that GSK Canada intends to purchase will be separately identified in
such forecast. Each BI Pharma Forecast shall cover a [*] forecast period
starting the [*] day of the [*] after the [*] in which GSK Canada provided such
BI Pharma Forecast to Corixa. By way of example, the BI Pharma Forecast which
GSK Canada provides by [*] shall cover the period from [*] until [*], and the BI
Pharma Forecast which GSK Canada provides by [*] shall cover the period from [*]
until [*]. The BI Pharma Forecasts shall be submitted to Corixa in the format
agreed upon by the Parties prior to the Effective Date (which format may be
amended by Corixa during the term of this Agreement), and shall be consistent
with the then-current manufacturing schedule of BI Pharma1. Such forecasts shall
not call for supply of more than the maximum number of Therapies stated in
Section 4.3(a) for calendar years 2003, 2004 and 2005. GSK Canada shall be
obligated to purchase from Corixa those portions of the BI Pharma Forecast that
are binding under the BI Pharma Agreements. The payment terms for such purchases
are set forth in Article 6 of this Agreement. Shortfalls shall be handled as set
forth in Section 4.16.
(ii) In the event either Corixa or GSK
Canada desires to reduce the size of an order previously placed with BI Pharma
for delivery within [*] months of such order, the percentage by which such order
may be reduced under the BI Pharma Agreements 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 BI Pharma Agreements permit a reduction in orders of up
to [*] for orders with delivery dates during a specified time period in the
future, and the Parties desire to reduce the order for that time period in the
Territory by [*] and the Corixa Territory by [*] then the reduction for the
Territory shall be limited to [*] while the order for the Corixa Territory is
reduced by the full [*] 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 order for the Territory.
(iii) If under the BI Pharma Agreements,
Corixa is obligated to take quantities of Tositumomab produced in excess of the
total amount originally ordered by GSK Canada, Corixa and Corixa's other
licensees and corporate partners (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
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(1) As of the Effective Date, BI Pharma manufactures Tositumomab and Packaged
Bulk Drug Substance [*] and delivers these items to McKesson and/or Nordion in
approximately [*].
25.
be allocated as between the Territory and the Corixa Territory [*] on the basis
of the [*] for delivery to each territory in [*].
(c) SUPPLY FROM NORDION.
(i) No later than [*] prior to the
commencement of each [*] during the term of this Agreement, GSK Canada shall
furnish to Corixa a written rolling [*] forecast of its anticipated purchase of
Therapies for the Territory which shall be consistent with the terms and
conditions of the Nordion Agreements (the "Nordion [*] Projection"). Such
estimate is non-binding and for planning purposes only in order to allow Corixa
to provide to Nordion GSK Canada's forecast, to ensure Nordion has all the
materials necessary to manufacture Iodine I 131 Tositumomab, including, without
limitation, enough available Isotope (as defined in the Nordion Agreements).
Each Nordion [*] Projection shall cover a [*] forecast period starting the [*]
day of the [*] after the [*] in which GSK Canada provided such Nordion [*]
Projection to Corixa. By way of example, the Nordion [*] Projection which GSK
Canada provides by [*] shall cover the period from [*] until [*]. The Nordion
[*] Projections shall be submitted to Corixa in the format provided by Corixa by
[*] (or any substitute format subsequently provided by Corixa). The number of
Therapies called for in each Nordion [*] Projection shall not exceed the number
of Therapies specified in the portion of the most recent BI Pharma Forecast that
pertains to the forecast period, unless permitted by Corixa on account of the
existence of excess GSK Canada-earmarked Tositumomab and Packaged Bulk Drug
Substance at McKesson and/or Nordion (as a result of previous Nordion [*]
Projections calling for fewer Therapies than the corresponding BI Pharma
Forecasts).
(ii) During the period up to the [*]
anniversary of commencement of Commercial Supply (as defined in the Nordion
Agreements), GSK Canada shall provide Corixa [*] prior to the [*] of each [*]
with a written forecast of GSK Canada's requirements (the "Forecast") for Iodine
I 131 Tositumomab for the [*] period commencing on such [*], as applicable, (the
"Forecast Period"). The Forecast shall include the type of label to be used and
shall set out Scheduled Batch Completion Dates. The first [*] of Scheduled Batch
Completion Dates provided by GSK Canada in each Forecast shall be binding (the
"Pre-Commercialization Firm Order"). The number of Therapies called for in each
Forecast shall not exceed the number of Therapies specified in the portion of
the most recent Nordion [*] Projection that pertains to the Forecast Period. For
each [*] that is [*] of the Forecast Period for a particular Forecast (the "Firm
Order"), if such Forecast specified that GSK Canada intended to purchase a
number of Therapies (which number shall not be less than [*]) for such week and
GSK Canada subsequently decides, prior to the placement of an order pursuant to
Section 4.3(c)(v) for such period, not to purchase any Therapies for such week,
then GSK Canada shall pay Corixa a cancellation fee equal to [*] of any
cancellation fee imposed upon Corixa pursuant to Section 9.2 of the Nordion
Agreements. GSK Canada shall pay such fee within thirty (30) days of Corixa's
invoice therefor.
(iii) During the period commencing after
the [*] anniversary of Commercial Supply, GSK Canada shall provide Corixa [*]
prior to the [*] with a written forecast of GSK Canada's requirements (the
"Commercial Forecast") for Iodine I 131 Tositumomab for
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the [*] period commencing on such [*] (the "Commercial Forecast Period"). The
Commercial Forecast shall include the type of label to be used and shall set out
Scheduled Batch Completion Dates. The [*] of Scheduled Batch Completion Dates in
each Commercial Forecast shall be binding (the "Post-Commercialization Firm
Order"). The number of Therapies called for in each Commercial Forecast shall
not exceed the number of Therapies specified in the portion of the most recent
Nordion [*] Projection that pertains to the Commercial Forecast Period. For each
week that is one of the [*] of the Commercial Forecast Period for a particular
Commercial Forecast (the "Firm Order"), if such Commercial Forecast specified
that GSK Canada intended to purchase a number of Therapies (which number shall
not be less than [*]) for such week and GSK Canada subsequently decides, prior
to the placement of an order pursuant to Section 4.3(c)(v) for such period, not
to purchase any Therapies for such week, then GSK Canada shall pay Corixa a
cancellation fee equal to [*] of any cancellation fee imposed upon Corixa
pursuant to Section 9.2 of the Nordion Agreements. GSK Canada shall pay such fee
within thirty (30) days of Corixa's invoice therefor.
(iv) Each Pre-Commercialization Firm
Order and Post-Commercialization Firm Order shall be known as a "Firm Order".
For the avoidance of doubt, the term "binding", solely as used in Sections
4.3(c)(ii) and 4.3(c)(iii), refers to the requirement for GSK Canada to [*]
produced at GSK Canada's request on the Scheduled Batch Completion Dates, [*] on
each such Scheduled Batch Completion Date has been determined. By way of
example, Exhibit E provides a schematic outlining the procedure provided for in
Sections 4.3(c)(ii) and 4.3(c)(iii) above.
(v) At least [*] prior to each
Scheduled Batch Completion Date, GSK Canada shall electronically provide to
Corixa, via the SB Bexxar Service Center, an order for all Therapies that it
wishes to receive following such Scheduled Batch Completion Date. Each order
shall specify the number of Therapies, the type(s) of label to be applied
(including labels in respect of Clinical Trials), and the site(s) of delivery
(provided that GSK Canada previously established, in accordance with Section
4.3(c)(vi), the legal authority of each such site to receive and possess the
Therapies). For each such site, GSK Canada shall include in such order its
account name, address, telephone number, radioactive license number, the
expiration date and license limits of such radioactive license, safety officer
contact name and phone number, date site was initiated (i.e. all training
completed) and the site owner's federal business number. GSK Canada may change
the site(s) of delivery of any Therapies or the number of Therapies to be
produced for GSK Canada (provided that such changes, together with all other
changes requested by Corixa or its other licensees, do not result in a change in
[*]) with respect to a particular order, by electronic notice to Corixa, via the
SB Bexxar Service Center, no later than [*] on the day that is [*] prior to the
applicable Scheduled Batch Completion Date, provided GSK Canada previously
established (in accordance with Section 4.3(c)(vi)) the legal authority of each
site specified in such notice to receive and possess Therapies and that GSK
Canada provides in such notice, the site-specific information identified above
for each site that was not listed in the original order. The number of Therapies
called for in each order shall not exceed the number of Therapies specified in
the portion of the most recent Forecast or Commercial Forecast that pertains to
such week. Each order shall be binding upon GSK Canada and GSK Canada shall
purchase from Corixa the number of Therapies specified in such order, as
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modified by any changes thereto submitted in accordance with this Section
4.3(c)(v). The payment terms for such purchases are set forth in Article 6 of
this Agreement. Shortfalls shall be handled as set forth in Section 4.16. If at
any time during the term of this Agreement, GSK Canada does not provide the
information described in this Section 4.3(c)(v) electronically via the SB Bexxar
Service Center, then the deadlines set forth in this Section 4.3(c)(v) for
providing such information to Corixa shall be adjusted to require GSK Canada to
provide such information to Corixa [*] earlier than the deadline stated herein.
(vi) GSK Canada will provide Corixa with
a list of destinations to which Nordion may be requested by Corixa, on behalf of
GSK Canada, to ship Iodine I 131 Tositumomab, no later than [*] days prior to
the first shipment of Iodine I 131 Tositumomab to any such site(s). Corixa will
notify GSK Canada regarding any regulatory requirements, identified by Nordion,
for documentation establishing the legal authority of such site(s) to receive
and possess (131) Iodine. GSK Canada shall promptly provide such documentation
to Corixa, and Corixa shall in turn provide to Nordion all such documentation
supplied by GSK Canada.
(d) SUPPLY FROM McKESSON.
(i) No later than the [*], GSK Canada
shall furnish to Corixa a written rolling forecast for the [*] period commencing
on the next calendar quarter (the "McKesson Forecast") of its requirements for
McKesson to package and label Tositumomab. Such forecast shall be identify the
number of vials of each product configuration to be labeled and packaged in each
[*] in such [*] period.
(ii) At least [*] in advance of the date
that GSK Canada wishes to receive delivery of labeled and packaged Tositumomab
in accordance with section 4.4(a) of this Agreement, GSK Canada shall provide a
firm order request to Corixa, in the format provided by Corixa, that specifies
the labeling and packaging run(s) to be performed by McKesson and date by which
GSK Canada desires delivery. Corixa shall use commercially reasonable efforts to
obtain a commitment from McKesson to perform such labeling and packaging
services within the timeframe requested by GSK Canada. If McKesson fails to make
such a commitment, Corixa shall negotiate with McKesson, on behalf of GSK
Canada, an alternative labeling and packaging schedule that is reasonably
acceptable to GSK Canada. GSK Canada shall purchase from Corixa, in accordance
with the terms set forth in Article 6, all quantities of Tositumomab labeled and
packaged by McKesson as a result of a firm order request provided by GSK Canada.
(e) ORDERING OF SEPARATE BATCHES. If GSK Canada
provides Corixa with a binding forecast or order pursuant to Section 4.3(b) or
4.3(c), that if placed by Corixa with BI Pharma or Nordion, as applicable, would
result in GSK Canada having an obligation to pay separate batch charges to
Corixa pursuant to Section 6.7(b), then Corixa shall inform GSK Canada promptly
after Corixa becomes aware of such circumstances and Corixa shall specify the
deadline for GSK Canada to notify Corixa that it still wishes to place such
binding forecast or order. If Corixa does not receive such notification from GSK
Canada by such deadline, it shall not place such binding forecast or order with
BI Pharma or Nordion, as applicable.
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(f) ORDER CAUSING A BATCH SIZE INCREASE. If GSK
Canada provides Corixa with a binding forecast or order pursuant to Section
4.3(b) or 4.3(c), that if placed in its entirety by Corixa with BI Pharma or
Nordion, as applicable, would result in GSK Canada having an obligation to pay
increased batch size charges to Corixa pursuant to Section 6.7(c), then Corixa
shall inform GSK Canada promptly after Corixa becomes aware of such
circumstances and Corixa shall specify the deadline for GSK Canada to notify
Corixa that it still wishes to place the entirety of such binding forecast or
order. If Corixa does not receive such notification from GSK Canada by such
deadline, it shall only place with BI Pharma or Nordion, as applicable, that
portion of such binding forecast or order that does not necessitate a larger
batch size than would have been made if GSK Canada had not attempted to place
any binding forecast or order for such period.
4.4 VIAL LABELING AND PACKAGING. The Therapies provided
to GSK Canada hereunder, including for Clinical Trial purposes, shall be vial
labeled and packaged prior to delivery to GSK Canada as follows:
(a) TOSITUMOMAB. GSK Canada shall provide to
McKesson (or another Third Party contract labeler of Corixa) pre-approved
labels, cartons and leaflets for Tositumomab that comply with all applicable
laws, rules and regulations in the Territory. Neither McKesson nor Corixa shall
have any obligation to inspect or approve such labels, except for any
obligations imposed by applicable laws, rules or regulations. At least [*] in
advance of each labeling run, GSK Canada shall supply McKesson with the labels,
cartons and leaflets required for such run and written instructions that specify
the appropriate packaging components for each product configuration to be
prepared in such run. GSK Canada shall inform Corixa prior to sending labels,
cartons or leaflets to McKesson, and Corixa will promptly pass such information
along to McKesson. The minimum batch size for vial labeling Tositumomab for
provision to GSK Canada shall be [*] Cold Components, with the exception that,
in calendar year 2003, [*] run will be performed on behalf of GSK Canada for [*]
Cold Components ordered by GSK Canada for such year, even though such number is
less than [*]. During the rest of the term of this Agreement, GSK Canada may
request that vial labeling be performed upon batches of less than [*] Cold
Components. Such reduced batch size vial labeling runs will be performed only if
McKesson agrees to perform such runs and if GSK Canada agrees to [*] Labeled,
packaged Tositumomab will be delivered to GSK Canada, in accordance with Section
4.5(a), in the shipping container that was validated by McKesson, on behalf of
Corixa, prior to the Effective Date or any mutually agreed substitute for such
shipping container. A temperature monitoring device shall be placed inside such
shipping container.
(b) IODINE I 131 TOSITUMOMAB. All Iodine I 131
Tositumomab shall be labeled with a primary label on the glass vial and a
secondary label on the lead pig. GSK Canada shall provide to Nordion
pre-approved secondary labels and leaflets (which leaflets shall be 8.5 x 11
inches in size) for Iodine I 131 Tositumomab that comply with all applicable
laws, rules and regulations in the Territory. Neither Nordion nor Corixa shall
have any obligation to inspect or approve such labels or leaflets, except for
any obligations imposed by applicable laws, rules or regulations. At least [*]
in advance of each labeling run, GSK Canada shall supply
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Nordion with the labels and leaflets required for such run and written
instructions that specify the appropriate label(s) and leaflets for each product
configuration to be prepared in such run.
4.5 DELIVERY; SHIPMENT; TITLE; DISTRIBUTION. The Cold
Components of Therapies ordered by GSK Canada pursuant to Section 4.3(b) will be
delivered to GSK Canada, pursuant to Section 4.5(a), whether or not GSK Canada
places a corresponding order for Therapies pursuant to Section 4.3(c). The Hot
Components of Therapies ordered pursuant to Section 4.3(c) shall be delivered to
GSK Canada pursuant to Section 4.5(b).
(a) TOSITUMOMAB.
(i) DELIVERY TO GSK CANADA. The
Tositumomab will be delivered to GSK Canada, FCA McKesson or an alternate Corixa
supplier or repository. "FCA" shall be construed in accordance with INCOTERMS
2000 of the International Chamber of Commerce. Corixa shall, on behalf of GSK
Canada, arrange for the exportation by GSK Canada of Tositumomab out of the
United States and the importation by GSK Canada of Tositumomab into Canada
pursuant to this Agreement. GSK Canada shall bear all expenses related to such
exportation and importation and the delivery of Tositumomab to GSK Canada's
storage facility, except for any shipping charges paid by Corixa pursuant to the
McKesson Agreement (which shall be included in the amounts invoiced pursuant to
Section 6.7).
(ii) DISTRIBUTION BY GSK CANADA.
Distribution of Tositumomab to radiopharmacies in the Territory shall be handled
exclusively by GSK Canada and shall be in accordance with all applicable laws,
rules and regulations. The expenses related to such distribution shall be solely
the responsibility of GSK Canada.
(1) Corixa shall transmit
electronically to GSK Canada information regarding when GSK Canada should ship
Tositumomab in order to fulfill orders received by the SB Bexxar Service Center
from a radiopharmacy in the Territory.
(2) GSK Canada shall transmit
electronically to Corixa the following information regarding such shipment of
Tositumomab: the name of the carrier, the date of shipment, the shipment
tracking number, and the estimated time of delivery.
(3) GSK Canada shall ensure
that the carrier electronically transmits to Corixa and the SB Bexxar Service
Center proof of delivery of such Tositumomab to the radiopharmacy. (4) GSK
Canada and Corixa shall develop and implement as soon as reasonably practicable
an appropriate manual alternative to the electronic transmission process
contemplated in Sections 4.5(a)(ii)(1)-(3) above and 4.5(b)(ii)(1)-(4) below to
be available for use in the event that the electronic interface is not operative
for any reason.
(b) IODINE I 131 TOSITUMOMAB.
(i) DELIVERY TO GSK CANADA. The Iodine
I 131 Tositumomab will be delivered to GSK Canada, FCA Carrier's vehicle at
Nordion's facility (or, if Section 3.2(c)(ii) of the Nordion Agreements applies,
FCA Carrier's distribution center or hub or, if
30.
Section 3.2(c)(iii) of the Nordion Agreements applies, FCA the destination
specified by GSK Canada for delivery of such Iodine I 131 Tositumomab). "FCA"
shall be construed in accordance with INCOTERMS 2000 of the International
Chamber of Commerce, and "Carrier" shall have the meaning set forth in the
Nordion Agreements. GSK Canada shall bear the responsibility for all expenses
related to the delivery of Packaged Bulk Drug Substance to Nordion's facility
(which will be coordinated by Corixa). Such expenses are included in the
computation of Standard Cost of Goods.
(ii) DISTRIBUTION ON BEHALF OF GSK
CANADA. GSK Canada shall bear the responsibility for all expenses related to the
delivery of Iodine I 131 Tositumomab from Nordion's facility to GSK Canada's
customers, as a component of the Standard Cost of Goods. For greater certainty,
notwithstanding GSK Canada's responsibility for all delivery expenses as
contemplated above, Corixa shall be responsible for coordinating, on GSK
Canada's behalf, shipment orders and delivery confirmations for the GSK Canada
Iodine I 000 Xxxxxxxxxxx (xxx "XXX Xxxxxx I 131 Product"). In particular, Corixa
shall:
(1) transmit electronically to
Nordion shipment orders provided to Corixa by the SB Bexxar Service Center with
respect the GSK Canada I 131 Product;
(2) receive electronically
from Nordion and/or the Carrier information relating to the delivery by Nordion
of the GSK Canada I 131 Product to the Carrier;
(3) receive electronically
from the Carrier information relating to proof of delivery by the Carrier of the
GSK Canada I 131 Product to the radiopharmacy; and
(4) update Corixa's internal
system to reflect the information received under (2) and (3) and promptly
provide this same information electronically to the SB Bexxar Service Center.
(c) TITLE. Title to the Tositumomab portion of
the individual Therapies shall pass to GSK Canada when the Tositumomab is
delivered to GSK Canada as set forth in Section 4.5(a)(i). Title to the Iodine I
131 Tositumomab portion of the individual Therapies shall pass to GSK Canada
when the Iodine I-131 Tositumomab is delivered to GSK Canada as set forth in
Section 4.5(b)(i).
