EX-10.14  COPY OF DISTRIBUTION AGREEMENT



 








Exhibit 10.14



CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO
RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED,
AND ARE SUBJECT TO A CONFIDENTIAL TREATMENT REQUEST. COPIES OF THIS
EXHIBIT CONTAINING  THE OMITTED INFORMATION HAVE BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. THE
OMITTED PORTIONS  OF THIS DOCUMENT ARE MARKED WITH A [***].




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 Calcitek Inc., a Delaware corporation with
offices at 1900 Aston Avenue, Carlsbad, California, U.S.A
(“Sulzer”).




W I T N E S S E T H:



WHEREAS, Tutogen collects 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 dental applications in the United
States is not extensive at the present time;



WHEREAS, Tutogen desires to process and distribute for itself allograft bone tissue products for
dental applications in the United States;



WHEREAS, Sulzer manufactures and sells worldwide a line of products used in dental applications and
maintains an understanding of the market for products used in dental  applications, including
products manufactured from processed allograft bone tissue; and



WHEREAS, Sulzer is willing to provide its expertise and support services to Tutogen in
consideration of Tutogen’s agreement to process for itself donated allograft bone tissue and to
make the processed tissue available to users in the US, using exclusively Sulzer’s expertise and
support services;



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 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.
	 
	 	1.3	 	“Clinical Expenses” shall have the meaning set forth in Section 5.3.
	 
	 	1.4	 	“Contract Year” shall mean the one-year period following the Effective Date of this
Agreement and each one-year period following each anniversary of the Effective Date of this
Agreement.
	 
	 	1.5	 	“Effective Date” shall mean the date on which this Agreement has been executed by an
authorized officer of each party, as witnessed on the signature page of this Agreement.





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Service Agreement - Page 1




 









 









	 	1.6	 	“FDA” shall mean the United States Food and Drug Administration.
	 
	 	1.7	 	“Field of Use” shall mean all uses of processed allograft bone tissue in or
adjoining the human maxilla or the human mandible.
	 
	 	1.8	 	“Permitted Successor” shall mean any
individual, corporation, 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.
	 
	 	1.9	 	“Processed Tissues” shall mean allograft bone tissue 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 Section
2 of the Processed Tissue Development and License Agreement of even date between Sulzer and an
Affiliate of Tutogen.
	 
	 	1.10	 	“Regulatory Plan” shall have the meaning set forth in Section 5.2.2.
	 
	 	1.11	 	“RTI Agreement” shall mean the Shaft Recovery and Service Reimbursement Agreement
between Tutogen and Regeneration Technologies Inc. (“RTI”), as successor to the University of
Florida Tissue Bank, effective as of 29 September 1998, as modified by Amendment thereto dated 28
June 1999, pursuant to which Tutogen supplies certain human donor bone tissue to RTI, which RTI
processes for use in surgical applications.
	 
	 	1.12	 	“Services” shall have the meaning set forth in Section 2.2.
	 
	 	1.13	 	“Territory” shall mean the United States, including its territories and possessions.
	 
	 	1.14	 	“Third Party” shall mean a person or entity other than Tutogen, any 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	 	Supply of Processed Tissue. During the term of this Agreement, to the extent that
it can do so without breaching an obligation under a pre-existing agreement, including the RTI
Agreement, Tutogen agrees to collect donated allograft bone tissue, process such bone tissue
itself using its proprietary Tutoplast® 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 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 field support personnel necessary to meet and communicate with
clinicians regarding the Processed Tissues and their use; and





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	 	2.2.2	 	preparing and distributing printed materials describing and promoting use
of the Processed Tissues.






	2.3	 	Exclusive Right. Tutogen hereby grants Sulzer the exclusive right during 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.
	 
	2.4	 	Consignment Inventory. Tutogen shall have the option to consign inventory 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. Tutogen shall mark the
consigned Processed Tissues as the sole property of Tutogen.
	 
	2.5	 	Consideration. In consideration of the rights granted by Tutogen to Sulzer in
this Section 2, Sulzer agrees to pay Tutogen US$ [***] by wire transfer pursuant to Tutogen’s
written instructions within five business days following the date on which Tutogen first
delivers an order for Processed Tissues obtained by use of the Services.






	3.	 	Sulzer’s Obligations






	3.1	 	Service Fees for Processed Tissues. Tutogen shall specify the appropriate fee
to Processed Tissue users for Tutogen’s services in making each of the Processed Tissues
available in the Territory. Based on its knowledge and understanding of dental-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 shall
provide Tutogen with a monthly forecast of demand for the Processed Tissues during the
succeeding six-month period. Commencing with the second calendar quarter of 2001 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.





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	4.	 	Tutogen’s Obligations





	4.1	 	Processed Tissue Supply. Tutogen agrees to use reasonable efforts to procure
donor allograft bone tissue, process the tissue using the Tutoplast® 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 Fee”)
for Sulzer’s services as set forth in Schedule B. 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 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
have an independent certified public accountant, selected by Sulzer and reasonably
acceptable to Tutogen, audit during normal business hours only such records of Tutogen
as are necessary to verify 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 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.
	 
	4.5	 	Processed Tissue Samples. Tutogen agrees to provide to Sulzer at no expense
to Sulzer such samples of the Processed Tissues as Sulzer may reasonably require to
assist it in the performance of the Services.
	 
	4.6	 	Training. Tutogen agrees to provide training services to Sulzer, as reasonably
requested by Sulzer, regarding the Tutoplast® process and the manufacture and use of the
Processed Tissues, Tutogen and Sulzer shall confer and agree upon





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Service Agreement - Page 4





 









 









on the scope of and location for the training services to be provided by Tutogen and the
distribution of the expenses for such training services.




