Exhibit (d)(3)
First Amended International Distribution Agreement
This Agreement is made by Tutogen Medical GmbH, a German corporation with
offices at IndustriestraBe 6, D-91077 Neunkirchen am Brand, Germany ("Tutogen")
and Sulzer Spine-Tech Inc., a Delaware corporation with offices at 7375 Bush
Lake Road, Minneapolis, Minnesota 55439-2027, U.S.A. ("Sulzer").
W I T N E S S E T H:
WHEREAS, Tutogen collects xenograft and donated allograft tissue from sources
throughout Europe and within the United States, processes such tissue itself or
provides such tissue for processing by others, and distributes xenograft and
donated allograft tissue products through various distributors throughout the
world;
WHEREAS, Sulzer manufactures and sells worldwide a line of products used in
spinal fusion surgery and desires to acquire from Tutogen the right to
distribute its xenograft and allograft bone tissue products worldwide, excluding
the United States, for use in spinal applications;
WHEREAS, Tutogen is in principle willing to terminate the right of its existing
distributors to sell xenograft and allograft bone tissue products for spinal
applications and to appoint Sulzer as its sole and exclusive distributor for
such products in such applications on the terms and conditions set forth herein;
WHEREAS, Tutogen and Sulzer entered into an agreement styled "International
Distribution Agreement," dated March 8, 2000, pursuant to which Tutogen
appointed Sulzer as the exclusive distributor worldwide, excluding the United
States, for Tutogen's xenograft and donated allograft bone tissue products for
applications in the spine; and
WHEREAS, Tutogen and Sulzer desire to make a new agreement that will supersede
the International Distribution Agreement dated March 8, 2000;
NOW, THEREFORE, in consideration of the foregoing premises and the terms and
conditions set forth below, the parties hereby agree as follows:
1. Definitions
1.1 "Affiliate" shall mean an entity that controls, is controlled by, or is
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under common control with a party. For purposes of this definition,
"control" shall mean the possession, directly or indirectly, of a
majority of the voting power of such entity (whether through ownership
of securities or partnership or other ownership interests, by contract
or otherwise); provided that, such entity shall be deemed an Affiliate
only so long as such control continues.
1.2 "Contract Year" shall mean the one-year period following the Effective
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Date of this Agreement and each one-year period following each
anniversary of the Effective Date of this Agreement.
1.3 "Effective Date" of this Agreement shall mean March 8, 2000.
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1.4 "Field of Use" shall mean all uses of processed xenograft and donated
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allograft bone tissue in and adjoining the human spine.
CONFIDENTIAL
1.5 "Permitted Successor" shall mean any individual, corporation,
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partnership, joint venture, association, trust, or any other entity or
organization of any kind or character that assumes the obligations of
a party under this Agreement as permitted according to the terms of
this Agreement.
1.6 "Products" shall mean the xenograft and allograft bone tissue products
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manufactured by Tutogen or an Affiliate of Tutogen or a Permitted
Successor of Tutogen and listed on Schedule A attached hereto. The
parties shall mutually agree on the addition of Products to Schedule
A.
1.7 "RTI Agreement" shall mean the Shaft Recovery and Service
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Reimbursement Agreement between Tutogen and Regeneration Technologies
Inc. ("RTI"), as successor to the University of Florida Tissue Bank,
effective as of 29 September 1998, including an amendment thereto
dated 28 June 1999, pursuant to which Tutogen supplies certain human
donor bone tissue to RTI, which RTI processes for use in spinal
applications.
1.8 "Sub-Territory" shall mean one of the following geographic regions or
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countries comprising in part the Territory: Western Europe (European
Union including Switzerland, Norway, Iceland, Turkey, and Israel);
Eastern Europe; South America (including Central America and Mexico);
Canada; Far East (excluding Japan); Japan; and Middle East (including
Africa).
1.9 "Territory" shall mean the entire world, exclusive of the United
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States, its territories and possessions.
1.10 "Third Party" shall mean a person or entity other than Tutogen, any
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Tutogen Affiliate, Sulzer, any Sulzer Affiliate or any officer,
director, or employee of Tutogen, any Tutogen Affiliate, Sulzer, or
any Sulzer Affiliate.
2. Grant of Rights
2.1 Exclusive Distribution. Tutogen hereby appoints Sulzer, and Sulzer
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hereby accepts the appointment during the term of this Agreement as
the exclusive distributor of the Products in the Territory for the
Field of Use.
2.2 Consideration. In consideration of the transfer of distribution rights
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in the Products for the Field of Use from Tutogen's existing
international distributors to Sulzer, Sulzer agrees to pay Tutogen
US$2 million as follows: US$1 million upon execution of this Agreement
and, provided that Tutogen has commenced delivery of Products to
Sulzer in response to Sulzer's purchase orders, US$1 million on
October 1, 2000.
3. Sulzer's Obligations
3.1 Marketing Efforts. Sulzer agrees to use commercially reasonable
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efforts to market and sell the Products throughout the Territory for
the Field of Use. Sulzer shall have no right or obligation to market
the Products for any use other than the Field of Use.
3.2 Support Services. Sulzer agrees to use commercially reasonable efforts
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to provide usual and customary support services to the surgeon-
customer for the Products.
CONFIDENTIAL First Amended International Distribution Agreement - Page 2
3.3 Instruments. Sulzer shall develop appropriate surgical instruments, as
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needed, to assist the surgeon in implanting each of the Products.
Sulzer shall also develop a standard surgical procedures for
implanting the Products. Tutogen shall assist Sulzer, as necessary, in
developing the instruments and surgical procedures.
3.4 Forecasting. Commencing with the third calendar quarter of 2000 and
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continuing quarterly thereafter, Sulzer shall provide Tutogen, no
later than 15 days prior to each calendar quarter, with a rolling
monthly forecast of sales of the Products for the succeeding 12
months. Sulzer's forecasts shall specify the anticipated sales by
Product, by Sub-Territory, and by month. Sulzer shall incur no
liability to Tutogen in the event that actual sales of the Products
differ from Sulzer's forecasts.
3.5 Minimum Annual Product Sales. As consideration for the exclusive right
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to sell the Products in the Territory, commencing with the ninth month
of the second Contract Year and continuing with each Contract Year
thereafter, Sulzer and Tutogen will establish certain minimum annual
goals for sales of the Products during the Contract Year as a means of
ensuring that Sulzer is using reasonable efforts to sell the Products
in each Sub-Territory within the Territory. Sulzer and Tutogen agree
to confer and mutually agree upon the minimum annual sales goals in
each Sub-Territory for each Contract Year, which shall be recorded on
Schedule B, during the three-month period commencing with the sixth
month of the second Contract Year. In the event that the sales for the
Products in a Sub-Territory in any Contract Year are less than the
goals established under Schedule B, provided that Sulzer's failure to
meet the minimum goals is not a result of a Force Majeure as described
in Section 9.2, Tutogen shall have the right, in its sole discretion,
to undertake for itself or to employ the services of an additional
third party, on an exclusive or a non-exclusive basis, to sell the
Product in that Sub-Territory only and for the Field of Use. Tutogen
shall exercise its option, if at all, by giving Sulzer written notice
of its election no later than 60 days following the end of the
Contract Year in question.
3.6 Sales Personnel. Sulzer shall use reasonable efforts to train its
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sales personnel in techniques for proper use and implantation of the
Processed Tissues.