(d) LIABILITY. Corixa shall not have any
liability on account of its coordination of shipment orders or confirmation of
delivery pursuant to Section 4.5(a) or 4.5(b). unless (i) Corixa was grossly
negligent or engaged in willful misconduct or (ii) Corixa can obtain
indemnification from McKesson or Nordion (as applicable), in which case Corixa
shall use commercially reasonable efforts to recover such indemnification and
GSK Canada shall be entitled to its pro rata share of such recovered
indemnification.
(e) DISTRIBUTION SYSTEM MODIFICATION. The
Parties acknowledge that the Bexxar distribution system for the Product, which
includes the electronic distribution systems of Corixa, the Bexxar Service
Center, McKesson and Nordion, and the interfaces among these
31.
systems, does not, as of the Effective Date, have the ability to perform the
electronic functions described in Sections 4.5(a)(ii) and 4.5(b)(ii). Corixa
will use commercially reasonable efforts to modify the components of the Bexxar
distribution system that are owned by Corixa (the "Corixa Distribution System")
to perform such functions. Corixa will also provide GSK Canada with an estimate
of costs of such modifications on the Corixa Distribution System, including
Corixa's out-of-pocket and personnel expenses. Within thirty (30) days of
receipt of an invoice from Corixa, GSK Canada shall reimburse Corixa for all
reasonable out-of-pocket and personnel expenses (which personnel expenses shall
be calculated at the Annual Clinical FTE Rate, even though such personnel work
in an information technology capacity rather than a clinical or regulatory
capacity) incurred by Corixa in connection with such modification of the Corixa
Distribution System. Corixa shall promptly forward to GSK Canada all invoices it
receives from the Bexxar Service Center, McKesson and Nordion for expenses they
incur in connection with such modification of their respective portions of the
Bexxar distribution system, including out-of-pocket and personnel expenses. GSK
Canada shall pay such invoices by the due dates. Corixa shall perform manually
all of the electronic functions described in Sections 4.5(a)(ii) and 4.5(b)(ii):
(1) until such time as the distribution system modification is complete and the
modified system has been fully tested and (2) at all times thereafter when the
distribution system is not operational or is undergoing maintenance. The Parties
shall work together to try to solve any problems Corixa encounters in trying to
modify its distribution system to perform the electronic functions described in
Sections 4.5(a)(ii) and 4.5(b)(ii), and the Parties are free to alter
distribution communication responsibilities in any manner that reasonably solves
such problems. The Parties shall comply with such altered responsibilities and
shall not be in breach of any obligations set forth in Sections 4.5(a)(ii) and
4.5(b)(ii) that are superseded by such alteration.
4.6 STORAGE. GSK Canada shall store the Tositumomab
provided to it pursuant to Section 4.5(a) in accordance with (i) Corixa's and
McKesson's specifications for storage and (ii) all applicable laws, rules and
regulations. It shall be GSK Canada's sole responsibility to establish and
maintain a site for such activities. Once each year during the term of the
Agreement, Corixa shall have the right to inspect such site, upon reasonable
notice to GSK Canada of the scope and focus of the inspection and during normal
business hours at a mutually agreed time, for compliance with such
specifications and laws, rules and regulations.
4.7 COMPLIANCE WITH SPECIFICATIONS.
(a) TOSITUMOMAB. For all Tositumomab provided to
GSK Canada hereunder, Corixa shall provide to GSK Canada, within fifteen (15)
business days of McKesson's release, (i) BI Pharma's Certificate of Analysis and
Batch Certificate, (ii) McKesson's Certificate of Manufacture, and (iii) a label
specimen. GSK Canada shall review such items within ten (10) business days of
receipt. Any Tositumomab ordered by GSK Canada but rejected by Corixa or its
agent on account of failure to comply with the Specifications will not be
delivered to GSK Canada. With respect to all Tositumomab not so rejected, GSK
Canada shall provide approval to Corixa to ship Tositumomab to GSK Canada unless
such analysis certificates provided by Corixa demonstrate that such Tositumomab
does not conform with the Specifications. In such case, GSK Canada shall
promptly inform Corixa and Corixa will reject such Tositumomab.
32.
GSK Canada will perform an identification test upon receipt of Tositumomab in
Canada. If the Tositumomab passes the identification test GSK Canada will
release the Tositumomab. If the Tositumomab fails the identification test, GSK
Canada shall promptly inform Corixa and reject the Tositumomab. In such case,
Corixa and GSK Canada will discuss the batch rejection and identify the root
cause. If the cause of the rejection was a result of the failure of either BI
Pharma or McKesson to comply with the specified order and contract terms with
Corixa, Corixa shall use commercially reasonable efforts to procure from BI
Pharma or McKesson, as applicable, any remedy available to Corixa pursuant to
the BI Pharma Agreement or McKesson Agreement, as applicable, for such
identification test failure. Corixa shall make available to GSK Canada all
remedies so procured by Corixa.
GSK Canada shall be responsible for setting up adequate facilities and
procedures for handling, storing and disposing of Tositumomab that does not pass
the identification test.
(b) IODINE I 131 TOSITUMOMAB.
(i) For all Iodine I 131 Tositumomab
provided to GSK Canada hereunder, Corixa shall provide to GSK Canada (1) a label
specimen, (2) Nordion's Certificate of Analysis and Certificate of Manufacture,
and (3) BI Pharma's Certificate of Analysis and Batch Certificate for the
Packaged Bulk Drug Substance used by Nordion. Corixa shall provide the BI Pharma
documentation on a one-time basis following the release of each Packaged Bulk
Drug Substance batch, and GSK Canada will be responsible for maintaining
archived Packaged Bulk Drug Substance release documents for Packaged Bulk Drug
Substance batches used at Nordion. After Corixa has completed its release of the
Product, Corixa shall provide the label specimen and Nordion documentation by
[*] on the [*], provided that there is not a delay in obtaining the requisite
information from Nordion. If such Iodine I 131 Tositumomab is for therapeutic
purposes and is manufactured by Nordion in a batch that includes Iodine I 131
Tositumomab intended for use in Europe (a "European Batch"), Corixa shall
provide the label specimen and Nordion documentation by [*] on the [*], provided
that there is not a delay in obtaining the requisite information from Nordion.
Corixa will inform GSK Canada at least [*] prior to the [*] if the batch being
made on such date is a European Batch.
(ii) GSK Canada shall review the items
provided by Corixa pursuant to Section 4.7(b)(i) within [*] after GSK Canada's
receipt of the label specimen and Nordion documentation (but no later than [*]
on the [*] or, with respect to each European Batch, no later than [*] on the day
after the [*]), unless Corixa provides such label specimen and Nordion
documentation more than [*] before the deadline for such provision (in which
case, GSK shall complete such review within [*] of receipt). Any Iodine I 131
Tositumomab ordered by GSK Canada but rejected by Corixa or its agent on account
of failure to comply with the Specifications will not be delivered to GSK
Canada. With respect to all such Iodine I 131 Tositumomab not so rejected, GSK
Canada shall send a facsimile to Corixa releasing such Iodine I 131 Tositumomab
by the review deadline stated in this Section 4.7(b)(ii) (but not later than [*]
on the [*] or, with respect to each European Batch, not
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later than [*] on the day after the [*], unless such Certificates of Analysis
provided by Corixa demonstrates that such Iodine I 131 Tositumomab does not
conform with the Specifications. In such case, GSK Canada shall promptly inform
Corixa by telephone and Corixa will reject such Iodine I 131 Tositumomab,
provided that the time for rejection has not passed. GSK Canada shall be
responsible for setting up adequate facilities and procedures for handling,
storing and disposing of Iodine I 131 Tositumomab that does not conform with
Specifications and that has been shipped from Nordion prior to a determination
of failure to comply with Specifications. GSK Canada shall not be responsible
for any failure of Nordion to handle, store and dispose of Iodine I 131
Tositumomab that does not conform with Specifications and that has not been
shipped from the Nordion facility at the time of determination of failure to
comply with Specifications, except that GSK Canada shall pay all costs
associated with Nordion's handling, storage and disposal of Iodine I 131
Tositumomab that fails to comply with Specifications on account of GSK Canada's
error or omission. GSK Canada understands that [*]. Corixa will use commercially
reasonable efforts to ensure that Nordion completes [*] as promptly as possible
and within [*] of release. Corixa will forthwith provide GSK Canada with the
results of such testing once received by Corixa.
(iii) GSK Canada understands that, under
the Nordion shipping practices in effect on the Effective Date, the Iodine I 131
Tositumomab that GSK Canada releases by the review deadline stated in Section
4.7(b)(ii) are eligible for shipment (1) by Purolator or FedEx, departing on the
[*], (2) by Air Canada, departing [*], or (3) by truck, departing [*] and
driving to Ottawa or Montreal hospitals.
4.8 CUSTOMER ORDERS. GSK Canada shall establish and
maintain infrastructure to collect and collate customer orders for Therapies and
to transfer information regarding such customer orders to Corixa's order
fulfillment system utilizing the SB Bexxar Service Center as outlined in Exhibit
F. The manual ordering system depicted in Exhibit F shall only be used if the
electronic ordering system depicted in Exhibit F is not functioning at the
relevant time. The Parties acknowledge that Exhibit F shows the Parties' current
understanding of a order fulfillment system that does not yet exist and that
will be modified by the Parties over time.
4.9 MANUFACTURING REGULATORY COMPLIANCE. Any manufacture
of Tositumomab and Iodine I 131 Tositumomab for development purposes or
commercial sale in the Territory shall be performed by or on behalf of Corixa,
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). If the FDA or Health Canada requires any
changes to the manufacturing process as a condition of obtaining Regulatory
Approval, then the Parties shall discuss whether to implement such changes and
how to allocate between the Parties the costs associated with implementing such
changes.
4.10 REGULATORY COMPLIANCE. GSK Canada shall be
responsible for establishing and maintaining infrastructure to ensure that
Tositumomab, Iodine I 131
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Tositumomab and the Product comply with applicable drug regulations in the
Territory. Corixa will be responsible for promptly notifying GSK Canada of any
relevant safety and/or chemistry changes in order to permit GSK Canada to
register such changes properly with Health Canada.
4.11 QUALITY POLICY MANUAL. Within ninety (90) days after
the Effective Date, the Parties shall agree upon a written document that shall
govern quality control issues with respect to Tositumomab and Iodine I 131
Tositumomab (the "Quality Policy Manual"). The Quality Policy Manual shall
cover, in greater detail than set forth in Sections 4.12, 4.13, 4.14 and 4.15,
changes, adverse event reporting, product complaints, and product recall. The
Quality Policy Manual may also cover additional quality-related topics. In the
event of a conflict between this Agreement and the Quality Policy Manual, the
terms of this Agreement shall prevail.
4.12 CHANGES.
(a) GENERALLY. Either Corixa or GSK Canada may
request a Specifications change intended to maintain high standards or to
conform the Specifications with those for the United States. The Parties shall
discuss in good faith the implementation of any such requested changes;
provided, however, that Corixa shall not make any revisions to any aspect of the
Product in the Territory without the prior written consent of GSK Canada in
accordance with the Change Control Operating Procedure (as that phrase is
defined in Section 4.12(c)). GSK Canada retains the right and responsibility for
final approval of the Specifications and labels for the Product in the
Territory. Either Corixa or GSK Canada may request a Specifications change
required for compliance with a regulatory act or legal requirement imposed by an
applicable governmental entity with jurisdiction in the Territory.
(b) LABELING AND PACKAGING CHANGES. From time to
time GSK Canada may require labeling or packaging changes that will affect the
labeling specifications for the Product. These changes may either be initiated
by GSK Canada or may be a requirement resulting from changes in cGMPs.
Notwithstanding the foregoing, GSK Canada shall not have the right to require
any change to the label that is etched on the glass vials for the Iodine I 131
Tositumomab. GSK Canada may request such a change, but it will only be
implemented with the consent of Corixa, SB and all of Corixa's other licensees
in the Corixa Territory who receive Iodine I 131 Tositumomab from Nordion.
(c) CHANGE CONTROL OPERATING PROCEDURE. The
procedure to be followed if either GSK Canada or Corixa desires to change any
aspect of the Product, including without limitation, any change in validation
requirements, or the Specifications, shall be set forth in the Quality Policy
Manual (such procedure is hereinafter referred to as the "Change Control
Operating Procedure"). The Parties agree to comply with the terms of the Quality
Policy Manual including, without limitation, the Change Control Operating
Procedure.
(d) POST INITIAL APPROVAL REGULATORY COMPLIANCE.
Corixa shall provide GSK Canada with as much advance notice as reasonably
possible before making any proposed changes in the Product safety labeling,
Product Specifications or manufacturing procedures for the Product that pertain
to the Territory and differ from that described in the NDS. Corixa shall
promptly allow GSK Canada to review the documentation required to support any
35.
such proposed change. Corixa shall also promptly notify GSK Canada of any
request that Corixa receives from the FDA or any other regulatory authority to
change the safety labeling or Product Specifications or manufacturing procedures
for the Product in the United States.
(e) DIFFERENT SPECIFICATIONS.
(i) This Section 4.12(e) shall apply if
(A) as a result of changes requested pursuant to this Section 4.12 or mandated
by Health Canada or the FDA, the specifications for the Product in the Territory
(which specifications shall include without limitation the Specifications, the
etched label for the glass vials holding Iodine I 131 Tositumomab, [*]) become
different from the specifications for the Product in the United States, and (B)
such difference would require a Third Party supplier of the Product to perform
procedures (other than labeling or packaging) with respect to Product intended
for use in the Territory that are different from the procedures it performs with
respect to Product intended for use in the Corixa Territory.
(ii) If under the circumstances set
forth in Section 4.12(e)(i), (A) such Third Party supplier agrees to perform
such different procedures, (B) GSK Canada agrees to pay all costs associated
with such different procedures, and (C) the implementation of such different
procedures will not delay or impair the production of Product for use in the
Corixa Territory, then Corixa's obligation to supply Product to GSK Canada in
accordance with this Article 4 shall persist (but shall be amended as
appropriate to accommodate the ramifications of the implementation of such
different procedures for the Territory).
(iii) If under the circumstances set
forth in Section 4.12,(e)(i), one or more of the items described in Sections
4.12(e)(ii)(A), 4.12(e)(ii)(B) and 4.12(e)(ii)(C) do not occur, then Corixa may,
upon [*] prior written notice to GSK Canada, terminate Article 4 in its
entirety. However, if the above circumstance arises within [*] of the proposed
implementation date of the relevant specification change, the notice period
shall be shortened accordingly so that in no event will such termination of
Article 4 be effective later than the proposed implementation date of the
relevant specification change. At any time following receipt of such notice,
either Corixa or GSK Canada may terminate this Agreement pursuant to Section
10.4(e).
4.13 ADVERSE EVENT REPORTING. Each of GSK Canada and
Corixa shall, at its own cost and expense, adopt and comply with the standard
policies and procedures, as set out in the Safety Data Exchange Protocol
attached as Exhibit G hereto, as that Exhibit may be amended from time to time
in accordance with the terms of this Agreement, in respect of the safety
monitoring of, and exchange of safety information related to, the Product.
4.14 PRODUCT COMPLAINTS. Each Party shall maintain a
record of all complaints it receives with respect to the Product (each, a
"Product Complaint"). For purposes of this Section 4.14, a "Product Complaint"
is a report of an actual or potential failure of the Product to meet the
standards set forth in regulatory filings or in agreements among the Parties.
The responsibilities of the Parties with respect to (a) notification of the
Product Complaint from
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the receiving Party to the other Parties and (b) the handling of Product
Complaints shall all be performed in accordance with a procedure to be mutually
agreed by the Parties after the Effective Date and set forth in the Quality
Policy Manual.
4.15 PRODUCT RECALL. The Parties shall immediately inform
each other in writing of all information related to (a) any incident relating to
the Product and/or any lot of the Product that is the subject of recall, market
withdrawal or correction, or (b) any Product that may require, whether based on
manufacturing defect, tampering, or otherwise, a recall, field alert, product
withdrawal or field correction arising from any defect in any such Product
provided under this Agreement. If either Corixa or GSK Canada believes that a
recall of Tositumomab and/or Iodine I 131 Tositumomab is desirable or required
by law, it will promptly notify the other Party. The Parties will then discuss
reasonably and in good faith whether such recall is appropriate or required and
the manner in which any recall shall be handled; provided, however, in the event
either Corixa or GSK Canada determines that a recall is necessary, such recall
shall be implemented. GSK Canada shall be solely responsible for the handling
and disposition of such recalls of Product in the Territory, pursuant to
procedures set forth in the Quality Policy Manual, and except as provided in the
immediately following sentence, GSK Canada shall be responsible for all costs
related to any such recall. Notwithstanding the immediately preceding sentence,
Corixa shall be responsible for the portion of any recall costs that are
directly attributable to (i) Corixa's gross negligence or intentional misconduct
or (ii) the act or omission of a Third Party supplier of the Product, but solely
to the extent that Corixa has the right, under its supply agreement with such
Third Party, to recover such costs from such Third Party, and Corixa shall use
commercially reasonable efforts to recover such costs. Corixa shall cooperate
with GSK Canada in allowing such recall in the Territory to occur pursuant to
the procedures in the Quality Policy Manual.
4.16 ALLOCATION IN THE EVENT OF PRODUCT SHORTAGES. This
Section 4.16 shall apply in the event that there is insufficient material to
either (1) supply to GSK Canada the number of Therapies it ordered pursuant to
Sections 4.3(b) and 4.3(c) or (2) fulfill Corixa's pending orders for Therapies
for use in the Corixa Territory. It shall also apply if the combined number of
Therapies that GSK Canada, Corixa, SB and Corixa's other licensees in the Corixa
Territory wish to obtain exceed the capacity of the relevant Third Party
manufacturers. If the problem is due to insufficient quantities of Iodine I 131
Tositumomab (arising from radiolabeling constraints rather than Tositumomab
shortages), then the available Therapies shall be allocated in accordance with
Section 4.16(a). If the problem is due to insufficient quantities of
Tositumomab, then the available Therapies shall be allocated in accordance with
Section 4.16(b). The purpose of these allocation rules is to permit GSK Canada
(with respect to the Territory) and Corixa independently (with respect to the
Corixa Territory) to make their respective long-term purchase decisions for
Therapies, with the benefits and risks of such purchase decisions to be
allocated to GSK Canada or Corixa, as the case may be.
(a) IODINE I 131 TOSITUMOMAB.
(i) Any Iodine I 131 Tositumomab
material from an insufficient batch produced by Nordion, from the facility in
Kanata in existence as of the
37.
Effective Date, shall be allocated as follows: [*] of the manufactured vials in
such batch shall be allocated to the Territory and [*] of the manufactured vials
in such 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 ceases to have any obligation to supply Iodine I 131 Tositumomab
for use in Europe, then Corixa shall notify GSK Canada in writing and,
commencing with the [*], the amount that Corixa had been obligated to allocate
to Europe under the circumstances set forth in this Section 4.16(a)(i), shall be
[*] between the Territory and the United States portion of the Corixa Territory
based on [*]. Such allocation to GSK Canada shall be in addition to the [*]
allocation specified in the first sentence of this Section 4.16(a)(i).
(ii) If after the Effective Date,
Corixa, alone or together with one or more of Corixa's partners in the Corixa
Territory, [*] shall not be available to GSK Canada unless (1) GSK Canada [*] or
(2) the [*], provided that such [*]. Corixa shall provide GSK Canada with
adequate notice for GSK Canada to decide whether it will [*]. If [*] is provided
by GSK Canada, [*] shall be limited to [*].