	5.	 	Regulatory Matters





	 	5.1	 	Import Compliance. Tutogen agrees to comply with and maintain compliance 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. The parties understand that as of the Effective Date
of this Agreement, allograft processed tissues are not regulated by the FDA as a medical
device. In the event that the FDA commences regulation of a Processed Tissue as a medical
device or other matter subsequent to the Effective Date, subject to the agreement of both
Sulzer and Tutogen within 90 days from the effective date of such FDA regulation, Tutogen
shall be responsible for applying
for regulatory approval from the FDA to make such regulated Processed Tissue
available in the Territory for the Field of Use.






	 	5.2.1	 	In the event that either.Sulzer or Tutogen, in its sole discretion,
does not agree to seek regulatory approval for the newly regulated Processed
Tissue, then such Processed Tissue shall be removed from Schedule A. If Tutogen
desires to seek regulatory approval, but Sulzer does not, Tutogen shall have the
right to seek regulatory approval for such Processed Tissue at its own expense and
to make such processed tissue available to users without obligation to Sulzer
under this Agreement. If Sulzer desires to seek regulatory approval for such
Processed Tissue, but Tutogen does not, Sulzer, subject to Tutogen’s agreement to
supply the processed tissue, shall have the right to seek regulatory approval for
such processed tissue at its own expense and to make such processed tissue
available to users without obligation to Tutogen under this Agreement.
	 
	 	5.2.2	 	In the event that Sulzer and Tutogen each agree to seek regulatory
approval for the newly regulated Processed Tissue, then the parties shall
forthwith meet and agree upon a plan pursuant to which Tutogen will seek
regulatory approval for the Processed Tissue from the FDA. (the “Regulatory
Plan”). The Regulatory Plan shall include an agreement as to the scope, timing,
and supervisory responsibility for preclinical studies, clinical trials,
regulatory submissions, and all other matters related to the FDA regulatory
approval process for the Processed Tissue. The parties shall meet at least once
annually to review and amend the Regulatory Plan as dictated by the current status
of the clinical and regulatory process.






	 	5.3	 	Clinical Expenses. Sulzer and Tutogen shall each pay one-half of all
out-of-pocket expenses incurred in execution of a Regulatory Plan subsequent to the
Effective Date, excluding salary, benefits, and other costs for employees of the parties
(the “Clinical Expenses”).






	 	5.3.1	 	In the absence of an agreement to the contrary, a party that
incurs Clinical Expenses in a calendar quarter shall invoice the other party
quarterly in arrears for one-half of such Clinical Expenses. The invoice shall
specify for each such expense the vendor, the purpose, and the





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date such expense was incurred and shall include a copy of supporting
documentation of the expense.




	 	5.3.2	 	A party receiving an invoice for Clinical Expenses, unless the invoice
is disputed, shall either pay the invoice or setoff the invoice with other Clinical
Expenses within 45 days from the date of the invoice.






	5.4	 	Ownership of Approvals. Tutogen shall be the record
owner of all FDA approvals to
make regulated Processed Tissues available in the Territory for the Field of Use.
	 
	5.5	 	Cooperation and Assistance. Tutogen and Sulzer agree to cooperate and assist one
another as the other may reasonably request regarding registration of and regulatory matters
relating to the Processed Tissues.
	 
	5.6	 	Processed Tissue Recalls. Tutogen, as manufacturer of the Processed Tissues, shall be
responsible for execution of and all expenses related to any recall of Processed Tissues,
including, but not limited to, retrieving recalled Processed Tissues from users, scrapping or
discarding recalled Processed Tissues, and resupplying users with replacement Processed
Tissues.







	6.	 	Trademarks





	6.1	 	License Grant. Tutogen grants Sulzer a nonexclusive license under Tutogen’s
trademark, Tutoplast® and Tutodent (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.
	 
	6.2	 	Approval of Marketing Publications. Sulzer shall provide Tutogen with samples of
all of Sulzer’s 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.
	 
	6.3	 	New Trademarks. Subject to the approval of Tutogen, which shall not be withheld
unreasonably, Sulzer shall have the right to adopt new trademarks of its choosing for use in
connection with the Processed Tissues.






	7.	 	Term and Termination






	7.1	 	Term. This Agreement shall be effective on the Effective Date and 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 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-





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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 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 Agreement
with or without cause at any time on or after 1 January 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	 	Interruption of Donor Availability. Notwithstanding the Force Majeure 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 7.5, Tutogen shall be entitled to retain any payments
made by Sulzer.
	 
	7.6	 	Refund of Clinical Expenses. In the event that the Agreement 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 payment of
Clinical Expenses, as determined in this Section 7.6, in obtaining or attempting to obtain
regulatory approval for Processed Tissues under Section 5. For each Processed Tissue as to
which Sulzer incurred unreimbursed Clinical Expenses, Tutogen shall be obligated to reimburse
an amount determined by multiplying the unreimbursed Clinical Expenses paid by Sulzer for that
Processed Tissue by the Reimbursement Ratio. The “Reimbursement Ratio” is





[***]



[***]




[***]




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[***] The reimbursed 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:






	 	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 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.





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	 	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 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
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 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:






	 	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.






	 	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.




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	 	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.






	8.6	 	Indemnity by Sulzer.






	 	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




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	 	 	 	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, 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 Xenograft Distribution Agreement and
the Processed Tissue Development and License Agreement, all between the parties or
their Affiliates of even date, 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.
	 
	 	9.1.2	 	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.




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	 	 	If to Tutogen:
	 
	 	 	Tutogen Medical, Inc.