4. Tutogen's Obligations
4.1 Product Supply. Tutogen agrees to use its best efforts to acquire
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xenograft and donor allograft bone tissue, process the tissue using
the Tutoplast(R) process according to Sulzer's forecasts for demand
for Products, manufacture the Products, and sell the Products to
Sulzer pursuant to purchase orders issued by Sulzer at the transfer
prices to which the parties shall agree and list in Schedule C
attached hereto. Sulzer shall pay the transfer price to Tutogen within
45 days from the date of Tutogen's invoice. In no event shall Tutogen
or an Affiliate of Tutogen or a Permitted Successor of Tutogen during
the term of this Agreement supply allograft bone tissue, whether
processed or unprocessed, to a Third Party for further distribution in
the Territory for the Field of Use; provided that, Tutogen shall be
permitted to deliver unprocessed allograft bone tissue
CONFIDENTIAL First Amended International Distribution Agreement - Page 3
pursuant to the RTI Agreement so long as Tutogen's supply of allograft
bone tissue exceeds the demand for Products under this Agreement.
4.2 Termination of Distribution Contracts. Tutogen shall terminate the
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right of its existing distributors, excluding Canada, Italy, Spain,
and Turkey, to distribute the Products for the Field of Use as soon as
possible after the Effective Date according to the terms of existing
distribution agreements, if any. Schedule D sets forth the dates by
which termination of Tutogen's existing distributors, excluding
Canada, Italy, Spain, and Turkey, shall be effective. Sulzer shall
have an immediate nonexclusive right to sell the Products for the
Field of Use in all countries listed in Schedule D, pending
termination of existing distribution agreements, to the extent
permissible under existing distribution agreements. The parties shall
consult regarding Tutogen's distributors in Canada, Italy, Spain, and
Turkey, which together represent a significant portion of Tutogen's
current revenue from sales of the Products, and Tutogen shall use its
best efforts to accommodate Sulzer's desired distribution in those
countries and terminate Tutogen's existing distributors, if so
determined by Sulzer after consultation. Tutogen agrees to insure that
any substantial inventory of the Products held by the distributors at
the time of their termination is either returned to Tutogen or
transferred to Sulzer.
5. Regulatory Matters
5.1 Import Compliance. Tutogen agrees to comply with and maintain
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compliance with all governmental rules, regulations, statutes, and
other laws of any kind necessary to acquire xenograft and donor
allograft tissue, manufacture the Products, and deliver the Products
to Sulzer within the Territory.
5.2 Regulatory Responsibilities. The parties understand that as of the
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Effective Date of this Agreement, the Products are regulated by
governmental authorities in most of the countries in the Territory,
and Tutogen has obtained approvals from such regulatory authorities to
sell many of the Products in such countries. As to Products for which
Tutogen has not obtained regulatory approval in a particular country
as of the Effective Date, or Products that first become regulated in a
particular country after the Effective Date, Sulzer, at its own cost,
shall be responsible for obtaining regulatory approval for such
Product in such country, as an agent for Tutogen; provided that,
Sulzer may elect upon written inquiry from Tutogen to remove such
Product from Schedule A (for purposes only of the particular country)
rather than to seek regulatory approval therefor. In the event that
Sulzer elects to remove a regulated Product from Schedule A (as to a
particular country), Tutogen shall have the right to seek regulatory
approval therefor at its own expense and to sell such Product in the
particular country without obligation to Sulzer under this Agreement.
5.4 Clinical Trial Costs. Tutogen agrees to bear all costs related to pre-
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clinical trials in support of Sulzer's efforts to obtain regulatory
approval for a Product. Sulzer agrees to bear all costs related to
clinical trials and filing for, obtaining, and maintaining the
regulatory approval.
5.5 Ownership of Approvals. Tutogen shall be the record owner of all
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regulatory approvals to sell Products in the Territory and for the
Field of Use.
CONFIDENTIAL First Amended International Distribution Agreement - Page 4
6. Trademark License and Product Labeling
6.1 License Grant. Tutogen grants Sulzer a nonexclusive license under
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Tutogen's trademarks, Tutoplast(R), Tutobone(R), and Spline Line(R),
to use the trademarks solely in connection with the Products and the
marketing thereof within the Territory for the Field of Use.
6.2 Publication Approvals. Sulzer shall provide Tutogen with samples of
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all marketing and other printed materials utilizing a trademark of
Tutogen in advance of publication of the same. Tutogen shall be deemed
to have approved such samples for actual use unless it objects in
writing within 10 business days following Sulzer's delivery of same.
6.3 Labeling. Tutogen agrees to include the trademarks of Sulzer on
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Product labels in a manner mutually agreeable to the parties.
7. Term and Termination
7.1 Term. This Agreement shall be effective on the Effective Date and
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shall remain in effect for an initial term of 10 Contract Years,
unless sooner terminated according to the terms set forth in this
Agreement. At the end of the tenth Contract Year and each succeeding
anniversary of the Effective Date, this Agreement shall renew
automatically for a successive one-year term unless one party gives
the other party written notice of termination at least 12 months in
advance of the renewal date.
7.2 Material Breach. If either party is in material breach of any
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obligation in this Agreement, the non-breaching party may give written
notice to the breaching party of its intention to terminate this
Agreement, and this Agreement will terminate 60 days after the giving
of such notice unless during the 60-day period (i) the breach has been
cured, or (ii) if a breach is incapable of cure within the 60-day
period, the breaching party has commenced action which is calculated
to result in a cure of the breach to the reasonable satisfaction of
the non-breaching party within 120 days after the giving of notice. If
at the end of the 60-day or 120-day period following a notice of
termination the parties disagree as to whether the Agreement has
terminated as provided in this paragraph, the parties shall continue
to perform under this Agreement until an arbitration tribunal
constituted as provided in this Agreement has ruled on the matter.
7.3 Insolvency. Either party may terminate this Agreement immediately on
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delivery of written notice to the other party (i) upon the institution
by or against such other party of insolvency, receivership, or
bankruptcy proceedings or any other proceedings for the settlement of
such party's debts; provided that, with respect to involuntary
proceedings, such proceedings are not dismissed within 120 days, (ii)
upon such other party's making an assignment for the benefit of
creditors, or (iii) upon such other party's dissolution or ceasing to
do business.
7.4 Termination Without Cause. Sulzer shall have the right to terminate
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this Agreement with or without cause at any time on or after January
15, 2002 provided that Sulzer shall have given Tutogen written notice
of termination at
CONFIDENTIAL First Amended International Distribution Agreement - Page 5
least 12 months in advance of the termination date. Sulzer's notice of
termination, if any, shall not relieve Sulzer of the obligation
thereafter to make the payments set forth in Section 2.2 above, and
Sulzer's termination under this Section 7.4 does not give Sulzer any
right to recover payments made prior to the effective date of
termination. In the event that Sulzer shall terminate this Agreement
without cause as provided in this Section 7.4, neither Sulzer nor any
Affiliate of Sulzer shall for a period of one year following the
effective date of termination enter into an agreement, either directly
or indirectly, to own, operate, advise, or have any interest in any
business relating to the Products in the Territory for the Field of
Use.
