Exhibit 00.xx
DISTRIBUTOR AGREEMENT
BETWEEN
OLYMPUS AMERICA INC.-ENDOSCOPE DIVISION
AND
MEDIVATORS, INC.
AUGUST 1, 1999
DISTRIBUTOR AGREEMENT
AGREEMENT made as of the 1st day of August, 1999 by and between
MEDIVATORS, INC., a company organized and existing under the laws of the State
of Minnesota, having its principal office at 0000 Xxxx Xxx Xxxxxx, Xxxxx 00,
Xxxxx, Xxxxxxxxx 00000-0000 (the "Company"), and OLYMPUS AMERICA INC.-ENDOSCOPE
DIVISION, a company organized and existing under the laws of the State of New
York, having its principal office at Xxx Xxxxxxxxx Xxxxxx Xxxxx, Xxxxxxxx, Xxx
Xxxx 00000-0000 ("OAI").
W I T N E S S E T H:
WHEREAS, the Company develops, manufactures, and markets a line of
automatic endoscope disinfectors and other related products; and
WHEREAS, OAI is a recognized distributor and supplier of medical and
scientific equipment within the Territory defined in Section 1.20 and OAI wishes
to distribute, market, and service the Products defined in Section 1.15 on an
exclusive basis within the Territory; and
WHEREAS, OAI wishes to engage in the purchase of the Products from the
Company and the resale and service of the Products within the Territory and
wishes to be appointed by the Company as the exclusive distributor and
semi-exclusive (as set forth in Section 2.5) servicer of the Products within the
Territory; and
WHEREAS, the Company is willing to appoint OAI as the exclusive
distributor and semi-exclusive servicer of the Products within the Territory on
the terms and conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the mutual covenants and promises
hereinafter set forth, the parties agree as follows:
ARTICLE 1. DEFINITIONS.
1.1 "AFFILIATE" shall mean a corporation or other entity that controls, is
controlled by or is under common control with, the designated party. "CONTROL"
shall mean the ownership, directly or indirectly, through one or more
intermediaries, of at least 49% of the shares of stock entitled to vote for the
election of directors in the case of a corporation (or comparable
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officers or representatives of the particular entity), or at least 49% of the
interest in profits in the case of a business entity other than a corporation,
except that in any country of incorporation or registration where the maximum
permitted by law is less than 49%, such lower maximum permitted percentage shall
be substituted.
1.2 "AGREEMENT" shall mean this Distributor Agreement, including the
Recitals, Schedules, and Exhibits hereto, as it may be amended or supplemented
from time to time in accordance with its terms.
1.3 "AGREEMENT TERM" shall have the meaning set forth in Section 8.1.
1.4 "ANCILLARY PRODUCTS" shall mean the accessories, consumables, and
replacement and repair parts (each manufactured by or for the Company) to and of
the Disinfectors. A list of such accessories, consumables, and replacement and
repair parts (with corresponding prices for the initial year of the Agreement
Term) is attached hereto as SCHEDULE 1.4.
1.5 "BUSINESS DAY" shall mean any day which is not a Saturday, Sunday, or
bank holiday in the State of New York.
1.6 COMPLAINT(S)" shall mean any written, electronic, or oral
communication that alleges deficiencies related to the identity, quality,
durability, reliability, safety, effectiveness, or performance of a device after
it is released for distribution.
1.7 "DESIGN VALIDATION" shall mean establishing by objective evidence that
device specifications conform with user needs and intended use(s). (21 C.F.R.
Part 820.3(z)(2))
1.8 "DISINFECTOR(S)" shall mean, collectively, the Company's disinfector
products and all accompanying standard accessories, a list of which is attached
hereto as SCHEDULE 1.8.
1.9 "EQUIPMENT" shall mean Olympus brand endoscopy equipment.
1.10 "FDA" shall mean the United States Food & Drug Administration.
1.11 "INTELLECTUAL PROPERTY" shall have the meaning set forth in Section
7.6.
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0.12 "OAI ENHANCEMENTS" shall have the meaning set forth in
Section 3.16.
1.13 "POST-AGREEMENT PERIOD" shall mean the seven-year period (or shorter
period if OAI opts to cease its performance of its Product Customer Service
functions in accordance with Section 2.5) following the end of the Agreement
Term.
1.14 "PROCESS VALIDATION" shall mean confirmation by examination and
provision of objective evidence that the particular requirements for a specific
intended use can be consistently fulfilled. (21 C.F.R. Part 820.3(z))
1.15 "PRODUCTS" shall mean, collectively, the Disinfectors, the Ancillary
Products, and all instruction and service manuals, to be distributed, serviced,
and/or otherwise provided by OAI hereunder; and Product Changes.
1.16 "PRODUCT CHANGES" shall mean any material changes, improvements,
alterations, modifications, new applications, and additional specifications to
or of the Products or the Products' labeling.
1.17 "PRODUCT CUSTOMER SERVICE" shall have the meaning set forth in
Section 2.5.
1.18 "RECALL" shall have the meaning set forth in Section 3.10.
1.19 "SOP" shall mean Standard Operating Procedure.
1.20 "TERRITORY" shall mean the United States of America, and Puerto Rico.
1.21 VERIFICATION" shall mean confirmation by examination and provision of
objective evidence that specified requirements have been fulfilled. (21 C.F.R.
Part 820.3(aa)).
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ARTICLE 2. APPOINTMENT OF OAI; PRODUCT CUSTOMER SERVICE.
2.1 APPOINTMENT AND ACCEPTANCE.
(a) Subject to the terms of this Agreement, the Company, to the full
extent of its legal rights, hereby appoints OAI, and OAI hereby accepts
appointment, as the exclusive distributor and semi-exclusive (as set forth in
Section 2.5) servicer of the Products within the Territory during the Agreement
Term. The Company and/or the Company's Affiliates shall not sell the Products,
or products that are substantially similar to or competitive with the Products,
directly or indirectly within the Territory to any person or entity other than
OAI, or otherwise provide the Products to any other entity which it knows or has
reason to know will sell or service the Products within the Territory, provided
that OAI is not in default under this Agreement. Notwithstanding the immediately
preceding sentence, in the event the Company wishes to distribute an endoscope
disinfection product which is competitive with but not substantially similar to
the Disinfector in design, price, features, and quality (a "Competitive
Product"), the Company shall grant OAI the right of first negotiation and right
of first refusal to become the exclusive distributor of such Competitive
Product, on substantially the same terms and conditions as those contained in
this Agreement (subject to good faith negotiation with respect to pricing,
purchase projections, and Schedules). If the Company and OAI fail to enter into
a definitive agreement with respect to OAI's exclusive distribution of such
Competitive Product, then the Company shall be entitled to distribute the
Competitive Product, directly or via a third party (but only if the distribution
arrangement with such third party contains equivalent terms and conditions as
those offered to OAI therefor).
(b) The Company hereby unconditionally and irrevocably grants to OAI
and OAI's Affiliates, a royalty-free, fully paid-up right and license, including
the right to grant sublicenses, under the Company's Intellectual Property, to
use, market, demonstrate, promote, sell, rent, lease, service, distribute,
and/or otherwise dispose of (or have others do any of the foregoing on OAI's
behalf) the Products within the Territory. OAI shall (i) have the right to sell
and service the Products directly to and for end users or through
subdistributors, dealers, and subservicers (which subdistributors, dealers, and
subservicers will be subject to the Company's approval, which approval will not
be unreasonably withheld or delayed), (ii) determine all terms and conditions of
sale and service to its customers, subdistributors, dealers, and subservicers,
including but not limited to prices (except that OAI may not represent and
warrant the Products in a manner inconsistent with the way the Company
represents and warrants the Products unless OAI receives
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the Company's consent to do so, which consent shall not be unreasonably withheld
or delayed), (iii) not sell or service the Products outside of the Territory or
authorize its subdistributors, dealers, or subservicers to sell or service the
Products outside of the Territory, and (iv) not sell the Products to anyone OAI
knows or has reason to know will sell the Products outside of the Territory. In
the event OAI sells or services the Products through subdistributors, dealers,
and/or subservicers, OAI shall require that such subdistributors, dealers,
and/or subservicers, comply with the provisions of this Agreement pertinent to
subdistributors, dealers, and subservicers.
2.2 LEADS. The Company shall forward to OAI any and all sales and service
inquiries received from Product customers or potential Product customers in the
Territory.
2.3 OAI SALES OF SUBSTANTIALLY SIMILAR PRODUCTS. OAI shall not (by itself
or with others) market, sell, or distribute products within the Territory that
are substantially similar, in price, design, features, and quality, to the
Products, PROVIDED that the Company is not in default under this Agreement.
Notwithstanding the foregoing or anything contained in this Agreement to the
contrary, if, for any reason, the Company fails to use commercially reasonable
and duly qualified efforts to satisfy OAI's reasonable requests for Product
Changes, incorporation of OAI Enhancements, or new product development, OAI has
the right (by itself or with others) to market, sell or distribute changed or
improved new products (even if substantially similar to the Products). If OAI
exercises this right, OAI's distribution rights to the Products shall become
non-exclusive and the restrictions on both parties set forth in Section 2.1(a)
and 2.3 shall be removed.
2.4 EMPLOYEE SOLICITATION. During the Agreement Term and for a period of
one year thereafter, neither OAI nor the Company shall solicit for employment
the other party's employees, agents, or representatives, without the prior
written consent of such other party.
