EXHIBIT (d)(5)
First Amended Processed Tissue Development and License Agreement
This Agreement is made by Tutogen Medical GmbH, a German corporation with
offices at Industriestrae 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 the Europe and within the United States, processes such tissue itself
or provides such tissue for processing by others, and makes processed tissue
available to users through various distributors throughout the world;
WHEREAS, Sulzer manufactures and sells worldwide a line of products used in the
spine and contemporaneous with this Agreement has agreed to provide certain
services to assist Tutogen in making processed tissues available in the United
States and has agreed to distribute elsewhere in the world Tutogen's processed
xenograft and allograft bone tissues for use in spinal applications;
WHEREAS, Tutogen has designed a proprietary processed tissue for application as
a spacer formed of bone tissue for use in spinal fusion surgery and desires to
collaborate with Sulzer on the development of this and other processed tissues
for use in spinal applications;
WHEREAS, Sulzer desires to collaborate with Tutogen on the development of
processed tissues for spinal applications and to license Tutogen's proprietary
processed tissue spacer;
NOW, THEREFORE, in consideration of the foregoing premises and the terms and
conditions set forth below, the parties hereby agree as follows:
1. Definitions
"Affiliate" shall mean an entity that controls, is controlled by, or is
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under common control with a party. For purposes of this definition,
"control" shall mean the possession, directly or indirectly, of a
majority of the voting power of such entity (whether through ownership
of securities or partnership or other ownership interests, by contract
or otherwise); provided that, such entity shall be deemed an Affiliate
only so long as such control continues.
"Composite Spacer" shall mean a spacer for use in the cervical or lumbar
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spine to promote spinal fusion comprised of *
1.3 "Composite Spacer Patent Application" shall mean any patent
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application owned by Tutogen or an Affiliate of Tutogen and relating
to a Composite Spacer, including United States patent application No.
* filed by Tutogen on *, entitled "Implant of Bone Matter."
*CONFIDENTIAL TREATMENT REQUEST BY SHEARMAN & STERLING.
CONFIDENTIAL
1.4 "Contract Year" shall mean the one-year period following the
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effective date of this Agreement and each one-year period following each
anniversary of the effective date of this Agreement.
"Effective Date" of this Agreement shall mean March 8, 2000.
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"Permitted Successor" shall mean any individual, corporation, partnership,
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joint venture, association, trust, or any other entity or organization
of any kind or character that assumes the obligations of a party under
this Agreement as permitted according to the terms of this Agreement.
"Processed Tissues" shall mean all xenograft and allograft bone tissues
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processed by Tutogen or an Affiliate of Tutogen or a Permitted
Successor of Tutogen for use in and adjoining the human spine.
"Third Party" shall mean a person or entity other than Tutogen, any Tutogen
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Affiliate, Sulzer, any Sulzer Affiliate or any officer, director, or
employee of Tutogen, any Tutogen Affiliate, Sulzer, or any Sulzer
Affiliate.
"Tutogen Licensed Patents" shall mean any and all patents relating to the
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Processed Tissues, 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 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. Any patent that issues from a Composite Spacer Patent
Application or from any patent application claiming priority based on
the same application as claimed in a Composite Spacer Patent
Application is a Tutogen Licensed Patent.
2. Composite Spacer and Other Processed Tissue Development
Tutogen and Sulzer agree to collaborate on development of the Composite
Spacer and other Processed Tissues, as follows:
2.1.1 Within 60 days following the Effective Date of this Agreement,
Sulzer shall use its best efforts to select the preferred design
for the lumbar and the cervical Composite Spacer from among
Tutogen's designs and for the preferred designs for other
Processed Tissues that the parties agree shall have priority
under this Agreement and shall deliver to Tutogen the final
specifications for such designs.
2.1.2 Tutogen shall use its best efforts to complete within 60 days
following Sulzer's delivery of the final specifications, the
final design and Tutogen's qualification testing for the lumbar
and cervical Composite Spacers and the other Processed Tissues
given priority and shall deliver to Sulzer 20 prototype units
each of each Composite Spacer and priority Processed
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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Tissue for testing by Sulzer. In addition, Tutogen shall use its
best efforts to deliver within 90 days following Sulzer's
delivery of the final specifications 20 sterile units each of
each Composite Spacer and priority Processed Tissue.
