DISTRIBUTOR AGREEMENT
BETWEEN
OLYMPUS AMERICA INC.,
CLINICAL INSTRUMENT DIVISION
AND
HEMAGEN DIAGNOSTICS, INC.
March 1, 1996
DISTRIBUTOR AGREEMENT
AGREEMENT effective as of the 1st day of March, 1996, by and between
HEMAGEN DIAGNOSTICS, INC., a company organized and existing under the laws of
Delaware and having its principal office at 00-00 Xxxx Xxxx Xxxx, Xxxxxxx, XX
00000 ("VENDOR"), and OLYMPUS AMERICA INC.-Clinical Instrument Division, a
company organized and existing under the laws of New York and having its
principal office at Xxx Xxxxxxxxx Xxxxxx Xxxxx, Xxxxxxxx, Xxx Xxxx 00000-0000
("OLYMPUS").
W I T N E S S E T H:
WHEREAS, VENDOR manufactures and sells a wide variety of highly refined
and specialized in vitro diagnostic reagents; and
WHEREAS, OLYMPUS is a recognized distributor and supplier of clinical,
medical, and scientific products; and
WHEREAS, OLYMPUS desires to engage in the purchase of the Products (as
defined in Section 1.10) from VENDOR for the purpose of resale, under the
OLYMPUS label, within the Territory; and
WHEREAS, VENDOR is willing to manufacture and sell the Products for and
to OLYMPUS on an exclusive basis within and for resale in North America and
Hawaii (and on a non-exclusive basis in all other areas of 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 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 percent 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 7.1.
1.4 "Business Day" shall mean any day which is not a Saturday, Sunday, or
bank holiday in the State of New York.
1.5 "Effective Date" shall mean the date first above written.
1.6 "FDA" shall mean the United States Food and Drug Administration.
1.7 "HPB" shall mean the Canadian Ministry of Health - Health Protection
Branch.
1.8 "Intellectual Property" shall have the meaning set forth in Section
6.6.
1.9 "OLYMPUS Analyzers" shall mean the OLYMPUS PK series of
immunohematology analyzers and all successor analyzers thereof.
1.10 "Products" shall mean, collectively, certain CMV (cytomegalovirus)
reagents to be used exclusively on the OLYMPUS Analyzers, a list of which
reagents is attached hereto as Schedule 1.10 (which Schedule may be amended
from time to time and at any time upon mutual written consent) and which shall
conform to the Specifications; documentation to accompany the Products as
reasonably required by OLYMPUS; and any Product Changes.
1.11 "Product Changes" shall mean any changes, improvements, alterations,
modifications, new generations, and substitutions to or of the Products or the
Products' labelling to include content, size, adhesive, ink, bottles or seals.
1.12 "Recall" shall have the meaning set forth in Section 3.9.
1.13 "Specifications" shall mean the specifications of the Products
attached hereto as part of Schedule 1.10.
1.14 "Territory" shall mean the entire world.
ARTICLE 2. PURCHASE AND SALE.
2.1 Territorial Exclusivity.
(a) During the Agreement Term, VENDOR agrees to sell the Products to
OLYMPUS and OLYMPUS shall purchase the Products from VENDOR (if OLYMPUS submits
a purchase order therefor) in accordance with and subject to the terms and
conditions of this Agreement. OLYMPUS shall be the exclusive distributor of the
Products within North America and Hawaii and the non-exclusive distributor of
the Products in all other areas of the Territory. VENDOR and VENDOR's
Affiliates shall not sell the Products, or CMV reagents based on similar
agglutination technology, directly or indirectly, or otherwise provide the
Products to any other entity for purposes of resale within North America and
Hawaii. During the Agreement Term, if VENDOR or a VENDOR Affiliate sells a
Product within North America and Hawaii directly or through a third party,
OLYMPUS shall receive from VENDOR a profit passover equal to the product of (a)
the difference between (i) the then-current Product price charged to OLYMPUS by
VENDOR and (ii) the then-current average sales price of such Product charged by
OLYMPUS to its customers, and (b) the number of units of such Product so sold
within North America and Hawaii by VENDOR, VENDOR's Affiliate or a third party.
Prior to conducting any marketing efforts or completing any sales in any area
of the Territory other than in North America and Hawaii, OLYMPUS shall notify
VENDOR in writing of its intent to begin such marketing efforts outside of
North America and Hawaii. In the event VENDOR appoints an exclusive distributor
of the Products in an area of the Territory other than North America and
Hawaii, OLYMPUS may no longer distribute the Products in such area of the
Territory, but OLYMPUS shall maintain its exclusivity in North America and
Hawaii. VENDOR shall give OLYMPUS 30 days' written notice prior to appointing
any such exclusive distributor in an area of the Territory other than North
America and Hawaii. Notwithstanding anything contained herein to the contrary,
in the event the Agreement Term is not extended in accordance with Section 7.1,
then, for the final 90 days of the Agreement Term, (i) OLYMPUS's distribution
rights in North America and Hawaii hereunder shall become non-exclusive, (ii)
OLYMPUS shall be entitled to purchase CMV reagents under OLYMPUS's name (but
not sell such CMV reagents) without any liability whatsoever, and (iii) VENDOR
shall have the right to market, but not sell, the Products in North America and
Hawaii.
(b) In consideration for its exclusive rights hereunder, OLYMPUS agrees
to purchase a minimum of 800,000 PH2000 PK CMV System tests (there are 2,000
tests per kit) per Agreement Term year, provided that VENDOR is not in default
under this Agreement. OLYMPUS's liability for failure to purchase such minimum
shall be limited to the difference between the dollar amount of such minimum
(CONFIDENTIAL TREATMENT REQUESTED) and the dollar amount of PH2000 PK CMV
System tests actually purchased by OLYMPUS. OLYMPUS shall not be liable for any
other damages, including without limitation indirect, special, incidental, or
consequential damages of any kind, including but not limited to damages for
lost profits, lost investments, or lost business opportunities.
(c) Except as set forth in the last sentence of Section 2.1(a)(ii),
OLYMPUS shall be entitled to develop (by itself and/or with others) but shall
not market or sell CMV reagents based on agglutination technology similar to
that which is contained in the Products. However, OLYMPUS shall be entitled to
develop, market, and sell (by itself and/or with others) CMV reagents which are
not based on agglutination technology similar to that which is contained in the
Products.
