DEVELOPMENT AND DISTRIBUTION AGREEMENT
This DEVELOPMENT AND DISTRIBUTION AGREEMENT (this 'Agreement') is
entered into as of the 8 day of June, 1998 ('Effective Date'), by and between
OSTEX INTERNATIONAL, INC., a Washington corporation having its principal place
of business at 0000 Xxxxxxx Xxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000
('Ostex'), and METRIKA, INC., a California corporation having its principal
place of business at 000 Xxxxxxx Xxxxxxx, Xxxxxxxxx, XX 00000 ('Metrika').
RECITALS
A. The Washington Research Foundation, a nonprofit Washington
corporation ('WRF'), is the owner, by way of assignment from the University of
Washington, of all right, title, and interest in certain technology developed
out of research conducted by Xx. Xxxxx Xxxx and generally described as the
'Urinary Assay for Bone Resorption.'
B. Pursuant to that certain Restated Exclusive License Agreement
between Ostex and WRF, effective June 29, 1992 as amended, the ('WRF/Ostex
Exclusive License Agreement'), WRF granted Ostex an exclusive, worldwide license
to make, have made, assign, sublicense, lease, develop, enhance, modify,
produce, reproduce, demonstrate, market, promote, sell, distribute, use, exploit
and otherwise commercialize and prepare derivations of certain of the Bone
Resorption Technology (as defined below).
C. Ostex engages in the research, development, manufacture, and sale of
diagnostic and therapeutic products in the field of bone and mineral metabolism
in applications related to bone resorption and collagen and connective tissue
degradation, and has developed a proprietary immunoassay to determine the levels
of NTx epitope collagen metabolite resulting from bone resorption ('NTx Assay
Technology' as further defined below), which it has implemented in a microtiter
format suitable for use in centralized laboratories ('Osteomark(R) Laboratory
Test').
D. Metrika has developed a single-use disposable diagnostic device
('Digital Response(R) Device' as defined below) which uses Metrika's proprietary
MODM(R) Technology (as defined below).
E. Ostex and Metrika entered into that certain Joint Development,
License and Co-Marketing Agreement dated April 10, 1997 ('Co-Marketing
Agreement') pursuant to which the parties would jointly develop, manufacture,
promote, market and sell a Digital Response Device incorporating Ostex's NTx
Assay Technology.
F. The parties now desire to supersede and replace the Co-Marketing
Agreement by entering into this Agreement pursuant to which Metrika will develop
and supply the NTx/Digital Response Device (as defined below) to Ostex, and
Ostex will have the exclusive right to market and distribute the NTx/Digital
Response Device throughout the world.
TERMS OF AGREEMENT
In consideration of the mutual covenants and agreements contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the parties agree as follows:
1. DEFINITIONS. The following definitions shall apply throughout
this Agreement.
'AFFILIATE' means, with respect to any person or entity, any
individual, corporation, company, firm, partnership or other entity controlled
by, in control of, or under common control with, such person or entity, where
'control' means direct or indirect legal or beneficial ownership of fifty
percent (50%) or more of the shares, business interests, or voting securities of
another corporation, company, firm, partnership or other entity.
'BONE RESORPTION TECHNOLOGY' means all technology to which
Ostex has any rights as of the Effective Date or during the Term of this
Agreement relating to assays, methods, and materials, including Critical
Reagents, for measuring bone collagen metabolites, including, without
limitation, that technology developed in connection with research conducted by
Xx. Xxxxx Xxxx, owned by the Washington Research Foundation, and licensed
exclusively to Ostex. The Bone Resorption Technology includes, without
limitation, the urinary diagnostic assay known as the Osteomark immunoassay.
'CLIA WAIVER' means the receipt of a certificate from the U.S.
Center for Disease Control confirming the waived status of the NTx/Digital
Response Device for POC applications pursuant to the Clinical Laboratory
Improvement Amendments of 1988 ('CLIA').
'CONFIDENTIAL INFORMATION' means any and all normally
non-public information communicated or disclosed by one party ('Discloser') to
the other party ('Recipient'), including information describing or relating to
the Discloser's business and marketing plans and strategies, financial
information, or customer information, and any and all information communicated
or disclosed by the Discloser to Recipient describing or relating to the
Discloser's research and development, Know-How, inventions, trade secrets,
technical data, formulae, drawings, designs, software, models, samples, kits,
processes, product development data and information, provided, however, that
'Confidential Information' shall not be deemed to include information which the
Recipient can demonstrate by written proof: (i) is now, or hereafter becomes,
through no fault on the part of the Recipient, generally known or available;
(ii) is known by the Recipient at the time of receiving such information; (iii)
is furnished generally to others by Discloser without restriction on disclosure;
(iv) is hereafter furnished to the Recipient by a third party unrelated to
Discloser, as a matter of right and without any breach of any duty of
non-disclosure; (v) is independently developed by the Recipient without use of
or reference to any Confidential Information of Discloser; or (vi) is the
subject of express written permission to disclose provided by Discloser. Without
limiting the generality of the foregoing, Confidential Information may include
information developed by a the Discloser during the course of this Agreement.
'COGS' means all costs of materials and components (including
purchase costs and royalties payable to third parties) and personnel expended on
manufacturing and quality control, relating to the Critical Regents supplied by
Ostex to Metrika
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
hereunder, plus a portion of manufacturing overhead
(including, but not limited to, inventory costs relating to spoilage, insurance,
depreciation, administrative expenses, indirect employee expenses and quality
assurance expenses) based on the portion of resources allocated to
manufacturing, calculated in accordance with U.S. generally accepted accounting
principles, less that portion of such costs attributable to capacity allocated
to other products manufactured by Ostex.
'CRITICAL REAGENTS' means the set of reagents required by
Metrika to be supplied by Ostex, or an Ostex appointed third party hereunder,
for use in the manufacture, quality control, and/or clinical trials or field
studies of the NTx/Digital Response Device. As of the Effective Date of this
Agreement, such Critical Reagents are limited to: (i) the XXXXX antibody (clone
designation XXXXX); (ii) the NTx Concentrate described in Ostex DOC No. 2007, or
equivalent material which can be used for formulation of controls and
calibrators; (iii) the Gold Reference Calibrators ('3000 nM Gold') described in
Ostex DOC No. 0019; and (iv) the FDA cleared Osteomark Laboratory Test Kit
manufactured by Ostex. These Critical Reagents may be changed upon mutual
agreement of the parties and reasonable notice to scale up to commercial
quantities. The specifications of the present Critical Reagents are attached
hereto as Exhibit C.
'DIGITAL RESPONSE DEVICE' means that certain diagnostic
platform developed by Metrika which uses MODM Technology for simultaneous
measurement of quantitative immunoassays and general chemistries in a
single-use, fully disposable in vitro diagnostic device. Such device includes a
small integrated liquid crystal display for display of results and a modified
serial port interface for communication with an accessory docking station. The
Digital Response Device is capable of calculating and displaying ratioed results
such as NTx (nM)/Creatinine (mM).
'DISCOVERY' means any scientific, technological, or commercial
invention, discovery, development, improvement, Know-How, or product made in the
course of performing the activities contemplated by the parties under this
Agreement, whether or not the same is patentable.
'FDA' means the U.S. Food and Drug Administration or any
successor agency thereof.
'FIELD OF USE' means the point-of-care (POC) (as defined
below) and over-the-counter (OTC) (as defined below) markets and any other
commercial markets.
'QSR' shall mean Quality System Regulation as such term is
defined under the laws and regulations promulgated by the FDA.
'METRIKA PATENT RIGHTS' means any and all patents and patent
applications or equivalent thereof, anywhere in the Territory relating to MODM
Technology and the Digital Response Device: (i) that would be infringed by the
unlicensed use, sale, offer for sale and importation of the NTx/Digital Response
Device in the Territory in the Field; (ii) that are owned or controlled by
Metrika as of the Effective Date and during the Term; and (iii) under which
Metrika has the right to license to Ostex hereunder.
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
'MODM TECHNOLOGY' means that certain proprietary technology
developed by Metrika which integrates digital electronics, micro-optics and dry
reagent chemistries and which allows quantitative, reflectance based
measurements of immunoassays (such as the measurement of urinary NTx levels) and
general chemistries (such as the measurement of urinary creatinine levels) to be
measured simultaneously.
'NTX ASSAY TECHNOLOGY' means an immunoassay for bone collagen
metabolites comprising an NTx Epitope, together with associated controls to
which Ostex has rights as of the Effective Date or during the Term of this
Agreement.
'NTX/DIGITAL RESPONSE DEVICE' means that certain Digital
Response Device incorporating NTx Assay Technology developed and supplied by
Metrika to Ostex pursuant to this Agreement as defined in the specifications
therefor attached hereto as EXHIBIT A ('SPECIFICATIONS').
'NTX EPITOPE' means a conformational structure included within
the natural crosslinked amino-terminal telopeptides from type I collagen, to
which the monoclonal antibody (mAb) produced from the hybridoma XXXXX and/or an
appropriate alternative antibody binds specifically by immunoaffinity, or
similar NTx epitopes resulting from bone resorption which may be developed or
marketed by Ostex in any form during the Term of this Agreement.
'OSTEX INTELLECTUAL PROPERTY RIGHTS' means all Ostex Patent
Rights and Ostex Know-How.
'OSTEX KNOW-HOW' means any method, information, procedure,
process, composition of matter, biological material, or other subject matter
relating to the NTx Assay Technology, Bone Resorption Technology or Critical
Reagents which: (i) has been developed or acquired by Ostex, prior to or during
the Term of this Agreement; (ii) may be required by Metrika to develop and
manufacture the NTx/Digital Response Device pursuant to this Agreement; and
(iii) Ostex has the right to license to Metrika hereunder.
'OSTEX PATENT RIGHTS' means any and all patents and patent
applications or equivalent thereof, anywhere in the Territory relating to the
NTx Assay Technology or Critical Reagents, including but not limited to those
patents and patent applications licensed to Ostex pursuant to the WRF/Ostex
Exclusive License Agreement: (i) that would be infringed by the unlicensed use
of the Critical Reagents and/or NTx Assay Technology and the unlicensed
development, manufacture and use of the NTx/Digital Response Device; (ii) that
are owned by or controlled by Ostex as of the Effective Date and during the
Term; and (iii) under which Ostex has the right to license to Metrika hereunder.
'OTC' shall mean XXXXXXXXXXXX.
'POC' shall mean XXXXXXXXXXXXX.
'SALE' shall mean any and all transactions whereby Ostex
sells, leases, rents, or otherwise transfers or disposes of to (i) any end-user,
including without
limitation any physician's office or clinical laboratory
purchaser, or (ii) any third-party distributor, any right of ownership, or any
other right to possession.
'SHELF-LIFE' shall mean the time interval from the date of
product manufacture to product shelf life expiration.
'TERRITORY' means all of the countries of the world.
2. LICENSE GRANTS.
2.1 OSTEX INTELLECTUAL PROPERTY RIGHTS. Subject to the terms
of this Agreement, Ostex hereby grants to Metrika and its Affiliates and
permitted assigns, for the Term of this Agreement, and Metrika hereby accepts, a
non-exclusive, worldwide (except in Japan) license in and under the Ostex
Intellectual Property Rights, to use the Critical Regents and the NTx Assay
Technology to develop, manufacture, and use (so long as such use is restricted
to the use required by Metrika to perform its responsibilities under this
Agreement or for Metrika's own internal research and development purposes
relating to the Digital Response Device or MODM Technology) the NTx/Digital
Response Device, and to sell the NTx/Digital Response Device only to Ostex. The
license granted to Metrika hereunder may not be sublicensed or transferred by
Metrika, except to third party manufacturers appointed by Metrika in accordance
with Section 4.2.
