EXHIBIT 10.14
LICENSE AND SUPPLY AGREEMENT
This License and Supply Agreement, effective as of April 1, 1996,
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(the "Effective Date") is made by and between Aastrom Biosciences, Inc., a
Michigan corporation having its principal place of business at Lobby L, Domino's
Farms, Xxx Xxxxx, Xxxxxxxx 00000 ("AASTROM") and Immunex Corporation, a
Washington corporation having its principal place of business at 00 Xxxxxxxxxx
Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 ("IMMUNEX").
AGREEMENT
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In consideration of the mutual covenants and undertakings set forth
herein, IMMUNEX and AASTROM hereby agree as follows:
1. BACKGROUND
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1.1 Development and Supply of Products and Technology.
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IMMUNEX has discovered and developed Cytokines (Pixykine(R) PIXY321, Flt3 ligand
and Leukine(R) GM-CSF) and enzyme-linked immunoassay ("ELISA") reagents for the
Cytokines ("Ancillary Materials"), that are collectively referred to herein as
"Supplied Products," and certain cell culture technology, that together with
Supplied Products are "Licensed Technology," and is the owner of certain patent
rights relating to the Licensed Technology ("Licensed Patent Rights") that may
be useful in or relate to the field of extracorporeal cell culture and
transplantation ("ECCAT"). IMMUNEX intends to supply AASTROM with Supplied
Product and to provide a nonexclusive license to AASTROM to the Licensed
Technology and Licensed Patent Rights for Supplied Product purchased by AASTROM,
subject to the terms of this Agreement.
1.2 Purchase and Use of Supplied Product and Licensed Technology.
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AASTROM is a developer of certain ECCAT systems (instrumentation and single-use
plastic disposables operated by the instrumentation, referred to herein as the
"Systems") and desires to purchase Supplied Products from IMMUNEX for
distribution, sale and use with the Systems. AASTROM also desires access to the
Licensed Technology and Licensed Patent Rights to make, use and sell the Systems
and services incorporating the Licensed Technology or otherwise covered by the
Licensed Patent Rights.
2. DEFINITIONS
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2.1 All initially capitalized terms shall have the meanings specified
below:
"Affiliate" shall mean any entity that directly or indirectly
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controls, is controlled by or is under common control with a party to this
Agreement. The term "control" as used herein shall mean the possession of the
power to direct or cause the direction of the management and the policies of an
entity, whether through the ownership of a majority of the outstanding voting
securities or by contract or otherwise.
"Ancillary Materials" shall mean ELISA reagents that are useful in
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assay or quantification of Cytokines, and other materials made available by
IMMUNEX to AASTROM to facilitate use of Licensed Technology.
"Calendar Quarter" shall mean each three-month period commencing
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January 1, April 1, July 1 and October 1 of each year during the Term.
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"Calendar Year" shall mean each twelve-month period commencing the
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first Calendar Quarter following the Effective Date of each year during the
Term.
"Confidential Information" shall mean any and all proprietary or
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confidential information owned by AASTROM or IMMUNEX that is provided to the
other party. Confidential Information shall not be deemed to include
information that:
(a) is or becomes known publicly through no fault of the recipient;
(b) is learned by the recipient from a Third Party entitled to
disclose it;
(c) is developed by the recipient independently of information
obtained from the disclosing party;
(d) is already known to the recipient before receipt from the
disclosing party, as shown by prior written records; or
(e) is released with the prior written consent of the disclosing
party.
"Cytokine" shall mean an IMMUNEX cytokine product identified
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in Exhibit B.
"Effective Date" shall mean the date set forth in the first
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paragraph of this Agreement.
"FDA" shall mean the United States Food and Drug Administration or any
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successor agency vested with administrative and regulatory authority to approve
testing and marketing of human pharmaceutical or biological therapeutic products
in the United States.
"Field" shall mean development, manufacture, testing, use and sale of
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systems, techniques, equipment, devices and associated technologies for
explanation, separation, culture, testing and transplantation of cells, referred
to collectively as "extracorporeal cell culture and transplantation" ("ECCAT").
The Field excludes all parenteral or in-vivo uses of Cytokines or Supplied
Products, which are expressly reserved to IMMUNEX.
"Force Majeure" shall mean any act of God or the public enemy, any
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accident, explosion, fire, storm, earthquake, flood, drought, peril of the sea,
riot, embargo, war or foreign, federal, state or municipal order issued by a
court or other authorized official, seizure, requisition or allocation, any
failure or delay of transportation, shortage of or inability to obtain supplies,
equipment, fuel or labor or any other circumstance or event beyond the
reasonable control of the party relying upon such circumstance or event;
provided, however, that no such Force Majeure circumstance or event shall excuse
any failure or delay beyond a period exceeding one hundred eighty (180) days
from the date such performance would have been due but for such circumstance or
event.
"GMP" shall mean the regulatory requirements for good manufacturing
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practices promulgated by the FDA under the Federal Food, Drug and Cosmetic Act,
as amended, 21 C.F.R. et seq.
"Improvement" shall mean any invention or improvement involving a
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Cytokine or Licensed Technology that is made by employees of AASTROM, whether
solely or jointly with employees of IMMUNEX.
"Licensed Patent Rights" shall mean the patents and patent
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applications identified in Exhibit A; any divisional, continuation or
continuation-in-part applications that
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claim priority based upon such applications; any patents that issue in respect
of the foregoing applications; and any reissues or extensions of such patents,
and any other patents or patent applications owned or controlled by IMMUNEX that
are necessary and useful to permit AASTROM to use and sell Licensed Technology
in the Field.
"Licensed Technology" shall mean the Cytokines, Ancillary Reagents,
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and any related technology, know-how, data, information and results that IMMUNEX
has a right to disclose or transfer to AASTROM, and that is necessary or useful
to permit AASTROM to use the Cytokines or Ancillary Materials and is transferred
to AASTROM.
"Licensed Trademarks" shall mean Cell Software(TM), Leukine(R) and
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Pixykine(R).
"Manufacturing Regulatory Documentation" shall mean a Drug Master File
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or other Regulatory Filing owned by IMMUNEX and filed with the FDA that contains
definitive technical information concerning a Supplied Product.
"Order" shall mean each quantity of a Supplied Product sold to AASTROM
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under a separate invoice.
"Person" shall mean any individual, partnership, corporation, firm,
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association, unincorporated organization, joint venture, trust or other entity.
"Purchase Order" shall have the meaning specified in Section 3.9
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hereof.
"Regulatory Filing" shall mean a filing with a regulatory agency, for
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example, the FDA, that concerns a Cytokine or use of a Cytokine in the Field.
"Supplied Product(s)" shall mean Cytokines and Ancillary Materials
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produced by IMMUNEX for AASTROM; or, as permitted under this Agreement, produced
by AASTROM or a Third Party.
"Supply Price" shall mean the price paid by AASTROM to IMMUNEX to
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obtain Supplied Product for sale or distribution to end users of Licensed
Technology.
