Note: Confidential treatment requested. Exhibit omits information that has
been filed separately with the Securities and Exchange Commission.
1
JOINT DEVELOPMENT, LICENSE
AND SUPPLY AGREEMENT
This Joint Development, License and Supply Agreement (this "Agreement")
is entered into as of the 14TH day of January, 1997 ("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 HOLOGIC, INC., a Delaware corporation having its principal
place of business at 000 Xxxxxxx Xxxxxx, Xxxxxxx, XX 00000 ("Hologic").
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" (as more particularly defined herein, the
"WRF Bone Resorption Technology").
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 the WRF Bone Resorption
Technology.
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 in SECTION 1.15 hereof), which it has implemented
in a microtiter format suitable for use in centralized laboratories
("OsteomarkAE Laboratory Test").
X. Xxxxx, Inc., a New Jersey Corporation with its principal place of
business at 000 Xxxx Xxxxxxx Xxxxxx, Xxxxxxxx, Xxx Xxxxxx 00000 ("Serex") also
engages in research and development of diagnostic products in various fields,
including the field of bone and mineral metabolism, and applications related to
bone resorption and collagen and connective tissue degradation; and has
developed a proprietary immunodiagnostic format for detection of analytes
associated with various disease states and conditions (including without
limitation the technology embodied in the patents and patent applications listed
in ATTACHMENT D hereto (the "Serex Patent Rights")), together known as the Serex
Antibody Release Assay ("XXXX Format"). Serex has also developed and is
continuing to develop an immunoassay to determine the levels of metabolites
resulting from bone resorption (targeted to a peptide linked pyridinoline
epitope collagen and potentially to other metabolites) suitable for various
uses, including point of care and home or other over-the-counter ("OTC") use
("PLP Assay").
E. Hologic engages in the research, development, manufacture, sale, and
lease of diagnostic equipment and other products in the field of bone
metabolism, including its lines of QDR x-xxx xxxx densitometers, Sahara
ultrasound bone sonometers and associated systems for analysis of bone
metabolism data. Pursuant to an agreement dated September 30, 1994 as amended,
(as amended, the "Hologic/Serex Agreement"), Hologic has entered into a
cooperation with Serex under which Hologic has funded Serex's development of the
PLP Assay for use with the XXXX Format, and has obtained certain exclusive
rights and licenses to distribute the products resulting from this cooperation.
In an associated undertaking, Hologic has undertaken to develop a meter suitable
for point of care use to read assays in the XXXX Format.
F. Ostex and Hologic desire to engage in a development project under
which Hologic will cause Serex to implement the NTx Assay Technology to work
with the XXXX Format in a strip format (the "NTx Meter Strip") and with a
Hologic-developed stand-alone meter for point of care use (the "NTx Meter"),
which NTx Meter Strip and NTx Meter are collectively referred to herein as the
"NTx Meter System". Hologic will arrange for manufacture of said NTx Meter
Strips and NTx Meters.
G. Ostex desires to contribute to this development project by granting
to Hologic a license to use the NTx Assay Technology in connection with this
development project, by providing "Critical Reagents" (as this term is defined
in SECTION 1.15 hereof) needed for this development project at no charge, by
contributing to the costs of said project, and by selling Critical Reagents
needed for manufacture of the NTx Meter Strips at its manufacturing cost, all as
more specifically described in this Agreement.
H. In return, Hologic and Ostex will each sell said NTx Meter Strips
and Meters, and shall share the profits thereof through the mechanism of
reciprocal royalties, all as more specifically described in this Agreement.
Hologic may also integrate its meter technology with and into other Hologic
products, and may sell such products without royalty.
I. Simultaneously with this Agreement, Ostex and Hologic have entered
into that certain Co-Promotion Agreement providing for the co-promotion of
Hologic products and Ostex's OsteomarkAE Laboratory Test in its microtiter
format in accord with the terms set out therein (the "Co-promotion Agreement").
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.
1.1 "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,
or the right to fifty percent (50%) or more of the income of such corporation,
company, firm, partnership or other entity. Notwithstanding the foregoing, Serex
shall be considered an affiliate of Hologic.
