EXHIBIT 10.1
*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.
BEXXAR SUPPLY AGREEMENT
between
MDS (Canada) Inc., through its division, MDS Nordion,
and
Xxxxxxx Pharmaceutical, Inc.
and Corixa Corporation
Dated as of July 1, 2003
BEXXAR SUPPLY AGREEMENT
THIS SUPPLY AGREEMENT (this "Agreement") is made, effective as of the
1st day of July, 2003 (the "Effective Date"), between MDS (Canada) Inc., through
its division, MDS Nordion ("Nordion"), and Xxxxxxx Pharmaceutical, Inc.
("Xxxxxxx") and Corixa Corporation (together with Xxxxxxx, collectively
"Corixa"), each a "Party" and collectively, the "Parties."
RECITALS
WHEREAS, Nordion and Xxxxxxx, a subsidiary of Corixa, entered into that
certain Development Agreement, dated November 15, 1995 (the "Development
Agreement"), that certain Facilities Agreement, dated August 31, 1998 (the
"Facilities Agreement"), and that certain Supply Agreement, dated August 31,
1998 (the "Previous Supply Agreement") (collectively, the Development Agreement,
the Facilities Agreement and the Previous Supply Agreement shall be referred to
herein as the "Previous Agreements"); and
WHEREAS, the Parties wish to terminate the Previous Agreements and
continue the relationship contemplated by the Facilities Agreement and the
Previous Supply Agreement in accordance with the terms contained herein;
NOW, THEREFORE, in consideration of the foregoing and the mutual
promises contained in this Agreement, the Parties agree as follows:
1. Definitions.
As used in this Agreement, the following terms shall have the meanings
set forth below:
1.1 "Affiliate" shall mean any entity or person which controls, is
controlled by or is under common control with either Party. For purposes of this
Section 1.1, control shall mean (a) in the case of corporate entities, the
direct or indirect ownership of more than one-half of the stock or participating
shares entitled to vote for the election of directors, and (b) in the case of a
partnership, the power to direct the management and policies of such
partnership.
1.2 "Adverse Events" shall mean any undesirable event or reaction
reported to or known by the Parties regarding the Labeled Drug that is
determined to be potentially associated with the use of the Labeled Drug in
humans.
1.3 "[*]" shall have the meaning given to it in Section 4.7(a).
1.4 "Authorization to Manufacture" shall have the meaning given to
it in Section 3.1(e).
1.5 "Agreement" shall have the meaning given to it in the first
paragraph hereof.
1.6 "B1 Antibody" shall mean the IgG2a anti-CD-20 murine
monoclonal antibody meeting the specifications in Exhibit 1.6 supplied by Corixa
to Nordion for the purposes of this Agreement.
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1.7 "Background Technology" shall mean all Nordion proprietary
technology, including patents, know-how, techniques, methods, processes and
trade secrets, which are licensed to Nordion by a party other than Corixa, or
owned, or controlled by Nordion and which Nordion owned or controlled or
received a license to prior to July 10, 1995 as evidenced by a writing or
prototype or as otherwise can be demonstrated by Nordion to have been owned or
controlled or licensed by it prior to July 10, 1995.
1.8 "Batch" shall mean a production batch of Labeled Drug
manufactured under this Agreement.
1.9 "Batch Capacity" shall mean the capacity of the Facility to
produce Labeled Drug.
1.10 "Bexxar Equipment" shall mean the Corixa Equipment and the
Nordion Equipment.
1.11 "Bexxar Freezer Carrier" shall mean the freezer trailer
located at the Nordion Site used for storage (or transport) of the Labeled Drug,
which trailer is owned by Corixa, and at Corixa's request is operated by Nordion
or its agents.
1.12 "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, with respect to Labeled Drug.
1.13 "Breach Notice" shall have the meaning given to it in Section
11.4.
1.14 "Carrier" shall mean a carrier approved in advance by Corixa.
1.15 "Carrier Hub Delivery" shall have the meaning given to it in
Section 3.2(c)(ii).
1.16 "CD-20 Antigen Cells" shall mean the CD20-positive indicator
cell line used for the determination of final drug product potency in the
Immunoreactive Fraction Assay, meeting the specifications in Exhibit 1.16,
supplied by Corixa to Nordion for the purposes of this Agreement.
1.17 "cGMP" shall mean the current good manufacturing practices
required by the FDA and set forth in the FD&C Act or FDA regulations, policies,
or guidelines in effect at a particular time for the manufacture, testing and
quality control of pharmaceutical materials as applied to biologics, together
with any other applicable regulations, except to the extent that the standards
for the manufacture, testing and quality control of pharmaceutical materials as
applied to biologics, or other applicable regulations, are higher or more
stringent in any other country, state or locality in the Territory than those
required by the FDA, in which case such country, state or locality's standards
will apply.
1.18 "Change Control Operating Procedure" shall have the meaning
given to it in Section 4.5.
1.19 "Claim" shall have the meaning given to it in Section 13.4.
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1.20 "Clinical Trial(s)" shall mean any trial for clinical
development of pharmaceutical products defined as "Phase I," "Phase II," "Phase
III," or "Treatment IND" in FDA regulations, as amended from time to time.
1.21 "CMC" shall have the meaning given to it in Section 5.11(b).
1.22 "Commercial Forecast" shall have the meaning given to it in
Section 3.1(c).
1.23 "Commercial Forecast Period" shall have the meaning given to
it in Section 3.1(c).
1.24 "Commercial Supply" shall mean the supply of Labeled Drug by
Nordion to Corixa for sale after regulatory approval of Labeled Drug has been
received by Corixa from the FDA in the United States.
1.25 "Complaint" shall mean any commentary, verbal or written,
received regarding dissatisfaction with the performance of the Labeled Drug in
relation to an Adverse Event, quality, transportation, quantity received versus
quantity ordered, scheduling, packaging or other situations not captured by the
foregoing headings.
1.26 "Confidential Information" shall have the meaning given to it
in Section 14.1.
1.27 "Corixa" shall have the meaning given to it in the first
paragraph of this Agreement.
1.28 "Corixa Equipment" shall mean that equipment and other items
listed on Exhibit 1.28.
1.29 "Corixa IP" shall mean any and all patents, trade secrets,
know-how, copyrights, trademarks and other intellectual property rights,
wherever existing, owned, controlled or licensed by Corixa.
1.30 "Xxxxxxx" shall have the meaning given to it in the first
paragraph of this Agreement.
1.31 "CPI" shall mean the Canadian Consumer Price Index.
1.32 "Delay" shall have the meaning given it in Section 6.1(a).
1.33 "Delay Cost" shall have the meaning given it in Section
6.1(c).
1.34 "Development Agreement" shall have the meaning given to it in
the Recitals.
1.35 "Deviations" shall mean unplanned events or departures from
approved procedures used in the manufacture or testing of Labeled Drug.
1.36 "Dispute" shall have the meaning given to it in Section
15.3(a).
1.37 "DMF" shall have the meaning given to it in Section 5.11(b).
1.38 "Effective Date" shall have the meaning given to it in the
first paragraph of this Agreement.
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1.39 "Environmental Regulations" shall mean any federal, state,
provincial, territorial or local environmental, health and safety and radiation
safety laws or regulations which are applicable to the manufacture of Labeled
Drug, or the removal of Bexxar Equipment and supplies and space used by or for
Nordion in the development, manufacture, storage, packaging, testing or delivery
of Labeled Drug, safely from service and render such equipment, supplies and
space safe, or dispose of it, as required by applicable laws and regulations.
1.40 "Extended Term" shall have the meaning given to it in Section
11.2.
1.41 "Facility" shall mean the rooms and areas at the Nordion Site
where Labeled Drug is actually manufactured, processed, handled, inspected,
stored or delivered (including, without limitation, the Bexxar Freezer Carrier
when Labeled Drug is stored in such carrier and delivered therefrom).
1.42 "Facilities Agreement" shall have the meaning given to it in
the Recitals.
1.43 "FDA" shall mean the United States Food and Drug
Administration or any successor agency thereto.
1.44 "FD&C Act" shall mean the United States Federal Food, Drug and
Cosmetic Act, as amended.
1.45 "Final Destination" shall have the meaning given to it in
Section 3.2(c)(i).
1.46 "Final Destination Delivery Time" shall have the meaning given
to it in Section 3.2(c)(i).
1.47 "Firm Order" shall have the meaning given to it in Section
3.1(d).
1.48 "Forecast" shall have the meaning given to it in Section
3.1(b).
1.49 "Forecast Period" shall have the meaning given to it in
Section 3.1(b).
1.50 "Force Majeure" shall have the meaning given to it in Section
16.9.
1.51 "General Claims Against Corixa" shall have the meaning given
to it in Section 13.2(a).
1.52 "General Claims Against Nordion" shall have the meaning given
to it in Section 13.1(a).
1.53 "Hot Cells" shall mean the lead and stainless steel enclosed
structure which provides for the containment of radioactive materials identified
as cells 26, 28 and 29 at the Facility.
1.54 "IND" shall mean an Investigational New Drug application and
any supplements thereto, as defined in FDA regulations, as amended from time to
time.
1.55 "Indemnitee" shall have the meaning given to it in Section
13.4.
1.56 "Indemnitor" shall have the meaning given to it in Section
13.4.
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1.57 "Initial Term" shall have the meaning given to it in Section
11.1.
1.58 "Iodine Supply Agreement" shall have the meaning given to it
in Section 2.3.
1.59 "IP Claims Against Corixa" shall have the meaning given to it
in Section 13.3(a).
1.60 "IP Claims Against Nordion" shall have the meaning given to it
in Section 13.3(b).
1.61 "Isotope" shall mean iodine (131)I.
1.62 "Isotope Specification" shall mean those specifications set
out in Exhibit 1.61(a) for [*] Isotope or set out in Exhibit 1.61(b) for [*]
Isotope, as appropriate.
1.63 "Labeled Drug" shall mean a pharmaceutical product containing
the Isotope-labeled B1 Antibody in either dosimetric or therapeutic final dosage
form meeting Specifications, for use in Clinical Trials or for commercial sale,
which has been, or is being, manufactured in accordance with the Process,
compounded, formulated, finished, filled, labeled, packaged and/or delivered by
Nordion pursuant to this Agreement.
1.64 "Maximum Batch Size" shall mean a [*] Ci (Xxxxx) Batch for
therapeutic Labeled Drug and a [*] Ci (Xxxxx) Batch for dosimetric Labeled Drug.
1.65 "Nonconformity" shall mean a failure of the Labeled Drug to
meet Specifications.
1.66 "Nordion" shall have the meaning given to it in the first
paragraph of this Agreement.
1.67 "Nordion Equipment" shall mean the equipment owned or
controlled by Nordion, excluding Corixa Equipment identified in Exhibit 1.28,
used in the manufacture, packaging or testing of Labeled Drug.
1.68 "Nordion IP" shall mean any and all patents, trade secrets,
know-how, copyrights, trademarks and other intellectual property rights,
wherever existing, owned, controlled or licensed by Nordion.
1.69 "Nordion Quality Policies" shall have the meaning given to it
in Section 5.1.
1.70 "Nordion Site" shall mean Nordion's plant (including, without
limitation, the Facility) located in Xxxxxx, Xxxxxxx, Xxxxxx.
1.71 "Nordion Site Delivery" shall have the meaning given to it in
Section 3.2(c)(i).
1.72 "Party" or "Parties" shall have the meaning given to it in
this first paragraph of this Agreement.
1.73 [*] shall mean [*] described at Exhibit 5.12(c).
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1.74 "Post-Commercialization Firm Order" shall have the meaning
given to it in Section 3.1(c).
1.75 "Pre-Commercialization Firm Order" shall have the meaning
given to it in Section 3.1(b).
1.76 "Previous Agreements" shall have the meaning given to it in
the Recitals.
1.77 "Previous Supply Agreement" shall have the meaning given to it
in the Recitals.
1.78 "Process" shall mean the process of formulation and dispensing
described in Nordion's Standard Operating Procedure 960702.SOP and 960703.SOP.
1.79 "Proposed Response" shall have the meaning given to it in
Section 5.12(a)(ii).
1.80 "Quality Policy Manual" shall mean that manual which provides
(i) how the Corixa Quality Assurance and Nordion Quality Assurance/Quality
Control departments interact with each other and (ii) the quality assurance
responsibilities of each in relation to the manufacturing, labeling, Release and
delivery of Labeled Drug.
1.81 "Recall" shall have the meaning given to it in Section 6.1(b).
1.82 "Release" shall mean the written quality assurance
authorization to deliver Labeled Drug, which is initially approved by Nordion
and finally approved by Corixa, pursuant to Section 5.2 and applicable
protocols.
1.83 "Scheduled Batch Completion Date" shall mean [*] with respect
to a therapeutic Batch and [*] with respect to a dosimetric Batch and such other
scheduled production day as agreed pursuant to a Forecast, Commercial Forecast
or Firm Order.
1.84 "Scheduled Vials" means, with respect to a Batch that is the
subject of a Delay, the total number of vials of Labeled Drug (i) ordered by
Corixa pursuant to an Authorization to Manufacture, and any changes thereto made
in accordance with Section 3.1(f), and (ii) finalized for delivery pursuant to
Section 3.2 (a). For the avoidance of doubt, with respect to the dosimetric form
of Labeled Drug, Scheduled Vials shall not include any vials of the dosimetric
form scheduled to be allocated into inventory and not scheduled for delivery
until at least the week following the scheduled date of Release of such Delayed
Batch.
1.85 "SOW" shall have the meaning given to it in Section 4.7(a).
1.86 "Specifications" shall mean the Labeled Drug specifications as
set forth in Exhibit 1.86.
1.87 "Territory" shall mean the United States of America and Canada
and any other countries mutually agreed to by the Parties.
1.88 "Territory DMF" shall have the meaning given to it in Section
5.11(b).
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1.89 "Validation" or "Validate" or "Validated" shall mean the
program mutually agreed to by the Parties by which documented evidence provides
a high degree of assurance that the Process, Bexxar Equipment and Facility meet
applicable regulatory requirements for validation and will consistently produce
Labeled Drug that meets Specifications and quality attributes as mutually agreed
by the Parties and the Process is effective and reproducible.
2. Supply.
2.1 Labeled Drug.
(a) General Terms. Nordion shall use the Process to
radiolabel B1 Antibody with Isotope to produce Labeled Drug that meets the
Specifications and is manufactured in conformity with cGMP requirements and all
other applicable laws, rules and regulations of the Territory and shall deliver
Labeled Drug for shipment as directed by Corixa. During the term of this
Agreement and any renewals thereof, Nordion shall manufacture and provide Corixa
with Labeled Drug that may be ordered by Corixa under this Agreement for the
purposes of Clinical Trial and commercial sale of Labeled Drug in the Territory.
