Document:

EX-10.32 Investment Management Trust Agreement

 

Exhibit
10.32

INVESTMENT MANAGEMENT TRUST AGREEMENT

     This Agreement is made as of December 28, 2006 by and between FREEDOM ACQUISITION HOLDINGS,
INC. (the “Company”) and Continental Stock Transfer & Trust Company (the
“Trustee”).

     WHEREAS, the Company’s Registration Statement on Form S-1, as amended, No. 333-136248
(together with any registration statement filed pursuant to Rule 462(b), the “Registration
Statement”), for its initial public offering of securities (the “IPO”) has been
declared effective as of December 21, 2006 by the Securities and Exchange Commission (the
“Effective Date”); and

     WHEREAS, Citigroup Global Markets Inc. (“Citigroup”) is acting as the representative
of the underwriters in the IPO; and

     WHEREAS, as described in the Registration Statement, $466,320,000 ($535,728,000 if the
underwriters’ over-allotment option is exercised in full) consisting of (i) $461,820,000 of the net
proceeds of the IPO ($531,228,000 if the underwriters’ over-allotment option is exercised in full)
after adjusting for certain offering expenses and (ii) $4,500,000 of the proceeds from the sale of
the Sponsors’ Warrants, will be delivered to the Trustee to be deposited and held in a trust
account for the benefit of the Company and the holders of the Company’s common stock, par value
$0.0001, issued in the IPO. The amount to be delivered to the Trustee will be referred to herein
as the “Property,” the stockholders for whose benefit the Trustee shall hold the Property
will be referred to as the “Public Stockholders,” and the Public Stockholders and the
Company will be referred to together as the “Beneficiaries”); and

     WHEREAS, a portion of the Property consists of $16,320,000 (or $18,768,000 if the
underwriters’ over-allotment option is exercised in full) attributable to the underwriters’
discount which Citigroup has agreed to deposit in the Trust Account (as defined below); and

     WHEREAS, the Company and the Trustee desire to enter into this Agreement to set forth the
terms and conditions pursuant to which the Trustee shall hold the Property;

     IT IS AGREED:

     1. Agreements and Covenants of Trustee. The Trustee hereby agrees and covenants to:

          (a) Hold the Property in trust for the Beneficiaries in accordance with the terms of this
Agreement in segregated trust accounts (the “Trust Account”) established by the Trustee at
branches of J.P. Morgan Chase N.Y. and Smith Barney, a division of Citigroup Global Markets, each
selected by the Trustee;

          (b) Manage, supervise and administer the Trust Account subject to the terms and conditions set
forth herein;

          (c) In a timely manner, upon the written instruction of the Company, to invest and reinvest
the Property in United States “government securities” and/or in any open ended money market fund(s)
selected by the Company meeting the conditions of Sections (c)(2), (c)(3) and (c)(4) of Rule 2a-7
promulgated under the Investment Company Act of 1940, as amended, as
determined by the Company. As used herein, “Government Security” means any Treasury
Bill issued by the United States, having a maturity of one hundred and eighty days or less;

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          (d) Collect and receive, when due, all principal and income arising from the Property, which
income, net of taxes, shall become part of the “Property,” as such term is used herein; and the
remaining income arising from the Property, net of taxes, up to $3,900,000 may be released to the
Company periodically to fund its working capital requirements;

          (e) Notify the Company and Citigroup of all communications received by it with respect to any
Property requiring action by the Company;

          (f) Supply any necessary information or documents as may be requested by the Company in
connection with the Company’s preparation of the tax returns relating to income from the Property
in the Trust Account or otherwise;

          (g) Participate in any plan or proceeding for protecting or enforcing any right or interest
arising from the Property if, as and when instructed by the Company and/or Citigroup in writing to
do so;

          (h) Render to the Company and to Citigroup, and to such other person as the Company may
instruct, monthly written statements of the activities of and amounts in the Trust Account
reflecting all receipts and disbursements of the Trust Account;

          (i) If there is any income or other tax obligation relating to the income from the Property in
the Trust Account as determined by the Company, then, from time to time, at the written instruction
of the Company, the Trustee shall promptly, to the extent there is not sufficient cash in the Trust
Account to pay such tax obligation, liquidate such assets held in the Trust Account as shall be
designated by the Company in writing, and disburse to the Company by wire transfer, out of the
Property in the Trust Account, the amount indicated by the Company as owing in respect of such
income tax obligation; and