7.5 Reimbursement of Regulatory Expenses. In the event that the Agreement
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terminates (i) by reason of Tutogen's notice of termination under
Section 7.1, or (ii) by reason of Tutogen's material breach under
Section 7.2, then Tutogen shall be obligated to reimburse Sulzer's
out-of-pocket expenditures, or a portion thereof as determined in this
Section 7.5, in obtaining or attempting to obtain regulatory approval
for Products under Section 5.2, including the out-of-pocket cost of
all pre-clinical, if any, and clinical trials and other expenses
directly related to the regulatory approval process (the "Clinical
Expenses"). For each Product as to which Sulzer has obtained or
attempted to obtain a regulatory approval, Tutogen shall be obligated
to reimburse an amount determined by multiplying the Clinical Expenses
for that Product by the Reimbursement Ratio. The "Reimbursement Ratio"
is
10 yrs - (t\\exp\\ - t\\app\\) / 10 yrs,
where t\\exp\\ is the effective date of termination of the Agreement
and t\\app\\ is the date of regulatory approval for the Product. For
example, if Sulzer obtains a regulatory approval for a Product at the
beginning of the second Contract Year after incurring $100,000 of
Clinical Expenses and the Agreement terminates at the beginning of the
fifth Contract Year, the Reimbursement Ratio is
10 yrs - (3 yrs) / 10 yrs = 0.7
and Tutogen owes Sulzer $70,000. The reimbursement amount shall be
paid in three equal annual installments due on the date of
termination, one year after termination, and two years after
termination, without interest.
8. Representations, Warranties, Indemnities, and Limitations of Liability
8.1 Tutogen. Tutogen represents and warrants to Sulzer, as follows:
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8.1.1 Tutogen has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations
hereunder, and the execution, delivery, and performance of
this Agreement have been validly authorized by Tutogen.
8.1.2 Tutogen has the right to grant to Sulzer the rights and
licenses granted in this Agreement.
8.1.3 As of the date of this Agreement, and to the best of its
knowledge and belief, neither the manufacture, nor the use,
nor the sale of the Products in the Territory constitutes a
misuse or misappropriation of confidential information or
trade secrets or a breach of confidence, and
CONFIDENTIAL First Amended International Distribution Agreement - Page 6
does not infringe or violate any valid patent, trademark, or
copyright or any other intellectual property rights of any
third party. Tutogen has disclosed to Sulzer all patents and
other intellectual property rights which, to Tutogen's
knowledge, may have a material effect on Sulzer's ability to
market the Products.
8.1.4 Tutogen has not received notice that the manufacture, use, or
sale of the Products violates any patent rights or any other
intellectual property right or constitutes a misappropriation
or misuse of trade secrets or proprietary information.
8.1.5 Tutogen shall promptly notify Sulzer of any claim of
infringement or misappropriation relating to the Products.
8.1.6 To the best of Tutogen's knowledge and belief, Tutogen's
procurement of donor allograft tissue complies fully with all
laws of the country in which the donor tissue is collected,
including all national, regional, and local laws.
8.1.7 To the best of Tutogen's knowledge and belief, Tutogen
possesses all governmental and other approvals required for
the collection and processing of donor allograft tissue, and
Tutogen shall use commercially reasonable efforts to maintain
all such approvals throughout the term of this Agreement.
8.1.8 For a period of 12 months from the date of Tutogen's delivery
to Sulzer, each Product shall be free from defects in
material, manufacturing, and workmanship, including, but not
limited to, disease, excluding defects caused by the abuse,
misuse, neglect, or by improper testing, handling, storage, or
use by a party other than Tutogen.
8.1.9 During the term of this Agreement, except as required by law
or by a pre-existing contractual obligation of Tutogen,
Tutogen will not, directly or through an Affiliate, assign,
sell, transfer, convey, or otherwise alienate in whole or in
part any right to receive donated allograft bone tissue
without the prior written agreement of Sulzer.
8.2 Liability for Breach of Product Warranty. If any failure to conform to
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the representation and warranty set forth in Section 8.1.9 appears
within the applicable warranty period, Tutogen will, at its option and
expense, correct any such failure by either replacing the defective or
non-conforming Product or by repairing such Product. In no event shall
the liability of Tutogen in connection with such warranty exceed the
cost of replacing or repairing the defective Product. The foregoing
shall constitute the exclusive remedy of Sulzer and the sole liability
of Tutogen whether in contract or in tort or otherwise relating to a
defect of a Product.
8.3 Exclusion of Other Warranties. The representations and warranties
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stated in Section 8.1 are expressly in lieu of all other warranties,
including, but not limited to, any implied warranty of merchantability
or of fitness, and constitute the only warranties made with respect to
any Product.
CONFIDENTIAL First Amended International Distribution Agreement - Page 7
8.4 Sulzer. Sulzer represents and warrants to Tutogen, as follows:
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8.4.1 Sulzer has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations hereunder,
and the execution, delivery, and performance of this Agreement
have been validly authorized by Sulzer.
8.5 Indemnity by Tutogen.
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8.5.1 Tutogen shall defend, indemnify, and hold harmless Sulzer against
any liability or damages from any third party claims, suits,
proceedings, demands, recoveries, or expenses ("Claims") to the
extent that such Claims arise from or are based upon: (i)
material breach by Tutogen of any of its representations or
warranties contained herein; or (ii) negligence, gross
negligence, or intentionally wrongful acts or omissions on the
part of Tutogen; provided that Sulzer: (a) promptly notifies
Tutogen in writing of any such Claim which comes to its
attention; (b) allows Tutogen to control the defense or
settlement of such Claim; (c) does not enter into any settlement
or compromise of such Claim without the express authorization of
Tutogen; and (d) reasonably cooperates with Tutogen in the
defense of such Claim, subject to Tutogen's payment of all
reasonable out-of-pocket expenses associated with such
cooperation by Sulzer. Sulzer shall have the right to participate
in a non-controlling fashion in such legal proceeding at its sole
expense.
8.5.2 No undertaking of Tutogen under this section shall extend to any
such alleged infringement or violation to the extent that it: (a)
arises from adherence to design modifications, specifications,
drawings, or written instructions which Tutogen is directed by
Sulzer to follow, but only if such alleged infringement or
violation does not reside in corresponding Product of Tutogen's
design or selection; or (b) arises from adherence to instructions
to apply Sulzer's trademark, trade name, or other company
identification; or (c) resides in a Product which is not of
Tutogen's origin and which is furnished by Sulzer to Tutogen for
use under this Agreement; or (d) relates to use of Products or
other items provided by Tutogen in combination with other
Products or items furnished either by Tutogen or others, which
combination was not installed, recommended, or otherwise approved
by Tutogen. In the foregoing cases numbered (a) through (d),
Sulzer will defend and hold Tutogen harmless, subject to the same
terms and conditions and exceptions stated above, with respect to
Tutogen's rights and obligations under this clause.
8.6 Indemnity by Sulzer.
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8.6.1 Sulzer shall defend, indemnify, and hold harmless Tutogen against
any liability or damages from any third party claims, suits,
proceedings, demands, recoveries, or expenses ("Claims") to the
extent that such Claims arise from or are based upon: (i)
material breach by Sulzer of any of its representations or
warranties contained herein; or (ii) negligence, gross
negligence, or intentionally wrongful acts or omissions on the
part of Sulzer; provided that Tutogen: (a) promptly notifies
Sulzer in writing of any such Claim which comes to its
CONFIDENTIAL First Amended International Distribution Agreement - Page 8
attention; (b) allows Sulzer to control the defense or settlement
of such Claim; (c) does not enter into any settlement or
compromise of such Claim without the express authorization of
Sulzer; and (d) reasonably cooperates with Sulzer in the defense
of such Claim, subject to Sulzer's payment of all reasonable out-
of-pocket expenses associated with such cooperation by Tutogen.
