EXHIBIT 10
SUPPLY AGREEMENT
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Clotalyst Thrombin Product
THIS AGREEMENT, made and entered into this 29th day of March 2005
("Effective Date"), by and between Cell Factors Technologies, Inc. ("CFT"), an
Indiana corporation, and affiliate of Biomet, Inc., having its principal offices
at ▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇, and ThermoGenesis Corp., ("TGC"),
a Delaware corporation having its principal offices at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇.
WITNESSETH:
WHEREAS, TGC sells thrombin processing disposables and reagent, has
expertise and intellectual property relating to autologous thrombin production
devices, and has the capability to manufacture certain OEM products;
WHEREAS, CFT develops, manufactures and distributes products that process
autologous human cells, such as contained in blood, to produce therapeutic
products;
WHEREAS, CFT desires to have TGC manufacture an autologous thrombin device,
incorporating TGC's Thrombin technology (as defined below) for sale by CFT under
the trademark Clotalyst(TM) device (as defined below);
NOW, THEREFORE, in consideration of the above recitals and in consideration
of the mutual agreements and undertakings set forth below, and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties agree as follows:
ARTICLE I
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Definitions
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1.1 "Clotalyst" means CFT's autologous clotting factor device and blood
processing disposables.
1.2 "Confidential Information" means all non-public information, whether in
written, oral or any other form, including, without limitation, data,
documentation, specifications, know-how, technical information, designs,
drawings, plans, blueprints, business plans, customer lists, pricing
information, forecasts, projections, analyses, and manufacturing processes that
the disclosing party (the "Disclosing Party") disclosed to the other party (the
"Receiving Party") or allowed the Receiving Party to observe, in the course of
the activity under this Agreement, which information is indicated at the time of
disclosure or observation as being confidential or proprietary in some manner;
provided, however, that if such information is not or cannot be so marked at the
time of disclosure or observation, the information shall still qualify as
Confidential Information if the Disclosing Party designates such information as
confidential to the Receiving Party in writing within thirty (30) days of
disclosure or observation. Notwithstanding the foregoing, Confidential
Information shall not include information that the Receiving Party can
demonstrate (a) was known to the Receiving Party on a non-confidential basis
prior to the disclosure by the Disclosing Party, (b) has become publicly
available without fault of the Receiving Party, or (c) was independently
developed without the use of Confidential Information by representatives of the
Receiving Party who did not have access to the Confidential Information as
established by contemporaneous written records.
1.3 "FDA" means the U.S. Food and Drug Administration, or any successor
agency thereto.
1.4 "Intellectual Property" means collectively, Patents, Trade Secrets,
Copyrights, Trademarks, moral rights, trade names, rights in trade dress and all
other intellectual property rights and proprietary rights, whether arising under
the laws of the United States or any other state, country or jurisdiction in the
world, including all rights or causes of action for infringement or
misappropriation of any of the foregoing. For purposes of this Agreement: (a)
"Patents" shall mean all patent rights and all right, title and interest in all
letters patent or equivalent rights and applications, including provisional
applications, for letters patent or rights, industrial and utility models,
industrial designs, ▇▇▇▇▇ patents, patents of importation, patents of addition,
certificates of invention and other government issued or granted indicia of
invention ownership, including any reissue, extension, division, continuation or
continuation-in-part applications throughout the world; (b) "Trade Secrets"
shall mean all right, title and interest in all trade secrets and trade secret
rights arising under common law, state law, federal law or laws of foreign
countries; (c) "Copyrights" shall mean all copyrights, and all other literary
property and authorship rights, and all right, title, and interest in all
copyrights, copyright registrations, certificates of copyright and copyrighted
interests throughout the world; and (d) "Trademarks" shall mean all right, title
and interest in all trademark, service ▇▇▇▇, trade name and trade dress rights
arising under the common law, state law, federal laws and laws of foreign
countries, and all right, title, and interest in all trademark, service ▇▇▇▇,
trade name and trade dress applications and registrations interests throughout
the world.