2.2 License. VENDOR hereby unconditionally and irrevocably grants to
OLYMPUS and OLYMPUS's Affiliates a royalty-free, fully paid-up right to use,
market, sell, grant sublicenses to end-users, and/or otherwise dispose of (or
have others do any of the foregoing on OLYMPUS's behalf) the Products
(exclusively in North America and Hawaii and non-exclusively elsewhere in the
Territory). OLYMPUS shall determine all terms and conditions of resale of the
Products to its customers, including but not limited to prices.
2.3 Order Processing. All purchase orders and amendments thereto must be
in writing, and should contain (in addition to the information set forth below
in Section 2.5, preferred shipping instructions, if any.
2.4 Product Delivery. All OLYMPUS purchase orders shall be for delivery
in not less than 90 days and shall be deemed accepted by VENDOR unless OLYMPUS
is notified to the contrary in writing by VENDOR within ten Business Days of
VENDOR's receipt of a written purchase order from OLYMPUS. Delivery shall be
made by VENDOR to any OLYMPUS destination point within North America or Hawaii
designated by OLYMPUS. OLYMPUS may cancel any purchase order provided that such
cancellation is made in writing no later than 15 days after VENDOR's receipt of
such purchase order. In addition, OLYMPUS may cancel a purchase order if
delivery of such purchase order is more than 30 days past due.
2.5 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 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. Title to and risk of loss for the Products sold to
OLYMPUS shall pass upon shipment of the Products to OLYMPUS. Except as
otherwise set forth in this Agreement to the contrary, (i) OLYMPUS shall
reimburse VENDOR for the shipping costs incurred by VENDOR in delivering the
Products to OLYMPUS, and (ii) OLYMPUS's purchase order shall fix Product
quantities, reference applicable pricing, and set destinations and delivery
schedules.
2.6 Inspection Rights.
(a) Procedure. OLYMPUS shall have the right, at OLYMPUS's expense, to
count and conduct an inspection of the shipped Products for a period of 15
Business Days following receipt of such Products at the designated incoming
delivery point or facility. If any Product fails such inspection, OLYMPUS shall
notify VENDOR in writing of such failure. OLYMPUS shall be entitled to reject
as defective those Product units with a remaining shelf life of twelve months
or less. If OLYMPUS fails to reject received Products within the aforementioned
15-Business Day inspection period, such Products shall be deemed accepted. If,
after conducting an investigation within 15 Business Days of such written
notice, VENDOR concurs that such Products failed to meet OLYMPUS's standards
for acceptance, then VENDOR agrees to accept and pay the shipping costs for (i)
the return of such defective Product and (ii) the delivery of the replacement
Product, provided that the defect is not the result of OLYMPUS negligence or
misuse such as the failure to properly store the Product while in OLYMPUS's
possession. If, after such investigation, VENDOR disagrees with OLYMPUS, then
the parties shall agree upon a mutually acceptable method to determine whether
or not the Products should be accepted by OLYMPUS. If the parties fail to agree
upon a method within ten Business Days, then the parties shall promptly agree
upon an independent quality control laboratory (the "Laboratory") to conduct an
inspection of the Products for purposes of determining if the Products should
be accepted by OLYMPUS or replaced, at no charge, by VENDOR. The determination
of the Laboratory shall be final and binding upon the parties and the party
that was proven incorrect in its inspection analysis shall bear the entire cost
of the Laboratory inspection. Upon delivery by VENDOR to OLYMPUS of replacement
Product, OLYMPUS and VENDOR will follow the inspection, (if necessary)
investigation, and (if necessary) resolution procedure set forth in this
Section 2.6(a) with respect to such replacement Product, except that, at this
point, in addition to the replacement remedy, OLYMPUS shall have the option of
receiving a full refund of the purchase proce paid for the original Product
delivered if the replacement Product is found by the Laboratory to be defective
or nonconforming. Inspection, testing, acceptance, or use of the Products, or
failure to do the same, on any occasion shall not affect VENDOR's obligation
under any warranty contained herein or any other rights or remedies available
to OLYMPUS whether at law or in equity, and such warranties, rights, and
remedies shall survive such inspection, testing, acceptance, and use.
(b) Certificates of Analysis. Certificates of analysis for each Product
will be provided to OLYMPUS at or prior to the time of final Product release
and with each shipment of Product. A form of certificate of analysis to be used
is attached hereto as Exhibit A. OLYMPUS has the right to reject any materials
for which certificates of analysis are not provided, after notification, within
two Business Days. VENDOR shall bear the costs and expenses associated with the
return of the Product to the VENDOR and will replace the Product at no charge
to OLYMPUS.
(c) Quantity Deficiency. If OLYMPUS finds any quantity deficiency in the
Product units received, OLYMPUS may, at its option, (i) require VENDOR to
immediately deliver the difference by air freight at VENDOR's expense, or (ii)
reduce the purchase price specified in the related purchase order accordingly.
If a Product shipment is incomplete (e.g., a kit is missing vials), OLYMPUS
may, at its option, (i) require VENDOR to ship an entirely new and complete
Product unit (e.g., new kit), rather than simply replace the incomplete aspect
of the Product unit, or (ii) reduce the purchase price specified in the related
purchase order accordingly.
(e) Over-shipment. If OLYMPUS finds an over-shipment of Product units,
OLYMPUS may store or return the excess Product units to VENDOR, both at
VENDOR's risk and expense. If OLYMPUS decides to retain such excess, OLYMPUS
shall increase the purchase amount specified in the related purchase order
accordingly .
2.7 Pricing & Payment.
(a) Pricing. The prices to be charged to OLYMPUS for the Products for the
duration of the Agreement Term shall be the prices set forth in Schedule 1.10
attached hereto. The prices to be charged to OLYMPUS for the Products do not
include package inserts (OLYMPUS shall provide its own package inserts to
VENDOR). OLYMPUS shall be free to set its own Product prices charged to its
(sub)distributors, dealers, and customers.
(b) Payment. OLYMPUS shall pay for all Products accepted by it no later
than 45 days from the date of shipment to OLYMPUS by VENDOR.
ARTICLE 3. OBLIGATIONS OF VENDOR.
3.1 Approvals and Clearances. VENDOR shall ensure that no Product is sold
to OLYMPUS before all required FDA pre-market approvals and clearances have
been obtained. VENDOR shall supply OLYMPUS with copies of all non-confidential
FDA submissions, questions, responses, acceptance letters, and other
communications and documentation regarding the Products. In addition, VENDOR
shall provide OLYMPUS with reasonable assistance in obtaining other
governmental or private approvals and clearances, including without limitation
those of the HPB.