Tutogen shall have the right to participate in a non-controlling
fashion in such legal proceeding at its sole expense.
8.6.2 No undertaking of Sulzer under this section shall extend to any
such alleged infringement or violation to the extent that it: (a)
arises from adherence to design modifications, specifications,
drawings, or written instructions which Sulzer is directed by
Tutogen to follow, but only if such alleged infringement or
violation does not reside in corresponding Product of Sulzer's
design or selection; or (b) arises from adherence to instructions
to apply Tutogen's trademark, trade name, or other company
identification; or (c) resides in a Product which is not of
Sulzer's origin and which is furnished by Tutogen to Sulzer for
use under this Agreement; or (d) relates to use of Products or
other items provided by Sulzer in combination with other Products
or other items, furnished either by Sulzer or others, which
combination was not installed, recommended or otherwise approved
by Sulzer. In the foregoing cases numbered (a) through (d),
Tutogen will defend and hold Sulzer harmless, subject to the same
terms and conditions and exceptions stated above with respect to
Sulzer's rights and obligations under this clause.
8.7 Limitation of Liability to Third Parties. The liability of Tutogen and
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Sulzer with respect to any and all claims, actions, proceedings, or suits
by any third party alleging infringement of patents, trademarks, or
copyrights or violation of trade secrets or proprietary rights because
of, or in connection with, any items furnished pursuant to this Agreement
shall be limited to the specific undertakings contained in this Section
8.
8.8 Exclusion of Consequential Damages. Neither Tutogen nor Sulzer shall in
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any event or under any circumstances, including, but not limited to
liability, delay, or warranty, be liable to the other for special or
consequential damages, including but not limited to, loss of profit or
revenue, loss of use of production line, or claims by customers for
service interruptions. The remedies for the parties set forth in this
Agreement are exclusive.
8.8 RTI Agreement. Notwithstanding anything herein to the contrary, nothing
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in this Agreement is intended to be, or shall be construed as being, a
breach, anticipatory or otherwise, of the RTI Agreement as it existed
following amendment on 28 June 1999.
9. Miscellaneous Provisions
9.1 Entire Agreement.
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9.1.1 This Agreement, together with the First Amended Umbrella
Agreement, the First Amended Option Agreement, the First Amended
U.S. Service Agreement, and the First Amended Processed Tissue
Development and
CONFIDENTIAL First Amended International Distribution Agreement - Page 9
License Agreement, all between the parties or their Affiliates,
embodies the final, complete, and exclusive understanding
between the parties and supersedes all previous agreements,
understandings, or arrangements between the parties with
respect to its subject matter, including the International
Distribution Agreement dated March 8, 2000.
9.1.2 The International Distribution Agreement dated March 8, 2000 is
hereby cancelled entirely and superseded by this Agreement.
9.1.3 No modification or waiver of any terms or conditions hereof,
nor any representations or warranties will be of any force or
effect unless such modification or waiver is in writing and
signed by an authorized officer of the party against whom
enforcement is sought.
9.2 Force Majeure. Neither party will be liable to the other for its failure
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to perform any of its obligations under this Agreement only during any
period in which such performance is delayed because of, or rendered
impracticable or impossible due to, circumstances beyond its reasonable
control, including but not limited to, strike, fire, flood, earthquake,
windstorm, governmental acts or orders or restrictions (including acts of
regulatory authorities and changes in the regulatory scheme for a
Product), failure of suppliers , or any other reason to the extent that
the failure to perform is beyond the reasonable control and not caused by
the negligence or willful misconduct of the non-performing party,
provided that the party experiencing the delay promptly notifies the
other of the delay.
9.3 Notices. All notices concerning this Agreement will be written in the
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English language and will be deemed to have been received (a) two days
after being properly sent by commercial overnight courier, or (b) one day
after being transmitted by confirmed facsimile, in each case addressed to
the address below:
If to Tutogen:
Tutogen Medical GmbH
IndustriestraBe 6,
D-91077 Neunkirchen am Brand
GERMANY
Attention: President and CEO
Telephone: 49 9131 7901-10
Facsimile: 49 9131 7901-12
With a copy to:
Dr. Dirk Lange
Foerster + Rutow
Irrestr. 17-19
90403 Nurnberg
GERMANY
Telephone: 49 (911) 23 569 00
Facsimile: 49 (911) 23 569 11
CONFIDENTIAL First Amended International Distribution Agreement - Page 10
If to Sulzer:
Sulzer Spine-Tech Inc.
7375 Bush Lake Road
Minneapolis, Minnesota 55439-2027
U.S.A.
Attention: President
Telephone: 1 (612) 832-5600
Facsimile: 1 (612) 832-6874
With a copy to:
Sulzer Medica USA Inc.
3 East Greenway Plaza, Suite 1600
Houston, Texas 77046
U.S.A.
Attention: General Counsel
Telephone: 1 (713) 561-6365
Facsimile: 1 (713) 561-6380
9.4 Governing Law. Recognizing that the laws within different international
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jurisdictions vary in their content and effect with respect to similar
subject matter, and that the parties desire uniformity and predictability
in interpretation and enforcement of this Agreement and related agreements
with international scope made contemporaneously by the parties and their
Affiliates, the parties have agreed to the following provisions regarding
applicable law to govern this Agreement: All matters affecting the
interpretation, form, validity, and performance of this Agreement shall be
decided under the laws of Switzerland (without application of the United
Nations Convention on the International Sale of Goods).
9.5 Partial Invalidity. In the event that any provision of this Agreement
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will be unenforceable or invalid under any applicable law or be so held by
applicable court decision, such unenforceability or invalidity will not
render this Agreement unenforceable or invalid as a whole, and, in such
event, such provision will be changed and interpreted so as best to
accomplish the objectives of such unenforceable or invalid provision
within the limits of applicable law or applicable court decisions.
9.6 Independent Contractors. Each party will act as an independent contractor
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under the terms of this Agreement. Except as otherwise provided in this
Agreement, neither party is, nor will it be deemed to be, an employee,
agent, partner, co-venturer, or legal representative of the other for any
purpose.
9.7 Nonassignability. Neither this Agreement nor any of the rights, interests,
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duties, or obligations under this Agreement shall be assigned or
delegated, in whole or in part, by operation of law or otherwise by any
party without the prior written consent of the other party, except that
either party may assign this Agreement to an Affiliate of such party;
provided that, in no event shall a party assign to an Affiliate less than
the entirety of its rights and obligations under this Agreement. Any
assignment made in violation of this Section 9.7 will be void and of no
effect. Subject to this Section 9.7, this Agreement shall be binding upon,
inure
CONFIDENTIAL First Amended International Distribution Agreement - Page 11
to the benefit of, and be enforceable by and against, the parties and
their Permitted Successors.
9.8 Compliance With Laws. Notwithstanding other provisions in this Agreement
--------------------
regarding a failure to comply with laws, in performing this Agreement,
each Party shall comply with all laws and government regulations
applicable in a particular country at all times.
9.9 Arbitration.
-----------
9.9.1 In the event the Parties are unable to resolve any dispute or
conflict arising from or relating to this Agreement within thirty
(30) days after it is formally presented for resolution by written
notice, any party may submit such conflict for resolution to the
Chief Executive Officers of the parties.
