MICRUS ENDOVASCULAR
CORPORATION
** 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.
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Page
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DEFINITIONS
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1
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DEVELOPMENT;
STEERING COMMITTEE
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6
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LICENSE
GRANTS
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9
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RESEARCH
PAYMENTS AND COSTS
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10
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LICENSE FEES;
ROYALTY PAYMENTS
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11
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ROYALTY
REPORTS, PAYMENTS AND ACCOUNTING
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12
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MANUFACTURING;
SUPPLY AND DISTRIBUTION
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13
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FORECASTS,
PURCHASE ORDERS, ORDER ACCEPTANCE
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15
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DELIVERY, LATE
DELIVERY, SHIPMENT DESTINATION, ACCEPTANCE
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16
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PRICES, PAYMENT
TERMS
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17
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PRODUCT
CHANGES
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17
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WARRANTIES,
REPRESENTATIONS AND COVENANTS
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18
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INDEMNIFICATION
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19
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TERM AND
TERMINATION
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21
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ASSURANCE OF
SUPPLY
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21
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REGULATORY
AFFAIRS
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22
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QUALITY
MANAGEMENT
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23
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LIMITED
WARRANTY
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23
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REPORTING,
PRODUCT ANALYSIS, VIGILANCE, REMEDIAL ACTION
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25
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LICENSED
PATENTS
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26
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CONFIDENTIALITY; PUBLICATIONS
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27
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MISCELLANEOUS
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27
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LICENSE, DEVELOPMENT
AND
DISTRIBUTION AGREEMENT
This LICENSE,
DEVELOPMENT AND DISTRIBUTION AGREEMENT (together with the
attachments and exhibits hereto, the “ Agreement
”) is entered into as of January 6, 2006 (the “
Effective Date ”) by and between Micrus Endovascular
Corporation, a corporation established under the laws of Delaware
and having its principal place of business at 610 Palomar Avenue,
Sunnyvale, CA 94085, USA (“Micrus”); and Biotronik AG,
a Swiss corporation having a principal place of business at
Ackerstrasse 6, CH-8180 Bülach, Switzerland (“
Biotronik ”).
WHEREAS, Biotronik
solely owns or controls intellectual property rights in certain
technology related to vascular interventional devices;
WHEREAS, Biotronik
is a leading manufacturer and distributor of interventional
cardiology devices and has developed proprietary technology for
stents and delivery systems;
WHEREAS, Micrus
desires to obtain from Biotronik an exclusive license for
neurovascular use and a co-exclusive license for carotid stent
products under all of Biotronik’s intellectual property, and
Biotronik desires to grant Micrus such licenses;
WHEREAS, Micrus
wishes to develop, manufacture, sterilise and label products for
neurovascular intervention in humans and to sell the developed
products;
WHEREAS, Biotronik
wishes to be appointed as contract developer and supplier for such
developed products, which includes development according to the
product specification of Micrus, manufacturing, sterilisation and
labelling of the products.
NOW, THEREFORE,
for and in consideration of the mutual observance of the covenants
hereinafter set forth and other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the
parties hereto agree as follows:
1.1 All references
to particular Exhibits, Articles and Sections shall mean the
Exhibits to, and Articles and Sections of, this Agreement, unless
otherwise specified. References to this “ Agreement
” include the Exhibits. For the purposes of this Agreement,
the following words and phrases shall have the following
meanings:
1.2 “
Affiliate ” of an entity means, for so long as one of
the following relationships is maintained, any corporation or other
business entity owned by, owning, or under common ownership with a
party to this Agreement to the extent of at least fifty percent
(50%) of the equity (or such lesser percentage that is the maximum
allowed to be
1
owned by a
foreign corporation in a particular jurisdiction) having the power
to vote on or direct the affairs of the entity and any person,
firm, partnership, corporation, or other entity actually controlled
by, controlling or under common control with a party to this
Agreement.
1.3 “
AMS ” means absorbable metal stents and the related
technology.
1.4 “
Calendar Quarter ” shall mean a period, with respect
to the first Calendar Quarter only, starting on the Effective Date
and ending March 31, 2006, and then each successive period of
three (3) consecutive calendar months ending June 30,
September 30 December 31, or March 31 of the
following year.
1.5 “
Claim ” means a complaint or proceeding filed or
initiated against a party hereto by a Third Tarty alleging damage
to, or infringement of the rights of, such third party or an
affiliate or predecessor in interest of such Third Party, or any
complaint or proceeding of a government agency alleging violation
of any law.
1.6 “
Confidential Information ” shall mean all written
information and data provided by one Party to the other hereunder
and marked “Confidential” or a reasonable equivalent
thereof or, if disclosed orally, visually or in some other form, is
summarized in writing, is identified as “Confidential”
and is provided to the other Party within thirty (30) days of
such disclosure, except any portion thereof which:
(a) is
known to the recipient, as evidenced by its written records, before
receipt thereof under this Agreement;
(b) is
disclosed to the recipient without restriction after acceptance of
this Agreement by a Third Party who has the right to make such
disclosure;
(c) is
or becomes part of the public domain through no breach of this or
any other Agreement; or
(d) is
independently developed, as evidenced by its written records, by or
for the recipient by individuals or entities without use of or
reference to the information disclosed to the recipient by the
disclosing Party hereunder.
