EXHIBIT 10.76
MASTER SUPPLY AGREEMENT
BETWEEN
AASTROM BIOSCIENCES, INC.
AND
ASTRO INSTRUMENTATION L.L.C.
AS REVISED BY AASTROM BIOSCIENCES, INC. ON FEBRUARY 14, 2003
TABLE OF CONTENTS
Page
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1. Definitions.............................................................................................. 1
2. Appointment of Supplier.................................................................................. 1
3. Agreement to Manufacture and Manufacturing Responsibilities.............................................. 2
3.1 Manufacture..................................................................................... 2
3.2 Changes......................................................................................... 2
3.3 Product Documentation........................................................................... 2
3.3.1 Device Master Record................................................................... 2
3.3.2 Engineering Changes.................................................................... 2
3.3.3 Scrap Costs............................................................................ 3
3.4 Testing......................................................................................... 3
3.5 Additional Products............................................................................. 3
3.6 Aastrom Equipment............................................................................... 3
3.7 Material Purchases and Supply Chain Management.................................................. 4
3.8 Insurance....................................................................................... 4
4. Commercial Terms and Pricing............................................................................. 4
4.1 Purchase Orders................................................................................. 4
4.2 Ordering and Forecasts.......................................................................... 4
4.2.1 Frozen Period.......................................................................... 4
4.2.2 Variable Period........................................................................ 5
4.2.3 Informative Period..................................................................... 5
4.3 Pricing and Cost Reductions..................................................................... 5
4.4 Packaging....................................................................................... 5
4.5 Test Report..................................................................................... 6
4.6 Aastrom Purchasing Rights....................................................................... 6
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TABLE OF CONTENTS
(continued)
Page
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4.7 Payment......................................................................................... 6
5. Quality, Workmanship and Warranty........................................................................ 6
5.1 Device History Record........................................................................... 6
5.2 Non-Confirming Products......................................................................... 6
5.3 Return of Goods................................................................................. 6
5.4 Warranty........................................................................................ 7
5.5 Inspection...................................................................................... 7
5.6 Warranty of Facility Registration and Compliance................................................ 7
5.7 Warranty of Design.............................................................................. 7
6. Spares Parts Inventory................................................................................... 7
7. Transfer of Title/Transportation......................................................................... 7
8. Refurbishment............................................................................................ 8
9. Force Majeure............................................................................................ 8
10. Termination.............................................................................................. 8
11. Proprietary Information.................................................................................. 9
11.1 Confidentiality................................................................................. 9
11.2 Aastrom's Property: Use of Property by Supplier................................................. 10
11.3 Inventions...................................................................................... 10
11.4 Nondisclosure................................................................................... 10
12. Right of Inspection...................................................................................... 10
13. Complete Agreement....................................................................................... 10
14. Law and Disputes......................................................................................... 11
14.1 Governing Law................................................................................... 11
14.2 Dispute Resolution.............................................................................. 11
TABLE OF CONTENTS
(continued)
Page
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15. Indemnification.......................................................................................... 11
16. Term of Agreement........................................................................................ 11
17. Assignment............................................................................................... 11
18. Severability............................................................................................. 11
19. Notices.................................................................................................. 11
20. Privity.................................................................................................. 12
21. Validity of Agreement Signed in Counterpart.............................................................. 12
EXHIBIT "A" PRODUCT PRICING...................................................................................... 14
EXHIBIT "B" PRICING FOR SPARE PARTS.............................................................................. 15
EXHIBIT "C" AASTROM EQUIPMENT.................................................................................... 16
EXHIBIT "D" AASTROM PURCHASE ORDER STANDARD TERMS AND CONDITIONS................................................. 17
LIST OF DEFINITIONS
Definition Location
---------- --------
AAA............................................................................. 14.2
Aastrom......................................................................... Introduction
Aastrom Equipment............................................................... 3.6
Aastrom Sourced Parts........................................................... 5.4
Affiliate....................................................................... 1.1
DHR............................................................................. 5.1
DMR............................................................................. 3.3.1
Products........................................................................ 1.2
RMA............................................................................. 5.3
RSL............................................................................. 6
Specifications.................................................................. 1.4
Supplier........................................................................ Introduction
Test Report..................................................................... 1.3
MASTER SUPPLY AGREEMENT
This Master Supply Agreement (this "Agreement") is effective as of the
date of the last signature between Aastrom Biosciences, Inc., located at Lobby
L, 24 Xxxxx Xxxxx Xxxxxx Dr., Xxx Xxxxx, XX 00000 ("Aastrom") and Astro
Instrumentation L.L.C. ("Supplier"), located at 00000 Xxxxxx Xxxxxxx,
Xxxxxxxxxxxx, Xxxx 00000.
WHEREAS, the following details reflect a consolidation of agreed upon
terms and conditions from previous communication,
WHEREAS, clause headings are for convenience only and shall not affect
or be deemed to affect the construction or interpretation of the terms and
conditions of this Agreement.
