SUPPLY AND DISTRIBUTORSHIP
AGREEMENT
This Agreement is entered into and effective as of
Date"), by and between XYZ ..............., Inc.
having its principal place of
business at ..... .......... Ave., ..... View, CA ……..("XYZ"), and YYY
.......... Corporation, having its principal place of
business at .......... ..........
Road, ………., ------------46250
("YYY"). YYY and XYZ are collectively
referred to as "Parties" and individually as "Party".
WITNESSETH:
WHEREAS, YYY and its Affiliates are in the business of
developing, making and
selling throughout the world various biochemical and medical products for
research, .........., and other purposes.
WHEREAS, XYZ is engaged in the business of developing
.......... systems,
chips and chemistries which are also often referred to as
"lab-on-chip"
technology.
WHEREAS, YYY desires to purchase, and be the exclusive
distributor, and XYZ
desires to sell to YYY and to appoint YYY as the exclusive distributor of
the Products (as defined herein) in accordance with the provisions of this
Agreement. In addition, YYY desires to acquire, and XYZ desires to grant to
YYY, for a limited time period, exclusive first rights
of refusal and the
right to negotiate to become a purchaser/licensee and the exclusive
distributor
of certain Additional Products (defined below) developed by XYZ.
NOW, THEREFORE, in consideration of the premises and
the mutual covenants
contained herein and for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties agree as follows:
1)
Definitions:
1.1 "Affiliate(s)" shall mean any other
entity currently controlling, controlled
by or under common control with YYY or XYZ, which in the case of YYY
shall include, without limitation, YYY .......... GmbH. "Control"
means that
more than fifty (50%) of the controlled entity's shares of ownership
interest
representing the right to make decisions for such entity are owned
or
controlled, directly or indirectly, by the controlling entity. An entity is
considered to be a related company only so long as such ownership or control
exists.
1.2 "Ordering Entity" shall mean an
Affiliate or any other entity designated by
YYY and approved by XYZ to purchase Product pursuant
to the terms of this
Agreement.
Confidential treatment has been requested for portions
of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as [*]. A complete version of
this exhibit has been
filed separately with the Securities and Exchange Commission.
Confidential Page 1 3/28/02
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1.3 "Products" shall mean XYZ's ..........-96 and ..........-384 products, and
including all future or next generation versions of these ..........-96 and
..........-384 products developed by XYZ which are
sub-microliter in scale and
incorporate means for evaporative compensation, packaged and labeled
for YYY,
as detailed in the Specification which is attached hereto as Exhibit B,
but
excluding any products which include means for separation of fluids or
compounds, including, without limitation, electrophoretic
separation or
isoelectric focusing.
1.4 "Specification" shall mean the YYY
specification for the Product attached
hereto and incorporated by reference as Exhibit B.
1.5 "Exclusive" status as a distributor or
"Exclusive" shall mean that subject
to the terms and conditions of this Agreement, YYY's
rights to market,
distribute and sell the Products within the Territory are sole and entire and
operate to exclude all others.
1.6
"Territory" shall mean worldwide.
1.7 "First Sales Year" shall mean the period
commencing on the date of launch of
Product by YYY and ending one (1) year
thereafter.
1.8 "FTEs" shall mean full time employee
equivalents of labor, based on a
standard work day. One FTE shall be one person working one day, or eight hours
worked collectively by more than one person. One FTE for a year shall be one
person working each day in a year, exclusive of holidays and vacation time
determined in accordance with XYZ's and YYY's, as the case may be,
customary practices and procedures. FTE's may be performed by employees,
consultants, contractors or other persons paid for by XYZ or YYY.
1.9 As used
above and in Section 6.15, the following terms shall mean:
1.9.1 ".......... [ * ]
Product" means [ * ]
1.9.2
".......... .......... Assay System" means [ *
]
1.9.3 "Additional
Products" shall singly or collectively refer to
[ * ]
2)
Confidential Information:
2.1 CONFIDENTIALITY OBLIGATIONS. For a period of [ * ] from the date of
disclosure, XYZ and YYY agree to (i) hold all
Confidential Information
(defined below) in trust and
confidence for the disclosing party, (ii) not to
disclose Confidential Information to parties other than its Affiliates and
contractors or agents, and (iii) not to use such Confidential Information other
than for the performance of such Party or its Affiliates or
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contractors or agents under this Agreement. "Confidential Information"
means (a)
information that relates to the disclosing party's past, present and future
efforts in research, development, manufacturing, and business activities that
is
disclosed to or obtained by the receiving party in connection with, and during
the term of, this Agreement and (b) all items prepared or submitted by the
disclosing party that are the property of the other party under the terms of
this Agreement, including drafts and associated materials. All Confidential
Information shall be in written, graphic, photographic
or other tangible form
and marked "Confidential", and information disclosed orally shall
be confirmed
in written summary form marked "Confidential" within thirty (30)
days after its
disclosure to the receiving party.
2.2 EXCEPTIONS. Any other provision hereof to the
contrary notwithstanding, it
is expressly understood and agreed by the Parties hereto that the
obligations of
confidence herein assumed shall not apply to any information which:
a. can be shown by
the receiving party to have been in its
possession prior to
disclosure to it by the transmitting party;
b. at the time of
the disclosure hereunder is, or thereafter
becomes, through no fault of the receiving party, part of
the public domain by publication or otherwise;
c. is furnished to
the receiving party by a third party after the
time of disclosure hereunder as a matter of right and
without restriction on its disclosure; or
d. is
independently developed by employees, agents or vendors of
the receiving party who have not had access to the
Confidential Information received from the disclosing party.
3)
Purchase Orders:
During the term of this Agreement, from time to time YYY
(or the Ordering
Entity) may issue purchase orders containing
instructions for specific
performance under this Agreement. YYY will accept only that specific
performance that has been pre-authorized, as evidenced by a purchase order, the
form and terms of which shall be mutually agreed (in the event of any
inconsistency between the terms of this Agreement and any purchase
order, the
terms of this Agreement shall prevail). The purchase order number should
always
be referenced on packing slips (bill of lading) and invoices for
Product(s).
4) Price:
4.1 The Parties agree that the price is as established
in attached Exhibit A,
"Pricing". The Pricing detailed in Exhibit A shall represent the
price terms
through the Initial Term of this Agreement. Subsequent to the Initial Term,
pricing shall be the result of good
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faith negotiations between the Parties.
