EXHIBIT 10.2
AGREEMENT BETWEEN IVAX DIAGNOSTICS, INC. AND SIGMA DIAGNOSTICS
This Distributorship Agreement (hereinafter the "Agreement") is between
IVAX DIAGNOSTICS, Inc., a corporation existing under the laws of Florida,
(together with its affiliates Delta Biologicals, Diamedix Corporation, and
Immunovision, Inc., hereinafter referred to as "IVAX Diagnostics"),and SIGMA
DIAGNOSTICS, Inc. (hereinafter "SIGMA"), a corporation existing under the laws
of Missouri.
WHEREAS, IVAX DIAGNOSTICS desires to sell and/or market its products and
SIGMA desires to purchase certain of IVAX DIAGNOSTICS's products for resale to
customers; and
WHEREAS, the parties desire to enter into an agreement setting forth the
terms of their relationship;
NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein, the parties do hereby agree as follows:
1. Products. The product(s) of IVAX DIAGNOSTICS covered by this Agreement are
set forth on Exhibit A attached hereto (hereinafter the "Product(s)"). For
avoidance of doubt, "Product" or "Products" means only products purchased
from IVAX DIAGNOSTICS, and marketed under a trademark or trade name of
SIGMA. IVAX DIAGNOSTICS reserves the right to discontinue or modify the
Products from time to time, and shall, to the extent practicable, give
SIGMA at least six (6) months prior written notice before discontinuation
or making changes to Product that would have an impact on any of IVAX
DIAGNOSTICS product verifications or validations, or changes in raw
materials that would alter the operating principle of the Products or other
changes that could impact product labeling or promotional literature;
provided, however, that IVAX DIAGNOSTICS shall be required to provide SIGMA
with only reasonable advance notice where such discontinuance or
modification is required to comply with any applicable legal or regulatory
requirement or the unanticipated modification or unavailability of raw
material. Additional products may be added to Exhibit A by mutual consent
of the Parties.
2. Appointment and Acceptance.
(a) IVAX DIAGNOSTICS hereby appoints SIGMA as their distributor of the
Product(s) and grants SIGMA the right and license to import, use,
possess, market, sell and distribute the Product(s) in the United
States and outside the United States (the "Territory") and the right
to extend to Affiliates, sub-distributors and purchasers rights of the
same scope as granted herein
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to use, possess, market, sell and distribute Product(s) in the
Territory subject to the provisions of Section 19 hereof.
(b) IVAX DIAGNOSTICS reserves the unlimited right to sell directly and
through distributors products similar to the Product, under its own
trademark or trade name or any other trade name or label.
IVAX DIAGNOSTICS reserves the unlimited right to sell a product
similar to the Product to any other company (ies), under any trade.
3. Term and Renewal. The term of this Agreement shall be for a period of three
(3) years, becoming effective on October 1, 2000 (the "Initial Term"), and
shall automatically renew for additional and successive terms of one (1)
year unless either party provides written notice of non-renewal at least
ninety (90) days prior to the close of the Initial Term or of any
anniversary date thereafter.
4. Terms of Sale.
(a) The price for the Products is outlined in Exhibit A.
The parties acknowledge that, in certain situations, SIGMA will face
substantial competition in marketing the Products. In these highly
competitive situations, IVAX DIAGNOSTICS will discuss with SIGMA the
possibility of reducing the Purchase Price so that SIGMA is able to
resell the Products at competitive prices.
(b) Payment terms are net forty-five (45) days from date of invoice.
(c) Title and risk of loss shall pass to SIGMA upon release of Products
for shipment by IVAX DIAGNOSTICS to the designated carrier. All
freight, applicable insurance charges, taxes, duties and similar
charges shall be the responsibility of SIGMA. IVAX DIAGNOSTICS will be
responsible for contracting freight services, in accordance with
Section 8(a) of this Agreement, for which SIGMA will be billed on a
shipment by shipment basis. Products are subject to acceptance by
SIGMA upon receipt in accordance with Section 9.