Now, Therefore, in consideration of the above premises and mutual
covenants herein, set forth, the parties hereto agree as follows:
1. Definitions.
For purposes of this Agreement:
1.1 "Affiliate" shall mean with respect to a party, an entity
which, directly or indirectly, majority owns, or is majority owned by, or is
under common majority ownership with, that party. For the purposes hereof, a
partnership shall be deemed an affiliate if Aastrom or Supplier is the managing
partner or is a general partner and has an active and significant economic
interest therein.
1.2 "Products" shall mean the products, component parts,
subassemblies and associated spare parts, listed in Exhibits "A" and "B" (as
applicable), or any other products that the parties from time to time hereafter
may mutually agree to add to this Agreement, for Supplier to make and/or
assemble and deliver to Aastrom under the terms and conditions of this
Agreement. The individual parts or subassemblies which comprise the Products,
and the processing and test instructions for each, are described in detail in
the documents referenced on Exhibits "A" and "B."
1.3 "Test Report" shall mean the actual measurements recorded on a
paper printout upon the completion of test procedures indicated on the
Specifications for the Products tested prior to shipment.
1.4 "Specifications" shall mean the drawings, specifications and
test instructions contained within the document (or set of documents) referenced
for each of the Products on Exhibits "A" and "B," copies of which have been or
will be delivered to Supplier.
2. Appointment of Supplier.
2.1 During the initial three (3) year term of this Agreement,
Aastrom shall regard Supplier as its preferred supplier for the Products and
will purchase its requirements for the Products from Supplier, provided however,
that nothing in this Agreement shall be deemed to preclude Aastrom from
manufacturing the Products itself or from utilizing alternate suppliers if
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Supplier is unable to meet Aastrom's requirements, remain cost competitive, or
otherwise fulfill its obligations under this Agreement.
2.2 If Aastrom believes that Supplier is not remaining cost
competitive, Aastrom may obtain a quote from another supplier to manufacture one
or more of the Products. If such a quote is ten percent (10%) or more lower than
Supplier's quoted price, Supplier shall reduce the price to the quoted price
within a reasonable time period (not to exceed sixty (60) days). Aastrom will
provide Supplier with the source and supporting information for the price quote
for Supplier's review. If Supplier is unable to match the price quote, then
Aastrom may elect to transfer manufacture of any number of the Products to the
alternate manufacturer.
2.3 Supplier will use best diligent efforts to search for methods
and means that will lead to cost reductions and savings for the Products.
Aastrom will cooperate with Supplier in these efforts.
3. Agreement to Manufacture and Manufacturing Responsibilities.
3.1 Manufacture. Supplier will manufacture the Products in
accordance with the Specifications. Supplier also agrees that Aastrom's Quality
Assurance Group shall have the right from time to time upon reasonable written
notice to perform quality audits of Supplier's facilities (or the facilities of
Supplier's subcontractors or Affiliates) to ensure that the Products are
manufactured in compliance with the Specifications. It is further understood
that Supplier shall have primary responsibility for management of its suppliers
and the resolution of technical issues.
3.2 Changes. Supplier shall notify Aastrom in writing prior to the
implementation of any process change or the use of any manufacturing facility
which differ from those processes or facilities which are used originally to
produce the Products.
3.3 Product Documentation.
3.3.1 Device Master Record. Supplier shall maintain working
drawings for manufacturing and testing the Products, including without
limitation, drawings and specifications for component parts to be acquired from
specified vendors, test and acceptance procedures and criteria, assembly and
subassembly specifications, drawings and requirements, costed xxxx of materials,
and manufacturing procedures (collectively called the "DMR"). Aastrom shall own
the DMR and all other manufacturing information relative to the Products, which
shall be considered Aastrom's confidential information under Section 11 hereof.
3.3.2 Engineering Changes.
(a) Aastrom may request that Supplier incorporate
engineering changes to any Product by submitting a written change request signed
by a designated Aastrom representative, or alternate. Supplier shall address
requested changes within one week. Supplier may initiate engineering changes
(e.g., in non-exclusive components or processes). Aastrom will be notified of
all changes prior to implementation; Aastrom has the right to review the
validation of any change, and Aastrom may reject any change which Aastrom deems
detrimental to the quality of the Product.
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(b) All documentation change activity will be handled
through Supplier's engineering notification system, subject to approval by
Aastrom.
(c) Aastrom shall be supplied copies of all revised
documentation in printed or electronic form upon release of that documentation.
(d) If the incorporation of such changes in
engineering causes a difference in the price for Supplier, both Aastrom and
Supplier will negotiate in good faith to agree and amend the prices contained in
Exhibits "A and B" to reflect such change in price.
(e) The Supplier shall not unreasonably refuse to
incorporate Aastrom's engineering change requests in a Product when requested by
Aastrom.
(f) Following execution of this Agreement, Aastrom
and Supplier shall prepare and mutually agree on a plan which describes how
changes are to be controlled, and identify the respective representatives which
shall be responsible to request, implement and validate the changes.