Payment shall be due thirty (30) days
after receipt of invoice.
4.2 PROMOTIONAL ITEMS. XYZ shall provide to YYY up to [ * ] Products per
year, on a schedule to be designated by YYY, at no charge for promotional
purposes. Promotional Products, not to exceed an additional [
* ] per year of
each, can be purchased at [ * ] of XYZ's fully
burdened Manufacturing Costs
for such promotional Products. "Manufacturing Costs" shall mean [ * ]
5) Term
and Termination:
5.1 INITIAL TERM AND EXTENSIONS. The "Initial
Term" of this Agreement shall
begin on the Effective Date and shall continue for 3 years. Subsequent to the
Initial Term, this Agreement shall be automatically
extended thereafter for one
(1) year periods unless
notice of intention not to extend this Agreement is
communicated in accordance with Section 13.7 at least six (6)
months prior to
the then current expiration date. Upon expiration of the Initial Term or
any
subsequent one year extension term, XYZ shall be entitled to (a) reasonable
termination charges for costs incurred up to the date of expiration by XYZ
for outstanding orders of Product by YYY or other Ordering Entity, (b)
share [
* ] in the course of its performance under this Agreement, (c) a transfer
of all
rights in promotional materials, internet content, samples, customer lists,
and
marketing material relating to Product which are developed by YYY and its
Affiliates in the course of its performance under this
Agreement, (d) the right
to negotiate in good faith a world-wide license, with the right to
sublicense,
to rights in trademarks used in connection with marketing and sale of
Product,
and (e) the right to negotiate in good faith with YYY to obtain [ * ],
provided that XYZ shall disclose such Confidential Information to any third
party under terms of confidentiality that are at least as strict as those
provided in Article 2 above.
5.2 TERMINATION FOR CAUSE. Either Party may terminate
this Agreement for cause
by providing the other with sixty (60) days' written notice. Cause shall
mean a
material breach of a material term of this Agreement, that is not cured by the
breaching party as quickly as possible, but in no event longer than the sixty
(60) day notice period. If
such breach is not cured prior to the sixty (60) day
notice period, the non-breaching Party will be left with all remedies at law
or
equity in addition to its right to terminate.
5.3 TERMINATION WITHOUT CAUSE. Commencing [ * ] after the Effective Date, YYY
reserves the right to terminate this Agreement without cause by providing [ * ]
written notice to XYZ. For termination without cause, XYZ shall be
entitled to (a) reasonable charges for costs incurred up to the date of
termination, (b) share [ * ] in the course of its performance under this
Agreement, (c) a transfer of all rights in promotional
materials, internet
content, samples, customer lists, and marketing material relating to Product
which are developed by YYY and its Affiliates in the course of its
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performance under this Agreement, (d) the [ * ], and (e) the right to negotiate
in good faith with YYY to obtain [ * ], provided that XYZ shall disclose
such Confidential Information to any third party under terms of
confidentiality
that are at least as strict as those provided in Article 2 above.
5.4 IMPACT ON CONFIDENTIAL INFORMATION. Subject to the
terms of Section 5.1
above, the Parties agree that in the event of termination or expiration of
this
Agreement, all Confidential Information which is the
property of YYY or
XYZ, shall be promptly returned to the disclosing
Party, except that one copy
thereof may be maintained in the file of the receiving Party's Law Department
to
document information disclosed by the other Party.
6) Supply
Arrangements:
6.1 DILIGENCE OBLIGATIONS. YYY will maintain its right
to be the exclusive
distributor of Product under this Agreement by its compliance with the following
diligence requirements set forth in Subsections 6.1.1 through 6.1.4 below. In
the event that YYY does not meet any of the following requirements, XYZ at
its option, shall have the right to either convert YYY's
distribution rights
from an exclusive to a non-exclusive status or provide notice of termination
in
accordance with the terms of Section 5.2 above.
6.1.1 Within
sixty (60) days after the Effective Date, the Parties shall
agree upon, and attach to this Agreement, a detailed Work
Plan,
including Milestone Dates, for YYY's
commercialization of Product,
including both the ..........-96 Product and the
..........-384 Product,
including, without limitation, sales training, technical
support and
assay support for miniaturization; and YYY shall use
reasonable
efforts to commercialize Product in accordance with the Work
Plan and
the Milestone Dates set forth therein.
6.1.2 The Parties agree that
the Work Plan for commercialization shall
require YYY to commit the following minimum
resources for ..........-96
Product
and ..........-384 Product: one (1)
marketing manager; and one (1)
project manager (technical);
the marketing manager and project manager
shall be part-time in calendar year 2001 and full time in
calendar year
2002 and thereafter. Assay and technical support will be available in
the
hundred percent (100%) of the worldwide key account
sales managers
(focused on
pharmaceutical and biotech companies) will be trained on
Product. During the
First Sales Year, XYZ
will miniaturize assays
for YYY's customers,
and will be compensated for
this activity
through the Transfer
Price paid by YYY
for Product, with
the
mechanism set forth
in Section 6.4 below. With regard to the period
after the First Sales Year,
the Work Plan will put in place a mutually
agreed upon plan for assay
support consistent with actual
sales and
projected sales growth.
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6.1.3 During
the First Sales Year, YYY shall use reasonable efforts to sell
Product
and its compliance with this diligence requirement shall be
determined by its actual sales and reasonable penetration of
Product
into the High Throughput Screening market.
6.1.4 For each subsequent twelve-month period after the First
Sales Year,
YYY
shall use reasonable efforts to sell Product and its compliance
with this diligence requirement shall be determined by YYY
generating
[ * ]
6.2 EXCLUSIVITY OBLIGATIONS. The Parties agree that
for the term of this
Agreement, and subject to the other terms and
conditions set forth herein, (a)
XYZ shall supply the Product exclusively to YYY and
utilize YYY as its
exclusive distributor for the Products and (b) YYY shall not develop or sell
any other sub-microliter product including means
for evaporative compensation
that directly competes with the Products for the drug screening market. YYY
shall purchase from XYZ the Products at the prices set forth in Exhibit A to
this Agreement, attached hereto and incorporated herein by reference. YYY is
under no obligation to purchase a minimum quantity of Products except as
specifically set forth in Sections 6.1, 6.5, and 6.12 below during
either the
Initial Term or any renewal term of this
Agreement. [ * ]
6.3
TRANSFER OF EXPERTISE TO YYY.
