Document:

EX-10.15  COPY OF DISTRIBUTION AGREEMENT

 

Exhibit
10.15

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 [***].

First Amended International 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
Spine-Tech Inc., a Delaware corporation with offices at 7375 Bush
Lake Road, Minneapolis, Minnesota 55439-2027, U.S.A,
(“Sulzer”).

W I T N
E S S E T H:

WHEREAS, Tutogen collects xenograft and donated allograft tissue from sources throughout
Europe and within the United States, processes such tissue itself or provides such tissue for
processing by others, and distributes xenograft and donated allograft tissue products through
various distributors throughout the world;

WHEREAS, Sulzer manufactures and sells worldwide a line of products used in spinal fusion surgery
and desires to acquire from Tutogen the right to distribute its
xenograft and allograft bone
tissue products worldwide, excluding the United States, for use in spinal applications;

WHEREAS, Tutogen is in principle willing to terminate the right of its existing distributors to
sell xenograft and allograft bone tissue products for spinal
applications and to appoint Sulzer as
its sole and exclusive distributor for such products in such applications on the terms and
conditions set forth herein;

WHEREAS, Tutogen and Sulzer entered into an agreement styled “International Distribution
Agreement,” dated March 8, 2000, pursuant to which Tutogen appointed Sulzer as the exclusive
distributor worldwide, excluding the United States, for
Tutogen’s xenograft and donated allograft
bone tissue products for applications in the spine; and

WHEREAS, Tutogen and Sulzer desire to make a new agreement that will supersede the International
Distribution Agreement dated March 8, 2000;

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

1. Definitions

	 	1.1	 	“Affiliate” shall mean an entity that
controls, is controlled by, or is under
common control with a party. For purposes of this definition, “control” shall
mean the possession, directly or indirectly, of a majority of the voting power of
such entity (whether through ownership of securities or partnership or other
ownership interests, by contract or otherwise); provided that, such entity shall
be deemed an Affiliate only so long as such control continues.
	 
	 	1.2	 	“Contract Year” shall mean the one-year period following the Effective Date of
this Agreement and each one-year period following each anniversary of the
Effective Date of this Agreement.
	 
	 	1.3	 	“Effective Data” of this Agreement shall mean March 8, 2000.
	 
	 	1.4	 	“Field of Use’ shall mean all uses of processed xenograft and donated
allograft bone tissue in and adjoining the human spine.

 

 

	 	1.5	 	“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.
	 
	 	1.6	 	“Products” shall mean the xenograft and allograft 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.
	 
	 	1.7	 	“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, including an
amendment thereto dated 28 June 1999, pursuant to which Tutogen supplies certain human
donor bone tissue to RTI, which RTI processes for use in spinal applications.
	 
	 	1.8	 	“Sub-Territory” shall mean one of the following geographic regions or countries
comprising in part the Territory: [***]
	 
	 	1.9	 	“Territory” shall mean the entire world, exclusive of the United States, its
territories and possessions.
	 
	 	1.10	 	“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 US[***] as follows: US[***]
upon execution of this Agreement and, provided that Tutogen has commenced
delivery of Products to Sulzer in response to Sulzer’s purchase
orders, US[***] on October 1, 2000.

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	 	Support Services. Sulzer agrees to use commercially reasonable efforts to
provide usual and customary support services to the surgeon-customer for the
Products.

First Amended International Distribution
Agreement - Page 2 

 

	 	3.3	 	Instruments. Sulzer shall develop appropriate surgical instruments,
as needed,
to assist the surgeon in implanting each of the Products. Sulzer shall also
develop a standard surgical procedures for implanting the Products. Tutogen
shall assist Sulzer, as necessary, in developing the instruments and surgical
procedures.
	 
	 	3.4	 	Forecasting. Commencing with the third calendar quarter of 2000 and
continuing quarterly thereafter, Sulzer shall provide Tutogen, no later than 15
days prior to each calendar quarter, with a rolling monthly forecast of sales of
the Products for the succeeding 12 months. Sulzer’s forecasts shall specify the
anticipated sales by Product, by Sub-Territory, and by month. Sulzer Shall incur
no liability to Tutogen in the event that actual sales of the Products differ from
Sulzer’s forecasts.
	 
	 	3.5	 	Minimum Annual Product Sales. As consideration tor the exclusive right to sell
the Products in the Territory, commencing with the ninth month of the second
Contract Year and continuing with each Contract Year thereafter, Sulzer and
Tutogen will establish certain minimum annual goals for sales of the Products
during the Contract Year as a means of ensuring that Sulzer is using
reasonable efforts to sell the Products in each sub-territory within
the Territory.
Sulzer and Tutogen agree to confer and mutually agree upon the minimum
annual sales goals in each Sub-Territory for each Contract Year, which shall be
recorded on Schedule 8, during the three-month period commencing with the
sixth month of the second Contract Year. In the event that the sales for the
Products in a Sub-Territory in any Contract Year are less than the goals
established under Schedule B, provided that Sulzer’s failure to meet the
minimum goals is not a result of a Force Majeure as described in Section 9.2,
Tutogen shall have the right, in its sole discretion, to undertake for itself or to
employ the services of an additional third party, on. an exclusive or a non-exclusive
basis, to sell the Product in that Sub-Territory only and for the
Field of Use. Tutogen shall exercise its option, if at all, by giving Sulzer written notice of
its election no later than 60 days following the end of the Contract Year in
question.
	 
	 	3.6	 	Sales Personnel. Sulzer shall use reasonable efforts to train its sales
personnel in techniques for proper use and implantation of the Processed Tissues.

4. Tutogen’s Obligations

	 	4.1	 	Product Supply. Tutogen agrees to use its best efforts
to acquire xenograft and
donor allograft bone tissue, process the tissue using the Tutoplast® process according to
Sulzer’s forecasts for demand for Products, manufacture the Products, and sell the Products
to Sulzer pursuant to purchase orders issued by Sulzer at the
transfer prices to which the
parties shall agree and list in Schedule C attached hereto. Sulzer shall pay the transfer
price to Tutogen within 45 days from the date of Tutogen’s invoice. In no event shall
Tutogen or an Affiliate of Tutogen or a Permitted Successor of Tutogen during the term of
this Agreement supply allograft bone tissue, whether processed or unprocessed, to a Third
Party for further distribution in the Territory for the Field of Use; provided that, Tutogen
shall be permitted to deliver unprocessed allograft bone tissue

First Amended International Distribution
Agreement - Page 3 

 

	 	 	 	pursuant to the RTI Agreement so long as Tutogen’s supply of allograft bone
tissue exceeds the demand for Products under this Agreement.
	 
	 	4.2	 	Termination of Distribution Contracts. Tutogen shall terminate the right of its
existing distributors, excluding [***] to distribute the Products for the Field of Use as
soon as possible after the Effective Date according to the terms of existing distribution
agreements, if any, Schedule D sets forth the dates by which termination of Tutogen’s
existing distributors, excluding [***], shall be effective. Sulzer shall have an immediate
nonexclusive right to sell the Products for the Field of Use in all countries listed in
Schedule D, pending termination of existing distribution agreements, to the extent
permissible under existing distribution agreements. The parties shall consult regarding
Tutogen’s distributors in [***], which together represent a significant portion of
Tutogen’s current revenue from sales of the Products, and Tutogen shall use its best
efforts to accommodate Sulzer’s desired distribution in those countries and terminate
Tutogen’s existing distributors, if so determined by Sulzer after consultation. Tutogen
agrees to insure that any substantial inventory of the Products held by the distributors at
the time of their termination is either returned to Tutogen or transferred to Sulzer.

5. Regulatory Matters

	 	5.1	 	Import Compliance. Tutogen agrees to comply with and maintain compliance
with all governmental rules, regulations, statutes, and other laws of any kind
necessary to acquire xenograft and donor allograft tissue, manufacture the
Products, and deliver the Products to Sulzer within the Territory.
	 
	 	5.2	 	Regulatory Responsibilities. The parties understand that as of the Effective
Date of this Agreement, the Products are regulated by governmental authorities
in most of the countries in the Territory, and Tutogen has obtained approvals
from such regulatory authorities to sell many of the Products in such countries.
As to Products for which Tutogen has not obtained regulatory approval in a
particular country as of the Effective Date, or Products that first become
regulated in a particular country after the Effective Date, Sulzer, at its own cost,
shall be responsible for obtaining regulatory approval for such Product in such
country, as an agent for Tutogen; provided that, Sulzer may elect upon written
inquiry from Tutogen to remove such Product from Schedule A (for purposes
only of the particular country) rather than to seek regulatory approval therefor.
In the event that Sulzer elects to remove a regulated Product from Schedule A
(as to a particular country), Tutogen shall have the right to seek regulatory
approval therefor at its own expense and to sell such Product in the particular
country without obligation to Sulzer under this Agreement.
	 
	 	5.4	 	Clinical Trial Costs. Tutogen agrees to bear all costs related to pre-clinical trials
in support of Sulzer’s efforts to obtain regulatory approval for a Product, Sulzer
agrees to bear all costs related to clinical trials and filing for, obtaining, and
maintaining the regulatory approval.
	 
	 	5.5	 	Ownership of Approvals. Tutogen shall be the record
owner of all regulatory
approvals to sell Products in the Territory and for the Field of Use.

First Amended International Distribution
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6. Trademark License and Product Labeling

	 	6.1	 	License Grant. Tutogen grants Sulzer a nonexclusive license under
Tutogen’s
trademarks, Tutoplast®, Tutobone®, and Spline Line®, to use the trademarks
solely in connection with the Products and the marketing thereof within the
Territory for the Field of Use.
	 
	 	6.2	 	Publication Approvals. Sulzer shall provide Tutogen with samples of all
marketing and other printed materials utilizing a trademark of Tutogen in
advance of publication of the same. Tutogen shall be deemed to have
approved such samples for actual use unless it objects in writing within 10
business days following Sulzer’s delivery of same.
	 
	 	6.3	 	Labeling. Tutogen agrees to include the trademarks of Sulzer on Product
labels
in a manner mutually agreeable to the parties.

