1
Exhibit 10.21
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
MASTER DISTRIBUTION AGREEMENT
This Master Distribution Agreement is made by and between Aspect Medical Systems
Inc., 000 Xxxxxxx Xxxxxx, Xxxxxx XX 00000, XXX, fax x0 000 000 0000 ("Aspect")
and Datex-Ohmeda Division, Instrumentarium Corp., Xxxxxxxxxxxxxx 0, XXX 00000
Xxxxxxxx, Xxxxxxx, fax x000 00 000 0000 ("D-O").
BACKGROUND
WHEREAS, D-O offers a range of medical device products and systems for use in
anesthesia and intensive care and has considerable commercial and technological
experience and appropriate organization, facilities and ability for marketing,
sale and distribution of medical device products and systems. D-O desires to
offer additional products to its customers and thus seeks to establish a
distribution relationship with Aspect [**] covering certain Aspect products;
WHEREAS, Aspect offers medical device products in the field of the measurement
of the effect of anesthetics on the brain with Aspect BIS technology. Aspect
desires to gain through D-O new sales opportunities for its products and enhance
its distribution channel and thus seeks to establish a distribution relationship
[**] with D-O and its Affiliates and distributors;
WHEREAS, Aspect and D-O intend to [**] certain Aspect products through a series
of regional agreements between Aspect and D-O's Affiliates and between Aspect
and D-O's distributors;
WHEREAS, this Agreement and the regional agreements to be entered between Aspect
and D-O's Affiliates and between Aspect and D-O's distributors set forth the
terms of the Alliance between Aspect and D-O and their respective Affiliates
and/or distributors relating to the subject matter hereof and are consequently
interrelated;
WHEREAS, the Parties believe that certain matters arising under the foregoing
agreements are best handled through this Agreement; and
NOW, THEREFORE, the Parties agree as follows:
MASTER DISTRIBUTION AGREEMENT 1
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AGREEMENT
1. DEFINITIONS
As used in this Agreement, the following terms shall have the following
meanings:
"AFFILIATE" means any firm, corporation or other legal entity that Controls, is
Controlled by or is under common Control with either Aspect or D-O (as the case
may be).
"ALLIANCE" means the relationship between Aspect and D-O and their respective
Affiliates and distributors, which is comprised of this Agreement and the
Distribution Agreements.
"ALLIANCE MANAGERS" is defined in Section 4.2 hereof.
"ASPECT PRODUCTS" means the Aspect products more closely specified in Appendix 4
hereto. Such products include the upgrades, modifications, improvements and
substitutes to the products, supplies, accessories, parts and related goods.
"BIS SENSOR" means a single use disposable sensor manufactured by Aspect for use
with the A-2000 or with the Aspect BIS Module Kit and that is required to
generate Aspect's Bispectral Index.
"BUSINESS DAY" means any day that is not a Saturday, a Sunday or other day on
which banks are required or authorized to be closed in the cities of Newton MA,
USA and/or Helsinki, Finland.
"CONTROL" OR "CONTROLLING" means the beneficial ownership, directly or
indirectly, of fifty (50) percent or more of the voting securities of a legal
entity.
"DISTRIBUTION AGREEMENTS" means those agreements between D-O (and/or its
Affiliates or distributors) and Aspect (and/or its Affiliates) that relate to
the distribution of the Aspect Products and are made on substantially similar
terms and conditions (no less favorable to the distributor whether it is D-O or
its Affiliate or distributor) as set forth [**] and as set forth [**] "[**]"
means the [**].
"PARTIES" means for purpose of this Agreement Aspect and D-O.
"STEERING COMMITTEE" is defined in Section 4.1 hereof.
"TRANSITION PERIOD" shall mean either the [**] or the [**] period of transition
depending on the agreement in question. The [**] period of transition, which is,
unless otherwise specified in this Agreement, applicable prior to the
termination of this Agreement or any of the Distribution Agreements with D-O
Affiliates and the [**] period of transition, which is, unless otherwise
specified in this Agreement, applicable prior to the termination of any of the
Distribution Agreements with D-O's distributors, and which commences [**] after
a notice of intent to terminate has been delivered pursuant to Sub-Sections
8.2.2 (Termination for Convenience) or 8.2.3 (Termination for Material Breach)
hereof that has not been rescinded in accordance with the terms of this
Agreement.
2. GENERAL PRINCIPLES
The Parties each agree that certain principles will guide corporate strategy and
decision-making in fulfilling the business objectives of the Alliance and the
individual initiatives of each of the Parties.
MASTER DISTRIBUTION AGREEMENT 2
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These guiding principles are: (a) the Alliance will be based on mutual trust and
respect; (b) the Alliance will require flexibility; (c) the Alliance will
support the business strategies of both Parties, including consistency with
Aspect and D-O standards of business conduct and strict compliance with all
legal requirements; (d) and that the Parties will cooperate to the best of their
abilities to provide commercial and clinical support to the end-user customers
and will consider success a common goal and achievement.
3. DURATION
This Agreement is effective from the date on which the Parties have signed this
Agreement (the "Effective Date"). Unless earlier terminated pursuant to other
terms hereof, this Agreement shall remain in effect for a period ending on the
termination or expiration of all of the Distribution Agreements.
4. MANAGEMENT
4.1 STEERING COMMITTEE.
4.1.1 Members. Upon the Effective Date, a steering committee shall be formed to
consist of two (2) representatives from each of Aspect and D-O (the "Steering
Committee"). Each Party shall appoint its respective representatives to the
Steering Committee from time to time, and may substitute one or more of its
representatives, in its sole discretion, effective upon notice to the other
Party of such change. Initial members of the Steering Committee are: Breck Eagle
and Xxxxxxx van Raamt representing Aspect, Antti Ritvos and Sami Ervio
representing D-O.
4.1.2 Meetings. At least two (2) times per calendar year, the Steering Committee
shall meet at a mutually agreed upon time and location. Special meetings may be
held at any time upon the request of one or more of the members of the Steering
Committee. The member(s) requesting a special meeting shall notify the other
Steering Committee members at least ten (10) Business Days prior to such meeting
and shall confirm receipt of such notification which shall indicate the purpose
of the special meeting and the business to be transacted at same. A minimum of
three Steering Committee members must agree upon any decision to be made by the
Steering Committee hereunder, including appointing chairperson from among the
members to preside at the Steering Committee meetings. Any Steering Committee
member may attend any Steering Committee meeting in person or by telephone.
Steering Committee shall maintain a single set of minutes of its meetings
approved by its members and copies of the minutes shall be supplied to each
member of the Steering Committee as promptly as practicable after such meetings.
4.1.3 Issues. The Steering Committee shall (a) ensure open communication between
the Parties; (b) be responsible for the management of the Alliance, including,
without limitation, the review and approval of public announcement plans; (c)
assess and discuss the progress of negotiating and executing the Distribution
Agreements; (d) make decisions on any modifications to the overall Alliance,
including, without limitation, modifications to the terms of this Agreement; (e)
monitor Parties performance under the Distribution Agreements; (f) oversee the
work of the Alliance Managers (as defined below); (g) attempt to resolve any
disputes between the Parties in accordance with Section 11.2 hereof; and (h)
determine whether a Distributor is entitled to the [**] as specified in Section
5.5.8 hereof.
MASTER DISTRIBUTION AGREEMENT 3
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4.2 ORGANIZATION OF DAILY MANAGEMENT OF THE ALLIANCE
4.2.1 Alliance Managers. Xxxxxx Xxxxxx shall act as Alliance Manager and
coordinate daily management of the Alliance on behalf of Aspect, and Xxxxx
Xxxxxx shall primarily act as Alliance Manager and coordinate daily management
of the Alliance on behalf of D-O. Xxxxx Xxxxxx shall also act as Alliance
Manager and coordinate daily management of the Alliance on behalf of D-O in case
the issue relates to D-O's distributors.
Both Aspect and D-O shall have the right to change its Alliance Managers
effective upon notice to the other Party of such change. The Alliance Managers
shall (i) have overall day-to-day responsibility for the coordination of the
Alliance; (ii) monitor the implementation of the distribution arrangements;
(iii) attempt to resolve any disputes between the Parties in accordance with
Section 11.2 hereof; and (iv) shall jointly report every six months in writing
to the Steering Committee regarding (a) the implementation of the distribution
arrangements; (b) Parties performance under the Distribution Agreements; (c)
comments or concerns with respect to any of the Distribution Agreements or the
Alliance in general; and (d) disputes submitted to Alliance Managers for
resolution.
5. DISTRIBUTION AGREEMENTS
5.1 GENERAL
5.1.1 The intention is that Aspect enters into Distribution Agreements with D-O
and/or its Affiliates and distributors and grants D-O and/or its Affiliates and
distributors [**]. However, the Parties have agreed that they will also
negotiate in good faith about D-O's and/or its Affiliate's or distributors'
distribution rights [**] to the extent Aspect elects to grant distribution
rights [**].
The Parties understand that the Distribution Agreements are non-exclusive and,
it is understood that Aspect shall offer D-O and/or its Affiliates and
distributors a Distribution Agreement with terms which will provide them with
[**] (i.e. other than the Parties or D-O's Affiliates or D-O's distributors) as
more closely specified in Clause 5.5.
5.1.2 It is also understood that Aspect has already entered into distribution
arrangements in certain territories around the world. [**], provided that it is
understood that Aspect's existing OEM partners will retain distribution rights
to Aspect products, and that Aspect may grant new distribution rights to Aspect
products [**] as further specified in Section 5.1.3.The schedule [**] is
specified in greater detail in attached Appendix 3. Aspect shall offer D-O
and/or its Affiliates or distributors distribution rights in those territories
[**] immediately after signing this agreement. Aspect shall [**] with third
parties with the exception of distribution agreements with its existing OEM
partners, or enter into new distribution agreements, with the exception of
distribution agreements [**] or with other future [**] who agree to [**] in
accordance with Section 5.1.3 of this Agreement, in the territories where D-O
and/or its Affiliates or distributors [**]
MASTER DISTRIBUTION AGREEMENT 4
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5.1.3 In the event that Aspect desires to grant distribution rights for the
Aspect Products [**] as of the date of this Agreement, [**], such [**] Aspect's
stand-alone BIS monitor and/or BIS Sensors [**] shall sell Aspect's stand-alone
BIS monitor and/or BIS Sensors to [**] Aspect at a price that is [**] the actual
average selling price [**] selling such products in the country where [**]
desires to sell the products.
5.1.4 The principal purpose of the distribution rights for the BIS Sensors is to
market BIS Sensors to end-user customers that have acquired D-O BIS modules or
Aspect stand-alone monitors from D-O, its Affiliates or distributors. However,
regarding effects in the EU/EEA, nothing in this Agreement and/or the
Distribution Agreements (including their Appendices) are meant or shall be
deemed to prevent, restrict or distort competition or to restrict parallel
imports or otherwise be in conflict with EU legislation .
5.2 NEGOTIATIONS. Each Party agrees to use their reasonable commercial efforts
to begin, through their respective Alliance Managers, Distribution Agreement
negotiations between Aspect and D-O Affiliates or between Aspect and D-O's
distributors in countries where Aspect and D-O agree to offer Aspect products
for sale within a reasonable period not to exceed [**] Business Days from the
Effective Date).
While Parties agree that the actual negotiations will be between Aspect and
applicable local D-O Affiliate representatives or between Aspect and applicable
D-O's distributors representatives, the Alliance Managers shall closely monitor
the negotiations and upon request provide assistance to the negotiators where
needed and attempt to resolve any disputes between the negotiating Parties in
accordance with Section 11.2 hereof, provided, however, that Aspect and D-O
cannot give any guarantee as to the success of those negotiations. Aspect and
D-O each agree that the spirit of mutual co-operation, trust and respect and
this Agreement shall be reflected in the negotiations. Aspect shall as soon as
possible provide D-O a copy of each executed Distribution Agreement.
5.3 CONTENT. Distribution Agreements with D-O's Affiliates shall be negotiated
and made on substantially similar terms and conditions as set forth [**] and
distribution Agreements with D-O's distributors shall be negotiated and made on
substantially similar terms and conditions as set forth [**]. Differences in the
terms and conditions of the said bases and a Distribution Agreement shall be
predominantly such that are needed to address local circumstances and business
practices and different market requirements. The Parties specifically agree that
the terms and conditions, including, without limitation, warranties,
indemnities, products and prices of a Distribution Agreement with a D-O
Affiliate shall be no less favorable [**] and prices set forth in Appendix 3
hereto and that the terms and conditions, including, without limitation,
warranties, indemnities, products and prices of a Distribution Agreement with a
D-O distributor shall be no less favorable [**] and prices set forth in Appendix
3 hereto unless otherwise agreed in this Agreement. The parties agree to review
the pricing initially following calendar year [**]. In the event that [**] the
prices [**] from Aspect, Aspect shall [**] [**] in Section 5.5.4 [**]. At any
time after the initial review D-O shall have the right, upon reasonable notice,
to engage an independent certified public accountant to examine the books and
records of Aspect to determine if D-O and/or its Affiliates or distributors has
been granted the prices consistent with Section 5.5.4 for entities purchasing
Aspect Products from Aspect and that Aspect has paid correctly [**]. The
independent certified public accountant shall only reveal to D-O whether D-O
received such specified pricing and if it did not the amount of such overcharge,
and the difference in the [**]. In no event shall the independent certified
public accountant disclose the specific prices or volumes of sales made by any
other
MASTER DISTRIBUTION AGREEMENT 5
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distributor of Aspect. The parties shall share the cost of the initial audit to
be conducted following calendar year 2001, and thereafter any such audit shall
be conducted at D-O's expense unless the audit reveals that D-O was not granted
the prices specified in Section 5.5.4 for entities purchasing Aspect Products
from Aspect, or incorrect [**], in which case Aspect shall reimburse D-O for the
costs of such audit and the aggregate overcharge or missing [**].
Aspect agrees in each case to give D-O Affiliates and/or D-O's distributors
distribution rights to each of the Aspect Products and sell and supply the
Aspect Products on the same prices as is set forth in Appendix 4 hereto unless
otherwise agreed in this Agreement. Total sale of the Aspect Products by Aspect
to D-O and its Affiliates and distributors under the Alliance will be taken into
account in determination of the applicable price level.
[**] provisions [**] with respect to current and future products of D-O and/or
its Affiliates and any such provisions shall be null and void and non-binding on
D-O, the respective D-O's Affiliate and/or the distributor. In addition, as long
as this Agreement is in force D-O shall allow its Affiliates and Distributors to
continue to sell Aspect Products after D-O releases its own product that is
competitive with the Aspect Product(s).
5.4 [**]. In the event that Aspect desires for business or other reasons to
change its business practice [**] to cover distribution of Aspect Products
within a certain region and/or country, D-O and/or its Affiliates or its
distributors shall have [**] any and all of such regions and/or countries. D-O
and/or its Affiliate or distributor, as the case may be, shall be notified by
Aspect that it shall within reasonable period not to exceed ninety (90) Business
Days respond to Aspect whether it is willing to accept [**] for the Aspect
Products within the applicable region and/or country. D-O's, its Affiliates or
distributors [**] shall not affect the term of the applicable Distribution
Agreement nor constitute grounds for early termination of the applicable
Distribution Agreement.
5.5 PRICING
5.5.1 The transfer price for the Aspect BIS Sensor and BIS Monitor will be [**].
When determining prices for D-O Affiliates and/or distributors, [**] will be
[**] for purposes of determining the applicable [**]. D-O has provided Aspect
with a good faith forecast of its and the D-O Affiliate's and/or distributor's
anticipated purchases of Aspect BIS Sensors and BIS Monitors for the first year
of this Agreement (which shall be deemed to be the period beginning on the date
of this Agreement and ending on December 31, 2001) and will provide updated good
faith forecasts for each calendar year thereafter at least thirty (30) days
prior to the first day of each calendar year, and the applicable [**] shall be
calculated on the basis of such forecasted purchases. For the first year of this
Agreement (which shall be deemed to be the period beginning on the date of this
Agreement and ending on December 31, 2001), D-O's forecast of its and the [**]
anticipated purchases of Aspect BIS Sensors shall entitle [**] to a per unit BIS
Sensor price of $[**] (in accordance with Appendix 4 hereto) and shall entitle
[**] to a per unit BIS Sensor price of $[**]. In the event that actual
cumulative sales of all Aspect Products result in a different [**] or D-O
pricing did not achieve the pricing set forth in Clause 5.5.4 with the
quantities being sold, the Party that did not benefit from such incorrect [**]
with respect to purchases from Aspect by D-O [**] shall be promptly compensated
for any overpayment or underpayment. The Steering Committee shall meet promptly
after June 30, 2001 to reevaluate the transfer prices being charged by Aspect
for the Aspect BIS Sensor and the BIS Monitor for the period through December
31, 2001 and the anticipated transfer prices for subsequent years of this
Agreement with a goal of [**] shown in Appendix 4 consistent with Section 5.5.4
of this Agreement.
MASTER DISTRIBUTION AGREEMENT 6
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5.5.3 Aspect agrees to provide D-O and its Affiliates and distributors with
worldwide non-exclusive distribution rights for Aspect's BIS Sensor except in
the Excluded Territories. Following introduction of Datex-Ohmeda's BIS Module
Aspect agrees [**] shall be [**] currently at [**].
5.5.4 V[**] are designed to provide D-O with a [**]5% [**] standalone BIS
monitor and/or BIS sensor. [**] are to be [**] that D-O feels reasonably
comfortable that it will achieve [**], and [**]will be [**] because [**].
5.5.5 When determining [**] for [**] D-O's Affiliates and distributors the [**]
quantity of the Aspect Products purchased by [**] will be used, exclusive of the
quantity purchased by [**] that have[**], but including the existing [**] that
are common for D-O and Aspect at the signing of this Agreement, Aspect will use
reasonable efforts [**] when negotiating future sensor prices as set forth in
Clause 5.5.4 above.
5.5.6 As noted in Section 5.5.1, D-O's distributors will be charged the same
unit price for BIS Sensors as D-O Affiliates [**]. During the first year of this
Agreement, the BIS Sensor unit price for D-O distributors shall be set initially
at $[**]. The $[**]transfer price paid by D-O distributors for BIS Sensors
shall be [**] in the [**]. This payment shall be made at the end of each
quarter. In the event that the unit price for BIS Sensors for D-O Affiliates
changes in the first year of the Agreement or in subsequent years, the unit
price of BIS Sensors for D-O distributors will also be adjusted such that the
unit price remains $[**].
5.5.7 Actual D-O prices and volume breaks are more closely specified in Appendix
4 hereto. Further, D-O and Aspect will discuss and agree on the qualitative and
quantitative criteria that must be met by D-O's Affiliates and distributors in
order to maintain the status of [**] (more closely specified in Clause 5.5.8).
5.5.8 [**] shall mean such [**] that (i) has [**], (ii) will be Aspect's [**] in
the development of special sales programs, strategies, and market development
programs, (iii) will receive [**] through web site inquiries, international
exhibitions, congresses, or trade shows for the country where such [**], and
(iv) will follow up on those leads. It is expected that as a result of the
[**]and the combined marketing and support activities of both D-O and Aspect,
the amount of business generated will provide [**].
Criteria which D-O's Affiliates or distributors must fulfill in order to obtain
and maintain t[**] are the following:
(a) acquire and maintain ample product knowledge of the BIS in its sales force
and among sales representatives and product specialists;
(b) exhibit the product where ever it is appropriate, and maintain a sufficient
promotional effort;
(c) follow up, in a timely fashion, on leads generated by D-O's promotional
activities and Aspect's activities and promotional actions ;
(d) develop a plan for selling Aspect Products for the BIS or integrate the BIS
in other (relevant) plans;
(e) put in place a sales incentive and/or bonus plan for relevant D-O sales
reps/other people that contains a BIS incentive not substantially inferior to
other incentives;
(f) establish a demo equipment budget sufficient to purchase an appropriate
number of BIS demo units and sensors; and
MASTER DISTRIBUTION AGREEMENT 7
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(g) cooperate with Aspect personnel to establish reasonable revenue targets for
the BIS and discuss corrective actions in case these targets are not obtained.
In the event that Aspect believes that D-O and/or one of its Affiliates or
distributors has not met the criteria specified above and is therefore [**] the
Steering Committee shall meet to determine whether D-O and/ or such Affiliate or
distributor is in fact not entitled to [**] in such countries. If the Steering
Committee can not reach a decision with respect to D-O's and/ or such Affiliate
or distributor's [**] in such countries, Aspect shall have the right to invoke
the Dispute Resolution procedures set forth in Section 11. If D-O and/or one of
its Affiliates or distributors is no longer entitled [**] in one or more
countries, then such entity shall retain distribution rights in such country or
countries but shall no longer be entitled to the benefits of [**] [**] In such
event, [**] such distributor shall not be included in any [**] for purposes of
determining [**] the like.
5.6 OTHER TERMS
5.6.1 Distribution Agreement with D-O's Affiliate
Unless earlier terminated pursuant to other terms of the Distribution Agreement
or this Agreement, the Distribution Agreement shall remain in effect for three
(3) years from the date the parties have signed the said Distribution Agreement.
Thereafter, unless terminated by either party with at least [**] [**] notice to
expire on the said date, the Distribution Agreement shall continue to be in
force for the successive one (1) year period at the time and may be terminated
by either Party (with or without cause) by giving to the other Party at least
[**] notice. There shall be no [**] in the event of a termination pursuant to
this Section 5.6.1.
5.6.2 Distribution Agreement with D-O's distributor
Unless earlier terminated pursuant to other terms of the Distribution Agreement
or this Agreement, the Distribution Agreement shall remain in effect for three
(3) years from the date the parties have signed the said Distribution Agreement.
Thereafter, unless terminated by either party with at least [**] notice to
expire on the said date, the Distribution Agreement shall continue to be in
force for the successive one (1) year period at the time and may be terminated
by either Party (with or without cause) by giving to the other Party at least
[**] notice. There shall be no Transition Period in the event of a termination
pursuant to this Section 5.6.2.
5.6.3 Aspect agrees to provide reasonable levels of marketing support and sales
training for D-O Affiliates and distributors
5.6.4 Aspect will offer distribution agreements to all D-O distributors at same
(or better) terms than are in the [**], and the same prices for similar
quantities and based on similar terms and conditions [**].
5.6.5 Payment terms will be set country by country to match the average payment
times from the end customers with a normal maximum of sixty (60) days. Ninety
(90) days payment time shall be used only in exceptional cases.
5.6.6 Location of warranty returns shall be the closest Aspect repair center to
D-O and/or its respective Affiliate or distributor.
5.6.7 The Steering Committee shall determine the method for calculating (or
estimating) the Aspect BIS Sensors sold for use with Datex-Ohmeda BIS modules in
USA and Canada.
MASTER DISTRIBUTION AGREEMENT 8
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5.6.8 In the event that Aspect BIS Sensors are sold directly by Aspect (e.g.
future Internet sales or tenders negotiated on the corporate level) for use with
Aspect monitors or D-O BIS modules in territories in which D-O is Aspect's [**]
D-O's Affiliates and/or distributors will be [**]. In the event that monitors
are sold directly by Aspect (as per the above) in territories in which D-O is
Aspect's [**] and has met the criteria to maintain the [**], D-O's Affiliates
and/or distributors [**] by Aspect [**].
6. COMPLIANCE WITH LAWS
The Parties shall fully comply with all applicable laws and regulations of
competent jurisdiction regarding this Agreement and further Aspect shall fully
comply with all applicable laws and regulations of competent jurisdiction
regarding the Distribution Agreements.
7. CONFIDENTIALITY
7.1 CONFIDENTIAL INFORMATION. Each Party and their respective Affiliates agrees
to hold, and to use reasonable efforts to cause its employees and
representatives to hold, in confidence all information of a confidential nature
received by one Party from the other Party or its Affiliate including, without
limitation, financial data, business plans, market information, the terms of
this Agreement and customer lists in the possession of receiving Party as of the
Effective Date or furnished to or obtained by the receiving Party after the
Effective Date, in any event not less than in a manner consistent with receiving
Party's treatment of its own confidential information. Receiving Party shall not
use such information for any purpose other than as contemplated under the
Alliance, without the disclosing Party's prior written consent.
7.2 EXCLUSIONS. The obligations of confidentiality and non-disclosure imposed
under this Section shall not apply to any portion of the received information
which: (a) was in the recipient's possession before receipt of the disclosure
hereunder; or (b) is published or is or otherwise becomes available to the
general public as part of the public domain without breach of this Agreement; or
(c) is furnished or made known to the recipient without any obligation to keep
it confidential by a third party under circumstances which are not known to the
recipient to involve a breach of the third party's obligations to a Party
hereto; or (d) is independently developed by the receiving Party, as proven by
receiving Party's documentation of independent development; or (e) is disclosed
by recipient with disclosing party's prior written approval.
7.3 REQUIRED DISCLOSURES. The provisions of this Section shall not preclude
disclosures required by law; provided, however, that each Party will use
reasonable efforts to notify the other, prior to making any such disclosure, and
permit the other to take such steps as it deems appropriate, including obtaining
a protective order, consistent with applicable law, to minimize any loss of
confidentiality.
7.4 SECURITY. The receiving Party shall be responsible for preventing
unauthorized remote access by the receiving Party's own agents and employees to
data transferred to or otherwise made available to the receiving Party under
this Agreement.
7.5 VALIDITY. The obligations of this Section 7 shall extend until and terminate
upon the [**] anniversary of the date of termination of this Agreement.
8. TERMINATION
8.1 SUBMISSION TO THE STEERING COMMITTEE PRIOR TO TERMINATION. Any notice of
intent to terminate this Agreement or any of the Distribution Agreements for
material breach shall be treated as a dispute and the Parties shall comply with
the dispute resolution mechanism set forth in Section 11.2 hereof. Except with
respect to notice of termination for material breach or pursuant to Sub-Section
8.2.4, in the event that one Party provides notice to the other Party of its
intent to terminate
MASTER DISTRIBUTION AGREEMENT 9
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one or more of the Distribution Agreements, but not the Alliance in its
entirety, then the Steering Committee shall meet during [**] period following
delivery of such notice of termination to discuss in good faith the implications
of the proposed termination on the overall Alliance between the Parties and the
need for any requisite change to the Alliance between the Parties. Except with
respect to notice of termination for material breach or pursuant to Sub-Section
8.2.4, in the event that one Party provides notice to the other Party of its
intent to terminate the Alliance in its entirety, then the Steering Committee
shall meet during [**] period following the delivery of such notice of
termination to consider in good faith alternatives to termination, including
modification of the Alliance.
8.2 GROUNDS FOR TERMINATION.
8.2.1 Mutual Consent
The Parties may agree to terminate this Agreement or any of the Distribution
Agreements upon mutual consent at any time.
MASTER DISTRIBUTION AGREEMENT 10
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8.2.2 Termination for Convenience
On or after to the [**] anniversary of this Agreement, either Party may at any
time deliver to the other Party a notice of intent to end the Alliance (with or
without cause). Unless the Parties have mutually agreed not to terminate the
Alliance within [**] days of delivery of the notice of intent to terminate as a
result of the meeting of the Steering Committee pursuant to Section 8.1 above or
otherwise, then this Agreement and the Distribution Agreements shall terminate
after the Transition Period which shall commence on the date of expiration of
the foregoing [**] day period.
8.2.3 Termination for Material Breach
In the event of a material breach of (a) this Agreement, the non-breaching Party
may end the Alliance by termination of this Agreement; or (b) any of the
Distribution Agreements, the non-breaching Party may end such Distribution
Agreement by termination of the same, if in either case such material breach is
not cured within [**] days after the delivery of notice of the intent to
terminate specifying in reasonable detail such material breach. Upon delivery of
such notice of intent to terminate for material breach the Parties shall attempt
to resolve the dispute in accordance with the dispute resolution mechanism set
forth in Section 11.2 hereof. In the event that the dispute cannot be resolved
in accordance with the provisions of Section 11.2 of this Agreement then the
Alliance or the Distribution Agreement in question, as the case may be, shall
terminate after the Transition Period which shall commence on the date of
expiration of the foregoing [**] day period.
8.2.4 Termination for Insolvency and Certain Other Reasons
Each Party shall have the right to terminate this Agreement effective upon
delivery of notice (as provided below in Section 12.4.) to the other Party if
the other Party: (a) makes an assignment for the benefit of creditors, or
becomes bankrupt or insolvent, or is petitioned into bankruptcy, or takes
advantage of any state, federal or foreign bankruptcy or insolvency act, or if a
receiver is appointed for all or any substantial part of its property and
business and such receiver remains undischarged for a period of thirty (30)
days; or (b) has its corporate existence terminated by voluntary or involuntary
dissolution; or (c) is acquired by a competitor or Competitor Affiliate (as
defined below in Section 12.5) of the remaining Party as set forth in Section
12.5 hereof.