2.5 PRODUCT CUSTOMER SERVICE. OAI and the Company shall maintain a
coordinated and comprehensive customer service and support mechanism to respond
to (i) customer inquiries regarding the use, operation, and/or maintenance of
the Products, and (ii) customer Product service and repair requirements. Product
Customer Service shall include, without limitation, the following items:
(a) TELEPHONE SUPPORT. The telephone support to be provided by the
Company is set forth on SCHEDULE 2.5 attached hereto.
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(b) CLM DISINFECTORS (MODELS MRX, 5001, AND
5002V). OAI shall perform all pre-installation site
evaluation, installation, and in-service customer orientation
of and for the CLM Disinfectors (as identified on SCHEDULE
1.8). The Company shall be responsible for performing all
service and repair (in-warranty and out-of-warranty) on the
CLM Disinfectors. The Company's labor rate for out-of-warranty
service and repairs shall be no more than $125.00 per hour for
the initial year of the Agreement Term, with per annum
increases thereafter limited to 7 1/2%. In conjunction with
the service and repair of the CLM Disinfectors, a "hot swap"
program will be in place. The CLM Disinfector "hot swap"
program will entail, without limitation, disconnection and
shipment of the CLM Disinfector unit to be repaired,
installation of a loaner unit at the customer site, shipment
to and re-installation of the repaired unit at the customer
site after repair, and disconnection and shipment of the
loaner unit back to the Company. The Company and OAI will
coordinate their efforts equally with respect to this "hot
swap" program. The Company will reimburse OAI at OAI's per
hour labor rate set forth on SCHEDULE 7.9 attached hereto (two
hours maximum) per "hot swap" of a CLM Disinfector in which
OAI assists the Company. If OAI is unable to assist the
Company in the "hot swap" program, the Company and OAI will
mutually select a third-party to perform the service, and the
Company shall pay the third-party's fees up to the
aforementioned two hour maximum limit per "hot swap" (with the
customer to be billed for any additional third-party fees in
excess of such two hour limit). Notwithstanding anything
contained in this Section 2.5(b) to the contrary, if more than
20% of CLM Disinfector placements result in a "hot swap", the
Company shall reimburse OAI for all amounts incurred in excess
of the aforementioned two hour maximum limit.
(c) DSD SENSOR INSTALLATION/REPLACEMENT PROGRAM.
The Company (or a third-party service organization reasonably
acceptable to OAI and the Company) shall be responsible for
the performance of, and all costs and expenses related to, the
upgrade of the FS-4 sensor on the DSD-91E Disinfector. This
upgrade program will be
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performed at no charge to the customers or OAI and will not be
implemented until OAI has been fully informed of the execution
plan and target completion date.
(d) OAI FUNCTIONS. Except as set forth in Sections 2.5(b) and 7.9,
OAI shall be responsible for initial Disinfector pre-installation site
evaluation, installation, in-service customer orientation, OAI sales and service
training, and repair with respect to and of the Products marketed or sold by OAI
within the Territory. Notwithstanding the foregoing, OAI may require the Company
to perform complicated repairs of OLYMPUS DSD Disinfectors. During the
Post-Agreement Period, OAI shall have the right, at its option, to either (i)
continue to perform these OAI functions for all Product customers existing prior
to the end of the Agreement Term or (ii) cease performing these OAI functions,
PROVIDED that if OAI chooses to cease performance, it must notify the Company of
such decision at least 90 days' prior to the start of the next year of the
Post-Agreement Period.
ARTICLE 3. OBLIGATIONS OF THE COMPANY.
3.1 TESTING, VERIFICATION, DESIGN VALIDATION, AND PROCESS VALIDATION. The
Company shall provide complete documentation which demonstrates that those
Products which require pre-market notification ("510(k)") clearance by the FDA
have been so cleared. Such documentation shall include, without limitation,
specifications, performance testing, Verification protocols and test results,
Design Validation protocols and test results, and Process Validation protocols
and test results. For those Products deemed by the Company not to require 510(k)
clearance, the Company shall provide to OAI documentation to support the
decision not to file 510(k)s with the FDA. With respect to the Disinfectors, the
Company shall conduct Verification, Design Validation, and Process Validation
activities to ensure the performance of the Disinfector, including but not
limited to the ability of the Disinfector to perform high-level disinfection
and/or sterilization of the Equipment and to safely remove all residual cleaning
and disinfecting materials and sterilizing agents from the Equipment. Subject to
Article 10 (Confidential Information) and requirements of law, and in order to
make certain representations to the FDA, the Company shall, as and when
requested by OAI, provide OAI with the results of its testing, Verification,
Design Validation, and Process Validation efforts with respect to the Products.
The Company shall bear its own direct and indirect costs incurred in the
performance of its activities hereunder. The Company shall make all reasonable
modifications to the Products to render them compatible with the Equipment. OAI
shall have no obligation to render any Equipment compatible with the Products.
Within 30 days after the date of
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this Agreement, each of OAI and the Company shall identify for the other, in
writing, its primary personnel contacts regarding communication of testing,
Verification, Design Validation, and Process Validation issues.
3.2 OAI AUDITS. OAI shall have the right, at its cost and expense, to
perform periodic audits of the Company (not less than one per annum) with
respect to the Products and the quality systems related thereto (including but
not limited to Quality System Regulations, 21 C.F.R. Part 820) to (i) determine
compliance with the then current published Good Manufacturing Practices
promulgated by the FDA, (ii) review in-house bench servicing activities of the
Company, and (iii) assess progress made on corrective/preventive actions arising
from previous audits. Such audits shall be performed during normal business
hours and upon not less than ten days' prior notice to the Company. Audit
frequency shall be determined by OAI based upon, but not limited to, trend
analysis of Complaints, the proposed introduction of new products, and/or
substantial changes to the Company's suppliers and/or manufacturing processes.
The parties will cooperate with each other to arrange such visits at mutually
convenient times. In addition, upon not less than ten days' prior notice, OAI
personnel may periodically travel to the Company's facilities, at OAI's cost and
expense, to observe testing, Verification activities, Design Validation
activities, and Process Validation activities, receive information with respect
thereto, and ensure that the Products are being tested in accordance with Good
Laboratory Practices (21 C.F.R. Part 58). Should the audit results indicate that
corrective/preventive action is required by the Company, the Company shall use
its best efforts to effect corrective/preventive action(s) in a timely manner.
The progress and effectiveness of the corrective/preventive action(s) are
subject to re-audit by OAI as outlined above.
3.3 APPROVALS AND CLEARANCES. The Company shall ensure that the Products
are not sold to OAI before all required governmental or private approvals and
clearances, including without limitation compliance with UL and '510(k) of the
Food, Drug, and Cosmetic Act of 1938 and Safe Medical Device Act of 1990, each
as amended, for the sale, lease, distribution or marketing of the Products have
been obtained.
3.4 COMPLAINTS. The Company shall conduct a complete and documented
investigation and shall use its best efforts to fully resolve Complaints
regarding the Products (whether such Complaints are received by the Company
directly, or via OAI, OAI's Affiliates, or a third party) in accordance with the
requirements for Complaint handling as defined and promulgated by the FDA in the
then current published Good Manufacturing
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Practices (21 C.F.R. Part 820) or any other applicable law, rule, or regulation.
OAI shall promptly forward to the Company all such Product Complaints received
by OAI. Product Complaints received or generated by OAI shall be communicated by
OAI to the Company via telecopy and/or U.S. Mail. Any and all Medical Device
Reports (MDR) Reportable Events shall be filed with the FDA (with a copy to OAI)
by the Company in accordance with all applicable laws, rules, and regulations
(including but not limited to 21 C.F.R. Part 803). The Company shall give OAI
prompt notice of Product Complaints received by the Company directly or via
third parties. All such Complaint investigations shall be performed and
completed promptly but in no event later than 30 days from receipt of the
Complaint by the Company. If as a result of the Company's investigation a
Product Change is necessary, the Company will perform and document such Product
Change (i) in accordance with this Agreement, (ii) at no charge to OAI, and
(iii) in consultation with OAI. OAI shall have the right to review all Product
Changes and corrective actions resulting from a Complaint investigation. If OAI
reviews such Product Changes and/or corrective actions and reasonably determines
that such Product Changes and/or corrective actions will likely result in
incompatibility/ineffectiveness of the Product(s) with respect to the Equipment
and/or the compromise of the Products' safety, then OAI will give the Company
notice of such findings with an attendant 30 days to develop a plan to resolve
such incompatibility/ineffectiveness. If the Company fails to develop such a
plan during such 30-day period, OAI may, in addition to all other rights and
remedies at law or in equity or otherwise, unilaterally terminate this Agreement
and all pending purchase orders pursuant to Section 8.2(c), PROVIDED notice of
such termination is given within 30 days of the end of the 30-day plan
development period.
2.5 SPECIAL INVESTIGATIONS; INQUIRIES.
(a) If any government, health or other regulatory
authorities or private standards boards in the Territory require any
clinical or other investigations to be performed with respect to the
Products and the quality systems related thereto (including but not
limited to Quality System Regulations, 21 C.F.R. Part 820), and the
Company has not performed such investigations or if, for any reason,
such authorities will not accept the results of the Company's
investigations, then the Company shall use its best efforts in
promptly undertaking and completing such investigations. Each Party
agrees to notify the other of any formal or informal inquiries
relating to the Products by the FDA or any other regulatory agency,
any private standards board, or any state or Federal government.
Included in such notification shall be a
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copy of the Form 483 (in the case of an FDA inquiry) or other
similar document left by or subsequently sent by the inquirer.