925 Allwood Road

Clifton, NJ 07012

USA

Attention: President and CEO

Telephone: 1 (973) 365-2799

Facsimile:   1 (973) 365-1690
	 
	 	 	With a copy to:
	 
	 	 	Tutogen Medical GmbH

Industriestraße 6,

D-91077 Neunkirchen am Brand

GERMANY

Attention: President and CEO

Telephone: 49 (9134) 99 88 110

Facsimile:   49 (9134) 99 88 119
	 
	 	 	and
	 
	 	 	Dr. Dirk Lange

Foerster + Rutow

Irrerstr. 17-19

90403 Nürnberg

GERMANY

Telephone: 49 (911) 23 569 00

Facsimile:   49 (911) 23 569 11
	 
	 	 	If to Sulzer:
	 
	 	 	Sulzer Calcitek Inc.

1900 Aston Avenue

Carlsbad, California 92008-7308

U.S.A.

Attention: President

Telephone: 1 (760) 431-9515

Facsimile:   1 (760) 431-9753
	 
	 	 	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




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	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. The United Nations Convention on Contracts for the
International Sale of Goods of April 11, 1980 shall not be applicable.
	 
	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 the
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, 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




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	 	 	 	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 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




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	 	 	 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 Calcitek Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Manfred Krüger
 

Manfred Krüger, President 

and Chief Executive Officer
	 	 
	 	By:
	 	/s/ Steven E. Hanson
 

Steven E. Hanson, President
	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date: September 29, 2000	 	 	 	Date: September 29, 2000	 	 






U.S. Service
Agreement - Page 15 









 




Schedule A — Processed Tissues




	 	 	 	 	 
	Tissue Description	 	Particle Size (microns)	 	Tissue Volume (cc)
	***
	 	***	 	***
	***
	 	***	 	***
	***
	 	***	 	***
	***
	 	***	 	***
	***
	 	***	 	***

















 






Schedule B




Sulzer’s Service Fees



During the first Contract Year, Sulzer’s Service Fee for a Processed Tissue shall be
equal to [***], as indicated in the table that follows:




	 	 	 
	Processed Tissue	 	Tutogen Processing Fee
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]
	 
	 	 
	[***]

	 	[***]





“Tutogen’s
Fee to Tissue User” shall be defined as [***].



Sulzer and Tutogen shall confer and agree upon the amount of Sulzer’s Service Fee after the first
Contract Year.





Schedule B to
U.S. Service Agreement - Page 16 









 





CERTAIN PORTIONS OF THIS EXHIBIT
HAVE BEEN OMITTED PURSUANT TO RULE 406 PROMULGATED UNDER THE
SECURITIES ACT OF 1933, AS AMENDED, AND ARE SUBJECT TO A CONFIDENTIAL TREATMENT REQUEST. COPIES OF
THIS EXHIBIT CONTAINING THE OMITTED INFORMATION HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. THE OMITTED PORTIONS OF THIS DOCUMENT ARE MARKED
WITH A [***].




Dental US




Agreement




(“Amendment Agreement”)




regarding the




Amendment




of the



U.S. Service Agreement between Tutogen Medical, Inc., a Florida corporation with offices at 925
Allwood Road, Clifton, NJ 07012, U.S.A. (“Tutogen”),
and Sulzer Dental Inc., a Delaware corporation
with offices at 1900 Aston Avenue, Carlsbad, California, U.SA.
(“Sulzer”) dated 29 September 2000
(the “Agreement”).



WHEREAS, under the Agreement, Sulzer agreed to provide its expertise and certain services to
enable Tutogen to make processed bone tissues for dental applications available to users in the
United States and Tutogen agreed to process for itself donated allograft bone tissue and to make
such bone tissue for dental applications available to users in the United States using exclusively
Sulzer’s expertise and support services;



WHEREAS, Tutogen and Sulzer desire to amend certain provisions of the Agreement;



NOW, THEREFORE, the Parties agree as follows:





	1.	 	Definitions
	 
	1.1	 	Unless the context otherwise requires or unless otherwise defined in this Amendment
Agreement, terms defined in the Agreement shall be of the same meaning herein.
	 
	1.2	 	Section 1.4 of the Agreement shall be deleted and replaced as follows:
	 
	 	 	As from January 1, 2002 “Contract Year” shall mean a calendar year.




 









 





- 2 -








Dental US





	1.3	 	The following new definitions shall be inserted in the Agreement:
	 
	1.3.1	 	“Next Contract Year” shall mean the Contract Year directly succeeding any Contract Year.
	 
	1.3.2	 	“Product Groups” shall mean:
	 
	 	 	[***]
	 
	1.3.3	 	“Tutogen’s Revenue” shall mean the amount of Tutogen’s Fee to Tissue User (as amended
from time to time) minus the amount of Sulzer’s Service Fees (as amended from time to time).
	 
	1.3.4	 	“Shortage” shall mean the figure representing
	 
	 	 	Tutogen’s Revenue expected to be earned by Tutogen as specified for each Product Group in the
Product Mix and in the increase, as the case may be, for any Contract Year
	 
	 	 	less
	 
	 	 	Tutogen’s Revenue actually earned by Tutogen for such Product Group during the respective
Contract Year, including any Refund paid by Tutogen to Sulzer for such Contract Year for such
Product Group.
	 
	1.4	 	The Sections 1.3 until 1.9 shall be re-numbered accordingly.
	 
	2.	 	Section 3.2. of the Agreement shall be deleted and replaced as follows:
	 
	3.2     Annual Forecast and Product Mix
	 
	3.2.1	 	No later than until 30 days before the beginning of each Contract Year, and for the
first Contract Year 2002 no later than February 28, 2002, Sulzer shall provide Tutogen with an
annual forecast of demand for Processed Tissue, specified by type and values at market prices for
the Product Groups, for Such Contract Year and specifying Tutogen’s Revenue expected to be
earned by Tutogen for such Contract Year (“Provisional Annual Forecast”).