"Systems" shall mean AASTROM's ECCAT systems, consisting of certain
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instrumentation and single-use plastic disposables for use with the
instrumentation, as well as any related documentation.
"Territory" shall mean North America, consisting of the United States
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of America and Canada, and their respective territories and possessions.
"Third Party" shall mean any Person other than a party to this
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Agreement or an Affiliate.
3. SUPPLY AND USE OF MATERIALS
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3.1 Supply of Supplied Products. Subject to the terms of this Agreement,
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IMMUNEX shall manufacture and sell to AASTROM, and AASTROM shall purchase
exclusively from IMMUNEX, AASTROM's requirements of the Supplied Products for
sale or use by AASTROM in conjunction with the Systems. AASTROM shall not be
obligated to purchase its requirements of GM-CSF from IMMUNEX in countries other
than the United States. All Supplied Products shall be sold and delivered to
AASTROM in the Territory, and all sales shall be deemed to have been made in the
United States.
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3.2 Supply Price. The Supply Price applicable to the Supplied Products to
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be sold by IMMUNEX to AASTROM pursuant to Section 3.1 hereof shall be that set
forth in Exhibit B, which is attached hereto and made a part of this Agreement.
3.3 Supply of Research Quantities of Cytokines for Preclinical Research.
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IMMUNEX shall provide reasonable research quantities of Cytokines and Ancillary
Materials to AASTROM solely for AASTROM's own use in preclinical research, and
not for resale or distribution to any other Person, at no charge to AASTROM.
3.4 Technical Assistance. Upon request and at no charge, IMMUNEX shall make
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its employees available (at their normal places of employment or by telephone)
to provide reasonable levels of technical assistance to AASTROM concerning
AASTROM's use of the Supplied Products or AASTROM's preparation of Regulatory
Filings.
3.5 Regulatory Filings. AASTROM shall file and be the owner of record for
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all Regulatory Filings developed by AASTROM applicable to use of Supplied
Products with the Systems. IMMUNEX shall permit AASTROM to cross-reference its
Drug Master Files and Regulatory Filings to enable AASTROM to complete
Regulatory Filings applicable to the Systems. IMMUNEX owns, and shall retain all
right, title and interest in and to the Manufacturing Regulatory Documentation,
and any other Regulatory Filing prepared and submitted by IMMUNEX to obtain or
maintain regulatory approval of a Supplied Product. Each party shall, upon
request and at no charge to the other, reasonably cooperate with and assist the
other in preparing Regulatory Filings. Such cooperation shall extend to
reasonable consultation by telephone or at the cooperating party's normal
business location, but shall not include preparation of Regulatory Filings for
the other party. All nonpublic information provided by one party to the other in
preparing Regulatory Filings shall be deemed to be Confidential Information of
the disclosing party. AASTROM's or IMMUNEX's right to cross-reference any
Regulatory Filings owned by the other shall not extend to any Confidential
Information of any Third Party that may be incorporated into a Regulatory
Filing.
3.6 Clinical Studies. AASTROM shall be independently and solely responsible
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for the design, implementation and evaluation of any human clinical studies used
to obtain clinical data for use in preparing Regulatory Filings. AASTROM shall
provide IMMUNEX with a complete copy of any clinical study protocol in which
Supplied Products are used, as well as copies of any final abstracts or
publications concerning the results of such study. AASTROM shall report any
serious and unexpected adverse event that occurs in a clinical study involving
Supplied Products. This report shall be provided by telephone or fax to the
Professional Services Department at IMMUNEX (fax: 000-000-0000) as soon as
possible and shall be confirmed and updated in writing within 24 hours after
occurrence.
3.7 Manufacture of Product for Clinical Studies and Commercial Sale.
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During the term of this Agreement, and for an additional one year period if
IMMUNEX notifies AASTROM that it will not renew the Agreement under Section 8.7,
and for two additional years should IMMUNEX cease supply per the terms of this
Agreement under Section 3.19, IMMUNEX shall use reasonable commercial efforts to
manufacture all of the requirements of AASTROM for each Supplied Product and
release all quantities ordered by AASTROM in the Calendar Quarter specified in
each accepted Purchase Order. IMMUNEX's supply obligations shall be limited in
any year, at its option, to the projected number of vials of each Supplied
Product specified by AASTROM in the Annual Requirements Forecast. In the event
of any supply constraint, IMMUNEX shall allocate the available quantities of
Supplied Products among itself and its licensees in a fair and equitable manner.
Each Supplied Product released to AASTROM for clinical studies or commercial
sale shall be
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manufactured in material compliance with current GMP and according to
manufacturing information in the Manufacturing Regulatory Documentation. IMMUNEX
shall perform sufficient quality control testing of all Supplied Products
released to AASTROM to establish compliance with any release specifications
required by the Manufacturing Regulatory Documentation.
3.8 Annual Requirements Forecast. AASTROM shall inform IMMUNEX of its
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forecasted requirements for each Supplied Product to be released to AASTROM
during each Calendar Year ("Annual Requirements Forecast"). Within 30 days
following the Effective Date, AASTROM shall provide IMMUNEX with a forecast of
its Supplied Product requirements by Calendar Quarter for the remainder of 1996.
On or before July 31 of each Calendar Year during the Term, AASTROM shall
provide IMMUNEX with a forecast of its Supplied Product requirements for each
Calendar Quarter of the following Calendar Year. Each such Annual Requirements
Forecast shall not constitute a Purchase Order but rather a non-binding estimate
to assist IMMUNEX in scheduling its facilities to manufacture Supplied Products.
In the event that AASTROM shall, during the first three Calendar Quarters of any
Calendar Year, fail to provide IMMUNEX with Purchase Orders for at least 25% of
the quantity of each Supplied Product specified in the Annual Requirements
Forecast applicable to such Calendar Year, IMMUNEX shall have the right to cease
supply of such Supplied Product pursuant to Section 3.19 hereof following notice
to AASTROM. Following the effective date of such notice, IMMUNEX shall provide
AASTROM with thirty (30) days in which to submit a Purchase Order that will
increase the quantity of Supplied Product subject to AASTROM's Purchase Orders
in such Calendar Year to at least 25% of the Annual Requirements Forecast
applicable to such Calendar Year.
3.9 Purchase Orders. On or before the first day of each Calendar Quarter
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during the Term, AASTROM shall provide IMMUNEX with a Purchase Order specifying
the quantity of each Supplied Product to be released to AASTROM in the following
Calendar Quarter and a schedule specifying the dates upon which such quantity,
or any fraction thereof, is to be released to AASTROM. Following acceptance by
IMMUNEX, a Purchase Order shall not be cancelable by AASTROM without the consent
of IMMUNEX. AASTROM may submit additional Purchase Orders during each Calendar
Quarter which IMMUNEX shall accept, provided that adequate quantities of
Supplied Products are available for supply to AASTROM and that such Purchase
Orders otherwise comply with all other terms of this Agreement. IMMUNEX shall
have no obligation to undertake additional production or vialing campaigns to
produce any Supplied Products for AASTROM that have not been specified in an
Annual Requirements Forecast or a Purchase Order provided in accordance with
this Section 3.9.