(b) TOSITUMOMAB. Any orders placed with BI
Pharma shall be a "Vested Order" for purposes of this Section 4.16(b), if it is
a firm order which has been accepted by BI Pharma and is scheduled for delivery
within [*] after the date of such order.
(i) If Corixa seeks to place a proposed
Vested Order for Tositumomab and is advised by BI Pharma that it will not accept
the full amount of such order (in which case such order does not become a Vested
Order), whether such order is for purposes of supply in the Territory or the
Corixa Territory, then Corixa shall consult with GSK Canada regarding the
allocation of available supply. Unless the Parties otherwise agree, all future
Vested Orders shall be allocated [*] to the Territory and [*] to the Corixa
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 BI Pharma's refusal to accept the full amount of
such order, BI Pharma 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.
(ii) If BI Pharma is unable to deliver
the full amount of a Vested Order, either because the amount delivered is less
than the amount ordered or because 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
Corixa Territory [*]. 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 Corixa Territory so as to [*]. (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
[*]. 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
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manufacturing plant in temporal proximity to each other. The allocation rule set
forth in this Section 4.16(b)(ii) shall restart for each calendar year, without
any carryover of shortfalls realized for a particular territory in the prior
calendar year.
4.17 TERMINATION OF SUPPLY OBLIGATIONS. If Corixa either
stops marketing the Product in the United States or stops supplying Product for
the United States market, then Corixa may, upon six (6) months' written notice
to GSK Canada, terminate Article 4 in its entirety. At any time following
receipt of such notice, GSK Canada may terminate this Agreement pursuant to
Section 10.5(b) or may request that the Parties take part in good faith
discussions regarding alternative means by which GSK Canada might obtain supply
of the Product.
4.18 U.N. CONVENTION NOT APPLICABLE. The Parties agree
that the U.N. Convention on Contracts for International Sales of Goods shall not
apply to this Agreement.
5. GREY-MARKET RESTRICTIONS
5.1 OVERVIEW. The Parties recognize that the value of the
intellectual property rights being conveyed hereunder to each Party will depend
on the degree to which products of one Party incorporating the intellectual
property rights are sold in areas in which another Party owns the intellectual
property rights. To permit the Parties to reach mutual agreement on the value of
the rights being conveyed, to minimize transaction costs, and to avoid future
litigation for infringement, the Parties have agreed as set forth in Sections
5.2 and 5.3.
5.2 NO SALES BY GSK CANADA OUTSIDE THE TERRITORY. GSK
Canada, its Affiliates (other than SB) and sublicensees and any successors or
assigns of GSK Canada or its Affiliates (other than SB) or sublicensees shall
not at any time during the term of this Agreement: (a) sell, market, promote or
distribute, directly or indirectly, the Product outside the Territory, or (b)
sell or distribute the Product to any person in the Territory if GSK Canada has
knowledge that such person intends to sell, or has in the past sold, such
Product outside the Territory. To the extent permitted by law, prior to
providing the Product to any Third Party distributor or licensee in the
Territory, GSK Canada and its Affiliates and sublicensees shall secure from such
Third Party its agreement to restrictions relating to outside the Territory
contained in this Agreement, including an agreement to refrain from knowingly
engaging, directly or indirectly, in parallel importation or dealing in "grey
market" products in connection with its sale and distribution of the Product.
5.3 NO SALES BY CORIXA INSIDE THE TERRITORY. Corixa, its
Affiliates and any successors or assigns of Corixa or its Affiliates shall not
at any time during the term of this Agreement enter into an agreement whereby it
will: (a) sell, market, promote or distribute, directly or indirectly, the
Product in the Territory (except to GSK Canada in accordance with the terms of
this Agreement); or (b) sell or distribute the Product to any person outside the
Territory if Corixa has knowledge that such person intends to sell, or has in
the past sold, such Product in the Territory. To the extent permitted by law,
such agreement shall secure from such Third Party its obligation to abide by the
restrictions relating to inside the Territory contained in this Agreement,
including to refrain from knowingly engaging, directly or indirectly, in
parallel importation or dealing in "grey market" products in connection with its
sale and distribution of the Product. The Parties acknowledge and agree that the
obligations set forth in part (b) of the
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first sentence of this Section 5.3 and the second sentence of this Section 5.3
only pertain to Corixa, its Affiliates and any successors or assigns of Corixa
or its Affiliates to the extent that they are parties to such agreements. Such
obligations shall not be interpreted to apply to agreements entered into by any
licensee or corporate partner of Corixa or its Affiliates in the Corixa
Territory.
6. ECONOMICS
6.1 LICENSE FEE.
(a) GSK Canada shall pay Corixa a non-refundable
license fee of CAD [*] upon the Effective Date.
(b) GSK Canada may deduct from the license fee
set forth in Section 6.1(a) the CAD [*] paid to Corixa pursuant to the LOI.
6.2 MILESTONES.
(a) GSK Canada shall pay Corixa the following
non-refundable, non-creditable amounts within five (5) days after occurrence of
each of the events specified below:
(i) CAD $[*] upon Initial Approval of
the Product in the Territory.
(ii) CAD $[*] upon the earlier of:
(1) The date that is [*] after
the Initial Approval; and
(2) The date of issuance of
[*] reimbursements for [*].
(b) GSK Canada shall pay Corixa the following
non-refundable, non-creditable amounts within thirty (30) days after the end of
each calendar quarter in which a sale causes an achievement specified below:
(i) CAD $[*] upon the first time that
Annual Net Sales exceed CAD $[*].
(ii) CAD $[*] upon the first time that
Annual Net Sales exceed CAD $[*].
(c) In addition to making the milestone payments
specified in Section 6.2(b), GSK Canada shall provide Corixa with written notice
of the occurrence of each achievement specified in Section 6.2(b) within fifteen
(15) days after the end of the calendar month in which the relevant sale was
made.
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(d) For the avoidance of doubt, in the event
that Annual Net Sales in a particular year exceed more than one amount that
gives rise to a milestone payment under Section 6.2(b), then GSK Canada shall
make all applicable milestone payments. For example, if Annual Net Sales in a
particular year are CAD $[*] and previous Annual Net Sales were less than CAD
$[*], GSK Canada shall make the milestone payments set forth in Sections
6.2(b)(i) and 6.2(b)(ii) (for a total of CAD $[*]) with respect to such year.
6.3 ROYALTIES.
(a) In partial consideration for the licenses
granted in Xxxxxxx 0.0, XXX Xxxxxx shall pay Corixa a running royalty of:
(i) [*] of Net Sales made during the
Initial Royalty Period;
(ii) [*] of Net Sales made during the
first (1st) calendar year after the Initial Royalty Period;
(iii) [*] of Net Sales made during the
second (2nd) calendar year after the Initial Royalty Period;
(iv) [*] of Net Sales made during the
third (3rd) calendar year after the Initial Royalty Period;
(v) [*] of Net Sales made during the
fourth (4th) calendar year after the Initial Royalty Period; and
(vi) [*] of Net Sales made during the
fifth (5th) calendar year after the Initial Royalty Period and all times
thereafter during the term of this Agreement. However, if in any given calendar
quarter during such period, there is a product [*] sold commercially in the
Territory (by a party other than GSK Canada and its Affiliates and sublicensees)
that contains a monoclonal antibody conjugated with an isotope or toxic moiety
and that is approved for at least one indication for which the Product is
approved, then the royalty rate for such calendar quarter shall be [*] of Net
Sales rather than [*] of Net Sales.
Such royalties do not include the royalties that GSK Canada is obligated to pay
in respect of the Xxxx-Xxxxxx Agreement and the Michigan Agreement, pursuant to
Section 6.4, or the Third Party Royalties that GSK Canada is obligated to pay
pursuant to Section 6.5. In addition to making the royalty payments specified in
Section 6.3(a), GSK Canada shall provide in writing to Corixa, within fifteen
(15) days after the end of each calendar month, the Net Sales amount for such
month, unless no sales were made in such month.
(b) Subject to Section 6.3(c), if the aggregate
royalty payments received by Corixa pursuant to Section 6.3(a) for Net Sales
made in calendar year [*] or any subsequent calendar year are not at least
CAD[*], then on the date upon which the last royalty payment pursuant to Section
6.3(a) is due for such calendar year, GSK Canada shall make an
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additional payment to Corixa equal to the difference between CAD[*] and such
aggregate royalty payments for such calendar year.
(c) The payments set forth in Section 6.3(b)
shall be adjusted as set forth in this Section 6.3(c) if the following
circumstances take place:
(i) GSK Canada places orders pursuant
to Sections 4.3(b), 4.3(c) and 4.3(d) for delivery of a number of Therapies
during a particular calendar year in which GSK Canada has a minimum royalty
obligation of CAD $[*] under Section 6.3(b);
(ii) the sale of such ordered number of
Therapies would have yielded (based upon the average Net Sales per Therapy in
the Territory in the preceding calendar year, as adjusted to reflect any
published Product price changes in the Territory that pertain to the entire
current calendar year) royalty payments under Section 6.3(a) equal to or greater
than CAD $[*];
(iii) the number of Therapies actually
supplied to GSK Canada in such calendar year is less than such ordered number of
Therapies; and
(iv) the aggregate royalty payments due
under Section 6.3(a) for such calendar year are less than CAD $[*].
If the foregoing circumstances all take place in respect to a particular
calendar year under which GSK Canada has a minimum royalty obligation of CAD
$[*] under Section 6.3(b), then such minimum royalty obligation in such calendar
year shall be reduced by an amount equal to the product of the following
equation:
A x B x (C-D)
A = the average Net Sales per Therapy in the Territory in
the preceding calendar year, as adjusted to reflect any
published Product price changes in the Territory that
pertain to the entire current calendar year (in CAD$)
B = the applicable royalty rate under Section 6.3(a) for such
calendar year
C = the number of Therapies ordered by GSK Canada pursuant
to Sections 4.3(b), 4.3(c) and 4.3(d) for delivery
during such calendar year
D = the number of Therapies actually delivered to GSK Canada
during such calendar year.
6.4 XXXX-XXXXXX AND UNIVERSITY OF MICHIGAN ROYALTIES. In
partial consideration for the sublicenses under the Xxxx-Xxxxxx Agreements and
the Michigan Agreement granted to GSK Canada pursuant to Section 2.1(a), GSK
Canada shall pay Corixa a running royalty of [*] of Net Sales throughout the
term of this Agreement, unless Corixa ceases
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to have any royalty obligations under either the Xxxx-Xxxxxx Agreements or the
Michigan Agreement (at which time GSK Canada's payment obligations under this
Section 6.4 shall expire). Such payments shall be made to Corixa within sixty
(60) days after the end of the calendar quarter in which such sales were made
and shall be accompanied by copies of all royalty-related documentation (either
originals or photocopies) and calculations required by the Xxxx-Xxxxxx
Agreements and the Michigan Agreement. Corixa shall include all amounts received
from GSK Canada pursuant to this Section 6.4 in the payments it makes under the
Xxxx-Xxxxxx Agreements or the Michigan Agreement, as applicable, unless such
amounts received from GSK Canada exceed Corixa's payment obligations under the
Xxxx-Xxxxxx Agreements and the Michigan Agreement. To the extent that the
amounts owed by GSK Canada pursuant to this Section 6.4 are not sufficient to
satisfy Corixa's payment obligations under the Xxxx-Xxxxxx Agreements or the
Michigan Agreement, respectively, as a result of the development, manufacture
(including manufacture outside the Territory for use, offer for sale, or sale in
the Territory), importation, use, offer for sale or sale of the Product in the
Territory after the Effective Date, Corixa shall supplement such amounts as
necessary to satisfy such payment obligations.
6.5 THIRD PARTY ROYALTIES. The Parties shall [*] all
Third Party Royalties. GSK Canada shall calculate the amounts and due dates of
all Third Party Royalty payments. GSK Canada shall pay Corixa [*] of each Third
Party Royalty payment at least fifteen (15) days before its due date. GSK Canada
shall include with such payment all calculations and documentation (either
originals or photocopies) required to be provided in conjunction with such
payment pursuant to the Third Party license agreement. Provided that Corixa
receives such calculations and documentation and GSK Canada's [*] the Third
Party Royalty payment by the date specified above in this Section 6.5, Corixa
shall submit to the Third Party licensor, by the due date calculated by GSK
Canada, (a) a payment equal to [*] the amount received from GSK Canada and (b)
all calculations and documentation provided by GSK Canada.
6.6 QUARTERLY PAYMENTS AND PAYMENT REPORTS. All payments
due under Section 6.3 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 of
Therapies sold during the relevant calendar quarter and the aggregate Net Sales
for such calendar quarter.
6.7 TRANSFER PRICE.
(a) CLINICAL AND COMMERCIAL SUPPLY.
(i) Subject to Sections 6.7(b) and
6.7(e), for each Cold Component provided to GSK Canada pursuant to Section
4.5(a), GSK Canada shall pay Corixa a transfer price equal to [*] of the
Standard Cost of Goods for such Cold Component.
(ii) Subject to Sections 6.7(b) and
6.7(e), for each Hot Component provided to GSK Canada pursuant to Section
4.5(b), GSK Canada shall pay Corixa a
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transfer price equal to X minus Y, where X is [*] of the Standard Cost of Goods
for the Therapy containing such Hot Component and Y is the total amount received
by Corixa or invoiced by Corixa within the past thirty (30) days and not yet
received, pursuant to Section 6.7(a)(i), for the two Cold Components in such
Therapy.
(b) SEPARATE BATCH CHARGES. The prices set forth
in Section 6.7(a) shall apply only when the Therapies provided to GSK Canada
were manufactured (both at BI Pharma and at Nordion) as part of a batch that
contained Therapies ordered by Corixa or another licensee or corporate partner
of Corixa. In the event that GSK Canada orders Therapies, pursuant to Section
4.3(b) or 4.3(c), to be manufactured at a time when there are no other orders
for Therapies, then GSK Canada shall pay all costs associated with manufacturing
such Therapies, regardless of the number of Therapies ordered. By way of
example, if GSK Canada places an order pursuant to Section 4.3(c) that results
in Nordion manufacturing a batch of Iodine I 131 Tositumomab solely for GSK
Canada, then Corixa shall charge GSK Canada for the Therapies derived from such
batch, an amount that includes (i) all of Nordion's charges for such batch, (ii)
[*] of the Standard Cost of Goods for the Cold Components in each such Therapy,
and (iii) [*] of the Standard Cost of Goods for the Packaged Bulk Drug Substance
used by Nordion to make the Hot Component in each such Therapy.
(c) INCREASED BATCH SIZE CHARGES. In the event
that GSK Canada orders, pursuant to Section 4.3(b), a number of Therapies that
requires a larger batch size to be made than would have been made without GSK
Canada's order, then GSK Canada shall bear, in addition to the amounts set forth
in Section 6.7(a), all incremental costs associated with such increase in batch
size and not recovered in the Standard Cost of Goods.
(d) PAYMENT TERMS. GSK Canada shall pay the
amounts described in this Section 6.7 within 30 days after the date of Corixa's
invoice therefor. Corixa shall send GSK Canada monthly invoices for Cold
Components, Hot Components or Therapies, as applicable, if there is a payment
due for such month.
(e) CREDIT. Corixa shall credit GSK Canada,
against any invoice for Cold Components, Hot Components or Therapies provided to
GSK Canada hereunder for use in a [*] pursuant to Section 3.9, an amount equal
to any payments made to Corixa by [*] for such Cold Components, Hot Components
or Therapies.
6.8 ACCOUNTING FOR EXCESS TOSITUMOMAB. The quantities of
Packaged Bulk Drug Substance that were manufactured by BI Pharma pursuant to GSK
Canada's BI Pharma Forecast but not made into Iodine I 131 Tositumomab shall be
stored by McKesson and/or Nordion until (a) such time as GSK Canada places an
order pursuant to Section 4.3(c)(v) for them to be made into Iodine I 131
Tositumomab, or (b) the expiration of the inventory period specified by Health
Canada (or a shorter time set forth in the Quality Policy Manual), whichever is
sooner. Corixa reserves the right to perform a quarterly assessment of the
amount of GSK Canada-earmarked Tositumomab and Packaged Bulk Drug Substance
being stored by McKesson and Nordion and the length of time that such
Tositumomab and Packaged Bulk Drug Substance has been stored by McKesson and
Nordion. For all such Tositumomab that has been stored for
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more than [*], Corixa reserves the right to invoice GSK Canada for [*] of the
Standard Cost of Goods for such Tositumomab. For all such Packaged Bulk Drug
Substance that has been stored for more than [*], Corixa reserves the right to
invoice GSK Canada for [*] of the Standard Cost of Goods for such Packaged Bulk
Drug Substance. Corixa also reserves the right to invoice GSK Canada for all
costs incurred by Corixa in connection with the storage of such Tositumomab or
Packaged Bulk Drug Substance. GSK Canada shall pay each such invoice within 30
days. If any such Tositumomab or Packaged Bulk Drug Substance is subsequently
converted into one or more Therapies, Corixa's invoice for the purchase of such
Therapies, as calculated in accordance with Section 6.7, shall include a credit
for the amount already paid by GSK Canada with respect to such Tositumomab or
Packaged Bulk Drug Substance.
6.9 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. All payment amounts specified in Canadian dollars in this Agreement
shall be converted into U.S. dollars using the average selling exchange rate for
conversion as published in the Wall Street Journal for the last business day of
each of the last two months which precede the due date for such payment. All
payments hereunder shall be noncreditable (unless otherwise specifically noted)
and nonrefundable, unless required in order to provide for the correction of
mistakes or errors in calculations.
6.10 TAXES. GSK Canada shall be entitled to deduct from
amounts otherwise due and payable hereunder, any withholding taxes in the
Territory, value-added taxes or other taxes, levies or charges with respect to
amounts payable hereunder, other than United States taxes, payable by GSK Canada
(except, with respect to payments made pursuant to Section 6.3, 6.4 or 6.5,
taxes that have already been deducted during the course of calculating Net
Sales), or any taxes required to be withheld by GSK Canada, to the extent GSK
Canada pays to the appropriate governmental authority on behalf of Corixa such
taxes, levies or charges. GSK Canada shall use reasonable efforts to minimize
any such taxes, levies or charges required to be withheld on behalf of Corixa by
GSK Canada. GSK Canada promptly shall deliver to Corixa proof of payment of all
such taxes, levies and other charges, together with copies of all communications
from or with such governmental authority with respect thereto. GSK Canada shall
cooperate with Corixa in efforts required for Corixa to receive any
reimbursement or refund of amounts so paid or withheld, and shall reimburse
Corixa for all out-of-pocket and personnel expenses incurred in connection with
such efforts.
6.11 CURRENCY OF PAYMENT. All dollar amounts contained in
this Agreement are in United States Dollars (US$) unless specifically designated
as Canadian Dollars (CAD$).
6.12 FOREIGN EXCHANGE. Conversion to U.S. dollars of sales
or other payments recorded in local currencies shall be made using the average
selling exchange rate for conversion as published in the Wall Street Journal for
the last business day of each of last two months of the calendar quarter in
which such sales or payments occurred.
6.13 RECORDS; INSPECTION. GSK Canada shall keep complete,
true and accurate books of account and records for the purpose of determining
the payments to be made
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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 be 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. GSK Canada shall promptly pay to
Corixa any unpaid amounts (plus interest) that are discovered in the course of
an inspection conducted under this Section 6.13. Such inspections 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 such inspection, whereupon all costs
relating to the inspection for such period will be paid promptly by GSK Canada.
Corixa shall refund GSK Canada any overpaid amounts that are discovered in the
course of an inspection conducted under this Section 6.13, to the extent that
such overpaid amounts exceed all costs relating to the inspection that led to
the discovery of such overpayment.
6.14 LATE PAYMENT PENALTY. Any payment due under this
Article 6 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.