3.3.3 Scrap Costs. Payment of material scrap or other costs
incurred by Supplier due to an engineering change order initiated by Aastrom are
the responsibility of Aastrom and are payable net 30 days after the time of
implementation of the engineering change order. If said engineering change order
is initiated by Supplier, then Supplier shall bear said material scrap and other
costs, unless the parties mutually agree otherwise prior to the change.
3.4 Testing. Supplier shall test the Products in accordance with
the test procedures and specification procedures described in the drawings
referenced on Exhibits "A" and "B" and such other procedures as may be supplied
by Aastrom and mutually agreed upon. Any test equipment supplied to Supplier by
Aastrom or designed and fabricated by Supplier for testing Products shall be
maintained and calibrated by Supplier at its expense. Supplier shall modify such
test equipment as may be necessary to accommodate any engineering changes made
to the Product, or mutually agreed upon. The costs of such changes shall be
borne between the parties as mutually agreed between Aastrom and Supplier.
3.5 Additional Products. Aastrom shall have the right to add
additional Products to this Agreement upon acceptance by Supplier.
3.6 Aastrom Equipment.
3.6.1 Supplier shall maintain and account for all tools,
tooling, fixtures, molds, dies, test equipment, and other equipment
(cumulatively, the "Aastrom Equipment") provided by Aastrom or paid for by
Aastrom for manufacture of the Products at the Supplier's facility or at any of
the Supplier's subcontractor's facilities. Supplier acknowledges that the
Aastrom Equipment is the sole and exclusive property of Aastrom, and the Aastrom
Equipment shall be identified and tagged as "Property of Aastrom Equipment." A
preliminary list of all Aastrom Equipment to be delivered by Aastrom to Supplier
is attached hereto as Exhibit "C", which shall be amended from time to time by
Aastrom upon future deliveries of additional Aastrom Equipment.
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3.6.2 Supplier shall use, maintain and repair all Aastrom
Equipment with the same level of care as Supplier would use, maintain and report
for its own equipment. If major repair of Aastrom Equipment is due to causes
other than Supplier's neglect, then Aastrom will be responsible for the costs
thereof.
3.6.3 Supplier shall not encumber any of the Aastrom
Equipment nor permit the Aastrom Equipment to be encumbered as a result of any
act or omission of Supplier or a subcontractor of Supplier.
3.6.4 Supplier shall not use, disassemble, modify or
transfer the Aastrom Equipment in any manner except as expressly permitted by
Aastrom and needed to perform Supplier's obligations under this Agreement.
Aastrom shall own any intellectual property rights in any improvements to the
Aastrom Equipment developed by Supplier, its Affiliates or subcontractors.
3.7 Material Purchases and Supply Chain Management. Supplier is
responsible for planning, purchasing, quality assurance, and payment for all
materials needed to satisfy their obligations under this Agreement. Supplier
agrees to take primary responsibility to resolve all material, technical and
quality issues related to sub-tier suppliers.
3.8 Insurance. All inventory of components and materials purchased
by Supplier to make Products shall be owned by Supplier and shall be insured
against risk of loss by Supplier. Any components and materials owned by Aastrom
and delivered to Supplier for Product production, together with the Aastrom
Equipment, shall be covered by Supplier's insurance policy for risk of loss
while said items remain in the facilities of Supplier (or its Affiliates or
subcontractors), with Aastrom being the loss payee therefore.
4. Commercial Terms and Pricing.
4.1 Purchase Orders. Aastrom may place its orders for Products on
Aastrom Purchase Order forms which are substantially the same as the Purchase
Order attached hereto as Exhibit "D". The terms and conditions printed on such
Purchase Order are incorporated herein by reference, but in the event such terms
and conditions conflict with the terms of this Agreement, then the terms and
conditions of this Agreement shall prevail.
4.2 Ordering and Forecasts. Aastrom shall specify its expected
requirements for Products to be manufactured by Supplier under the terms of this
Agreement by issuing a 12-month rolling forecast on a monthly basis. The
forecast shall indicate Aastrom's best estimate, on a monthly basis, as to the
number of each of the Products which Aastrom anticipates purchasing, and the
shipment date when Aastrom expects to need each of the Products. This 12-month
rolling forecast will be divided into the following three (3) periods:
4.2.1 Frozen Period:
Within this rolling period, the delivery dates and quantities are
fixed. This period will be the first four (4) week period of each forecast.
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Aastrom commits to purchasing and receiving and not amending the
specific weekly quantities within this rolling period, without prior agreement
with Supplier. Weekly quantities outside this period can be subject to change.
4.2.2 Variable Period:
This rolling period is the eight (8) week period which follows
immediately after the Frozen Period of each forecast. During this variable
period, Supplier is allowed to purchase parts and, if necessary assemble
Products, in order to meet the forecasted delivery dates for the Products.
Aastrom is obliged ultimately to purchase the Products specified for the
variable period, but Aastrom may elect to purchase such Products either during
or after the variable period.
4.2.3 Informative Period:
This period follows immediately after the variable period. The length
of this period will be for the balance of the rolling twelve (12) month period.
During this period, Aastrom has no obligation to purchase any Product or parts.
