Exhibit (d)(4)
First Amended U.S. Service Agreement
This Agreement is made by Tutogen Medical, Inc., a Florida corporation with
offices at 925 Allwood Road, Clifton, NJ 07012, U.S.A. ("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 makes processed tissue
available to users through various distributors throughout the world, including
the United States;
WHEREAS, Tutogen's distribution of processed bone tissue for spinal applications
in the United States is not extensive at the present time;
WHEREAS, Tutogen entered into a Shaft Recovery and Service Reimbursement
Agreement with 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 (collectively, the "RTI Agreement"),
pursuant to which Tutogen supplies certain human donor bone tissue to RTI, which
RTI processes for use in spinal applications;
WHEREAS, Tutogen has the right under the RTI Agreement "to develop and
distribute products, which products may or may not compete with RTI";
WHEREAS, Tutogen desires to process and distribute for itself allograft bone
tissue products for spinal applications in the United States;
WHEREAS, Sulzer manufactures and sells worldwide a line of products used in the
spine and maintains an understanding and expertise of the market for products
used in the spine, including products manufactured from processed xenograft and
allograft bone tissue;
WHEREAS, Tutogen desires to process such tissue itself and make the processed
bone tissues available in the United States using Sulzer's expertise and support
services,
WHEREAS, Sulzer is willing to provide its expertise and support services to
Tutogen in consideration of Tutogen's agreement to process for itself xenograft
and donated allograft bone tissue and to make the processed tissue available to
users in the US, using exclusively Sulzer's expertise and support services and
as much of the donated allograft bone tissue currently provided to RTI under the
RTI Agreement as Tutogen is able to disseminate with the assistance of Sulzer
according to the demand therefor;
WHEREAS, Tutogen and Sulzer entered into an agreement styled "US Service
Agreement," dated March 8, 2000, pursuant to which Sulzer agreed to provide
exclusive services to enable Tutogen to make processed bone tissues available to
users in the United States; and
CONFIDENTIAL First Amended U.S. Service Agreement - Page 1
WHEREAS, Tutogen and Sulzer desire to make a new agreement that will supersede
the US Service 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 "Average Aging Date" shall have the meaning set forth in Section 4.2.
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1.3 "Contract Year" shall mean the one-year period following the Effective Date
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of this Agreement and each one-year period following each anniversary of
the Effective Date of this Agreement.
1.4 "Effective Date" shall mean March 8, 2000.
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1.5 "Field of Use" shall mean all uses of processed xenograft and allograft
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bone tissue in and adjoining the human spine.
1.6. "Permitted Successor" shall mean any individual, corporation, partnership,
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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.
1.7 "Processed Tissues" shall mean xenograft and allograft bone tissue
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processed by Tutogen or an Affiliate of Tutogen or a Permitted Successor of
Tutogen, as listed in Schedule A attached hereto. The parties shall
mutually agree as to the addition of processed tissues to Schedule A. To
the extent that a Processed Tissue is not available from Tutogen at the
time of its listing on Schedule A, the parties agree to collaborate on its
final design and development in accordance with Sections 2 and 3 of the
First Amended Processed Tissue Development and License Agreement of even
date between Sulzer and an Affiliate of Tutogen.
1.8 "Services" shall have the meaning set forth in Section 2.2.
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1.9 "Territory" shall mean the United States, including its territories and
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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.
CONFIDENTIAL First Amended U.S. Service Agreement - Page 2
2. Grant of Rights
2.1 Supply of Processed Tissue. During the term of this Agreement, to the
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extent that it can do so without breaching an obligation under a pre-
existing agreement, including the RTI Agreement, Tutogen agrees to collect
xenograft and donated allograft bone tissue, process such bone tissue
itself using its proprietary Tutoplast(R) process, manufacture the
Processed Tissues, and make the Processed Tissues available in the
Territory for the Field of Use using the Services of Sulzer.