All non-public
information concerning neurovascular use developed during the
course of work performed under this Agreement shall be deemed to be
the Confidential Information of Micrus , unless specified otherwise
in the applicable written Statement of Work. All non-public
information concerning coronary or distal use developed during the
course of work performed under this Agreement shall be deemed to be
the Confidential Information of Biotronik , unless specified
otherwise in the applicable written Statement of Work.
1.7 “
Contract Year ” shall mean a period, with respect to
the first Contract Year only, starting on the Effective Date and
ending on March 31, 2007 and then each successive period of
twelve (12) consecutive calendar months commencing on April 1
and ending on March 31 of the following year.
2
1.8 “
Deliverables ” shall mean all tangible items to be
delivered by Biotronik to Micrus as specified in a Statement of
Work which will be developed pursuant to this Agreement and shall
be deemed to include, but not be limited to, written descriptions,
manuals, data-sheets, drawings, photographs, models, prototypes,
tapes, disks, masks and circuitry.
1.9 “
Developed Product ” shall mean any device, component
and composition developed during the course of a project under this
Agreement. The Products which the Parties have already agreed to
develop (subject, with respect to each such Product, to the
execution of a Statement of Work) are listed and specified in
Exhibit A which is attached to this Agreement, and may be
revised from time to time by the mutual written agreement of the
Parties. Developed Product and Product may be used interchangeably
herein.
1.10 “
Development Steering Committee ” shall have the
meaning set forth in Section 2.6.
1.11 “
FTE ” shall mean a minimum of forty (40) hours
per week for individual Biotronik scientific employees assigned to
perform a project under a particular Statement of Work, or its
equivalent if a given employee is assigned on a part-time basis and
therefore multiple employees are added to provide a single
FTE.
1.12 “
Fully Burdened Manufacturing Cost ” shall mean the
cumulative cost of a Product and shall include the direct and
indirect cost of procuring and/or producing the Product in
accordance with generally accepted accounting principles applied on
a consistent basis by Biotronik. Direct costs shall include direct
labor (including fringe benefits), direct materials (including
taxes and duties) and third-party contract and licensing costs
required to manufacture the Product, as well as all costs related
to the approval process. Indirect costs (to be allocated to the
production effort) shall include, but not be limited to, items
treated as ‘manufacturing overhead,’ such as indirect
labor and materials, reasonable fringe benefits, occupancy costs,
depreciation of property, plant and equipment used in the
manufacturing process and other costs reasonably allocable to the
manufacturing process, to the extent that the foregoing are
directly related to the production effort. For purposes of this
Agreement, unless otherwise stated in the applicable Statement of
Work, indirect costs shall be deemed to equal 40% of direct costs.
Included in the cost of Product shall be manufacturing variances,
including inventory reserves and non-conforming production runs.
The Fully Burdened Manufacturing Costs for each Product shall be as
set forth in the applicable Statement of Work.
1.13 “
GAAP ” or “ U.S. generally accepted
accounting principles ” shall mean the conventions, rules
and procedures governing accounting practices as established, and
revised or amended, by the U.S. Financial Accounting Standards
Board or the U.S. Securities and Exchange Commission.
1.14 “
Know-How ” shall mean all unpatented Confidential
Information of Biotronik, technical information, materials and
know-how owned and/or controlled by Biotronik now and/or during the
Term, which relates to Licensed Patents or any Product and
shall
3
include,
without limitation, all chemical, pharmacological, toxicological,
clinical, assay, control and manufacturing data and any other
information, biological materials or related technology relating to
any Product and that can reasonably be deemed to be useful or
essential for the development and commercialization of any Licensed
Product and strains, samples, analytical tools, etc.
1.15 “
Licensed Patents ” shall mean (i) the patents and
patent applications listed in Exhibit B; (ii) any
international and foreign counterparts thereof; (iii) any
divisionals, continuations, continuations-in-part, refilings, and
extensions of any of the foregoing patents and patent applications
(iii) all substitutions, reissues, renewals, reexaminations,
patents of addition, and inventors certificates thereof; and
(iv) all patents issuing from or claiming a priority date from
any of the foregoing (which shall be deemed to have been added to
Exhibit B); any Patents of Biotronik or its affiliates added
to Exhibit B from time to time (which shall include any
Patents covering Licensed Technology as identified by either Party
from time to time).
1.16 “
Licensed Technology ” shall mean (i) the Licensed
Patents; (ii) the Product Know-How; (iii) Proprietary
Rights; (iv) Technical Information; (v) the design of the
product, inventions, analytical reference materials in or related
to the Licensed Patents or any of the products listed on
Exhibit A; and (vi) any other technology that Biotronik
or its Affiliates may from time to time own, develop or license
(for any period reasonably licenseable) from a Third Partiy during
the Term, to the extent such technology has potential neurovascular
applications, including without limitation balloon catheters,
stents (including AMS) and stent delivery systems.
