EXHIBIT (d)(6)
Xenograft Distribution Agreement
This Agreement is made by Tutogen Medical GmbH, a German corporation with
offices at IndustriestraBe 6, D-91077 Neunkirchen am Brand, Germany ("Tutogen")
and Sulzer Calcitek Inc., a Delaware corporation with offices at 1900 Aston
Avenue, Carlsbad, California, U.S.A. ("Sulzer").
W I T N E S S E T H:
WHEREAS, Tutogen collects xenograft bone tissue, processes such tissue, and
distributes xenograft bone tissue products through various distributors
throughout the world;
WHEREAS, Sulzer manufactures and sells worldwide a line of products used in
dental applications and desires to acquire from Tutogen the right to distribute
its xenograft bone tissue products worldwide for use in dental applications;
WHEREAS, Tutogen is willing to terminate the right of its existing distributors
to sell xenograft bone tissue products for dental applications and to appoint
Sulzer as its sole and exclusive distributor for such products in such
applications on the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the foregoing premises and the terms and
conditions set forth below, the parties hereby agree as follows:
Definitions
1.1 "Affiliate" shall mean an entity that controls, is controlled by, or is
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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.
1.2 "Clinical Costs" shall have the meaning set forth in Section 5.3.
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1.3 "Contract Year" shall mean the one-year period following the Effective
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Date of this Agreement and each one-year period following each
anniversary of the Effective Date of this Agreement.
1.4 "Effective Date" shall mean the date on which this Agreement has been
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executed by an authorized officer of each party, as witnessed on the
signature page of this Agreement.
1.5 "FDA" shall mean the United States Food and Drug Administration.
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1.6 "Field of Use" shall mean all uses of processed xenograft bone tissue in
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or adjoining the human maxilla or the human mandible.
1.7 "Minimum Sales Goals" shall have the meaning set forth in Section 3.4.
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1.8 "Minimums Negotiation Period" shall have the meaning set forth in Section
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3.4.1.
1.9 "Permitted Successor" shall mean any individual, corporation,
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partnership, joint venture, association, trust, or any other entity or
organization of any kind or
CONFIDENTIAL
character that assumes the obligations of a party under this Agreement as
permitted according to the terms of this Agreement.
1.10 "Products" shall mean the xenograft bone tissue products manufactured by
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Tutogen or an Affiliate of Tutogen or a Permitted Successor of Tutogen
and listed on Schedule A attached hereto. The parties shall mutually
agree on the addition of Products to Schedule A.
1.11 "Regulatory Plan" shall have the meaning set forth in Section 5.2.2.
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1.12 "Sub-Territory" shall mean one of the following geographic regions or
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countries comprising in part the Territory: Western Europe (European
Union including Switzerland, Norway, Iceland, Turkey, and Israel);
Eastern Europe; South America (including Central America and Mexico);
United States of America; Canada; Far East (excluding Japan); Japan; and
Middle East (including Africa).
1.13 "Territory" shall mean the entire world.
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1.14 "Third Party" shall mean a person or entity other than Tutogen, any
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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
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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
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the Products for the Field of Use from Tutogen's existing international
distributors to Sulzer, Sulzer agrees to pay Tutogen a total of
US$800,000 by wire transfer pursuant to Tutogen's written instruction, as
follows:
2.2.1 US$400,000 shall be paid within five business days following
execution of this Agreement;
2.2.2 US$200,000 shall be paid within five business days following
Sulzer's first delivery of a Product in Western Europe; and
2.2.3 US$200,000 shall be paid within five business days following
Tutogen's delivery to Sulzer of a copy of a written notice from
the FDA confirming a 510(k) approval for commercial sales of a
Product in the United States.
3. Sulzer's Obligations
3.1 Marketing Efforts. Sulzer agrees to use commercially reasonable efforts
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to market and sell the Products throughout the Territory for the Field of
Use. Sulzer shall have no right or obligation to market the Products for
any use other than the Field of Use.
