Exhibit 10.15
***Certain confidential
information contained in this document, marked by brackets, has
been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
AMENDED AND RESTATED DISTRIBUTION
AGREEMENT
This Amended and Restated
Distribution Agreement (“Agreement”) is made as of this
1st day of November, 2004 by and between: MICRUS CORPORATION, a
Delaware corporation, having a principal place of business at 610
Palomar Avenue, Sunnyvale, California 94085, United States , and
its subsidiaries (collectively “Micrus”) and NEUROLOGIC
(UK) LIMITED, a company organized under the laws of the United
Kingdom, and having a principal place of business at Albreda House,
Lydgate Lane, Sheffield, S10 5FH, United Kingdom
(“Distributor”).
WHEREAS, Micrus
has developed implantable, three-dimensional microcoils and related
accessory products to be used in the Field, as hereinafter defined,
and may develop other products for use in the Field; and
WHEREAS,
Distributor has substantial experience in marketing medical
products and desires to distribute the Products, as hereinafter
defined, in the territory of [***];
WHEREAS, Micrus is
willing to use Distributor as its exclusive distributor of the
Products for use in the Field, in the territory of [***], subject
to the terms and conditions of this Agreement; and
WHEREAS, Micrus
and Neurologic UK have entered into a Distribution Agreement dated
as of May 1, 2000 (the “Original Agreement”) and wish
to amend and restate the Original Agreement in its entirely as set
forth below.
NOW
THEREFORE, in consideration of the premises and the mutual
covenants herein recited, and other good and valuable
considerations, the receipt of which is acknowledged, it is agreed
as follows:
ARTICLE I — DEFINITIONS
As
used in this Agreement, the following terms, whether used in the
singular or plural, shall have the meanings indicated:
1.1
“ Effective Date ” shall mean April 1,
2004.
1.2
“ Field ” shall mean the field of interventional
neuroradiology, or such field(s) as to which the parties may agree
in writing.
1.3
“ Marketing Authorizations ” shall mean all
authorizations, licenses, approvals, and registrations to import,
market and distribute the Products in the Territory pursuant to the
terms of this Agreement, as may be required by an appropriate
governmental agency, except any CE Mark, which such mark shall be
obtained and maintained by Micrus.
1.4
“ Product(s )” shall mean (a) the
implantable, three-dimensional micro-coils, together with a
resistive heat-activated delivery device, developed, manufactured,
or made available to Distributor by Micrus, and (b) any other
Micrus product which utilizes Micrus’ licensed, patented or
proprietary micro-coil and related delivery device technology; both
of the foregoing (a) and (b) solely as used in the Field
and as delivered to Distributor from time to time by Micrus under
this Agreement.
1.5
“ Territory ” shall mean the geographic
territories of [***].
***Confidential Treatment
Requested.
ARTICLE II — APPOINTMENT OF
DISTRIBUTOR
2.1
Appointment of Distributor . Subject to the terms and
conditions of this Agreement (including, without limitation,
Article VI), Micrus hereby appoints Distributor as its
exclusive distributor of the Product within the Territory.
Distributor agrees that it shall not sell, advertise, distribute or
otherwise transfer or assist in the transfer of any product that
competes with the Product. Distributor may distribute the Product
only as packaged by Micrus. Distributor shall not sell, advertise,
distribute, or otherwise transfer or assist in the transfer of the
Product outside the Territory or to persons or entities located
outside the Territory, except that, solely to the extent necessary
to comply with the EEC Treaty (also known as the Treaty of Rome),
Distributor will not be prevented from distributing Products to
persons or entities outside the Territory who (i) are located
and take delivery within the EEC, (ii) are not solicited by
Distributor (or any of Distributor’s associate distributors
or sub-distributors pre-approved by Micrus as set forth below), and
(iii) approach Distributor (or any of Distributor’s
associate distributors or sub-distributors pre-approved by Micrus
as set forth below) in the Territory on their own initiative.