2.2 METRIKA INTELLECTUAL PROPERTY RIGHTS. Subject to the terms
of this Agreement, Metrika hereby grants to Ostex and its Affiliates and
permitted assigns, for the Term of this Agreement, and Ostex hereby accepts, an
exclusive (as set forth in Section 5.2.1), license in and under the Metrika
Patent Rights, to market, promote, have marketed and promoted, sell, have sold,
distribute and have distributed (but not to make or have made) throughout the
Territory, the NTx/Digital Response Device within the Field of Use. The license
granted to Ostex hereunder may not be sublicensed or transferred by Ostex,
except to Subdistributors in accordance with Section 5.1.
2.3 RESERVATION OF RIGHTS. Except as expressly provided
herein, no right, title, or license is granted, whether express or implied, by
either party to the other to such party's Intellectual Property Rights. Nothing
in this Agreement shall be deemed to restrict either party's right to exploit
any of its own Intellectual Property Rights not expressly granted to the other
party hereunder.
3. DEVELOPMENT.
3.1 METRIKA RESPONSIBILITIES. Subject to the terms and
conditions of this Agreement, Metrika shall be responsible for development of
the NTx/Digital Response Device. In addition, Metrika shall be responsible for:
(i) performing clinical trials and obtaining FDA clearance to market and sell
the NTx/Digital Response Device for POC applications in the U.S.; (ii) obtaining
CLIA Waiver for the NTx/Digital Response Device for POC applications; (iii)
obtaining and maintaining the CE Xxxx and all other required pan-European
certifications for the NTx/Digital Response Device, and
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
(iv) providing reasonable assistance and existing performance or stability data
reasonably requested by Ostex and/or its appointed distributors which is
necessary to obtain marketing and/or reimbursement approval for countries other
than the United States. Ostex and Metrika hereby agree to the pre-launch working
relationship responsibilities for the POC NTx/Digital Response Device as set
forth in EXHIBIT B hereto.
3.2 DEVELOPMENT TIMELINE. Metrika shall use its reasonable
commercial efforts to obtain 510(k) clearance for the NTx/Digital Response
Device for POC applications prior to XXXXX and obtain CLIA Waiver of the
NTx/Digital Response Device for POC applications prior to XXXXX. Notwithstanding
anything to the contrary in Section 10 of this Agreement, if Metrika fails to
obtain such 510(k) clearance or CLIA Waiver by the dates sets forth in this
Section 3.2, Ostex may elect to terminate this Agreement immediately, with no
cure period available to Metrika, upon written notice to Metrika. Such
termination shall constitute Ostex's sole and exclusive remedy for such failure
by Metrika to meet such dates.
3.3 DOCKING STATIONS. If Metrika develops, during the Term, a
universal docking station for use with Digital Response Devices, Metrika will
make such docking station available to Ostex on terms XXXXXXXXXXXXXX under which
Metrika has made such instrument(s) available to third parties, including third
party distributors, provided that: (i) such third party has not paid Metrika a
license, development or other fee for rights to such instrument(s); or (ii)
there are no terms, commercial circumstances and conditions which would
compensate for Metrika's granting of such more favorable terms to such third
parties; or (iii) such reasonably less terms are no less than a XXXXXX margin to
Metrika, so long as Metrika is not making such docking station available at more
favorable terms (XXXXXXXXXXXXX Metrika) to third parties that are not described
by (i) or (ii) of this Section 3.3.
3.4 OSTEX RESPONSIBILITIES.
3.4.1 CRITICAL REAGENTS FOR DEVELOPMENT OF
NTX/DIGITAL RESPONSE DEVICE. Ostex shall
supply to Metrika such reasonable quantities of Critical Reagents as shall be
necessary or useful for the purpose of Metrika performing its responsibilities
described under Section 3.1.
3.4.2 ASSISTANCE TO METRIKA. Upon reasonable
request by Metrika, Ostex shall make
available key employees to provide consultation, advice, assistance, and
scientific direction to Metrika relating to development of the NTx/Digital
Response Device. Without limiting the generality of the foregoing, Ostex shall
make available to Metrika personnel trained in and knowledgeable of the Bone
Resorption Technology and performance characteristics of the NTx Assay
Technology. Except as otherwise specifically provided in this Agreement, each
party shall bear its own costs and
expenses associated with all facilities, materials, and employee time devoted to
this effort. Neither party shall be obligated to disclose their Confidential
Information to the other, except to the extent necessary for the performance of
each party's obligations under this Agreement. Ostex shall assist Metrika, at
either party's reasonable request, in the technical training of a mutually
determined number of Metrika's employees, such training to include provision of
information as to the nature, use and proper care of Critical Reagents. Any such
training shall be provided at Ostex's principal place of
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
business, and Metrika shall be solely responsible for all costs of
transportation, lodging, and other expenses of trainees incidental to such
training. During the Term hereof, Ostex shall use its commercially reasonable
efforts to respond to technical questions or problems which may arise from time
to time in connection with the Critical Reagents and NTx Assay Technology.
3.4.3 CLINICAL AND REGULATORY. Other than as
provided in Section 3.1, Ostex shall be
responsible for all additional clinical and other regulatory activities and
obtaining all required approvals to market, distribute, and sell the NTx/Digital
Response Device in the Territory in the Field of Use. Ostex may contract Metrika
to perform any such regulatory activities upon terms and conditions to be agreed
to by the parties.
3.5 ACCESS TO CLINICAL DATA. Each party shall provide the
other party with full access to all clinical trial data and regulatory
submissions, in such party's possession or control. It is acknowledged that such
information will be subject to the confidentiality provisions set out in this
Agreement, to the extent applicable, as well as confidentiality provisions
necessary to protect patient privacy; provided, however, that such information
may, as necessary and appropriate, be transmitted to proper regulatory
authorities in connection with the seeking of regulatory product approvals, and
may be used in connection with Ostex's marketing activities for the NTx/Digital
Response Device.
4. MANUFACTURE AND SUPPLY.
4.1 MANUFACTURING. Metrika shall develop the capacity to
manufacture reasonable commercial quantities of the NTx/Digital Response Device
in accordance with the Specifications and QSR, and thereafter Metrika shall
manufacture or have manufactured NTx/Digital Response Devices for supply to
Ostex pursuant to Section 4.5. Metrika shall, during the Term, in good faith,
diligently attempt to extend the Shelf-Life of the NTx/Digital Response, with
the objective of achieving a Shelf-Life of no less than XXXXX months by the time
the NTx/Digital Response Device receives 510 (k) clearance and the goal of
continuously extending the Shelf-Life to not less than XXXXX months. Metrika
will generate and document data to support Shelf-Life extensions in accordance
with FDA regulatory requirements including QSR. Metrika shall notify Ostex in
writing within thirty (30) days of achieving any extension of Shelf-Life and
will provide Ostex with any supporting data and documentation therefor.
4.2 THIRD-PARTY MANUFACTURING ON BEHALF OF METRIKA. Metrika
shall have the right to appoint a third party manufacturer(s) to conduct strip
manufacturing, final assembly, and/or quality control of the NTx/Digital
Response Device, provided that Metrika shall promptly notify Ostex in writing of
any such appointment(s). In the event that Metrika licenses a third party to
manufacture NTx/Digital Response Devices to be supplied to Ostex under this
Agreement, Metrika shall ensure and provide evidence to Ostex demonstrating that
such third-party manufacturer complies with QSR and all
applicable governmental regulations relating thereto and is in
compliance with the quality standards established by the International Standards
Organization, Rules 9002 and amendments or successors thereto ('ISO 9000') or
warrants that it will comply with such standards when legally required to do so.
4.3 PRODUCT WARRANT; QUALITY CONTROL. Metrika warrants to
Ostex that all NTx/Digital Response Devices sold by Metrika to Ostex hereunder
shall (i) comply with the Specifications when used in accordance with applicable
Metrika instructions, as may be modified by mutual agreement of the parties,
(ii) be free from defects in material and workmanship, and (iii) comply with all
applicable laws, rules and regulations related to the manufacture and
distribution of such product (to the extent applicable to a manufacturer).
Without limiting the generality of the foregoing, Metrika warrants that all
NTx/Digital Response Devices manufactured and supplied for the United States
market under this Agreement shall be manufactured, tested, documented, packaged,
and transported in compliance with QSR and that all NTx/Digital Response Devices
manufactured and supplied under this Agreement, regardless of intended market,
shall be manufactured, tested, documented, packaged and transported in
compliance with appropriate quality assurance requirements agreed to by the
parties. Ostex shall have the right to audit and inspect Metrika facilities,
books, and records, during normal business hours and upon reasonable notice to
Metrika, but only to the extent reasonably necessary to confirm such compliance,
and only in good faith. Metrika further represents that it is working toward
compliance with the quality standards established by ISO 9000 and warrants that
it will comply with such standards when legally required to do so. In the event
that Ostex demonstrates that any NTx/Digital Response Device supplied pursuant
to this Agreement fails to meet these specifications and warranties during the
Shelf-Life of such NTx/Digital Response Device, Metrika shall, as Ostex's sole
remedy for such failure, immediately replace said product (demonstrated by Ostex
as non-conforming, in accordance with reasonable procedures), with product which
conforms to the above specifications and warranties. These warranties shall not
apply to any item that is subjected to abuse, stress, or misuse, or used in any
manner inconsistent with applicable Metrika instructions.
4.4 CRITICAL REAGENTS FOR MANUFACTURING NTX/DIGITAL RESPONSE
DEVICE. Ostex shall supply to Metrika (or such manufacturer(s) as Metrika shall
designate), and Metrika (or said manufacturer(s)) shall purchase from Ostex,
Metrika's (or said manufacturer's) requirements for Critical Reagents for the
purpose of manufacturing the NTx/Digital Response Device pursuant to the terms
and conditions of this Agreement.
4.4.1 FORECAST OF DEMAND. Within sixty (60) days of
the start of each calendar
quarter, Metrika or its designated manufacturer(s) shall deliver to Ostex a
'rolling' forecast of quantities of Critical Reagents to be purchased by Metrika
and its designated manufacturer(s) and supplied by Ostex during the following
quarter, and each of the subsequent three quarters (the 'Rolling Forecast').
Each Rolling Forecast shall be considered a purchase order with respect to the
forecasted demand for Critical Reagents over the first three (3) months thereof.
The forecasted demand for the remaining three quarters of each Rolling Forecast
shall be used by Ostex for planning purposes, but shall not be binding on
Metrika and its designated manufacturer(s).
4.4.2 FAILURE TO SUPPLY. In the event that Ostex
does not meet the demand for Critical Reagents ordered pursuant to Section,
4.4.1, excepting a suspension of further shipment pursuant to Section 4.4.4, in
addition to all other rights available hereunder, Metrika shall be relieved of
all supply obligations to Ostex of NTx/Digital Response Devices hereunder until
Ostex is able to supply Metrika's, or its designated manufacturer's, demand for
Critical Reagents.
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
4.4.3 PRICE. Metrika or its designated
manufacturer(s) shall pay Ostex a non-royalty transfer price for Critical
Reagents ('Transfer Price'). All Critical Reagents, excluding the FDA cleared,
96 well Osteomark Laboratory Test Kit manufactured by Ostex, will have a
Transfer Price equal to (i) XXXXX; or (ii) XXXXXXXXXXX; or
(iii) some other mutually agreed upon Transfer Price. Ostex shall maintain
accurate books and records with respect to the calculation of XXXXX the Critical
Reagents supplied to Metrika hereunder for a period of three (3) years. Upon the
request of Metrika, Ostex will provide access to an independent public
accountant designated by Metrika, but no more than once per calendar year,
during regular business hours and upon reasonable advance prior notice, to all
accounting records necessary or appropriate to verify XXXXX for Critical
Reagents supplied to Metrika hereunder. Any adjustment determined appropriate by
such audit shall be due and payable within thirty (30) days following completion
of such audit, together with interest calculated at a rate equal to the prime
lending rate reported in the Wall Street Journal for the last day of the audited
period plus two percent (+2%), or the maximum interest rate then permitted under
applicable laws, whichever rate is lower. All costs for such audits shall be
borne by Metrika unless the audit shows an over charge of XXXXX or more, in
which case the costs of said audit shall be borne by Ostex. The Transfer Price
for the FDA cleared, 96 well Osteomark Laboratory Test Kit manufactured by Ostex
shall be XXXXX each.