3.10 Supplied Product Specifications; Development of New Formulations.
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Immediately following the Effective Date, IMMUNEX shall provide Supplied
Products to AASTROM in the available vialed formulations and vial sizes
specified in the current Drug Master Files applicable to such Supplied Products.
As new vialed formulations or vial sizes become available, IMMUNEX shall provide
such new formulations or vial sizes to AASTROM and cause the Manufacturing
Regulatory Documentation to be amended or supplemented to reflect all
specifications applicable to such new formulations or vial sizes. IMMUNEX shall
use reasonable commercial efforts to develop a 250 ug vialed formulation of each
of PIXY321 and Flt3L. IMMUNEX shall have no obligation under this Agreement to
develop any other vial sizes or formulations for AASTROM.
3.11 Specification Changes. Unless otherwise agreed by the parties,
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IMMUNEX shall have no obligation to manufacture any Cytokine for AASTROM
according to processes or specifications that vary from those set forth in the
applicable Manufacturing
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Regulatory Documentation. Following the establishment of a standard formulation
for each Cytokine, IMMUNEX shall use reasonable commercial efforts to maintain
the integrity and consistency of all specifications applicable to Cytokines. In
the event that IMMUNEX deems it necessary to revise any specifications,
procedures or Manufacturing Regulatory Documentation applicable to a Cytokine,
IMMUNEX shall provide reasonable advance notice of any such revision to AASTROM.
All specification changes that result in procedures or limits that exceed or
differ from those set forth in the Manufacturing Regulatory Documentation shall
be submitted to the FDA before being implemented. IMMUNEX shall take reasonable
actions in consultation with AASTROM to ensure that any such changes do not
compromise any clinical study or Regulatory Filing of AASTROM.
3.12 Quality Control Testing and Release of Products. Following manufacture
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of each lot from which any Order is to be provided to AASTROM hereunder, IMMUNEX
shall perform all quality control testing required to establish compliance of
the lot with applicable specifications. A certificate of analysis shall be
issued upon satisfactory completion of quality control testing of such lot. If
quality control testing is successfully completed and a Purchase Order has been
received, an Order shall be released to AASTROM on the date specified in the
Purchase Order (the "Release Date"). Upon the Release Date, (a) IMMUNEX shall
ship the Order to a location in the Territory as instructed by AASTROM, (b) upon
receipt, title to such Order shall transfer to AASTROM, and (c) AASTROM shall be
invoiced for the Order at the Supply Price at that time in effect.
3.13 Documentation. Not later than the time of delivery of each Order,
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IMMUNEX shall provide AASTROM with a certificate of analysis applicable to each
lot of Supplied Products included in each Order released to AASTROM. IMMUNEX
shall document each step of the manufacturing and processing procedure and shall
maintain retention samples of each lot in accordance with applicable FDA
requirements. Complete batch records for all Supplied Products manufactured for
AASTROM shall be maintained at IMMUNEX for inspection at any time by AASTROM at
IMMUNEX's place of business upon reasonable notice to IMMUNEX. Any proprietary
information of IMMUNEX contained in such batch records shall be deemed to be
Confidential Information of IMMUNEX.
3.14 Storage and Shipping. Following release, each Order shall be held for
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AASTROM by IMMUNEX in secure storage for use by or shipment to AASTROM or to
such other recipient as instructed by AASTROM. All Orders shall be shipped FOB
IMMUNEX's United States facility to a location in the Territory as designated by
AASTROM with the insurance paid by IMMUNEX. AASTROM shall be responsible for all
shipping charges, which shall be itemized on each invoice by IMMUNEX. Title to
and risk of loss for each Order shall transfer to AASTROM upon delivery to
AASTROM's designated delivery location. AASTROM shall provide IMMUNEX with a
specific list of approved carriers that meet AASTROM's specifications for
handling during shipment. AASTROM shall be solely responsible for any
reshipments of Supplied Products or any shipments of Supplied Products outside
the Territory.
3.15 Minimum Order Quantity. IMMUNEX will not act in the capacity of a
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distributor of Supplied Products to AASTROM's customers. At any time during the
Term of this Agreement, IMMUNEX may establish reasonable minimum Order
quantities (which will not exceed, absent AASTROM's consent, one Calendar
Quarter's projected purchases as set forth in the applicable Annual Requirements
Forecast) if AASTROM does not provide Purchase Orders specifying economically
efficient Order quantities, or otherwise increase the prices charged to AASTROM
for Supplied Products to include any additional costs incurred in filling
Purchase Orders that do not meet reasonable minimum quantities.
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3.16 Acceptance; Payment Terms. Payment for each Order released to AASTROM
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shall be due forty-five (45) days following delivery and invoice, during which
period AASTROM shall perform its acceptance testing. IMMUNEX shall provide
AASTROM with descriptions of its release testing procedures and specifications
to permit AASTROM to conform its acceptance testing to the methods used by
IMMUNEX. If AASTROM provides evidence that such Order fails to meet the release
specifications set forth in the Manufacturing Regulatory Documentation that are
at that time in effect, payment shall not be due until the failure is corrected.
If the results of quality control testing by AASTROM do not agree with those
obtained by IMMUNEX, AASTROM shall promptly so notify IMMUNEX and the acceptance
period shall be extended forty-five (45) days to enable the parties to retest
the Order or otherwise attempt to reconcile their differences. In the event that
such differences cannot be resolved by the parties, the parties shall designate
an independent testing laboratory to test the Order. The findings of such
independent testing laboratory shall be binding on the parties, absent manifest
error. The expenses shall be borne by the party adversely affected by such
findings. IMMUNEX shall have no obligation to supply additional Orders of
Supplied Products to AASTROM if AASTROM declines to accept any Order due to the
application of any specifications or acceptance testing procedures that are
different from the release testing procedures and specifications employed by
IMMUNEX, if such Order otherwise complies with the procedures and specifications
employed by IMMUNEX. A late payment charge of 1% of the outstanding unpaid
balance per month shall be payable if invoiced charges are not paid when due.
3.17 Facility Visits. Upon reasonable prior notice to IMMUNEX, AASTROM or
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its designee may (but shall not be required to) have its representatives audit
IMMUNEX's production of Supplied Products for material compliance with current
GMP, including observing at any time the manufacture of any Supplied Product, or
any quality control or other services provided by IMMUNEX. These representatives
shall comply with all applicable safety and security rules while present at
facilities owned or operated by IMMUNEX.
3.18 Scheduling of Campaigns; Delays. IMMUNEX shall employ reasonable
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commercial efforts to maintain inventories of all Supplied Products sufficient
to meet AASTROM's commercial requirements as specified in each Annual
Requirements Forecast. IMMUNEX shall promptly advise AASTROM of significant
unanticipated delays in the release of any Order. IMMUNEX shall not be liable to
AASTROM for any delay in providing any Order, or the documentation relating to
any Order, if such delay is caused by Force Majeure.