          (j) Commence liquidation of the Trust Account only upon receipt of and only in accordance with
the terms of a letter (the “Termination Letter”), in a form substantially similar to that
attached hereto as either Exhibit A or Exhibit B, signed on behalf of the Company
by its Chief Executive Officer or other authorized officer, and complete the liquidation of the
Trust Account and distribute the Property in the Trust Account only as directed in the Termination
Letter and the other documents referred to therein.

     2. Limited Distributions of Income From Trust Account.

          (a) If there is any income or other tax obligation relating to the income from the Property in
the Trust Account as determined by the Company, then, at the written instruction of the Company,
the Trustee shall disburse to the Company by wire transfer, out of the Property in the Trust
Account, the amount indicated by the Company as required to pay income taxes; and

          (b) Upon written request from the Company in a form substantially similar to that attached
hereto as Exhibit C, which may be given not more than once in any calendar quarter, the
Trustee shall distribute to the Company by wire transfer an amount equal to the income collected on
the Property through the last day of the calendar quarter immediately

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preceding the date of receipt of the Company’s request; provided, however, that the maximum
amount of distributions, net of taxes, that the Company may request and the Trustee shall
distribute pursuant to this Section 2(b) shall be $3,900,000. The first such distribution shall
include income through the first full calendar quarter following the effective date of the IPO,
with the Company’s request made after such date. It is understood that the Trustee’s only
responsibility under this section is to follow the instruction of the Company; and

          (c) Except as provided in Sections 2(a) and 2(b) above, no other distributions from the Trust
Account shall be permitted except in accordance with Sections 1(i) and 1(j) hereof.

     3. Agreements and Covenants of the Company. The Company hereby agrees and covenants
to:

          (a) Give all instructions to the Trustee hereunder in writing, signed by the Company’s Chief
Executive Officer or other authorized officer. In addition, except with respect to its duties
under Section 1(i) above, the Trustee shall be entitled to rely on, and shall be protected in
relying on, any verbal or telephonic advice or instruction which it in good faith believes to be
given by any one of the persons authorized above to give written instructions, provided that the
Company shall promptly confirm such instructions in writing;

          (b) Hold the Trustee harmless and indemnify the Trustee from and against, any and all
expenses, including reasonable counsel fees and disbursements, or loss suffered by the Trustee in
connection with any action, suit or other proceeding brought against the Trustee involving any
claim, or in connection with any claim or demand which in any way arises out of or relates to this
Agreement, the services of the Trustee hereunder, or the Property or any income earned from
investment of the Property, except for expenses and losses resulting from the Trustee’s gross
negligence or willful misconduct. Promptly after the receipt by the Trustee of notice of demand or
claim or the commencement of any action, suit or proceeding, pursuant to which the Trustee intends
to seek indemnification under this Section, it shall notify the Company in writing of such claim
(hereinafter referred to as the “Indemnified Claim”). The Trustee shall have the right to
conduct and manage the defense against such Indemnified Claim. The Company may participate in such
action with its own counsel; and

          (c) Pay the Trustee an initial acceptance fee, an annual fee and a transaction processing fee
for each disbursement made pursuant to Sections 2(a) and 2(b) as set forth on Schedule A
hereto, which fees shall be subject to modification by the parties from time to time. It is
expressly understood that the Property shall not be used to pay such fees and further agreed that
said transaction processing fees shall be deducted by the Trustee from the disbursements made to
the Company pursuant to Section 2(b). The Company shall pay the Trustee the initial acceptance fee
and first year’s fee at the consummation of the IPO and thereafter on the anniversary of the
Effective Date. The Trustee shall refund to the Company the annual fee (on a pro rata basis) with
respect to any period after the liquidation of the Trust Fund. The Company shall not be
responsible for any other fees or charges of the Trustee except as set forth in this Section 3(c)
and as may be provided in Section 3(b) hereof (it being expressly understood that the Property
shall not be used to make any payments to the Trustee under such Sections).