(b) The Medical Device Directive notification requirements for Vigilance
Reporting specify that product performance or malfunction, regardless of
geographical location of occurrence, must be reviewed and/or reported to the
Company's Notified Body in a specified time period. Therefore, any outside
agency notification must be reported to the Company if related to injury,
Product performance or malfunction prior to or in parallel to any documentation
filings such as FDA Medical Device Reports. OAI shall notify the Company's
Regulatory Affairs Dept. via fax at (000) 000-0000 (or other fax number provided
to OAI in writing). The Company shall be required to acknowledge said
notification to OAI's Regulatory Affairs Dept. via fax at (000) 000-0000 (or
other fax number provided to the Company in writing).
3.6 PRODUCT CHANGES. The Company shall give OAI 90 days written notice of
any proposed Product Change not relating to or resulting from a Product
Complaint (as described in Section 3.4). The third to last and penultimate
sentences of Section 3.4 are incorporated into this Section 3.6 by reference.
The Company shall, prior to the implementation of a Product Change, promptly
obtain all approvals and clearances, if any, required to manufacture the
Product(s) and sell the Product(s) (as changed, modified, or added) within the
Territory. All Product Changes, regardless of whether initiated by OAI or the
Company, shall be implemented in accordance with an SOP which details a
procedure including, without limitation, Engineering Change Requests and
Engineering Change Orders. OAI and the Company shall consult with each other and
mutually decide whether a particular Product Change requires a Pre-market
Notification to the FDA, including without limitation a 510(k) or PMA
notification. A change of a supplier by the Company shall not constitute a
Product Change, PROVIDED that the Company has performed Process Validation and
Design Validation (in accordance with the FDA Guidance document, "Validation and
Documentation Inspection Guide" dated 1993) with respect to the new supplier and
the new materials supplied. Significant process changes are also subject to
Process Validation activities. OAI shall have the opportunity to review all
Design Validation and Process Validation protocols (for changes in supplier
and/or process) and test results prior to the implementation of same by the
Company. All Product Changes developed by the Company shall be owned by the
Company.
3.7 DOCUMENTATION & TRAINING. The Company shall furnish to OAI, without
additional charge and for the duration of the Agreement Term and for a period of
two years thereafter, the
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following:
(a) DOCUMENTATION. All technical information, documentation and test
data necessary to inventory, market, sell, ship, repair and maintain the
Products within the Territory. Such materials shall be consistent with similar
information furnished to other distributors of the Products and/or similar
products manufactured by the Company. The Company hereby grants to OAI a
fully-paid, non-transferable license for the Agreement Term to copy or otherwise
reproduce all or portions of the Company's brochures, or to incorporate portions
of the Company-copyrighted material in Product brochures or advertising material
composed by OAI, PROVIDED that (i) OAI shall submit such materials composed by
OAI which incorporate the Company-copyrighted material to the Company for prior
written approval, which approval shall not be unreasonably withheld or delayed,
and (ii) OAI uses such materials solely to fulfill its obligations under this
Agreement. Such reproduction will not apply to proprietary and confidential
information and will be subject to all applicable copyright laws. An SOP will be
developed, within 90 days after the date of this Agreement, which SOP shall
detail the process of documentation accumulation, storage, and transfer between
OAI and the Company.
(b) TRAINING. Periodic in-person training of OAI's sales, service
and customer support staff at a location selected by OAI. Field service training
will be detailed in a formal curriculum which must include, without limitation,
required testing and recertification intervals. Each of the Company and OAI will
bear the costs and expenses of its respective personnel in connection with such
training. Notwithstanding the foregoing, the Company shall hire and maintain, at
its sole cost and expense, a Technical Liaison (with a reasonable travel budget)
who will interact with appropriate OAI personnel.
3.8 NONINTERFERENCE. The Company covenants that it shall not interfere
with OAI's rights and obligations as the exclusive distributor and
semi-exclusive servicer of the Products as set forth in Article 2.
3.9 INSURANCE. Commencing on the first date of Product delivery until the
expiration of the pertinent statute of limitations, the Company shall maintain
product liability insurance with an insurance company in the amount of
$1,000,000, naming OAI as an additional insured, for any injury to persons or
property resulting from the manufacture, testing, demonstration, marketing,
sale, lease, rental, distribution or use of the Product. Copies of such policy
and any notices thereunder shall be forwarded to OAI along with 30 days' prior
notice of
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termination or cancellation of such policy.
3.10 RECALLS. In the event that any Product defect or regulatory or
governmental action requires a Product's recall, destruction, withholding from
the market, or other action (a "Recall"), the Company shall bear all costs and
expenses of such Recall. OAI shall reasonably assist the Company, at the
Company's cost and expense, in carrying out any such Recall. OAI shall bear the
costs and expenses of a Recall if such Recall is the direct result of any act or
omission to act attributable principally to OAI. If a Recall is the direct
result of acts or omissions to act attributable to both the Company and OAI, or
should it prove impossible to assign fault for such Recall, the Company and OAI
shall share the costs and expenses of such Recall equally.
3.11 ANCILLARY PRODUCTS.
(a) During the Agreement Term and the Post-Agreement Period, the
Company agrees to offer for sale to OAI all Ancillary Products for the
Disinfectors. During the Post-Agreement Period, OAI will only (i) sell or
provide Ancillary Products in connection with Product Customer Service to
Product customers existing prior to the end of the Agreement Term and (ii)
except as provided in the last sentence of Section 4.3, buy Ancillary Products
from the Company or the Company's dealer, distributor or reseller. If OAI ceases
performance of its Product Customer Service functions in accordance with the
last sentence of Section 2.5(e), the Company need not continue to offer the
Ancillary Products for sale to OAI.
(b) During the Post-Agreement Period, the prices charged to OAI for
the Ancillary Products shall be as set forth on SCHEDULE 3.11 attached hereto.
(c) The Company shall use its best efforts to stock sufficient
inventory of Ancillary Products to support the Disinfector units delivered to
OAI's customers. If and when necessary, the Company shall use its best efforts
to ship Ancillary Products overnight, at OAI's cost (unless overnight shipment
is made necessary due to the fault of the Company), in the event OAI does not
have such Ancillary Product in stock. In the event the Company is unable to
supply such Ancillary Products and obtain another source of supply for OAI, then
such inability shall be considered noncompliance with this Section and the
Company shall use commercially reasonable efforts, with neither obligation nor
charge to OAI, to provide OAI with drawings and other documents required to
either manufacture or buy such Ancillary Products and the technical information
or any other rights necessary for OAI to manufacture or obtain such Ancillary
Products from other sources, together with a non-exclusive
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license to make or have made such Ancillary Products for the exclusive purpose
of supporting Product customers (and, once the Agreement Term has ended, only
Product customers existing prior to the end of the Agreement Term) within the
Territory. The technical information includes, by example and not by way of
limitation (i) manufacturing drawings and specifications of materials and parts
comprising the Ancillary Products and components thereof; (ii) manufacturing
drawings and specifications covering special tooling and operation thereof;
(iii) a detailed list of all commercially available accessories, consumables,
parts and components purchased by the Company on the open market, disclosing the
model/part number, name and location of the supplier and price lists for the
purchase thereof; and (iv) one complete copy of the source code used in the
preparation of any software licensed or otherwise acquired by OAI from the
Company, PROVIDED, HOWEVER, that such source code shall remain the property of
the Company (or third-party owner thereof) and shall be separately licensed to
OAI for OAI's possession and use exclusively for maintenance of OAI's customers.
The aforementioned drawings, documents, and technical information provided to
OAI (and all copies thereof) shall be returned to the Company once the Company
is able to supply the Ancillary Products.
3.12 PACKING AND MARKING. The Company shall pack and xxxx the Products in
accordance with applicable laws and regulations. The Company shall prominently
and permanently affix OAI's trade name, trademark, colors, and logo (the "OAI
Marks") and may permanently but less prominently (i.e., location, font, color)
affix the Company's trade name, trademark, and logo (the "Company Marks") on the
Products, all Product packaging, printed materials, labels, and tags as mutually
agreed between the parties. Any use by the Company of the OAI Marks or any trade
name, trademark, or logo which is similar to an OAI Xxxx, and the goodwill of
any business associated with such trade names, trademarks, or logos, shall inure
to the benefit of OAI. Upon termination or expiration of this Agreement, the
Company shall (i) not sell any product (including the Products) which is
packaged and/or marked in materials containing or with the OAI Marks and (ii)
immediately cease any use of the OAI Marks. Except as expressly set forth
herein, (a) the Company shall not have any right to use nor shall the Company
acquire any right, title, license, or other interest in the "OLYMPUS" name, or
any trade name, trademark, or logo belonging to OAI, including but not limited
to the OAI Marks, and (b) OAI shall not have any right to use nor shall OAI
acquire any right, title, license, or other interest in the "MEDIVATORS" name,
or any trade name, trademark, or logo belonging to the Company, including but
not limited to the Company Marks. The Company hereby grants to OAI the right and
license to use the Company Marks exclusively with respect to the Products and in
accordance with this Agreement.
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3.13 LABELING. The Company shall give OAI a reasonable opportunity to
review and approve all Product labeling contained on and distributed with the
Products and such labeling shall comply with all FDA rules and regulations
(including but not limited to 21 C.F.R. Part 801).
