Exhibit 10.52
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
DISTRIBUTION AGREEMENT
EFFECTIVE on the 9th day of September, 1999 (the "Effective Date"), by
and between CALYPTE BIOMEDICAL CORPORATION, a corporation having an office at
0000 Xxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx 00000 (hereinafter referred to as
"SUPPLIER") and XXXXXX-XXXXXXX, INC., a corporation organized and existing
pursuant to the laws of the State of Delaware, U.S.A., and having its
principal office at 1345 Avenue of the Americas, Xxx Xxxx, Xxx Xxxx 00000
(hereinafter referred to as "CW").
W I T N E S S E T H: THAT
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WHEREAS, SUPPLIER desires to supply CW with the Products (as hereinafter
defined) for use and sale by CW, and CW desires to purchase, market,
distribute and sell the Products on the terms and conditions herein set forth.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, SUPPLIER and CW mutually agree as follows:
ARTICLE I
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DEFINITIONS
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The following terms as used in this Agreement shall have the following
meanings:
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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1. "Affiliate" shall mean a corporation or any other entity that
directly, or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with, the designated party, but
only for so long as the relationship exists.
2. "Territory" shall mean the United States, its territories,
possessions and Puerto Rico.
3. "Third Party" shall mean any person, association of any kind, or
body corporation other than CW or its Affiliates or SUPPLIER or its
Affiliates.
4. "Contract Year" shall mean the period commencing on the Effective
Date of this Agreement and ending twelve (12) months after the Effective Date
and subsequent twelve (12) month periods commencing on the anniversary of the
day immediately following the end of the first Contract Year during the term
of this Agreement.
5. "Information and Data" shall mean information, know-how, secret
process, technical data, patents and techniques regarding the Products, their
method of formulation and manufacture and their use and application presently
owned or possessed by SUPPLIER or hereafter developed, acquired or possessed
by SUPPLIER.
6. "Products" shall mean collectively the products listed on Schedule
A, attached to this Agreement and incorporated herein by reference, and any
improvements to those products and any additional products added to this
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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Agreement in accordance with its terms or as a result of the mutual written
agreement of the parties hereto.
7. "Average Selling Price" shall mean the actual revenues received by
CW for sales of the Products after allowance for trade and cash discounts,
rebates, allowances, returns, free goods and replacements actually granted,
shipping costs and taxes and other governmental charges, except income taxes,
applicable to sales divided by the total number of units sold.
ARTICLE II
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RIGHTS
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1. During the term hereof, CW and its Affiliates shall have the
exclusive right to market, promote, distribute and sell the urine-based
Products, and the co-exclusive right, along with SUPPLIER, to market,
promote, distribute and sell the serum-based Products, in all markets in the
Territory, excluding life insurance testing and blood bank screening. CW
shall have the right to sublicense its rights hereunder and to subcontract
its activities hereunder with the prior written approval of SUPPLIER, which
shall not be unreasonably withheld. Any sublicense agreement between CW and
a sublicensee hereunder shall require that the sublicensee comply with the
terms related to promotion, advertising and complaint documentation, as
described in Article IV 5 and 6 hereof. The Products distributed by CW and
its Affiliates in the Territory will initially be sold under the SUPPLIER'S
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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label, and the Product box shall bear a label provided to SUPPLIER by CW and
affixed by SUPPLIER, which identifies the Product as one distributed by
Xxxxxxx Laboratories. [**] In the event that Product is sold with Xxxxxxx
Laboratories labeling, there shall be an acknowledgement on the label that
SUPPLIER is the manufacturer/developer of the Products, which acknowledgement
shall be in the form, shall have the content and shall be placed on the
labels for the Products as set forth on Schedule B.
2. [**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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2. (Continued) [**]
3. [**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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3. (Continued) [**]
4. [**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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4. (Continued) [**]
5. Notwithstanding anything provided herein to the contrary, SUPPLIER
shall not have the right to terminate CW'S exclusivity or co-exclusivity for
failure of CW to purchase quantities which CW would have had to purchase in
order for CW to maintain exclusivity or co-exclusivity, as the case may be,
if the reason for CW'S failure to purchase such quantities is that SUPPLIER
has failed to supply to CW the Products ordered by CW as provided in this
Agreement or if CW'S failure to purchase such quantities is as a result of
recall or as a result of failure of the Products to perform properly in
accordance with Supplier's published specifications therefore(but excluding
customer misuse) when used by CW customers.