8.3 DISTRIBUTION AGREEMENTS. Except as otherwise set forth in this Agreement,
the termination of any of the Distribution Agreements shall be made in
accordance with the termination provisions set forth in the applicable
Distribution Agreement.
8.4 EFFECT ON TERMINATION. Unless expressly otherwise agreed, on termination of
this Agreement each of the Distribution Agreements shall [**]. Termination of
this Agreement or any of the Distribution Agreements, for any reason, shall not
affect any rights or obligations which have accrued to either Party prior to the
effective date of the termination or prejudice any other rights or remedies that
either Party may have at law or in equity nor, unless this Agreement has been
terminated to a breach of this Agreement by D-O, prohibit D-O, its Affiliates
and Distributors from selling inventory of the Aspect Products after termination
and purchase and sell spare parts to their customers.
8.5 CUSTOMER INTERESTS. Upon termination of this Agreement or any of the
Distribution Agreements each Party shall act in good faith to work with the
other Party to ensure that the on-going needs of the customers of each Party are
properly considered with respect to any of either Party's post-termination
actions.
MASTER DISTRIBUTION AGREEMENT 11
12
8.6 DISPUTES DURING TRANSITION PERIOD OR SUBSEQUENT TO TERMINATION. Any dispute
or claim made by either Party under this Agreement or any of the Distribution
Agreements during any Transition Period or subsequent to termination of the
applicable agreement shall be handled as a dispute in accordance of Section 11.2
hereof. In the event that the Steering Committee or Alliance Managers are no
longer functioning then the dispute or claim shall be submitted directly to the
former representatives of each Party on the Steering Committee for resolution
within [**]Business Days. In the event that such dispute or claim is not
resolved in accordance with Section 11.2 of this Agreement, then either Party
may pursue any rights available under the provisions of this Agreement or the
applicable Distribution Agreement with respect to disputes or claims that are
not resolved by the Steering Committee.
9. PUBLIC ANNOUNCEMENTS Neither Party shall make, or cause to be made, any press
release or public announcements in respect to this Agreement or the Alliance
contemplated hereby or otherwise communicate with any news media without prior
approval of the other Party, and the Parties shall cooperate as to the timing
and contents of any such announcement.
10. FORCE MAJEURE Either Party shall be entitled to suspend performance of its
obligations under this Agreement to the extent that such performance is impeded
or made unreasonably onerous by any of the following circumstances: industrial
disputes and any other circumstance beyond the control of the respective Party
such as fire, war (whether declared or not), extensive military mobilization,
insurrection, requisition, seizure, embargo, restrictions in the use of power
and defects or delays in deliveries by subcontractors caused by any such
circumstances referred to in this Sub-Section. The Parties shall without delay
notify each other of any occurrence of force majeure and of the discontinuance
thereof.
11. CHOICE OF LAW; DISPUTE RESOLUTION; FURTHER PROCEEDINGS
11.1 CHOICE OF LAW This Agreement shall be governed by and construed according
to the laws of the Netherlands.
11.2 DISPUTE RESOLUTION. The Parties acknowledge that the expeditious and
equitable settlement of disputes that may arise under the Alliance is to their
mutual advantage. To this end, prior to taking any action as provided in
Sub-Section 11.3 below, the Parties shall initially submit to the Alliance
Managers and the Steering Committee for resolution any claim or dispute arising
out of or in connection with the Alliance as set forth in this Sub-Section 11.2.
11.2.1. Submission of Dispute to the Alliance Managers. Any claim or dispute
arising out of or in connection with the Distribution Agreements that is not
resolved by representatives of the Parties at the local level pursuant to the
terms of the applicable agreement shall be submitted to the respective Alliance
Managers for resolution in accordance with the provisions of this Agreement. One
or both Parties shall prepare such submission with a written description of the
matter in dispute. The Alliance Managers shall attempt to resolve the dispute in
good faith within a reasonable period not to exceed [**] Business Days from the
date of a notice from either Party to the other describing such claim.
11.2.2 Submission of Dispute to the Steering Committee. If a claim or dispute is
not resolved within [**] Business Days in accordance with Sub-Section 11.2.1
hereof and the Alliance Managers have not agreed upon any extension thereof,
then the claim or dispute shall be automatically submitted to the Steering
Committee for resolution within a subsequent [**]Business Days period. One or
both Alliance Managers shall prepare such submission with a written description
of the
MASTER DISTRIBUTION AGREEMENT 12
13
matter in dispute. The representatives of each Party on the Steering Committee
shall meet, present the respective positions of the Parties, and attempt to
resolve the dispute in good faith. During such subsequent [**] day period, if it
becomes obvious that the Steering Committee is unable to resolve the dispute,
the Steering Committee shall attempt to agree on an alternative means to resolve
the dispute that is appropriate to the specific nature of the dispute,
including, without limitation, use of consultants, specialists, mediation or
other alternative business forums for dispute resolution.
11.3 FURTHER PROCEEDINGS.
11.3.1 Arbitration. In the event the Parties are unable to resolve a claim or
dispute in the spirit of mutual cooperation in accordance with Sub-Section 11.2
above, any claim or dispute that relates to this Agreement or to the Alliance in
its entirety, upon written request of either Party, shall be resolved by binding
arbitration by one arbitrator conducted in the English language in the
Netherlands under the commercial arbitration rules of the United Nations
Commission on International Trade Law. The arbitrator shall be appointed by the
Netherlands Arbitration Institute, Rotterdam. If the rules of the Netherlands
Arbitration Institute permit the arbitral award to be rendered within thirty
(30) days from the initiation of the arbitration, the arbitral award shall be
rendered within thirty (30) days of the initiation of the arbitration.
Otherwise, the award shall be rendered as quickly as permitted under such rules.
The arbitral award shall be final and binding upon the Parties. Judgment upon
the award rendered may be entered in any Court having jurisdiction or
application may be made to such Court for a juridical acceptance of the award
and an order of enforcement, as the case may be.
Any claim or dispute arising out of or in connection with a specific
Distribution Agreement, which the Parties are unable to resolve in accordance
with Sub-Section 11.2, and where another procedure for dispute resolution is
specifically set forth in such Distribution Agreement, the Parties agree to
follow such procedure, including, without limitation, choice of law and venue.
11.3.2 Intellectual Property Claims. Notwithstanding the aforesaid, any dispute
regarding a Party's need to protect or enforce any patent, trademark, copyright
or other intellectual property right, confidential information or trade secrets,
or as part of litigation commenced by a third party shall allow the Party to
undertake legal proceedings in the Court of a Party's domicile, main place of
business or other appropriate Court.
12. MISCELLANEOUS PROVISIONS
12.1 ENTIRE AGREEMENT; AMENDMENT. This Agreement and all Appendices attached
hereto, cancels all prior agreements and represents the entire agreement between
the Parties relating to the subject matter hereof there being no prior written
or oral promises or representations not incorporated herein. This Agreement may
be amended or varied only by an expressly written instrument signed by duly
authorized representatives of both Parties.
12.2 WAIVER. The temporary, limited or specific waiver of any term, provision or
condition of this Agreement shall not be considered a waiver of any other term,
condition or provision thereof, nor of any subsequent breach of the same term,
condition or provision.
12.3 SEVERABILITY. If any of the provisions of this Agreement shall be declared
illegal or unenforceable by an arbitrator or any Court of competent
jurisdiction, the validity of the remaining provisions shall not be affected
thereby, and the Parties agree to do all things and co-operate in all ways open
to them to obtain substantially the same results, or as much thereof as may be
possible, including the amendment or alteration of this Agreement.
MASTER DISTRIBUTION AGREEMENT 13
14
12.4 NOTICES. All notices and other communications required under this Agreement
shall be in writing and shall be deemed to have been given if delivered by hand,
or sent by courier or facsimile transmission (provided that in case of facsimile
transmission, a confirmation copy of the notice shall be delivered by hand or
sent by courier within 2 days of transmission), addressed:
if to Aspect at: Aspect Medical Systems Inc.
000 Xxxxxxx Xxxxxx, Xxxxxx XX 00000, XXX
fax +1
Attn: Chief Executive Officer
if to D-O at: Datex-Ohmeda Division, Instrumentarium Corp.
Xxxxxxxxxxxxxx 0, XXX 00000 Xxxxxxxx, Xxxxxxx,
fax x000 00 000 0000
Attn: Chief Operating Officer
With copy to: Datex-Ohmeda Division, Instrumentarium Corp.
Xxxxxxxxxxxxxx 0, XXX 00000 Xxxxxxxx, Xxxxxxx,
fax x000 00 000 0000
Attn: Director, Legal Affairs
until notice of a change in address or addressee is given as provided in this
Section. All notices given in accordance with this Section shall be effective,
if delivered by hand or courier, at the time of delivery, and, if communicated
by facsimile transmission, at the time of transmission.
12.5 ASSIGNMENT. Except in connection with the sale of all or substantially all
of the assets, stock or business of a Party to which this Agreement relates,
neither Party may assign, transfer or sublicense any of the rights or
obligations under this Agreement without the prior written consent of the other
Party, which consent shall not be unreasonably withheld or delayed; provided,
however, that if [**] of one Party is acquiring the other Party, [**].
Otherwise, this Agreement transfers with the sale of all or substantially all of
the assets, stock, or business of a Party to which this Agreement relates.
Either Party may assign this Agreement without consent to an Affiliate
(collectively the "Permitted Assignees"). Assignment to a Permitted Assignee
shall not relieve the assigning Party of its responsibility for its obligations
of this Agreement. An assignment for purposes of this provision shall include
any transaction, including but not limited to, any merger, consolidation or
purchase of stock that results in a third party that is not a Permitted Assignee
Controlling directly or indirectly, a Party to this Agreement. This Agreement
will [**]. For the purpose of this provision [**]. No sale, assignment or other
transfer of any rights or obligations of a Party hereunder shall be effective
unless the purchaser, assignee or transferee assumes such Party's obligations
under this Agreement.
12.6 RELATIONSHIP OF THE PARTIES. This Agreement shall not be construed as a
joint venture or constitute either Party the agent or partner of the other, but
shall at all times be construed as an agreement between two independent Parties
and shall be deemed to have been drafted by both Parties equally with full
awareness of the terms hereof and the consequences thereof. Neither Party has
express or implied authority to bind the other in any manner whatsoever.
12.7 LANGUAGE; USE OF WORDS; HEADINGS. All correspondence and documentation to
be exchanged between the Parties shall be prepared in the English language. The
use of words of the singular is
MASTER DISTRIBUTION AGREEMENT 14
15
intended to include, wherever appropriate, the plural and vice-versa. The
headings of this Agreement are inserted for convenience only, and shall not be
used for interpretation of the Agreement.
12.8 SURVIVAL. The rights and obligations of the Parties under Sections 6, 7, 8,
9, 10, 11 and 12 shall survive any termination or expiration of this Agreement.
12.9 PRECEDENCE. The Parties agree, individually and on behalf of their
Affiliates that the Distribution Agreements are to be governed by the terms of
this Agreement. In event of any inconsistency between the terms of any of the
Distribution Agreements and this Agreement, the terms of this Agreement shall
govern unless the Distribution Agreement evidences an unambiguous intent to the
contrary, in which case the Distribution Agreement shall govern.
MASTER DISTRIBUTION AGREEMENT 15
16
The Parties agree to be bound by this Agreement. This Agreement shall be
executed in two counterparts, each of which shall be deemed an original for all
purposes. A signed copy of the Agreement transmitted by facsimile shall be
deemed for all purposes the equivalent of a signed original.
IN WITNESS WHEREOF, the Parties have by their duly authorized representatives
executed this Agreement on 1st day of September 2000.
ASPECT MEDICAL SYSTEMS INC. DATEX-OHMEDA DIVISION
INSTRUMENTARIUM CORPORATION
/s/ X. Xxxxxxxxxxxx Eagle /s/ Hannu Anjopals
------------------------- ---------------------------
Name: X.X. Eagle Name: Hannu Anjopals
Chairman Title: Executive Director
/s/ Xxxxxx Xxxxxxx
---------------------------
Name: Xxxxxx Xxxxxxx
Title: Group Treasurer
APPENDICES:
Appendix 1 [**]
Appendix 2 [**]
Appendix 3 List of Aspects current Distribution Agreements
Appendix 4 Aspect Products and Prices
MASTER DISTRIBUTION AGREEMENT 16
17
MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX 1 TO THE MASTER DISTRIBUTION AGREEMENT
BETWEEN ASPECT MEDICAL SYSTEMS AND
DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORPORATION
------------------------------------------------------------------
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
BETWEEN ASPECT MEDICAL SYSTEMS
AND
[ ]
Confidential
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
GENERAL
This Distribution Agreement between Aspect Medical Systems (referred to
herein as "AMS"), with its principal offices at 000 Xxxxxxx Xxxxxx, Xxxxxx,
XX 00000 and xxx (referred to herein as "the Distributor) (the "Parties")
is effective xxxx ("Effective Date").
WHEREAS AMS has entered into an Alliance with Datex-Ohmeda for the
distribution of certain products of Aspect through affiliates and
distribution partners of Datex-Ohmeda; and,
WHEREAS Aspect manufactures medical products and seeks to establish a
distribution channel in certain territories; and,
WHEREAS Distributor distributes medical products and seeks to distribute
additional products to its customers; and,
WHEREAS AMS desires to appoint Distributor as an authorized distributor in
certain territories of certain medical products, accessories and related
goods to be supplied by AMS and Distributor desires to accept such
appointment.
THEREFORE Distributor agrees to purchase and AMS agrees to sell such
Products upon the following terms and conditions:
ARTICLE 1. DEFINITIONS
The following terms have the meaning indicated here when used in this
Agreement:
"ALLIANCE": Co-operation agreed between Aspect Medical Systems and
Datex-Ohmeda Division of Instrumentarium Corporation "Datex-Ohmeda"
"AFFILIATE": Any person, firm, corporation, other legal entity which
controls or is controlled by or under common control with either AMS or
Distributor.
"PRICES": Net US$ prices at which AMS shall sell Products to Distributor as
set forth in Exhibit 1.
"PRODUCTS": All medical products, supplies, accessories, parts and related
goods listed in Exhibit 1 as well as any and all upgrades, adaptations,
modifications, improvements and substitutes to the products, supplies,
accessories, parts and related goods listed in Exhibit 1.
"TERRITORIES": Countries and locations as set forth in Exhibit 2.
ARTICLE 2. APPOINTMENT
2.1 AMS hereby appoints Distributor as a Distributor for the Products in
the Territories.
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
2.2 Distributor may not actively sell outside the Territories without AMS's
prior written consent. However within European Community countries
Distributor can answer to European tenders according to EU law.
2.3 In order to achieve better coverage in the Territories Distributor
shall have the right to appoint local firms as its local sub-distributors
in the Territories. AMS agrees and confirms that Distributor may
sub-contract any or all of its obligations hereunder pursuant to Article 7
provided that Distributor shall remain liable to AMS for any obligations
under this Agreement being performed by any subcontractor.
ARTICLE 3. RELATIONSHIP
3.1 The relationship of Distributor to AMS shall be that of an independent
contractor engaged in purchasing Products from AMS for resale to
Distributor's customers. AMS is committed to entering into a [**] with
Distributor in the Territory. Accordingly, [**] with other distributors for
Products, with the [**] distribution arrangements with OEM partners. OEM
partners will retain distribution rights to the Products but AMS will [**]
distribution agreements for the Products with third parties other than OEM
partners as long as Distributor maintains [**].
3.2 Nothing contained in this Agreement shall be deemed to create a
partnership or joint venture between the Parties. Neither the making nor
the performance of this Agreement shall be construed in any manner to have
established a joint venture or partnership.
3.3 Neither Party shall hold itself out as the agent of the other, nor
shall they incur any indebtedness or obligations in the name of, or which
shall be binding on the other, without the prior written consent of the
other. Each Party assumes full responsibility for its own personnel under
laws and regulations of the governmental authorities of the competent
jurisdiction.
[**] shall mean such [**] that (i) has [**], (ii) will be Aspect's partner
in the development of special sales programs, strategies, and market
development programs, (iii) will [**] through web site inquiries,
international exhibitions, congresses, or trade shows for the country where
such distribution partner [**], and (iv) will follow up on those leads. It
is expected that as a result of the [**] and the combined marketing and
support activities of Distributor, Datex-Ohmeda and Aspect, the amount of
business generated will [**].
Criteria which D-O's Affiliates or distributors must fulfill in order to
obtain and maintain the [**] are the following:
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
(a) acquire and maintain ample product knowledge of the BIS in its sales
force and among sales representatives and product specialists;
(b) exhibit the product where ever it is appropriate, and maintain a
sufficient promotional effort;
(c) follow up, in a timely fashion, on leads generated by Distributor or
Datex-Ohmeda's promotional activities and Aspect's activities and
promotional actions;
(d) develop a plan for selling Aspect Products or integrate the Aspect
Products in other (relevant) plans;
(e) put in place a sales incentive and/or bonus plan for relevant
Distributor sales reps/other commercial people that contains a BIS
incentive not substantially inferior to other incentives;
(f) establish a demo equipment budget sufficient to purchase an appropriate
number of BIS demo units and sensors; and
(g) cooperate with Aspect personnel to establish reasonable revenue targets
for the BIS and discuss corrective actions in case these targets are not
obtained.
In the event that Aspect believes that Distributor has not met the criteria
specified above and is therefore no longer entitled to be [**] in one or
more countries, a determination as to the entitlement to the [**] shall be
made by the Alliance steering committee, that includes two members from AMS
and two members from Datex-Ohmeda.
ARTICLE 4. AGREEMENT PRECEDENCE AND DOCUMENTS
4.1 This Agreement supersedes any previous communication, representations,
or agreements between the Parties, whether oral or written, regarding
transactions hereunder.
4.2 All Exhibits attached to the Agreement shall be deemed a part of this
Agreement and incorporated herein. Terms that are defined in this
Agreement, and used in any Exhibit, have the same meaning in the Exhibit as
in this Agreement. The following Exhibits are hereby made a part of this
Agreement:
Exhibit 1 - Products and Prices
Exhibit 2 - Territories
Exhibit 3 - General Provisions
Exhibit 4 - Product Support Requirements
Confidential
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE 5. TERM OF AGREEMENT
This Agreement shall remain in effect until the earlier of (a) three (3)
years from the date the parties have signed this Agreement or (b) the
termination or expiration of the Alliance. Thereafter, unless terminated
because of termination of the Alliance or by either party with at least
[**] notice prior the last day of the then current term, the Distribution
Agreement shall continue to be in force for successive one (1) years
periods and may be terminated by either Party (with or without cause) by
giving to the other Party at least [**] notice. In the event of such
expiration or any early termination, this Agreement shall continue to apply
to all orders previously accepted by AMS unless cancelled by Distributor
pursuant to Article 6.
ARTICLE 6. TERMINATION
6.1 This Agreement shall [**]. Upon the [**] Aspect shall promptly notify
the Distributor. In addition, to the extent permitted by law, if either
Party becomes insolvent, is unable to pay its debts when due, files for
bankruptcy, is subject of involuntary bankruptcy, has a receiver appointed,
or has its assets assigned, the other Party may terminate this Agreement
immediately upon notice to the other party and may cancel any unfulfilled
obligations.
6.2 If either Party hereto shall fail to perform any of the obligations
imposed upon it under the terms of this Agreement, the other Party may
terminate the Agreement upon [**] written notice. Such termination shall be
effective [**] after the date of the written notice of the failure unless
the other Party cures the breach within such [**] period.
6.3 Distributor shall immediately cease to be an authorized AMS distributor
upon the effective date of expiration or termination of this Agreement.
Distributor shall thereafter refrain from representing itself as an
authorized AMS distributor and from using any AMS trademark or trade name.
Upon termination of the Agreement, AMS will have no obligation to
repurchase any or all of the Products which Distributor may have in its
possession at the time of termination. Aspect may, however, at its option,
agree to repurchase any or all of such Products, or may arrange the
purchase of such Products by successor distributors or customers in the
Territory. In the event Aspect fails to purchase, or to arrange the
purchase of, such Products, Distributor shall be permitted to sell its
existing inventory of Products for a period not to exceed ninety (90) days
following the effective date of the termination of this Agreement.
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
ARTICLE 7. ASSIGNMENT AND MODIFICATION OF AGREEMENT
7.1 During the term of this Agreement, the rights of the Distributor under
this Agreement shall not be assigned nor shall the performance of
Distributor's duties hereunder be delegated, except as set forth in Section
2.3 above, without AMS's prior written consent which shall not be
unreasonably withheld except either Distributor may assign this Agreement
(i) to an Affiliate that is an Affiliate or (ii) to an Affiliate whose
assets consist entirely of the assets of an Affiliate or Affiliates
(collectively the "permitted assignees").
7.2 An assignment of such rights for purpose of Section 7.1 shall include
any transaction including but not limited to, any merger, consolidation or
purchase of stock that results in a third party that is not a permitted
assignee controlling, directly or indirectly, a legal entity that holds
such rights. For purpose of this provision, the term "control" shall mean
the beneficial ownership, directly or indirectly, of fifty per cent (50%)
or more of voting shares of such entity.
7.3 No sale, assignment or other transfer of any rights of a Party
hereunder shall be effective unless the purchaser, assignee or transferee
assumes such Party's obligations under this Agreement. Any assignment shall
not relieve the assigning Party of its responsibility for obligations
hereunder.
7.4 Except as set forth in Article 7.5 below, modifications of this
Agreement shall be effective and binding only if agreed in writing and
executed by respective duly authorized representative of each of the
Parties hereto.
7.5 Distributor may, at its option, delete Products from individual
Territories.
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
7.6 Neither Party's failure to exercise any of its rights under this
Agreement will constitute or be deemed a waiver or forfeiture of those
rights.
7.7 This Agreement may be assigned by Distributor to any new company that
is formed, acquired etc. [**] in the Territories.
ARTICLE 8. PRICES AND PAYMENTS
8.1 Distributor sets the end user selling prices at the sole judgement of
the Distributor.
8.2 Prices, which Distributor shall pay AMS for the Products purchased,
shall be the prices appearing in the Exhibit 1. Assuming Distributor
remains [**], it shall be entitled to the prices shown in Exhibit 1 [**].
In the event that Distributor fails to meet the criteria [**] it shall
retain its distribution rights but the prices to which it shall be entitled
shall be those set forth in Exhibit 1 based on the actual volume of sales
of Products [**].
Demonstration Price/initial stocking order price for the AS2000 System will
be [**] the agreed price of Exhibit 1. Demonstration Prices for the BIS
Sensor will be [**] the agreed price of Exhibit 1 (50 Sensors) for a
maximum of [**] per A2000 per year.
If there are additions or changes to Products, Distributor will have the
right to purchase, market and distribute these products and prices will be
established and Exhibits so revised.
8.3 Prices include the Product, labeling and packaging.
8.4 The prices set forth in Exhibit 1 may be revised not more often than
once per year based on market conditions, supplier costs and the expected
unit volume of Products purchased under this Agreement. If both Parties do
not agree upon the revised prices, then prices shall fall back to the prior
agreed upon prices.
8.5 Orders issued by Distributor with requested or acknowledged delivery
dates within 90 days after the effective date of any price change will be
billed at the lower price. This includes backlog and orders already placed
but have not received acknowledged delivery dates.
8.6 Payment shall be in U.S. dollars, in net. Payment terms will be [set
country by country to match the average payment times from the end
customers with a normal maximum of sixty (60) days. Ninety (90) days
payment time shall be used only in exceptional cases]. Invoices must
include details such as Distributor order number and quantities as
reference.
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
8.7 In competitive situations or as part of a large order, Distributor and
AMS may agree on a special price arrangement and/or payment terms and split
the cost of additional discounts.
ARTICLE 9. SHIPMENT AND DELIVERY
9.1 Distributor will submit written (fax or electronic) orders to AMS.
Acknowledgment of delivery date will be received by Distributor within no
more than five work days. Distributor will not be obligated to stock
Products. Distributor may without charge postpone, decrease, increase or
cancel any order by notice to AMS, if such notice is given at least thirty
(30) days prior to the delivery date. Distributor may without charge
decrease any order by a maximum of [**]% by notice to AMS, if such notice
is given within less than thirty (30) days prior to the delivery date.
9.2 AMS will make every reasonable effort to meet delivery within thirty
(30) days or the date quoted or acknowledged. AMS shall give Distributor
prompt notice of any prospective failure to meet the acknowledged delivery
date. If AMS fails to deliver Products for thirty (30) days beyond the
agreed delivery date, Distributor may cancel such orders without charge.
AMS shall be liable to pay actual damages incurred by Distributor because
of AMS's failure to deliver such Products within thirty (30) days of the
acknowledged delivery date, provided, however, that Distributor must notify
AMS of any late delivery penalties that might be imposed by any prospective
customer for Aspect Products at the time Distributor orders Products for
such customer, and that such penalties may not exceed [**]% of
Distributor's purchase price for such Products unless otherwise agreed to
by the Parties.
9.3 Distributor may request changes in delivery dates, and quantity for
Products appearing on its orders at no charge provided written notice of
said changes is received by AMS at least ten (10) working days prior to
requested delivery date.
9.4 Upon Distributor's request with the necessary information, AMS shall
evaluate special requests for suitability of software or suitability of a
particular hardware interface between Products and hardware/software used
by Distributor's customers and inform Distributor of the result within a
reasonable time.
9.5 AMS shall provide a packing list with Distributor's purchase order
number, Distributor product numbers (the Distributor equivalent of AMS's
part numbers), serial numbers, quantity shipped and date shipped with each
unit shipped. If applicable, the packing list should also provide lot
number, or batch number.
9.6 AMS shall preserve, package, handle, and pack Products so as to protect
the
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Products from loss or damage, in conformance with good commercial practice,
government regulations, and other applicable requirements. AMS shall xxxx
the exterior of the boxes with the associated Product and serial numbers of
the contents. AMS shall be responsible for any loss or damage due to its
failure to properly preserve, package, handle, or pack Products.
Distributor shall not be required to assert any claims for such loss or
damage against the common carrier involved. AMS will ship Products in the
final packaging as intended to be received by the end user as ordered.
9.7 Products will be shipped EXW Aspect's plant or warehouse (as such term
is used in Incoterms 2000) at the Netherlands, USA or any other AMS
facility. Unless Distributor gives Aspect instructions as to the method of
shipment, Aspect will select the method of shipment and may, at Aspect's
option, pay transportation, insurance and similar charges. Distributor
shall reimburse Aspect for all such charges that Aspect pays.
9.8 Distributor will be the exporter of record and obtains duty drawback
rights to Products for which Distributor paid the duty. If Products
delivered under this Agreement are imported, AMS shall when possible allow
Distributor to be the importer of record. If Distributor is not the
importer of record and AMS obtains duty drawback rights to the Products for
which Distributor paid the duty, AMS shall, upon Distributor's request,
provide Distributor with documents required by the customs authorities of
the country of receipt to prove importation and transfer duty drawback
rights to Distributor
9.9 Items missing in shipment that are the fault of Aspect will be promptly
replaced and shipped at no charge to Distributor within one (1) week from
written notice by Distributor.
ARTICLE 10. ADVERTISING, PROMOTIONS, TRADEMARKS AND COPYRIGHTED MATERIAL
10.1 AMS agrees to provide reasonable quantities of current or new sales
literature, artwork, advertising materials, promotional plans and other
information or programs in relevant languages mutually agreed by the
Parties reasonably related to this Agreement. Distributor specific
literature and advertising will be the responsibility of Distributor,
provided however that such literature shall be consistent in all respects
with the documentation supplied by Aspect and shall not include any claims,
warranties or information concerning any Aspect Products that are not
included in the documentation supplied by Aspect. AMS will provide
recommended reference sites and will actively pursue clinical evaluations
and the development of local country reference sites and clinical trials.
10.2 AMS hereby grants Distributor a revocable license to use any AMS
trademark or trade name associated with the Products solely in the
advertisement and promotion of the Products during the term of this
Agreement. Except as provided in this paragraph, Distributor shall have no
right, title or interest in or to any patent,
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trademark of trade name belonging to AMS.
10.3 AMS hereby grants Distributor a revocable license to reproduce
materials provided to Distributor by AMS as is reasonable for promotion,
demonstration, sale and support of AMS Products, including but not limited
to posting such materials on the Internet, Intranet, or web.