3.2 Forecasting. Within 60 days following the execution of this Agreement,
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Sulzer shall provide Tutogen with a monthly forecast of demand for the
Products during the succeeding six-month period. Commencing with the
second calendar quarter
CONFIDENTIAL Xenograft Distribution Agreement - Page 2
of 2001 and continuing quarterly thereafter, Sulzer shall provide
Tutogen, no later than 15 days prior to each calendar quarter, with a
rolling monthly forecast of sales of the Products for the succeeding 12
months. Sulzer's forecasts shall specify the anticipated sales by
Product, by Sub-Territory, and by month. Sulzer shall incur no liability
to Tutogen in the event that actual sales of the Products differ from
Sulzer's forecasts.
3.3 Sales Personnel. Sulzer shall use reasonable efforts to train its sales
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personnel in techniques for proper use of the Products.
3.4 Minimum Sales Goals. Between the 21st month following the Effective Date
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and the end of the second Contract Year, Sulzer and Tutogen shall agree
to minimum annual goals for sales (measured by units of Product) for the
Products by Sub-Territory (the "Minimum Sales Goals") for the third,
fourth, and fifth Contract Years. The Minimum Sales Goals shall be
recorded on Schedule B. The parties acknowledge that sales of the
Products in any particular Sub-Territory is a function of many factors,
some of which are beyond the control of Sulzer. Accordingly, the parties'
intent in establishing Minimum Sales Goals is to insure that Sulzer uses
reasonable efforts to promote the sale of the Products in a particular
Sub-Territory and not to guarantee Tutogen a minimum income.
3.4.1 In the three-month period preceding the end of the fifth
Contract Year, and every three years thereafter during the term
of this Agreement (such three-month period being the "Minimums
Negotiation Period"), the parties shall agree on Minimum Sales
Goals of the Products by Territory for three consecutive years.
3.4.2 For each Territory in which a Product is first approved for
commercial sale subsequent to the Effective Date, the parties
shall establish initial Minimum Sales Goals within two years
after the date of Product approval, from that date through the
next Minimums Negotiation Period, with subsequent Minimum Sales
Goals for the Product thereafter established during the
Minimums Negotiation Period as provided by the procedure first
set forth herein.
3.4.3 If the parties have not reached agreement on the Minimum Sales
Goals in a particular Sub-Territory for a particular year
within a time frame specified herein, the parties shall resolve
the matter by binding arbitration as provided in Section 9.9 of
this Agreement.
3.4.4 In the event that Sulzer fails to meet the Minimum Sales Goal
for a Product in any Sub-Territory in any year, then Tutogen
shall have the option (i) to engage in co-promotion of the
Product, at Tutogen's sole expense, in the Territory in which
the Minimum Sales Goal was not met, or (ii) to co-distribute
the Product (either directly or through a Third Party) in the
Sub-Territory in which the Minimum Sales Goal was not met.
3.4.5 In the event that Sulzer fails to meet the Minimum Sales Goal
for a Product in a Sub-Territory for two consecutive years,
then Tutogen shall have the option to terminate Sulzer's right
and license to distribute the Product in that particular Sub-
Territory on 30 days written notice to Sulzer.
CONFIDENTIAL Xenograft Distribution Agreement - Page 3
3.4.6 Following termination of Sulzer's right to distribute a Product
in a particular Sub-Territory, Tutogen shall have the right to
license a Third Party to distribute a product for the same
indication in such Sub-Territory. Tutogen shall exercise its
option to co-promote, co-distribute, or terminate, if at all,
by written notice to Sulzer within 90 days following the date
on which such option matures. The remedies set forth herein for
Sulzer's failure to meet the Minimum Sales Goal are exclusive,
and Sulzer shall have no duty to pay Tutogen any amount for
failure to achieve the Minimum Sales Goal.