6.15 SUBLICENSES. In the event GSK Canada grants
sublicenses to others to sell the Product, such sublicenses shall include an
obligation for the sublicensee to account for and report its sales of the
Product on the same basis as if such sales were Net Sales by GSK Canada, and GSK
Canada shall pay to Corixa, with respect to such sales, royalties as if such
sales of the sublicensee were Net Sales of GSK Canada.
7. INTELLECTUAL PROPERTY.
7.1 OWNERSHIP.
(a) Corixa shall own the entire right, title and
interest in and to any and all Product Inventions, and Patents covering such
Product Inventions. GSK Canada hereby assigns to Corixa any and all interest GSK
Canada would otherwise have in each Product Invention which is made solely or
jointly by GSK Canada or its sublicensees during the term of this Agreement. GSK
Canada hereby covenants that it shall obtain from each sublicensee hereunder an
assignment to GSK Canada of any and all interest such sublicensee would
otherwise have in each Product Invention which is made solely or jointly by such
sublicensee; title to such Product Inventions shall pass from GSK Canada to
Corixa pursuant to the preceding sentence. For clarity, for purpose of this
Section 7.1(a), the term sublicensee shall not include physicians or other end
users who administer the Product to patients. GSK Canada and its sublicensees
and the inventors affiliated with GSK Canada or its sublicensees shall execute
any documents required by Corixa to confirm Corixa's ownership of such Product
Inventions and shall cooperate with all efforts by Corixa to obtain Patents
claiming such Product Inventions. Each Party shall own the entire right, title
and interest in and to any and all of its Sole Other
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Inventions, and Patents covering such Sole Other Inventions. GSK Canada and
Corixa shall each own an undivided one-half interest in and to any and all Joint
Other Inventions and Patents covering such Joint Other Inventions (the "Joint
Other Patents"), with inventorship to be determined under the patent laws of the
United States. GSK Canada 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.
(b) GSK Canada hereby covenants that it will
[*].
7.2 DISCLOSURE. GSK Canada shall submit a written report
to Corixa within 60 days of the end of each calendar quarter describing any
Product Invention arising during the prior quarter. Corixa and GSK Canada shall
each submit a written report to the other within 60 days of the end of each
quarter describing any Joint Other Invention arising during the prior quarter
which it believes may be patentable. The Parties shall mutually decide whether
to file a patent application for a Joint Other Invention, as discussed in
Section 7.3.
7.3 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 the filing,
prosecution and maintenance of all Patents claiming Product Inventions and shall
bear all expenses associated therewith with respect to the Corixa Territory, to
the extent that such expenses are not reimbursed by GSK Canada pursuant to
Section 7.3(d).
(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.
(d) Subject to Sections 7.3(e) and 7.3(f), GSK
Canada shall reimburse Corixa for the following percentages of expenses incurred
by Corixa after the Effective Date with respect to the filing, prosecution and
maintenance of Patents disclosing or claiming Corixa Intellectual Property
Rights:
(i) [*] of the expenses incurred by
Corixa for the filing and prosecution (solely to the extent that such
prosecution is prior to the filing date of the related PCT application) of each
United States patent application disclosing or claiming Corixa Intellectual
Property Rights, provided that such application is intended to be used as the
basis for a priority date for a PCT patent application claiming such Corixa
Intellectual Property Rights;
(ii) [*] of the expenses incurred by
Corixa for the filing and prosecution of each PCT patent application claiming
Corixa Intellectual Property Rights;
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(iii) [*] of the expenses incurred by
Corixa after the Effective Date for the prosecution and maintenance of each
Patent set forth on Exhibit A as of the Effective Date and all issued Patents
arising therefrom; and
(iv) [*] of the expenses incurred by
Corixa for the filing, prosecution and maintenance of (A) each Canadian patent
application filed after the Effective Date and arising from the entry into the
national phase in Canada of a PCT patent application claiming Corixa
Intellectual Property Rights and (B) all issued Patents arising therefrom.
(e) If Corixa receives reimbursement from Third
Parties or SB for expenses described in Section 7.3(d)(i) or 7.3(d)(ii) and the
sum of such reimbursement plus the reimbursement that GSK Canada is obligated to
make pursuant to such Section would exceed [*] of such expenses, then Corixa
shall reduce the amount owed by GSK Canada pursuant to such Section to the
extent necessary to make such sum is equal to or less than [*] of such expenses.
(f) If GSK Canada decides, without invoking
patent exhaustion or any other principle related to its purchase of the Product
from Corixa, that it does not need to retain its license under Section 2.1(a)
with respect to one or more Patents claiming Corixa Intellectual Property
Rights, then GSK Canada may provide Corixa with written notice of such decision.
If Corixa agrees that GSK Canada does not require a license to such Patents to
perform GSK Canada's obligations under this Agreement without infringing such
Patents, then it shall inform GSK Canada in writing and such Patents shall be
come "Opt-Out Patents." GSK Canada shall not have the obligation to reimburse
Corixa for any expenses associated with the Opt-Out Patents that are incurred
after the date when Corixa receives such GSK Canada's notice. The Opt-Out
Patents, together with the corresponding PCT patent application and all United
States patent application(s) to which such corresponding PCT patent application
claims priority, shall be excluded from the definition of Corixa Intellectual
Property Rights. If Corixa believes in good faith that GSK Canada requires a
license to such Patents to perform its obligations under this Agreement, then it
shall inform GSK Canada in writing and such dispute shall be resolved as set
forth in Section 13.1, with the understanding that patent exhaustion or any
other principle related to GSK Canada's purchase of the Product from Corixa
shall not be a sufficient basis for a determination that GSK Canada does not
require a license to such Patents to perform GSK Canada's obligations under this
Agreement without infringing such Patents. If such dispute is resolved in GSK
Canada's favor, then such Patents shall be come "Opt-Out Patents." GSK Canada
shall not have the obligation to reimburse Corixa for any expenses associated
with such Opt-Out Patents that are incurred after the date that such dispute is
resolved. Such Opt-Out Patents, together with the corresponding PCT patent
application and all United States patent application(s) to which such
corresponding PCT patent application claims priority, shall be excluded from the
definition of Corixa Intellectual Property Rights. If such dispute is resolved
in Corixa's favor, GSK Canada shall continue to pay patent expenses in
accordance with Section 7.3(d); failure to pay such expenses shall be deemed a
material breach and shall give Corixa the right to terminate this Agreement in
accordance with Section 10.6. This Section 7.3(f) shall not apply to the Patents
set forth on Exhibit A as of the Effective Date and all issued Patents arising
therefrom.
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7.4 ENFORCEMENT OF PATENT RIGHTS AND DEFENSE OF PATENT
INVALIDITY CLAIMS.
(a) If any Party becomes aware of any Third
Party activity in the Territory that (i) infringes a Patent in the Corixa
Intellectual Property Rights and (ii) falls within the scope of the license
granted to GSK Canada in Section 2.1(a), then that Party shall give prompt
written notice to the other Parties within thirty (30) days after having
knowledge of such infringement. Corixa shall have the primary right, but not the
obligation, to institute, prosecute or control any action or proceeding, with
respect to such Third Party activity, by counsel of its own choice.
(b) The notification required by Section 7.4(a)
applies in all cases. All other provisions of this Section 7.4 apply to:
(i) All Patents that are in the Corixa
Intellectual Property Rights on the Effective Date and that Corixa has or
obtains the right to enforce. With respect to those Patents that are in the
Corixa Intellectual Property Rights on the Effective Date but that Corixa does
not have the right to enforce, Corixa shall use commercially reasonable efforts
to obtain such right after the notice described in Section 7.4(a) is provided;
and
(ii) All Patents licensed pursuant to
Section 2.6 of this Agreement, except to the extent that Corixa's rights under
such Patents are only by way of a license that denies Corixa or its sublicensee
the right to enforce such Patent. Corixa shall use commercially reasonable
efforts to avoid such a license that denies such rights.
(c) If Corixa institutes an action or proceeding
described in Section 7.4(a), then (i) GSK Canada shall have the right (at its
own expense) to participate in such action or proceeding and to be represented
by counsel of its own choice, and (ii) GSK Canada shall, at the request and
expense of Corixa, be joined as a party to the suit. Any damages, accounting for
profits, payment in settlements, or other monetary recovery arising from such an
action or proceeding shall be applied, after deduction of any amounts owed to
the Third Party licensor(s) (if any) of such Patent, first to reimburse the
reasonable costs and expenses of the Parties in connection with such action or
proceeding, on a pro rata basis if the total is insufficient to cover all
reasonable costs and expenses, with any balance divided between the Parties with
[*] going to Corixa and [*] going to GSK Canada.
(d) If Corixa fails to bring such an action or
proceeding described in Section 7.4(a) within a period of one hundred twenty
(120) days after the notice described in Section 7.4(a) is provided, then GSK
Canada shall have the right, but not the obligation, to bring and control such
an action or proceeding, with respect to such Third Party activity, 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, accounting for profits or settlements, or monetary award recovered
shall be applied to reimburse the reasonable costs and expenses of the Parties
in connection with such litigation, on a pro rata basis if the total is
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insufficient to cover all reasonable costs and expenses, and the balance shall
be divided with [*] going to GSK Canada and [*] going to Corixa.
(e) The allocation of rights and
responsibilities set forth in Sections 7.4(a), 7.4(c) and 7.4(d) shall also
apply to the defense of any suit alleging that a Patent in the Corixa
Intellectual Property Rights is invalid, with Corixa having the primary right,
but not the obligation, to defend such a suit and GSK Canada having the right to
do so if Corixa does not take on such defense before the fifth-last day allowed
by law for filing a statement of defense. If GSK Canada invokes that right to
file a statement of defense or of intent to defend, Corixa shall have until one
hundred and twenty (120) days after the suit was filed to take over the defense.
If a claim of patent invalidity is made in the course of a patent infringement
suit brought by Corixa or GSK Canada pursuant to Section 7.4(c) or 7.4(d), the
Party that brought such suit shall be responsible for defending such claim and
the role of the other Parties with respect to such claim shall be the same as
its role, pursuant to Section 7.4(c) or 7.4(d) (whichever is applicable), with
respect to such suit.
(f) If GSK Canada receives a notice of
allegation under the Patented Medicines (Notice of Compliance) Regulations, then
GSK Canada shall give written notice to the Corixa within seven (7) days after
receipt of the notice. Corixa shall have the primary right, but not the
obligation, to institute a proceeding in response to that allegation by counsel
of its own choice, and if necessary may do so in the name of GSK Canada. If
Corixa has not instituted such a proceeding within thirty (30) days after the
date of the notice of allegation, GSK Canada shall have the right, but not the
obligation, to institute a proceeding in response to that allegation by counsel
of its own choice, and if necessary may do so in the name of Corixa. The other
Parties shall fully co-operate with the Party that institutes such a proceeding,
and shall execute such documents and do such acts and things as, in the
reasonable opinion of the Party that instituted the proceeding, may be necessary
or desirable for the purposes of the proceeding. If a Party institutes such
proceeding under the written objection of the other Parties, then such
instituting Party (i) shall be responsible for all costs of the proceeding,
including costs incurred by the other Parties in the course of co-operating, and
(ii) shall indemnify the other Parties for any damages awarded against the other
Parties on account of the proceeding. If no such written objection exists at the
time a Party institutes such proceeding, then the Parties shall share equally
all reasonable costs of the proceeding and any damages that may be awarded
against either Corixa or GSK Canada on account of the proceeding.
(g) Neither Corixa nor GSK Canada shall settle
or terminate any proceeding or litigation described in this Section 7.4 in a
manner that affects the rights of the other Party without the consent in writing
of the other Party, which shall not be unreasonably withheld or delayed.
7.5 DEFENSE OF THIRD PARTY PATENT INFRINGEMENT CLAIMS.
(a) Each Party shall give prompt written notice
to the other Parties upon becoming aware of any allegation that the manufacture,
use, importation, offer for sale or sale of Product in the Territory infringes
the Patent rights of a Third Party in the Territory. This
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applies to both formal allegations by way of legal action, and informal direct
or indirect allegations in writing. The Parties shall promptly evaluate the
merits of such allegation and decide how they wish to respond to such
allegation. If any Party reasonably believes (i) that the Third Party could
probably obtain an injunction to halt the manufacture, use, import, offer for
sale or sale of Product in the Territory or (ii) that continued manufacture,
use, import, offer for sale or sale of Product in the Territory would expose any
Party to a substantial risk of liability for damages, the Parties shall discuss
reasonably and in good faith whether the Parties shall seek a license to such
Third Party Patent or whether the Parties should voluntarily halt their
activities under this Agreement.
(b) If the Parties decide to seek a license to
such Third Party Patent, then they shall proceed in accordance with Section 2.6.
(c) If the Parties agree to voluntarily halt
their activities under this Agreement, then they shall halt such activities
until they agree otherwise, an event of Force Majeure shall be deemed to have
occurred, all Parties shall be entitled to invoke the provisions of Xxxxxxx
00.0, xxx XXX Xxxxxx shall be entitled to suspend payments required by this
Agreement for as long as the deemed Force Majeure continues. After such deemed
Force Majeure has continued for [*], each Party shall be entitled to terminate
this Agreement pursuant to Section 10.7(b).
(d) If Corixa and GSK Canada disagree whether
the activities under this Agreement should be halted, then the Party that wishes
to halt activities may do so unless the other Party agrees to indemnify the
first Party with respect to all liabilities associated with continuing such
activities.
(i) If the other Party does not agree
to indemnify the first Party, then the first Party shall be entitled to halt its
activities under this Agreement. If the first Party does so, then the other
Party shall also be entitled to halt its activities under this Agreement, an
event of Force Majeure shall be deemed to have occurred, all Parties shall be
entitled to invoke the provisions of Xxxxxxx 00.0, xxx XXX Xxxxxx shall be
entitled to suspend payments required by this Agreement for as long as the
deemed Force Majeure continues. After such deemed Force Majeure has continued
for [*], any Party shall be entitled to terminate this Agreement pursuant to
Section 10.7(b).
(ii) If the other Party agrees to
indemnify the first Party, then all Parties shall continue to carry out all
activities under this Agreement (unless such Third Party obtains an injunction
prohibiting such activities, in which case Section 7.5(f) shall apply) and the
indemnifying Party shall control and bear all expenses associated with, the
defense of any infringement suit brought against any or all of the Parties by
such Third Party with respect to such Patent in the Territory and shall pay all
awards or settlements arising from such suit. The indemnified Party shall, at
the expense of the indemnifying Party, provide all assistance reasonably
requested by the indemnifying Party with respect to the defense of such suit.
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(e) If the Parties agree to continue
their activities under this Agreement, they shall cooperate diligently with each
other in defending against any such allegation, and shall provide to each other
documentation and persons necessary to assist in such defense. Before legal
action commences, each Party shall bear its own costs for dealing with the
allegation. After legal action commences, GSK Canada shall have the primary
responsibility for defending the legal action at its own cost, regardless of
whether Corixa is named as a party to the action, but GSK Canada shall be
entitled to reduce all royalty payments it owes pursuant to Section 6.3 and all
milestone payments it owes pursuant to Section 6.2 by up to [*] percent each
until one-half of GSK Canada's cost of defending such action has been deducted
from such payments. If only one Party is named in the legal action, it may add
the other Parties as co-defendants or third parties if the other Parties'
presence is required by law or gives substantial juridical advantage to the
defense. Corixa shall have the right to participate in such action and to be
represented, at its own expense, by counsel of its own choice. Each Party shall
pay fifty percent (50%) of all court-ordered assessments of damages and costs or
payments in settlement. GSK Canada may not settle or terminate such a legal
action in any manner that affects the rights of Corixa without the written
consent of the Corixa.
(f) If a Third Party obtains an
injunction to halt GSK Canada's sale of the Product in the Territory and/or
Corixa's supply of the Product to GSK Canada, the Parties shall comply with such
injunction and shall cease all activities under this Agreement, an event of
Force Majeure shall be deemed to have occurred, all Parties shall be entitled to
invoke the provisions of Xxxxxxx 00.0, xxx XXX Xxxxxx shall be entitled to
suspend payments required by this Agreement for as long as the deemed Force
Majeure continues. After such deemed Force Majeure has continued for eighteen
(18) months, each Party shall be entitled to terminate this Agreement pursuant
to Section 10.7(b).
7.6 PATENT MARKING. GSK Canada shall include, on the
Product label and packaging in the Territory and all promotional materials
regarding the Product in the Territory, all information, regarding the Patents
in the Territory in the Corixa Intellectual Property Rights that claim the
Product or its manufacture or use, that is necessary or desirable to preserve
the rights of the Parties to recover all possible damages from Third Party
infringers of such Patents.
8. TRADEMARK MATTERS.
8.1 OWNERSHIP OF THE LICENSED MARKS. GSK Canada agrees
and acknowledges that it has no interest, right, or title in the Licensed Marks
other than the license granted in Section 2.1(b) and that it will not obtain any
rights in or to the Licensed Marks through their use in connection with the
Product. The Parties further agree that Corixa is and will continue to be the
sole and exclusive owner of all right, title and interest in and to each
Licensed Xxxx in any form or embodiment thereof and agree that all goodwill
associated with or attached to the Licensed Marks arising out of the use thereof
by GSK Canada shall inure to the benefit of Corixa.
8.2 NO CONTEST. GSK Canada agrees that it will neither
contest, oppose or challenge, nor assist any party in contesting, opposing or
challenging, Corixa's ownership of the
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Licensed Marks or the distinctiveness or validity of the Licensed Marks. GSK
Canada agrees that it will not at any time do or suffer to be done any act or
thing that will in any way impair Corixa's ownership of or rights in and to the
Licensed Marks or any registration thereof. GSK Canada will not register or
attempt to register any Licensed Xxxx in the Territory nor oppose Corixa's
registration of any Licensed Xxxx, alone or with other words or designs, in the
Territory. GSK Canada shall, on the reasonable request of Corixa, give Corixa or
an authorized representative thereof necessary information as to the use of the
Licensed Marks pursuant to this Agreement which Corixa may require and will
render any assistance reasonably required by Corixa in maintaining the
registrations of the Licensed Marks.
8.3 USE OF THE LICENSED MARKS. GSK Canada agrees to
comply with all applicable laws and regulations pertaining to the proper use and
designation of the Licensed Marks. Additionally, GSK Canada shall:
(a) use the Licensed Marks upon or in relation
to the Product only in such manner that the distinctiveness, reputation, and
validity of the Licensed Marks shall not be impaired. Without prejudice to the
generality of the foregoing, GSK Canada shall ensure in particular that the
Licensed Marks are accompanied by words accurately describing the nature of the
goods or services to which it relates, and ensure that the Licensed Marks are
displayed as set forth in Exhibit C (or any update thereto);
(b) subject to Section 8.3(g), where space and
law permit, comply with the reasonable requirements of Corixa as to the form,
manner, scale and context of use of the Licensed Marks, the use of the
statements to accompany them, as well as the containers, packaging and related
marketing and promotional materials to be used for the Product.
(c) display the proper form of trademark and
service xxxx notice associated with each Licensed Xxxx in accordance with
instructions received from Corixa;
(d) subject to Section 8.3(g), where space and
law permit, include, on any item which bears a Licensed Xxxx, a statement
identifying Corixa as the owner of such Licensed Xxxx and stating that GSK
Canada is an authorized user of such Licensed Xxxx;
(e) not conduct, without the written consent of
Corixa, the whole or any part of its business under a business name or trading
style which incorporates any of the Licensed Marks or which in the opinion of
Corixa might impair the validity, reputation or distinctiveness of any of the
Licensed Marks;
(f) neither use nor display any of the Licensed
Marks in such relation to any other xxxx or marks owned by any Third Party, GSK
Canada or an Affiliate of GSK Canada as to suggest that the multiple marks
constitute a single or composite trademark, service xxxx, or are under the same
proprietorship; and
(g) where space is limiting, GSK Canada shall
propose to Corixa alternative(s) to the requirements of Sections 8.3(b) and
8.3(d), as applicable, that fit within the available space and achieve, to the
extent possible, the goals of Sections 8.3(b) and 8.3(d), as applicable, and GSK
Canada shall use the alternative(s) approved by Corixa.