7. Term and Termination

	 	7.1	 	Term. This Agreement shall be effective on the Effective Date and
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 cura
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, (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 January 15, 2002
provided that Sulzer shall have given Tutogen written notice of termination at

First Amended International Distribution
Agreement - Page 5 

 

	 	 	 	least 12 months in advance of the termination date. Sulzer’s notice of
termination, if any, shall not relieve Sulzer of the obligation thereafter to make
the payments set forth in Section 2.2 above, and Sulzer’s termination under this
Section 7.4 does not give Sulzer any right to recover payments made prior to the
effective date of termination. In the event that Sulzer shall terminate this
Agreement without cause as provided in this Section 7.4, neither Sulzer nor any
Affiliate of Sulzer shall for a period of one year following the
effective date of
termination enter into an agreement, either directly or indirectly, to own, operate,
advise, or have any interest in any business relating to the Products in the
Territory for the Field of Use.
	 
	 	7.5	 	Reimbursement of Regulatory Expenses. In the event that the Agreement
terminates (i) by reason of Tutogen’s notice of termination under Section 7.1, or
(ii) by reason of Tutogen’s material breach under
Section 7.2, then Tutogen shall be
obligated to reimburse Sulzer’s out-of-pocket expenditures, or a portion thereof as
determined in this Section 7.5, in obtaining or attempting to obtain regulatory
approval for Products under Section 5.2, including the out-of-pocket cost of all
pre-clinical, if any, and clinical trials and other expenses directly related to the
regulatory approval process (the “Clinical Expenses”). For each Product as to which
Sulzer has obtained or attempted to obtain a regulatory approval, Tutogen shall be
obligated to reimburse an amount determined by multiplying the Clinical Expenses for
that Product by the Reimbursement Ratio. The “Reimbursement
Ratio” is
	 
	 		 	[***]
	 
	 		 	[***]
	 
	 		 	[***]
	 
	 		 	[***] The
reimbursement amount shall be paid in three equal annual installments due on the date
of termination, one year after termination, and two years after termination, without
interest.

8. Representations, Warranties, Indemnities, and Limitations of Liability

	 	8.1	 	Tutogen. Tutogen represents and warrants to Sulzer, as follows:

	 	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

First Amended International Distribution
Agreement - Page 6 

 

	 	 	 	does not infringe or violate any valid patent, trademark, or copyright
or any other intellectual property rights of any third party. Tutogen has
disclosed to Sulzer all patents and other intellectual property rights which,
to Tutogen’s knowledge, may have a material effect on Sulzer’s ability to
market the Products.
	 
	 	8.1.4	 	Tutogen has not received notice that the manufacture, use, or sale of
the Products violates any patent rights or any other intellectual
property right or constitutes a misappropriation or misuse of trade
secrets or proprietary information.
	 
	 	8.1.5	 	Tutogen shall promptly notify Sulzer of any claim of infringement or
misappropriation relating to the Products.
	 
	 	8.1.6	 	To the best of Tutogen’s knowledge and belief, Tutogen’s procurement
of donor allograft tissue complies fully with all laws of the country in
which the donor tissue is collected, including all national, regional, and
local laws.
	 
	 	8.1.7	 	To the best of Tutogen’s knowledge and belief, Tutogen possesses all
governmental and other approvals required for the collection and
processing of donor allograft tissue, and Tutogen shall use
commercially reasonable efforts to maintain all such approvals
throughout the term of this Agreement.
	 
	 	8.1.8	 	For a period of 12 months from the date of Tutogen’s delivery to
Sulzer, each Product shall be free from defects in material,
manufacturing, and workmanship, including, but not limited to, disease,
excluding defects caused by the abuse, misuse, neglect, or by
improper testing, handling, storage, or use by a party other than
Tutogen.
	 
	 	8.1.9	 	During the term of this Agreement, except as required by law or by a
pre-existing contractual obligation of Tutogen, Tutogen will not, directly
or through an Affiliate, assign, sell, transfer, convey, or otherwise
alienate in whole or in part any right to receive donated allograft bone
tissue without the prior written agreement of Sulzer.

	 	8.2	 	Liability for Breach of Product Warranty. If any failure to conform to the
representation and warranty set forth in Section 8.1.9 appears within the applicable
warranty period, Tutogen will, at its option and expense, correct any such failure by
either replacing the defective or non-conforming Product or by repairing such Product.
In no event shall the liability of Tutogen in connection with such warranty exceed the
cost of replacing or repairing the defective Product. The foregoing shall constitute the
exclusive remedy of Sulzer and the sole liability of Tutogen whether in contract or in
tort or otherwise relating to a defect of a Product.
	 
	 	8.3	 	Exclusion of Other Warranties. The representations and warranties 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.

First Amended International
Distribution Agreement - Page 7 

 

	 	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 validity 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.
	 
	 	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

First Amended International Distribution
Agreement - Page 8 

 

	 	 	 	attention; (b) allows Sulzer to control the defense or settlement of such
Claim; (c) does not enter into any settlement or compromise of such Claim without
the express authorization of Sulzer; and (d) reasonably cooperates with Sulzer in
the defense of such Claim, subject to Sulzer’s payment of all reasonable
out-of-pocket expenses associated with such cooperation by Tutogen. Tutogen shall
have the right to participate in a non-controlling fashion in such legal proceeding
at its sole expense.
	 
	 	8.6.2	 	No undertaking of Sulzer under this section shall extend to any such alleged
Infringement or violation to the extent that it: (a) arises from adherence to design
modifications, specifications, drawings, or written instructions which Sulzer is
directed by Tutogen to follow, but only if such alleged infringement or violation does
not reside in corresponding Product of Sulzer’s design or selection; or (b) arises
from adherence to instructions to apply Tutogen’s trademark, trade name, or other
company identification; or (c) resides in a Product which is not
of Sulzer’s origin
and which is furnished by Tutogen to Sulzer for use under this Agreement; or (d)
relates to use of Products or other items provided by Sulzer in combination with other
Products or other items, furnished either by Sulzer or others, which combination was
not installed, recommended or otherwise approved by Sulzer. In the foregoing cases
numbered (a) through (d), Tutogen will defend and hold Sulzer harmless, subject to the
same terms and conditions and exceptions stated above with respect to Sulzer’s rights
and obligations under this clause.

	8.7	 	Limitation of Liability to Third Parties. The liability of Tutogen and 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.
	 
	8.8	 	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 First Amended Umbrella Agreement, the First
Amended Option Agreement, the First Amended U.S. Service Agreement, and the First
Amended Processed Tissue Development and

First
Amended International Distribution Agreement - Page 9

 

 

	 	 	 	License Agreement, all between the parties or their
Affiliates, embodies the
final, complete, and exclusive understanding between the parties and supersedes all
previous agreements, understandings, or arrangements between the parties with respect
to its subject matter, including the International Distribution Agreement dated March
8, 2000.
	 
	 	9.1.2	 	The International Distribution Agreement dated March 8, 2000 is hereby cancelled
entirely and superseded by this Agreement.
	 
	 	9.1.3	 	No modification or waiver of any terms or conditions hereof, nor any representations
or warranties will be of any force or effect unless such modification or waiver is in
writing and signed by an authorized officer of the party against whom enforcement is
sought.

	9.2	 	Force Majeure. Neither party will be liable to the other for its failure 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:

If to Tutogen:

Tutogen Medical GmbH

Industriestraße 6,

D-91077 Neunkirchen am Brand

GERMANY

Attention: President and CEO

Telephone: 49 9131 7901-10

Facsimile:   49 9131 7901-12

With a copy to:

Dr. Dirk Lange

Foerster + Rutow

Irrestr. 17-19

90403 Nürnberg

GERMANY

Telephone: 49 (911) 23 569 00

Facsimile:   49 (911) 23 569 11

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If to Sulzer:

Sulzer Spine-Tech Inc.

7375 Bush Lake Road

Minneapolis, Minnesota 55439-2027

U.S.A.

Attention: President

Telephone: 1 (612) 832-5600

Facsimile:   1 (612) 832-6874

With a copy to:

Sulzer
Medica USA Inc.

3 East Greenway Plaza, Suite 1600

Houston, Texas 77046

U.S.A.

Attention: General Counsel

Telephone: 1 (713) 561-6365

Facsimile:   1 (713) 561-6380

	9.4	 	Governing Law. Recognizing that the laws within different international jurisdictions
vary in their content and effect with respect to similar subject matter, and that the parties
desire uniformity and predictability in interpretation and enforcement of this Agreement and
related agreements with International scope made contemporaneously by the parties and their
Affiliates, the parties have agreed to the following provisions regarding applicable law to
govern this Agreement. All matters affecting the interpretation, form, validity, and
performance of this Agreement shall be decided under the laws of Switzerland (without
application of the United Nations Convention on the International Sale of Goods).
	 
	9.5	 	Partial-Invalidity. In the event that any provision of this Agreement will be
unenforceable or invalid under any applicable law or be so held by applicable court decision,
such unenforceability or invalidity will not render this Agreement unenforceable or invalid as
a whole, and, in such event, such provision will be changed and interpreted so as best to
accomplish the objectives of such unenforceable or invalid provision within the limits of
applicable law or applicable court decisions.
	 
	9.6	 	Independent Contractors. Each party will act as an Independent contractor under the
terms of this Agreement. Except as otherwise provided in this Agreement, 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

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	 	 	to the benefit of, and be enforceable by and against, the parties and their
Permitted Successors.
	 
	9.8	 	Compliance With Laws. Notwithstanding other provisions in this Agreement regarding a
failure to comply with laws, in performing this Agreement, each Party shall comply with all
laws and government regulations applicable in a particular country at all times.
	 
	9.9	 	Arbitration.

	 	9.9.1	 	In the event the Parties are unable to resolve any dispute or conflict
arising from or relating to this Agreement within thirty (30) days after it is
formally presented for resolution by written notice, any party may submit such
conflict for resolution to the Chief Executive Officers of the parties.
	 
	 	9.9.2	 	In the event the Chief Executive Officers of the parties are unable to
resolve such conflict within thirty (30) days after having such conflict submitted to
them for resolution, the disputes shall be finally settled under the Rules of
Conciliation and Arbitration of the International Chamber of Commerce in Paris
(“Rules”) by three arbitrators appointed in accordance with the Rules.
	 
	 	9.9.3	 	The place of arbitration shall be Zurich. The procedural law of this place
shall apply where the Rules are silent.
	 
	 	9.9.4	 	The arbitral award shall be substantiated in writing. The arbitral tribunal
shall decide on the matter of costs of the arbitration.
	 
