DISTRIBUTION AGREEMENT
EXHIBIT
10.11
CERTAIN
PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED PURSUANT TO RULE 406 PROMULGATED
UNDER THE SECURITIES ACT OF 1933, AS AMENDED, AND ARE SUBJECT TO A CONFIDENTIAL
TREATMENT REQUEST. COPIES OF THE EXHIBITS CONTAINING THE OMITTED
INFORMATION HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION. THE OMITTED PORTIONS OF THIS DOCUMENT ARE MARKED WITH ””
[***]”.
This
Distribution Agreement (this "Agreement") is made and entered into as of
August
17, 2007 (the "Effective Date"), by and between Xxxxxx Dental, Inc., a Delaware
corporation ("Zimmer"), and Tutogen Medical, Inc., a Florida corporation
("Tutogen").
Recitals
A. Tutogen
develops, manufactures and markets bio-implants and medical devices for tissue
and bone repair and other surgical solutions, including the Products (as
defined
below).
X. Xxxxxx
distributes a variety of dental products manufactured by itself and
others.
X. Xxxxxx
and Tutogen are currently parties to the following agreements (in each case,
as
amended) (i) the U.S. Service Agreement dated September 29, 2000 (the "U.S.
Agreement"), (ii) the Xenograft Distribution Agreement dated September 29,
2000
(the "Xenograft Agreement"), (iii) the Canadian Distribution Agreement dated
August 1, 2004 (the "Canada Agreement"), and (iv) the Agreement to Distribute
Tutogen Products dated January 1, 2006 (the "Latin America
Agreement").
D. Tutogen
desires to appoint Zimmer as the exclusive distributor of the Products
throughout the Exclusive Territory (as defined below) and as a non-exclusive
distributor of the Products throughout the Non-Exclusive Territory (as defined
below) for all uses and applications in the Field (as defined below), and
Zimmer
desires to accept such appointment, all in accordance with the terms and
conditions of this Agreement.
Agreement
In
consideration of the mutual covenants contained in this Agreement, Zimmer
and
Tutogen agree as follows:
ARTICLE
I
DEFINITIONS
AND RULES OF CONSTRUCTION
1.1. Definitions.
(a) Terms
Defined in this Article. For purposes of this Agreement, the
following terms shall have the following meanings:
"Affiliate"
means, with respect to an entity, a Person that directly, or indirectly through
one or more intermediaries, controls, is controlled by, or is under common
control with, the entity. For this purpose, "control" of an entity
means the possession, direct or indirect, of the power to direct or cause
the
direction of the management and policies of the entity, whether through the
ownership of voting securities, by contract or otherwise.
"Applicable
Laws" means all applicable common law, statutes, ordinances, rules,
regulations or orders of any Governmental Authority, including Regulatory
Laws.
"Business
Day" means any day other than a Saturday, a Sunday or a day on which
banks in New York are authorized or obligated by law or executive order to
remain closed.
"Change
of Control" means, with respect to an entity, a transaction or series
of related transactions as a result of which a Person or group of Persons
acting
in concert directly or indirectly acquires control of the entity or acquires
ownership of all or substantially all of its assets. The
transaction(s) may be in any form or combination of forms, including an issuance
of voting securities, a grant of one or more proxies, a merger (whether or
not
the entity survives), a consolidation, a share exchange, a reorganization
or an
asset sale. For this purpose, "control" of an entity means the
possession, direct or indirect, of the power to direct or cause the direction
of
the management and policies of the entity, whether through the ownership
of
voting securities, by contract or otherwise.
"Exclusive
Territory" means the countries and jurisdictions listed on Exhibit
A attached hereto, including those countries and jurisdictions added
pursuant to Section 2.2 hereof.
"Field"
means any and all dental and oral maxillofacial applications.
"Field
Action" means any correction or removal action by Zimmer or Tutogen due
to safety, efficacy, quality or regulatory compliance concerns, including
actions to recover title to or possession of, or to halt distribution of,
Products that previously have been shipped to customers.
"Governmental
Authority" means any country in which the Product is manufactured,
sterilized, marketed, sold, tested, investigated or otherwise regulated,
and all
states or other political subdivisions thereof and supranational bodies
applicable thereto, including the European Union, and all agencies, commissions,
officials, courts or other instrumentalities of the foregoing.
"Insolvency
Event" means that the Party (a) has commenced a voluntary
proceeding under any insolvency law, (b) had an involuntary proceeding
commenced against it under any insolvency law which has continued undismissed
or
unstayed for sixty (60) consecutive days, (c) had a receiver, trustee
or similar official appointed for it or for any substantial part of its
property, (d) made an assignment for the benefit of creditors or
(e) had an order for relief entered with respect to it by a court of
competent jurisdiction under any insolvency law. For purposes hereof,
the term "insolvency law" means any applicable bankruptcy, insolvency or
other
similar law now or hereafter in effect.
"Intellectual
Property" means (a) discoveries, inventions, improvements,
concepts and ideas, whether or not patentable, (b) works of authorship
fixed in a tangible medium of expression, (c) Trademarks, (d) trade
secrets and know-how and (e) all proprietary rights relating thereto,
including all applications, registrations and renewals in connection
therewith.
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"Marketing
Approval" means, with respect to any country or jurisdiction, the act
of the applicable Regulatory Authority that is necessary under applicable
Regulatory Laws for the manufacture, marketing, distribution and sale of
the
Product in that country or jurisdiction, and satisfaction of all applicable
regulatory and notification requirements and, to the extent applicable, the
grant of Pricing Approval.
"Non-Exclusive
Territory" means [***].
"Party"
means Zimmer or Tutogen, as the context requires.
"Person"
means any individual, group or entity, including Governmental
Authorities.
"Point
of Destination" means the location to which a Product is to be shipped,
as designated by Zimmer in the applicable firm order.
"Pricing
Approval" means, with respect to any country or jurisdiction in which
Governmental Authorities determine the pricing at which products will be
reimbursed, the approval, agreement, determination or decision by the applicable
authorities establishing that pricing.
"Products"
means the Tutogen grafts set forth on Exhibit B hereto.
"Product
Complaint" means any expression by a Third Party of
dissatisfaction relating to the identity, durability, reliability, safety,
efficacy or performance of any Product, including actual or suspected product
tampering, contamination, mislabeling or misformulation.
"Regulatory
Authority" means, with respect to any country or jurisdiction, any
Governmental Authority involved in granting Marketing Approval or Pricing
Approval or in administering Regulatory Laws in that country or
jurisdiction.
"Regulatory
Laws" means all Applicable Laws governing (a) the import, export,
testing, sterilization, investigation, manufacture, marketing or sale of
the
Product, (b) establishing recordkeeping or reporting obligations,
(c) Field Actions or (d) similar regulatory matters.
"Specifications"
means, with respect to each Product, (a) Tutogen's design and functionality
specifications relating to the Product, (b) any design and functionality
specifications provided by Tutogen in its sales literature or other product
documentation and (c) any specifications for manufacturing, testing,
sterilization, storing, packaging, shipping or labeling the Product set forth
in
any approved application for Marketing Approval and any supplements and
amendments thereto.