2.1.3 Sulzer shall use its best efforts to complete, within 60 days
following delivery of sterile units of the lumbar and cervical
Composite Spacers and the priority Processed Tissues to Sulzer,
its testing and either accept or reject, with explanation, the
design of the lumbar and cervical Composite Spacers and the
priority Processed Tissues. In the event that Sulzer rejects the
design of one or the other Composite Spacer or any of the
Processed Tissues, the parties shall collaborate on such changes
to the design as are necessary to make the Composite Spacer or
Processed Tissue acceptable to Sulzer, and the parties shall
agree upon a revised development schedule, having in mind the
goal of an expeditious development of an acceptable Processed
Tissue.
2.1.4 Sulzer shall use its best efforts to complete, within 90 days
following Sulzer's delivery of the final specifications for
lumbar and cervical spacers, the design and testing of the
surgical instruments needed for implanting a priority Processed
Tissue. Sulzer shall use its best efforts to complete, within 150
days following Sulzer's delivery of the final specifications for
lumbar and cervical spacers, the design and testing of the
surgical instruments needed for implanting other Processed
Tissues, as mutually agreed by the parties.
Tutogen and Sulzer agree to use their best efforts to complete the
development of the Composite Spacer and priority Processed Tissues and
to begin processing of same for use within 210 days following the
Effective Date of this Agreement.
Each party shall bear its own expenses in connection with development of
the Composite Spacer and priority Processed Tissues.
At such time as Sulzer accepts the design of the lumbar and cervical
Composite Spacers and the other Processed Tissues, such tissues shall
become Processed Tissues within the meaning of the U.S. Service
Agreement and the International Distribution Agreement of even date
between the parties or their Affiliates.
3. New Processed Tissue Development and Existing Processed Tissue Improvement
During the term of this Agreement, the parties anticipate that each party
will conceive ideas for new Processed Tissues or for improvements to
existing Processed Tissues. If a party conceiving an idea for a new
Processed Tissue or for an improvement to an existing Processed Tissue
wishes to pursue development of that idea, it shall propose
development of the idea, if at all, solely to the other party. The
parties shall not disclose ideas for new Processed Tissues or for
improvements to existing Processed Tissues conceived during the term
of this Agreement to any Third Party, whether such potential
disclosure is during the term of this Agreement or after its
termination, except as provided in this Section 3.2.3.
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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A party shall propose a development project for an idea by submitting to
the other party a written description of the proposed new Processed
Tissue or Processed Tissue improvement. The party receiving the
proposal shall evaluate the proposal and respond in writing to the
proposing party within 30 days of receipt of the proposal, either
accepting or rejecting the proposal.
3.1.1 The receiving party is under no obligation to accept the proposal
or otherwise to participate in any project proposed by the other
party.
3.1.2 If the receiving party accepts the proposal, the parties shall
meet and prepare a project plan, agreeing to a development
schedule and allocating project development responsibilities and
project costs between the parties. Project responsibilities and
costs may or may not be allocated equally between the parties.
3.1.3 If the receiving party rejects the proposal, the proposing party
shall be free to pursue the project on its own or to collaborate
on the project with a Third Party; provided that, in so doing the
proposing party shall not violate or breach any other term of this
Agreement or any term of the First Amended U.S. Service Agreement,
the First Amended International Distribution Agreement, or the
First Amended Option Agreement, all of even date herewith.
Tutogen shall have the right to process bone tissue for any Processed
Tissue developed or improved as a result of collaboration between the
parties under this Section 3.
Any Processed Tissue developed or improved as a result of collaboration
between the parties under this Section 3 shall become a "Processed
Tissue" within the meaning of the First Amended U.S. Service Agreement
and a "Product" within the meaning of the First Amended International
Distribution Agreement, both of even date between the parties or their
Affiliates.
4. License
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 Sulzer and its Affiliates during the term of
this Agreement an exclusive, worldwide (excluding the United States),
fully paid-up license or sublicense, as the case may be, under all
Tutogen Licensed Patents to use and sell the Processed Tissues,
including, but not limited to, the Composite Spacer. This license
excludes the United States because Sulzer will not make, use, sell, or
offer to sell the Processed Tissues in the United States.
In consideration of the exclusive license granted in this Section 4 to use
and sell the Composite Spacer, Sulzer agrees to pay Tutogen
US$1,000,000 by wire transfer on 5 January 2002; provided that, Sulzer
shall be under no obligation to pay any amount for the license granted
in this Section 4 unless and until Tutogen shall have delivered at
least 500 units of Composite Spacer or as many units of Composite
Spacer as shall have been requested by purchase order for delivery by 1
January 2002, whichever is less.