 









 






- 3 - 






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	3.2.2	 	Within ten business days after receipt of the Provisional
Annual Forecast, Tutogen
shall evaluate whether and to what extent it will be feasible for Tutogen to use reasonable efforts
as outlined in Section 4.1 of the Agreement to deliver Processed Tissue for each Product Group as
specified in the Provisional Annual Forecast and notify Sulzer of its confirmation of the
Provisional Annual Forecast or of any reduction thereof (the “Binding Annual forecast”). The
Binding Annual Forecast shall be the relevant forecast for Tutogen to use  reasonable
efforts as outlined in Section 4.1 of the Agreement. 80% of each Product Group as specified in the
Binding Annual Forecast shall be the “Product Mix” (as referred to in Section 1.3.4) for the
related Contract Year.
	 
	3.2.4	 	The Product Mix for the Contract Year 2002 is set out in Annex 1 to this Amendment
Agreement. According thereto, the value of the Product Mix for the
Contract Year 2002 amounts to USD
[***].
	 
	3.	 	A new Section 3.3 shall be added to the Agreement:
	 
	3.3          Increase of the Product Mix
	 
	3.3.1	 	Any increase of the Binding Annual Forecast of the running Contract Year shall be valid only
provided that
	 
	3.3.1.1	 	the increase is specified according to the structure of the
Provisional Annual Forecast
(Section 3.2.1), and
	 
	3.3.1.2	 	the increase has been mutually agreed in writing by the Parties.
 

The amount by which any Binding Annual Forecast has been increased validly shall be the “Increase”.
	 
	3.3.3	 	Tutogen’s obligation to use reasonable efforts as per
Section 4.1 of the Agreement shall
also apply in respect to an Increase.




 









 




- 4 -







Dental US





	4.	 	A new Section 3.4 shall be added to the Agreement:
	 
	3.4      Shortage and Refund
	 
	3.4.1	 	In the event that for any Contract Year a Shortage occurs,
Sulzer shall pay Tutogen within 30
calendar days after the end of the related Contract Year the amount of such Shortage, provided that
such Shortage is not a result of Tutogen’s failure to deliver Processed Tissue as provided in the
Product Mix or the Increase.
	 
	3.4.2	 	In case Sulzer has paid in any Contract Year a Shortage to Tutogen for Processed Tissue of
any Product Group (in accordance with Section 3.4.1), and Tutogen delivers to users and receives a
fee in the Next Contract Year for Processed Tissue of the same Product Group in respect of which
such Shortage had been paid, such Shortage shall be compensated by Tutogen by paying to Sulzer the
entire amount of Tutogen’s fee to Tissue User (and not only Sulzer’s Service Fee) in connection
with such Processed Tissue minus a general overhead fee of [***] of such amount (“Refund”). With the
sole exception of the Refund as defined in the foregoing sentence, any other refund, compensation,
set-off, whatsoever, of a Shortage paid by Sulzer shall be excluded.
	 
	3.4.3	 	If at the end of any Next Contract Year specific Processed Tissue for which a Shortage has
been paid, has not been sold by Tutogen, Tutogen shall be entitled to keep this Shortage as final
payment. Ownership and possession of such specific Processed Tissue shall remain with Tutogen at
Tutogen’s free disposal without restriction and shall not be transferred to Sulzer.
	 
	5.	 	A new Section 3.5 shall be added to the Agreement:
	 
	3.5      Guarantee
	 
	3.5.1	 	As a security for its (potential) payment obligation for the Shortage(s), Sulzer shall
provide Tutogen by 15 February of every Contract Year, and for the Contract Year
2002 no later than March 8, 2002, with a guarantee of Sulzer Medica AG (as speci-




 









 





- 5 -







Dental US





	 	 	fied in Annex 2) covering the amount of the expected
Tutogen’s Revenue as specified in the
Product Mix of the running Contract Year.
	 
	3.5.2	 	If for any Contract Year such guarantee is not provided to Tutogen by 15 February of
such Contract Year (for the Contract Year 2002 the date being March 8, 2002). Tutogen shall request
Sulzer in writing to provide such guarantee within thirty (30) days, and if after the expiry of
such thirty (30) days period such guarantee is still not provided, Tutogen shall be entitled to
terminate the Agreement (as amended) with immediate effect. Section 7.2 of the Agreement shall not
apply.
	 
	3.5.3	 	If during any Contract Year an Increase has been agreed upon, Tutogen is entitled to request
that Sulzer provides a new guarantee of Sulzer Medica AG also covering the amount of the expected
Tutogen’s Revenue as specified in such Increase. If such new guarantee of Sulzer Medica AG is not
provided to Tutogen within thirty (30) days upon Tutogen’s request, Tutogen shall request Sulzer
again in writing to provide such guarantee within fifteen (15) days, and if after the expiry of
such fifteen (15) days period such guarantee is still not provided, Tutogen shall be entitled to
terminate the Agreement (as amended) with immediate effect Section 7.2 of the Agreement shall not
apply. Upon Tutogen’s receipt of such new guarantee to Tutogen, any guarantee previously provided
in such Contract Year shall automatically become ineffective.




In all
other respects (including the current system of establishing Tutogen’s Fee to Tissue User and Sulzer’s Service Fees), the Agreement, as hereby amended, remains unchanged
and fully enforced.




	 	 	 	 	 	 	 	 	 	 	 
	Tutogen Medical, Inc.	 	 	 	Sulzer Dental Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Manfred Krüger
 

	 	 
	 	By:
	 	/s/ Steven Hanson
 

	 	 
	 	 	Manfred Krüger, President and CEO	 	 	 	 	 	Steven Hanson	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date: 28.02.02	 	 	 	Date: March 4, 2002	 	 






 









 






CERTAIN
PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO RULE 406 PROMULGATED UNDER
THE SECURITIES ACT OF 1933, AS AMENDED, AND ARE SUBJECT TO A CONFIDENTIAL TREATMENT REQUEST.
COPIES OF THIS EXHIBIT CONTAINING THE OMITTED INFORMATION HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. THE OMITTED PORTIONS OF THIS DOCUMENT ARE MARKED WITH A [***].