5. Reciprocal Termination Rights. Either IVAX DIAGNOSTICS or SIGMA may
terminate this Agreement for cause immediately by written notice upon the
occurrence of any of the following events:
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(a) If the other ceases to do business or otherwise terminates its
business operations;
(b) If the other shall fail to promptly secure or renew any license,
registration, permit, authorization or approval necessary for the
conduct of its business in the manner contemplated by this Agreement
including an assessment of such systems and procedures as may be
necessary for legal marketing within a country or territory or if any
such license, registration, permit, authorization or approval is
revoked or suspended and not reinstated within thirty (30) days;
(c) If the other breaches any material provision of this Agreement and
fails to cure such breach within sixty (60) days of written notice
describing the breach;
(d) If the other becomes insolvent or seeks protection under any
bankruptcy, receivership, trust deed, creditors arrangement,
composition or comparable proceeding, or if any such proceeding is
instituted against the other (and not dismissed with sixty (60) days);
or
(e) If a material representation of the other becomes false or misleading
and the other party fails to render such representation true in all
material respects within sixty (60) days of written notice describing
the false or misleading representation.
6. Rights Upon Termination. Any termination or expiration of the Agreement
shall not release IVAX DIAGNOSTICS or SIGMA from paying any amount that may
then be owed from any obligation at the date of termination hereunder. Each
party understands that the rights of termination hereunder are absolute.
Neither party shall incur any liability whatsoever for any damage, loss or
expenses of any kind suffered or incurred by the other (or for any
compensation to the other) arising from or incident to any termination of
this Agreement in accordance with the terms hereof whether or not such
party is aware of any such damage, loss or expenses. Termination is not the
sole remedy under this Agreement and, whether or not termination is
effected; all other remedies will remain available. IVAX DIAGNOSTICS agrees
that during the period between the notice of termination and the effective
date thereof, it will honor SIGMA's orders for Products.
7. SIGMA's Duties. SIGMA shall:
(a) use reasonable commercial efforts to advertise and promote the sale of
the Products in a commercially
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ethical manner, instructing its sales people to refrain from
disparaging remarks about the competitive products of IVAX DIAGNOSTICS
(b) obtain advance written authorization from IVAX DIAGNOSTICS prior to
returning any of the Products.
(c) maintain properly trained sales force of adequate size to represent
and promote the sales of the Products and provide instructions to
customers in the use of the Products. SIGMA shall be responsible for
developing its own marketing plan and system for distributing the
Products.
(d) carry in stock an inventory of Products sufficient to meet the needs
of SIGMA's customers in the Territory.
(e) apply for and obtain all necessary licenses, permits and other
authorizations required by local law or regulation in relation to the
promotion, marketing, distribution and supply of the Products in any
jurisdiction in which SIGMA sells the Products.
(f) maintain separate and detailed accurate and complete records of all
transactions in respect of the Products, including, but not limited
to, such records as identify all customer purchases by Product and
serial and/or lot number, and possess the capability to notify all
purchasers in the event of a Product recall or corrective action.
(g) make no contracts or commitments on behalf of IVAX DIAGNOSTICS or make
any promises or representations or give any warranties or guarantees
with respect to the Products on behalf of IVAX DIAGNOSTICS.
(h) comply with all laws and regulations and requirements applicable to a
seller of in-vitro diagnostics products, and with all laws and
regulations and requirements of governmental agencies having
jurisdiction within the Territory.
8. IVAX DIAGNOSTICS Duties. IVAX DIAGNOSTICS shall:
(a) make reasonable efforts, in good faith, to ship SIGMA's orders for
Products within ninety (90) days from date of order receipt, at the
prices set forth in Section 4(a). SIGMA shall specify the method of
shipment and insurance and IVAX DIAGNOSTICS shall make reasonable
efforts, in good faith, to comply with such specifications. If no such
specification is made, or if the specification cannot be reasonably
complied with
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after notice to SIGMA and an opportunity to resolve the issues
surrounding IVAX DIAGNOSTICS alleged inability to comply, IVAX
DIAGNOSTICS may select a reasonable manner of shipment and insurance.
(b) comply with all laws and regulations and requirements applicable to
IVAX DIAGNOSTICS as a manufacturer of in-vitro diagnostic products,
and assisting Sigma Diagnostics with meeting mutual requirements for
documentation, quality and test data.
(c) except as authorized in writing by SIGMA; refrain absolutely from
using the trademark or trade name and logo of SIGMA in connection with
the marketing, distribution and sale of any Product.
(d) provide reasonable technical assistance to SIGMA's personnel necessary
for the marketing of the Products.