4.3 Pricing and Cost Reductions.
4.3.1 Supplier shall sell to Aastrom Product at a firm and
fixed price per Exhibits "A" and "B" for one year, subject to reductions
pursuant to Sections 4.3.3 and 4.3.4.
4.3.2 Following the end of the one (1) year fixed price
period, if the price of lower tier supplied material (third party to Supplier)
changes from time to time, the actual differential in price of such material to
Supplier will be reflected in the pricing structure in Exhibits "A" and "B", and
a new Product selling price will be placed in effect at a time that the new cost
is incurred by Supplier; provided however, that Supplier shall use its best
efforts to minimize the extent of any price increases to such material,
including, but not limited to, by finding alternate suppliers and purchasing
materials in bulk and at other discounts. Supplier will provide written notice
to Aastrom of any permitted price changes at least 60 days prior to the
effective date of any price change.
4.3.3 Supplier may at any time suggest changes to Aastrom,
however small, that will result in improved performance, reliability or yield of
Products. Supplier agrees to perform value engineering and value analysis with
the goal of reducing Product costs over the commercial life of the Products.
Reductions in costs resulting from changes that are suggested by Supplier and
accepted by Aastrom shall be shared equally between both parties, by reducing
the price of applicable Products by one-half (1/2) the amount of such cost
reductions.
4.3.4 If Aastrom decides to purchase additional tooling to
increase production of assemblies of an existing design, all of the cost
reductions that occur as a result of this activity will be immediately passed on
to Aastrom. If Aastrom recommends any changes to an existing design or process
that reduce costs, all of these cost reductions or changes will be reflected in
a lower unit price.
4.4 Packaging. Supplier shall package all Products in suitable
containers for protection during shipments by air or ocean freight worldwide and
for storage. Packaging shall be
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approved by Aastrom. Unit packaging requirements are specified in the Product
documentation referenced in Exhibits "A" and "B".
4.5 Test Report. Supplier will provide with each shipment a copy
of the "Test Report" for each Product contained therein.
4.6 Shipment Release Certification. On shipment of each
Instrument, Supplier shall deliver to Aastrom information set forth in the
Aastrom Quality Plan and a written certification that the Instrument was
manufactured in accordance with the Specifications and DMR and has passed all
DMR requirements for Product Release. Such certification shall reference the
serial number of the Instrument unit shipped.
4.7 Aastrom Purchasing Rights. It is understood and agreed that
purchases under this Agreement, may be made directly from Supplier by Aastrom's
parent, Affiliate and subsidiary companies, or by other entities authorized by
Aastrom in writing to Supplier, and the provisions contained herein shall be
equally applicable to said purchases.
4.8 Payment. Supplier shall be paid net 30 days following the
later of (i) shipment from Supplier's factory in Strongsville, Ohio, and (ii)
Aastrom's receipt of an invoice for the shipment.
5. Quality, Workmanship and Warranty.
5.1 Device History Record. Supplier agrees to comply with
Aastrom's Quality Assurance Procedures and Aastrom's engineering documentation
for the Product. A Device History Record ("DHR") is to be maintained by the
Supplier for assemblies. The DHR shall include, without limitation, lot numbers
of components for each Product, any deviations from specifications (for the
Product or component) or procedures in the production of the Product, and
documentation of any tests or measurement values used in determining the
acceptability of the Product or components. Supplier will copy Aastrom on any or
all portions of the DHR as Aastrom may request. Any portion of the DHR to be
sent to Aastrom will be part of the assembly process and will be controlled by
Supplier's documentation change system. It will be the responsibility of the
final test technician to insure that this information is passed on to the
appropriate Aastrom representative.
5.2 Non-Confirming Products. Aastrom is entitled to reject any
Product (or any component thereof) furnished by Supplier which fails to conform
to the Specifications. Supplier agrees to use its best effort and resources to
immediately repair or replace any non-conforming Product or component within 30
days following receipt of such returned Product or component (or such longer
period as is demonstrated by Supplier and accepted by Aastrom as being required
for the repair or replacement). All cost of shipment to and from resulting from
properly rejected Products or components found to be non-conforming shall be
borne by Supplier. In the event that Supplier is unable to repair or replace a
non-conforming Product or component within the applicable time period, Aastrom
shall be entitled (at its option) to require Supplier to make additional
attempts to repair or replace the Product or component, or to give a full refund
or credit for the price paid for such Product or component.
5.3 Return of Goods. In the case that Aastrom returns Products (or
any component thereof) to Supplier for any reason, it is understood that if the
Products or components have been
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in contact with Biohazardous materials, Aastrom will first decontaminate these
Products or components, or in the case that Aastrom is not able to
decontaminate, the Aastrom shall remove all fluids and disposables and tag the
Product or component as Bio-Hazardous. All returned Products or components shall
have a Returned Material Authorization ("RMA") number. The RMA number shall be
requested by Aastrom to Supplier's Customer Service Representative for each
Product before the Product will be shipped to Supplier. Supplier shall issue the
RMA number within 72 hours after Aastrom requests the RMA number.