"Territory"
means the Exclusive Territory and the Non-Exclusive Territory.
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"Third Party"
means any Person other than the Parties and their Affiliates.
"Trademarks"
means all trademarks, service marks, trade dress, logos and trade
names, together with all translations, adaptations, derivations and combinations
thereof (including all goodwill associated therewith), and all applications,
registrations and renewals in connection therewith.
"Tutogen
IP" means all Intellectual Property that is subject as of the Effective
Date, or becomes subject during the Term, to Tutogen's control and that is
necessary or useful for the manufacture, testing, use, promotion, marketing,
sale or distribution of the Product.
"United States"
means the United States of America, including its territories,
commonwealths and possessions.
(b) Terms
Defined Elsewhere. Capitalized terms not defined in
Section 1.1(a) shall have the meanings specified elsewhere in the text of
this Agreement. Those terms include the following:
|
Term
|
Section
|
|
Agreement
|
Opening
paragraph
|
|
Binding
Forecast
|
3.1
|
|
Canada
Agreement
|
Recitals
|
|
Claim
|
7.1(c)
|
|
Commercialization
License
|
7.3
|
|
Confidential
Information
|
6.1(a)
|
|
Distribute
|
2.1(a)
|
|
Effective
Date
|
Opening
paragraph
|
|
Forecast
|
3.1
|
|
Initial
Term
|
10.1
|
|
Latin
America Agreement
|
Recitals
|
|
Marketing
Partners
|
2.1(a)
|
|
Tutogen
|
Opening
paragraph
|
|
Product
Liability Claim
|
9.1(a)
|
|
QA/RA
Agreement
|
5.3
|
|
Renewal
Term
|
10.1
|
|
Term
|
10.1
|
|
U.S.
Agreement
|
Recitals
|
|
Xenograft
Agreement
|
Recitals
|
|
Zimmer
|
Opening
paragraph
|
1.2. Rules
of Construction.
(a) When
a reference is made in this Agreement to a Recital, an Article, a Section
or an
Exhibit, such reference is to a Recital, Article or Section of, or an Exhibit
to, this Agreement, unless otherwise indicated.
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(b) Whenever
the words "include," "includes" or "including" are used in this Agreement,
they
shall be understood to be followed by the words "without
limitation."
(c) Pronouns,
including "he," "she" and "it," when used in reference to any Person, shall
be
deemed applicable to entities or individuals, male or female, as appropriate
in
any given case.
(d) Article,
Section and other headings contained in this Agreement are for reference
purposes only and are not intended to describe, interpret, define or limit
the
scope, extent or intent of any provision of this Agreement.
(e) Standard
variations on defined terms (such as the plural form of a term defined in
the
singular form, and the past tense of a term defined in the present tense)
shall
be deemed to have meanings that correlate to the meanings of the defined
terms.
ARTICLE
II
DISTRIBUTION
2.1. Distribution
Rights.
(a) Tutogen
hereby grants to Xxxxxx, and Xxxxxx hereby accepts, the exclusive right to
promote, market, sell and distribute (collectively, "Distribute") the Products
throughout the Exclusive Territory for all uses and applications in the
Field. Zimmer shall have the right to appoint Third Parties
("Marketing Partners") to participate in the Distribution of the Products
in the
Exclusive Territory. Tutogen shall not, directly or indirectly,
Distribute, or permit Distribution of, any allograft or xenograft products
anywhere in the Exclusive Territory for any uses or applications in the Field,
either on its own behalf or through any Affiliate or Third Party for as
long as this Agreement is in effect.
(b) Tutogen
hereby grants to Xxxxxx, and Xxxxxx hereby accepts, a non-exclusive right
to
Distribute the Products (except for the Tutodent Product which will be branded
under a separate name) throughout the Non-Exclusive Territory for all uses
and
applications in the Field. Zimmer shall have the right to appoint
Marketing Partners to participate in the Distribution of such Products in
the
Non-Exclusive Territory.
2.2. Additional
Countries for the Territory.
(a) Upon
the Effective Date, Zimmer shall have the exclusive right to Distribute human
Products in [***] for use in the Field, and
[***] shall be included within the Exclusive
Territory solely
for such purpose. Zimmer shall have the exclusive right to Distribute
all Products in [***] for use in the Field no later than
[***].
(b) Prior
to Distributing, or permitting Distribution of, any Product for use in the
Field
in any country outside of the Territory, Tutogen first shall offer Zimmer
the
right to Distribute the Product in such country. Tutogen shall
provide written notice to Zimmer regarding the proposed Distribution arrangement
for the Product in such country and Zimmer shall have thirty (30) days from
its
receipt of Tutogen's written notice to notify Tutogen whether it is interested
in the Distribution arrangement. If Zimmer notifies Tutogen within
such 30-day period that it desires to Distribute the Product in such country,
then the country shall be added to the Exclusive Territory. If Zimmer
fails to respond to Tutogen within such 30-day period or if Zimmer notifies
Tutogen that it is not interested in pursuing the Distribution arrangement,
then
Tutogen shall be free to Distribute, or permit Distribution of, the Product
in
such country. Notwithstanding the foregoing, after the Effective
Date, Tutogen shall not enter into any agreements or other commitments that
would limit or restrict Tutogen's ability to xxxxx Xxxxxx exclusive Distribution
rights for the Products in the Field in any country.
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(c) It
shall be Tutogen's responsibility to ensure that it has the unrestricted
right
to expand the Exclusive Territory (and thereby expand the geographic scope
of
Xxxxxx'x exclusive Distribution rights) pursuant this Section 2.2 without
violating, conflicting with, resulting in the breach of, or constituting
a
default under any contract or agreement to which Tutogen is a party or by
which
any of its properties or businesses are bound. Exhibit A to
this Agreement shall be updated to reflect any countries added to the Exclusive
Territory under this Section 2.2.
2.3. Competitive
Products.[***] Nothing in this Agreement shall
preclude Xxxxxx'x third-party Marketing Partners from distributing and promoting
any products that compete directly or indirectly with the Products, provided
that such Marketing Partners are not distributing or promoting such products
on
behalf of Zimmer.
2.4. Marketing
and Sales Activities. Zimmer shall have control and
authority over its marketing activities for the Products in the
Field. Xxxxxx'x marketing and sales efforts may include development
of collateral marketing materials, surgical training, attendance at professional
tradeshows, and pre-clinical and clinical studies, at Xxxxxx'x
cost. Zimmer shall provide Tutogen with a reasonable opportunity to
review and approve all marketing and collateral materials relating to the
Products solely for purposes of compliance with Regulatory Laws, which approval
shall not be unreasonably withheld or delayed.
2.5. Branding. The
Products shall be branded as directed by Zimmer. Tutogen shall adapt
packaging and labeling for the Products as instructed by Zimmer to meet Xxxxxx'x
branding standards. The costs for any change in branding will be
borne by Zimmer.