3.14 REPAIR HISTORY. In the event a repair to a Product is necessary, the
Company shall promptly provide OAI with the repair history of such Product, upon
OAI's request. Moreover, the Company shall provide OAI with written monthly
reports detailing the Company's Product Customer Service functions performed. In
addition, OAI will provide to the Company, upon the Company's request, the
repair history of Disinfector units sold during the term of the prior
Distributor Agreement between the parties dated March 12, 1996.
3.15 DEMONSTRATION AND TRAINING UNITS. During the Agreement Term, OAI will
have the right to purchase from the Company a reasonable number of Disinfector
demonstration and training units as OAI requires, at a price discounted by 30%
off of then-current list price. Such demonstration and training units will be
marked as such and will not be for re-sale.
2.16 PRODUCT DEVELOPMENT.
(a) The parties shall, within 30 days after the date of this Agreement,
form a multi-functional Product Development Committee which will identify
mutually agreed-upon new product opportunities and prioritize the application of
resources for endoscopy-related product improvements and/or the development of
next-generation endoscopy-related products.
(b) OAI and the Company shall exchange ideas and plans for a "Total GI
Endoscopy" suite (including but not limited to endo-therapy products,
endoscopes, and washers/disinfectors) with components which will interact with
each other and the EndoWorks(TM) computer system.
(c) The Company agrees to evaluate and use commercially reasonable efforts
to incorporate OAI's reasonably conceptualized and documented design changes
and/or enhancements to the Products ("OAI Enhancements"). Any increase or
reduction in the Company's manufacturing costs (labor and materials) resulting
from OAI Enhancements shall be reflected in reasonable price adjustments. Any
engineering/design costs and delivery dates for OAI Enhancements shall be quoted
to OAI for its approval and payment. Any related tooling purchased by OAI for
the Company's use in implementing OAI Enhancements shall be owned by OAI and
shall be used exclusively for the benefit of OAI. Any and all
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Intellectual Property relating to OAI Enhancements shall be owned by OAI and the
Company shall receive a non-exclusive license to use such OAI Enhancements on
the Products for the balance of the Agreement Term (on a royalty-free basis) and
for a period of nine months thereafter, PROVIDED that (i) use of such license
shall not cause the Company to compete with OAI or any OAI Affiliate during the
Agreement Term and (ii) the Company remits a mutually agreed-upon royalty (based
on the enhanced value of the affected product(s)) to OAI during the
aforementioned nine-month post-Agreement grace period. (The license during the
Agreement Term may be granted on a worldwide basis depending on OAI's evaluation
of its impact on OAI's Affiliates.) The Company shall not use the OAI
Enhancements for itself or for any other party for any purpose other than the
performance of its obligations hereunder. Product design changes and/or
enhancements conceived jointly by OAI and the Company shall be owned by OAI and
the Company jointly.
(d) OAI's audit rights set forth in Section 3.2 shall apply to this
Section as well.
3.17 QUALITY DISPUTE RESOLUTION. Within 60 days after the date of this
Agreement, OAI and the Company shall establish an SOP with respect to the
resolution of disputes that may arise between the parties in connection with the
regulatory and quality issues covered by Sections 3.1, 3.2. 3.3, 3.4, 3.5, 3.6,
3.7, 3.10, 3.13, 3.14, 4.4, 7.8(b), 7.8(c), and/or 7.10.
ARTICLE 4. OBLIGATIONS OF OAI.
4.1 PURCHASE PROJECTIONS. OAI projects that it will, during each year
of the Agreement Term, purchase the dollar volume of Products corresponding
to such year set forth on SCHEDULE 4.1 attached hereto, PROVIDED that OAI and
the Company develop (in a timely manner) the sales support infrastructure to
justify such purchase projections. If, at the end of an Agreement Term year,
it is determined that such year's purchase projection has not been met, the
Company may terminate this Agreement pursuant to Section 8.2(d) or modify
OAI's distribution rights to non-exclusive status. Such decision to terminate
or to remove exclusivity must be made within 60 days after the close of the
particular Agreement Term year. If during such 60-day period the Company
decides to terminate this Agreement or remove OAI's exclusivity, the Company
shall give OAI 30 days' prior written notice. During such 30-day notice
period, OAI shall have the right to cure the purchase projection shortfall,
and cancel the Company's decision to terminate or remove exclusivity, by
remitting to the Company the amount set forth in Section 8.2(d). Failure by
the Company to send such notice during such 60-day period shall mean OAI's
rights under Section 2.1 shall continue
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on an exclusive basis for at least the ensuing year of the Agreement Term. If
the Company elects to remove OAI's exclusivity in accordance with this Section
and OAI fails to revive the exclusivity as set forth in this Section 4.1, then
the restrictions on both parties set forth in Sections 2.1(a), 2.2, and 2.3 and
the foregoing purchase projections shall be canceled. Notwithstanding anything
contained herein to the contrary, the aforementioned purchase projections shall
not constitute a commitment by OAI to purchase such projected amount of Products
and OAI shall not have any liability whatsoever to the Company in the event such
projections are not satisfied.
4.2 SCOPE OF RESPONSIBILITY. During the Agreement Term, OAI shall, at its
own cost and expense, use commercially reasonable efforts to sell the Products
and perform its Product Customer Service obligations within the Territory. OAI
shall keep the Company reasonably informed, by means of the reports required by
Section 4.7, of market information and OAI's sales and marketing activities.
During the Agreement Term and the Post-Agreement Period, OAI shall not take any
action which would impair or diminish the reputation of the Company or the
Products. The parties agree that OAI's marketing, sale, or distribution of
changed or improved new products or products substantially similar to the
Products in accordance with the provisions of this Agreement, shall NOT
constitute impairment to or diminishment of the reputation of the Company or the
Products.
4.3 ALTERATION OF PRODUCTS. During the Agreement Term and the
Post-Agreement Period, OAI shall not alter, modify or substitute components of
the Products (except for Product Customer Service performed in the ordinary
course of business) or specifications relative thereto without the written
consent of the Company, which consent shall not be unreasonably withheld or
delayed. In effecting repairs on the Products, OAI shall use only Ancillary
Products purchased from or authorized by the Company. However, in the event of
an emergency, OAI may purchase Ancillary Products from a third-party retail
source.
4.4 RECONDITIONING DISINFECTORS UNITS. In the event a Disinfector unit is
returned by a customer due to OAI or customer administrative error (unrelated to
the Company), OAI shall bear the reasonable costs and expenses required to
disconnect, ship back, and/or recondition such Disinfector unit (collectively,
the "Reconditioning Expenses"). If a Disinfector unit is returned because the
customer elects not to purchase after an evaluation, OAI and the Company shall
bear the Reconditioning Expenses equally. (OAI shall inform the Company in
advance of placing a Disinfector unit for evaluation.) If a Disinfector unit is
returned because it has failed to perform in accordance with specifications
(e.g., component part failure), the Company shall
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bear the Reconditioning Expenses. Within six months after the date of this
Agreement, the parties will have formulated and begin implementation of SOPs
that deal specifically with the reconditioning of Disinfectors.
4.5 MARKETING. During the Agreement Term, OAI shall, at its own cost and
expense, use commercially reasonable efforts to market the Products in the
Territory. OAI shall attend major trade shows relating to the Products. OAI and
the Company shall meet semi-annually to review prior activity and to plot future
strategy.
4.6 INVENTORY. OAI shall maintain a working inventory of the Products
adequate, in OAI's sole and absolute discretion, to handle the reasonably
anticipated demand and to render satisfactory Product Customer Service to
Product customers.
4.7 MONTHLY SALES ACTIVITY AND INVENTORY REPORT. During the Agreement
Term, OAI shall submit to the Company by the 20th day of each month a written
Sales Activity and Inventory Report summarizing sales activity, Product Customer
Service activity (including repair history), and inventory status of the
Products for the prior month.
4.8 PROHIBITED SALES. During the Agreement Term and the Post-Agreement
Period, except as expressly agreed by the Company in writing, OAI shall not (i)
sell any Product for resale or for export out of the Territory; (ii) export any
Product from the Territory; or (iii) sell any Product to any person, firm or
company in the Territory which OAI knows or has reason to believe intends to
resell or export the Product out of the Territory.
4.9 INSURANCE. Commencing on the first date of Product delivery until the
expiration of the pertinent statute of limitations, OAI shall maintain
comprehensive general liability, automobile liability, and workers' compensation
insurance in the amount of $1,000,000 each, covering its activities hereunder as
a distributor and servicer of the Products. Evidence of such insurance shall be
provided to the Company upon reasonable request.
4.10 EQUIPMENT MODIFICATIONS. OAI will give the Company at least 90 days'
prior notice of modifications to the Equipment that will likely result in
incompatibility/ineffectiveness of the Products with respect to the Equipment.
The Company shall not be in default hereunder if it is unable to conform the
Products to such Equipment modifications.
4.11 SOLE REMEDY. Except as set forth in Section 9.3, the
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Company's sole remedy for the breach by OAI of any of the obligations contained
in this Article 4 shall be termination of this Agreement in accordance with
Section 8.2(b) or (d), as the case may be.
ARTICLE 5. PURCHASE ORDERS.
5.1 GENERAL. During the Agreement Term and, with respect to the Ancillary
Products, during the Post-Agreement Period as well, the Company agrees to sell
the Products to OAI and OAI may purchase the Products from the Company (if OAI
submits a purchase order therefor) and such purchases shall be governed by, in
accordance with, and subject to the terms and conditions of this Agreement. On
or about the date of this Agreement, OAI shall provide the Company with a
purchase order for the initial three months of the Agreement Term. Beginning
with the second month of the Agreement Term, in each month of the Agreement Term
OAI shall provide the Company with (a) a purchase order for the third month
following such month and (b) if OAI so elects, increased purchase orders for the
ensuing two months following such month.