     4. Limitations of Liability. The Trustee shall have no responsibility or liability
to:

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          (a) Take any action with respect to the Property, other than as directed in Section 1 hereof
and the Trustee shall have no liability to any party except for liability arising out of its own
gross negligence or willful misconduct;

          (b) Institute any proceeding for the collection of any principal and income arising from, or
institute, appear in or defend any proceeding of any kind with respect to, any of the Property
unless and until it shall have received written instructions from the Company given as provided
herein to do so and the Company shall have advanced or guaranteed to it funds sufficient to pay any
expenses incident thereto;

          (c) Change the investment of any Property, other than in compliance with Section 1(c);

          (d) Refund any depreciation in principal of any Property;

          (e) Assume that the authority of any person designated by the Company to give instructions
hereunder shall not be continuing unless provided otherwise in such designation, or unless the
Company shall have delivered a written revocation of such authority to the Trustee;

          (f) The other parties hereto or to anyone else for any action taken or omitted by it, or any
action suffered by it to be taken or omitted, in good faith and in the exercise of its own best
judgment, except for its gross negligence or willful misconduct. The Trustee may rely conclusively
and shall be protected in acting upon any order, judgment, instruction, notice, demand,
certificate, opinion or advice of counsel (including counsel chosen by the Trustee), statement,
instrument, report or other paper or document (not only as to its due execution and the validity
and effectiveness of its provisions, but also as to the truth and acceptability of any information
therein contained) which is believed by the Trustee, in good faith, to be genuine and to be signed
or presented by the proper person or persons. The Trustee shall not be bound by any notice or
demand, or any waiver, modification, termination or rescission of this agreement or any of the
terms hereof, unless evidenced by a written instrument delivered to the Trustee signed by the
proper party or parties and, if the duties or rights of the Trustee are affected, unless it shall
give its prior written consent thereto;

          (g) Verify the correctness of the information set forth in the Registration Statement or to
confirm or assure that any acquisition made by the Company or any other action taken by it is as
contemplated by the Registration Statement;

          (h) As and to the extent requested from time to time by the Company, prepare, execute and file
such tax reports, income or other tax returns and pay any taxes with respect to income and
activities relating to the Trust Account, regardless of whether such tax is payable by the Trust
Account or the Company (including but not limited to income tax obligations), it being expressly
understood that as set forth in Section 1(i), if there is any income or other tax obligation
relating to the Trust Account or the Property in the Trust Account, as determined from time to time
by the Company and regardless of whether such tax is payable by the Company or the Trust, at the
written instruction of the Company, the Trustee shall make funds available in cash from the
Property in the Trust Account an amount specified by the Company as owing to the applicable taxing
authority, which amount shall be paid directly to the Company by
electronic funds transfer, account debit or other method of payment, and the Company shall
forward such payment to the taxing authority; and

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          (i) Verify calculations, qualify or otherwise approve Company requests for distributions
pursuant to Sections 1(i), 2(a) or 2(b) above.

     5. Termination. This Agreement shall terminate as follows:

          (a) If the Trustee gives written notice to the Company that it desires to resign under this
Agreement, the Company shall use its reasonable efforts to locate a successor trustee. At such
time that the Company notifies the Trustee that a successor trustee has been appointed by the
Company and has agreed to become subject to the terms of this Agreement, the Trustee shall transfer
the management of the Trust Account to the successor trustee, including but not limited to the
transfer of copies of the reports and statements relating to the Trust Account, whereupon this
Agreement shall terminate; provided, however, that, in the event that the Company does not locate a
successor trustee within ninety days of receipt of the resignation notice from the Trustee, the
Trustee may submit an application to have the Property deposited with the United States District
Court for the Southern District of New York and upon such deposit, the Trustee shall be immune from
any liability; or

          (b) At such time that the Trustee has completed the liquidation of the Trust Account in
accordance with the provisions of Section 1(j) hereof, and distributed the Property in accordance
with the provisions of the Termination Letter, this Agreement shall terminate except with respect
to Section 3(b).