(b) Batch Capacity and Maximum Batch Size. Nordion shall
maintain the Batch Capacity necessary to produce [*] Batches per [*] period, up
to a maximum of [*] Batches per year. Nordion hereby agrees to produce such
Batches of Labeled Drug up to a Maximum Batch Size at the Facility to the extent
ordered by Corixa. It is understood and agreed that Corixa may order a Batch
that is smaller than the Maximum Batch Size in accordance with the Process. In
the event Corixa's requirements for Batch Capacity or Maximum Batch Size
increase, the Parties shall meet in good faith to discuss increasing the Batch
Capacity or the Maximum Batch Size.
2.2 B1 Antibody.
(a) General Terms. Corixa or, at Corixa's discretion, its
designee shall provide B1 Antibody and CD-20 Antigen Cells to Nordion, [*], in
sufficient quantities and quality to allow Nordion to meet its obligations
hereunder. Nordion shall store, [*], B1 Antibody and CD-20 Antigen Cells in
accordance with the specifications designated by Corixa. Corixa shall at all
times own, including while remaining a raw material or used in the manufacture
of Labeled Drug at the Nordion Site, (i) the B1 Antibody, and (ii) the CD-20
Antigen Cells. Nordion agrees that it will use the CD-20 Antigen Cells and the
B1 Antibody provided by Corixa only for production of Labeled Drug, unless
otherwise instructed in writing by Corixa.
(b) Unavailability or Scarcity of B1 Antibody. It is
understood that Corixa's obligation to supply B1 Antibody and CD-20 Antigen
Cells to Nordion is conditional upon its ability to obtain a sufficient supply
of the B1 Antibody and CD-20 Antigen Cells. Corixa will use commercially
reasonable efforts to notify Nordion upon Corixa's knowledge of a shortage of
the B1 Antibody or CD-20 Antigen Cells if such shortage will impact the
manufacture of Labeled Drug. Corixa shall not be liable for any delays in the
supply of B1 Antibody or CD-20 Antigen Cells under Section 2.2(a); provided,
however, that any such delays in the supply of B1 Antibody or CD-20 Antigen
Cells will excuse Nordion's performance of actions related to such B1 Antibody
or CD-20 Antigen Cells to the extent Nordion's non-performance was caused by
such delay in the supply of B1 Antibody or CD-20
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Antigen Cells and that such delay or failure to supply B1 Antibody or CD-20
Antigen Cells (unless due to a Force Majeure) will not impact Corixa's minimum
purchase commitment.
2.3 Isotope. The supply of [*] Isotope shall be governed by the
Iodine Supply Agreement dated September 13, 2000 between Nordion and Xxxxxxx
(the "Iodine Supply Agreement"). Upon termination or expiration of the Iodine
Supply Agreement, Corixa shall be entitled to purchase [*] Isotope from Nordion
in accordance with the pricing set out in Exhibit 9.1, or at Corixa's option,
and upon Isotope specifications and conditions to be agreed with Nordion, shall
be permitted to purchase [*] Isotope from a third party for use by Nordion in
the manufacture of Labeled Drug. [*] Isotope supplied by Nordion for use in
Labeled Drug shall conform to the [*] Isotope Specifications set out in Exhibit
1.61(b).
3. Orders and Delivery.
3.1 Forecasts.
(a) [*] Forecasting. No later than [*] prior to the
commencement of each [*] during the term of this Agreement, Corixa shall
identify the number of Batches of Labeled Drug per week that Corixa estimates it
may need for the next [*]. Such estimate is non-binding and for planning
purposes only in order to allow Nordion to ensure it has all the materials
necessary to manufacture Labeled Drug, including, without limitation, enough
available Isotope.
(b) Pre-Commercialization Firm Order. During the period
up to the [*] of commencement of Commercial Supply, Corixa on the [*], shall
provide Nordion with a written forecast of Corixa's Clinical Trial and/or
Commercial Supply requirements (the "Forecast") for Labeled Drug for the next[*]
(the "Forecast Period"). Nordion, at its cost, shall maintain in inventory
sufficient ingredients to manufacture the identified number of Batches provided
for in the most recent Forecast. The Forecast shall include an estimated size of
each Batch and the type of label to be used and shall set out Scheduled Batch
Completion Dates. The first [*] of Scheduled Batch Completion Dates provided by
Corixa in each Forecast shall be binding (the "Pre-Commercialization Firm
Order").
(c) Post-Commercialization Firm Order. During the period
commencing after the [*] of Commercial Supply, Corixa on the [*], shall provide
Nordion with a written forecast of Corixa's Clinical Trial and/or Commercial
Supply requirements (the "Commercial Forecast") for Labeled Drug for the next
[*] (the "Commercial Forecast Period"). Nordion, at its cost, shall maintain in
inventory sufficient ingredients to manufacture the identified number of Batches
provided for in the most recent Commercial Forecast. The Forecast shall include
an estimated size of each Batch and the type of label to be used and shall set
out Scheduled Batch Completion Dates. The first [*] of Scheduled Batch
Completion Dates in each Commercial Forecast shall be binding (the
"Post-Commercialization Firm Order").
(d) Firm Order. 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" as used in Sections 3.1(b) and (c) refers
to the requirement for Labeled Drug to be produced on the Scheduled Batch
Completion Dates, but not to Batch size. By way of example, Exhibit 3.1 provides
a schematic outlining the procedure provided for in Section 3.1 (b) and (c)
above.
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(e) Authorization to Manufacture. At least [*]
immediately prior to the Scheduled Batch Completion Date, Corixa will provide an
authorization to manufacture setting forth the Batch size and type(s) of label
(the "Authorization to Manufacture").
(f) Changes. At any time until [*] Eastern Time on the
day that is at least [*] prior to the Scheduled Batch Completion Date, Corixa
may make changes to the [*] as set out in the Authorization to Manufacture.
Under extraordinary circumstances, Nordion will manufacture on days other than
normally scheduled production runs. The Parties will agree on a holiday schedule
and modify the production schedule accordingly.
(g) Minimum Purchase Requirements. During the period
prior to Commercial Supply of Labeled Drug, Corixa shall [*] During the [*]
period of Commercial Supply of Labeled Drug, Corixa shall purchase at least [*]
Batches. Following the [*] period of Commercial Supply of Labeled Drug and
during each succeeding [*] period during the term of this Agreement, Corixa
shall purchase at least [*] Batches. It is expressly understood and agreed that
except for the commitments contained in this Section 3.1(g), Corixa has no
specific or minimum commitment to purchase any amounts of Labeled Drug. The
Parties further understand and agree that the minimum commitment for a given [*]
period will be reduced by a pro rata amount (rounded to the nearest whole Batch)
in the event that the Batch Capacity is reduced during such [*] period for
reasons due to Force Majeure or attributable to Nordion. By way of example only,
if the Facility were only open for [*] in a [*] period (rather than [*] then the
minimum commitment for such [*] period would be reduced by [*] percent [*] or
[*] Batches if such Batch Capacity reduction occurs during the first [*] of
Commercial Supply and [*] Batches if such Batch capacity reduction occurs
thereafter.
(h) Cancellation Fees. A Batch which is the subject of a
Firm Order shall be subject to the cancellation fee specified in Section 9.2.
3.2 Shipment and Delivery.
(a) Finalizing Orders. By [*]. Eastern Time, no later
than [*] prior to the Scheduled Batch Completion Date, or at such time as
otherwise mutually agreed in writing by the Parties, Corixa will finalize [*]
and [*]. Nordion shall not ship any Batch of Labeled Drug that fails to meet
Specifications, subject to Corixa's rights under this Agreement. Nordion
reserves the right to refuse to make available for delivery Labeled Drug to a
shipping address that has not been previously licensed.
(b) Designation of Final Destinations. Corixa will
provide Nordion with a list of destinations to which Nordion may be requested by
Corixa to ship Labeled Drug, no later than [*] prior to the first shipment of
Labeled Drug to any such site(s), or at such time as otherwise mutually agreed
in writing by the Parties. Nordion will promptly review each site(s) license
with respect to its ability to receive Isotope and shall advise Corixa of any
regulatory requirements for documentation establishing the legal authority of
such site(s) to receive and possess Isotope. Corixa shall promptly provide
Nordion with such documentation as Nordion may reasonably require confirming
compliance with regulatory requirements.
(c) Delivery. Nordion shall make delivery of the Labeled
Drug, as follows:
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(i) Except as otherwise provided below, Labeled
Drug supplied under this Agreement shall be delivered FCA (Incoterms 2000)
Carrier's vehicle at the Nordion Site by the cut off date and time the Carrier
specifies to Nordion that the Labeled Drug must be made available to such
Carrier for pick up at the Nordion Site for Carrier to be able to deliver such
Labeled Drug to the Final Destination by the Final Destination Delivery Time
("Nordion Site Delivery"). For purposes of this Section 3.2(c), the "Final
Destination" shall mean the destination specified by Corixa for delivery of the
Labeled Drug and "Final Destination Delivery Time" shall mean [*] on the date
designated by Corixa for delivery of Labeled Drug to the Final Destination, such
date to be at least [*] following the Scheduled Batch Completion Date. For the
destinations of Hawaii, Alaska and Puerto Rico, the date and [*] shall be
replaced with the date and time designated by the Carrier for delivery of
Labeled Drug to such Final Destination to meet Corixa's requirements.
(ii) In the event that Nordion cannot make the
Nordion Site Delivery, such Labeled Drug may be delivered by Nordion FCA
Carrier's distribution center or hub by the cut off date and time the Carrier
specifies to Nordion the Labeled Drug must be made available to the Carrier at
the Carrier's distribution center or hub for Carrier to deliver such Labeled
Drug to the Final Destination by the Final Destination Delivery Time ("Carrier
Hub Delivery").
(iii) In the event that Nordion cannot make the
Nordion Site Delivery or Carrier Hub Delivery as provided above, Nordion may
have such Labeled Drug delivered FCA the Final Destination.
4. Manufacture.
4.1 Failure To Meet Material Obligations. In the event that
Nordion fails to meet one or more of the material obligations under this
Agreement (except to the extent caused by Corixa or its agents during the term
hereof) or Corixa determines that Nordion will not be able to meet one or more
of the material obligations, Nordion and Corixa shall immediately meet to
discuss the matter in good faith. At such meeting, Nordion shall provide Corixa
with its best estimate as to when it will be able to meet such obligations.
Unless Nordion is able to provide Corixa with reasonable assurances, within [*]
of such meeting, that such material obligations will be met, [*] following the
notice and remedial period (if such obligations remain unremedied) contained in
Section 11.4. Nothing in this Section 4.1 shall be read to limit any of Corixa's
rights under Section 6 or otherwise. [*].
4.2 Compliance with Law; Handling of Labeled Drug. While the B1
Antibody, Isotope and Labeled Drug are in its possession or under its control,
Nordion shall be responsible for complying with all applicable statutory and
regulatory requirements of the Territory regarding the manufacture, handling,
storage, labeling, packaging and transportation of Labeled Drug. In performing
its obligations under this Agreement, Nordion shall comply with all applicable
environmental and health and safety laws.
4.3 Site of Manufacture. Nordion shall manufacture and package
Labeled Drug in the Facility and shall do so in compliance with all applicable
Environmental Regulations.
4.4 Approval of Manufacturing Changes.
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(a) General. Either Party may request a Specifications
change intended to maintain high standards. The Parties shall discuss in good
faith the implementation of any such requested changes; provided, however, that
Nordion shall not make any revisions to any aspect of the manufacturing or
Labeled Drug handling process without the prior written consent of Corixa in
accordance with the Change Control Operating Procedure. Corixa retains the right
and responsibility for final approval of the Specifications and labels for the
Labeled Drug. Either Party 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) Capital Expenditures.
(i) In the event a material cGMP, legal or
regulatory change (required by regulation) to the Facility and/or pharmaceutical
areas(s) used in association with the Facility requires a capital expenditure of
an amount up to [*] US dollars [*] per regulatory event, [*] responsible for
such capital expenditure.
(ii) In the event a material cGMP or legal or
regulatory change (required by regulation) to the Facility and/or pharmaceutical
areas(s) used in association with the Facility requires a capital expenditure in
excess of [*] US dollars ([*] per regulatory event, the Parties shall agree upon
the changes to be made and the amount of any necessary capital expenditure. If
the Parties disagree on the changes required to comply or costs related to a
cGMP or regulatory change, then the Parties shall agree on an independent third
party to determine the issue and the most cost effective way to achieve the
desired result. The amount of such cost in excess of [*] U.S. dollars ([*] will
be [*]. Notwithstanding the foregoing, in no event shall either Party be
required to make any such required capital expenditures in excess of [*] US
dollars [*] if Corixa determines, in its reasonable discretion, that such
required capital expenditure is not economically feasible or would otherwise
render this Agreement no longer economically viable. For the avoidance of doubt,
in the event that Nordion is unable to manufacture Labeled Drug in conformance
with cGMP requirements or applicable laws, rules or regulations, due to Corixa's
decision, pursuant to this section, not to make the required capital
expenditures to bring the Facility into conformance with cGMP requirements or
applicable laws, rules or regulations, this Agreement shall forthwith terminate.
Such termination shall not constitute a termination under Section 6, 11.3 or
11.4 and Corixa shall not be obligated to pay any termination fee in connection
with such termination.
(c) Labeling and Packaging Changes. From time to time
Corixa may require labeling or packaging changes that will affect all or
substantially all of the Labeled Drug. These changes may either be initiated by
Corixa or may be a requirement resulting from changes in cGMPs. Unless such
change is required to meet cGMP requirements as provided in Section 4.4(b)
above, Corixa will reimburse Nordion for its costs associated with such a change
at a rate that is mutually agreed upon by the Parties
4.5 Change Control Operating Procedure. The procedure to be
followed if either Corixa or Nordion desires to change any aspect of the
manufacturing procedure for Labeled Drug, including without limitation, any
change in Validation requirements, the Specifications as described in Section
4.4(a) above, the B1 Antibody specifications or the CD-20 Antigen Cell
specifications is set forth in
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the Quality Policy Manual (such procedure is hereinafter referred to as the
"Change Control Operating Procedure"). Until such time as the Change Control
Operating Procedure is agreed to by the Parties, they shall continue to follow
the existing change control procedures. In addition, Nordion undertakes not to
implement any change to the Isotope Specifications or modification to the
Isotope process that could impact the quality or safety of the Isotope or the
Labeled Drug or impact the BLA without the prior written consent of Corixa, not
to be unreasonably withheld. The Parties agree to comply with the terms of the
Quality Policy Manual, including, without limitation, such Change Control
Operating Procedure.