1.2 "WRF Bone Resorption Technology" means all technology to
which Ostex has rights relating to assays, methods, and materials, including
Critical Reagents, for measuring bone collagen metabolites; having first been
developed from research conducted by Xx. Xxxxx Xxxx, owned by the Washington
Research Foundation, and licensed exclusively to Ostex. The WRF Bone Resorption
Technology includes, without limitation, the urinary diagnostic assay known as
the Osteomark immunoassay.
1.3 "Confidential Information" means (a) any and all normally
non-public information communicated or disclosed by one party ("Discloser") to
the other party ("Recipient") describing or relating to the Disclosing Party's
business and marketing plans and strategies, financial information, or customer
information, and (b) any and all information communicated or disclosed by the
Discloser to Recipient describing or relating to the Disclosing Party's research
and development, Know-How, inventions, trade secrets, technical data, formulae,
drawings, designs, software, models, samples, kits, processes, product
development data and information and other data and information related to the
business of Discloser, labeled or specified in writing as "Confidential" or the
equivalent, or if orally disclosed, labeled "Confidential" or the equivalent,
and reduced to writing within thirty (30) days of such oral disclosure;
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 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; 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 during the course of this Agreement.
1.4 "COGS" means all costs of materials and components
(including purchase costs and royalties) and personnel expended on fabrication,
quality control, and regulatory documentation, plus a portion of overhead based
on the portion of resources allocated to manufacturing and shipping, calculated
in accord with generally accepted accounting principles.
1.5 "Critical Reagents" means the set of reagents supplied by
Ostex for use in the development of the NTx Meter Strips, currently consisting
of: monoclonal antibodies or fragments thereof, for example the monoclonal
antibody produced by hybridoma 1H11, that shows specific immunoaffinity for the
NTx Epitope (at concentrations to be agreed on, appropriate for use in the NTx
Meter Test) antibody diluent; analyte (NTx Epitope)-containing controls; and
other reagents. Reagents will be supplied by Ostex "in bulk," provided that
Ostex shall also supply a reasonable number of Osteomark(R) Laboratory Test Kits
in a microtiter plate format for Serex use for comparison and control purposes.
As of the effective date of this Agreement, Critical Reagents include the 1H11
monoclonal antibody, diluent, calibrators and controls. These reagents may be
changed upon mutual agreement of the parties and upon reasonable notice to scale
up to commercial quantities. The term "Critical Reagents" shall also include any
improvement to or successor antibody(ies) with immunoaffinity to the NTx Epitope
or similar epitopes resulting from bone resorption which may be developed or
marketed by Ostex in any form during the term of this Agreement.
1.6 "Discovery" means any scientific, technological, or
commercial invention, discovery, development, improvement, Know-How, or product
resulting from the activities contemplated by the parties under this Agreement,
whether or not the same is patentable.
1.7 "Distribution Network" shall mean a party to this
Agreement acting as a seller together with its authorized resellers and
sublicensees.
1.8 "Field of Use" means use with the XXXX Format, and the
associated NTx Meter or other Hologic meter technology for use as a point of
care device.
1.9 "First Commercial Sale" means the first Sale of a NTx
Meter System by the Distribution Network for a value in an arms length
transaction with an independent third party following approval for Sale by the
United States Food and Drug Administration of the NTx Meter System.
1.10 "Gross Profit" means Net Sales less COGS.
1.11 "Gross Sales" means gross receipts, royalties, fees and
other valuable consideration of any kind received directly or indirectly by, or
credited to the benefit of the seller and permitted Affiliates in connection
with all Sales to end-users and third-party distributors. Without limiting the
generality of the foregoing, Gross Sales include without limitation, interest,
late charges, time-price differentials and other receipts or credits of a
similar nature.
1.12 "Know-How" means any method, information, procedure,
process, composition of matter, biological material, or other subject matter.
1.12.1 "Hologic Know-How" means Know-How that
has been developed or acquired by Hologic, prior to or during the term of
this Agreement.
1.12.2 "Ostex Know-How" means Know-How that has
been developed or acquired by Ostex, prior to or during the term of this
Agreement.