     6. Miscellaneous.

          (a) The Company and the Trustee each acknowledge that the Trustee will follow the security
procedures set forth below with respect to funds transferred from the Trust Account. The Company
and the Trustee will each restrict access to confidential information relating to such security
procedures to authorized persons. Each party must notify the other party immediately if it has
reason to believe unauthorized persons may have obtained access to such information, or of any
change in its authorized personnel. In executing funds transfers, the Trustee will rely upon
account numbers or other identifying numbers of a beneficiary, beneficiary’s bank or intermediary
bank, rather than names. The Trustee shall not be liable for any loss, liability or expense
resulting from any error in an account number or other identifying number, provided it has
accurately transmitted the numbers provided.

          (b) This Agreement shall be governed by and construed and enforced in accordance with the laws
of the State of New York, without giving effect to conflict of laws. It may be executed in several
counterparts, each one of which shall constitute an original, and together shall constitute but one
instrument.

          (c) This Agreement contains the entire agreement and understanding of the parties hereto with
respect to the subject matter hereof. This Agreement or any provision hereof may only be changed,
amended or modified by a writing signed by each of the parties hereto; provided, however, that no
such change, amendment or modification may be made without the prior written consent of Citigroup.
Any other change, waiver, amendment or modification to this Agreement shall be subject to approval
by a majority of the Public Stockholders. As to any
claim, cross-claim or counterclaim in any way relating to this Agreement, each party waives
the right to trial by jury.

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          (d) The parties hereto consent to the jurisdiction and venue of any state or federal court
located in the City of New York for purposes of resolving any disputes hereunder.

          (e) Any notice, consent or request to be given in connection with any of the terms or
provisions of this Agreement shall be in writing and shall be sent by express mail or similar
private courier service, by certified mail (return receipt requested), by hand delivery or by
facsimile transmission:

if to the Trustee, to:

Continental Stock Transfer & Trust Company

17 Battery Place, 8th Floor

New York, New York 10004

Attn: Steven Nelson, President

Fax No.: (212) 509-5150

if to the Company, to:

Freedom Acquisition Holdings, Inc.

1114 Avenue of the Americas, 41st Floor

New York, New York 10036

Attn: Nicolas Berggruen, President

Fax No.: (212) 382-0120

in either case with a copy to:

Citigroup Global Markets Inc.

388 Greenwich Street

New York, NY 10013

Facsimile: (212) 723-8871

Attn: David Spivak

and

Greenberg Traurig, LLP

MetLife Building

200 Park Avenue

New York, New York 10166

Attn: Alan I. Annex, Esq.

Fax No.: (212) 801-6400

          (f) This Agreement may not be assigned by the Trustee without the prior written consent of the
Company and Citigroup. This Agreement may be assigned by the Company to a wholly-owned subsidiary
of the Company upon written notice to the Trustee.

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          (g) Each of the Trustee and the Company hereby represents that it has the full right and power
and has been duly authorized to enter into this Agreement and to perform its respective obligations
as contemplated hereunder. The Trustee acknowledges and agrees that it shall not make any claims
or proceed against the Trust Account, including by way of set-off, and shall not be entitled to
part of the Property under any circumstance.

          (h) The Trustee hereby consents to the inclusion of Continental Stock Transfer & Trust Company
in the Registration Statement and other materials relating to the IPO.

[Signatures appear on following page]

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     IN WITNESS WHEREOF, the parties have duly executed this Investment Management Trust Agreement
as of the date first written above.

	 	 	 	 	 
	 	CONTINENTAL STOCK TRANSFER &
TRUST COMPANY, as Trustee

 	 
	 	By:  	/s/ Frank A. Di Paolo
 	 
	 	 	Name:  	Frank A. Di Paolo 	 
	 	 	Title:  	CFO 	 
	 
	 	FREEDOM ACQUISITION HOLDINGS, INC.