ARTICLE 11. SALES AND SUPPORT
11.1 Distributor will provide AMS with a forecast of annual projected sales
unit volumes. Quantities listed in such correspondence between the Parties
are only estimates made as an accommodation for planning purposes and do
not constitute a commitment to purchase such quantity. Distributor may
revise any forecasts in its sole discretion.
11.2 Distributor agrees to purchase reasonable quantity of demonstration
Products and to maintain reasonable number of trained staff capable of
demonstrating and selling the Products. AMS agrees to provide, at its
costs, reasonable sales training and material and support to the
Distributor. Distributor agrees to participate in AMS's sales and marketing
meetings, reasonable Product and competitive training courses or product
launch meetings as mutually agreed upon, however, not be more often than
once a year. AMS agrees to provide sales training in a mutually agreeable
location each six (6) months and upon product launch if sooner.
11.3 Distributor agrees to maintain reasonable number of trained staff
capable of supporting the Products. AMS agrees to provide, at no charge,
reasonable service training and support. Distributor agrees to participate
in AMS's service training programs as mutually agreed upon. AMS undertakes
to provide initial technical service training prior to the time that
distribution into the Territory is to commence. Thereafter Distributor will
send technicians to update technical knowledge as mutually agreed upon.
11.4 AMS shall provide documentation to enable Distributor to establish the
support plan and deliver support services for the Products and Territories.
The Product support plan shall be prepared by both Parties and agreed upon
prior to the time distribution is to commence. AMS shall support the
Distributor with service information, parts (as provided in Section 11.5),
training and technical and clinical assistance and back-up support by
letter, fax, e-mail or telephone as appropriate.
11.5 Distributor agrees to purchase reasonable quantity of necessary spare
parts and test equipment according to AMS's recommendation to support
systems installed in Territories. Spare parts to support in-warranty
repairs will be replaced for Distributor at no cost. Out-of-warranty spare
parts are at Distributor's cost.
11.6 Distributor shall use its reasonable efforts to handle and resolve
feedback from its customers. AMS shall have ultimate responsibility for
resolution of Product
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
related issues. Problems that can not be resolved locally will be escalated
in accordance with Article 26.
ARTICLE 12. QUALITY ASSURANCE, REGULATORY COMPLIANCE
12.1 AMS agrees to maintain ISO9001, US GMP 21 CFR 820, EN46001 and
Directive 93/42/EEC Annex II certification status and compliance with the
Food and Drug Administration's (FDA) Quality System Regulation, the Medical
Device Directive and/or appropriate regulations that apply to countries
within and outside the European Union. As manufacturer, AMS will comply
with all applicable regulations and standards that pertain to manufacturers
for Products and Territories set forth herein.
12.2 Distributor will, from time to time, inform AMS of applicable
regulations in the Territories and AMS shall ensure that Products comply
with all such regulations as provided in Section 14.3.
12.3 Upon request, AMS agrees to furnish to Distributor any information
required to enable the Distributor to comply with all applicable
regulations and standards that pertain to distributors for Products and
Territories set forth herein.
12.4 AMS shall be responsible, at AMS's cost, for the regulatory
compliance, including, but not limited to, validation of Products for use
with other Products, Product claims, regulatory approvals and Clearances,
and product labelling in languages required in the Territory. The
Distributor is responsible to assist Aspect, at no cost to Aspect, in
documentation translation and other in country-specific issues.
ARTICLE 13. MODIFICATION OF PRODUCTS
13.1 All Products marketed by Distributor shall be sold only in the form as
packaged by AMS. Distributor shall not alter or change Product or its
package, prior to sale.
13.2 AMS shall provide Distributor written notice of all Product
discontinuance 6 months prior to the last order date.
13.3 AMS agrees to make reasonable efforts to ensure backward compatibility
for all enhancements to the current Products.
ARTICLE 14. EXPORT CERTIFICATION, PRODUCT REGISTRATION AND LOCALIZATION
14.1 Upon request, AMS shall provide at its own costs and expenses export
certificates issued by US Government and other documents that are necessary
for import and sale of the Products in the defined Territories. As required
by governments of any Territory, AMS agrees to site inspections of AMS's
factory.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
14.2 AMS shall obtain and maintain at its costs all such Product
registrations that are necessary for demonstration and sale of Products as
required by law in the defined Territories.
14.3 AMS shall comply with all applicable regulatory requirements for
Product localization, including labeling and documentation as required in
countries local languages within the Territories.
14.4 Upon mutual agreement, Distributor may provide Product registration
and/or localization assistance. In the case of documentation localization,
all master documentation is maintained and controlled, for the purpose of
quality system compliance, at AMS's expense by AMS.
ARTICLE 15. IMPORT LICENSES AND EXPORT CONTROLS
15.1 AMS shall be responsible for obtaining and maintaining any export
license(s) required for delivery of the Products to Distributor under this
Agreement.
15.2 Upon Distributor's request, AMS shall provide an appropriate
certification stating the country of origin for Products, sufficient to
satisfy the requirements of (i) the customs authorities of the country of
ultimate destination, (ii) any applicable export licensing regulations,
including those of the United States, and (iii) requirements for duty
drawback.
15.3 AMS shall xxxx every Product (or the Product's container if there is
not room on the Product itself) with the country of origin. AMS shall, in
marking the Products, comply with the requirements of the customs
authorities of the country of ultimate destination. For each shipment of
Products of US origin issue a certificate specifying the US Export Control
Classification Number (ECCN number). Products must not be knowingly resold,
exported or re-exported in violation of the US Export Administration Act.
ARTICLE 16. WARRANTY AND LIMITATION OF REMEDIES
16.1. AMS agrees to remedy any defect in the Products resulting from faulty
materials or workmanship, as specified below.
AMS's obligation set forth herein shall apply only to defects appearing
within a period of [**] from the date of delivery of the A-2000 or similar
product by the Distributor to the end user or [**] from the date of
delivery of the A-2000 or similar product by AMS to the Distributor,
whichever occurs first.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
AMS's obligation set forth herein shall apply only to defects appearing
within a period of [**] from the date of manufacture of the Aspect BIS
Sensor. AMS agrees to ship only such Aspect BIS Sensors that have a shelf
life of at least [**].
AMS's obligation set forth herein shall apply only to defects appearing
within a period of [**] from the date of delivery of the cables by the
Distributor to the end user or [**] from the date of delivery of the cables
by AMS to the Distributor, whichever occurs first.
Any repaired or replaced A-2000 or similar product or Aspect BIS Sensor or
part thereof shall be subject to such obligations for the greater of the
remainder of the original period specified in this Section 16.1 or [**].
16.2 Distributor will supply a copy of the User Warranty with each Warranty
Product sold herein which AMS has provided the Distributor.
16.3 If Distributor finds that any Product is defective prior to its sale
by Distributor, Distributor shall contact an authorized AMS representative
and describe the defect. AMS will grant approval, provide the values for
customs purposes, and a return authorization number for repair or
replacement of the Product. Distributor undertakes to quote the
authorization number on all documentation that accompanies Products being
returned. Distributor should ensure that equipment is suitably packed for
export and that accurate values, as specified by AMS, are used in
documentation. These defective Products will be promptly replaced at no
charge to Distributor.
16.4 After AMS approves the return of the defective Products, AMS will
inform Distributor as to the return location and send return labels to
Distributor or advise all details by electronic means.
16.5 AMS shall be entitled to verify the reason for the return and to
determine in its discretion whether to replace (rather than repair) the
unit. AMS shall not repair or replace units free of charge if the failure
is due to any of the following reasons:
(i) Damage from abuse or misuse by Distributor;
(ii) Attempted repair by Distributor through an unauthorized
service center.
16.6 AMS warrants that no Product provided hereunder shall be adulterated
or misbranded, within the meaning of the Federal Food, Drug, and Cosmetic
Act.
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16.7 AMS warrants that the Products provided herein will be "Year 2000
Compliant". Year 2000 Compliant Products will perform without error, loss
of data or loss of functionality arising from any failure to process,
calculate, compare or sequence date data accurately. In addition, Year 2000
Compliant Products will not cause any associated products or systems in
which they may be used to fail in any of the ways described above.
16.8 AMS warrants that that all Products shall (i) conform strictly to its
specifications, (ii) be free from defects in design, material, and
workmanship, (iii) be free from all liens, encumbrances, and other claims
against title, (iv) have correct and adequate warning labels or
instructions relating to the use, handling, maintaining or function of the
products.
16.9 In addition to warranties specified above, where an exceptionally high
failure rate occurs (more than double the annual failure rate quoted in
Exhibit 4, Product Support Requirements), AMS undertakes to apply
additional resources to return the failure rate to normal as soon as
reasonably practicable. In this case AMS shall promptly notify the
Distributor.
ARTICLE 17. IN-WARRANTY REPAIR
17.1 AMS shall cover parts costs and labor costs for field repair during
the warranty period as set forth in Article 16.1 unless AMS decides that
the Product shall be returned at AMS's cost to its repair facility for
warranty repair. In case of field repairs by the Distributor, the
Distributor may purchase replacement parts for no charge from AMS and the
labor costs will be reimbursed by AMS.
17.2 If Warranty Products are returned to AMS as more closely specified in
Exhibit 3 hereto, then parts and labor costs for returned Products and
transportation, insurance and handling charges of shipment of Product to
AMS for repair or replacement and other possible costs/expenses are covered
by AMS. Repaired or replaced Warranty Products will also be returned to
sender at AMS's expense.
17.3 Distributor shall perform installation services at Distributor's
expense.
ARTICLE 18. OUT OF WARRANTY REPAIR
18.1 Distributor or its customer shall bear all shipping charges for
out-of-warranty repairs.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
18.2 Repairs made by AMS outside of the warranty period shall be billed at
the AMS repair charge set forth in Exhibit 1. Such out-of-warranty repairs
will have a [**] parts warranty.
18.3. Out of warranty repairs will be performed by AMS at AMS's facility
set forth in Exhibit 3.
18.4 AMS guarantees that either compatible spare parts or compatible
replacement products will be available for the Distributor on reasonable
commercial terms for a period of at least [**] from the delivery by AMS of
the Aspect Product in question.
ARTICLE 19. COMPLAINTS, QUALITY RECORDS AND RECALLS
19.1 Distributor will notify, in writing, AMS's quality assurance
department of all Product complaints or any regulatory/conformance issues
that may affect the marketability of Products. AMS shall notify the
appropriate regulatory agent(s) if required and shall conduct any safety
investigations or other necessary follow-up activities. Distributor will
provide any information essential to such activities. AMS will promptly
notify Distributor if corrective action is necessary in the Territory.
19.2 Distributor shall keep records of the names and addresses of customers
and Product serial numbers for the active Product life to enable
Distributor to notify customers of Product safety information. Distributor
shall maintain the following information when distributing AMS's Products:
- Name and address of initial consignee
- Identification of device and quantity of devices shipped
- Date of shipment
19.3 Upon request, but not more than once per year, Distributor will supply
AMS a quarterly report of repairs, maintenance or service activity for
Products. The report will include the product number, serial number, fault
found, action taken and date of the activity.
19.4 In the event of any corrective or preventive action, including,
without limitation recall or field correction of a Product required by a
governmental agency for safety reasons, or requested by AMS, which is the
result of AMS's failure to supply Products that (1) conform in all material
respects to the applicable published specifications or (2) are free from
defects in material and workmanship, AMS agrees to repair or replace at its
own cost all Products subject to the corrective or preventive action and
previously delivered to Distributor. AMS also agrees to consult with
Distributor to establish a reasonable process for managing the corrective
or preventive action and AMS shall be responsible for all reasonable
out-
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of-pocket expenditures incurred by Distributor (including, but not limited
to shipping costs, labor and travel costs) that are consistent with the
corrective or preventive action process agreed to by the Parties. In the
event the corrective or preventive action is not required by a governmental
agency for safety reasons, but is instead requested by AMS at its sole
discretion, AMS will be responsible for determining the scope of such
action, including the number of units, timeframe for the action, criteria
for completion. In such event AMS shall be liable for the cost of repair or
replacement and reimbursement of costs to Distributor as set forth above.
Distributor agrees to maintain all necessary sales records to facilitate
the corrective or preventive action.
ARTICLE 20. PRODUCT STEWARDSHIP
20.1 AMS shall accept back, free of charge, any material including the
Products and packaging returned freight prepaid by Distributor from any
country that legally requires product take back from the user at the end of
product life.
20.2 AMS shall, upon request, provide available environmentally related
information regarding materials included in Products and packaging that AMS
ships to Distributor including material safety data sheets.
ARTICLE 21. FORCE MAJEURE
No Party to this Agreement shall be liable for failure or delay of
performance of any of its obligations hereunder if such failure or delay is
due to causes beyond its reasonable control including, without limitation,
natural disasters, fires, earthquake or storm, strikes, failures of public
utilities or common carriers, acts of war, or intervention, acts restraints
or regulations of any governmental authority including compliance with any
order of any governmental considerations; provided that any such delay or
failure shall be remedied by such Party as soon as possible after removal
of the cause of such failure. A Party suffering such delay or which expects
to suffer such delay shall promptly notify the other Party in writing of
the cause and expected duration of such delay. In the event a delay lasts
or is expected to last more than sixty (60) days the other Party shall have
the option to terminate this Agreement upon written notice.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE 22. CONFIDENTIALITY AND COMPETITION
22.1 The Parties hereby undertake to treat as strictly confidential, even
after the Agreement has terminated, each other's trade secrets and
non-public information. The receiving Party shall not use such information
for any purpose other than as contemplated under this Agreement, without
the disclosing Party's prior written consent. Both Parties agree to keep in
confidence the terms and conditions of this Agreement (the Parties shall
provide a copy of this Agreement to Datex-Ohmeda who shall keep the terms
and conditions of this Agreement in confidence). The obligations of this
Article shall extend until and terminate upon the third (3rd) anniversary
of the date of termination of this Agreement.
22.2 Distributor agrees that it shall [**]. Notwithstanding the aforesaid,
the Distributor may purchase, promote, represent, sell or otherwise deal
with the current and future products of Datex-Ohmeda and/or its Affiliates.
Any non-compete provisions regarding the Datex-Ohmeda and/or its Affiliates
products shall be null and void and non-binding on Distributor. [In case
the distribution agreement in question affects the trade within the EU/EEA,
and the distribution agreement is non-exclusive, no non-competition clauses
may be added to the agreement.]
ARTICLE 23. INTELLECTUAL PROPERTY RIGHTS AND INDEMNITY
AMS agrees to indemnify and hold harmless and defend at its own expense
Distributor and its Affiliates from and against any and all liabilities,
claims, demands, damages, costs and expenses or money judgements (including
legal fees) incurred by or rendered against Distributor and its Affiliates
arising from claims of infringement of copyright, patents, trade marks,
industrial designs or other intellectual property rights issued or
subsisting under the laws of the country in which Distributor distributes
the Products under this Agreement, if notified promptly in writing and
given, at AMS's cost, information, assistance and sole authority to defend
or settle the same. In case said Product is in such suit held to infringe
and the use or sale of said Product is enjoined, or in the case of a
settlement as referred to above, AMS shall have the option at its own
expense, to procure for Distributor the right to continue using or selling
said Product, or replace same with a non-infringing Product, or modify same
so it becomes non-infringing; in the event that none of the previous
options are commercially feasible, then AMS shall grant a refund to
Distributor of the price paid by Distributor for any of such Products
returned to AMS by Distributor. Notwithstanding anything to the contrary
above, in no event shall AMS have any liability under this Section 23 for
any such claims resulting from (a) modifications to the Products by
Distributor where the unmodified Products do not infringe, (b) the
combination of the Products by Distributor with other products not provided
or accepted (whether explicit or
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
implicit acceptance) by AMS where the non combined Products do not
infringe, or (c) use of the Products by Distributor for purposes for which
they were not intended. The foregoing states the entire liability of AMS
for infringement by Products furnished herein.
ARTICLE 24. INDEMNITY AND LIMITATION OF LIABILITY
24.1 AMS shall indemnify Distributor and its Affiliates from and against
any and all liabilities, claims, demands, damages, costs and expenses or
money judgements (including legal fees) incurred by or rendered against any
of them from third party claims or actions for personal injury or property
damage which arise out of a defect due to defective design, parts,
packaging, labeling, instructions,faulty workmanship or materials of
Products of which AMS is the manufacturer or is the Party responsible for
failure to warn except to the extent that such personal injuries or
property damage arise out of Distributor's (or its Affiliates) negligence
or breach of this Agreement (as set forth in herein).
24.2 EXCEPT AS PROVIDED HEREIN, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO
THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR
PUNITIVE DAMAGES OF ANY KIND WHATSOEVER INCLUDING BUT NOT LIMITED TO LOST
PROFITS, IN CONJUNCTION WITH OR ARISING OUT OF THE PERFORMANCE UNDER THIS
AGREEMENT OR THE USE OR PERFORMANCE OF PRODUCTS AND SUPPORT SERVICES EVEN
IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
CONSEQUENTIAL LOSS FOR THE PURPOSES OF THIS AGREEMENT SHALL MEAN AND
INCLUDE WITHOUT LIMITATION OF THE GENERAL STATEMENT EARLIER APPEARING, IN
EACH CASE WHETHER ARISING IN TORT OR CONTRACT AND INCLUDING IN EACH CASE
NEGLIGENCE:
(a) LOSS OF PROFITS;
(b) LOSS OF CONTRACTS;
(c) LOSS OF ANTICIPATED SAVINGS;
(d) LOSS OF DATA;
(e) LOSS OF BUSINESS;
(f) LOSS OF GOODWILL;
(g) LOSS OF REVENUE.
24.3 The above limitation of liability shall not apply to damages with
respect to the indemnity for the infringement of intellectual property
rights as provided in Article 23.
24.4 This indemnity shall not be affected or terminated by reason of
termination or expiration of this Agreement.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE 25. INSURANCE
Upon request, AMS shall provide evidence of product liability, general
liability and property damage insurance against an insurable claim or
claims, which might or could arise regarding AMS products purchased from
AMS. Such insurance will contain a minimum limit of liability for bodily
injury and property damage of not less than [**] US$.
ARTICLE 26. APPLICABLE LAW AND DISPUTE RESOLUTION
26.1. This Agreement and the Orders, acknowledgements of Orders and sales
contracts thereunder are to be construed, governed by and interpreted in
accordance with the laws of the Netherlands.
26.2. Prior to taking any action as provided in Clause 26.3 below, the
parties shall attempt to resolve any claim or controversy arising out of
this Agreement by way of amicable negotiations within a reasonable period
not to exceed thirty (30) days after the date of a notice from either party
to the other describing such claim or controversy.
26.3. All disputes between Aspect and Distributor arising out of or
relating to this Agreement shall be finally resolved by arbitration by one
arbitrator conducted in the English language in the Netherlands under the
commercial arbitration rules of the United Nations Commission on
International Trade Law. The arbitrator shall be appointed by the
Netherlands Arbitration Institute, Rotterdam. The arbitration costs will be
decided by the arbitrator. Notwithstanding anything contained in this
Section to the contrary, each party shall have the right to institute
judicial proceedings against the other party or anyone acting by, through
or under such other party, in order to enforce the instituting party's
rights hereunder through reformation of contract, specific performance,
injunction or similar equitable relief.
26.4. Judgement upon the award rendered may be entered in any Court having
jurisdiction or application may be made to such Court for a judicial
acceptance of the award and an order of enforcement, as the case may be.
26.5. Notwithstanding the aforesaid, any dispute regarding a Party's need
to protect or enforce any patent, trademark, copyright or other
intellectual property right, confidential information or trade secrets, or
as part of litigation commenced by a third party shall allow the Party to
undertake legal proceedings in the Court of a Party's domicile, main place
of business or other appropriate Court.
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ARTICLE 27. ADMINISTRATION AND NOTICES
Any notices pursuant to this Agreement shall be sent to the address(s)
specified in Exhibit 3- General Provisions.
This agreement has been signed in three copies, one for the Distributor,
one for AMS, and one for Datex-Ohmeda.
By signing this document, the Parties below indicate their Agreement with
and acceptance of this Agreement, including all Exhibits.
SIGNATURES
For Aspect Medical Systems
----------------------------------- -----------------------------------
Authorized Representative Signature Authorized Representative Signature
Name: Name:
Title: Title:
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
EXHIBIT 1 - PRODUCTS AND PRICES
(A) BIS SENSOR PRICES:
------------------------------------------------------------------------------------
[**] BIS SENSOR PRICE
------------------------------------------------------------------------------------
[**] [**] Period covered:
------------------------------------------------------------------------------------
[**] [**] [**] [**] thru 2002 and
December subsequent
31, 2001 years
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
------------------------------------------------------------------------------------
[**] [**] [**]
------------------------------------------------------------------------------------
TBD: to be established by managers of Alliance
(B) A2000 - BIS monitor prices:
[**] price
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
Price of A2000 [**] Demo units: $ [**]
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EXHIBIT 2 - TERRITORIES
---------------------------------------------------------------------------
The following Exhibit is attached to and form part of the Distribution
Agreement between AMS and DATEX-OHMEDA
---------------------------------------------------------------------------
Herein, the Territories are established for the above referenced Agreement.
---------------------------------------------
REGIONS
---------------------------------------------
---------------------------------------------
---------------------------------------------
---------------------------------------------
---------------------------------------------
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EXHIBIT 3 - GENERAL PROVISIONS
---------------------------------------------------------------------------
The following Exhibit is attached to and form part of the Distribution
Agreement between AMS and DATEX-OHMEDA
---------------------------------------------------------------------------
Any notice pursuant to this Agreement should be sent certified mail to the
Address(s) below:
DATEX-OHMEDA
AMS's address
Ship-to address for Products from AMS to DATEX-OHMEDA:
Invoice-to address for Products from AMS to DATEX-OHMEDA:
For information concerning this Agreement, contact the appropriate person
below:
--------------------------------------------------------------------------------
AMS COMPANY ROLE: NAME: LOCATION: PHONE NUMBER:
--------------------------------------------------------------------------------
VP SALES INTERNATIONAL Xxxxx Xxxxxxxx Netherlands 0031-71-572-5935
--------------------------------------------------------------------------------
QUALITY/REGULATORY Xxxxxxxxx Xxxxxxx Xxxxxx, Mass 000 000 0000
ASSURANCE MANAGER
--------------------------------------------------------------------------------
SERVICE TECHNICAL Xxx Xxxxxxxxxx Xxxxxx, Mass 000 000 0000
SUPPORT MANAGER
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
DATEX-OHMEDA ROLE: NAME: LOCATION: PHONE NUMBER:
--------------------------------------------------------------------------------
ALLIANCE MANAGER
--------------------------------------------------------------------------------
QUALITY/REGULATORY
ENGINEER
--------------------------------------------------------------------------------
SERVICE TECHNICAL
SUPPORT MANAGER
--------------------------------------------------------------------------------
ORDER FULFILLMENT
ENGINEER
--------------------------------------------------------------------------------
PRODUCT MANAGER
--------------------------------------------------------------------------------
PROGRAM MANAGER
--------------------------------------------------------------------------------
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
EXHIBIT 4 - PRODUCT SUPPORT REQUIREMENTS
---------------------------------------------------------------------------
The following Exhibit is attached to and form part of the Distribution
Agreement between Aspect Medical Systems and DATEX-OHMEDA
---------------------------------------------------------------------------
The following Exhibit establishes the support requirements for the A-2000
Monitoring System covered by this Agreement.
1. GENERAL SUPPORT STRATEGY: The support strategy consists of [**] at the
Newton, MA facility or by DATEX-OHMEDA in the field.
2. FAILURE RATE: The expected failure rate of the installed base per month for
the Monitoring System is [**]% and for the Converter is [**]%.
3. MEAN TIME TO REPAIR: The average labor time to repair ([**]) a monitor is
[**].
4. AVERAGE PARTS COSTS PER FAILURE: The average parts cost per repair ([**])
is the price of the power board in Exhibit 1.
5. PARTS AVAILABILITY: AMS will provide spare parts within [**] of receipt of
order.
6. RESPONSE TIME: AMS will use reasonable efforts to respond to escalated
customer issues within [**].
7. REPAIR PARTS INVENTORY: AMS recommends spare parts stock of [**] boards and
[**] displays for every [**] monitors sold.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX 2 TO THE MASTER DISTRIBUTION AGREEMENT
BETWEEN ASPECT MEDICAL SYSTEMS AND
DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORPORATION
------------------------------------------------------------------
------------------------------------------------------------------
MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
BETWEEN ASPECT MEDICAL SYSTEMS
AND
[ ]
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GENERAL
This Distribution Agreement between Aspect Medical Systems (referred to
herein as "AMS"), with its principal offices at 000 Xxxxxxx Xxxxxx, Xxxxxx,
XX 00000 and xxx (referred to herein as "the Distributor) (the "Parties")
is effective xxxx ("Effective Date").
WHEREAS AMS has entered into an Alliance with Datex-Ohmeda for the
distribution of certain products of Aspect through affiliates and
distribution partners of Datex-Ohmeda; and,
WHEREAS Aspect manufactures medical products and seeks to establish a
distribution channel in certain territories; and,
WHEREAS Distributor distributes medical products and seeks to distribute
additional products to its customers; and,
WHEREAS AMS desires to appoint Distributor as an authorized distributor in
certain territories of certain medical products, accessories and related
goods to be supplied by AMS and Distributor desires to accept such
appointment.
THEREFORE Distributor agrees to purchase and AMS agrees to sell such
Products upon the following terms and conditions:
ARTICLE 1. DEFINITIONS
The following terms have the meaning indicated here when used in this
Agreement:
"ALLIANCE": Co-operation agreed between Aspect Medical Systems and
Datex-Ohmeda Division of Instrumentarium Corporation "Datex-Ohmeda"
"AFFILIATE": Any person, firm, corporation, other legal entity which
controls or is controlled by or under common control with either AMS or
Distributor.
"PRICES": Net US$ prices at which AMS shall sell Products to Distributor as
set forth in Exhibit 1.
"PRODUCTS": All medical products, supplies, accessories, parts and related
goods listed in Exhibit 1 as well as any and all upgrades, adaptations,
modifications, improvements and substitutes to the products, supplies,
accessories, parts and related goods listed in Exhibit 1.
"TERRITORIES": Countries and locations as set forth in Exhibit 2.
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ARTICLE 2. APPOINTMENT
2.1 AMS hereby appoints Distributor as a Distributor for the Products in
the Territories.
2.2 Distributor may not actively sell outside the Territories without AMS's
prior written consent,. However within European Community countries
Distributor can answer to European tenders according to EU law.
2.3 In order to achieve better coverage in the Territories Distributor
shall have the right to appoint local firms as its local sub-distributors
in the Territories. AMS agrees and confirms that Distributor may
sub-contract any or all of its obligations hereunder pursuant to Article 7
provided that Distributor shall remain liable to AMS for any obligations
under this Agreement being performed by any subcontractor.
ARTICLE 3. RELATIONSHIP
3.1 The relationship of Distributor to AMS shall be that of an independent
contractor engaged in purchasing Products from AMS for resale to
Distributor's customers. AMS is committed to entering into a [**] with
Distributor in the Territory. Accordingly, [**] with other distributors for
Products, with the [**] distribution arrangements with OEM partners. OEM
partners will retain distribution rights to the Products but AMS will [**]
distribution agreements for the Products with third parties other than OEM
partners as long as Distributor maintains [**].
3.2 Nothing contained in this Agreement shall be deemed to create a
partnership or joint venture between the Parties. Neither the making nor
the performance of this Agreement shall be construed in any manner to have
established a joint venture or partnership.
3.3 Neither Party shall hold itself out as the agent of the other, nor
shall they incur any indebtedness or obligations in the name of, or which
shall be binding on the other, without the prior written consent of the
other. Each Party assumes full responsibility for its own personnel under
laws and regulations of the governmental authorities of the competent
jurisdiction.
[**] shall mean such [**] that (i) has [**], (ii) will be Aspect's partner
in the development of special sales programs, strategies, and market
development programs, (iii) will [**] through web site inquiries,
international exhibitions, congresses, or trade shows for the country where
such distribution partner [**], and (iv) will follow up on those leads. It
is expected that as a result of the [**] and the combined marketing and
support activities of Distributor, Datex-Ohmeda and Aspect, the amount of
business generated will [**].