	 	9.9.5	 	The language to be used in the arbitral proceedings shall be English.

	9.10	 	Confidentiality. The parties acknowledge that by reason of their relationship
hereunder, each has had and will continue to have access to certain information and materials
concerning the other’s business, plans, customers, technology, and/or products that is
considered by a party to be confidential (“Confidential Information”) and of substantial value
to that party, which value would be impaired if such information were disclosed to third
parties. To the extent that such information is considered confidential, the disclosing party
will so indicate to the receiving party, in the case of information in documentary or other
tangible form, by labeling it conspicuously as “CONFIDENTIAL” (or words of similar import) and
in the case of information conveyed verbally, by identifying same in writing within ten days
after the first verbal disclosure. Each party agrees that it will not use in any way other
than as expressly authorized or contemplated under this Agreement, nor disclose to any third
party, any such Confidential Information revealed to it by the other party, and will take
commercially reasonable precautions (and will cause its Affiliates to take commercially
reasonable precautions) to protect the confidentiality of such
information and with no less
restrictive precautions than it takes to protect its own confidential Information. Each party
will disclose Confidential Information only to those of its employees who have a need to know
such information. If Confidential information is required to be disclosed in response to an
order by a court or other government body, or if otherwise required to be disclosed by law, or
if necessary to establish the rights of a party under this Agreement, the receiving party
shall use commercially reasonable efforts to provide the disclosing party with advance notice
of such required disclosure to give the

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	 	 	disclosing party sufficient time to seek a protective order or other protective measures,
if any are available, for such Confidential Information. “Confidential Information” does not
include information, materials, technical data or know-how which: (i) is rightfully in the
possession of the receiving party at the time of disclosure as shown by the receiving party’s
files and records immediately prior to the time of disclosure; (ii) prior to or after the time
of disclosure becomes part of the public knowledge or literature, not as a result of any
inaction or action of the receiving party; (iii) is independently developed by a party without
the use of any Confidential Information of the other parties; (iv) is obtained from any third
party who is authorized to disclose such data and information without obligation of
confidentiality, or (v) is approved for release by the
disclosing party. This Section 9.10
shall survive termination of this Agreement for a period of two years.
	 
	9.11	 	Public Relations And Announcements. The parties shall agree upon and issue a press
release upon the signing of this Agreement including a summary of the relationship established
under this Agreement. No party shall issue a press release or any other published statement
that refers to another party, its Affiliates or the other party’s products without first
obtaining the agreement of such other party as to the form and content of the statement, which
approval shall be timely and not unreasonably withheld.

     In witness whereof, the parties have each caused this Agreement to be signed and delivered by
their duly authorized representatives on the dates set forth below in duplicate, each of which will
be treated for all purposes as an original.

	 	 	 	 	 	 	 	 	 
	Tutogen Medical GmbH	 	Sulzer Spine-Tech, Inc.	 	 
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Manfred Krüger
	 	By:
	 	/s/ P. Richard Lunsford
	 	 
	 

	 	 
	 	 	 	 	 	 
	 

	 	Manfred Krüger
	 	 	 	P. Richard Lunsford	 	 
	 

	 	Managing Director
	 	 	 	President	 	 
	 
	 	 	 	 	 	 	 	 
	Date: 29 September, 2000	 	Date: 29 Sept 2000	 	 

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Schedule A — Products

[***]

 

 

Schedule B
— Minimum Sales Goals

[***]

 

 

Schedule C
— Transfer Prices

[***]

 

 

Schedule D
— Termination of Existing Distributors

[***]

 

 

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 [***].

Exclusive License and Distribution Agreement

This
Agreement is made by Tutogen Medical, Inc., a Florida corporation with offices at 1130
McBride Avenue, West Paterson, NJ 07424 (“Tutogen”)
and Centerpulse Spine-Tech Inc., a Delaware
corporation with offices at 7375 Bush Lake Road, Minneapolis, Minnesota 55439-2027, U.S.A.
(“Spine-Tech” or, together with Tutogen, the
“Parties”).

W I T N
E S S E T H:

WHEREAS,
Tutogen and Spine-Tech each acknowledge that the processing and use of Allograft
and Xenograft tissue for human transplantation purposes is in the public interest and in the
interest of medicine generally, and that this Agreement will enhance these interests through
facilitating the availability of processed tissue for use in medical procedures and thereby
advance the medical and scientific application thereof;

WHEREAS, the Parties or their affiliates are parties to a series of agreements, including the
First Amended US Service Agreement, as amended, the First Amended Processed Tissue Development
and License Agreement, the First Amended Option Agreement, the Termination and Option Agreement,
and the First Amended Umbrella Agreement (collectively, the “Prior Agreements”);

WHEREAS, the Parties now wish to redefine the terms governing their relationship by
entering into this Agreement; and

WHEREAS, in performing this Agreement, the Parties intend to engage only in conduct that is in
full compliance with applicable laws and regulations including, but not limited to, the Food and
Drug Administration (FDA) rules pertaining to human and animal tissues for transplantation and
the FDA rules pertaining to medical devices and tissues for transplantation, the American
Association of Tissue Banks (AATB) Standards and the National Organ Transplant Act;

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	 	“Allograft” shall mean donated human cells and/or tissue intended for
transplantation into another human.
	 
	 	1.3	 	“Binding Annual Minimum Forecast” shall have the meaning set forth in Section 3.9.
	 
	 	1.4	 	“Binding Order” shall have the meaning set forth in Section 3.6.
	 
	 	1.5	 	“Biologic Implants” shall mean Xenograft and Allograft bone tissue processed
and manufactured by Tutogen or an Affiliate of Tutogen or a Permitted Successor of Tutogen,
as listed in Exhibit A attached hereto. The parties shall mutually agree as to the addition
of processed tissues to Exhibit A.

CONFIDENTIAL

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	 	1.6	 	“Biologic Implant Category” shall mean any of the categories of Biologic
Implants listed on Exhibit A and any other categories to which the parties may
subsequently agree in writing.
	 
	 	1.7	 	“Effective Date” shall mean the date as of which authorized representatives
of both Parties have executed this Agreement.
	 
	 	1.8	 	“End-User Fee” shall have the meaning set forth in Section 3.5.
	 
	 	1.9	 	“Field of Use” shall mean all uses of processed Xenograft and Allograft bone tissue
in and adjoining the human spine.
	 
	 	1.10	 	“Guaranteed Minimum” shall have the meaning set forth in Section 3.9.
	 
	 	1.11	 	“Medical Devices” shall mean an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar article that is intended for use in
the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or
prevention of disease and that are regulated by the FDA.
	 
	 	1.12	 	“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.
	 
	 	1.13	 	“Prior Agreements” shall have the meaning set forth in the Preamble.
	 
	 	1.14	 	“Ship-In, Ship-Out Kit (“SISO”)” shall mean a kit of multiple sizes or types of
Biologic Implants to be delivered to an end-user for use in surgery, whereby a surgeon can
select the appropriate size Biologic Implant at the time of surgery, with the kit thereafter
returned by the end-user.
	 
	 	1.15	 	“Specialty Biologic Implants” shall mean Biologic Implants within the following
Biologic Implant Categories: ALIF Rings, ALIF Cancellous Blocks, Cervical Specialty
Radius, PLIF, and any other Biologic Implants to which the parties may subsequently agree in
writing.
	 
	 	1.16	 	“Specifications” shall mean the manufacturing, packaging, and storage
specifications for Biologic Implants as agreed in writing between Tutogen and Spine-Tech.
	 
	 	1.17	 	“Spine-Tech Services” shall have the meaning set forth in Section 2.1.
	 
	 	1.18	 	“Termination Date” shall mean March 8, 2010.
	 
	 	1.19	 	“Territory” shall mean the United States, including its territories and
possessions and Canada.
	 
	 	1.20	 	“Traditional Biologic Implants” shall mean all Biologic Implants that are not
Specialty Biologic Implants.
	 
	 	1.21	 	“Transfer Fee” shall have the meaning set forth in Section 3.3.
	 
	 	1.22	 	“Third-Party” shall mean a person or entity other than Tutogen, any Tutogen
Affiliate, Spine-Tech, any Spine-Tech Affiliate or any officer, director, or employee of Tutogen, any
Tutogen Affiliate, Spine-Tech, or any Spine-Tech Affiliate.
	 
	 	1.23	 	“Tutogen Services” shall have the meaning set forth in Section 3.1.
	 
	 	1.24	 	 “Tutogen Licensed Patents” shall mean any and all patents relating to the Biologic
Implants, owned by or licensed to Tutogen (to the extent that a sub-license granted by
Tutogen pursuant to this Agreement is permitted under the respective license granted to

CONFIDENTIAL

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	 	 	 	Tutogen), issued in any country from patent applications filed prior to or during the term
of this Agreement, including all patents maturing from continuations,
continuations-in-part, and divisional applications or reissues or reexaminations of such
patents and patent applications, and further including all patents which are foreign
counterparts of the foregoing patents and patent applications, regardless of whether such
patent matures from a convention or non-convention case, and any other substitution,
renewal, extension, addition, utility model, or other patent, in any country, that claims
priority based on such an application.
	 
	 	1.25	 	“Xenograft” shall mean animal tissue intended for transplantation into a human.

2.
Grant of Rights

	 	2.1	 	Exclusive Distributor Appointment. During the term of this Agreement,
Tutogen hereby appoints Spine-Tech as its exclusive distributor for Biologic Implants for
the Field of Use throughout the Territory. Spine-Tech agrees to use commercially reasonable
efforts to distribute Biologic Implants for the Field of Use throughout the Territory.
Spine-Tech’s distribution services (“Spine-Tech Services”) shall include, without
limitation, (i) developing marketing and training literature and aids for Biologic
Implants; (ii) training Spine-Tech marketing and distribution personnel; (iii) conducting
training courses and seminars to educate medical professionals, surgeons, customer
support staff, hospital personnel and buying groups related to Biologic Implants in the use
of Biologic Implants, including educating surgeons and staff on Biologic Implant design,
ordering, delivery and stocking procedures; (iv) exhibiting Biologic Implants at medical
society meetings; (v) promoting Biologic Implants in association with Spine-Tech’s other
educational services and marketing efforts; (vi) supporting at a clinical level the
marketing and distribution efforts of Tutogen and Spine-Tech by making available surgical
case coverage for Biologic Implants; (vii) proper storage of arid maintenance of a
distribution system for an inventory of Biologic Implants for the purpose of meeting the
clinical needs of surgeons and hospitals; (viii) designing and developing surgical
instruments and surgical techniques for implantation of the Biologic Implants; (ix)
distributing sets of surgical instruments for the surgical implantation of Biologic
Implants; (x) preparing and maintaining records in compliance with Exhibit F; and (xi)
distributing Biological Implants for use in treating injuries to or diseases of the spine.
	 