3.2 Bottling, Packing and Labelling; Trademarks.
(a) All Product bottles, packages and labels shall (i) be designed by
OLYMPUS and/or its designees with the assistance of VENDOR, if requested, (ii)
be subsequently produced or purchased by VENDOR, and (iii) meet all
requirements specified by OLYMPUS in writing. Notwithstanding the foregoing, if
any bottling, packaging, or labels are to contain VENDOR's name or trademark,
then VENDOR must approve such bottling, packaging, package inserts, or labels,
which approval shall not be unreasonably withheld or delayed. The incremental
cost of any bottle, package or label changes requested by OLYMPUS (including
without limitation engineering and equipment costs) will be borne by OLYMPUS.
Such requested changes shall be in writing and shall be reasonable. OLYMPUS
shall select and incur the cost of the manufacture, design, text, and vendor of
the Product's package inserts, and shall provide such package inserts to VENDOR
for shipment along with the Products. VENDOR shall not be liable if shipment of
the Products is delayed solely due to OLYMPUS's late delivery or failure to
deliver the package inserts to VENDOR.
(b) VENDOR shall, at no additional charge to OLYMPUS, bottle, pack and
label the Products in accordance with OLYMPUS's instructions and the
Specifications. VENDOR shall permanently affix OLYMPUS's Product number, trade
name, trademark, colors, and logo (the "Authorized Trademarks") and lot numbers
on all Product bottling, packaging, labels and other printed materials in
accordance with OLYMPUS's instructions. Upon termination or expiration of this
Agreement, VENDOR shall not sell any Product which is bottled or packaged in
materials containing the Authorized Trademarks. Except as expressly set forth
herein, VENDOR shall not acquire any right, title, license or other interest in
the OLYMPUS name, or any trade name, trademark, or logo belonging to OLYMPUS.
All Product labelling shall comply with all applicable FDA rules and
regulations. In addition, VENDOR shall provide OLYMPUS with reasonable
assistance in complying with other applicable governmental rules and
regulations, including without limitation those of the HPB.
(c) Any use by VENDOR of the Authorized Trademarks or any trade name,
trademark, or logo which is similar to an Authorized Trademark, and the
goodwill of any business associated with such trade names, trademarks, or
logos, shall inure to the benefit of OLYMPUS.
(d) Except as set forth in Section 2.2, nothing herein shall give OLYMPUS
any right, title, or interest in or license to use any Intellectual Property of
VENDOR.
(e) During the Agreement Term, VENDOR shall not apply VENDOR's or any
third party's name, trademark, or logo to the Products or to any bottling,
packaging, labels, inserts, or other printed materials provided with the
Products, except (i) for an identifying reference stating "Manufactured for
Olympus America Inc. by Hemagen Diagnostics, Inc." in a font and location as
set forth in Schedule 3.2 attached hereto to the extent to which OLYMPUS may so
request and instruct, or if VENDOR may by law be required to identify itself as
the manufacturer or supplier thereof or (ii) with respect to Products to be
marketed and sold outside of North America and Hawaii under a name other than
that of OLYMPUS.
3.3 Product Changes. VENDOR shall give OLYMPUS 90 days' prior written
notice of any proposed Product Changes, which OLYMPUS may accept or reject in
its sole and absolute discretion unless such change is required by governmental
agency, law, rule or regulation. If a Product Change is not required by
governmental agency, law, rule or regulation and OLYMPUS chooses to reject a
Product Change, then VENDOR shall continue to manufacture and sell Products to
OLYMPUS without implementing such proposed Product Changes. However, if VENDOR
implements such Product Change without OLYMPUS's approval, OLYMPUS may, in
addition to all other rights and remedies at law or in equity or otherwise,
terminate this Agreement and all pending purchase orders pursuan to Section
7.2(c). If OLYMPUS accepts a Product Change, VENDOR shall, prior to
implementation, promptly obtain all FDA approvals and clearances required to
manufacture the Product and sell the Product (as changed, modified, or added)
within the United States, including without limitation validating the Product.
No Product Change shall be implemented and effective unless and until it is
accepted for sale by OLYMPUS except if such Product Change is required by
governmental agency, law, rule or regulation. All Product Changes (including
without limitation those required by governmental agency, law, rule or
regulation) shall require validation data and protocols that are acceptable to
OLYMPUS, which acceptance shall not be unreasonably withheld or delayed. A
change of a supplier by VENDOR shall not constitute a Product Change except
that OLYMPUS must receive reasonable prior written notice of VENDOR's use of a
supplier that had not been previously qualified by VENDOR. Notwithstanding
anything contained herein to the contrary, if a Product Change which is
required by a governmental agency, law, rule or regulation renders a Product
useless with respect to its intended purposes or in connection with the OLYMPUS
Analyzers, this Agreement shall be terminated immediately in accordance with
Section 7.2(c).
3.4 Technical Assistance & Support.
(a) VENDOR shall furnish to OLYMPUS, without additional charge and for
the duration of the Agreement Term and (unless otherwise stated) for a period
of one year thereafter, the following technical assistance and support:
(i) Documentation. All technical information, Material and Safety
Data Sheet (MSDS) information, documentation and test data necessary to market,
sell and otherwise distribute the Products within the Territory. Such materials
shall be consistent with similar information furnished to other distributors or
resellers of similar products manufactured by VENDOR. VENDOR hereby grants to
OLYMPUS a fully-paid license for the Agreement Term to copy or otherwise
reproduce all or portions of VENDOR's brochures, or to incorporate portions of
VENDOR-copyrighted material in Product brochures or advertising material
composed by OLYMPUS, provided that OLYMPUS shall submit such materials composed
by OLYMPUS which incorporate such VENDOR-copyrighted material to VENDOR for
prior approval, which approval shall not be unreasonably withheld or delayed.
Such license will survive the expiration or termination of this Agreement for a
period of time equal to the longest remaining shelf-life of a Product in
OLYMPUS's inventory (the "Longest Shelf-life") and such reproduction will be
subject to all applicable copyright laws. Notwithstanding anything contained
herein to the contrary, those materials which incorporate authorized
VENDOR-copyrighted material and which have been disseminated during the
Agreement Term and the Longest Shelf-life thereafter, may be used in perpetuity
by the recipients thereof.
(ii) Telephone Support. On-going telephone support, via a
non-exclusive toll-free telephone number, to OLYMPUS personnel and, upon
request of OLYMPUS, to OLYMPUS's customers. Such telephone support shall
respond to all reasonable requests for information or other technical support
regarding Product use, storage, handling, shipping, clean-up and disposal,
claims, efficacy, and regulatory clearance. Such telephone support shall be
available only during VENDOR's normal business hours of 9 a.m. to 5 p.m.
(Eastern).