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Criteria which D-O's Affiliates or distributors must fulfill in order to
obtain and maintain the [**] are the following:
(a) acquire and maintain ample product knowledge of the BIS in its sales
force and among sales representatives and product specialists;
(b) exhibit the product where ever it is appropriate, and maintain a
sufficient promotional effort;
(c) follow up, in a timely fashion, on leads generated by Distributor or
Datex-Ohmeda's promotional activities and Aspect's activities and
promotional actions;
(d) develop a plan for selling Aspect Products or integrate the Aspect
Products in other (relevant) plans;
(e) put in place a sales incentive and/or bonus plan for relevant
Distributor sales reps/other commercial people that contains a BIS
incentive not substantially inferior to other incentives;
(f) establish a demo equipment budget sufficient to purchase an appropriate
number of BIS demo units and sensors; and
(g) cooperate with Aspect personnel to establish reasonable revenue targets
for the BIS and discuss corrective actions in case these targets are not
obtained.
In the event that Aspect believes that Distributor has not met the criteria
specified above and is therefore no longer entitled to be [**] in one or
more countries, a determination as to the entitlement to the [**] shall be
made by the Alliance steering committee, that includes two members from AMS
and two members from Datex-Ohmeda.
ARTICLE 4. AGREEMENT PRECEDENCE AND DOCUMENTS
4.1 This Agreement supersedes any previous communication, representations,
or agreements between the Parties, whether oral or written, regarding
transactions hereunder.
4.2 All Exhibits attached to the Agreement shall be deemed a part of this
Agreement and incorporated herein. Terms that are defined in this
Agreement, and used in any Exhibit, have the same meaning in the Exhibit as
in this Agreement. The following Exhibits are hereby made a part of this
Agreement:
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Exhibit 1 - Products and Prices
Exhibit 2 - Territories
Exhibit 3 - General Provisions
Exhibit 4 - Product Support Requirements
ARTICLE 5. TERM OF AGREEMENT
This Agreement shall remain in effect until the earlier of (a) three (3)
years from the date the parties have signed this Agreement or (b) the
termination or expiration of the Alliance. Thereafter, unless terminated
because of termination of the Alliance or by either party with at least
[**]' notice prior the last day of the then current term, the Distribution
Agreement shall continue to be in force for successive one (1) years
periods and may be terminated by either Party (with or without cause) by
giving to the other Party at least [**] notice. In the event of such
expiration or any early termination, this Agreement shall continue to apply
to all orders previously accepted by AMS unless cancelled by Distributor
pursuant to Article 6.
ARTICLE 6. TERMINATION
6.1 This Agreement shall [**]. Upon the [**] Aspect shall promptly notify
the Distributor. In addition, to the extent permitted by law, if either
Party becomes insolvent, is unable to pay its debts when due, files for
bankruptcy, is subject of involuntary bankruptcy, has a receiver appointed,
or has its assets assigned, the other Party may terminate this Agreement
immediately upon notice to the other party and may cancel any unfulfilled
obligations.
6.2 If either Party hereto shall fail to perform any of the obligations
imposed upon it under the terms of this Agreement, the other Party may
terminate the Agreement upon [**] written notice. Such termination shall be
effective three months after the date of the written notice of the failure
unless the other Party cures the breach within such [**] period.
6.3 Distributor shall immediately cease to be an authorized AMS distributor
upon the effective date of expiration or termination of this Agreement.
Distributor shall thereafter refrain from representing itself as an
authorized AMS distributor and from using any AMS trademark or trade name.
Upon termination of the Agreement, AMS will have no obligation to
repurchase any or all of the Products which Distributor may have in its
possession at the time of termination. Aspect may, however, at its option,
agree to repurchase any or all of such Products, or may arrange the
purchase of such Products by successor distributors or customers in the
Territory. In the event Aspect fails to purchase, or to arrange the
purchase
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of, such Products, Distributor shall be permitted to sell its existing
inventory of Products for a period not to exceed ninety (90) days following
the effective date of the termination of this Agreement.
ARTICLE 7. ASSIGNMENT AND MODIFICATION OF AGREEMENT
7.1 During the term of this Agreement, the rights of the Distributor under
this Agreement shall not be assigned nor shall the performance of
Distributor's duties hereunder be delegated, except as set forth in Section
2.3 above, without AMS's prior written consent which shall not be
unreasonably withheld except either Distributor may assign this Agreement
(i) to an Affiliate that is an Affiliate or (ii) to an Affiliate whose
assets consist entirely of the assets of an Affiliate or Affiliates
(collectively the "permitted assignees").
7.2 An assignment of such rights for purpose of Section 7.1 shall include
any transaction including but not limited to, any merger, consolidation or
purchase of stock that results in a third party that is not a permitted
assignee controlling, directly or indirectly, a legal entity that holds
such rights. For purpose of this provision, the term "control" shall mean
the beneficial ownership, directly or indirectly, of fifty per cent (50%)
or more of voting shares of such entity.
7.3 No sale, assignment or other transfer of any rights of a Party
hereunder shall be effective unless the purchaser, assignee or transferee
assumes such Party's obligations under this Agreement. Any assignment shall
not relieve the assigning Party of its responsibility for obligations
hereunder.
7.4 Except as set forth in Article 7.5 below, modifications of this
Agreement shall be effective and binding only if agreed in writing and
executed by respective duly authorized representative of each of the
Parties hereto.
7.5 Distributor may, at its option, delete Products from individual
Territories.
7.6 Neither Party's failure to exercise any of its rights under this
Agreement will constitute or be deemed a waiver or forfeiture of those
rights.
7.7 This Agreement may be assigned by Distributor to any new company that
is formed, acquired etc. [**] in the Territories.
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ARTICLE 8. PRICES AND PAYMENTS
8.1 Distributor sets the end user selling prices at the sole judgement of
the Distributor.
8.2 Prices, which Distributor shall pay AMS for the Products purchased,
shall be the prices appearing in the Exhibit 1. Assuming Distributor
remains [**], it shall be entitled to the prices shown in Exhibit 1 [**] In
the event that Distributor fails to meet the criteria [**] it shall retain
its distribution rights but the prices to which it shall be entitled shall
be those set forth in Exhibit 1 based on the actual volume of sales of
Products [**].
Demonstration Price/initial stocking order price for the AS2000 System will
be [**] the agreed price of Exhibit 1. Demonstration Prices for the BIS
Sensor will be [**] the agreed price of Exhibit 1 (50 Sensors) for a
maximum of [**] per A2000 per year.
If there are additions or changes to Products, Distributor will have the
right to purchase, market and distribute these products and prices will be
established and Exhibits so revised.
8.3 Prices include the Product, labeling and packaging.
8.4 The prices set forth in Exhibit 1 may be revised not more often than
once per year based on market conditions, supplier costs and the expected
unit volume of Products purchased under this Agreement. If both Parties do
not agree upon the revised prices, then prices shall fall back to the prior
agreed upon prices.
8.5 Orders issued by Distributor with requested or acknowledged delivery
dates within 90 days after the effective date of any price change will be
billed at the lower price. This includes backlog and orders already placed
but have not received acknowledged delivery dates.
8.6 Payment shall be in U.S. dollars, in net. Payment terms will be [set
country by country to match the average payment times from the end
customers with a normal maximum of sixty (60) days. Ninety (90) days
payment time shall be used only in exceptional cases]. Invoices must
include details such as Distributor order number and quantities as
reference.
8.7 In competitive situations or as part of a large order, Distributor and
AMS may agree on a special price arrangement and/or payment terms and split
the cost of additional discounts.
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ARTICLE 9. SHIPMENT AND DELIVERY
9.1 Distributor will submit written (fax or electronic) orders to AMS.
Acknowledgment of delivery date will be received by Distributor within no
more than five work days. Distributor will not be obligated to stock
Products. Distributor may without charge postpone, decrease, increase or
cancel any order by notice to AMS, if such notice is given at least thirty
(30) days prior to the delivery date. Distributor may without charge
decrease any order by a maximum of [**]% by notice to AMS, if such notice
is given within less than thirty (30) days prior to the delivery date.
9.2 AMS will make every reasonable effort to meet delivery within thirty
(30) days or the date quoted or acknowledged. AMS shall give Distributor
prompt notice of any prospective failure to meet the acknowledged delivery
date. If AMS fails to deliver Products for thirty (30) days beyond the
agreed delivery date, Distributor may cancel such orders without charge.
AMS shall be liable to pay actual damages incurred by Distributor because
of AMS's failure to deliver such Products within thirty (30) days of the
acknowledged delivery date, provided, however, that Distributor must notify
AMS of any late delivery penalties that might be imposed by any prospective
customer for Aspect Products at the time Distributor orders Products for
such customer, and that such penalties may not exceed [**]% of
Distributor's purchase price for such Products unless otherwise agreed to
by the Parties.
9.3 Distributor may request changes in delivery dates, and quantity for
Products appearing on its orders at no charge provided written notice of
said changes is received by AMS at least ten (10) working days prior to
requested delivery date.
9.4 Upon Distributor's request with the necessary information, AMS shall
evaluate special requests for suitability of software or suitability of a
particular hardware interface between Products and hardware/software used
by Distributor's customers and inform Distributor of the result within a
reasonable time.
9.5 AMS shall provide a packing list with Distributor's purchase order
number, Distributor product numbers (the Distributor equivalent of AMS's
part numbers), serial numbers, quantity shipped and date shipped with each
unit shipped. If applicable, the packing list should also provide lot
number, or batch number.
9.6 AMS shall preserve, package, handle, and pack Products so as to protect
the Products from loss or damage, in conformance with good commercial
practice, government regulations, and other applicable requirements. AMS
shall xxxx the exterior of the boxes with the associated Product and serial
numbers of the contents. AMS shall be responsible for any loss or damage
due to its failure to
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properly preserve, package, handle, or pack Products. Distributor shall not
be required to assert any claims for such loss or damage against the common
carrier involved. AMS will ship Products in the final packaging as intended
to be received by the end user as ordered.
9.7 Products will be shipped EXW Aspect's plant or warehouse (as such term
is used in Incoterms 2000) at the Netherlands, USA or any other AMS
facility. Unless Distributor gives Aspect instructions as to the method of
shipment, Aspect will select the method of shipment and may, at Aspect's
option, pay transportation, insurance and similar charges. Distributor
shall reimburse Aspect for all such charges that Aspect pays.
9.8 Distributor will be the exporter of record and obtains duty drawback
rights to Products for which Distributor paid the duty. If Products
delivered under this Agreement are imported, AMS shall when possible allow
Distributor to be the importer of record. If Distributor is not the
importer of record and AMS obtains duty drawback rights to the Products for
which Distributor paid the duty, AMS shall, upon Distributor's request,
provide Distributor with documents required by the customs authorities of
the country of receipt to prove importation and transfer duty drawback
rights to Distributor.
9.9 Items missing in shipment that are the fault of Aspect will be promptly
replaced and shipped at no charge to Distributor within one (1) week from
written notice by Distributor.
ARTICLE 10. ADVERTISING, PROMOTIONS, TRADEMARKS AND COPYRIGHTED MATERIAL
10.1 AMS agrees to provide reasonable quantities of current or new sales
literature, artwork, advertising materials, promotional plans and other
information or programs in relevant languages mutually agreed by the
Parties reasonably related to this Agreement. Distributor specific
literature and advertising will be the responsibility of Distributor,
provided however that such literature shall be consistent in all respects
with the documentation supplied by Aspect and shall not include any claims,
warranties or information concerning any Aspect Products that are not
included in the documentation supplied by Aspect. AMS will provide
recommended reference sites and will actively pursue clinical evaluations
and the development of local country reference sites and clinical trials.
10.2 AMS hereby grants Distributor a revocable license to use any AMS
trademark or trade name associated with the Products solely in the
advertisement and promotion of the Products during the term of this
Agreement. Except as provided in this paragraph, Distributor shall have no
right, title or interest in or to any patent, trademark of trade name
belonging to AMS.
10.3 AMS hereby grants Distributor a revocable license to reproduce
materials provided to Distributor by AMS as is reasonable for promotion,
demonstration,
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sale and support of AMS Products, including but not limited to posting such
materials on the Internet, Intranet, or web.
ARTICLE 11. SALES AND SUPPORT
11.1 Distributor will provide AMS with a forecast of annual projected sales
unit volumes. Quantities listed in such correspondence between the Parties
are only estimates made as an accommodation for planning purposes and do
not constitute a commitment to purchase such quantity. Distributor may
revise any forecasts in its sole discretion.
11.2 Distributor agrees to purchase reasonable quantity of demonstration
Products and to maintain reasonable number of trained staff capable of
demonstrating and selling the Products. AMS agrees to provide, at its
costs, reasonable sales training and material and support to the
Distributor. Distributor agrees to participate in AMS's sales and marketing
meetings, reasonable Product and competitive training courses or product
launch meetings as mutually agreed upon, however, not be more often than
once a year. AMS agrees to provide sales training in a mutually agreeable
location each six (6) months and upon product launch if sooner.
11.3 Distributor agrees to maintain reasonable number of trained staff
capable of supporting the Products. AMS agrees to provide, at no charge,
reasonable service training and support. Distributor agrees to participate
in AMS's service training programs as mutually agreed upon. AMS undertakes
to provide initial technical service training prior to the time that
distribution into the Territory is to commence. Thereafter Distributor will
send technicians to update technical knowledge as mutually agreed upon.
11.4 AMS shall provide documentation to enable Distributor to establish the
support plan and deliver support services for the Products and Territories.
The Product support plan shall be prepared by both Parties and agreed upon
prior to the time distribution is to commence. AMS shall support the
Distributor with service information, parts (as provided in Section 11.5),
training and technical and clinical assistance and back-up support by
letter, fax, e-mail or telephone as appropriate.
11.5 Distributor agrees to purchase reasonable quantity of necessary spare
parts and test equipment according to AMS's recommendation to support
systems installed in Territories. Spare parts to support in-warranty
repairs will be replaced for Distributor at no cost. Out-of-warranty spare
parts are at Distributor's cost.
11.6 Distributor shall use its reasonable efforts to handle and resolve
feedback from its customers. AMS shall have ultimate responsibility for
resolution of Product related issues. Problems that can not be resolved
locally will be escalated in accordance with Article 26.
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ARTICLE 12. QUALITY ASSURANCE, REGULATORY COMPLIANCE
12.1 AMS agrees to maintain ISO9001, US GMP 21 CFR 820, EN46001 and
Directive 93/42/EEC Annex II certification status and compliance with the
Food and Drug Administration's (FDA) Quality System Regulation, the Medical
Device Directive and/or appropriate regulations that apply to countries
within and outside the European Union. As manufacturer, AMS will comply
with all applicable regulations and standards that pertain to manufacturers
for Products and Territories set forth herein.
12.2 Distributor will, from time to time, inform AMS of applicable
regulations in the Territories and AMS shall ensure that Products comply
with all such regulations as provided in Section 14.3.
12.3 Upon request, AMS agrees to furnish to Distributor any information
required to enable the Distributor to comply with all applicable
regulations and standards that pertain to distributors for Products and
Territories set forth herein.
12.4 AMS shall be responsible, at AMS's cost, for the regulatory
compliance, including, but not limited to, validation of Products for use
with other Products, Product claims, regulatory approvals and Clearances,
and product labelling in languages required in the Territory. The
Distributor is responsible to assist Aspect, at no cost to Aspect, in
documentation translation and other in country-specific issues.
ARTICLE 13. MODIFICATION OF PRODUCTS
13.1 All Products marketed by Distributor shall be sold only in the form as
packaged by AMS. Distributor shall not alter or change Product or its
package, prior to sale.
13.2 AMS shall provide Distributor written notice of all Product
discontinuance 6 months prior to the last order date.
13.3 AMS agrees to make reasonable efforts to ensure backward compatibility
for all enhancements to the current Products.
ARTICLE 14. EXPORT CERTIFICATION, PRODUCT REGISTRATION AND LOCALIZATION
14.1 Upon request, AMS shall provide at its own costs and expenses export
certificates issued by US Government and other documents that are necessary
for import and sale of the Products in the defined Territories. As required
by governments of any Territory, AMS agrees to site inspections of AMS's
factory.
14.2 AMS shall obtain and maintain at its costs all such Product
registrations that are necessary for demonstration and sale of Products as
required by law in the defined Territories.
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14.3 AMS shall comply with all applicable regulatory requirements for
Product localization, including labeling and documentation as required in
countries local languages within the Territories.
14.4 Upon mutual agreement, Distributor may provide Product registration
and/or localization assistance. In the case of documentation localization,
all master documentation is maintained and controlled, for the purpose of
quality system compliance, at AMS's expense by AMS.
ARTICLE 15. IMPORT LICENSES AND EXPORT CONTROLS
15.1 AMS shall be responsible for obtaining and maintaining any export
license(s) required for delivery of the Products to Distributor under this
Agreement.
15.2 Upon Distributor's request, AMS shall provide an appropriate
certification stating the country of origin for Products, sufficient to
satisfy the requirements of (i) the customs authorities of the country of
ultimate destination, (ii) any applicable export licensing regulations,
including those of the United States, and (iii) requirements for duty
drawback.
15.3 AMS shall xxxx every Product (or the Product's container if there is
not room on the Product itself) with the country of origin. AMS shall, in
marking the Products, comply with the requirements of the customs
authorities of the country of ultimate destination. For each shipment of
Products of US origin issue a certificate specifying the US Export Control
Classification Number (ECCN number). Products must not be knowingly resold,
exported or re-exported in violation of the US Export Administration Act.
ARTICLE 16. WARRANTY AND LIMITATION OF REMEDIES
16.1. AMS agrees to remedy any defect in the Products resulting from faulty
materials or workmanship, as specified below.
AMS's obligation set forth herein shall apply only to defects appearing
within a period of [**] from the date of delivery of the A-2000 or similar
product by the Distributor to the end user or [**] from the date of
delivery of the A-2000 or similar product by AMS to the Distributor,
whichever occurs first.
AMS's obligation set forth herein shall apply only to defects appearing
within a period of [**] from the date of manufacture of the Aspect BIS
Sensor. AMS agrees to ship only such Aspect BIS Sensors that have a shelf
life of at least [**].
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AMS's obligation set forth herein shall apply only to defects appearing
within a period of [**] from the date of delivery of the cables by the
Distributor to the end user or [**] from the date of delivery of the cables
by AMS to the Distributor, whichever occurs first.
Any repaired or replaced A-2000 or similar product or Aspect BIS Sensor or
part thereof shall be subject to such obligations for the greater of the
remainder of the original period specified in this Section 16.1 or [**].
16.2 Distributor will supply a copy of the User Warranty with each Warranty
Product sold herein which AMS has provided the Distributor.
16.3 If Distributor finds that any Product is defective prior to its sale
by Distributor, Distributor shall contact an authorized AMS representative
and describe the defect. AMS will grant approval, provide the values for
customs purposes, and a return authorization number for repair or
replacement of the Product. Distributor undertakes to quote the
authorization number on all documentation that accompanies Products being
returned. Distributor should ensure that equipment is suitably packed for
export and that accurate values, as specified by AMS, are used in
documentation. These defective Products will be promptly replaced at no
charge to Distributor.
16.4 After AMS approves the return of the defective Products, AMS will
inform Distributor as to the return location and send return labels to
Distributor or advise all details by electronic means.
16.5 AMS shall be entitled to verify the reason for the return and to
determine in its discretion whether to replace (rather than repair) the
unit. AMS shall not repair or replace units free of charge if the failure
is due to any of the following reasons:
(i) Damage from abuse or misuse by Distributor;
(ii) Attempted repair by Distributor through an unauthorized
service center.
16.6 AMS warrants that no Product provided hereunder shall be adulterated
or misbranded, within the meaning of the Federal Food, Drug, and Cosmetic
Act.
16.7 AMS warrants that the Products provided herein will be "Year 2000
Compliant". Year 2000 Compliant Products will perform without error, loss
of data or loss of functionality arising from any failure to process,
calculate, compare or sequence date data accurately. In addition, Year 2000
Compliant Products will not cause any associated products or systems in
which they may be used to fail in any of the ways described above.
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16.8 AMS warrants that that all Products shall (i) conform strictly to its
specifications, (ii) be free from defects in design, material, and
workmanship, (iii) be free from all liens, encumbrances, and other claims
against title, (iv) have correct and adequate warning labels or
instructions relating to the use, handling, maintaining or function of the
products.
16.9 In addition to warranties specified above, where an exceptionally high
failure rate occurs (more than double the annual failure rate quoted in
Exhibit 4, Product Support Requirements), AMS undertakes to apply
additional resources to return the failure rate to normal as soon as
reasonably practicable. In this case AMS shall promptly notify the
Distributor.
ARTICLE 17. IN-WARRANTY REPAIR
17.1 AMS shall cover parts costs and labor costs for field repair during
the warranty period as set forth in Article 16.1 unless AMS decides that
the Product shall be returned at AMS's cost to its repair facility for
warranty repair. In case of field repairs by the Distributor, the
Distributor may purchase replacement parts for no charge from AMS and the
labor costs will be reimbursed by AMS.
17.2 If Warranty Products are returned to AMS as more closely specified in
Exhibit 3 hereto, then parts and labor costs for returned Products and
transportation, insurance and handling charges of shipment of Product to
AMS for repair or replacement and other possible costs/expenses are covered
by AMS. Repaired or replaced Warranty Products will also be returned to
sender at AMS's expense.
17.3 Distributor shall perform installation services at Distributor's
expense.
ARTICLE 18. OUT OF WARRANTY REPAIR
18.1 Distributor or its customer shall bear all shipping charges for
out-of-warranty repairs.
18.2 Repairs made by AMS outside of the warranty period shall be billed at
the AMS repair charge set forth in Exhibit 1. Such out-of-warranty repairs
will have a [**] parts warranty.
18.3. Out of warranty repairs will be performed by AMS at AMS's facility
set forth in Exhibit 3.
18.4 AMS guarantees that either compatible spare parts or compatible
replacement products will be available for the Distributor on reasonable
commercial terms for a period of at least [**] from the delivery by AMS of
the Aspect Product in question.
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ARTICLE 19. COMPLAINTS, QUALITY RECORDS AND RECALLS
19.1 Distributor will notify, in writing, AMS's quality assurance
department of all Product complaints or any regulatory/conformance issues
that may affect the marketability of Products. AMS shall notify the
appropriate regulatory agent(s) if required and shall conduct any safety
investigations or other necessary follow-up activities. Distributor will
provide any information essential to such activities. AMS will promptly
notify Distributor if corrective action is necessary in the Territory.
19.2 Distributor shall keep records of the names and addresses of customers
and Product serial numbers for the active Product life to enable
Distributor to notify customers of Product safety information. Distributor
shall maintain the following information when distributing AMS's Products:
- Name and address of initial consignee
- Identification of device and quantity of devices shipped
- Date of shipment
19.3 Upon request, but not more than once per year, Distributor will supply
AMS a quarterly report of repairs, maintenance or service activity for
Products. The report will include the product number, serial number, fault
found, action taken and date of the activity.
19.4 In the event of any corrective or preventive action, including,
without limitation recall or field correction of a Product required by a
governmental agency for safety reasons, or requested by AMS, which is the
result of AMS's failure to supply Products that (1) conform in all material
respects to the applicable published specifications or (2) are free from
defects in material and workmanship, AMS agrees to repair or replace at its
own cost all Products subject to the corrective or preventive action and
previously delivered to Distributor. AMS also agrees to consult with
Distributor to establish a reasonable process for managing the corrective
or preventive action and AMS shall be responsible for all reasonable
out-of-pocket expenditures incurred by Distributor (including, but not
limited to shipping costs, labor and travel costs) that are consistent with
the corrective or preventive action process agreed to by the Parties. In
the event the corrective or preventive action is not required by a
governmental agency for safety reasons, but is instead requested by AMS at
its sole discretion, AMS will be responsible for determining the scope of
such action, including the number of units, timeframe for the action,
criteria for completion. In such event AMS shall be liable for the cost of
repair or replacement and reimbursement of costs to Distributor as set
forth above. Distributor agrees to maintain all necessary sales records to
facilitate the corrective or preventive action.
Confidential
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE 20. PRODUCT STEWARDSHIP
20.1 AMS shall accept back, free of charge, any material including the
Products and packaging returned freight prepaid by Distributor from any
country that legally requires product take back from the user at the end of
product life.
20.2 AMS shall, upon request, provide available environmentally related
information regarding materials included in Products and packaging that AMS
ships to Distributor including material safety data sheets.
ARTICLE 21. FORCE MAJEURE
No Party to this Agreement shall be liable for failure or delay of
performance of any of its obligations hereunder if such failure or delay is
due to causes beyond its reasonable control including, without limitation,
natural disasters, fires, earthquake or storm, strikes, failures of public
utilities or common carriers, acts of war, or intervention, acts restraints
or regulations of any governmental authority including compliance with any
order of any governmental considerations; provided that any such delay or
failure shall be remedied by such Party as soon as possible after removal
of the cause of such failure. A Party suffering such delay or which expects
to suffer such delay shall promptly notify the other Party in writing of
the cause and expected duration of such delay. In the event a delay lasts
or is expected to last more than sixty (60) days the other Party shall have
the option to terminate this Agreement upon written notice.
ARTICLE 22. CONFIDENTIALITY AND COMPETITION
22.1 The Parties hereby undertake to treat as strictly confidential, even
after the Agreement has terminated, each other's trade secrets and
non-public information. The receiving Party shall not use such information
for any purpose other than as contemplated under this Agreement, without
the disclosing Party's prior written consent. Both Parties agree to keep in
confidence the terms and conditions of this Agreement (the Parties shall
provide a copy of this Agreement to Datex-Ohmeda who shall keep the terms
and conditions of this Agreement in confidence). The obligations of this
Article shall extend until and terminate upon the third (3rd) anniversary
of the date of termination of this Agreement.
22.2 Distributor agrees that it shall [**]. Notwithstanding the aforesaid,
the Distributor may purchase, promote, represent, sell or otherwise deal
with the current and future products of Datex-Ohmeda and/or its Affiliates.
Any non-compete provisions regarding the Datex-Ohmeda and/or its Affiliates
products shall be null and void and non-binding on Distributor. [In case
the distribution agreement in question affects the trade within the EU/EEA,
and the distribution
Confidential
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
agreement is non-exclusive, no non-competition clauses may be added to the
agreement.]
ARTICLE 23. INTELLECTUAL PROPERTY RIGHTS AND INDEMNITY
AMS agrees to indemnify and hold harmless and defend at its own expense
Distributor and its Affiliates from and against any and all liabilities,
claims, demands, damages, costs and expenses or money judgements (including
legal fees) incurred by or rendered against Distributor and its Affiliates
arising from claims of infringement of copyright, patents, trade marks,
industrial designs or other intellectual property rights issued or
subsisting under the laws of the country in which Distributor distributes
the Products under this Agreement, if notified promptly in writing and
given, at AMS's cost, information, assistance and sole authority to defend
or settle the same. In case said Product is in such suit held to infringe
and the use or sale of said Product is enjoined, or in the case of a
settlement as referred to above, AMS shall have the option at its own
expense, to procure for Distributor the right to continue using or selling
said Product, or replace same with a non-infringing Product, or modify same
so it becomes non-infringing; in the event that none of the previous
options are commercially feasible, then AMS shall grant a refund to
Distributor of the price paid by Distributor for any of such Products
returned to AMS by Distributor. Notwithstanding anything to the contrary
above, in no event shall AMS have any liability under this Section 23 for
any such claims resulting from (a) modifications to the Products by
Distributor where the unmodified Products do not infringe, (b) the
combination of the Products by Distributor with other products not provided
or accepted (whether explicit or implicit acceptance) by AMS where the non
combined Products do not infringe, or (c) use of the Products by
Distributor for purposes for which they were not intended. The foregoing
states the entire liability of AMS for infringement by Products furnished
herein.
ARTICLE 24. INDEMNITY AND LIMITATION OF LIABILITY
24.1 AMS shall indemnify Distributor and its Affiliates from and against
any and all liabilities, claims, demands, damages, costs and expenses or
money judgements (including legal fees) incurred by or rendered against any
of them from third party claims or actions for personal injury or property
damage which arise out of a defect due to defective design, parts,
packaging, labeling, instructions,faulty workmanship or materials of
Products of which AMS is the manufacturer or is the Party responsible for
failure to warn except to the extent that such personal injuries or
property damage arise out of Distributor's (or its Affiliates) negligence
or breach of this Agreement (as set forth in herein).