4.4.4 PAYMENT. Payment for each shipment of
Critical Reagents shall be made by Metrika or its designated
manufacturer(s) within thirty (30) days of the date of invoice, it being agreed
that such invoice shall not be dated prior to shipment of the Critical Reagents
to which such invoice relates. In the event that
Metrika or its designated manufacturer(s) fails to comply with the payment terms
of this Section 4.4.4, Ostex shall have the right, in addition to all other
rights available under this Agreement, to (i) suspend further shipment of
Critical Reagents until such breach is cured or (ii) with Metrika's written
approval, offset amounts owed by Ostex to Metrika for the NTx/Digital Response
Device invoiced pursuant to Section 4.5.6 with the amount owed under this
Section 4.4.4.
4.4.5 ACTIONS REQUIRING OSTEX'S PRIOR
WRITTEN CONSENT. Metrika shall not, without Ostex's prior written consent,
which consent may be withheld at Ostex's sole discretion, manufacture or use any
Critical Reagent to the extent such Critical Reagents are proprietary to Ostex.
4.4.6 THIRD-PARTY MANUFACTURING ON BEHALF OF
OSTEX. In the event that Ostex contracts with a third party to manufacture
Critical Reagents to be supplied under this Agreement, Ostex shall ensure and
provide evidence to Metrika demonstrating that
such third-party manufacturer complies with QSR and all applicable governmental
regulations relating thereto and is in compliance with the quality standards
established by the International Standards Organization, Rules 9002 and
amendments or successors thereto ('ISO 9000') or warrants that it will comply
with such standards when legally required to do so.
4.4.7 PRODUCT WARRANTY; QUALITY
CONTROL. Ostex warrants to Metrika and its designated manufacturer(s) that
all Critical Reagents sold by Ostex or its contract manufacturer hereunder shall
(i) comply with the specifications therefor attached hereto as EXHIBIT C and
amendments thereto as mutually agreed upon by the parties, (ii) be free from
defects in material and workmanship, and (iii) comply with all applicable laws,
rules and regulations related to the manufacture and distribution of such
product (to the extent applicable to a manufacturer). Without limiting the
generality of the foregoing, Ostex warrants that all Critical Reagents
manufactured and supplied to Metrika and its designated manufacturer under this
Agreement shall be manufactured, tested, documented, packaged, and transported
in compliance with QSR by the 510(k) clearance date; and that all Critical
Reagents manufactured and supplied under this Agreement, shall be manufactured,
tested, documented, packaged and transported in compliance with Metrika's
reasonable quality assurance requirements. Metrika shall have the right to audit
and inspect Ostex facilities, books, and records to confirm such compliance.
Ostex further represents that it is working toward compliance with the
quality standards established by ISO 9000 and warrants that it will comply with
such standards when legally required to do so. In the event that Metrika or its
designated manufacturer(s) demonstrates within one year of receipt that any
Critical Reagent supplied pursuant to this Agreement fails to meet these
specifications and warranties, Ostex shall, as Metrika's sole remedy for such
failure, immediately replace said product (demonstrated by Metrika or its
designated manufacturer(s) as non-conforming, in accordance with reasonable
procedures), with product which conforms to the above specifications and
warranties. These warranties shall not apply to any item that is subjected to
abuse, stress, or misuse, or used in any manner inconsistent with applicable
Ostex instructions.
4.4.8 DELIVERY. All Critical Reagents
purchased under this Agreement shall be shipped to the location set forth
in the purchase order therefor, F.O.B. Origin. All freight and insurance shall
be paid by Metrika. Title and risk of loss passes to Metrika when the Product
leaves Ostex's or its third party's manufacturing facility. Metrika shall be
solely responsible for the payment of all freight and insurance and other costs,
expenses, fees, duties, imports and charges of whatever kind in nature arising
from the shipment, delivery or importation of the Critical Reagents to Metrika's
place of manufacture. Metrika shall solely be responsible for taking all actions
necessary to obtain clearance to import the Critical Reagents to Metrika's place
of manufacture and Metrika warrants that it will comply in all respects with any
applicable export restrictions for the Critical Reagents.
4.4.9 INVENTORY. At all times during the Term
of this Agreement, Ostex shall supply and keep sufficient inventory of
Critical Reagents to carry out reasonable demand or orders for the NTx/Digital
Response Device(s) without undue delay.
4.5 SUPPLY OF NTX/DIGITAL RESPONSE DEVICE. Subject to the
terms and conditions of this Agreement, Metrika shall supply, and Ostex shall
purchase from
Metrika (or its designated manufacturer), all of Ostex's
requirements for NTx/Digital Response Devices for sale in the Territory in the
Field of Use hereunder.
4.5.1 MINIMUMS. Commencing from the receipt of 510(k)
clearance of the NTx/Digital Response device, Ostex shall be obligated to
purchase from Metrika minimum quantities of NTx/Digital Response Devices per
month, or such quantity per quarter equal to the sum of the quantities required
for 3 individual months ('Minimum Volumes') in accordance with the chart
attached hereto as EXHIBIT D; provided, however, Ostex shall not be required to
purchase the Minimum Volumes applicable for a month if, during such month: (A)
the NTx/Digital Response Device does not have either: (i) the required CLIA
Waiver status; or (ii) the required Shelf-Life as set forth in EXHIBIT D; or (B)
supplies of the NTx/Digital Response Device are not timely delivered by Metrika
or its designated manufacturer to Ostex in accordance with this Agreement,
unless such failure by Metrika or its designated manufacturer to supply
NTx/Digital Response Devices to Ostex results from the failure of Ostex or its
designated manufacturer to timely supply Critical Reagents to Metrika in
accordance with this Agreement; or (C) the NTx/Digital Response Device does not
meet the Specifications in Exhibit A, unless such non-conformance of the
NTx/Digital Response Device to the Specifications is due to the non-conformance
of any of the Critical Reagents used in the manufacture or quality control of
the NTx/Digital Response Device to the specifications for Critical Reagents in
Exhibit C.
4.5.2 FORECAST OF DEMAND. Within sixty (60)
days of the start of each calendar quarter, Ostex shall deliver to Metrika
a rolling forecast, by quarters, of the quantities of the NTx/Digital Response
Device for which Ostex expects to submit purchase orders during the subsequent
four quarters (the 'Rolling Forecast'). Ostex shall be obligated to submit
purchase orders for NTx/Digital Response Devices in accordance with the
quantities corresponding to the first quarter of each Rolling Forecast. The
quantities forecasted for the remaining period of each Rolling Forecast shall be
used by Metrika for planning purposes and shall not be binding on Ostex.
4.5.3 ORDER AND ACCEPTANCE. All orders for the
NTx/Digital Response Device shall be by means of signed written purchase
orders by Ostex to Metrika, sent to Metrika at Metrika's address for notice
hereunder specifying the required quantity and delivery address, and requesting
a delivery date not less than sixty (60) days after Metrika's receipt of such
purchase order. Orders may initially be placed by telephone or telecopy;
PROVIDED, HOWEVER, that a signed confirming purchase order is received in
writing (which may include telecopy transmission) by Metrika. Notwithstanding
anything herein to the contrary, no order shall be binding upon Metrika until
accepted by Metrika in writing. Each party may cancel or reschedule purchase
orders only with prior written approval of the other party.
4.5.4 DELIVERY. NTx/Digital Response Devices
shall be delivered on the date specified in the purchase orders hereunder.
Metrika agrees to deliver NTx/Digital Response Devices no later than two (2)
months after its date of manufacture.
All NTx/Digital Response Devices delivered pursuant
to the terms of this Agreement shall be delivered pre-labeled and packaged
in a product box with a dropper and package insert. Metrika shall provide
NTx/Digital Response Devices, foil pouched and labeled with a single-color laser
printed label, and one dropper sealed in each pouch. Ostex shall provide the
product box, package insert and all other labels ('Packaging Materials') for
Metrika's use in packaging the NTx/Digital Response Device as described
hereunder. Metrika shall suitably pack the NTx/Digital Response Device for
shipment by surface or air, at Ostex's discretion, in Metrika's standard
shipping cartons. Metrika shall ship the NTx/Digital Response Device to Ostex
using the carrier specified in the purchase order; PROVIDED, HOWEVER, that if
Ostex does not provide instructions with respect to the carrier to be used,
Metrika shall select the carrier. The NTx/Digital Response Device shall be
shipped F.O.B. Metrika's manufacturing facility in Sunnyvale, California. All
freight and insurance shall be paid by Ostex. Title and risk of loss passes to
Ostex when the Product leaves Metrika's manufacturing facility. Ostex shall be
solely responsible for the payment of all freight and insurance and other costs,
expenses, fees, duties, imports and charges of whatever kind in nature arising
from the shipment, delivery or importation of the NTx/Digital Response Device
into the Territory. Ostex shall solely be responsible for taking all actions
necessary to obtain clearance to import the NTx/Digital Response Device into and
throughout the Territory and Ostex warrants that it will comply in all respects
with any applicable export restrictions for the NTx/Digital Response Device. The
Parties will work together in the event of supply problems to ensure customers
do not switch to alternative products.
4.5.5 INVOICING. Metrika shall submit an
invoice, packing list and airway xxxx to Ostex upon each shipment of the
NTx/Digital Response Device ordered by Ostex. All invoices and other shipping
documents shall be sent first by fax, followed by business mail to Ostex's
address for notices hereunder, without regard to the actual shipping address.
Each such invoice shall state Ostex's aggregate and unit invoice price for the
NTx/Digital Response Device in a given shipment.
4.5.6 PRICING AND PAYMENT. The transfer price
for each unit of NTx/Digital Response Device hereunder shall be as set
forth in EXHIBIT D hereto. Ostex shall make all payments under the Agreement to
Metrika in United States dollars as directed by Metrika within thirty (30) days
after the receipt by Ostex of the invoice.
5. COMMERCIALIZATION AND DISTRIBUTION.
5.1 COMMERCIALIZATION AND DISTRIBUTION SALES. Subject to the
terms and conditions of this Agreement, Ostex shall have the exclusive (as
defined in Section 5.2.1 hereto) right to market, promote, have marketed and
promoted, sell, have sold, distribute and have distributed the NTx/Digital
Response Device throughout the Territory within the Field of Use. Subject to
Section 5.2.2, Ostex agrees to use its best efforts to market and sell the
NTx/Digital Response Device in the Territory in the Field of Use; provided,
however, the parties acknowledge that prior to the Effective Date, Ostex has
granted to Mochida Pharmaceutical Company, Ltd. ('Mochida') exclusive rights to
commercialize
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
the NTx Assay Technology in Japan, and therefore Ostex shall not have the right
to promote, market and sell the NTx/ Digital Response Device in Japan without
the prior agreement of Mochida, provided, however, that Ostex agrees to use its
reasonable commercial efforts to obtain rights from Mochida for the promotion,
marketing and sale of the NTx/Digital Response Device in Japan or have Mochida
distribute the NTx/Digital Response Device in Japan. Ostex shall have the right
to appoint subdistributors for the NTx/Digital Response Device
('Subdistributors').