6.3.1
TRANSFER OF SALES/MARKETING EXPERTISE. Subject to the
confidentiality terms above and to the terms of XYZ's agreements
with third parties regarding, among other matters, assays,
dispensers
and materials developed by the third parties and/or XYZ, XYZ
will, at no additional cost to YYY, transfer to YYY its body
of
expertise that directly relates to sales and marketing of
the Product,
including expertise regarding use of the Product, customer
segmentation, customer list, marketing materials, internet
content,
samples, presentations, sales tools, assay miniaturization,
and
qualifying dispensers , knowledge of which is instrumental
to sales and
marketing of the Product (collectively, the "Product
Sales and
Marketing Expertise"). This transfer will commence upon
the execution
of this Agreement and be completed within three (3) months
of the
Effective Date. Two (2) YYY employees will be designated by
YYY to
serve as primary representatives to receive the Sales and
Marketing
Expertise from XYZ. XYZ will provide these YYY
representatives,
at no charge to YYY, with any training at XYZ's facilities that
may reasonably be required in order for the Sales and
Marketing
Expertise to be effectively transferred to YYY. The transfer
of Sales
and Marketing Expertise will not be considered complete
until all
transferable, current assays have been transferred to YYY,
and
YYY's and XYZ's primary representatives have determined, each in
their reasonable discretion, that no other training or
consultation
with XYZ representatives will be necessary in order for YYY
to
effectively sell, market and
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use the transferred assays. XYZ understands and agrees that
successful transfer of the Sales and Marketing Expertise is
instrumental to YYY's ability to
sell the Product, and thus agrees it
will use its reasonable commercial efforts to ensure all
Sales and
Marketing Expertise is transferred to YYY as expeditiously as
possible.
6.3.2
TRANSFER OF TECHNICAL/PRODUCT SUPPORT EXPERTISE. Subject to the
confidentiality terms above and to the terms of XYZ's agreements
with third parties regarding, among other matters, assays,
dispensers
and materials developed by the third parties and/or XYZ, XYZ
will, at no additional cost to YYY, transfer to YYY its
entire body
of expertise that directly relates to technical support or
use of the
Product, including expertise regarding developing miniaturized
homogeneous assay and qualifying dispensers (collectively,
the
"Technical Support Expertise"). XYZ represents and
warrants that
XYZ
possesses a transferable body of Technical Support Expertise,
and XYZ will make reasonable efforts to transfer such
expertise, in
accordance with this Section 6.3.2, such that YYY will be
able to
provide technical support and assistance relating to the
Product at a
level substantially similar to the support provided by XYZ
during
the First Sales Year pursuant to Section 6.4. This transfer
will
commence upon the date for such transfer ap..........ing in the Work Plan and
be completed within twelve (12) months of such date. Two (2)
YYY
employees will be designated by YYY to serve as primary
representatives to receive the Technical Support Expertise
from XYZ
(and these YYY representatives need not be the same
representatives
designated to receive the Sales and Marketing Expertise
described in
Section 6.3.1). XYZ will provide these YYY representatives,
at no
charge to YYY, with any training at XYZ's
facilities that may
reasonably be required in order for the Technical Support
Expertise to
be effectively transferred to YYY. The transfer of Technical
Support
Expertise will not be considered complete until all transferable,
current assays have been transferred to YYY, and YYY's and XYZ's
primary representatives have determined, each in their
reasonable
discretion, that no other training or consultation with XYZ
representatives will be necessary in order for YYY to
effectively
manage, utilize and fully support the transferred assays. On
or before
twelve (12) months after the Effective Date, YYY will in
good faith
provide XYZ in writing a list of items of expertise yet to
be
transferred and the Parties will agree in good faith to a
plan for
transfer of such items.
6.4 TECHNICAL SUPPORT. During the First Sales Year,
XYZ will provide support
and assistance to YYY for the development of miniaturized homogeneous
assays
for use on the Products XYZ shall be compensated for such support and
assistance through the Transfer Price as managed by an account ("Account")
that
will track the ordered .......... 96 Product other than the Initial Order
according
to Transfer Prices set forth in Exhibit A. Every order by YYY to XYZ of
Product shall credit this account with the number of
Products ordered. Every
order by YYY to XYZ for a single assay miniaturization project (involving
one homogeneous assay), for a potential or actual
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YYY customer, shall debit this Account [ * ] At the outset, the Account will [
* ]. Thereafter, [ * ].
Hence, as an example, [ * ]. XYZ shall make
reasonable efforts to successfully complete all assay miniaturization projects.
However, part of the initial technology transfer from
XYZ to YYY will
include a description of what types of assays constitute reasonable model
assays
for miniaturization. Both parties recognize that some potential customers
may
request work on an unreasonably difficult, or even impossible, assay.
6.5 INITIAL
PURCHASE OF ..........-96. YYY will make
an initial purchase of
[ * ] of ..........-96 Product at
the pricing and scheduling as defined in
Exhibit
A. No initial purchase of any other Product will be
required hereunder.
6.6
PURCHASE ORDERS. Subject to
Sections 6.10 and 6.12, YYY shall submit
purchase orders to XYZ for the quantities of Products desired. Such purchase
orders shall constitute the only authorization for XYZ to provide Products to
YYY.
6.7 DELIVERY. XYZ shall deliver the Products in the
quantities and on the
dates specified in the delivery schedules to YYY's
purchase orders, F.O.B.
(..........,
carriers, third party direct bill. The transfer price terms in this Agreement
contemplate that the manufacture of Products shall be made in the
and all shipments will be made to locations in the
to other countries or between other countries will require mutually agreed
upon
adjustments of the transfer price terms of this Agreement; and unless otherwise
mutually agreed in writing, any brokers' fees, customs duties, value added taxes
and any freight, insurance, taxes or other costs which are not imposed on
XYZ
under the definition "FOB (place of shipment)" in INCOTERMS, will
be the sole
responsibility of YYY.
6.8 CHANGES TO ORDERS. YYY shall have the right to
make changes to purchase
order quantities and delivery dates provided said changes are in conformance
within the firm lead-time and forecasting terms as established under Sections
6.10 and 6.12.