4. Tutogen's Obligations
4.1 Product Supply. Tutogen agrees to use its best efforts to acquire
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xenograft bone tissue, process the tissue using the Tutoplast process
according to Sulzer's forecasts for demand for Products, manufacture
the Products, package and label the Products as required for
distribution in the different countries within the Territory, and sell
the Products to Sulzer pursuant to purchase orders issued by Sulzer at
the transfer prices listed in Schedule C attached hereto. Sulzer shall
pay the transfer price to Tutogen within 45 days from the date of
Tutogen's invoice. In no event shall Tutogen or an Affiliate of
Tutogen or a Permitted Successor of Tutogen during the term of this
Agreement supply xenograft bone tissue to a Third Party for
distribution in the Territory for the Field of Use.
4.2 Termination of Distribution Contracts. Tutogen shall terminate the
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right of its existing distributors to distribute the Products for the
Field of Use as soon as possible after the Effective Date according to
the terms of existing distribution agreements, if any. Tutogen agrees
to insure that any substantial inventory of the Products held by the
distributors at the time of their termination is either returned to
Tutogen or transferred to Sulzer.
4.3 Training. Tutogen agrees to provide training services to Sulzer, as
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reasonably requested by Sulzer, regarding the Tutoplast process and
the manufacture and use of the Products. Tutogen and Sulzer shall
confer and agree upon on the scope of and location for the training
services to be provided by Tutogen and the distribution of the
expenses for such training services.
5. Regulatory Matters
5.1 Import Compliance. Tutogen agrees to comply with and maintain
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compliance with all governmental rules, regulations, statutes, and
other laws of any kind relating to acquisition of xenograft tissue,
manufacture the Products, packaging and labeling of the Products, and
delivery of the Products to Sulzer for distribution within the
Territory.
5.2 Regulatory Responsibilities. The parties understand that as of the
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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
CONFIDENTIAL Xenograft Distribution Agreement - Page 4
particular country after the Effective Date, subject to the agreement
of both Sulzer and Tutogen to seek regulatory approval therefor,
Tutogen shall be responsible for applying for regulatory approval for
such Products.
5.2.1 In the event that either Sulzer or Tutogen, in its sole
discretion, does not agree to seek regulatory approval for
a regulated Product in a particular country, then such
Product shall be removed from Schedule A as to that
particular country. If Tutogen desires to seek regulatory
approval, but Sulzer does not, then Tutogen shall have the
right to seek regulatory approval for such product at its
own expense and to distribute such product without
obligation to Sulzer under this Agreement. If Sulzer
desires to seek regulatory approval for such product, but
Tutogen does not, Sulzer, subject to Tutogen's agreement
to supply the product, shall have the right to seek
regulatory approval for such product at its own expense
and to distribute the product without obligation to
Tutogen under this Agreement.
5.2.2 In the event that Sulzer and Tutogen each agree to seek
regulatory approval for a Product, then the parties shall
forthwith meet and agree upon a plan pursuant to which
Tutogen will seek regulatory approval for the Product from
the regulatory body in question (the "Regulatory Plan").
The Regulatory Plan shall include an agreement as to the
scope, timing, and supervisory responsibility for
preclinical studies, clinical trials, regulatory
submissions, and all other matters related to the
regulatory approval process for the Product. The parties
shall meet at least once annually to review and amend the
Regulatory Plan as dictated by the current status of the
clinical and regulatory process.
5.2.3 Sulzer and Tutogen hereby specifically agree to seek a
510(k) approval from the FDA for use of bovine cancellous
chips for periodontal defects in the United States. The
parties shall meet within 90 days following the Effective
Date and agree upon a Regulatory Plan therefor.
5.3 Clinical Expenses. Sulzer and Tutogen shall each pay one-half of all
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out-of-pocket expenses incurred in execution of a Regulatory Plan
subsequent to the Effective Date, excluding salary, benefits, and
other costs for employees of the parties (the "Clinical Expenses").
5.3.1 In the absence of an agreement otherwise, a party that
incurs Clinical Expenses in a calendar quarter shall
invoice the other party quarterly in arrears for one-half
of such Clinical Expenses. The invoice shall specify for
each such expense the vendor, the purpose, and the date
such expense was incurred and shall include a copy of
supporting documentation of the expense.