1.5 "Product(s)" means TGC's Thrombin disposable and Reagent that meets the
performance specification in Appendix A and will be sold under the CFT
trademark, Clotalyst
1.6 "Territory" means all countries of the world.
1.7 "TGC Point of Shipment" means as TGC's manufacturing facilities as
defined in the Uniform Commercial Code.
1.8 "Thrombin Technology" means TGC's thrombin disposables and reagent as
specified in U.S. Patent No. 6,472,162: 6,274,090 and other patents pending.
ARTICLE II
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Terms and Conditions of Sale
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2.1 Purchase. TGC shall supply Product and CFT shall purchase Product at
the transfer price according to the terms and condition of sale set forth below.
2.2 Development Fee. As an advance payment for engineering and development
of the Product, CFT shall pay TGC a one-time payment in the sum of ^Removed
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934^ within 30 days
after Agreement execution.
EXHIBIT 10
2.3 Forecast. Within thirty (30) days after the Agreement is executed, CFT
shall provide TGC with a rolling 12 month estimated forecast with a purchase
order for two-quarter (six-month) delivery forecast. The delivery forecast will
be updated each calendar quarter, and provided to TGC within thirty days after
the end of each calendar quarter. Both quarters of each six (6) month delivery
forecast shall be binding, and the second six (6) months of the rolling annual
forecast shall be non-binding.
2.4 Transfer Price. All prices for Products purchased by CFT hereunder
shall be F.O.B., TGC Point of Shipment. The transfer price for the Products
manufactured by TGC shall be the sum of ^Removed pursuant to Rule 24b-2 under
the Securities Exchange Act of 1934^.
2.5 Minimum Purchases. CFT shall purchase from TGC the following minimum
volumes of Products based on years after the Agreement Effective Date:
Minimum Purchases
Year Without FDA Clearance
------------------------------- -------------------------------
1 2,500
2 5,000
3 10,000
4 15,000
5 20,000
Upon FDA clearance, the minimum volume of Product will increase to 20,000
Products for each full year, beginning on the date of FDA clearance, through the
term of the Agreement. If CFT does not purchase the applicable minimum volumes
of Products, TGC shall invoice and CFT shall pay the applicable penalty of
^Removed pursuant to Rule 24b-2 under the Securities Exchange Act of 1934^ for
each Product that was not purchased from the applicable minimum volume, i.e.,
(Product minimum volume - Products purchased) x ^Removed pursuant to Rule 24b-2
under the Securities Exchange Act of 1934^.
2.6 Samples. In order to assist CFT with the introduction of the Products
into the market, TGC agrees to provide CFT with a reasonable number of Product
sample units, labeled as such, at a cost of ^Removed pursuant to Rule 24b-2
under the Securities Exchange Act of 1934^ of the applicable transfer price.
2.7 Purchase Order. All orders for the Products shall reflect delivery
forecast amounts and be by means of a written purchase order which shall be
submitted to TGC at TGC's address for notice purposes set forth in Article 8.1,
and shall request a delivery date. Orders may be placed by facsimile
transmission or, upon the parties' agreement, on TGC's website or by e-mail;
provided, however, that a confirming purchase order is received by TGC ten (10)
business days after such order. It is understood that CFT and TGC may use their
standard purchase order and sales agreement forms during the performance of this
Agreement. Any purchase order, sales agreement or other form used by CFT or TGC
shall be for convenience only and any terms or provisions contained therein
which are in addition to or inconsistent with those contained herein shall have
and be of no force and effect; provided, however, that the terms on such
documents shall be effective to the extent they set forth quantities, scheduled
delivery dates and, as applicable, mode of shipment.
2.8 Acceptance and Rejection of Purchase Order. All CFT purchase orders
conforming with Article 2.6 above that are not rejected within thirty (30) days
after the purchase order is submitted shall be accepted by TGC. TGC shall notify
CFT in writing of any rejected order within thirty (30) days after the purchase
order is submitted. TGC shall have no liability to CFT with respect to purchase
orders that are rejected.