 	 
	 	By:  	/s/ Nicolas Berggruen
 	 
	 	 	Name:  	Nicolas Berggruen 	 
	 	 	Title:  	President 	 
	 

[Signature Page to Investment Management Trust Agreement]

8

 

EXHIBIT A

[Letterhead of Company]

[Insert date]

Continental Stock Transfer & Trust Company

17 Battery Place, 8th Floor

New York, New York 10004

Attn: Steven Nelson, President

     Re:      Trust Account No. [      ] Termination Letter

Gentlemen:

     Pursuant to Section 1(i) of the Investment Management Trust Agreement between Freedom
Acquisition Holdings, Inc. (the “Company”) and Continental Stock Transfer & Trust Company
(the “Trustee”), dated as of December 28, 2006 (the “Trust Agreement”), this is to
advise you that the Company has entered into an agreement (“Business Agreement”) with
_________ (the “Target Business”) to consummate a business combination with Target
Business (a “Business Combination”) on or about [INSERT DATE]. The Company shall notify
you at least 48 hours in advance of the actual date of the consummation of the Business Combination
(the “Consummation Date”).

     In accordance with the terms of the Trust Agreement, we hereby authorize you to commence
liquidation of the Trust Account to the effect that, on the Consummation Date, all of funds held in
the Trust Account will be immediately available for transfer to the account or accounts that the
Company shall direct in writing on the Consummation Date.

     On the Consummation Date (i) counsel for the Company shall deliver to you written notification
that the Business Combination has been consummated and (ii) the Company shall deliver to you
written instructions with respect to the transfer of the funds held in the Trust Account (the
“Instruction Letter”). You are hereby directed and authorized to transfer the funds held
in the Trust Account immediately upon your receipt of the counsel’s letter and the Instruction
Letter. In the event that certain deposits held in the Trust Account may not be liquidated by the
Consummation Date without penalty, you will notify the Company of the same and the Company shall
direct you as to whether such funds should remain in the Trust Account and distributed after the
Consummation Date to the Company. Upon the distribution of all the funds in the Trust Account
pursuant to the terms hereof, the Trust Agreement shall be terminated.

     In the event that the Business Combination is not consummated on the Consummation Date
described in the notice thereof and we have not notified you on or before the original Consummation
Date of a new Consummation Date, then the funds held in the Trust Account shall be reinvested as
provided in the Trust Agreement on the business day immediately following the Consummation Date as
set forth in the notice.

	 	 	 	 	 
	 	Very truly yours,

FREEDOM ACQUISITION HOLDINGS, INC.

 	 
	 	By:  	
 	 
	 	 	Name:  	 	 
	 	 	Title:  	 	 

 

 

	 	 	 	 	 

EXHIBIT B

[Letterhead of Company]

[Insert date]

Continental Stock Transfer & Trust Company

17 Battery Place, 8th Floor

New York, New York

Attn: Steven Nelson, President

     Re:      Trust Account No. [      ] Termination Letter

Gentlemen:

     Pursuant to Section 1(i) of the Investment Management Trust Agreement between Freedom
Acquisition Holdings, Inc. (the “Company”) and Continental Stock Transfer & Trust Company
(the “Trustee”), dated as of December 28, 2006 (the “Trust Agreement”), this is to
advise you that Company has been dissolved due to the Company’s inability to effect a Business
Combination within the time frame specified in the Company’s prospectus relating to its IPO.
Attached hereto is a certified copy of the Certificate of Dissolution as filed with the Delaware
Secretary of State.

     In accordance with the terms of the Trust Agreement, we hereby authorize you to commence
liquidation of the Trust Account. You will notify the Company and [___] (the
“Designated Paying Agent”) in writing as to when all of the funds in the Trust Account will
be available for immediate transfer (the “Transfer Date”). The Designated Paying Agent
shall thereafter notify you as to the account or accounts of the Designated Paying Agent that the
funds in the Trust Account should be transferred to on the Transfer Date so that the Designated
Paying Agent may commence distribution of such funds in accordance with the Company’s instructions.
You shall have no obligation to oversee the Designated Paying Agent’s distribution of the funds.
Upon the payment to the Designated Paying Agent of all the funds in the Trust Account, the Trust
Agreement shall terminate in accordance with the terms thereof.

	 	 	 	 	 
	 	Very truly yours,

FREEDOM ACQUISITION HOLDINGS, INC.