1.17 “
Minimum Purchase Orders ” shall mean either the yearly
or the quarterly minimum purchase amounts as agreed upon in the
applicable Statement of Work, which will be reviewed at least once
a year and shall be adapted to Biotronik ´s reasonable
expectations in Micrus ´ reasonably commercializing each
Product.
1.18 “
Net Sales ” shall mean the gross amount received by
Micrus or an Affiliate of Micrus for the sale or other disposition
to a Third Party of a Product, less the following deductions for
amounts actually incurred related to such sale or other disposition
and included in the gross invoiced amount: (a) normal,
customary sales commissions, customary credits and customary
rebates and customary allowances and customary adjustments for
rejections, recalls or returns (in the case of commissions to
employees or Affiliates of Micrus the commission shall be
deductible up to [***] % of the net price per product only);
(b) freight, insurance; (c) sales, use, excise,
value-added and similar taxes or duties imposed on the
sale.
1.19 “
Party ” shall mean either Micus or Biotronik, and
“Parties” shall mean both Micrus and
Biotronik.
“
Product ” shall mean a Developed Product that both
(a) has been accepted by Micrus under Section 2.13;
(b) is approved for sale and distribution by all applicable
regulatory bodies and (c) the manufacture, use, sale, offer for
sale or importation of which, but for
*** 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.
4
the license
granted hereunder, would infringe one or more Valid Claims of
Licensed Patents. Product and Developed Product may be used
interchangeably herein.
1.20 “
Proprietary Rights ” shall mean any and all inventions
disclosed, described or claimed in the Licensed Patents,
(a) any
and all trade secrets and Technical Information relating to the
Developed Product;
(b) any
and all copyrights relating to or covering the Developed Product or
Technical Information; and
(c) all
other intellectual property of any type under the laws of any
country throughout the world relating to or covering the Developed
Product, methods of manufacture, methods of use, and any other
novel invention the practice of which is necessary to exploit the
Developed Product.
1.21 “
Product Specifications ” shall mean any and all
requirements of the Developed Products, including but not limited
to technical, physical, chemical, environmental, labelling,
packaging and supplementary requirements described in the product
specifications and applicable Statement of Work.
1.22 “
Statement of Work ” shall have the meaning given in
Section 2.2.
1.23 “
Technical Information ” shall mean any technical data
or information relating to the Product, including, without
limitation, know-how, data, skill, expertise, experience, models,
drawings, materials, records, any and all preclinical and clinical
studies including safety and efficacy data, procedures of testing
and quality control requirements or any part or combination
thereof, necessary to market the Product.
1.24 “
Term ” shall have the meaning set forth in
Section 14.1.
1.25 “
Third Party ” shall mean a natural person,
corporation, partnership, trust, joint venture, governmental
authority or other legal entity or organization other than the
Parties and/or their Affiliates.
1.26 “
Valid Claim ” shall mean, with respect to each
country, a claim of an issued, unexpired patent included in the
Licensed Patents or the Joint Research Program Patents, that has
not been (a) held invalid or unenforceable by a final court or
governmental agency of competent jurisdiction or pursuant to
binding arbitration, or (b) admitted in writing to be invalid
or unenforceable by the holder(s) by reissue, disclaimer or
otherwise. Unless (a) or (b) applies, an issued patent is
considered to be unexpired for a period of twelve years from the
date of signing of this agreement on. Micrus agrees not to
challenge any of Biotronik ´s patents or Licensed
Patents.
1.30 “
Warranty Period ” shall mean the time period
commencing upon shipment of a Product to Micrus or its designee and
ending on the Product expiration date as indicated on the Product
label.
5
1.31
Interpretive Rules. For purposes of this Agreement, except
as otherwise expressly provided herein or unless the context
otherwise requires: (a) defined terms include the plural as
well as the singular (and vice versa) and the use of any gender
shall be deemed to include the other gender; (b) references to
“ Articles ,” “ Sections ”
and other subdivisions and to “ Schedules ” and
“ Exhibits ” without reference to a document,
are to designated Articles, Sections and other subdivisions of, and
to Schedules and Exhibits to, this Agreement; (c) unless
otherwise set forth herein, the use of the term “
including ” means “ including but not limited
to ”; and (d) the words “ herein
,” “ hereof ,” “ hereunder
” and other words of similar import refer to this Agreement
as a whole and not to any particular provision.
2.
DEVELOPMENT; STEERING COMMITTEE.
2.1
Collaboration. The parties shall collaborate in the
development of Developed Products for neurovascular applications.
The parties agree that the end goal of the research programs shall
be the creation of Products. No material deviation in the subject
matter, scope and development schedule of such research and
development program shall be made without the mutual written
agreement of both parties.
2.2 Scope of
Project. Biotronik and Micrus are concurrently executing the
Statement of Work attached hereto as Exhibit C .
Biotronik and Micrus may from time to time enter into separate
statements of work for other development projects (each of which, a
“Statement of Work”), as the parties mutually agree and
each such Statement of Work shall be governed by this Agreement.