4.6 Scheduled Maintenance. Subject to the remainder of this
Section 4.6, Nordion shall be entitled, at its own expense, [*] notice, to shut
down the Facility for scheduled maintenance for a maximum period not to [*]
period during any calendar year, unless otherwise mutually agreed. The shut down
shall occur during the [*], unless otherwise mutually agreed. The scheduling of
the shut down shall not interfere with Nordion's ability to deliver Labeled Drug
pursuant to a Firm Order issued by Corixa prior to Corixa's receipt of a notice
of the exact shut down dates. Corixa shall be entitled to approve the date of
such scheduled maintenance or to request that such date be rescheduled. Corixa's
approval of such scheduled maintenance shall not be unreasonably withheld.
4.7 [*].
(a) [*]. Corixa shall have the right to [*] Nordion
agrees to use commercially reasonable efforts to assist Corixa in that regard,
at Corixa's expense, upon commercially reasonable terms as agreed to in a
Statement of Work (an "SOW").
(b) Process Development Work. Corixa shall have the right
to [*].
4.8 Continuous Improvement. Any continuous improvement made by
Nordion under an SOW in the manufacture of Labeled Drug which [*] between the
Parties as agreed to in the applicable SOW.
5. Quality Assurance and Regulatory Matters.
5.1 Quality Assurance; Quality Control. Nordion shall implement
and perform operating procedures and controls for sampling, stability and other
testing of materials, and for Validation, documentation and Release of the
Labeled Drug and such other quality assurance and quality control procedures as
are consistent with the cGMPs and the Nordion quality policies and
documentations (collectively, "Nordion Quality Policies").
5.2 Product Release. In connection with each Release, Nordion
shall certify in writing that each Batch of Labeled Drug was produced and tested
in compliance with (i) the Specifications, (ii) cGMP requirements, (iii) the IND
or BLA, as applicable, and (iv) all other applicable regulatory requirements, in
accordance with procedures agreed between Corixa and Nordion. Nordion will
provide Corixa with the applicable Batch records, including without limitation,
a copy of any applicable Deviation or other investigatory reports and product
information sheet, in final form, and/or any other certificate required by the
applicable regulatory authorities for Release of each Batch of the Labeled Drug.
The format and routing of these documents are further described in the Quality
Policy
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Manual. Corixa may, in its reasonable discretion, withhold Release based upon
the contents of any of these records.
5.3 Quality Control Program. [*].
5.4 Compliance Standards.
(a) Nordion Quality Policies. Throughout the term of this
Agreement, Nordion shall notify Corixa in advance of any material change in the
Nordion Quality Policies which directly has an impact on the Labeled Drug.
Further, Corixa, at its expense, shall have the right to access the Nordion
Quality Policies during Corixa's annual audit described in Section 5.12 (b) (ii)
for the purpose of verifying Nordion's compliance with the Nordion Quality
Policies.
(b) Compliance with cGMPs, Nordion Quality Policies,
Legal Requirements or Regulatory Acts. Nordion shall be responsible for
identifying and implementing, in accordance with its obligations under Sections
4 and 5, any actions required to bring Nordion into compliance with cGMPs,
Nordion Quality Policies or any regulatory act or legal requirement imposed by
an applicable governmental entity with jurisdiction in the Territory. Subject to
Section 4.4(b)(ii), Nordion shall have the sole responsibility for reviewing
cGMPs, legal requirements and regulatory acts in order to identify and implement
any actions required for compliance therewith. Nordion shall implement any such
changes as promptly as practicable after the changes are adopted (but in no
event later than the effective date of such change), unless the effective date
falls after a termination of this Agreement for which notice has been previously
given.
(c) Compliance with Health, Safety and Environmental
Guidelines. In the performance of its obligations under this Agreement, Nordion
shall comply with any and all regulatory acts or legal requirements imposed by
an applicable governmental entity with jurisdiction in the Territory related to
health, safety or the environment or Environmental Regulations. Nordion is
solely responsible for the safety and health of its employees and shall take
such actions as are necessary to protect its employees' safety and health,
including, without limitation, providing its employees with all required
information and training concerning any potential hazards involved in the
manufacture, packaging, storage and supply of the Labeled Drug and taking any
precautionary measures to protect its employees from any such hazards.
5.5 Corixa Holds and Rejections. Corixa shall notify Nordion of
Corixa's investigation of a Nonconformity or a Deviation (and any related
report). Corixa will give Nordion any such notice within thirty (30) days after
receipt of such Labeled Drug by Corixa or Corixa's designee that received such
Labeled Drug. Corixa's notice shall state the basis for such investigation and
Corixa will be permitted to investigate such deviations and nonconformity.
5.6 Deviation; Nonconformity. Labeled Drug, as well as
intermediate drug product related to the Labeled Drug which are in Nonconformity
or subject to a Deviation will be segregated from conforming products in a
manner consistent with cGMP, the Quality Policy Manual and the Nordion Quality
Policies. The existence of any Nonconformity and Deviations and their related
investigations will be reported to Corixa promptly in writing.
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5.7 Complaints and Adverse Events.
(a) Notification. Nordion shall notify Corixa as soon as
possible, but at least within one (1) business day of receipt or becoming aware
of information that may be an Adverse Event. Nordion shall in each successive
quarter notify Corixa of Complaints received by Nordion in the prior quarter
during the term of this Agreement.
(b) Investigations. Nordion will cooperate and support
Corixa in its investigation of Complaints, Adverse Events, Deviations and
Nonconformities in a timely manner.
5.8 Certain Labeled Drug Events.
(a) Notification and Cooperation. In the event either
Party shall be required (or shall voluntarily decide) to initiate a recall,
withdrawal or field correction of, or a field alert report or comparable report
with respect to any Labeled Drug manufactured by Nordion pursuant to this
Agreement, whether or not such recall, withdrawal, field correction or field
alert report has been requested or ordered by any governmental body, the
initiating Party shall notify the other Party's most senior quality assurance
officer, and the Parties shall fully cooperate to implement the same.
(b) Coordination of Efforts. In the event Nordion
believes that a recall, withdrawal, field correction, field alert report or
comparable report with respect to any Labeled Drug may be necessary and/or
appropriate, Nordion shall immediately notify Corixa. The Parties shall
cooperate with each other in determining the necessity and nature of such
action; provided, however, that Nordion shall take no action to effect the same
without the written concurrence of Corixa. If Corixa does not concur with any
recall, withdrawal, field correction, field alert report or comparable report
recommended by Nordion, then, without limiting any liability Corixa otherwise
has under this Agreement, Corixa shall be liable under this Section 5.8 for any
losses incurred by Nordion or Corixa that could have been avoided but for the
delay, except to any extent Nordion withheld material information or
misrepresented the material information upon which Corixa made its
determination.
(c) Records and Recalls. Corixa and/or its designee shall
maintain records of all sales of Labeled Drug and customers sufficient to
adequately administer a recall, market withdrawal or correction for a period of
five (5) years after termination or expiration of this Agreement. Except as
required by law, Corixa and/or its designee shall serve as the sole point of
contact with the FDA or other applicable governmental entity or regulatory
authority concerning any recalls, market withdrawals or corrections with respect
to Labeled Drug.
5.9 Reporting, Contacts and Statements. Corixa will be solely
responsible for communicating Complaints, Adverse Events and the results of
investigations related thereto, to the public and/or regulatory authorities. In
the event that Nordion is contacted by the public and/or regulatory authorities
regarding Complaints, Adverse Events or the results of investigations related
thereto, Nordion shall make no comment, unless otherwise required by law,
regulation or order and shall refer such inquiry to Corixa. Corixa will use
commercially reasonable efforts to keep Nordion appropriately informed prior to
any such communication with the public or authorities that relates to Nordion's
activities under this Agreement. In the event Corixa communicates any
Complaints, Adverse Events or the results of investigations related thereto to
the public and/or regulatory authorities which mentions Nordion by name or by
inference, Nordion shall be entitled to respond to such
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communication. With respect to any recall, withdrawal, field correction, field
alert report or comparable report related to any Labeled Drug, Corixa shall be
entitled to make contact with the applicable governmental body and/or regulatory
authority and shall be responsible for coordinating all of the necessary
activities in connection with any such recall, withdrawal, field correction,
field alert report or comparable report. Nordion shall collaborate with Corixa
on the content of any such statement. In the event that Nordion is required to
communicate with the FDA with respect to a recall of Labeled Drug or otherwise
regarding Labeled Drug, Nordion shall immediately notify Corixa of such
communication with the FDA.
5.10 Regulatory Approvals.
(a) Updates and Notices. Upon Nordion's reasonable
request, Corixa shall provide updates to Nordion of (i) the progress of clinical
development of the Labeled Drug as it relates to manufacturing operations; (ii)
the fact of any IND or BLA submissions to the FDA relating to Labeled Drug, and
(iii) copies of the applicable sections of any regulatory filings which
reference Nordion or Nordion activities. In addition, Corixa shall promptly
advise Nordion, at Nordion's request, in matters pertaining to U.S. regulatory
requirements relating to Nordion's activities hereunder. Corixa shall also
provide to Nordion reasonable advance notice of any regulatory submission
containing information or data provided by Nordion to Corixa that Corixa intends
and is permitted to disclose to regulatory agencies under this Agreement.
Nordion shall also provide to Corixa reasonable advance notice of any regulatory
submission containing information or data provided by Corixa to Nordion that
Nordion intends and is permitted to disclose to regulatory agencies under this
Agreement.
(b) Regulatory Changes. Each Party shall promptly notify
the other of new or amended regulatory requirements of which it becomes aware
that are relevant to the manufacture of Labeled Drug under this Agreement and
that are required by the FDA, and any other applicable governmental entity in
the Territory, or other applicable laws or governmental regulations and shall
confer with each other and agree with respect to the best means to comply with
such requirements. Any changes required by the forgoing sentence that are to the
Corixa Equipment, Process or Specifications shall be paid for by Nordion,
subject to the provisions of Section 4.4(b)(ii) and the SOWs attached hereto as
Exhibit 7.
5.11 Registrations, Listings, Authorizations and Approvals.
(a) Labeled Drug. Corixa or its designee shall be
responsible for obtaining and maintaining such drug licenses, registrations,
listings, authorizations and approvals as the FDA or any other applicable
governmental entity may require to enable use of Labeled Drug in Clinical Trials
and marketing of Labeled Drug wherever such activities will occur. Nordion
shall, to the extent it has information in it possession, provide assistance to
Corixa in obtaining and maintaining all licenses, registrations, listings,
authorizations and approvals of any governmental entities necessary for the use
of Labeled Drug in Clinical Trials and marketing of Labeled Drug wherever such
activities will occur. Corixa and/or its designee shall serve as the point of
contact with the FDA and any other applicable governmental entity concerning
licenses, registration, authorizations or approvals required to use Labeled Drug
in Clinical Trials or market Labeled Drug, but may, as appropriate, request
Nordion's assistance with the FDA and/or other applicable governmental entity
communications.
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(b) Drug Master Files. Nordion shall, at Nordion's
expense, update its Isotope Drug Master File with the FDA ("DMF"), as may be
required for the chemistry, manufacture and control ("CMC") section for the IND
or BLA for the Labeled Drug, or corresponding portions of any submission for a
license, registration, authorization or approval required by other applicable
governmental entities in the Territory for Clinical Trials or for marketing
Labeled Drug ("Territory DMF").. Upon Corixa's request, and subject to Nordion's
prior review and approval of the submission that references the DMF or Territory
DMF, which approval shall not be unreasonably withheld or delayed, Nordion shall
grant to Corixa a right of reference to such DMF or Territory DMF and shall
provide Corixa:
(i) A letter of access to the DMF and the
Territory DMF allowing regulatory review of the DMF and the Territory DMF by the
FDA, Health Canada or equivalent agency in the Territory in conjunction with
Corixa's Labeled Drug regulatory submission; and
(ii) Any information related to the Process
required for CMC purposes or for comparable purposes in the Territory. In the
event that Nordion is contacted by the FDA, Health Canada or equivalent agency
in the Territory regarding the DMF or Territory DMF to the extent it has an
impact on Labeled Drug, Nordion shall promptly provide Corixa with notice of
such contact and provide written confirmation to Corixa within five (5) business
days that Nordion received inquiries from the FDA, Health Canada or equivalent
agency in the Territory and shall advise Corixa of the estimated time and
proposed nature of Nordion's response. Nordion shall respond promptly to any and
all such inquiries from the FDA, Health Canada or equivalent agency in the
Territory.
(c) Nordion Site. Nordion shall, at Nordion's expense,
obtain and maintain all necessary licenses, registrations, authorizations and
approvals, with respect to the Nordion Site, which are necessary to develop,
manufacture, handle, store, label, package, transport and deliver Labeled Drug
under cGMP conditions and other regulatory requirements, including without
limitation, the use and handling of radioactive materials and Nordion Site
licenses. Except with respect to correspondence relating directly to the DMF or
Territory DMF, Nordion shall provide Corixa with summaries or copies of any
correspondence sent from Nordion to governmental entities relating to Labeled
Drug at the time such correspondence is sent by Nordion, purged of Nordion
proprietary and/or confidential information and trade secrets. Nordion shall
provide Corixa with summaries or copies of any comments, responses, notices or
other correspondence received by Nordion from any governmental entity relating
to Labeled Drug within five (5) business days of receipt of such correspondence
by Nordion, purged of any Nordion proprietary information and/or trade secrets.
5.12 Inspections.
(a) By Governmental Entities.
(i) Upon the request of any governmental entity
or any third party entity authorized by a governmental entity, such entity shall
have access to observe and inspect the Nordion Site and procedures used for the
storage of B1 Antibody for the Labeled Drug and the manufacture, testing,
storage or shipment of Labeled Drug, including without limitation, manufacturing
operations, and to audit such facilities for compliance with cGMP and/or other
applicable regulatory standards. To the extent it has advance notice, Nordion
shall give Corixa notice of any inspections or audits by a governmental entity
(or a third party authorized by a governmental entity) of the above-mentioned
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facilities or procedures within at least twenty-four (24) hours prior to the
commencement of said inspection or audit. In all events, Nordion shall provide
Corixa with a verbal summary of such inspection or audit at the end of each day
in which inspection activity occurs and a written report within five (5)
business days of the inspection or audit. Such summary and report will be
subject to the confidentiality requirements of Section 14.