	 	2.2	 	Covenant of Exclusivity. In no event shall Tutogen or an Affiliate of
Tutogen or a Permitted Successor of Tutogen during the term of this Agreement, either
directly or through a Third-Party distributor, supply Allograft or Xenograft bone
tissue, whether processed or unprocessed, in the Territory for the Field of Use,
subject however to the provisions of the last sentence of Section 3.2.
	 
	 	2.3	 	License Agreement. Subject to the right of Tutogen under license agreements
with third parties to grant sublicenses, Tutogen hereby grants (and will cause its Affiliates
to grant) to Spine-Tech and its Affiliates during the term of this Agreement an exclusive,
fully paid-up license or sublicense, as the case may be, under all Tutogen Licensed Patents
to use and sell the Biologic Implants for the Field of Use throughout the Territory.
	 
	 	2.4	 	Trademark License. Tutogen grants Spine-Tech a nonexclusive license
under Tutogen’s trademarks, Tutoplast®, Spine Line®, and any future trademark
adopted by Tutogen in connection with the Biologic Implants or their processing or
manufacture, to use the trademarks solely in connection with the Biologic Implants
in the performance of Spine-Tech’s Services within the Territory for the Field of Use.

CONFIDENTIAL

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3.
Obligations and Responsibilities of the Parties

	 	3.1	 	Manufacture of Biologic Implants. To the extent that it can do so without
breaching an obligation under a pre-existing agreement Tutogen shall use commercially
reasonable efforts to obtain or procure Xenograft and donor Allograft bone tissue, process
the tissue using the Tutoplast® process, and manufacture the Biologic Implants according to
the Specifications and pursuant to Binding Orders received from Spine-Tech. More
specifically, Tutogen’s services under this Agreement (“Tutogen Services”) include, without
limitation, (i) identifying donors/animals whose tissue is safe to harvest for the treatment
of disease and injuries to human patients; (ii) harvesting, transporting and storing
donor/animal tissue according to all applicable regulations; (iii) separately processing the
harvested tissue from each donor/animal in a manner that eliminates the threat of disease
transmission by cross contamination but preserves the integrity of the tissue for subsequent
implantation (i.e., according to the Tutoplast® process); (iv) machining the processed tissue
in a clean room environment into Biologic Implants suitable for the treatment of human
disease and injury; (v) packaging the Biologic Implants for terminal packaging sterilization
that preserves the integrity and assures the sterility of the implants during storage and
shipment; (vi) establishing and maintaining quality control and tissue traceability records
and procedures designed so that the tissue can be traced from the donor to the end-user
(patient) or other final disposition (the parties recognize that certain of this information
will need to be obtained by Tutogen from other parties, including Spine-Tech); (vii) maintain
tissue reference samples and donor records; (viii) maintain records of customer complaints;
and (ix) storing and transporting the Biologic Implants in a manner that preserves the
efficacy and sterility of the Biologic Implants.
	 
	 	3.2	 	Priority of Supply. The Parties acknowledge and agree that Allograft bone is a
resource of limited supply and that Tutogen’s obligation under this Agreement to deliver
Allograft Biologic Implants to Spine-Tech shall have priority over any obligations of Tutogen
to deliver Allograft bone products outside the Territory so long as Tutogen has not yet
supplied to Spine-Tech [***] of the Biologic Implants subject to the current year’s BMAF (as
defined below). If for a calendar year Tutogen has supplied [***] of the Biologic Implants
covered by that year’s BMAF, then Tutogen shall use all commercially reasonable efforts to
supply additional Biologic Implants to Spine-Tech per Spine-Tech’s Binding Orders and in such
event Tutogen may allocate the supply of Allograft bone products among its customers. In the
event of supply constraints affecting Tutogen’s ability to meet Spine-Tech’s Binding Orders
and the demands of a Spine-Tech Affiliate, Spine-Tech agrees to cooperate with Tutogen and
the Spine-Tech Affiliate in seeking to resolve the matter. Without in any way limiting its
obligations under the first sentence of this section, to the extent that it is first able to
meet Spine-Tech’s forecasted demand for Biologic Implants, Tutogen may supply excess
unprocessed bone tissue to others within the Territory.
	 
	 	3.3	 	Tutogen’s Transfer Fees. Tutogen alone shall specify the appropriate fee (the
“Transfer Fee”) for Tutogen’s services (the parties acknowledge there is no charge associated
with donor tissue, the fee includes the reasonable costs of procuring, processing and
handling such tissue) in making each of the Biologic Implants available to Spine-Tech for
distribution in the Territory. The parties specifically acknowledge that Tutogen’s Transfer
Fee is intended to be reasonable payment for the Tutogen Services. Tutogen’s initial Transfer
Fees, which shall be effective at least through December 31, 2003, are set

CONFIDENTIAL

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	 	 	 	forth in Exhibit B attached hereto. As of January 1, 2004, Tutogen may increase its Transfer
Fees effective 90 days after written notice to Spine-Tech; provided that, Tutogen may
increase a Transfer Fee not more than [***] in any [***] period and by no more than [***] on
Traditional Biologic Implants or [***] on Specialty Biologic Implants in any [***] period,
and further provided that, Tutogen’s Transfer Fee increases shall not be constrained by the
foregoing percentage caps to the extent that such increases are justified to the reasonable
satisfaction of Spine-Tech by increases in Tutogen’s costs (e.g., due to changes in FDA
regulatory requirements or other unforeseen regulatory events) or to the extent that
Spine-Tech increases its End-User Fees by a percentage in excess of the foregoing percentage
caps.
	 
	 	3.4	 	SISO Kits and Consignment Inventory
	 
	 	 	 	3.4.1 In connection with Binding Orders for inventory of Biologic Implants to be used
in Ship-In, Ship-Out Kits (both current and new) or held on
consignment on an end-user’s premises, Tutogen’s Transfer
Fee shall be [***]. The number of SISO kits to be supplied by Tutogen to Spine-Tech for new biologic implants shall be calculated based upon the past
practices of the parties.
	 
	 	 	 	3.4.2. The existing consignment inventory of Tutogen relating to Biologic Implants, as
reflected on Exhibit D will be transferred to Spine-Tech. Spine-Tech will pay to Tutogen
for the Biologic Implants held on consignment, a Transfer Fee equal
to [***].
The amount due based upon Exhibit D shall be adjusted to reflect the results of a physical inventory
conducted at the time of transfer. The parties acknowledge that the value of consignment
inventory each year may increase over the prior year by the corresponding increase in the
BMAF for that year.
	 
	 	3.5	 	Spine-Tech’s End-User Fees. Spine-Tech alone shall specify the appropriate fee (the
“End-User Fee”) for its services in making each of the Biologic Implants available to end
users in the Territory (the parties acknowledge there is no charge associated with donor
tissue, the fee includes the reasonable costs of procuring, processing, handling, marketing,
and distributing such tissue). The parties specifically acknowledge that Spine-Tech’s End-User
Fee is intended to be reasonable payment for the Spine-Tech Services.
	 
	 	3.6	 	Order, Delivery and Inspection. Spine-Tech shall submit written orders (“Binding
Orders”) to Tutogen specifying the type, quantity, and requested delivery date for each
Biologic Implant Spine-Tech desires to receive. Spine-Tech shall submit each Binding Order at
least 90 days prior to the requested delivery date. Tutogen, at its expense, shall use
commercially reasonable efforts to ship the Biologic Implants for delivery to Spine-Tech by
the requested delivery date. Tutogen agrees that all current Biologic Implants shipped by
Tutogen shall have a shelf life of at least 42 months as of the date of shipment. Tutogen
agrees that the shelf life for new Biologic Implants, shall be the greater of (i) 12 months
from the date of irradiation, or (ii) the time period listed on the Biologic Implant’s
packaging measured as of the date of shipment, and the parties acknowledge that the shelf life
of new Biologic Implants (as reflected on its packaging) is expected to increase over time
following the products market introduction. Spine-Tech shall visually inspect Biologic
Implants (without breaching the sterile packaging thereof) and shall return ship to Tutogen
within three weeks from the date of receipt those Biologic Implants found to be not in
conformance with the Specifications along with documentation that the Biologic Implants have
been stored and transported in a manner

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	 	 	 	that preserves their efficacy and sterility. Spine-Tech agrees to remit the Transfer Fee for
Biologic Implants not timely returned as non-conforming.
	 
	 	3.7	 	Invoicing and Payment. Tutogen shall invoice Spine-Tech for the Transfer Fee upon
shipment of the Biologic Implants. Spine-Tech shall pay Tutogen’s invoices within 75 days of
the invoice date.
	 
	 	3.8	 	Quarterly Forecasts. No later than the first business day of each calendar quarter,
Spine- Tech shall provide Tutogen with a rolling monthly forecast of anticipated demand for
the Biologic Implants for the succeeding twelve-month period. Spine-Tech’s forecasts shall
specify the anticipated demand by type of Biologic Implant and by month. Spine-Tech shall
incur no liability to Tutogen in the event that Spine-Tech’s Binding Orders for Biologic
Implants differ from Spine-Tech’s quarterly forecasts, subject however to Spine-Tech’s BMAF
obligations under Section 3.9.
	 