5.2 DISINFECTOR INVENTORY AND DELIVERY. Upon submission by OAI of purchase
orders (in accordance with Section 5.5) for Disinfector units, the Company
shall, within 30 days, have such Disinfector units physically available in a
segregated OAI inventory (not commingled with other product inventory of the
Company) at the Company's principal shipping facility. Such segregated OAI
inventory shall be maintained by the Company at no charge to OAI. Upon receipt
of shipping instructions by the Company from OAI, the Company shall, within five
Business Days, ship the Disinfector units from the segregated OAI inventory to
the OAI customer(s) within the Territory designated by such shipping
instructions, provided that OAI has sufficient inventory to cover the order. OAI
shall bear the initial shipping costs incurred in delivering brand new or
newly-ordered reconditioned Disinfector units to OAI customers. OAI will also
bear the shipping costs incurred in delivering replacement units to customers
which are needed due to OAI administrative or customer error. OAI may cancel
shipping instructions and, at its option, either arrange for pick-up and
shipment or receive a credit for Disinfector units whose delivery is more than
ten days past due. The Company shall provide OAI with a written monthly
inventory report (with a copy to OAI's Vice President of Operations at the
address set forth in Section 11.4) listing the Disinfector units located in the
segregated section of the Company's principal shipping facility.
5.3 ANCILLARY PRODUCT DELIVERY. Upon submission by OAI of a purchase order
(in accordance with Section 5.5) for Ancillary
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Products, the Company shall, within 30 days, deliver such Ancillary
Products to OAI or the OAI customer(s) within the Territory, as designated by
OAI on the purchase order. OAI shall bear the shipping costs incurred by the
Company in delivering the Ancillary Products to OAI or OAI's customers. If
delivery of such purchase order is more than 30 days past due, OAI may, at its
option, either (i) cancel the purchase order for Ancillary Products or (ii)
elect to proceed with the solution set forth in Section 3.11(c). If OAI or OAI's
customer finds any quantity deficiency in the Ancillary Product units, OAI may,
at its option, (i) require the Company to immediately deliver the difference by
air freight at the Company's expense, or (ii) reduce the purchase price
specified in the related purchase order accordingly. If OAI or OAI's customer
finds an over-shipment of Ancillary Product units, OAI and/or the OAI customer
may store the excess units or return the excess units to the Company, both at
the Company's risk and expense.
5.4 TITLE; RISK OF LOSS. Title to and risk of loss for the Products sold
to OAI shall pass to OAI upon (i) placement of the Disinfector units into the
segregated OAI inventory at the Company's principal shipping facility (with
respect to the Disinfectors), and (ii) receipt of the Ancillary Products by the
carrier selected by OAI to deliver the Ancillary Products to OAI or OAI's
customers.
5.5 CONDITIONS OF SALE. The order terms and conditions set forth in this
Agreement shall govern all orders made under this Agreement, and any standard
printed order forms or other documents of either party (such as those contained
on a quotation, proposal, purchase order, or invoice) shall have no force or
effect with respect to such orders unless such form or document specifically
states that it is an amendment to this Agreement and is signed by an authorized
signatory of each party. Notwithstanding the foregoing, OAI's purchase order may
indicate the following terms which shall govern: Product quantity, delivery
destination and schedule, and a reference to the applicable pricing. OAI shall
have no obligation to purchase until it submits a purchase order to the Company.
An OAI purchase order shall be deemed accepted by the Company unless OAI is
notified to the contrary in writing by the Company within seven days of the
Company's receipt of such purchase order from OAI. An appropriate
policy/procedure will be developed to handle special requests.
5.6 PRICE.
(a) PRICING. During the first year of the Agreement Term, the price
to be charged to OAI for (i) the Disinfector shall be fixed as set forth in
SCHEDULE 1.8 attached hereto, and (ii) the Ancillary Products shall be fixed as
set forth in
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SCHEDULE 1.4 attached hereto. During each of the second, third and fourth years
of the Agreement Term, the Company may only increase the prices for the Products
once by no greater than ten percent (10%) per Agreement Term year, UNLESS the
cost of a major component increases sufficiently to warrant a price increase
above the foregoing 10% limit. In the event the Company wishes to increase
prices by more than the 10% limit due to a major component increase, the Company
shall substantiate and justify such increase to OAI in writing, and OAI will
then have the option to locate the component from a third-party at a lower price
for the Company's purchase of such third-party component in order to reduce or
eliminate the price increase to OAI. Price increases due to mutually agreed-upon
Product additions and/or enhancements will not be limited by the foregoing 10%
limit. Any permitted annual price increases must be communicated to OAI during
the 60 days immediately prior to the start of the Agreement Term year and shall
take effect on the first day of such Agreement Term year. Product pricing shall
only be adjusted in accordance with this Section 5.6(a) unless otherwise agreed
by the parties. Instruction manuals shall be included in the price of the
Products. OAI shall be free to set its own Product prices charged to its
subdistributors, dealers, and customers.
(b) PAYMENT. OAI shall pay for Disinfector units no later than 30
days from (i) placement by the Company of the Disinfector units in OAI inventory
AND (ii) the date of the corresponding invoice. OAI shall pay for all Ancillary
Products received and not rejected (within ten days) by OAI or OAI customers no
later than 30 days from the date of the Company's invoice corresponding to such
Ancillary Products received and not rejected (within ten days). All payments
overdue by more than ten Business Days shall generate a one and one-half percent
(1 1/2%) late payment penalty (or the highest rate permitted by law if less than
one and one-half percent (1 1/2%) per month) for each month such payment is
overdue.
5.7 UPON TERMINATION. Unless OAI decides that it does not want a purchase
order or shipping instruction filled, any purchase order/shipping instruction
submitted by OAI but not shipped by the Company prior to the date that notice of
termination is delivered hereunder or the date that this Agreement otherwise
expires, shall be timely delivered to OAI's segregated inventory at the
Company's principal shipping facility or the destination points designated by
OAI (as the case may be), PROVIDED that such termination did not arise from
OAI's default.
ARTICLE 6. REPRESENTATIONS AND WARRANTIES OF OAI.
OAI hereby covenants, represents and warrants to the Company, its successors and
permitted assigns that:
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6.1 DUE ORGANIZATION. OAI is a corporation duly organized, validly
existing and in good standing under the laws of the State of New York, and has
the full power and authority to conduct all activities conducted by it under
this Agreement.
6.2 AUTHORIZATION TO EXECUTE. The person executing this Agreement on
behalf of OAI has been duly authorized to do so by all requisite corporate and
other action of OAI, and this Agreement has been duly executed and delivered to
the Company by such person.
6.3 VALIDITY OF AGREEMENT. This Agreement is the legal, valid and binding
obligation of OAI, enforceable in accordance with its terms.
6.4 NO CONFLICT. To the knowledge of OAI, the execution, delivery and
performance of this Agreement by OAI does not and will not conflict with or
result in a breach of any agreement, instrument or understanding, oral or
written, to which OAI is a party. There is no litigation, arbitration or
administrative proceeding pending or threatened which would, in any event,
conflict with or result in a breach of this Agreement or interfere with OAI's
obligations hereunder.
6.5 COMPLIANCE. OAI shall ensure that, in marketing and selling the
Products, it shall (i) comply with all applicable laws and regulations and (ii)
not engage in any deceptive or misleading practices.
ARTICLE 7. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
The Company hereby covenants, represents and warrants to OAI, its successors and
permitted assigns, and to OAI's customers that:
7.1 DUE ORGANIZATION. The Company is a corporation duly organized, validly
existing, and in good standing under the laws of the State of Minnesota, and has
the full power and authority to conduct all activities conducted by it under
this Agreement.
7.2 AUTHORIZATION TO EXECUTE. The person executing this Agreement on
behalf of the Company has been duly authorized to do so by all requisite
corporate and other action of the Company, and this Agreement has been duly
executed and delivered to OAI by such person.
7.3 VALIDITY OF AGREEMENT. This Agreement is the legal, valid and binding
obligation of the Company, enforceable in accordance with its terms.
7.4 NO CONFLICT. To the knowledge of the Company, the
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execution, delivery and performance of this Agreement by the Company does not
and will not conflict with or result in a breach of any agreement, instrument or
understanding, oral or written, to which the Company is a party. There is no
litigation, arbitration or administrative proceeding pending or threatened which
would, in any event, conflict with or result in a breach of this Agreement or
interfere with the Company's obligations hereunder.
7.5 RIGHT TO USE TECHNOLOGY. The Company has the legally enforceable right
to use all technology contained within or related to the Products, whether
patented or unpatented, for the purposes specified in this Agreement, and such
use of such technology does not violate any agreement, instrument or
understanding, oral or written, to which the Company is a party.
7.6 WARRANTY OF NON-INFRINGEMENT. The Products do not incorporate or
infringe upon any copyright, patent, trademark, service xxxx, trade name, trade
secret, idea, process, know-how, development, invention, or any other form of
intellectual property (collectively "Intellectual Property") not owned by or
licensed to the Company. The Company will promptly notify OAI of any alleged or
actual infringement by the Company of any Intellectual Property relating to the
Products or their manufacture. Nothing in this Agreement shall be deemed to
confer upon either OAI or the Company any right, title, interest, or license,
express or implied, to or in any of the other party's current or future
Intellectual Property or in the goodwill now or hereafter associated therewith.