(ii) Nordion shall notify Corixa within five (5)
business days of any written or oral inquiries, notifications with respect to
inspection activity by any governmental entity (or any third party authorized by
a governmental entity) on matters that could adversely affect, whether directly
or indirectly, Nordion's ability to perform under this Agreement. Nordion shall
provide a reasonable description to Corixa of any such governmental inquiries,
notifications or inspections promptly (but in no event later than five (5)
business days) after such visit or inquiry. Nordion shall furnish to Corixa
within five (5) business days after receipt, a summary of any report or
correspondence issued by the governmental entity (or a third party authorized by
a governmental entity) in connection with such visit or inquiry, including
without limitation, any FDA Form 483 (List of Inspectional Observations) or
warning letter with respect to Labeled Drug. Nordion shall also furnish to
Corixa not later than five (5) business days after the time it provides such to
a governmental entity, summaries of any and all proposed responses or
explanations relating to the items set forth above (each a "Proposed Response"),
in each case purged only of trade secrets or other Nordion Confidential
Information. After the filing of a response with the appropriate governmental
entity, Nordion shall notify Corixa of any further oral and/or written contacts
with the governmental entity or its representative relating to Nordion's
production of Labeled Drug.
(iii) Nordion shall promptly rectify or resolve
any deficiencies noted by a governmental entity or its third party
representative in a report or correspondence issued to Nordion, provided such
deficiency is not related to any new or amended regulatory requirement as
described in Section 5.10(b) in which case Section 5.10(b) applies.
(b) By Corixa, its Affiliates and/or Representatives.
Corixa, its Affiliates or representatives as mutually agreed (subject to
execution of a confidentiality agreement in the form attached hereto as Exhibit
5.12(b)), shall have reasonable access to the Facility and related Labeled Drug
procedures for the purpose of:
(i) At least once per calendar quarter, and more
frequently in Corixa's reasonable discretion, observing the Process relating to
Labeled Drug; and
(ii) Annually auditing the Facility for
compliance with Specifications, cGMP and other applicable regulatory
requirements and standards relating to the Labeled Drug. Such audit shall not
exceed three (3) days in duration unless mutually agreed otherwise.
(c) [*].
[*].
5.13 Records and Reports. Nordion shall maintain all records
necessary to evidence compliance with (i) all applicable laws, regulations and
other requirements of applicable governmental
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entities in the Territory relating to the manufacture of Labeled Drug; (ii)
relevant sections of the applicable IND or BLA relevant to Labeled Drug and
corresponding licenses, registrations, authorizations or approvals for foreign
jurisdiction(s) as advised by Corixa and agreed between the Parties; (iii) the
Specifications and Isotope Specifications; and (iv) material obligations and
performance under this Agreement. All such records shall be maintained at
Nordion for at least that amount of time as required by law, regulation or cGMP.
Prior to destruction of any record after such time, Nordion shall give written
notice to Corixa upon which Corixa shall have the right to request that Nordion
maintain such records in an off-site storage facility for such longer period as
Corixa requests, provided that Corixa pays all reasonable costs associated with
such off-site storage. Upon Corixa's prior written request and at Corixa's sole
expense, Nordion agrees to provide Corixa with access to such records that are
stored at an off-site facility. Nordion will provide, on a quarterly basis,
manufacturing overview reports for discussion and review with Corixa at
quarterly manufacturing meetings.
6. Failure to Supply.
6.1 Batch Default.
(a) Definition of Delay. For purposes of this Agreement,
"Delay" shall mean a failure by Nordion to make delivery, pursuant to the
provisions of Section 3.2(c), of a Batch which meets Specifications and shall
not include any such failure caused by an act or omission of Corixa or its
agents or representatives. For the avoidance of doubt, such a failure of
delivery with respect [*] within a Batch shall constitute a Delay with respect
to such Batch.
(b) Definition of Recall. For purposes of this Agreement,
"Recall" shall mean a recall or market withdrawal or correction of Labeled Drug
due to Nordion's error, factors within Nordion or its agent's control, including
without limitation, Nordion or its agent's handling, manufacture, packaging or
storage of Labeled Drug, the Labeled Drug's failure to meet Specifications
(provided such failure to meet Specifications is not caused by the B1 Antibody,
the CD-20 Antigen Cells or an act or omission of Corixa or its agents or
representatives) or to the failure of Isotope used in the manufacture of Labeled
Drug to meet the Isotope Specifications.
(c) Definition of Delay Cost. For purposes of this
Agreement, "Delay Cost" shall mean, for any Batch which is subject to a Delay,
the sum of (i) the actual, documented cost [*] in such Batch and [*]; and (ii)
an amount equal to the [*] of: (v) the product of [*] (for a Delay of [*] or
less) or [*]) (for a Delay of more than [*]) multiplied by the Scheduled Vials;
or (w) [*] per Batch of Labeled Drug subject of a Delay. The [*] provided for in
Section 6.1(c) (ii) above shall automatically increase once per year on each
anniversary of the Effective Date as follows: (x) on the first anniversary of
the Effective Date by an amount equal to the [*] of the percentage increase in
CPI in the previous twelve (12) month period and [*] percent [*] (y) on the
second anniversary of the Effective Date by an amount equal to the [*] of the
percentage increase in CPI in the previous twelve (12) month period and [*]
percent [*] and (z) on each of the third and following anniversaries of the
Effective Date of the Agreement by an amount equal to the [*] of the percentage
increase in CPI in the previous twelve (12) month period and [*].
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6.2 Remedies for Delay.
(a) Dosimetric or Therapeutic Supply. Notwithstanding
anything in this Agreement to the contrary, Corixa shall not be required to pay
for any Batches which are not delivered pursuant to Section 3.2(c) regardless of
whether such Batch is manufactured; provided, however, if Corixa would otherwise
be required to pay for a Batch which Nordion attempts to deliver pursuant to
Section 3.2(c)(i) and such Batch would have been successfully delivered but for
a failure of the Carrier to arrive after Nordion contacted such Carrier in a
timely manner, Corixa shall pay for such Batch. In the event a dosimetric or
therapeutic Batch is the subject of a Delay of less than or equal to [*], the
purchase price for the affected Batch, replacement Batch or next Batch shall be
reduced by the sum of [*] percent [*] of such purchase price plus the Delay
Costs. In the event a dosimetric or therapeutic Batch is the subject of a Delay
of more than [*] but less than [*], the purchase price for the affected Batch,
replacement Batch or next Batch shall be reduced by the sum of [*] percent [*]
of such purchase price plus the Delay Costs. In the event a dosimetric or
therapeutic Batch is the subject of a Delay of more than [*], the purchase price
for the affected Batch, replacement Batch or next Batch shall be reduced by the
sum of [*] percent [*] of such purchase price plus the Delay Costs. The
discounts set out in this section are not cumulative.
(b) Termination. In the event that either: (i) [*] or
more dosimetric Batches are the subject of a Delay in any [*]; or (ii) [*] or
more therapeutic Batches are the subject of a Delay in any [*], Corixa may, at
its option, terminate this Agreement upon [*] days written notice at any time
within [*] days of the date of the last Delay giving rise to Corixa's right to
terminate.
(c) Reduction in Minimums. Corixa's minimum purchase
commitments described at Section 3.1(g) for any given [*] period will be reduced
by [*] for each dosimetric Batch which is subject to a Delay enduring more than
[*]. For each therapeutic Batch which is subject to a Delay enduring more than
[*], the minimum purchase commitment for the [*] period in which such
therapeutic Batch Delay occurs, will be reduced by [*].
6.3 Remedies for Recall. In the event of a Recall, Corixa shall be
relieved of any obligation to pay the purchase price for such Batch, and Nordion
shall indemnify Corixa for the following out-of-pocket costs incurred in
connection with such Recall: (i) Delay Costs; (ii) the out of pocket cost of
return of Labeled Drug to Nordion (if applicable); (iii) Isotope costs incurred
in connection with any Recalled Batch under the Iodine Supply Agreement for
Iodine used in the production of the Batch subject of the Recall; and (iv) the
actual cost to Corixa of B1 Antibody and CD-20 Antigen Cells. In the event of a
Recall, [*].
7. Statements of Work. The Parties are currently performing under certain
signed SOWs. The Parties acknowledge and agree that, unless otherwise agreed by
the Parties, no additional engineering, development or other work will be
required to implement the terms of this Agreement other than that work required
by the SOWs listed on Exhibit 7. If Nordion and Corixa cannot agree on a SOW
within [*] of Corixa's receipt of Nordion's proposal, the matter shall be
referred to the executive steering committee currently constituted and born from
past practice between Corixa and Nordion with respect to executive management of
Labeled Drug operations.
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8. Maintenance, Facility Use and Asset Ownership.
8.1 Maintenance.
(a) Prior to the implementation and completion of the work with
respect to each piece of equipment set out in the following
[*] SOWs[*], as identified in Exhibit 7 [*] (i) Nordion shall
in accordance with cGMPs [*] repair, maintenance and service
contracts of all equipment excluding the equipment subject of
a [*] and (ii) Corixa and Nordion shall, [*] of repair,
maintenance and service contracts of those pieces of equipment
subject of a [*].
In the event that the [*] is agreed to by Corixa and Nordion
prior to [*], the [*] set out in item (ii) above shall only
continue until the completion of the [*] or [*], whichever
occurs first. In the event that agreement is not reached on a
[*] prior to [*] that agreement is not reached, [*] set out in
item (ii) above shall be [*]. Corixa shall not, pursuant to
item (ii) above, be liable for the expense of repair,
maintenance and service contracts in excess of [*] United
States dollars [*] in each [*].
In addition, Nordion and Corixa shall [*] of implementation
and completion of [*]. For the avoidance of doubt all work
carried out under an applicable [*] shall be in accordance
with the terms of that [*].
The labor rate applicable by Nordion for the purpose of this
section shall be [*] United States dollars [*] per hour.
(b) After completion and implementation of the work with respect
to each piece of equipment in a [*] under the [*], Nordion
shall in accordance with cGMPs as of such date, bear the
expense of repair, maintenance and service contracts of such
piece of equipment.
8.2 Facility Use.
(a) Radiolabeling B1 Antibody. The Facility shall use the
Process to radiolabel B1 Antibody in accordance with cGMP and all other
requirements set forth in this Agreement in those Batch sizes according to the
I-131 quantity set forth in Exhibit 9.1.
(b) Restrictions on Use of Facility. During the term of
this Agreement, Nordion may not use those portions of the Facility that are
solely dedicated to the manufacturing or packaging of Labeled Drug for any
purpose other than producing Labeled Drug for Corixa or for conducting
additional experiments at Corixa's direction per an agreed upon SOW.
(c) Facility Validated. Nordion acknowledges and agrees
that the Process has been Validated at the Facility and that Nordion is capable
of producing the Labeled Drug in accordance with the Process. Nordion shall be
responsible for all cost arising from producing the Labeled Drug in accordance
with the Validated Process.
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8.3 Corixa Equipment. Subject to Sections 8.4,11.7(b) and/or as
otherwise set out in this this Agreement, all right, title and interest in and
to the Corixa Equipment shall belong to and remain the property of Corixa.
Subject to the foregoing and Section 8.4, Nordion shall own all other assets
purchased under the Previous Agreements.
8.4 Hot Cell Ownership. Nordion has purchased the Hot Cells on
behalf of Corixa. Until transfer of the Hot Cells to Nordion in accordance with
this Agreement, Corixa shall retain all right, title and interest in and to such
Hot Cells; provided that Nordion shall have the exclusive right to use the Hot
Cells for the sole purpose of producing and supplying Labeled Drug to Corixa
pursuant to this Agreement. Corixa represents and warrants that the Hot Cells
are not encumbered, and shall, during the term of this Agreement, remain free
and clear of any and all encumbrances, including, without limitation, mortgages,
charges and liens. Corixa shall use commercially reasonable efforts to ensure
that no effective financing statement or other instrument similar in effect
covering all or any part of the Hot Cells is on file in any recording office. In
the event of termination (for any reason ) or expiration of this Agreement, or
effective May 31, 2004, whichever is earlier, in consideration of $1.00 and
other valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, Corixa hereby transfers to Nordion (without any further formality
of conveyance) ownership of the Hot Cells. During the term of this Agreement,
the Hot Cells shall be used by Nordion for the purpose of producing and
supplying Labeled Drug to Corixa in accordance with this Agreement. Until such
time as Corixa has transferred the Hot Cells to Nordion, Nordion is hereby
granted a continuing first priority security interest in the Hot Cells securing
the obligation of Corixa to effect transfer of the Hot Cells to Nordion and the
obligation of Corixa to not create any interest in the Hot Cells that would
constitute an encumbrance, charge, lien or other impediment to the transfer of
the Hot Cells to Nordion. The security interest in the Hot Cells, effective
January 1, 1996, under the Facilities Agreement continues under this Agreement
and is perfected by the continuous and ongoing possession of the Hot Cells by
Nordion. Notwithstanding the applicable law set out in this Agreement, the laws
of Ontario, Canada shall govern the security interest created herein.
9. Payments.
9.1 Pricing. The purchase price for each Batch of Labeled Drug
that is produced by Nordion in accordance with a Firm Order and that meets
Specifications is provided in Exhibit 9.1. Upon expiration or early termination
of the Iodine Supply Agreement, the purchase price for each Batch of Labeled
Drug shall be adjusted as provided for in Exhibit 9.1. In the event that Corixa
purchases more than [*] Batches in a given [*] period, the Parties will meet to
discuss changing the per-Batch purchase price for the Labeled Drug.
9.2 Cancellation Fees. Subject to any additional payments set
forth in this Section 9.2, Corixa may cancel a scheduled Batch at any time prior
to the Scheduled Batch Completion Date. In the event of a cancellation by Corixa
of a Batch subject to a Firm Order during the period prior to the [*] of the
Commercial Supply, Corixa agrees to pay Nordion a fee of [*] percent [*] of the
applicable Batch price. Without limiting Corixa's obligation with respect to the
minimum purchase commitments under this Agreement, in the event that Corixa
cancels a Batch subject to a Firm Order after the [*] of Commercial Supply,
Corixa, subject to a reconciliation as set out below, shall pay Nordion a fee of
[*] percent [*] of the applicable Batch price. [*]. The cancellation fees
referenced in this Section 9.2 shall
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be invoiced by Nordion on an ongoing basis, and a reconciliation shall occur at
the end of each successive [*] period after the [*] of the commencement of
Commercial Supply. [*].