(iii) On-Site Support. At OLYMPUS's request and at mutually
convenient times, VENDOR will provide on-site support at the OLYMPUS facility
or customer site to investigate performance problems. When such on-site support
is provided within North America and Hawaii, each party shall be responsible
for its own costs associated with such visits. If OLYMPUS requests on-site
support in an area of the Territory other than North America or Hawaii, OLYMPUS
shall be responsible for all of VENDOR's out-of-pocket costs and expenses
(including travel, food, and lodging) associated therewith.
(b) OLYMPUS Training. To assist VENDOR in better understanding the
OLYMPUS Analyzers, OLYMPUS will provide VENDOR, at OLYMPUS's sole and absolute
discretion, with training on the OLYMPUS Analyzers at no charge to VENDOR,
except that VENDOR will be responsible for its travel and lodging expenses in
connection therewith.
3.5 Insurance. Commencing on the first date of Product delivery until the
expiration of the most remote statute of limitations in the United States,
VENDOR shall maintain product liability insurance with an insurance company in
the amount of $1,000,000.00, naming OLYMPUS as an additional insured, for any
death or bodily injury or property damage resulting from the manufacture,
design, testing, sale, or use of the Products. Copies of all such policies and
any certificates or notices thereunder shall be forwarded to OLYMPUS along with
prior notice of termination or cancellation of such policies.
3.6 Audits. OLYMPUS shall have the right (at OLYMPUS's expense) to
perform a commercially reasonable audit of VENDOR's compliance with FDA rules
and regulations (including without limitation the then current published Good
Manufacturing Practices (21 C.F.R. Part 820) and any other applicable laws,
rules, or regulations with respect to the Products, during normal business
hours and upon prior notice to VENDOR and subject to Article 9-CONFIDENTIAL
INFORMATION). The VENDOR facility being audited must be operational during the
audit and producing the Product. Olympus shall also receive access to the batch
history records of the Products. The parties will cooperate with each other to
arrange such visits at mutually convenient times. In addition, OLYMPUS
personnel may periodically travel to VENDOR's facilities to observe testing and
validation activities, receive information with respect thereto (subject to
Article 9-CONFIDENTIAL INFORMATION), and ensure that the Products are being
tested in accordance with Good Laboratory Practices (21 C.F.R. Part 58). The
parties understand and agree that certain information and documentation may
contain certain highly confidential Product formulation trade secrets of
VENDOR. VENDOR, in its sole discretion, may give limited or no access to such
information or documentation during any OLYMPUS audit or inspection of VENDOR's
facilities. The withholding of any such information or documentation pursuant
to this Section shall not be deemed in breach of VENDORs obligations under this
Agreement. Notwithstanding the foregoing, OLYMPUS must , at a minimum, be
permitted to conduct audits of VENDOR (except certain highly confidential
Product formulation trade secrets of VENDOR) which comply with the then current
published Good Manufacturing Practices (21 C.F.R. Part 820) and any other
applicable laws, rules, and regulations.
3.7 Complaints. In the event OLYMPUS cannot resolve customer complaints
regarding the Products, OLYMPUS shall forward such complaints to VENDOR and
VENDOR shall conduct a complete and documented investigation and shall respond
to and use its best efforts to resolve such complaints in accordance with the
requirements for complaint handling as promulgated by the FDA in the then
current published Good Manufacturing Practices (21 C.F.R. Part 820) or any
other applicable laws, rules, or regulations. All such complaint investigations
shall be performed and completed promptly but in no event later than 30 days
from receipt of the complaint by VENDOR unless VENDOR is delayed due to
third-party circumstances beyond VENDORs control. If as a result of VENDOR's
investigation a Product Change is necessary, VENDOR will perform, validate, and
document such Product Change in accordance with this Agreement, to OLYMPUS's
sole and complete satisfaction and at no charge to OLYMPUS. OLYMPUS shall have
the right to review and approve (in writing) all changes or corrective actions
resulting from a complaint investigation prior to the implementation of such
changes or corrective actions. VENDOR shall notify OLYMPUS immediately of any
claims that it receives of Product defects. VENDOR shall maintain a reasonable
inventory (i.e., not less than one percent of the total lot) of retention
materials for complaint investigations. Retention materials shall be clearly
marked as to lot origin.
3.8 Special Investigations; Inquiries. If the FDA requires any clinical
or other investigations to be performed on or with respect to the Products, and
VENDOR has ot performed such investigations or if, for any reason, the FDA will
not accept the results of VENDOR's investigations, then VENDOR shall use its
best efforts in promptly undertaking and completing such investigations. VENDOR
agrees to notify OLYMPUS in writing of any formal or informal inquiries
relating to the Products by the FDA or HPB, or any other regulatory agency, or
any state or Federal government. Included in such notification shall be a copy
of the relevant portions of the Form 483 and/or warning letters (in the case of
an FDA inquiry) or other similar document left by or subsequently sent by the
inquirer to VENDOR.
3.9 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"), VENDOR shall bear all costs and
expenses of such Recall if such Recall is the result of any act or omission to
act attributable solely to VENDOR. OLYMPUS shall reasonably assist VENDOR, at
VENDOR's cost and expense, in carrying out any such Recall. OLYMPUS shall bear
all costs and expenses of a Recall if such Recall is the result of any act or
omission to act attributable solely to OLYMPUS. VENDOR shall reasonably assist
OLYMPUS, at OLYMPUS's cost and expense, in carrying out any such Recall. If a
Recall is the result of acts or omissions to act attributable to both VENDOR
and OLYMPUS, or should it prove impossible to assign fault for such Recall,
VENDOR and OLYMPUS shall share the costs and expenses of such Recall equally.
3.10 Sales Leads. VENDOR shall forward to OLYMPUS any and all inquiries
received from Product customers or potential Product customers within North
America and Hawaii.
ARTICLE 4 OBLIGATIONS OF OLYMPUS
4.1 Trade and Advertising Practices. OLYMPUS shall not engage in any
unfair trade practices or make any false or misleading statements or
representations in its advertising, printed material, or otherwise with respect
to the Products, VENDOR and/or the VENDOR's Intellectual Property. OLYMPUS
shall, at its cost, correct or change any materially objectionable false or
misleading statements or representations made by OLYMPUS. If OLYMPUS advertises
the Products, such advertising shall be in compliance with all applicable state
and federal laws and regulations of the particular area of the Territory.