3.19 Alternate Source of Supply. In the event that IMMUNEX elects to
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discontinue supplying AASTROM with any Supplied Product as provided in Section
3.8 above, or is prevented by Force Majeure from supplying AASTROM with any
Supplied Product for a period of at least one hundred eighty (180) days, IMMUNEX
shall use reasonable commercial efforts to xxxxx XXXXXXX a nonexclusive license
to make or have made the Cytokine corresponding to such Supplied Product for use
or sale in the Field and Territory, transfer to AASTROM or its designee (which
could include, for example, a mutually acceptable contract manufacturer) all
Licensed Technology and any available license rights (apart from facilities,
commercially available raw materials or equipment) that are necessary or useful
in manufacturing such Cytokine in an alternative facility, and shall use
reasonable commercial efforts to cooperate with AASTROM to continue to supply
Supplied Product from its inventories to meet AASTROM's requirements for
Supplied Product until an alternate source of supply is established. IMMUNEX
shall not be obligated to grant such licenses or transfer any technologies in
the event that a dispute over acceptance procedures or specifications cannot be
resolved as provided in Section 3.16 hereof, or IMMUNEX and AASTROM are unable
to resolve any dispute over pricing. In such event, AASTROM
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shall be entitled to terminate this Agreement, subject to the liquidated damages
provisions of Section 8.4 hereof.
3.20 Place of Payment. Payments by AASTROM to IMMUNEX will be made in
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United States Dollars by wire transfer to an account designated by IMMUNEX
located in the United States.
4. GRANT OF LICENSE
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4.1 License. IMMUNEX hereby grants AASTROM a nonexclusive license under
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the Licensed Patents and Licensed Technology, to use and sell the Supplied
Products in the Field and Territory. The license granted hereunder includes the
right to grant sublicenses to purchasers or distributors of the Systems, to
preclinical or clinical investigators, or Affiliates of AASTROM, to use or sell
the Supplied Products in the Field and Territory, but excludes the right to sell
or to use the Supplied Products outside the Field and Territory. The scope of
the Territory to which this license applies may be amended during the Term.
4.2 Expanded Territorial Rights. IMMUNEX and AASTROM each desire to extend
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the Territory to which the license granted pursuant to Section 4.1 hereof
applies to include all countries in the world ("Expanded Territorial Rights").
IMMUNEX has commenced negotiations with American Cyanamid Company and American
Home Products Corporation ("AHP") to obtain rights under prior agreements with
such companies enabling IMMUNEX to grant the Expanded Territorial Rights to
AASTROM. IMMUNEX shall continue such negotiations, and any other negotiations
that it deems reasonably necessary to secure appropriate licenses and rights
necessary to extend and protect such Expanded Territorial Rights. Pending
resolution of such negotiations, IMMUNEX will not object to the commencement of
any clinical trials by AASTROM outside of the Territory using Supplied Products
sold to AASTROM in the Territory. If such negotiations are successful, IMMUNEX
shall immediately amend this Agreement, at no additional charge or fee to
AASTROM, to xxxxx XXXXXXX Expanded Territorial Rights.
4.3 Licensed Trademarks. IMMUNEX hereby grants AASTROM a nonexclusive
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license to make, have made, use and sell products and services using the
Licensed Trademarks in the Field and Territory, solely in connection with
AASTROM's use, sale and distribution of Supplied Products for use in conjunction
with the Systems. AASTROM's use of Licensed Trademarks shall at all times comply
with all reasonable instructions and specifications provided by IMMUNEX.
4.4 Non-competition. During the term of this Agreement, neither IMMUNEX nor
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any Affiliate of IMMUNEX shall directly compete with AASTROM by selling Supplied
Products to AASTROM's customers for use with the Systems. AASTROM shall not sell
or distribute Supplied Products to customers of IMMUNEX or customers of other
companies to which IMMUNEX provides Supplied Products for use with proprietary
systems of such other companies. In the event that IMMUNEX enters into any
subsequent supply or license agreements with other companies for Supplied
Products, IMMUNEX shall obtain a covenant from such companies that they will not
sell or distribute Supplied Products to AASTROM's customers for use with the
Systems.
5. FEES AND ROYALTIES
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5.1 Fees. In consideration of the value of research and development
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previously conducted by IMMUNEX in developing the----Supplied Products
and Ancillary Materials and in assisting AASTROM with its development
efforts prior to the Effective Date,
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AASTROM shall pay IMMUNEX a Signing Fee of $1,500,000, due and payable thirty
(30) days following the Effective Date. In order to maintain its license and
supply rights, AASTROM shall pay IMMUNEX an annual Fee of $1,000,000, which
shall be due and payable on each one year anniversary of the Effective Date
during the Term. If any such Annual Fee is not paid when due, IMMUNEX shall have
the right to terminate this Agreement for material breach, upon notice to
AASTROM as provided in Section 8.2(a) hereof.
5.2 Royalties. AASTROM shall have no obligation to pay royalties to IMMUNEX
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in respect of the licenses granted to AASTROM under Section 4 hereof, or
otherwise in respect of the use or sale of Supplied Products that are supplied
by IMMUNEX. In the event that AASTROM or its designee manufactures any Cytokine
that is subject to Licensed Patent Rights or is manufactured using Licensed
Technology transferred by IMMUNEX to AASTROM or AASTROM's designee as provided
in Section 3.19 hereof, AASTROM shall pay IMMUNEX royalties in respect of the
net sales value of such Cytokine, as well as pay any royalties to Third Parties
that IMMUNEX would have been obligated to pay in respect of the net sales value
of such Cytokine. The royalties payable to IMMUNEX by AASTROM, as well as all
other terms applicable to the reporting any payment of such royalties, shall be
determined by good-faith negotiation between IMMUNEX and AASTROM, taking into
account the value of the Licensed Technology, customary commercial practices in
the U.S. biotechnology, pharmaceutical and medical device industries, and other
relevant factors.
5.3 Records. AASTROM shall keep and maintain, in accordance with generally
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accepted accounting principles, proper and complete records and books of account
documenting all sales or other dispositions of Supplied Products as well as
sales or other dispositions of the Systems that include Supplied Products. At
IMMUNEX's request and expense, AASTROM shall permit an independent public
accounting firm selected by IMMUNEX to have access, not more than once in any
consecutive four Calendar Quarters, to such books and records for the sole
purpose of verifying sales reported by AASTROM to IMMUNEX for purposes of
Exhibit B, or for calculating any royalties due IMMUNEX.
