Exhibit 10.16
DISTRIBUTION
AGREEMENT
between
HemoSense, Inc
600 Valley Way
Milpitas, CA 95035 USA
represented by Jim Merselis
CEO HemoSense Inc.
- hereinafter referred to as
“HemoSense” -
and
Inamed KG
Heinz Galinski Str.l
13347 Berlin
represented by Ina Battke
Managing Shareholder of Inamed KG
- hereinafter referred to as
“Inamed” -
Preamble
The two parties have agreed to interpret this
agreement in a positive sense for the benefit of both of them and
to cooperate in a spirit of partnership
HemoSense wishes to market anticoagulants in
Europea and abroad and to continuously increase its market
presence. For this purpose HemoSense plans to put distributors in
place in the various regional and national markets who will not
only market the products, but also be technically and
professionally qualified to train people to use the product and its
technical applications. One of these local distributors will be
Inamed. The products will be imported to Germany by HemoSense or by
a third party commissioned by HemoSense. Said third party will also
be responsible - on the basis of a separate agreement with
HemoSense - for maintaining centralized storage facilities for the
products, delivering the products to the distributors as and when
ordered by them, and processing the financial side of the
individual transactions. However, it is not the responsibility of
the third party to deliver or market the products to end
users.
§ 1 Subject Matter of the
Agreement
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(1)
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Effective
01.04.2003 HemoSense assigns to Inamed the right to distribute the
Contractual Products defined in § 2 in the Contractual
Territory defined in § 3.
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(2)
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Inamed shall
purchase and sell the Products in its own name and for its own
account.
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(3)
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Inamed shall
act as a free and independent contractor.
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(4)
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Unless
otherwise agreed in writing in a particular case, Inamed shall have
no right to represent HemoSense for the purpose of entering into
legal transactions, nor to assume obligations on HemoSense’s
behalf. Inamed shall refrain from doing anything that may give
third parties the impression that they are authorized to do
so.
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***
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Confidential
treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the
Commission.
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(5)
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HemoSense shall
be entitled to appoint a representative to represent its marketing
interests. At the time of entry into this agreement, this function
is being performed by the firm of I•Med•Pro GmbH,
Max-Planck-Str. 22, 50858 Cologne. HemoSense reserve the right to
appoint the representative themselves and, if need be, to replace
the representative and dismiss it without replacement, had to limit
or cancel its responsibilities and proxy and the nature and scope
thereof at any time by written or electronic communication to
Inamed. Details of the powers of representation of
I•Med•Pro GmbH are set forth in Exhibit 3 . They
have no powers other than those set forth therein.
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§ 2 Products
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(1)
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Contractual
Products are the products listed in Attachment 1.
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(2)
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Should
HemoSense decide after conclusion of this agreement to add further
products to its sales program, they may be offered to Inamed for
them to distribute, but subject to newly defined conditions. If the
product newly added to the sales program is the followup product of
a product withdrawn from the sales program and if it is similar in
terms of price and function to the same, the newly-added products
shall automatically become a Contractual Product, with the result
that the terms and conditions hereof shall automatically
apply.
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(3)
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Within its
general distribution policy is entitled to change single
Contractual Products or withdraw single products from the
Contractual Products; the total supply of Contractual Products,
however, shall not be changed considerably hereby; Inamed will be
given at least 2 months prior written notice of any such changes.
If, when Inamed receive a written notice from HemoSense, they have
already concluded a purchase contract with a client for the
product(s) concerned or otherwise given some relevant binding
declaration, and if Inamed inform HemoSense accordingly immediately
after receiving written notice, then HemoSense shall be obliged to
sell and deliver to Inamed the number of products
concerned.
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§ 3 Contractual
Territory
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(1)
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The Contractual
Territory is the territory described in Attachment 2 (the
Länder ).
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(2)
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The parties are
in agreement that the Contractual Territory will be Inamed’s
main sales territory, it being understood that this shall not
constitute any geographical limitation on Inamed’s
distribution rights.
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(3)
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Inamed
distribution rights are non-exclusive. HemoSense shall have the
right to distribute the Contractual Products through other
distribution intermediaries.
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§ 4 Obligations of
Inamed
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(1)
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Inamed shall
preserve the confidentiality of the business and trade secrets of
HemoSense, including after expiry of this Agreement. Inamed shall
also oblige their employees accordingly.
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(2)
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Inamed shall
inform HemoSense about the market situation in the Contractual
Territory and, upon learning of legal changes or of changes in
requirements for official approval, about customers’
requests, the popularity of the Contractual Products,
the
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***
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Confidential
treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the
Commission.
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activities of competitors which are
important for the business success of the Contractual Products in
the Contractual Territory. The reports to be submitted by Inamed
shall not contain any information about the names and addresses of
customers; HemoSense is not interested in the single customer
relationships of Inamed. HemoSense is entitled to regularly inspect
Inamed’s business premises for quality control purposes (ISO
9001/9002) upon prior timely agreement of the date; HemoSense is
not entitled to inspect Inamed’s business records.
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(3)
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Inamed is aware
that the Contractual Products are medical devices that are governed
by special legislation. This applies in particular to the system of
reporting injuries to patients which is regulated by the law.