5.3.2 A party receiving an invoice for Clinical Expenses, unless
the invoice is disputed, shall either pay the invoice or
setoff the invoice with other Clinical Expenses within 45
days from the date of the invoice.
5.4 Ownership of Approvals. Tutogen shall be the record owner of all
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regulatory approvals to sell Products in the Territory for the Field
of Use.
5.5 Product Recalls. Tutogen, as manufacturer of the Products, shall be
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responsible for execution of and all expenses related to any recall of
Products, including, but
CONFIDENTIAL Xenograft Distribution Agreement - Page 5
not limited to, retrieving recalled Products from users, scrapping or
discarding recalled Products, and resupplying users with replacement
Products.
6. Trademark License and Product Labeling
6.1 License Grant. Tutogen grants Sulzer a nonexclusive license under
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Tutogen's trademarks, Tutoplast and Tutodent, to use the trademarks
solely in connection with the Products and the marketing thereof
within the Territory for the Field of Use.
6.2 Approval of Marketing Publications. Sulzer shall provide Tutogen with
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samples of all of Sulzer's marketing and other printed materials
utilizing a trademark of Tutogen in advance of publication of the
same. Tutogen shall be deemed to have approved such samples for actual
use unless it objects in writing within 10 business days following
Sulzer's delivery of same.
6.3 Labeling. Tutogen agrees to include the trademarks of Sulzer on
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Product labels in a manner mutually agreeable to the parties.
6.4 New Trademarks. Subject to the approval of Tutogen, which shall not be
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withheld unreasonably, Sulzer shall have the right to adopt new
trademarks of its choosing for use in connection with the Products.
7. Term and Termination
7.1 Term. This Agreement shall be effective on the Effective Date and
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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 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
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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.
7.3 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,
CONFIDENTIAL Xenograft Distribution Agreement - Page 6
(ii) upon such other party's making an assignment for the benefit of
creditors, or (iii) upon such other party's dissolution or ceasing to
do business.
7.4 Refund of Clinical Expenses. In the event that the Agreement
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terminates (i) by reason of Tutogen's notice of termination under
Section 7.1, or (ii) by reason of Tutogen's material breach under
Section 7.2, then Tutogen shall be obligated to refund Sulzer's
payment of Clinical Expenses, as determined in this Section 7.4, in
obtaining or attempting to obtain regulatory approval for Products
under Section 5.2. For each Product as to which Sulzer has reimbursed
a portion of Clinical Expenses paid by Tutogen, Tutogen shall be
obligated to refund an amount determined by multiplying the Clinical
Expenses for that Product by the Refund Ratio. The "Refund Ratio" is
10 yrs - (t\\exp\\ - \\tapp\\) / 10 yrs,
where t\\exp\\ is the effective date of termination of the Agreement
and t\\app\\ is the date of regulatory approval for the Product. For
example, if Tutogen obtains a regulatory approval for a Product at the
beginning of the second Contract Year after incurring $100,000 of
Clinical Expenses reimbursed by Sulzer and the Agreement terminates at
the beginning of the fifth Contract Year, the Refund Ratio is
10 yrs - (3 yrs) / 10 yrs = 0.7
and Tutogen owes Sulzer $70,000. The refund amount shall be paid in
three equal annual installments due on the date of termination, one
year after termination, and two years after termination, without
interest.
8. Representations, Warranties, Indemnities, and Limitations of Liability
8.1 Tutogen. Tutogen represents and warrants to Sulzer, as follows:
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8.1.1 Tutogen has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations
hereunder, and the execution, delivery, and performance of
this Agreement have been validly authorized by Tutogen.
8.1.2 Tutogen has the right to grant to Sulzer the rights and
licenses granted in this Agreement.
8.1.3 As of the date of this Agreement, and to the best of its
knowledge and belief, neither the manufacture, nor the use,
nor the sale of the Products in the Territory constitutes a
misuse or misappropriation of confidential information or
trade secrets or a breach of confidence, and does not
infringe or violate any valid patent, trademark, or
copyright or any other intellectual property rights of any
third party. Tutogen has disclosed to Sulzer all patents and
other intellectual property rights which, to Tutogen's
knowledge, may have a material effect on Sulzer's ability to
market the Products.