6. INTELLECTUAL PROPERTY
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6.1 Inventions. AASTROM shall inform IMMUNEX of any material Improvement
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that is made by its employees, provided such Improvement has been formalized as
a disclosure. Title to any invention made by an employee or employees of either
party in connection with its activities under this Agreement shall vest in the
employer of such employee or employees in accordance with the patent laws of the
United States. Inventions made jointly by one or more employees of each party
shall be jointly owned. Each party shall inform the other in the event that its
employees report the making of a joint invention. Each party shall cooperate
with the other in completing any patent applications to secure patent rights for
inventions in which the other has an ownership interest, and in perfecting such
other party's legal title thereto. If AASTROM does not itself elect to obtain
patent coverage in any territory for any disclosed Improvement that is made
solely by its employees, it shall provide IMMUNEX with the opportunity to
prepare and file appropriate patent applications covering the disclosed
Improvement. Any patent rights resulting from such patent applications will be
included within the scope of Licensed Patent Rights.
6.2 Notification and Abatement of Patent Infringement. AASTROM shall notify
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IMMUNEX of any infringement known to AASTROM by any Person of any Licensed
Patent Rights that apply also to operations of AASTROM, and shall provide
IMMUNEX with the available evidence, if any, of such infringement. If such
infringement is demonstrated by AASTROM to have resulted in competitive harm, or
would reasonably be
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expected to result in harm to AASTROM, AASTROM shall have the right to request
that IMMUNEX commence suit or otherwise xxxxx such infringement. If, following
such notice, IMMUNEX has not commenced such suit within one hundred eighty (180)
days following such notice, AASTROM shall have the right to suspend payment of
any annual fees or royalties payable hereunder (but not any payments for
Supplied Products) until IMMUNEX commences such suit or otherwise abates the
infringement by licensing or otherwise. IMMUNEX shall not be obligated to
undertake any patent enforcement activities if AASTROM has not paid IMMUNEX
total annual fees equal to at least $3,500,000.
IMMUNEX shall not be obligated to enforce Licensed Patent Rights against
more than one infringer at any one time.
6.3 General Obligation of Confidentiality. During the Term and for a period
-------------------------------------
of five (5) years thereafter, AASTROM and IMMUNEX shall maintain in confidence
the respective Confidential Information received or obtained from the other
party, and use such Confidential Information solely for the purposes
contemplated and permitted by this Agreement. Each party shall maintain
communications to each other in confidence. Each party acknowledges that all
Confidential Information exchanged or developed hereunder shall be owned by the
transferor and shall continue to be owned by the transferor following transfer.
6.4 Permitted Disclosures. Notwithstanding Section 6.3 hereof, IMMUNEX and
---------------------
AASTROM shall, to the extent necessary, have the right to disclose and use
Confidential Information of the other party:
(a) to prepare or supplement any Regulatory Filing applicable to the
use of a Supplied Product in the Field, or otherwise to assist in securing
institutional or government approval to clinically test or government approval
to market a Supplied Product for use in the Field; or
(b) where the disclosure and use of the Confidential Information will
be useful or necessary to the procurement of Licensed Patent Rights;
provided that the affected party shall have been notified of such disclosure and
that any such disclosure shall be in confidence and subject to provisions the
same, or substantially the same, as those in Section 6.3 hereof, whenever
reasonably possible.
6.5 Publicity, Use of Names or Trademarks. Neither party shall originate
-------------------------------------
any press release concerning this Agreement or the subject matter hereof without
the prior written approval of the other party, which approval shall not be
unreasonably withheld. Except as provided in Section 4.3 hereof with respect to
Licensed Trademarks, neither party shall have the right to use the name or any
trade name or trademark of the other in any form of publicity, advertising, or
solicitation without the prior written approval of the other party. The
trademarks Immunex(R), Leukine(R), Pixykine(R) and Cell Software(TM) are the
exclusive property of IMMUNEX.
7. WARRANTIES AND REPRESENTATIONS
------------------------------
7.1 Warranties and Representations of IMMUNEX. IMMUNEX represents and
-----------------------------------------
warrants to AASTROM that:
(a) IMMUNEX is a corporation duly organized, validly existing and in
good standing under the laws of the State of Washington and has all necessary
corporate power to enter into and perform its obligations under this Agreement;
10
(b) the execution, delivery and performance of this Agreement by
IMMUNEX have been duly authorized and approved by all necessary corporate
action, and that the Agreement is binding upon and enforceable against IMMUNEX
in accordance with its terms (subject to bankruptcy and similar laws affecting
the rights of creditors generally);
(c) IMMUNEX is the owner of the Licensed Patent Rights, Licensed
Technology and Licensed Trademarks, and has the right to xxxxx XXXXXXX the
licenses granted hereunder, subject to any dominating patent rights of third
parties (for example, IL-3 or GM-CSF patents owned or controlled by Genetics
Institute, Inc. or Sandoz AG) and the rights of AHP under applicable agreements
with IMMUNEX;
(d) IMMUNEX is not aware of any special or unusual hazards that would
arise as a result of AASTROM's use of Licensed Technology as permitted
hereunder;
(e) Each lot of each Supplied Product delivered to AASTROM hereunder
shall be manufactured, tested and released in material compliance with current
GMP and the applicable Manufacturing Regulatory Documentation; and
(f) Any documentation provided to AASTROM by IMMUNEX concerning any
Supplied Product or Drug Master File shall be accurate in all material respects.
7.2 Warranties and Representations of AASTROM. AASTROM represents and
warrants to IMMUNEX that:
(a) AASTROM is a corporation duly organized, validly existing and in
good standing under the laws of the State of Michigan and has all necessary
corporate power to enter into and perform its obligations under this Agreement;
(b) the execution, delivery and performance of this Agreement by
AASTROM have been duly authorized and approved by all necessary corporate
action, and that the Agreement is binding upon and enforceable against AASTROM
in accordance with its terms (subject to bankruptcy and similar laws affecting
the rights of creditors generally); and
(c) AASTROM shall use the Licensed Technology in compliance with all
applicable federal, state and local laws and regulations.
7.3 Limitation of Liability. IMMUNEX has no knowledge or awareness of or
-----------------------
control over the manner in which AASTROM intends to use the Licensed Technology.
IMMUNEX shall not be liable to AASTROM for any losses, damages, costs or
expenses of any nature incurred or suffered by AASTROM or by a Third Party,
arising out of any dispute or other claims or proceedings made by or brought
against AASTROM, (including, without limitation, product liability claims and
claims by a Third Party alleging infringement of its intellectual property
rights by the use or sale of any Supplied Product or System), nor shall IMMUNEX
be responsible in any way for dealing with any such disputes, claims or
proceedings, except to the extent that any such dispute, claim or proceeding
arises from (a) a breach by IMMUNEX of any warranty set forth in Section 7.1
hereof, or (b) any failure by IMMUNEX to manufacture, test, document or release
any Supplied Product in material compliance with current GMP and the applicable
Manufacturing Regulatory Documentation. IMMUNEX shall not be responsible to
AASTROM for any interruption in supply that is caused by Force Majeure. EXCEPT
AS SET FORTH IN SECTION 7.1(e) HEREOF, IMMUNEX MAKES NO PRODUCT WARRANTY,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. IMMUNEX
11
SHALL NOT BE LIABLE FOR ANY USE OF LICENSED TECHNOLOGY BY AASTROM OR FOR ANY
LOSS, CLAIM, DAMAGE, OR LIABILITY, OF ANY KIND OR NATURE, WHICH MAY ARISE FROM
OR IN CONNECTION WITH THIS AGREEMENT OR FROM THE USE, HANDLING OR STORAGE OF THE
SUPPLIED PRODUCTS OR ANCILLARY MATERIALS. NEITHER PARTY TO THIS AGREEMENT SHALL
BE ENTITLED TO RECOVER FROM THE OTHER ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
PUNITIVE DAMAGES.