Biotronik agrees to perform the development work described in each
Statement of Work and to develop and test Developed Products
meeting the technical specifications set forth in the applicable
Statement of Work.
2.3 Development
Schedule. A timeline and schedule, including the major product
milestones and target dates with respect to one or more Product(s),
shall be described in each Statement of Work. The parties agree
that the development schedule set forth shall be a reasonable
schedule for the development work to be performed, and each party
will put forth commercially reasonable efforts to comply with the
timelines. Once signed by authorized representatives of both
parties a Statement of Work shall become part of this
Agreement.
2.4 Development
Responsibilities. Subject to the terms and conditions contained
in this Agreement, Biotronik hereby agrees to use reasonable
efforts to develop and obtain regulatory approval in the European
Union (CE-Mark) and in the United States for manufacture and supply
the Developed Products conforming to the Product Specifications in
sufficient quantity (to meet demand therefore (i.e. at least [***]%
of the Minimum Purchase Order amount for such Product). Biotronik
will use reasonable efforts to perform development, clinical and
regulatory approval activities in accordance with the applicable
Project Schedule.
2.5 Diligence
in Development. Biotronik will use reasonable efforts
consistent with effort used in Biotronik’s own priority
research and development program
*** 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.
6
to conduct the
research under and in accordance with the development program as
described in each Statement of Work.
2.6
Establishment and General Responsibilities of the Development
Steering Committee. A Development Steering Committee (the
“Development Steering Committee”) shall be established
within thirty (30) days after the Effective Date of this
Agreement. The Development Steering Committee shall consist of four
(4) members, two (2) individuals appointed by Biotronik and
two (2) individuals appointed by Micrus, in each event identified
through written notice to the other party in accordance with this
Agreement. Any member of the Development Steering Committee may
designate a substitute to attend and perform the functions of that
member at any meeting of the Development Steering Committee. The
Development Steering Committee shall be responsible for review and
adoption of annual budgets for development activities and annual
budgets for clinical development activities, coordination of the
supply of preclinical and clinical grade test materials, and the
monitoring and oversight of the development program and the
clinical activities, provided that each Statement of Work shall be
subject to the approval of the Parties, and no change to a
Statement or Work that would affect Micrus’ funding
obligations thereunder (amount or milestones) shall be made without
the approval of Micrus.
2.7
Meetings. Meetings of the Development Steering Committee
shall be held, at a minimum, every six (6) months (or more
frequently as agreed by the Development Steering Committee), and
will be held alternatively in California (such meetings to be
chaired by an individual from Micrus) and Switzerland (such
meetings to be chaired by an individual from Biotronik), or at such
other location as may be determined by the Development Steering
Committee, including, if applicable, by telephone. A quorum of the
Development Steering Committee shall require the attendance of all
four (4) members or their respective designees. A final copy
of the minutes of each meeting, clearly describing any formal
actions taken by the Development Steering Committee, shall be
approved and signed by a representative from each party within
thirty (30) days after the meeting. Any modifications to the
development program generally, a particular Statement of Work or
any clinical program (including the work, budget and timeline
therefor) formally approved at any Development Steering Committee
meeting shall be included in or attached to the minutes for such
meeting. The Development Steering Committee will operate by
unanimous consent, with each party having a single vote.
2.8
Professional Standards. Biotronik shall make all
commercially reasonable efforts to progress the development work in
a timely manner using the highest professional standards consistent
with good clinical practice and adherence to applicable laws and
regulations. If Biotronik is delayed at any time in the progress of
the timelines in the Project Schedule by causes beyond the control
of Biotronik, then the timeline shall be extended by a Change Order
Agreement for such reasonable time as the parties will agree but no
longer than the time period of such delay outside their control.
Agreement to such a Change Order Agreement will not be unreasonably
withheld by Biotronik. Any such changes that result in additional
charges shall be reflected in reasonable modifications to the
budget and payment schedule.
7
(a) During
the course of performance in connection with a Statement of Work,
the parties may desire a change in scope of the anticipated effort.
Requests for changes in services and all applicable modifications
in compensation must be reflected in writing by a Change Order
Agreement and expressly approved by an authorized individual on
behalf of each of Biotronik and Micrus. Notwithstanding the above,
an exception will apply if a requested modification involves the
safety of a human subject, at which case Biotronik shall act on the
requested change, and when practicable, to give written notice
immediately to Micrus by telephone promptly followed in
writing.
(b) Change
Orders may be approved and forwarded via hand-delivery, facsimile,
electronic mail, or overnight courier. Absent compelling reasons,
Change Orders will be considered and a response will be given
within fifteen (15) days of Micrus’ or Biotronik’s
request for same.
2.10
Expenses. Except as expressly agreed otherwise by Micrus in
a Statement of Work, Biotronik shall bear all of its own expenses
arising from its performance of its obligations under this
Agreement and each Statement of Work issued hereunder, including
(without limitation) expenses for facilities, work spaces,
utilities, management, clerical and reproduction services,
supplies, and the like.
2.11 Monthly
Reports. Biotronik agrees to provide to Micrus at least monthly
with a written report of the progress of the work required under
each Statement of Work issued hereunder, any anticipated problems
(resolved or unresolved), and any indication of delay in fixed or
tentative schedules.