Xenograft Distribution Agreement



This Agreement is made by Tutogen Medical GmbH, a German corporation with offices at
Industriestraße 6, D-91077 Neunkirchen am Brand, Germany
(“Tutogen”) and Sulzer Calcitek Inc., a
Delaware corporation with offices at 1900 Aston Avenue, Carlsbad,
California, U.S.A. (“Sulzer”).




W I T N E S S E T H:



WHEREAS, Tutogen collects xenograft bone tissue, processes such tissue, and distributes xenograft
bone tissue products through various distributors throughout the

world;



WHEREAS, Sulzer manufactures and sells worldwide a line of products used in dental applications and
desires to acquire from Tutogen the right to distribute its xenograft bone tissue products
worldwide for use in dental applications;



WHEREAS, Tutogen is willing to terminate the right of its existing distributors to sell xenograft
bone tissue products for dental 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;



NOW, THEREFORE, in consideration of the foregoing premises and the terms and conditions set
forth below, the parties hereby agree as follows:



Definitions





	 	1.1	 	“Affiliate” shall mean an entity that controls, is controlled by, or is 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	 	“Clinical Costs” shall have the meaning set forth in Section 5.3.
	 
	 	1.3	 	“Contract Year” shall mean the one-year period following the Effective Date
of this Agreement and each one-year period following each anniversary of the Effective
Date of this Agreement.
	 
	 	1.4	 	“Effective Date” shall mean the date on which this Agreement has been
executed by an authorized officer of each party, as witnessed on the signature page of
this Agreement.
	 
	 	1.5	 	“FDA” shall mean the United States Food and Drug Administration.
	 
	 	1.6	 	“Field of Use” shall mean all uses of processed xenograft bone tissue
in or adjoining the human maxilla or the human mandible.
	 
	 	1.7	 	“Minimum Sales Goals” shall have the meaning set forth in Section 3.4.
	 
	 	1.8	 	“Minimums Negotiation Period” shall have the meaning set forth in Section 3.4.1.
	 
	 	1.9	 	“Permitted Successor” shall mean any individual, corporation, 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.
	 
	 	1.10	 	“Products” shall mean the xenograft bone tissue products 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.
	 
	 	1.11	 	“Regulatory Plan” shall have the meaning set forth in Section 5.2.2.
	 
	 	1.12	 	“Sub-Territory” shall mean one of the following geographic regions or countries
comprising in part the Territory: [***].
	 
	 	1.13	 	“Territory” shall mean the entire world.
	 
	 	1.14	 	“Third Party” shall mean a person or entity other than Tutogen, any 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 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 in the
Products for the Field of Use from Tutogen’s existing international distributors to Sulzer,
Sulzer agrees to pay Tutogen a total of US$[***] by wire transfer pursuant to
Tutogen’s written
instruction, as follows:






	 	2.2.1	 	US$ [***] shall be paid within [***];
	 
	 	2.2.2	 	US$ [***] shall be paid within [***] and
	 
	 	2.2.3	 	US$ [***] shall be paid within [***]





3.
Sulzer’s Obligations





	 	3.1	 	Marketing Efforts. Sulzer agrees to use commercially reasonable 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	 	Forecasting. Within 60 days following the execution of this Agreement, Sulzer
shall provide Tutogen with a monthly forecast of demand for the Products during
the succeeding six-month period. Commencing with the second calendar quarter





Xenograft
Distribution Agreement - Page 2





 









 









	 	 	 	of 2001 and 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.
	 
	 	3.3	 	Sales Personnel. Sulzer shall use reasonable efforts to train its sales personnel in
techniques for proper use of the Products.
	 
	 	3.4	 	Minimum Sales Goals. Between the 21st month following the Effective Date
and the end of the second Contract Year, Sulzer and Tutogen shall agree to minimum annual
goals for sales (measured by units of Product) for the Products by Sub-Territory (the “Minimum
Sales Goals”) for the third, fourth, and fifth Contract Years. The Minimum Sales Goals shall
be recorded on Schedule B. The parties acknowledge that sales of the Products in any
particular Sub-Territory is a function of many factors, some of which are beyond the control
of Sulzer. Accordingly, the parties’ intent in establishing Minimum Sales Goals is to insure
that Sulzer uses reasonable efforts to promote the sale of the Products in a particular
Sub-Territory and not to guarantee Tutogen a minimum income.






	 	3.4.1	 	In the three-month period preceding the end of the fifth Contract Year,
and every three years thereafter during the term of this Agreement (such three-month
period being the “Minimums Negotiation Period”), the parties shall agree on Minimum
Sales Goals of the Products by Territory for three consecutive years.
	 
	 	3.4.2	 	For each Territory in which a Product is first approved for commercial
sale subsequent to the Effective Date, the parties shall establish initial Minimum
Sales Goals within two years after the date of Product approval, from that date
through the next Minimums Negotiation Period, with subsequent Minimum Sales Goals
for the Product thereafter established during the Minimums Negotiation Period as
provided by the procedure first set forth herein.
	 
	 	3.4.3	 	If the parties have not reached agreement on the Minimum Sales Goals in
a particular Sub-Territory for a particular year within a time frame specified
herein, the parties shall resolve the matter by binding arbitration as provided in
Section 9.9 of this Agreement.
	 
	 	3.4.4	 	In the event that Sulzer fails to meet the Minimum Sales Goal for a
Product in any Sub-Territory in any year, then Tutogen shall have the option (i) to
engage in co-promotion of the Product, at Tutogen’s sole expense, in the Territory
in which the Minimum Sales Goal was not met, or (ii) to co-distribute the Product
(either directly or through a Third Party) in the Sub-Territory in which the Minimum
Sales Goal was not met.
	 