5.4 Warranty. Supplier warrants to Aastrom that Product
manufactured and supplied to Aastrom shall conform to the Specifications and/or
any other mutually agreed upon acceptance criteria and shall be free from
defects in workmanship and process related material defects for a period of 18
months following shipment; provided however, as to any parts, supplies or
components furnished by a third party source arranged by Aastrom ("Aastrom
Sourced Parts"), if a shorter warranty is given by the third party source, then
that shorter warranty shall apply to that Aastrom Sourced Part. Supplier's
obligations under this warranty are specified in Sections 5.1 and 5.2. Supplier
acknowledges and agrees that this warranty is also for the benefit of the
end-user customer who ultimately acquires the Products.
5.4.1 Aastrom shall perform initial warranty evaluation on
the Products and submit samples of returned Products to Supplier for its further
evaluation and confirmation of defects of Product failure.
5.4.2 Products returned to Supplier in which no defect is
found, or the defect was caused by Aastrom, or an Affiliate or subsidiary or
customer of Aastrom, shall be at the expense of Aastrom. Supplier shall invoice
Aastrom for the costs incurred by Supplier for said conforming Products, such as
freight charges, time, and materials.
5.5 Inspection. Aastrom shall have the right to inspect any and
all Products at Supplier's facility(s) prior to shipment by Supplier, in order
to ensure conformity to the Specifications, Aastrom's acceptance criteria, test
requirements, or other mutually agreed upon acceptance criteria.
5.6 Warranty of Facility Registration and Compliance. Supplier
shall assemble all of the Products in an environment where current good
manufacturing practices are followed. Supplier represents and warrants that (i)
it is registered by the FDA as a contract medical device manufacturer in
accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 (as
amended), and (ii) it has achieved EN 46001 certification, and (iii) it will
maintain said registration and certification in good standing, and (iv) it will
manufacture the Products in compliance with all applicable local, state and
federal laws, regulations, and orders.
5.7 Warranty of Design. Supplier warrants that the Products shall
be free from defects in design as to those specific elements that Supplier is
primarily responsible for in the design. Supplier makes no warranty as to the
design for those elements of the Product for which Supplier was not primarily
responsible.
6. Spares Parts Inventory. Aastrom shall provide a Recommended Spares List
("RSL") for Products, and Supplier shall at all times maintain an inventory of
spares equal to the average of one (1) month's of Aastrom's forecasted needs
over a 12 month period on a rolling basis.
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Aastrom's subsidiaries, affiliates, and other designated entities may order
spares per the pricing listed in Exhibit "B". Supplier agrees to provide spares
requirements for Products for a period of no less than seven (7) years after
delivery of the last commercial Product. Supplier shall be relieved of this
obligation upon Aastrom's execution of an agreement with another supplier for
the Products covered hereunder.
7. Transfer of Title/Transportation. All Products shipped shall be FOB
Strongsville, OH. Title will transfer upon shipment of the Product by Supplier.
Aastrom shall pay the cost and insurance of transportation and shall instruct
Supplier as to the method of transportation to be used for each delivery.
Products shall be shipped directly to Aastrom, unless otherwise instructed by
Aastrom in writing.
8. Refurbishment.
Supplier further agrees to refurbish and repair "out-of-warranty"
Products (or any component thereof), or "in-warranty" Products or components
containing defects caused by Aastrom. The cost to refurbish such Products or
components shall be negotiated between Supplier and Aastrom in good faith, based
on Supplier's normal overhead and profit rates and on the extent of labor and
material required to restore the Products or components to the Specifications.
Supplier shall provide Aastrom a written quotation for said refurbishment or
repair work within (10) business days after receiving the returned Products or
components for evaluation. Aastrom shall indicate to Supplier the shipping
destination for such refurbished Products and or components.
9. Force Majeure.
9.1 Failure of either party to perform for this Agreement in whole
or in part, shall be excused if such failure is the result of force majeure and
acts of God, including, but not limited to, flood, wind and lightning,
insurrections, strikes, riots, war and warlike operations, civil commotion,
fires, explosions, accidents, the acts or orders of any governmental agency,
acts of the public enemy, and laws or regulations or restrictions of the
governmental entity or of any agency or instrumentality thereof.
9.2 If performance of this Agreement is excused pursuant to the
foregoing section the party thus excused shall use reasonable efforts to
perform, and the party excused from performance shall resume performance with
the utmost dispatch when such circumstances are avoided, removed or corrected.
9.3 If the circumstances of force majeure last longer than sixty
(60) days, the party which has not declared the force majeure shall have the
right to cancel this Agreement upon thirty (30) days prior written notice to
other party.
10. Termination.
10.1 Aastrom may terminate this Agreement, for any reason and
without cause, on not less than ninety (90) days prior written termination
notice given to Supplier.
10.2 Supplier may terminate this Agreement after the initial three
(3) year term, for any reason and without cause, on not less than a 12-month
written termination notice given to
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Aastrom. Supplier shall continue to supply production quantities of Products to
Aastrom to the extent that component parts and finished goods in Supplier 's
inventory may permit.