1.12.3 "Serex Know-How" means Know-How that has
been developed or acquired by Serex, prior to or during the term of this
Agreement.
1.13 "Hologic Intellectual Property Rights" means all Hologic
Know-How, trade secrets, Confidential Information, Hologic patent rights and
other intellectual property rights owned or controlled by Hologic individually
or in conjunction with others and related to the field of bone and mineral
metabolism, meter technology, biochemical markers, or medical practice,
including but not limited to Hologic's rights to Serex Intellectual Property
Rights pursuant to the Hologic/Serex Agreement.
1.14 "Serex Intellectual Property Rights" means all Serex
Know-How, trade secrets, Confidential Information, Serex Patent Rights, and
other intellectual property rights owned or controlled by Serex and individually
or in conjunction with others and related to the field of bone and mineral
metabolism, meter technology, biochemical markers, diagnostic products and
methods, or medical practice, including but not limited to the PLP Assay and the
XXXX Format.
1.15 "NTx Assay Technology" means a urine- or serum-based
immunoassay for bone collagen metabolites comprising an NTx Epitope, and any
successor immunoassay utilizing WRF Bone Resorption Technology, together with
associated controls and other products, the manufacture, use, offer for sale or
Sale of which would, but for the licenses granted herein, infringe a Valid
Claim.
1.16 "Net Sales" means Gross Sales, less normal and customary
trade, quantity, and cash discounts allowed and actually taken, allowances for
credits granted or returns, and commissions paid or allowed to third-party
distributors.
1.17 "NTx Epitope" means a conformational structure included
within the natural crosslinked telopeptides from type I collagen, to which the
monoclonal antibody (mAb) produced from the hybridoma 1H11 binds specifically by
immunoaffinity.
1.18 "Ostex Intellectual Property Rights" means all Ostex
Patent Rights, Ostex Know-How, trade secrets, Confidential Information statutory
and common-law trademark rights, and other intellectual property rights owned,
licensed or controlled by Ostex during the term of this Agreement and related to
the WRF Bone Resorption Technology.
1.19 "Ostex Patent Rights" means all rights of Ostex,
as licensee under the WRF/Ostex Exclusive License Agreement, in and
to any and all subject matter claimed in or disclosed by U.S. patents and
patent applications referred to in the WRF/Ostex Exclusive License
Agreement, including without limitation U.S. Patent Application Serial No.
118,234 filed November 6, 1987, and any divisions, continuations,
continuations-in-part or reissues arising therefrom or issuing thereon, U.S.
Patent No. 4,973,666 issued November 27, 1990, U.S. Patent No. 5,140,103 issued
August 18, 1992, U.S. Patent No. 5,300,434 issued April 5, 1994, U.S. Patent No.
5,320,970 issued June 14, 1994, U.S. Patent No. 5,532,169 issued July 2, 1996,
U.S. Patent No. 5,455,179 issued October 3, 1995, U.S. Patent No. 5,473,052
issued December 5, 1995, U.S. Patent No. 5,576,189 issued November 19, 1996,
U.S. Patent No. 5,472,884 issued December 5, 1995 along with any and all other
patent rights applicable, owned by WRF and licensed to Ostex, and related to,
derived from, or claiming priority from any such U.S. patent applications,
including without limitation International Application No. PCT/US88/03722,
International Application No. PCT/US90/7015, International Application No.
PCT/US92/04104.
1.19A "Hologic Patent Rights" means all rights of Hologic in
and to any and all subject matter claimed in or disclosed by U.S. patents and
patent applications owned or assigned to Hologic relating to the subject matter
of the Hologic/Serex Agreement.
1.20 "Sale" means any and all transactions whereby a party or
its Affiliates sell, lease, rent, or otherwise transfer or dispose 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.
1.21 "Valid Claim" means a claim in any unexpired Ostex Patent
Right which has not been held invalid by a non-appealed or unappealable decision
by a court or other appropriate body of competent jurisdiction.