24.2 EXCEPT AS PROVIDED HEREIN, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO
THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR
PUNITIVE DAMAGES OF ANY KIND WHATSOEVER INCLUDING BUT NOT LIMITED TO LOST
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PROFITS, IN CONJUNCTION WITH OR ARISING OUT OF THE PERFORMANCE UNDER THIS
AGREEMENT OR THE USE OR PERFORMANCE OF PRODUCTS AND SUPPORT SERVICES EVEN
IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
CONSEQUENTIAL LOSS FOR THE PURPOSES OF THIS AGREEMENT SHALL MEAN AND
INCLUDE WITHOUT LIMITATION OF THE GENERAL STATEMENT EARLIER APPEARING, IN
EACH CASE WHETHER ARISING IN TORT OR CONTRACT AND INCLUDING IN EACH CASE
NEGLIGENCE:
(a) LOSS OF PROFITS;
(b) LOSS OF CONTRACTS;
(c) LOSS OF ANTICIPATED SAVINGS;
(d) LOSS OF DATA;
(e) LOSS OF BUSINESS;
(f) LOSS OF GOODWILL;
(g) LOSS OF REVENUE.
24.3 The above limitation of liability shall not apply to damages with
respect to the indemnity for the infringement of intellectual property
rights as provided in Article 23.
24.4 This indemnity shall not be affected or terminated by reason of
termination or expiration of this Agreement.
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
ARTICLE 25. INSURANCE
Upon request, AMS shall provide evidence of product liability, general
liability and property damage insurance against an insurable claim or
claims, which might or could arise regarding AMS products purchased from
AMS. Such insurance will contain a minimum limit of liability for bodily
injury and property damage of not less than [**] US$.
ARTICLE 26. APPLICABLE LAW AND DISPUTE RESOLUTION
26.1. This Agreement and the Orders, acknowledgements of Orders and sales
contracts thereunder are to be construed, governed by and interpreted in
accordance with the laws of the Netherlands.
26.2 Prior to taking any action as provided in Clause 26.3 below, the
parties shall attempt to resolve any claim or controversy arising out of
this Agreement by way of amicable negotiations within a reasonable period
not to exceed thirty (30) days after the date of a notice from either party
to the other describing such claim or controversy.
26.3. All disputes between Aspect and Distributor arising out of or
relating to this Agreement shall be finally resolved by arbitration by one
arbitrator conducted in the English language in the Netherlands under the
commercial arbitration rules of the United Nations Commission on
International Trade Law. The arbitrator shall be appointed by the
Netherlands Arbitration Institute, Rotterdam. The arbitration costs will be
decided by the arbitrator. Notwithstanding anything contained in this
Section to the contrary, each party shall have the right to institute
judicial proceedings against the other party or anyone acting by, through
or under such other party, in order to enforce the instituting party's
rights hereunder through reformation of contract, specific performance,
injunction or similar equitable relief.
26.4. Judgement upon the award rendered may be entered in any Court having
jurisdiction or application may be made to such Court for a judicial
acceptance of the award and an order of enforcement, as the case may be.
26.5. Notwithstanding the aforesaid, any dispute regarding a Party's need
to protect or enforce any patent, trademark, copyright or other
intellectual property right, confidential information or trade secrets, or
as part of litigation commenced by a third party shall allow the Party to
undertake legal proceedings in the Court of a Party's domicile, main place
of business or other appropriate Court.
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ARTICLE 27. ADMINISTRATION AND NOTICES
Any notices pursuant to this Agreement shall be sent to the address(s)
specified in Exhibit 3- General Provisions.
This agreement has been signed in three copies, one for the Distributor,
one for AMS, and one for Datex-Ohmeda.
By signing this document, the Parties below indicate their Agreement with
and acceptance of this Agreement, including all Exhibits.
SIGNATURES
For Aspect Medical Systems
----------------------------------- -----------------------------------
Authorized Representative Signature Authorized Representative Signature
Name: Name:
Title: Title:
------------------------------
------------------------------
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
EXHIBIT 1 - PRODUCTS AND PRICES
(A) BIS SENSOR PRICES:
------------------------------------------------------------------------------------
[**] BIS SENSOR PRICE
------------------------------------------------------------------------------------
[**] [**] Period covered:
------------------------------------------------------------------------------------
Low high Low high thru 2002 and
December subsequent
31, 2001 years
------------------------------------------------------------------------------------
[**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**]
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[**] [**] [**]
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TBD: to be established by managers of Alliance
(B) A2000 - BIS monitor prices:
[**] price
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
PRICE OF A2000 [**] DEMO UNITS: $[**]
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EXHIBIT 2 - TERRITORIES
---------------------------------------------------------------------------
The following Exhibit is attached to and form part of the Distribution
Agreement between AMS and DATEX-OHMEDA
---------------------------------------------------------------------------
Herein, the Territories are established for the above referenced Agreement.
---------------------------------------------
REGIONS
---------------------------------------------
---------------------------------------------
---------------------------------------------
---------------------------------------------
---------------------------------------------
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EXHIBIT 3 - GENERAL PROVISIONS
---------------------------------------------------------------------------
The following Exhibit is attached to and form part of the Distribution
Agreement between AMS and DATEX-OHMEDA
---------------------------------------------------------------------------
Any notice pursuant to this Agreement should be sent certified mail to the
Address(s) below:
DATEX-OHMEDA
AMS's address
Ship-to address for Products from AMS to DATEX-OHMEDA:
Invoice-to address for Products from AMS to DATEX-OHMEDA:
For information concerning this Agreement, contact the appropriate person
below:
--------------------------------------------------------------------------------
AMS COMPANY ROLE: NAME: LOCATION: PHONE NUMBER:
--------------------------------------------------------------------------------
VP SALES INTERNATIONAL Xxxxx Xxxxxxxx Netherlands 0031-71-572-5935
--------------------------------------------------------------------------------
QUALITY/ REGULATORY Xxxxxxxxx Xxxxxxx Xxxxxx, Mass 000 000 0000
ASSURANCE MANAGER
--------------------------------------------------------------------------------
SERVICE TECHNICAL Xxx Xxxxxxxxxx Xxxxxx, Mass 000 000 0000
SUPPORT MANAGER
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
DATEX-OHMEDA ROLE: NAME: LOCATION: PHONE NUMBER:
--------------------------------------------------------------------------------
ALLIANCE MANAGER
--------------------------------------------------------------------------------
QUALITY/REGULATORY
ENGINEER
--------------------------------------------------------------------------------
SERVICE TECHNICAL
SUPPORT MANAGER
--------------------------------------------------------------------------------
ORDER FULFILLMENT
ENGINEER
--------------------------------------------------------------------------------
PRODUCT MANAGER
--------------------------------------------------------------------------------
PROGRAM MANAGER
--------------------------------------------------------------------------------
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MEDICAL PRODUCTS DISTRIBUTION AGREEMENT
EXHIBIT 4 - PRODUCT SUPPORT REQUIREMENTS
---------------------------------------------------------------------------
The following Exhibit is attached to and form part of the Distribution
Agreement between Aspect Medical Systems and DATEX-OHMEDA
---------------------------------------------------------------------------
The following Exhibit establishes the support requirements for the A-2000
Monitoring System covered by this Agreement.
1. GENERAL SUPPORT STRATEGY: The support strategy consists of [**] at the
Newton, MA facility or by DATEX-OHMEDA in the field.
2. FAILURE RATE: The expected failure rate of the installed base per month for
the Monitoring System is [**]% and for the Converter is [**]%.
3. MEAN TIME TO REPAIR: The average labor time to repair [**] a monitor is
[**].
4. AVERAGE PARTS COSTS PER FAILURE: The average parts cost per repair [**] is
the price of the power board in Exhibit 1.
5. PARTS AVAILABILITY: AMS will provide spare parts within [**] of receipt of
order.
6. RESPONSE TIME: AMS will use reasonable efforts to respond to escalated
customer issues within [**].
7. REPAIR PARTS INVENTORY: AMS recommends spare parts stock of [**] boards
and[**]displays for every [**] monitors sold.
Confidential
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX 3 - LIST OF ASPECTS CURRENT DISTRIBUTION AGREEMENTS
1 [**] in all areas [**] by special arrangement. Agreement is currently
re-negotiated, maintaining "access" [**]
2 [**]by agreement only to areas [**] exclusive discussions/negotiations to
re-define "access to"/distribution [**]
3 All independents and some other [**] distributors below [**]
4 Standard contract paragraph 8.2, re: contract renewal applies (see separate
attachment)
COUNTRY DISTRIBUTION STATUS
--------------------------------------------------------------
COUNTRY DISTRIBUTOR OEM OR YES/NO RESOLUTION BY:
INDEPENDENT
CONTRACT
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[**]
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[**]
MASTER DISTRIBUTION AGREEMENT
66
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
--------------------------------------------------------------
COUNTRY DISTRIBUTOR OEM OR RESOLUTION BY:
INDEPENDENT
CONTRACT
YES/NO
--------------------------------------------------------------
--------------------------------------------------------------
[**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**]
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[**]General:
1 No activity [**]
2 [**]
3 [**] (see notes)
4 [**]
MASTER DISTRIBUTION AGREEMENT
67
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
--------------------------------------------------------------
COUNTRY DISTRIBUTOR OEM OR RESOLUTION BY:
INDEPENDENT
CONTRACT
YES/NO
--------------------------------------------------------------
[**] [**] [**] [**] [**]
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[**] [**]
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MASTER DISTRIBUTION AGREEMENT
68
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX 4 - ASPECT PRODUCTS AND PRICES
(A) BIS Sensor prices:
----------------------------------------------------------------------------------------------------------------------
[**] BIS sensor price
----------------------------------------------------------------------------------------------------------------------
[**] [**] period
covered:
----------------------------------------------------------------------------------------------------------------------
low high Low high thru 2001 2002 2003 2004 2005
----------------------------------------------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
----------------------------------------------------------------------------------------------------------------------
[**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**] [**]
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[**] [**] [**] [**] [**] [**]
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[**] [**] [**]
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(B) A2000 - BIS monitor prices:
[**] price
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
[**] $[**]
Price of A2000 [**]
Demo units: $[**]
MASTER DISTRIBUTION AGREEMENT
69
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
OEM - PURCHASE AGREEMENT
FOR [**] SENSOR
This Agreement is made between Datex-Ohmeda Division, Instrumentarium
Corporation, with offices at Xxxxxxxxxxxxxx 0, XXX-00000 Xxxxx-Xxxxxx, Xxxxxxx,
fax no x000 00 000 0000 (hereinafter referred to as "D-O"), and Aspect Medical
Systems Inc, with offices at 000 Xxxxxxx Xxxxxx, Xxxxxx, XX 00000, XXX fax no +1
000 000 0000 (hereinafter referred to as "Aspect") (D-O and Aspect each being a
"Party", and collectively the "Parties"). The Parties hereby agree as follows:
0. Definitions.
"Affiliate" shall mean, with respect to any specified party, any other legal
entity that directly or indirectly controls, is controlled by or is under common
control with, such specified party.
"Aspect Products" shall mean collectively the [**] Sensor, Sensor Connector,
Cable Connector and the [**].
"Aspect's Bispectral Index" or "BIS" is Aspect's proprietary processed EEG
parameter that measures the hypnotic effects of anesthetic and sedative agents
on the brain during surgery.
"[**]" or "[**]" is Datex-Ohmeda's proprietary processed [**] that measures the
[**] effects of [**] on the [**].
"BIS Sensor" means a single use disposable sensor manufactured by Aspect for use
with the A-2000, the D-O BIS Module, or with the Aspect BIS Module Kit and that
is required to generate Aspect's Bispectral Index.
"Cable Connector" shall mean the mating connector to the Sensor Connector which
are to be used with the [**] Sensor.
"[**] Sensor" means a [**] sensor manufactured by Aspect including the Sensor
Connector for use with [**] that incorporate level-of-consciousness monitoring
technology [**].
"D-O Patient Monitors" means any patient monitoring system, standalone monitor,
or module, manufactured by or for D-O that displays D-O's Index and certain EEG
data (waveforms, numerics, status info), and provides setup and operation
information (user interface), alarming, and network connectivity.
"D-O BIS Module" is the sum of all components involved in integrating the BIS
with D-O Patient Monitors.
"Sensor Connector" shall mean the connector to be used with the [**] Sensor.
[**]"means the Aspect technology which may be [**] with the [**] Sensors.
1. Purchase and Sale Obligations; Licenses
1
70
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
1.1 (a) For the term of this Agreement, subject to the terms and conditions of
this Agreement and subject to Aspects ability to supply the requested quantities
of disposable sensors that meet the mutually agreed technical specifications and
level of quality for such sensors, [**], including, but not limited to, the [**]
Sensor. The purchase prices for [**] Sensors based on Aspect's Zip Prep(TM)
technology are listed in Appendix 1 ([**] Sensors: Price List). The parties
acknowledge that the [**] Sensor may be [**] and that prices for such sensor
will be mutually agreed upon. Notwithstanding anything to the contrary above,
the [**] specified in this Section 1.1(a) shall terminate when neither D-O nor
any D-O Affiliate is [**] defined in the Master Distribution Agreement entered
into by the Parties on even date herewith.
1.1 (b) Aspect shall not provide [**] Sensors either directly or indirectly to
any third party unless requested to do so by D-O during the term of this
Agreement and thereafter.
1.2 Subject to this Agreement, Aspect shall supply to D-O only such [**]
Sensors that conform to the mutually agreed technical specifications. Included
in these specifications is the requirement that the [**] Sensors [**] [**], and
that [**] Sensors [**]. Similarly, it is agreed by both Parties that Aspect BIS
Sensors [**]. Aspect BIS Sensors will [**]. Aspect is aware that the [**]
Sensors are used as a part of or in connection with medical devices and that D-O
has high quality demands for any products it purchases. Aspect responsibilities
for maintaining quality control and quality of [**] Sensors are specified in
Section 6 hereof. Neither party shall have the right to amend or alter the
mutually agreed technical specifications without the prior written approval of
the other party.
During the term of this Agreement Aspect agrees that D-O and its Affiliates may
purchase the Cable Connectors [**]. Aspect shall keep D-O informed of the
manufacturer of the Cable Connector. If the Cable Connector manufacturer is not
able to manufacture sufficient quantities of Cable Connectors for [**] using the
tooling and molds used for Aspect's requirements of Cable Connectors or if the
Cable Connectors are different than the cable connectors sold for use with
Aspect's products, [**] shall pay the manufacturer to acquire additional tooling
and molds to manufacture the Cable Connectors for D-O.
During the term of this Agreement Aspect hereby grants to D-O and its Affiliates
a non-exclusive, non-transferable (except as provided in Section 15.9),
perpetual, irrevocable and royalty-free worldwide license, without the right to
sublicense, the right for D-O, its Affiliates, distributors and sub-distributors
to sell, market and distribute the Sensor Connectors and/or Cable Connectors to
be used with the [**] Sensor.
1.3 Each Party may, in its discretion, cause some of its obligations under this
Agreement to be performed, and permit some of its rights hereunder related to
the same to be exercised, by one or more of its Affiliates. Each Party agrees
that, without requiring evidence of assignment or delegation of authority, it
will accept performance of obligations by the other Party's Affiliate. Each
Party will accept and honour demands for performance of it's obligations
hereunder made by the other Party's Affiliate.
1.4 In the event the use of Aspect's [**] is required by D-O, and/or its
OEM-customers and/or their distributors to interface the [**] Sensor to D-O
Patient Monitors, Aspect hereby grants to D-O and its Affiliates a
non-exclusive, non-transferable, perpetual, and royalty-free worldwide license,
without the right to sublicense to use [**] provided by Aspect and [**] for
purposes of interfacing the [**] Sensor to D-O Patient Monitors and to D-O, its
Affiliates, distributors and/or sub-distributors to distribute object code
versions of [**] for use with [**]Sensors.
2
71
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
1.5 D-O shall not disclose, furnish, transfer, distribute or otherwise make
available [**] or any portion thereof in any form to any third party (other than
making the use of [**] available to purchasers of [**] Sensors and to D-O's
distributors, sub-distributors and Affiliates that are distributing the [**]
Sensors) and shall not duplicate [**] or any part thereof (other than for D-O's
internal use) except as permitted under Section 12.4 of this Agreement.
1.6 Title to and ownership of any and all proprietary rights in or related to
[**] shall at all times remain with Aspect and/or its licensor(s). Nothing in
this Agreement shall be construed as a sale of any rights [**]. All references
in this Agreement to sale, resale or purchase of the [**] Sensors or the
components thereof, or references or like effect, shall, with respect to the
[**] mean licenses or sublicenses of the [**] pursuant to this Section 1.6.
2. ESTIMATED PURCHASES
2.1 Forecasts. At least quarterly, D-O shall submit to Aspect forecasts of its
anticipated monthly requirement of the [**] Sensors for the subsequent twelve
(12) months. The purchase forecasts are not binding on D-O.The forecasts shall
be provided in good faith. Aspect shall notify D-O of its inability to supply
according to D-O's forecasts no later than five (5) weeks prior to the forecast
date of shipment and in such case shall inform D-O of the maximum amount it is
able to supply.
3. ORDERS
3.1 Parties to Sales. Unless expressly otherwise agreed, all sales under this
Agreement shall be between Aspect as seller and D-O as purchaser.
3.2 Purchase Orders. Every purchase order given by D-O ("Order") is deemed to
be a separate purchase contract under the terms of this Agreement. Aspect will
accept orders if they are placed by D-O under agreed prices and other conditions
of this Agreement to the extent orders are made within the scope described in
Section 3.3.
3.3 Order Acknowledgements. D-O Orders shall be acknowledged by Aspect within
five (5) working days after receipt of the Order, provided that the Order
conforms to this Agreement and that the requested delivery time is within the
agreed lead time and the quantity ordered does not exceed by more than [**]
percent ([**]%) the quantity of such [**] Sensors ordered in any of the three
(3) preceding months.
3.4 Cancellation Charges. In the event of the cancellation of any Order by D-O,
Aspect has the right to charge cancellation charges based on actual damages
caused to Aspect. The maximum amount of damages may not however exceed the
following charges listed below.
The cancellation charges are based on the number of days prior to scheduled
delivery date that written notice of cancellation is received by Aspect, as
outlined below:
[**] weeks prior to acknowledged delivery [**]
[**] weeks prior to acknowledged delivery [**]% of order value
[**] weeks prior to acknowledged delivery [**]% of order value
[**] weeks prior to acknowledged delivery [**]% of order value
[**] week prior to acknowledged delivery [**]% of order value
3
72
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
3.5 Lead Times. Lead Times for [**] Sensors are expected to be less than [**].
In the event raw materials unique to the [**] Sensor purchased by Aspect to meet
D-O's forecast of its anticipated requirements for [**] Sensors within the lead
time specified in this Section 3.5 are not utilized by Aspect because D-O's
actual orders are less than forecast, D-O shall reimburse Aspect for the costs
of its excess inventory up to the quantity which does not exceed the quantity
forecasted and up to the amount of the purchase price of the raw materials
provided that the seller of such raw materials does not repurchase such raw
materials from Aspect.
3.6 Orders in Excess of Forecasts. If D-O requests deliveries that exceed the
limits indicated in Section 3.3, D-O may make such additional orders of the [**]
Sensors and Aspect shall exercise reasonable commercial efforts to deliver the
[**] Sensors so ordered within the delivery time requested by D-O No contract
shall be deemed to have been entered into between Aspect and D-O unless and
until Aspect has confirmed the respective order in writing. Aspect agrees to
indicate its approval or refusal of D-O's additional purchase orders within five
(5) working days from the receipt thereof.
4. DELIVERIES
4.1 Unless expressly otherwise agreed in writing, all orders shall be delivered
by Aspect FCA Newton, Massachusetts (Incoterms 2000).
4.2 Aspect shall notify D-O of any anticipated delivery problems in advance.
4.3 In the event that delivery of a shipment is delayed by more than [**] from
the specified delivery time for causes other than force majeure (as described in
Section 14) or an act or omission on the part of D-O, D-O is [**] as follows.
The [**] shall be [**] in case there is [**] caused to D-O at [**] the purchase
price [**]. However the [**] shall [**] the purchase price. If only a part of
the [**] Sensors to be delivered as one shipment is delayed, the [**] purchase
price which is attributable to the [**] Sensors that cannot in consequence of
the delay be taken into use by D-O. If the delay in delivery is such that D-O
[**] and the [**] Sensors are still not delivered, D-O may in writing demand
delivery within a final reasonable period [**]. Such [**] shall be [**] by D-O
by [**] amounts otherwise owed to Aspect by D-O.
If Aspect does not deliver within such final period then D-O shall be entitled
to terminate the respective delivery contract and cancel all the outstanding
binding orders. In such event D-O's obligation to reimburse the amount of the
purchase price of the raw materials (as more closely specified in Section 3.5)
shall not be applied.
4.4 If [**] Sensors delivered by the Aspect do not conform to this Agreement as
to quality and D-O's order as to quantity, D-O shall be entitled to reject such
non-conforming [**] Sensors. Aspect shall within [**] weeks after notification
of the rejection, at its option and expense, either repair or replace properly
rejected [**] Sensors. Aspect shall pay all transportation charges of properly
rejected [**] Sensors. The delivery of the Products shall be considered delayed
in accordance with Section 4.3 if Aspect has not delivered the repaired or
replacement [**] Sensors and D-O has not received them (DDP Incoterms 2000) in
agreed quantities and in full conformance with this Agreement within [**] weeks
of the notification of rejection.
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4.5 The [**] Sensors shall be packed, marked and labelled by Aspect in
accordance with the reasonable instructions given by D-O. In case no
instructions have been given, the [**] Sensors shall be packed with due care to
avoid damages during shipment.
5. PRICES AND TERMS OF PAYMENT
5.1 (a) Aspect shall sell and D-O shall purchase the [**] Sensors during the
calendar year at the prices set forth in Appendix 1. The parties have agreed to
initiate at least once a year discussions on market conditions and trends as
well as [**] Sensors.
(b) In addition, the Parties will meet and discuss the [**]
(c) In the event that the [**] of the sensors sold [**] to end users in the
[**] percent ([**]%), if Aspect wished to retain the [**] obligations of D-O set
forth in Section 1.1(a), Aspect shall [**] the [**] Sensors [**].(For example,
the if [**] of the Aspect [**] and the [**] to [**], then Aspect shall [**] the
[**] Sensors by [**]). In case Aspect [**] as set forth in this Section, t[**].
(d) Aspect shall allow an independent certified public accountant engaged by
D-O to examine its records to determine compliance with Section 5.1 (c). Any
examination shall be at the expense of D-O, shall occur during regular business
hours at Aspect's offices and shall not interfere unreasonably with Aspect's
regular activities. D-O shall give Aspect at least thirty (30) days notice of
the date of each such examination and the name of the accountant who will be
conducting the examination. In case Aspect has elected to retain exclusivity as
provided in Section 5.1(c) and the audit reveals that there is any
non-compliance in the pricing, Aspect agrees change its pricing in order to
comply with this Agreement and refund any excess priced paid by D-O to Aspect
within fourteen (14) days of the date of the examination report, which details
such non-compliance. In the event the non-compliance of the pricing exceeds five
percent (5%) or more, Aspect shall pay the costs of such examination.
5.2 [**] Purchases. If the prices are given in several levels corresponding to
[**]the [**] Sensors to be purchased [**], the price level to be applied shall
be [**] given as specified in Section 2.1 multiplied [**]. If [**] D-O changes
its purchase schedule so that the amount actually purchased [**] corresponds to
another price level, any difference, whether increase or decrease, in the [**]
Sensors ordered [**] shall be calculated and compensated [**] of the [**].
A[**] costs incurred by Aspect in connection with development of the [**]
sensor, including graphic design, translation costs, costs of producing
prototype sensors, unique tooling and molds, etc.[**]Aspect's engineering costs
associated with development of [**] Sensors shall be billed at Aspect's standard
rate, currently US $[**]/hr. Aspect agrees to provide lump-sum quotations for
various alternatives. [**] is required for all NRE costs. Ongoing engineering
support requested by D-O for purposes of modifying the [**] Sensor, and for
which [**] has been provided, shall be paid [**] based on Aspect's standard
billing rates, which are currently US $[**] per hour. Aspect shall have the
right to change such rates charged [**] by no more than the average percentage
change in the wage level of the engineering support staff, but not more than
[**] percent ([**]%) per year during the term of this Agreement.
5.3 Unless expressly otherwise agreed in writing, payment for all [**] Sensors
shall be made by D-O in the currency specified in Appendix 1 by SWIFT transfer
within [**] from shipment date of the [**] Sensors to D-O's premises or such
other destination as may have been specified in the Order, provided that the
quality and quantity of the [**] Sensors delivered conforms to this Agreement
and the respective Order. Any late payments shall bear interest at the rate of
one percent (1%) per month.
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6. QUALITY ASSURANCE
6.1 Aspect shall maintain quality control procedures in compliance with the
requirements of the following quality systems ISO 9001, EN 46001, US GMP 00 XXX
000 ("xxx US GMP") and the Council Directive 93/42/EEC concerning medical
devices promulgated by the Council of the European Communities as amended ("the
MDD").
6.2 Aspect's quality assurance and test plan will be submitted to D-O for
approval. From time to time, Aspect may make changes to its test plan. Any such
changes will also be submitted to D-O for approval. D-O agrees to not
unreasonably withhold its approval. If requested by D-O, Aspect shall provide
D-O with appropriate documents evidencing that the [**] Sensors comply with the
requirements of the MDD and US GMP and any applicable product standards.
6.3 Aspect shall test or have tested for them on a sampled basis the [**]
Sensors before they are delivered to D-O to ensure that defective [**] Sensors
will not be delivered. A certificate of compliance, certifying compliance with
this Section 6.3, signed by an Aspect employee (e.g. a quality inspector) will
be supplied with each shipment. The representative of D-O may participate in
such tests. The test reports shall be kept on file for a period of [**] years
from the date of manufacture. Test reports will be provided upon request of D-O.
6.4 D-O reserves the right, by itself or through its appointed representative,
during regular business hours and following reasonable notice to Aspect, to
inspect Aspect's physical facilities and Aspect's quality control procedures in
order to assure compliance with the Specifications, quality requirements and
other applicable standards. In the event that D-O determines that the quality
procedures applied by Aspect are insufficient as to ensure consistent acceptable
quality, D-O shall specifically inform Aspect thereof Aspect agrees to undertake
any such corrective measures without delay. Aspect agrees to take all
appropriate measures in order to ensure compliance of its sub-suppliers with the
foregoing.
7. REGULATORY REQUIREMENTS
7.1.1 Aspect agrees to deliver to D-O all information reasonably required by D-O
to get and maintain regulatory approvals including but not limited to the MDD CE
marking and the US FDA 510(k) for the [**] Sensor.
7.1.2 The Parties confirm that in relation to the MDD requirements D-O shall be
regarded as manufacturer of [**] Sensors. Aspect warrants that the [**] Sensors
conform to the requirements established in the MDD and will affix, if
appropriate, the CE xxxx to all the [**] Sensors and packaging. D-O agrees that
the appropriate labelling of the [**] Sensors and the obtaining of
registrations, tests and/or approvals from relevant authorities, where
necessary, is the responsibility of D-O and will be done at D-O's cost. D-O
shall, during the term of this Agreement, keep all regulatory approvals for the
[**] Sensors in full force and effect at D-O's expense. Any act or notifications
of authorities, that might lead to cancellation or modification of such
approvals, shall be immediately communicated to Aspect in writing and the
Parties shall jointly agree on appropriate corrective measures.
7.2 D-O shall fully comply with all applicable laws and regulations of the
competent jurisdiction in the territories in which D-O will sell the [**]
Sensors. In particular, D-O shall ensure that the [**] Sensors as well as D-O's
activities in relation thereto conform to all legislation, rules, regulations
and statutory requirements existing from time to time and Aspect shall ensure
that its activities in relation to this Agreement conform to all legislation,
rules, regulations and statutory requirements existing from time to time.
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7.3 Each Party shall be responsible for record keeping under US regulations
such as 21 CFR Part 803, the European Union MDD regulations and under the record
keeping requirements of any other country as may be applicable. If required by
the laws or regulations of any country, each Party shall notify the other Party
on a quarterly basis, of complaints received relating to [**] Sensors sold by
Aspect to D-O and/or its Affiliates. If either Party becomes aware of an event
where there is reasonable suspicion that [**] Sensors contributed to or caused a
death or serious injury or an event where a [**] Sensor malfunctioned and, if
that malfunction occurred again, it could cause death or serious injury, such
Party shall use its best efforts to give such notice to the other Party orally
within twenty-four (24) hours from the receipt of such complaint or becoming
aware of such event and shall use its best efforts to confirm such notice by
telefax within twenty-four (24) hours after giving oral notice.