6.9 DISASTER RECOVERY PLAN. In order to demonstrate
supply risk management to
YYY, within six (6) months after the Effective Date of
this Agreement, XYZ
shall document and maintain a YYY disaster recovery plan ("Plan")
which would
be implemented in the event of a significant or catastrophic event
affecting the
supply of Products. As a provision of the Plan, the Parties shall agree upon
terms for XYZ to grant to YYY a limited time period, non-exclusive,
royalty-free license to manufacture the Products or sublicense a
mutually
agreeable third party to do the same to prevent an interruption in supply. Upon
such occurrence, XYZ shall immediately provide to YYY written detailed
information and technical assistance sufficient for YYY or a third party to
manufacture the Products, including, but not limited to:
1) approved raw material vendor list,
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2) raw material specifications,
3) quality control procedures and,
4) detailed manufacturing instructions
(collectively the "Detailed Manufacturing
Instructions")
If XYZ can resume supplying Products to YYY's requirements, YYY or a
third party shall discontinue manufacturing the Products following production
restart, where XYZ warrants that XYZ has the capacity and capability of
satisfying YYY's full demand for Products. In such case
the manufacturing
license with YYY and any sublicense with a third party shall terminate and the
originals and all copies of Detailed Manufacturing Instructions shall be
promptly returned to XYZ. YYY and any sublicensee
shall hold all Detailed
Manufacturing Instructions as confidential
information, defined in Section 2.
6.10 FIRM LEAD-TIME. Subject to the terms of Section
6.12, firm lead-time for
Products shall be negotiated in good faith, to be [ * ]. YYY may not affect
changes to purchase orders within firm lead-time without the consent of XYZ.
Should XYZ not have Products in the quantities
ordered, ready for shipment on
the requested purchase order date, where YYY has provided the firm
lead-time
stated above, and expedited freight is required by YYY to meet production
needs, XYZ shall be financially responsible for any incremental shipping cost
associated with such expedited freight. Notwithstanding any terms of this
Section 6.10 or Section 6.12 to the contrary, if YYY
wishes to place order(s)
for Product that would require XYZ to have a manufacturing capacity [ * ],
the firm lead-time for any such order(s) shall be [ * ] and also YYY shall
provide a special forecast for such order(s) in advance of the time period
provided in Section 6.12.
6.11 AUDIT. Subject to the confidentiality provisions
of Section 2 hereof,
XYZ shall make its records and facilities involved in
the manufacturing and
testing of the current Product and all future Products, available to YYY
personnel at reasonable and mutually convenient times (not to exceed once each
calendar year) during normal business hours for audit purposes and shall take
any reasonable actions required by YYY to facilitate such audit. XYZ shall
address any issues YYY may have within a reasonable timeframe.
6.12 FORECASTS. In order to facilitate XYZ's forward planning process for
Products, and to assist XYZ in making certain
decisions relative to inventory
of long lead time raw materials, starting at the commencement of the First
Sales
Year, YYY shall provide prior to the last day of each
quarter on an "as needed
" basis a non-binding forecast of its requirements for the
Products for the
following four (4) quarters. If XYZ determines that it has insufficient
capacity to meet the quantities stated in the forecast, XYZ shall notify
YYY within thirty (30) days after the date of receipt
of the forecast that
such condition exists, and will present recommendations regarding
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capacity changes to meet the forecast. In any event, after the First Sales Year,
YYY shall be obligated to place firm lead time orders
(according to Section
6.10) for a given quarter of a total amount that is [ * ] of the forecasted
requirements for such quarter according to the forecast that is
provided
immediately before that quarter ("Obligated Orders"). For example, [ * ]
Products for that second quarter. During the First Sales Year the Obligated
Orders for a given quarter shall be [
* ] of the most recent forecast for that
quarter. Always XYZ shall use reasonable commercial efforts to fill orders
that exceed Obligated Orders.
6.13 VALIDATION OF SUB-MICROLITER DISPENSERS. At the
Effective Date of this
Agreement, XYZ has qualified two suppliers of sub-microliter dispensers that
have been validated for use with the ..........-96 Product; such dispensers
are (1)
[ * ] dispenser manufactured and sold as of the Effective Date by [ * ] and
(2)
[ * ] dispenser manufactured and sold as of the Effective Date by [ * ].
Furthermore the Parties will also cooperate regarding
the best technical and
business relationship with other suppliers of sub-microliter
dispensers. YYY
will evaluate in good faith whether to enter into a co-marketing agreement
with
liquid dispensing robot vendors.
6.14 AVAILABILITY OF THE ..........-384 PRODUCT. XYZ
agrees to commit all
reasonable efforts consistent with the priority of XYZ's
other projects, in
order to assure the successful development of the ..........-384 Product. The
launch
is presently contemplated, based on XYZ's
current development schedule for
..........-384 Product, to occur [ *
]. If the Parties decide that an [ * ] (and
will also make appropriate changes to the Work Plan for YYY's
launch and sales
of ..........-384 Product).
6.15 RIGHTS
OF NEGOTIATION FOR ADDITIONAL PRODUCTS.
6.15.1
CONSIDERATION. In consideration of the rights granted to YYY
by XYZ pursuant to the following subsections of this Section
6.15,
[* ] the Effective Date of this Agreement, YYY shall pay by
wire
transfer to XYZ [ * ]. Both Parties will negotiate in good
faith [
*]. The
Parties agree that, absent an agreement by both Parties to the
contrary, the cost to YYY [ * ]. XYZ will use reasonable
efforts
to complete the Workplan and will
submit a written report of results [
* ].
6.15.2
NEGOTIATION RIGHTS. Both Parties recognize that XYZ is
developing proprietary technology(s) of interest to both
Parties,
specifically technology for Additional Products defined in
1.9, and the
desire of both Parties to commercialize these Additional
Products. In
consideration of the fee set forth in Subsection 6.15.1,
during a
period [ * ] agrees that YYY will be given the exclusive
first rights
of refusal and the right to negotiate [ * ].
6.15.3 EXPANSION. During the [ * ],
XYZ will also discuss
expanding rights [ * ].
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7)
CHANGES:
7.1 CHANGES BY YYY. YYY reserves the right to propose
changes to the Product
or to the Specifications and XYZ shall not unreasonably withhold its
approval
of such changes to the Product or Specification. Upon receiving such
written
request from YYY, supplier shall submit within a reasonable time, but in no
event longer than 90 days, a report to YYY setting forth its best judgment as
to the probable effect on the supply of the Product and the cost of the
proposed
change. If the changes would result in any significant increase in
manufacturing
costs and/or in a significant development effort by XYZ, the Parties shall
negotiate in good faith an increase of the transfer price terms for the Product
as so changed. In any event, XYZ shall not proceed with any change that
would
affect form, fit or function without written authorization from YYY, which
authorization YYY shall not unreasonably withhold.