5.2 EXCLUSIVITY.
5.2.1 During the Term of this Agreement, Metrika
shall not itself market or sell, or
grant rights to third parties to market or sell, the NTx/Digital Response Device
or any other Digital Response Device that measures XXXXXXX that will compete
with the NTx/Digital Response Device.
5.2.2 The parties acknowledge that Ostex has
disclosed to Metrika that prior to the
Effective Date, Ostex has entered into an agreement with (i) Hologic, Inc. dated
January 14, 1997, whereby Ostex will be marketing and selling a Serex developed
device containing the NTx Assay Technology ('Serex Device') and (ii) Xxxxxxx and
Xxxxxxx Clinical Diagnostics, Inc. ('JJCD') dated June 7, 1995, whereby JJCD has
(a) rights to manufacture and market an over-the-counter and/or POC devices
incorporating the NTx Assay Technology, (b) rights to incorporate the NTx Assay
Technology into JJCD's laboratory based clinical analyzer , and (c) rights to
sell Ostex's Osteomark microtiter plate assay product . Ostex hereby agrees that
during the Term of this Agreement, other than the Serex Device and the JJCD
over-the-counter or POC products, it will not itself market or sell, or grant
rights to third parties to market or sell, in the Territory (except Japan) any
other XXXXXXXXXXXXXXX device containing the NTx Assay Technology, XXXXXXXXX,
other than the NTx/Digital Response Device.
5.3 OPTION TO OSTEX. Metrika hereby grants to Ostex an
exclusive option to negotiate and enter into an agreement with Metrika for the
worldwide, exclusive distribution rights to a Digital Response Device measuring
XXXXXXX, which option may be exercised during the period commencing from the
Effective Date and expiring XXXXXXX ('Option Period'); provided, however, any
obligations and rights of the parties pursuant to this Section 5.3 shall be
extinguished if the parties have not entered into a definitive agreement within
one (1) month after the expiration of the Option Period.
5.4 OVER-THE-COUNTER APPLICATIONS. If Ostex signs an agreement
with a company to assist Ostex in the marketing of the NTx/Digital Response
Device to the over-the-counter market, and that agreement includes an up-front
payment to Ostex, Metrika will receive XXXXX payment received by Ostex and XXXXX
given in consideration for such over-the-counter marketing rights. Metrika's
portion of such payments or fees will be calculated based on the amount
remaining from such payments or fees after Ostex has paid WRF such compensation
that it is entitled to as described in the WRF/Ostex Exclusive License
Agreement. Fees shall include any royalty, license, option, and milestone fees
paid for the marketing rights described herein, but shall not include
non-monetary consideration, such as payment by the company of clinical,
regulatory, or packaging costs incurred by Ostex for adaptation of the
NTx/Digital Response Device for the over-the-counter market. Ostex agrees to
inform Metrika of all discussions, negotiations and subsequent deals with any
over-the-counter partners.
5.5 REPRESENTATIONS TO CUSTOMERS. Ostex shall not incur any
liability on behalf of Metrika, nor describe or hold itself out as an employee
or representative of Metrika, nor make any claims, warranties or representations
with respect to the NTx/Digital Response Device except as previously approved in
writing by Metrika.
5.6 SERIOUS INJURY. Each party shall, within twenty-four
hours, advise the other by telephone, (with follow-up hard copy, receipt
confirmed) of any adverse effect or malfunction related to the NTx/Digital
Response Devices or the Critical Reagents of which the notifying party gains
knowledge during the Term of this Agreement that may have caused or contributed
to, or should it reoccur is likely to cause or contribute to, serious injury,
illness, or death. The notifying party shall include in the notification the
name, address, and telephone number of the person or entity purchasing the
product in question, the name, address, and telephone of the patient (if
different), and the lot or serial number of the Critical Reagents or NTx/Digital
Response Device involved in the incident, as appropriate.
5.7 PRODUCT RECALL. If either party believes that a recall of
the NTx/Digital Response Device is necessary or appropriate, it will promptly
notify the other, and the parties will (unless such recall is required by law)
discuss whether such recall is necessary or appropriate, and shall discuss the
manner in which any agreed or required recall shall be conducted. If a recall is
not required by law and the parties cannot agree whether the recall is necessary
or appropriate, either party may elect to conduct the recall in question. The
parties shall cooperate with each other in conducting any such recall. All out
of pocket costs of a required or agreed recall shall be shared equally by the
parties, unless and to the extent that such recall is the result of a breach of
the warranties hereunder by one party, in which case such costs shall be borne
by the breaching party. All costs of a recall to which the parties have not
agreed shall be borne by the party that elects to conduct the recall, provided
that if a court of competent jurisdiction determines that said recall was caused
by (i) the fact that any Critical Reagents are in violation of applicable law or
the terms of this Agreement, or any error, defect or misrepresentation in the
Packaging Material, then the costs and expenses of such recall as well as any
reasonable attorneys' fees related to such determination shall be borne by
Ostex, or (ii) the fact that any NTx/Digital Response Device as supplied by
Metrika is in violation of applicable law or the terms of this Agreement other
than for reasons set forth in (i) above, then the costs and expenses of such
recall as well as any reasonable attorneys' fees related to such determination
shall be borne by Metrika. Each party shall maintain complete and accurate
records of all products manufactured or sold by it for such periods as required
by law. Nothing in this Section 5.7 shall be construed to modify or limit any
legal obligation of either party with respect to any recall.
5.8 CORRECTIVE ACTION. If any government agency with
jurisdiction shall request or order any corrective action with respect to any
Critical Reagent, or NTx/Digital Response Devices, including but not limited to
any recall, customer notice, restriction, change, market action, or modification
of the product in question, and the cause or basis for such corrective action is
primarily attributable to a condition, fact, or action that constitutes a breach
by a party of any of its warranties, representations or covenants contained
herein, then such party shall be liable for and shall reimburse the other party
for all costs incurred as a result of such action, including replacement cost of
any product affected thereby.
6. TRANSFER OF STOCK. On the Effective Date, Ostex shall assign and
transfer to Metrika 40,000 shares of Metrika stock in accordance with the terms
and conditions of the Stock Transfer Agreement by and between the parties of
even date herewith. In addition, Ostex agrees to fully vest and register under
applicable securities laws the 70,633 shares of Ostex stock owned by Metrika as
of the effective date on the earlier of: (i) the date CLIA Waiver is obtained
for the NTx/Digital Response Device or (ii) two (2) years from April 10, 1997 in
accordance with the terms and conditions of the Amendment No. 1 to the Stock
Purchase Agreement by and between the parties of even date herewith.
7. STANDOFF PERIOD. In the event that Metrika makes an initial public
offering of Metrika stock ('IPO'), Ostex acknowledges that pursuant to that
certain Fourth Amended and Restated Investor's Rights Agreement dated May 7,
1998, among Metrika, Ostex and certain other shareholders of Metrika named
therein, Ostex has agreed to a 180 day standoff period beginning on the
effective date of the IPO before Ostex sells any shares of Metrika stock,
provided that the underwriters of such IPO request such a standoff period of all
such shareholders.
8. OWNERSHIP OF DISCOVERIES. It is the intent of the parties that the
ownership of any and all Discoveries resulting from this Agreement, regardless
of inventorship, shall: (a) vest solely in Ostex if such rights relate
exclusively to the NTx Assay Technology; (b) vest solely in Metrika if such
rights relate exclusively to the MODM Technology and/or the Digital Response
Device; and (c) in all other cases vest in the party or parties of the inventor.
9. CONFIDENTIALITY.
9.1. OBLIGATION NOT TO DISCLOSE CONFIDENTIAL INFORMATION.
Recipient shall not at any time, and shall cause its permitted assigns and
sublicensees to commit not to at any time for a period of seven (7) years
following the termination of this Agreement, disclose or otherwise make known or
available to any person, firm, corporation, or other entity other than Discloser
any Confidential Information received from the Discloser without the express
prior written consent of that Discloser. With respect to Confidential
Information developed under this Agreement and which is not Confidential
Information of one party only, neither party shall disclose or otherwise make
such Confidential Information known or available to any person, firm,
corporation, or other entity without the express prior written consent of the
other party, not to be unreasonably withheld or delayed. Recipient shall utilize
reasonable procedures to safeguard Confidential Information, including releasing
Confidential Information only to those employees and legal representatives to
whom disclosure is necessary or appropriate for the Recipient to undertake its
responsibility pursuant to this Agreement. Notwithstanding the above, Recipient
may disclose Confidential Information of Discloser to (i) its legal
representatives, prospective investors, (so long a such disclosure of
Confidential Information is limited to the existence of this Agreement and its
basic terms and conditions), permitted assigns and contract manufacturers under
conditions as to assure the confidential treatment thereof by such persons, and
(ii) as required by law or to comply with applicable governmental regulations or
court orders.
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
9.2 RECIPIENT'S OWN USE OF CONFIDENTIAL INFORMATION. Recipient
shall not make any use, directly or indirectly, of any Confidential Information
of the Discloser except in the ordinary course of business pursuant to this
Agreement or any other specific, written agreement entered into between Ostex
and Metrika.
9.3 SPECIFIC PERFORMANCE. The parties acknowledge that: (a)
the covenants set forth in this Section 9 are essential to the activities
contemplated by this Agreement; (b) but for the agreement of each party to
comply with such covenants, neither party would have entered into such
activities; (c) each party has consulted with or has had the opportunity to
consult with counsel and has been advised in all respects concerning the
reasonableness of such covenants as to time and scope; (d) Discloser may have no
adequate remedy at law if Recipient violates or fails to perform under this
Section 9; and (e) Discloser shall have the right, in addition to any other
rights it may have, to seek from a court of competent jurisdiction preliminary
and permanent injunctive relief to restrain any breach or threatened breach or
otherwise to specifically enforce Recipient's obligations under this Section 9
if Recipient fails to perform in accordance herewith.
10. TERM AND TERMINATION.
10.1 INITIAL LICENSE TERM. This Agreement shall be in full
force and effect commencing on the Effective Date and, unless earlier terminated
in accordance with this Section 10, shall remain in effect for XXXXX after CLIA
Waiver is received (the 'Initial Term'); provided, however, on XXXXX after CLIA
Waiver, if requested by a party, the parties agree to negotiate in good faith a
renewal term of this Agreement ('Renewal Term'), under terms that are mutually
agreed upon by both parties. The Initial Term and any Renewal Term shall be
collectively referred to as 'Term'.
10.2 TERMINATION FOR BREACH. Except for termination by Ostex
pursuant to Section 3.2, in the event either party shall have materially
breached or defaulted in the performance of a material obligation hereunder, the
non-breaching party may terminate this Agreement by written notice to the
breaching party stating in reasonable detail the alleged breach and its intent
to terminate this Agreement if such breach is not cured within forty-five (45)
days from the receipt of such notice by the breaching party. This Agreement
shall terminate if such material breach is not cured by the breaching party
within such forty-five (45) day period. Without limiting the generality of the
foregoing, a 'material breach' or 'failure to perform' shall include without
limitation, any material failure to remit payments, or failure to comply with
any financial reporting requirement, or material failure to maintain Ostex's
rights pursuant to the WRF/Ostex Exclusive License Agreement.
10.3 BANKRUPTCY OF A PARTY. Either party may terminate this
Agreement and the rights granted hereunder, effective upon giving written notice
of such termination to the other party, if such other party enters into any
proceeding, whether voluntary or otherwise, in bankruptcy, reorganization, or
arrangement for the appointment of a receiver or trustee to take possession of
such other party's assets or any other proceeding under any law for the relief
of creditors, or makes an assignment for the benefit of creditors.