4.2 Compliance. OLYMPUS, at its own expense shall comply with all
applicable laws, rules and regulations required of it in the areas of the
Territory in which it is distributing the Products, in order to market or sell
the Products in such areas. OLYMPUS agrees, at its own expense, to comply with
all applicable laws, regulations and orders governing the sale, disposition,
shipment and import of the Products and to purchase and maintain in effect all
licenses, permits and authorizations from all government agencies as may be
necessary to perform its obligations hereunder (other than those required by
the FDA). Unless such information is proprietary, VENDOR will supply OLYMPUS
with any required information (such as FDA 510(k) data) which OLYMPUS shall
reasonably request for the sole purpose of obtaining licenses and permits.
OLYMPUS will maintain and, when required by the FDA, provide to VENDOR, subject
to Article 9 (CONFIDENTIAL INFORMATION) a list of OLYMPUS's lot numbers for the
Products with VENDOR's corresponding Product lot numbers (if different).
Subject to Article 9 (CONFIDENTIAL INFORMATION), VENDOR shall provide OLYMPUS
with any and all information (except certain highly confidential Product
formulation trade secrets of VENDOR) which OLYMPUS may require in order to
comply with this Section 4.2.
4.3 Promotional Materials. OLYMPUS shall be responsible for the creation
and distribution of its own promotional and marketing materials regarding the
Products, and for the development and implementation of all Product marketing
and sales strategies. VENDOR shall provide OLYMPUS with reasonable assistance
in connection with the foregoing.
4.4 OLYMPUS Training. OLYMPUS will provide VENDOR, at OLYMPUS's sole and
aboslute discretion and at no charge to VENDOR, with training on the OLYMPUS
Analyzers at no charge to VENDOR, except that VENDOR shall be responsible for
its out-of-pocket costs and expenses (including without limiation travel, food
and lodging in connection therewith).
4.5 Insurance. Commencing on the first date of Product delivery until the
expiration of the most remote statute of limitations in the United States,
OLYMPUS shall maintain comprehensive general liability insurance (which
includes product liability insurance) with an insurance company in the amount
of $1,000,000.00 covering its activities hereunder as a distributor of the
Products. Evidence of such insurance shall be provided to VENDOR upon
reasonable request.
ARTICLE 5. REPRESENTATIONS AND WARRANTIES OF OLYMPUS.
OLYMPUS hereby represents and warrants to VENDOR, its successors and permitted
assigns that:
5.1 Due Organization. OLYMPUS 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.
5.2 Authorization to Execute. The person executing this Agreement on
behalf of OLYMPUS has been duly authorized to do so by all requisite corporate
and other action of OLYMPUS, and this Agreement has been duly executed and
delivered to VENDOR by such person.
5.3 Validity of Agreement. This Agreement is the legal, valid and binding
obligation of OLYMPUS, enforceable in accordance with its terms.
5.4 No Conflict. To the knowledge of OLYMPUS, the execution, delivery and
performance of this Agreement by OLYMPUS does not and will not conflict with or
result in a breach of any agreement, instrument or understanding, oral or
written, to which OLYMPUS 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
OLYMPUS's obligations hereunder.
ARTICLE 6. REPRESENTATIONS AND WARRANTIES OF VENDOR.
VENDOR hereby covenants, represents and warrants to OLYMPUS, its successors and
permitted assigns that:
6.1 Due Organization. VENDOR is a corporation duly organized, validly
existing, and in good standing under the laws of the state of Delaware, 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 VENDOR has been duly authorized to do so by all requisite corporate
and other action of VENDOR, and this Agreement has been duly executed and
delivered to OLYMPUS by such person.
6.3 Validity of Agreement. This Agreement is the legal, valid and binding
obligation of VENDOR, enforceable in accordance with its terms.
6.4 No Conflict. To the knowledge of VENDOR, the execution, delivery and
performance of this Agreement by VENDOR does not and will not conflict with or
result in a breach of any agreement, instrument or understanding, oral or
written, to which VENDOR 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
VENDOR's obligations hereunder.
6.5 Right to Use Technology. VENDOR has the legally enforceable right to
use all technology contained within or related to the Products, whether
patented or unpatented, and the use of such technology does not violate any
agreement, instrument or understanding, oral or written, to which VENDOR is a
party.
6.6 Warranty of Non-Infringement. VENDOR is, and for the Agreement Term
VENDOR will be, the sole and exclusive owner of all right, title and interest
in and to the Products. The Products do not incorporate or infringe upon any
copyright, patent, trademark, service xxxx, trade name, idea, process,
know-how, development, invention, technology, or any other form of intellectual
property (collectively "Intellectual Property") not owned by or licensed to
VENDOR. VENDOR will promptly notify OLYMPUS of any alleged or actual
infringement by VENDOR of any Intellectual Property relating to the Products or
their manufacture.
6.7 Right to Sell for Resale; Ability to Deliver. VENDOR has the right to
sell the Products to OLYMPUS for resale by OLYMPUS exclusively within North
America and Hawaii and non-exclusively elsewhere in the Territory. VENDOR has
and will have the ability to timely deliver, at a minimum, the minimum amount
of Products (as set forth in Section 2.1) ordered by OLYMPUS during the
Agreement Term.
6.8 Product Quality.
(a) The Products to be sold and delivered to OLYMPUS hereunder shall (i)
conform to the Specifications, (ii) be merchantable and fit for their
particular purpose, (iii) be fully compatible with and suitable for the OLYMPUS
Analyzers provided that a modification to the OLYMPUS Analyzers by OLYMPUS or
OLYMPUS's Affiliates do not cause the incompatibility or unsuitability, and
(iv) be new and free from defects in design, materials and workmanship.
(b) VENDOR shall possess a Quality Assurance System that adheres to all
applicable laws, rules and regulations, including without limitation the
practices and regulations of the FDA (including but not limited to current Good
Manufacturing Practices as expressed in 21 C.F.R. Part 820). OLYMPUS have the
right to inspect VENDOR's manufacturing facility for such compliance in
accordance with Section 3.6 (Audits).
6.9 Product Warranty.
(a) With respect to each Product unit sold and delivered to OLYMPUS,
VENDOR shall, at no charge to OLYMPUS, replace any defective or non-conforming
Product unit by reason of breach of any warranty by VENDOR hereunder, within 45
days after receipt by VENDOR of the defective or non-conforming Product unit.
If any replacement Product is found by OLYMPUS to be defective or
non-conforming, VENDOR shall, at OLYMPUS's option and at no charge to OLYMPUS,
replace or fully refund the purchase price paid for the original defective or
non-conforming Product delivered, within 15 days after receipt by VENDOR of the
defective or non-conforming replacement Product unit.
(b) The warranty period for replacement or refund (as the case may be)
shall be the useful life of the Product as indicated on the Product bottle.