9.3 Invoicing and Payment.
(a) Nordion. No more frequently than monthly, Nordion
will provide Corixa with an invoice for the purchase price for each Batch of
Labeled Drug delivered to Corixa or Corixa's designees and maintenance cost and
expense as per Section 8.1, not previously invoiced. Such invoices will be due
and payable within [*] of receipt by Corixa.
(b) Corixa. No more frequently than monthly, Corixa will
provide Nordion with an invoice for any amounts payable to Corixa pursuant to
this Agreement. Such invoices will be due and payable within [*] of receipt by
Nordion.
9.4 Price Increase. All amounts due to Nordion pursuant to this
Agreement shall be payable in U.S. dollars. Nordion may increase the amounts
payable from Corixa to Nordion hereunder no more than once per year as follows:
(a) on the [*] of the Effective Date by an amount equal to the [*] of the
percentage increase in CPI in the previous twelve (12) month period and [*]
percent [*] (b) on the [*] of the Effective Date by an amount equal to the [*]
of the percentage increase in CPI in the previous twelve (12) month period and
[*] percent [*] and (c) on each of the [*] and [*] of the Effective Date of this
Agreement by an amount equal to the [*] of the percentage increase in CPI in the
previous twelve (12) month period and [*].
9.5 Supporting Documentation. Any amounts requested or invoiced by
Corixa to Nordion, including without limitation, other payments, credits or
price reductions provided due to Delays or Recalls, shall be supported by
accompanying documentation in support of the amounts invoiced or claimed.
9.6 Record Retention; Audits.
(a) Record Keeping. Nordion shall keep accurate books and
accounts of records in connection with amounts invoiced to Corixa under this
Agreement (excluding fixed price items agreed to by Corixa and Nordion) or any
SOW (excluding fixed price items agreed to by Corixa and Nordion) in sufficient
detail to permit accurate determination of all figures necessary for
verification of all compensation invoiced to Corixa hereunder or thereunder.
Nordion shall maintain such records for a period of three (3) years after the
end of the year in which they were generated.
(b) Audits. Upon reasonable notice to Nordion, Corixa
shall have the right to have an independent certified public accountant,
selected by Corixa and acceptable to Nordion, acting reasonably, to audit
Nordion's records pertaining to amounts invoiced to Corixa. If the Parties agree
that Nordion is to provide goods or services at a fixed price (as opposed to on
a time and materials basis) such items shall not be subject to audit. Such audit
shall take place during normal business hours; provided, however, that such
audit shall not take place more frequently than [*] and shall not cover such
records for more than the preceding [*]. Such audit shall be at Corixa's
expense; provided, however, that if such audit yields a discrepancy of [*] or
greater in Nordion's favor, [*] the amount of over-payment within thirty (30)
days of the final audit report. Upon reasonable notice to Corixa, for
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the purposes of sections 6.1 (c) and 6.3, Nordion may require and Corixa shall
provide a statement executed by Corixa's Chief Financial Officer certifying as
true and correct any costs claimed from Nordion pursuant to such sections.
10. Intellectual Property.
10.1 Licensing.
(a) Limited License to Nordion. Corixa hereby grants to
Nordion a non-exclusive, nontransferable, non-sublicensable, royalty-free
license during the term of this Agreement to use data, information and
technology provided by Corixa to Nordion that relates to B1 Antibody
radiolabeling, for the limited purpose of assisting Nordion to carry out its
obligations under this Agreement. The data, information and technology licensed
hereunder shall be Corixa Confidential Information as that term is used at
Section 14.1 of this Agreement.
(b) Limited License to Corixa. Nordion hereby grants to
Corixa a worldwide, nonexclusive, royalty free, perpetual license, with right to
sublicense, to use any Nordion IP used in the process of manufacturing Labeled
Drug as disclosed in the BLA, for the sole and limited purpose of selling,
having sold, distributing, having distributed, manufacturing and having
manufactured Isotope radiolabeled B-1 Antibody, except for any Nordion IP
related to [*].
(c) No Other Grant. It is agreed that disclosure of data,
information or technology by Nordion or Corixa to the other during the term of
this Agreement shall not, except to the extent granted herein, constitute any
grant, option or license under any patent, technology or other rights held by
Nordion or Corixa.
(d) Licensing Related Indemnification. Corixa shall
defend, indemnify and hold Nordion, its Affiliates and their respective
directors, officers, employees and agents, harmless from and against any
damages, claims, liabilities and expenses, (including without limitation,
reasonable attorney's fees) resulting from a claim or suit arising out of any
proceeding (including without limitation, any proceeding claiming infringement
of patents or other proprietary rights of third parties) instituted by a third
party, other than an Affiliate or licensee of Nordion, based on Corixa's or any
of its sublicensees' use of the Nordion IP licensed to Corixa pursuant to
Section 10.1(b). Nordion shall defend, indemnify and hold Corixa, its Affiliates
and their respective directors, officers, employees and agents, harmless from
and against any damages, claims, liabilities and expenses, (including without
limitation, reasonable attorney's fees) resulting from a claim or suit arising
out of any proceeding (including without limitation, any proceeding claiming
infringement of patents or other proprietary rights of third parties) instituted
by a third party, other than an Affiliate or licensee of Corixa, based on
Nordion's or any of its sublicensees' use of the Corixa IP licensed to Nordion
pursuant to Section 10.2(d).
10.2 Ownership.
(a) Nordion IP. The Parties acknowledge and agree that as
between the Parties, the Nordion IP is and shall remain the property of Nordion.
(b) Corixa IP. The Parties acknowledge and agree that as
between the Parties, the Corixa IP is and shall remain the property of Corixa.
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(c) Technology Developed Under this Agreement or Previous
Agreements. Nordion agrees and Corixa acknowledges that any and all ideas,
improvements, inventions and works of authorship, and any and all intellectual
property rights in any of the foregoing, conceived, written, created or first
reduced to practice in the performance of this Agreement, or the Previous
Agreements, except to the extent that it embodies the Background Technology or
improvements to the Background Technology, shall be the sole and exclusive
property of Corixa. Except as set forth in this Section 10.2, Corixa is and
shall be vested with all right, title and interest, including without
limitation, any intellectual property rights, in such ideas, improvements,
inventions and works of authorship. Nordion hereby assigns to Corixa all right,
title and interest in and to any and all such ideas, improvements, inventions
and works of authorship.
(d) Additional Limited License to Nordion. Corixa hereby
grants to Nordion a non-exclusive, [*], worldwide, royalty-free, perpetual
license to exploit all ideas, improvements, inventions and works of authorship
assigned to or vested in Corixa as described in Section 10.2(c) for any
application, except the development or manufacture of [*].
10.3 Corixa Proprietary Information. All data, information or
technology supplied to Nordion by Corixa to assist Nordion in carrying out its
obligations hereunder or under the Previous Agreements shall remain the property
of Corixa and shall be returned by Nordion to Corixa upon expiration or early
termination of this Agreement.
10.4 Patent Applications. Nordion shall execute all papers and
documents, including without limitation, patent applications, invention
assignments and copyright assignments, and otherwise shall assist Corixa as
reasonably required to perfect in Corixa the rights, title and other interests
in Nordion's work product expressly granted to Corixa under this Agreement.
Reasonable costs related to such assistance, if required, shall be paid by
Corixa.
11. Term and Termination.
11.1 Term. The term of this Agreement shall commence upon the
Effective Date, and unless terminated earlier or extended as provided hereunder,
shall expire seven (7) years thereafter (the "Initial Term").
11.2 Extension of Term. The term of this Agreement may be extended
for an additional three (3)-year period (the "Extended Term"), at either
Parties' request following the third anniversary of the Effective Date, by
providing written notification that the requesting Party wishes to extend the
term of this Agreement to the non-requesting Party not less than two (2) years
prior to the expiration of the Initial Term. The non-requesting Party shall have
one hundred and eighty (180) days from the date of receipt, to agree to the
Extended Term, otherwise the Agreement will terminate at the end of the Initial
Term. Any notice given pursuant to this Section 11.2 shall be made to the Chief
Executive Officer and General Counsel of the non-requesting Party and shall be
sent via certified mail with a return receipt requested.
11.3 Termination by Corixa. Corixa may terminate this Agreement for
convenience at any time on or after the [*] of the Effective Date. Such notice
of termination shall provide Nordion at least [*] prior written notice. In the
event Corixa elects to terminate under this Section 11.3, Corixa shall pay
Nordion the applicable fee, as provided below, on the date such termination
becomes effective. If Corixa's termination of this Agreement is effective on the
[*] of the Effective Date, Corixa shall pay
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Nordion a fee of [*] US dollars [*] Thereafter such fee shall be reduced by [*]
US dollars [*] per year as follows: if Corixa's termination of this Agreement is
effective during the [*] year of this Agreement, the fee shall be [*] US dollars
[*]; if Corixa's termination of this Agreement is effective during the [*] year
of this Agreement, the fee shall be [*] US dollars [*] if Corixa's termination
of this Agreement is effective during the [*] year of this Agreement, the fee
shall be [*] US dollars [*] and if Corixa's termination of this Agreement is
effective during the [*] year of this Agreement, the fee shall be [*] US dollars
[*] After the [*] year of the Agreement, there shall be no further termination
fee.
11.4 Termination for Breach. This Agreement may be terminated by
either Party in the event of the material breach by the other Party of the terms
and conditions herein; provided, however, the other Party shall first give to
the breaching Party written notice of the proposed termination of this Agreement
(a "Breach Notice"), specifying the grounds therefor. An event of material
breach by Nordion shall include without limitation, a failure by Nordion to meet
the obligations as set forth in Section 4.1. Upon receipt of the Breach Notice,
the breaching Party shall have sixty (60) days to respond by curing such breach
within such cure period (or thirty (30) days with respect to failure by Corixa
to pay any amounts hereunder when due, other than with respect to those amounts
which Corixa in good faith disputes are due to Nordion). If the breaching Party
does not cure such breach, the other Party may immediately terminate this
Agreement. Termination of this Agreement pursuant to this Section shall not
affect any other rights or remedies which may be available to the non-breaching
Party. In the event of material breach by Corixa which is not remedied in
accordance with this Section 11.4, Nordion shall be entitled to suspend supply
of Labeled Drug in addition to any other recourse it may have.
11.5 Termination for Failure to obtain BLA Approval. This Agreement
may be terminated by either Party in the event that regulatory approval by the
FDA for the commercial sale of Labeled Drug does not occur by [*].
11.6 Termination for Insolvency. A Party may terminate this
Agreement upon the occurrence of either of the following:
(a) Involuntary Bankruptcy Filing. The other Party is
subject to the entry of a decree or order for relief by a court having
jurisdiction in the premises in respect of such Party in an involuntary case
under the Federal Bankruptcy Code in the United States of America or the
Bankruptcy and Insolvency Act in Canada, as now constituted or hereafter
amended, or any other applicable national, federal or state insolvency or other
similar law and the continuance of any such decree or order unstayed and in
effect for a period of sixty (60) consecutive days; or
(b) Voluntary Bankruptcy Filing. The filing by the other
Party of a petition for relief under the Federal Bankruptcy Code in the United
States of America or the Bankruptcy and Insolvency Act in Canada, as now
constituted or hereafter amended, or any other applicable federal or state
insolvency or other similar law.
11.7 Consequences of Expiration or Early Termination.
(a) Post-Expiration/Termination Supply. Upon expiration
or early termination of this Agreement, Nordion (except if the Agreement is
terminated by Nordion due to material breach by
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Corixa pursuant to Section 11.4 or termination for bankruptcy pursuant to
section 11.6, in which case Nordion may elect to discontinue manufacture and
supply of Labeled Drug) shall manufacture and supply, and Corixa shall purchase
in accordance with the provisions hereof (provided that Nordion is able to
manufacture Labeled Drug and is not prevented from manufacturing or supplying
Labeled Drug for regulatory reasons or Force Majeure), any and all amounts of
Labeled Drug ordered pursuant to a Firm Order by Corixa prior to the date on
which such notice of termination is given; provided, however, that Corixa may
cancel any such order and pay a cancellation fee if required by Section 9.2 of
this Agreement.
(b) Post-Expiration/Termination Rights and Obligations.
Upon expiration or termination of this Agreement for any reason, including,
without limitation, termination pursuant to Sections 6 (Failure to Supply), 11.3
(termination by Corixa for convenience), 11.4 (breach), 11.5 (BLA non-approval),
11.6 (bankruptcy) or 16.8 (Force Majeure), in addition to the respective rights
of each Party contained in this Agreement: (i) Nordion shall be entitled to
receive and Corixa shall pay all amounts due and owing by Corixa, [*] by Corixa
for all amounts Nordion owes to Corixa; (ii) Nordion shall, within seventy-five
(75) days after termination or expiration (subject to decontamination and/or
disposal (if applicable)), return, except as provided below, the Corixa
Equipment in Nordion's possession, provided that the transfer, decontamination
and/or disposal costs of the Corixa Equipment shall be at Corixa's cost and
expense unless the termination is by Corixa pursuant to Sections 6, 11.4 or
16.8, in which case Nordion shall pay for such transfer, decontamination and/or
disposal costs; (iii) Nordion shall, within one hundred and twenty (120) days
after termination or expiration, [*] (subject to any regulatory requirement to
the contrary), excluding Nordion IP related [*] provided that preparation of the
documents for delivery to Corixa in this subitem (iii) shall be at Corixa's cost
and expense, unless the termination is by Corixa pursuant to Section 6, 11.4 or
16.8, in which case Nordion shall bear such costs, (iv) Nordion shall receive or
retain ownership of the Hot Cells in accordance with Section 8.4; (v) Nordion
shall return the BLA to Corixa, and (vi), Nordion shall return to Corixa all
remaining B1 Antibody and CD-20 Antigen Cells; provided that such transfer shall
be at Corixa's cost and expense unless the termination is by Corixa pursuant to
Section 6, 11.4 or 16.8, in which case Nordion shall pay for such transfer.