2.12 Site
Visits. Biotronik shall, from time to time and upon reasonable
notice, allow access to its premises by Micrus for purposes of
design review, “walkthroughs,” and discussions between
Micrus and Biotronik management and personnel concerning the status
and conduct of work being performed under any Statement of Work
issued hereunder.
2.13 Delivery
and Acceptance. Biotronik shall deliver each Deliverable called
for by the applicable Statement of Work, including prototypes and
final Developed Products, upon completion, for testing and
acceptance to Micrus. Biotronik shall memorialize such delivery in
a Delivery Confirmation that sets forth the nature and condition of
the Deliverables, the medium of delivery, and the date of their
delivery. Unless a different procedure for testing and acceptance
is set forth in the applicable Statement of Work, Micrus shall
commence acceptance testing following its receipt of the
Deliverables at Micrus’ own facilities. Upon completion of
such testing, but no longer than after four weeks, Micrus shall
issue to Biotronik a written notice of acceptance or rejection of
the Deliverables. In the event of rejection, Micrus shall give its
reasons for rejection to Biotronik in reasonable detail. Biotronik
shall use reasonable commercial efforts to correct any deficiencies
or nonconformities and resubmit the rejected items as promptly as
possible until the Deliverables are accepted; provided, however,
that upon the third or any subsequent rejection or if the
corrections are not
8
made within
reasonable time to be mutually agreed upon after the initial
rejection, Micrus may terminate the Statement of Work or, at
Micrus’ election, this Agreement, unless the Deliverables are
accepted during the notice period. Additionally, Micrus may, at its
option, itself correct the deficiencies or engage a third party to
correct such deficiencies, and Biotronik shall provide all
reasonable assistance requested to Micrus and in such corrective
actions, Micrus shall be permitted to set-off reasonable costs
incurred for such corrective actions against future payments owed
to Biotronik under this Agreement.
3.1 Grant of
License. Biotronik hereby grants to Micrus the exclusive
(subject only to the provisions of Section 3.2), worldwide,
perpetual, irrevocable (except as expressly provided herein)
license under the Licensed Technology to develop, have developed,
use, sell (directly or through its Affiliates and distributors),
offer for sale and import, manufacture, and have manufactured
Products, all of the foregoing for neurovascular applications only.
For the sake of clarity, by “neurovascular
applications” the Parties mean applications to treat
aneurysms or arteriovenous malformations (AVMs) as well as other
vascular conditions of the brain and the spinal cord.
In case any of the
Confidential Information leads to a patent, Biotronik hereby
undertakes to license it free of charge to Micrus for neurovascular
use, as Micrus undertakes to license it free of charge to Biotronik
for cardiovascular use.
3.2
Exclusivity. The license will be exclusive, and Biotronik
and its Affiliates shall not sell (a) Developed Products or
(b) any other products for neurovascular applications.
Additionally, Biotronik and its Affiliates shall not license or
grant rights under any Licensed Technology to any Third Party for
neurovascular applications. Notwithstanding the foregoing,
Biotronik shall have the right to have manufactured and sell
(directly or through its Affiliates only) carotid stents developed
by Biotronik using the Licensed Technology that are Developed
Products hereunder, for any application other than neurovascular
applications, provided that Biotronik pays half of the costs of
development of such product (including clinical and regulatory
expenses) in accordance with a Statement of Work signed by the
Parties with respect to such Product.
3.3
Clawback. If Micrus has not fulfilled a yearly Minimum
Purchase Order of an approved Product, then Biotronik shall have
the right to terminate the license only with respect to such
Product by giving sixty (60) days advance written notice to
Micrus, provided that Micrus may avoid such termination by curing
said default during the sixty (60) day notice period. The
AMS-Neuro license, however, will be terminated irrespective of the
above mentioned requirements, if there is no commercial product
available five years after the signing of this agreement unless
such failure is due to the fault of Biotronik, and provided further
that if on the fifth anniversary of the Effective date one or more
products incorporating AMS technology is in an active EU or USA
regulatory approval process, i.e. file submitted or pivotal trial
ongoing, the deadline for delivery of a commercial product shall be
extended to six years from the Effective Date.
9
3.4 Biotronik
Exclusive Rights. Micrus agrees that, for so long as Biotronik
is (a) not in breach of its development or manufacturing
obligations hereunder (b) able to meet Micrus’
reasonable requirements for development and manufacture of
Products, Micrus will use Biotronik as its sole contract developer
with respect to Products and its sole manufacturer of Products. If
Micrus intends to seek a Third Party manufacturer or developer with
respect to Products, Micrus will notify Biotronik in writing at
least thirty (30) days prior to the commencement of such Third
Party’s services (unless Micrus has previously notified
Biotronik of a breach hereunder which breach remains uncured), and
Biotronik shall have an opportunity to cure any breach or commit to
additional services during such thirty (30) day period,
subject to Micrus’ reasonable approval of the correction or
proposed services.
4. RESEARCH
PAYMENTS AND COSTS.