	 	3.9	 	Binding Minimum Annual Forecast.
	 
	 	 	 	3.9.1 As consideration for the exclusive distribution rights granted in Section 2.1,
Spine-Tech will provide Tutogen with a binding minimum annual forecast of annual fees for
Biologic Implants (“Binding Minimum Annual Forecast” or “BMAF”) by the first business day in
October each year. The BMAF shall specify for each Biologic Implant Category (i) a forecast
for the total End-User Fees expected to be received for the year and (ii) the total Transfer
Fees payable to Tutogen based on achievement of [***] of the total forecasted End-User
Fees (the “Guaranteed Minimum”). If Tutogen believes it may not be capable of meeting the
estimated demand for a Biologic Implant Category, it shall notify Spine-Tech in writing of
its objection stating the nature of its objection and the amount it is capable of supplying
for each category to which it objects and the parties shall use reasonable efforts to
resolve the matter. If they are unable to do so the BMAF shall be reduced to reflect the
amount that Tutogen has indicated it is capable of supplying for that Biologic Implant
Category but in no event can the reduction be more than [***]. As a means of ensuring that
Spine-Tech is using commercially reasonable efforts to distribute the Biologic Implants, the
parties agree that the total End-User Fees forecasted in the BMAF for each year shall exceed
by at least [***] the total End-User Fees forecasted in the BMAF for the preceding
year. The BMAF for 2003 is attached hereto as Exhibit E.
	 
	 	 	 	3.9.2 In the event that the total of all Transfer Fees paid to Tutogen for Biologic Implants
in any Biologic Implant Category for a given year is less than the Guaranteed Minimum for
that Biologic Implant Category, provided that Spine-Tech’s failure to achieve the Guaranteed
Minimum is not a result of a Force Majeure as described in Section 8.2 and is not a result of
a failure by Tutogen to deliver on a timely basis Biologic Implants specified by Spine-Tech
in a Binding Order, Spine-Tech shall deliver to Tutogen no later than the first business day
in March of the succeeding year a Binding Order for such Biologic Implants as are necessary
to achieve the Guaranteed Minimum for that Biologic Implant Category. In the event that
Tutogen fails to deliver Biologic Implants within [***] of the date specified
in a Binding Order, then the Guaranteed Minimum for the Biologic Implant Category so
affected shall be reduced by [***] of the Transfer Fees for the number of Biologic Implants
 [***] [***]. In the
event that Tutogen delivers Biologic Implants  [***]  after the
delivery date specified in a Binding Order, then the Guaranteed Minimum for the Biologic
Implant Category so affected shall be reduced by [***] of the Transfer Fees for the number
of Biologic Implants [***].

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	 	 	3.9.3 As security for its obligations with respect to the Guaranteed Minimums,
Spine-Tech agrees to deliver no later than February 15 of each year a written guarantee by
Centerpulse Ltd. (or its successor), substantially in the form
attached hereto as Exhibit C,
for payment of the Guaranteed Minimums for that year. If Spine-Tech fails to deliver the
guarantee by February 15, Tutogen shall request in writing that Spine-Tech provide the
guarantee within 30 days. If Spine-Tech then fails to deliver
the guarantee with such 30
day period, then Tutogen shall be entitled to terminate the Agreement with immediate
effect on written notice to Spine-Tech. Notwithstanding the above, the guarantee for 2003
is to be provided by May 15, 2003.

	3.10	 	Instrumentation. Spine-Tech, at its sole expense, shall be responsible for the design and
manufacture of instrumentation needed for the surgical implantation of the Biologic
Implants.
	 
	3.11	 	Reports. Beginning with the month of May of 2003, Spine-Tech shall provide a monthly
report to Tutogen setting forth the total End-User Fees invoiced in the preceding month
and year-to-date and the average End-User Fee by Biologic Implant Category for the
preceding month and year-to-date. Tutogen shall provide a monthly report to Spine-Tech
setting forth by Biologic Implant Category (i) the number of Biologic Implants currently
in production and (ii) the number of Biologic Implants currently held in inventory. For all
sales prior to May 1, 2003 for which Tutogen has not yet paid Spine-Tech its marketing
fees, Tutogen shall provide a monthly report to Spine-Tech of Spine-Tech customer
accounts receivable aging for Tutogen, by the 15th day of the following month. For all
such sales, Tutogen shall also provide a monthly report to Spine-Tech of cash collected
by Tutogen for Spine-Tech customers, by the 15th day of the following month. Any
marketing fees due Spine-Tech shall be remitted with such report.
	 
	3.12	 	Changes in Tissue Processing and Manufacturing. Tutogen shall notify Spine-Tech in
writing regarding any proposed modifications to its tissue processing procedures or its
Biologic Implant manufacturing process at least 60 days prior to the proposed date for
implementing such modifications (the “Modification Date”). As to any proposed
modification, Spine-Tech shall have a right to approve or disapprove any such proposed
modification based on demonstrable concerns relating to patient safety or the efficacy of
the Biologic Implant; however, Spine-Tech’s approval shall not be unreasonably
withheld, and Spine-Tech shall be deemed to have approved any such modification
proposed by Tutogen if Spine-Tech has not provided Tutogen written notice that it
opposes the modification and the reasons therefore at least 15 days prior to the
Modification Date. Spine-Tech shall have no right of approval under this Section 3.12 if
such modification is required by government laws or regulations.

4. Development of New Biologic Implants

	4.1	 	The Parties either alone or in cooperation with one another may develop new Biologic
Implants. If the parties agree to cooperate in the development of a new Biologic Implant,
they shall agree to a specification, a development schedule and a budget allocating the
costs and responsibilities between them.

5. Regulatory Matters

	5.1	 	Import Compliance. Tutogen agrees to comply with and maintain compliance with all
applicable governmental rules, regulations, statutes and other laws of any kind necessary

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	 	 	to manufacture, import into and distribute the Biologic Implants within the Territory,
including, without limitation, FDA laws, regulation and guidance, including the then
current Good Tissue Practices Regulations), the National Organ Transplant Act, the
AATB Standards and other generally accepted industry standards.
	 
	5.2	 	Medical Device Approvals. The parties understand that as of the date of this Agreement,
Biologic Implants made from processed Xenograft tissues, are a Medical Device. In the
event that a Xenograft processed tissue is added as a Biologic Implant, or in the event
that the FDA commences regulation of Allograft Biologic Implants as a Medical Device
or other matter subsequent to the Effective Date, Spine-Tech, as agent for Tutogen, shall
be responsible for assisting Tutogen in obtaining and maintaining approval from the FDA
to make such regulated Biologic Implant available in the Territory for the Field of Use,
including the conduct of preclinical studies and clinical trials, as provided in Section 5.3,
and the preparation and filing of all applications, reports, and other documents for the
FDA; provided that, Spine-Tech may elect within 90 days following the effective date of
such FDA regulation to remove such regulated Biologic Implant from Schedule A rather
than to seek approval therefore from the FDA. Spine-Tech’s election to remove a
regulated Biologic Implant from Schedule A shall not be a basis for termination of the
Agreement by Tutogen. In the event that Spine-Tech elects to remove a regulated
Biologic Implant from Schedule A, Tutogen shall have the right to seek FDA approval
therefore at its own expense and to make such processed tissue available to users without
obligation to Spine-Tech under this Agreement.
	 
	5.3	 	Costs for Clinical Studies. In the event that Spine-Tech agrees to undertake regulatory
approval for a Biologic Implant as a Medical Device, Tutogen agrees to bear all costs
related to pre-clinical studies in support of Spine-Tech’s efforts to obtain FDA approvals
for Biologic Implants. Spine-Tech agrees to bear all other costs, including the costs for
all clinical trials and the costs for preparation and filing of all applications, reports, and
other documents for obtaining and maintaining the approvals.
	 
	5.4	 	Ownership of Approvals. Tutogen shall be the record owner of all FDA approvals to
make regulated Biologic Implants available in the Territory for the Field of Use.
	 
	5.5	 	Assistance to Spine-Tech. Tutogen, at its own expense, agrees to provide such assistance
and support to Spine-Tech, as Spine-Tech may reasonably request in the performance of
Spine-Tech’s obligations under this Section 5.
	 
	5.6	 	Regulatory Requirements for Distributors. Spine-Tech agrees to comply with Tutogen’s
Regulatory Requirements for Distributors, as set forth in Exhibit F attached hereto and
other applicable laws or regulations. To the extent that a requirement in the attached
Regulatory Requirements for Distributors conflicts with a term in the body of this
Agreement, the term in the body of this Agreement shall control over the term in the
attached Regulatory Requirements for Distributors.
	 
	5.7	 	Complaint-Handling Procedures. Each Party shall notify the other in writing within five
business days, or earlier if required by applicable law or regulation, following receipt of
notice of a complaint (including an actual or potential adverse event) regarding a
Biologic Implant, whether distributed by Spine-Tech or another distributor, including
copies of any documentation received in connection with the complaint. Tutogen shall be
responsible for investigating, monitoring, reporting and resolving all complaints from
surgeons, hospitals and patients related to a Biologic Implant, including the preparation
and filing of any Medical Device reports or other adverse event report with appropriate
regulatory agencies. Within 30 days, or in the case of (iii) below, within 5 days,
following Spine-Tech’s request, Tutogen shall provide Spine-Tech (i) with a report

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	 	 	listing all complaints related to specified Biologic Implants for a specified period, or (ii)
with a report describing the resolution or current status of a specific complaint, or (iii)
with specific tissue donor information, subject to Tutogen’s compliance with its
obligations relating to donor confidentiality. Spine-Tech shall provide reasonable
assistance and cooperation to Tutogen in the handling of complaints.
	 
	5.8	 	Policies and Procedures. Each Party shall have coordinated policies and procedures for
handling Biologic Implants covered by this Agreement for: (i) customer complaints; (ii)
the reporting and investigation of errors and accidents that may affect the safety, purity,
or potency of a product; (iii) implementation of corrective and preventive action; product
process investigations; (iv) adverse outcome; and (v) product recalls. These procedures
shall outline notification timelines that are consistent with all applicable laws and
regulation. Upon written request a party shall make such policies and procedures
available to the other party for review and comment.
	 
	5.9	 	Product Recalls. In the event of a recall of Biologic Implants due solely to the fault or
actions of one party, such party shall bear the entire costs of the recall. In all other cases,
the costs shall be borne equally.

6. Term and Termination

	6.1	 	Term. This Agreement shall be effective on the Effective Date and shall remain in effect
through the Termination Date, unless sooner terminated according to the terms set forth
in this Agreement. On the Termination Date and each succeeding anniversary of the
Termination Date, this Agreement shall renew automatically for successive one-year
terms unless one party gives the other party written notice of termination at least 12
months in advance of the renewal date.
	 