2.2 Sulzer's Services. Sulzer shall use reasonable efforts to provide the
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following services (the "Services") to Tutogen, as soon as is reasonably
possible following the Effective Date, for the purpose of making Processed
Tissues available to users in the Territory for the Field of Use:
2.2.1 providing and training all field support personnel necessary to
meet and communicate with surgeons regarding the Processed
Tissues and their use and to provide case support for surgeons;
2.2.2 providing a Processed Tissue order entry system accessible by
Sulzer for the purpose of entering orders for Processed Tissues
and accessible by Tutogen for the purpose of receiving Processed
Tissue orders and shipment instructions and for the purpose of
checking the status of an order at any time;
2.2.3 providing and training all telephone and order entry support
personnel necessary for collecting and transmitting Processed
Tissue orders from surgeons and patient care providers and for
answering questions regarding the Processed Tissues;
2.2.4 developing surgical instruments and surgical techniques for
implantation of the Processed Tissues and manufacturing and
distributing sets of surgical instruments;
2.2.5 preparing and distributing printed materials, including surgical
procedures, promoting and describing proper use and surgical
implantation of the Processed Tissues; and
2.2.6 training surgeons as necessary regarding the proper surgical
technique for implanting the Processed Tissues.
2.3 Exclusive Right. Tutogen hereby grants Sulzer the exclusive right during
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the term of this Agreement to provide the Services for the Processed
Tissues in the Territory for the Field of Use. So long as donated allograft
bone tissue continues to be available to Tutogen or any of its Affiliates
or its Permitted Successors during the term of this Agreement, including
tissues collected from sources available to Tutogen or its Affiliates as of
the Effective Date, as well as tissues collected from sources developed by
Tutogen or its Affiliates or its Permitted Successors during the term of
this Agreement, Tutogen or its Permitted Successors shall make the
Processed Tissues available to users in the Territory using exclusively the
Services of Sulzer. During the term of this Agreement, neither Tutogen, nor
any Affiliate of Tutogen, nor any Permitted Successor of Tutogen shall
permit or engage an entity other than Sulzer to provide the Services in the
Territory for the Field of Use.
CONFIDENTIAL First Amended U.S. Service Agreement - Page 3
2.4 Consignment Inventory. Tutogen shall have the option to consign inventory
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of the Processed Tissues to Sulzer for the benefit of Processed Tissue
users in circumstances in which users could not timely obtain the Processed
Tissues directly from Tutogen. In no event shall Sulzer acquire title to
the consigned Processed Tissues. Sulzer shall mark the consigned Processed
Tissues as the sole property of Tutogen.
3. Sulzer's Obligations
3.1 Service Fees for Processed Tissues. Tutogen shall specify the appropriate
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fee for Tutogen's services in making each of the Processed Tissues
available to users in the Territory. Based on its knowledge and
understanding of spine-related matters, Sulzer shall advise Tutogen on
appropriate fees and recommend such fees for Tutogen's services for each
Processed Tissue, including adjustments in such fees as necessary in
Sulzer's opinion. In no event shall any payment be made to Tutogen or
Sulzer for any donated human tissue.
3.2 Forecasting. Within 30 days following execution of this Agreement, Sulzer
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shall provide Tutogen with a monthly forecast of demand for the Processed
Tissues during the succeeding six-month period. Commencing with the third
calendar quarter of 2000 and continuing quarterly thereafter, Sulzer shall
provide Tutogen, no later than 15 days prior to each calendar quarter, with
a rolling monthly forecast of demand for the Processed Tissues for the
succeeding 12 months. Sulzer's forecasts shall specify the anticipated
demand by Processed Tissue and by month. Sulzer shall incur no liability
to Tutogen in the event that actual demand for the Processed Tissues
differs from Sulzer's forecasts. As soon as is reasonably possible
following execution of this Agreement, Sulzer and Tutogen shall meet and
discuss in good faith a possible agreement regarding a means by which to
avoid, or assist Tutogen with the cost of, excessive inventory carrying
cost.