2.6. Training
Support. Tutogen shall provide, at no charge to Zimmer, a
reasonable number of technical sales training sessions for sales personnel
of
Zimmer and its Marketing Partners, at times and locations mutually agreed
by the
Parties. Zimmer shall be primarily responsible for training end users
in the field.
2.7. Sample
Products. At Xxxxxx'x request, Tutogen shall provide a
reasonable amount of sample Products for use with Xxxxxx'x sales force, trade
shows, promotional activities, training classes and the
like. Transfer pricing for the sample Products is set forth in
Exhibit C.
2.8. Acceptance
of Products. Zimmer, its Marketing Partners and/or the end
users of the Products shall have a reasonable right of inspection to verify
that
the Products conform to the applicable firm order and the terms of this
Agreement. Any non-conforming Product shall be returned to
Tutogen. Tutogen shall bear all costs of return (including freight
and insurance) and shall either replace the defective or nonconforming Product
without charge (including payment of freight and insurance for delivery of
the
replacement product) or, at Xxxxxx'x request, refund to Zimmer the entire
amount
paid in connection with the rejected Product. Nothing in this
Section, including the exercise of rights hereunder, shall be construed as
a
waiver of Xxxxxx'x indemnification rights, its warranty rights or any other
common law or statutory remedies.
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ARTICLE
III
PURCHASING
3.1. Forecasts
and Firm Orders. On a monthly basis Zimmer shall provide to
Tutogen a twelve (12) month rolling forecast of the anticipated quantities
of the Products that Zimmer expects to order on a country-by-country basis
(each, a "Forecast"). The first four (4) months of each Forecast
shall be binding (each, a "Binding Forecast") and Zimmer agrees to place
firm
orders for at least that number Products set forth in each Binding Forecast
(on
an aggregate basis and not on a country-by-country basis, unless there are
special packaging requirements for a particular country in which case Zimmer
shall place firm orders for at least that number of Products set forth in
the
Binding Forecast for such country). The remaining eight (8)
months of each Forecast shall be non-binding and for planning purposes
only. The first Forecast will be delivered to Tutogen upon execution
of this Agreement.
3.2. Fulfillment
of Firm Orders. Tutogen shall use commercially reasonable
efforts to fulfill all firm orders for the Product submitted by Zimmer pursuant
to this Section 3.2 and to deliver Products by the delivery date requested
in the applicable purchase order. Zimmer shall place firm orders for
the Product no less than one hundred and twenty (120) days prior to the
requested delivery date. Firm orders shall be in Xxxxxx'x standard
form as modified from time to time. Firm orders may be submitted via
e-mail. Each firm order shall be deemed accepted, once confirmed by
Tutogen. If any term in any firm order or confirmation conflicts with
any term in this Agreement, the term in this Agreement shall govern and
control.
3.3. Transfer
Pricing.
(a) The
processing fees (referred to herein as "transfer pricing") for the Products
purchased during the Initial Term is set forth in Exhibit B attached
hereto. After the expiration of the Initial Term, Tutogen shall be
entitled to increase the transfer pricing for any Product [***]
per Renewal Term, provided that Tutogen notifies Zimmer in writing regarding
the
pricing increase at least one hundred twenty-five (125) days prior to the
commencement of the applicable Renewal Term.
(b) A
surcharge shall be applied for any firm order with aggregate transfer pricing
less than €5,000 for purchases made in euros and $6,500 for purchases made in
U.S. dollars, which surcharge shall be the greater of 10% of the transfer
pricing in the firm order or €100 for purchases made in euros and $100 for
purchases made in U.S. dollars.
(c) The
transfer pricing is for processing finished Products (i.e. packaged, labeled
and
sterilized). Subject to Section 3.5(c) below, Zimmer shall be
responsible for all freight and delivery charges and any other costs for
shipment of the Products from Tutogen's facilities in Neunkirchen, Germany
or
Alachua, Florida to the Point of Destination specified in the applicable
firm
order.
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(d) In
the event of an unforeseen, extraordinary event that causes a significant
increase in Tutogen's costs to provide the Product to Zimmer (e.g. adverse
regulatory actions), appropriate representatives from Zimmer and Tutogen
will
discuss potential adjustments to the pricing set forth in Exhibit B;
provided, however, that nothing in this Section 3.3 shall be construed to
require Zimmer to agree to any such adjustment or to relieve Tutogen of its
obligations to provide the Products to Zimmer at the transfer pricing provided
herein.
3.4. Payment
Terms. Tutogen shall deliver to Zimmer an invoice for each
firm order, which invoice shall contain customary information, including
the
quantity of Products delivered. Payment terms for undisputed amounts
due shall be [***] from the date of
shipment. Payments hereunder will be made in U.S. dollars or euros as
indicated in Exhibit B hereto. A discount of one percent
(1%) calculated on the invoice total shall be applied in the case of payment
within ten (10) days after Xxxxxx'x receipt of the applicable
invoice.
3.5. Shipping.
(a) All
shipments shall be to the Point of Destination by a carrier selected by
Zimmer. Tutogen shall use commercially reasonable efforts to deliver
the Products to the carrier designated by Xxxxxx no later than the delivery
date
set forth in the applicable firm order. In the event that Tutogen is
not able to timely deliver an entire firm order, Tutogen shall (i) deliver
as
much of the firm order as possible, and (ii) provide immediate notice to
Zimmer
of the anticipated shortfall, which notice shall specify the cause for the
delay
and the estimated delivery date for the remaining Products.
(b) Tutogen
shall package, label, store and ship all Products in compliance with Applicable
Laws and in accordance with good commercial and industry
practice. The Products shall be delivered to the Point of Destination
sterile and ready for resale. Tutogen shall package the Products
suitably for export and appropriately to prevent damage during
shipment. The packing slip/delivery note shall have the part number,
purchase order number and delivery quantity.
(c) The
Products shall be shipped F.O.B. Tutogen's facilities in either Neunkirchen,
Germany or Alachua, Florida. At Xxxxxx'x expense, Tutogen shall ship
the Products to the Point of Destination designated by Zimmer in the applicable
firm order. Notwithstanding the foregoing, in the event that Tutogen
is unable to fulfill an entire firm order in one shipment or Tutogen makes
multiple shipments for a single firm order for any other reason (unless
requested by Zimmer), then Tutogen shall bear the shipping costs and expenses
for all such additional shipments.
(d) With
respect to Products to be distributed in Germany, Tutogen shall deliver the
Products directly to customers and end users as requested by Zimmer, until
such
time that Zimmer obtains (i) ISO certification for the Products and (ii)
any
wholesale license required by Regulatory Authorities in Germany.
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3.6. Tutogen
Inventory. Upon execution of this Agreement, Zimmer agrees
to purchase Tutogen's inventory of Products as specified in Exhibit D
hereto, in the quantities and at the transfer prices and other terms detailed
in
such exhibit. Title to such inventory shall transfer to Zimmer
effective as of the Effective Date. Payment for such inventory shall
be made to Tutogen within 15 Business Days of the Effective
Date. Products in such Inventory shall be stored by Tutogen at its
facilities at no additional charge to Zimmer until Zimmer provides delivery
instructions for such Products. Tutogen shall store the inventory in
compliance with Applicable Laws and in accordance with good commercial and
industry practice.