Written notice of non-conforming Product must be received by VENDOR within
three months from the end of the Product's useful life. At the time of their
receipt by OLYMPUS, the Products shall have a shelf life of at least 12 months.
VENDOR shall not be responsible for any variation from the specifications or
any failure to satisfy the shelf life requirement to the extent such variation
or failure is caused by misuse or improper storage or handling of the Products.
(c) Shipping costs incurred by OLYMPUS and risk of loss upon return of
Product units to VENDOR for replacement or refund (as the case may be) shall be
borne by VENDOR. Shipping costs incurred by VENDOR and risk of loss upon
delivery of the replacement Product unit to OLYMPUS shall be borne by VENDOR.
(d) The foregoing warranty shall not limit or exclude OLYMPUS's other
remedies hereunder, at law, or in equity.
6.10 Compliance. VENDOR has ensured and shall continue to ensure that, in
manufacturing and selling the Products, 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 pre-market FDA approvals and
clearances.
6.11 Price Warranty. VENDOR warrants that the prices listed on Schedule
1.10 shall include without limitation, bottling, packaging, labeling, storage,
boxing, and crating. Additional charges shall be added for insurance and
shipping (except as otherwise provided herein), sales taxes and (if OLYMPUS
requests) package
6.12 OLYMPUS Warranties. Any additional warranty offered by OLYMPUS or
any modification of VENDOR's warranties without the prior written approval of
VENDOR shall be the sole responsiblity of OLYMPUS.
6.13 Disclaimer. NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, THE
WARRANTIES OF VENDOR IN THIS ARTICLE 6 ARE THE SOLE AND EXCLUSIVE WARRANTIES
PROVIDED TO OLYMPUS AND TO CONSUMERS AND ARE IN LIEU OF ALL OTHER WARRANTIES,
WHETHER WRITTEN OR ORAL, IMPLIED OR STATUTORY. ALL WARRANTIES OF VENDOR WITH
RESPECT TO THE PRODUCTS ARE SUBJECT TO COMPLIANCE WITH VENDOR'S USE, STORAGE,
AND HANDLING INSTRUCTIONS, AND ARE LIMITED TO THE SPECIFIED SHELF LIFE OF THE
PRODUCTS.
ARTICLE 7. TERM AND TERMINATION.
7.1 Term. This Agreement shall remain in full force and effect commencing
on the Effective Date and expiring on the second anniversary of such date (the
"Agreement Term") unless earlier terminated pursuant to Section 7.2.
Notwithstanding the foregoing, (i) the parties may, upon mutual written
agreement at least 90 days prior to the end of the second year of the Agreement
Term, extend the Agreement Term by one additional year and (ii) the Agreement
Term may be suspended pursuant to the provisions of Section 10.1 (Force
Majeure) of this Agreement.
7.2 Events of Termination. This Agreement may be terminated without
limiting any party's rights to any other remedies:
(a) Immediately upon written notice by either party (the "Terminating
Party") to the other party (the "Breaching Party") if:
(i) the Breaching Party has not materially performed or has
otherwise materially breached its obligations hereunder and
if such nonperformance or breach is incapable of cure; or
(ii) 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) the Breaching Party shall make an assignment for the benefit
of its creditors.
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) and (iii).
(b) By the Terminating Party upon the expiration of 30 days (or such
additional period as the Terminating Party may authorize) after the
Breaching Party's receipt of written notice of its breach or
non-performance of its material obligations hereunder and if such
breach or non-performance is capable of cure and has not been cured
within such 30 day period.
(c) By OLYMPUS upon 30 days' prior written notice to VENDOR of a
Product Change rejection pursuant to Seciton 3.3
7.3 Purchase Orders. Unless OLYMPUS decides that it does not wish to have
a purchase order filled, any purchase order placed by OLYMPUS (i) prior to the
date that notice of termination is delivered hereunder or the date that this
Agreement otherwise expires and (ii) for shipment no later than 90 days after
such termination or expiration date; shall be timely delivered to the
destination points designated by OLYMPUS, provided that (a) such termination
did not arise from OLYMPUS's default and (b) OLYMPUS remits a 50% deposit for
those deliveries to be made after the termination or expiration date. Such
deposit(s) must be segregated by VENDOR in a separate bank account not
intermingled with VENDOR's funds, and shall remain the property of OLMPUS until
such time as delivery of the corresponding Products have been made.
7.4 Rights and Obligations upon Termination. Upon termination of this
Agreement, OLYMPUS shall have the right to (i) sell all Products ordered or in
inventory and (ii) provide on-going support and service to its customers.
Notwithstanding anything contained herein to the contrary and without limiting
OLYMPUS's other remedies, in the event this Agreement is terminated and VENDOR
is the Breaching Party, OLYMPUS shall have the right to require VENDOR to
repurchase (at the price paid by OLYMPUS) any portion of or all ordered
Products and OLYMPUS's inventory of Products provided such Products are in
their original packaging and suitable for resale by VENDOR. For purposes of
this Section, if a Product has at least three months of shelf-life remaining,
it can still be considered "suitable for resale" hereunder. In the event this
Agreement is terminated and OLYMPUS is the Breaching Party (as defined in
Section 7.2), OLYMPUS shall immediately discontinue any previously authorized
use of any of VENDOR's intellectual property and shall immediately cease all
conduct that might cause anyone to believe that OLYMPUS is authorized to market
or sell Products or is otherwise connected with VENDOR, and VENDOR may itself
or through others, commence sale, distribution and service of Products in North
America and Hawaii.
7.5 Termination or Expiration Damages. Each party hereto agrees that if
this Agreement is terminated rightfully and in good faith by the other pursuant
to the terms of this Agreement, the Terminating Party (as defined in Section
7.2) shall not be liable to the other party for any termination compensation
whatsoever, whether based upon goodwill established, clientele obtained,
expenditures incurred, investments made, activities undertaken or otherwise.
Termination of this Agreement for any reason whatsoever shall not relieve
either of the parties hereto from making payment of monies due to the other,
from fulfilling obligations incurred up to the effective date of termination,
or as otherwise expressly provided in this Agreement.
7.6 Survival. Sections 2.1(b) (last sentence only), 2.1(c), 2.2, 2.4,
2.5, 2.6, 2.7, 3.1, 3.2(b), 3.2(c), 3.2(d), 3.3, 3.4(a), 3.5, 3.7, 3.8, 3.9,
4.1, 4.5, 5.3, 5.4, 6.3, 6.4, 6.5, 6.6, 6.7 (first sentence only), 6.8(a), 6.9,
6.10, 6.11, 6.12, 6.13, 7.3, 7.4, 7.5, and Articles 8, 9, and 10 (except
Section 10.6) shall survive the execution, and termination or expiration of
this Agreement.