3.3 Minimum Annual Demand. As consideration for the exclusive right to provide
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the Services, commencing with the ninth month of the second Contract Year
(a partial annual minimum demand) and continuing with each Contract Year
thereafter, Sulzer and Tutogen will establish minimum annual demand goals
for the Processed Tissues for the Contract Year as a means of ensuring that
Sulzer is using reasonable efforts to provide the Services in the
Territory. Sulzer and Tutogen agree to confer and mutually agree upon the
minimum annual demand goals 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 demand for the
Processed Tissues in any Contract Year is 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 to provide the Services
for the Processed Tissues in the Territory 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. In the event that Tutogen elects to exercise its option,
Sulzer shall nonetheless retain its right, on a non-exclusive basis, to
make provide the Services in the Territory for the Field of Use.
CONFIDENTIAL First Amended U.S. Service Agreement - Page 4
4. Tutogen's Obligations
4.1 Processed Tissue Supply. Tutogen agrees to use reasonable efforts to
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procure xenograft and donor allograft bone tissue, process the tissue using
the Tutoplast(R) process according to Sulzer's forecasts of demand for
Processed Tissues (Section 3.2), deliver the Processed Tissues to users in
a timely manner, and invoice the users for Tutogen's services in a timely
manner. 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 obligated, as contemplated by Section 2.1 of this
Agreement, to supply Processed Tissues directly to users, and Tutogen shall
be permitted to deliver unprocessed allograft bone tissue pursuant to the
RTI Agreement so long as Tutogen's supply of allograft bone tissue exceeds
the demand for Processed Tissues under this Agreement.
4.2 Sulzer's Service Fee. Tutogen agrees to pay Sulzer a fee (the "Service
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Fee") for Sulzer's services as set forth in Schedule C. The Service Fee
shall be paid by Tutogen monthly no later than the Average Aging Date. The
"Average Aging Date" shall be fixed annually at the onset of each new
Contract Year and shall be the last business day of the month during which
Tutogen invoices the user for its services, plus the average aging period
for Tutogen's invoices for services during the preceding Contract Year.
The Average Aging Date shall be 90 days for the first Contract Year. The
Service Fee shall be deemed to cover all services rendered by Sulzer under
this Agreement, irrespective of whether such services are encompassed by
the Services specified in Section 2.2 above, whether they are expressly
mentioned elsewhere in this Agreement, or whether they are not mentioned.
4.3 Report. Tutogen shall prepare and deliver to Sulzer within 15 days
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following the end of each month a report detailing for each order completed
during the preceding month: the user, the number of Processed Tissue units
delivered, the fee for Tutogen's services invoiced in connection with each
such Processed Tissue unit, and the amount of Sulzer's Service Fee for each
Processed Tissue unit.
4.4 Audit. Upon reasonable notice to Tutogen, Sulzer shall have the right to
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have an independent certified public accountant, selected by Sulzer and
reasonably acceptable to Tutogen, audit Tutogen's records during normal
business hours to verify all records pertaining to the calculation of the
Service Fee; provided, however, that such audit shall not take place more
frequently than once a year and shall not cover records for more than the
preceding four (4) years. Any such audit shall be at the expense of the
Sulzer unless such audit concludes that Tutogen has underpaid the Service
Fee by more than five percent, in which case such audit shall be at the
expense of Tutogen.
CONFIDENTIAL First Amended U.S. Service Agreement - Page 5
5. Regulatory Matters
5.1 Import Compliance. Tutogen agrees to comply with and maintain compliance
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with all governmental rules, regulations, statutes and other laws of any
kind necessary to import into and distribute the Processed Tissues within
the Territory.
5.2 Regulatory Responsibilities.
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5.2.1 The parties understand that as of the Effective Date of this
Agreement, xenograft processed tissues, but not allograft
processed tissues, are regulated by the U.S. Food and Drug
Administration ("FDA") as a medical device. In the event that a
regulated xenograft processed tissue is added as a Processed
Tissue, or in the event that the FDA commences regulation of a
Processed Tissue as a medical device or other matter subsequent
to the Effective Date, Sulzer, as agent for Tutogen, shall be
responsible for obtaining and maintaining approval from the FDA
to make such regulated Processed Tissue available in the
Territory for the Field of Use, including the conduct of
preclinical studies and clinical trials and the preparation and
filing of all applications, reports, and other documents for the
FDA; provided that, Sulzer may elect within 90 days following the
effective date of such FDA regulation to remove such regulated
Processed Tissue from Schedule A rather than to seek approval
therefor from the FDA. Sulzer's election to remove a regulated
Processed Tissue from Schedule A shall not be a basis for
termination of the Agreement by Tutogen.