2.9 Invoicing; Payment. TGC shall submit an invoice to CFT with each
shipment of the Products ordered by CFT. Each invoice shall be due and payable
in full within sixty (60) days from the date of such invoice, and any delinquent
account shall bear interest at the greater of one and one half percent (1 1/2%)
per month or the maximum legal rate. All invoices shall be sent to CFT's address
for notice purposes set forth in Article 8.1, without regard to the actual
shipping address for the Products. Each such invoice shall state CFT's aggregate
and unit purchase price for Products in the relevant shipment, plus any freight,
taxes or other costs incident to the purchase or shipment initially paid by TGC
and to be borne by CFT hereunder. CFT shall make all payments to TGC under this
Agreement in United States dollars in immediately available funds to a bank
account designated by TGC in such invoice, or otherwise designated by TGC in
writing. CFT shall not take any credits or offsets against amounts billed to CFT
by TGC without TGC's prior written consent.
2.10 Shipping; Risk of Loss.
(a) All Products delivered by TGC pursuant to this Agreement shall be
suitably packed for the designated carrier in TGC's standard shipping
cartons, marked for shipment to such location or locations as CFT may
designate, and delivered to CFT or its carrier, F.O.B., TGC Point of
Shipment. Risk of loss for the Products shall pass to CFT upon delivery to
the carrier at the F.O.B., TGC Point of Shipment.
(b) TGC shall ship all Products in accordance with CFT's delivery
instructions specified in CFT's purchase orders; provided, however, that if
CFT does not provide delivery instructions with respect to the carrier to
be used, TGC may use its customary carrier. CFT shall also bear all
applicable taxes and duties that may be assessed against the Products after
delivery to the carrier F.O.B., TGC Point of Shipment.
(c) TGC shall use its good faith efforts to ship the Products for
delivery by the requested date on CFT's purchase order for the Products.
All shipments of Products shall be deemed to conform to the relevant
purchase order unless TGC receives from CFT, no later than thirty (30) days
after the receiving date of a given shipment, written notice specifying the
shipment, the purchase order number and exact nature of the discrepancy
between the shipment and the order. If the quantity of Product delivered
does not equal at least 75% of the binding six month forecast (referenced
in item 2.2) as executed with valid purchase orders, then CFT shall have
the right to obtain an alternative supply of Product, provided CFT pays TGC
a running royalty of ^Removed pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934^ for each Clotalyst device during the remaining term
of this Agreement.
2.11 Cancellation. CFT may reschedule, redirect or cancel delivery of
Products only upon written notice to TGC sixty (60) days prior to delivery.
However, if CFT cancels delivery of any Products within forty-five (45) days of
scheduled shipment, CFT shall pay to TGC a restocking charge equal to ^Removed
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934^ of the
purchase price for such purchase order.
2.12 Product Warranty. TGC warrants that the Products delivered to CFT
shall be free from defects in material and workmanship and that such warranty
shall pass through to the customers of CFT. TGC's sole responsibility with
respect to the foregoing warranty is to replace any Product with a defect for
which TGC is responsible that either CFT or its customers reject as being
non-conforming to product specifications within ninety (90) days from the date
of delivery to CFT. TGC shall instruct CFT to either destroy or return the
non-conforming Product to TGC, freight C.O.D., to TGC's facility located in the
U.K. Article 2.11 shall not be construed in a manner that would in any way limit
the indemnification provisions of Article 5 of this Agreement, unless expressly
stated to limit the indemnification provisions.