(e) provide necessary documentation to assist SIGMA in meeting
requirements to register Products in the Territory and comply with all
laws and regulations, and requirements applicable to SIGMA as a
distributor of in-vitro diagnostics products, and where possible,
allow SIGMA to reference prior registrations by IVAX DIAGNOSTICS and
if necessary to support CE marking, provide access to Sigma personnel
as well as to notified body personnel of the IVAX manufacturing site
as required by EU regulation.
(f) provide SIGMA with copies of the 510(k) premarket notifications
submitted for the Products, if applicable, copies of documents
describing specifications for the Products, and copies of all current
and future correspondence with the FDA pertaining to the Products.
IVAX DIAGNOSTICS will comply with the FDA's current GMP regulations in
the manufacture of all Products. If needed to comply with any change
in the law or FDA's GMP regulations or policies, Sigma shall be given
the right to inspect IVAX DIAGNOSTICS manufacturing facilities for the
Products and GMP records pertaining to the manufacture of the
Products. If any action should be taken by the FDA to restrict or
prevent the distribution of any of the Product for more than sixty
(60) days, and such restriction is not due to any act or omission of
SIGMA, then upon notice to IVAX DIAGNOSTICS, SIGMA shall have the
right to terminate this Agreement as to such Product. In such event,
IVAX DIAGNOSTICS shall replace any affected inventory of Products
under this section or refund to SIGMA the purchase price it paid to
IVAX DIAGNOSTICS for such inventory if IVAX DIAGNOSTICS is
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unable to replace the Products with comparable inventory. In addition,
IVAX DIAGNOSTICS shall replace or repurchase any affected inventory of
Product, which SIGMA replaces or repurchases from SIGMA's customers,
at the price SIGMA paid IVAX DIAGNOSTICS for such inventory.
(g) comply with the Federal Food, Drug, and Cosmetic Act. The Products
comprising each shipment or other delivery hereafter made by IVAX
DIAGNOSTICS to, or on the order of, SIGMA, as of the date of such
shipment or delivery, shall be, on such date, not adulterated or
misbranded within the meaning of the Federal Food, Drug, and Cosmetic
Act.
(h) perform any necessary task to insure the Product complies with any
changes or redefinition's of standardization required by domestic and
international scientific bodies covering minimum performance
guidelines, which are economically feasible; provided that IVAX
DIAGNOSTICS shall be entitled to adjust the purchase price of any
Product affected by any such change to the extent of IVAX DIAGNOSTICS
actual cost. If IVAX DIAGNOSTICS determines that the required change
is not economically feasible, SIGMA shall have the right to pay the
cost of such change and IVAX DIAGNOSTICS agrees to make such changes
exclusively for Sigma.
(i) offer its products, which are competitive to the Products in a
commercially ethical manner, instructing its sales people (i) not to
disclose to customers that IVAX DIAGNOSTICS manufactures the Products
for SIGMA and (ii) to refrain from disparaging remarks about the
Products.
(i) during the term of this Agreement use its best efforts to modify the
Product as required to maintain the Product's competitiveness in the
market place as SIGMA and IVAX DIAGNOSTICS shall mutually agree upon
in good faith. If such modifications are to be made to the Products
purchased by SIGMA only, and are not used to modify the products that
are sold by IVAX DIAGNOSTICS, then SIGMA shall be responsible for the
cost associated with such modifications.
9. Performance Standards.
(a) Quality specifications and Characteristics. IVAX DIAGNOSTICS shall
deliver to SIGMA Products having the quality specifications agreed
upon by the parties as set forth in the Product insert ("Quality
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Specifications"). These Quality Specifications and Characteristics may
be modified from time to time to meet the future requirements of the
parties and changes will be communicable to Sigma prior to
implementation. In such cases, the parties agree to negotiate in good
faith to find a solution that can be mutually agreed to by the
parties.
(b) Certificates of Analysis. Concurrent with shipment, IVAX DIAGNOSTICS
shall fax to SIGMA Certificates of Analysis, in the form set forth in
Exhibit B, for each Product sold to SIGMA, confirming that the Product
meets the Quality Specifications.