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8.4 OBTAINING AND MAINTAINING REGISTRATIONS.
(a) The Parties intend the Licensed Marks to be
the same as the trademarks used in the United States with respect to the
Product. In the event that Corixa's efforts to register in the Territory a
trademark listed on Exhibit C are not successful with respect to the Product,
then Corixa may update Exhibit C to list any substitute trademark(s) applied for
by Corixa in the Territory for use in conjunction with the Product. Corixa may
also update Exhibit C periodically to reflect changes in registration status.
(b) If GSK Canada wants a Potential Licensed
Xxxx to be applied for registration in the Territory, it shall notify Corixa in
writing by [*]. Corixa shall file such application in the Territory by [*] and
such application and any resulting registration shall become a Licensed Xxxx
upon such filing (and shall be added to Exhibit C). If Corixa files a
registration application in the Territory by [*] for any other Potential
Licensed Xxxx, it shall notify GSK Canada in writing and such application and
any resulting registration shall become a Licensed Xxxx upon such filing (and
shall be added to Exhibit C). If the Parties at any time decide to pursue any
other trademarks in the Territory for use in connection with the Product, such
trademarks shall be added to Exhibit C and shall thereby become Licensed Marks.
(c) Corixa shall be responsible for the
registration of the Licensed Marks and maintenance of the Licensed Marks after
their registration, including, but not limited to, filing all necessary
maintenance and use documents, applying for renewal, and payment of any required
periodic taxes or fees due in connection with such registration. Provided that
GSK Canada is using such Licensed Xxxx in connection with the Product or is
reimbursing Corixa for all registration and maintenance costs it incurs with
respect to such Licensed Xxxx, Corixa shall not allow such Licensed Xxxx
registration to lapse, or the application for registration of such Licensed Xxxx
to be abandoned, unless such application is rejected. Corixa may invoice GSK
Canada, in which case GSK Canada shall promptly pay, for reimbursement of costs
incurred by Corixa after the Effective Date in relation to obtaining or
maintaining the registration of: (i) the Licensed Xxxx "BEXXAR", (ii) each
former Potential Licensed Xxxx that became a Licensed Xxxx at the request of GSK
Canada, and (iii) any other Licensed Xxxx for which GSK Canada agreed to pay
such costs when the Parties agreed to add such trademark to Exhibit C.
(d) Corixa shall execute any required documents,
to provide upon request any required records, and otherwise to cooperate fully
with GSK Canada as may be necessary to accomplish the recordal of the license in
Section 2.1(b) in the Territory if GSK Canada seeks such recordal. In such
event, the expenses for recordal will be borne by GSK Canada.
(e) GSK Canada shall execute any documents as
shall reasonably be required by Corixa to confirm Corixa's ownership of the
Licensed Marks or to otherwise give effect to the provisions of this Article 8.
8.5 QUALITY CONTROL. The nature and quality of the
Licensed Product, and all advertising and promotional uses of the Licensed Marks
by GSK Canada, shall conform to or
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exceed industry standards during such period for products similar to the
Licensed Product. GSK Canada shall permit Corixa or its duly authorized
representative at all reasonable times, and on reasonable notice, to enter the
premises of GSK Canada for the purpose of inspecting the Licensed Product and
shall at the request of the Corixa or such authorized representative furnish, at
GSK Canada's expense, such samples of the Licensed Product for inspection and
analysis as may reasonably be requested.
8.6 ENFORCEMENT OF LICENSED MARKS.
(a) If any Party becomes aware of actual or
threatened infringement in the Territory of any Licensed Xxxx or of a xxxx or
name confusingly similar to any Licensed Xxxx, such Party shall promptly so
notify the other Parties in writing. Corixa shall have the first right, but not
the obligation, to bring infringement or unfair competition actions in the
Territory involving a Licensed Xxxx. Corixa shall have sole control of the
conduct of any such actions which it brings. Corixa shall bear the entire cost
and expense associated with such action, and any recovery or compensation
resulting from such proceeding, including without limitation non-monetary
rights, shall belong entirely to Corixa.
(b) If Corixa fails to take action against such
threatened or actual infringement with respect to any Licensed Xxxx other than
"POWERED BY CORIXA", within a reasonable period and in any case not less than
thirty (30) days, the Parties shall meet to discuss whether Corixa intends to
proceed and whether steps should be taken to preserve rights, such as filing
notices or seeking extensions of time for responses. If Corixa declines to
proceed, or if GSK Canada reasonably and in good faith believes that Corixa will
not proceed within time limits effective for preserving the full value of such
Licensed Xxxx, GSK Canada may serve written notice to Corixa that GSK Canada
intends to proceed. At any time after the service of such notice, GSK Canada may
thereafter take such action as it deems necessary to enforce its exclusive
rights in and to such Licensed Xxxx in the Territory, including without
limitation the right, but not the obligation, to bring, at its own expense, an
infringement action or file any other appropriate action or claim related to
infringement of such Licensed Xxxx against any Third Party. Corixa shall, at the
request and expense of GSK Canada, cooperate and provide reasonable assistance
in any action described in this Section 8.6(b) and, if required by law, join
such action. In such events, the expenses for enforcement will be borne by GSK
Canada, and GSK Canada shall be entitled to keep [*] of damages recovered by
court order or by settlement (after the deduction of GSK Canada's enforcement
expenses net of any recovery of such expenses from the Third Party), and shall
pay the remaining [*] to Corixa. GSK Canada shall not settle or accept any
settlement from any Third Party in connection with the adverse use of any
Licensed Xxxx without the prior written consent of Corixa (such consent not to
be unreasonably withheld).
8.7 THIRD PARTY TRADEMARK LITIGATION.
(a) Each Party shall give prompt written notice
to the other Parties upon becoming aware of any challenge or likely challenge to
the Licensed Marks in the Territory. Such challenges may be: (i) an allegation
that any activity involving a Licensed Xxxx
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infringes the trademark rights of a Third Party in the Territory, (ii) an
allegation that a Licensed Xxxx is invalidly registered, or (iii) an allegation
that a Licensed Xxxx should be expunged from the Register of Trademarks. The
Parties shall cooperate diligently with each other in defending against any
challenge, and shall provide to each other documentation and persons necessary
to assist in such defense.
(b) Before legal action commences with respect
to a Licensed Xxxx other than (i) "POWERED BY CORIXA" or (ii) a former Potential
Licensed Xxxx that became a Licensed Xxxx without any request from GSK Canada,
each Party shall bear its own costs for dealing with the challenge. After such
legal action commences, Corixa shall have the primary right, but not the
obligation, for defending such legal action at its own cost, regardless of
whether GSK Canada is named as a party to the action. If only one Party is named
in the legal action, it may add the other Parties as co-defendants or third
parties if the other Parties' presence is required by law or gives substantial
juridical advantage to the defense. If Corixa takes control of the defense of
such legal action, GSK Canada shall have the right (at its own expense) to
participate in such action or proceeding and to be represented by counsel of its
own choice. Each Party shall pay fifty percent (50%) of all court-ordered
assessments of damages and costs or payments in settlement, unless Corixa
agreed, pursuant to Section 8.8, to indemnify GSK Canada with respect to such
suit (in which case GSK Canada's participation in such suit shall be limited to
that requested by Corixa at Corixa's expense). Corixa may not settle or
terminate such a legal action in any manner that affects the rights of GSK
Canada without the written consent of the GSK Canada (which shall not be
unreasonably withheld).
(c) If Corixa does not take control of the
defense of a legal action described in Section 8.7(b) before the fifth-last day
allowed by law for filing a statement of defense, GSK Canada shall have the
right but not the obligation to defend such legal action at its own cost. If GSK
Canada invokes that right to file a statement of defense or of intent to defend,
Corixa shall have until one hundred and twenty (120) days after the suit was
filed to take over the defense. When GSK Canada is conducting such a defense,
GSK Canada shall be entitled to reduce all royalty payments it owes pursuant to
Section 6.3 and all milestone payments it owes pursuant to Section 6.2 by up to
[*] percent each until [*] of GSK Canada's cost of defending such action has
been deducted from such payments. Corixa shall have the right (at its own
expense) to participate in such action and to be represented by counsel of its
own choice. Each Party shall pay fifty percent (50%) of all court-ordered
assessments of damages and costs or payments in settlement, unless GSK Canada
agreed, pursuant to Section 8.8, to indemnify Corixa with respect to such suit
(in which case Corixa's participation in such suit shall be limited to that
requested by GSK Canada at GSK Canada's expense). GSK Canada may not settle or
terminate such a legal action in any manner that affects the rights of Corixa
without the written consent of the Corixa (which shall not be unreasonably
withheld).
(d) Corixa shall have the sole right, but not
the obligation, to defend, at its expense, any legal action described in Section
8.7(a) with respect to "Powered by Corixa" or a former Potential Licensed Xxxx
that became a Licensed Xxxx without any request from GSK Canada. Corixa shall
pay all court-ordered assessments of damages and cost or payments in settlement
of such action.
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8.8 OBLIGATION TO USE LICENSED MARKS. Subject to Section
8.3(b) and the rest of this Xxxxxxx 0.0, XXX Xxxxxx and all of its sublicensees
permitted by Section 2.1(c) are required to use the Licensed Marks "BEXXAR" and
"POWERED BY CORIXA" and all other Licensed Marks agreed upon by the Parties, on
and in connection with the Product in the Territory at all times for all
purposes and in all contexts. If GSK Canada wishes to discontinue using one of
these Licensed Marks in connection with the Product in the Territory, GSK Canada
shall have a good faith discussion with Corixa about the reasons it desires to
discontinue such use and the likely effects on all Parties and their Affiliates.
Corixa shall consider such reasons in good faith and shall agree to such
discontinuation if it reasonably believes that such reasons are reasonable and
the likely effects are acceptable. If such reason was GSK Canada's good faith
concern that continued use of such Licensed Xxxx in connection with the Product
presents an unacceptable level of potential liability for the infringement of a
Third Party's trademark, then Corixa may only require such continued use if it
indemnifies GSK Canada with respect to a trademark infringement action with
respect to such Licensed Xxxx pursuant to Section 8.7. Similarly Corixa may
request that GSK Canada discontinue use of a Licensed Xxxx in connection with
the Product in the Territory if it has a good faith concern that such continued
use presents an unacceptable level of potential liability for the infringement
of a Third Party's trademark, then GSK Canada may only continue to use such
Licensed Xxxx if it indemnifies Corixa with respect to a trademark infringement
action with respect to such Licensed Xxxx pursuant to Section 8.7.
8.9 EXCLUSIVITY OF TRADEMARK. Corixa shall not use in
Canada, or authorize others to use in Canada, the Licensed Xxxx "BEXXAR" or a
confusingly similar trademark in association with any goods or services, except
pursuant to this Agreement or pursuant to agreements performed in the Territory
for the benefit of GSK Canada or the Corixa Territory. GSK Canada acknowledges
that, pursuant to the Nordion Agreement, Nordion uses in Canada the Licensed
Xxxx "BEXXAR" with Corixa's permission in conjunction with manufacturing and
labeling, on behalf of Corixa or a sublicensee of Corixa, Iodine I 131
Tositumomab intended for use in the Territory or the Corixa Territory, and that
such use is not a breach of the previous sentence. GSK Canada further
acknowledges that Corixa may participate in one or more Cross-Territory Clinical
Trials and that use of the Licensed Xxxx "BEXXAR" in Canada in connection with a
Cross-Territory Clinical Trial is not a breach of the first sentence of this
Section 8.9.
8.10 USE OF MARKS OTHER THAN LICENSED MARKS. GSK Canada
shall not use, on or with respect to the Product in the Territory, any trademark
owned by GSK Canada (other than the GSK Canada name) or a Third Party without
obtaining the prior written approval of Corixa, which approval shall not be
unreasonably withheld. If GSK Canada wishes to use, on or with respect to the
Product in the Territory, any trademark owned by Corixa that is not a Licensed
Xxxx, the Parties shall discuss the matter and GSK Canada shall not use such
trademark until such time as Corixa grants GSK Canada a license (on mutually
agreeable terms) to do so.
9. CONFIDENTIALITY.
9.1 NONDISCLOSURE OF CONFIDENTIAL INFORMATION. All
Information disclosed by one Party to another 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
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Agreement expires or terminates, a Party receiving Confidential Information of
another Party will (a) 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), (b) not disclose such Confidential Information to any Third
Party without prior written consent of the disclosing Party, except for
disclosures made in confidence to any Third Party manufacturer of Tositumomab or
Iodine I 131 Tositumomab, and (c) not use such Confidential Information for any
purpose except those permitted by this Agreement.
9.2 EXCEPTIONS. The obligations in Section 9.1 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
(e) Has been independently developed by the
receiving Party without the aid, application or use of Confidential Information.
9.3 AUTHORIZED DISCLOSURE. A Party may disclose the
Confidential Information belonging to another Party to the extent such
disclosure is reasonably necessary in the following instances:
(a) Filing or prosecuting Patents relating to
Inventions or the Product;
(b) Regulatory filings;
(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, and for greater certainty, to
investigators (in the case of sharing CIBs, EISRs, research results, etc.) 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 9.
In addition, Corixa shall have the right to disclose Confidential
Information 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
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parties to a written confidentiality agreement on terms at least equivalent to
that set forth in this Article 9.
The Parties acknowledge that the terms of this Agreement shall be
treated as Confidential Information of all 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 9.
In addition, a copy of this Agreement may be filed by Corixa with the Securities
and Exchange Commission (the "SEC"). Corixa shall be entitled to make such a
required filing, provided that it requests confidential treatment of at least
the commercial terms and sensitive technical terms hereof to the extent such
confidential treatment is reasonably available to Corixa. In the event of any
such filing, Corixa will provide GSK Canada with a copy of the Agreement marked
to show provisions for which Corixa intends to seek confidential treatment and
shall reasonably consider and incorporate GSK Canada's comments thereon to the
extent such comments are (A) consistent with the legal requirements governing
redaction of information from material agreements that must be publicly filed
and (B) received by Corixa a reasonable amount of time prior to the filing date.
GSK Canada recognizes that United States laws and SEC policies and regulations
to which Corixa is subject may require Corixa to disclose publicly certain terms
of this Agreement that neither of the parties wishes to disclose, and that
Corixa is entitled hereunder to make such required disclosures.
In any event, the Parties agree to take all reasonable action to avoid
disclosure of Confidential Information except as permitted hereunder.
9.4 TERMINATION OF PRIOR AGREEMENTS. This Agreement
supersedes all non-disclosure agreements entered into by the Parties prior to
the Effective Date, except for the Confidential Information and Non-Disclosure
Agreement made as of February 4, 2003 by and between GSK Canada, Corixa
Corporation, SB and Xxxxxxx Pharmaceutical (the "Four-Way NDA"). All Information
exchanged between the Parties prior to the Effective Date, except for
Information exchanged pursuant to the Four-Way NDA, shall be deemed Confidential
Information and shall be subject to the terms of this Article 9. Notwithstanding
Paragraph 11 of the LOI (which paragraph shall not survive termination of the
LOI pursuant to Section 13.4), all Information exchanged between the Parties
pursuant to the LOI shall be deemed Confidential Information and shall be
subject to the terms of this Article 9, rather than the terms of the Four-Way
NDA.
9.5 PUBLICITY. The Parties have agreed upon the content
of a joint public announcement of the execution of this Agreement; such
announcement shall be made upon or after the execution of this Agreement. 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 all 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 Parties, although the other Parties shall be given prompt
notice of any such legally required disclosure and to the extent practicable the
disclosing Party shall provide the other Parties an opportunity to comment on
the proposed disclosure.
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9.6 PUBLICATIONS. GSK Canada 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 Xxxxxxx 0.0, XXX
Xxxxxx agrees to provide Corixa the opportunity to review any proposed
abstracts, manuscripts or presentations which relate to the Product at least 30
days prior to its intended submission for publication or presentation and
agrees, upon request, not to submit any such abstract or manuscript for
publication or make any such presentation 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. All Parties understand that a reasonable
commercial strategy may require delay of publication or presentation of
information for filing of patent applications. The Parties agree to review and
consider delay of publication or presentation and filing of patent applications
under certain circumstances. GSK Canada shall follow the procedures set forth in
this Section 9.6 with respect to each verbal presentation that contains
information not previously reviewed and approved by Corixa pursuant to this
Section 9.6. No Party shall have the right to publish or present Confidential
Information of another Party which is subject to Section 9.1. Nothing contained
in this Section 9.6 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.
10. TERM AND TERMINATION.
10.1 TERM. This Agreement shall become effective on the
Effective Date and shall remain in effect until it is terminated pursuant to
Section 10.2, 10.3, 10.4, 10.5, 10.6, 10.7 or 13.18.
10.2 TERMINATION FOR EXCLUSIVITY BREACH. If the events set
forth in Section 2.7 occur, then Corixa may terminate this Agreement by
providing written notice thereof to GSK Canada. Such termination shall be
effective six (6) months after GSK Canada's receipt of such notice.
10.3 TERMINATION FOR DILIGENCE FAILURE. If GSK Canada
fails to achieve any of the diligence obligations set forth in Section 3.4(b) by
the date specified (including any extensions of such date provided in such
Section 3.4(b) as a result of Force Majeure), then Corixa may terminate this
Agreement by providing written notice thereof to GSK Canada. Such termination
shall be effective upon GSK Canada's receipt of such notice.
10.4 MUTUAL TERMINATION FOR CAUSE. If any of the events
described in this Section 10.4 occur, then the Party having knowledge of such
occurrence shall immediately provide written notice thereof to the other Parties
and each Party may terminate this Agreement by providing written notice of
termination to the other Parties, which termination notice shall be provided no
more than sixty (60) days after the notice of occurrence. Failure to provide
such notice of occurrence shall not prevent any Party from terminating this
Agreement in accordance with the terms of this Section 10.4. If only one Party
has knowledge of the occurrence of an event described in this Section 10.4 and
such Party fails to provide immediate notice of its occurrence, then such Party
shall only have sixty (60) days from the date of occurrence of such event in
which to notify the other Parties that it is terminating this Agreement, whereas
each of the other Parties shall have sixty (60) days from the date it becomes
aware of the occurrence of
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such event in which to notify the first Party that it is terminating this
Agreement. If all Parties have knowledge of the occurrence of an event described
in this Section 10.4 and none of the Parties provides immediate notice of its
occurrence, then each Party shall only have sixty (60) days from the date of
occurrence of such event in which to notify the other Parties that it is
terminating this Agreement.
(a) Corixa receives written notice from SB that
SB is terminating the SB Agreement;
(b) Despite GSK Canada's Diligent Efforts to
achieve reimbursement of the Product in the provinces of Ontario, Quebec,
British Columbia and Alberta, such reimbursement is not achieved in one or more
of such provinces by twenty-four (24) months after Initial Approval;
(c) The price set by the Patented Medicines
Prices Review Board for the Product is less than CAD $[*] and GSK Canada has
exhausted all rights to appeal such price;
(d) [*] sets the price of [*] in the Territory
at or below CAD $[*];
(e) GSK Canada receives notice from Corixa,
pursuant to Section 4.12(e)(iii), that Corixa is terminating its supply
obligations under Article 4;
(f) There is a Force Majeure event that results
in an interruption of Product supply that persists for at least ninety (90)
days; or
(g) Despite GSK Canada's Diligent Efforts to
promote and sell the Product in the Territory, fewer than [*] patients are
treated with the Product in the Territory during the third (3rd) year after
Initial Approval.