8.1.4 Tutogen has not received notice that the manufacture, use,
or sale of the Products violates any patent rights or any
other intellectual property right or constitutes a
misappropriation or misuse of trade secrets or proprietary
information.
CONFIDENTIAL Xenograft Distribution Agreement - Page 7
8.1.5 Tutogen shall promptly notify Sulzer of any claim of
infringement or misappropriation relating to the Products.
8.1.6 To the best of Tutogen's knowledge and belief, Tutogen
possesses all governmental and other approvals required for
the collection and processing of xenograft tissue, and
Tutogen shall use commercially reasonable efforts to
maintain all such approvals throughout the term of this
Agreement.
8.1.7 For a period of 12 months from the date of Tutogen's
delivery to Sulzer, each Product shall be free from defects
in material, manufacturing, and workmanship, including, but
not limited to, disease, excluding defects caused by the
abuse, misuse, neglect, or by improper testing, handling,
storage, or use by a party other than Tutogen.
8.2 Liability for Breach of Product Warranty. If any failure to conform to
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the representation and warranty set forth in Section 8.1.7 appears
within the applicable warranty period, Tutogen will, at its option and
expense, correct any such failure by either replacing the defective or
non-conforming Product or by repairing such Product. In no event shall
the liability of Tutogen in connection with such warranty exceed the
cost of replacing or repairing the defective Product. The foregoing
shall constitute the exclusive remedy of Sulzer and the sole liability
of Tutogen whether in contract or in tort or otherwise relating to a
defect of a Product.
8.3 Exclusion of Other Warranties. The representations and warranties
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stated in Section 8.1 are expressly in lieu of all other warranties,
including, but not limited to, any implied warranty of merchantability
or of fitness, and constitute the only warranties made with respect to
any Product.
8.4 Sulzer. Sulzer represents and warrants to Tutogen, as follows:
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8.4.1 Sulzer has the corporate power and authority to execute and
deliver this Agreement and to perform its obligations
hereunder, and the execution, delivery, and performance of
this Agreement have been validly authorized by Sulzer.
8.5 Indemnity by Tutogen.
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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
CONFIDENTIAL Xenograft Distribution Agreement - Page 8
right to participate in a non-controlling fashion in such
legal proceeding at its sole expense.
8.5.2 No undertaking of Tutogen under this section shall extend to
any such alleged infringement or violation to the extent
that it: (a) arises from adherence to design modifications,
specifications, drawings, or written instructions which
Tutogen is directed by Sulzer to follow, but only if such
alleged infringement or violation does not reside in
corresponding Product of Tutogen's design or selection; or
(b) arises from adherence to instructions to apply Sulzer's
trademark, trade name, or other company identification; or
(c) resides in a Product which is not of Tutogen's origin
and which is furnished by Sulzer to Tutogen for use under
this Agreement; or (d) relates to use of Products or other
items provided by Tutogen in combination with other Products
or items furnished either by Tutogen or others, which
combination was not installed, recommended, or otherwise
approved by Tutogen. In the foregoing cases numbered (a)
through (d), Sulzer will defend and hold Tutogen harmless,
subject to the same terms and conditions and exceptions
stated above, with respect to Tutogen's rights and
obligations under this clause.
8.6 Indemnity by Sulzer.
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8.6.1 Sulzer shall defend, indemnify, and hold harmless Tutogen
against any liability or damages from any third party
claims, suits, proceedings, demands, recoveries, or expenses
("Claims") to the extent that such Claims arise from or are
based upon: (i) material breach by Sulzer of any of its
representations or warranties contained herein; or (ii)
negligence, gross negligence, or intentionally wrongful acts
or omissions on the part of Sulzer; provided that Tutogen:
(a) promptly notifies Sulzer in writing of any such Claim
which comes to its attention; (b) allows Sulzer to control
the defense or settlement of such Claim; (c) does not enter
into any settlement or compromise of such Claim without the
express authorization of Sulzer; and (d) reasonably
cooperates with Sulzer in the defense of such Claim, subject
to Sulzer's payment of all reasonable out-of-pocket expenses
associated with such cooperation by Tutogen. Tutogen shall
have the right to participate in a non-controlling fashion
in such legal proceeding at its sole expense.