6. Notwithstanding any provision in this Agreement to the contrary,
nothing herein shall be deemed to grant SUPPLIER or its Affiliates or any
Third Party any rights in or to any of CW'S or CW'S Affiliates' patent rights
or other intellectual property rights; nor, except as specifically provided
herein, to grant to CW or its Affiliates any rights in or to any of
Supplier's or Supplier's Affiliates' patent rights or other intellectual
property rights to CW or its Affiliates.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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ARTICLE III
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PURCHASE OF PRODUCTS AND SUPPLY OF SAMPLES
------------------------------------------
1. During the term of this Agreement, SUPPLIER shall manufacture the
Products at its plants at 0000 Xxxxxx Xxxxxx Xxxxxxxx, Xxxxxxxxxx 00000
and/or 0000 Xxxx Xxxx Xxxxx, Xxxxxxxxx, XX 00000 or such other location as
shall be mutually agreed to in writing by the parties, and shall sell to CW
such quantities of Products as CW orders from SUPPLIER from time to time as
provided herein, labeled and packaged by SUPPLIER as specified by CW,
provided such labeling and packaging is commercially reasonable and not
excessive in cost to SUPPLIER, and conforms to FDA and other applicable
regulations.
2. SUPPLIER shall sell the Products to CW in fully labeled packaged
form at the prices set forth in Schedule C hereto incorporated herein by
reference, F.O.B. SUPPLIER'S plant in Berkeley, California or Rockville, MD
as the case may be. In the event CW requests in writing that Product be sold
in bulk packaged form, SUPPLIER shall use its best efforts to sell the
Product to CW in this form, subject to the approval of the US FDA, if such
approval is required. The price of the Products to be used as samples is
also set forth on Schedule C. Except as provided below with respect to any
agreement between CW and a Third Party, SUPPLIER shall be responsible for any
royalty due a Third Party in connection with the Products which SUPPLIER
supplies to CW hereunder.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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3. Within ninety (90) days after receipt by SUPPLIER of a written
order from CW for Products, SUPPLIER shall ship the Products to CW's
warehouse in Cranbury, New Jersey, but on an exceptions basis if requested by
CW in writing, SUPPLIER shall make commercially reasonable efforts to ship
Products directly to CW'S customers, in accordance with the shipping
instructions received by SUPPLIER from CW. Shipping charges will be prepaid
by SUPPLIER and will be charged on the invoices by SUPPLIER to CW. Supplier
shall be responsible for establishing shelf life subject to CW'S approval.
SUPPLIER shall ship Products with the best shelf life possible, with CW'S
understanding that such shelf life may be influenced by factors beyond
SUPPLIER'S control, including, but not limited to, FDA lot release procedures
and orders from CW which were not forecasted to SUPPLIER by CW. In any
event, SUPPLIER will not ship EIA test products or Western Blot test products
to CW with less than six (6) months and three (3) months remaining shelf
life, respectively, without CW'S written consent. SUPPLIER shall be
responsible for establishing SHELF life subject to CW'S approval. SUPPLIER
shall invoice CW for the Products upon the shipment of the Products by
SUPPLIER as directed by CW in writing. In the event the Products supplied by
SUPPLIER hereunder are found by CW not to conform to the specifications
agreed to between the parties and set forth in Schedule D, as such failure to
conform is determined by CW following the quality control tests set forth in
Schedule E attached hereto and incorporated herein as reference, or shall
otherwise be found to be defective, CW shall so notify SUPPLIER
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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and SUPPLIER shall after verifying the defect with its own testing, at
SUPPLIER'S cost, replace such defective quantity of the Products and at
SUPPLIER'S cost, ship such replacement Products to CW to the location to
which such defective Products were shipped, or such other location specified
by CW, as quickly as commercially feasible after the giving of such notice to
SUPPLIER by CW. If SUPPLIER'S quality assurance personnel disagree with CW'S
assessment, the parties shall mutually agree upon an independent testing
laboratory and the parties agree to abide by the decision of such laboratory
as to whether the Products are defective. If the independent testing
laboratory determines that the Products are defective, the cost of such
testing shall be paid for by SUPPLIER. If the independent testing laboratory
determines that the Products are not defective, the cost of such testing
shall be paid for by CW. CW shall accept or reject the Products within
thirty (30) days following its receipt of each shipment of the Products. In
the event that CW does not reject in writing any portion of a shipment within
thirty (30) days after its receipt of such shipment, such lack of response
shall be deemed acceptance of the Products not so rejected. Products may be
rejected only due to defects in the Products or their failure to meet
specifications set forth in Schedule D which failure can be ascertained at
such time by the quality control tests specified on Schedule E hereto. Such
acceptance or rejection shall not apply to defects or failure of the Products
to meet specifications which do not become apparent until a later date
(hereinafter referred to as "Non-apparent Defects"). CW shall have a
reasonable
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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period of time after it learns of such Non-apparent Defects to reject such
Products by so notifying SUPPLIER in writing thereof. Following SUPPLIER'S
or an independent testing laboratory's verification of such defects, SUPPLIER
may issue a Returned Goods Authorization Number to CW so that some or all
rejected Products can be returned by CW to SUPPLIER at SUPPLIER'S expense.
Alternatively, SUPPLIER may request that CW destroy, at SUPPLIER'S expense,
some or all of the affected Products at SUPPLIER'S expense. Under no
circumstance shall CW return Product to SUPPLIER without a SUPPLIER issued
Return Goods Authorization Number. The costs of testing by such independent
testing laboratory to determine whether such Products are defective shall be
paid by CW or SUPPLIER as determined under this section with respect to other
defects discovered by CW. The terms of all purchase orders shall be
consistent with the terms of this Agreement and, in the event of any
inconsistency, the terms provided herein shall prevail.