5.2.2 In the event that Sulzer elects to remove a regulated Processed
Tissue from Schedule A, Tutogen shall have the right to seek FDA
approval therefor at its own expense and to make such processed
tissue available to users without obligation to Sulzer under this
Agreement.
5.3 Regulatory Costs. Tutogen agrees to bear all costs related to pre-clinical
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studies in support of Sulzer's efforts to obtain FDA approvals for
Processed Tissues. Sulzer agrees to bear all other costs, including the
costs for all clinical trials and the costs for preparation and filing of
all applications, reports, and other documents for obtaining and
maintaining the approvals.
5.4 Ownership of Approvals. Tutogen shall be the record owner of all FDA
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approvals to make regulated Processed Tissues available in the Territory
for the Field of Use.
5.5 Assistance to Sulzer. Tutogen, at its own expense, agrees to provide such
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assistance and support to Sulzer, as Sulzer may reasonably request in the
performance of Sulzer's obligations under this Section 5.
6. Trademark License
6.1 License Grant. Tutogen grants Sulzer a nonexclusive license under
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Tutogen's trademarks, Tutoplast(R) and Spine Line(R) (the "Trademarks"), to
use the Trademarks solely in connection with the Processed Tissues in the
performance of Sulzer's Services within the Territory for the Field of Use.
CONFIDENTIAL First Amended U.S. Service Agreement - Page 6
6.2 Publication Approvals. Sulzer shall provide Tutogen with samples of all
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printed materials utilizing a Trademark 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.
7. Term and Termination
7.1 Term. This Agreement shall be effective on the Effective Date and shall
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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 obligation
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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 this
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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 least 12 months in advance of the termination date. 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 Processed Tissues in the
Territory for the Field of Use.
7.5 Termination for Material Adverse Effect. Sulzer shall have the right to
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terminate this Agreement on 60 days written notice to Tutogen in the event
that: (i) Tutogen declines to follow Sulzer's recommendation in setting the
amount of the fee for Tutogen's services in making a Processed Tissue
available to users in the Territory, and (ii) sales of Sulzer's BAK
interbody fusion cage (or successor product) decline over any consecutive
three-month period; provided that, the
CONFIDENTIAL First Amended U.S. Service Agreement - Page 7
Agreement shall not terminate according to this Section 7.5 if Tutogen,
during the 60-day notice period prior to termination, shall adjust the
amount of its fee to the fee recommended by Sulzer.
7.6 Interruption of Donor Availability. Notwithstanding the Force Majeure
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provision in Section 9.2, in the event that Tutogen is unable to supply
Processed Tissues for a continuous period of six months because Tutogen,
for whatever reason, is unable to obtain tissue donors, Sulzer shall have
the right to terminate this Agreement. In the event that Sulzer terminates
this Agreement pursuant to this Section 7.6, Tutogen shall be entitled to
retain any payments made by Sulzer.
7.7 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 7.7, in
obtaining or attempting to obtain regulatory approval for Processed Tissues
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 Processed
Tissue 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 Processed Tissue 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 Processed Tissue. For
example, if Sulzer obtains a regulatory approval for a Processed Tissue 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 within 60 days of the date of
termination, one year after termination, and two years after termination,
without interest.
8. Representations, Warranties, Indemnities, and Limitation of Liabilities
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 processing of, nor the use of,
nor the collection of fees related to the Processed Tissues in
the Territory constitutes a misuse or misappropriation of
confidential information or trade secrets
CONFIDENTIAL First Amended U.S. Service Agreement - Page 8
or a breach of confidence, and 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 make available the Processed Tissues.
