Exhibit (d)(2)
First Amended Option 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 Medica A.G., a Swiss corporation with offices at Zucherstrasse 12,
8401 Winterthur, Switzerland ("Sulzer Medica").
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 processed tissues
through various distributors throughout the world;
WHEREAS, Sulzer Medica develops, manufactures, and markets worldwide certain
medical implants and surgical products through wholly-owned subsidiaries in its
Joint and Fracture Care, Spine Care, Dental Care, and Cardiovascular Care
businesses;
WHEREAS, Tutogen, or an affiliate of Tutogen, and Sulzer Spine-Tech Inc., a
wholly-owned subsidiary of Sulzer Medica in its Spine Care business, have
entered into a U.S. Service Agreement, an International Distribution Agreement,
and a Processed Tissue Development and License Agreement, all dated 8 March
2000, by which Sulzer Spine-Tech Inc. will market in the United States and
distribute internationally certain processed tissues of Tutogen for surgical
application in the human spine;
WHEREAS, Sulzer Medica desires to evaluate the possibility of marketing and
distributing Tutogen's processed tissues in its Joint and Fracture Care and
Dental Care businesses;
WHEREAS, Tutogen desires to expand its marketing and distribution relationship
with Sulzer Medica, but needs a decision from Sulzer Medica within a reasonable
period of time in order to continue to grow its business; and
WHEREAS, Tutogen and Sulzer Medica entered into an Option Agreement dated 8
March 2000 and now desire to make a new agreement that will supersede that
agreement;
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 "Effective Date" shall mean 8 March 2000.
--------------
CONFIDENTIAL
1.3 "Option Period" shall mean the period of time, following the Effective
-------------
Date of this Agreement, during which Sulzer Medica may exercise its
option. The Option Period, which may vary by Processed Tissue, is set
forth in Schedule A.
1.4 "Processed Tissues" shall mean the xenograft and allograft bone
-----------------
tissues processed by Tutogen, as listed in Schedule A, as amended from
time to time.
1.5 "Territory" shall mean the United States of America, including its
---------
territories and possessions ("US") and the rest of the world ("XUS").
2. Grant of Option
2.1 In consideration of the value to Tutogen of expanding its existing
marketing and distribution relationship with a single international
entity, Tutogen hereby grants Sulzer Medica the option for the Option
Period as defined between the Parties in Schedule A to enter into one
or more agreements with Tutogen for the exclusive right to market or
distribute the Processed Tissues in the Territory.
3. Exercise of Option
3.1 Sulzer Medica shall exercise its option, if at all, by delivering a
written notice to Tutogen within the Option Period specifying the
Processed Tissue that Sulzer Medica desires to market or distribute.
3.2 Sulzer Medica may exercise its option as to some or all of the
Processed Tissues at one time or at different times within the Option
Period.
3.3 If Sulzer Medica exercises its option as to a Processed Tissue,
Tutogen and Sulzer Medica shall immediately commence negotiations on
an agreement giving Sulzer Medica the exclusive right to distribute or
make available the Processed Tissue.
3.4 Tutogen agrees that during the Option Period and for a period of 60
days following Sulzer Medica's notice exercising its option in a
Processed Tissue, it shall refrain from negotiations with any party
other than Sulzer Medica regarding the distribution making available
of such Processed Tissue in the Territory. On expiration of the Option
Period, and provided that Sulzer has not exercised the option for a
particular Processed Tissue, any and all option rights of Sulzer as to
a particular Processed Tissue shall be waived.
4. Term and Termination
4.1 Term. This Agreement shall be effective on the Effective Date and
----
shall remain in effect until expiration of the longest Option Period
or until the expiration of 60 days following Sulzer Medica's last
timely notice that it is exercising its option, whichever is later.
CONFIDENTIAL First Amended Option Agreement-Page 2
5. Representations, Warranties, and Limitations of Liability
5.1 Tutogen. Tutogen represents and warrants to Sulzer Medica, as follows:
-------
5.1.1 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.
5.1.2 Tutogen has the right to grant to Sulzer the option granted in
this Agreement.
5.2 Sulzer Medica. Sulzer Medica represents and warrants to Tutogen, as
-------------
follows:
5.2.1 Sulzer Medica 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 Medica.
5.3 Exclusion of Other Warranties. The representations and warranties
-----------------------------
stated above 5.1 and 5.2 are expressly in lieu of all other warranties
arising out of this Agreement, including but not limited to any
warranty, express or implied; of merchantability or of fitness, and
constitute the only warranties made with respect to any order or the
equipment covered thereby.
5.4 Limitation of Liability. Any and all liability between the parties
-----------------------
arising out of this Agreement is excluded.
6. Miscellaneous Provisions
6.1 Entire Agreement.
----------------
6.1.1 This Agreement, together with the First Amended U.S. Service
Agreement, the First Amended International Distribution
Agreement, and the First Amended Processed Tissue Development and
License Agreement, and the First Amended Umbrella Agreement, all
of even date 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 Option Agreement dated 8 March 2000.
6.1.2 The Option Agreement dated 8 March 2000 is hereby cancelled
entirely and superseded by this Agreement.
6.1.3 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.