 	 
	 	By:  	
 	 
	 	 	Name:  	 	 
	 	 	Title:  	 	 

 

 

	 	 	 	 	 

EXHIBIT C

[Letterhead of Company]

[Insert date]

Continental Stock Transfer & Trust Company

17 Battery Place, 8th Floor

New York, New York

Attn: Steven Nelson

     Re:      Trust
Account No. [      ] -
Distribution of Income on Property

     Gentlemen:

     Pursuant to Section 2(b) of the Investment Management Trust Agreement between Freedom Acquisition
Holdings, Inc. (the “Company”) and Continental Stock Transfer & Trust Company (the “Trustee”),
dated as of December 28, 2006 (the “Trust Agreement”), we are requesting for our working capital
purposes that you deliver to us $___representing income earned on the Property from
___to ___. In accordance with the terms of the Trust Agreement, you are hereby
directed and authorized to transfer said amount, less any fees due the Trustee pursuant to Section
3(c) of the Trust Agreement, immediately upon your receipt of this letter to the Company’s
operating account at:

	 	 	 
	Bank:

	 	[_________]
	ABA #:

	 	[_________]
	Account Name:

	 	[_________]
	Account Number:

	 	[_________]
	Reference:

	 	Distribution of Income Earned on Trust Property

	 	 	 	 	 
	 	Very truly yours,

FREEDOM ACQUISITION HOLDINGS, INC.

 	 
	 	By:  	
 	 
	 	 	Name:  	 	 
	 	 	Title:  	 	 

 

 

	 	 	 	 	 

	 	 	 	 	 
	 	 	AUTHORIZED	 
	AUTHORIZED INDIVIDUAL(S)	 	TELEPHONE	 
	FOR TELEPHONE CALL BACK	 	NUMBER(S)	 
	 
	 	 	 	 
	Company:
	 	 	 	 
	 
	 	 	 	 
	Freedom Acquisition Holdings, Inc.

1114 Avenue of the Americas, 41st Floor

New York, New York 10036

Attn: Nicolas Berggruen, President
	 	 	(212) 380-2230	 
	 
	 	 	 	 
	Trustee:
	 	 	 	 
	 
	 	 	 	 
	Continental Stock Transfer & Trust Company

17 Battery Place, 8th Floor

New York, New York 10004

Attn: Steven Nelson, President
	 	 	(212) 509-5150	 

 

 

SCHEDULE A

Schedule
of fees pursuant to Section 3(c) of Investment Management Trust
Agreement between
Freedom Acquisition Holdings, Inc. and

Continental Stock Transfer & Trust Company

	 	 	 	 	 	 	 	 	 	 	 
	 
	 	Fee Item	 	 	Time and Method of Payment	 	 	Amount	 
	 	Initial acceptance fee

	 	 	Initial closing of IPO by
wire transfer
	 	 	$	1,000	 	 
	 	Annual fee

	 	 	First year, initial closing
of IPO by wire transfer;
thereafter on the anniversary
of the effective date of the
IPO by wire transfer or check
	 	 	$	3,000	 	 
	 	Transaction processing fee for

disbursements to Company under

Sections 2(a) and 2(b)

	 	 	Deduction by Trustee from
disbursement made to Company
under Section 2(b)
	 	 	$	250	 	 
	 

	 	 	 	 	 
	Dated: December 28, 2006 	Agreed:

 	 
	 	
 	 
	 	Authorized Officer 	 
	 	Continental Stock Transfer & Trust Co.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.

U.S.
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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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

U.S. Service
Agreement - Page 13 

 

	 	 	 	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

U.S. Service
Agreement - Page 14 

 

	 	 	 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.

 

 

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	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”).

 

 

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Dental US

	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.

 

 

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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.

Xenograft
Distribution Agreement - Page 3

 

 

	 	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

Xenograft
Distribution Agreement  - Page 4

 

 

	 	 	 	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

Xenograft
Distribution Agreement - Page 5

 

 

	 	 	 	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,

Xenograft
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.

Xenograft
Distribution Agreement - Page 7

 

 

	 	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

Xenograft
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

Xenograft
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:

Xenograft
Distribution Agreement - Page 10

 

 

	 	 	 
	 

	 	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.

Xenograft
Distribution Agreement - Page 11

 

 

	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.

Xenograft
Distribution Agreement -  Page 12

 

 

	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.

Xenograft
Distribution Agreement - Page 13

 

 

	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	 	 

Xenograft
Distribution Agreement - Page 14

 

 

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.

 

 

- 2 -

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

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