7.4 AASTROM's Right to Indemnification. IMMUNEX shall indemnify each of
----------------------------------
AASTROM, its successors and assigns, and the directors, officers, employees,
agents and counsel thereof (the "AASTROM Indemnitees"), pay on demand and
protect, defend, save and hold each AASTROM Indemnitee harmless from and
against, on an after-tax basis, any and all liabilities, damages, losses,
settlements, claims, actions, suits, penalties, fines, costs or expenses
(including, without limitation, reasonable attorneys' fees) (any of the
foregoing, a "Claim") incurred by or asserted against any AASTROM Indemnitee of
whatever kind or nature, including, without limitation, any claim or liability
based upon negligence, warranty, strict liability, violation of government
regulation or infringement of patent or other proprietary rights, arising from
or occurring as a result of (a) the use of any Licensed Technology by IMMUNEX or
any Affiliate, agent or Third Party licensee of IMMUNEX (other than AASTROM) or
(b) any breach of this Agreement by IMMUNEX, (including (i) any breach by
IMMUNEX of any warranty set forth in Section 7.1 hereof, or (ii) any failure by
IMMUNEX to manufacture, test, document or release any Supplied Product in
material compliance with current GMP and the applicable Manufacturing Regulatory
Documentation) except in any case claims resulting from the gross negligence or
willful misconduct of AASTROM. AASTROM shall promptly notify IMMUNEX of any
Claim, upon becoming aware thereof, and permit IMMUNEX at IMMUNEX's cost to
defend against such Claim and shall cooperate in the defense thereof. Neither
IMMUNEX nor AASTROM shall enter into, or permit, any settlement of any such
Claim without the express written consent of the other party. AASTROM may, at
its option and expense, have its own counsel participate in any proceeding that
is under the direction of IMMUNEX and will cooperate with IMMUNEX or its insurer
in the disposition of any such matter.
7.5 IMMUNEX Right to Indemnification. AASTROM shall indemnify each of
--------------------------------
IMMUNEX, its successors and assigns, and the directors, officers, employees,
agents and counsel thereof (the "IMMUNEX Indemnitees"), pay on demand and
protect, defend, save and hold each IMMUNEX Indemnitee harmless from and
against, on an after-tax basis, any and all Claims incurred by or asserted
against any IMMUNEX Indemnitee of whatever kind or nature, including, without
limitation, any claim or liability based upon negligence, warranty, strict
liability or violation of government regulation, arising from or occurring as a
result of (a) the use of any Supplied Product, Licensed Technology or Licensed
Patent Rights by AASTROM or any Affiliate, agent or employee of AASTROM, (b) any
breach of this Agreement by AASTROM, or (c) infringement of patent or other
proprietary rights of a Third Party, except in any case claims resulting from
the gross negligence or willful misconduct of IMMUNEX. IMMUNEX shall promptly
notify AASTROM of any Claim, upon becoming aware thereof, and permit AASTROM at
AASTROM's cost to defend against such Claim and shall cooperate in the defense
thereof. Neither IMMUNEX nor AASTROM shall enter into, or permit, any settlement
of any such Claim without the express written consent of the other party.
IMMUNEX may, at its option and expense, have its own counsel participate in any
proceeding that is under the direction of AASTROM and will cooperate with
AASTROM or its insurer in the disposition of any such matter.
12
8. TERM AND TERMINATION
--------------------
8.1 Normal Termination. Unless terminated early or renewed as provided
------------------
hereunder, this Agreement shall commence on the Effective Date and shall
terminate upon the fifth (5th) anniversary of the Effective Date (the "Term").
8.2 Termination by IMMUNEX. IMMUNEX shall have the right to terminate this
----------------------
Agreement, including the licenses granted pursuant to Sections 4.1 and 4.2
hereof, effective immediately upon written notice of termination to AASTROM in
the event that:
(a) AASTROM fails to perform or observe or otherwise breaches any of
its material obligations under this Agreement and such failure or breach
continues unremedied for a period of sixty (60) days after receipt by AASTROM of
written notice thereof from IMMUNEX;
(b) a proceeding or case shall be commenced without the application or
consent of AASTROM and such proceeding or case shall continue undismissed, or an
order, judgment or decree approving or ordering any of the following shall be
entered and continue unstayed and in effect, for a period of forty-five (45)
days from and after the date service of process is effected upon AASTROM,
seeking (i) AASTROM's liquidation, reorganization, dissolution or winding-up, or
the composition or readjustment of its debts, (ii) the appointment of a trustee,
receiver, custodian, liquidation or the like of AASTROM or of all or any
substantial part of its assets, or (iii) similar relief in respect of AASTROM
under any law relating to bankruptcy, insolvency, reorganization, winding-up or
the composition or readjustment of debts.
8.3 Termination by AASTROM for Cause other than Material Breach by IMMUNEX.
----------------------------------------------------------------------
Subject to Section 8.4 hereof, AASTROM shall have the right to terminate this
Agreement at any time, effective immediately upon written notice of termination
to IMMUNEX.
8.4 Liquidated Damages upon Early Termination. Following the Effective Date,
-----------------------------------------
Immunex will commit personnel, incur expenses and devote its resources to
develop specialized formulations or vial sizes for the Supplied Products. In the
event that AASTROM terminates this Agreement pursuant to Section 8.3 hereof
prior to the payment to IMMUNEX of Annual Fees under Section 5.1 hereof equal to
* AASTROM shall pay IMMUNEX liquidated damages that are equal to *
Such liquidated damages shall be paid by AASTROM to IMMUNEX within thirty (30)
days following receipt of an invoice detailing the calculation thereof.
8.5 Termination by AASTROM for Material Breach. AASTROM shall have the right
------------------------------------------
to terminate this Agreement, including the licenses granted pursuant to Sections
4.1 and 4.2 hereof, effective immediately upon written notice of termination to
IMMUNEX in the event that:
(a) IMMUNEX fails to perform or observe or otherwise breaches any of
its material obligations under this Agreement and such failure or breach
continues unremedied
*CONFIDENTIAL PORTION REDACTED AND FILED SEPARATELY WITH THE COMMISSION
13
for a period of sixty (60) days after receipt by IMMUNEX of written notice
thereof from AASTROM;
(b) a proceeding or case shall be commenced without the application or
consent of IMMUNEX and such proceeding or case shall continue undismissed, or an
order, judgment or decree approving or ordering any of the following shall be
entered and continue unstayed and in effect, for a period of forty-five (45)
days from and after the date service of process is effected upon IMMUNEX,
seeking (i) IMMUNEX's liquidation, reorganization, dissolution or winding-up, or
the composition or readjustment of its debts, (ii) the appointment of a trustee,
receiver, custodian, liquidation or the like of IMMUNEX or of all or any
substantial part of its assets, or (iii) similar relief in respect of IMMUNEX
under any law relating to bankruptcy, insolvency, reorganization, winding-up or
the composition or readjustment of debts.