ARTICLE 8. INDEMNIFICATION.
8.1 Vendor Infringement Indemnity.
(a) Should any aspect of any Product become the subject of any
Intellectual Property infringement claim, action, or proceeding, VENDOR shall
either (i) obtain a license that would permit OLYMPUS to exercise all rights
granted to it under this Agreement or (ii) modify the Product to render it
non-infringing. VENDOR shall bear the cost of such license or modification.
Notwithstanding the foregoing, should any aspect of the Product become the
subject of any actual Intellectual Property infringement claim, action, or
proceeding, OLYMPUS may, without limiting its remedies and at its sole and
absolute discretion, either (i) suspend purchases of the Products from VENDOR
or (ii) terminate this Agreement, both without any liability whatsoever. In
addition, if such Intellectual Property infringement claim, action, or
proceeding is found to be meritorious (in the opinion of qualified independent
counsel reasonably acceptable to OLYMPUS and VENDOR), OLYMPUS shall have the
right to require VENDOR to repurchase (at the price paid by OLYMPUS) any
portion of or all ordered Products and OLYMPUS's inventory of Products.
(b) In addition to its obligations under subsection 8.1(a) above and
provided that VENDOR receives prompt written notice of any Intellectual
Property infringement claim, action, or proceeding covered by this Section 8.1,
VENDOR shall at all times indemnify and hold harmless OLYMPUS, 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, costs, and expenses payable to the third party
claiming Intellectual Property infringement, (ii) all of OLYMPUS's reasonable
attorneys' fees and disbursements, settlement costs, judgments, court costs and
expenses, incurred by OLYMPUS in any action or proceeding between VENDOR and
OLYMPUS and/or between OLYMPUS and any third party or otherwise, (iii)
reimbursement for the cost of Products that can no longer be sold, and (iv) any
other losses, costs, expenses, and damages incurred by OLYMPUS arising out of
or resulting from any Intellectual Property infringement claim, action or
proceeding between VENDOR and OLYMPUS and/or between OLYMPUS and any third
party or otherwise. The failure of OLYMPUS to give prompt notice shall not
result in the loss of indemnification unless VENDOR shall have been materially
prejudiced thereby.
(c) OLYMPUS shall not be entitled to the foregoing Intellectual Property
infringement indemnity from VENDOR to the extent that the Intellectual Property
infringement claim, action, or proceeding arises or results from any changes to
the Products made by OLYMPUS without VENDOR's written authorization, provided
the Products have not been modified by VENDOR without OLYMPUS's knowledge and
prior written consent.
8.2 VENDOR Product Liability and Other Damage Indemnity.
(a) VENDOR shall at all times indemnify and hold harmless OLYMPUS, 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 OLYMPUS's reasonable attorneys' fees and
disbursements, court costs and expenses, incurred by OLYMPUS in any action or
proceeding between VENDOR and OLYMPUS (if OLYMPUS is the prevailing party)
and/or between OLYMPUS and any third party (attorneys' fees and disbursements
only to the extent VENDOR fails to defend) 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 such Product or any component thereof, (ii)
misrepresentations made in connection with the promotion, marketing, sale,
distribution, use, safety, or efficacy of such Product based upon information
supplied to OLYMPUS by VENDOR, (iii) the contents of any labelling, inserts,
instruction manuals, or related documentation prepared by VENDOR or based upon
information supplied to OLYMPUS by VENDOR, or (iv) a Product Recall. VENDOR
shall have the right to control the defense and settlement of a third party
claim, action, or proceeding which is the subject of this indemnity, provided
that VENDOR shall not voluntarily make any payment, assume any obligation, or
settle or compromise an third party claim, action, or proceeding without the
express written approval of OLYMPUS (unless such settlement and/or compromise
releases OLYMPUS from all liability relating to such third party claim, action,
or proceeding).
(b) OLYMPUS shall not be entitled to the foregoing indemnity from VENDOR
to the extent that the claim, action, or proceeding arises or results from (i)
representations made by OLYMPUS regarding the Product which are different than
or in addition to the representations made by VENDOR to OLYMPUS, or (ii)
changes to the Product made by OLYMPUS, provided the Product is not defective
and has not been modified by VENDOR without OLYMPUS's knowledge and prior
written consent.
8.3 OLYMPUS Product Liability and Other Damage Indemnity.
(a)OLYMPUS shall at all times indemnify and hold harmless VENDOR, 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 VENDOR's reasonable attorneys' fees and
disbursements, court costs and expenses, incurred by VENDOR in any action or
proceeding between VENDOR and OLYMPUS (if VENDOR is the prevailing party)
and/or between VENDOR and any third party (attorneys' fees and disbursements
only to the extent OLYMPUS fails to defend) arising out of or resulting from
(I) representations (unless approved by VENDOR) made by OLYMPUS regarding a
Product which representations are different than or in addition to the
representations made by VENDOR to OLYMPUS, (ii) changes to a Product made by
OLYMPUS (provided the Product is not defective and has not been modified by
VENDOR without OLYMPUS's knowledge and prior written consent), or (iii) failure
of OLYMPUS to follow use, handling, or storage instructions with respect to the
Products. OLYMPUS shall have the right to control the defense and settlement of
a third party claim, action, or proceeding which is the subject of this
indemnity, provided that OLYMPUS shall not voluntarily make any payment, assume
any obligation, or settle or compromise an third party claim, action, or
proceeding without the express written approval of VENDOR (unless such
settlement and/or compromise releases OLYMPUS from all liability relating to
such third party claim, action, or proceeding).
(b) Notwithstanding the foregoing, VENDOR shall not be entitled to the
foregoing indemnity from OLYMPUS to the extent that the claim, action, or
proceeding arises or results 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 such Product or any
component thereof, (ii) misrepresentations made in connection with the
promotion, marketing, sale, distribution, use, safety, or efficacy of such
Product based upon information supplied to OLYMPUS by VENDOR, (iii) the
contents of any labelling, inserts, instruction manuals, or related
documentation prepared by VENDOR or based upon information supplied to OLYMPUS
by VENDOR, or (iv) a Product Recall.