9.9.2 In the event the Chief Executive Officers of the parties are
unable to resolve such conflict within thirty (30) days after
having such conflict submitted to them for resolution, the
disputes shall be finally settled under the Rules of Conciliation
and Arbitration of the International Chamber of Commerce in Paris
("Rules") by three arbitrators appointed in accordance with the
Rules.
9.9.3 The place of arbitration shall be Zurich. The procedural law of
this place shall apply where the Rules are silent.
9.9.4 The arbitral award shall be substantiated in writing. The arbitral
tribunal shall decide on the matter of costs of the arbitration.
9.9.5 The language to be used in the arbitral proceedings shall be
English.
9.10 Confidentiality. The parties acknowledge that by reason of their
---------------
relationship hereunder, each has had and will continue to have access to
certain information and materials concerning the other's business, plans,
customers, technology, and/or products that is considered by a party to
be confidential ("Confidential Information") and of substantial value to
that party, which value would be impaired if such information were
disclosed to third parties. To the extent that such information is
considered confidential, the disclosing party will so indicate to the
receiving party, in the case of information in documentary or other
tangible form, by labeling it conspicuously as "CONFIDENTIAL" (or words
of similar import) and in the case of information conveyed verbally, by
identifying same in writing within ten days after the first verbal
disclosure. Each party agrees that it will not use in any way other than
as expressly authorized or contemplated under this Agreement, nor
disclose to any third party, any such Confidential Information revealed
to it by the other party, and will take commercially reasonable
precautions (and will cause its Affiliates to take commercially
reasonable precautions) to protect the confidentiality of such
information and with no less restrictive precautions than it takes to
protect its own confidential information. Each party will disclose
Confidential Information only to those of its employees who have a need
to know such information. If Confidential Information is required to be
disclosed in response to an order by a court or other government body, or
if otherwise required to be disclosed by law, or if necessary to
establish the rights of a party under this Agreement, the receiving party
shall use commercially reasonable efforts to provide the disclosing party
with advance notice of such required disclosure to give the
CONFIDENTIAL First Amended International Distribution Agreement - Page 12
disclosing party sufficient time to seek a protective order or other
protective measures, if any are available, for such Confidential
Information. "Confidential Information" does not include information,
materials, technical data or know-how which: (i) is rightfully in the
possession of the receiving party at the time of disclosure as shown by
the receiving party's files and records immediately prior to the time of
disclosure; (ii) prior to or after the time of disclosure becomes part of
the public knowledge or literature, not as a result of any inaction or
action of the receiving party; (iii) is independently developed by a
party without the use of any Confidential Information of the other
parties; (iv) is obtained from any third party who is authorized to
disclose such data and information without obligation of confidentiality,
or (v) is approved for release by the disclosing party. This Section 9.10
shall survive termination of this Agreement for a period of two years.
9.11 Public Relations And Announcements. The parties shall agree upon and
----------------------------------
issue a press release upon the signing of this Agreement including a
summary of the relationship established under this Agreement. No party
shall issue a press release or any other published statement that refers
to another party, its Affiliates or the other party's products without
first obtaining the agreement of such other party as to the form and
content of the statement, which approval shall be timely and not
unreasonably withheld.
In witness whereof, the parties have each caused this Agreement to be
signed and delivered by their duly authorized representatives on the dates set
forth below in duplicate, each of which will be treated for all purposes as an
original.
Tutogen Medical GmbH Sulzer Spine-Tech, Inc.
By: /s/ Manfred Kruger By: /s/ P. Richard Lunsford
--------------------------- ---------------------------
Manfred Kruger P. Richard Lunsford
Managing Director President
CONFIDENTIAL First Amended International Distribution Agreement - Page 13
Schedule A - Products
Category 1 Products
REF Number Product Description A= B= C= D=
01.14000.001 Tricortical Wedge, Iliac (8-0x24x6x0degrees) 8-10 24 6 0(degrees)
01.14000.002 Tricortical Wedge, Iliac (8-0x24x7x0degrees) 8-10 24 7 0(degrees)
01.14000.003 Tricortical Wedge, Iliac (8-0x24x8x0degrees) 8-10 24 8 0(degrees)
01.14000.004 Tricortical Wedge, Iliac (8-0x24x9x0degrees) 8-10 24 9 0(degrees)
01.14000.005 Tricortical Wedge, Iliac (8-x24x10x0degrees) 8-10 24 10 0(degrees)
01.14000.006 Tricortical Wedge, Iliac (8-0x24x12x0degrees) 8-10 24 12 0(degrees)
01.14000.007 Tricortical Wedge, Iliac (8-0x24x14x0degrees) 8-10 24 14 0(degrees)
01.14000.008 Tricortical Wedge, Iliac (8-0x24x16x0degrees) 8-10 24 16 0(degrees)
01.14000.009 Tricortical Wedge, Iliac (8-0x24x50x0degrees) 8-10 24 50 0(degrees)
01.14000.010 Tricortical Wedge, Iliac (8-0x24x100x0degrees) 8-10 24 100 0(degrees)
01.14000.011 Tricortical Wedge, Iliac (8-10x24x8x4degrees) 8-10 24 8 4(degrees)
01.14000.012 Tricortical Wedge, Iliac (8-10x24x9x4degrees) 8-10 24 9 4(degrees)
01.14000.013 Tricortical Wedge, Iliac (8-10x24x11x4degrees) 8-10 24 11 4(degrees)
01.14000.014 Tricortical Wedge, Iliac (8-10x24x13x4degrees) 8-10 24 13 4(degrees)
01.14000.015 Tricortical Wedge, Iliac (8-10x24x15x4degrees) 8-10 24 15 4(degrees)
01.14000.016 Tricortical Wedge, Iliac (*10x12x6x0degrees) *10 12 6 0(degrees)