	 	3.4.5	 	In the event that Sulzer fails to meet the Minimum Sales Goal for a
Product in a Sub-Territory for two consecutive years, then Tutogen shall have the
option to terminate Sulzer’s right and license to distribute the Product in that
particular Sub-Territory on 30 days written notice to Sulzer.





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	 	3.4.6	 	Following termination of Sulzer’s right to distribute a Product in a
particular Sub-Territory, Tutogen shall have the right to license a Third Party
to distribute a product for the same indication in such Sub-Territory. Tutogen
shall exercise its option to co-promote, co-distribute, or terminate, if at all,
by written notice to Sulzer within 90 days following the date on which such
option matures. The remedies set forth herein for Sulzer’s failure to meet the
Minimum Sales Goal are exclusive, and Sulzer shall have no duty to pay Tutogen
any amount for failure to achieve the Minimum Sales Goal.





4. Tutogen’s Obligations





	 	4.1	 	Product Supply. Tutogen agrees to use its best efforts to acquire xenograft bone
tissue, process the tissue using the Tutoptast® process according to Sulzer’s forecasts for
demand for Products, manufacture the Products, package and label the Products as required
for distribution in the different countries within the Territory, and sell the Products to
Sulzer pursuant to purchase orders issued by Sulzer at the transfer prices listed 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 xenograft bone
tissue to a Third Party for distribution in the Territory for the Field of Use.
	 
	 	4.2	 	Termination of Distribution Contracts. Tutogen shall terminate the right of its
existing distributors 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.
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.
	 
	 	4.3	 	Training. Tutogen agrees to provide training services to Sulzer, as reasonably
requested by Sulzer, regarding the Tutoplast® process and the manufacture and use of the
Products. Tutogen and Sulzer shall confer and agree upon on the scope of and location for
the training services to be provided by Tutogen and the distribution of the expenses for
such training services.





5. Regulatory Matters





	 	5.1	 	 Import Compliance. Tutogen agrees to comply with and maintain compliance
with all governmental rules, regulations, statutes, and other laws of any kind relating to
acquisition of xenograft tissue, manufacture the Products, packaging and labeling of the
Products, and delivery of the Products to Sulzer for distribution within the Territory.
	 
	 	5.2	 	Regulatory Responsibilities. The parties understand that as of the 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





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	 	 	 	particular country after the Effective Date, subject to the agreement of both
Sulzer and Tutogen to seek regulatory approval therefore, Tutogen shall be
responsible for applying for regulatory approval for such Products.






	 	5.2.1	 	In the event that either Sulzer or Tutogen, in its sole discretion,
does not agree to seek regulatory approval for a regulated Product in a
particular country, then such Product shall be removed from Schedule A as to
that particular country. If Tutogen desires to seek regulatory approval, but
Sulzer does not, then Tutogen shall have the right to seek regulatory approval
for such product at its own expense and to distribute such product without
obligation to Sulzer under this Agreement. If Sulzer desires to seek regulatory
approval for such product, but Tutogen does not, Sulzer, subject to Tutogen’s
agreement to supply the product, shall have the right to seek regulatory
approval for such product at its own expense and to distribute the product
without obligation to Tutogen under this Agreement.
	 
	 	5.2.2	 	In the event that Sulzer and Tutogen each agree to seek regulatory
approval for a Product, then the parties shall forthwith meet and agree upon a
plan pursuant to which Tutogen will seek regulatory approval for the Product
from the regulatory body in question (the “Regulatory Plan”). The Regulatory
Plan shall include an agreement as to the scope, timing, and supervisory
responsibility for preclinical studies, clinical trials, regulatory submissions,
and all other matters related to the regulatory approval process for the Product.
The parties shall meet at least once annually to review and amend the Regulatory
Plan as dictated by the current status of the clinical and regulatory process.
	 
	 	5.2.3	 	Sulzer and Tutogen hereby specifically agree to seek a 510(k)
approval from the FDA for [***]. The parties shall meet
within 90 days following the Effective Date and agree upon a
Regulatory Plan therefor.






	 	5.3	 	Clinical Expenses. Sulzer and Tutogen shall each pay one-half of all
out-of-pocket expenses incurred in execution of a Regulatory Plan subsequent to the
Effective Date, excluding salary, benefits, and other costs for employees of the parties
(the “Clinical Expenses”).






	 	5.3.1	 	In the absence of an agreement otherwise, a party that incurs
Clinical Expenses in a calendar quarter shall invoice the other party quarterly
in arrears for one-half of such Clinical Expenses. The invoice shall specify
for each such expense the vendor, the purpose, and the date such expense was
incurred and shall include a copy of supporting documentation of the expense.
	 
	 	5.3.2	 	A party receiving an invoice for Clinical Expenses, unless the invoice is
disputed, shall either pay the invoice or setoff the invoice with other Clinical
Expenses within 45 days from the date of the invoice.






	 	5.4	 	Ownership of Approvals. Tutogen shall be the record owner of all regulatory approvals
to sell Products in the Territory for the Field of Use.
	 
	 	5.5	 	Product Recalls. Tutogen, as manufacturer of the Products, shall be responsible for execution
of and all expenses related to any recall of Products, including, but





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	 	 	 	not limited to, retrieving recalled Products from users, scrapping or discarding
recalled Products, and resupplying users with replacement Products.





6.
Trademark License and Product Labeling





	 	6.1	 	License Grant. Tutogen grants Sulzer a nonexclusive license under Tutogen’s
trademarks, Tutoplast® and Tutodent, to use the trademarks solely in connection with the
Products and the marketing thereof within the Territory for the Field of Use.
	 
	 	6.2	 	Approval of Marketing Publications. Sulzer shall provide Tutogen with samples of
all of Sulzer’s 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 Product labels in
a manner mutually agreeable to the parties.
	 