4. [**]
5. Monthly, by the 8th day of each month, CW shall provide SUPPLIER
with a twelve (12) month rolling forecast of CW'S projected requirements of
the Products for the Territory, the first three (3) months of which shall be
binding. SUPPLIER shall produce and ship to CW and if requested by CW, in
writing, shall ship directly to CW'S customers or CW'S Affiliates,
sufficient Products so as to meet CW'S firm monthly commitment. SUPPLIER
shall use its best efforts to produce and ship to CW, or if requested by CW
in writing to ship directly to CW'S
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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customers Products ordered by CW over CW'S forecast. Products shipped by
SUPPLIER that are requested by CW, in writing, but which were not in the
relevant CW forecast may be not CW-labeled and/or may have less shelf life
than CW requested, but only with CW'S written agreement in each such instance.
6. During the term of this Agreement, SUPPLIER shall maintain on hand
sufficient quantities of qualified raw materials for the Products as
necessary to produce and deliver within the required time frames the
quantities of the Products in the Territory as specified in CW'S latest
twelve (12) month rolling forecast.
7. [**]
ARTICLE IV
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MANUFACTURE, PACKAGING, APPROVALS AND TECHNICAL SERVICE
-------------------------------------------------------
1. The Products supplied by SUPPLIER hereunder shall meet the
specifications set forth in Schedule D attached hereto and shall pass the
quality control tests set forth in Schedule E hereto.
2. SUPPLIER shall arrange for the performance and reporting to CW of
quality control tests on the Products and provide CW the results in the form
of the
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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Certificate of Analysis set forth in Schedule F.
3. SUPPLIER shall grant access to its facilities and request that its
product materials and manufacturing testing subcontractors and contract
manufacturers grant access to their facilities to CW'S manufacturing, quality
control and compliance inspectors or their designees and such other
inspectors as determined by CW from time to time, at times during normal
working hours requested in advance by CW during the term of this Agreement,
and shall allow such inspectors to inspect the manufacturing and quality
control testing operations and compliance procedures relating to the Products
and all manufacturing and quality control records relating thereto. Such
inspectors shall conduct their inspection in such a manner as not to
unreasonably interfere with normal business operations.
4. SUPPLIER shall at its cost and expense use diligent efforts to
obtain and maintain approvals for CW to distribute and sell the Products
throughout the Territory. SUPPLIER shall provide to CW all information and
data used by SUPPLIER to obtain and maintain approval to market the Products
from the appropriate governmental agencies. CW shall have the right to use
all such information and data except Supplier's confidential manufacturing
information in connection with the marketing of the Products throughout the
Territory, as CW believes in good faith to be necessary, and CW shall have
the right to refer to all information and data which SUPPLIER has filed with
any governmental agency relating to the Products.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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5. SUPPLIER shall supply to CW copies of all data on the Products
SUPPLIER has, including raw data, which CW requires and requests of SUPPLIER
in good faith, in order to support claims for the Products, the claims in the
Products inserts and in order to support advertising and promotional claims
for the Products. CW shall not release any promotional materials for the
Products without prior written approval of SUPPLIER, which approval shall not
be unreasonably withheld or delayed.
6. CW and SUPPLIER shall maintain complaint files in accordance with
all applicable laws and regulations and shall promptly and fully communicate
with each other with respect thereto. CW shall instruct its customers,
sublicensees, and subcontractors to direct inquiries regarding Product
failure to CW'S Technical Services staff. In the event that CW Technical
Services efforts fail to rectify the alleged failure, then SUPPLIER'S
Technical Services staff shall be notified by CW and SUPPLIER'S Technical
Services staff shall diligently investigate the alleged failure and if a
Product failure is confirmed, diligently rectify it. CW and SUPPLIER shall
investigate each complaint reported to it of a failure of the Products and
shall maintain a written record of each such investigation. CW and SUPPLIER
shall, immediately after receiving each such complaint and promptly after
completing each investigation, send the other party a copy of each such
complaint, a full report on each investigation conducted by or on behalf of
the sending party, and a copy of any medical device report submitted to the
FDA under the Medical Device
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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Reporting regulations. Supplier shall conduct on going Product surveillance
in accordance with all applicable laws and regulations and shall retain
sufficient Product with which to carry out such Product surveillance program.
7. SUPPLIER shall promptly notify CW of any FDA or other governmental
inspection of SUPPLIER or any of SUPPLIER'S contract manufacturers that
relates in any manner to the Products, including without limitation their
manufacturing operations, disposal of the Products and the safety, and health
of employees engaged in the manufacture, storage or distribution of the
Products, and SUPPLIER shall promptly provide CW with a written report of the
results of each such inspection. In addition, SUPPLIER shall immediately
request an unpurged copy of the inspection report from the FDA or any other
governmental authority under the Freedom of Information Act, and immediately
after receiving it, forward the report to CW. Each of the parties will
promptly send the other a copy of any notices, reports or other
communications it receives from the FDA or any other governmental authority,
including without limitation any foreign governmental authority, anywhere in
the world concerning the Products.