8.6.2 No undertaking of Sulzer under this section shall extend to
any such alleged infringement or violation to the extent
that it: (a) arises from adherence to design modifications,
specifications, drawings, or written instructions which
Sulzer is directed by Tutogen to follow, but only if such
alleged infringement or violation does not reside in
corresponding Product of Sulzer's design or selection; or
(b) arises from adherence to instructions to apply Tutogen's
trademark, trade name, or other company identification; or
(c) resides in a Product which is not of Sulzer's origin and
which is furnished by Tutogen to Sulzer for use under this
Agreement; or (d) relates to use of Products or other items
provided by Sulzer in combination with other Products or
other items, furnished either by Sulzer or others, which
combination was not installed, recommended or otherwise
approved by Sulzer. In the
CONFIDENTIAL Xenograft Distribution Agreement - Page 9
foregoing cases numbered (a) through (d), Tutogen will
defend and hold Sulzer harmless, subject to the same terms
and conditions and exceptions stated above with respect to
Sulzer's rights and obligations under this clause.
8.7 Limitation of Liability to Third Parties. The liability of Tutogen and
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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 8.
8.8 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.
9. Miscellaneous Provisions
9.1 Entire Agreement.
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9.1.1 This Agreement, together with the U.S. Service Agreement and
the Processed Tissue Development and License Agreement, all
between the parties or their Affiliates of even date, embodies
the final, complete, and exclusive understanding between the
parties and supersedes all previous agreements, understandings,
or arrangements between the parties with respect to its subject
matter.
9.1.2 No modification or waiver of any terms or conditions hereof,
nor any representations or warranties will be of any force or
effect unless such modification or waiver is in writing and
signed by an authorized officer of the party against whom
enforcement is sought.
9.2 Force Majeure. Neither party will be liable to the other for its
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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 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
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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:
CONFIDENTIAL Xenograft Distribution Agreement - Page 10
If to Tutogen:
Tutogen Medical GmbH
IndustriestraBe 6,
D-91077 Neunkirchen am Brand
GERMANY
Attention: President and CEO
Telephone: 49 (9134) 99 88 110
Facsimile: 49 (9134) 99 88 119
With a copy to:
Dr. Dirk Lange
Foerster + Rutow
Irrestr. 17-19
90403 Nurnberg
GERMANY
Telephone: 49 (911) 23 569 00
Facsimile: 49 (911) 23 569 11
If to Sulzer:
Sulzer Calcitek Inc.
1900 Aston Avenue
Carlsbad, California 92008-7308
U.S.A.
Attention: President
Telephone: 1 (760) 431-9515
Facsimile: 1 (760) 431-9753
With a copy to:
Sulzer Medica USA Inc.
3 East Greenway Plaza, Suite 1600
Houston, Texas 77046
U.S.A.
Attention: General Counsel
Telephone: 1 (713) 561-6365
Facsimile: 1 (713) 561-6380
9.4 Governing Law. Recognizing that the laws within different international
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jurisdictions vary in their content and effect with respect to similar
subject matter, and that the parties desire uniformity and predictability
in interpretation and enforcement of this Agreement and related agreements
with international scope made contemporaneously by the parties and their
Affiliates, the parties have agreed to the following provisions regarding
applicable law to govern this Agreement: All matters affecting the
interpretation, form, validity, and performance of this Agreement shall be
decided under the laws of Switzerland. The United Nations Convention on
Contracts for the International Sale of Goods of April 11, 1980 shall not
be applicable.
CONFIDENTIAL Xenograft Distribution Agreement - Page 11
9.5 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 the applicable law or applicable court decisions.
9.6 Independent Contractors. Each party will act as an independent contractor
-----------------------
under the terms of this Agreement. Except as otherwise provided in this
Agreement, neither party is, nor will it be deemed to be, an employee,
agent, partner, co-venturer, or legal representative of the other for any
purpose.