(c) Product Acceptance. SIGMA shall accept the Products based on the
Certificate of Analysis delivered by IVAX DIAGNOSTICS. Should at
anytime prior to expiration of the product dating the Product fails to
meet the Quality Specifications, after toubleshooting, by Sigma
personnel, the product does not meet the specifications SIGMA shall
notify IVAX DIAGNOSTICS hereof and immediately thereafter provide IVAX
DIAGNOSTICS with records and information pertaining to the problems
associated with the Product. IVAX DIAGNOSTICS shall have 20days after
receipt of SIGMA's notice within which t0 accept or reject SIGMA's
claims. If, following a review of the problems and after conducting
its own tests, IVAX DIAGNOSTICS agrees that such Product does not
conform to the Quality Specifications, IVAX DIAGNOSTICS shall provide
SIGMA, free of any additional charge, with new deliveries of the same
quantity of the Products affected or items necessary to make the
Product acceptable to Sigma, or, in IVAX DIAGNOSTICS discretion and at
its cost, IVAX DIAGNOSTICS may promptly reprocess the nonconforming
Products to meet the Quality Specifications. In either event, SIGMA
shall return, at IVAX DIAGNOSTIC's expense, the particular lot or
shipment of the Product, which does not comply with the Quality
Specifications if requested to do so by IVAX DIAGNOSTICS. Any dispute
arising under this Section 9(c) shall be resolved by arbitration as
outlined in Section 21.
10. Product Recall
(a) IVAX DIAGNOSTICS shall maintain an appropriate record of all claims
made or to be made regarding the Products performance.
(b) Each party shall keep the other informed of any formal action relating
to any specific lot of Product sold to SIGMA hereunder by any
regulatory agency of any state,
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national government, or government agency having jurisdiction.
(c) Should any governmental or corporate action require a medical device
reportable (MDR) event, a medical device vigilance system report
(MDVS), a recall or field corrections, or withholding from market of
Product sold by IVAX DIAGNOSTICS to SIGMA, SIGMA shall bear the
reasonable, direct costs and expenses of the MDR, MDVS, recall or
field correction if such action is the result of any fault or omission
attributable to SIGMA. IVAX DIAGNOSTICS shall bear the reasonable,
direct costs and expenses of the MDR, MDVS, recall or field correction
and the actual costs of replacing the Products if such action is the
result of any fault or omission attributable to IVAX DIAGNOSTICS.
Should such MDR, MDVS, recall or field correction result from the
fault of both parties, the parties shall share the costs of Products
and the actual cost of replacing the Products in proportion to their
respective degree of fault.
11. Product Complaints
(a) Should either party experience any quality problem of any specific
lot(s) of Product supplied to SIGMA by IVAX DIAGNOSTICS, such party
will notify the other in writing by facsimile prior to the initiation
of a MDR, MDVS, field correction or recall and the parties shall
consult with each other regarding the proper corrective action,
provided that each party retains the right to correct quality
problems, as it deems appropriate, with or without the concurrence of
the other. All information about Product complaints shall be
considered "Confidential Information" under the terms of this
Agreement.
(b) Either party shall immediately notify the other party in writing
should it become aware of any defect or condition that renders any
lot(s) of Product supplied by IVAX DIAGNOSTICS to SIGMA in violation
of the United States Food, Drug and Cosmetic Act, or of a similar law
of any jurisdiction or country where the Product is sold. The parties
shall share with each other all data on confirmed lot specific Product
complaints including, but not limited to, complaints or information
regarding performance and/or allegations or reports of any negative
effect from the use or misuse of such affected lot of Products as soon
as such data is available. Each party will provide reasonable
assistance to the other in resolving customer complaints to the extent
the complaint arises out of any fault or omission of the party whose
assistance is requested. However,
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SIGMA shall have sole responsibility and authority to interact
directly with SIGMA's customers in the resolution of such complaints
and IVAX DIAGNOSTICS agrees that it will only interact with SIGMA in
such matters.
(c) IVAX DIAGNOSTICS shall evaluate and investigate all customer
complaints in connection with the Products which may be brought to its
attention, in writing, by SIGMA; which are believed in good faith by
SIGMA to arise out of a fault or omission attributable to IVAX
DIAGNOSTICS. Within twenty (20) calendar days following receipt from
SIGMA of the original notification of each such complaint, IVAX
DIAGNOSTICS agrees to provide SIGMA with a written interim or final
complaint investigation report as well as corrective and preventive
actions if applicable. All such Product complaints reported to IVAX
DIAGNOSTICS by SIGMA shall be reviewed monthly by IVAX DIAGNOSTICS
until closure, and a summary report thereof will be provided by IVAX
DIAGNOSTICS to SIGMA.