6.2 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
CONFIDENTIAL First Amended Option Agreement-Page 3
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.
6.3 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
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 Medica A.G.
Zurcherstrasse 12
8401 Winterthur
SWITZERLAND
Attention: President and CEO
Telephone: 41 52 262 53 50
Facsimile: 41 52 262 00 59
CONFIDENTIAL First Amended Option Agreement-Page 4
With a copy to:
Sulzer Medica USA Inc.
3 East Greenway Plaza, Suite 1600
Houston, Texas 77046
U.S.A.
Attention: General Counsel
Telephone: (713) 561-6365
Facsimile: (713) 561-6380
6.4 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).
6.5 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.
6.6 Independent Contractors. Each party will act as an independent
-----------------------
contractor under the terms of 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.
6.7 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 6.7 will be void and of no effect. Subject to this
Section 6.7, this Agreement shall be binding upon, inure to the
benefit of, and be enforceable by and against, the parties and their
Permitted Successors.
6.8 Arbitration.
-----------
6.8.1 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.
CONFIDENTIAL First Amended Option Agreement-Page 5
6.8.2 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.
6.8.3 The place of arbitration shall be Zurich. The procedural law of
this place shall apply where the Rules are silent.
6.8.4 The arbitral award shall be substantiated in writing. The
arbitral tribunal shall decide on the matter of costs of the
arbitration.
6.8.5 The language to be used in the arbitral proceedings shall be
English.
6.9 Confidentiality. The parties acknowledge that by reason of their
---------------
relationship hereunder, each has had and will continue to have access
to certain information and materials concerning the other's business,
plans, customers, technology, and/or Processed Tissues that is
considered by a party to be confidential ("Confidential Information")
and of substantial value to that party, which value would be impaired
if such information were disclosed to third parties. To the extent
that such information is considered confidential, the disclosing party
will so indicate to the receiving party, in the case of information in
documentary or other tangible form, by labeling it conspicuously as
"CONFIDENTIAL" (or words of similar import) and in the case of
information conveyed verbally, by identifying same in writing within
ten days after the first verbal disclosure. Each party agrees that it
will not use in any way other than as expressly authorized or
contemplated under this Agreement, nor disclose to any third party,
any such Confidential Information revealed to it by the other party,
and will take reasonable precautions (and will cause its Affiliates to
take reasonable precautions) to protect the confidentiality of such
information and with no less restrictive precautions than it takes to
protect its own confidential information. Each party will disclose
Confidential Information only to those of its employees who have a
need to know such information. If Confidential Information is required
to be disclosed in response to an order by a court or other government
body, or if otherwise required to be disclosed by law, or if necessary
to establish the rights of a party under this Agreement, the receiving
party shall use reasonable efforts to provide the disclosing party
with advance notice of such required disclosure to give the disclosing
party sufficient time to seek a protective order or other protective
measures, if any are available, for such Confidential Information.
"Confidential Information" does not include information, materials,
technical data or know-how which: (i) is rightfully in the possession
of the receiving party at the time of disclosure as shown by the
receiving party's files and records immediately prior to the time of
disclosure; (ii) prior to or after the time of disclosure becomes part
of the public knowledge or literature, not as a result of any inaction
or action of the receiving party; (iii) is independently developed by
a party without the use of any Confidential Information of the other
parties; (iv) is obtained from any third party who is authorized to
disclose such data and information without obligation of
confidentiality, or (v) is approved for release by the disclosing
party.
CONFIDENTIAL First Amended Option Agreement-Page 6
6.10 Public Relations And Announcements. The parties shall agree upon and
----------------------------------
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.
Tutogen Medical, Inc. Sulzer Medica A.G.
/s/ Manfred Kruger /s/ Andre P. Buchel
By:--------------------------- By:-------------------------------
Manfred Kruger Andre P. Buchel
President and CEO President and CEO
/s/ Josef Ruegg
By:-------------------------------
Josef Ruegg
September 29, 2000 September 29, 2000
Date:------------------------- Date:-----------------------------
CONFIDENTIAL First Amended Option Agreement-Page 7
Schedule A
- -----------------------------------------------------------------------------------------------------------------------------
Field of use Processed Tissue Range Option Period
- ------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------
1. Spine as defined none
- ------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------
2. Traumatology/Orthopedic General bone fixation 6 Months
- ------------------------------------------------------------------------------------------------------------------------------
Pins 6 Months
- ------------------------------------------------------------------------------------------------------------------------------
Screws 6 Months
- ------------------------------------------------------------------------------------------------------------------------------
Nails 6 Months
- ------------------------------------------------------------------------------------------------------------------------------
Plates 6 Months
- ------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------
3. Hip Acetabulum Caps 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
Bone blocks (various sizes) 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
Granulate 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
Screws 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
Nails 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
Pins 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
Dowels 24 Months
- ------------------------------------------------------------------------------------------------------------------------------
- ------------------------------------------------------------------------------------------------------------------------------
4. General Orthopedic Surgery (also applicable AAA and BMP Bonegraft 24 Months
for field of use 1-4 of this schedule)
(additional R&D work to be done)
- ------------------------------------------------------------------------------------------------------------------------------
CONFIDENTIAL Schedule A to Option Agreement-Page 1