7.2 CHANGES BY XYZ. XYZ must have written
authorization from YYY (which
authorization YYY shall not unreasonably withhold) prior to
incorporating any
change into production that may effect the form, fit, function, reliability,
product labeling, ap..........ance, or interchangeability of
any Product furnished to
YYY or its Affiliates. Changes incorporated by XYZ's
vendors /
manufacturers / contractors / subcontractors are also included in
the
requirement. Shipments incorporating such changes will not be made until
authorization is obtained by YYY's Source
Development Group at the receiving
location (which authorization YYY shall not unreasonably withhold). XYZ is
to maintain control records documenting the effective dates, lot numbers,
and/or
serial numbers of all engineering and process changes. The document control
system must ensure that obsolete drawings and specifications are removed from
all areas of use.
7.3 NEW PRODUCT . Should
either Party wish to pursue an opportunity for
development and commercialization of a new Product that differs substantially
from the ..........-96 Product and ..........-384 Product ("New
Product"), [ * ]
8)
WARRANTIES:
8.1 PRODUCT QUALITY; INDEMNIFICATION. XYZ expressly
warrants that all
Products furnished under this Agreement shall conform
to all Specifications,
will be free from manufacturing defect(s). This warranty shall apply for a
period of [ * ] following date of manufacture of Products by XYZ or its
contractor, unless otherwise expressly provided for herein. YYY agrees to
inspect Product upon its receipt and notify XYZ, in writing within fifteen
(15) days after receipt, of
Products that do not conform to Specifications
("Nonconforming Product"). XYZ and YYY will
agree upon a Replace of
Material Authorization Program (RMA Program")
under which XYZ would be
obligated to promptly correct, repair or replace Nonconforming Product, in
accordance with industry best practices. In accordance with the RMA
------------------------
[ * ]
Certain information on this page has been omitted and
filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions.
Page 11
<PAGE>
Program, XYZ will make corrections, repairs or
replacements necessary to cure
breach of this warranty, provided, however, that (a) XYZ reserves the right
to inspect and test, at its own cost, any Nonconforming Product; (b) the
Nonconforming Product has not been altered, repaired,
or modified without the
prior approval of XYZ; (c) the Nonconforming Product has not been damaged as
a result of accident, disaster, abuse, misuse, lack of maintenance or
damage
during shipment and/or storage. XYZ agrees to reimburse YYY for such
activity provided that such activity is consistent with the RMA Program or YYY
has received prior authorization to do so from XYZ and abides by any
conditions agreed upon by XYZ and YYY with respect to such actions. To the
extent that YYY is not able, or authorized to make said corrections, repairs
or replacements, XYZ will perform same within thirty (30) days or such
other
period provided in the RMA Plan, including replacement parts, labor,
installation, etc., necessary to correct and meet the warranty.
XYZ SPECIFICALLY DISCLAIMS, WITH RESPECT TO PRODUCT
FURNISHED HEREUNDER, ALL
OTHER WARRANTIES, EXPRESSED OR IMPLIED, ANY WARRANTIES
OTHER THAN THOSE
EXPRESSLY PROVIDED IN THIS SECTION 8.1, INCLUDING, BUT
NOT LIMITED TO, THE
IMPLIED WARRANTIES OF MERCHANTABILTY AND
FITNESS FOR A PARTICULAR USE.
8.2 ORDER FULFILLMENT. XYZ agrees that XYZ or its
Affiliate or contractor
shall use all reasonable efforts to fill YYY's or
an Ordering Entity's
purchase order in accordance with the lead-time specified in Sections 6.10 and
6.12.
8.3 TERM OF MANUFACTURING. Subject to the termination
provisions above, XYZ
warrants to YYY that it or contractor(s) will continue to manufacture and
offer the Products throughout the Initial Term of this Agreement. After such
date, XYZ warrants to YYY that in the event that XYZ elects to no longer
offer the Products as specified in Exhibit A, XYZ shall provide YYY with at
least six (6) months prior notice of such intent, and allow YYY to order the
Products during such six (6) months. Notwithstanding any other terms of this
Agreement, XYZ may, in its discretion, fulfill its obligations under this
Agreement to supply Product by contracting manufacture
thereof to a third party
contractor(s) approved by YYY, which approval(s) shall not be
unreasonably
withheld.
8.4 RECALLS. As used herein, "Initiated
Recall" shall mean a recall (a)
initiated at the direction of the Federal Food and Drug Administration or other
regulatory authority, arising out of, based on, or caused by defects in
materials or workmanship, improper manufacture of the Products, or failure of
the Products to meet the Specifications; or (b) initiated voluntarily by
either
Party where evidence indicates that defects in
materials or workmanship,
improper manufacture of the Products, or failure of the Products to meet the
Specifications warrants such a recall. Each Party shall promptly notify the
other Party of any situation which may lead to an Initiated Recall of the
Products, however, YYY and XYZ shall have joint
authority as to whether to
institute a voluntary recall. YYY shall notify XYZ, in writing, if it is
required to implement a total or
Page 12
<PAGE>
partial Initiated Recall. Both Parties agree to work together to properly
manage
an Initiated Recall, foremost in terms of urgency and safety for the end
customer, and secondly for the efficient utilization of resources to accomplish
such Initiated Recall. The costs of any total or partial Initiated Recall
shall
be allocated as follows, regardless of whether it was recalled by XYZ,
YYY,
or a governmental or regulatory authority: (a) if the defects or problems
giving
rise to the reason for the Initiated Recall can reasonably be deemed to be
the
direct result of negligent or willful acts or
omissions on the part of XYZ,
XYZ shall bear the out-of-pocket costs and expenses
associated with the
Initiated Recall; (b) if the defects or problems
giving rise to the reason for
the Initiated Recall can reasonably be deemed to be the direct result of
negligent or willful acts or omissions on the part of
YYY, YYY shall bear
the out-of-pocket costs and expenses associated with the Initiated Recall;
(c)
if the defects or problems giving rise to the reason for the Initiated
Recall
can reasonably deemed to be the direct result of negligent or willful acts or
omissions by both Parties, each Party will bear a portion of the out-of-pocket
costs and expenses roughly commensurate with its proportional responsibility
for
the Initiated Recall, and (d) if it cannot reasonably be determined which
party
was responsible for the defects or problems giving rise to the reason for
the
Initiated Recall, then the Parties shall equally share
the out-of-pocket costs
and expenses associated with the Initiated Recall.