10.3 This Agreement may be terminated at any time upon mutual
consent of the parties to this Agreement.
10.4 Either party may terminate this Agreement for material breach
of any of its provisions by the other party upon thirty (30) days prior written
notice to the other, if during such thirty (30) day notice period the default is
not corrected to the reasonable satisfaction of the non-defaulting party. In
addition, either party may immediately terminate this Agreement by giving the
other party written notice if such other party has entered into or committed any
act of liquidation, bankruptcy, insolvency, receivership or assignment for the
benefit of creditors, to the extent such act is permitted by law.
10.5 Obligations Upon Termination.
10.5.1 Upon any termination of this Agreement, (i) both
parties shall fully perform all of their obligations accruing up through the
date of termination, and (ii) at the request of Aastrom, Supplier will
immediately return to Aastrom, or its designee, all Aastrom Equipment, any
information, specifications, drawings, procedures, manufacturing records
(including the DMR and DHR), description of manufacturing methods and processes
required by government agencies, and all other items in printed or electronic
form that Aastrom may reasonably request related to Products, and (iii) other
items which have been or will be paid for by Aastrom, such as all finished
goods, work in process or raw materials inventory either on hand and
non-returnable or on order and non-cancelable, purchased and/or manufactured as
a result of Aastrom's purchase orders or written authorization to procure such
material. Aastrom shall have no obligation to purchase finished goods, work in
process or raw materials that in its reasonable determination are discrepant or
deficient per the Specifications or that are outside the Frozen Period or
Variable Period referenced in Sections 4.2.1 or 4.2.2 above.
10.5.2 To the extent applicable, the obligations under
Sections 10.5, 11, 14 and 15 shall survive any termination of this Agreement for
a period of ten (10) years after the termination of this Agreement.
10.5.3 Supplier shall provide reasonable cooperation to
transition manufacturing operations for Products to an alternative manufacturer
by promptly supplying Aastrom upon request with copies of all Aastrom
documentation at the reasonable expense of Aastrom. Supplier shall complete any
work in process if so requested by Aastrom upon termination of this Agreement.
11. Proprietary Information.
11.1 Confidentiality. The provisions and arrangements made under
this Agreement are confidential between parties. Each party shall protect
confidential information in the same manner it protects its own confidential
materials. Neither party shall make any reference to this Agreement or any
provision thereof in any publicly disseminated literature, printed matter, or
other publicity issued by or for it, except (i) as required by law, (ii) in
connection with a public or private offer or sale of securities, a business
collaboration or transaction, or a governmental or industry regulatory
communication, or (iii) in a fashion and at a time mutually agreed upon by
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both parties after the execution of this Agreement. After Aastrom has sold
Products in the ordinary course of business, Supplier may add Aastrom to
Supplier's list of customers and may show external photographs of Products for
marketing purposes but may not disclose the other business terms of this
Agreement to other third parties.
11.2 Aastrom's Property: Use of Property by Supplier. Supplier
recognizes the proprietary interest of Aastrom in the techniques, designs,
specifications, drawings and other technical data now existing or developed
during the term of this Agreement relating to the Products and their use.
Supplier acknowledges and agrees that such techniques, designs, specifications,
drawings and technical data relating to the Products and their use, whether
developed by Supplier alone, in conjunction with others, or otherwise, shall be
and is the property of Aastrom. Supplier shall cooperate fully in communicating
to Aastrom or its agents the property described above. Supplier hereby waives
any and all right, title and interest in and to such proprietary information.
Supplier shall have the right to use any technology, information, samples,
documents and other proprietary information of Aastrom provided in connection
with the manufacturing activities described herein solely and exclusively for
the purpose of manufacturing Products for Aastrom and for no other purpose.
11.3 Inventions. As to any improvement to the Products, any
component thereof or any disposable used in connection therewith, which is made
by Supplier's employees or agents in the course of Supplier's work for Aastrom,
or as a result thereof, which improvement constitutes a patentable invention,
(a) Supplier hereby agrees to promptly disclose the same to Aastrom, (b) Aastrom
shall own all right, title and interest in such invention, (c) Supplier hereby
agrees to cause the inventor to execute any assignments requested by Aastrom in
order to perfect Aastrom's ownership rights in the invention; and (d) Supplier
shall cause said inventor to sign appropriate patent applications prepared at
the expense of Aastrom.
11.4 Nondisclosure. Supplier acknowledges and agrees that Aastrom
is entitled to prevent Aastrom's competitors from obtaining and utilizing
Aastrom's trade secrets. Supplier agrees during the term hereof and thereafter
to hold Aastrom's trade secrets and other confidential or proprietary
information in strictest confidence and not to use them for purposes other than
performance hereunder, and not to disclose them or allow them to be disclosed,
directly or indirectly, to any other person or entity, other than to persons
engaged by Supplier for the purpose of performance hereunder, without Aastrom's
written consent. Supplier acknowledges the confidential nature of its
relationship with Aastrom and of any information relating to the Products,
Aastrom, or it distributors, agents, clients or customers which Supplier may
obtain during the term hereof. Supplier also agrees to place any persons to whom
said information is disclosed for purposes of performance hereunder under a
legal obligation to treat such information as strictly confidential on terms no
less restrictive than those contained herein.