9.7 Nonassignability. Neither this Agreement nor any of the rights, interests,
----------------
duties, or obligations under this Agreement shall be assigned or
delegated, in whole or in part, by operation of law or otherwise by any
party without the prior written consent of the other party, except that
either party may assign this Agreement to an Affiliate of such party;
provided that, in no event shall a party assign to an Affiliate less than
the entirety of its rights and obligations under this Agreement. Any
assignment made in violation of this Section 9.7 will be void and of no
effect. Subject to this Section 9.7, this Agreement shall be binding upon,
inure to the benefit of, and be enforceable by and against, the parties
and their Permitted Successors.
9.8 Compliance With Laws. Notwithstanding other provisions in this Agreement
--------------------
regarding a failure to comply with laws, in performing this Agreement,
each Party shall comply with all laws and government regulations
applicable in a particular country at all times.
9.9 Arbitration.
-----------
9.9.1 In the event the Parties are unable to resolve any dispute or
conflict arising from or relating to this Agreement within thirty
(30) days after it is formally presented for resolution by written
notice, any party may submit such conflict for resolution to the
Chief Executive Officers of the parties.
9.9.2 In the event the Chief Executive Officers of the parties are
unable to resolve such conflict within thirty (30) days after
having such conflict submitted to them for resolution, the
disputes shall be finally settled under the Rules of Conciliation
and Arbitration of the International Chamber of Commerce in Paris
("Rules") by three arbitrators appointed in accordance with the
Rules.
9.9.3 The place of arbitration shall be Zurich. The procedural law of
this place shall apply where the Rules are silent.
9.9.4 The arbitral award shall be substantiated in writing. The arbitral
tribunal shall decide on the matter of costs of the arbitration.
9.9.5 The language to be used in the arbitral proceedings shall be
English.
CONFIDENTIAL Xenograft Distribution Agreement - Page 12
9.10 Confidentiality. The parties acknowledge that by reason of their
---------------
relationship hereunder, each has had and will continue to have access to
certain information and materials concerning the other's business, plans,
customers, technology, and/or products that is considered by a party to
be confidential ("Confidential Information") and of substantial value to
that party, which value would be impaired if such information were
disclosed to third parties. To the extent that such information is
considered confidential, the disclosing party will so indicate to the
receiving party, in the case of information in documentary or other
tangible form, by labeling it conspicuously as "CONFIDENTIAL" (or words
of similar import) and in the case of information conveyed verbally, by
identifying same in writing within ten days after the first verbal
disclosure. Each party agrees that it will not use in any way other than
as expressly authorized or contemplated under this Agreement, nor
disclose to any third party, any such Confidential Information revealed
to it by the other party, and will take commercially reasonable
precautions (and will cause its Affiliates to take commercially
reasonable precautions) to protect the confidentiality of such
information and with no less restrictive precautions than it takes to
protect its own confidential information. Each party will disclose
Confidential Information only to those of its employees who have a need
to know such information. If Confidential Information is required to be
disclosed in response to an order by a court or other government body, or
if otherwise required to be disclosed by law, or if necessary to
establish the rights of a party under this Agreement, the receiving party
shall use commercially reasonable efforts to provide the disclosing party
with advance notice of such required disclosure to give the disclosing
party sufficient time to seek a protective order or other protective
measures, if any are available, for such Confidential Information.
"Confidential Information" does not include information, materials,
technical data or know-how which: (i) is rightfully in the possession of
the receiving party at the time of disclosure as shown by the receiving
party's files and records immediately prior to the time of disclosure;
(ii) prior to or after the time of disclosure becomes part of the public
knowledge or literature, not as a result of any inaction or action of the
receiving party; (iii) is independently developed by a party without the
use of any Confidential Information of the other parties; (iv) is
obtained from any third party who is authorized to disclose such data and
information without obligation of confidentiality, or (v) is approved for
release by the disclosing party. This Section 9.10 shall survive
termination of this Agreement for a period of two years.