3.7. Local
Tissue Banks. For any countries that require distribution of
an allograft Product through a local tissue bank, both Zimmer and Tutogen
will
negotiate in good faith a change in the process and costs for orders, shipments
and payments.
ARTICLE
IV
MANUFACTURING
4.1. Inventory. Tutogen
shall maintain sufficient manufacturing capacity (including appropriate
manufacturing, storage and distribution facilities and qualified personnel)
to
meet Xxxxxx'x forecasted demand for the Products.
4.2. Manufacturing. The
Products shall be manufactured and sterilized in accordance with the
Specifications and with all Applicable Laws. Tutogen shall maintain
throughout the Term and for the specified shelf life of the Product (or for
such
longer period as may be required by Applicable Laws) accurate and complete
records relating to its manufacture, sterilization and testing of the Products,
including all records required under Applicable Laws.
4.3. Product
Modifications. Tutogen shall not alter or modify the
Products or their labeling without the prior written consent of
Zimmer.
4.4. Product
Warranty. Tutogen warrants to Zimmer, its Marketing Partners
and the end users of each Product, that the Product, when delivered in
accordance with the applicable firm order, will (i) conform to the
Specifications, (ii) have been manufactured, tested, stored, packaged,
labeled, sterilized and shipped in compliance with Applicable Laws and
(iii) be free of defects in design, material, engineering, fabrication and
workmanship. The foregoing warranty shall be in effect with respect
to each Product for the labeled shelf life of the
Product. Tutogen further warrants to Zimmer that the Product, when
delivered, shall be free and clear of any liens, security interests or
encumbrances of any nature whatsoever. TUTOGEN DISCLAIMS ALL IMPLIED
WARRANTIES, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
4.5. Subcontracting. Tutogen
shall comply with all Applicable Laws related to suppliers, subcontractors
and
vendors and Tutogen shall require that all of its suppliers, subcontractors
and
vendors providing services or products in relation to the Products are in
compliance with all Applicable Laws with regard to such services and
products. Tutogen shall remain primarily responsible for performance
of its obligations hereunder, including obligations relating to Product quality
assurance, compliance with Applicable Laws and confidential information,
regardless of whether any of Tutogen's obligations are undertaken by a
subcontractor.
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ARTICLE
V
REGULATORY
MATTERS
5.1. Compliance
with Laws. Each Party shall comply in all material respects
with all Applicable Laws that pertain to its activities under this Agreement
and, except as otherwise provided for herein, shall bear the entire cost
and
expense of such compliance.
5.2. Marketing
Approvals. Tutogen represents and warrants to Zimmer that it
has applied for and received Marketing Approval for the Products in the
countries specified in Exhibit E hereto, and that such approvals are in
good standing. The Parties acknowledge that existing Marketing Approvals
may need to be modified or supplemented in certain countries in order to
permit
the rebranding and Distribution of the Products by Zimmer. At
Xxxxxx'x request, to the extent that Marketing Approval has not been obtained
for a Product in any country or jurisdiction within the Territory, Tutogen
shall
use commercially reasonable efforts to obtain Marketing Approval for such
Product in such country or jurisdiction. Tutogen shall have primary
responsibility for all communications, submissions and interactions with
the
Regulatory Authorities for the purpose of obtaining and maintaining Marketing
Approvals. Tutogen shall be responsible for the cost of original registrations
and maintenance of the product registration. Zimmer shall be responsible
for all
costs and expenses incurred during the Term relating to modification of the
original registration in an effort to rebrand the products and registration
of
facilities. To the extent permitted under Applicable Laws, Tutogen
hereby grants to Zimmer the fully paid up right to use any and all regulatory
approvals and clearances related to the Products, for use in the Field of
Use,
owned by or licensed to Tutogen and existing as of the Effective Date or
obtained during the Term.
5.3. Quality
Assurance / Regulatory Affairs Document. Concurrently with
the execution of this Agreement, the Parties shall enter into a QA/RA agreement
setting forth procedures and protocols for quality assurance and regulatory
affairs relating to the Product (the "QA/RA Agreement"). To the
extent that any term in the QA/RA Agreement conflicts with any term of this
Agreement, this Agreement shall govern and control.
5.4. Actions
by Regulatory Authorities. Tutogen shall be responsible to
Regulatory Authorities throughout the Territory as the manufacturer of the
Products. If either Party receives notice of an inspection,
investigation, inquiry, import or export ban, product seizure, enforcement
proceeding or similar action by a Regulatory Authority with respect to the
Product or a Party's activities in connection with the Product, it will notify
the other Party within forty-eight (48) hours after its receipt of notice
of the action and will promptly deliver to the other Party copies of all
relevant documents received from the Regulatory Authority. The
Parties shall cooperate in response to the action, including providing
information and documentation as requested by the Regulatory
Authority. If the action primarily concerns Xxxxxx'x activities, then
Zimmer shall have primary responsibility to respond to the Regulatory Authority;
otherwise, Tutogen shall have primary responsibility to respond. In
either case, upon request of the responding Party, the other Party shall
provide
consulting advice and assistance with the response.
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5.5. Inspections. Zimmer
shall have the right, upon reasonable prior notice to Tutogen and not more
frequently than once a year and during regular business hours, to inspect
and
audit Tutogen's facilities and operations for the purpose of verifying Tutogen's
compliance with its obligations under Regulatory Laws and applicable quality
system requirements, including the right to (a) inspect and take samples of
the Product, (b) observe manufacturing and related operations, processes
and methods, (c) review documentation and (d) conduct quality
assurance, quality system and regulatory compliance audits.
5.6. Product
Labels. Tutogen shall have sole responsibility for obtaining
all necessary Product labels and for negotiating the language of the Product
labels with the applicable Regulatory Authorities in the Territory; however,
Tutogen shall not propose or agree to specific content without Xxxxxx'x prior
approval.
5.7. Product
Complaints and Reports. The Parties each shall collect and
record Product Complaints (and any other events required to be recorded under
Applicable Laws) in accordance with Applicable Laws and their standard
procedures and policies in effect from time to time. Each Party shall
provide to the other Party reports of such complaints or events within
seventy-two (72) hours after receipt. Tutogen shall be
responsible for investigating all Product Complaints. Tutogen shall
be responsible for submitting to the Regulatory Authorities all required
reports
and other materials, including annual reports, distribution reports and safety
reports. Each Party shall immediately notify the other Party of any
material information it learns concerning the safety or efficacy of the Product,
regardless of whether formal reporting to any Regulatory Authority is
required.
5.8. Traceability. Tutogen
shall maintain manufacturing and traceability records with respect to the
Products, including TUR forms and records by lot number. Xxxxxx shall
maintain records of distribution in the Territory, on a lot number basis,
and
make this information available to Tutogen as required for compliance with
Applicable Laws. Xxxxxx shall use reasonable efforts to encourage its
customers to return completed TUR forms to Tutogen.