9)
QUALITY:
9.1 RECORDS. In compliance with its own internal
quality systems, each Party
shall keep reproducible records of all data pertaining to its performance
under
this Agreement.
9.2 REVIEW OF RECORDS. Upon thirty (30) days prior
written, each Party shall
make its records and facilities involved in the performance of this Agreement
available to the other Party's personnel at reasonable and mutually convenient
times during normal business hours for quality system audit purposes and
shall
take any reasonable actions required by the reviewing Party to facilitate
such
audit.
9.3 ISO 9001 CERTIFICATION. XYZ,
and all manufacturing facilities involved in
the production of the Product, agree to be ISO certified on the effective
date,
or, if not, to actively pursue such certification during the term of this
Agreement. Until such time ISO certification is obtained, XYZ will make
available all quality test procedures to YYY, in order for YYY to meet
current corporate ISO standards.
9.4 SAMPLES. For purposes of quality control testing
and approval by YYY,
XYZ shall upon request supply to YYY [ * ] ..........-96 Product (and
..........-384 Product when commercially available)
within two (2) weeks of
notification. During each 12-month period of the Agreement,
additional
quantities [ * ] of ..........-96 Product (and ..........-384 Product when
commercially
available) will be supplied [ * ] of XYZ's fully
burdened Manufacturing Costs
(as defined in Section 4.2), therefor.
------------------
[*] Certain information on this page has been omitted
and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
Page 13
<PAGE>
9.5 NON-CONFORMING PRODUCT. Any
Nonconforming Product at the customer site
may be replaced in
accordance with the
terms of the RMA Plan as
provided in Section 8.1 above.
10)
INDEMNIFICATION:
10.1 THIRD
PARTY INFRINGEMENT:
10.1.1
PATENT INDEMNIFICATION. Each Party ("Provider") will defend and
indemnify the
other Party ("Recipient") against a claim that any
information, design, specification, instruction, software,
data or
material furnished by the Provider (collectively,
"Material") and used
by the Recipient infringes a patent held by a party other
than XYZ,
YYY or
their Affiliates ("Third Party Patent") provided that (a) the
Recipient notifies the Provider in writing within five (5) business
days of its knowledge of the claim; (b) the Recipient gives
Provider
sole control of the defense and
all related settlement negotiation; and
(c) the Recipient provides the Provider with the assistance,
information and authority reasonably necessary to perform
the above;
reasonable out-of-pocket expenses incurred by the Recipient
in
providing such assistance will be reimbursed by the
Provider. The
Provider shall have no liability for any claim of infringement
resulting from (i) the Recipient's
use of a superseded or altered
release of some or all of the Material if infringement would
have been
avoided by the use of a subsequent unaltered release of the
Material
which is provided to the Recipient; or (ii) any information,
design,
specification, instruction, software, data or material not
furnished by
the Provider.
10.1.2
REMEDY FOR INDEMNIFICATION. In the event that some or all of the
Material
is believed by the Provider or is held to infringe a Third
Party
Patent, Provider shall have the option, at its expense, (a) to
modify the Material to be non-infringing; (b) to obtain for
the
Recipient a license to continue using the Material; or (c) to require
return of the infringing Material and all rights thereto
from the
Recipient. If XYZ is the Provider and it elects option (c)
above and
such return materially affects YYY's
ability to use the Material,
YYY
shall notify XYZ in writing concerning the infringement.
XYZ
shall have sixty (60) days to remedy said infringement. If
XYZ is
unable to remedy, YYY may, at its option and upon sixty
(60) days prior written notice to XYZ, require XYZ to return to
YYY all
amounts paid by YYY to XYZ under this Agreement, limited
to the amount of YYY's actual
damages for infringement of the Third
Party Patent. If YYY is the Provider and it elects option
(c) above
and such return materially affects XYZ's
ability to complete its
performance under this Agreement, YYY shall have sixty (60)
days to
remedy such infringement. If YYY is unable to remedy, XYZ
may at
its option and upon sixty (60) days prior written notice to
YYY,
terminate this Agreement, and YYY shall pay XYZ for all
services
rendered and costs incurred in performance of its
obligations under
this Agreement from the Effective Date of this Agreement
through the
date of termination on a time and
Page 14
<PAGE>
materials or percent of completion basis as applicable,
limited to the
amount of XYZ's actual damages for
infringement of the Third Party
Patent.
10.1.3
EXCEPTIONS. Notwithstanding any terms of this Section 10.1 to
the contrary, XYZ's obligations to
defend and indemnify under
Subsection 10.1.1 and to return amounts paid by YYY under Subsection
10.1.2 shall only apply to the extent that any claim of patent
infringement relates to the use, manufacture or sale of the
Product
itself as such Product was actually manufactured by XYZ for
YYY.
For
example, without limiting the foregoing, in no event shall XYZ
have any liability under this Section 10.1 for any claim of
infringement relating to assays, methods or compositions
which may be
utilized together with the Product, including, among others,
any assays
that it may have transferred to or developed for YYY
pursuant to
Section 6.3 or 6.4 above.
10.2
LIABILITY:
10.2.1 LIABILITY
OF XYZ. XYZ shall indemnify, defend and hold
YYY
harmless from any and all claims, demands, actions and causes of
action against YYY in connection with any and all injuries,
losses,
damages or liability of any kind whatsoever (except for
indirect or
consequential damages) that is directly attributable to
breach by
XYZ and
its Affiliates and contractors of their obligations under
this Agreement. This indemnification obligation shall
include, without
limiting the generality of the foregoing, reasonable
attorneys' fees
and other costs or expenses incurred in connection with the defense or
settlement of any and all claims, demands, actions or causes
of action.
XYZ's obligations hereunder to defend and indemnify are
subject to
the conditions that YYY promptly notifies XYZ of any such
claim or
demand and permit XYZ to have sole control the defense and
settlement thereof.