8.1.4 Tutogen has not received notice that the processing of, use of,
or collection of service fees related to the Processed Tissues
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 Processed Tissues.
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
reasonable efforts to maintain all such approvals throughout the
term of this Agreement.
8.1.8 To the best of Tutogen's knowledge and belief, Tutogen's
distribution of the Processed Tissues as contemplated under this
Agreement complies fully with the United States National Organ
Transplant Act ("NOTA"), 42 U.S.C. section 274e. Tutogen shall
give Sulzer immediate notice in the event that Tutogen becomes
aware of an investigation or inquiry from any regulatory or
governmental authority of a potential violation of NOTA.
8.1.9 For a period of 12 months from the date of Tutogen's delivery to
a user, each Processed Tissue 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.
8.1.10 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 Processed Tissue Warranty. If any failure to
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conform to 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 either by replacing the defective or
non-conforming Processed Tissue or by repairing such Processed Tissue. In
no event shall the liability of Tutogen in connection with such warranty
exceed the cost of replacing or repairing the defective Processed Tissue.
The foregoing shall constitute the
CONFIDENTIAL First Amended U.S. Service Agreement - Page 9
exclusive remedy of Sulzer and the sole liability of Tutogen whether in
contract or in tort or otherwise relating to a defect of a Processed
Tissue.
8.3 Exclusion of Other Warranties. The representations and warranties stated
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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 Processed
Tissue.
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 Processed Tissue 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 Processed Tissue
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
Processed Tissues or other items provided by Tutogen in
combination with other Processed Tissues 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.
CONFIDENTIAL First Amended U.S. Service Agreement - Page 10
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 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 Processed Tissue 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 Processed Tissue
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
Processed Tissues or other items provided by Sulzer in
combination with other Processed Tissues 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
----------------------------------------
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
----------------------------------
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.
8.9 RTI Agreement. Notwithstanding anything herein to the contrary, nothing in
-------------
this Agreement is intended to be, or shall be construed as being, a breach,
CONFIDENTIAL First Amended U.S. Service Agreement - Page 11
anticipatory or otherwise, of the RTI Agreement as it existed following
amendment on 28 June 1999.
9. Miscellaneous Provisions
9.1 Entire Agreement.
----------------
9.1.1 This Agreement, together with the First Amended Umbrella
Agreement, the First Amended Option Agreement, the First Amended
International Distribution Agreement, and the First Amended
Processed Tissue Development and 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 US
Service Agreement dated March 8, 2000.
9.1.2 The US Service 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
-------------
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 Processed
Tissue), 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
-------
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, Inc.
Industriestrae 6,
D-91077 Neunkirchen am Brand
GERMANY
Attention: President and CEO
Telephone: 49 9131 7901-10
Facsimile: 49 9131 7901-12
CONFIDENTIAL First Amended U.S. Service Agreement - Page 12
With a copy to:
Dr. Dirk Lange
Foerster + Rutow
Irrerstr. 17-19
90403 Nurnberg
GERMANY
Telephone: 49 (911) 23 569 00
Facsimile: 49 (911) 23 569 11
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 the United States and
-------------
international 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 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
-----------------------
under the terms of this Agreement. Except as otherwise provided in this
Agreement,
CONFIDENTIAL First Amended U.S. Service Agreement - Page 13
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,
----------------
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 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 applicable laws and government regulations at
all times, including but not limited to any applicable laws and regulations
of the United States regarding the export or re-export or release of
technology and technical data.
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
dispute 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 Processed Tissues 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
CONFIDENTIAL First Amended U.S. Service Agreement - Page 14
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 reasonable precautions (and will cause its Affiliates to take
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 reasonable efforts to provide
the disclosing party with advance notice of such required disclosure to
give the 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 Processed Tissues
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, Inc. Sulzer Spine-Tech, Inc.