7.4 Each Party shall be responsible for reporting under US reporting
requirements such as 21 CFR Part 803, the European Union reporting requirements
and under the reporting requirements of any other country as may be applicable.
Before submitting a report involving [**] Sensors , the reporting Party shall
use its reasonable efforts to notify the other Party with any information
relating to any incident involving [**] Sensors. Copies of such reports shall be
sent to the other Party without delay. If FDA or other authorities contact
either Party to inquire about or investigate the [**] Sensors sold under this
Agreement, the contacted Party, unless required to maintain confidentiality by
such authorities, shall inform the other Party immediately thereof. The Parties
shall co-operate closely to clear any regulatory issues or potential regulatory
issues promptly.
7.5 Sections 7.2 to 7.4 above shall remain in effect even after the expiration
of this Agreement.
8. WARRANTY AND LIABILITY; DIVISION OF LIABILITY, RECALLS
8.1 In addition to and not in limitation of any other provisions of this
Agreement, Aspect represents and warrants that the [**] Sensors shall be
manufactured in accordance with Sections 6 and 7 above, shall be free from
defects in design, material and workmanship for the periods set forth in Section
8.3 below, and shall conform to the applicable specifications for the periods
set forth in Section 8.3 below. Aspect agrees to remedy any defect in the [**]
Sensors supplied by Aspect resulting from faulty design, materials or
workmanship or non-conformance with the specifications and quality requirements
specified in this Agreement in accordance with the provisions of this Section 8
other than defects resulting from a D-O design made by D-O.
8.2 On receiving D-O's notice of a defect covered by the provisions of this
Section 8, Aspect shall at no cost to D-O either deliver a replacement of the
defective [**] Sensors or repair or have the [**] Sensors or parts in question
repaired.
8.3 Aspect's obligation set forth in Section 8.1 shall apply only to defects
appearing within a period of [**] months from the date of manufacture of the
[**] Sensor. Aspect agrees to ship only such [**] Sensors that have a shelf life
of at least [**] months. Any repaired or replaced [**] Sensors or part thereof
shall be subject to such obligations for the greater of the remainder of the
original period specified in this Section 8.3 or [**] days.
8.4 Aspect has no obligation under this Agreement to make repairs of any [**]
Sensor or part thereof which has been subjected to any detrimental exposure, or
has been involved in an accident or has otherwise been handled or stored
improperly.
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8.5 (a) Aspect shall indemnify, defend and hold D-O, its Affiliates,
distributors, sub-distributors (collectively, the "D-O Indemnified Parties")
harmless from and against any and all liability, loss, damages, costs and
expenses (including, without limitation, reasonable attorney's fees) which such
D-O Indemnified Parties may incur, suffer or be required to pay as a result of
any property damage, injury, illness or death of any person arising out of or in
connection with the marketing, distribution, use, sale or lease by the D-O
Indemnified Parties of any Aspect Products to the extent any such claim relates
to (i) the design (to the extent that the design was not provided by D-O),
manufacture or use of such Aspect Product (including any component thereof), or
(ii) the failure of such Aspect Product to comply with applicable product
specifications or other similar information provided to D-O by Aspect, or (iii)
any incorrect or inadequate warning labels or instructions that are or should be
incorporated into or accompany (or should accompany) such Aspect Product, or (v)
any failure by Aspect to provide correct and adequate warning labels or
instructions relating to the use, handling or function of such Aspect Product.
D-O shall provide Aspect with prompt written notice of any such claim or claims.
Upon receipt of Aspect's acknowledgement of its obligation to indemnify, defend
and hold harmless the D-O Indemnified Parties against any such claim, D-O shall
permit Aspect to assume the defence of such claim or claims and shall provide to
Aspect, at Aspect's expense, such information and assistance as Aspect may
reasonably require with respect to such claim; provided that Aspect shall not
consent to any injunction against D-O or any other D-O Indemnified Party other
than an injunction prohibiting the manufacture and/or sale of the applicable
Aspect Product without first obtaining D-O's prior written consent, which
consent shall not be unreasonably withheld or delayed; and provided further that
in no event shall Aspect without prior written consent of D-O, settle any claim
against any D-O Indemnified Party or consent to the entry of any judgment (1)
that contains any admission by or finding against such D-O Indemnified Party
other than an agreement to discontinue the manufacture and/or sale of the
applicable Aspect Product, (2) that includes any relief to the claimant to be
provided by D-O other than monetary relief to be paid in full by Aspect, or (3)
that does not include as an unconditional term thereof the giving by the
plaintiff or claimant to such D-O Indemnified Party a release from all liability
in respect of such claim. Should D-O desire to have its own counsel participate
in any such action, the cost of such counsel shall be exclusively D-O's. In the
event that D-O, its Affiliates and distributors cannot continue the distribution
of the applicable Aspect Product due to an injunction or an agreement to
discontinue the manufacture and/or sale of the applicable Aspect Product, Aspect
shall accept return of such Aspect Products from D-O, its Affiliates and
distributors and refund the amounts paid to Aspect for such returned Aspect
Products. If it is determined that a claim for which Aspect has defended and
indemnified D-O was the result of the misuse of the Aspect Product or the use of
the Aspect Product in a manner or for a purpose that is contrary to the
regulatory approval obtained for such Aspect Product, then D-O shall reimburse
Aspect for [**] the out-of-pocket costs and expenses incurred by Aspect in
connection with such defense and indemnification. Liability under this Section
8.5 shall be in proportion to each Party's contribution to the acts that gave
rise to the liability.
(b) D-O shall indemnify, defend and hold Aspect harmless from and against any
and all liability, loss, damages, costs and expenses which Aspect may incur,
suffer or be required to pay by reason of the D-O Patient Monitors (other than
any [**] Sensors) which results in property damage and/or injury, illness or
death of any person if it is established that such property damage and/or
injury, illness or death resulted solely from a defect or alleged defect in any
design of the [**] Sensors made by D-O or in any D-O Patient Monitors or
components (including D-O Patient Monitor's or component's defective or
insufficient user's instructions, packing, labels or markings and including an
omission and/or negligence of D-O to perform any act which, as between Aspect
and D-O was primarily D-O's responsibility) in which any Aspect Product is
incorporated to the extent any such claim does not relate to any matter for
which Aspect is obligated to provide indemnification under Section 8.5(a) and
provided further that Aspect shall inform D-O thereof as soon as it learns of
any such property
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damage and/or injury, illness or death and shall provide D-O reasonable
assistance at D-O's cost and shall give D-O the sole control over the defense
and settlement of any such claim or claims. Such liability shall be in
proportion of each party's contribution to the acts that gave rise to the
liability.
8.6 Each Party shall maintain at its cost with a reputable and financially
secure insurance company a general third party liability and products liability
insurance in an amount as each Party considers to be reasonable. Each Party
shall maintain the said insurance for the entire lifetime of the [**] Sensors
and D-O Patient Monitors. At a Party's request, the the other Party shall
furnish certificates of insurance evidencing such coverage and providing that
said insurance will not be materially decreased, altered or cancelled without
giving the other party no less than thirty (30) days written notice thereof.
8.7 Aspect shall maintain serial and/or lot number and date of shipment records
for all [**] Sensors and D-O shall maintain serial and/or lot number and date of
shipment records for all [**] Sensors shipped to end users so that, if necessary
for tracing or recall purposes, the manufacturing and delivery of the [**]
Sensors can be identified. Each Party shall give its assistance to the other
Party in tracing or recall situations by making the records available. Each
Party shall promptly make such records available to the other Party if any
authority in any country requests such records from such Party.
8.8 In the event that a corrective action (including notifications or recalls)
is required with respect to any of the [**] Sensors sold to D-O's customer or an
end user that have been incorporated in any of the customer's products and
distributed by the customer, and such action (i) is required by Aspect to comply
with applicable laws or regulations, (ii) is determined by Aspect in its
discretion for a reasonable business purpose or for safety reasons or (iii) is
the result of Aspect's failure to supply [**] Sensors that (a) conform in all
material respects to the applicable standards or (b) are free from defect in
material and workmanship (when given normal, proper and intended usage) other
than defects resulting from a design made by D-O, Aspect shall be [**] Aspect
agrees to consult with D-O to establish a reasonable process for managing the
corrective action and Aspect shall be responsible for all reasonable
out-of-pocket expenditure (including shipping and labor costs) incurred by D-O,
its Affiliates, distributors and subdistributors if Aspect fails to take such
action. In the event that Aspect is required to take such action to comply with
applicable laws or regulations or such action is reasonably necessary as
determined by D-O in good faith for safety reasons and for the failure of the
[**] Sensors to comply with specifications (other than a minor deviation from
such specifications) and fails to do so, D-O shall have the right to take such
action and Aspect shall [**] in connection with such action by D-O. If it is
determined by an arbitrator that such action was not necessary for safety
reasons and for the failure of the [**] Sensors to comply with specifications
(other than a minor deviation from such specifications), D-O shall [**] in
connection with such action.
EXCEPT AS PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER
REPRESENTATIONS OR WARRANTIES CONCERNING THE USE AND/OR FUNCTIONALITY OF THE
ASPECT PRODUCTS OR D-O PATIENT MONITOR AND EACH PARTY HEREBY DISCLAIMS ALL OTHER
REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE ASPECT
PRODUCTS OR D-O PATIENT MONITORS, INCLUDING BUT NOT LIMITED TO THE IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT.
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9. TRADEMARKS AND OTHER INTELLECTUAL PROPERTY RIGHTS
9.1 Neither Party shall use or refer to the other Party's name or trademarks in
any other form or manner or for any other purpose than what is expressly allowed
in this Agreement. All artwork, packages and labels (if any) prepared by either
Party in connection with the other Party's name shall be sent to the other Party
for approval.
9.2 Neither Party shall be entitled to acquire or retain for its own use any
trademarks or trade names owned or generally used by the other Party or any
confusingly similar trademarks or names.
9.3 (a) Aspect represents that (i) it has not been determined to be infringing
any patents or other rights with respect to any Aspect Products (including any
component thereof) and (ii) no person has asserted that the use, manufacture or
sale of any Aspect Products (including any components thereof) anywhere in the
world infringes any patent or other proprietary right of such person. Aspect
shall indemnify, defend and hold harmless the D-O Indemnified Parties against
any suit or proceeding, including any costs, damages liabilities and expenses
(including, without limitation, reasonable attorney's fees) in connection
therewith, brought against such parties arising out of or relating to any
infringement or claim of infringement of patents, trademarks, copyrights, or
trade secrets by (i) any Aspect Products (including any component thereof), (ii)
any portion of any labeling affixed to any Aspect Products, (iii) any operating
manuals, instructions for use or packaging for software used in connection with
any Aspect Products that accompany such products when shipped. D-O shall provide
Aspect with prompt written notice of such claim and also of any suit brought in
connection therewith. Upon receipt of Aspect's acknowledgement of its obligation
to indemnify, defend and hold harmless the D-O Indemnified Parties against any
such claim, Aspect shall be given the right by D-O to defend and/or settle the
same, provided, however that in no event shall Aspect without prior written
consent of D-O, settle any such claim or consent to the entry of any judgment
against D-O (1) that contains any admission by or finding against such D-O
Indemnified Party other than an agreement to discontinue the manufacture, use
and/or sale of the applicable Aspect Product, (2) that includes any relief to
the claimant to be provided by D-O other than monetary relief to be paid in full
by Aspect, or (3) that does not include as an unconditional term thereof the
giving by the plaintiff or claimant to such D-O Indemnified Party a release from
all liability in respect of such claim. Should D-O desire to have its own
counsel participate in any such action, the cost of such counsel shall be
exclusively D-O's.
In the event that Aspect determines that it is likely that such Aspect Products
will be found to be infringing products or if the manufacture, use or sale of
such Aspect Products is enjoined, Aspect shall, at its expense, replace such
Aspect Products with noninfringing products of compatible functionality,
specification and use, modify such Aspect Products to make them noninfringing
(while maintaining compatible functionality, specification and use) or obtain
right for D-O to continue to use and sell such Aspect Products. In the event
that none of the foregoing alternatives are reasonably available to Aspect,
Aspect shall accept the return of any infringing Aspect Products (and, at D-O's
election (which election shall not serve to disclaim or waive any other rights
or remedies available to D-O), Aspect shall repay to D-O, or shall provide an
appropriate credit to the account of D-O for, all amounts paid by D-O to Aspect
in respect of such returned products) and, in addition to any and all other
remedies available to D-O, Aspect shall reimburse D-O for any amounts returned
by D-O to customers of such infringing Aspect Product up to any amounts paid to
Aspect therefor.
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The obligations set forth herein shall continue even after the expiration of
this Agreement. Aspect shall have no liability or obligation to D-O Indemnified
Parties hereunder with respect to any patent, copyright, trade secret or other
intellectual property infringement, misappropriation or claim thereof based upon
(i) use of the [**] Sensors by D-O in combination with products or software not
specified or provided by Aspect (only to the extent D-O has done so without
Aspect's written consent), (ii) modifications, alterations or enhancements of
the [**] Sensors not created by or for Aspect, (iii) the use of the [**] Sensors
by D-O (or other D-O Indemnified Party) in a manner or for a purpose not
specified in the Aspect documentation furnished to D-O where such claim would
not have occurred but for such misuse or use, (iv) a design made by D-O, or (v)
Aspect's conformance with the written instructions or specifications of D-O.
Aspect shall notify D-O if it believes that any use of the Aspect Products in
combination with products or software not specified or provided by Aspect, is
likely to result in a claim of infringement or misappropriation.
(b) D-O represents that (i) it has not been determined to be infringing any
patents or other rights with respect to any components of the D-O Patient
Monitors (the "D-O Components") and (ii) no person has asserted that D-O's
manufacture or sale of the D-O Components anywhere in the world infringes any
patent or other proprietary right of such person. D-O shall defend and hold
harmless Aspect against any suit or proceeding brought against Aspect based on a
claim that the D-O Components or any part thereof or any aspect of the [**]
Sensors designed by D-O constitutes an infringement of any patent or other
proprietary right of a third party and against any costs and damages in
connection therewith provided that upon any such claim being made against
Aspect, D-O shall be notified promptly of such claim and also of any suit
brought in connection therewith and shall have the sole right to defend and/or
settle the same. The obligations set forth herein shall continue even after the
expiration of this Agreement. D-O shall have no liability or obligation to
Aspect hereunder with respect to any patent, copyright, trade secret or other
intellectual property infringement, misappropriation or claim thereof based upon
modifications, alterations or enhancements of the D-O Components or [**] Sensors
not created by or for D-O or for other intellectual property infringement,
misappropriation or claim arising out of or relating to any infringement or
claim of infringement of patents, trademarks, copyrights, or trade secrets by
(i) any Aspect Products (including any component thereof but excluding the
design made by D-O regarding the [**] Sensors), (ii) any portion of any labeling
affixed to any Aspect Products, (iii) any operating manuals, instructions for
use or packaging for software, if any, used in connection with any Aspect
Products that accompany such products when shipped.
10. TOOLS AND MOULDS
10.1 Any equipment and tools provided or paid for by D-O and used in the
manufacture of the Aspect Products shall remain the property of D-O. Such
equipment or any equipment which D-O has designed or which has been designed for
D-O for its purposes and paid for by D-O, may not be used for the manufacture of
any other products supplied to anyone else but D-O.
10.2 Aspect shall service and maintain the equipment and tools as necessary for
their proper functioning at D-O's expense after receiving D-O's prior written
approval.
10.3 Aspect shall store the equipment and tools owned by D-O properly and xxxx
them as D-O's property.
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Exchange Commission. Asterisks denote omissions.
11. TRADE SECRETS; CONFIDENTIALITY
11.1 This Agreement and all documents, drawings, manuals and other materials
related thereto and transmitted between the Parties shall be treated as
confidential by the Parties and their employees and such information shall not
be disclosed to any third party. Each Party shall arrange proper filing for
specifications and drawings given by the other Party. Any drawings or
specifications and all copies thereof shall be returned to the supplying Party
after the supplying Party has provided new replacement specifications or
drawings. Each Party shall nominate a person in its organization who shall be in
charge of the filing and shall inform this person of the confidentiality
requirements of this Agreement.
11.2 Within fourteen (14) days after termination of this Agreement the each
Party shall return all specifications and drawings of the other Party and all
copies thereof (in any media) unless a Party is required to retain such material
under applicable laws or regulations. All information consisting of documents,
notes and other writings prepared by one Party based on non-public data of the
other Party shall be destroyed.
11.3 Each Party shall not, and each Party shall ensure that its officers and
employees will not, whether during the term or after the termination of this
Agreement, use any non-public information relating to the other Party or any of
its Affiliates or their products, technology, designs or tools for other
purposes than the fulfilment of such Party's obligations hereunder.
11.4 Aspect shall not during the term of this Agreement or thereafter sell to
third parties any products that are manufactured in accordance with proprietary
technical specifications, technology, designs or tools provided by D-O.
11.5 In case of unauthorised use by either Party, its Affiliates or employees
of the such non-public technologies, designs or tools of the other Party, the
receiving Party shall be obliged to compensate any costs, damages and losses
incurred by the disclosing Party due to such unauthorised use.
11.6 The obligations set forth in this Section 11 shall continue even after the
expiration of this Agreement.
12. TERM AND TERMINATION
12.1 This Agreement is effective from the date on which the Parties have signed
this Agreement ("the Effective Date"). Unless earlier terminated pursuant to
other terms hereof, this Agreement shall remain in effect until December 31,
2005 (the "Initial Term"). Thereafter unless terminated by either Party with at
least [**] notice prior to said expiration date, this Agreement shall
automatically renew itself for successive one year terms (the "Renewal Term"),
provided that either Party may terminate this Agreement effective at the end of
the current term by giving notice to the other Party at least [**] before the
scheduled expiration date.
12.2 This Agreement may be terminated at any time without prior notice in case
of a breach or failure by a Party to perform any of the obligations set forth in
this Agreement, which breach or failure shall not have been remedied by the
Party within a period of [**] from the date of the written notice thereof by the
other Party. Aspect shall also have the right to terminate this Agreement in the
event that D-O does not purchase [**] percent ([**]%) of its annual volume of
[**] Sensors from Aspect upon [**] prior written notice to D-O.
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12.3 Neither Party shall by reason of the termination or expiration of this
Agreement in accordance with its terms be liable to the other Party for
compensation, reimbursement or damages on account of lost prospective profits or
anticipated sales, or on account of expenditures, investments, leaves or
commitments by the other Party or on any other account.
12.4 Upon expiration of this Agreement or a termination for any reason other
than on the grounds of an uncured breach or failure by D-O as provided in
Section 12.2, Aspect hereby grants to D-O, its Affiliates, distributors or
sub-distributors a non-exclusive, non-transferable (except as provided in
Section 15.9), perpetual, irrevocable and royalty-free worldwide license,
without the right to sublicense, (a) to use [**] provided by Aspect solely for
purposes of manufacturing or having manufactured sensors to be used to [**] or
[**] and distributing object code versions of [**] for use with such sensor.
Further upon termination or expiration of this Agreement, Aspect hereby grants
to D-O and its Affiliates a non-exclusive, non-transferable (except as provided
in Section 15.9), perpetual, irrevocable and royalty-free worldwide license,
without the right to sublicense, to manufacture, have manufactured or purchase
Sensor Connectors and/or Cable Connectors to be used with the [**] Sensor and
the right for D-O, its Affiliates, distributors and sub-distributors the right
to sell, market and distribute these products.
13. APPLICABLE LAW AND DISPUTE RESOLUTION
13.1 This Agreement and the Orders and acknowledgements of Orders thereunder
are to be construed, governed by and interpreted in accordance with the laws of
the Netherlands.
13.2 Prior to taking any action as provided in Section 13.3 below, the parties
shall attempt to resolve any claim or controversy arising out of this Agreement
by way of amicable negotiations within a reasonable period not to exceed [**]
after the date of a notice from either party to the other describing such claim
or controversy.
13.3 All disputes arising out of or relating to this Agreement shall be finally
resolved by arbitration by one arbitrator conducted in the English language in
the Netherlands under the commercial arbitration rules of the United Nations
Commission on International Trade Law. The arbitrator shall be appointed by the
Netherlands Arbitration Institute, Rotterdam. The arbitration costs will be
decided by the arbitrator. Notwithstanding anything contained in this Section to
the contrary, each party shall have the right to institute judicial proceedings
against the other party or anyone acting by, through or under such other party,
in order to enforce the instituting party's rights hereunder through reformation
of contract, specific performance, injunction or similar equitable relief.
13.4 Judgment upon the award rendered may be entered in any Court having
jurisdiction or application may be made to such Court for a judicial acceptance
of the award and an order of enforcement, as the case may be.
13.5 Notwithstanding the aforesaid, any dispute regarding a Party's need to
protect or enforce any patent, trademark, copyright or other intellectual
property right, confidential information or trade secrets, or as part of
litigation commenced by a third party shall allow the Party to undertake legal
proceedings in the Court of a Party's domicile, main place of business or other
appropriate Court.
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14. FORCE MAJEURE
14.1 Either Party shall be entitled to suspend performance of its obligations
under this Agreement to the extent that such performance is impeded or made
unreasonably onerous by any of the following circumstances: industrial disputes
and any other circumstance beyond the control of the Parties such as fire, war
(whether declared or not), extensive military mobilisation, insurrection,
requisition, seizure, embargo, and delays in deliveries by sub-suppliers caused
by force majeure.
14.2 The Parties shall without delay notify each other of any occurrence of
force majeure and the discontinuance thereof.
14.3 Regardless of any other provision in this Agreement to the contrary,
either Party shall be entitled to terminate a purchase contract under this
Agreement by notice in writing to the other Party if performance of the contract
is suspended under Section 14.1 above for more than six months.
15. GENERAL PROVISIONS
15.1 Entire Agreement. As of the Effective Date, this Agreement cancels all
prior agreements and represents the entire agreement between the Parties
relating to the subject matter thereof. It supersedes any and all promises,
representations, warranties and other statements, whether written or oral, made
by or on behalf of either Party to the other Party relating to the subject
matter of this Agreement. This Agreement may be amended or varied only by an
expressly written instrument signed by duly authorised representatives of both
Parties.
15.2 Waivers. The temporary, limited or specific waiver of any term, provision
or condition of this Agreement shall not be considered a waiver of any other
term, condition or provision thereof, nor of any subsequent breach of the same
term, condition or provision.
15.3 Unenforceability. If any of the provisions of this Agreement shall be
declared illegal or unenforceable by any Court of competent jurisdiction, the
validity of the remaining provisions shall not be affected thereby, and the
Parties agree to do all things and co-operate in all ways open to them to obtain
substantially the same results, or as much thereof as may be possible, including
the amendment or alteration of this Agreement.
15.4 Notices. Any notice and other communication under this Agreement shall be
in writing and shall be deemed to have been duly given (i) upon personal
delivery; or (ii) on the date of sending by telefax at the address set forth on
the first page of this Agreement; or (iii) upon receipt if mailed, first class
and certified or registered mail, postage prepaid, addressed to the Party for
whom they are intended. Such addresses may be changed by notice to the other
Party given in the above manner.
15.5 LIMITATION OF LIABILITY. EXCEPT AS PROVIDED IN SECTION 8.5 AND 9.3, EACH
PARTY'S LIABILITY ARISING OUT OF THE MANUFACTURE, SALE OR SUPPLYING OF [**]
SENSORS OR THEIR USE OR DISPOSITION, WHETHER BASED UPON WARRANTY, CONTRACT, TORT
OR OTHERWISE, SHALL NOT EXCEED FIVE MILLION U.S. DOLLARS ($5,000,000). EXCEPT AS
PROVIDED IN SECTIONS 8.5 AND 9.3 OF THIS AGREEMENT, THE PARTIES SHALL NOT BE
LIABLE TO EACH OTHER FOR SPECIAL, CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT
DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFIT OR REVENUES OR COST OF
CAPITAL.
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Exchange Commission. Asterisks denote omissions.
15.6 Publicity. Neither Party shall originate any publicity, news release or
other public announcement relating to this Agreement or the existence of an
arrangement between the Parties without the prior written approval of the other
Party, except as otherwise required by law.
15.7 No Agency. Nothing contained in this Agreement shall be deemed to
constitute either Party as the agent or representative of the other Party, or
both Parties as joint venturers or partners for any purpose. Neither Party shall
be responsible for the acts or omissions of the other Party, and neither Party
shall have authority to speak for, represent or obligate the other Party in any
way without prior written authority from the other Party.
15.8 Survival of Obligations. Unless otherwise stated in this Agreement all
obligations of either Party under (Warranty and Liability; Division of
Liability, Recalls (Section 8)), (Regulatory Requirements (Section 7)),
(Trademark and Other Intellectual Property Rights (Section 9)), (Trade Secrets;
Confidentiality (Section 11)), (Limitation of Liability (Clause 15.5)),
(Applicable Law and Dispute Resolution (Section 13)) and Sections 1.1 (b) and
12.4 shall survive the expiration or termination of this Agreement and continue
to be enforceable.
15.9 Assignment. Except in connection with the sale of all or substantially all
of the assets, stock or business of a Party to which this Agreement relates,
neither Party may assign, transfer or sublicense any of the rights or
obligations under this Agreement without the prior written consent of the other
Party, which consent shall not be unreasonably withheld or delayed; provided,
however, that [**] of one Party is acquiring the other Party, [**]. Otherwise,
this Agreement transfers with the sale of all or substantially all of the
assets, stock, or business of a Party to which this Agreement relates. Either
Party may assign this Agreement to an Affiliate (collectively the "Permitted
Assignees"). Assignment to a Permitted Assignee shall not relieve the assigning
Party of its responsibility for its obligations of this Agreement. An assignment
for purposes of this provision shall include any transaction, including but not
limited to, any merger, consolidation or purchase of stock that results in a
third party that is not a Permitted Assignee Controlling directly or indirectly,
a Party to this Agreement. This Agreement will [**] For the purpose of this
provision [**] No sale, assignment or other transfer of any rights or
obligations of a Party hereunder shall be effective unless the purchaser,
assignee or transferee assumes such Party's obligations under this Agreement.
15.10 Order of Interpretation. The Parties agree to be bound by this Agreement.
The Appendices 1 to 2 attached hereto form part of and shall be deemed to be
incorporated in this Agreement. In case of any conflict or inconsistency between
this present document and its Appendices, this present document shall prevail.
All references to the Agreement shall be interpreted to include its Appendices.
15.11 Headings. Captions and headings contained in this Agreement have been
included for ease of reference and convenience and shall not be considered in
interpreting or construing this Agreement.
15.12 Export. D-O shall not export, or instruct or authorize any third party to
export, [**] Sensors or other products, information or materials provided by
Aspect hereunder, to any country for which the United States requires any export
license or other governmental approval at the time of export without first
obtaining such license or approval. It shall be D-O's responsibility to comply
with the latest United States export regulations.
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Exchange Commission. Asterisks denote omissions.
This Agreement shall be executed in two counterparts, each of which shall be
deemed an original for all purposes. A signed copy of the Agreement transmitted
by facsimile shall be deemed for all purposes the equivalent of a signed
original.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorised representatives on _________________ ____, 2000.
DATEX-OHMEDA DIVISION, ASPECT MEDICAL SYSTEMS INC.
INSTRUMENTARIUM CORPORATION
/s/ Hannu Anjopals /s/ X. Xxxxxxxxxxxx Eagle
------------------------------- ---------------------------------
Name: Hannu Anjopals Name: X.X. Eagle
Title: Title: Chairman
/s/ Xxxxxx Xxxxxxx
-------------------------------
Name: Xxxxxx Xxxxxxx
Title: Group Treasurer
APPENDICES:
1. [**] Sensors: Price List
2. Aspect BIS Sensor [**] specifications
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Exchange Commission. Asterisks denote omissions.
Appendix 1
[**] SENSORS: PRICE LIST
[**] Sensor Pricing (assumes that the [**] Sensor is [**]; specifications for
Aspect's [**]Sensor [**] are included in Appendix 2)
--------------------------------------------------------------------------------
[**] Price to D-O
--------------------------------------------------------------------------------
[**] $[**]
--------------------------------------------------------------------------------
[**] $[**]
--------------------------------------------------------------------------------
[**] $[**]
--------------------------------------------------------------------------------
[**] $[**]
--------------------------------------------------------------------------------
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Appendix 2
ASPECT BIS SENSOR [**] SPECIFICATIONS
TECHNICAL SPECIFICATION
[drawing of sensor]
Overview:
The Sensor [**] is a single patient use disposable pre-gelled electrode array
that is applied directly to the patient's forehead and temple to be used in
conjunction with Bispectral Index(TM) monitors. The Sensor [**] is designed to
provide ease of use and electrode placement accuracy. It collects EEG signals
from the forehead and the temple areas.