Any termination pursuant to this Section 10.4 shall be effective six (6) months
after the other Party's receipt of the terminating Party's notice of
termination, except for termination pursuant to Section 10.4(a) which shall be
effective four (4) months after such receipt and termination pursuant to Section
10.4(f) which shall be effective thirty (30) days after such receipt.
10.5 GSK CANADA TERMINATION FOR CAUSE. If any of the
following events occur, then GSK Canada may terminate this Agreement within
sixty (60) days of such event by providing written notice thereof to Corixa:
(a) GSK Canada is materially adversely affected
by the terms of a new supply agreement entered into by Corixa pursuant to
Section 4.1(b), the amendment of an Existing Supply Agreement, or the
corresponding amendment of this Agreement pursuant to Section 4.1(b). GSK
Canada's notice shall document the materially adversely affect xxxx XXX Xxxxxx.
If there is a dispute over whether GSK Canada was materially adversely affected
by such new supply agreement or such amendment of this Agreement, such dispute
shall be resolved in accordance with Section 13.1 and this Agreement shall only
be terminated if such dispute is resolved in GSK Canada's favor;
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(b) GSK Canada receives notice from Corixa,
pursuant to Section 4.17, that Corixa is terminating its supply obligations
under Article 4; or
(c) GSK Canada's aggregate share of Third Party
Royalties pursuant to Section 6.5 exceeds [*] of Net Sales.
Termination pursuant to Section 10.5(a) or 10.5(c) shall be effective ninety
(90) days after Corixa's receipt of GSK Canada's notice of such termination.
Termination pursuant to Section 10.5(b) shall be effective on the date specified
in GSK Canada's notice of Agreement termination, provided that such date is not
prior to the effective date of Corix's termination of Article 4.
10.6 TERMINATION FOR MATERIAL BREACH.
(a) If any Party believes that another Party is
in material breach of a material obligation 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
such 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 60 days either to cure
such breach or, if cure cannot be reasonably effected within such 60 day period,
to deliver to the other Parties 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) business days
to cure such breach for nonpayment.
(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 30 days
advance written notice.
10.7 FORCE MAJEURE TERMINATION. If a Force Majeure event
that prevents the performance of one Party persists for the applicable duration
stated in this Section 10.7, then the other Parties shall have the right to
terminate this Agreement upon thirty (30) days' prior written notice to the
non-performing Party:
(a) 12 months, if such Force Majeure is due to
regulatory delays (including delays attributable to Health Canada or the FDA) or
is a Force Majeure that entitles GSK Canada to an extension of time under
Section 3.4(c); or
(b) 18 months, with respect to any other Force
Majeure (including those described in Sections 7.5(c), 7.5(d)(i) and 7.5(f)),
except for a supply interruption Force Majeure that is described in Section
10.4(f).
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10.8 TERMINATION-RELATED REMEDIES. Termination is the sole
remedy available to any Party who terminates this Agreement pursuant to Section
10.2, 10.4, 10.5 or 10.7. The non-terminating Party shall not have the right to
seek or obtain any remedy for any loss arising from such termination, provided
that such termination was carried out in accordance with the terms of this
Agreement. The non-terminating Party may nevertheless pursue and obtain all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement by the terminating Party.
10.9 TERMINATION DISPUTES. If a Party gives notice of
termination under this Article 10 and another Party disputes whether such notice
was proper, then the issue of whether this Agreement has been terminated shall
be resolved in accordance with Section 13.1. 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 thirty (30) days
following the resolution of such dispute. 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.
10.10 EFFECT OF TERMINATION; SURVIVAL.
(a) In the event of termination of this
Agreement for any reason other than (i) Corixa's termination pursuant to Section
10.4 or 10.7 or (ii) GSK Canada's termination pursuant to Section 10.6, the
following provisions of this Agreement shall survive: Sections 2.3, 2.4, 3.12,
6.12, 6.13, 7.1, 7.3(a)-(c), 7.5, 8.7, 9.1, 9.2, 9.3, 9.4, 9.5, 10.8, 10.10,
11.6, 13.1, 13.2, 13.3, 13.4, 13.11, 13.12, 13.19, 13.20 and 13.21, and Articles
1 and 12, and GSK Canada shall, within 60 days of such termination, transfer and
assign to Corixa, at no cost to Corixa, all clinical data, manufacturing data,
regulatory filings (including without limitation all NDSs), regulatory approvals
and licenses (including without limitation all DINs and DELs), and other
documents owned by GSK Canada that pertain to the Product in the Territory. The
provisions of Sections 7.5 and 8.7 shall only survive termination with respect
to suits filed during the term of the Agreement.
(b) In the event of termination of this
Agreement by Corixa pursuant to Section 10.4 or 10.7 or by GSK Canada pursuant
to Section 10.6, the following provisions of this Agreement shall survive:
Sections 3.12, 6.12, 6.13, 7.1, 7.3(a)-(c), 7.5, 8.7, 9.1, 9.2, 9.3, 9.4, 9.5,
10.8, 10.10, 11.6, 13.1, 13.2, 13.3, 13.4, 13.11, 13.12, 13.19, 13.20 and 13.21,
and Articles 1 and 12. The provisions of Sections 7.5 and 8.7 shall only survive
termination with respect to suits filed during the term of the Agreement.
(c) In the event of termination of this
Agreement for any reason, GSK Canada shall (i) promptly return to Corixa or
destroy, as instructed by Corixa, all Tositumomab in the possession of GSK
Canada, its Affiliates or sublicensees; and (ii) destroy, pursuant to the
Quality Policy Manual, all Iodine I 131 Tositumomab in the possession of GSK
Canada, its Affiliates or sublicensees.
(d) 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, subject to Section 10.8, preclude
any Party from pursuing all rights and remedies it may
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have hereunder or at law or in equity with respect to any breach of this
Agreement nor prejudice any Party's right to obtain performance of any
obligation.
11. REPRESENTATIONS AND COVENANTS
11.1 REPRESENTATIONS AND WARRANTIES OF CORIXA. Corixa
represents and warrants to GSK Canada that, as of the Effective Date:
(a) Corixa is duly organized, validly existing,
and in good standing under the laws of the State of Delaware.
(b) Corixa has all requisite corporate power and
authority to execute, deliver, and perform this Agreement and to consummate the
transactions contemplated herein.
(c) The execution, delivery, and performance of
this Agreement by Corixa do not, and the consummation of the transactions
contemplated herein will not, (i) violate any provisions of Corixa's
organizational documents, bylaws, any law or regulation applicable to Corixa and
in effect on the Effective Date, or any agreement, mortgage, lease, instrument,
order, judgment, or decree to which Corixa is a party or is bound or (ii) result
in the creation or acceleration of any lien charge, security interest, or other
encumbrance on the Corixa Intellectual Property Rights in the Territory in the
Field, except for the licenses set forth in Section 2.1(a) and the right of
first negotiation set forth in Section 2.8.
(d) Corixa has duly and properly taken all
action required by laws or its organizational documents, to authorize the
execution, delivery, and performance by Corixa of this Agreement and the
consummation of the transactions contemplated hereby. This Agreement has been
duly executed and delivered by Corixa and constitutes legal, valid, and binding
obligations of Corixa enforceable against it in accordance with its terms,
except as enforcement may be affected by bankruptcy, insolvency, or other
similar laws and by general principles of equity.
(e) No consent, authorization, permit or
approval of, or filing with or notice to, any regulatory authority or any other
person not a party to this Agreement is required or necessary to be obtained by
Corixa or on its behalf in connection with the execution, delivery, and
performance by Corixa of this Agreement or to consummate the transactions
contemplated hereby, except for any consents, authorizations, permits or
approvals of, or filings with or notices in connection with the Xxxx-Xxxxxx
Agreements, Michigan Agreement, BI Pharma Agreements, McKesson Agreement and
Nordion Agreements. Notwithstanding the foregoing, Corixa or its Affiliate has
obtained prior to the Effective Date, all consents (if any) that are required,
pursuant to the Xxxx-Xxxxxx Agreement and the Michigan Agreement, to be obtained
prior to the granting of the licenses set forth in Section 2.1(a).
(f) From January 1, 2002 until the Effective
Date, except for the letter agreement dated January 11, 2002 amending the BI
Pharma Agreement, another amendment to the BI Pharma Agreement dated February
24, 2003, and the Bexxar Supply Agreement with Nordion expected to be dated in
June, 2003, neither Corixa nor any Affiliate of Corixa has (i) entered into any
material agreement with respect to (A) the Corixa Intellectual Property Rights
in the Territory in the Field or (B) the Licensed Xxxx "BEXXAR" in the
Territory, (ii) modified
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any material agreement with respect to (A) the Corixa Intellectual Property
Rights in the Territory in the Field or (B) the Licensed Xxxx "BEXXAR" in the
Territory, or (iii) entered into or amended any contract, agreement, commitment
or arrangement (other than the LOI) to effect any of the matters referred to in
this paragraph.
(g) Except as otherwise disclosed in this
Agreement, Corixa or its Affiliates are the owners, licensees or sublicensees of
the Corixa Intellectual Property Rights in the Territory in the Field and of the
Licensed Marks in the Territory. As of the Effective Date, the (i) Corixa
Intellectual Property Rights in the Territory in the Field that are owned by
Corixa or its Affiliates and (ii) the Licensed Marks in the Territory, are free
and clear of all liens and encumbrances, except for liens for taxes not yet due
and payable and a lien by Banque Nationale de Paris.
(h) To Corixa's knowledge (without any duty to
inquire with any person or source of information outside Corixa), as of the
Effective Date, there is no claim, outstanding commitment to any governmental
regulatory agency (other than an agency that reviews patent or trademark
applications or grants patent or trademark rights), action, suit, proceeding,
investigation, or arbitration pending or threatened against Corixa relating to
the validity or enforceability of (i) the Corixa Intellectual Property Rights in
the Territory in the Field or (ii) the Licensed Marks in the Territory.
11.2 REPRESENTATIONS AND WARRANTIES OF CORIXA RELATING TO
INTELLECTUAL PROPERTY. Corixa represents and warrants to GSK Canada that to its
knowledge as of the Effective Date (without any duty to inquire with any person
or source of information outside Corixa):
(a) Neither Corixa nor its Affiliates has
received any written notice of any claim or allegation that any of the
development, manufacture, importation, use or sale by Corixa or its Affiliate,
agent or (sub)licensee of the Product in the Territory in the Field infringes on
any patents or other intellectual property rights of any Third Party, or that
the manufacture of the Product in Germany by BI Pharma infringes on any patents
or other intellectual property rights of any Third Party.
(b) There is no claim, action, suit, or
proceeding, pending or threatened in writing, alleging that the development,
manufacture, importation, use or sale by Corixa or its Affiliate, agent or
(sub)licensee of the Licensed Product in the Territory in the Field infringes
any patents or other intellectual property rights of Third Parties.
(c) Neither Corixa nor any of its Affiliates has
granted any licenses to, authorized, or permitted any Third Party (other than
Nordion) to use any of the Corixa Intellectual Property Rights in the Territory
in the Field with respect to the Product or to use the Licensed Xxxx "BEXXAR" in
the Territory, except that Xxxxxxx Pharmaceutical granted a license, under
certain Corixa Intellectual Property Rights, to SB pursuant to the SB Agreement,
but such license was terminated by a letter agreement between Xxxxxxx
Pharmaceutical and SB dated April 20, 2000.
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(d) As of the Effective Date, and excluding (i)
any manufacturing know-how, (ii) any trademarks, and (iii) any intellectual
property rights pertaining to the manufacture or purification of monoclonal
antibodies, there are not, any intellectual property rights, including without
limitation any Patents, trade secrets, or know-how, (A) that are either owned by
or licensed to Corixa or its Affiliates, (B) that are not included in the Corixa
Intellectual Property Rights and (C) that would be infringed by the development,
use, importation or sale of the Product in the Territory in the Field by or on
behalf of GSK Canada.
(e) The clinical and regulatory data regarding
the Product that Corixa has provided to GSK Canada is true and accurate in all
material respects as of the date provided to GSK Canada, and Corixa has to its
knowledge provided GSK Canada with access to all clinical and regulatory data
regarding the Product that (i) was in Corixa's possession prior to the Effective
Date and could be disclosed to GSK Canada without breaching any confidentiality
obligations and (ii) would reasonably be believed to be material to GSK Canada's
decision to enter into this Agreement.
11.3 REPRESENTATIONS AND WARRANTIES OF GSK CANADA. GSK
Canada represents and warrants to Corixa that, as of the Effective Date:
(a) GSK Canada is duly organized, validly
existing, and in good standing under the laws of Canada.
(b) GSK Canada has all requisite corporate power
and authority to execute, deliver, and perform this Agreement and to consummate
the transactions contemplated herein.
(c) The execution, delivery, and performance of
this Agreement by GSK Canada do not, and the consummation of the transactions
contemplated herein will not violate any provisions of GSK Canada's
organizational documents, bylaws, any law or regulation applicable to GSK Canada
and in effect on the Effective Date, or any agreement, mortgage, lease,
instrument, order, judgment, or decree to which GSK Canada is a party or is
bound.
(d) GSK Canada has duly and properly taken all
action required by laws or its organizational documents, to authorize the
execution, delivery, and performance of this Agreement and the consummation of
the transactions contemplated hereby. This Agreement has been duly executed and
delivered by GSK Canada and constitutes legal, valid, and binding obligations of
GSK Canada enforceable against it in accordance with their terms, except as
enforcement may be affected by bankruptcy, insolvency, or other similar laws and
by general principles of equity.
(e) No consent, authorization, permit or
approval of, or filing with or notice to, any regulatory authority or any other
person not a party to this Agreement is required or necessary to be obtained by
GSK Canada or on its behalf in connection with the execution, delivery, and
performance by GSK Canada of this Agreement or to consummate the transactions
contemplated hereby.
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(f) GSK Canada has not assigned or licensed, nor
does it owe a duty to assign or license, any Invention to any of its Affiliates
or any Third Party, and all Product Inventions assigned by GSK Canada to Corixa
pursuant to Section 7.1 will, as a result of such assignment, be solely owned by
Corixa and not be subject to any liens, security interests or other
encumbrances.
11.4 SURVIVAL OF REPRESENTATIONS AND WARRANTIES. The
representations and warranties contained in this Article 11 and the
indemnification with respect thereto pursuant to Article 12 shall survive the
Effective Date and continue for the Term of this Agreement.
11.5 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.
11.6 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE WARRANTIES
SET FORTH IN SECTIONS 11.1, 11.2 AND 11.3, NONE OF THE PARTIES GRANTS AND EACH
PARTY HEREBY EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS, STATUTORY
OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF DESIGN, MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS.
12. INDEMNIFICATION, INSURANCE AND LIMITATION OF LIABILITY.
12.1 INDEMNIFICATION.
(a) GSK Canada hereby agrees to defend and hold
harmless Corixa and its agents, directors 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) labeling or packaging, use or storage
by GSK Canada or its Affiliates, sublicensees or agents of Tositumomab, Iodine I
131 Tositumomab or the Product, (ii) sale of the Product in the Territory, or
(iii) the breach of any representation or warranty made by GSK Canada in, or the
breach of any other covenant or provision of, this Agreement, except to the
extent such Losses result from an activity as to which Corixa is obliged to
indemnify GSK Canada pursuant to Section 12.1(b).
(b) Corixa hereby agrees to defend and hold
harmless GSK Canada and its agents, directors 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 or Iodine I
131 Tositumomab provided to GSK Canada by Corixa to comply with the relevant
Specifications at the time of delivery to GSK Canada, (ii) the failure of Corixa
to comply with GMP during its manufacture of Tositumomab or Iodine I 131
Tositumomab, or (iii) the breach of any representation or warranty made by
Corixa in, or the breach of any other covenant or provision of, this Agreement,
except to the extent such Losses result from an activity as to which GSK Canada
is obliged to indemnify Corixa pursuant to Section 12.1(a).
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(c) In the event that a Party (the "Indemnified
Party") is seeking indemnification under Section 12.1(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.
12.2 INSURANCE. Corixa and GSK Canada shall each procure
and maintain insurance, including product liability insurance, adequate to cover
its obligations hereunder and which are consistent with normal business
practices of prudent corporations similarly situated at all times during which
the Product is being clinically tested with human subjects or commercially
distributed or sold. The Parties acknowledge and agree that such insurance shall
not be construed to create a limit of Corixa's or GSK Canada's liability with
respect to its indemnification obligations under this Article 12. Each Party
shall provide the other with written evidence of such insurance upon request.
Each Party shall provide the other with written notice at least thirty (30) days
prior to the cancellation, non-renewal or material change in such insurance or
self-insurance which materially adversely affects the rights of the other Party
hereunder.
12.3 LIMITATION OF LIABILITY. EXCEPT AS SPECIFICALLY
PROVIDED IN SECTION 12.1 AND EXCEPT IN THE EVENT OF THE BREACH OF AN OBLIGATION
SET FORTH IN SECTION 2.2, 2.4 OR 9.1, IN NO EVENT SHALL ANY PARTY, ITS
DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER
PARTIES 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.
13. MISCELLANEOUS.
13.1 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
commercial operations of each Party and, if not resolved by the commercial
operations heads, by referring the disputed matter to the respective Chief
Executive Officers of each Party. Any Party may initiate such informal dispute
resolution by sending written notice of the dispute to the other Parties, 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 13.3, any Party may seek to have
such dispute resolved by binding arbitration with a single arbitrator (or three
arbitrators, if a Party so requests) under the commercial rules of the American
Arbitration Association. The Parties hereby consent to conduct such binding
arbitration procedures in English in Chicago, Illinois, U.S.A.
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13.2 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 giving effect to
conflicts of law rules that would require the application of laws of a different
state.
13.3 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 the Product or of the
Licensed Marks shall be submitted to a court of competent jurisdiction in the
territory in which such Patent or trademark rights were granted or arose.
13.4 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 (including the LOI), with the exception
of the Four-Way NDA described in Section 9.4. Paragraphs 2(d), 7 and 8 of the
LOI shall survive such termination, and Corixa may retain all amounts received
from GSK Canada pursuant to the LOI. 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.
13.5 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 GSK Canada from time to time. Each Party agrees that it will not
export, directly or indirectly, any technical information acquired from another
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.
13.6 BANKRUPTCY.
(a) All rights and licenses granted under or
pursuant to this Agreement, including amendments hereto, by each Party to
another Party are, for all purposes of Section 365(n) of Title 11 of the U.S.
Code ("Title 11"), licenses of rights to intellectual property as defined in
Title 11. Each Party agrees during the term of this Agreement to create and
maintain current copies or, if not amenable to copying, detailed descriptions or
other appropriate embodiments, to the extent feasible, of all such intellectual
property. If a case is commenced by or against either Corixa or GSK Canada (the
"Bankrupt Party") under Title 11, then, unless and until this Agreement is
rejected as provided in Title 11, the Bankrupt Party (in any capacity, including
debtor-in-possession) and its successors and assigns (including, without
limitation, a Title 11 Trustee) shall, at the election of the Bankrupt Party
made within 60 days after the commencement of the case (or, if no such election
is made, immediately upon the request of the non-Bankrupt Party) either (i)
perform all of the obligations provided in this Agreement to be
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performed by the Bankrupt Party including, where applicable and without
limitation, providing to the non-Bankrupt Party portions of such intellectual
property (including embodiments thereof) held by the Bankrupt Party and such
successors and assigns or otherwise available to them or (ii) provide to the
non-Bankrupt Party all such intellectual property (including all embodiments
thereof) held by the Bankrupt Party and such successors and assigns or otherwise
available to them.