CONFIDENTIAL Xenograft Distribution Agreement - Page 13
9.11 Public Relations And Announcements. The parties shall agree upon and
----------------------------------
issue a press release upon the signing of this Agreement including a
summary of the relationship established under this Agreement. No party
shall issue a press release or any other published statement that refers
to another party, its Affiliates or the other party's products without
first obtaining the agreement of such other party as to the form and
content of the statement, which approval shall be timely and not
unreasonably withheld.
In witness whereof, the parties have each caused this Agreement to be
signed and delivered by their duly authorized representatives on the
dates set forth below in duplicate, each of which will be treated for all
purposes as an original.
Tutogen Medical GmbH Sulzer Calcitek Inc.
By: /s/ Manfred Kruger By: /s/ Steven E. Hanson
------------------ --------------------
Manfred Kruger Steven E. Hanson
Managing Director President
Date: September 29, 2000 Date: September 29, 2000
------------------ ------------------
CONFIDENTIAL Xenograft Distribution Agreement - Page 14
Schedule A - Products
- -------------------------------------------------------------------------------------------------
Description Particle Size (microns) Tissue Volume (cc)
- -------------------------------------------------------------------------------------------------
Bovine Cancellous Chips 250-1000 0.5
- -------------------------------------------------------------------------------------------------
Bovine Cancellous Chips 250-1000 1.0
- -------------------------------------------------------------------------------------------------
Bovine Cancellous Chips 1000-2000 0.5
- -------------------------------------------------------------------------------------------------
Bovine Cancellous Chips 1000-2000 1.0
- -------------------------------------------------------------------------------------------------
Bovine Cancellous Chips 1000-2000 2.0
- -------------------------------------------------------------------------------------------------
CONFIDENTIAL Schedule A to Xenograft Distribution Agreement - Page 1
Schedule B - Minimum Sales Goals
Contract Year 1
- ---------------
No Minimum Sales
Contract Year 2
- ---------------
No Minimum Sales
Contract Year 3
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
Canada ______________
Contract Year 4
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
Canada ______________
CONFIDENTIAL Schedule B to Xenograft Distribution Agreement - Page 1
Contract Year 5
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
Canada ______________
Contract Year 6
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
Canada ______________
Contract Year 7
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
CONFIDENTIAL Schedule B to Xenograft Distribution Agreement - Page 2
Canada _______________
Contract Year 8
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
Canada ______________
Contract Year 9
- ---------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
Japan ______________
Middle East ______________
Canada ______________
Contract Year 10
- ----------------
Sub-Territory Minimum Sales Goals (Total Product Units)
------------- -----------------------------------------
Western Europe ______________
Eastern Europe ______________
South America ______________
Far East ______________
CONFIDENTIAL Schedule B to Xenograft Distribution Agreement - Page 3
Japan ______________
Middle East ______________
Canada ______________
CONFIDENTIAL Schedule B to Xenograft Distribution Agreement - Page 4
Schedule C - Transfer Price
The Transfer Price for the Products during the First Contract Year is set forth
in the table below.
- --------------------------------------------------------------------------------
Product Transfer Price
- --------------------------------------------------------------------------------
Bovine Cancellous Chips, 250-1000 micro, 0.5 cc *
- --------------------------------------------------------------------------------
Bovine Cancellous Chips, 250-1000 micro, 1.0 cc *
- --------------------------------------------------------------------------------
Bovine Cancellous Chips, 1000-2000 micro, 0.5 cc *
- --------------------------------------------------------------------------------
Bovine Cancellous Chips, 1000-2000 micro, 1.0 cc *
- --------------------------------------------------------------------------------
Bovine Cancellous Chips, 1000-2000 micro, 2.0 cc *
- --------------------------------------------------------------------------------
Sulzer and Tutogen shall confer and agree upon the amount of Transfer Price
after the first Contract Year.
*CONFIDENTIAL TREATMENT REQUEST BY SHEARMAN & STERLING.
CONFIDENTIAL Schedule C to Xenograft Distribution Agreement - Page 1