	6.2	 	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; provided that, if a party attempts
without the prior written consent of the other party to assign its rights, interests, duties, or
obligations under this Agreement to a Third Party in violation of Section 8.7, then the
other party shall have the right to terminate this Agreement immediately on written notice
with no obligation to await final resolution of an arbitration proceeding, and the first
party may seek emergency relief in the courts, notwithstanding such party’s obligation to
arbitrate disputes arising from this Agreement.
	 
	6.3	 	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

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	 	 	an assignment for the benefit of creditors, or (iii) upon such other party’s dissolution or
ceasing to do business.
	 
	6.4	 	Termination Without Cause. Spine-Tech shall have the right to terminate this Agreement
without cause at any time; provided that, Spine-Tech shall have given Tutogen written
notice of termination at least 12 months in advance of the termination date. In the event
that Spine-Tech terminates this Agreement without cause as provided in this Section 6.4,
neither Spine-Tech nor any Affiliate of Spine-Tech 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
Biologic Implants in the Territory for the Field of Use.
	 
	6.5	 	Interruption of Donor Availability. Notwithstanding the Force Majeure provision in
Section 8.2, in the event that Tutogen is unable to supply Biologic Implants for a
continuous period of six months because Tutogen, for whatever reason, is unable to
obtain tissue donors, Spine-Tech shall have the right to terminate
this Agreement. In the
event that Spine-Tech terminates this Agreement pursuant to this Section 6.5, Tutogen
shall be entitled to retain any payments made by Spine-Tech.
	 
	6.6	 	Reimbursement of Regulatory Expenses. In the event that the Agreement terminates (i)
by reason of Tutogen’ s notice of termination under Section 6.1, or (ii) by reason of
Tutogen’s material breach under Section 6.2, then Tutogen shall be obligated to
reimburse Spine-Tech’s out-of-pocket expenditures, or a portion thereof as determined in
this Section 6.6, in obtaining or attempting to obtain regulatory approval for Biologic
Implants under Section 5.2, including the out-of-pocket cost of all pre-clinical, if any, and
clinical trials and other expenses directly related to the regulatory approval process (the
“Clinical Expenses”). For each Biologic Implant as to which Spine-Tech has obtained or
attempted to obtain a regulatory approval, Tutogen shall be obligated to reimburse an
amount determined by multiplying the Clinical Expenses for that Biologic Implant by the
Reimbursement Ratio. The “Reimbursement Ratio” is
	 
	 	 	[***]
	 
	 	 	[***]
	 
	 	 	[***]
	 
	 	 	[***] The reimbursement amount shall be paid in
three equal annual installments due within 60 days of the date of termination, one year
after termination, and two years after termination, without interest.
	 
	6.7.	 	Post-Termination Inventory. Upon termination of this
Agreement, Spine-Tech shall have
the right to distribute its remaining inventory of Biologic Implants.

7. Representations, Warranties, Indemnities, and Limitation of Liabilities

	7.1	 	Tutogen. Tutogen represents and warrants to Spine-Tech, as follows:

	 	7.1.1	 	Tutogen has the corporate power and authority to execute and deliver this
Agreement and to perform its obligations hereunder, and the execution,

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	 	 	 	delivery, and performance of this Agreement have been validly authorized by
Tutogen.
	 
	 	7.1.2	 	Tutogen has the right to grant to
Spine-Tech the rights and licenses granted in
this Agreement.
	 
	 	7.1.3	 	As of the effective 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 Biologic Implants 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 Spine-Tech all patents and other intellectual property rights
which, to Tutogen’s knowledge, may have a material effect on Spine-Tech’s
ability to make available the Biologic Implants.
	 
	 	7.1.4	 	Tutogen has not received notice that the processing of, use of, or collection of
 fees related to the Biologic Implants violates any patent rights or any other
intellectual property right or constitutes a misappropriation or misuse of trade
secrets or proprietary information.
	 
	 	7.1.5	 	Tutogen shall promptly notify Spine-Tech of any claim of infringement or
misappropriation relating to the Biologic Implants.
	 
	 	7.1.6	 	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.
	 
	 	7.1.7	 	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.
	 
	 	7.1.8	 	To the best of Tutogen’s knowledge and belief, Tutogen’s distribution of the
Biologic Implants as contemplated under this Agreement complies fully with
the United States National Organ Transplant Act, 42 U.S.C. section 274e.
Tutogen shall give Spine-Tech 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.
	 
	 	7.1.9	 	With respect to the Biologic Implants listed on Exhibit A, as of the Effective
Date, for a period of at least 42 months from the date of Tutogen’s shipment
to Spine-Tech, each Biologic Implant 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. With respect
to new Biologic Implants, for a period which is the greater of (i) 12 months
from the date of irradiation, or (ii) the time period listed on the Biologic
Implant’s packaging measured as of the date of shipment, each such new
Biologic Implant 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.

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	 	7.1.10	 	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 which will or may affect Tutogen’s commitment to meet its obligations under
this Agreement without the prior written agreement of Spine-Tech, provided however, that Tutogen
may reject Allograft bone tissue that is not within its specifications.

	7.2	 	Liability for Breach of Biologic Implant Warranty. If any failure to conform to
the representation and warranty set forth in Section 7.1.9 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 Biologic Implant or by repairing such Biologic Implant. In no event
shall the liability of Tutogen in connection with such warranty exceed the cost of replacing or
repairing the defective Biologic Implant. The foregoing shall constitute the exclusive remedy of
Spine-Tech and the sole liability of Tutogen whether in contract or in tort or otherwise relating
to a defect of a Biologic Implant.
	 
	7.3	 	Exclusion of Other Warranties. The representations and warranties stated in
Section 7.1 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 Biologic Implant.
	 
	7.4	 	Spine-Tech. Spine-Tech represents and warrants to Tutogen, as follows:

	 	7.4.1	 	Spine-Tech 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 Spine-Tech.

	7.5	 	Indemnity by Tutogen.

	 	7.5.1	 	Tutogen shall defend, indemnify, and hold harmless Spine-Tech 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
Spine-Tech: (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 Spine-Tech.
Spine-Tech shall have the right to participate in a non-controlling fashion in such legal
proceeding at its sole expense.
	 
	 	7.5.2	 	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 Spine-Tech to
follow, but only if such alleged infringement or violation does not reside in a corresponding
Biologic Implant

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of Tutogen’s design or selection; or (b) arises from adherence to instructions to apply
Spine-Tech’s trademark, trade name, or other company identification; or (c) resides in a Biologic
Implant which is not of Tutogen’s origin and which is furnished by Spine-Tech to Tutogen for use
under this Agreement; or (d) relates to use of Biologic Implants or other items provided by Tutogen
in combination with other Biologic Implants 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), Spine-Tech 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.

	7.6	 	Indemnity by Spine-Tech.

	 	7.6.1	 	Spine-Tech 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
Spine-Tech of any of its representations or warranties contained herein; or (ii) negligence, gross negligence, or
intentionally wrongful acts or omissions on the part of Spine-Tech;
provided that Tutogen: (a)
promptly notifies Spine-Tech in writing of any such Claim which comes to its attention; (b) allows
Spine-Tech 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 Spine-Tech; and (d)
reasonably cooperates with Spine-Tech in the defense of such Claim, subject to Spine-Tech’s payment
of ail 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.
	 
	 	7.6.2	 	No undertaking of Spine-Tech 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 Spine-Tech is directed by Tutogen to
follow, but only if such alleged infringement or violation does not reside in a corresponding
Biologic Implant of Spine-Tech’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
Biologic Implant which is not of Spine-Tech’s origin and which is furnished by Tutogen to
Spine-Tech for use under this Agreement; or (d) relates to use of Biologic Implants or other items
provided by Spine-Tech in combination with other Biologic Implants or other items, furnished either
by Spine-Tech or others, which combination was not installed, recommended or otherwise approved by
Spine-Tech. In the foregoing cases numbered (a) through (d), Tutogen will defend and hold
Spine-Tech harmless, subject to the same terms and conditions and exceptions stated above with
respect to Spine-Tech’s rights and obligations under this clause.

	7.7	 	 Limitation of Liability to Third Parties. The liability of Tutogen and Spine-Tech
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 7.

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	    7.8	 	Exclusion of Consequential Damages. Neither Tutogen nor Spine-Tech 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.	 	Miscellaneous Provisions
	 
	    8.1	 	Entire Agreement.

	 	    8.1.1	 	This Agreement 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.
	 
	 	    8.1.2	 	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.

	    8.2	 	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 Biologic Implant), failure of suppliers,
acts of terrorism, 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.
	 
	    8.3	 	Notices. All notices concerning this Agreement will be written in the English
language and will be deemed to have been received (a) two days after being properly sent by commercial overnight
courier, or (b) one day after being transmitted by confirmed facsimile, in each case addressed to
the address below:

If to Tutogen:

Tutogen Medical, Inc.

1130 McBride Avenue, Third Floor

West Paterson, NJ 07424

Attention: President and CEO

Telephone: (973) 785-0004

Facsimile:  (973) 785-1930

With a copy to:

Tutogen Medical GmbH

Industriestrabe 6,

D-91077 Neunkirchen am Brand

GERMANY

Attention: Managing Director

Telephone: 49 (9134) 9988 110

Facsimile:  49 (9134) 9988 119

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If to Spine-Tech:

Centerpulse Spine-Tech Inc.

7375 Bush Lake Road

Minneapolis, Minnesota 55439-2027

Attention: President

Telephone: (952) 832-5600

Facsimile:   (952) 832-6874

With a copy to:

Centerpulse Spine-Tech Inc.

7375 Bush Lake Road

Minneapolis, Minnesota 55439-2027

Attention: Vice President — Legal

Telephone: (952) 832-5600

Facsimile:   (952) 832-6874

	 	8.4	 	Governing Law. All matters affecting the interpretation, form, validity, and
performance of this Agreement shall be decided under the laws of the State of Florida, without
application of principles of conflicts of laws.
	 
	 	8.5	 	 Partial Invalidity. In the event that any provision of this Agreement will be
unenforceable or invalid under any applicable law or be so held by applicable court decision, such
unenforceability or invalidity will not render this Agreement unenforceable or invalid as a whole,
and, in such event, such provision will be changed  and interpreted so as best to accomplish
the objectives of such unenforceable or invalid provision within the limits of applicable law or
applicable court decisions. In addition, in the event that a regulatory or other governmental
enforcement authority determines that the Parties’ relationship or the fees paid to the parties in
connection with the Biologic Implants are improper, the Parties agree that this Agreement shall be
reformed to the extent necessary to render the relationship or fees proper.
	 