(b) If a Title 11 case is commenced by or
against the Bankrupt Party and this Agreement is rejected as provided in Title
11 and the non-Bankrupt Party elects to retain its rights hereunder as provided
in Title 11, then the Bankrupt Party (in any capacity, including
debtor-in-possession) and its successors and assigns (including, without
limitations, a Title 11 Trustee) shall provide to the non-Bankrupt Party all
such intellectual property (including all embodiments thereof) held by the
Bankrupt Party and such successors and assigns or otherwise available to them
immediately upon the non-Bankrupt Party's written request therefor. Whenever the
Bankrupt Party or any of its successors or assigns provides to the non-Bankrupt
Party any of the intellectual property licensed hereunder (or any embodiment
thereof) pursuant to this Section 13.6, the non-Bankrupt Party shall have the
right to perform the obligations of the Bankrupt Party hereunder with respect to
such intellectual property, but neither such provision nor such performance by
the non-Bankrupt Party shall release the Bankrupt Party from any such obligation
or liability for failing to perform it.
(c) All rights, powers and remedies of the
non-Bankrupt Party provided herein are in addition to and not in substitution
for any and all other rights, powers and remedies now or hereafter existing at
law or in equity (including, without limitation, Title 11) in the event of the
commencement of a Title 11 case by or against the Bankrupt Party. The
non-Bankrupt Party, in addition to the rights, power and remedies expressly
provided herein, shall be entitled to exercise all other such rights and powers
and resort to all other such remedies as may now or hereafter exist at law or in
equity (including, without limitation, under Title 11) in such event. The
Parties agree that they intend the foregoing non-Bankrupt Party rights to extend
to the maximum extent permitted by law and any provisions of applicable
contracts with Third Parties, including without limitation for purposes of Title
11, (i) the right of access to any intellectual property (including all
embodiments thereof) of the Bankrupt Party or any Third Party with whom the
Bankrupt Party contracts to perform an obligation of the Bankrupt Party under
this Agreement, and, in the case of the Third Party, which is necessary for the
development, registration and manufacture of licensed products and (ii) the
right to contract directly with any Third Party described in (i) in this
sentence to complete the contracted work. Any intellectual property provided
pursuant to the provisions of this Section 13.6 shall be subject to the licenses
set forth elsewhere in this Agreement and the payment obligations of this
Agreement, which shall be deemed to be royalties for purposes of Title 11.
13.7 FORCE MAJEURE. All 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 Parties. 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, revolution,
acts of public enemies, blockade
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or embargo, terrorist act, voluntary or involuntary compliance with any
regulation, law or order of any government, war, civil commotion, labor
disruption, strike or lock-out, epidemic, failure or default of public utilities
or common carriers, destruction of production facilities or materials by fire,
earthquake, flood, explosion, storm or like catastrophe, casualty or accident,
failure of suppliers to provide materials, services, equipment or machinery,
interruption of or delay in transportation; 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, unless such Force Majeure specifically
precludes the payment process.
13.8 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: Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000, X.X.X.
Attention: General Counsel
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 GSK Canada: GlaxoSmithKline Inc.
0000 Xxxxxxxxxxx Xxxx Xxxxx
Xxxxxxxxxxx, Xxxxxxx
Xxxxxx X0X 0X0
Attention: General Counsel
With a copy to: Blake, Xxxxxxx & Xxxxxxx LLP
World Exchange Plaza
00 X'Xxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxx, Xxxxxxx
Xxxxxx X0X 0X0
Attention: Xxxx X. Xxxxxxx
13.9 CONSENTS NOT UNREASONABLY WITHHELD OR DELAYED.
Whenever provision is made in this Agreement for any Party to secure the consent
or approval of another Party, 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.
71.
13.10 MAINTENANCE OF RECORDS. Each Party shall keep and
maintain all records required by law or regulation with respect to the Product
and shall make copies of such records available to the other Parties upon
request.
13.11 NO STRICT CONSTRUCTION. This Agreement has been
prepared jointly and shall not be strictly construed against any Party.
13.12 ENGLISH. This Agreement has been prepared in English
and shall be interpreted solely in English.
13.13 ASSIGNMENT. None of the Parties may assign or
transfer this Agreement or any rights or obligations hereunder without the prior
written consent of the other Parties, except a Party may make such an assignment
without the other Parties' consent to an Affiliate or to a successor to
substantially all of the business of such Party, whether in merger, a sale of
stock, sale of assets or other transaction. In addition, this Agreement shall be
binding upon the successors of any of the Parties hereto, whether occasioned by
statutory merger, amalgamation, arrangement or other statutory procedure under
which one legal entity takes title to the assets of the other legal entity which
in turn loses its existence by operation of law. Any such successor, permitted
successor or assignee of rights and/or obligations hereunder shall, in a writing
to the other Parties, 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 any Party in
violation of the terms of this Section 13.13 shall be null and void and of no
legal effect.
13.14 HARDSHIP. If, during the term of the Agreement,
performance of the Agreement should lead to unreasonable hardship for any of the
Parties, taking the interests of all Parties into account, all Parties shall
endeavor to agree in good faith to amend the Agreement in the light of the
change in circumstances.
13.15 ELECTRONIC DATA INTERCHANGE. If all 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.
13.16 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.
13.17 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.
13.18 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
72.
Parties, after making good faith effort, are unable to effectively replace an
invalid or unenforceable provision pursuant to this Section 13.18, 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 Parties. Such termination shall be in
accordance with the provisions of Sections 10.10(a), 10.10(c) and 10.10(d) of
this Agreement.
13.19 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.
13.20 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.
13.21 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.
13.22 TIME IS OF THE ESSENCE. Time shall be of the essence
hereof.
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.
GLAXOSMITHKLINE INC. CORIXA CORPORATION
By: /s/ X. Xxxxxxxxx By: /s/ Xxxxxx Xxxxxx
---------------------------- -------------------------------------
Title: V.P. Business Deveopment Title: Xxxxxx Xxxxxx, Ph.D Chairman &CEO
Date: May 27, 2003 Date: 5-27-2003
XXXXXXX PHARMACEUTICAL, INC.
By: /s/ Xxxxxx Xxxxxx
-------------------------------------
Title: Xxxxxx Xxxxxx, Ph.D President
Date: 5-27-2003
73.
EXHIBIT A
PATENTS
---------------------------------------------------------------------------------------------------------------
APPLICATION PATENT APPLICATION
CASE NO. NUMBER FILING DATE NUMBER ISSUE DATE STATUS OWNER CO-OWNER
---------------------------------------------------------------------------------------------------------------
[*] [*] [*] Pending [*] [*]
---------------------------------------------------------------------------------------------------------------
[*] [*] [*] Pending [*] [*]
---------------------------------------------------------------------------------------------------------------
[*] [*] [*] Pending [*] [*]
---------------------------------------------------------------------------------------------------------------
----------------------------------
* Confidential Treatment requested.
1.
EXHIBIT B PROCEDURE FOR CALCULATING STANDARD COST OF GOODS
The calculation described in this Exhibit B was performed by the Parties prior
to the Effective Date. Based on such calculation, the Parties have agreed that
the Standard Cost of Goods for a complete Therapy will be US[*] from the
Effective Date until the earlier [*] If [*] takes place before [*], the Standard
Cost of Goods computed for [*] (in accordance with the next paragraph) shall be
applied for the portion of [*].
The calculation described in this Exhibit B shall be performed annually by [*]
of each year, to determine the Standard Cost of Goods for the following year.
Such new Standard Cost of Goods shall be implemented on January 1st of the
applicable year (except for [*] and shall serve as a non-binding estimate for
future years.
The number of clinical and commercial Therapies anticipated to be supplied for
the US, Canadian, and other markets during a particular year shall be the
"Forecast Volume" for such year. Such number shall be determined based upon
forecasts provided by the JMC (with respect to the Territory), Corixa and SB
(with respect to the United States), and Corixa (with respect to the rest of the
Corixa Territory). The costs of producing those Therapies will be estimated and
divided by the number of Therapies to arrive at a Standard Cost of Goods. In
estimating the costs to produce the "Forecast Volume", appropriate allowances
shall be made for extra therapeutic vials needed in certain Therapies, losses of
Packaged Bulk Drug Substance in processing, QA and retention requirements, and
other factors affecting yields.
Cost of Cold Component will be the estimated US dollar purchase price for the
forecast year for two 16 ml and one 3 ml Tositumomab vials (regardless whether
used in conjunction with the dosimetric or therapeutic doses of Iodine I 131
Tositumomab), plus a [*] to account for shipping costs and handling costs.
Should experience indicate a provision for handling losses is required,
appropriate adjustment will be made.
Cost of the Packaged Bulk Drug Substance for the Hot Component will be the
estimated US dollar purchase price for the forecast year for the Packaged Bulk
Drug Substance required to support the Forecast Volume, allowing for losses due
to batch and container sizes as well as other production related losses, plus a
[*] to account for shipping costs and handling costs.
Cost of (131) Iodine will be the estimated annual cost, [*] computed as the
total direct cost of acquisition for the year divided by the Forecast Volume.
Cost of conjugation will be the total forecast cost for the Forecast Volume,
including batch costs and incremental per unit package costs, at a forecast
production schedule based on the forecasts provided by the Parties and SB.
Indirect costs will be the sum of forecasted costs for QA and Materials
Management FTE's as provided in the SB Agreement, divided by the Forecast
Volume.
Distribution costs will be the sum of all forecasted Third Party costs to
transport Cold Components in bulk from the labeling facility to GSK Canada's
storage facility and Hot Components from Nordion to their final destinations,
divided by the Forecast Volume.
----------------------------------
* Confidential Treatment requested.
1.
EXHIBIT C
LICENSED MARKS
-------------------------------------------------------------------------------------------------------------------
FILING ISSUE APPLICABLE GOODS/
XXXX DATE APP. NO. REG. NO. DATE SERVICES STATUS
-------------------------------------------------------------------------------------------------------------------
BEXXAR 9/17/97 856,386 5; Pharmaceuticals for the Allowed.
treatment of cancer Extension of Time to
file Dec. of Use
granted. Dec. of Use
due: 9/17/03.
--------------------------------------------------------------------------------------------------------------------
POWERED 1/26/01 1,090,895 5; Vaccines, pharmaceuticals, Allowed.
BY and therapeutic chemical Dec. of Use Due:
CORIXA compositions for the treatment 1/26/2004.
of cancer, infectious diseases,
viral diseases and autoimmune
disorders; medical diagnostic
preparations; immunostimulants,
and vaccine adjuvants, all for
human and veterinary use.
--------------------------------------------------------------------------------------------------------------------
USE OF LICENSED MARKS
"Bexxar(TM) therapy"
"Powered by Corixa(TM)technology"
1.
EXHIBIT D
POTENTIAL LICENSED MARKS
-------------------------------------
XXXX CLASS/GOODS REMARKS
-------------------------------------
[*] [*] [*]
------------------------------------
[*] [*] [*]
-------------------------------------
[*] [*] [*]
------------------------------------
[*] [*] [*]
-------------------------------------
[*] [*] [*]
-------------------------------------
[*] [*] [*]
-------------------------------------
USE OF POTENTIAL LICENSED MARKS
[*]
----------------------------------
* Confidential Treatment requested.
1.
EXHIBIT E
FORECASTS AND FIRM ORDER SCHEMATIC
[*] [*] [*]
------------------------------------------
[*] [*] [*] [*]
------------------------------------------
[*] [*]
------------------------------------------
[*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*]
------------------------------------------
[*] [*] [*] [*]
------------------------------------------
----------------------------------
* Confidential Treatment requested.
1.
EXHIBIT F
SUPPLY CHAIN FLOW CHARTS
FOR ILLUSTRATIVE PURPOSES ONLY. THESE CHARTS ARE NOT CONTRACTUALLY BINDING AND
MAY BE REVISED BY THE PARTIES AT ANY TIME.
BEXXAR CANADIAN ORDERING PROCESS - MANUAL
[*]
----------------------------------
* Confidential Treatment requested.
1.
BEXXAR CANADIAN ORDERING PROCESS -
ELECTRONIC INTERFACES
[*]
----------------------------------
* Confidential Treatment requested.
2.
EXHIBIT G
SAFETY DATA EXCHANGE PROTOCOL
INTENT:
GlaxoSmithKline Inc. ("GlaxoSmithKline Canada") and Corixa Corporation
("Corixa", and collectively with GlaxoSmithKline Canada, the "Parties" or
individually, a "Party") agree that this Safety Data Exchange Protocol ("SDE
Protocol") is required to specify the safety-related data which must be provided
by each Party in order to fulfill reporting obligations for BEXXAR therapy. The
SDE Protocol specifies the timelines for exchange of all safety data.
1. DEFINITIONS (CONSISTENT WITH ICH GUIDELINE E2A)
All definitions relating to this SDE agreement are included below. The original
sources of reference for these definitions are the ICH-E2A guidelines. Where a
term is not defined or further clarified in the E2A document, GlaxoSmithKline
Canada has provided a definition taking into account FDA and other relevant
regulatory guidelines.
ADVERSE EVENT (AE)
Any untoward medical occurrence in a patient or clinical investigation subject,
temporally associated with the use of a medicinal product, whether or not
considered related to the medicinal product.
An AE can therefore be any unfavourable and unintended sign (including an
abnormal laboratory finding), symptom, or disease (new or exacerbated)
temporally associated with the use of a medicinal product. For marketed
medicinal products, this also includes failure to produce expected benefits
(i.e. lack of efficacy), abuse or misuse.
SERIOUS ADVERSE EVENT (SAE)
A serious adverse event is any untoward medical occurrence that, at any dose:\
a) Results in death.
b) Is life-threatening.
NOTE: The term 'life-threatening' in the definition of 'serious' refers
to an event in which the subject was at risk of death at the time of the
event. It does not refer to an event, which hypothetically might have
caused death, if it were more severe.
c) Requires hospitalisation or prolongation of existing hospitalisation.
NOTE: In general, hospitalisation signifies that the subject has been
detained (usually involving at least an overnight stay) at the hospital
or emergency xxxx for observation and/or treatment that would not have
been appropriate in the physician's office or out-patient setting.
Complications that occur during hospitalisation are AEs. If a
complication prolongs hospitalisation or fulfils any other serious
criteria, the event is
1.
serious. When in doubt as to whether "hospitalisation" occurred or was
necessary, the AE should be considered serious.
Hospitalisation for elective treatment of a pre-existing condition that
did not worsen from baseline or increase in frequency or severity is not
considered an AE.
d) Results in disability/incapacity, or
NOTE: The term disability means a substantial disruption of a person's
ability to conduct normal life functions. This definition is not
intended to include experiences of relatively minor medical significance
such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza,
and accidental trauma (e.g. sprained ankle) which may interfere or
prevent everyday life functions but do not constitute a substantial
disruption.
e) Is a congenital anomaly/birth defect in a child from a parent who was
exposed to BEXXAR therapy.
f) Medically significant: Other medically important conditions (e.g., the AE
does not meet any of the above serious criteria but based on appropriate
medical judgment, may have jeopardized the patient or required medical or
surgical intervention to prevent one of the serious outcomes listed in
these criteria). These should also be considered serious. Examples of such
events are invasive or malignant cancers, intensive treatment in an
emergency room or at home for allergic bronchospasm, blood dyscrasias or
convulsions that do not result in hospitalisation, or development of drug
dependency or drug abuse.
For spontaneous AE reports:
An adverse event will also be considered serious if a health professional
reporter or a company safety physician or designee indicates that he/she
considers the event to be serious (e.g. if he/she indicates the event to be
incapacitating even if it does not fulfill the definition given above).
SPONTANEOUS AE REPORTS
Includes all Adverse Event reports associated with marketed medicinal products
from any source (health professional, consumer, patient, lawyer, company sales
representative, relative, etc.) regardless of how well documented as long as the
four minimum data requirements are present (i.e., an identifiable patient, an
identifiable reporter, BEXXAR therapy, and an adverse event). All such reports
are included, not just those that meet the definition of "serious". Non-serious
adverse event reports are subject to regulatory reporting in the post-marketing
setting. A causal relationship does not need to be established. Spontaneous
reports may also be of the following types: literature reports, mass
communication media reports, reports in unpublished manuscripts, reports
received from regulatory authorities, etc.
CORE SAFETY INFORMATION
Core Safety Information (CSI) is the minimum essential clinical safety
information for a medicinal product, approved by Corixa on prescribing
information (labeling), which is included in the prescribing information in all
geographic locations where the medicinal product is marketed.
IDENTIFIABLE PATIENT
2.
A patient is considered identifiable in an Adverse Event or pregnancy report
when it is clear that an individual is involved. Such reports are notified to
Corixa even if no formal patient identity is available.
2. GLOBAL SAFETY DATABASE
Corixa will be the designated world-wide safety database for BEXXAR therapy.
Corixa will hold the international safety database of AE reports and pregnancy
reports received by either company or its affliates/licensees worldwide for
BEXXAR therapy. Direct access will not be granted to GlaxoSmithKline Canada but
all reasonable assistance {e.g. line listings/ Periodic Safety Update Reports
(PSURs)} in responding to safety inquiries will be provided upon request.
3. PERIODIC REPORTING
The responsibility for compilation of PSURs for BEXXAR therapy will lie with
Corixa. GlaxoSmithKline Canada will promptly on request provide Corixa with all
the necessary data (i.e. relevant sales and/or usage figures from the company's
territories) required for PSUR production.
Two weeks prior to submission of the PSUR, Corixa will provide confidential
copies of the near-final draft PSUR to GlaxoSmithKline Canada for review and
comments. GlaxoSmithKline Canada will provide comments to Corixa within one week
of receipt to avoid delay of submission. Corixa will supply GlaxoSmithKline
Canada with an electronic copy of each final PSUR generated in accordance with
ICH guidelines for regulatory reporting within 60 days of the data lock point.
Both parties will be responsible for regulatory submission of the PSURs in their
own territories in order to maintain marketing authorizations.
PSURs are under no circumstances to be quoted in any marketing presentation or
publication.
4. LANGUAGE AND MEANS OF EXCHANGE
Exchange of all safety data including Core Safety Information changes will be in
English.
All adverse event (AE) reports according to this protocol will be exchanged in
formats specified in section - called Expedited Reporting
AE data will be exchanged by fax only. As technology permits, alternative
mechanisms for exchange of safety information may be negotiated as long as the
exchange of information remains secure, proprietary, and within regulatory
expectations.
3.
Date of first receipt by the original recipient of any AE report must be
recorded on each report exchanged. This includes initial and follow-up receipt
dates.
Exchange of all updates to the Core Safety Information and supporting data will
be by e-mail to the appropriate contact person (see section entitled Contacts).
5. CORE SAFETY INFORMATION
The Core Safety Information will be written and maintained by Corixa. Comments
on the Core Safety Information must be submitted to Corixa by GlaxoSmithKline
Canada within two weeks of receipt of the document. Updated Core Safety
Information and supporting data will be sent from Corixa to GlaxoSmithKline
Canada Regulatory Affairs for consideration according to agreed timelines.
For changes related to major safety issues, Corixa will send the updated Core
Safety Information and supporting data to the appropriate contact person in
Regulatory Affairs, GlaxoSmithKline Canada within 24 hours of the updated Core
Safety Information being approved internally. For all other changes, Corixa will
send the updated Core Safety Information and supporting data to the appropriate
contact person in Regulatory Affairs, GlaxoSmithKline Canada within 30 days of
being approved internally.
6. EXPEDITED REPORTING
AE data (CIOMS l - Council for International Organization of Medical Sciences)
will be exchanged via the Safety/Pharmacovigilance departments of the companies
involved as identified in section called Contacts.