10.4 RIGHTS AND DUTIES UPON TERMINATION.
10.4.1 PAYMENTS. Upon termination of this
Agreement, each party shall pay to the other all payments that are due and
have accrued and are outstanding as of the date of termination.
10.4.2 RETURN OF MATERIALS. Within thirty
(30) days following termination of this Agreement, each party having
possession of or control over any Confidential Information of the other party
shall return to such other party all written and otherwise recorded or stored
matter containing such Confidential Information, including all original matter
and all copies thereof; provided, however, that each party's legal department or
outside counsel may retain one copy of the Confidential Information in its
confidentially maintained files, solely for the purpose of identifying
information to be protected pursuant to any applicable non-disclosure
obligation.
10.4.3 NTX/DIGITAL RESPONSE DEVICES REMAINING.
Upon termination of this Agreement, Ostex shall have the right to sell
NTx/Digital Response Devices then remaining in its possession within a
reasonable time after termination hereof.
10.4.4 SURVIVAL OF TERMS. Notwithstanding any
other provision herein to the contrary,
Sections 1, 4.3, , 4.4.7, 5.6, 5.7, 5.8, 6, 7, 8, 9, 10.4, 11, 13, 15, 16, 18
and 20 of this Agreement shall survive any termination or expiration hereof.
Except as set forth herein, all rights, duties and obligations of the parties
hereunder shall terminate upon the termination or expiration of this Agreement.
10.4.5 EFFECT OF DISPUTED BREACH. In the
event of any disputed breach under this
Agreement, except for termination by Ostex pursuant to Section 3.2, running of
the time period in which a party must cure a breach of this Agreement shall be
suspended as to the matter of the dispute pending an arbitration decision that a
breach has in fact occurred; PROVIDED that during such suspension, one hundred
fifty percent (150%) of any amount in dispute shall be placed into an
interest-bearing escrow account, and upon resolution of the dispute, the
substantially prevailing party shall be entitled to be paid (1) the disputed
amount, plus (2) interest thereon during the suspension at the rate of ten
percent (10%) per annum, plus (3) its attorneys' fees relating to the dispute.
11. REPRESENTATIONS. WARRANTIES AND INDEMNITIES.
11.1 BY OSTEX. Ostex represents and warrants to Metrika as
follows:
11.1.1 ORGANIZATION AND AUTHORITY. As of the
Effective Date of the Agreement, Ostex is
a corporation duly organized, validly existing and in good standing under the
laws of the State of Washington, USA, has all requisite corporate power and
authority to carry on its business and perform its obligations hereunder, and is
duly qualified to do business in any of those
jurisdictions in the United States of
America where failure to qualify could have a material adverse effect on its
ability to perform its obligations hereunder. The execution and delivery of this
Agreement by Ostex, and the performance of the obligations of Ostex contemplated
hereby, have been duly and validly authorized by all necessary legal action on
its part, and this Agreement is legal, valid and binding against Ostex in
accordance with its terms. Except as have been or will be obtained by Ostex, no
permit, consent, approval or authorization of; or declaration to or filing with,
any person, party or governmental or regulatory authority of the United States
is required in connection with the delivery, consummation and/or performance by
Ostex of this Agreement.
11.1.2 OSTEX PATENT RIGHTS AND OSTEX KNOW-HOW.
During the Term: (a) Ostex will either
have or will procure (including taking any required licenses under third party
Intellectual Property Rights at its sole expense, including any necessary
royalty payments) all rights necessary for Metrika to enjoy the rights to Ostex
Intellectual Property Rights granted in Section 2.1; (b) Ostex will take all
necessary actions to maintain all Ostex Patent Rights commensurate with the
license grant in Section 2.1 in full force and effect, and (c) Ostex will
maintain the WRF/Ostex Exclusive License Agreement in full force and effect and
will be responsible for any and all license fees and royalties payable to WRF
thereunder.
11.1.3 NO DEFAULT. The execution, delivery and
performance of this Agreement by Ostex
does not and shall not conflict with, result in a breach of; or constitute a
default under (with or without the giving of notice, or the passage of time, or
both), any agreement or instrument to which Ostex is a party or by which it is
bound.
11.1.4 OSTEX'S DISCLAIMER OF OTHER WARRANTIES.
Ostex disclaims all implied warranties, including without limitation any
warranty of merchantability or fitness for a particular purpose.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, OSTEX MAKES NO REPRESENTATIONS
AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING NO
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
11.2 BY METRIKA. Metrika represents and warrants to
Ostex as follows:
11.2.1 ORGANIZATION AND AUTHORITY. As of the
Effective Date of the Agreement, Metrika
is duly organized, validly existing and in good standing under the laws of
California, USA and has all requisite power and authority to carry on its
business and the performance of its obligations hereunder, and is duly qualified
to do business in any of those jurisdictions where failure to qualify could have
a material adverse effect on its ability to perform its obligations hereunder.
The execution and delivery of this Agreement by Metrika, and the performance of
the obligations contemplated hereby, have been duly and validly authorized by
all necessary legal action on its part, and this Agreement is legal, valid and
binding against Metrika in accordance with its terms. Except as have been or
will be obtained by Metrika, no permit, consent, approval or authorization of;
or declaration to or filing with, any person, party or governmental or
regulatory authority having jurisdiction is required in connection with the
delivery, consummation and/or performance of this Agreement.
11.2.2 METRIKA PATENT RIGHTS. During the Term:
(a) Metrika will either have or will
procure (including taking any required licenses under third party Intellectual
Property Rights at its sole expense, including any necessary royalty payments)
all rights necessary for Ostex to enjoy the rights to Metrika Patent Rights
granted in Section 2.2; and (b) Metrika will take all necessary actions to
maintain all Metrika Patent Rights commensurate with the license grant in
Section 2.2 in full force and effect.
11.2.3 NO DEFAULT. The execution, delivery and
performance of this Agreement by Metrika
does not and shall not conflict with, result in a breach of; or constitute a
default under (with or without the giving of notice, or the passage of time, or
both), any agreement or instrument to which Metrika is a party or by which it is
bound.
11.2.4 METRIKA'S DISCLAIMER OF OTHER
WARRANTIES. Metrika disclaims all implied warranties, including without
limitation any warranty of merchantability or fitness for a particular purpose.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, OSTEX MAKES NO REPRESENTATIONS
AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING NO
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
11.3 U.S. FOREIGN CORRUPT PRACTICES ACT. Each party shall
indemnify, defend and hold the other party, its subsidiaries and Affiliates, and
the directors, officers, employees and agents of any of them, harmless from and
against all and any claims, proceedings, losses, fines, expenses (including
without limitation reasonable attorneys fees and expenses) and penalties
incurred by said party arising out of any Prohibited Practice committed by said
party or any of its officers, directors, shareholders, employees, or agents.
For purposes of this Section 11.3, the following shall be deemed a
'Prohibited Practice'; the offer, payment, promise to pay, or authorization of
the paying of any money, or the offer, giving, promise to give or authorization
of the giving of anything of value to any officer or employee of any government
or any department, agency or instrumentality thereof; or any person acting in an
official capacity for or on behalf of any such government, department, agency or
instrumentality, or any political party or official thereof; or any candidate
for political office, or any intermediary for any such persons or party, in each
case for purposes of (a) influencing any act or decision of any such persons or
party in their or its official capacity, or (b) inducing any such person or
party to do or omit to do any act in violation of the lawful duty of such person
or party, or (c) inducing any such person or party to use their or its influence
with any government or instrumentality thereof to affect or influence any act or
decision of any such government or instrumentality, in each case (a), (b) and
(c) in order to assist the applicable party hereto in obtaining or retaining
business for, or with, or directing business to, any person or entity in
violation of the U.S. Foreign Corrupt Practices Act.
11.4 GOVERNMENTAL COMPLIANCE. Each party shall obtain
and maintain all required licenses, permits, certificates and
authorizations needed to perform its obligations under this Agreement for the
effectiveness of this Agreement in all
jurisdictions where said party operates, for the import and
for the export of the NTx/Digital Response Devices, and for the marketing,
distribution and Sale of the NTx/Digital Response Devices. Metrika will hold and
solely own all regulatory approvals for the NTx/Digital Response Device.
12. THIRD-PARTY INFRINGEMENT. If, during the Term of this Agreement,
either party becomes aware that one or more third parties are infringing or are
threatening to infringe the Ostex Patent Rights or the Metrika Patent Rights,
said party (the 'Notifying Party') shall immediately provide to the other party
all details in said party's knowledge or possession concerning the kind and
character of the infringement and any other pertinent information that said
party may have.
13. DEFENSE OF THIRD-PARTY CLAIMS.
13.1 METRIKA DEFENSE OF THIRD-PARTY CLAIMS AND INDEMNITY. To
the extent that any claim, suit, or other legal proceeding is threatened or
commenced against Ostex or WRF that is founded on an allegation that the Digital
Response Device or MODM Technology as incorporated into the NTx/Digital Response
Device infringes any trade secret, patent, or copyright belonging to a third
party, Ostex will give Metrika prompt written notice of such legal proceeding
and Metrika may elect to assume sole control of the defense to or settlement of
such dispute. Ostex shall cooperate fully with Metrika in any defense,
settlement or compromise made by Metrika. Ostex shall not enter into any
settlement agreement or other voluntary resolution of any such claim, suit, or
other legal proceeding without obtaining Metrika's prior written consent
thereto. If Ostex has complied fully with the procedures set forth in this
Section 13.1, Metrika will indemnify and hold Ostex and WRF harmless from and
against any loss, cost, damage, or other expenses, including reasonable
attorneys' fees, incurred by Ostex and WRF as a result of such claim, suit or
legal proceeding. If a final injunction is obtained against Ostex's marketing
and sale of the NTx/Digital Response Devices, or if in the opinion of Metrika
the subject NTx/Digital Response Devices are likely to become the subject of a
successful claim of infringement, Metrika may, at its option and expense, (i)
procure for Ostex the right to continue its performance under this Agreement,
(ii) replace or modify the NTx/Digital Response Devices so that they become
non-infringing, or (iii) if neither (i) or (ii) are reasonably available,
terminate this Agreement without further obligation or liability. This
indemnification provision shall not apply and Metrika shall have no liability to
the extent that the NTx/Digital Response Device has been modified or tampered
with in any way without the express written consent of Metrika, or if Ostex has
any interest in the claim, suit or other legal proceeding, or any license to any
right so asserted.
13.2 OSTEX DEFENSE OF THIRD-PARTY CLAIMS AND INDEMNITY. To the extent that any
claim, suit, or other legal proceeding is threatened or commenced against
Metrika that is founded on an allegation that the NTx Assay Technology or
Critical Reagents as used in the NTx/Digital Response Device or use of the
NTx/Digital Response Device specifically to assay NTx in urine, infringes any
trade secret, patent, or copyright belonging to a third
party, Metrika will give Ostex prompt written notice of such legal proceeding
and Ostex may elect to assume sole control of the defense to or settlement of
such dispute. Metrika shall cooperate fully with Ostex in any defense,
settlement or compromise made by Ostex. Metrika shall not enter into any
settlement agreement or other voluntary resolution of any such
claim, suit, or other legal proceeding without obtaining Ostex's prior written
consent thereto. If Metrika has complied fully with the procedures set forth in
this Section 13.2, Ostex will indemnify and hold Metrika harmless from and
against any loss, cost, damage, or other expenses including reasonable
attorneys' fees incurred by Metrika as a result of such claim, suit or legal
proceeding. If a final injunction is obtained against Metrika's use of the NTx
Assay Technology or Critical Reagents in the NTx/Digital Response Device, or if
in the opinion of Ostex the NTx Assay Technology or Critical Reagents are likely
to become the subject of a successful claim of infringement, Ostex may, at its
option and expense, (i) procure for Metrika the right to continue using the NTx
Assay Technology or Critical Reagents in accordance with terms of this
Agreement, (ii) replace or modify the NTx Assay Technology or Critical Reagents
so that it (they) becomes non-infringing, or (iii) if neither (i) or (ii) are
reasonably available, accept return of the Critical Reagents held by Metrika and
its designated manufacturer(s) in inventory, and terminate this Agreement
without further obligation or liability. This indemnification provision shall
not apply and Ostex shall have no liability to the extent that NTx Assay
Technology or Critical Reagents have been modified or tampered with in any way
without the express written consent of Ostex, or if Metrika has any interest in
the claim, suit or other legal proceeding, or any license to any right so
asserted.