11.5 Exclusivity
11.5.1 Continuing Prohibition. At all times both during and
after the term of this Agreement, Supplier shall not make or sell, or enable
others to make or sell, the Instruments, excepting only for making and selling
the Instruments for Aastrom. Similarly, at all times Supplier shall not use, or
enable others to use, any of Aastrom's proprietary information as described in
Section 11.
10
11.5.2 No Similar Product. During the term of this
Agreement, and during the term of any similar manufacturing agreement between
Supplier and Aastrom, and for a period of three (3) years thereafter, Supplier
shall not (a) participate in the design or development by any party other than
Aastrom of any cell production system which uses any technologies which are
similar to one or more of the significant proprietary technologies utilized by
the Instruments; provided, however, Supplier may continue to perform its
existing customer agreements which were in place as of the effective date of
this Agreement, and Supplier may manufacture products that have cell culture
applications so long as said products are not competitive with Aastrom's
Instruments and so long as said products do not use substantially identical
subassemblies; or (b) manufacture, assemble, produce, ship or in any other way
make available for use or distribution, by any party other than Aastrom, any
cell production system which uses any technologies which are similar to one or
more of the significant proprietary technologies used by the Instruments.
11.5.3 No Use of Aastrom's Proprietary Information. Even
after the three (3) years specified in section 11.5.2, Supplier shall not
thereafter render any services or make or sell any product for any other party
which services or product use or arise out of technology developed or owned by
Aastrom or developed by Supplier on behalf of Aastrom. Such methods or systems
shall include, without limitation, those presently in the course of development
by Aastrom and those which shall be developed by Supplier and/or Aastrom and/or
the other design contractors in furtherance of this Agreement. Supplier
acknowledges and agrees that Aastrom has a legitimate business purpose in
precluding Supplier for divulging or otherwise using any and all information
derived by Supplier in the course of performing this Agreement, and that Aastrom
intends to use these Instruments and related methods and systems for its own
business purpose and competitive advantage in the marketplace.
12. Right of Inspection. Aastrom shall have the right under normal business
hours to visit Supplier's facilities to conduct evaluations and review the
performance of Supplier's obligations under this Agreement. Aastrom shall also
have the right to meet with Supplier personnel and review development,
production, process, and quality records relevant to the subject matter in this
Agreement subject to the confidentiality Agreement signed under separate form
between Supplier and Aastrom. Aastrom shall provide reasonable notice to
Supplier prior to each such visit.
12.1 FDA Inspection Reports. Supplier shall provide Aastrom with
copies of any FDA Form 483 observations, follow-up warning letters and/or
close-out reports for those portions of FDA CGMP/QSR compliance inspection
reports relating specifically to the Instruments or the System's regulatory
submission for any facility where the Instruments are manufactured and will work
closely with Aastrom when responding to Form 483 observations that impact the
Instruments or System. Additionally, Supplier shall advise Aastrom of any Form
483 observations not directly related to the System, but affecting the Quality
Systems that are used in manufacture of the Instruments. Supplier shall
immediately report to Aastrom in writing any adverse events, circumstances, or
potential problems relating to Suppliers registrations or inspections that could
adversely effect the Instrument or System approval. Supplier shall furnish to
Aastrom a copy of the facility registrations and inspection reports specifically
related to the System applicable as of the date of this Agreement and throughout
the term of this Agreement. Supplier shall allow Aastrom and its agent to review
and inspect Suppliers facilities, and regulatory compliance files, and
correspondence to and from the FDA regarding inspections,
11
registrations, and audits that pertain directly to the Instruments or any
regulatory submission with regard to the System.
13. Complete Agreement The terms and conditions of this Agreement shall replace
any previous terms and conditions between Supplier and Aastrom relating to the
Products.
14. Law and Disputes.
14.1 Governing Law. The construction, validity and performance of
this Agreement shall be governed by the laws of the State of Michigan, USA,
excluding its principles regarding conflicts of law.
14.2 Dispute Resolution. Any controversy or claim rising out of or
relating to this Agreement, or the breach or interpretation hereof, shall be
resolved through good faith negotiation between the executive officers of the
parties hereto. Any controversy or claim not resolved by mutual agreement shall
be submitted to binding arbitration in Ann Arbor, Michigan, in accordance with
the rules of the American Arbitration Association ("AAA") as then in effect; and
judgment upon the award rendered in such arbitration shall be final and may be
entered in any court having jurisdiction thereof. Notice of the demand for
arbitration shall be filed in writing with the other party to this agreement and
with the AAA. In no event shall the demand for arbitration be made after the
date when institution of legal or equitable proceedings based on such claim,
dispute, or other matter in question would be barred by the applicable statue of
limitations. This Agreement to arbitrate shall be specifically enforceable under
the prevailing arbitration law. The party most prevailing in said arbitration,
as determined by the arbitrator based upon the parties' representative claims
and positions, shall be entitled to recover from the non-prevailing party all
attorneys' fees and other costs incurred in connection with the arbitration
proceeding.