The Sensor [**] contains Aspect's ZipPrep(TM) technology, [**]. This patented
technology [**]The Sensor [**] connects to the monitor via a single connector
that is low profile and easy to insert and remove. The Sensor [**] contains an
[**] device (module) that stores information concerning sensor:
[ ] LOT #
[ ] Expiration Date
[ ] BIS Configuration (Sensor Type)
[ ] Sensor Integrity/Validation
Intended Use: To be used in conjunction with the BIS Monitoring
System
Single patient use device: Disposable.
Adult patient use
Rx Only
Length of Use (Duration): [**]
[**]:
The [**] is a self-contained integrated circuit that contains digital
information about the sensor. It utilizes [**] that helps prevent tampering.
Shelf life [**]
Shipping Temperature [**]
Operating Temperature [**]
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OEM - PURCHASE AGREEMENT
FOR ASPECT BIS TECHNOLOGY
This Agreement is made between Datex-Ohmeda Division, Instrumentarium
Corporation, with offices at Xxxxxxxxxxxxxx 0, XXX-00000 Xxxxx-Xxxxxx, Xxxxxxx,
fax no x000 00 000 0000 (hereinafter referred to as "D-O"), and Aspect Medical
Systems Inc, with offices at 000 Xxxxxxx Xxxxxx, Xxxxxx, XX 00000, XXX fax no
x0000 000 0000 (hereinafter referred to as "Aspect") (D-O and Aspect each being
a "Party", and collectively the "Parties"). The Parties hereby agree as follows:
0. DEFINITIONS.
"A-2000" means Aspect's stand-alone BIS monitor for use with the Aspect BIS
Sensor and that generates Aspect's Bispectral Index.
"Affiliate" shall mean, with respect to any specified party, any other legal
entity that directly or indirectly controls, is controlled by or is under common
control with, such specified party.
"Aspect BIS Engine" is the processing unit for deriving the BIS from the raw EEG
signal.
"DSC Cable" is a cable used to connect the DSC-3 to the Aspect BIS Engine.
"Digital Signal Converter-3" (or "DSC-3") is used to amplify the analog EEG
signals as acquired by the BIS sensors and convert it from analog to digital
signals. The DSC-3 is used by D-O BIS Module customers to obtain the BIS.
"Aspect BIS Module Kit" means the bundle of all components of the D-O BIS Module
that are developed and manufactured by Aspect and licensed/sold to D-O under
this Agreement, namely DSC-3, DSC Cable, the Software and Aspect BIS Engine.
"Aspect's Bispectral Index" or "BIS" is Aspect's proprietary processed EEG
parameter that measures the hypnotic effects of anesthetic and sedative agents
on the brain during surgery.
"Aspect Products" means the Aspect BIS Module Kit and any other product that can
be ordered by D-O as listed in Appendix 1 (Aspect Products and Purchase Prices).
"BIS Sensor" means a single use disposable sensor manufactured by Aspect for use
with the A-2000 or with the Aspect BIS Module Kit and that is required to
generate Aspect's Bispectral Index.
"D-O Patient Monitors" means any multi-parameter patient monitoring system
manufactured by or for D-O that displays BIS and certain EEG data (waveforms,
numerics, status info), and provides setup and operation information (user
interface), alarming, and network connectivity.
"D-O BIS Module" is the sum of all components involved in integrating the BIS
with D-O Patient Monitors.
"Software" means the software which is included in the Aspect BIS Module Kit.
For the avoidance of doubt all provisions which apply to Aspect BIS Module Kit
shall apply to the Software provided that any reference to a "sale" of the
Software shall be interpreted as a license of the Software.
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1. PURCHASE AND SALE OBLIGATIONS; LICENSES
1.1 For the term of this Agreement, subject to the terms and conditions of this
Agreement, Aspect agrees to sell and D-O agrees to purchase the Aspect Products
listed in Appendix 1 (Aspect Products and Purchase Prices).
The components of the Aspect BIS Module Kits purchased from Aspect under this
Agreement shall only be used as components in, incorporated into, or integrated
with, systems and products of D-O which D-O, its Affiliates, distributors or
sub-distributors sell or lease to third-party users in the regular course of
business. The principal purpose of the parties is that the components of the
Aspect BIS Module Kits shall only be resold, leased, rented, licensed or
otherwise transferred to third parties for use as a part of a D-O BIS Module or
as replacement parts used in D-O BIS Modules. D-O , its Affiliates, distributors
or sub-distributors shall only sell Aspect approved accessories including cables
and sensor products in connection with any D-O BIS Module. Aspect agrees to
provide D-O with all information in its possession that is necessary for the
interfacing of the Aspect BIS Module Kits with D-O BIS Modules.
1.2 Subject to the terms of this Agreement, Aspect shall supply to D-O only
such Aspect Products that conform to technical specifications defined in
Appendix 2 hereto. Aspect is aware that the Aspect Products are used as a part
of or in connection with medical devices and that D-O has high quality demands
for any products it purchases. Aspect responsibilities for maintaining quality
control and quality of Aspect Products are specified in Section 6 hereof.
1.3 Aspect shall notify D-O in writing of all planned changes in the Aspect
Products if said changes could have an effect on the specification, form, fit or
function of the Aspect Products or to its interfacing to D-O Patient Monitors.
1.4 [**] before implementation of any changes to the Aspect BIS Module Kit
described in Section 1.3 [**] taken by Aspect pursuant to [**] which case Aspect
shall have the right to make such change without the consent of D-O, however
Aspect shall notify D-O thereof in advance. If Aspect proposes to improve or
modify the Aspect BIS Module Kit, it shall give at least 90 days prior written
notice to D-O. If D-O gives its consent to the proposed modification, the
modified Aspect BIS Module Kit shall replace the prior version of the Aspect BIS
Module Kit and the terms and conditions of this Agreement shall continue to
apply. D-O agrees not to unreasonably withhold its approval of any such changes.
If the modified Aspect BIS Module Kit is not acceptable to D-O, D-O shall have
the right to place a final order for Aspect BIS Module Kits required by D-O.
Aspect shall use its reasonable efforts to deliver the Aspect BIS Module Kits so
ordered, however the delivery times regarding such final order shall be agreed
separately between the Parties.
1.5 If Aspect plans to remove any of the Aspect Products from its product line,
it shall notify D-O about the intended removal in writing [**]. Before the
expiration of the [**] D-O shall have the right to place a final order for the
applicable Aspect Products required by D-O. Aspect shall use its reasonable
efforts to deliver the Aspect Products so ordered, however the delivery times
regarding such final order shall be agreed separately between the Parties.
1.6 Aspect guarantees that either compatible spare parts or compatible
replacement products will be available on reasonable commercial terms for a
period of at least [**] from the delivery by Aspect of the Aspect Product in
question.
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Exchange Commission. Asterisks denote omissions.
1.7 Each Party may, in its discretion, cause some of its obligations under this
Agreement to be performed, and permit some of its rights hereunder related to
the same to be exercised, by one or more of its Affiliates. Each Party agrees
that, without requiring evidence of assignment or delegation of authority, it
will accept performance of obligations by the other Party's's Affiliate. Each
Party will accept and honour demands for performance of it's obligations
hereunder made by the other Party's Affiliate.
1.8 Subject to the terms and conditions of this Agreement, Aspect agrees to
sell to D-O, on a non-exclusive basis, Aspect BIS Sensors for resale outside
North America. The principal purpose of the parties regarding the above
mentioned distribution is that D-O, its Affiliates, distributors or
sub-distributors supply Aspect BIS Sensors to end-user customers that have
acquired D-O BIS Modules or Aspect stand-alone monitors from D-O, its
Affiliates, distributors or sub-distributors. D-O shall not actively market the
Aspect BIS Sensors to any other customers. However, regarding effects in the
EU/EEA, nothing in this Agreement is meant or shall be deemed to prevent,
restrict or distort competition or to restrict parallel imports or otherwise be
in conflict with the EU-laws. Prices for Aspect BIS Sensors purchased by D-O
hereunder shall be as set forth in Appendix 1 (Aspect Products and Purchase
Prices). Aspect [**], that the [**] for the Aspect BIS Sensors from time to time
during the term of this Agreement are [**] under similar terms and conditions.
(For example, if another company has invested in Aspect, has funded research and
development or has guaranteed minimum purchases, Aspect shall have the [**]
terms.)
1.9
1.9.1 Aspect hereby grants to D-O, its Affiliates, distributors or
sub-distributors a non-exclusive and non-transferable worldwide license, without
the right to sublicense (except to purchasers of D-O BIS Modules), during the
term of this Agreement to use the Software provided by Aspect solely in
connection with operation of the components of Aspect BIS Module Kit in the D-O
BIS Module.
1.9.2 After the termination or expiration of this Agreement, Aspect grants to
D-O, its Affiliates, distributors or sub-distributors a right to use the
Software used in conjunction with the D-O BIS Modules being sold by D-O, its
Affiliates, distributors or sub-distributors on the date of termination with
respect to service and support of installed D-O BIS Modules, after termination
of the Agreement and a right to distribute the Software as part of Aspect BIS
Module Kits in its inventory following termination of this Agreement on grounds
other than a non-payment without a valid reason by D-O. All rights granted to
D-O's, its Affiliates', distributors' or sub-distributors' customers to use the
Software with the D-O BIS Modules shall survive any termination of this
Agreement as long as such customers remain in compliance with the documentation
supplied by Aspect to D-O for such Aspect Products. Aspect agrees to co-operate
with D-O, its Affiliates, distributors or sub-distributors at D-O's, its
Affiliates', distributors' or sub-distributors' cost in order for D-O, its
Affiliates, distributors or sub-distributors to be able to fulfil their
commitments towards the customers regarding the Aspect Products after the
termination of this Agreement.
1.9.3 D-O shall not disclose, furnish, transfer, distribute or otherwise make
available the Software or any portion thereof in any form to any third party
(other than to purchasers of D-O BIS Modules and to D-O<180>s distributors
sub-distributors and Affiliates that are distributing the Aspect BIS Module
Kits) and shall not duplicate the Software or any part thereof (other than for
D-O's internal use).
1.9.4 Title to and ownership of any and all proprietary rights in or related to
the Software thereof shall at all times remain with Aspect or its licensor(s).
Nothing in this Agreement shall be construed as a sale of any rights in the
Software. All references in this Agreement to sale, resale or purchase of the
Aspect BIS Module Kits or the components thereof, or references or like effect,
shall, with respect to the Software mean licenses or sublicenses of the Software
pursuant to this Section 1.9.
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Exchange Commission. Asterisks denote omissions.
1.9.5 D-O, its distributors, sub-distributors, its Affiliates and purchasers of
D-O BIS Modules shall not disassemble, decompile or otherwise reverse engineer
the Software or any part thereof, except if Aspect is required under applicable
law to permit D-O or purchasers of D-O BIS Modules to reverse engineer any
Software. In such event, D-O, its Affiliates, distributors, sub-distributors and
purchasers of D-O BIS Modules, as applicable, may reverse engineer the Software
but only to the extent Aspect is required to permit such reverse engineering.
D-O shall retain and shall not alter or obscure any notices, markings or other
insignia which are affixed to the Software or any part thereof at the time it
receives such Software.
2. ESTIMATED PURCHASES
Forecasts. At least quarterly, D-O shall submit to Aspect forecasts of its
anticipated monthly requirement of the Aspect Products for the subsequent twelve
(12) months. The purchase forecasts are not binding on D-O. The forecasts shall
be provided in good faith. Aspect shall notify D-O of its inability to supply
according to D-O's forecasts no later than five (5) weeks prior to the forecast
date of shipment and in such case shall inform D-O of the maximum amount it is
able to supply.
3. ORDERS
3.1 Parties to Sales. Unless expressly otherwise agreed, all sales under this
Agreement shall be between Aspect as seller and D-O as purchaser.
3.2 Purchase Orders. Every purchase order given by D-O ("Order") is deemed to
be a separate purchase contract under the terms of this Agreement. Aspect will
accept orders if they are placed by D-O under agreed prices and other conditions
of this Agreement to the extent orders are made within the scope described in
Clause 3.3.
3.3 Order Acknowledgements. D-O Orders shall be acknowledged by Aspect within
five (5) working days after receipt of the Order, provided that the Order
conforms to this Agreement and that the requested delivery time is within the
agreed lead time and the quantity ordered does not exceed by more than the
greater of [**] units or [**] percent ([**]%) of the quantity of such Aspect
Product ordered in any of the three (3) preceding months.
3.4 Cancellation Charges. In the event of the cancellation of any Order by D-O,
Aspect has the right to charge cancellation charges based on actual damages
caused to Aspect. The maximum amount of damages may not however exceed the
following charges listed below.
The cancellation charges are based on the number of days prior to scheduled
delivery date that written notice of cancellation is received by Aspect, as
outlined below:
[**] weeks prior to acknowledged delivery [**]
[**] weeks prior to acknowledged delivery [**]% of order value
[**] weeks prior to acknowledged delivery [**]% of order value
[**] weeks prior to acknowledged delivery [**]% of order value
[**] weeks prior to acknowledged delivery [**]% of order value
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Exchange Commission. Asterisks denote omissions.
3.5 Lead Times. Lead times for the Aspect BIS Module Kit are expected to be
[**] weeks . Lead Times for BIS Sensors are expected to be less than [**] weeks.
Notwithstanding the foregoing, it is Aspect's intention to operate with lead
times for BIS Module Kits of less than [**] weeks and lead times for BIS Sensors
of less than [**] business days. If Orders for BIS Sensors are cancelled within
[**] weeks of the acknowledged delivery date, Aspect has the right to charge a
cancellation charge based on actual damages caused to Aspect which however may
not exceed the charges set forth in Clause 3.4. The maximum cancellation charge
for BIS Sensors may not exceed [**]% of the Order value.
3.6 Orders in Excess of Forecasts. If D-O requests deliveries that exceed the
limits indicated in Clause 3.3, D-O may make such additional orders of the
Aspect Products and Aspect shall exercise its best efforts to deliver the Aspect
Products so ordered within the delivery time requested by D-O, provided that if
Aspect is not able to supply the quantity of Aspect Products ordered by D-O,
Aspect shall allocate such Aspect Products on a pro-rata basis among all of its
customers of the applicable Aspect products, provided, however, that Aspect will
endeavor to disproportionately allocate such Products to D-O whenever it is
reasonable to do so. No contract shall be deemed to have been entered into
between Aspect and D-O unless and until Aspect has confirmed the respective
order in writing. Aspect agrees to indicate its approval or refusal of D-O's
additional purchase orders within five (5) working days from the receipt
thereof.
4. DELIVERIES
4.1 Unless expressly otherwise agreed in writing, all orders shall be delivered
by Aspect FCA Newton, Massachusetts (Incoterms 2000).
4.2 Aspect shall notify D-O of any anticipated delivery problems in advance.
4.3 In the event that delivery of a shipment is delayed by more than [**] from
the specified delivery time for causes other than force majeure (as described in
Section 14 below) or an act or omission on the part of D-O, D-O is [**] as
follows.
The [**] shall be [**] in case there is [**] caused to D-O at [**] the purchase
price [**]. However the [**] shall [**] the purchase price. If only a part of
the Aspect Products to be delivered as one shipment is delayed, the [**]
purchase price which is attributable to the Aspect Products that cannot in
consequence of the delay be taken into use by D-O. If the delay in delivery is
such that D-O [**] and the Aspect Products are still not delivered, D-O may in
writing demand delivery within a final reasonable period [**]. Such [**] shall
be [**] by D-O by [**] amounts otherwise owed to Aspect by D-O.
If Aspect does not deliver within such final period then D-O shall be entitled
to terminate the respective delivery contract and cancel all the outstanding
binding orders.
4.4 If Aspect Products delivered by Aspect do not conform to this Agreement as
to quality and D-O's order as to quantity, D-O shall be entitled to reject such
non-conforming Aspect Products. Aspect shall within [**] weeks after
notification of the rejection, at its option and expense, either repair or
replace properly rejected Aspect Products. Aspect shall pay all transportation
charges of properly rejected Aspect Products. The delivery of the Products shall
be considered delayed in accordance with Section 4.3 if Aspect has not delivered
the repaired or replacement Aspect Products and D-O has not received them (DDP
Incoterms 2000) in agreed quantities and in full conformance with this Agreement
within [**] weeks after notification of the rejection.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
4.5 The Aspect BIS Module Kits shall be packed, marked and labelled by Aspect
in accordance with the reasonable instructions given by D-O. In case no
instructions have been given, the Aspect BIS Module Kits shall be packed with
due care to avoid damages during shipment.
5. PRICES AND TERMS OF PAYMENT
5.1 Aspect shall sell and D-O shall purchase the Aspect Products during the
calendar year at the prices set forth in Appendix 1. The parties have agreed to
initiate [**] discussions on market conditions and trends as well as pricing of
Aspect Products. Aspect [**] that the [**] from [**] are [**] than [**] and
[**].
5.2 [**]Sales of Aspect BIS Sensors. During the term of this Agreement, for
each Aspect BIS Sensor sold by Aspect to D-O customers [**] for use with D-O BIS
Modules, Aspect shall [**] by Aspect for such Aspect BIS Sensors. Aspect shall
[**] on a calendar quarterly basis. With such quarterly payments, Aspect shall
provide to D-O a list of D-O customers to which such sales were made, the number
of Aspect BIS Sensors sold in that quarter, and the revenue realized from the
sale of the Aspect BIS Sensors by Aspect. This quarterly payment shall be
provided to D-O no later than thirty (30) days following the end of each
calendar quarter. In the event that Aspect's standalone BIS monitors and/or the
BIS modules of other manufacturers have also been installed at such sites in
addition to D-O BIS Modules, [**] on Aspect BIS Sensor sales intended for use
with D-O BIS Modules. The Parties will agree upon a reasonable basis for
estimating the number of BIS Sensors used with D-O BIS Modules in such an event
(e.g. a pro rata determination based on the total number of BIS units of
different types installed at such locations during the period) and will
calculate the total Aspect BIS Sensor [**] accordingly. To facilitate such
calculations, D-O will be responsible for providing Aspect with documentation,
on a quarterly basis, of the total number of D-O BIS Modules installed in the
U.S. and Canada, the locations of such D-O BIS Modules, and the dates of
installation.
Aspect shall keep full and accurate records and books of account containing all
particulars necessary showing the amount of [**] hereunder for each Aspect BIS
Sensor sold by Aspect to D-O customers [**] for use with D-O BIS Modules. Aspect
shall allow D-O to engage an independent certified public accountant to examine
its records to determine compliance with this Clause 5.2. Any examination shall
be at the expense of D-O, shall occur during regular business hours at Aspect's
offices and shall not interfere unreasonably with Aspect's regular activities.
D-O shall give Aspect at least thirty (30) days notice of the date of each such
examination and the name of the accountant who will be conducting the
examination. Aspect agrees to pay D-O any amounts owning as a result of Aspect's
non-compliance with the payment provisions of this Agreement, and D-O shall
return any amounts overpaid by Aspect, within fourteen (14) days of the date of
the examination report, which details such non-compliance. In the event such
amounts owed by Aspect to D-O exceeds five percent (5%) of total [**] due,
Aspect shall pay the costs of such examination.
5.3 Purchase Price and License Fees for Aspect BIS Module Kit. For each Aspect
BIS Module Kit that D-O purchases from Aspect, D-O shall pay a purchase price
for the Aspect BIS Module Kit and a license fee for the Software as specified in
Appendix 1 (Aspect Products and Purchase Prices).
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
5.4 Volume Purchases. If the prices are given in several levels corresponding
to the quantities of the Aspect Products to be purchased during the calendar
year, the price level to be applied shall be determined initially based on the
amount of purchases specified in D-O's first purchase forecast given as
specified in Clause 2.1. multiplied to reflect the whole calendar year. If
during the calendar year D-O changes its purchase schedule so that the amount
actually purchased during the calendar year corresponds to another price level,
any difference, whether increase or decrease, in the price of Aspect Products
ordered during that calendar year shall be calculated and compensated before the
end of January of the succeeding year.
5.5 Aspect agrees to provide [**] to D-O [**]. If D-O requests [**] that [**]
amount, the Parties will mutually agree [**].
5.6 Further improvement projects will be mutually agreed on.
5.7 Unless expressly otherwise agreed in writing, payment for all Aspect
Products shall be made by D-O in the currency specified in Appendix 1 by SWIFT
transfer within sixty (60) days from shipment date of the Aspect Products to
D-O's premises or such other destination as may have been specified in the
Order, provided that the quality and quantity of the Aspect Products delivered
conforms to this Agreement and the respective Order. Any late payments shall
bear interest at the rate of one percent (1%) per month.
6. QUALITY ASSURANCE
6.1 Aspect shall maintain quality control procedures in compliance with the
requirements of the following quality systems ISO 9001, EN 46001, US GMP 00 XXX
000 ("xxx US GMP") and the Council Directive 93/42/EEC concerning medical
devices promulgated by the Council of the European Communities as amended ("the
MDD").
6.2 Aspect's quality assurance and test plan will be submitted to D-O for
approval. From time to time, Aspect may make changes to its test plan. Any such
changes will also be submitted to D-O for approval. D-O agrees to not
unreasonably withhold its approval. If requested by D-O, Aspect shall provide
D-O with appropriate documents evidencing that the Aspect Products comply with
the requirements of the MDD and US GMP and any applicable product standards.
6.3 Aspect shall test or have tested for them the Aspect BIS Module Kits before
they are delivered to D-O to ensure that defective Aspect BIS Module Kits shall
not be delivered. Aspect shall test or have tested for them on a sampled basis
the BIS Sensors before they are delivered to D-O to ensure that defective BIS
Sensors will not be delivered. A certificate of compliance, certifying
compliance with this Section 6.3, signed by an Aspect employee (e.g. a quality
inspector) will be supplied with each shipment. The representative of D-O may
participate in such tests. The test reports shall be kept on file for a period
of [**] years from the date of manufacture. Test reports will be provided upon
request of D-O.
6.4 D-O reserves the right, by itself or through its appointed representative,
during regular business hours and following reasonable notice to Aspect, to
inspect Aspect's physical facilities and Aspect's quality control procedures in
order to assure compliance with the Specifications, quality requirements and
other applicable standards. In the event that D-O determines that the quality
procedures applied by Aspect are insufficient as to ensure consistent acceptable
quality, D-O shall specifically inform Aspect thereof Aspect agrees to undertake
any such corrective measures without delay. Aspect agrees to take all
appropriate measures in order to ensure compliance of its sub-suppliers with the
foregoing.
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7. REGULATORY REQUIREMENTS
7.1.1 The Parties confirm that in relation to the MDD requirements D-O shall be
regarded as the manufacturer of the D-O BIS Module. Aspect agrees to deliver to
D-O all information reasonably required by D-O to get and maintain regulatory
approvals including but not limited to the MDD CE marking and the US FDA 510(k)
for the D-O BIS Module that D-O plans to incorporate into its products.
7.1.2 The Parties confirm that in relation to the MDD requirements Aspect shall
be regarded as manufacturer of Aspect Products. Aspect warrants that the Aspect
Products conform to the requirements established in the MDD and will affix, if
appropriate, the CE xxxx to all the Aspect Products and packaging.
Aspect agrees that the appropriate labelling of the BIS Sensors, DSC Cable and
DSC-3 and the obtaining of registrations, tests and/or approvals from relevant
authorities, where necessary, is the responsibility of Aspect and will be done
at Aspect's cost.
Aspect shall, during the term of this Agreement, keep all regulatory approvals
for the BIS Sensors, DSC Cable and DSC-3 in full force and effect at Aspect's
expense. Any act or notifications of authorities, that might lead to
cancellation or modification of such approvals, shall be immediately
communicated to D-O in writing and the Parties shall jointly agree on
appropriate corrective measures.
7.2 Each Party shall fully comply with all applicable laws and regulations of
the competent jurisdiction in the territories in which D-O and Aspect have
mutually agreed that D-O will sell its products containing the Aspect BIS Module
Kits. The territory in this agreement shall be worldwide unless otherwise agreed
between the parties. In particular, Aspect shall ensure that the Aspect's
Products as well as Aspect's activities in relation to this Agreement conform to
all legislation, rules, regulations and statutory requirements existing from
time to time and D-O shall ensure that the D-O BIS Module as well as D-O's
activities in relation to this Agreement conform to all legislation, rules,
regulations and statutory requirements existing from time to time.
7.3 Each Party shall be responsible for record keeping under US regulations
such as 21 CFR Part 803, the European Union MDD regulations and under the record
keeping requirements of any other country as may be applicable. If required by
the laws or regulations of any country, each Party shall notify the other Party
on a quarterly basis, of complaints received relating to the D-O BIS Module or
the Aspect Products sold to D-O and/or its Affiliates.
If either Party becomes aware of an event where there is reasonable suspicion
that the D-O BIS Module, or the Aspect Products contributed to or caused a death
or serious injury or an event where a D-O BIS Module or the Aspect Products have
malfunctioned and, if that malfunction occurred again, it could cause death or
serious injury, such Party shall use its best efforts to give such notice to the
other Party orally within 24 hours from the receipt of such complaint or
becoming aware of such event and shall use its best efforts to confirm such
notice by telefax within 24 hours after giving oral notice.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
7.4 Each Party shall be responsible for reporting under US reporting
requirements such as 21 CFR Part 803, the European Union reporting requirements
and under the reporting requirements of any other country as may be applicable.
Before submitting a report involving a D-O BIS Module or the Aspect Products,
the reporting Party shall use its reasonable efforts to notify the other Party
with any information relating to any incident involving a D-O BIS Module or the
Aspect Products. Before submitting a report involving an Aspect Product which
would have an effect on a D-O BIS Module, the reporting Party shall use its
reasonable efforts to notify the other Party with any information relating to
any incident involving such Aspect Product. Copies of such reports shall be sent
to the other Party without delay.
If FDA or other authorities contact either Party to inquire about or investigate
the D-O BIS Modules or Aspect products sold under this Agreement, the contacted
Party, unless required to maintain confidentiality by such authorities, shall
inform the other Party immediately thereof. The Parties shall co-operate closely
to clear any regulatory issues or potential regulatory issues promptly.
7.5 Sections 7.2 to 7.4 above shall remain in effect even after the expiration
of this Agreement.
8. WARRANTY AND LIABILITY; DIVISION OF LIABILITY, RECALLS
8.1 In addition to and not in limitation of any other provisions of this
Agreement, Aspect represents and warrants that the Aspect Products shall be
manufactured in accordance with Sections 6 and 7 above, shall be free from
defects in design, material and workmanship for the periods set forth in Section
8.3 below, and shall conform to the applicable specifications for the periods
set forth in Section 8.3 below. Aspect agrees to remedy any defect in the Aspect
Products supplied by Aspect resulting from faulty design, materials or
workmanship or non-conformance with the specifications and quality requirements
specified in this Agreement in accordance with the provisions of this Section 8.
8.2 On receiving D-O's notice of a defect covered by the provisions of this
Section 8, Aspect shall at no cost to D-O either deliver a replacement of the
defective Aspect Product or repair or have the Aspect Product or part in
question repaired.
8.3 Aspect's obligation set forth in Clause 8.1 shall apply only to defects
appearing within a period of [**] months from the date of delivery of the Aspect
BIS Module Kit by D-O to the end user or [**] months from the date of delivery
of the Aspect BIS Module Kit by Aspect to D-O, whichever occurs first.
Aspect's obligation set forth in Clause 8.1 shall apply only to defects
appearing within a period of [**] months from the date of manufacture of the
Aspect BIS Sensor. Aspect agrees to ship only such Aspect BIS Sensors that have
a shelf life of at least [**] months.
Aspect's obligation set forth in Clause 8.1 shall apply only to defects
appearing within a period of [**] months from the date of delivery of the cables
by D-O to the end user or [**] months from the date of delivery of the cables by
Aspect to D-O, whichever occurs first.
Any repaired or replaced DSC-3, Aspect BIS Engine or Aspect BIS Sensor or part
thereof shall be subject to such obligations for the greater of the remainder of
the original period specified in this Section 8.3 or [**] days.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
8.4 Aspect's obligation set forth in Sections 8.1 through 8.3 shall not apply
to expendable components, such as, but not limited to, fuses and bulbs; nor
shall Aspect have any obligation under this Agreement to make repairs of any
Aspect Product or part thereof which has been subjected to any detrimental
exposure, or has been involved in an accident or has otherwise been handled or
stored improperly.