13.3 SHARED DEFENSE OF THIRD-PARTY CLAIMS. With respect to any
claim, suit or other legal proceeding threatened or commenced against Metrika or
Ostex that is founded, in whole or in part, on an allegation that the
NTx/Digital Response Device infringes any trade secret, patent or copyright
belonging to a third party, which claim, suit or other legal proceeding is not
covered by the provisions of Section 13.1 or 13.2 above, the parties agree to
share control of the defense or settlement of such claim and shall share equally
all costs and liabilities resulting from such claim, suit or other legal
proceeding.
14. USE OF TRADEMARKS AND TRADE NAMES.
14.1 RESTRICTED RIGHTS TO USE. No provision of this Agreement
shall be interpreted or construed as conferring upon either party any right to
use in labeling, advertising, marketing, publicizing or otherwise promoting the
NTx/Digital Response Device, any name, trade name, trademark, or other
designation (or derivation thereof) of the other party hereto or WRF or the
University of Washington, except as expressly provided under this Section 14.
14.2 USE OF NAMES AND MARKS IN LABELING. The NTx/Digital
Response Device shall be sold under tradenames and/or trademarks selected by
Ostex; provided, however, that each NTx/Digital Response Device shall be labeled
with: (i) a Metrika trademark selected by Metrika ('Metrika Trademark') and (ii)
a statement identifying that such NTx/Digital Response Device was manufactured
by Metrika for exclusive distribution by Ostex ('Identifying Statement') both in
sizes and locations mutually agreeable to the parties. Metrika shall also have
the right to review and approve all claims relating to the intended use of
NTx/Digital Response Devices contained in
package inserts and other promotional materials, which
approval shall not be unreasonably withheld. Metrika hereby grants to Ostex a
non-transferable, non-exclusive license, concurrent with the Term of this
Agreement, to use such Identifying Statement and Metrika Trademark solely for
the purposes set forth herein. Neither party shall use any trademark of the
other party with respect to products not covered by this Agreement. Each party
shall have the right to review and approve the use of its marks in any proposed
product literature, advertising material or material for publication. In the
event that any action or proceeding is initiated against Metrika, Ostex, or any
other licensee or distributor of Ostex in any country alleging that any Metrika
Trademark infringes the trademark rights of the third party initiating such
action or proceeding, Ostex may continue to market NTx/Digital Response Devices
within such country without said Metrika Trademark affixed thereto (but with
such other trademark as Metrika may reasonably specify) pending resolution of
the dispute as to trademark rights.
14.3 TRADEMARK REGISTRATION. Ostex shall be responsible for
the registration, maintenance and enforcement of its own trade names and
trademarks for the NTx/Digital Response Product. Each party shall from time to
time, and in any event upon the issuance of additional registrations, modify its
use of trademarks to incorporate proper notice of registration and other claims
of right, in accordance with the laws and customs of the various countries in
which it operates pursuant to this Agreement.
15. ASSIGNMENT AND SUBLICENSE.
15.1 BY METRIKA. Except as specifically permitted by this
Agreement, Metrika shall not assign, sublicense, delegate, or in any other
manner transfer any of its rights, privileges, obligations or duties under this
Agreement to any third party without the prior written consent of Ostex, which
consent may be withheld in Ostex's sole and absolute discretion, provided that
this provision shall not apply to any merger, consolidation, or sale of
substantially all of the assets of Metrika, or any third-party acquisition of a
majority of the business interests or voting shares of Metrika, provided that
the surviving party shall within a reasonable period following the final closing
of such transaction, expressly agree in writing to be bound by this agreement.
Any attempt by Metrika to assign, sublicense, delegate or otherwise transfer any
right, privilege, obligation or duty under this Agreement other than in
accordance with this Section 15 shall be void and shall, at the option of Ostex,
be cause for immediate termination of this Agreement and all licenses granted
hereunder.
15.2 BY OSTEX. Except as specifically permitted by this
Agreement, Ostex shall not assign, sublicense, delegate, or in any other manner
transfer any of its rights, privileges, obligations or duties under this
Agreement to any third party without the prior written consent of Metrika, which
consent may be withheld in Metrika's sole and absolute discretion, provided that
this provision shall not apply to any merger, consolidation, or sale of
substantially all of the assets of Ostex, or any third-party acquisition of a
majority of the business interests or voting shares of Ostex, provided that the
surviving party shall within a reasonable period following the final closing of
such transaction, expressly agree in writing to be bound by this agreement. Any
attempt by Ostex to assign, sublicense, delegate or otherwise transfer any
right, privilege, obligation or duty under this Agreement other than in
accordance with this Section 15 shall be void and shall, at the option of
Metrika, be cause for immediate termination of this Agreement and all licenses
granted hereunder.
16. ARBITRATION.
16.1 AGREEMENT TO SETTLE DISPUTES BY ARBITRATION. At the
request through notice of either Ostex or Metrika, any controversy or claim
arising between the parties and related to or arising out of the construction,
interpretation, or enforcement of any term or condition of this Agreement or any
transaction hereunder (including the decision to enter into this Agreement),
which controversy or claim cannot first be settled amicably between the parties
(including without limitation through utilization of third-party mediation
agreed to by both parties), shall be submitted to arbitration. Such arbitration
shall be conducted in Seattle, Washington, if initiated by Metrika, or in San
Francisco, California, if initiated by Ostex, and in either case shall be
conducted in accordance with the applicable Rules of the American Arbitration
Association in effect on the date of such controversy or claim.
16.2 APPOINTMENT OF ARBITRATORS. Within thirty (30) days after
the delivery pursuant to Section 16.1 above of a notice of request for
arbitration, Metrika and Ostex shall each appoint one independent person as an
arbitrator to hear and determine the dispute. The two persons so chosen shall by
agreement select a third, impartial arbitrator, which selection shall be final
and conclusive upon both parties. Each arbitrator shall be experienced in
international and domestic manufacturing and distribution of products similar to
the NTx/Digital Response Device. If either party fails to designate its
arbitrator within sixty (60) days after the notice of arbitration is received,
then the arbitrator designated by the one party shall act as the sole arbitrator
and shall be deemed to be the single, mutually approved arbitrator to resolve
the dispute.
16.3 ARBITRATORS' POWERS. The arbitrators shall have all the
powers of a State or Federal Court located at the site of the arbitration,
including the power to order specific enforcement of this Agreement and to order
the production of relevant and non-privileged documents by one party for
inspection and duplication by the other party prior to the arbitration hearing;
provided, however, that the arbitrators shall be bound by this Agreement with
regard to the restriction on consequential, incidental, and punitive damages as
set forth in this Agreement.
16.4 DISCOVERY. The arbitrators prior to the hearing shall
grant discovery pursuant to the intendment of the Federal Rules of Civil
Procedure, and as the arbitrators determine to be appropriate under the
circumstances.
16.5 PROTECTIVE ORDER. In the event of arbitration and at the
request of either Ostex or Metrika, in order to protect Confidential Information
and any other matter that either party would normally not reveal to third
parties, the arbitrators shall enter a protective order in such form as the
parties shall stipulate or as the arbitrators shall determine is suitable. Among
other things, the protective order shall stipulate that the arbitrators
themselves shall receive any information designated by either party as
'confidential' solely for purposes of assessing the facts and law for purposes
of the arbitration, and shall not otherwise use or disclose such matter. At the
request of either
party, the protective order shall be entered as an award of
the arbitration panel and shall enable either party to obtain the assistance of
a court of competent jurisdiction to enter equitable decrees or other relief to
enforce the provisions of the order as if it had been entered by that court.
16.6 EFFECT OF DECISION. The decision of the arbitrators shall
state the reason for the award and shall be final, binding and conclusive upon
the parties. The parties shall comply with such decision in good faith as if it
were a final decision of a court. Judgment upon the award shall be entered in
any court of competent jurisdiction. Any award made in connection with any
arbitration shall be made in U.S. Dollars.
16.7 RIGHTS OF THIRD PARTIES. Notwithstanding the agreement to
arbitrate any dispute between Ostex and Metrika, in the event that a controversy
or claim between Ostex and Metrika involves an adjudication of the rights of a
third party, and that third party does not agree to submit to arbitration and
would under Rule 19(a) of the Federal Rules of Civil Procedure, if feasible, be
joined as an indispensable party, then the dispute shall be brought to, and
determined by, a court of the competent jurisdiction.
16.8 INTERIM RELIEF. Upon the application of either party to
this Agreement, and whether or not an arbitration, mediation or attempt to
settle amicably has yet been initiated, all courts having jurisdiction over one
or more of the parties are authorized to: (i) issue and enforce in any lawful
manner such temporary restraining orders, preliminary injunctions and other
interim measures of relief as may be necessary to prevent harm to a party's
interests or as otherwise may be appropriate pending the conclusion of
arbitration proceedings pursuant to this Agreement; and (ii) enter and enforce
in any lawful manner such judgments for permanent equitable relief as may be
necessary to prevent harm to a party's interests or as otherwise may be
appropriate following the issuance of arbitral awards pursuant to this
Agreement.
17. PUBLICITY. No party shall announce or publicize this Agreement or
any terms thereof without the advance written consent of the others (which
approval shall not be unreasonably withheld), provided that either party may
disclose the existence of this Agreement and such terms of this Agreement to its
prospective investors and as may be required by law or by regulations of any
governmental agency.
18. RESPONSIBILITY FOR CLAIMS. In order to distribute between
themselves the responsibility for the handling and expense of claims arising out
of the manufacture, distribution, Sale or use of NTx/Digital Response Devices,
the parties agree as follows:
18.1 OSTEX LIABILITY. Ostex shall defend, indemnify and hold
harmless Metrika against any liability or damages from any claims, suits,
proceedings, demands, recoveries or expenses ('Claims') to the extent that such
Claims arises from or is based upon: (i) defects in the NTx/Digital Response
Device to the extent that such defects are due to the Critical Reagents sold by
Ostex or NTx Assay Technology licensed by Ostex pursuant to this Agreement; or
(ii) product claims or selling efforts whether written or oral, made or alleged
to be made, by Ostex in its advertising, publicity, promotion, or
Sale of the NTx/Digital Response Device where such product
claims or selling efforts were not approved by Metrika; (iii) any breach by
Ostex of any of its representations or warranties contained herein; or (iv) any
negligent or intentionally wrongful acts or omissions on the part of Ostex or
its Subdistributors; provided that Metrika: (a) promptly notifies Ostex in
writing of any such Claim which comes to its attention; (b) allows Ostex to
control the defense or settlement of such Claim; (c) does not enter into any
settlement or compromise of such Claim without the express authorization of
Ostex; and (d) reasonably cooperates with Ostex in the defense of such Claim,
subject to Ostex's payment of all expenses associated with such cooperation by
Metrika. Metrika shall have the right to participate in a non-controlling
fashion in such legal proceeding at its sole expense.