8. If, as a result of an FDA inspection or as a result of any
complaints or for any other reason SUPPLIER or any of its contract
manufacturers decide to alter the Products, or any components of the
Products, or materially alter manufacturing procedures, quality control
testing operations and/or compliance procedures relating to any of the
Products, CW shall be given written notice of such proposed
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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alteration at least ninety (90) days prior to its implementation or such
shorter period agreed to in writing by CW, and such notice shall be
accompanied by a written report which justifies the contemplated change(s)
and no alteration shall be made without CW'S written approval which CW shall
not unreasonably withhold. In the event such changes are mandated by the
FDA, SUPPLIER will provide written notice to CW, but such changes will not
require the written approval of CW.
9. Copies, notices and reports under Article IV 6, 7 and 8 above shall
be sent to CW'S Vice President of Quality Control, Vice President of Safety,
Health and Environmental Affairs and Vice President of Compliance at the
following address:
Xxxxxx-Xxxxxxx, Inc.
P. O. Xxx #0000
Xxxx Xxxx Xxxx
Xxxxxxxx, Xxx Xxxxxx 00000
10. In the event that CW'S inspectors or their designees find that
SUPPLIER'S manufacturing operations are not reasonably in conformance with
Quality System Regulations of the Federal Food and Drug Administration
("QSR's") or any other pertinent laws or regulations, SUPPLIER shall
promptly, after receiving written notice thereof from CW, correct them to
the mutual satisfaction of CW and SUPPLIER so as to bring them into
compliance with QSR's or other pertinent laws or regulations.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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11. CW shall provide technical service CW determines is appropriate to
its customers of the Products. SUPPLIER shall provide to CW without
additional cost all technical support which CW reasonably requires in order
for CW to provide technical service to CW'S customers.
ARTICLE V
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TERM OF AGREEMENT
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This Agreement shall commence on the Effective Date and, unless sooner
terminated as provided in Article XII, shall remain in effect for an initial
term of five (5) years after the Effective Date (the "Initial Term"). Not
less than ninety (90) days prior to the end of the initial five (5) year
term, the parties will determine and agree in writing the terms and
conditions under which the Agreement may be extended. If the parties have
not so agreed in writing by ninety (90) days prior to the end of the Initial
Term, this Agreement will terminate automatically at the end of the Initial
Term.
ARTICLE VI
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LABELS, INSERTS, PACKAGING MATERIALS AND MARKETING
--------------------------------------------------
1. Subject to Article II and Article IV 5, CW shall determine in its
sole discretion but after consultation with SUPPLIER as to relevant
regulatory matters, how the Products are to be marketed, promoted and
distributed and the labels,
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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labeling, inserts, packaging materials for the Products including the graphic
elements on them as well as the copy, artwork and layout provided all labels
are compatible with SUPPLIER'S packaging equipment and are in accordance with
applicable laws and regulations. Notwithstanding the above, the shipping
cartons and containers and the labeling and markings thereon used in the
transportation of the Products from SUPPLIER to CW or its designees shall be
the responsibility of SUPPLIER and shall conform to all applicable laws and
regulations, including applicable governmental marketing authorizations.
ARTICLE VII
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IMPROVEMENTS AND CLAIMS
-----------------------
Promptly upon completing the development of any change or improvement to
the Products and promptly upon acquiring any change or improvement
(hereinafter all changes and/or improvements shall be referred to as
"Improvements") to the Products, SUPPLIER shall provide CW with the
information listed in Schedule G hereto, incorporated herein by reference,
regarding such Improvements. All such Improvements shall automatically be
included in the rights granted to CW hereunder and CW shall have exclusive or
co-exclusive rights, as the case may be, to market, promote, distribute and
sell the Products incorporating such Improvement in the Territory under the
terms and conditions of this Agreement as apply to the Products. If CW
desires to purchase the Products with
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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such Improvements, CW shall notify SUPPLIER in writing, and SUPPLIER shall
supply to CW such quantities of the Products with such Improvements as CW
shall order from SUPPLIER. The price of the Products with Improvements shall
be the same price as provided in Schedule C except that SUPPLIER may increase
the price by an amount equal to the amount which permits SUPPLIER to maintain
the same gross profit margins with respect to the Product to which the price
increase applies as SUPPLIER was achieving with respect to such Product
during the one year period prior to the introduction into such Product of the
relevant Improvement. On written request by CW, SUPPLIER will provide
verification to the reasonable satisfaction of CW that such increase is
necessary to maintain the same gross profit margins with respect to the
Product to which that price increase applies as SUPPLIER was achieving with
respect to such Product in the one year period prior to the introduction into
such Product of the relevant Improvement. Determination of such increase in
costs shall be in accordance with generally accepted accounting principles
consistently applied in the manner in use by SUPPLIER at the time of
executing this Agreement. SUPPLIER will maintain records of such costs for a
minimum of three (3) years after the period to which such records pertain and
CW shall have the right to audit such costs. Those records shall be open
during reasonable business hours to CW'S accountants and to a certified
public accounting firm selected by CW and acceptable to SUPPLIER, which
acceptance shall not be unreasonably withheld, who shall, at CW'S expense,
have access to
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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such cost records for the purpose of verifying whether the increase in costs
are calculated in accordance with this Article VII. Such accountants shall
treat as confidential, subject to the provision of Article XIII hereof, any
information about SUPPLIER to which they are exposed in the course of such
audit other than the aforesaid costs (provided that neither such accountants
nor CW will publicly reveal such costs except to the extent legally required
to do so or necessary to enforce CW's rights hereunder) and such accountants'
opinion as to their accuracy. In the event a controversy arises concerning
said costs, the SUPPLIER shall retain its books and records relating to such
costs until the resolution of the controversy.