By: /s/ Manfred Kruger By: /s/ P. Richard Lunsford
------------------ -----------------------
Manfred Kruger, President P. Richard Lunsford, President
and Chief Executive Officer
Date: September 29, 2000 Date: September 29, 2000
------------------ ------------------
CONFIDENTIAL First Amended U.S. Service Agreement - Page 15
Schedule A - Processed Tissues
Category 1 Tissues
REF Number Product Description A= B= C= D=
01.14000.001 Tricortical Wedge, Iliac (8-0x24x6x0degrees) 8-10 24 6 0degrees
01.14000.002 Tricortical Wedge, Iliac (8-0x24x7x0degrees) 8-10 24 7 0degrees
01.14000.003 Tricortical Wedge, Iliac (8-0x24x8x0degrees) 8-10 24 8 0degrees
01.14000.004 Tricortical Wedge, Iliac (8-0x24x9x0degrees) 8-10 24 9 0degrees
01.14000.005 Tricortical Wedge, Iliac (8-x24x10x0degrees) 8-10 24 10 0degrees
01.14000.006 Tricortical Wedge, Iliac (8-0x24x12x0degrees) 8-10 24 12 0degrees
01.14000.007 Tricortical Wedge, Iliac (8-0x24x14x0degrees) 8-10 24 14 0degrees
01.14000.008 Tricortical Wedge, Iliac (8-0x24x16x0degrees) 8-10 24 16 0degrees
01.14000.009 Tricortical Wedge, Iliac (8-0x24x50x0degrees) 8-10 24 50 0degrees
01.14000.010 Tricortical Wedge, Iliac (8-0x24x100x0degrees) 8-10 24 100 0degrees
01.14000.011 Tricortical Wedge, Iliac (8-10x24x8x4degrees) 8-10 24 8 4degrees
01.14000.012 Tricortical Wedge, Iliac (8-10x24x9x4degrees) 8-10 24 9 4degrees
01.14000.013 Tricortical Wedge, Iliac (8-10x24x11x4degrees) 8-10 24 11 4degrees
01.14000.014 Tricortical Wedge, Iliac (8-10x24x13x4degrees) 8-10 24 13 4degrees
01.14000.015 Tricortical Wedge, Iliac (8-10x24x15x4degrees) 8-10 24 15 4degrees
01.14000.016 Tricortical Wedge, Iliac (*10x12x6x0degrees) *10 12 6 0degrees
01.14000.017 Tricortical Wedge, Iliac (*10x12x7x0degrees) *10 12 7 0degrees
01.14000.018 Tricortical Wedge, Iliac (*10x12x8x0degrees) *10 12 8 0degrees
01.14000.019 Tricortical Wedge, Iliac (*10x12x9x0degrees) *10 12 9 0degrees
01.14000.020 Tricortical Wedge, Iliac (*10x24x10x0degrees) *10 24 10 0degrees
01.14000.021 Tricortical Wedge, Iliac (*10x24x12x0degrees) *10 24 12 0degrees
01.14000.022 Tricortical Wedge, Iliac (*10x24x14x0degrees) *10 24 14 0degrees
01.14000.023 Tricortical Wedge, Iliac (*10x24x16x0degrees) *10 24 16 0degrees
01.14000.024 Tricortical Wedge, Iliac (*10x24x50x0degrees) *10 24 50 0degrees
01.14000.025 Tricortical Wedge, Iliac (*10x24x100x0degrees) *10 24 100 0degrees
01.14000.026 Tricortical Wedge, Iliac (*10x12x8x4degrees) *10 12 8 4degrees
01.14000.027 Tricortical Wedge, Iliac (*10x12x9x4degrees) *10 12 9 4degrees
01.14000.028 Tricortical Wedge, Iliac (*10x12x11x4degrees) *10 12 11 4degrees
01.14000.029 Tricortical Wedge, Iliac (*10x24x11x4degrees) *10 24 11 4degrees
01.14000.030 Tricortical Wedge, Iliac (*10x24x13x4degrees) *10 24 13 4degrees
01.14000.031 Tricortical Wedge, Iliac (*10x24x15x4degrees) *10 24 15 4degrees
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
* more than
CONFIDENTIAL Schedule A to U.S. Service 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 0degrees
01.14003.002 Wedge, Fibula (7x0degrees) 7 0degrees
01.14003.003 Wedge, Fibula (8x0degrees) 8 0degrees
01.14003.004 Wedge, Fibula (9x0degrees) 9 0degrees
01.14003.005 Wedge, Fibula (10x0degrees) 10 0degrees