2.13 Exclusive Warranty. THE FOREGOING WARRANTIES AND REMEDIES ARE
EXCLUSIVE AND ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, EITHER IN
FACT OR BY OPERATION OF LAW, STATUTORY OR OTHERWISE INCLUDING WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT OF THIRD
PARTY RIGHTS TO THE FULLEST EXTENT PERMITTED BY LAW. TGC NEITHER ASSUMES NOR
AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT ANY OTHER LIABILITY IN CONNECTION
WITH THE SALE, INSTALLATION, MAINTENANCE OR USE OR THE RESULTS OF THE USE OF THE
PRODUCT(S), DOCUMENTATION NOR ANY OTHER ITEMS OR MATERIALS PROVIDED HEREUNDER IN
TERMS OF CORRECTNESS, COMPLETENESS, ACCURACY, RELIABILITY, OR OTHERWISE.
2.14 Return Materials Procedure. In the event that any Product purchased
hereunder is defective or fails to conform to the warranties set forth in
Section 2.12, TGC will replace the defective or non-conforming Product. All
Product returns must be assigned a Return Authorization ("RA") number. To obtain
an RA number, the CFT shall notify TGC of the description of the Product,
quantity, reason for return and date of purchase of Product to be returned. All
Product returns from CFT or its customers shall be sent directly to TGC, insured
by CFT or its customer. The RA number shall be prominently displayed on the
outside of the shipping box and the Product shall be packaged to protect them
from shipping damage.
2.15 Continuity of Product Supply. TGC shall maintain for CFT an exclusive
inventory of Products, not to be reduced by CFT purchase order amounts, as
follows: five hundred (500) Products beginning six (6) months after the
Agreement Effective Date until one (1) year after the Effective Date, and one
thousand (1,000) Products beginning one (1) year after the Effective date until
six (6) months before the end of the Agreement term. If TGC fails to maintain at
least fifty percent (50%) of the exclusive inventory of Products for CFT, CFT
may provide notice to TGC to correct the exclusive inventory deficiency, and TGC
shall have 90 days to correct the Product supply problem. If TGC does not
correct the Product supply problem within 90 days by demonstrating that TGC is
maintaining at least 50% of the exclusive inventory of Products, TGC agrees to
grant CFT a nonexclusive license under U.S. Patent No. 6,472,162 to make, use,
sell, offer to sell, and import the Product provided CFT pays TGC a ^Removed
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934^ royalty on net
sales of each Product.
ARTICLE III
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Manufacturing and Regulatory Requirements
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3.1 Manufacturing. TGC shall be responsible for manufacturing Products in
accordance with Quality System Regulation, 21 CFR Part 820 (Medical Devices),
and applicable pharmaceutical/biologics regulations, and all other applicable
regulatory requirements. TGC shall notify CFT, in advance, of any proposed
changes in the manufacturing of the Products, and any such manufacturing changes
shall be subject to CFT's review and approval.
3.2 Technical Support. TGC shall provide CFT with reasonable technical
support to evaluate the Product upon request by CFT.
3.3 TGC Regulatory Responsibilities
(a) Approvals. TGC shall be responsible for obtaining and maintaining
any and all reasonably necessary regulatory approvals and clearances
required for marketing and selling Thrombin Reagent in the Territory
including TGC's tasks identified in Appendix B to this Agreement.
(b) FDA Accession Number. TGC shall provide CFT with the Product name
under which the Product was cleared by the FDA and the FDA accession number
for the new drug approval (NDA), abbreviated new drug approval (ANDA), or
biological license application, as appropriate, so CFT can access TGC's
Product FDA file.
(c) Labeling. TGC shall label Products with TGC's primary closure
labeling.
3.4 CFT Regulatory Responsibilities
(a) Approvals. CFT shall be responsible for obtaining and maintaining
any and all reasonably necessary regulatory approvals and clearances
required for marketing, distributing and selling the Clotalyst in the
Territory including CFT's tasks identified in Appendix B to this Agreement.
(b) Labeling. CFT shall provide TGC with a copy of secondary closure
labeling and other labeling such as brochures and package inserts, and TGC
shall evaluate the CFT's labeling to ensure CFT's labeling is consistent
with TGC's primary closure labeling.