4.1 Development
Research Funding. Research and development costs relating to
Developed Products shall be borne solely by Micrus except as
expressly herein set forth or as set forth in the applicable
Statement of Work (Lekton and Lekton blue not to exceed
€
120.000). Each Statement of Work
shall contain an annual budget for each Developed Product and the
method for calculating costs incurred, including detailed FTE rates
applicable to the project, together with any mark-up agreed to. The
Parties agree that the mark-up applicable to development costs
shall be [***] percent ([***]%) unless specified otherwise in an
applicable Statement of Work. To the extent Biotronik incurs costs
that are reflected in a written pre-approved budget (or if exceed
the budget have been pre-approved in writing by Micrus), Biotronik
shall invoice Micrus at the end of the then-current Calendar
Quarter and Micrus shall make payment to Biotronik to reimburse
such costs within 60 days of billing.
4.2
Reports. With each quarterly invoice under Section 4.1,
Biotronik shall deliver a full and accurate accounting of
development costs (by Product) for the relevant Calendar Quarter
and a computation of the amounts payable.
4.3
Procedures. Biotronik shall keep full and accurate
accounting records of all costs in sufficient detail to determine
the amounts payable under Section 4.1. Upon reasonable notice
to Biotronik, Micrus shall have the right during normal business
hours to have an independent certified public accountant, selected
by Micrus and acceptable to Biotronik, audit on a confidential
basis Biotronik’s financial records pertaining to development
activities to verify the costs payable pursuant to this Agreement;
provided, however, that such audit shall not take place more
frequently than once in a Contract Year. An adjustment in payment
shall be made upon demonstration of any underpayment or
overpayment. Micrus agrees to cause the independent accountant to
maintain any Biotronik financial records as Confidential
Information subject to the restrictions of
Section 22.
4.4 Cost of
Audits. The fees and expenses of an audit requested by Micrus
pursuant to Section 4.3 shall be borne by Micrus; provided,
however, that if any audit reveals that Biotronik overcharged
Micrus under this Agreement as to the period being audited by more
than five percent (5.0%) of the amount that was payable for such
period,
*** 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.
10
then Biotronik
shall, in addition to paying immediately to Micrus any such
deficiency, reimburse Micrus for the cost of such audit.
4.5 Period to
be Kept. Biotronik shall retain all books and records it is
required to maintain hereunder for the longer of: (a) five
(5) years from the date of the invoice to which they pertain;
or (b) the applicable time period as required by the laws of
the country in which the cost originated.
5. LICENSE
FEES; ROYALTY PAYMENTS.
5.1 License
Fees. Micrus shall make the following payments to Biotronik
under this Agreement by wire transfer of immediately available
funds:
(a) Micrus
will pay Biotronik an amount of € 500’000 within 5 business after the
Effective Date.
(b) Micrus
will pay Biotronik an amount of € 500’000 after Biotronik has obtained CE
Mark approval for stenosis application for the Lekton Blue but no
later than December 31, 2006.
(c) Micrus
will pay Biotronik an amount of € 500’000 after Biotronik has obtained CE
Mark approval for scaffolding (i.e. ischemic and aneurysm)
applications for Lekton Blue, but no later than December 31,
2006.
(d) Micrus
will pay Biotronik an amount of € 100’000 once the CE Marks for stenosis
application for the amber Lekton Motion Neuro has been approved by
February 28. 2006,
(e) Micrus
will pay Biotronik an amount of € 100’000 once the CE Marks for scaffolding
application for amber Lekton Motion Neuro has been approved by
February 28. 2006.
5.2
Royalties. In consideration of the worldwide license rights
granted herein, Micrus shall pay to Biotronik royalties equal to
[***] percent ([***] %) of Net Sales in any country where a Product
is distributed. Micrus’ obligation to pay royalties to
Biotronik under this Section 5.2 shall be imposed only once
with respect to the same unit of Product, regardless of the number
of Valid Claims pertaining thereto and regardless of the number of
persons and countries involved in the manufacture, distribution and
sale thereof. For the sake of clarity (and without limiting the
provisions of Section 20.1 and 20.2 below), the obligation to
pay royalties with respect to a Product shall apply so long as the
Product is covered by one or more Valid Claims in either the United
States or the European Union, provided that Biotronik will use
reasonable efforts to obtain protection for any existing and new
patents included in the Licensed Patents (to the extent not
time-barred as of the Effective Date) in the United States, the
European Union, Japan, China, Mexico, Argentina and
Brazil.
*** 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.
11
5.3 Terms of
Payment. Within sixty (60) days following the end of each
Calendar Quarter during the Term, Micrus shall pay earned royalties
based on Net Sales during the previous Calendar Quarter. All
royalty payments due to Biotronik shall be made in EUROS by wire
transfer, as directed in writing by Biotronik.
5.4 Taxation
of Royalties. Insofar as any earned royalties that are due
Biotronik under this Agreement are subject to taxation where the
taxes are imposed on Biotronik, Biotronik agrees to bear such
taxes. Biotronik hereby authorizes Micrus to withhold such taxes
from the payments which are payable to Biotronik in accordance with
this Agreement if Micrus is either required to do so under the laws
of any jurisdiction or directed to do so by an agency of the
government of any jurisdiction. Micrus shall furnish Biotronik with
the best available evidence of payment whenever Micrus deducts such
tax from any payments due Biotronik.