8.6 Effect of Termination. In the event of any termination of this
---------------------
Agreement, all amounts previously invoiced and unpaid, or any accrued royalties
due IMMUNEX, shall be due and payable as of the time of termination, except for
any liquidated damages due pursuant to Section 8.4 which shall be paid as
provided therein. Upon termination, all rights and licenses granted pursuant to
Section 4.1 and 4.2 hereof shall immediately terminate, but the provisions of
Sections 6.3 and 6.4 hereof relating to Confidential Information and AASTROM
shall cease use of all IMMUNEX trademarks. The liability and indemnification
provisions of Sections 7.3, 7.4 and 7.5 hereof shall survive termination or
expiration of this Agreement only with respect to Claims that arose from acts or
circumstances that occurred prior to termination.
8.7 Renewal. Subject to the provisions set forth below and in Sections 3.19
-------
and 5.2, Immunex hereby grants AASTROM an option to renew this Agreement, or any
amendment or renewal thereof, for an additional five (5) year term to commence
upon expiration of the Term, provided that AASTROM notifies IMMUNEX of its
intent to renew at least one year prior to the fifth (5th) anniversary of the
Effective Date. AASTROM and IMMUNEX will negotiate the Supply Price applicable
to the Supplied Product for the Renewal Term in good faith, said Supply Price to
reflect any reasonable changes in manufacturing costs incurred by IMMUNEX that
would cause a decreased profit margin to IMMUNEX in comparison with that
attained during the initial term of the Agreement, AASTROM's profit margin on
sales of the Systems, or any increases or decreases in the price charged by
AASTROM or its licensees to customers for the Systems. If IMMUNEX elects to not
renew the Agreement, then IMMUNEX will continue to supply AASTROM with Licensed
Technology for two additional years from the date of written notification to
AASTROM of IMMUNEX's intent not to renew, during which period IMMUNEX shall
grant the licenses and transfer to AASTROM or its designee the Licensed
Technology (apart from facilities, equipment or commercially available supplies)
that is necessary or useful to manufacture Supplied Product in an alternative
facility as provided in Section 3.19.
9. MISCELLANEOUS PROVISIONS
------------------------
9.1 No Implied Waivers; Rights Cumulative. No failure on the part of IMMUNEX
-------------------------------------
or AASTROM to exercise and no delay in exercising any right, power, remedy or
privilege under this Agreement, or provided by statute or at law or in equity or
otherwise, including, without limitation, the right or power to terminate this
Agreement, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.
14
9.2 Survival. All agreements, covenants, representations, warranties and
--------
indemnities set forth in this Agreement shall survive the execution and delivery
of this Agreement.
9.3 Notices. All notices, requests and other communications to IMMUNEX or
-------
AASTROM hereunder shall be in writing (including telecopy or similar electronic
transmissions), shall refer specifically to this Agreement and shall be
personally delivered or sent by telecopy (fax) or other electronic facsimile
transmission or by registered mail, or certified mail, return receipt requested,
postage prepaid, in each case to the respective address specified below (or to
such address as may be specified in writing to the other party hereto):
Immunex Corporation
00 Xxxxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
FAX: (000) 000-0000
Aastrom Biosciences, Inc.
Lobby L, Domino's Farms
Xxx Xxxxx, Xxxxxxxx 00000
Attention: President
FAX: (000) 000-0000
9.4 Further Assurances. Each of IMMUNEX and AASTROM agrees to duly execute
------------------
and deliver, or cause to be duly executed and delivered, such further
instruments and do and cause to be done such further acts and things, including,
without limitation, the filing of such additional assignments, agreements,
documents and instruments, that may be necessary or as the other party hereto
may at any time and from time to time reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes of, or to
better assure and confirm unto such other party its rights and remedies under,
this Agreement.
9.5 Successors and Assigns. The terms and provisions of this Agreement shall
----------------------
inure to the benefit of, and be binding upon, IMMUNEX, AASTROM, and their
respective successors and permitted assigns as provided in this Section. IMMUNEX
shall have the right to assign or otherwise transfer any of its rights and
interests, or delegate any of its obligations, to an Affiliate of IMMUNEX
provided that such Affiliate agrees in writing to carry out in full any
obligations to AASTROM that are assigned to it. Either party shall have the
right to assign all of its rights and interests and delegate all of its
obligations under this Agreement to any Person that is the successor in interest
to the assigning party in any merger, consolidation or sale involving
substantially all of the business and assets of the assigning party. Any other
assignment or delegation shall only be valid and effective if the other party
has provided its prior express written consent. Any attempt to assign or
delegate any portion of this Agreement in violation of this Section shall be
null and void. Subject to the foregoing, any reference to IMMUNEX or AASTROM
hereunder shall be deemed to include the successors thereto and assigns thereof.
9.6 Amendments. No amendment, modification, waiver, termination or discharge
----------
of any provision of this Agreement, nor consent to any departure by IMMUNEX or
AASTROM therefrom, shall in any event be effective unless the same shall be in
writing specifically identifying this Agreement and the provision intended to be
amended, modified, waived, terminated or discharged and signed by IMMUNEX and
AASTROM,
15
and each such amendment, modification, waiver, termination or discharge shall be
effective only in the specific instance and for the specific purpose for which
given. No provision of this Agreement shall be varied, contradicted or explained
by any oral agreement, course of dealing or performance or any other matter
not set forth in an agreement in writing and signed by IMMUNEX and AASTROM.
9.7 Governing Law. This Agreement shall in all respects, including all
-------------
matters of construction, validity and performance, be governed by, and construed
and enforced in accordance with, the laws of the state of Washington applicable
to contracts entered into in that state between citizens of that state and to be
performed wholly within that state without reference to any rules governing
conflicts of laws.
9.8 Severability. If any provision hereof should be held invalid, illegal
------------
or unenforceable in any respect in any jurisdiction, then, to the fullest extent
permitted by law, (a) all other provisions hereof shall remain in full force and
effect in such jurisdiction and shall be liberally construed in order to carry
out the intentions of the parties hereto as nearly as may be possible and (b)
such invalidity, illegality or unenforceability shall not affect the validity,
legality or enforceability of such provision in any other jurisdiction. To the
extent permitted by applicable law, IMMUNEX and AASTROM hereby waive any
provision of law that would render any provision hereof prohibited or
unenforceable in any respect.