01.14000.017 Tricortical Wedge, Iliac (*10x12x7x0degrees) *10 12 7 0(degrees)
01.14000.018 Tricortical Wedge, Iliac (*10x12x8x0degrees) *10 12 8 0(degrees)
01.14000.019 Tricortical Wedge, Iliac (*10x12x9x0degrees) *10 12 9 0(degrees)
01.14000.020 Tricortical Wedge, Iliac (*10x24x10x0degrees) *10 24 10 0(degrees)
01.14000.021 Tricortical Wedge, Iliac (*10x24x12x0degrees) *10 24 12 0(degrees)
01.14000.022 Tricortical Wedge, Iliac (*10x24x14x0degrees) *10 24 14 0(degrees)
01.14000.023 Tricortical Wedge, Iliac (*10x24x16x0degrees) *10 24 16 0(degrees)
01.14000.024 Tricortical Wedge, Iliac (*10x24x50x0degrees) *10 24 50 0(degrees)
01.14000.025 Tricortical Wedge, Iliac (*10x24x100x0degrees) *10 24 100 0(degrees)
01.14000.026 Tricortical Wedge, Iliac (*10x12x8x4degrees) *10 12 8 4(degrees)
01.14000.027 Tricortical Wedge, Iliac (*10x12x9x4degrees) *10 12 9 4(degrees)
01.14000.028 Tricortical Wedge, Iliac (*10x12x11x4degrees) *10 12 11 4(degrees)
01.14000.029 Tricortical Wedge, Iliac (*10x24x11x4degrees) *10 24 11 4(degrees)
01.14000.030 Tricortical Wedge, Iliac (*10x24x13x4degrees) *10 24 13 4(degrees)
01.14000.031 Tricortical Wedge, Iliac (*10x24x15x4degrees) *10 24 15 4(degrees)
REF Number Product Description A= B=
01.14001.001 Tricortical Dowel, Iliac (12.5x24x 13) 12.5 13
01.14001.002 Tricortical Dowel, Iliac (12.5x24x 15) 12.5 15
01.14001.003 Tricortical Dowel, Iliac (12.5x24x 17) 12.5 17
01.14001.004 Tricortical Dowel, Iliac (12.5x24x 19) 12.5 19
* denotes more than
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 1
REF Number Product Description A= B=
01.14002.001 Bone Dowel, Patella ( 10x13) 10 13
01.14002.002 Bone Dowel, Patella ( 12x13) 12 13
01.14002.003 Bone Dowel, Patella ( 14x13) 14 13
01.14002.004 Bone Dowel, Patella ( 16x13) 16 13
01.14002.005 Bone Dowel, Patella ( 10x*16) 10 *16
01.14002.006 Bone Dowel, Patella ( 12x*16) 12 *16
01.14002.007 Bone Dowel, Patella ( 14x*16) 14 *16
01.14002.008 Bone Dowel, Patella ( 16x*16) 16 *16
REF Number Product Description A= B=
01.14003.001 Wedge, Fibula (6x0degrees) 6 0(degrees)
01.14003.002 Wedge, Fibula (7x0degrees) 7 0(degrees)
01.14003.003 Wedge, Fibula (8x0degrees) 8 0(degrees)
01.14003.004 Wedge, Fibula (9x0degrees) 9 0(degrees)
01.14003.005 Wedge, Fibula (10x0degrees) 10 0(degrees)
01.14003.006 Wedge, Fibula (50x0degrees) 50 0(degrees)
01.14003.007 Wedge, Fibula (100x0degrees) 100 0(degrees)
01.14003.008 Wedge, Fibula (8x4degrees) 8 4(degrees)
01.14003.009 Wedge, Fibula (9x4degrees) 9 4(degrees)
REF Number Product Description A= B=
01.14004.001 Ring Graft, Femur (8x0degrees) 8 0(degrees)
01.14004.002 Ring Graft, Femur (10x0degrees) 10 0(degrees)
01.14004.003 Ring Graft, Femur (12x0degrees) 12 0(degrees)
01.14004.004 Ring Graft, Femur (14x0degrees) 14 0(degrees)
01.14004.005 Ring Graft, Femur (16x0degrees) 16 0(degrees)
01.14004.006 Ring Graft, Femur (30x0degrees) 30 0(degrees)
01.14004.007 Ring Graft, Femur (50x0degrees) 50 0(degrees)
01.14004.008 Ring Graft, Femur (100x0degrees) 100 0(degrees)
01.14004.009 Ring Graft, Femur (11x6degrees) 11 6(degrees)
01.14004.010 Ring Graft, Femur (13x6degrees) 13 6(degrees)
01.14004.011 Ring Graft, Femur (15x6degrees) 15 6(degrees)
01.14004.012 Ring Graft, Femur (17x6degrees) 17 6(degrees)
* greater than
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 2
REF Number Product Description A= B= C= D=
01.14005.001 Tricortical wedge, Calcaneus (9.5x24x6x0degrees) 9.5 24 6 0(degrees)
01.14005.002 Tricortical wedge, Calcaneus (9.5x24x7x0degrees) 9.5 24 7 0(degrees)
01.14005.003 Tricortical wedge, Calcaneus (9.5x24x8x0degrees) 9.5 24 8 0(degrees)
01.14005.004 Tricortical wedge, Calcaneus (9.5x24x9x0degrees) 9.5 24 9 0(degrees)
01.14005.005 Tricortical wedge, Calcaneus (9.5x24x10x0degrees) 9.5 24 10 0(degrees)
01.14005.006 Tricortical wedge, Calcaneus (9.5x24x12x0degrees) 9.5 24 12 0(degrees)
01.14005.007 Tricortical wedge, Calcaneus (9.5x24x14x0degrees) 9.5 24 14 0(degrees)
01.14005.008 Tricortical wedge, Calcaneus (9.5x24x16x0degrees) 9.5 24 16 0(degrees)
01.14005.009 Tricortical wedge, Calcaneus (9.5x24x8x4degrees) 9.5 24 8 4(degrees)
01.14005.010 Tricortical wedge, Calcaneus (9.5x24x9x4degrees) 9.5 24 9 4(degrees)
01.14005.011 Tricortical wedge, Calcaneus (9.5x24x11x4degrees) 9.5 24 11 4(degrees)
01.14005.012 Tricortical wedge, Calcaneus (9.5x24x13x4degrees) 9.5 24 13 4(degrees)
01.14005.013 Tricortical wedge, Calcaneus (9.5x24x15x4degrees) 9.5 24 15 4(degrees)
01.14005.014 Tricortical wedge, Calcaneus (12.5x12x6x0degrees) 12.5 12 6 0(degrees)
01.14005.015 Tricortical wedge, Calcaneus (12.5x12x7x0degrees) 12.5 12 7 0(degrees)
01.14005.016 Tricortical wedge, Calcaneus (12.5x12x8x0degrees) 12.5 12 8 0(degrees)
01.14005.017 Tricortical wedge, Calcaneus (12.5x12x9x0degrees) 12.5 12 9 0(degrees)
01.14005.018 Tricortical wedge, Calcaneus (12.5x24x10x0degrees) 12.5 24 10 0(degrees)
01.14005.019 Tricortical wedge, Calcaneus (12.5x24x12x0degrees) 12.5 24 12 0(degrees)
01.14005.020 Tricortical wedge, Calcaneus (12.5x24x14x0degrees) 12.5 24 14 0(degrees)
01.14005.021 Tricortical wedge, Calcaneus (12.5x24x16x0degrees) 12.5 24 16 0(degrees)
01.14005.022 Tricortical wedge, Calcaneus (12.5x12x8x4degrees) 12.5 12 8 4(degrees)
01.14005.023 Tricortical wedge, Calcaneus (12.5x12x9x4degrees) 12.5 12 9 4(degrees)
01.14005.024 Tricortical wedge, Calcaneus (12.5x12x11x4degrees) 12.5 12 11 4(degrees)
01.14005.025 Tricortical wedge, Calcaneus (12.5x24x11x4degrees) 12.5 24 11 4(degrees)
01.14005.026 Tricortical wedge, Calcaneus (12.5x24x13x4degrees) 12.5 24 13 4(degrees)
01.14005.027 Tricortical wedge, Calcaneus (12.5x24x15x4degrees) 12.5 24 15 4(degrees)
REF Number Product Description A= B = C= D=
01.14006.001 Tricortical Wedge, Patella (8-10x24x6x0degrees) 8-10 24 6 0(degrees)
01.14006.002 Tricortical Wedge, Patella (8-10x24x7x0degrees) 8-10 24 7 0(degrees)
01.14006.003 Tricortical Wedge, Patella (8-10x24x8x0degrees) 8-10 24 8 0(degrees)
01.14006.004 Tricortical Wedge, Patella (8-10x24x9x0degrees) 8-10 24 9 0(degrees)
01.14006.005 Tricortical Wedge, Patella (8-10x24x10x0degrees) 8-10 24 10 0(degrees)