5.5 Royalty
Reduction for Third Party Patents. In the event any Products
sold or otherwise distributed by Micrus or its Third Party
Sublicensee(s) is covered by one or more patents owned or
controlled by a Third Party, then the Royalty in accordance with
section 5.2 payable by Micrus to Biotronik under this Agreement
shall be reduced by the amount paid by Micrus to such Third Party,
provided that in no event shall the amount due to Biotronik
hereunder thereby be reduced to less than 10 % and by more than
fifty percent (50%). A Royalty reduction shall not take place if
Micrus succeeds in licensing in a license from a third party at a
lesser price than demanded by Biotronik.
5.6 Royalty
Term; Single Royalty. Royalties shall be earned and paid to
Biotronik until the last Valid Claim under the Licensed Patents
covering the Product expires. No royalties shall be payable on
sales of Products between Micrus and any Affiliate of Micrus,
provided that such Affiliate is not an end user of such
Products.
5.7 Currency
Transfer Restrictions. If in any country payment or transfer of
funds out of such country is prohibited by law or regulation, the
parties hereto shall confer regarding the terms and conditions on
which Products shall be sold in such countries, including the
possibility of payment of royalties to Biotronik in local currency
to a bank account in such country or the renegotiation of royalties
for such sales, and in the absence of any other agreement by the
parties, such funds payable to Micrus shall be deposited in
whatever currency is allowable by Biotronik in an accredited bank
in that country that is acceptable to Biotronik.
6. ROYALTY
REPORTS, PAYMENTS AND ACCOUNTING.
6.1
Reports. With each quarterly payment made under
Section 5.2, Micrus shall deliver a full and accurate
accounting of all Net Sales (by Product) for the relevant Calendar
Quarter and a computation of the aggregate earned royalties
payable.
6.2
Procedures. Micrus shall keep full and accurate accounting
records of Net Sales in sufficient detail to determine the
royalties payable to Biotronik. Upon reasonable notice to Micrus,
Biotronik shall have the right during normal business hours to have
an independent certified public accountant, selected by Biotronik
and acceptable
12
to Micrus,
audit on a confidential basis Micrus’ financial records
pertaining to Product to verify the royalties payable pursuant to
this Agreement; provided, however, that such audit shall not
(a) take place more frequently than once in a Contract Year,
or (b) cover records for more than the time period required
for Micrus to report its taxes under the applicable country laws.
An adjustment in payment shall be made upon demonstration of any
underpayment or overpayment. Biotronik agrees to cause the
independent accountant to maintain any Micrus financial records as
Confidential Information subject to the restrictions of
Section 22.
6.3 Cost of
Audits. The fees and expenses of an audit requested by
Biotronik pursuant to Section 6.2 shall be borne by Biotronik;
provided, however, that if any audit reveals that Micrus underpaid
the royalties due to Biotronik under this Agreement as to the
period being audited by more than five percent (5.0%) of the amount
that was payable for such period, then Micrus shall, in addition to
paying immediately to Biotronik any such deficiency, reimburse
Biotronik for the cost of such audit.
6.4 Period to
be Kept. Micrus shall retain all books and records it is
required to maintain hereunder for the longer of: (a) five
(5) years from the date of the royalty payment to which they
pertain; or (b) the applicable time period as required by the
laws of the country in which the royalty has been
generated.
6.5
Marketing. Upon sale of a Product, Micrus shall use
commercially reasonable efforts, consistent with its customary
practices, to mark such Product (or where this is impractical, the
Product packaging) with appropriate patent numbers according to all
of the relevant laws. Such marking shall be in accordance with the
requirements of the individual foreign countries, insofar as
foreign sales are concerned.
7.
MANUFACTURING; SUPPLY AND DISTRIBUTION.
7.1 Exclusive
Distribution Rights. Biotronik hereby appoints Micrus, and
Micrus hereby accepts appointment, as exclusive distributor of the
Developed Products for neurovascular applications during the term
of this Agreement. Accordingly, Biotronik shall not during the term
of this Agreement, supply Developed Products to any Third Party
without Micrus’ prior written consent, which may be withheld
by Micrus at its sole discretion.
7.2 Packaging
and Labeling. Biotronik shall supply the Products ready for
sale in accordance with packaging and labeling instructions as
specified in the Product Specification. The Product labeling shall
include the statement “Manufactured exclusively for Micrus
Endovascular Corporation” or such similar wording as is
approved by Micrus, subject to the provisions of applicable
law.
7.3 Alteration
of Products, Expired Products.
(a) Micrus
shall not be allowed to alter, amend or modify the Product or any
Product packaging or labeling without prior written consent of
Biotronik.
13
(b) Micrus
shall not sell any Products beyond their stated expiration date.
Biotronik will not take any responsibility on expired Products and
therefore will not refurbish or replace expired Products once
accepted by Micrus.