5.9. Field
Actions. If either Party in good faith determines that a
removal, correction, recall or other Field Action involving a Product or
its
labeling is warranted (whether or not required by a Regulatory Authority),
such
Party shall immediately notify the other Party in writing and shall advise
such
other Party of the reasons underlying its determination that a removal,
correction, recall or other Field Action is warranted. The Parties
shall consult with each other as to any action to be taken in regard to such
removal, correction, recall or other Field Action. If, after
consultations, either Party in good faith believes that such a removal,
correction, recall or Field Action should be undertaken with respect the
Product
or its labeling, the Parties shall cooperate in carrying out the
same. Tutogen shall be responsible for all of Xxxxxx'x reasonable
out-of-pocket costs and expenses, including the replacement cost of the
Products, in the event of removals, corrections, recalls or other Field Actions
with respect to any Product unless such removal, correction, recall or other
Field Action was due to an act or omission of Xxxxxx, in which case Xxxxxx
shall
be responsible for Tutogen's reasonable out-of-pocket costs and expenses
in
connection therewith. Tutogen shall be responsible for any
required reporting to Regulatory Authorities with respect to any removal,
correction, recall or other Field Action involving the Product or its
labeling.
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ARTICLE
VI
CONFIDENTIALITY
6.1. Confidentiality. In
the course of their activities pursuant to this Agreement, the Parties
anticipate that they may disclose Confidential Information to one another
and
that either Party may, from time to time, be either the disclosing Party
or the
recipient of Confidential Information. The Parties wish to protect
such Confidential Information in accordance with this
Section 6.1. The provisions of this Section shall apply to
disclosures furnished to or received by a Party and its agents and
representatives (which may include agents and representatives of its Affiliates
and Marketing Partners). Each Party shall advise its agents and
representatives of the requirements of this Section and shall be responsible
to
ensure their compliance with such provisions.
(a) For
purposes hereof, "Confidential Information" with respect to a disclosing
Party
means all information, in any form or media that the disclosing Party furnishes
to the recipient, whether furnished before or after the Effective Date, and
all
notes, analyses, compilations, studies and other materials, whether prepared
by
the recipient or others, that contain or reflect such information; provided,
however, that Confidential Information does not include information that
(i) is or hereafter becomes generally available to the public other than as
a result of a disclosure by the recipient, (ii) was already known to the
recipient prior to receipt from the disclosing Party as evidenced by prior
written documents in its possession not subject to an existing confidentiality
obligation to the disclosing Party, (iii) is disclosed to the recipient on
a non-confidential basis by a person who is not in default of any
confidentiality obligation to the disclosing Party or (iv) is developed by
or on behalf of the recipient without reliance on confidential information
received hereunder. The contents of this Agreement shall be deemed to
be Confidential Information of each Party.
(b) The
recipient of Confidential Information shall (i) maintain its
confidentiality using efforts and precautions at least as great as those
it uses
and takes to protect its own confidential information and trade secrets;
(ii) use such Confidential Information solely in connection with the
discharge of its obligations under this Agreement and (iii) not disclose
such Confidential Information to any person other than those of its agents
and
representatives who need to know such Confidential Information in order to
accomplish the objectives for which it was disclosed. Notwithstanding
the foregoing, the recipient of Confidential Information may disclose it
to the
extent necessary to comply with applicable laws or regulations or with an
order
issued by a court or regulatory body with competent jurisdiction; provided
that,
in connection with such disclosure, the recipient uses commercially reasonable
efforts to obtain confidential treatment or an appropriate protective order,
to
the extent available, with respect to such Confidential
Information.
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(c) Upon
request of the disclosing Party, the recipient of Confidential Information
shall
promptly redeliver to the disclosing Party all Confidential Information provided
to the recipient in tangible form, and the recipient shall not retain any
copies, extracts or other reproductions, in whole or in part, of such
Confidential Information. All notes or other work product prepared by
the recipient based upon or incorporating Confidential Information of the
disclosing Party shall be destroyed, and such destruction shall be certified
in
writing to the disclosing Party by an authorized representative of the recipient
who supervised such destruction. Notwithstanding the foregoing,
in-house legal counsel to the recipient shall be permitted to retain in its
files one copy of all Confidential Information to evidence the scope of the
Party's obligation of confidentiality.
(d) The
obligations under this Section shall remain in effect from the Effective
Date
through the third anniversary of the expiration or termination of this
Agreement.
(e) In
addition to any other remedies available in law or equity, the disclosing
Party
shall be entitled to temporary and permanent injunctive relief in the event
of a
breach (or threatened breach) under this Section.
(f) The
provisions of this Section shall supersede and replace any prior agreements
between the Parties relating to Confidential Information covered
hereby.
6.2. Publicity. Neither
Tutogen nor Xxxxxx shall issue any press release or otherwise publicize the
subject matter of this Agreement without the prior written approval of the
other
Party, except to the extent that such press release or other public announcement
is required by law in the opinion of legal counsel to the releasing Party
or
that the substance thereof has been previously reviewed and released by the
other Party or is in the public domain through no fault of the releasing
Party. In the event of a required press release or other public
announcement, the releasing Party shall provide the other Party with a copy
of
the proposed text prior to such announcement. The Parties agree that
if either Party is required to file this Agreement with any Governmental
Authority, the releasing Party shall redact the financial terms of this
Agreement to the extent possible in order to keep the financial terms of
this
Agreement confidential.
ARTICLE
VII
INTELLECTUAL
PROPERTY RIGHTS
7.1. IP
Representations. Tutogen hereby represents and warrants to,
and covenants with, Xxxxxx as follows:
(a) Tutogen
owns or holds valid and enforceable rights to use and license (to the extent
a
license is required), without infringing, misappropriating or violating the
rights of any Person, any Intellectual Property that is necessary for
(i) Tutogen to manufacture and sell the Product, (ii) Xxxxxx to
Distribute the Product as contemplated by this Agreement and (iii) Tutogen
to grant to Xxxxxx and its Marketing Partners the Distribution rights under
this
Agreement.
(b) Tutogen
has not previously granted any license, covenant not to xxx or other right
that
would be inconsistent with or conflict with the grant of the Distribution
rights
under this Agreement.
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(c) No
Person has asserted a claim, suit, proceeding, action or demand (a "Claim")
with
respect to any of the Tutogen IP, which Claim (i) challenges the validity
of Tutogen's interest in the Tutogen IP, (ii) alleges that Tutogen's use or
practice of the Tutogen IP infringes, misappropriates or violates the rights
of
any Person or (iii) seeks to enjoin or restrain Tutogen's use or practice
of the Tutogen IP in any manner that would interfere with the transactions
contemplated by this Agreement. Tutogen has no knowledge that any
Person intends to assert such a Claim.
7.2. Trademarks. Xxxxxx
and its Marketing Partners shall have the right to use Tutogen's Trademarks
associated with the Product (including, without limitation, Tutoplast® and Tutodent®) for
Product marketing purposes and as may be necessary in order to comply with
applicable Regulatory Laws. Xxxxxx and its Marketing Partners shall
comply with the reasonable quality control instructions of Tutogen as to
the
form and manner in which such Trademarks shall be used. Any
Trademarks developed by Xxxxxx for the Product shall be owned exclusively
by
Xxxxxx. Other than as expressly provided herein, no Party shall
acquire or have any right to use the name or Trademarks of the other Party
without its prior written consent.