ARTICLE VIII
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RIGHT OF FIRST REFUSAL
------------------------------
[**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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RIGHT OF FIRST REFUSAL (Continued)
---------------------------------------
[**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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ARTICLE IX
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WARRANTY, INDEMNITY AND INSURANCE
---------------------------------
1. SUPPLIER guarantees and warrants with respect to the Products it
manufactures or has manufactured for it and supplies or has supplied to CW
and its Affiliates hereunder:
(a) that the Products supplied hereunder shall conform to, and be
manufactured and delivered to CW in accordance with the specifications set
forth in Schedule D, and pass the quality control tests set forth on Schedule
E and will be manufactured in plants which have been registered with the
United States Food and Drug Administration which are in compliance with, and
that the Products shall at all times be manufactured in accordance with, the
applicable QSR's and shall be in compliance with all other applicable
Federal, State and local Laws and Regulations;
(b) that the Products when delivered by SUPPLIER to CW, CW's
Affiliates or CW's customers will not be adulterated or misbranded within the
meaning of the Federal Food, Drug and Cosmetic Act and regulations
thereunder, nor within the meaning of any substantially similar state or
municipal law, nor is any such Product one which may not under such Act or
other law be introduced into interstate or intrastate commerce, and shall
conform with the applicable laws and regulations administered by the
Environmental Protection Agency, Consumer
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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Product Safety Commission, the Department of Transportation, Occupational
Safety and Health Administration or Interstate Commerce Commission, as
applicable;
(c) that the Products have been manufactured in accordance with
the provisions of the Fair Labor Standards Act of 1938, as amended, to the
extent applicable;
(d) that SUPPLIER has not received significant complaints relating
to the Products either with respect to the number of complaints received or
the kind of complaints received such that a reasonable person would question
the safety, efficacy, accuracy or reliability of the Products or the methods
for manufacturing or testing them; and
(e) that SUPPLIER owns and/or has the right to sublicense all
rights to the Products, that it owns and/or has the rights to sublicense to
SUPPLIERS subcontractors, the manufacturing of the Products and has all
information necessary to manufacture the Products and that SUPPLIER has the
right to enter into this Agreement and to license CW to distribute and sell
the Products as provided herein.
2. (a) SUPPLIER shall protect, defend, indemnify and hold CW and its
Affiliates and their officers and directors, employees, agents, successors
and assigns, harmless from all demands, claims, actions, liability, loss,
damage, costs and expenses including without limitation reasonable fees and
costs of attorneys
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
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incurred by CW or its Affiliates resulting or arising from any claim of
injury or death to any Third Party or injury or damage to property of any
Third Party, (1) caused by or claimed to be caused by any defects in the
Products supplied by SUPPLIER to CW or its Affiliates or CW'S customers, (2)
caused by or claimed to be caused by any error, omission, intentional
misconduct or a failure or regulatory non-compliance by SUPPLIER, its Agents
or Affiliates in the manufacturing, labeling or packaging of any of the
Products, or (3) caused by or claimed to be caused by the development,
manufacturing, packaging or supplying of the Products by SUPPLIER under this
Agreement, or (4) caused by or claimed to be caused by the breach of any
warranty in Article IX hereof, whether said demands, claims, liability, loss,
damage, costs and expense is sustained by SUPPLIER or CW or its Affiliates or
any Third Party, except to the extent such claimed injury or death or damage
is caused by CW or its agents or Affiliates. In the event of any claim
arising under Article IX, prompt written notice of such claim shall be given
by CW to SUPPLIER. SUPPLIER shall have the right to conduct the defense in
respect thereof but CW may have counsel present at its own expense and shall
be entitled, at CW'S expense to participate in the defense of any such claim.
CW shall cooperate with SUPPLIER in such defense at the expense of SUPPLIER.