01.14003.006 Wedge, Fibula (50x0degrees) 50 0degrees
01.14003.007 Wedge, Fibula (100x0degrees) 100 0degrees
01.14003.008 Wedge, Fibula (8x4degrees) 8 4degrees
01.14003.009 Wedge, Fibula (9x4degrees) 9 4degrees
REF Number Product Description A= B=
01.14004.001 Ring Graft, Femur (8x0degrees) 8 0degrees
01.14004.002 Ring Graft, Femur (10x0degrees) 10 0degrees
01.14004.003 Ring Graft, Femur (12x0degrees) 12 0degrees
01.14004.004 Ring Graft, Femur (14x0degrees) 14 0degrees
01.14004.005 Ring Graft, Femur (16x0degrees) 16 0degrees
01.14004.006 Ring Graft, Femur (30x0degrees) 30 0degrees
01.14004.007 Ring Graft, Femur (50x0degrees) 50 0degrees
01.14004.008 Ring Graft, Femur (100x0degrees) 100 0degrees
01.14004.009 Ring Graft, Femur (11x6degrees) 11 6degrees
01.14004.010 Ring Graft, Femur (13x6degrees) 13 6degrees
01.14004.011 Ring Graft, Femur (15x6degrees) 15 6degrees
01.14004.012 Ring Graft, Femur (17x6degrees) 17 6degrees
* more than
CONFIDENTIAL Schedule A to U.S. Service 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)
* more than
CONFIDENTIAL Schedule A to U.S. Service 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 ( 10x13) 10 13
01.14007.002 Bone Dowel, Calcaneus ( 12x13) 12 13
01.14007.003 Bone Dowel, Calcaneus ( 14x13) 14 13
01.14007.004 Bone Dowel, Calcaneus ( 16x13) 16 13
01.14007.005 Bone Dowel, Calcaneus ( 10x20) 10 20
01.14007.006 Bone Dowel, Calcaneus ( 12x20) 12 20
01.14007.007 Bone Dowel, Calcaneus ( 14x20) 14 20
01.14007.008 Bone Dowel, Calcaneus ( 16x20) 16 20
REF Number Product Description A= B=
01.14008.001 Bone Dowel, Iliac ( 10x13) 10 13
01.14008.002 Bone Dowel, Iliac ( 12x13) 12 13
01.14008.003 Bone Dowel, Iliac ( 14x13) 14 13
01.14008.004 Bone Dowel, Iliac ( 16x13) 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 0degrees
01.14010.002 Wedge, Radius (7x0degrees) 7 0degrees
01.14010.003 Wedge, Radius (8x0degrees) 8 0degrees
01.14010.004 Wedge, Radius (9x0degrees) 9 0degrees
01.14010.005 Wedge, Radius (10x0degrees) 10 0degrees
01.14010.006 Wedge, Radius (50x0degrees) 50 0degrees
01.14010.007 Wedge, Radius (100x0degrees) 100 0degrees
01.14010.008 Wedge, Radius (8x4degrees) 8 4degrees
01.14010.009 Wedge, Radius (9x4degrees) 9 4degrees
* more than
CONFIDENTIAL Schedule A to U.S. Service Agreement - Page 4
REF Number Product Description A= B=
01.14011.001 Ring Graft, Tibia (8x0degrees) 8 0degrees
01.14011.002 Ring Graft, Tibia (10x0degrees) 10 0degrees
01.14011.003 Ring Graft, Tibia (12x0degrees) 12 0degrees
01.14011.004 Ring Graft, Tibia (14x0degrees) 14 0degrees
01.14011.005 Ring Graft, Tibia (16x0degrees) 16 0degrees
01.14011.006 Ring Graft, Tibia (30x0degrees) 30 0degrees
01.14011.007 Ring Graft, Tibia (50x0degrees) 50 0degrees
01.14011.008 Ring Graft, Tibia (100x0degrees) 100 0degrees
01.14011.009 Ring Graft, Tibia (11x6degrees) 11 6degrees
01.14011.010 Ring Graft, Tibia (13x6degrees) 13 6degrees
01.14011.011 Ring Graft, Tibia (15x6degrees) 15 6degrees
01.14011.012 Ring Graft, Tibia (17x6degrees) 17 6degrees
REF Number Product Description A= B=
01.14012.001 Ring Graft, Humerus (8x0degrees) 8 0degrees
01.14012.002 Ring Graft, Humerus (10x0degrees) 10 0degrees
01.14012.003 Ring Graft, Humerus (12x0degrees) 12 0degrees
01.14012.004 Ring Graft, Humerus (14x0degrees) 14 0degrees