	 	6.4	 	New Trademarks. Subject to the approval of Tutogen, which shall not be withheld
unreasonably, Sulzer shall have the right to adopt new trademarks of its choosing for use
in connection with the Products.





7.
Term and Termination





	 	7.1	 	Term. This Agreement shall be effective on the Effective Date and 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 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 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,





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Distribution Agreement - Page 6




 









 






	 	 	 	
(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	 	Refund of Clinical Expenses. In the event that the Agreement 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 refund
Sulzer’s payment of Clinical Expenses, as determined in this Section 7.4, in obtaining
or attempting to obtain regulatory approval for Products under Section 5.2. For each
Product as to which Sulzer has reimbursed a portion of Clinical Expenses paid by
Tutogen, Tutogen shall be obligated to refund an amount determined by multiplying the
Clinical Expenses for that Product by the Refund Ratio. The “Refund Ratio” is






	 	 	 	[***]







	 	 	 	[***]






	 	 	 	[***]






	 	 	 	[***]. The refund 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:






	 	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 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.





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	 	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 possesses all
governmental and other approvals required for the collection and processing of
xenograft tissue, and Tutogen shall use commercially reasonable efforts to
maintain all such approvals throughout the term of this Agreement.
	 
	 	8.1.7	 	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.






	 	8.2	 	Liability for Breach of Product Warranty. If any failure to conform to the
representation and warranty set forth in Section 8.1.7 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 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.
	 
	 	8.4	 	Sulzer. Sulzer represents and warrants to Tutogen, as follows:






	 	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 Tutoqen.






	 	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





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Distribution Agreement - Page 8





 









 









	 	 	 	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.






	 	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 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





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Distribution Agreement - Page 9






 









 









	 	 	 	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.





9. Miscellaneous Provisions





	 	9.1	 	Entire Agreement.






	 	9.1.1	 	This Agreement, together with the U.S. Service Agreement and the Processed
Tissue Development and License Agreement, all between the parties or their Affiliates
of even date, 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.
	 
	 	9.1.2	 	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 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 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:





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	 	If to Tutogen:
	 
	 	 
	 

	 	Tutogen Medical GmbH
	 

	 	Industriestrabe 6,
	 

	 	D-91077 Neunkirchen am Brand
	 

	 	GERMANY
	 

	 	Attention: President and CEO
	 

	 	Telephone: 49 (9134) 99 88 110
	 

	 	Facsimile:  49 (9134) 99 88 119
	 
	 	 
	 

	 	With a copy to:
	 
	 	 
	 

	 	Dr. Dirk Lange
	 

	 	Foerster + Rutow
	 

	 	Irrestr. 17-19
	 

	 	90403 Nürnberg
	 

	 	GERMANY
	 

	 	Telephone: 49 (911) 23 569 00
	 

	 	Facsimile:  49 (911) 23 569 11
	 
	 	 
	 

	 	If to Sulzer:
	 
	 	 
	 

	 	Sulzer Calcitek Inc.
	 

	 	1900 Aston Avenue
	 

	 	Carlsbad, California 92008-7308
	 

	 	U.S.A.
	 

	 	Attention: President
	 

	 	Telephone: 1 (760) 431-9515
	 

	 	Facsimile:  1 (760) 431-9753
	 
	 	 
	 

	 	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
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. The United Nations Convention on
Contracts for the International Sale of Goods of April 11, 1980 shall not be applicable.





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	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 the 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, 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
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.





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	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 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.





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	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 Calcitek Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Manfred Krüger
 

Manfred Krüger
	 	 	 	By:
	 	/s/ Steven E. Hanson
 

Steven E. Hanson
	 	 
	 

	 	Managing Director
	 	 	 	 	 	President	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date:

	 	September 29, 2000
	 	 	 	Date:
	 	September 29, 2000	 	 






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Schedule A — Products




	 	 	 	 	 
	Description	 	Particle Size (microns)	 	Tissue Volume (cc)
	***
	 	***	 	***
	***
	 	***	 	***
	***
	 	***	 	***
	***
	 	***	 	***
	***
	 	***	 	***


















 





Schedule
B — Minimum Sales Goals

 







Contract Year 1 [***]




 




 




Contract Year 2 [***]




 




 




Contract Year 3 [***]

 




 




Contract Year 4 [***]

 




 




Schedule B to Xenograft Distribution Agreement — Page 1




 









 




Contract Year 5 [***]

 




 




Contract Year 6 [***]

 




 




Contract Year 7 [***]

 




 




Schedule B to Xenograft Distribution Agreement — Page 2




 









 




Contract Year 8 [***]




 




 




Contract Year 9 [***]




 




 




Contract Year 10 [***]




Schedule B to Xenograft Distribution Agreement — Page 3





 








 





Schedule C
— Transfer Price





     The Transfer Price for the Products during the First Contract Year is set forth in the table below.



	 	 	 
	Product	 	Transfer
Price
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]
	[***]
	 	[***]







     Sulzer and Tutogen shall confer and agree upon the amount of Transfer Price after the first
Contract Year.



Schedule
C to Xenograft Distribution Agreement - Page 1





 










 





Xenograft Distribution Amendment Agreement (“Dental International”)



CERTAIN
PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO
RULE 406 PROMULGATED UNDER THE SECURITIES
ACT OF 1933, AS AMENDED, AND ARE SUBJECT TO A CONFIDENTIAL TREATMENT REQUEST. COPIES OF THIS
EXHIBIT CONTAINING THE OMITTED INFORMATION HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. THE OMITTED PORTIONS OF THIS DOCUMENT ARE MARKED WITH A [***].