ARTICLE IV
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Term and Termination
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4.1 Term. This Agreement shall commence on the date hereof and shall
continue for five (5) years. ----
4.2 Termination by Material Breach. In addition to other rights and
remedies, TGC or CFT may terminate this Agreement by giving written notice of
termination to the other party if the other party materially breaches any term
of this Agreement. This written notice must be delivered at least sixty (60)
days prior to the effective date of termination. If the other party cures the
identified breach within sixty (60) days after receipt of the notice, the notice
of termination will have no effect.
4.3 Rights Upon a Change of Control. During the term of this Agreement, if
there is a Change of Control (as defined below), each party hereby covenants and
agrees that it shall ensure that the rights of the other party shall continue
unaffected on the terms and conditions contained herein, and shall issue to the
other party a written statement confirming such continuing rights within ten
(10) business days of the effective date of the Change of Control. For purposes
hereof, a Change in Control shall mean (i) the direct or indirect sale or other
disposition (in one or more related transactions to one or more parties) of all
or substantially all of the assets of a party, or (ii) the direct or indirect
transfer of more than fifty percent (50%) of the outstanding voting interests of
a party, whether in a single transaction or series of related transactions.
ARTICLE V
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Insurance and Indemnification
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5.1 Patent, Copyright and Proprietary Rights Indemnity
(a) TGC shall, at its expense, defend and indemnify CFT and its
officers, directors, agents and employees harmless for damages and
reasonable expenses (including attorneys' fees) related to any suits or
claims by a third party brought against CFT alleging that the Product sold
pursuant to this Agreement infringe the Intellectual Property rights of
others provided that TGC is promptly notified, rendered reasonable
assistance by CFT as required, and permitted to direct the defense or
settlement negotiations. The foregoing obligation of TGC does not apply
with respect to the Product or portions or components thereof which is or
was: (i) made in whole or in part in accordance with CFT's specifications
or instructions and such CFT specifications are the source of the alleged
infringement, (ii) combined with other products, processes or materials
where the alleged infringement relates to such combination, provided that
the alleged infringement claim could not be made but for such combination,
(iii) where CFT continues allegedly infringing activity after TGC has
determined in good faith that there is no defensible position and being
notified in writing by TGC thereof or after receiving a modification
delivered at TGC's expense that would have avoided the alleged
infringement, or (iv) where CFT's use of the Product is not in accordance
with this Agreement.
(b) CFT shall indemnify and hold TGC and its officers, directors,
agents and employees harmless from all damages, settlements, attorneys'
fees and expenses related to a claim of infringement or misappropriation
which is determined by a ruling of any court of competent jurisdiction or
by a mutually-agreed arbitrator, or by mutual agreement of the parties, to
have been principally caused by CFT's conduct. TGC shall have no liability
for any infringing combinations arising from the integration of the Product
together with other products provided by CFT or any third party, provided
that the alleged infringement claim could not be made but for such
combination.
(c) Should the use of Products by CFT be enjoined, or in the event TGC
wishes to minimize its potential liability hereunder, TGC may, at its
option, either: (i) modify the infringing item so that it no longer
infringes but remains fully functionally equivalent; (ii) obtain for CFT,
at TGC's expense, the right to continue use of such item; or (iii) if none
of the foregoing is feasible, TGC may take back such infringing item or
items and refund to CFT the purchase price paid therefore, less amortized
depreciation on a five (5) year straight line basis. The foregoing in this
Article shall be TGC's sole liability and CFT's sole remedy for
infringement or misappropriation of third party intellectual property or
proprietary rights.