01.14012.005 Ring Graft, Humerus (16x0degrees) 16 0degrees
01.14012.006 Ring Graft, Humerus (30x0degrees) 30 0degrees
01.14012.007 Ring Graft, Humerus (50x0degrees) 50 0degrees
01.14012.008 Ring Graft, Humerus (100x0degrees) 100 0degrees
01.14012.009 Ring Graft, Humerus (11x6degrees) 11 6degrees
01.14012.010 Ring Graft, Humerus (13x6degrees) 13 6degrees
01.14012.011 Ring Graft, Humerus (15x6degrees) 15 6degrees
01.14012.012 Ring Graft, Humerus (17x6degrees) 17 6degrees
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
CONFIDENTIAL Schedule A to U.S. Service Agreement - Page 5
Category 2 Tissues
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)
Category 3 Tissues
Lumbar and cervical spacers formed of a composite of cancellous and cortical
allograft bone machined and combined in proprietary shapes and designs.
CONFIDENTIAL Schedule A to U.S. Service Agreement - Page 6
Schedule B - Minimum Annual Demand
Contract Year Minimum Demand (Total Units of Processed Tissue)
1 0
2 (3 months) ______
3 ______
4 ______
5 ______
6 ______
7 ______
8 ______
9 ______
10 ______
CONFIDENTIAL Schedule B to U.S. Service Agreement - Page 1
Schedule C
Sulzer's Service Fees
- --------------------------------------------------------------------------------
Type of Processed Tissue Service Fee as a Percentage of
Tutogen's Fee to Tissue User
- --------------------------------------------------------------------------------
Category 1 Tissues *
- --------------------------------------------------------------------------------
Category 2 Tissues (Lumbar) *
- --------------------------------------------------------------------------------
Category 2 Tissues (Cervical) *
- --------------------------------------------------------------------------------
Category 3 Tissues *
- --------------------------------------------------------------------------------
"Tutogen's Fee to Tissue User" shall be defined as the gross amount of the fee
invoiced to the user for Tutogen's services in making the Processed Tissues
available, less discounts and allowances, returns, taxes and other levies by a
governmental authority, and unreimbursed shipping charges. In the event that
"Tutogen's Fee to Tissue User" for any particular Category 2 Tissue or Category
3 Tissue does not exceed the Minimum Fee specified therefor in the table below,
then Sulzer's Service Fee for that particular tissue shall not be the fee
specified therefor above and the parties shall negotiate a new Service Fee for
Sulzer for the particular tissue, taking account of changed circumstances.
- --------------------------------------------------------------------------------
Type of Processed Tissue Minimum Tutogen Fee to Tissue User
- --------------------------------------------------------------------------------
Category 2 Tissues (Lumbar)
- --------------------------------------------------------------------------------
Category 2 Tissues (Cervical)
- --------------------------------------------------------------------------------
Category 3 Tissues
- --------------------------------------------------------------------------------
*CONFIDENTIAL TREATMENT REQUEST BY SHEARMAN & STERLING.
CONFIDENTIAL Schedule C to U.S. Service Agreement - Page 2