No settlement of any such matter where CW is a party to the claim or is a
defendant with respect thereto, shall be made without the written approval of
CW which shall not be unreasonably withheld.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
24
(b) SUPPLIER shall protect, defend, indemnify and hold CW and its
Affiliates and their respective directors, officers, employees, agents,
successors and assigns harmless from and against any and all demands, claims,
actions, liability, loss, damage, cost and expense (including without
limitation reasonable fees and costs of attorneys incurred by CW or its
Affiliates) resulting or arising out of any claim by a Third Party that the
Products or the manufacture or processing used in or in connection with the
Products infringes any valid and enforceable patents or other intellectual
property rights of such Third Party or to the extent that any other claim or
action is made or brought against CW or its Affiliates or SUPPLIER by a Third
Party, whether or not a director, officer, employee or agent of SUPPLIER,
relating to SUPPLIER'S manufacture of the Products. CW shall give SUPPLIER
prompt written notice of any such claim asserted against CW or CW'S
Affiliates. SUPPLIER shall have the right to conduct the defense in respect
of such claim, but CW may have counsel present at CW'S own expense and shall
be entitled, at CW'S expense, to participate in the defense of any such
claim. No settlement of any such matter, where CW is a party to the claim or
is a defendant, with respect thereto, shall be made without the written
approval of CW which shall not be unreasonably withheld.
(c) SUPPLIER shall protect, defend, indemnify and hold harmless
CW and its Affiliates against any liability, loss, damage, cost and expense
(including without limitation, reasonable fees and the costs of attorney's
incurred by
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
25
CW or its Affiliates), incurred by CW or its Affiliates to effect, or as a
result of, a recall of any Products that is requested by the FDA (including a
recall or safety alert effected by CW or its Affiliates voluntarily to
forestall regulatory or other action by the FDA or other governmental
authority, including without limitation any foreign governmental authority,
anywhere in the world, provided that, if time and circumstances permit, CW
shall consult with Supplier reasonably in advance of initiating any such
voluntary recall), provided that the reason for such recall is attributable
to a defect or failure of the Products or an error, omission, intentional
misconduct, failure or regulatory non-compliance by SUPPLIER in the
manufacture, labeling, or packaging of the Products. To the extent that time
and circumstances permit, CW shall give SUPPLIER notice of a recall or
safety alert requested or imposed by any regulatory body affecting the
Products.
(d) Provided the Environmental Conditions (as hereinafter defined)
were not caused by CW, SUPPLIER shall to defend, indemnify and save harmless
CW, its officers, directors, employees, agents, successors and assigns, from
and against any damage, liability, loss, claims, cost or expense (including
without limitation reasonable fees and costs of attorneys' incurred by CW or
its Affiliates), arising out of any claim by any person, government or other
entity, however arising for personal injury, wrongful death, property damage,
economic loss, costs of abatement, costs of remediation, damage to natural
resources, civil penalties, or any other claim, demand, notice, or expense
arising out of or relating to:
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
26
( i) the presence, generation, handling, treatment, storage,
disposal, discharge, or release of any solid waste, hazardous waste,
hazardous substance, toxic substance, petroleum, contaminant or pollutant, or
any other environmental condition, on, at, beneath, or near SUPPLIER'S
facility; and,
(ii) the presence, generation, handling, treatment, storage,
disposal, discharge, or release of any solid waste, hazardous waste,
hazardous substance, petroleum, toxic substance, contaminant or pollutant,
from SUPPLIER'S facility to another facility, site, or property not owned or
controlled by CW or its Affiliates. The items listed in (i) and (ii) are
referred to as the "Environmental Conditions".
(e) [**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
27
[**]
SUPPLIER shall provide CW with Certificates of Insurance coverage
showing that SUPPLIER possesses the above insurance at the stated limits and
which provides that said insurance cannot be cancelled except after at least
thirty (30) days' prior written notice to CW. SUPPLIER shall immediately notify
CW in writing of any erosion in the above stated limits. SUPPLIER hereby
waives any rights of subrogation.
3. This Article IX shall survive termination of this Agreement.
ARTICLE X
---------
PRODUCT REPRESENTATION
----------------------
Any statements, representations, promotional materials or advertisements
concerning the Products which are not made in reliance on or supported by
information or data supplied in writing by SUPPLIER shall be the sole
responsibility of CW, and CW shall protect, defend, indemnify and hold
harmless SUPPLIER and its directors, officers, employees, agents, successors
and assigns from and against any and all demands, claims, actions, liability,
loss, damage, cost and expense (including reasonable fees and costs of
attorney's) resulting or arising, directly or
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
28
indirectly, out of any such statements, representations, promotional
materials or advertisements covering the Products which are not made in
reliance on or supported by information or data supplied by SUPPLIER, whether
such demands, claims, actions, liability, loss, damage, cost and expense is
sustained by SUPPLIER or CW or any Third Party. In the event of any claim
arising under this covenant of indemnity, prompt written notice of the claim
shall be given to CW which shall have the right to conduct the defense in
respect thereto, but SUPPLIER may have counsel present at SUPPLIER'S own
expense and shall be entitled at SUPPLIER'S expense to participate in the
defense of any such claim. SUPPLIER shall cooperate with CW in such defense
at the expense of CW. No settlement of any such matter shall be made without
the written approval of SUPPLIER and CW, which shall not be unreasonably
withheld.