7.4 Marketing
Efforts. Micrus shall have the following obligations with
respect to the marketing and distribution of the
Products:
(a) to
use reasonable commercial efforts to further the promotion,
marketing, and distribution of the Products;
(b) to
provide adequate and appropriate training to its staff concerning
the Products;
(c) to
use sales and technical literature as well as promotional artwork
and training materials provided by Biotronik and reasonably
acceptable to Micrus. Where appropriate, Micrus may alter such
materials or develop any other materials in connection with the
marketing and distribution of Products (product brochures and sales
aids), which shall be subject to Biotronik’s prior written
approval, which shall not be unreasonably withheld or delayed.
Biotronik retains all right, title and interest in materials
developed by Biotronik, and Micrus retains all right, title and
interest in materials developed by Micrus.
7.5
Trademarks. Micrus shall be the owner of and have the right
to select new trademarks to be used in connection with the
Products. To the extent (if any) that Biotronik is authorized by
this Agreement to distribute Products, Biotronik shall have the
right to distribute the Products free of charge under any trademark
of its own. Micrus shall have the right to use the already existing
Trademarks in Biotronik ´s property for said Products in
accordance with good customary trademark practice, and to avoid
taking any action that would in any manner impair or detract from
the value of the Trademark or the goodwill and reputation of either
Biotronik. Micrus acknowledges Biotronik’s ownership of
Trademarks and related goodwill.
7.6 Customer
Service. Micrus shall provide customer service, including, but
not limited to, taking orders, responding to customer inquiries,
fulfilling requests for quotes on Product pricing, forwarding
Product complaints to Biotronik on a timely basis, as legally
required and providing such assistance and information as is
reasonably requested.
7.7 Sales and
Technical Literature.
(a) Biotronik
shall provide to Micrus sales, advertising and technical literature
and materials required by Micrus and shall make available copies of
promotional artwork it may have prepared. If available, Biotronik
may provide the same to Micrus in electronic format.
(b) Any
adjustments or modifications of sales, advertising and technical
literature to the requirements of Micrus shall be charged to and
covered by
14
Micrus. Said
cost coverage is subject to quotation and budget approval by Micrus
prior to commencement of any adjustment or modification. Payments
are limited to the approved budget and shall be paid after
acceptance of the adjustment or modification by Micrus. Biotronik
shall hold the copyright of any adjusted or modified sales,
advertising and technical literature.
8.
FORECASTS, PURCHASE ORDERS, ORDER ACCEPTANCE.
(a) Micrus
agrees to provide Biotronik with a 12 (twelve) months binding
forecast indicating Micrus’ intended purchases of the
Products detailed to the individual variant by catalogue number and
the calendar month of forecasted purchase. Micrus agrees to reach a
double digit market share in the US and Europe for each
Product.
(b) Such
forecast shall be updated by Micrus on a rolling monthly basis for
each succeeding 12 (months) months period and shall be used
for purposes of facilitating Micrus’ marketing plans and
permitting Biotronik and its suppliers to meet their lead times for
the Products. Micrus will use its commercially reasonable efforts
to notify Biotronik promptly of any changes in its
forecast.
(a) Micrus
shall order Products by means of written Purchase Orders. The
Purchase Order shall specify applicable prices, quantities by
catalogue number, shipping schedule, shipping instructions,
applicable Product Specification, any special requirements, and
other similar matters which are necessary for the individual
transaction. All orders are subject to acceptance by Biotronik,
provided that Biotronik may only refuse a Purchase Order to the
extent expressly permitted by this Agreement.
(b) The
first 3 (three) months of each forecast shall be covered by a
firm Purchase Order in an amount of Products equal to such forecast
for such three month period, and the quantitites to be ordered in
the firm Purchase Order for the following month shall shall not
deviate form the prior months ´s twelve-month forecasted
quantities for such month by more than minus 50 % (minus fifty
percent). Biotronik shall accept Purchase Orders calling for
quantities exceeding the forecasted quantities but may limit
accepted quantities to 130 % of the most recently forecasted
quantities. Afterwards, Micrus will place Purchase Orders every
month covering an additional month of supply period.
8.3 Order
Acceptance. Biotronik shall accept or refuse in writing
Micrus’ issuance of any Purchase Order, within 5
(five) business days from the date when the order has been
received and shall not be refused without just cause. Any Purchase
Order that is not rejected within the above stated period shall be
deemed accepted.
8.4 Lead
Time. Biotronik’s lead-time between cleared purchase
order and product shipment is 6 (six) weeks.
15
8.5 Purchase
before Approval. If Micrus submits firm Purchase Orders to
Biotronik before actual regulatory approval of the Products in
Europe (CE-Mark) or US (FDA-mark), and if Biotronik accepts such
orders, then if the regulatory approval of the Products as
evidenced by a CE-mark or FDA-approval is not obtained prior to or
on the ordered shipment date, then without further liability of the
parties such Purchase Order shall be deemed to be completely
cancelled.
8.6 Minimum
Purchase Orders. Micrus shall order the quarterly or annual
Minimum Purchase Order quantities of each Product as
shown
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