	 	8.6	 	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.
	 
	 	8.7	 	 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 8.7 will be void and of no
effect. Subject to this Section 8.7, this Agreement shall be binding upon, inure to the benefit of,
and be enforceable by and against, the parties and their Permitted Successors.
	 
	 	8.8	 	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 state and
federal laws and government regulations at all times, including but not limited to the National
Organ Transplant Act and any applicable laws and all

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	 	 	FDA regulations that pertain to Allograft or
Xenograft tissues for transplantation. The Parties understand and agree that both will operate in
conformity with all AATB current standards of practice when such standards are not in contravention
to any federal, state or local law. In addition, the Parties agree that their conduct and the
performance of their obligations hereunder shall be strictly in accordance with all conditions set
forth on any applicable donation consent form that was obtained and executed in connection with the
provision of tissue pursuant to this Agreement and of which a Party has prior notice.
	 
	8.9	 	Arbitration. 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 to the other, any party may submit such conflict for
resolution to the Chief Executive Officers of the parties. 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 resolved by binding
arbitration before a single arbitrator conducted according to the Rules for Non-Administered
Arbitration of Commercial Disputes of the Center for Public Resources. The arbitration proceeding
shall be conducted in New York, New York.
	 
	8.10	 	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 Biologic Implants 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.

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	 	8.11	 	Inspections. Tutogen and Spine-Tech each agree to allow the other to inspect
their respective facilities and review their respective procedures and methods of operation with
respect to their obligations under this agreement once every twelve months. Any such inspection
must be during normal business hours, upon reasonable notice, and scheduled at a mutually
convenient time. The party conducting the inspection shall provide reasonable advance notice of its
desire to inspect; the nature of the inspection; and identify the staff that will perform the
inspection. During the inspection such party agrees to maintain in confidence any information
obtained or observed as part of such inspection and conduct themselves in such a manner as to
minimize the disruption to day-to-day operations.
	 
	 	8.12	 	Disposal of Tissue. If Allograft or Xenograft bone tissue provided under this
Agreement is deemed by Spine-Tech as not acceptable for transplantation, Spine-Tech is authorized
to dispose of the tissue in accordance with applicable law and regulations.
	 
	 	8.13	 	Signatures and Counterparts. Signatures of the parties may be transmitted via facsimile
and this agreement may be executed in one or more counterparts each of which shall be an original
and all of which shall constitute together the same document.
	 
	 	9.	 	Provisions Related to Transition from the Prior Agreements
	 
	 	9.1	 	Termination of the Prior Agreements. As of the Effective Date, the Prior
Agreements shall terminate and cease to be of any force or effect except as provided in this
Section 9.
	 
	 	9.2	 	Fees Due Spine-Tech. Any Service Fees owed by Tutogen as of the Effective Date shall be
remitted to Spine-Tech within thirty (30) days after Tutogen collects the underlying outstanding
receivable from the end user. Upon reasonable notice to Tutogen, Spine-Tech shall have the right to
have an independent certified public accountant, selected by Spine-Tech and reasonably acceptable
to Tutogen, audit Tutogen’s records during normal business hours to verify all records pertaining
to the calculation of the Service Fee; provided, however, that such audit shall not take place more
frequently than once a year and shall not cover records for more than the preceding four (4) years.
Any such audit shall be at the expense of Spine-Tech 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. In addition, Spine-Tech may offset its
obligations under Sections 9.3 and 9.4
below against any fees due Spine-Tech by Tutogen, such offset not to exceed $300,000.
	 
	 	9.3	 	Existing Ship-In, Ship-Out Inventory. Spine-Tech agrees to submit a Binding Order to
purchase Tutogen’s existing inventory of Ship-In, Ship-Out Kits as detailed in Exhibit D. The
Transfer Fee for this inventory shall be [***] Payment terms shall be
[***].
	 
	 	9.4	 	Consignment Inventory. The Parties acknowledge that as of the Effective Date Tutogen
has entered into and maintains certain obligations with respect to agreements with certain end
users relating to consignment of Biologic Implants to such end users, as reflected on Exhibit D.
The Parties hereby agree that Tutogen will continue to administer such agreements for a period of
up to 90 days following the Effective Date, during which time Spine-Tech will arrange with the end
users to assume responsibility for such consignment inventory. Tutogen agrees to cooperate with
transition of its consignment obligations to Spine-Tech. Tutogen’s Transfer Fee in connection with
existing consignment inventory shall be [***].

CONFIDENTIAL

- 17 -

 

	9.5	 	Outstanding Marketing Fees. Upon execution, any then outstanding marketing fees
due Spine-Tech will be remitted by Tutogen only upon collection of the underlying outstanding
receivable from the tissue user. Tutogen agrees to use reasonably diligent efforts to collect such
amounts.
	 
	9.6	 	Outstanding Service Fees. The parties agree to use reasonable efforts to resolve within the
next 45 days, the issue of the outstanding service fees due Spine-Tech from Tutogen for
services prior to the Effective Date. The parties also acknowledge that the offset of up to
$300,000 per Section 9.2 is not an admission by Tutogen that such amount is due to Spine-Tech.

This space intentionally left blank

CONFIDENTIAL

- 18 -

 

     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.	 	 	 	Centerpulse Spine-Tech, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Manfred Krüger
	 	 	 	By:
	 	/s/ Michael McCormick	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	Manfred Krüger, President

and Chief Executive Officer	 	 	 	Michael McCormick, President	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date: 10.04.03	 	 	 	Date: 4/8/03	 	 

CONFIDENTIAL

- 19 -

 

Exhibit A — Biologic Implants

	 	 	 	 	 
	Category	 	Item	 	Description
	 
	[***]
	 	[***]	 	[***]

 

EXHIBIT B — INITIAL TRANSFER FEES

[***] 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

			
	Page 1 of 2
	 	TTG 2003 Contact Exhibit B — Transfer Fees.xls

 

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 [***].

Amendment to Exclusive License and Distribution Agreement

This Amendment (this “Amendment”) amends that certain Exclusive License and
Distribution Agreement dated on or around April 8, 2003 between
Tutogen Medical, Inc., a
Florida corporation with offices at 1130 McBride Avenue, West Paterson, NJ 07424
(“Tutogen”) and Zimmer
Spine, Inc. (f/k/a Centerpulse Spine-Tech Inc.), a Delaware
corporation with offices at 7375 Bush Lake Road, Minneapolis, Minnesota 55439-2027, U.S.A.
(“Zimmer Spine” or, together with Tutogen, the “Parties”) (the “Original Agreement”),

W I T N E S S E T H:

WHEREAS, the Parties wish to amend the Original Agreement by entering into this
Amendment;

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

1. Amendments to Definitions

	1.1	 	References throughout the Original Agreement to “Spine-Tech” shall be deleted and
replaced with “Zimmer Spine”.
	 
	1.2	 	Sections 1.3 and 1.16 shall each be amended and restated in their entirety to read as
follows:

	 	1.3	 	“Annual Minimum Forecast” or
“AMF” shall have the meaning set forth in Section 3.9.
	 
	 	1.16	 	“Specifications” shall mean the manufacturing, packaging, and
storage specifications for Biologic Implants as set forth in Exhibit G
and as agreed in writing by authorized representatives of Tutogen and
Zimmer Spine.

	1.3	 	References throughout the Original Agreement to “Binding Annual Minimum Forecast”
or “BMAF” shall be deleted and replaced with “Annual Minimum Forecast”.
	 
	1.4	 	A new definition shall be added in Section 1.26 to read as follows:

	 	1.26	 	“Steering Committee” shall mean a standing committee
made up of representatives of both Parties, made up of three (3)
senior representatives from each Party, and representing, to the
extent feasible, the (i) sales/marketing, (ii) operations and (iii)
business development or finance functions of each Party.

2. Amendments in Section 3

	2.1	 	Section 3.3 shall be amended and restated in its entirety to read as follows:

	 	3.3	 	Tutogen’s Transfer Fees. Tutogen alone shall specify
the appropriate fee (the “Transfer Fee”) for Tutogen’s services (the parties
acknowledge there is no charge associated with donor tissue, the fee
includes the

	 	 	 
	CONFIDENTIAL	 	Amendment to Exclusive License and Distribution
Agreement - Page 1

 

 

	 	 	 	reasonable costs of procuring, processing and handling such tissue) in making
each of the Biologic Implants available to Zimmer Spine for distribution in the
Territory. The parties specifically acknowledge that Tutogen’s Transfer Fee is
intended to be reasonable payment for the Tutogen Services. Tutogen’s initial
Transfer Fees, which shall be effective at least through
December 31, 2005, are set
forth in Exhibit B attached hereto. As of January 1, 2006.
Tutogen may increase its
Transfer Fees effective 90 days after written notice to Zimmer Spine; provided that
such increases are justified to the reasonable satisfaction of Zimmer Spine by
increases in Tutogen’s costs (e.g. due to changes in FDA
regulatory requirements,
other unforeseen regulatory events, or due to cost increases in tissue sourcing).
If Zimmer Spine has been able to increase its End-User Fees over the prior year’s
End-User Fees, then Tutogen may increase its Transfer Fee utilizing the same
percentage increase as Zimmer Spine’s rate increase. If Zimmer Spine’s End-User
Fees decrease from the prior year, Tutogen will negotiate in good faith a
proportionate reduction in the Transfer Fees.

	2.2	 	Section 3.4 shall be deleted in its entirety.
	 
	2.3	 	In Section 3.6, the fourth sentence shall be deleted and replaced with the following:
	 
	 	 	Tutogen agrees that all Biologic Implants shipped by Tutogen shall have a shelf life
of at least 30 months as of the date of shipment, provided that Zimmer Spine may, by
mutual agreement with Tutogen, accept product with a lower shelf life.
	 
	2.4	 	In Section 3.7, the second sentence shall be deleted and replaced with the following:
	 
	 	 	Zimmer Spine shall pay Tutogen’s invoices within 75 days of the invoice date or sooner if
so mutually agreed by the parties, subject to offset for any product returns pursuant to
Section 3.6 that have not already been credited.
	 