ARTICLE XI
----------
TRADEMARKS
----------
During the term hereof, and thereafter solely in connection with selling
of remaining inventory of Products, CW and its Affiliates shall have the
right to use for the Products and the marketing and sale of the Products
hereunder, trademarks owned by CW and/or its Affiliates, and/or licensed to
CW and/or its Affiliates by third parties, and SUPPLIER shall have no rights
with respect to said trademarks whatsoever. In the event CW desires, during
the term hereof and to the extent
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
29
necessary for CW and its Affiliates to sell off their remaining inventory of
Products after termination or expiration of this Agreement, CW shall have the
right but not the obligation to use SUPPLIER'S trademarks and copyrights and
if CW uses such trademarks and/or copyrights, CW shall use in customary size
and placement on the Products and their packaging, -Registered Trademark- or
-TM- symbols and customary copyright notice with respect to such trademarks
or copyright, also indicating SUPPLIER'S ownership thereof. If SUPPLIER
advises CW, IN WRITING, that SUPPLIER has obtained a patent covering a
particular Product, CW shall, at SUPPLIER'S written request, include an
appropriate notice or symbol as requested by SUPPLIER indicating that such
patent covers the Product.
ARTICLE XII
-----------
TERMINATION FOR BREACH, ETC.
----------------------------
1. After termination of this Agreement, CW shall have the right to
market, distribute and sell the Products purchased from SUPPLIER pursuant to
the terms hereof during the term of this Agreement.
2. Notwithstanding any provision in this Agreement to the contrary,
failure by CW or SUPPLIER to comply substantially with any of their
respective material obligations and conditions contained in this Agreement
shall entitle the other party to give to the party in default written notice
requiring such other party to cure good such default. If such default is not
cured within forty-five (45) days after
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
30
giving of such notice, the notifying party shall be entitled (without
prejudice to any of its other's rights under this Agreement) to terminate
this Agreement by giving at least forty-five (45) days written notice of
termination to the other party, except that a default in payment must be
cured within thirty (30) days after the giving of notice requiring the
defaulting party to cure such default, and the Agreement shall terminate
thirty (30) days after said notice is given, if such payment default is not
timely cured. The right of either party to terminate this Agreement as
herein provided shall not be affected in any way by the terminating party's
waiver of or failure to take action with respect to any previous default of
the other party. Termination of this Agreement shall not relieve either party
of its obligations incurred prior to termination and not fully discharged by
the date of such termination.
3. Within thirty (30) days after termination of this Agreement, CW
shall pay SUPPLIER any and all amounts still owed SUPPLIER for all Products
either (a) ordered by CW and delivered to and accepted by CW or (b) shipped
by SUPPLIER to CW'S customers at CW'S request, in each case prior to such
termination.
ARTICLE XIII
------------
CONFIDENTIALITY
---------------
During the term of this Agreement and subsequent thereto, CW and
SUPPLIER each shall exercise at least the same degree of care to safeguard
the confidentiality of confidential, or proprietary and trade secret
information disclosed
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
31
to it by the other party and any intellectual and proprietary rights therein
as it would exercise to safeguard the confidentiality of its own
confidential, proprietary or trade secret information. Any confidential,
proprietary or trade secret information, designated as such, disclosed
hereunder: (i) orally and then promptly reduced to writing and provided by
the disclosing party to the other party or (ii) in writing by the disclosing
party at the time of disclosure shall be maintained in confidence by the
party receiving the disclosure and shall not be utilized for any purpose
except for the purposes contemplated by this Agreement and shall not be
disclosed to any Affiliate or Third Party unless they have executed a writing
obligating themselves to the terms of this Article XIII. These obligations
to maintain in confidence and not use the aforesaid confidential, proprietary
or trade secret information shall not apply to: (a) any such information in
the public domain at the time of disclosure or which falls into the public
domain otherwise than through breach of this Article, (b) any such
information which, at the time of disclosure, was demonstrably already known
to or in the possession of the party receiving disclosure, without breach of
this Agreement, (c) any such information which, following such disclosure, is
obtained by the party receiving disclosure from a Third Party not under an
obligation of confidentiality with respect to such information to the
disclosing party, or (d) which is independently developed by employees of the
party receiving the disclosure or affiliated companies who have not had
access to the relevant confidential, proprietary or trade secret information
of the other party hereto
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
32
provided hereunder.
Notwithstanding any provision in this Agreement to the contrary,
confidential, proprietary or trade secret information which must by law be
divulged to governmental authorities in connection with the performance of
this Agreement or otherwise can be disclosed to such governmental authorities
provided that the disclosing party follows applicable governmental
regulations and/or procedures to seek to require that the governmental
authorities hold such information in confidence and notifies the other party,
in writing, of such disclosure, if feasible, reasonably prior to such
disclosure. This Article XIII shall survive termination of this Agreement.