(d) IVAX DIAGNOSTICS will report to SIGMA all data and/or information
pertaining to adverse reports on any lot of Product supplied by IVAX
DIAGNOSTICS for distribution by SIGMA, which would have a materially
adverse impact on performance of the Products.
12. Warranties.
(a) IVAX DIAGNOSTICS warrants that the Products which may be the subject
of 510(k) premarket notifications have not been significantly changed
or modified in design, components, method of manufacture or intended
use from the Products as described in those 510 (k) premarket
notifications, as applicable and will notify Sigma in advance of any
changes in accordance with Section 1.
(b) IVAX DIAGNOSTICS warrants that all Products manufactured and supplied
under this Agreement shall at the time of shipment meet the Quality
Specifications of IVAX DIAGNOSTICS. IVAX DIAGNOSTICS further warrants
that prior to shipment to SIGMA, all of its standard tests and quality
control procedures have been carried out in relation to each lot of
the Products with satisfactory results. IVAX DIAGNOSTICS MAKES NO
WARRANTY EXPRESSED OR IMPLIED WITH RESPECT TO THE PRODUCTS BEYOND THAT
WHICH IS SET FORTH IN THIS AGREEMENT INCLUDING THE WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.
(c) Upon its verification of any claim of defect or
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nonconformity of any Product arising out of a fault or omission
attributable to IVAX DIAGNOSTICS, during the term of this Agreement,
IVAX DIAGNOSTICS will provide SIGMA with a replacement to the extent
necessary to honor IVAX DIAGNOSTICCs warranties contained in Section
9(a) hereof, or make good any shortages or noncompleted deliveries and
shall pay all associated freight and insurance associated therewith.
(d) IVAX DIAGNOSTICS liability under any legal or equitable theory to
SIGMA with respect to the Products and/or the relationship described
in this Agreement shall be limited to the replacement of the unit, or
if impractical, return of the purchase price paid by SIGMA for such
unit.
(e) As of the date hereof, IVAX DIAGNOSTICS warrants that it has no
knowledge that the manufacture, use or sale of all or any of the
Products under this Agreement, nor any method of using such Products
infringes on any patent or other intellectual property right of a
third party, and IVAX DIAGNOSTICS has not received any. notification
from any third party alleging that the manufacture, use or sale of any
such Product does or would infringe any patent or other intellectual
property.
13. Packaging and Intellectual Property. IVAX DIAGNOSTICS shall be responsible
for packaging and labeling the Products. After the initial order SIGMA will
distribute the Products only with all appropriate labeling, packaging, and
Product literature and only under SIGMA's applicable trademarks and trade
names and not with IVAX DIAGNOSTIC's trademarks or trade names. SIGMA
recognizes IVAX DIAGNOSTICS right, title and interest in its patents,
trademarks, trade names and copyrights, trade secrets and proprietary
information in connection with the Products, and SIGMA shall not claim any
ownership right thereto inconsistent with this Agreement, or dispute the
validity thereof. In the event any third party shall contest IVAX
DIAGNOSTICS rights to its patents, trademarks, trade names or copyrights,
trade secrets or propriety rights, SIGMA shall, at IVAX DIAGNOSTICS sole
expense, render reasonable assistance to IVAX DIAGNOSTICS in defending such
claims. In the event that any third party shall contest the validity of any
trademark or trade name of SIGMA used on or in relation to a Product, SIGMA
will, at its own expense, defend and indemnify IVAX DIAGNOSTICS against any
claim brought by such third party and will reimburse IVAX DIAGNOSTICS for
all reasonable expenses incident to the adoption and implementation of a
new SIGMA trademark or trade name for the Products.
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14. Compliance With Other Agreements. Each party represents and warrants that
the execution and delivery by it of this Agreement and the performance by
it of its obligations hereunder will not, with or without the giving of
notice or the passage of time, violate any judgement, writ, injunction or
order of any court, arbitration or governmental agency or conflict with,
result in the breach of any provisions of, or the termination of, or
constitute a default under, any agreement to which IVAX DIAGNOSTICS or
SIGMA is a party or by which it is or may be bound.