	2.5	 	Section 3.8 shall be amended and restated in its entirety to read as follows:

	 	3.8	 	Monthly Forecasts. No later than the first business day of each
calendar month, Zimmer Spine shall provide Tutogen with a rolling monthly forecast
of anticipated demand for the Biologic Implants for the succeeding twelve-month
period. Zimmer Spine’s forecasts shall specify the anticipated demand by type of
Biologic Implant and by month. The first four (4) months of each rolling forecast
shall be binding on Zimmer Spine and shall be confirmed by appropriate Binding
Orders, but with respect to any rolling forecast Zimmer Spine shall incur no
liability to Tutogen with regards to the last eight (8) months thereof, subject
however to Zimmer Spine’s Annual Minimum Forecast obligations under Section 3.9.

	 	 	 
	CONFIDENTIAL	 	Amendment to Exclusive License and Distribution
Agreement - Page 2

 

 

	2.6	 	Section 3.9 shall be amended and restated in its entirety to read as follows:

	 	3.9	 	Annual Minimum Forecast.

	 	3.9.1	 	The rolling forecast provided by Zimmer Spine with respect to any
12-month period beginning in January will constitute Zimmer Spine’s annual minimum
forecast of annual fees for Biologic Implants (“Annual Minimum Forecast” or
“AMF”). Such AMF shall specify for each Biologic Implant
Category (i) a
forecast for the total End-User Fees expected to be received for the year and (ii)
the total Transfer Fees payable to Tutogen based on achievement of [***] of the
total forecasted End-User Fees (the “Guaranteed Minimum”). If Tutogen believes it
may not be capable of meeting the estimated demand for a Biologic Implant Category,
it shall notify Zimmer Spine in writing of its objection stating the nature of its
objection and the amount it is capable of supplying for each category to which it
objects. Zimmer Spine will then revise its AMF based on Tutogen’s projected
capabilities and submit a revised AMF to Tutogen. The parties shall use reasonable
efforts to resolve the matter. If they are unable to do so then Zimmer Spine’s
latest revised AMF shall go into effect for the following year. As a means of
ensuring that Zimmer Spine is using commercially reasonable efforts to distribute
the Biologic Implants, the parties agree that the total End-User Fees forecasted in
the AMF for each year for a given product mix shall exceed the total End-User Fees
forecasted in the AMF for the preceding year for the same product mix by a
proportion equal at least to the growth rate of the market for the same product
mix, as measured by Millennium or another major third party source acceptable to
both Parties; and Zimmer Spine shall be deemed to have satisfied its obligations so
to use commercially reasonable efforts upon achievement of such target.
	 
	 	3.9.2	 	In the event that the total of all Transfer Fees paid to Tutogen for
Biologic Implants for a given year is less than the Guaranteed Minimum,
provided that Zimmer Spine’s failure to achieve the Guaranteed
Minimum is not a result of a Force Majeure as described in Section 8.2
and is not a result of a failure by Tutogen to deliver on a timely basis
Biologic Implants specified by Zimmer Spine in a Binding Order,
Zimmer Spine shall deliver to Tutogen no later than the first business
day in March of the succeeding year a Binding Order for such Biologic
Implants as are necessary to achieve the Guaranteed Minimum.
Notwithstanding the foregoing, in lieu of delivery of such a Binding
Order Zimmer Spine may, at its option, make a cash payment to Tutogen
equal to [***] of the shortfall in full satisfaction of its obligation under
the first sentence of this Section 3.9.2.
	 
	 	3.9.3	 	Instrumentation. Zimmer Spine, at its sole expense, shall be responsible
for the design and manufacture of instrumentation needed for the surgical implantation of the Biologic Implants.
	 
	 	3.9.4	 	Waiver of 2005 AMF. For purposes of clarification, the Parties confirm
that it is their intent to waive the AMF for 2005 in order to permit the Parties to reconcile/rationalize inventories and product offerings.

	 	 	 
	CONFIDENTIAL	 	Amendment to Exclusive License and Distribution
Agreement - Page 3

 

 

     2.7 Section 3.11 shall be deleted in its entirety and replaced with the following:

	 	3.11	 	Reports. Beginning with the month of August 2005, contemporaneously with
delivery of the forecast described in Section 3.8, Zimmer Spine shall deliver to
Tutogen a monthly report that sets forth year-to-date sales information and
current inventory levels, in each case broken down by part number or product
family. In addition, within one week of receipt of a purchase order from Zimmer
Spine, Tutogen shall deliver to Zimmer Spine a written order acknowledgment
on Tutogen letterhead.

4. Amendment in Section 8

	 	Section 8.9 shall be amended and restated in its entirety to read as follows:

	 	8.9	 	Dispute Resolution. Any dispute or conflict arising from or
relating to this Agreement shall initially be referred by either party to the
Steering Committee for resolution. In the event that the Steering Committee is
unable to resolve such dispute or conflict within thirty (30) days after it is
formally presented for resolution, either Party may submit such conflict for
resolution to the Chief Executive Officers of the Parties. 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 resolved by binding arbitration before a single arbitrator conducted
according to the Rules for Non-Administered Arbitration of Commercial Disputes of
the Center for Public Resources. The arbitration proceeding shall be conducted in
New York, New York.

5. Amendments to Certain Exhibits

	 	With regard to the Exhibits attached to the Original Agreement:

	 	(i)	 	The Parties intend to amend and restate Exhibit A in its entirety to a
form to be mutually agreed by the Parties.
	 
	 	(ii)	 	The Parties intend to amend and restate Exhibit B in its entirety to a form
to be mutually agreed by the Parties.
	 
	 	(iii)	 	Exhibits C and D shall be deleted in their entirety.
	 
	 	(iv)	 	The Parties intend to amend and restate Exhibit E in its entirety to a form
to be mutually agreed by the Parties.
	 
	 	(v)	 	The Parties intend to attach a new Exhibit G in a form to be mutually
agreed by the Parties.

	 	 	 
	CONFIDENTIAL	 	Amendment to Exclusive License and Distribution
Agreement - Page 4

 

 

6. Effective Date

	 	 	 	This Amendment is entered into and made effective as of
June 30, 2005. As herein
amended, the Original Agreement is hereby ratified and confirmed in all respects.

	 	 	 
	CONFIDENTIAL	 	Amendment to Exclusive License and Distribution
Agreement - Page 5

 

 

     In witness whereof, the Parties have each caused this Amendment 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.
	 	 	 	Zimmer Spine, Inc.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Guy Mayer
	 	By:
	 	/s/ Terry Schlotterback
	 

	 	 
	 	 	 	 
	 

	 	Guy Mayer,
	 	 	 	Terry Schlotterback, President

	 

	 	Chief Executive Officer	 	 	 	 
	 
	 	 	 	 	 	 
	Date:

	 	7-12-05
	 	Date:
	 	 13 JUL 05

	 	 	 
	CONFIDENTIAL	 	Amendment to Exclusive License and Distribution
Agreement - Page 6EX-10.16  COPY OF ASSIGNMENT AGREEMENT

 

Exhibit 10.16

Assignment Agreement

between

Centerpulse France S.A.S. (formerly Sulzer Orthopédie S.A.), a company
duly organized and existing under the laws of France with its registered
offices at 127, avenue René Jacot, 25461 Etupes Cedex, France

(hereinafter “Assignor”)

and

Zimmer GmbH, a company duly organized and existing under the laws of
Switzerland with its registered offices at Sulzer Allee 8, 8404
Winterthur, Switzerland

(hereinafter “Assignee”)

and

Tutogen Medical GmbH, a company duly organized and existing under the
laws of Germany with its registered offices at 91077 Neunkirchen am Brand,
Germany

Whereas, the Assignor and Tutogen Medical GmbH have entered into an Agreement
dated January 9, 2002.

Whereas, Zimmer Group is restructuring its operations following the
acquisition of Centerpulse in October 2003;

Now, therefore, the parties hereto agree as follows:

	1.	 	The Assignee hereby replaces the Assignor
as the party to the Agreement, such
replacement being made effective as of signature date of this
Assignment Agreement (“Transfer Date”). Tutogen Medical GmbH hereby expressly
agrees with this replacement and accepts that the Assignee, and not the
Assignor is the party to the Agreement as of the Transfer Date. Thereafter,
references to in the Agreement shall refer to the Assignee, as appropriate.

	2.	 	The Assignor hereby assigns to the Assignee all of its rights in and under the
Agreement, whether accrued before or after the Transfer Date, and delegates all of
its duties remaining after the Transfer Date, and accepts such assignments and
delegations. It shall be understood that Assignee will have the right
to delegate specific duties to its designees.

 

 

	3.	 	Notices to be sent to the Assignee shall be made in writing and
shall be sent to the following address:

Zimmer GmbH

Mr. Mike Humphris

Sulzer Allee
8/P.O.Box
CH-8404
Winterthur

	4.	 	All other terms of the Agreement shall remain unchanged.

IN WITNESS WHEREOF, the parties hereto have executed this Assignment Agreement by their duly authorized officers or representatives:

	 	 	 	 	 	 	 
	Centerpulse France S.A.S.  	 	 
	 
	 	 	 	 	 	 
	/s/ Mariano Moreno	 	 
	 	 	 
	Name:

	 	Mariano Moreno	 	 	 	 
	 

	 	 	 	 	 	 
	Title:

	 	Managing Director	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Place and date:	 	 
	 
	 	 	 	 	 	 
	ETURED 05/07/05	 	 
	 	 	 

	 	 	 	 	 	 	 
	Zimmer GmbH  	 	 
	 
	 	 	 	 	 	 
	/s/ RICHARD FRITSCHI	 	 
	 	 	 
	Name:

	 	RICHARD FRITSCHI	 	 	 	 
	 

	 	 	 	 	 	 
	Title:

	 	President Europe Australasia	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Place and date:	 	 
	 
	 	 	 	 	 	 
	Winterthur 28/06/05	 	 
	 	 	 

	 	 	 	 	 	 	 
	Agreed by: Tutogen Medical GmbH  	 	 
	 
	 	 	 	 	 	 
	/s/ MANFRED KRÜGER	 	 
	 	 	 
	Name:

	 	MANFRED KRÜGER	 	 	 	 
	 

	 	 	 	 	 	 
	Title:
	 	 	 	 	 	 
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Place and date:	 	 
	 
	 	 	 	 	 	 
	Neunkinhen 12/07/05

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