Micrus reserves the right to grant similar distribution rights in
the Product to third parties for distribution and sale outside of
the Territory; provided , however , such third
parties shall be prohibited from selling or distributing the
Product within the Territory during the term of this Agreement.
Distributor has no authority to appoint an associate distributor or
sub-distributor of the Product without the prior written
authorization of Micrus. If such authorization is given, each such
distributor or sub-distributor shall be bound in writing to
restrictions at least as strict as those restrictions imposed on
Distributor under this Agreement.
2.2
Relationship of Parties . The relationship of Micrus and
Distributor established by this Agreement is that of independent
contractors, and nothing contained in this Agreement shall be
construed to: (i) give either party the power to direct or
control the day-to-day activities of the other; or (ii) allow
Distributor to create or assume any obligation on behalf of Micrus
for any purpose whatsoever. All financial obligations associated
with Distributor business are the sole responsibility of
Distributor. All sales and other agreements between Distributor and
its customers are Distributor’s exclusive responsibility and
shall have no effect on Distributor’s or Micrus’
obligations under this Agreement.
2.3
Marketing Authorizations .
2.3.1
Micrus Obligations . Micrus shall deliver to Distributor all
scientific, clinical, toxicological, and manufacturing data in the
possession of Micrus and necessary to obtain all required Marketing
Authorizations within the Territory, provided Distributor maintains
all such data as confidential pursuant to
Article VII.
2.3.2
Distributor Obligations . At its own expense, Distributor
shall use its best efforts to obtain all necessary Marketing
Authorizations within the Territory. Specifically, Distributor
agrees that it will undertake to manage, at Distributor’s
expense, all animal trials and human clinical trials required to
obtain the Marketing Authorizations. These approvals will be
obtained jointly in the name of Micrus and Distributor. Upon
termination of this Agreement, Distributor agrees to transfer all
of its rights, title and interest in and to such approvals to
Micrus, or any third party as may be designated in writing by
Micrus. Distributor shall provide Micrus with written quarterly
progress reports of its efforts to obtain Marketing Authorizations.
Distributor agrees not to sell or distribute the Product in any
geographic region within the Territory until such time as all
Marketing Authorizations in such geographic region have duly been
obtained, and to act at all times in a manner consistent with such
Marketing Authorizations.
2
2.4
Trademarks
2.4.1
License . Micrus hereby grants to Distributor the
non-transferable, non-assignable, non-sublicensable right and
license to use its trademarks, service marks, and tradenames that
Micrus may adopt from time to time (the “Trademarks”)
solely on or in connection with Distributor’s promotion, sale
and distribution of the Product within the Territory as authorized
under this Agreement for the term of this Agreement. Distributor
shall have the right to indicate to the public that it is an
authorized distributor of the Product. Distributor shall not alter
or remove any Trademark applied to the Product. Nothing herein
shall grant to Distributor any right, title or interest in the
Trademarks. All use of the Trademarks, and will goodwill associated
therewith, shall inure to the benefit of Micrus. At no time during
or after the term of this Agreement shall Distributor challenge or
assist others to challenge the Trademarks or the registration
thereof or attempt to register any trademarks, marks or trade names
confusingly similar to those of Micrus.
2.4.2
Approval of Representations . Distributor shall respect the
Trademarks and follow the instructions of Micrus as to all usage of
the Trademarks, including, without limitation, complying with
Micrus’ quality control requirements and submitting samples
of Distributor’s use of the Trademarks to Micrus for
approval. If any of the Trademarks are to be used in conjunction
with any other mark on or in relation to the Product, then the
Trademark shall be presented equally legibly, equally prominently,
and of the same or greater size than the other mark(s) but
nevertheless separated from the other trademark so that each
appears to be a mark in its own right, distinct from the other
mark(s).