The Marketing Authorization/Licence Holder (GlaxoSmithKline Canada) will be
responsible for expedited reporting of AE reports to Canadian regulatory
authority.
Corixa will be responsible to have a safety physician, or designee, assess
medical seriousness of all AEs to meet the requirements for section f) of the
serious adverse event definition.
All regulatory authority sourced reports will be exchanged within the same
timelines as for spontaneous or clinical trial reports as appropriate.
In all countries the "clock start" date for regulatory reporting and exchange of
AE data for expedited reporting will be when either company receives first
notification of a report.
a) SPONTANEOUS REPORTS (FROM ANY SOURCE)
GlaxoSmithKline Canada and Corixa will exchange spontaneous AE data (foreign
and domestic) with BEXXAR therapy according to the timelines below:
4.
-------------------------------------------------------------------------------------
ADVERSE EVENT TYPE
(INITIAL AND FOLLOW-UP REPORTS) GLAXOSMITHKLINE CANADA AND CORIXA
-------------------------------------------------------------------------------------
All serious AEs and GlaxoSmithKline Canada will
GlaxoSmithKline Canada provide Corixa with source documents
identified lack of efficacy reports within 3 calendar days.
Corixa will provide GlaxoSmithKline
Canada with CIOMS 1 documents for all
serious events and GlaxoSmithKline
Canada identified lack of efficacy
reports within 12 calendar days.
-------------------------------------------------------------------------------------
Non-serious AEs and pregnancies GlaxoSmithKline Canada will provide
without serious complications* Corixa with source documents for all
Canadian non-serious events within 7
calendar days of initial notification.
Corixa is not required to provide the
CIOMS 1 reports for non-serious AEs **to
GlaxoSmithKline Canada for expedited
reporting purposes.
-------------------------------------------------------------------------------------
* pregnancies with complications which fall into the definition of an SAE
must be exchanged according to the timelines of SAEs
**Not including GlaxoSmithKline Canada identified lack of efficacy reports.
b) CLINICAL TRIAL REPORTS
Should any Party or its affiliates conduct clinical trials with BEXXAR
therapy or provide BEXXAR therapy for named patient use, GlaxoSmithKline
Canada and Corixa will exchange AE data (foreign and domestic) according to
the timelines below:
----------------------------------------------------------------------------------
ADVERSE EVENT TYPE
(INITIAL AND FOLLOW-UP REPORTS) GLAXOSMITHKLINE CANADA TO CORIXA
----------------------------------------------------------------------------------
Serious attributable fatal or 24 hours or within 3 calendar days if
life-threatening AEs this period includes a weekend or
public holiday
----------------------------------------------------------------------------------
All other SAEs and pregnancies 48 hours or within 3 calendar
days if this period includes a
weekend or public holiday
----------------------------------------------------------------------------------
Non-serious AEs from named 5 calendar days
patients/compassionate use
----------------------------------------------------------------------------------
Non-serious AEs from clinical studies not required to send to Corixa
----------------------------------------------------------------------------------
-----------------------------------------------------------------------------
ADVERSE EVENT TYPE
(INITIAL AND FOLLOW-UP REPORTS) CORIXA TO GLAXOSMITHKLINE CANADA
-----------------------------------------------------------------------------
Serious attributable unexpected fatal or 5 calendar days
life-threatening AEs
-----------------------------------------------------------------------------
All other serious attributable unexpected 12 calendar days
AEs
-----------------------------------------------------------------------------
5.
Corixa will be responsible for creating Expedited Investigator Safety
Reports (EISRs) / Investigational New Drug Safety Reports with Analysis of
Similar Events (INDSR with ASIME investigator safety letters) and providing
them to GlaxoSmithKline Canada within 12 calendars for expedited reporting.
GlaxoSmithKline Canada and Corixa will each be responsible for notifying
investigators in their own studies of serious AE reports as necessary,
within their own territories, according to the respective company standard
operating procedure and local regulations.
FOLLOW-UP
The Marketing Authorisation/Licence Holder (GlaxoSmithKline Canada) is
responsible for appropriate follow-up of an AE report and timely
transmission of relevant new information to Corixa. Corixa would be
required to indicate to GlaxoSmithKline Canada if any follow up is required
on clinical trial SAE reports.
Information on follow-up will be forwarded within the timelines specified
for initial information unless the follow-up data changes the status of the
AE (i.e. if the follow-up data changes a non-serious AE to serious, the
timeframe for reporting serious AEs should be observed).
LITERATURE
Corixa will review relevant medical/scientific literature worldwide for AE
reports with BEXXAR therapy and provide CIOMS I reports with a copy of the
publication attached, to GlaxoSmithKline Canada. Corixa will send these
data forward within the same timelines as for spontaneous or clinical trial
case reports as appropriate.
ACKNOWLEDGEMENTS
Corixa will send an acknowledgement to GlaxoSmithKline Canada as soon as a
report is received. Corixa will acknowledge serious cases within 7 days.
Acknowledgements of serious cases should include dates of receipt and
Corixa reference numbers. These acknowledgements will be used to confirm
receipt of reports. If no acknowledgement is received by GlaxoSmithKline
Canada the report will be resent as soon as possible.
PRODUCT COMPLAINTS
GlaxoSmithKline Canada will send to Corixa all Canadian medical product
complaints associated with AE or pregnancy reports with BEXXAR therapy.
Follow-up of medical product complaints involving AE or pregnancy reports
must be carried out as for any other AE or pregnancy report.
7. REGULATORY ENQUIRIES
Each company will keep the other informed of any safety-related regulatory
enquiries with BEXXAR therapy as soon as possible and will co-operate in
providing requested information promptly. The company holding the global safety
database (Corixa) will draft a joint statement for review and comment by
GlaxoSmithKline Canada before submission.
6.
8. REVIEW AND REVISIONS
This SDE protocol may be amended from time to time to improve compliance with
regulatory reporting or as necessary, or as and when required by agreement
between the parties. Each party may recommend a change in the protocol.
9. TERMINATION OF THE SDE PROTOCOL
This Protocol will be co-terminous with the Licensing and Supply Agreement
between the Parties and Xxxxxxx Pharmaceutical, Inc.
10. GENERAL MANAGEMENT OF SAFETY
If either company becomes aware of a safety issue with BEXXAR therapy, that
company will alert the other/s as soon as possible. Supporting documentation
will be sent as soon as possible thereafter.
Public statements by either company on the safety of BEXXAR therapy, which go
beyond the scope of the Core Safety Information, must, as far as practical, be
approved by both parties before publication.
Each company will inform the other when involving an external expert for an
opinion on any safety matter relating to BEXXAR therapy. This does not include
consultation on single case reports for clinical guidance where this is only to
be used within the company requesting the opinion.
11. CONTACTS
GlaxoSmithKline Canada Contacts
-------------------------------------------------------------------
General Enquiries [*] GlaxoSmithKline Canada
7333 Xxxxxxxxxxx, XX
Xxxxxx X0X 0X0
Tel: [*]
Fax: [*]
E-mail: [*]
-------------------------------------------------------------------
Spontaneous and clinical [*] GlaxoSmithKline Canada
trial cases 7333 Xxxxxxxxxxx, XX
Xxxxxx X0X 0X0
Tel: [*]
Fax: [*]
E-mail: [*]
-------------------------------------------------------------------
Regulatory Affairs [*] GlaxoSmithKline Canada
7333 Xxxxxxxxxxx, XX
Xxxxxx X0X 0X0
----------------------------------
* Confidential Treatment requested.
7.
Tel: [*]
Fax: [*]
E-mail: [*]
Corixa Contacts
----------------------------------------------------------------------
General Enquiries [*] Corixa Corporation
000 Xxxxxxx Xxxx.
Xx. Xxx Xxxxxxxxx, XX 00000
Tel: [*]
Fax: [*]
E-mail: [*]
----------------------------------------------------------------------
Spontaneous and clinical [*] Corixa Corporation
trial cases 000 Xxxxxxx Xxxx.
Xx. Xxx Xxxxxxxxx, XX 00000
Tel: [*]
Fax: [*]
E-mail: [*]
----------------------------------------------------------------------
Regulatory Affairs [*] Corixa Corporation
000 Xxxxxxx Xxxx.
Xx. Xxx Xxxxxxxxx, XX 00000
Tel: [*]
Fax: [*]
E-mail: [*]
----------------------------------
* Confidential Treatment requested.
8.
TABLE OF CONTENTS
PAGE
1. DEFINITIONS................................................................................ 1
1.1 "Affiliate"....................................................................... 1
1.2 "Annual Clinical FTE Rate"........................................................ 2
1.3 "Annual Net Sales"................................................................ 2
1.4 "Batch Certificate"............................................................... 2
1.5 "BI Pharma"....................................................................... 2
1.6 "BI Pharma Agreements"............................................................ 2
1.7 "BLA"............................................................................. 2
1.8 "Business Day" or "business day".................................................. 2
1.9 "Certificate of Analysis"......................................................... 2
1.10 "Certificate of Manufacture"...................................................... 3
1.11 "Clinical Trial".................................................................. 3
1.12 "Cold Component".................................................................. 3
1.13 "Confidential Information"........................................................ 3
1.14 "Controlled"...................................................................... 3
1.15 "Corixa Intellectual Property Rights"............................................. 3
1.16 "Corixa Post-Approval Trial"...................................................... 3
1.17 "Corixa Territory "............................................................... 3
1.18 "Cross-Territory Clinical Trial".................................................. 4
1.19 "Xxxx-Xxxxxx Agreements".......................................................... 4
1.20 "DEL"............................................................................. 4
1.21 "Diligent Efforts"................................................................ 4
1.22 "DIN"............................................................................. 4
1.23 "Existing Supply Agreements"...................................................... 4
1.24 "FD&C Act"........................................................................ 4
1.25 "FDA"............................................................................. 4
1.26 "Field"........................................................................... 4
1.27 "First Commercial Sale"........................................................... 4
1.28 "Force Majeure"................................................................... 5
1.29 "FTE"............................................................................. 5
i.
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.30 "Good Clinical Practice" or "GCP"................................................. 5
1.31 "Good Laboratory Practice" or "GLP"............................................... 5
1.32 "Good Manufacturing Practice" or "GMP"............................................ 5
1.33 "GSK Canada Intellectual Property Rights"......................................... 5
1.34 "Health Canada"................................................................... 5
1.35 "Hot Component"................................................................... 5
1.36 "Information"..................................................................... 5
1.37 "Initial Approval"................................................................ 5
1.38 "Initial Royalty Period".......................................................... 6
1.39 "Intellectual Property Rights".................................................... 6
1.40 "Invention"....................................................................... 6
1.41 "Iodine I 131 Tositumomab"........................................................ 6
1.42 "Joint Marketing Committee"....................................................... 6
1.43 "Joint Other Inventions".......................................................... 6
1.44 "Licensed Xxxx"................................................................... 6
1.45 "Licensed Product"................................................................ 7
1.46 "Licensed Services"............................................................... 7
1.47 "LOI"............................................................................. 7
1.48 "Marketing Plan".................................................................. 7
1.49 "McKesson"........................................................................ 7
1.50 "McKesson Agreement".............................................................. 7
1.51 "Michigan Agreement".............................................................. 7
1.52 "NDS"............................................................................. 7
1.53 "Net Sales"....................................................................... 7
1.54 "Nordion"......................................................................... 8
1.55 "Nordion Agreements".............................................................. 8
1.56 "Other Invention"................................................................. 8
1.57 "Packaged Bulk Drug Substance".................................................... 8
1.58 "Patent".......................................................................... 8
1.59 "Potential Licensed Xxxx"......................................................... 8
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1.60 "Product"......................................................................... 8
1.61 "Product Invention"............................................................... 8
1.62 "QA/QC Costs"..................................................................... 8
1.63 "Qualifying Clinical Trial" ...................................................... 8
1.64 "Quality Policy Manual"........................................................... 8
1.65 "Regulatory Approval"............................................................. 9
1.66 "SB".............................................................................. 9
1.67 "SB Agreement".................................................................... 9
1.68 "Scheduled Batch Completion Date"................................................. 9
1.69 "Sole Other Inventions"........................................................... 9
1.70 "Specifications".................................................................. 9
1.71 "Standard Cost of Goods".......................................................... 9
1.72 "Taxes"........................................................................... 10
1.73 "Territory"....................................................................... 10
1.74 "Therapy"......................................................................... 10
1.75 "Third Party"..................................................................... 10
1.76 "Third Party Royalties"........................................................... 10
1.77 "Tositumomab"..................................................................... 11
2. LICENSES AND EXCLUSIVITY................................................................... 11
2.1 Licenses to GSK Canada............................................................ 11
2.2 Negative Covenant................................................................. 12
2.3 Licenses to Corixa................................................................ 12
2.4 Negative Covenant................................................................. 12
2.5 Existing Third Party Licenses..................................................... 12
2.6 New Third Party Licenses.......................................................... 12
2.7 Exclusivity....................................................................... 13
2.8 Right of First Negotiation........................................................ 13
2.9 Conversion to Distributorship..................................................... 14
3. REGISTRATION AND MARKETING................................................................. 14
3.1 Overview.......................................................................... 14
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3.2 Joint Marketing Committee (JMC)................................................... 14
3.3 Subteams from SB Agreement........................................................ 16
3.4 Diligence......................................................................... 16
3.5 Marketing Plan.................................................................... 17
3.6 Transfer of Pre-existing Data..................................................... 17
3.7 Clinical Trials Solely in the Territory........................................... 18
3.8 Clinical Trials Solely in the Corixa Territory.................................... 19
3.9 Cross-Territory Clinical Trials................................................... 20
3.10 Regulatory Filings in the Territory............................................... 21
3.11 Reporting......................................................................... 22
3.12 Records........................................................................... 22
3.13 Pricing........................................................................... 22
3.14 Reimbursement..................................................................... 23
3.15 Compliance........................................................................ 23
4. MANUFACTURING AND SUPPLY OF THERAPIES...................................................... 23
4.1 General Understanding............................................................. 23
4.2 Requirements Contract............................................................. 24
4.3 Forecasts and Ordering............................................................ 24
4.4 Vial Labeling and Packaging....................................................... 29
4.5 Delivery; Shipment; Title; Distribution........................................... 30
4.6 Storage........................................................................... 32
4.7 Compliance with Specifications.................................................... 32
4.8 Customer Orders................................................................... 34
4.9 Manufacturing Regulatory Compliance............................................... 34
4.10 Regulatory Compliance............................................................. 34
4.11 Quality Policy Manual............................................................. 35
4.12 Changes........................................................................... 35
4.13 Adverse Event Reporting........................................................... 36
4.14 Product Complaints................................................................ 36
4.15 Product Recall.................................................................... 37
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4.16 Allocation in the Event of Product Shortages...................................... 37
4.17 Termination of Supply Obligations................................................. 39
4.18 U.N. Convention Not Applicable.................................................... 39
5. GREY-MARKET RESTRICTIONS................................................................... 39
5.1 Overview.......................................................................... 39
5.2 No Sales By GSK Canada Outside the Territory...................................... 39
5.3 No Sales By Corixa Inside the Territory........................................... 39
6. ECONOMICS.................................................................................. 40
6.1 License Fee....................................................................... 40
6.2 Milestones........................................................................ 40
6.3 Royalties......................................................................... 41
6.4 Xxxx-Xxxxxx and University of Michigan Royalties.................................. 42
6.5 Third Party Royalties............................................................. 43
6.6 Quarterly Payments and Payment Reports............................................ 43
6.7 Transfer Price.................................................................... 43
6.8 Accounting for Excess Tositumomab................................................. 44
6.9 Payment Method.................................................................... 45
6.10 Taxes............................................................................. 45
6.11 Currency of Payment............................................................... 45
6.12 Foreign Exchange.................................................................. 45
6.13 Records; Inspection............................................................... 45
6.14 Late Payment Penalty.............................................................. 46
6.15 Sublicenses....................................................................... 46
7. INTELLECTUAL PROPERTY...................................................................... 46
7.1 Ownership......................................................................... 46
7.2 Disclosure........................................................................ 47
7.3 Patent Prosecution and Maintenance; Abandonment................................... 47
7.4 Enforcement of Patent Rights and Defense of Patent Invalidity Claims.............. 49
7.5 Defense of Third Party Patent Infringement Claims................................. 50
7.6 Patent Marking.................................................................... 52
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8. TRADEMARK MATTERS.......................................................................... 52
8.1 Ownership of the Licensed Marks................................................... 52
8.2 No Contest........................................................................ 52
8.3 Use of the Licensed Marks......................................................... 53
8.4 Obtaining and Maintaining Registrations........................................... 54
8.5 Quality Control................................................................... 54
8.6 Enforcement of Licensed Marks..................................................... 55
8.7 Third Party Trademark Litigation.................................................. 55
8.8 Obligation to Use Licensed Marks.................................................. 57
8.9 Exclusivity of Trademark.......................................................... 57
8.10 Use of Marks other than Licensed Marks............................................ 57
9. CONFIDENTIALITY............................................................................ 57
9.1 Nondisclosure of Confidential Information......................................... 57
9.2 Exceptions........................................................................ 58
9.3 Authorized Disclosure............................................................. 58
9.4 Termination of Prior Agreements................................................... 59
9.5 Publicity......................................................................... 59
9.6 Publications...................................................................... 60
10. TERM AND TERMINATION....................................................................... 60
10.1 Term.............................................................................. 60
10.2 Termination for Exclusivity Breach................................................ 60
10.3 Termination for Diligence Failure................................................. 60
10.4 Mutual Termination for Cause...................................................... 60
10.5 GSK Canada Termination for Cause.................................................. 61
10.6 Termination for Material Breach................................................... 62
10.7 Force Majeure Termination......................................................... 62
10.8 Termination-Related Remedies...................................................... 63
10.9 Termination Disputes.............................................................. 63
10.10 Effect of Termination; Survival................................................... 63
11. REPRESENTATIONS AND COVENANTS.............................................................. 64
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11.1 Representations and Warranties of Corixa.......................................... 64
11.2 Representations and Warranties of Corixa Relating to Intellectual Property........ 65
11.3 Representations and Warranties of GSK Canada...................................... 66
11.4 Survival of Representations and Warranties........................................ 67
11.5 Performance by Affiliates......................................................... 67
11.6 Disclaimer of Warranties.......................................................... 67
12. INDEMNIFICATION, INSURANCE AND LIMITATION OF LIABILITY..................................... 67
12.1 Indemnification................................................................... 67
12.2 Insurance......................................................................... 68
12.3 Limitation of Liability........................................................... 68
13. MISCELLANEOUS.............................................................................. 68
13.1 Dispute Resolution................................................................ 68
13.2 Governing Law..................................................................... 69
13.3 Patents and Trademarks............................................................ 69
13.4 Entire Agreement; Amendment....................................................... 69
13.5 Export Control.................................................................... 69
13.6 Bankruptcy........................................................................ 69
13.7 Force Majeure..................................................................... 70
13.8 Notices........................................................................... 71
13.9 Consents Not Unreasonably Withheld or Delayed..................................... 71
13.10 Maintenance of Records............................................................ 72
13.11 No Strict Construction............................................................ 72
13.12 English........................................................................... 72
13.13 Assignment........................................................................ 72
13.14 Hardship.......................................................................... 72
13.15 Electronic Data Interchange....................................................... 72
13.16 Counterparts...................................................................... 72
13.17 Further Actions................................................................... 72
13.18 Severability...................................................................... 72
13.19 Ambiguities....................................................................... 73
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13.20 Headings.......................................................................... 73
13.21 No Waiver......................................................................... 73
13.22 Time is of the Essence............................................................ 73
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