10.2.2
LIABILITY OF YYY. YYY shall indemnify, defend and hold
XYZ
harmless from any and all claims, demands, actions and causes of
action against YYY in connection with any and all injuries,
losses,
damages or liability of any kind whatsoever (except for
indirect or
consequential damages) directly attributable to the breach
by YYY or
its Affiliates of their obligations under this Agreement or
to the sale
of Product or use by third parties of Product that is sold
by YYY or
its Affiliates under this Agreement. This indemnification
obligation
shall include, without limiting the generality of the
foregoing,
reasonable attorneys' fees and other costs or expenses
incurred in
connection with the defense or
settlement of any and all claims,
demands, actions or causes of action. YYY's
obligations to defend and
indemnify is subject to the conditions that XYZ promptly
notifies
YYY of
any such claim or demand and permit YYY to have sole control
the defense and settlement
thereof.
11) FORCE
MAJEURE:
Page 15
<PAGE>
Except as otherwise provided in this Agreement, each
of the Parties hereto shall
be excused from the performance of its obligations thereunder
in the event such
performance is prevented by force majeure and such excuse
shall continue as long
as the condition constituting such force majeure
continues, plus thirty (30)
days after the termination of such condition. For the purpose of this
Agreement,
force majeure is defined as follows: Causes beyond
the control of XYZ or
YYY, including, but without limitation, regulations,
laws or acts of any
government, destruction of XYZ's facilities or material
by fire, or failure
of public utilities or common carrier or embargo.
12)
INSOLVENCY:
Either Party may, at its option, terminate this
Agreement upon thirty (30) days'
prior written notice without liability in the event of:
a)
Insolvency of the other Party or,
b)
Voluntary filing of petition for bankruptcy by the other Party, or
c) Any
filing of involuntary bankruptcy against the other Party, or
d)
Appointment of receiver or trustee for the other Party, or
e) An
assignment for the benefit of the other Party's creditors, or
f) Any
other act for the protection of debtors is filed by or against
either Party.
For purposes of this Agreement, a Party is
"insolvent" who either has ceased to
pay its debts in the ordinary course of business or cannot pay its debts as
they
become due or is insolvent within the meaning of the federal bankruptcy law.
13) GENERAL
PROVISIONS:
13.1 ASSIGNABILITY. Each Party shall have the right to
assign this Agreement or
its obligations hereunder to its Affiliates or any third party who obtains
Control of such Party. As used in this Section 13.1, "Control"
means the
acquisition of a majority of the outstanding voting securities of the Party.
13.2 SURVIVABILITY. The rights and obligations of
Section 2 (Confidentiality),
Section 8 (Warranties), Section 5 (Term and
Termination), Section 10
(Indemnification) and Section 13 (General Provisions)
shall survive any
termination of this Agreement and shall bind the Parties and their legal
representatives, successors, and assigns.
13.3 ENTIRE AGREEMENT. This Agreement embodies the
entire understanding and
agreement among the Parties and supersedes all previous negotiations,
representations, writings and agreements, written, or oral, with
respect to the
subject matter herein. Any additional terms or conflicting terms or conditions
contained in any other document pursuant to the subject matter herein are hereby
abrogated. XYZ and YYY agree that this Agreement shall not be altered,
amended or modified, except in writing that is signed by an authorized
representative of both Parties.
Page 16
<PAGE>
13.4 NON-WAIVER. No term or provision hereof shall be
deemed waived and no
breach excused unless such waiver or consent shall be in writing and signed by
a
duly authorized representative of the Party claimed to have waived or
consented.
13.5 SEVERABILITY. If any provision of this Agreement
is invalid or
unenforceable under any statute or rule or law, the provision is to
that extent
to be deemed omitted, and the remaining provisions shall not be affected
in any
way.
13.6
RELATIONSHIP OF THE PARTIES:
13.6.1 XYZ
and YYY intend that an independent contractor
relationship shall be created by this Agreement, and nothing
herein
shall be construed as creating an employer/employee
relationship,
partnership, joint venture, or concerted action.
13.6.2
Personnel assigned by either Party to provide deliverables under
this Agreement will be employees or contractors of said
Party and will
not for any purpose be considered employees or agents of the
other
Party. Each Party assumes full responsibility for the
actions of such
personnel and contractors while performing all its
obligations
hereunder, either at XYZ or YYY facility, and shall be
solely
responsible for their supervision, daily direction and
control, payment
of salary (including withholding of income taxes and social
security),
workmen's compensation and occupational disease insurance as
required
by law, comprehensive public liability insurance, compensation,
disability benefits and the like.
13.6.3
XYZ agrees that, while its personnel or contractors are on
YYY's premises, they will conform to all YYY's work rules, safety
regulations and its standard practices governing behavior of its own
employees. Also, XYZ agrees to require such personnel and
contractors to work in a manner which will comply with all
federal,
state and local laws and regulations governing said work
practices.
13.7 NOTICES. All notices, demands and communications
provided for in this
Agreement shall be in writing and shall be deemed
effective by a Party upon hand
delivery or when mailed, postage prepaid, by registered or certified mail, to
the other Party or its copy designee at the respective addresses listed
below,
unless and until such address is changed by giving written notice thereof in
like manner.
To
YYY: YYY
.......... Corporation
..........
.......... Road
.........., IN 46250
Attn: Purchasing
Manager
(with
a copy to the Law Department at the same
address)
To XYZ XYZ ..............., Inc.
Page 17
<PAGE>
..... ..........
Avenue
.....
Attn: .......... .
.........., CEO and President
(with a
copy to the Legal Department at the same
address)
13.8 EXPORT OF DATA. XYZ agrees to comply with all
applicable Federal, State
and local laws, regulations and ordinances, including but not limited to
the
Regulations of the United States Department of
Commerce relating to the Export
of Technical Data, insofar as they relate to the subject matter described
herein.
13.9
GOVERNING LAW:
13.9.1
The Agreement shall be governed by the laws of the state of
faith attempt to settle as promptly as possible any and all
disputes
arising from this Agreement or a transaction conducted
pursuant to this
Agreement;
but failing an amicable settlement, exclusive jurisdiction
and venue over such dispute shall be in a court of competent
jurisdiction residing in Marion County, Indiana or
13.9.2
XYZ and YYY shall do all things necessary to comply with
all applicable Federal, State and local laws, regulations
and
ordinances relating to services to be performed under this
Agreement.