2. LICENSE GRANTS.
2.1 NTX METER STRIP. Ostex hereby grants to Hologic and to
Hologic's "permitted assigns" for the term of this Agreement, and Hologic hereby
accepts, a nonexclusive, worldwide, nontransferable license in and under the
Ostex Patent Rights and Ostex Know-How, to develop, manufacture and have
manufactured, and to market, promote, offer to sell, sell, distribute and have
marketed, promoted, sold and distributed in any country in the World except
Japan, the NTx Meter System (incorporating the NTx Assay Technology and
utilizing the Critical Reagents) within the Field of Use, all in return for the
Ostex rights set out herein.
2.2 HOLOGIC OPTION TO MANUFACTURE.
2.2.1 CRITICAL REAGENTS FOR NTX METER STRIP(S).
Ostex hereby grants Hologic an option, exercisable by Hologic pursuant to
the terms of SECTION 6.3.3 below, to a temporary, non-exclusive,
nontransferable, royalty-bearing license under the Ostex Patent Rights and Ostex
Know-How to manufacture or have manufactured, purify or have purified, Critical
Reagents at a manufacturing facility in the United States (or such other country
as the parties may agree), for the sole purpose of manufacturing NTx Meter
Strips for distribution within the Field of Use pursuant to the terms of this
Agreement.
2.2.2 The terms of any license granted pursuant
to SECTION 2.2.1 shall be subject to payment to Ostex of a royalty equal to
the transfer price for such Critical Reagents had such Reagents been
manufactured and delivered by Ostex, less a deduction equal to Hologic's COGS
therefor, provided that if such COGS exceeds the transfer price and the
resultant number is a negative number, Hologic shall take a credit against any
amounts due to Ostex pursuant to SECTION 7.4 of this Agreement.
2.2.3 Any license granted pursuant to the
option of this SECTION 2.2 shall be revocable by Ostex upon ninety (90)
days prior notice accompanied by demonstration by Ostex that it has recovered
the manufacturing capacity to resume supply of Hologic's anticipated needs as
forecasted pursuant to SECTION 6.3.1 hereof (provided, however, that such
license may be revoked no sooner than six (6) months following Hologic's
exercise of the option, and upon reasonable agreement as to appropriate
phase-out of Hologic production, phase-in of Ostex production, and coverage of
any Hologic start-up and termination costs, whereupon Hologic will again have
available to it, in the event of subsequent default by Ostex as described in
SECTION 6.3.3, a license option under this SECTION 2.2.
2.3 EXPRESS RESERVATION OF RIGHTS. The scope of
license granted by Ostex to Hologic hereunder is limited by the scope of
the express grants set forth in this SECTION 2. Without limiting the generality
of the foregoing:
2.3.1 RIGHTS SPECIFICALLY EXCLUDED FROM SCOPE
OF GRANT TO HOLOGIC. Ostex retains all rights in the WRF Bone Resorption
Technology and Ostex Intellectual Property Rights, including without limitation
all rights with respect to all products, applications, fields of use, markets
and uses, that are not expressly included within the scope of the grant of
rights to Hologic as set forth in this Agreement. This Agreement shall not under
any circumstances be construed or interpreted to provide for the grant, license,
or any other transfer to Hologic or Serex of any rights in the WRF Bone
Resorption Technology, other than the right to use Critical Reagents supplied by
Ostex hereunder within the scope of the license as granted in this SECTION 2.
2.3.2 HOLOGIC AND SEREX. Hologic and Serex shall
retain their respective ownership and control of all Hologic and Serex
Intellectual Property Rights and other proprietary rights and interests in and
relating to the XXXX Format, meter technology, and PLP Assay.
2.3.3 ACTIONS REQUIRING OSTEX'S PRIOR WRITTEN
CONSENT. Hologic shall not, without Ostex's prior written consent, which
consent may be withheld at Ostex's sole discretion, manufacture or use any
Critical Reagent other than as provided for within the scope of the license
grants as set forth in this SECTION 2.