2.5
Provision of Data. Distributor agrees to provide Micrus
promptly with all clinical and technical information and data with
respect to the Product which it develops during the term of this
Agreement. Distributor further agrees to communicate promptly to
Micrus any and all modifications, design changes or improvements to
the Products suggested by any of Distributor’s customers,
distributors, employees or agents. Distributor further agrees that
Micrus shall have, and is hereby assigned, any and all right, title
and interest in and to any such suggested modifications, design
changes or improvements to the Products without the payment of any
additional consideration therefor either to Distributor or its
customers, distributors, employees or agents. Distributor will also
promptly notify Micrus of any infringement of any of the
Trademarks, patent or other proprietary rights relating to the
Products of which Distributor becomes aware.
ARTICLE III — PURCHASE OF
PRODUCT
3.1
Terms and Conditions. All purchases of Product by
Distributor from Micrus during the term of this Agreement shall be
subject to the terms and conditions of this Agreement.
3.2
Prices .
3.2.1
Subject to this Section 3.2, Micrus will sell Product to
Distributor at the preferential prices shown in Exhibit A
(“Purchase Price”) until [***] after the Effective Date
or until such time the pricing is revised in accordance with this
Agreement, whichever is earlier. The parties agree to discuss, in
good faith, increases and revisions to the prices, within at least
[***] from the Effective Date of this Agreement, based on [***] and
as relevant. The differences between the Purchase Price and
Distributor’s selling price to its customers shall be
Distributor’s sole remuneration for sale of the Product.
Distributor shall have sole discretion to establish the resale
price of the Product to third parties subject only to any
regulatory or governmental limitations.
3.2.2
The Purchase Price shall be revised [***], and at such other times
as the parties may agree in writing. Such revisions shall apply to
all orders for the affected Product received after the effective
date of revision. [***]
3.2.3 All prices
are [***].
***Confidential Treatment
Requested.
3
3.3
Taxes . The Purchase Price will be net of any Distributor
federal, state or local taxes that may be applicable to the
Product. When Micrus has the legal obligation to collect such
taxes, the appropriate amount shall be added to Distributor’s
invoice and paid by Distributor, unless Distributor provides Micrus
with a valid tax exemption certificate authorized by the
appropriate taxing authority. Micrus agrees to pay any United
States federal, state or local taxes, duties or other governmental
assessments that may be required to ship Product to
Distributor.
3.4
Order and Acceptance . All orders for Product submitted by
Distributor shall be initiated by written purchase orders sent to
Micrus via a method set forth in Section 11.5 and requesting a
delivery date during the term of this Agreement; provided, however,
that an order may initially be placed orally, by telefax or by
e-mail if a confirming written purchase order is received by Micrus
within [***] after said oral, telefax or e-mail order. To
facilitate Micrus’ production scheduling, Distributor shall
submit purchase orders to Micrus at least [***] prior to the first
day of the requested month of delivery. No order shall be binding
upon Micrus until accepted by Micrus in writing, and Micrus shall
have no liability to Distributor with respect to purchase orders
that are not so accepted. Micrus shall either: (i) notify
Distributor, in writing, of the acceptance or rejection of an order
(or any portion thereof) and of the assigned delivery date for
accepted orders with [***] of receipt of the purchase order; or
(ii) send Product pursuant to such accepted order. No partial
fulfillment of an order shall constitute a commitment to fulfill
the entire order, absent the written acceptance of such entire
order. Micrus shall use its commercially reasonable efforts to
deliver Product at the time specified in its written acceptance of
Distributor’s purchase orders. Micrus reserves the right at
any time to discontinue the manufacture, supply or sale of any
Product, to make changes in materials or design, or to add
improvements to any Product, without incurring any liability
whatsoever.
3.5
Terms of Purchase Orders . Distributor’s purchase
orders submitted to Micrus from time to time with respect to
Product to be purchased hereunder shall be governed by the terms of
this Agreement, and nothing contained in any such purchase order
shall in any way modify such terms of purchase or add any
additional terms or conditions.