15. Indemnification. Aastrom agrees, at its cost, to defend and hold Supplier
harmless from any claim by any person, firm, corporation or governmental unit
which arises out of the sale or use of the Products with respect to property
damage or bodily injury, unless such claim is caused by or arises out of the (i)
malfeasance or negligent acts or omissions of Supplier, or (ii) a breach by
Supplier of its obligations under this Agreement, or (iii) non-conforming
Products supplied by Supplier
16. Term of Agreement. The initial term of this Agreement shall be for three (3)
years following the effective date hereof. The term shall be automatically
extended after the initial term for a continuing term until terminated in
accordance with Section 10.
17. Assignment: Neither party may directly or indirectly assign or transfer this
Agreement, in whole or on part, to any third party without the other party's
prior written consent, which consent shall not be unreasonably withheld or
delayed. Notwithstanding the above, Aastrom and Supplier may assign its rights
and obligations hereunder to a subsidiary or Affiliate or to a purchaser of its
business relating to the Products without the prior written consent of the
other.
18. Severability: In the event of any provision of this Agreement shall be
invalid, void, illegal, or unenforceable, the remaining provisions hereof
nevertheless will continue in full force and effect without being impaired or
invalidated in any way.
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19. Notices. Any notices from either party which affect this Agreement shall be
in writing and sent by mail, fax, or telex to the address of the other party as
set out below, or such other address as may from time to time have been notified
in writing by either party in question to the other.
13
In the case of notices to Aastrom:
Aastrom Biosciences, Inc.
Attn: Vice President, Administrative and Financial Operations
00 Xxxxx Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Fax: (000) 000-0000
In the case of notices to Supplier
Astro Instrumentation L.L.C.
Attn: Vice President/General Manager
00000 Xxxxxx Xxxxxxx
Xxxxxxxxxxxx, Xxxx 00000
Fax: ( ) ___-____
20. Privity: The relationship established between the Supplier and Aastrom shall
be solely that of seller and buyer, and neither party shall be in any way the
agent or representative of the other party for any purpose whatsoever, and shall
have no right to create or assume any obligation or responsibility of any kind,
whether express or implied, in the name of or on behalf of the of the party to
bind the other party in any manner whatsoever.
21. Validity of Agreement Signed in Counterpart. This Agreement may be signed in
counterparts, each of which shall be an original, but all of which shall be
deemed to be one and the same instrument, and shall be valid and binding when so
signed. A party may evidence its signature and delivery by faxing a signed copy
of this Agreement to the other party.
IN WITNESS WHEREOF, the parties have caused their respective duly
authorized representatives to sign this Agreement in counterparts, putting this
Agreement in effect as of the date when both parties have signed.
ASTRO INSTRUMENTATION LLC AASTROM BIOSCIENCES, INC.
By: /s/ Xxxxx Xxxxxxxxx By: /s/ Xxxx Xxxxxx
_______________________ ___________________
Xxxxx Xxxxxxxxx Xxxx Xxxxxx
Vice President / General Manager Senior Vice President, Administrative and
Financial Operations
Dated: February 14, 2003 Dated: February 14, 2003
_________________ _________________
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LIST OF EXHIBITS
Exhibit Title
------- -----
A Product Pricing
B Pricing for Spare Parts
C Aastrom Equipment
D Aastrom Purchase Order - Standard Terms and Conditions
15
EXHIBIT "A"
PRODUCT PRICING
COMPONENT UNIT PRICES:
UNIT
PART SELLING
NUMBER DESCRIPTION PRICE
A1604 Processor, as defined in final assembly drawing 936520 $15,175.38
A1542 Rack, as defined in final assembly drawing 923627 $13,661.31
A1647 Incubator, as defined in final assembly drawing 936507 $ 7,744.44
A1665 System Manager Accessory Kit, as defined in final $ 767.18
assembly drawing 936520
16
EXHIBIT "B"
PRICING FOR SPARE PARTS
Part Unit
Number Description Drawing Price
------ ----------- ------- -----
42495 PCBA, AA205, PRO 932424 TBD
46527 PCBA, AA200, INC 937027 TBD
46528 PCBA, AA201, INC 937028 TBD
46529 PCBA, AA202, INC 937029 TBD
46532 POLE ASSY, PROC 937032 TBD
46522 PCBA, AA208, Rack/Processor 937052 TBD
46555 PWR SPLY ASSY 937055 TBD
77578 PCBA, Switchover Control, Rack 958287 XXX
00000 XXXX, XX 209, Rack 937059 XXX
00000 XXXX, XX 202 Satellite Board 955606 TBD
17
EXHIBIT "C"
AASTROM EQUIPMENT
To be Prepared
18
EXHIBIT "D"
AASTROM PURCHASE ORDER
STANDARD TERMS AND CONDITIONS
COPY OF AASTROM PURCHASE ORDER TO BE ATTACHED
19