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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5. Intellectual Property Rights
5.1 Tutogen and Sulzer each shall own an undivided one-half interest in
all jointly developed intellectual property, including patent
applications and patents as to which employees of both parties are
named as an inventor. Sulzer shall have primary responsibility for
filing and prosecuting patent applications and maintaining patents on
jointly developed and owned inventions. Tutogen shall contribute one-
half of all expenses incurred in connection with such filing,
prosecution, and maintenance; provided that, Tutogen shall have no
obligation to reimburse patent-related expenses that it has not first
approved. In the event that Tutogen refuses to approve any such
patent-related expenses and that Sulzer elects to incur the expense
itself, Sulzer shall be the sole owner of any rights resulting
therefrom. In the event that Sulzer elects not to pursue patent
protection for any jointly developed and owned invention, Tutogen
shall have the right, at its sole expense, to pursue patent protection
for the invention, and Tutogen shall be the sole owner of any rights
resulting therefrom.
5.2 In the event that a Third Party is infringing any jointly owned
intellectual property, Sulzer, at its option, shall have the right to
bring and control any litigation brought against such Third Party for
such infringement, and Tutogen shall cooperate with Sulzer. If Sulzer
elects not to prosecute such litigation, Tutogen shall have the right
to bring and control such litigation. Both parties shall share equally
in the expenses and proceeds of such litigation; provided that, if a
party elects not to contribute its share of the expenses of such
litigation, it forfeits any right to share in the proceeds of such
litigation, but shall nonetheless cooperate with the party prosecuting
such litigation at the reasonable expense of the prosecuting party.
6. Term and Termination
6.1 Term. This Agreement shall be effective on the Effective Date and
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shall remain in effect for an initial term of 10 Contract Years,
unless sooner terminated according to the terms set forth below. 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.
6.2 Material Breach. If either party is in material breach of any
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obligation in this Agreement, the non-breaching party may give written
notice to the breaching party of its intention to terminate this
Agreement, and this Agreement will terminate 60 days after the giving
of such notice unless during the 60-day period (i) the breach has been
cured, or (ii) if a breach is incapable of cure within the 60-day
period, the breaching party has commenced action which is calculated
to result in a cure of the breach to the reasonable satisfaction of
the non-breaching party within 120 days after the giving of notice. If
at the end of the 60-day or 120-day period following a notice of
termination the parties disagree as to whether the Agreement has
terminated as provided in this paragraph, the parties shall continue
to perform under this Agreement until an arbitration tribunal
constituted as provided in this Agreement has ruled on the matter.
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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6.3 Insolvency. Either party may terminate this Agreement immediately on
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delivery of written notice to the other party (i) upon the institution
by or against such other party of insolvency, receivership, or
bankruptcy proceedings or any other proceedings for the settlement of
such party's debts; provided that, with respect to involuntary
proceedings, such proceedings are not dismissed within 120 days, (ii)
upon such other party's making an assignment for the benefit of
creditors, or (iii) upon such other party's dissolution or ceasing to
do business.
6.4 Termination Without Cause. Sulzer shall have the right to terminate
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this Agreement with or without cause at any time on or after January
15, 2002 provided that Sulzer shall have given Tutogen written notice
of termination at 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 payment set forth in Section 4.2
above, and Sulzer's termination under this Section 6.4 does not give
Sulzer any right to recover payments made prior to the effective date
of termination.
7. Representations, Warranties, Indemnities and Liabilities
7.1 Tutogen. Tutogen represents and warrants to Sulzer, as follows:
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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, delivery and performance of this
Agreement have been validly authorized by Tutogen.
7.1.2 Tutogen has the right to grant to Sulzer the rights and
licenses granted in this Agreement.
7.2 Sulzer. Sulzer represents and warrants to Tutogen, as follows:
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7.2.1 Sulzer has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations
hereunder, and the execution, delivery, and performance of
this Agreement have been validly authorized by Sulzer.
7.3 Indemnity by Tutogen.
7.3.1 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
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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right to participate in a non-controlling fashion in such legal
proceeding at its sole expense.