7.7 RIGHT TO SELL FOR RESALE; ABILITY TO DELIVER. The Company has the
right to sell the Products to OAI for resale by OAI in the Territory. The
Company has and will have the ability to timely deliver all of the Product units
ordered by OAI during the Agreement Term and Post-Agreement Period. The Company
shall not be liable for any indirect, special, incidental or consequential
damages (including but not limited to lost profits, lost investments, and lost
business opportunities) resulting from its failure to timely deliver any
Product.
7.8 PRODUCT QUALITY.
(a) The Products to be sold to OAI hereunder shall (i) meet their
respective published specifications during the warranty periods set forth in
Section 7.9(b) and (ii) be new and free from defects in design, materials, and
workmanship.
(b) The Company shall possess a Quality System (as defined in
current Good Manufacturing Practices) that adheres to all applicable laws, rules
and regulations, including without limitation the practices and regulations of
the FDA (including
23
but not limited to current Good Manufacturing Practices as expressed in 21
C.F.R. Part 820 and Pre-Market Notification Procedures of 21 C.F.R. Part 807,
Subpart E). In addition, the Company shall hire and maintain sufficient
personnel devoted substantially to process quality control.
(c) Within 30 days after the date of this Agreement, OAI and the
Company shall form a Continual Quality Improvement (CQI) Task Force. The CQI
Task Force will meet or teleconference at least monthly to review and/or
establish Product quality, parts handling and delivery, and quantifiable Product
quality improvement goals and corresponding timelines. The success of the CQI
Task Force will be measured using Customer Satisfaction Index Data.
7.9 PRODUCT WARRANTY.
(a) Subject to the "hot swap" program set forth in Section 2.5(b),
with respect to each Product unit sold to OAI and delivered to an OAI customer,
the Company shall, at no charge to OAI for parts, labor, and material, replace
or render fully operational any non-conforming or defective Product part or
material by reason of the breach by the Company of the warranty set forth in
Section 7.8(a), within ten days after receipt by the Company of the
non-conforming or defective Product part or material. The Company shall, within
the aforementioned ten-day period plus an additional ten days, reasonably
determine whether the Product part or material is non-conforming or defective,
and whether it is covered by this warranty. OAI shall reimburse the Company for
the cost of any replacement or repair part delivered by the Company in place of
a Product part or material which, within the combined twenty-day period referred
to in the preceding sentence, is reasonably determined by the Company not to be
(i) non-conforming or defective or (ii) covered by this warranty; PROVIDED, that
the Company returns to OAI the Product part or material initially sent by OAI.
OAI will perform the labor itself or via a third-party service provider with the
cost billed back to the Company at OAI's per hour labor rate set forth on
SCHEDULE 7.9 attached hereto, for all labor associated with the repair or
replacement of defective or non-conforming Product parts. Notwithstanding the
foregoing, the LABOR cost for a DSD Disinfector in-warranty service call that is
not due to a defective or non-conforming Product part shall be borne by OAI.
(b) Except as otherwise agreed in writing by the parties, the
warranty period for all (i) Disinfectors shall be the earlier of (x) twelve
months after the date the Disinfector unit is installed at the OAI customer's
facility or (y) 15 months after the shipment date; (ii) Ancillary Products shall
be 90 days commencing on the date of use by the customer; and (iii) replacement
DSD printers shall be six months commencing on the
24
date of use by the customer.
(c) Notwithstanding the foregoing, in the event of failure by the
Company to repair or replace non-conforming or defective Product parts, material
or units under warranty within the respective time periods set forth in Section
7.9(a), (i) OAI may, at its sole and absolute discretion after informing the
Company of its intentions, make such corrections or replace such Product parts,
material, or units and charge the Company for the cost incurred by OAI in doing
so and (ii) the Company shall reimburse OAI for any and all reasonable
additional costs and expenses incurred by OAI as a result of such failure to
repair or replace, which costs and expenses would not have been incurred if not
for such failure to repair or replace. Failure of the Company to repair or
replace within 30 days, shall entitle OAI to a full refund for the affected
Product unit(s), provided the affected Product units are returned to the Company
in a timely fashion. The foregoing reimbursement plan shall continue until the
non-conforming Product parts, material, or units are repaired, replaced, or
refunded.
(d) OAI must receive prior written authorization from the Company
prior to returning entire Disinfector units or Major Defect parts to the
Company. Such written authorization shall not be unreasonably withheld or
delayed. OAI must package, in a commercially reasonable fashion, the Disinfector
units and Major Defect parts to be returned to the Company. Shipping costs
incurred by OAI and risk of loss upon return of Product parts, material, or
authorized Disinfector units to the Company for repair or replacement (in
accordance with this Section 7.9) shall be borne by the Company. Shipping costs
incurred by the Company and risk of loss upon delivery of the repaired or
replacement Product parts, material, or Disinfector units to OAI shall be borne
by the Company. The parties shall create SOPs which outline Product part
procurement and Returned Goods Authorization procedures.
(e) Inspection, testing, acceptance, or use (or failure to do the
same) of the Products on any occasion shall not affect OAI's rights and the
Company's obligations under this Agreement or any other rights or remedies
available to OAI whether at law, in equity, or otherwise, and such warranties,
rights, and remedies shall survive such inspection, testing, acceptance, and
use.
(f) The foregoing warranty shall not limit or exclude OAI's other
remedies hereunder, at law, or in equity. Notwithstanding the preceding
sentence, in no event shall the Company be liable for indirect, incidental,
consequential, or special damages, including but not limited to damages for lost
25
profits, lost investments, or lost business opportunities.
7.10 COMPLIANCE. The Company has ensured and shall continue to ensure
that, in manufacturing and selling the Products to OAI, it shall (i) comply with
all applicable laws and regulations, (ii) not engage in any deceptive or
misleading practices, and (iii) obtain and maintain all required governmental
and private approvals and clearances (including without limitation compliance
with UL, '510(k) of the Food, Drug, and Cosmetic Act of 1938, as amended, and
the Safe Medical Devices Act of 1990, as amended).
7.11 PRICE WARRANTY. The Company warrants that the prices referenced in
Section 5.6(a) and SCHEDULES 1.4 AND 1.8 shall be complete and no additional
charges of any kind (except for shipping costs) shall be added without OAI's
prior written consent. Examples of additional charges include, but shall not be
limited to, packaging, labeling, (re)stocking, storage, insurance, boxing, or
crating.
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ARTICLE 8. TERM AND TERMINATION.
8.1 TERM. This Agreement shall remain in full force and effect commencing
on the date first above written and expiring on the fourth (4th) anniversary
therefrom (the "Agreement Term") unless earlier terminated pursuant to Section
8.2. Notwithstanding the foregoing, the Agreement Term may be suspended pursuant
to the provisions of Section 11.1 of this Agreement.
8.2 EVENTS OF TERMINATION. This Agreement may be terminated, without
limiting any party's rights to other remedies, as follows:
(a) Upon ten days' written notice by either party (the "Terminating
Party") to the other party (the "Breaching Party"):
(i) if the Breaching Party has not performed or has
materially breached its obligations hereunder and if
such nonperformance or breach is incapable of cure; or
(ii) if any proceeding in bankruptcy, reorganization or
arrangement for the appointment of a receiver or a
trustee to take possession of the Breaching Party's
assets or any similar proceeding under the law for
relief of creditors shall be instituted by or against
the Breaching Party; or
(iii) if the Breaching Party shall make an assignment for the
benefit of its creditors; or
(iv) if the Breaching Party sells or otherwise transfers,
singly or in the aggregate, 25% or more of its ownership
or assets without the prior written consent of the
Terminating Party; or
(v) in accordance with Section 11.1 (FORCE MAJEURE).
The Breaching Party immediately shall notify the Terminating Party
in writing of the occurrence of any event of the type described in
clauses (a)(ii), (iii), and (iv).
(b) By the Terminating Party upon the expiration of 30
27
days (or such additional period as the Terminating Party may authorize) after
the Breaching Party's receipt of written notice of its material breach or
non-performance of its obligations hereunder and if such breach or
non-performance is capable of cure and has not been cured.
(c) By OAI upon 30 days' prior written notice to
the Company of the rejection of a Product Change or corrective
action in accordance with Section 3.4.
(d) By the Company upon 30 days' prior written notice to OAI of
OAI's failure to meet an annual purchase projection in accordance with Section
4.1. However, OAI shall have the right, at its option, to remit to the Company
the portion of such Agreement Term year's purchase projection shortfall
attributable to the Company's documented gross profit (i.e., Product pricing set
forth in Section 5.6(a) LESS cost of goods sold) during such 30-day notice
period and thus cure and revive the Agreement.
(e) By OAI, without cause and without liability, upon nine months'
prior written notice to the Company, PROVIDED that during such nine-month
period, OAI will continue to purchase the Products from the Company at a volume
equal to or exceeding the average purchases for the six-month period prior to
the date of the written termination notice. If OAI elects to terminate this
Agreement in accordance with this Section 8.2(e), then the restrictions on both
parties set forth in Sections 2.1(a), 2.2, and 2.3 shall be canceled.
8.3 RIGHTS AND OBLIGATIONS UPON TERMINATION. Upon expiration or earlier
termination of this Agreement, OAI shall have the right to (i) sell all Product
units ordered by OAI customers, (ii) within 30 days of the date of termination,
sell all Product units in OAI inventory (whether at OAI's or the Company's
facility), and (iii) provide ongoing Product Customer Service to its customers
in accordance with this Agreement.