7.3. Commercialization
License. Tutogen hereby grants to Xxxxxx a royalty-free
license and right, with the right to sublicense, under the Tutogen IP and
all
improvements and future developments with respect thereto, to use, sell,
offer
to sell, have sold, and import/export the Products in the Field throughout
the
Territory (the "Commercialization License"). The Commercialization
License shall be exclusive for the Exclusive Territory and non-exclusive
for the
Non-Exclusive Territory. The Commercialization License shall be
deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, a license to rights to "intellectual property" as defined
therein. Xxxxxx, as licensee of such rights, shall have the rights
and elections with respect thereto as specified in the United States
Bankruptcy Code. This Agreement shall be deemed to be an "agreement
supplemental to" the Commercialization License for purposes of
Section 365(n) of the United States Bankruptcy Code.
ARTICLE
VIII
REPRESENTATIONS
AND WARRANTIES
Each
Party hereby represents and warrants to, and covenants with, the other Party
that:
(a) It
is a corporation duly organized, validly existing and, if relevant in its
jurisdiction of organization, in good standing under the laws of its
jurisdiction of organization and has the power and authority to own, lease
and
operate its assets and to conduct the business now being conducted by
it. It has all requisite power and authority to enter into this
Agreement and to perform its obligations hereunder.
(b) The
execution, delivery and performance by it of this Agreement and the consummation
by it of the transactions contemplated hereby have been duly authorized and
approved by all necessary corporate or equivalent action on its
part. This Agreement has been duly executed and delivered by it and
constitutes its legal, valid and binding obligation, enforceable against
it in
accordance with its terms, except as the same may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or other laws relating
to or
affecting creditors' rights generally and by general equity
principles.
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(c) The
execution, delivery and performance by it of this Agreement and the consummation
by it of the transactions contemplated hereby do not and will
not: (i) violate any Applicable Laws; (ii) conflict with,
or result in the breach of any provision of, its certificate of incorporation,
bylaws or equivalent organizational documents; (iii) result in the creation
of any lien or encumbrance of any nature upon any property being transferred
or
licensed by it pursuant to this Agreement or (iv) violate, conflict with,
result in the breach or termination of, or constitute a default under (or
event
which, with notice, lapse of time or both, would constitute a default under),
any permit, contract or agreement to which it is a party or by which any
of its
properties or businesses are bound.
(d) No
authorization, consent or approval of, or notice to or filing with, any
Governmental Authority is required for the execution, delivery and performance
by it of this Agreement, other than Marketing Approvals that have not been
obtained prior to the Effective Date.
ARTICLE
IX
INDEMNIFICATION
AND INSURANCE
9.1. Indemnification
by Tutogen.
(a) Tutogen
shall indemnify and hold harmless Xxxxxx and its Affiliates and Marketing
Partners and their respective shareholders, directors, officers, employees
and
agents from and against any and all liabilities, damages, losses, penalties,
fines, costs and expenses, including reasonable attorneys' fees, paid or
incurred by them in connection with any Claim based upon or arising
from: (i) any bodily injury, death or property damage resulting
from any defect in the design, engineering, fabrication, manufacture or label
(including the label warnings) of any Product or from the failure of any
Product
to conform to the applicable Specifications therefor (a "Product Liability
Claim"); (ii) any infringement or violation of a Third-Party's Intellectual
Property as a result of the use, manufacture, sale or distribution of the
Product; (iii) any facts or circumstances that would constitute a breach by
Tutogen of any of its representations, warranties or obligations under this
Agreement; (iv) any violation by Tutogen of Applicable Laws or (v) any
negligent or more culpable act or omission of Tutogen or its Affiliates or
subcontractors or any of their respective employees or agents relating to
the
activities subject to this Agreement.
(b) Xxxxxx
shall give Tutogen prompt written notice of any Claim with respect to which
Tutogen's indemnification obligations may apply, but any delay or failure
of
such notice shall not excuse Tutogen's indemnification obligations except
to the
extent that Tutogen's legal position is prejudiced thereby. Tutogen
shall have the right to assume and control the defense and settlement of
any
such Claim; except that Xxxxxx shall have the right to assume and control,
at
Tutogen's expense, the defense and settlement of any such Claim
if: (i) Xxxxxx reasonably determines that there is a conflict of
interest between Xxxxxx and Tutogen with respect to such Claim;
(ii) Tutogen fails to employ counsel reasonably satisfactory to Xxxxxx to
represent Xxxxxx within a reasonable time after Tutogen's receipt of notice
of
the Claim or (iii) in the reasonable opinion of counsel to Xxxxxx, the
Claim could result in Xxxxxx becoming subject to injunctive or other
non-monetary relief that could have a material adverse effect on Xxxxxx'x
ongoing business. The Party not controlling the defense shall have
the right to participate in the Claim at its own expense, but in any event
shall
cooperate with the controlling Party in the investigation and defense of
the
Claim.
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(c) If
Tutogen is entitled to, and does, assume and control the defense and settlement
of any Claim with respect to which its indemnification obligations apply,
then
Tutogen shall not settle such Claim without Xxxxxx'x prior written consent
(which consent shall not be unreasonably withheld or delayed), unless
(i) the sole relief provided in such settlement is monetary in nature and
shall be paid in full by Tutogen and (ii) such settlement does not include
any finding or admission of a violation by Xxxxxx of any Applicable Laws
or
Third Party's rights. Whenever Xxxxxx assumes and controls the
defense and settlement of a Claim with respect to which Tutogen's
indemnification obligations apply, Tutogen shall not be liable for any
settlement thereof effected by Xxxxxx unless Xxxxxx shall have obtained
Tutogen's prior written consent to the proposed settlement (which consent
shall
not be unreasonably withheld or delayed).
(d) Tutogen
shall maintain, from the Effective Date through the first anniversary of
the
expiration date of the Term, a policy of insurance for Product Liability
Claims. Such policy shall (i) have a per occurrence limit of at
least $1,000,000 and an annual aggregate limit of at least $5,000,000,
(ii) name Xxxxxx as an additional insured and (iii) provide for at
least thirty (30) days' advance written notice to Xxxxxx of
cancellation or material change in coverage. Tutogen shall provide
evidence of such coverage to Xxxxxx promptly following execution of this
Agreement and annually thereafter. If Tutogen breaches its obligation
to maintain insurance, (x) Xxxxxx shall have the right to obtain coverage
as required on Tutogen's behalf and at Tutogen's expense, (y) Xxxxxx shall
have the right to set-off the cost of such coverage against any payment owed
to
Tutogen for Product purchases and (z) Tutogen shall indemnify Xxxxxx from
and against all costs and expenses associated with obtaining such
coverage.
9.2. Indemnification
by Xxxxxx.