7.3.2 No undertaking of Tutogen under this section shall extend to any
such alleged infringement or violation to the extent that it: (a)
arises from adherence to design modifications, specifications,
drawings, or written instructions which Tutogen is directed by
Sulzer to follow, but only if such alleged infringement or violation
does not reside in corresponding Processed Tissue of Tutogen's
design or selection; or (b) arises from adherence to instructions to
apply Sulzer's trademark, trade name, or other company
identification; or (c) resides in a Processed Tissue which is not of
Tutogen's origin and which is furnished by Sulzer to Tutogen for use
under this Agreement; or (d) relates to use of Processed Tissues or
other items provided by Tutogen in combination with other Processed
Tissues or items furnished either by Tutogen or others, which
combination was not installed, recommended, or otherwise approved by
Tutogen. In the foregoing cases numbered (a) through (d), Sulzer
will defend and hold Tutogen harmless, subject to the same terms and
conditions and exceptions stated above, with respect to Tutogen's
rights and obligations under this clause.
7.4 Indemnity by Sulzer.
7.4.1 Sulzer shall defend, indemnify, and hold harmless Tutogen against
any liability or damages from any third party claims, suits,
proceedings, demands, recoveries, or expenses ("Claims") to the
extent that such Claims arise from or are based upon: (i) material
breach by Sulzer of any of its representations or warranties
contained herein; or (ii) negligence, gross negligence, or
intentionally wrongful acts or omissions on the part of Sulzer;
provided that Tutogen: (a) promptly notifies Sulzer in writing of
any such Claim which comes to its attention; (b) allows Sulzer to
control the defense or settlement of such Claim; (c) does not enter
into any settlement or compromise of such Claim without the express
authorization of Sulzer; and (d) reasonably cooperates with Sulzer
in the defense of such Claim, subject to Sulzer's payment of all
reasonable out-of-pocket expenses associated with such cooperation
by Tutogen. Tutogen shall have the right to participate in a non-
controlling fashion in such legal proceeding at its sole expense.
7.4.2 No undertaking of Sulzer under this section shall extend to any
such alleged infringement or violation to the extent that it: (a)
arises from adherence to design modifications, specifications,
drawings, or written instructions which Sulzer is directed by
Tutogen to follow, but only if such alleged infringement or
violation does not reside in corresponding Processed Tissue of
Sulzer's design or selection; or (b) arises from adherence to
instructions to apply Tutogen's trademark, trade name, or other
company identification; or (c) resides in a Processed Tissue which
is not of Sulzer's origin and which is furnished by Tutogen to
Sulzer for use under this Agreement; or (d) relates to use of
Processed Tissues or other items provided by Sulzer in combination
with other Processed Tissues or other items, furnished either by
Sulzer or others, which combination was not installed, recommended
or otherwise
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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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.
7.5 Limitation of Liability to Third Parties. The liability of Tutogen and
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Sulzer with respect to any and all claims, actions, proceedings, or
suits by any third party alleging infringement of patents, trademarks,
or copyrights or violation of trade secrets or proprietary rights
because of, or in connection with, any items furnished pursuant to
this Agreement shall be limited to the specific undertakings contained
in this Section 7.
7.6 Exclusion of Consequential Damages. Neither Tutogen nor Sulzer shall
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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
Entire Agreement.
8.1.1 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 International
Distribution 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 Processed Tissue
Development and License Agreement dated March 8, 2000.
8.1.2 The Processed Tissue Development and License Agreement dated March
8, 2000 is hereby cancelled entirely and superseded by this
Agreement.
8.1.3 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.
8.2 Force Majeure. Neither party will be liable to the other for its
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failure to perform any of its obligations under this Agreement only
during any period in which such performance is delayed because of, or
rendered impracticable or impossible due to, circumstances beyond its
reasonable control, including but not limited to, strike, fire, flood,
earthquake, windstorm, governmental acts or orders or restrictions
(including acts of regulatory authorities and changes in the regulatory
scheme for a Processed Tissue), failure of suppliers, or any other
reason to the extent that the failure to perform is beyond the
reasonable control and not caused by the negligence or willful
misconduct of the non-performing party, provided that the party
experiencing the delay promptly notifies the other of the delay.
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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8.3 Notices. All notices concerning this Agreement will be written in the
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English language and will be deemed to have been received (a) two days
after being properly sent by commercial overnight courier, or (b) one
day after being transmitted by confirmed facsimile, in each case
addressed to the address below:
If to Tutogen:
Tutogen Medical GmbH
Wetterkreuz 19 A
D-91058 Erlangen-Tennerlohe
GERMANY
Attention: President and CEO
Telephone: 49 9131 7901-10
Facsimile: 49 9131 7901-12
With a copy to:
Dr. Dirk Lange
Foerster + Rutow
Irrerstr. 17-19
90403 Nurnberg
GERMANY
Telephone: 49 (911) 23 569 00
Facsimile: 49 (911) 23 569 11
If to Sulzer:
Sulzer Spine-Tech Inc.