3.6
Payment . Micrus shall submit an invoice to Distributor upon
each shipment of Product ordered by Distributor. The invoice shall
set forth the Purchase Price for the Product in a given shipment
plus any freight, taxes or other applicable costs initially paid by
Micrus but to be borne by Distributor. Payment shall be made by
Distributor by wire transfer, check or other instrument approved in
writing by Micrus. Payment terms shall be the full invoiced amount
to be paid by Distributor to Micrus within [***] of the date of the
invoice; which payment terms shall be reviewed after the first year
of this Agreement for payment terms applicable to subsequent years
of the then-current term of the Agreement; provided, however, that
any revision to the payment terms must be made by a mutually agreed
to writing executed by both parties. Any invoiced amount not
received within [***] of the date of invoice shall be subject to a
service charge of [***], or if lower, the maximum interest rate
allowed by law. Distributor shall pay all of Micrus’ costs
and expenses (including reasonable attorney’s fees) to
enforce and preserve Micrus’ rights under this Subsection
3.6. If at any time an outstanding invoice for Product shipped to
Distributor becomes unpaid and outstanding for greater than [***],
at Micrus’ option, Micrus may require that Distributor effect
payment by means of an irrevocable letter of credit drawn on a bank
approved by Micrus; the letter of credit shall be upon terms
acceptable by Micrus, shall allow for partial shipment, and shall
be in an amount equal to Distributor’s purchase price for the
Product plus all applicable taxes, shipping charges, and other
charges to be borne by Distributor. All exchange, interest, banking
collection and other charges shall be at Distributor’s
expense.
***Confidential Treatment
Requested.
4
3.7
Quarterly Reports . Within forty-five (45) days after
the end of each quarter, Distributor shall provide Micrus with a
written sales breakdown, including without limitation, the amount
and type of Product, and names of end users of the Product sold
during the period.
ARTICLE IV — SUPPLY OF
PRODUCT
4.1
Terms of Distributor Requirements . Subject to the terms and
conditions of this Agreement (including, without limitation,
Section 3.4), Micrus agrees to sell and Distributor agrees to
purchase from Micrus Distributor’s entire requirements of
products of the type provided by Micrus under this Agreement,
solely for distribution and/or sale in the Territory. Micrus shall
use commercially reasonable efforts to manufacture the Product and,
subject to Section 3.4, supply them to Distributor in
quantities sufficient to satisfy Distributor’s needs in
accordance with the provisions of this Article IV, provided
Distributor submits to Micrus purchase estimates pursuant to
Section 4.2.
4.2
Purchase Estimates . Distributor shall submit to Micrus,
beginning ninety (90) days before the first anticipated order
of Product and within the first ten (10) days after the
beginning of each calendar quarter thereafter, a non-binding good
faith estimate of the amount of Product to be required and
purchased by Distributor for both the next three months and the
next twelve-month periods.
4.3
Inspection and Dispute Resolution Relating to Satisfaction of
Product Specifications . The following provisions relate to
inspection and resolution of disputes:
4.3.1
Rejection of Product . Distributor shall inspect all Product
promptly upon receipt thereof and may reject any Product pursuant
to this Section 4.3.1 that fails to meet the specifications
set forth in Micrus’ current product specifications for the
Product. Any Product not properly rejected within thirty
(30) days of receipt of that Product at Distributor’s
facility after customs clearance for import (the “Rejection
Period”) shall be deemed accepted. To reject a Product,
Distributor shall within the Rejection Period, (i) notify
Micrus in writing by telefax or by mail (with confirmation of
transmission) of its rejection and the reason for the rejection,
and (ii) return, at its expense, the rejected Product to
Micrus (the “Returned Product”) in the same condition
in which it was delivered to Distributor. All claims made by
Distributor after its inspection of the Product shall be handled on
a case-by-case basis during which time Micrus shall have the right
to first inspect any Product involved before being required to take
any action with respect thereto. Micrus shall make its
investigation within thirty (30) days of receipt of notice of
a claim from Distributor. Micrus shall, at its expense, replace
Product it determines to be defective and ship such replacement
Product freight prepaid. In no event shall Micrus be liable under
this Agreement for any failure of any Product to meet the
specifications due to modification or improper use, storage or
shipment of the Product by Distributor or anyone receiving the
Product from or on behalf of Distributor.