YYY and
XYZ are federal contractors with obligations from various
Federal
Laws, Code of Federal Regulations (CFR), Public Laws, and
Executive Orders, such as Equal Employment
utilization of small, small disadvantaged, woman owned,
veteran and HUB
zone businesses per the Federal Acquisition Regulations
(FAR). Each
Party
agrees to comply with the obligations contained in the applicable
federal laws and regulations, as well as any applicable
state or local
laws or regulations of a similar nature. Each Party agrees
to provide,
at the other Party's request, any and all documentation
required to
substantiate such compliance.
13.10 PRODUCT MARKING. In the labeling
and packaging inserts for Product, unless
the Parties otherwise mutually agree, YYY include the following reference:
"Developed and Manufactured by XYZ
..............., Inc."
13.11 USE OF TRADEMARK AND NAME. Each Party may not
use the other Party's name
or trademarks, or refer to or disclose the existence of this Agreement or
the
obligations performed hereunder, directly or indirectly, without the prior
written consent of the other Party. If YYY wishes to use the ..........
trademark
in connection with its performance under this Agreement, it shall promptly
notify XYZ and the Parties shall negotiate in good faith a separate license
agreement.
Page 18
<PAGE>
IN WITNESS WHEREOF, the Parties hereto have caused
this Agreement to be executed
by their duly authorized representatives.
YYY .......... Corporation XYZ ...............,
Inc.
[illegible] /s/ .......... M. ..........
-------------------------------------- ------------------------------------
Name Name
VP business Planning President, CEO
-------------------------------------- ------------------------------------
Title Title
-------------------------------------- ------------------------------------
Date Date
--------------------------------------
Name
--------------------------------------
Title
--------------------------------------
Date
Page 19
<PAGE>
Exhibit A
Pricing - ..........-96
[*]
[ * ] Certain information on this page has been
omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
Page 20
<PAGE>
Exhibit B
Products and
Specifications
1. Custom packaged ..........-96
Product with YYY provided labels
and
packaging materials.
2.
Custom packaged ..........-384 Product with YYY provided labels and
packaging materials.
..........(TM) 96
Product Definition Document
PRODUCT DESCRIPTION
--------------------------------------------------------------------------------
..........(TM) ..........
Devices utilize a novel 96-channel design that enables
the miniaturization of biochemical assays to nanoliter
volumes. Conventional
technology used to miniaturize assay volumes met with a range of unique problems
principally associated with evaporation. Now the .......... device solves these
challenges by overcoming evaporation issues with an elegant and proprietary
design.
--------------------------------------------------------------------------------
BENEFITS OF THE .......... .......... DEVICE
--------------------------------------------------------------------------------
|X|
Controls evaporation while maintaining sample integrity at nanoliter
volumes
|X| Ensures
proper mixing at nanoliter volumes
|X| Enables
assay CV ~10%
|X| Allows
library screening with previously impractical amounts of target
|X|
Decreases reagent usage up to 100 fold
--------------------------------------------------------------------------------
Physical Specifications
1)
Plate Materials
a. Techmer 666
Black Styrene Resin
b. Plasma Treated Trycite 3000 Film
2)
Dimensional Specifications
A. Overall
a. Length 125.00 +/- 0.15mm
Page 21
<PAGE>
b. Height 14.50 +/-0.20mm
c. Width 85.5 +/- 0.5mm
d. Well Pitch 9.0 mm
B. Wells
a. ECW (Evaporation Control Well) 2.0 mm (W) X 1.5 mm (H)
b. AW (Assay Well) 1.5 mm (W) X 1.5 mm (H)
c. AR (Auxiliary
Reservoir) 2.0 mm (W) X 1.5 mm
Functional Specifications
(A summary of release data for Lots # AC121400 & #201
is available upon request)
A.
Fill Test
99.9% of the wells fill
B.
Test Compound Retention Test (Doc #1103, available on request)
To document the performance of the ..........TM 96-pattern Card
when the Test Compound (using Fluorescein as a surrogate) is
pre-mixed and added via the Evaporation Control
Well
Specification:
less than 80% Retention
% CV greater than 15% per plate
% CV greater than 15% (7 cards/group)
C.
Diffusion Test (Doc #1104 available upon request)
To determine the retention rate of fluorescein
in the assay
wells of an ..........TM Card
Specification:
less than 80% signal remaining in the Assay
Well
% CV greater than 15% (6 cards/group)
D.
Stability Specification (Doc #1101 available on request)
To document product shelf life
Stability Specification:
One year from date of manufacture stored at room temperature
of between 19(Degree) C and 25(Degree) C
Page 22
<PAGE>
XYZ will continue the stability studies to establish not less
than eighteen (18) months stability.
E.
Functional Assay Data (Doc #1102 [Protease]; Doc #1111 [Alkaline
Phosphatase]; Protocols available on request)
To perform functional assays for releasing commercial lots of
the ..........Device. Initial lots of
.......... 96 (
201) were released with the Cathepsin L protease assay. Future
lots manufactured will be released with the
Alkaline
Phosphatase assay, which is currently in validation.
Specification:
% CV greater than 15% per card tested
z factor greater than 0.5
QUALITY ASSURANCE SAMPLING PLAN
Production samples are tested according to the Manufacturer's Control
Plan #
0001059. (Control Plan available on request).
1. ..........-96 Leak Test
Procedure/Specifications: 100% QC
Definition:
Before each leak test, vacuum is energized against a closed
valve and quantified (~ 28 in Hg). This value
becomes the
`reference' vacuum value for each test. A `seal
plate' is then
placed and sealed against the card skirt.
Vacuum is drawn
against the card cavity where the film has been
welded and
held
for approximately 4 sec, after which a 2nd vacuum reading
is captured. If this 2nd vacuum reading is less
than 95% of
the reference value, the card is considered to
have failed the
test. A failed vacuum test means that air is
flowing between
the film and the energy directors, indicative
of a faulty
weld.
Specification:
Vacuum reading less than 95% of reference value
2.
Metrology Dimensional Testing
Parts are pulled every hour and dimensionally inspected
according to the Manufacturer's Control Plan.
3.
Functional Testing
Page 23
<PAGE>
Parts are
pulled every hour and functionally tested for % Fill, Test
Compound Retention, Diffusion, and Functional Assay requirements.
PACKAGING REQUIREMENTS
A. Lot size TBD
B. Packaging TBD
1.
Labeling
2. Container
..........(TM)
384
PRODUCT DEFINITION
DOCUMENT
Preliminary Product Description
[ * ]
Physical and Functional Specifications
[ * ]
-------------------
[ * ] Certain information on this page has been
omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
Page 24