7375 Bush Lake Road
Minneapolis, Minnesota 55439-2027
U.S.A.
Attention: President
Telephone: 1 (612) 832-5600
Facsimile: 1 (612) 832-6874
With a copy to:
Sulzer Medica USA Inc.
3 East Greenway Plaza, Suite 1600
Houston, Texas 77046
U.S.A.
Attention: General Counsel
Telephone: 1 (713) 561-6365
Facsimile: 1 (713) 561-6380
8.4 Governing Law. Recognizing that the laws within different
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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
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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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 of the International Sale of Goods).
8.5 Partial Invalidity. In the event that any provision of this Agreement
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will be unenforceable or invalid under any applicable law or be so
held by applicable court decision, such unenforceability or invalidity
will not render this Agreement unenforceable or invalid as a whole,
and, in such event, such provision will be changed and interpreted so
as best to accomplish the objectives of such unenforceable or invalid
provision within the limits of applicable law or applicable court
decisions.
8.6 Independent Contractors. Each party will act as an independent
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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,
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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 any other provision in this
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Agreement regarding a failure to comply with laws, in performing this
Agreement, each Party shall comply with all applicable laws and
government regulations at all times, including but not limited to any
applicable laws and regulations of the United States regarding the
export or re-export or release of technology and technical data.
8.9 Arbitration.
8.9.1 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.
8.9.2 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.
8.9.3 The place of arbitration shall be Zurich. The procedural law of
this place shall apply where the Rules are silent.
CONFIDENTIAL First Amended Processed issue Development and License Agreement
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8.9.4 The arbitral award shall be substantiated in writing. The
arbitral tribunal shall decide on the matter of costs of the
arbitration.
8.9.5 The language to be used in the arbitral proceedings shall be
English.
8.10 Confidentiality. The parties acknowledge that by reason of their
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relationship hereunder, each has had and will continue to have access
to certain information and materials concerning the other's business,
plans, customers, technology, and/or Processed Tissues that is
considered by a party to be confidential ("Confidential Information")
and of substantial value to that party, which value would be impaired
if such information were disclosed to third parties. To the extent
that such information is considered confidential, the disclosing party
will so indicate to the receiving party, in the case of information in
documentary or other tangible form, by labeling it conspicuously as
"CONFIDENTIAL" (or words of similar import) and in the case of
information conveyed verbally, by identifying same in writing within
ten days after the first verbal disclosure. Each party agrees that it
will not use in any way other than as expressly authorized or
contemplated under this Agreement, nor disclose to any third party,
any such Confidential Information revealed to it by the other party,
and will take reasonable precautions (and will cause its Affiliates to
take reasonable precautions) to protect the confidentiality of such
information and with no less restrictive precautions than it takes to
protect its own confidential information. Each party will disclose
Confidential Information only to those of its employees who have a
need to know such information. If Confidential Information is required
to be disclosed in response to an order by a court or other government
body, or if otherwise required to be disclosed by law, or if necessary
to establish the rights of a party under this Agreement, the receiving
party shall use reasonable efforts to provide the disclosing party
with advance notice of such required disclosure to give the disclosing
party sufficient time to seek a protective order or other protective
measures, if any are available, for such Confidential Information.
"Confidential Information" does not include information, materials,
technical data or know-how which: (i) is rightfully in the possession
of the receiving party at the time of disclosure as shown by the
receiving party's files and records immediately prior to the time of
disclosure; (ii) prior to or after the time of disclosure becomes part
of the public knowledge or literature, not as a result of any inaction
or action of the receiving party; (iii) is independently developed by
a party without the use of any Confidential Information of the other
parties; (iv) is obtained from any third party who is authorized to
disclose such data and information without obligation of
confidentiality, or (v) is approved for release by the disclosing
party. This Section 8.10 shall survive termination of this Agreement
for a period of two years.
8.11 Public Relations And Announcements. The parties shall agree upon and
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issue a press release upon the signing of 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.
CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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Tutogen Medical GmbH Sulzer Spine-Tech, Inc.
By: /s/ Manfred Kruger By: /s/ P. Richard Lunsford
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Manfred Kruger P. Richard Lunsford
Managing Director President
Date: September 29, 2000 Date: September 29, 2000
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CONFIDENTIAL First Amended Processed Tissue Development and License Agreement
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