8.4 Notices. Each party shall give prompt written notice to the other of
any claim, liability, loss, cost, damage, or expense for which such party seeks
indemnification under this Article 8. If the indemnified party wishes to enter
the defense of a claim, action, or proceeding being defended by the
indemnifying party, the indemnified party may do so at its own cost, with
control of the defense of the claim, action, or proceeding remaining with the
indemnifying party. If the indemnified party wishes to settle a claim, action,
or proceeding for which it is being indemnified under this Article 8, the
indemnified party must first obtain the written approval of the indemnifying
party.
ARTICLE 9. CONFIDENTIAL INFORMATION.
For purposes of this Agreement, the term "Confidential Information" shall mean
all documents, clearly marked as "PROPRIETARY" or "CONFIDENTIAL" , relating to
the respective products and businesses of the parties which (i) is disclosed,
upon request, by one party hereto to the other and (ii) is claimed by the
disclosing party to be secret, confidential and proprietary to the disclosing
party.
During the Agreement Term and for a period of one year thereafter, each party
(except as is explicitly otherwise required hereby) shall keep confidential,
shall not use 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 obligations of confidentiality imposed upon the parties by the foregoing
paragraph shall not apply with respect to any alleged Confidential Information
which:
(a) is known to the recipient thereof prior to receipt thereof from the
other party hereto (as evidenced by said recipient's written or
other recorded records);
(b) is disclosed to said recipient by a third party who has the right
to make such disclosure;
(c) is or becomes a part of the public domain or public knowledge
through no fault of the said recipient;
(d) is independently developed by the recipient (as evidenced by said
recipient's written or other recorded records); and
(e) is required to be disclosed under operation of law.
ARTICLE 10. MISCELLANEOUS.
10.1 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 term of this Agreement may be suspended for the period of such
inability, but not to exceed six months. For the purposes of this Agreement,
force majeure shall mean causes beyond either party's control including,
without limitation, 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.
(Non)Compliance with laws or government regulations shall not constitute a
force majeure event.
10.2 Relationship. The relationship created between VENDOR and OLYMPUS by
this Agreement shall be that of independent contractors. Neither OLYMPUS nor
VENDOR shall be deemed an agent, representative, partner, joint venturer, or
employee of the other party. Neither VENDOR nor OLYMPUS 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.
10.3 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 subsection (a) shall result in any additional expense to the
other party. Any purported assignment in contravention of this subsection (a)
shall, at the option of the non-assigning party, be null and void and of no
effect.
(b) Except as otherwise provided above, this Agreement will be binding
upon and inure to the benefit of the successors and assigns of the parties.
10.4 Notices. Any notice 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:
To VENDOR: Hemagen Diagnostics, Inc.
00-00 Xxxx Xxxx Xxxx
Xxxxxxx, XX 00000
Fax: 000-000-0000
Attention: General Counsel
To OLYMPUS: Olympus America Inc.
Clinical Instrument Division
Xxx Xxxxxxxxx Xxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxx 00000-0000
Fax: 000-000-0000
Attention: Division Manager
with a copy to OLYMPUS's General Counsel at the same address (Fax:
000-000-0000).
Any notice, consent, or other communication given in conformity with this
Section shall be deemed effective when received by the addressee, if delivered
by hand or facsimile transmission, and seven days after mailing, if mailed.
10.5 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. Any
controversy, dispute or claim instituted by VENDOR 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. Any controversy,
dispute or claim instituted by OLYMPUS with respect to any provision of this
Agreement shall be adjudicated exclusively by a court of competent jurisdiction
within Middlesex County, the Commonwealth of Massachusetts, or the Federal
District Court in the Commonwealth of Massachusetts.
10.6 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.
10.7 Entire Agreement. Except for OLYMPUS purchase orders pending as of
the Effective Date, this Agreement constitutes the entire agreement between
VENDOR and OLYMPUS with respect to the subject matter hereof. All prior or
contemporaneous agreements, proposals, understandings, representations, and
communications, whether written or oral, between or involving VENDOR and
OLYMPUS concerning this subject matter, including without limitation the
Exclusive Product Agreement between the parties dated as of February 28, 1989
and any amendments thereto (the "Exclusive Product Agreement") are hereby
cancelled and superseded. This Agreement may be amended or modified only in a
writing executed by both parties, which states that it is an amendment or
modification to this Agreement.
10.8 Severability. If any provision or part thereof of this Agreement is
held 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.
10.9 Taxes. Except as otherwise expressly provided in this Agreement,
each party shall be responsible for payment of its own taxes.
10.10 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.
10.11 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.
10.12 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.
10.13 Rights and Remedies Cumulative; 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. Each party's sole remedy
for the breach by the otehr party of any obligations contained in this
Agreement shall be recovery of direct damages, if any, and/or termination of
this Agreement in accordance with Section 7.2. Except with respect to Section
8.1, in no event shall either pafty be liable to the other party under this
Agreement for indirect, special, incidental, or consequential damages of any
ind, including but not limited to damages for lost profits, lost investments,
or lost business opportunities (collectively "Consequential Damages"). OLYMPUS
and VENDOR hereby agree that direct damages shall not include or contain
Consequential Damages.
10.14 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 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.
HEMAGEN DIAGNOSTICS, INC.
By: /s/ Xxxx Xxxxxxxxx
Name: Xxxx Xxxxxxxxx
Title: President
OLYMPUS AMERICA INC.-Clinical Instrument Division
By: /s/ Xxxxxxx Xxxxx
Name: Xxxxxxx Xxxxx
Title: Vice President & Division Manager
SCHEDULE 1.10
PRODUCTS, PRICING AND SPECIFICATIONS
CONFIDENTIAL TREATMENT REQUESTED
ALSO SEE ATTACHED FOR SPECIFICATIONS
CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 3.2
MANUFACTURER IDENTIFICATION
1. Package Inserts
In the next scheduled revision or printing of the package inserts for the
PK CMV System and PK CMV System Controls, the following manufacturer
identification will be incorporated:
Manfactured by: Manufactured for:
HEMAGEN DIAGNOSTICS INC. OLYMPUS AMERICA, INC.
Xxxxxxx, XX 00000 Xxxxxxxx, XX 00000
This information will be on the last page of the package inserts for PK CMV
System and PK CMV System contorls, in a font and type size equivalent to that
used in the text of the body of the package insert.
2. PK CMV System Kit
In the next scheduled revision or printing of the artwork for the PK CMV
System, the following manufacturer identification will be incorporated:
Manfactured by: Manufactured for:
HEMAGEN DIAGNOSTICS INC. OLYMPUS AMERICA, INC.
Xxxxxxx, XX 00000 Xxxxxxxx, XX 00000
This information will be incorporated on the back panel of the Kit, in an
equivalent font and type size equivalent to that used for the components,
active ingredients, and distributor information.