(a) Xxxxxx
shall indemnify and hold harmless Tutogen and its Affiliates and their
respective shareholders, directors, officers, employees and agents from and
against any and all liabilities, damages, losses, penalties, fines, costs
and
expenses, including reasonable attorneys' fees, paid or incurred by them
in
connection with any Claim based upon or arising from: (i) any
facts or circumstances that would constitute a breach by Xxxxxx of any of
its
representations, warranties or obligations under this Agreement; (ii) any
violation by Xxxxxx of Applicable Laws or (iii) any negligent or more
culpable act or omission of Xxxxxx or its Affiliates or Marketing Partners
or
any of their respective employees or agents relating to the activities subject
to this Agreement.
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(b) Tutogen
shall give Xxxxxx prompt written notice of any Claim with respect to which
Xxxxxx'x indemnification obligations may apply, but any delay or failure
of such
notice shall not excuse Xxxxxx'x indemnification obligations except to the
extent that Xxxxxx'x legal position is prejudiced thereby. Xxxxxx
shall have the right to assume and control the defense and settlement of
any
such Claim; except that Tutogen shall have the right to assume and control,
at
Xxxxxx'x expense, the defense and settlement of any such Claim
if: (i) Tutogen reasonably determines that there is a conflict
of interest between Xxxxxx and Tutogen with respect to such Claim;
(ii) Xxxxxx fails to employ counsel reasonably satisfactory to Tutogen to
represent Tutogen within a reasonable time after Xxxxxx'x receipt of notice
of
the Claim or (iii) in the reasonable opinion of counsel to Tutogen, the
Claim could result in Tutogen becoming subject to injunctive or other
non-monetary relief that could have a material adverse effect on Tutogen's
ongoing business. The Party not controlling the defense shall have
the right to participate in the Claim at its own expense, but in any event
shall
cooperate with the controlling Party in the investigation and defense of
the
Claim.
(c) If
Xxxxxx is entitled to, and does, assume and control the defense and settlement
of any Claim with respect to which its indemnification obligations apply,
then
Xxxxxx shall not settle such Claim without Tutogen's prior written consent
(which consent shall not be unreasonably withheld or delayed), unless
(i) the sole relief provided in such settlement is monetary in nature and
shall be paid in full by Xxxxxx and (ii) such settlement does not include
any finding or admission of a violation by Tutogen of any Applicable Laws
or
Third Party's rights. Whenever Tutogen assumes and controls the
defense and settlement of a Claim with respect to which Xxxxxx'x indemnification
obligations apply, Xxxxxx shall not be liable for any settlement thereof
effected by Tutogen unless Tutogen shall have obtained Xxxxxx'x prior written
consent to the proposed settlement (which consent shall not be unreasonably
withheld or delayed).
9.3. Combined
Obligations. To the extent that Xxxxxx and Tutogen have
indemnification obligations to one another in connection with a single Claim,
Xxxxxx and Tutogen shall contribute to the aggregate damages arising from
such
Claim in such proportion as is appropriate to reflect their relative
responsibilities for such damages, as well as any other relevant equitable
considerations. The amount paid or payable by Xxxxxx or Tutogen for
purposes of apportioning the aggregate damages shall be deemed to include
all
reasonable legal fees and expenses incurred by such Party in connection with
investigating, preparing for or defending against such Claim.
ARTICLE
X
TERM
AND TERMINATION
10.1. Term. Unless
earlier terminated in accordance with Section 10.2, the initial term of
this Agreement (the "Initial Term") shall begin on the Effective Date and
shall
continue in effect until September 29, 2010. The Initial Term shall
be automatically extended for one year renewal terms (each, a "Renewal Term"),
unless at least one hundred twenty (120) days prior to the expiration
of the Initial Term or the applicable Renewal Term either Party notifies
the
other Party in writing that it desires not to renew the Initial Term or Renewal
Term, as applicable. The period from the Effective Date through the
date of expiration or termination of this Agreement shall be referred to
as the
"Term."
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10.2. Termination. This
Agreement may be terminated prior to the expiration of the Initial Term or
any
Renewal Term as follows:
(a) If
a Party is dissolved under applicable corporate law or becomes subject to
an
Insolvency Event, the other Party may terminate this Agreement by delivering
written notice of its decision to do so within sixty (60) days after actual
knowledge of the dissolution or the Insolvency Event.
(b) If
either Party believes the other is in material default of this Agreement,
it may
give notice of such default to the other Party, and the defaulting Party
shall
have thirty (30) days in which to remedy the default. If
the default is not remedied within such thirty (30) day period, the
non-defaulting Party may terminate this Agreement immediately upon delivery
to
the defaulting Party of a written notice of termination. The
non-defaulting Party's right to terminate this Agreement shall not be construed
as an exclusive remedy.
(c) If
a Party is subject to a Change of Control and the acquiring Person is, in
the
other Party's reasonable judgment, a direct competitor to the other Party,
then
the Party that is not subject to the Change of Control may terminate this
Agreement effective immediately upon delivery of written notice of termination,
provided that such notice must be delivered within sixty (60) days after
consummation of the Change of Control. For purposes hereof, a direct
competitor of Xxxxxx shall include any direct competitor of Xxxxxx, Inc.,
a
Delaware corporation, or any direct or indirect subsidiary of Xxxxxx,
Inc. For purposes hereof, a direct competitor of Tutogen shall
include any Person that process or distributes allograft or xenograft
products.
(d) Either
Party may terminate this Agreement in accordance with the terms of
Section 11.2.
10.3. Order
Fulfillment; Depletion of Inventory. Upon the expiration or
termination of this Agreement, (a) at Xxxxxx'x request, Tutogen shall
continue to manufacture and deliver all Products that are the subject of
a firm
order from Xxxxxx as of the date of expiration or termination and
(b) Xxxxxx shall be permitted to sell to depletion any remaining inventory
of the Products, including any Products delivered pursuant to clause (a)
above. Xxxxxx shall use commercially reasonable efforts to sell the
remaining inventory of the Products within six (6) months of the date of
expiration or termination. After the expiration of such six-month
period, Xxxxxx shall continue to have the right to sell to depletion any
remaining inventory of the Products, provided that Tutogen shall have the
option
to repurchase any such remaining inventory at the transfer price paid by
Xxxxxx
for such Products.
10.4. Survival. Termination
or expiration of this Agreement for any reason shall be without prejudice
to any
rights that shall have accrued to the benefit of any Party prior to such
termination or expiration. The following Articles and Sections shall
survive the expiration or termination of this
Agreement: Articles VI, IX and X and Sections 2.8, 4.2,
4.4, 5.4, 5.7, 5.8, 5.9, 11.4 and 11.9.
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ARTICLE
XI
MISCELLANEOUS
11.1.
Agency. Neither Party is, nor shall be deemed to be,
an employee, agent, partner or legal representative of the other Party for
any
purpose. Neither Party shall have the right, power or authority to
enter into any contracts in the name of, or on behalf of, the other Party,
nor
shall either Party have the right, power or authority to pledge the credit
of
the other Party in any way or hold itself out as having the authority to
do
so.