01.14006.006 Tricortical Wedge, Patella (8-10x24x12x0degrees) 8-10 24 12 0(degrees)
01.14006.007 Tricortical Wedge, Patella (8-10x24x14x0degrees) 8-10 24 14 0(degrees)
01.14006.008 Tricortical Wedge, Patella (8-10x24x16x0degrees) 8-10 24 16 0(degrees)
01.14006.009 Tricortical Wedge, Patella (8-10x24x8x4degrees) 8-10 24 8 4(degrees)
01.14006.010 Tricortical Wedge, Patella (8-10x24x9x4degrees) 8-10 24 9 4(degrees)
01.14006.011 Tricortical Wedge, Patella (8-10x24x11x4degrees) 8-10 24 11 4(degrees)
01.14006.012 Tricortical Wedge, Patella (8-10x24x13x4degrees) 8-10 24 13 4(degrees)
01.14006.013 Tricortical Wedge, Patella (8-10x24x15x4degrees) 8-10 24 15 4(degrees)
01.14006.014 Tricortical Wedge, Patella (*10x12x6x0degrees) *10 12 6 0(degrees)
01.14006.015 Tricortical Wedge, Patella (*10x12x7x0degrees) *10 12 7 0(degrees)
01.14006.016 Tricortical Wedge, Patella (*10x12x8x0degrees) *10 12 8 0(degrees)
01.14006.017 Tricortical Wedge, Patella (*10x12x9x0degrees) *10 12 9 0(degrees)
01.14006.018 Tricortical Wedge, Patella (*10x24x10x0degrees) *10 24 10 0(degrees)
01.14006.019 Tricortical Wedge, Patella (*10x24x12x0degrees) *10 24 12 0(degrees)
01.14006.020 Tricortical Wedge, Patella (*10x24x14x0degrees) *10 24 14 0(degrees)
* greater than
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 3
01.14006.021 Tricortical Wedge, Patella (*10x24x16x0degrees) *10 24 16 0(degrees)
01.14006.022 Tricortical Wedge, Patella (*10x12x8x4degrees) *10 12 8 4(degrees)
01.14006.023 Tricortical Wedge, Patella (*10x12x9x4degrees) *10 12 9 4(degrees)
01.14006.024 Tricortical Wedge, Patella (*10x12x11x4degrees) *10 12 11 4(degrees)
01.14006.025 Tricortical Wedge, Patella (*10x24x11x4degrees) *10 24 11 4(degrees)
01.14006.026 Tricortical Wedge, Patella (*10x24x13x4degrees) *10 24 13 4(degrees)
01.14006.027 Tricortical Wedge, Patella (*10x24x15x4degrees) *10 24 15 4(degrees)
REF Number Product Description A= B=
01.14007.001 Bone Dowel, Calcaneus ( degrees10x13) 10 13
01.14007.002 Bone Dowel, Calcaneus ( degrees12x13) 12 13
01.14007.003 Bone Dowel, Calcaneus ( degrees14x13) 14 13
01.14007.004 Bone Dowel, Calcaneus ( degrees16x13) 16 13
01.14007.005 Bone Dowel, Calcaneus ( degrees10x20) 10 20
01.14007.006 Bone Dowel, Calcaneus ( degrees12x20) 12 20
01.14007.007 Bone Dowel, Calcaneus ( degrees14x20) 14 20
01.14007.008 Bone Dowel, Calcaneus ( degrees16x20) 16 20
REF Number Product Description A= B=
01.14008.001 Bone Dowel, Iliac ( degrees10x13) 10 13
01.14008.002 Bone Dowel, Iliac ( degrees12x13) 12 13
01.14008.003 Bone Dowel, Iliac ( degrees14x13) 14 13
01.14008.004 Bone Dowel, Iliac ( degrees16x13) 16 13
REF Number Product Description A= B=
01.14009.001 Wedge, Ulna (6x0degrees) 6 0(degrees)
01.14009.002 Wedge, Ulna (7x0degrees) 7 0(degrees)
01.14009.003 Wedge, Ulna (8x0degrees) 8 0(degrees)
01.14009.004 Wedge, Ulna (9x0degrees) 9 0(degrees)
01.14009.005 Wedge, Ulna (10x0degrees) 10 0(degrees)
01.14009.006 Wedge, Ulna (50x0degrees) 50 0(degrees)
01.14009.007 Wedge, Ulna (100x0degrees) 100 0(degrees)
01.14009.008 Wedge, Ulna (8x4degrees) 8 4(degrees)
01.14009.009 Wedge, Ulna (9x4degrees) 9 4(degrees)
REF Number Product Description A= B=
01.14010.001 Wedge, Radius (6x0degrees) 6 0(degrees)
01.14010.002 Wedge, Radius (7x0degrees) 7 0(degrees)
01.14010.003 Wedge, Radius (8x0degrees) 8 0(degrees)
01.14010.004 Wedge, Radius (9x0degrees) 9 0(degrees)
01.14010.005 Wedge, Radius (10x0degrees) 10 0(degrees)
01.14010.006 Wedge, Radius (50x0degrees) 50 0(degrees)
01.14010.007 Wedge, Radius (100x0degrees) 100 0(degrees)
01.14010.008 Wedge, Radius (8x4degrees) 8 4(degrees)
01.14010.009 Wedge, Radius (9x4degrees) 9 4(degrees)
* greater than
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 4
REF Number Product Description A= B=
01.14011.001 Ring Graft, Tibia (8x0degrees) 8 0(degrees)
01.14011.002 Ring Graft, Tibia (10x0degrees) 10 0(degrees)
01.14011.003 Ring Graft, Tibia (12x0degrees) 12 0(degrees)
01.14011.004 Ring Graft, Tibia (14x0degrees) 14 0(degrees)
01.14011.005 Ring Graft, Tibia (16x0degrees) 16 0(degrees)
01.14011.006 Ring Graft, Tibia (30x0degrees) 30 0(degrees)
01.14011.007 Ring Graft, Tibia (50x0degrees) 50 0(degrees)
01.14011.008 Ring Graft, Tibia (100x0degrees) 100 0(degrees)
01.14011.009 Ring Graft, Tibia (11x6degrees) 11 6(degrees)
01.14011.010 Ring Graft, Tibia (13x6degrees) 13 6(degrees)
01.14011.011 Ring Graft, Tibia (15x6degrees) 15 6(degrees)
01.14011.012 Ring Graft, Tibia (17x6degrees) 17 6(degrees)
REF Number Product Description A= B=
01.14012.001 Ring Graft, Humerus (8x0degrees) 8 0(degrees)
01.14012.002 Ring Graft, Humerus (10x0degrees) 10 0(degrees)
01.14012.003 Ring Graft, Humerus (12x0degrees) 12 0(degrees)
01.14012.004 Ring Graft, Humerus (14x0degrees) 14 0(degrees)
01.14012.005 Ring Graft, Humerus (16x0degrees) 16 0(degrees)
01.14012.006 Ring Graft, Humerus (30x0degrees) 30 0(degrees)
01.14012.007 Ring Graft, Humerus (50x0degrees) 50 0(degrees)
01.14012.008 Ring Graft, Humerus (100x0degrees) 100 0(degrees)
01.14012.009 Ring Graft, Humerus (11x6degrees) 11 6(degrees)
01.14012.010 Ring Graft, Humerus (13x6degrees) 13 6(degrees)
01.14012.011 Ring Graft, Humerus (15x6degrees) 15 6(degrees)
01.14012.012 Ring Graft, Humerus (17x6degrees) 17 6(degrees)
REF Number Product Description Size= Volume=
01.14014.001 Cortico-Cancellous Chips (2-4mm x 15cc) 2-4 15cc
01.14014.002 Cortico-Cancellous Chips (2-4mm x 30cc) 2-4 30cc
01.14014.003 Cortico-Cancellous Chips (4-10mm x 15cc) 4-10 15cc
01.14014.004 Cortico-Cancellous Chips (4-10mm x 30cc) 4-10 30cc
01.14014.005 Cortico-Cancellous Chips (4-10mm x 60cc) 4-10 60cc
Category 2 Products
Posterior Lateral Interbody Fusion Spacer (allograft bone tissue)
Anterior Lateral Interbody Fusion Spacer (allograft bone tissue)
Cervical Dowel (allograft bone tissue), 10 mm and 14 mm
Cervical Wedge (allograft bone tissue)
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 5
Category 3 Products
Lumbar and cervical spacers formed of a composite of cancellous and cortical
allograft bone machined and combined in proprietary shapes and designs.