8.4 TERMINATION OR EXPIRATION DAMAGES. Notwithstanding anything contained
in this Agreement to the contrary, neither OAI nor the Company shall be liable
to the other, or to any other business entity or subdistributor, solely by
reason of the expiration or termination of this Agreement regardless of the
rationale for or propriety of any termination or expiration. The exculpation
from liability shall be for any losses or damages of any kind whatsoever,
including, but not limited to, direct, indirect, special, consequential or
incidental damages sustained by reason of such termination, including but not
limited to, any claim for loss of compensation or profits or for loss of
prospective compensation or prospective profits in respect of
28
sales of any of the Products or on account of any expenditures, investments,
leases, capital improvements or any other commitments made by either party in
connection with their respective businesses made in reliance upon or by virtue
of this Agreement or otherwise.
8.5 SURVIVAL. Sections 2.4, 2.5, 3.4, 3.5, 3.7, 3.9, 3.10, 3.11, 3.12, 4.2
(last two sentences only), 4.3, 4.8, 4.9, 4.11, 5.1, 5.2 (but only with respect
to purchase orders submitted prior to the end of the Agreement Term), 5.3, 5.4,
5.5, 5.6(b), 5.7, 6.3, 6.4, 6.5, 7.3, 7.4, 7.5, 7.6, 7.7, 7.8(a), 7.9, 7.10,
7.11, 8.3, 8.4, and 8.5, and Articles 9, 10, and 11 (except Section 11.6)
hereof, shall survive the expiration or earlier termination of this Agreement.
In certain Sections, the survival period will be limited to the duration of the
post-Agreement Term time-frame set forth in such Sections.
ARTICLE 9. INDEMNIFICATION.
9.1 COMPANY INFRINGEMENT INDEMNITY.
(a) Should any aspect of any Product become the subject of any
third-party Intellectual Property infringement claim, action, or proceeding, the
Company shall, at its option and expense, use its best efforts to (i) obtain a
license that would permit OAI to exercise all rights granted to it under this
Agreement or (ii) modify the Product to make it non-infringing. During the
period of time in which the Company is pursuing the foregoing remedies, OAI may
suspend purchases of the Product from the Company without any liability
whatsoever. Notwithstanding the foregoing, should the Company fail to accomplish
either one of the foregoing remedies within 60 days, OAI's remedies shall be
limited to (x) the indemnification received from the Company pursuant to this
Article 9, (y) the right, in OAI's sole and absolute discretion, to terminate
this Agreement without any liability whatsoever, and (z) require the Company to
repurchase (at the price paid by OAI plus shipping costs) any portion of or all
ordered Product units and OAI's inventory of Products.
(b) In addition to its obligations under subsection (a) above and
provided that the Company receives prompt written notice of any Intellectual
Property infringement claim, action, or proceeding that arises out of, results
from, or relates to a Product, the Company shall at all times defend, indemnify,
and hold harmless OAI, its successors and permitted assigns, and any of its
officers, directors, employees, representatives, and/or agents, or each of them,
from and against any and all claims, liabilities, losses, costs, damages, and
expenses including but not limited to (i) the damages, losses, costs, and
expenses payable to the third party claiming Intellectual Property infringement,
(ii) all of OAI's reasonable attorneys' fees and
29
disbursements, settlement costs, judgments, court costs and expenses incurred by
OAI (attorneys' fees and disbursements only in the event the Company fails to
defend), (iii) reimbursement for the cost of Product that can no longer be sold,
and (iv) any other direct losses, costs, expenses, and damages incurred by OAI
arising out of or resulting from any Intellectual Property infringement claim,
action, or proceeding between OAI and any third party. OAI shall give the
Company prompt notice upon learning of an Intellectual Property infringement
claim, action, or proceeding and provide to the Company, at the Company's
expense, reasonable assistance in connection with a third party Intellectual
Property infringement claim, action, or proceeding. The failure of OAI to give
prompt notice shall not result in the loss of indemnification unless the Company
shall have been materially prejudiced thereby.
(c) OAI shall not be entitled to the foregoing Intellectual Property
infringement indemnity from the Company to the extent that the Intellectual
Property infringement claim, action, or proceeding arises or results solely from
changes to the Product made by OAI without the authorization of the Company.
9.2 COMPANY PRODUCT LIABILITY AND OTHER DAMAGE INDEMNITY.
(a) The Company shall at all times defend, indemnify, and hold
harmless OAI, its successors and permitted assigns and any of its officers,
directors, employees, representatives, and/or agents, or each of them, from and
against any and all claims, liabilities, losses, costs, damages, and expenses,
including but not limited to all of OAI's reasonable attorneys' fees and
disbursements, settlement costs, judgments, court costs and expenses (attorneys'
fees and disbursements only in the event the Company fails to defend); incurred
by OAI in any action or proceeding between OAI and any third party arising out
of or resulting from (i) a defect or alleged defect in a Product, including
without limitation defects relating to manufacturing, improper testing, or
design, or any breach of warranty regarding the Product or any component
thereof, (ii) misrepresentations made in connection with the promotion,
marketing, sale, distribution, use, safety, or efficacy of the Product based
upon information supplied to OAI by the Company, (iii) the contents of any
labeling, inserts, instruction manuals, or related documentation prepared by the
Company or based upon information supplied to OAI by the Company, or (iv) a
Product Recall. OAI shall provide to the Company, at the Company's expense,
reasonable assistance in connection with a third party action or proceeding of
the kind described in this Section 9.2(a). In no event shall the Company be
liable for indirect, incidental, consequential, or special damages, including
but not limited to damages for lost profits, lost investments, or lost business
opportunities.
30
(b) OAI shall not be entitled to the foregoing indemnity from the
Company to the extent that the claim, action, or proceeding arises or results
solely from (i) unauthorized representations made by OAI regarding the Product
which are different than or in addition to the representations made by the
Company to OAI, (ii) changes to the Product made by OAI without the
authorization of the Company, or (iii) claims regarding the material
compatibility of the Equipment after being treated with the Product, PROVIDED
the Product is not defective and has not been modified by the Company without
OAI's knowledge and prior written consent.
9.3 OAI PRODUCT LIABILITY AND OTHER DAMAGE INDEMNITY.
(a) OAI shall at all times defend, indemnify, and hold harmless the
Company, its successors and permitted assigns and any of its officers,
directors, employees, representatives, and/or agents, or each of them, from and
against any and all claims, liabilities, losses, costs, damages, and expenses,
including but not limited to all of the Company's reasonable attorneys' fees and
disbursements, settlement costs, judgments, court costs and expenses (attorneys'
fees and disbursements only in the event OAI fails to defend); incurred by the
Company in any action or proceeding between the Company and any third party
arising out of or resulting from (i) misrepresentations by OAI made in
connection with the promotion, marketing, sale, distribution, use, safety, or
efficacy of the Products or (ii) the unauthorized contents of any literature,
marketing materials, or related materials prepared solely by OAI or (iii)
modifications made to the Products by OAI that were not authorized by this
Agreement or not otherwise authorized by the Company. The Company shall provide
to OAI, at OAI's expense, reasonable assistance in connection with a third party
action or proceeding of the kind described in this Section 9.3(a). In no event
shall OAI be liable for indirect, incidental, consequential, or special damages,
including but not limited to damages for lost profits, lost investments, or lost
business opportunities.
(b) The Company shall not be entitled to the foregoing indemnity
from OAI to the extent that the claim, action, or proceeding arises or results
solely from (i) a defect or alleged defect in a Product, including without
limitation defects relating to manufacturing, improper testing, or design, or
any breach of warranty regarding the Product or any component thereof (except a
defect resulting from an unauthorized Product modification made by OAI), (ii)
misrepresentations made in connection with the promotion, marketing, sale,
distribution, use, safety, or efficacy of the Product based upon information
supplied to OAI by the Company, (iii) the contents of any
31
labeling, inserts, instruction manuals, or related documentation prepared by the
Company or based upon information supplied to OAI by the Company, or (iv) a
Product Recall.
ARTICLE 10. CONFIDENTIAL INFORMATION.
OAI and the Company each recognizes that documents marked "CONFIDENTIAL"
or "PROPRIETARY" and disclosed by one party to the other hereunder is of
proprietary value to the disclosing party and are to be considered highly
confidential ("Confidential Information"). Each party agrees not to disclose
such Confidential Information to others (except its employees who reasonably
require the Confidential Information for the purposes hereof and who are bound
to it by a like obligation of confidentiality), or to use it for purposes
outside this Agreement, without the express prior written consent of the other
party ( which consent shall not be unreasonably withheld), EXCEPT that neither
party shall be prevented from disclosing that portion of Confidential
Information received from the other which (i) can be demonstrated by written
records to be known to the recipient at the time of receipt; (ii) was
subsequently otherwise legally acquired by such party from a third party having
an independent right to disclose the information; (iii) is now or later becomes
publicly known without breach of this Agreement by either party; (iv) is
required to be disclosed by order of a court, administrative agency, or other
governmental body, PROVIDED that the recipient has given reasonable advance
notice to allow the disclosing party the opportunity to seek a protective order
or otherwise prevent or limit such disclosure; or (v) is or has been
independently developed by employees of the recipient without reference to the
Confidential Information. Each party's obligation of confidentiality shall be in
force during the Agreement Term and any extension thereof and shall extend for a
period of two (2) years from the expiration or early termination of this
Agreement.