Notwithstanding the foregoing, Nordion shall, for a period of one (1) year after
termination or expiration of this Agreement, as soon as reasonably practicable
but in no event later than thirty (30) days after receipt of written notice from
Corixa, deliver to Corixa a copy of those records, reports and other documents
within Nordion's possession or control that are required by the regulatory
agency to be delivered or maintained by Corixa in order for Corixa to remain in
compliance with applicable regulatory requirements in the Territory. If Corixa
fails to acknowledge its intent to take delivery of the Corixa Equipment, B1
Antibody or CD-20 Antigen Cells, within thirty (30) days of the receipt of
Nordion's notice of intention to ship such equipment, B1 Antibody, or CD-20
Antigen Cells and/or Corixa does not accept such shipment(s), all right, title
and interest in and to such equipment shall immediately transfer to Nordion and
Nordion shall destroy all B1 Antibody and CD-20 Antigen Cells in its possession
or control.
(c) Survival. Upon expiration or termination of this
Agreement, any claims or causes of action arising hereunder prior to such
expiration or termination together with the rights and obligations of the
Parties under Sections 1, 4.2, 5.7, 5.8, 5.9, 5.13, 8.3, 8.4, 9.6, 10.1 (b), (c)
and (d), 10.2, 10.3, 10.4, 11.3, 11.4, 11.7, 12, 13.1, 13.2, 13.3, 13.4, 13.5,
13.6, 14, 15 and 16 shall survive such expiration or termination in accordance
with their terms.
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12. Representations, Warranties and Disclaimers.
12.1 Corixa. Corixa represents and warrants and covenants that:
(a) B1 Antibody and CD-20 Antigen Cells. The B1 Antibody
and CD-20 Antigen Cells when supplied to Nordion shall (i) be manufactured in
accordance with cGMP and all applicable FDA regulations, including, without
limitation, the submission of appropriate regulatory documents, (ii) not be
misbranded or otherwise of a nature that may not be introduced into United
States interstate commerce, and (iii) meet the specifications respectively set
out in Exhibit 1.6 and 1.16;
(b) Corixa IP. Except as set forth in Exhibit 12.1, as of
the Effective Date and to Corixa's best information and belief, (i) Corixa is
the owner or licensee of Corixa IP used in connection with this Agreement, (ii)
the Corixa IP used in connection with this Agreement does not infringe any
patents, copyright or other industrial or intellectual property rights of third
parties, (iii) Corixa has the right to grant the license set forth in Section
10.1 and the right to permit Nordion to use the Corixa IP used in connection
with this Agreement to carry out Nordion's obligations as contemplated herein,
and (iv) Corixa has not received any notice or adverse claim of infringement of
any patent contained in the Corixa IP used in connection with this Agreement;
and
(c) Infringement. Except as set forth in Exhibit 12.1, as
of the Effective Date, to the best of Corixa's knowledge, there are no
intellectual property rights, including, without limitation, valid United States
patents, that would be infringed by the manufacture, use or sale of Labeled Drug
or the use of the Process. Notwithstanding the preceding sentence, Corixa makes
no warranty with respect to intellectual property rights relating to any
processes performed by Nordion hereunder except for that portion of any process
contributed by Corixa.
12.2 Nordion. Nordion represents and warrants and covenants that:
(a) Labeled Drug. Provided Corixa is in compliance with
its warranty under Section 12.1, and provided the Labeled Drug is not subject to
misuse, abuse or improper storage following delivery, the Labeled Drug,
including, without limitation, any labeling and other packaging for the Labeled
Drug, for the period from the date of manufacture to the expiry date set out on
each vial of Labeled Drug, (i) will conform to the Specifications, (ii) has been
manufactured, handled, stored, labeled, packaged and delivered in accordance
with the Specifications and applicable standard operating procedures and this
Agreement, (iii) has been manufactured, handled, stored, labeled, packaged and
delivered in accordance with cGMP and all other applicable laws, regulations and
other requirements of all applicable governmental entities in the Territory,
(iv) has been manufactured consistent with relevant sections of the IND or BLA,
as applicable, and corresponding licenses, registrations, authorizations or
approvals for Labeled Drug for each foreign jurisdiction, as previously advised
by Corixa and agreed by the Parties, and (v) will not be (A) misbranded by
Nordion within the meaning of the FD&C Act, or (B) of a nature that may not be
introduced into United States interstate commerce. Furthermore, Nordion
represents, warrants and covenants that it will comply with all Environmental
Regulations.
(b) Nordion IP. As of the Effective Date, to Nordion's
best information and belief, (i) Nordion is the owner of the Nordion IP used in
connection with this Agreement, (ii) the Nordion IP used in connection with this
Agreement does not infringe any patents, copyright or other industrial or
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intellectual property rights of third parties, (iii) Nordion has the right to
use the Nordion IP used in connection with this Agreement to carry out its
obligations as contemplated herein, (iv) Nordion has not received any notice of
adverse claim or infringement of any patent relating to the Nordion IP used in
connection with this Agreement, and (v) there is no action or proceeding pending
or insofar as Nordion knows or ought to know, threatened against Nordion before
any court, administrative agency or other tribunal which might have a material
adverse effect on Nordion's business.
(c) Destroyed or Returned Items. Exhibit 1.28 provides a
complete and accurate list of all items and equipment owned by Corixa which are
located at the Nordion Site. Exhibit 12.2(c) contains a complete and accurate
list of items or equipment, that as of the Effective Date, (i) were owned by
Corixa but which have been destroyed or (ii) are owned by Corixa and have been
returned to Corixa by or on behalf of Nordion.
12.3 Mutual. Each Party hereby represents and warrants to the other
that this Agreement is legal and valid and the obligations binding upon such
Party are enforceable in accordance with their terms, and that the execution,
delivery and performance of this Agreement does not conflict with any agreement,
instrument or understanding, oral or written, to which such Party may be bound,
nor to its knowledge violate any law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.
12.4 No Other Warranties. Except as expressly provided in this
Agreement, neither Party makes any representations or warranties to the other
Party and each Party disclaims all other warranties, whether express or implied,
statutory or otherwise, including without limitation, any implied warranties of
merchantability or fitness for a particular purpose.
13. Indemnification.
13.1 By Corixa.
(a) Indemnification Obligation. Subject to Nordion's
compliance with Section 13.4, Corixa agrees to indemnify, defend and hold
Nordion and its Affiliates and their respective directors, officers, employees
and agents harmless from and against any damages, claims, liabilities and
expenses, including, without limitation, reasonable attorneys' fees, resulting
from any third party claims or suits ("General Claims Against Nordion") arising
out of (i) the use, handling, shipment, marketing or sale of Labeled Drug, (ii)
Corixa's breach of any of its covenants, warranties or representations
hereunder, or (iii) Corixa's negligent acts or omissions or willful misconduct.
(b) Exceptions to Indemnification Obligations.
Notwithstanding the foregoing, Corixa will not be required to indemnify, defend
or hold Nordion or its Affiliates and their respective directors, officers,
employees and agents harmless from and against any General Claims Against
Nordion to the extent arising out of (i) Nordion's breach of any of its
warranties or representations hereunder; (ii) Nordion's negligent acts or
omissions or willful misconduct; (iii) any failure by Nordion to manufacture
Labeled Drug to meet the Specifications; (iv) any failure of Nordion to
manufacture, handle, store, label, package, or transport Labeled Drug in
accordance with cGMP or any other applicable laws, regulations or other
requirements of any applicable governmental entity in the Territory; or (v) any
failure of Nordion to manufacture Labeled Drug consistent with the applicable
sections of the IND or BLA, as applicable, and any corresponding licenses,
registrations, authorizations
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or approvals in the Territory. Notwithstanding anything in this Section 13.1,
General Claims Against Nordion shall not include IP Claims Against Nordion.
13.2 By Nordion.
(a) Indemnification Obligation. Subject to Corixa's
compliance with Section 13.4, Nordion agrees to indemnify, defend and hold
Corixa and its Affiliates and their respective directors, officers, employees
and agents harmless from and against any damages, claims, liabilities and
expenses, including, without limitation, reasonable attorneys' fees, resulting
from any third party claims or suits ("General Claims Against Corixa") arising
out of (i) Nordion's manufacture, handling, storage, labeling, packaging or
delivery of Labeled Drug; (ii) Nordion's breach of any of its covenants,
warranties or representations hereunder; (iii) Nordion's negligent acts or
omissions or willful misconduct; (iv) any failure by Nordion to manufacture
Labeled Drug to meet the Specifications; (v) any failure of Nordion to
manufacture, handle, store, label, package, or transport Labeled Drug in
accordance with cGMP or any other applicable laws, regulations or other
requirements of any applicable governmental entity in the Territory; or (vi) any
failure of Nordion to manufacture Labeled Drug consistent with the applicable
sections of the IND or BLA, as applicable, and any corresponding licenses,
registrations, authorizations or approvals in the Territory.
(b) Exceptions to Indemnification Obligations.
Notwithstanding the foregoing, Nordion will not be required to indemnify, defend
and hold Corixa or its Affiliates and their respective directors, officers,
employees and agents harmless from and against any General Claims Against Corixa
to the extent arising out of (i) Corixa's breach of any of its warranties or
representations hereunder, or (ii) Corixa's negligent acts or omissions or
willful misconduct. Notwithstanding anything in this Section 13.2, General
Claims Against Corixa shall not include IP Claims Against Corixa.
13.3 Intellectual Property Claims.
(a) Indemnification by Nordion. Subject to Corixa's
compliance with Section 13.4, Nordion agrees to indemnify, defend and hold
Corixa and its Affiliates and their respective directors, officers, employees
and agents harmless from and against any damages, claims, liabilities and
expenses (including without limitation, reasonable attorneys' fees) resulting
from any third party claims or suits arising out of any proceeding instituted by
or on behalf of a third party based upon a claim that the Process used in
manufacturing the Labeled Drug infringes a patent in the Territory or any other
proprietary rights of a third party ("IP Claims Against Corixa").
Notwithstanding the foregoing, Nordion will not be required to indemnify, defend
and hold Corixa or its Affiliates and their respective directors, officers,
employees and agents harmless from and against any IP Claims Against Corixa
arising out of the infringement of any third party intellectual property right
by the manufacturing Process to the extent developed solely by Corixa.
(b) Indemnification by Corixa. Subject to Nordion's
compliance with Section 13.4, Corixa agrees to indemnify, defend and hold
Nordion and its Affiliates and their respective directors, officers, employees
and agents harmless from and against any damages, claims, liabilities and
expenses (including without limitation reasonable attorneys' fees) resulting
from any third party claims or suits (including without limitation those claims
and suits listed in Exhibit 12.1) arising out of any proceeding instituted by or
on behalf of a third party based upon a claim that the manufacture, use or sale
of
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Labeled Drug infringes a patent in the Territory or any other proprietary rights
of a third party ("IP Claims Against Nordion"). Notwithstanding the foregoing,
Corixa will not be required to indemnify, defend and hold Nordion and its
Affiliates and their respective directors, officers, employees and agents
harmless from and against any IP Claims Against Nordion arising out of the
infringement of any third party intellectual property right by any manufacturing
processes to the extent (i) developed by Nordion, either alone or with one or
more third parties, (ii) developed for Nordion by one or more third parties, or
(iii) jointly developed by Corixa and Nordion.
13.4 Indemnification Procedures. A Party (the "Indemnitee") which
intends to claim indemnification under this Section 13 or Section 10.1(d) shall
promptly notify the other Party (the "Indemnitor") in writing of any action,
claim or other matter (a "Claim") in respect of which the Indemnitee or any of
its Affiliates, or any of their respective directors, officers, employees or
agents intend to claim such indemnification; provided, however, the failure to
provide such notice within a reasonable period of time shall not relieve the
Indemnitor of any of its obligations hereunder, except to the extent the
Indemnitor is prejudiced by such failure. The Indemnitee agrees to the complete
control of the defense of such Claim by the Indemnitor. The Indemnitee, its
Affiliates and their respective directors, officers, employees and agents shall
cooperate fully with the Indemnitor and its legal representatives at the
Indemnitor's sole cost and expense in the investigation and defense of any such
Claim.
13.5 Right to Participate in Defense. Without limiting Section
13.4, any Indemnitee shall be entitled to participate in, but not control, the
defense of such Claims and to engage counsel of its choice for such purpose;
provided, however, that such engagement shall be at the Indemnitee's own expense
unless (a) the engagement thereof has been specifically authorized by the
Indemnitor in writing, (b) the Indemnitor has failed to assume the defense and
engage counsel in accordance with Section 13.4 (in which case the Indemnitee
shall control the defense), or (c) in the reasonable judgment of Indemnitee's
legal counsel, a material conflict of interest between the Indemnitee and the
Indemnitor exists in respect of any such Claim, provided that, in any event, the
other provisions of this Section 13 shall continue to apply to such Claim.
13.6 Settlement. With respect to any losses relating solely to the
payment of money damages in connection with a Claim covered by this Section 13
or Section 10.1(d) and that will not result in the Indemnitee's becoming subject
to injunctive or other relief or otherwise adversely affect the business of the
Indemnitee in any manner, and as to which the Indemnitor shall have acknowledged
in writing the obligation to indemnify the Indemnitee hereunder, the Indemnitor
shall have the sole right to consent to the entry of any judgment, enter into
any settlement or otherwise dispose of such Claim, on such terms as the
Indemnitor, in its sole discretion, shall deem appropriate. With respect to all
other such Claims, where the Indemnitor has assumed the defense of such Claims
in accordance with this Section 13, the Indemnitor shall have authority to
consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Claims provided it obtains the prior written consent of the
Indemnitee (which consent shall not be unreasonably withheld or delayed). The
Indemnitor shall not be liable for any settlement or other disposition that is
reached without the prior written consent of the Indemnitor. Regardless of
whether the Indemnitor chooses to defend or prosecute any third party claim, no
Indemnitee or any of its Affiliates, or any of their respective directors,
officers, employees or agents shall admit any liability with respect to, or
settle, compromise or discharge, any such Claims without the prior written
consent of the Indemnitor.
-30-
13.7 Nordion Insurance. Nordion shall at all times during the term
of this Agreement maintain in full force and effect with a reputable insurance
carrier(s) the following policies of insurance:
(a) Commercial General Liability. Commercial General
Liability Insurance, covering products liability, including bodily injury and
property damage to third parties. The initial limits of coverage shall be a
minimum of [*] US dollars [*] per occurrence and in the aggregate for bodily
injury/property damage (which insurance may be on a claims made or occurrence
basis). Nordion and Corixa agree to, at least on an annual basis, review the
coverage limits. Corixa shall be added as an additional insured on such general
liability policy as its interest may appear. Nordion shall upon request provide
to Corixa a certificate(s) of insurance evidencing such coverage. The policy
shall contain a cross liability clause and shall provide for severability of
interest such that breach of a policy condition by any one insured shall not
affect the rights of the other insured.