TUTOPATCH Bovine Pericardium
Prod No. Size
68350 2 cm x 3 cm
68351 4 cm x 5 cm
68352 4 cm x 10 cm
68353 6 cm x 14 cm
68354 6 cm x 14 cm
68355 12 cm x 16 cm
68356 1.5 cm x 2 cm
68357 2 cm x 10 cm
68358 3 cm x 4 cm
68359 14 mm diameter
68360 5 cm x 11 cm
68361 1.5 cm x 3 cm
68362 7 cm x 8 cm
68363 2 cm x 25 cm
68364 0.3 cm x 12 cm
68365 1.5 cm x 30 cm
68366 14 cm x 20 cm
TUTOBONE Bovine Cancellous
Prod No Size
68300 1 cm x 1 cm x 2 cm
68301 1 cm x 2 cm x 2 cm
68302 2 cm x 2 cm x 3 cm
68303 chips, 4-10 mm, 30 cc
68304 chips, 4-10 mm, 60 cc
68305 chips, 4-10 mm, 100 cc
68306 M chips, 1-2 mm, 0.5 cc
68307 M chips, 1-2 mm, 1 cc
68308 M chips, 1-2 mm, 2 cc
68309 dowel 11 mm, length 20 mm
68310 dowel 12 mm, length 20 mm
68311 dowel 14 mm, length 20 mm
68312 dowel 16 mm, length 20 mm
68313 chips, 4-10 mm, 15 cc
68314 chips, 2-4 mm, 15 cc
68315 chips, 2-4 mm, 30 cc
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 6
68316 chips, 0.25-1 mm, 0.5 cc
68317 chips, 0.25-1 mm, 1 cc
68318 chips, 4-10 mm, 5 cc
68319 chips, 2-4 mm, 3 cc
68320 wedge 35 mm x 22 mm x 5 mm
68321 wedge 35 mm x 22 mm x 8 mm
68322 wedge 35 mm x 22 mm x 12 mm
68323 wedge 35 mm x 25 mm x 14 mm
68324 wedge 40 mm x 25 mm x 12 mm
68325 wedge 40 mm x 25 mm x 14 mm
68326 plate 25 mm x 15 mm x 3 mm
68327 rod 35 mm x 4 mm x 3 mm
68328 wedge 35 mm x 22 mm x 10 mm
68329 wedge 35 mm x 25 mm x 10 mm
68335 dowel 14 mm, length 14 mm
68340 wedge 40 mm x 25 mm x 10 mm
TUTOBONE Bovine Cancellous
Prod. No. Size
68600 14 mm x 12 mm x 4 mm
68601 14 mm x 12 mm x 5 mm
68602 14 mm x 12 mm x 6 mm
68603 14 mm x 12 mm x 7 mm
68604 14 mm x 12 mm x 8 mm
68605 14 mm x 12 mm x 9 mm
68606 14 mm x 12 mm x 10 mm
68610 14 mm x 12 mm x 4 mm
68611 14 mm x 12 mm x 5 mm
68612 14 mm x 12 mm x 6 mm
68613 14 mm x 12 mm x 7 mm
68614 14 mm x 12 mm x 8 mm
68615 14 mm x 12 mm x 9 mm
68616 16 mm x 14 mm x 5 mm
68617 16 mm x 14 mm x 6 mm
68618 16 mm x 14 mm x 7 mm
68619 16 mm x 14 mm x 8 mm
68620 16 mm x 14 mm x 9 mm
68630 14 mm x 12 mm x 12 mm
68631 14 mm x 12 mm x 14 mm
68632 14 mm x 12 mm x 16 mm
68633 14 mm x 12 mm x 18 mm
68634 14 mm x 12 mm x 20 mm
68635 14 mm x 12 mm x 22 mm
68636 14 mm x 12 mm x 24 mm
68637 14 mm x 12 mm x 26 mm
68650 15 mm x 30 mm x 20 mm
68651 15 mm x 30 mm x 25 mm
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 7
68652 15 mm x 30 mm x 30 mm
68653 15 mm x 30 mm x 35 mm
68654 15 mm x 30 mm x 40 mm
68655 15 mm x 30 mm x 45 mm
68656 15 mm x 30 mm x 50 mm
68657 15 mm x 30 mm x 55 mm
68658 15 mm x 30 mm x 60 mm
68665 dowel 12 mm plus chips 15cc
CONFIDENTIAL Schedule A to International Distribution Agreement - Page 8
Schedule B - Minimum Annual Sales
Contract Year 1
- ---------------
No Minimum Sales
Contract Year 2
- ---------------
No Minimum Sales
Contract Year 3
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
Canada ______
Contract Year 4
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
Canada ______
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 1
Contract Year 5
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
Canada ______
Contract Year 6
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
Canada ______
Contract Year 7
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 2
Canada ______
Contract Year 8
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
Canada ______
Contract Year 9
- ---------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
Japan ______
Middle East ______
Canada ______
Contract Year 10
- ----------------
Sub-Territory Minimum Annual Sales (Total Product Units)
------------- ------------------------------------------
Western Europe ______
Eastern Europe ______
South America ______
Far East ______
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 3
Japan ______
Middle East ______
Canada ______
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 4
Schedule C - Transfer Price
Product Transfer Price
------- --------------
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 1
Schedule D - Termination of Existing Distributors
Country Effective Date of Termination
- ------- -----------------------------
Austria 31 March 2001
Belgium / Luxembourg 20 May 2001
Cypress 31 May 2000
Ecuador 31 May 2000
Germany 31 May 2000
Greece 30 September 2000
Guatemala 31 May 2000
Hong Kong 31 May 2000
Hungary 31 May 2000
Jordan 31 May 2000
Korea 31 May 2000
Netherlands 01 January 2001
New Zealand 31 May 2000
Oman, Bahrain, Quatar 30 September 2000
Peru 01 September 2000
Portugal 14 February 2001
Rumania 31 May 2000
Scandinavia 31 May 2000
Singapore 30 April 2001
Slovenia 31 May 2000
South Africa 31 May 2000
Switzerland 01 March 2001
Syria 31 May 2000
Taiwan 31 May 2000
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 1
Thailand 31 May 2000
Country Effective Date of Termination
- ----------------------- -----------------------------
United Arab Emirates 31 December 2000
United Kingdom 01 February 2001
Uruguay 31 May 2000
USA 31 May 2000
CONFIDENTIAL Schedule B to International Distribution Agreement - Page 2