Inamed agrees to comply with this legislation, too, and to notify
the competent bodies of any occurrences without delay.
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(4)
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Inamed shall
immediately inform HemoSense of all actual and suspected violations
of fair competition and all actual and suspected infringements of
labeling and name rights, intellectual property rights, copyrights
and related rights by third parties of which they become aware and
which affect HemoSense or the Contractual products. Inamed shall
use their best efforts to support HemoSense in defending itself
against such infringements.
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(5)
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Inamed shall
instruct their customers in the proper use and maintenance of the
Contractual Products.
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(6)
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Inamed shall be
obliged to distribute the Contractual Products under the trademarks
and packed and presented as specific by HemoSense.
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(7)
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Inamed shall
provide regular training courses for their staff during the life of
this Agreement.
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§ 5 Obligations of
HemoSense
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(1)
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HemoSense is
obliged to take into reasonable consideration the interests of
Inamed and support Inamed in their activities.
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(2)
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HemoSense must
provide Inamed with the information and documents required for its
distribution activities, such as instruction materials and
brochures, free of charge. All documents - to the extent not
provided to customers or the training centers in the ordinary
course of Inamed’s business - shall remain the property of
HemoSense.
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(3)
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At the
beginning of the Agreement HemoSense shall offer two training
sessions for the Contractual Products, which Inamed should
attend.
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(4)
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HemoSense shall
ensure that the distribution of the Contractual Products in the
Contractual Territory accordance with the provisions of this
Agreement does not lead to the violation of any statutes or
regulations and, in particular, that any official permits,
designations and approvals needed have been issued by the health
insurance funds (Krankenkassen).
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(5)
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HemoSense shall
keep confidential the business and trade secrets of Inamed and
oblige its employees accordingly; this obligation shall survice the
termination of this Agreement.
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***
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Confidential
treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the
Commission.
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(6)
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HemoSense shall
take measures to guarantee Inamed sufficient supplies of strips for
patients using the INRatio Kit for a period of [***] - particularly
in the event of insolvency. [***] of these strips will be deposited
in trust by HemoSense at the latter’s expense with a third
party to be designated by HemoSense. Until further notice the
trustee shall be the firm of I•Med•Pro GmbH. The strips
will be deposited for a period of [***] months from the date of
delivery of the device concerned to Inamed. As the [***] pass, the
number of strips deposited may be reduced pro rata; once the [***]
period has expired there is no longer any need for any strips to be
deposited for the device concerned. On enquiry Inamed shall inform
HemoSense without delay about the delivery dates of the devices and
the residual periods. Inamed may only require the trustee to
surrender the strips if and to the extent that it needs them in
order to be able to perform its own delivery obligations
vis-à-vis customers and HemoSense is not in a position to
supply the strips. HemoSense reserves the right to find equivalent
solutions (e.g. replace the devices with other makes available on
the market). HemoSense shall inform Inamed without delay if it
starts using a different trustee.
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§ 6 Minimum Purchase,
Inventory, Sales Planning
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(1)
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Inamed plans to
purchase and take delivery of the following quantities of
Contractual Products from HemoSense:
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a.
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in the first
year after signing of the Agreement and approval: [***] INRatio
Kits and [***] Strips (boxes with 12 strips each)
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b.
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on conclusion
of the Agreement: a starter pack with 10 INRatio Kits.
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(2)
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Inamed shall be
obliged to set up and maintain at their own expense an inventory
with a complete range of the Contractual Products.
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(3)
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Each month
Inamed shall prepare a sales forecast for the next six
months.
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§ 7 Prices and Terms of
Payment
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(1)
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HemoSense shall
sell the Contractual Products to Inamed at its end user list prices
applicable at the time of entry into the respective sales contract,
less a discount of a certain amount. The end user list prices in
force at the time of entry into this Agreement and the respective
discounts are set forth in Attachment 1.
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(2)
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For each order
of at least [***] INRatio Kits Inamed will receive a training set
free of charge.
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(3)
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By granting the
discount pursuant to the above, all claims of Inamed’s
against HemoSense in connection with their activities to be
performed under this Agreement shall be fully settled. This does
not apply to claims out of other agreements yet to be concluded
(e.g. marketing agreements).
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(4)
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The following
terms of payment shall apply to individual sales contracts which
are concluded and performed between HemoSense and Inamed under this
Agreement:
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a.
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All
HemoSense’s prices are exclusive of the applicable statutory
value-added tax and apply ex warehouse of HemoSense’s
European importer (currently I•Med•Pro GmbH) and do not
include forwarding costs, which shall be invoiced separately.
Inamed will not be charged any forwarding costs if Contractual
Products to a value of at least [***] after deduction of discounts
are ordered.
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b.
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HemoSense’s invoices shall be due for
payment within 30 days of delivery; [***] cash discount will be
granted in case of payment within 14 calendar days of delivery.
Payments by Inamed shall not be deemed to have been made until
HemoSense is able to dispose of the amount concerned. In the
event
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***
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Confidential
treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission.
Omitted portions have been filed separately with the
Commission.
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that Inamed is in default, HemoSense
shall be entitled to demand default interests in the applicable
statutory amount. On provision of evidence, HemoSense can claim
further damages for default.