5.2 Indemnification for Product Liability. CFT shall, at its expense,
defend and indemnify TGC and its officers, directors, agents and employees
harmless for damages and reasonable expenses (including attorneys' fees) related
to any suits or claims by a third party brought against TGC alleging that the
Clotalyst sold pursuant to this Agreement resulted in death or injury to a
patient based, whether based upon a theory of product liability, warranty,
defective product, or otherwise. TGC shall, at its expense, defend and indemnify
CFT and its officers, directors, agents and employees harmless for damages and
reasonable expenses (including attorneys' fees) related to any suits or claims
by a third party brought against CFT alleging that the Products sold pursuant to
this Agreement resulted in death or injury to a patient based, whether based
upon a theory of product liability, warranty, defective product, or otherwise.
5.3 General Indemnification. Each party (the "Indemnitor") shall defend,
indemnify, and hold the other party (the "Indemnitee") harmless from and against
any claims, losses, actions, demands or damages, including reasonable attorney's
fees, resulting from any act, omission, negligence or performance under this
Agreement by the Indemnitor, its users, agents or representatives. This
indemnity shall not apply to the extent the portion of such claim, liability,
loss, cost, damage or expense is the result of the negligence or willful
misconduct of the Indemnitee, its users, agents or representatives, or to the
extent liability is disclaimed or limited by either party under this Article 2.
The indemnity obligations set forth in this paragraph are contingent upon: (a)
the Indemnitee giving notice to the Indemnitor of any such claim(s); (b) the
Indemnitor having sole control of the defense or settlement of the claim; and
(c) at the Indemnitor's request and expense, the Indemnitee cooperating in the
investigation and defense of such claim(s); provided, however, that failure to
give notice shall not void Indemnitor's obligations under this paragraph unless
the failure materially and adversely ▇▇▇▇▇ Indemnitor.
5.4 Insurance. Each party shall purchase and maintain, during the term of
this Agreement, policies of insurance which, at a minimum, include both
comprehensive general liability and product liability. Each such policy shall
have endorsements or coverage with limits of not less than $1,000,000 per
occurrence and $1,000,000 in the aggregate for general liability coverage, and
$2,000,000 per occurrence and $2,000,000 in the aggregate for product liability
coverage. In the event a party's insurance is on a "claims made" basis, such
party shall purchase and maintain the extension of coverage or "tail" for a
period of one year following the Termination Date or last date of sale of the
Products under this Agreement, whichever is the latest date.
ARTICLE VI
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Patents
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6.1 Infringement by Third Parties. In the event that a third party
infringes any patent of TGC covering the Products, TGC may, in its sole
discretion, bring suit or otherwise ▇▇▇▇▇ the infringement. If TGC chooses to
take such action, CFT may elect to participate in the prosecution of the action,
provided that it equally shares the cost and expenses incurred in connection
with such action. If CFT elects to participate in the action, it shall be
entitled to receive fifty percent (50%) of any recovery made by TGC after
reimbursement of each party's direct litigation costs and expenses. In the event
that TGC chooses not to take such action, CFT shall be free to pursue any such
claim against a third party at its sole cost and expense and TGC shall, without
further consideration therefore, perform all reasonable acts necessary for CFT
to pursue such a claim. Any recovery made by CFT from such action shall be
retained by CFT.
ARTICLE VII
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Confidential Information
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7.1 Confidential Information. In performing the obligations under this
Agreement, CFT and TGC may come into contact with, be given access to, and, in
some instances, contribute to each other's Confidential Information. In
consideration of permitting CFT and TGC to have access to each other's
Confidential Information, during the term of this Agreement and at all times
thereafter, CFT and TGC agree that they shall not disclose to any third party
any Confidential Information of the other party without the other party's prior
written consent. CFT and TGC shall only make the Confidential Information of the
other party available to its employees on a need-to-know basis and agree to take
appropriate action by instruction or agreement with their respective employees
for a permitted access to the Confidential Information to satisfy the
obligations under this Article 7.1.