15. Indemnity.
(a) Except as limited by the remainder of this paragraph, IVAX DIAGNOSTICS
hereby agrees to indemnify SIGMA against claims of third parties for
injuries to their persons arising from the use of Products supplied by
IVAX DIAGNOSTICS to SIGMA hereunder. This indemnity shall not apply
to, and IVAX DIAGNOSTICS shall not be liable for, claims for injuries
caused by or arising from:
(1) any act or failure to act on the part of SIGMA, its employees,
representatives, agents, subdistributors or affiliates in
packaging, handling, storing, promoting or otherwise distributing
such Products; or
(2) any representation or warranty concerning the Products made by or
on behalf of SIGMA and not specifically authorized by IVAX
DIAGNOSTICS; or
(3) claims where the use of the Products by any customer was not in
accordance with the use prescribed by IVAX DIAGNOSTICS; or
(4) SIGMA's failure to disseminate to purchasers or end-users any
Product Information which IVAX DIAGNOSTICS has made available to
SIGMA; or
(5) claims where IVAX DIAGNOSTICS has not been notified in writing
within thirty (30) days of SIGMA's first notice of the claim; or
(6) claims where SIGMA fails to furnish evidence in its possession or
fails to fully cooperate with IVAX DIAGNOSTICS in preparing the
defense;
(7) claims where IVAX DIAGNOSTICS is not given the option to assume
the sole defense of the claim at IVAX DIAGNOSTIC's expense.
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(b) Except as limited by the remainder of this paragraph, SIGMA hereby
agrees to indemnify IVAX DIAGNOSTICS against claims of third parties
arising from the use of Products supplied by IVAX DIAGNOSTICS to SIGMA
hereunder. This indemnity shall not apply to, and SIGMA shall not be
liable for, claims caused by or arising from:
(1) any act or failure to act on the part of IVAX DIAGNOSTICS, its
employees, representatives, agents or affiliates in
manufacturing, testing, packaging, labeling, handling or storing
such Products; or
(2) the breach of any representation or warranty concerning the
Products made by or on behalf of IVAX DIAGNOSTICS; or
(3) claims where SIGMA has not been notified in writing within thirty
(30) days of IVAX DIAGNOSTICS' first notice of the claim; or
(4) claims where IVAX DIAGNOSTICS fails to furnish evidence in its
possession or fails to fully cooperate with SIGMA in preparing
the defense; or
(5) claims where SIGMA is not given the option to assume the sole
defense of the claim at SIGMA's expense.
(c) IVAX DIAGNOSTICS shall indemnify SIGMA from any claims of patent
infringement relating to a Product subject to this Agreement provided
SIGMA gives IVAX DIAGNOSTICS notice within thirty (30) days of SIGMA'
s first notice of the claim, and permits IVAX DIAGNOSTICS to assume
the sole defense of the claim at IVAX DIAGNOSTICS expense; provided,
however, that the claim is not based on (i) the sale or use of any
Product in combination with any other product which is not
specifically authorized by IVAX DIAGNOSTICS; (ii) the application of
any Product in any manner not specifically authorized by IVAX
DIAGNOSTICS.
(d) SIGMA shall indemnify IVAX DIAGNOSTICS from any claims of trademark
infringement relating to a Product subject to this Agreement, provided
IVAX DIAGNOSTICS gives SIGMA notice within thirty (30) days of IVAX
DIAGNOSTICS' first notice of the claim, and permits SIGMA to assume
the sole defense of the claim at SIGMA'S expense; and provided that
the claim is based on the use of a SIGMA trademark or trade name.
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(e) Not withstanding anything above to the contrary, in the event of a 3rd
party claim arising out of this Agreement, in which neither IVAX
DIAGNOSTICS or SIGMA is in breach of this Agreement or is negligent,
each party shall pay its respective legal expenses and damages caused
by such claim.
