DISTRIBUTION AGREEMENTDistribution Agreement |
|
|
You are currently viewing: This Distribution Agreement involves
TUTOGEN MEDICAL INC | Zimmer Dental, Inc. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
|
|
|
Search Distribution Agreement by:
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 ”” [***]”.
DISTRIBUTION AGREEMENT
This
Distribution Agreement (this "Agreement") is made and entered
into as of August 17, 2007 (the "Effective Date"), by and
between Zimmer 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).
B. Zimmer
distributes a variety of dental products manufactured by
itself and others.
C. Zimmer
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.
-
2 -
"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.
-
3 -
"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.
-
4 -
(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 Zimmer, and Zimmer 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 Zimmer, and Zimmer 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
grant Zimmer exclusive Distribution rights for the Products in the
Field in any country.
-
5 -
(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 Zimmer's 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 Zimmer's 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. Zimmer's marketing and sales
efforts may include development of collateral marketing materials,
surgical training, attendance at professional tradeshows, and
pre-clinical and clinical studies, at Zimmer's
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 Zimmer's 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 Zimmer's request,
Tutogen shall provide a reasonable amount of sample Products
for use with Zimmer's 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 Zimmer's 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 Zimmer's
indemnification rights, its warranty rights or any other common law
or statutory remedies.
-
6 -
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 Zimmer's 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.
-
7 -
(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 Zimmer's 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 Zimmer 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 Zimmer's
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.
-
8 -
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 Zimmer's 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.
-
9 -