4.3.2
Resolution of Disputes Relating to Product Specifications .
If the parties hereto fail to agree as to whether a delivered
quantity of Product meets its agreed specifications, then the
parties shall cooperate to have the Product in dispute analyzed by
a jointly selected qualified independent testing
laboratory.
4.3.3
Return of Product After Rejection Period . After the
Rejection Period, Micrus’ limited warranty as stated in
Section 8.1 hereof shall be applied. If Micrus tests and
inspects the Returned Product and determines that such Returned
Product (i) has been physically damaged, (ii) has been
modified or improperly used, stored or shipped by Distributor or
anyone receiving the Product from or on behalf of Distributor, or
(iii) performs according to Micrus’ written
specifications, no credit will be given to Distributor. If upon
such test and inspections such Returned Product (a) has not
been physically damaged, (b) has not been modified or
improperly used, stored or shipped by Distributor or anyone
receiving the Product from or on behalf of Distributor, and
(c) does not perform to Micrus’ written specifications,
these Returned Products will be replaced at no cost to Distributor.
In all cases of physical damage or modification to, or improper
use, storage or shipment of, Returned Product, no credit will be
given to Distributor.
5
4.4
Title . Title and risk of loss pass to Distributor when
Product leaves Micrus’ manufacturing facility. Distributor
shall be solely responsible for the payment of all freight and
insurance and other costs, expenses, fees, duties, imports, and
charges of whatever kind or nature arising from the shipment,
delivery, and importation of Product into the Territory.
Distributor shall solely be responsible for taking all actions
necessary to obtain clearance to import Product into the Territory
and Distributor warrants that it will comply in all respects with
any restrictions set forth in the export license for every Product
purchased hereunder.
4.5
Reporting . Distributor agrees to report to Micrus any
information from any source, including, without limitation,
employees, distributors, agents, customers, user facilities,
individuals, or medical or scientific literature, whether published
or unpublished, that reasonably suggests that there is a problem
with the Product or a probability that the Product or a similar
product has caused or contributed to a death, serious illness or
serious injury, including but not limited to, severe or permanent
disability, stroke, or brain damage as promptly as possible but
within five (5) days of receipt of information of such event.
Distributor agrees not to disclose any such information referred to
herein to any third party without the prior written consent of
Micrus.
4.5.1
Serious illness means an event that is life threatening, results in
permanent impairment of a body function or permanent damage to the
body structure, or necessitates immediate medical or surgical
intervention to preclude permanent impairment of a body function or
permanent damage to a body structure.
4.5.2
Serious injury means an event that is life threatening, results in
permanent impairment of a body function or permanent damage to a
body structure, or necessitates medical or surgical intervention to
preclude permanent impairment of a body function or permanent
damage to a body structure.
4.6
Monitoring . Each of the parties hereto shall monitor all
relevant journals and media communications for information on
factors materially affecting the use or efficacy of the Product and
shall promptly inform the other party of such information. The
informing party may provide in writing its evaluation of such
information. Either party shall promptly inform the other if it has
actual knowledge of any measures which are necessary to eliminate
or minimize any risk associated with the use of the Product or a
specific production lot of the Product.
ARTICLE V — ADDITIONAL OBLIGATIONS OF
DISTRIBUTOR
5.1
Marketing Obligations . Distributor agrees to use its best
efforts to successfully promote and distribute the Product, at its
own expense, in the Territory using diligent and vigorous efforts
to maximize sales and market penetration at the earliest date. Such
efforts shall include, but are not limited to, preparing
promotional materials, advertising the Product in trade
publications within the Territory, partic
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