(b) Property Insurance. Property Insurance covering
damage to B1 Antibody and Corixa Equipment while it remains on Nordion's
premises or in Nordion's possession and control, in amounts not less than the
replacement cost thereof, and provided further that any such proceeds shall be
used to repair or replace such damaged or destroyed assets. Such policy shall
designate Corixa as a loss payee where its interests may appear in the event of
any insured loss or damage to B1 Antibody or Corixa Equipment. Nordion shall
upon request provide to Corixa a certificate(s) of insurance evidencing such
coverage. The policy shall contain a cross liability clause and shall provide
for severability of interest such that breach of a policy condition by any one
insured shall not affect the rights of the other insured.
(c) Self Insurance; Termination of Insurance.
Notwithstanding the foregoing with respect to such General Liability and/or
Property Insurance policies, [*], provided that Nordion still must provide
Corixa with a certificate regarding such insurance. In the event that any such
insurance policy held by Nordion pursuant to this section is to be terminated or
cancelled by the insurer or Nordion, Nordion shall (to the extent possible)
provide notice to Corixa at least thirty (30) days prior to such termination or
cancellation. Nothing in this section shall serve to limit in any way the
indemnification provisions set out in this Agreement.
13.8 Corixa Insurance. Corixa shall at all times during the term of
this Agreement maintain in full force and effect with a reputable insurance
carrier(s) the following policies of insurance:
(a) Commercial General Liability Insurance. Commercial
General Liability Insurance, covering products liability, including bodily
injury and property damage to third parties. The initial limits of coverage
shall be a minimum of [*] US dollars [*] per occurrence and in the aggregate for
bodily injury/property damage (which insurance may be on a claims made or
occurrence basis). Corixa and Nordion agree to, at least on an annual basis,
review the coverage limits. Nordion shall be added as an additional insured on
such general liability policy as its interest may appear. Corixa shall, upon
request, provide to Nordion a certificate(s) of insurance evidencing such
coverage. The policy shall contain a cross liability clause and shall provide
for severability of interest such that breach of a policy condition by any one
insured shall not affect the rights of the other insured.
-----------------------------------
* Confidential treatment requested.
-31-
(b) Property Insurance. Property Insurance covering
damage to B1 Antibody, while the B1 Antibody remains on Corixa's premises or in
Corixa's possession and control, in amounts not less than the replacement cost
thereof, and provided further that any such proceeds shall be used to repair or
replace such damaged or destroyed assets. The insurance policy shall designate
Corixa as a loss payee where its interests may appear in the event of any
insured loss or damage to B1 Antibody. Corixa shall upon request provide to
Nordion a certificate(s) of insurance evidencing such coverage. The policy shall
contain a cross liability clause and shall provide for severability of interest
such that breach of a policy condition by any one insured shall not affect the
rights of the other insured.
(c) Self Insurance; Termination of Insurance.
Notwithstanding the foregoing with respect to such General Liability and/or
Property Insurance policies, [*], provided that Corixa still must provide
Nordion with a certificate regarding such insurance. In the event that any such
insurance policy held by Corixa pursuant to this section is to be terminated or
cancelled by the insurer or Corixa, Corixa shall, (to the extent possible)
provide notice to Nordion at least thirty (30) days prior to such termination or
cancellation. Nothing in this section shall serve to limit in any way the
indemnification provisions set out in this Agreement.
14. Confidentiality.
14.1 Obligations. Except as set forth below, all information
disclosed by one Party to the other Party in connection with this Agreement or
the Previous Agreements hereunder shall be deemed to be the disclosing Party's
"Confidential Information." Confidential Information shall include, but not be
limited to, information relating to the B1 Antibody and the structure of Labeled
Drug, any know-how relating to the process for the production of Labeled Drug,
and the manufacturing cost and other financial arrangements made pursuant to
this Agreement. Each Party agrees that it will take the same steps to protect
the confidentiality of the other Party's Confidential Information as it takes to
protect its own proprietary and confidential information, which shall in no
event be less than reasonable steps. Each Party and its employees and agents
shall protect and keep confidential and shall not use, publish or otherwise
disclose to any third party, except as permitted by this Agreement, or with the
other Party's written consent, the other Party's Confidential Information.
Except as provided in Section 14.2, Corixa's Confidential Information includes,
without limitation, the Corixa IP, the Specifications, the Process, and the
content of Corixa's BLA and IND applications, except to the extent it contains
Nordion Confidential Information. Except as provided in Section 14.2, Nordion's
Confidential Information includes, without limitation, the Nordion IP (including
improvements to Nordion IP), Isotope Specifications, and Background Technology
(including improvements thereto). The content of this Agreement and Quality
Policy Manual shall be deemed to be the Confidential Information of both
Parties.
14.2 Exceptions. For the purposes of this Agreement, Confidential
Information shall not include such information that:
(a) Was already known to the receiving Party at the time
of disclosure by the other Party, other than under an obligation of
confidentiality; or
(b) Was generally available to the public or was
otherwise part of the public domain at the time of disclosure or became
generally available to the public or otherwise part of the public
-----------------------------------
* Confidential treatment requested.
-32-
domain after disclosure other than through any act or omission of the receiving
Party in breach of this Agreement;
(c) Was lawfully disclosed to the receiving Party, other
than under an obligation of confidentiality, by a third party who had no
obligation not to disclose such information to others; or
(d) Was independently developed by or for the receiving
Party without the aid, application or use of Confidential Information, as can be
shown by the receiving Party through documentary evidence.
14.3 Authorized Disclosure. Each Party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably necessary for
prosecuting or defending against litigation, complying with applicable
government laws or regulations or conducting preclinical or Clinical Trials,
provided that if a Party is required by law or regulation to make any such
disclosure of the other Party's Confidential Information, it will, except where
impracticable for necessary disclosures (for example, in the event of medical
emergency), give reasonable advance notice to the other Party of such disclosure
requirement and will use its reasonable efforts to secure confidential treatment
of such Confidential Information required to be disclosed. In addition, upon
prior written approval of Nordion, Corixa may disclose, under a comparable
obligation of confidentiality and on a need-to-know basis, information received
under this Agreement to its other partners for the development or
commercialization of Labeled Drug. Neither Party shall disclose Confidential
Information of the other Party in any patent filings without the prior written
consent of the other Party.
14.4 External Communications. Subject to Section 5.9 governing
communications of Complaints, Adverse Events and results of investigations
related thereto to the public and/or regulatory authorities, any other press
releases or other similar public communication by either Party relating to this
Agreement shall be approved in advance by the other Party, which approval shall
not be unreasonably withheld or delayed. Those press releases or other similar
public communications required by applicable laws, regulations, rules or orders
may be provided without advance written consent of the other party, provided (i)
the communication is provided to such Party as soon as practicable after the
release or communication thereof, and (ii) any such disclosure does not contain
the Confidential Information of such Party. If such communication contains
Confidential Information of a Party, such Party shall be entitled to receive the
communication in advance of its release and, to the extent permitted by law,
purge the communication of its Confidential Information. Any disclosures of
information for which consent has previously been obtained (and information of a
similar nature to that which has been previously disclosed publicly with respect
to this Agreement), shall not require advance approval.
14.5 Survival. All obligations of confidentiality and non-use
imposed upon the Parties under this Agreement shall expire ten (10) years after
the expiration or termination of this Agreement.
15. Governing Law; Dispute Resolution.
15.1 Governing Law. This Agreement will be governed by, construed
and enforced in accordance with the laws of the State of New York without regard
to principles of conflicts of law, as applied to contracts executed and
performed in New York by New York residents. The application of the United
Nations Convention for the International Sale of Goods is expressly excluded.
-33-
15.2 Consent to Jurisdiction. Each of the Parties hereby submits to
the nonexclusive jurisdiction of the United States federal and state courts
located in the City, State and County of New York solely in respect of the
interpretation and enforcement of the provisions of this Agreement, and hereby
waives, and agrees not to assert, as a defense in any action, suit or proceeding
for the interpretation or enforcement of this Agreement, that it is not subject
thereto or that such action, suit or proceeding may not be brought or is not
maintainable in such courts or that this Agreement may not be enforced in or by
such courts or that its property is exempt or immune from jurisdiction execution
or enforcement, that the suit, action or proceeding is brought in an
inconvenient forum, or that the venue of the suit, action or proceeding is
improper.
15.3 Dispute Resolution.
(a) Good Faith Negotiations. If the Parties fail to
resolve any claim, dispute, or controversy ("Dispute") of whatever nature
arising out of or relating to this Agreement (other than one relating to the
validity, enforceability, infringement or misappropriation of intellectual
property rights, which shall not be subject to this Section 15.3(a)), or
concerning the interpretation, effect, termination, validity, performance,
and/or breach of this Agreement, either Party may refer the Dispute, to such
officers as the Parties may designate in writing from time to time, for
attempted resolution by good faith negotiations within thirty (30) days after
such notice is received. If such Dispute is not solved by the end of such thirty
(30) day period, the Parties shall be free to pursue any legal or equitable
remedy available to them. Each Party will bear its own attorneys' fees and other
costs and expenses.
(b) Intellectual Property. Notwithstanding anything to
the contrary, any disputes regarding the validity, scope, enforceability,
infringement or misappropriation of patents, copyright, trade secrets or
trademarks shall be submitted to a court of competent jurisdiction in the
territory in which such rights apply.
16. General Provisions.
16.1 Independent Contractors. Corixa and Nordion shall be
independent contractors and shall not be deemed to be partners, joint venturers
or each other's agents, and neither Party shall have the right to act on behalf
of the other, except as is expressly set forth in this Agreement.
16.2 Disclaimer of Consequential Damages. Except for damages
arising out of a breach of Section 10 (Intellectual Property) or 14
(Confidentiality), in no event shall either Party be liable to the other Party
or its Affiliates for indirect, contingent, incidental, special or consequential
damages, including without limitation, any claim for damages based on lost
profits, cost of capital, loss of business opportunity or loss of time.
16.3 Entire Agreement; Amendment.
(a) Entire Agreement. This Agreement, which includes the
attached Exhibits, contains the sole and entire understanding of the Parties
related to its subject matter and supersedes all prior or contemporaneous oral
or written agreements concerning the subject matter as of the Effective Date.
(b) Amendment. This Agreement cannot be changed orally
and no modification of this Agreement will be recognized or have any effect,
unless the writing in which it is set forth is
-34-
signed by authorized representatives of Nordion and Corixa, nor will any waiver
of any of the provisions of this Agreement be effective unless in writing and
signed by the Party to be charged therewith.
(c) Survival Under Previous Agreements. The Parties agree
that the Previous Agreements are hereby terminated and of no further force and
effect. Notwithstanding the forgoing, Sections 8, 9, 14 and 21 of the
Development Agreement, Sections 2.6(c), 5.3, 5.4, 11.2, 11.3, 11.5, 11.6 and
Article 7 of the Facilities Agreement and Sections 8.6, 9.3, 10.3, 10.4, 16.2,
16.4, 16.6 and Article 12 (except Sections 12.5 and 12.6) of the Previous Supply
Agreement, shall survive in accordance with their terms.
16.4 No Conflicts. To the extent that the terms of the Iodine
Supply Agreement or the Quality Policy Manual are inconsistent with the terms of
this Agreement, the terms of this Agreement shall govern.
16.5 Assignment. This Agreement shall inure to the benefit of, and
be binding upon, the respective successors and assigns of the Parties. Without
the written consent of the other Party hereto, which shall not be unreasonably
withheld, neither Party shall sell, transfer, assign, pledge or otherwise
dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; provided,
however, that either party may assign or transfer this Agreement or any of its
rights or obligations hereunder without the consent of the other Party (a) to
any Affiliate of such Party, subject to the assigning Party remaining jointly
and severally liable under this Agreement with such Affiliate assignee or (b) to
any third party with which it merges or consolidates, or to which it transfers
all or substantially all of its assets to which this Agreement relates; provided
further that in any such event ((a) or (b)) such Affiliate assignee, third party
assignee or surviving entity assumes in writing all of the assigning Party's
obligations under this Agreement. Any purported assignment or transfer in
violation of this Section shall be void ab initio and of no force or effect.
16.6 Waiver. Failure or delay by either Party to enforce at any
time any of the provisions of this Agreement shall not be construed as a waiver
of its rights hereunder. Any waiver of a breach of any provision hereof shall
not affect either Party's rights in the event of any additional breach.
16.7 Notice. All notices under this Agreement must be made in
writing and mailed or delivered to the following:
Corixa: Corixa Corporation
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000 U.S.A.
Attn: Chief Executive Officer
Copy: General Counsel
-35-
Nordion:. MDS Nordion.
000 Xxxxx Xxxx
Xxxxxx, Xxxxxxx X0X 0X0 XXXXXX
Attn: Senior Vice President, Nuclear Medicine
Copy: General Counsel
16.8 Force Majeure. If the performance of any part of this
Agreement by either Party, or of any obligation under this Agreement, including,
without limitation, Section 6, is prevented, restricted, interfered with or
delayed by reason of an event of Force Majeure, the Party so affected shall,
upon giving written notice to the other Party, be excused from such performance
to the extent and for the duration of such prevention, restriction, interference
or delay; provided, however, that the affected Party shall use commercially
reasonable efforts to avoid or remove such event of Force Majeure and shall
continue performance with the utmost dispatch whenever such causes are removed.
In the event a Force Majeure prevents either Party from carrying out its
obligations for a period in excess of sixty (60) days, then the other Party may
terminate this Agreement upon thirty (30) days prior written notice; provided,
however, that any such termination by Corixa shall not be deemed a termination
under Section 11.3. Without limiting the generality of the foregoing and for the
avoidance of doubt, a Force Majeure event affecting Nordion shall result in a
reduction of the applicable minimum purchase commitment provided for in Section
3.1(g).
16.9 Definition of Force Majeure. "Force Majeure" shall mean an
event beyond the reasonable control of a Party which prevents, delays or
interferes with the performance by such Party of any of its obligations
hereunder, if such event occurs by reason of: an act of God; flood; fire;
explosion; casualty or accident; war; revolution; civil commotion; acts of
public enemies; blockade or embargo; terrorist act; or any law, order or
proclamation of any government; failure of suppliers to provide materials,
services, equipment or machinery; interruption of or delay in transportation;
strike or labor disruption; or any other cause, whether similar or dissimilar to
those above enumerated.