18.2 METRIKA LIABILITY. Metrika shall be liable for and shall
indemnify and hold Ostex harmless against any liability or damages from any
Claims to the extent that such Claims arises from or is based upon: (i) defects
in the NTx/Digital Response Device (other than to the extent that such defects
are due to the Critical Reagents or NTx Assay Technology); or (ii) any breach by
Metrika of any of its representations or warranties contained herein or (iii)
any negligent or intentionally wrongful acts or omissions on the part of Metrika
or its designated manufacturer(s); provided that Ostex: (a) promptly notifies
Metrika in writing of any such Claim which comes to its attention; (b) allows
Metrika to control the defense or settlement of such Claim; (c) does not enter
into any settlement or compromise of such Claim without the express
authorization of Metrika; and (d) reasonably cooperates with Metrika in the
defense of such Claim, subject to Metrika's payment of all expenses associated
with such cooperation by Ostex. Ostex shall have the right to participate in a
non-controlling fashion in such legal proceeding at its sole expense.
18.3 CONSEQUENTIAL, INCIDENTAL AND PUNITIVE DAMAGES. NEITHER PARTY
SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR
PUNITIVE DAMAGES THAT MAY ARISE OUT OF THIS AGREEMENT (INCLUDING BUT NOT LIMITED
TO DAMAGES FOR LOSS OF SALES, POTENTIAL SALES, PROFITS OR BUSINESS), OTHER THAN
PURSUANT TO ITS OBLIGATIONS UNDER SECTIONS 9, 13.1, 13.2, 18.1, 18.2 OR AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, REGARDLESS OF WHETHER SUCH OTHER
PARTY HAS BEEN INFORMED OF THE POSSIBILITY THAT SUCH DAMAGES MAY OCCUR.
19. NOTICE. Any notice given in regard to this Agreement shall be given
in writing and shall be delivered personally, or shall be sent by first class
mail or registered certified mail, postage, and charges prepaid, to:
if to Ostex:
Ostex International, Inc.
0000 Xxxxxxx Xxx Xxxxx
Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Attention: President
Copy to:
Xxxxxxx Coie LLP
0000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxxxxxx, XX 00000
Attn: Xxxxx X. Xxxxxxxxx
if to Metrika:
Metrika, Inc.
000 Xxxxxxx Xxxxxxx
Xxxxxxxxx, Xxxxxxxxxx 00000
Attention CEO
Copy to: Venture Law Group
0000 Xxxx Xxxx Xxxx
Xxxxx Xxxx, Xxxxxxxxxx 00000
Attn: Xxxxxxx Xxxx
Any notice so given shall be effective upon the date of actual receipt by the
addressee as evidenced by return receipt or other written confirmation. Either
party may by advance notice given pursuant to this Section 19 designate a
substitute address for receipt of future notices.
20. GOVERNING LAW. All claims or controversies asserted by Ostex
against Metrika shall be construed and enforced in accordance with the laws of
California. Any judicial action by Ostex relating to the relationship between
the parties pursuant to this Agreement, or goods purchased or licensed hereunder
(together with any counterclaims asserted by Metrika), shall be brought and
tried in the State or Federal Courts located in California. All claims or
controversies asserted by Metrika against Ostex shall be construed and enforced
in accordance with the laws of the State of Washington. Any judicial action by
Metrika relating to the relationship between the parties pursuant to this
Agreement, or goods purchased or licensed hereunder (together with any
counterclaims asserted by Ostex), shall be brought and tried in the State or
Federal Courts located in the State of Washington. Notwithstanding the
foregoing, interpretation and enforcement of the provisions of Section 16 shall
be governed by and construed in accordance with the Federal Arbitration Act.
21. INTEGRATION AND TERMINATION OF CO-MARKETING AGREEMENT. It is the
desire and intent of the parties to provide certainty as to their future rights
and undertakings herein. The parties in this Agreement have incorporated all
representations, warranties, covenants, commitments and understandings on which
they have relied in entering into this (i) Agreement; (ii) the Stock Transfer
Agreement (referred to in Section 6 above); and (iii) the Amendment No. 1 to the
Stock Purchase Agreement (referred to in Section 6 above), and neither party
makes any covenant or other commitment to the other
concerning its future action. Accordingly, this (i) Agreement; (ii) the
Stock Transfer Agreement (referred to in Section 6 above); and (iii) the
Amendment No. 1 to the Stock Purchase Agreement (referred to in Section 6 above)
(i) constitutes the entire agreement and understanding between the parties and
there are no promises, representations, conditions, provisions or terms related
thereto other than those contained in (i) this Agreement; (ii) the Stock
Transfer Agreement (referred to in Section 6 above); and (iii) the Amendment No.
1 to the Stock Purchase Agreement (referred to in Section 6 above), and (ii)
supersedes all previous undertakings, agreements and representation between the
parties, written or oral, with respect to the subject matter hereof. No
modification of; addition to, or waiver of any provisions of this (i) Agreement;
(ii) the Stock Transfer Agreement (referred to in Section 6 above); and (iii)
the Amendment No. 1 to the Stock Purchase Agreement (referred to in Section 6
above) shall be binding upon either party hereto unless the same shall be in
writing duly executed by a duly authorized representative of both parties
hereto. The parties agree that the Co-Marketing Agreement is hereby terminated
and superseded in its entirety by (i) this Agreement; (ii) the Stock Transfer
Agreement (referred to in Section 6 above); and (iii) the Amendment No. 1 to the
Stock Purchase Agreement (referred to in Section 6 above).
22. MODIFICATION. No modification to this Agreement shall be
enforceable unless made in writing and signed by an authorized representative of
each party.
23. SEVERABILITY. In the event that any provision of this Agreement is
determined to be invalid or unenforceable for any reason, such provision shall
be deemed inoperative only to the extent that it violates or conflicts with law
or public policy and shall be deemed modified to the extent necessary to conform
thereto, and all other provisions hereof shall remain in full force and effect.
24. WAIVER. No express or implied waiver by either party of any right
or remedy with respect to a default by the other party under any provision of
this Agreement shall be deemed, interpreted or construed as a waiver of any
right or remedy with respect to any other default under the same or any other
provision hereof.
25. SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon and
shall inure to the benefit of the parties' respective successors and assigns,
subject to the restrictions on assignment set forth in Section 15 above.
26. STANDSTILL PROVISION. During the Term of this Agreement, Metrika
shall not make any offer for, and shall not actually acquire any legal or
beneficial interest in the common stock or other securities of Ostex without the
prior written consent of Ostex's Board of Directors other than with respect to
such interests already held by Metrika prior to the date hereof, and Ostex shall
not make any offer for, and shall not actually acquire any legal or beneficial
interest in the common stock or other securities of Metrika, other than with
respect to such interests already held by Ostex or its Affiliates prior to the
date hereof, without the prior written consent of Metrika's Board of Directors.
The parties each agree that any violation of this provision would cause
irreparable harm to the other party. The parties each agree that the other party
shall be entitled to all equitable remedies available to it to prevent violation
of this provision, as well as all other legal remedies, and if successful in any
claim, may recover from the violating party all reasonable costs and attorneys
fees expended by it in seeking such remedy.
27. INDEPENDENT CONTRACTOR. The relationship of Metrika and Ostex
established by this Agreement is that of independent contractors, and nothing
contained in this Agreement shall be construed to (i) give either party the
power to direct or control the day-to-day activities of the other, (ii)
constitute the parties as partners, joint venturers, co-owners or otherwise as
participates in a joint or common undertaking, or (iii) allow a party to create
or assume any obligation on behalf of the other party for any purpose
whatsoever.
IN WITNESS WHEREOF, the parties hereto have duly executed this
agreement the day and year last written below.
DATED AND EFFECTIVE as of the date first written above.
METRIKA, INC. OSTEX INTERNATIONAL, INC.
By: /S/ XXXXXXX X. XXXXX By: /S/ XXXXXX X. XXXXXXX
--------------------- -----------------------
Name: Xxxxxxx X. Xxxxx Name: Xxxxxx X. Xxxxxxx
Title: President and CEO Title: President & CEO
Date: June 8, 1998 Date: June 11, 1998
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
EXHIBIT A
SPECIFICATIONS FOR NTX/DIGITAL RESPONSE DEVICE
1.0 TIME TO RESULT
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
2.0 SAMPLE TYPES
XXXXXXXXXXXXXXXXXXXXXXXXX
3.0 SAMPLE STORAGE
Samples can be stored for XXXXXXXXXXXXXXXXXXXXXXXXX, or subjected
XXXXXXXXXXXXXXXX adversely affecting assay results.
4.0 SAMPLE VOLUME
For 510(k) clearance, the device will operate with a minimum sample
volume XXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
5.0 DEVICE ORIENTATION
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
6.0 CALIBRATION
There will be no calibration required by the user. Each device will be
factory calibrated. The calibration will be valid until the labeled
expiration date.
7.0 STABILITY
7.1 SHELF LIFE
7.0.1 Definition: Shelf life is defined as the time
interval from the date of manufacture to product
expiration.
7.0.2 Minimum acceptable shelf life:
Non-CLIA waived Product Sales: XXXXXXX
XXXXX of CLIA waived Product Sales: XXXXXXXXX
XXXXX of CLIA waived Product Sales: XXXXX
XXXXX of CLIA waived Product Sales: XXXXX
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
7.2 OPEN PACKAGE LIFE
XXXXXXXXXXXX conditions specified in 8.1 and 8.2.
8.0 OPERATING ENVIRONMENT
8.1 TEMPERATURE
XXXXXXXXXX
8.2 HUMIDITY
XXXXXXXXXX
8.3 AMBIENT LIGHT
The device will not be adversely affected by ambient light.
8.4 STORAGE AND SHIPPING CONDITIONS
8.4.1 Storage Condition
PRIOR TO CLIA WAIVER, acceptable product storage
conditions will be: Refrigerated
XXXXXXXXX
AT THE TIME OF CLIA WAIVER, acceptable product
storage conditions will be: Room
Temperature XXXXXXXXX
8.4.2 Shipping Condition
PRIOR TO CLIA WAIVER, acceptable product shipping
conditions will be: Refrigerated
XXXXXXXXXXXXX
AT THE TIME OF CLIA WAIVER, acceptable product
shipping conditions will be: Ambient
9.0 ACCURACY (MAXIMUM ALLOWABLE BIAS FROM REFERENCE)
9.1 NTx: XXX
9.2 Creatinine: XXX
10.0 PRECISION (TOTAL CLINICAL)
10.1 NTX
XXXXXXX
XXXXXXX
10.2 CREATININE
For 510(k) clearance: XXXXXXXX
Within XXXXX after CLIA waiver: XXXXXXX
11.0 ASSAY RANGE
11.1 NTX
For 510(k) clearance: XXXXXXXXXXX
Within XXXXX after CLIA waiver: XXXXXXXX
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
11.2 CREATININE
For 510(k) clearance: XXXXXXXXXX
Within XXXXXX after CLIA waiver: XXXXXXXXXX
12.0 INTERFERING SUBSTANCES
12.1 NTX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXX
12.2 CREATININE
XXXXXXXXXXXXXXXXXXXXXXXXXX
13.0 RELIABILITY
13.1 ERROR CONDITIONS
XXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXX
13.2 MISUSE (PRODUCT LAUNCH)
XXXXXXXXXXXXXXXXXXXXXXXXXXXX
13.3 FUNCTIONAL RELIABILITY
The functional reliability goal for released products is as
follows:
XXXXX of Product Sales
XXXXX XXXXX
XXXXX XXXXX
XXXXX of Product Sales XXXXX
XXXXX of Product Sales XXXXX
This excludes all failures from improper use by the user.
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
EXHIBIT B
METRIKA AND OSTEX PRE-LAUNCH RESPONSIBILITIES
A. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXX
B. XXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXX. The lot configuration components
which comprise a clinical lot, and production staging with respect to
clinical trials is completed at Metrika's
discretion.XXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
C. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
D. Ostex, at their discretion, can conduct a pre-commercialization launch
audit which includes QA, QC, manufacturing and product performance. Metrika
agrees to assist in these audits. Test devices associated with these audits
will be paid for by Ostex and be included in the non CLIA or CLIA waived
purchases noted in Exhibit D.
E. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
EXHIBIT C
SPECIFICATIONS FOR CRITICAL REAGENTS
SPECIFICATION SHEET
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXX
XXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXX
XXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXX
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
TITLE LOT NO. DOC NO. REV PAGE
NTX CONCENTRATE 2007 G 00 XX 00
---- XXXXXXXXXX 0 ----
XX DATA SHEET
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
Volume NTx nmol/mL NTx Total Protein Protein Specific
(mL) BCE step 8.1 nmoles (= mg/mL step Total mg (= Activity =
vol (mL) * 8.3 protein ([OBJECT
nmol/mL BCE) (mg/mL) * OMITTED])
Vol (mL))
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
7.3.4 XXXXX Step 7.3.3
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
7.10 XXXXX Step 7.9
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
7.22 XXXXX Step 7.20
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
7.28 XXXXX Step 7.27
------------------- ----------- -------------- -------------- -------------- -------------- ----------------
Total nanomole yield = Tot nm step 7.3.4/tot nm step 7.28 x 100 = %
-------
QC Materials Used:
Osteomark(R)kit PN 9005 or 9006 LN , calibrator diluent PN 2022 LN
----- --
PBS PN 2003 LN , Gold 300 pmol/mL NTx from PN 4010 LN 336C04
------------
(A) Assay 1, Dilution 1 (D) Assay 2, Dilution 1
(B) Assay 1, Dilution 2 (E) Assay 2, Dilution 2
(C) Avg. of (A) and (B) F) Avg. of (D) and (E)
(G) Percent Difference of (C) and (F) (If (G) > 20%, repeat steps 8.1.3 to
8.1.5) (H) Average of (A), (B), (D) and (E) (Record (H) in the table above)
Note: Percent difference between x and y = 100 * (absolute value (x -
y)/(average (x, y))
Number of aliquots:
Volume per aliquot:
Total volume to inventory:
Total nanomoles BCE to inventory:
Expiration Date:
Initials:
Checked By:
Date:
==================================================================
QC Analyst Signature: Date:
Record Reviewed By: Date:
Quality Control
Record Reviewed By: Date:
Quality Assurance
Released: Not Released:
TITLE LOT NO. DOC NO. REV PAGE
QUALIFICATION OF GOLD 0019 B 1 - 6
REFERENCE CALIBRATORS
TEST METHOD
--------------------------------------------------------------------
DOCUMENT CONTROL HISTORY:
CHANGE REQUEST NUMBER REVISION DATE PROOFED BY
ECO 0554 A 01/27/97 X. Xxxxx
New
ECO 0563 B
Change Gold Reference Lot
------------------------------------------------------------------------
DOCUMENT APPROVAL
Quality Assurance Manufacturing Development
XXXXX XXXXXXXXX XXXX XXXXX XXXX XXXXXX
Date: 01/27/97 Date: 01/20/97 Date: 01/23/97
---------------------------------------------------------------------------
This document contains proprietary information which shall not be
reproduced, transferred to other documents, disclosed to others, used for
manufacturing or any other purpose without document control approval and/or
prior written permission of Ostex International, Inc.
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
1.0 PURPOSE
The purpose of this document is to establish a test method for
qualifying gold reference calibrators.
2.0 APPLICABILITY
2.1 4011 NTx Calibrator Panel
2.2 P083 Assignment of Expiration Dates
3.0 HEALTH AND SAFETY INFORMATION
Osteomark(R) calibrators contain material derived from human bone. The
bone has been thoroughly processed and the donor has been tested and
found negative for Hepatitis B Surface Antigen and antibody HIV.
However, no known test can offer absolute assurance that human products
will not transmit Hepatitis, HIV, or other viruses.
4.0 MATERIALS/EQUIPMENT
4.1 XXXXXXXXXXXXXXX
4.2 All material needed to run the Osteomark(R)EIA kit, as per
the Osteomark(R)instructional insert (PN
7002).
4.3 Gold Calibrators, Lot 058-144.
4.4 XXXXXXXXXXXXXX
4.5 Caps, XXXXXXXXXXXXXXXX. Same number as vials above.
4.6 Labels, blank. Need to fit on the vials in 4.4, XXXXX.
5.0 OTHER INFORMATION
5.1 Shelf life: XXXXXXXXXXXXXX.
5.2 Storage conditions: XXXXXXXXXXXXXX.
5.3 Unit of measure: ea.
6.0 PROCEDURE
6.1 Select a set of 1, 30, 100, 300, 1000, and 3000 nM calibrators
which come from the same part number 4011 lot, and which have
passed the quality control procedure in document 4011. The
calibrators must be from a lot which did not undergo any
adjustments after being diluted from the 3000 nM calibrator.
6.2 If the calibrators are not already filled, aliquot the
calibrators into 0.5 mL volumes in polypropylene vials (PN
1093) with polypropylene caps (PN 1090). Record the procedure
used and lot numbers of all materials in a laboratory
notebook. Assign the calibrators a lot number corresponding to
the notebook number and page. If the calibrators are not
already labeled, label each vial as gold calibrator, and with
lot number, concentration, and expiration date.
6.3 Run an assay following the method specified in the
Osteomark(R) instructional insert, PN 7002. Use previously
released and matched components except for calibrators. Gold
Calibrators (Ref) and the Calibrators being tested (Test) will
be used instead of kit calibrators. Use the following plate
map. (Note: Test xxxxx and Ref xxxxx are reversed every
strip). This assay is to be run at least three and no more
than four times for each calibrator (count valid assays only).
1 2 3 4 5 6 7 8 9 10 11 12
1nm 30nm 100nm 300nm 1000bnm 3000 nm
A Test Ref Test Ref Test Ref Test Ref Test Ref Test Ref
B Ref Test Ref Test Ref Test Ref Test Ref Test Ref Test
C Test Ref Test Ref Test Ref Test Ref Test Ref Test Ref
D Ref Test Ref Test Ref Test Ref Test Ref Test Ref Test
E Test Ref Test Ref Test Ref Test Ref Test Ref Test Ref
F Ref Test Ref Test Ref Test Ref Test Ref Test Ref Test
G Test Ref Test Ref Test Ref Test Ref Test Ref Test Ref
H Ref Test Ref Test Ref Test Ref Test Ref Test Ref Test
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
7.0 ACCEPTANCE CRITERIA
7.1 For each assay, calculate the coefficient of variance (% CV)
of the eight OD replicates of 'Test' xxxxx and the 'Ref' xxxxx
for each calibrator. The assay is valid for that calibrator if
the % CV is less than or equal XXXXXXX.
7.2 For each assay, determine the Test/Ref ratio (T/R) for each
calibrator. Divide the mean Test OD result by the mean
Reference OD result.
7.3 a) A calibrator passes acceptance criteria if the
Test/Ref ratio is XXXXXX for all three
assays.
b) A calibrator fails acceptance criteria if the
Test/Ref ratio falls XXXXX for two or more assays.
c) If a calibrator has a test/reference ratio XXXXXX.
7.4 Calculate the average Test/Ref ratio for the 3000 nM
calibrator using all valid results from step 6.3. The average
Test/Ref ratio passes acceptance criteria if it is XXXXXX.
7.5 The calibrator set will be accepted as gold if all calibrators
in the set pass acceptance criteria in steps 7.3 and 7.4.
7.6 If the calibrator set is accepted as gold, initiate ECO of
Document 4011 and Test Method 0019 to refer to the new gold
lot. File the results in the QA files under Gold Calibrators.
Label the container holding the calibrators with description,
lot number, concentration and expiration date.
XXXXXXXXXXX.
The following plate map will be required for testing calibrators
per step 7.3c.
1 2 3 4
Calibrator 1 Calibrator 2
A Test Ref Test Ref
B Ref Test Ref Test
C Test Ref Test Ref
D Ref Test Ref Test
E Test Ref Test Ref
F Ref Test Ref Test
G Test Ref Test Ref
H Ref Test Ref Test
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
QC DATA SHEET
Assay IDs: _________________________________
Reference kit lot number: _____ Gold Calibrator Panel lot number: ____________
Attach a print-out for all raw OD data and curve calculations and results.
1 nm 30nm 100nm 300nm 1000nm 3000nm
Test % CV
---- ---- ---- ---- ----- ----
Ref % CV
---- ---- ---- ---- ----- ----
Test/Ref
---- ---- ---- ---- ----- ----
Asasy 1 Pass/Fail
---- ---- ---- ---- ----- ----
Test % CV
---- ---- ---- ---- ----- ----
Ref % CV
---- ---- ---- ---- ----- ----
Test/Ref
---- ---- ---- ---- ----- ----
Asasy 2 Pass/Fail
---- ---- ---- ---- ----- ----
Test % CV
---- ---- ---- ---- ----- ----
Ref % CV
---- ---- ---- ---- ----- ----
Test/Ref
---- ---- ---- ---- ----- ----
Asasy 3 Pass/Fail
---- ---- ---- ---- ----- ----
Test % CV
---- ---- ---- ---- ----- ----
Ref % CV
---- ---- ---- ---- ----- ----
Test/Ref
---- ---- ---- ---- ----- ----
Asasy 4 Pass/Fail
---- ---- ---- ---- ----- ----
Pass/Fail
---- ---- ---- ---- ----- ----
Validity criteria XXXX. Acceptance Criteria for 1,30,100,300,1000
and 3000 nm calibrators: XXXXXXXXXXXXX
Average 3000 nm Test/Ref :
Avg. Pass/Fail :
Acceptance Criteria for 3000 nm average: XXXXXXXXXXX
COMMENTS
-------------------------------------------------------------------------
Record reviewed by: ____________________ _________
Quality Control Date
Released _________ Not Released _________
Record reviewed by: ____________________ _________
------------------------
Quality Assurance Date
Released _________ Not Released _________
NOTE: CONFIDENTIAL TREATMENT REQUESTED.
EXHIBIT D
MINIMUMS AND PRICE LIST
--------------------------------- ----------------------- -------------- --------------------------- ------------
MINIMUM VOLUMES (2) PRICE ($) PRICE ABOVE MINIMUM SHELF LIFE
VOLUMES (3)
----------------------- ---------------------------
Phase/Year Per Month Per 12 at Minimum Volume Price ($) (months)
Month Volumes (units above
Period minimum)
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
Non CLIA waived (1) XXXX XXXX XXXX XXXX XXXX XXXX
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
XXXX CLIA Waived Total XXXX XXXX
XXXXX XXXX XXXX XXXX XXXX XXXX XXXX
XXXXX XXXX XXXX XXXX XXXX XXXX XXXX
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
XXXX CLIA waived XXXX XXXX XXXX XXXX XXXX XXXX
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
XXXX CLIA waived XXXX XXXX XXXX XXXX XXXX XXXX
--------------------------------- ------------ ---------- -------------- --------------- ----------- ------------
(1) In the event that CLIA waiver occurs before XXXXX, the Minimum Volumes
and associated transfer Price obligations for Ostex will shift to the XXXXX
CLIA Waived Volumes and transfer Prices immediately upon Ostex being provided
with CLIA waiver documentation by Metrika.
(2) Minimum unit volume per month increases are contingent upon attaining
both the above noted CLIA waived status and shelf life specifications, as
well as the product specifications in Exhibit A.
(3) For twelve-month periods where the unit volume is greater than the
number of units noted as Minimum Volumes, regardless of shelf life, any
additional units purchased by Ostex during that twelve-month period will be at
the prices indicated in the 'Price Above Minimum' column.