7.2 Confidential Treatment for Business Terms. In addition, incident to
TGC's filing of this Agreement with the Securities and Exchange Commission, the
parties agree that certain confidential and competitive information with respect
to pricing will not be publicly disclosed, and TGC agrees that it will request
under the United States securities laws, including Rule 24b-2 promulgated under
the Securities Exchange Act of 1934, as amended, and use its reasonable best
efforts to seek, confidential treatment of certain information contained in this
Agreement.
ARTICLE VIII
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Miscellaneous
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8.1 Notices. Any notice, request, demand, or other communication required
or permitted under this Agreement, shall be deemed to be properly given by the
sender and received by the addressee (a) if personally delivered; (b) three (3)
days after deposit in the mails if mailed by certified or registered air mail,
postage prepaid; (c) one (1) day after being sent by facsimile with confirmation
sent as provided in (b) above; or (d) one (1) day after being sent by commercial
overnight mail, addressed as follows, and in the case of facsimile transmission,
to the appropriate facsimile number shown below:
If to TGC: THERMOGENESIS CORP.
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No.: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇▇▇▇▇▇▇,
President & COO
With a copy to: ▇▇▇▇▇▇ Eng & ▇▇▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile No.: (▇▇▇)▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇ ▇▇▇▇▇, Esq.
If to CFT: Biomet, Inc.
▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: General Counsel
With a copy to: Cell Factor Technologies
▇▇ ▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: Mr. ▇▇▇▇ ▇▇▇▇▇▇▇,
Vice President, Technical Affairs
8.2 Relationship of the Parties. Nothing contained in this Agreement shall
be construed to place the parties in a relationship of partners, joint ventures,
or principal and agent. Neither party is authorized to assume or undertake any
obligation of any kind, expressed or implied, on behalf of the other party.
8.3 Non-Assignment. Neither party shall assign any of its rights or
obligations hereunder without the prior written consent of the other party;
provided, however, that neither parties' consent shall be required in connection
with the transfer of the other party's rights or obligations under this
Agreement incident to a merger, consolidation, reorganization or acquisition of
substantially all the assets of either party.
8.4 Waiver of Breach. The waiver or failure of either party to exercise in
any respect any right provided for under this Agreement shall not be deemed to
be a waiver of any future right hereunder.
8.5 Legal Interpretation. This Agreement shall be construed and interpreted
in accordance with the law of the State of Indiana and the federal law of the
United States, without regards to conflicts of laws principles.
8.6 Arbitration. All disputes, claims or controversies arising from or
relating to this contract or the relationships which result from this contract
shall be resolved by binding arbitration under the rules of the then current CPR
Institute for Dispute Resolution, by one arbitrator. The decision of the
arbitrator shall be final. The place of arbitration shall be South Bend,
Indiana. This arbitration contract is made pursuant to a transaction in
interstate commerce, and shall be governed by the Federal Arbitration Act. Any
judgment upon the award rendered by the arbitrator may be entered by any court
having jurisdiction thereof. The parties voluntarily and knowingly waive any
right they have to a jury trial. The arbitrator is not empowered to award
punitive damages or damages in excess of compensatory damages and each party
hereby irrevocably waives any right to recover any damages other than
compensatory damages with respect to any dispute resolved by arbitration. The
parties also agree that neither shall have the right to participate as a
representative or member of any class of claimants pertaining to a claim subject
to arbitration under this agreement. The parties further agree that neither
shall have the right to consolidate claims subject to arbitration under this
agreement.
8.7 Modification. This Agreement may not be modified or altered except by
written instrument duly executed by CFT and TGC.
8.8 Entire Agreement. This Agreement contains the entire agreement of the
parties hereto with respect to the subject matter hereof and shall be deemed to
supersede all prior agreements, whether written or oral, and the terms and
provisions of any such prior agreement shall be deemed to have been merged into
this Agreement.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the date first above written.
ThermoGenesis Corp. Cell Factor Technologies, Inc.
By By
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President & Chief Operating Officer Vice President, Technical Affairs
Appendixes:
A - Product Performance Specification
B - Regulatory Requirements
C - Product Quality