Neither OAI nor the Company shall (i) use or communicate any research results
without the other party's express written consent, and then only for the
purposes expressly set forth in such consent, (ii) disseminate any advertisement
or other printed material with respect to the Products and the Equipment,
without the prior written consent of the other party, which consent shall not be
unreasonably withheld or delayed, or (iii) disclose the exhibits and schedules
to this Agreement to any third party; unless such use, communication,
production, dissemination, or disclosure is required under operation of law (in
which case the affected party shall be notified in writing in advance and given
an opportunity to seek a protective order). Requests for consent under this
Article 10 must either be granted or rejected within five Business Days.
32
ARTICLE 11. MISCELLANEOUS.
11.1 FORCE MAJEURE. Each party hereto shall be excused from the
performance of its obligations hereunder in the event such performance is
prevented by FORCE MAJEURE, and such excuse shall continue for so long as the
condition constituting such FORCE MAJEURE and any consequences resulting from
such condition continues. In addition, in the event the condition constituting
the FORCE MAJEURE causes a substantial inability by either party hereto to
manufacture, deliver, sell or otherwise distribute, as the case may be, the
Products, the Agreement Term may be suspended for the period of such inability,
but not to exceed six months. If the inability goes beyond such six-month
period, either party may terminate this Agreement in accordance with Section
8.2(a). For the purposes of this Agreement, FORCE MAJEURE shall mean causes
beyond either party's control including acts of God; war, riot or civil
commotion; damage to or destruction of production facilities or materials by
fire, earthquake, storm or other disaster; strikes or other labor disturbances;
epidemic; failure or default of public utilities or common carriers; and other
similar acts. Compliance with laws or government regulations shall not
constitute a FORCE MAJEURE event.
11.2 REPRESENTATIONS; RELATIONSHIP. No party is authorized on behalf of
the other party to make any statements, claims, representations or warranties or
to act on behalf of the other party with respect to the Products, or otherwise,
except as specifically authorized by this Agreement or in a writing signed by
both parties. The relationship created between the Company and OAI by this
Agreement shall be that of manufacturer and seller. Neither OAI nor the Company
shall be deemed an agent, representative, partner, joint venturer, or employee
of the other party. Neither the Company nor OAI shall have the right to enter
into any contracts or commitments or to make any representations or warranties,
whether express or implied, in the name of or on behalf of the other party, or
to bind the other party in any respect whatsoever, unless agreed to in writing
or expressly permitted in this Agreement.
11.3 ASSIGNMENT; BINDING EFFECT.
(a) Neither party to this Agreement may assign all or any part of
its rights and obligations under this Agreement, except to an Affiliate, without
the prior written consent of the other party. No permitted assignment by any
party pursuant to this Section 11.3(a) shall result in any additional expense to
the other party. Any purported assignment in contravention of this Section
11.3(a) shall, at the option of the non-assigning party, be null and void and of
no effect.
33
(b) Except as otherwise provided above, this Agreement will be
binding upon and inure to the benefit of the successors and permitted assigns of
the parties.
(c) Notwithstanding anything contained in this Agreement to the
contrary, all obligations of and restrictions on the parties set forth in this
Agreement shall not be deemed obligations of and restrictions on any of the
parties' respective Affiliates, EXCEPT if this Agreement is assigned to an
Affiliate pursuant to Section 11.3(a).
11.4 NOTICES. Any notice, consent, or other communication required or
permitted to be given to either party under this Agreement shall be given in
writing and shall be delivered (i) by hand, or (ii) by registered or certified
mail, postage prepaid and return receipt requested, or (iii) by confirmed
facsimile transmission; addressed to each party at the following address or such
other address as may be designated by such party by notice pursuant to this
Section 11.4:
To the Company: MediVators, Inc.
0000 Xxxx Xxx Xxxxxx
Xxxxx 00
Xxxxx, Xxxxxxxxx 00000-0000
Fax: 000-000-0000
ATTENTION: President
with a copy to: (a) Xxxxxxxx Xxxxxx Xxxxxxxxxx
& Xxxxxxxxx, LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Fax: 000-000-0000
ATTENTION: Xxxx X. Xxxxxx, Esq.
and
(b) Cantel Industries, Inc.
0000 Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, Xxx Xxxxxx 00000
Fax: 000-000-0000
ATTENTION: President
To OAI: Olympus America Inc.-Endoscope Division
Xxx Xxxxxxxxx Xxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxx 00000-0000
Fax: 000-000-0000
ATTENTION: Division Manager and, by
separate copy, General Counsel (Fax: 000-000-0000)
Any notice, consent, or other communication given in conformity with this
Section 11.4 shall be deemed effective when received by
34
the addressee, if delivered by hand or facsimile transmission, and seven days
after mailing, if mailed. Notwithstanding the foregoing, all notice, consent, or
other communication copies sent hereunder to Cantel Industries, Inc. shall be
sent as a courtesy and failure by OAI to send notice, consent, or other
communication to Cantel Industries, Inc. shall not be deemed or construed as
defective notice, consent, or other communication hereunder.
11.5 GOVERNING LAW; SUBMISSION TO JURISDICTION. This Agreement and any
other documents or instruments related hereto and all transactions hereunder
shall be deemed to have been made within and under the laws of the State of New
York, including the Uniform Commercial Code of the State of New York, and for
all purposes shall be governed by and construed in accordance with the laws of
the State of New York without regard to the conflict of laws rules thereof. The
parties expressly agree that any controversy, dispute or claim with respect to
any provision of this Agreement shall be adjudicated exclusively by a court of
competent jurisdiction within Suffolk County, the State of New York, or the
Federal District Court for the Eastern District of New York, applying New York
law without regard to the rules of conflicts of law and the Company and OAI
waive any objections either may have and consent to the personal jurisdiction
and the designation of a forum or venue of the courts set forth herein,
including without limitation waiving a motion to change or transfer venue.
Notwithstanding the foregoing, either party may, in any jurisdiction, seek to
enforce, collect, or take any other action to effectuate a judgment, order, or
decree obtained from a court in Suffolk County, State of New York or the Federal
District Court for the Eastern District of New York.
11.6 EXECUTION OF ADDITIONAL DOCUMENTS. Each party hereto agrees to
execute and deliver such documents as may be necessary or desirable to carry out
the provisions of this Agreement.
11.7 ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
between the Company and OAI with respect to the subject matter hereof. All prior
or contemporaneous agreements, proposals, understandings, representations, and
communications with respect to the subject matter hereof, whether written or
oral, between or involving the Company and OAI hereby are cancelled and
superseded, including without limitation the Distributor Agreement between the
parties dated March 12, 1996. Notwithstanding the foregoing, such Distributor
Agreement shall continue to apply to Products and their corresponding orders
shipped by the Company to OAI prior to August 1, 1999. Pending purchase orders
placed but not shipped prior to August 1, 1999 shall be governed by this
Agreement and not the 1996 Distributor Agreement. This Agreement may be amended
or modified only in a
35
writing executed by both parties which states that it is an amendment or
modification to this Agreement.
11.8 SEVERABILITY. If any provision or part thereof of this Agreement is
held by a court of competent jurisdiction to be invalid, void or unenforceable,
the remaining provisions or parts thereof of this Agreement shall continue in
full force without being impaired or invalidated in any way, to the maximum
extent possible consistent with the intent of the parties in entering into this
Agreement.
11.9 TAXES. Each party shall be responsible for payment of its own taxes.
11.10 COUNTERPARTS. This Agreement may be executed in duplicate
counterparts, each of which when so executed shall be deemed to be an original
and both of which when taken together shall constitute one and the same
instrument.
11.11 NO WAIVER. No waiver of any right under this Agreement shall be
deemed effective unless contained in a writing signed by the party charged with
such waiver, and no waiver of any breach or failure to perform shall be deemed
to be a waiver of any future breach or failure to perform or of any other
provisions of this Agreement.
11.12 HEADINGS. The headings contained herein are for reference only and
are not a part of this Agreement and shall not be used in connection with the
interpretation of this Agreement.
11.13 RIGHTS AND REMEDIES CUMULATIVE; DIRECT DAMAGES. All rights and
remedies hereunder are cumulative and may be enforced separately or concurrently
and from time to time, unless otherwise specifically stated herein. The
enforcement of any particular remedy shall not constitute an election of
remedies, and no remedy is exclusive unless specifically stated herein. Except
with respect to Section 9.1 and Article 10, neither party shall be liable under
this Agreement for any indirect, special, incidental, or consequential damages
of any kind, including but not limited to damages for lost profits, lost
investments, or lost business opportunities (collectively, "Consequential
Damages"). Except with respect to Section 9.1 and Article 10, OAI and the
Company hereby agree that direct damages shall not include or contain
Consequential Damages.
11.14 CONTRACT INTERPRETATION. Each party hereto acknowledges that it has
had ample opportunity to review and comment on this Agreement. This Agreement
shall be read and interpreted according to its plain meaning and an ambiguity
shall
36
not be construed against either party. It is expressly agreed by the parties
that the judicial rule of construction that a document should be more strictly
construed against the draftsperson thereof shall NOT apply to any provision of
this Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.
MEDIVATORS, INC.
By: /s/ XXX XXXXXX
-----------------------------
Name: Xxx Xxxxxx
Title: President
OLYMPUS AMERICA INC.
ENDOSCOPE DIVISION
By: /s/ XXXXX XXXXXXXXX
-----------------------------
Name: Xxxxx Xxxxxxxxx
Title: Vice President & Division Manager
37