ARTICLE XIV
-----------
INTERPRETATION
--------------
The construction, validity and performance of this Agreement shall be
governed in all respects by the laws of the State of New York. The validity,
construction, and interpretation of this Agreement shall be governed by the
internal laws of the State of New York. In connection with any dispute or
controversy arising out of or relating to this Agreement, both parties
consent to the jurisdiction of and venue in the United States Federal
District Court for the Southern District of New York.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
33
ARTICLE XV
----------
FORCE MAJEURE
-------------
If the performance of this Agreement or of any obligations hereunder,
except for the payment of monies, is prevented, restricted or interfered with
by reason of any cause beyond the reasonable control of the affected party,
except for the payment of monies, the party so affected upon prompt notice to
the other party shall be excused from such performance to the extent of such
prevention, restriction or interference, provided that the party so affected
shall use its best efforts to avoid or remove such cause of non-performance
and shall continue performance hereunder with the utmost dispatch whenever
such causes are removed.
ARTICLE XVI
-----------
NOTICES
-------
Any notice required or permitted to be given under this Agreement shall
be mailed by express mail with a reputable carrier including national
couriers such as Fed Ex, registered or certified first-class mail, postage
prepaid, or by facsimile with confirmed answerback, addressed to the party to
be notified at its address stated at the beginning of this Agreement (with
facsimile numbers on the signature page hereof), or at such other address as
may hereafter be furnished in writing to the notifying party, except those
copies, notices and reports under Article IV 6, 7 and 8
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
34
hereof shall be addressed as specified in Article IV 9 hereof.
ARTICLE XVII
------------
WAIVER
------
The failure on the part of SUPPLIER or CW to exercise or enforce any
rights conferred upon such party hereunder shall not be deemed to be a
waiver of any such rights nor operate to bar the exercise or enforcement
thereof by such party at any time or times thereafter.
ARTICLE XVIII
-------------
ASSIGNABILITY
-------------
This Agreement, and all rights and obligations hereunder, are personal
as between the parties, and except as provided below, shall not be assigned
in whole or in part by either of the parties to any other person or company
without the prior written consent of the other party except by a party to the
successor or assignee of substantially all such party's business relating to
diagnostic products for professional use. CW may assign this Agreement or
any of its rights or obligations hereunder to an Affiliate, acceptable to
SUPPLIER, which acceptance Supplier shall not, acting in good faith,
unreasonably withhold, which has agreed in writing to be bound hereby.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
35
ARTICLE XIX
-----------
ENTIRE AGREEMENT
----------------
This Agreement constitutes the entire agreement between the parties with
respect to the specific subject matter hereof, and replaces and supersedes
any other previous understandings and agreements between them with respect
thereto including those understandings and agreements that may be contained
in correspondence or in verbal interchanges between the parties and their
attorneys. Neither party shall be bound by any definition, condition,
warranty or representation other than as expressly stated in this Agreement.
No waiver or modification of this Agreement shall be valid except by written
agreement executed by the parties hereto.
ARTICLE XX
----------
SEVERABILITY
------------
If any provision of this Agreement should be proven unlawful or
non-enforceable, such provision will be considered a nullity, but such
nullity will not affect the validity of the remaining terms and conditions of
this Agreement, and the parties shall substitute, to the extent lawfully
permissible, a new provision embodying the intentions of the parties.
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
36
ARTICLE XXI
-----------
INDEPENDENT CONTRACTOR
----------------------
The parties are independent contractors as to each other, and neither is an
agent, employee or legal representative of the other and neither party shall
execute any agreement or other instrument purporting to bind the other or
hold themselves out as an agent, employee, or legal representative of the
other party. This Agreement shall not be deemed to establish an agency
relationship, joint venture or partnership between SUPPLIER and CW.
ARTICLE XXII
------------
MISCELLANEOUS
-------------
1. Neither party may disclose the terms and conditions of this
Agreement to any Third Party, person or company, except as may be required by
law or except that either party may disclose such terms to a prospective
successor or assignee of substantially all its business relating to
diagnostic products, without the prior written consent of the other party, or
to such party's principal shareholders, current and future banks and
prospective investors provided that, if reasonably feasible, in each case of
such disclosure the recipient is bound by a written obligation to the
disclosing party hereto, to keep such information confidential.
2. As used in this Agreement, the singular includes the plural and
plural includes the singular, wherever so required by fact or context. The
headings
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
37
appearing at the beginning of the numbered articles hereof have been inserted
for convenience only and do not constitute a part of this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their representative duly authorized officers as of the effective
date.
CALYPTE BIOMEDICAL CORPORATION
By: /s/ Xxxxxxx X. Xxxxxx
----------------------------
Title: CEO
-------------------------
Facsimile: 000-000-0000
XXXXXX-XXXXXXX, INC.
By: /s/ Xxxxx Xxxxxx
----------------------------
Xxxxx Xxxxxx
Title: President
-------------------------
Facsimile: 000-000-0000
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
38
Schedules A - G
[**]
THE SYMBOL "[**]" IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
39