11.2. Force
Majeure. If the performance of any obligation under this
Agreement is prevented, restricted or interfered with by reason of war,
revolution, civil commotion, acts of terrorism, blockade, embargo, strikes,
government acts or similar event which is beyond the reasonable control of
the
Party affected, then the Party so affected shall, upon giving prior written
notice to the other Party, be excused from such performance to the extent
of
such prevention, restriction, or interference, provided that the Party so
affected shall use commercially reasonable efforts to avoid or remove such
causes of nonperformance, and shall continue performance hereunder with
reasonable dispatch whenever such causes are removed. If such
conditions inhibiting complete performance shall continue in excess of
ninety (90) days, then the Party that is not affected by the force majeure
event shall have the option, by delivery of written notice of termination
to the
affected Party, to terminate this Agreement. The Parties agree that
issues or problems with tissue supply (except as a result of changes in
applicable Regulatory Laws) will not constitute a force majeure
event.
11.3. Entire
Agreement; Amendments. This Agreement, together with the
QA/RA Agreement, constitutes the entire agreement between the Parties hereto
concerning its subject matter and supersedes all previous negotiations,
agreements and commitments with respect thereto. This Agreement
specifically supersedes the Latin America Agreement, and the Latin America
Agreement is hereby terminated. This Agreement specifically
supersedes the Xenograft Agreement with respect to all countries covered
under
such agreement except the United States, and the Xenograft Agreement shall
remain in effect solely with respect to the United States. This
Agreement does not supersede the U.S. Agreement or the Canada Agreement,
and
such agreements shall remain in effect in accordance with their respective
terms. This Agreement shall not be released, discharged, amended or
modified in any manner except by a written instrument signed by duly authorized
officers or representatives of each of the Parties hereto.
11.4. Governing
Law. This Agreement shall be governed by and interpreted in
accordance with the substantive laws of the State of Indiana, without regard
to
its choice of law rules.
11.5. Partial
Illegality. If any provision of this Agreement, or the
application thereof to any Party or circumstances, shall be declared void,
illegal or unenforceable, the remainder of this Agreement shall be valid
and
enforceable to the extent permitted by Applicable Laws. In such
event, the Parties shall use their best efforts to replace the invalid or
unenforceable provision by a provision that, to the extent permitted by
Applicable Laws, achieves the purposes intended under the invalid or
unenforceable provision. Any deviation by either Party from the terms
and provisions of this Agreement in order to comply with Applicable Laws
shall
not be considered a breach of this Agreement.
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11.6. Waiver
of Compliance. No provision of this Agreement shall be
waived by any act, omission or knowledge of a Party or its agents or employees,
except by an instrument in writing expressly waiving such provision and signed
by a duly authorized officer of the waiving Party, which waiver shall be
effective only with respect to the specific obligation and instance described
therein.
11.7. Notices. All
notices and other communications in connection with this Agreement, other
than
firm orders which are governed by Section 3.2, shall be in writing and
shall be sent to the respective Parties at the following addresses, or to
such
other addresses as may be designated by the Parties in writing from time
to time
in accordance with this Section, by registered or certified mail, postage
prepaid, or by express courier service, service fee prepaid, or by facsimile
in
accordance with this Section.
To
Tutogen: Tutogen
Medical, Inc.
00000
Xxxxxxxx Xxxx, Xxx 00
Xxxxxxx,
XX 00000
Attn: President
Fax
No.
(000) 000-0000
To
Xxxxxx: Xxxxxx
Dental, Inc.
0000
Xxxxx Xxxxxx
Xxxxxxxx,
Xxxxxxxxxx 00000
Attn: President
Fax
No. (000) 000-0000
With
a
copy
to: Xxxxxx
Legal Department
000
Xxxx
Xxxx Xxxxxx
Xxxxxx,
XX 00000
Attn: Assistant
General Counsel
Fax
No.
(000) 000-0000
All
notices shall be deemed given and received (i) if delivered by hand,
immediately, (ii) if sent by mail, three (3) Business Days after
posting, (iii) if delivered by express courier service, the next Business
Day in the jurisdiction of the recipient or (iv) if sent by fax, at the time
shown in the confirmed electronic receipt, or on the first Business day
thereafter if the notice is not sent on a Business Day.
11.8. Counterparts. This
Agreement may be executed in counterparts, each of which shall be deemed
to be
an original and all of which together shall be deemed to be one and the same
instrument.
11.9. Limitation
on Liability. Except with respect to the Parties'
indemnification obligations, neither Party shall be liable to the other for
indirect, incidental, consequential, punitive or special damages, including
but
not limited to lost profits, arising from or relating to any breach of this
Agreement, regardless of any notice of the possibility of such
damages.
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11.10. Further
Actions. Each Party agrees, subsequent to the execution and
delivery of this Agreement and without any additional consideration, to execute,
acknowledge and deliver such further documents and instruments, and to do
all
such other acts, as may be necessary or appropriate in order to carry out
the
purposes and intent of this Agreement.
11.11. Assignment.
Except as otherwise provided herein, neither Party shall have the
right
to assign any of its rights or obligations under this Agreement without the
prior written consent of the other Party. Without limiting the
termination rights set forth in Section 10.2(C), either Party, without any
need
for consent from the other Party, may assign this Agreement or any of its
rights
and/or obligations hereunder to an Affiliate or in connection with a merger
or
other business combination or the sale of substantially all of the assets
of
such assigning Party; provided, however, that no such assignment shall relieve
the assigning Party of its obligations hereunder. If and to the
extent that a Party assigns any of its rights and/or obligations hereunder
in
accordance with this Section 11.11, then this Agreement shall be binding
upon the assignee to the same extent as if it were a Party hereto, and each
reference herein to the name of the assigning Party shall be deemed to include
the assignee. Any assignment not in accordance with this
Section 11.11 shall be void.
11.12. Jointly
Prepared. This Agreement has been prepared jointly and shall
not be strictly construed against either Party.
11.13. Third
Party Rights. Except as otherwise expressly provided herein,
this Agreement is not intended to confer any benefits upon, or create any
rights
in favor of any Person other than the Parties.
11.14. Expenses. Except
as otherwise expressly provided in this Agreement, each Party shall be
responsible for its own expenses incurred in connection with this Agreement
and
the transactions contemplated hereby.
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IN
WITNESS WHEREOF, each Party has caused this Agreement to be executed by its
respective duly authorized representative as of the Effective Date.
TUTOGEN
MEDICAL, INC.
By:
Name:
Title:
XXXXXX
DENTAL, INC.
By:
Name:
Title:
Solely
for the purpose of Section 11.3,
acknowledged
and agreed by:
TUTOGEN
MEDICAL GMBH
By:
Name:
Title:
-
22
-
EXHIBIT
A
Exclusive
Territory
[***]
EXHIBIT
B
Products
and Transfer Pricing
[***]
EXHIBIT
C
Price
for Sample Products
[***]
-
2
-
Exhibit
D
German
Dental Inventory
[***]
- 3
-
EXHIBIT
E
Territory
Distribution
Approval Status
[***]
- 4
-