8.5 (a) Aspect shall indemnify, defend and hold D-O, its Affiliates,
distributors and sub-distributors (collectively, the "D-O Indemnified Parties")
harmless from and against any and all liability, loss, damages, costs and
expenses (including, without limitation, reasonable attorney's fees) which such
D-O Indemnified Parties may incur, suffer or be required to pay as a result of
any property damage, injury, illness or death of any person arising out of or in
connection with the marketing, distribution, sale or lease by the D-O
Indemnified Parties of any Aspect Product (whether as stand-alone product or
when incorporated into, used as a component in, or integrated with, D-O Patient
Monitors) to the extent any such claim relates to (i) the design, manufacture or
use of such Aspect Product (including any component thereof), or (ii) the
failure of such Aspect Product to comply with applicable product specifications
or other similar information provided to D-O by Aspect (including information
necessary for D-O to interface the Aspect BIS Module Kit with D-O Patient
Monitors), or (iv) any incorrect or inadequate warning labels or instructions
that are or should be incorporated into or accompany (or should accompany) such
Aspect Product, or (v) any failure by Aspect to provide correct and adequate
warning labels or instructions relating to the use, handling or function of such
Aspect Product. D-O shall provide Aspect with prompt written notice of any such
claim or claims. Upon receipt of Aspect's acknowledgement of its obligation to
indemnify, defend and hold harmless the D-O Indemnified Parties against any such
claim, D-O shall permit Aspect to assume the defence of such claim or claims and
shall provide to Aspect, at Aspect's expense, such information and assistance as
Aspect may reasonably require with respect to such claim; provided that, Aspect
shall not consent to any injunction against D-O or any other D-O Indemnified
Party other than an injunction prohibiting the manufacture and/or sale of the
applicable Aspect Product without first obtaining D-O's prior written consent,
which consent shall not be unreasonably withheld or delayed; and provided
further that in no event shall Aspect without prior written consent of D-O,
settle any claim against any D-O Indemnified Party or consent to the entry of
any judgment (1) that contains any admission by or finding against such D-O
Indemnified Party other than an agreement to discontinue the manufacture and/or
sale of the applicable Aspect Product, (2) that includes any relief to the
claimant to be provided by D-O other than monetary relief to be paid in full by
Aspect, or (3) that does not include as an unconditional term thereof the giving
by the plaintiff or claimant to such D-O Indemnified Party a release from all
liability in respect of such claim. Should D-O desire to have its own counsel
participate in any such action, the cost of such counsel shall be exclusively
D-O's. In the event that D-O, its Affiliates and distributors cannot continue
the distribution of the applicable Aspect Product due to an injunction or an
agreement to discontinue the manufacture and/or sale of the applicable Aspect
Product, Aspect shall accept return of such Aspect Products from D-O, its
Affiliates and distributors and refund the amounts paid to Aspect for such
returned Aspect Products. If it is determined that a claim for which Aspect has
defended and indemnified D-O was the result of the misuse of the Aspect Product
or the use of the Aspect Product in a manner or for a purpose that is contrary
to the regulatory approval obtained for such Aspect Product, then D-O shall
reimburse Aspect for [**] the out-of-pocket costs and expenses incurred by
Aspect in connection with such defense and indemnification. Liability under this
Section 8.5 shall be in proportion to each Party's contribution to the acts that
gave rise to the liability.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
(b) D-O shall indemnify, defend and hold Aspect harmless from and against any
and all liability, loss, damages, costs and expenses (including, without
limitation, reasonable attorney's fees) which Aspect may incur, suffer or be
required to pay as a result of any property damage, injury, illness or death of
any person arising out of or in connection with the marketing, distribution,
sale or lease by D-O (or any D-O Indemnified Party) of any D-O Patient Monitor
in which any Aspect Product is incorporated into to the extent any such claim
does not relate to any matter for which Aspect is obligated to provide
indemnification under Section 8.5 (a) and provided further that Aspect shall
provide D-O with prompt written notice writing of any such claim or claims and
shall provide D-O reasonable assistance at D-O's cost and shall give D-O the
sole control over the defence and settlement of any such claim or claims. Should
Aspect desire to have its own counsel participate in any such action, the cost
of such counsel shall be exclusively Aspect's.
8.6 Each Party shall maintain at its cost with a reputable and financially
secure insurance company a general third party liability and products liability
insurance in an amount as each Party considers to be reasonable. Each Party
shall maintain the said insurance for the entire lifetime of the Aspect Products
and D-O Patient Monitors. At a Party's request, the other Party shall furnish
certificates of insurance evidencing such coverage and providing that said
insurance will not be materially decreased, altered or cancelled without giving
the other party no less than thirty (30) days written notice thereof.
8.7 Aspect shall maintain serial and/or lot number and date of shipment records
for each Aspect Products and D-O shall maintain serial and/or lot number and
date of shipment records for each D-O BIS Module so that, if necessary for
tracing or recall purposes, the manufacturing and delivery of the Aspect
Products or D-O BIS Module can be identified. Each Party shall give its
assistance to the other Party in tracing or recall situations by making the
records available. Each Party shall promptly make such records available to the
other Party if any authority in any country requests such records from such
Party.
8.8 In the event that Aspect desires to take a corrective action (including
notifications or recalls) with respect to any of the Aspect Products sold to
D-O's customer or an end user that have been incorporated in any of the
customer's products and distributed by the customer, and such action (i) is
required by Aspect to comply with applicable laws or regulations, (ii) is
determined by Aspect in its discretion for a reasonable business purpose or for
safety reasons or (iii) is the result of Aspect's failure to supply Aspect
Products that (a) conform in all material respects to the applicable standards
or (b) are free from defect in material and workmanship (when given normal,
proper and intended usage), Aspect shall be responsible for the repair or
replacement of the Aspect Products [**]. Aspect agrees to consult with D-O to
establish a reasonable process for managing the corrective action and Aspect
shall be responsible for [**] if Aspect fails to take such action. In the event
that Aspect is required to take such action to comply with applicable laws or
regulations or such action is reasonably necessary for safety reasons and for
the failure of the Aspect Products to comply with specifications (other than a
minor deviation from such specifications) and Aspect fails to take such action ,
D-O shall have the right to take such action and Aspect [**] incurred in
connection with such action by D-O.
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8.9 Aspect warrants that its Aspect Products and the information technology
owned or used by the Aspect (the "IT-Systems") are year 2000 compliant and they
will not cease to be so at any time prior to, during or after the year 2000.
Year 2000 compliance means Aspect BIS Module Kit's or IT-System's capability to
correctly differentiate between years, in different centuries, that end in the
same two digits, and will accurately process date/time data from, into and
between the twentieth and twenty-first centuries, including leap year
calculations and unusual date situations (e.g 9/9/99).
8.10 EXCEPT AS PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY OTHER
REPRESENTATIONS OR WARRANTIES CONCERNING THE USE AND/OR FUNCTIONALITY OF THEIR
RESPECTIVE PRODUCTS AND EACH PARTY HEREBY DISCLAIMS ALL OTHER REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO SAME , INCLUDING BUT NOT LIMITED
TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE
AND NONINFRINGEMENT.
9. TRADEMARKS AND OTHER INTELLECTUAL PROPERTY RIGHTS
9.1 Neither Party shall use or refer to the other Party's name or trademarks in
any other form or manner or for any other purpose than what is expressly allowed
in this Agreement. All artwork, packages and labels (if any) prepared by either
Party in connection with the other Party's name shall be sent to the other Party
for approval.
9.2 Neither Party shall be entitled to acquire or retain for its own use any
trademarks or trade names owned or generally used by the other Party or any
confusingly similar trademarks or names.
9.3 (a) Aspect represents that (i) it has not been determined to be infringing
any patents or other rights with respect to any Aspect Products (including any
component thereof) and (ii) no person has asserted that the use, manufacture or
sale of any Aspect Products (including any components thereof) anywhere in the
world infringes any patent or other proprietary right of such person. Aspect
shall indemnify, defend and hold harmless the D-O Indemnified Parties against
any suit or proceeding, including any costs, damages liabilities and expenses
(including, without limitation, reasonable attorney's fees) in connection
therewith, brought against such parties arising out of or relating to any
infringement or claim of infringement of patents, trademarks, copyrights, or
trade secrets by (i) any Aspect Products (including any component thereof), (ii)
any portion of any labeling affixed to any Aspect Products, (iii) trade marks or
service marks owned or used by Aspect to name or identify itself or any of its
products, including any Aspect Products, (iv) any operating manuals,
instructions for use or packaging for software used in connection with any
Aspect Products that accompany such products when shipped, and/or (v) any
portion of any advertising, publicity or promotional material published by or at
Aspect's request. D-O shall provide Aspect with prompt written notice of such
claim and also of any suit brought in connection therewith. Upon receipt of
Aspect's acknowledgement of its obligation to indemnify, defend and hold
harmless the D-O Indemnified Parties against any such claim, Aspect shall be
given the right by D-O to defend and/or settle the same, provided, however that
in no event shall Aspect without prior written consent of D-O, settle any such
claim or consent to the entry of any judgment against D-O (1) that contains any
admission by or finding against such D-O Indemnified Party other than an
agreement to discontinue the manufacture, use and/or sale of the applicable
Aspect Product, (2) that includes any relief to the claimant to be provided by
D-O other than monetary relief to be paid in full by Aspect, or (3) that does
not include as an unconditional term thereof the giving by the plaintiff or
claimant to such D-O Indemnified Party a release from all liability in respect
of such claim. Should D-O desire to have its own counsel participate in any such
action, the cost of such counsel shall be exclusively D-O's.
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In the event that Aspect determines that it is likely that such Aspect Products
will be found to be infringing products or if the manufacture, use or sale of
such Aspect Products is enjoined, Aspect shall, at its expense, replace such
Aspect Products with noninfringing products of compatible functionality,
specification and use, modify such Aspect Products to make them noninfringing
(while maintaining compatible functionality, specification and use) or obtain
right for D-O to continue to manufacture, use and sell such Aspect Products. In
the event that none of the foregoing alternatives are reasonably available to
Aspect, Aspect shall accept the return of any infringing Aspect Products (and,
at D-O's election (which election shall not serve to disclaim or waive any other
rights or remedies available to D-O), Aspect shall repay to D-O, or shall
provide an appropriate credit to the account of D-O for, all amounts paid by D-O
to Aspect in respect of such products) and, in addition to any and all other
remedies available to D-O, Aspect shall reimburse D-O for any amounts returned
by D-O to customers of such infringing Aspect Products up to any amounts paid to
Aspect therefor.
The obligations set forth herein shall continue even after the expiration of
this Agreement. Aspect shall have no liability or obligation to D-O Indemnified
Parties hereunder with respect to any patent, copyright, trade secret or other
intellectual property infringement, misappropriation or claim thereof based upon
(i) use of the Aspect Products by D-O in combination with products or software
not specified or provided by Aspect (only to the extent D-O has done so without
Aspect's written consent), (ii) modifications, alterations or enhancements of
the Aspect Products not created by, for and with the written consent of Aspect,
or (iii) the use of the Aspect Products by D-O (or any other D-O Indemnified
Party) in a manner or for a purpose not specified in the Aspect documentation
furnished to D-O where such claim would not have occurred but for such misuse or
use. Aspect shall notify D-O if it believes that any use of the Aspect Products
in combination with products or software not specified or provided by Aspect, is
likely to result in a claim of infringement or misappropriation.
(b) D-O represents that (i) it has not been determined to be infringing any
patents or other rights with respect to the D-O Patient Monitors, excluding any
Aspect Products or Aspect components, and (ii) no person has asserted that D-O's
manufacture or sale of such D-O Patient Monitors anywhere in the world infringes
any patent or other proprietary right of such person. D-O shall indemnify,
defend and hold harmless Aspect against any suit or proceeding, including any
costs, damages liabilities and expenses (including, without limitation,
reasonable attorney's fees) of Aspect in connection therewith brought against
Aspect based on a claim that the such D-O Patient Monitors or any part thereof
(exclusive of the Aspect Products (or any component thereof)) constitutes an
infringement of any patent or other proprietary right of a third party. Aspect
shall provide D-O with prompt written notice of such claim and also of any suit
brought in connection therewith.
The obligations set forth herein shall continue even after the expiration of
this Agreement. D-O shall have no liability or obligation to Aspect hereunder
with respect to any patent, copyright, trade secret or other intellectual
property infringement, misappropriation or claim thereof arising out of or
relating to any infringement or claim of infringement of patents, trademarks,
copyrights, or trade secrets by (i) any Aspect Products (including any component
thereof), (ii) any portion of any labeling affixed to any Aspect Products, (iii)
trade marks or service marks owned or used by Aspect to name or identify itself
or any of its products, including any Aspect Products, (iv) any operating
manuals, instructions for use or licensing folder for software used in
connection with any Aspect Products that accompany such products when shipped,
and/or (v) any portion of any advertising, publicity or promotional material
published by or at Aspect's request.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
11. TRADE SECRETS; CONFIDENTIALITY; [**]
11.1 This Agreement and all documents, drawings, manuals and other materials
related thereto and transmitted between the Parties shall be treated as
confidential by the Parties and their employees and such information shall not
be disclosed to any third party. Each Party shall arrange proper filing for
specifications and drawings given by the other Party. Any drawings or
specifications and all copies thereof shall be returned to the supplying Party
after the supplying Party has provided new replacement specifications or
drawings. Each Party shall nominate a person in its organization who shall be in
charge of the filing and shall inform this person of the confidentiality
requirements of this Agreement.
11.2 Within fourteen (14) days after termination of this Agreement the each
Party shall return all specifications and drawings of the other Party and all
copies thereof (in any media) unless a Party is required to retain such material
under applicable laws or regulations. All information consisting of documents,
notes and other writings prepared by one Party based on non-public data of the
other Party shall be destroyed.
11.3 Each Party shall not, and each Party shall ensure that its officers and
employees will not, whether during the term or after the termination of this
Agreement, use any non-public information relating to the other Party or any of
its Affiliates or their products, technology, designs or tools for other
purposes than the fulfilment of such Party's obligations hereunder.
11.4 Aspect shall not during the term of this Agreement or thereafter sell to
third parties any products that are manufactured in accordance with proprietary
technical specifications, technology, designs or tools provided by D-O.
11.5 In case of unauthorised use by either Party, its Affiliates or employees of
the such non-public technologies, designs or tools of the other Party, the
receiving Party shall be obliged to compensate any costs, damages and losses
incurred by the disclosing Party due to such unauthorised use.
11.6 Aspect acknowledges that [**] and that [**] by D-O during the term of this
Agreement. Nothing in this Agreement shall [**] prior to the [**] provided that
(a) [**] as soon as reasonably practical, (b) in the event that [**], D-O agrees
to [**] as soon as possible thereafter, and (c) D-O agrees to [**] the D-O
[**].
11.7 Subject to the provisions of Section 11.6, during the initial term of this
Agreement (that is, for the period through December 31, 2005), D-O may [**] For
the purposes of this Agreement [**] other than D-O or its Affiliates [**] D-O
agrees that during the initial term of this Agreement it shall [**] and/or [**]
in the [**]. In the event that [**] will be [**] provided, however, that [**].
11.8 D-O agrees that the D-O BIS module will not be actively promoted or
marketed in a product configuration (a stand-alone single parameter monitor)
that competes directly with Aspect's A-2000 Monitor.
11.9 The obligations set forth in this Section 11 shall continue even after the
expiration of this Agreement.
14
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
12. TERM AND TERMINATION
12.1 This Agreement is effective from the date on which the Parties have signed
this Agreement ("the Effective Date"). Unless earlier terminated pursuant to
other terms hereof, this Agreement shall remain in effect until December 31,
2005 (the "Initial Term"). Thereafter unless terminated by either Party with at
least [**]' notice prior to said expiration date, this Agreement shall
automatically renew itself for successive one year terms (the "Renewal Term"),
provided that either Party may terminate this Agreement effective at the end of
the current term by giving notice to the other Party at least [**] before the
scheduled expiration date.
12.2 This Agreement may be terminated at any time without prior notice in case
of a breach or failure by a Party to perform any of the obligations set forth in
this Agreement, which breach or failure shall not have been remedied by the
Party within a period of thirty (30) days from the date of the written notice
thereof by the other Party.
12.3 Neither Party shall by reason of the termination or expiration of this
Agreement in accordance with its terms be liable to the other Party for
compensation, reimbursement or damages on account of lost prospective profits or
anticipated sales, or on account of expenditures, investments, leaves or
commitments by the other Party or on any other account.
13. APPLICABLE LAW AND DISPUTE RESOLUTION
13.1 This Agreement and the Orders, acknowledgements of Orders and sales
contracts thereunder are to be construed, governed by and interpreted in
accordance with the laws of the Netherlands.
13.2 Prior to taking any action as provided in Clause 13.3 below, the parties
shall attempt to resolve any claim or controversy arising out of this Agreement
by way of amicable negotiations within a reasonable period not to exceed thirty
(30) days after the date of a notice from either party to the other describing
such claim or controversy.
13.3 All disputes between Aspect and D-O arising out of or relating to this
Agreement shall be finally resolved by arbitration by one arbitrator conducted
in the English language in the Netherlands under the commercial arbitration
rules of the United Nations Commission on International Trade Law. The
arbitrator shall be appointed by the Netherlands Arbitration Institute,
Rotterdam. The arbitration costs will be decided by the arbitrator.
Notwithstanding anything contained in this Section to the contrary, each party
shall have the right to institute judicial proceedings against the other party
or anyone acting by, through or under such other party, in order to enforce the
instituting party's rights hereunder through reformation of contract, specific
performance, injunction or similar equitable relief.
13.4 Judgement upon the award rendered may be entered in any Court having
jurisdiction or application may be made to such Court for a judicial acceptance
of the award and an order of enforcement, as the case may be.
13.5 Notwithstanding the aforesaid, any dispute regarding a Party's need to
protect or enforce any patent, trademark, copyright or other intellectual
property right, confidential information or trade secrets, or as part of
litigation commenced by a third party shall allow the Party to undertake legal
proceedings in the Court of a Party's domicile, main place of business or other
appropriate Court.
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14. FORCE MAJEURE
14.1 Either Party shall be entitled to suspend performance of its obligations
under this Agreement to the extent that such performance is impeded or made
unreasonably onerous by any of the following circumstances: industrial disputes
and any other circumstance beyond the control of the Parties such as fire, war
(whether declared or not), extensive military mobilisation, insurrection,
requisition, seizure, embargo, and delays in deliveries by sub-suppliers caused
by force majeure.
14.2. The Parties shall without delay notify each other of any occurrence of
force majeure and the discontinuance thereof.
14.3. Regardless of any other provision in this Agreement to the contrary,
either Party shall be entitled to terminate a purchase contract under this
Agreement by notice in writing to the other Party if performance of the contract
is suspended under Clause 14.1 above for more than six (6) months.
15. GENERAL PROVISIONS
15.1 Entire Agreement. As of the Effective Date, this Agreement cancels all
prior agreements and represents the entire agreement between the Parties
relating to the subject matter thereof. It supersedes any and all promises,
representations, warranties and other statements, whether written or oral, made
by or on behalf of either Party to the other Party relating to the subject
matter of this Agreement. This Agreement may be amended or varied only by an
expressly written instrument signed by duly authorised representatives of both
Parties.
15.2 Waivers. The temporary, limited or specific waiver of any term, provision
or condition of this Agreement shall not be considered a waiver of any other
term, condition or provision thereof, nor of any subsequent breach of the same
term, condition or provision.
15.3 Unenforceability. If any of the provisions of this Agreement shall be
declared illegal or unenforceable by any Court of competent jurisdiction, the
validity of the remaining provisions shall not be affected thereby, and the
Parties agree to do all things and co-operate in all ways open to them to obtain
substantially the same results, or as much thereof as may be possible, including
the amendment or alteration of this Agreement.
15.4 Notices. Any notice and other communication under this Agreement shall be
in writing and shall be deemed to have been duly given (i) upon personal
delivery; or (ii) on the date of sending by telefax at the address set forth on
the first page of this Agreement; or (iii) upon receipt if mailed, first class
and certified or registered mail, postage prepaid, addressed to the Party for
whom they are intended. Such addresses may be changed by notice to the other
Party given in the above manner.
15.5 Limitation of Liability. EXCEPT AS PROVIDED IN SECTIONS 8.5 AND 9.3, EACH
PARTY'S LIABILITY ARISING OUT OF THE MANUFACTURE, SALE OR SUPPLYING OF ASPECT
PRODUCTS OR THEIR USE OR DISPOSITION, WHETHER BASED UPON WARRANTY, CONTRACT,
TORT OR OTHERWISE SHALL NOT EXCEED FIVE MILLION DOLLARS ($5,000,000US). EXCEPT
AS PROVIDED IN SECTIONS 8.5 AND 9.3 OF THIS AGREEMENT, THE PARTIES SHALL NOT BE
LIABLE TO EACH OTHER FOR SPECIAL, CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT
DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFIT OR REVENUES OR COST OF
CAPITAL.
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
15.6 Publicity. Neither Party shall originate any publicity, news release or
other public announcement relating to this Agreement or the existence of an
arrangement between the Parties without the prior written approval of the other
Party, except as otherwise required by law.
15.7 No Agency. Nothing contained in this Agreement shall be deemed to
constitute either Party as the agent or representative of the other Party, or
both Parties as joint venturers or partners for any purpose. Neither Party shall
be responsible for the acts or omissions of the other Party, and neither Party
shall have authority to speak for, represent or obligate the other Party in any
way without prior written authority from the other Party.
15.8 Survival of Obligations. Unless otherwise stated in this Agreement all
obligations of either Party under (Regulatory Requirements (Section 7)),
(Warranty and Liability; Division of Liability, Recalls (Section 8)), (Trademark
and Other Intellectual Property Rights (Section 9)), (Trade Secrets;
Confidentiality; Competition (Section 11)), (Applicable Law and Dispute
Resolution (Section 13)) and Clause 15.5 (Limitation of Liability) and Clause
1.9.2 shall survive the expiration or termination of this Agreement and continue
to be enforceable.
15.9 Assignment. Except in connection with the sale of all or substantially all
of the assets, stock or business of a Party to which this Agreement relates,
neither Party may assign, transfer or sublicense any of the rights or
obligations under this Agreement without the prior written consent of the other
Party, which consent shall not be unreasonably withheld or delayed; provided,
however, that [**] of one Party is acquiring the other Party, [**]. Otherwise,
this Agreement transfers with the sale of all or substantially all of the
assets, stock, or business of a Party to which this Agreement relates. Either
Party may assign this Agreement to an Affiliate (collectively the "Permitted
Assignees"). Assignment to a Permitted Assignee shall not relieve the assigning
Party of its responsibility for its obligations of this Agreement. An assignment
for purposes of this provision shall include any transaction, including but not
limited to, any merger, consolidation or purchase of stock that results in a
third party that is not a Permitted Assignee Controlling directly or indirectly,
a Party to this Agreement. This Agreement will [**] For the purpose of this
provision [**] shall mean including, without limitation, [**]. No sale,
assignment or other transfer of any rights or obligations of a Party hereunder
shall be effective unless the purchaser, assignee or transferee assumes such
Party's obligations under this Agreement.
15.10 Order of Interpretation. The Parties agree to be bound by this Agreement.
The Appendices 1 to 2 attached hereto form part of and shall be deemed to be
incorporated in this Agreement. In case of any conflict or inconsistency between
this present document and its Appendices, this present document shall prevail.
All references to the Agreement shall be interpreted to include its Appendices.
15.11 Headings. Captions and headings contained in this Agreement have been
included for ease of reference and convenience and shall not be considered in
interpreting or construing this Agreement.
15.12 Export. D-O shall not export, or instruct or authorize any third party to
export, Aspect Products (including when integrated into a D-O patient Monitor)
or other products, information or materials provided by Aspect hereunder, to any
country for which the United States requires any export license or other
governmental approval at the time of export without first obtaining such license
or approval. It shall be D-O's responsibility to comply with the latest United
States export regulations.
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This Agreement shall be executed in two counterparts, each of which shall be
deemed an original for all purposes. A signed copy of the Agreement transmitted
by facsimile shall be deemed for all purposes the equivalent of a signed
original.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorised representatives on September 1, 2000.
DATEX-OHMEDA DIVISION, ASPECT MEDICAL SYSTEMS INC.
INSTRUMENTARIUM CORPORATION
/s/ Hannu Anjopals /s/ X. Xxxxxxxxxxxx Eagle
------------------------------- --------------------------------
NAME: Hannu Anjopals NAME: X. X. Eagle
TITLE: Executive Director TITLE: Chairman
/s/Xxxxxx Xxxxxxx
-------------------------------
NAME: Xxxxxx Xxxxxxx
TITLE: Group Treasurer
APPENDICES:
1. Aspect Products and Price List
2. Aspect BIS Module Kits Specifications
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX 1
ASPECT PRODUCTS AND PURCHASE PRICES
A) ASPECT BIS MODULE KIT:
List price for Aspect BIS Module Kit: $[**] (includes $[**] for components and
$[**] for BIS license) [**]:
--------------------- ------------------ ---------------
QUANTITY PER YEAR PRICE [**]
(COMPONENTS +
LICENSE)
--------------------- ------------------ ---------------
[**] $[**] [**]
[**] $[**] [**]%
[**] $[**] [**]%
--------------------- ------------------ ---------------
The price for Aspect BIS Module Kits ordered by D-O for development purposes is
$[**] USD.
B) ASPECT BIS SENSOR:
--------------------------------------------------------------------------------
[**] BIS SENSOR PRICE
--------------------------------------------------------------------------------
per year Per quarter period covered:
--------------------------------------------------------------------------------
low high Low high thru 2001 2002 2003 2004 2005
--------------------------------------------------------------------------------
[**] [**] [**] [**] [**]
[**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**]
--------------------------------------------------------------------------------
C) ASPECT SPARE PARTS/ACCESSORY PRICES
--------------------------------------------------------------------------------
Orderable Aspect D-O
Parts / Products List Price Price
(US$) (US$) - Note A
--------------------------------------------------------------------------------
DSC-3 (replacement) $[**] $[**]
BIS Engine PCB (replacement) $[**] $[**]
Sensor Cable (replacement) $[**] $[**]
User Manual $[**] $[**]
--------------------------------------------------------------------------------
D) CURRENCY
United States Dollars
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
APPENDIX 2
SPECIFICATIONS - ASPECT BIS MODULE KIT
Aspect's BIS Module Kit is designed specifically for OEM applications and allows
the integration of Aspect's BIS monitoring technology into OEM equipment. The
BIS Module Kit will interface to the patient via the Aspect BIS sensor and to
the OEM equipment utilizing [**] the necessary power connections.
The BIS Module Kit consists of a Digital Signal Converter (DSC-3) that [**]
resides in the OEM equipment. The DSC-3 is a [**] to the BIS Engine circuit
board that provides the patient [**]. The [**] are transmitted [**] from the
DSC-3 to the BIS Engine circuit board [**] at the DSC-3.
The small BIS Engine circuit board [**] on the [**]. The board is constructed
using double-sided surface mount techniques. The connections to the BIS Engine
circuit board are [**] connections. Two means of connecting to the BIS Engine
are provided: [**] connectors on one side and [**] connectors on the opposite
side.
[**]
Digital Output: [**]
[**]Main Parameters: [**]
Electrical Safety: [**]
Power: [**]
[**] [**]
Note: Most of the [**] that is located near the patient and is therefore [**].
Maximum calculated power [**]
ENVIRONMENTAL REQUIREMENTS
------------- ----------------
IEC601-1 BIS ENGINE
--------------- -------------------------- ------------- ----------------
Temperature Range [**] [**]
OPERATION Humidity (non-condensing) [**] [**]
Atmospheric Pressure [**] [**]
--------------- -------------------------- ------------- ----------------
Artifact Rejection: [**]Bispectral Index: [**]
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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
DIGITAL SIGNAL CONVERTER (DSC-3)
Description: [**] to the patient
[**]
Weight: [**]
Dimensions: [**]
[**]
Cable Length: [**]
BIS ENGINE PCB
Physical: [**]
Processing Power: [**]
SOFTWARE UPGRADES
The BIS engine software is stored [**]. Software upgrades can be accomplished
[**].
SERIAL IDENTIFIER
Each BIS engine is given a unique serial identifier. This allows for electronic
identification/tracking of every BIS Engine.