16. Force Majeure. Neither party shall be responsible for any failure to
perform due to causes beyond its control. These causes shall include, but
not be limited to, fire, storm, flood, earthquake, explosion, wars, riots,
civil disorder, sabotage, quarantine restrictions, labor disputes, labor
shortages, transportation embargoes, or failure or delays or disruption in
manufacturing process, curtailment of or failure in obtaining fuel or
electrical power, or the acts of any governmental authority, or
instrumentality's, orders of any court or tribunal whether foreign or
domestic, exchange restrictions, acts of God, acts of the Federal
Government or any agency thereof, acts of any state or local government or
agency thereof, or shortage of materials or any similar or dissimilar
occurrence beyond the reasonable control of the party which is prevented,
interrupted or delayed in the performance of its obligations hereunder. In
no event shall IVAX DIAGNOSTICS be under any obligations to purchase
Products or similar products from any third party in order to supply same
to SIGMA hereunder. Any force majeure event shall not excuse performance by
the party but shall delay performance, unless such force majeure continues
for a period in excess of one hundred thirty five(135) days. In such event,
the party seeking performance, as its sole and exclusive remedy, many
cancel its obligations under this Agreement.
17. Insurance. IVAX DIAGNOSTICS and SIGMA shall keep in force during the term
of this Agreement product liability insurance, in such amounts as may be
customary for like sized businesses undertaking like responsibilities to
those contemplated by this Agreement. SIGMA and IVAX DIAGNOSTICS shall
submit a certificate of insurance to the other evidencing such coverage
upon written request therefor.
18. Confidentiality.
(a) Confidentiality Defined. For the purposes of this Agreement, the term
"Confidential Information" shall be any information relating to the
Products, including information embodying concepts, ideas, techniques,
proprietary information, know-how, formulations, market data, customer
lists, product specifications and accounting data which is disclosed
by one party hereto to the other.
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(b) Non-Disclosure. During the period that this Agreement remains in
effect and for a period of three (3) years following termination
hereof, each party (except as is explicitly otherwise required hereby)
shall keep confidential, shall not use for itself or for the benefit
of others and shall not copy or allow to be copied in whole or in part
any Confidential Information disclosed to such party by the other. The
obligation of confidentiality imposed upon the parties by the
foregoing paragraph shall not apply with respect to any alleged
Confidential Information which:
(1) is known to the recipient thereof, as evidenced by said
recipient's written records, prior to receipt thereof from the
other party hereto;
(2) is disclosed to said recipient after the date hereof by the third
party who has the right to make such disclosures and who does not
violate any confidentiality agreement with the affected party
hereto;
(3) is or becomes a part of the public domain through no fault of the
said recipient; or
(4) is required by law or judicial or administrative process to be
disclosed.
(c) IVAX DIAGNOSTICS and SIGMA shall agree to keep confidential and not
disclose to third parties, the contents of this Agreement except as
required by law or stock exchange rules, in which case the party
required to disclose confidential information shall provide the other
party with as much notice as is practicable.
(d) Each party agrees to limit access to Confidential Information to
employees and agents having a need to know and to protect Confidential
Information to the same extent as it protects its own trade secrets.
19. Appointment of Sub-Distributors. SIGMA may assign, sublicense, delegate, or
otherwise transfer the performance of the rights and obligations hereunder
to qualified and reputable sub-distributors, provided, however, that: (i)
SIGMA shall be liable to IVAX DIAGNOSTICS for the errors, negligent acts
and omissions of its sub-distributor's as if such errors, negligent acts
and omissions were its own, including any breach of any provision of this
Agreement by the sub-distributors; (ii) SIGMA shall have and retain full
control of any sub-distributors utilized, and shall be responsible for the
performance by any sub-distributor; and (iii) SIGMA shall not be relieved
of the responsibility for
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the proper performance and completion of the sub-distributed portions of
its obligations hereunder.
20. Successors. This agreement shall be binding upon the successors of IVAX
DIAGNOSTICS and SIGMA, including successors who acquire the business assets
of IVAX DIAGNOSTICS and SIGMA.
21. Resolution of Disputes. In the event of any controversy or claim arising
under or in relation to this agreement, including any issue about payment
of amounts due, the parties shall, in good faith, attempt to resolve the
controversy or claim by negotiation. If the controversy or claim cannot be
resolved within sixty (60) days, then it shall be settled exclusively by
arbitration in accordance with the Arbitration Rules of the American
Arbitration Association (AAA) and shall be held in Atlanta, GA. There shall
be three arbitrators: one selected by the party who requests arbitration
who shall notify the other party of the person selected at the time that
notice of arbitration is sent; one selected by the other party within ten
(10) days of receipt of notice of arbitration and one selected by the
parties jointly within ten (10) calendar days thereafter or, failing their
agreement, selected pursuant to the rules of the AAA. No arbitrator shall
be related to, employed by, or have at any time a substantial ongoing
business relationship with any party hereto or any of their respective
affiliates. The losing party in the arbitration shall reimburse the
prevailing party for all costs and expenses, including reasonable attorney
fees, incurred in connection with the arbitration. The decision of the
arbitrators shall be final and binding on the parties and judgement upon
the award rendered by the arbitrators may be entered by any court having
jurisdiction thereof. The provisions of this arbitration clause shall not
be applied to the determination of questions affecting validity or scope of
any trademarks or other intellectual property rights.