9.9 Headings. Headings used herein are for convenience only and shall not
--------
in any way affect the construction of, or be taken into consideration in
interpreting, this Agreement.
9.10 Execution in Counterparts. This Agreement may be executed in any number
-------------------------
of counterparts, each of which counterparts, when so executed and delivered,
shall be deemed to be an original, and all of which counterparts, taken
together, shall constitute one and the same instrument.
9.11 Entire Agreement. This Agreement constitutes, on and as of the date
----------------
hereof, the entire agreement of IMMUNEX and AASTROM with respect to the subject
matter hereof, and all prior or contemporaneous understandings or agreements,
whether written or oral, between IMMUNEX and AASTROM with respect to such
subject matter are hereby superseded in their entireties.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized officers as of the date first written above.
IMMUNEX CORPORATION AASTROM BIOSCIENCES, INC.
By /s/ Xxxxx X. Xxxxxxxxx By /s/ R. Xxxxxxx Xxxxxxxxx
---------------------- ------------------------
Title Senior Vice President Title President/CEO
--------------------- -------------
16
EXHIBIT A: LICENSED PATENT RIGHTS
NOTE: LICENSE TO INTERNATIONAL RIGHTS IS SUBJECT TO PRIOR CONSENT OF AMERICAN
HOME PRODUCTS CORPORATION
Technology Country (Application SN) Filing Date
Patent Number (Priority Date)
---------------------------------------------------------------------------------------
PIXYKINE(R) United States 5,073,627 8/14/90 (8/22/89)
rh GM-CSF/IL-3 fusion 5,108,910 3/22/91 (8/22/89)
protein
Australia 632372 8/14/90 (8/22/89)
Canada (2,054,608) 10/31/91 (8/22/89)
Germany DD297,188 8/22/90 (8/22/89)
Europe 0489116 8/14/90 (8/22/89)
Austria 0489116 8/14/90 (8/22/89)
Belgium 0489116 8/14/90 (8/22/89)
Denmark 0489116 8/14/90 (8/22/89)
France 0489116 8/14/90 (8/22/89)
Italy 0489116 8/14/90 (8/22/89)
Germany 0489116 8/14/90 (8/22/89)
Luxembourg 0489116 8/14/90 (8/22/89)
Liechtenstein 0489116 8/14/90 (8/22/89)
Netherlands 0489116 8/14/90 (8/22/89)
Spain 0489116 8/14/90 (8/22/89)
Sweden 0489116 8/14/90 (8/22/89)
Switzerland 0489116 8/14/90 (8/22/89)
United Kingdom 0489116 8/14/90 (8/22/89)
Finland (920764) 8/14/90 (8/22/89)
Ireland 64202 8/21/90 (8/22/89)
Japan (513381/90) 8/14/90 (8/22/89)
Mexico (92 03426) 6/25/92 (8/22/89)
Malaysia (XX0000000) 11/22/91 (8/22/89)
Norway (920703) 8/14/90 (8/22/89)
Philippines (44030) 3/11/92 (8/22/89)
PCT (PCT/US90/04599) 8/14/90 (8/22/89)
---------------------------------------------------------------------------------------
00
---------------------------------------------------------------------------------------
xx Xxx0X Xxxxxx Xxxxxx (08/243,545) 5/11/94 (5/24/93)
(08/444,626) 5/19/95 (5/24/93)
(08/444,632) 5/19/95 (5/24/93)
(08/444,625) 5/19/95 (5/24/93)
(08/444,627) 5/19/95 (5/24/93)
Australia 69877/94 5/12/94
Canada 5/12/94
Europe (94303575.8) 5/19/95 (5/24/93)
Finland 955646 5/12/94
Israel (109677) 5/18/94 (5/24/93)
Japan 500715/95 5/12/94
Korea 705236/1995 5/12/94
Mexico (943806) 5/23/94 (5/24/93)
Malaysia (PI 9401321) 5/24/94 (5/24/93)
Norway 954735 5/12/94
New Zealand 267541 5/12/94
South Africa 94/3490 5/20/94 (5/24/93)
Thailand (022529) 5/23/94 (5/24/93)
Taiwan (83105225) 6/8/94 (6/8/94)
Taiwan (83110743) 11/18/94 (11/18/94)
PCT (PCT/US94/05365) 5/12/94 (5/24/93)
---------------------------------------------------------------------------------------
Method for Improving United States 5,199,942 9/26/91 (6/7/91)
Autologous
Transplantation Australia (21793/92) 6/5/92 (6/7/91)
Canada (2,109,699) 6/5/92 (6/7/91)
Europe (92913333.8) 6/5/92 (6/7/91)
Japan (500649/93) 6/5/92 (6/7/91)
PCT (PCT/US92/04686) 6/5/92 (6/7/91)
---------------------------------------------------------------------------------------
Extracorporeal Cell United States (08/399,404) 3/6/95 (3/6/95)
Culture and
Transplantation Kits PCT (PCT/US95/02886) 3/7/95 (3/6/95)
---------------------------------------------------------------------------------------
LEUKINE(R) United States 5,391,485 8/6/85
rh GM-CSF 5,229,496 10/6/88
5,393,870 5/27/93
Canada (514,337) 7/22/86
---------------------------------------------------------------------------------------
18
EXHIBIT B: PRICE OF SUPPLIED PRODUCT
During the first year of the Term, IMMUNEX will sell Supplied Product to
AASTROM at the following Supply Prices:
Product Price
------- -----
GMP Pixykine(R) PIXY321 * per vial
GMP Flt3L * per vial
GMP Leukine(R) GM-CSF Current published
(250 microgram vial) list price less*
Initial Orders for Pixykine(R) and Flt3L will be supplied at 1.5 mg vials
from available inventories of lyophilized product. As new formulations or vial
sizes become available, they will be supplied in subsequent Orders at the prices
listed above. AASTROM and IMMUNEX currently anticipate that formulation
development work should have the goal of developing 250 microgram liquid
formulations for PIXY321 and Flt3L.
*
On each anniversary of the Effective Date, IMMUNEX shall have the right to raise
the prices charged AASTROM for Pixykine(R) and Flt3L by a percentage equal to
the percentage increase in the Index (defined below) for the 12 month period
ending with December of the Calendar Year immediately preceding such anniversary
date (such increase, the "CPI Increase"). For purposes of this Agreement, the
term "Index" shall mean the Consumer Price Index for all Urban Consumers (CPI-U)
- U.S. City Average. All Items (1982-1984 = 100), as published by the United
States Bureau of Labor Statistics, or if such index is no longer published, then
the index most comparable thereto, as reasonably determined by IMMUNEX.
Ancillary Materials will be supplied at no charge by IMMUNEX to AASTROM in
reasonable quantities sufficient to permit AASTROM to assay any Order provided
to AASTROM, or to complete preclinical research or validation of new
applications.
License and Supply Agreement.
----------------------------
*CONFIDENTIAL PORTION REDACTED AND FILED
SEPARATELY WITH THE COMMISSION
19