Agreement

(“Amendment Agreement”)




regarding the




Partial Termination and Amendment




of the



Xenograft
Distribution Agreement between Tutogen Medical GmbH, a German corporation with offices
at Industriestrasse 6, D-91077 Neunkirchen am Brand, Germany,
(“Tutogen”) and Sulzer Dental
Inc., a Delaware corporation with offices at 1900 Aston Avenue, Carlsbad, California, U.S.A.
(“Sulzer”) dated 29 September 2000 (the “Agreement”).



WHEREAS, under the Agreement, Tutogen has appointed Sulzer as its exclusive distributor for the
entire world for processed xenograft bone tissues for use in dental applications;



WHEREAS,
Tutogen and Sulzer desire to terminate the Agreement for all countries except for France,
Germany, Israel, and the United States, combined, however, with an option of Sulzer to
reacquire distribution rights for other countries at a later time.



NOW, THEREFORE, the Parties agree as follows:





	1.	 	Definitions
	 
	 	 	Unless the context otherwise requires or unless otherwise defined in this Amendment, terms
defined in the Agreement shall be of the same meaning herein.
	 
	2.	 	The Parties hereby agree that the Agreement shall be terminated with effect as from the date
of signature of this Amendment Agreement in respect to all countries except for France, Germany,
Israel, and the United States. Accordingly, (subject only to the option as per Section
10.4. below) all rights and obligations of the Parties hereunder shall forthwith only relate to
France, Germany, Israel, and the United States (including its possession and territories) and every
provision of the Agreement, even if not expressly amended by this Amendment Agreement, shall be
construed accordingly.




 









 











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Xenograft Distribution Amendment Agreement (“Dental International”)





	3.	 	With the exception of unpaid invoices from one Party to the other for products and services
provided in accordance with the Agreement, both Parties herewith release each other from any
and all obligations and liabilities they may have assumed against each other under or in
connection with the Agreement in respect to any country other than France, Germany, Israel,
and the United States (including its possession and territories) and herewith waive all
potential rights to any claim, liabilities, demands, and causes of action they may have
against each other in respect to such countries based on or in connection with this Agreement.
	 
	4.	 	Section 1.12. of the Agreement shall be deleted and replaced as follows:
	 
	 	 	“Country” shall mean any country in the Territory.
	 
	5.	 	Section 1.13. of the Agreement shall be deleted and replaced as follows:
	 
	 	 	“Territory” shall mean France, Germany, Israel, and the United States including its
territories and possessions.
	 
	6.	 	References to the term “Sub-Territory” in the Agreement, including, but not limited to
Sections 3.2. and 3.4., shall be replaced by the term “Country”.
	 
	7.	 	A new Section 10 with the heading “Distribution Rights in other Countries” shall be added
to the Agreement:






	 	10.1.	 	Appointment of Third Party Distributors by Tutogen. Tutogen is free to
appoint orher distributors for the Products in all countries outside the Territory,
provided, however, that it shall appoint such third party distributor only on the
basis of a distribution agreement substantially in the form of the draft in the
Annex hereto and provided that such distribution agreements with
third party
distributors can be terminated (without cause) by Tutogen at any time upon 15
months notice.
	 
	 	10.2.	 	Use of Tutogen’s Trademarks and Tradenames. Outside the Territory Sulzer
shall remove and discontinue the use of any sign or any other designation containing
any of Tutogen’s trademarks or trade names, provided that Sulzer shall have the
right to continue to use stationary, brochures and other documents that are already
printed at the date of the Amendment Agreement for a period of 180 days after the
date hereof.




 









 











- 3 -




Xenograft Distribution Amendment Agreement (“Dental International”)





	 	10.3.	 	Review. At least every 15 months, for the first time at the latest by July
2003, Tutogen and Sulzer shall review the market situation in countries outside the
Territory in order to evaluate a potential future collaboration (including the
reacquisition of the distribution rights by Sulzer) in such countries.
	 
	 	10.4.	 	Option.
	 
	 	10.4.1	 	Tutogen hereby grants Sulzer the option to re-acquire distribution rights for any
and all countries outside the Territory under the following conditions:






	 	(a)	 	Sulzer shall indemnify Tutogen against any and all claims of
Tutogen’s
existing distributor for such country resulting from the termination
of the respective distribution relationship by Tutogen.
	 
	 	(b)	 	Sulzer shall pay to Tutogen an amount equaling to [***] accrued
under the distributor relationship existing in such country during the last 12
months preceding the termination of the respective distributor relationship.
Sulzer is, however, entitled to set off any net profits accrued by
Tutogen out of the new distributor relationship with Sulzer during the first 12
months after the distributor relationship between Sulzer and Tutogen has become
effective.






	 	10.4.2	 	Sulzer may exercise the option specified in 10.4.1 for a particular country at
any time until 29 September 2010. In case Sulzer exercises its option in
respect to a country, the Parties shall either amend Section 1.13. of the Agreement
so to include such country into the term “Territory” or conclude a new distributor
agreement in respect to such country, substantially in the form of
the Agreement.






	8.	 	Any press release and other announcement to the public, shareholders, authorities,
stock exchange and employees regarding the partial termination of the
Agreement
shall only be made in a form mutually agreed on by the Parties.




In all other respects, the Agreement, as hereby amended, remains unchanged and fully enforced.




 









 








- 4 -




Xenograft Distribution Amendment Agreement (“Dental International”)




	 	 	 	 	 
	 	Tutogen Medical GmbH

	 	 	Sulzer Dental Inc.
	 
	 	 	 

	By: 
	/s/
Manfred Krüger

	 	By: 
	/s/ Steven Hanson
	 	 

	 	 	 
	 	Manfred Krüger, President and CEO

	 	 	Steven Hanson
	 
	 	 	 

	 	Date: 28.02.02

	 	 	Date: March 4, 2002
	 
	 	 	 

	 	Annex: Distribution Agreement