22. Notices. Any notice or other communication required or that shall be given
pursuant to this Agreement shall be deemed sufficient if delivered
personally, sent by facsimile, telegraph, or sent by certified, registered
or express mail, postage prepaid to the address or facsimile number set
forth below:
To IVAX DIAGNOSTICS: WITH A COPY TO:
IVAX DIAGNOSTICS, INC. IVAX CORPORATION
0000 Xxxxxxxx Xxxx. 0000 Xxxxxxxx Xxxx.
Xxxxx, XX 00000 Xxxxx, XX 00000
Facsimile No: (000) 000-0000 Facsimile No: (000)000-0000
Attn: President Attn: General Counsel
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To SIGMA:
Sigma Diagnostics
000 Xxxxx Xxxxx Xxxxxx
Xx. Xxxxx, Xxxxxxxx 00000
Facsimile No: (000) 000-0000
Attn: Vice President, Administration
Either party may change the address to which notice to it is to be given,
as provided herein.
23. Entire Agreement. This Agreement and the exhibits referred to herein
constitute the entire agreement between the parties and supersede all prior
proposals, communications, representations and agreements, whether written
or oral, with respect to the subject matter hereof. No change to the
written terms of this Agreement shall be made except by written
instrumentation executed by the parties hereto.
24. No Waiver. The failure of either party to enforce at any time any of the
provisions of this Agreement shall not be construed to be a waiver of those
provisions or of the right of that party thereafter to enforce those
provisions.
25. Severability. If any provision of this Agreement is or becomes or is deemed
invalid, illegal or unenforceable in any jurisdiction in which the
Agreement is sought to be enforced, (a) such provision shall be deemed and
amended to conform to applicable laws of such jurisdiction so as to be
valid and enforceable or, if it cannot be so amended without materially
altering the intention of the parties, it shall be stricken; (b) the
validity, legality and enforceability of such provision will not in any way
be affected or impaired thereby in any other jurisdiction; and (c) the
remainder of this Agreement shall remain in full force and effect.
26. Headings. The headings of this Agreement are included only for ease of
reference and shall not affect the interpretation of this Agreement in any
manner.
27. Counterparts. This Agreement may be executed in any number of counterparts,
each of which shall be deemed an original but all of which together shall
constitute one and the same instrument.
28. No Third Party Rights. The provisions of this Agreement are for the
exclusive benefit of the parties to this Agreement, and no other party
(including without limitation any creditor of any party to this Agreement)
shall have any right or claim against any party to this Agreement by reason
of those provisions or be entitled to enforce any of those provisions
against any party to this Agreement.
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29. Relationship of Parties. This Agreement shall not constitute or be
construed as creating a partnership or joint venture between SIGMA and IVAX
DIAGNOSTICS, and neither party shall be liable for any debts or obligations
of the other party.
30. Limitation of Liability. Neither SIGMA nor IVAX DIAGNOSTICS nor any of
their affiliates, employees, agents, officers or subcontractors shall have
any liability for special, incidental, consequential or punitive damages or
for economic loss as a result of any breach of this Agreement.
31. Performance by Affiliates. SIGMA acknowledges and agrees that IVAX
DIAGNOSTICS may perform certain of its obligations hereunder through its
affiliates.
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32. THIS AGREEMENT CONTAINS A BINDING ARBITRATION PROVISION, WHICH MAY BE
ENFORCED BY THE PARTIES.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duty authorized officers or authorized representatives
IVAX DIAGNOSTICS,INC.
By:/s/ Xxxxx X. Xxxxxx
---------------------------------------
Title:Vice President-Business Developments
------------------------------------
Date: 10-12-00
-------------------------------------
SIGMA DIAGNOSTICS, INC.
By:/s/
----------------------------
Title: X.X.Xxxxxxxx Development
--------------------------
Date: 10/9/00
--------------------------
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