16.10 No Subcontracting.
(a) Prohibition. Under no circumstances will Nordion
subcontract out to a third party all or any part of the development,
manufacturing or testing of (i) Labeled Drug, or (ii) the B1 Antibody without
the prior written consent of Corixa.
(b) Exceptions. Except as set forth in subsection (a),
Nordion may subcontract out to a third party the development, manufacturing or
testing of any materials used in the manufacture of Labeled Drug, provided that
(i) Nordion provides Corixa with prior written notice of such subcontracting
arrangement and any subsequent changes thereto, (ii) Corixa may audit Nordion's
subcontractor qualification criteria and review Nordion's subcontractor audits,
and (iii) Corixa may direct a replacement of such subcontractor in its
reasonable discretion and reimburse Nordion for all incremental costs associated
with such replacement, unless such direction from Corixa is due to a failure to
perform by such subcontractor.
16.11 Headings. The headings herein are for the purpose of
convenience of reference only and are not intended to define or limit the
contents of this Agreement.
-36-
16.12 Remedies. All remedies contained herein shall be cumulative
and in addition to any other rights or remedies that may be available to such
Party.
16.13 Time is of the Essence. Any reference to a specific number of
days or to the "delivery" or "Release" of any item or to any action which is
required to be taken hereunder shall be interpreted in the context that time is
of the essence in this Agreement.
16.14 Cooperation. Each of he Parties shall, and shall cause their
respective Affiliates, if applicable, to cooperate with the other with respect
to the filing and maintenance of any and all regulatory approvals relating to
Labeled Drug required by any relevant governmental agency or entity. Upon
reasonable request of a Party, such cooperation shall include access during
normal business hours afforded to the records and information that are
reasonably relevant to such approvals, and making employees and agents available
on a mutually convenient basis to provide additional information and explanation
of any material provided hereunder, and the Party seeking regulatory approval
shall reimburse the other Party for all its reasonable out-of-pocket expenses in
connection therewith.
16.15 Advice of Legal Counsel. Each Party acknowledges and
represents that, in executing this Agreement, it has had the opportunity to seek
advice as to its legal rights from legal counsel and that the person signing on
its behalf has read and understood all of the terms and provisions of this
Agreement. This Agreement shall not be construed against either Party by reason
of the drafting or preparation thereof.
16.16 Severability. In the event that any one or more of the
provisions contained in this Agreement should be held invalid, illegal or
unenforceable in any respect, the validity, legality and enforceability of the
remaining provisions contained herein shall not in any way be affected or
impaired thereby. The Parties agree to replace any invalid provision or parts
thereof by new provision(s) which closely approximate the economic and
proprietary results intended by the Parties.
16.17 Currency. All amounts set out in this Agreement shall be in
United States dollars.
16.18 Compliance. This Agreement shall be carried out in compliance
with all applicable laws, rules, regulations and orders of federal, state,
provincial, territorial or local governments and in compliance with the
applicable by-laws and/or articles of the Parties.
[Remainder of Page Intentionally Left Blank]
-37-
16.18 Counterparts. This Agreement may be signed in counterparts,
each of which shall be deemed an original and all of which shall together
constitute one document.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers as of the date first
written above.
MDS (CANADA) INC., through its division, CORIXA CORPORATION
MDS NORDION
By: /s/ Xxxx Xxxxxxx By: /s/ Xxxxxxxx Xxxxxx
------------------------------ ------------------------
Name: Xxxx Xxxxxxx Name: Xxxxxxxx Xxxxxx
Title: Senior Vice President, Title: Senior Vice President and
Nuclear Medicine Chief Financial Officer
XXXXXXX PHARMACEUTICAL, INC.
By: /s/ Xxxxxxxx Xxxxxx
-------------------------------
Name: Xxxxxxxx Xxxxxx
Title: Chief Financial Officer
-38-
Exhibit 1.6
B1 Antibody Specifications
Attribute Test Method Specification
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
-----------------------------------
* Confidential treatment requested.
B1 Antibody Specifications (cont's) End of Shelf-Life Specifications:
Attribute Test Method Specification
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
* Performed at Packaged Bulk expiry
-----------------------------------
* Confidential treatment requested.
Exhibit 1.16
CD-20 Antigen Cells Specification
=================================================
Attribute Test Method Specification
=================================================
[*] [*] [*]
=================================================
B-1 Antibody End of Shelf-Life Specifications
=================================================
Attribute Test Method Specification
=================================================
[*] [*] [*]
=================================================
-----------------------------------
* Confidential treatment requested.
Exhibit 1.28
Corixa Equipment
PURCH YR IN MDSN
YEAR SRV PO# PS# INVOICE # VENDOR DESCRIPTION FACILITY COMMENTS
----- ----- --- --- --------- ------ ----------- -------- --------
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
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[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
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[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
[*] [*] [*] [*] [*] [*] [*] [*] [*]
-----------------------------------
* Confidential treatment requested.
Exhibit 1.61(a)
[*] ISOTOPE SPECIFICATIONS (SODIUM IODIDE I-131)
--------------------------------
Characteristic
--------------------------------
[*] [*]
--------------------------------
[*] [*]
--------------------------------
[*] [*]
--------------------------------
[*] [*]
--------------------------------
[*] [*]
--------------------------------
[*] [*]
--------------------------------
[*] [*]
--------------------------------
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* Confidential treatment requested.
Exhibit 1.61(b)
[*] Isotope Specifications (Sodium Iodide I-131)
--------------------------------
Characteristic
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* Confidential treatment requested.
Exhibit 1.86
Specifications
================================================================================
Labeled Drug Dosimetric Dosage Form (960702.SPE)
================================================================================
[*]
-----------------------------------
* Confidential treatment requested.
================================================================================
Labeled Drug Therapeutic Dosage Form (960703.SPE)
================================================================================
[*]
-----------------------------------
* Confidential treatment requested.
Exhibit 3.1
Forecasts and Firm Order Schematic
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-----------------------------------
* Confidential treatment requested.
Exhibit 5.3
QUALITY POLICY MANUAL
[[*]]
-----------------------------------
* Confidential treatment requested.
Exhibit 5.12(b)
CONFIDENTIALITY AGREEMENT
(Corixa, Affiliates, Representatives)
TO: MDS Nordion, a division of MDS (Canada) Inc.
000 Xxxxx Xxxx
Xxxxxx, XX X0X 0X0
Xxxxxx
("Nordion")
WHEREAS:
(i) Corixa Corporation and Xxxxxxx Pharmaceutical, Inc., (collectively
referred to as "Corixa") and Nordion, have entered into a Bexxar Supply
Agreement dated as of the ____ day of ____ 2003 (the "Agreement"),
(ii) Pursuant to and in accordance with the terms and conditions of section
5.12 (b) of the Agreement Corixa, its Affiliates and representatives as
mutually agreed, shall have access to Nordion's I-131 labeled B-1
Antibody ("Labeled Drug") manufacturing facility (the "Facility") and
related Labeled Drug procedures, and
(iii) Pursuant to the Agreement it has been agreed that access to the
Facility by such persons shall only be permitted by Nordion subject to
execution of a confidentiality agreement.
NOW, THEREFORE, in consideration of Nordion permitting ___________________,
("Recipient") having place of business at ____________, access to the Facility,
Recipient agrees and undertakes as follows:
1. Preservation of Confidential Information
Recipient agrees to preserve as confidential all Confidential
Information which it may obtain while having access to Nordion's plant,
the Facility and/or to Nordion's Labeled Drug procedures.
2. Permissible Disclosure
The Confidential Information shall only be used for the purpose of
observation of the Process (as defined in the Agreement), and/or audit
for determination of compliance of the Facility to specifications,
cGMPs and other regulatory requirements as related to Labeled Drug and
not for any other use or purpose, commercial or otherwise (the
"Purpose"). Recipient shall not without the prior written consent of
Nordion, disclose any of the Confidential Information to any third
party, save to Recipient's directors, officers, or employees who have a
need to know such information to accomplish the Purpose and who shall
be informed of the confidential nature of the information and who shall
be bound by a similar obligation of confidentiality.
3. Return of Confidential Information
All right title and interest in and to the Confidential Information
shall be retained by Nordion. All Confidential Information including
copies, summaries and notes related thereto, shall be promptly
surrendered to Nordion upon expiration or termination of this agreement
or such earlier date as requested by Nordion in writing.
4. Limitations of Confidentiality
"Confidential Information" means all information, whether disclosed
orally, in writing, via other media or tangible form, or obtained by
observation or inspection, concerning the functionality and operations
of Nordion's plant, Facility layout, Nordion's data, trade secrets,
patents, software, processes, methods, know how, technical information,
designs, drawings, formulas, concepts, reports, product development
activities, material samples, business plans, forecasts, marketing
plans, customer and supplier lists, business strategies and financial
information, and such other information as by its nature or designation
is confidential or proprietary information.
Notwithstanding the foregoing "Confidential Information" shall not
include information which:
(a) at the time of disclosure to the Recipient is or thereafter
becomes part of the public domain through no act or omission
of Recipient or its employees, agents or representatives,
(b) at the time of disclosure to the Recipient has been or
thereafter is lawfully disclosed to Recipient by a person
under no obligation of confidentiality to Nordion with respect
to such information,
(c) is independently developed as shown by written records, by an
agent or employee of the Recipient having no knowledge of or
access to any Confidential Information disclosed hereunder,
(d) is required to be disclosed due to judicial process or
authority, provided that Recipient shall provide Nordion
prompt written notice thereof in order to permit Nordion to
seek a protective order,
(e) was known to Recipient, without restriction, at the time of
disclosure, as demonstrated by files in existence at the time
of disclosure,
(f) is disclosed with the prior written approval of Nordion, or
(g) is disclosed generally to third parties by Nordion without
restrictions similar to those contained in this Agreement.
The Recipient shall have the burden of demonstrating that information
which would otherwise constitute Confidential Information is within the
scope of the above exceptions to confidentiality.
5. Term
Recipient shall maintain the Confidential Information in confidence for
a period of ten (10) years from the date of signature set out below.
This agreement may be terminated by either party at any time upon
written notice to the other party. Termination of this agreement shall
not affect
Recipient's continuing obligations hereunder, with respect to
Confidential Information received up to the date of termination.
6. Injunctive Relief
Recipient acknowledges that the Confidential Information constitutes
and contains confidential and proprietary information of a special and
unique nature and value. Recipient also acknowledges that Nordion may
suffer irreparable harm in the event of breach of Recipient's
obligations and that monetary damages may be inadequate to compensate
Nordion for such breach. Recipient accordingly agrees that in the event
of a breach or threatened breach of its obligations under this
Agreement, Nordion shall in addition to any other remedies available,
be entitled to seek injunctive relief.
7. No License
The disclosure of Confidential Information to Recipient shall not be
construed as granting Recipient any right or license with respect to
the Confidential Information.
8. Severability
This agreement contains the entire agreement with respect to its
subject matter and no modification or waiver shall be binding unless
set out in writing. If any provision of this agreement is held to be
invalid, illegal, or unenforceable, such invalidity, illegality or
unenforceability shall not affect any other portion of this agreement
and there shall be deemed substituted therefor such provision as will
most fully realize the intent of the parties expressed in this
agreement to the fullest extent permitted by applicable law.
9. Assignment
This agreement shall not be assigned by Recipient in whole or in part
without the prior written consent of Nordion and shall be binding upon
the parties, their respective successors and permitted assigns.
10. Applicable Law
This Agreement will be governed by, construed and enforced in
accordance with the laws of the the Province of Ontario, Canada without
regard to principles of conflicts of law.
IN WITNESS whereof the Recipient has executed this Agreement as of the _____ day
of _____.
(RECIPIENT)
By: ___________________________
Exhibit 5.12(c)
[*]
-----------------------------------
* Confidential treatment requested.
Exhibit 5.12 (c)(vi)
[*]
-----------------------------------
* Confidential treatment requested.
Exhibit 7
STATEMENTS OF WORK
[*]
-----------------------------------
* Confidential treatment requested.
EXHIBIT 9.1 BATCH PRICING ($US)
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-----------------------------------
* Confidential treatment requested.
Exhibit 12.1
Schedule of Claims and Suits
1. On September 10, 2001, IDEC Pharmaceuticals ("IDEC") filed a complaint
against Corixa and the University of Michigan in the US District Court for the
Southern District of California, case docket #01CV1637IEG (RBB), seeking to
invalidate seven of Corixa's US patents (US Patent Nos. 5,595,721, 5,843,398,
6,015,542, 6,022,521, 6,090,365, 6,251,362, and 6,287,537) that claim
compositions of matter comprising Bexxar(R) and methods of treating B-cell
non-Hodgkin's lymphoma with same therapy. (There are no foreign counterparts to
these patents.) On September 11, 2001, Corixa and the University of Michigan
filed a counterclaim against IDEC in the US District Court for the District of
Delaware, asserting that IDEC's marketing of its product, Zevalin(R) (a murine,
radiolabeled, anti-CD20 antibody), infringes four of the seven Corixa US
patents-in-suit in the suit that IDEC filed (US Patent Nos. 5,595,721,
6,015,542, 6,090,365, and 6,287,537). On July 16, 2002, following an order
transferring the second case to the US District Court for the Southern District
of California, these two actions were consolidated and are still pending in the
US District Court for the Southern District of California.
2. On June 2, 2003, IDEC moved to amend its complaint to add a claim for
declaratory judgment relief of non-infringement and invalidity of our US Patent
No. 6,565,827. Issued Patent No. 6,565,827 covers composition of matter used in
the treatment of B-cell non-Hodgkin's lymphoma. Also on June 2, 2003, IDEC filed
a separate lawsuit in the US District Court for the Southern District of
California, seeking declaratory judgment of non-infringement and invalidity of
issued Patent No. 6,565,827.
3. On February 25, 2003, IDEC filed a complaint against Corixa and
GlaxoSmithKline, case docket #03CV00380J, for patent infringement of the US
Reissue patent, US RE38,008, which claims methods of enhancing the delivery of
conjugated antibodies to solid tumor target cells. (There are equivalent patents
to US RE 38,008 that have issued in Canada and in the European Union, but IDEC
has not filed suit against Corixa or GlaxoSmithKline on either of these
patents).
-----------------------------------
* Confidential treatment requested.
Exhibit 12.2(c)
Returned or Destroyed Items
Purch Yr In MDSN
Year Srv PO# PS# Invoice # Vendor Description Facility Comments
----- ----- --- --- --------- ------ ----------- -------- --------
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---------------
*Confidential treatment requested.