2.3.4 COMPULSORY LICENSES. Ostex and Hologic
acknowledge that the Ostex Patent Rights are subject to the rights and
limitations of United States Code, Title 35, Chapter 18, and administrative
regulations thereunder, and equivalents thereof in other jurisdictions, and that
the grants of licenses under SECTION 2 above are subject to such rights and
limitations. In the event that Ostex receives notice that any governmental
agency in any country or territory having valid authority and jurisdiction has
granted, or intends to grant or to cause to be granted, a compulsory license
with respect to all or any portion of the Ostex Patent Rights, Ostex shall so
notify Hologic and shall grant that third party a license to exercise the Ostex
Patent Rights to the extent required by the governmental agency. The grant of
such license to a third party or the taking of rights by or on behalf of any
government shall under no circumstances be considered a breach of this Agreement
by Ostex, provided that Hologic shall be deemed to have received an equivalent
license under the same terms and conditions.
2.4 OSTEX RIGHT TO DISTRIBUTE NTX METER SYSTEM. Hologic hereby
grants to Ostex and its Affiliates for the term of this Agreement, and Ostex
hereby accepts, a nonexclusive, nontransferable license in and under Hologic
Intellectual Property Rights, to market, promote, sell, distribute and have
marketed, promoted, sold and distributed under Ostex's trademarks in any country
in the World, the NTx Meter System all in return for the Hologic rights set out
herein.
3. SUPPLY OF CRITICAL REAGENTS.
3.1. CRITICAL REAGENTS FOR DEVELOPMENT OF NTX METER STRIP(S).
Ostex shall supply to Hologic and to its designee, Serex, without charge, such
reasonable quantities of Critical Reagents as shall be necessary or useful for
the purpose of developing NTx Meter Strip(s) pursuant to the terms and
conditions of this Agreement, together with such reasonable consulting advice as
Hologic or Serex may request.
3.2 CRITICAL REAGENTS FOR MANUFACTURING NTX METER STRIP(S).
Ostex shall sell to Hologic (or such manufacturer(s) as Hologic shall
designate), and Hologic (or said manufacturer(s)) shall purchase from Ostex,
Critical Reagents for the purpose of manufacturing NTx Meter Strip(s) pursuant
to the terms and conditions of this Agreement.
3.2.1 Hologic or its designated manufacturer(s)
shall pay Ostex a non-royalty transfer price for Critical Reagents sold
pursuant to this SECTION 3 equal to Ostex' COGS therefor.
3.2.2 Payment for each shipment of Critical
Reagents shall be made by Hologic or its designated manufacturer(s) within
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 Hologic or its designated manufacturer(s) fails to comply with
the payment terms of this SECTION 3, Ostex shall have the right, in addition to
all other rights available under this Agreement, to suspend further shipment of
Critical Reagents until such breach is cured.
3.3 THIRD-PARTY MANUFACTURING ON BEHALF OF OSTEX. In the event
that Ostex licenses a third party to manufacture Critical Reagents to be
supplied under this Agreement, Ostex shall ensure and provide evidence to
Hologic demonstrating that such third-party manufacturer complies with good
manufacturing practices (GMP) and all applicable governmental regulations
relating thereto and is either in compliance with or working toward compliance
with the quality standards established by the International Standards
Organization, Rules 9000 et seq. and amendments or successors thereto ("ISO
9000").
3.4 PRODUCT WARRANTY; QUALITY CONTROL. Ostex warrants to
Hologic and its designated manufacturer(s) that all Critical Reagents sold by
Ostex hereunder shall (i) comply with the specifications set out in ATTACHMENT
3.4 hereof when used in accord with Ostex instructions for use, and amendments
thereto as mutually agreed upon by the parties, (ii) be free from defects in
material, workmanship and design, 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 for the United States market under this Agreement
shall be manufactured, tested, documented, packaged, and transported in
compliance with GMP requirements of the FDA including, without limitation, 21
CFR Part 820 and any amendments or successors thereto; and that all Critical
Reagents manufactured and supplied under this Agreement, regardless of intended
market, shall be manufactured, tested, documented, packaged and transported in
compliance with Hologic's reasonable quality assurance requirements. Hologic
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 Hologic 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 Hologic's sole remedy
for such failure, immediately replace said product (demonstrated by Hologic or
its designated manufacturer(s) as non-conforming in accord with Ostex's
reasonable standard 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.
3.5 DELIVERY. All Critical Reagents purchased
under this Agreement shall be shipped F.O.B. Origin.
3.6 INVENTORY. At all times during the distribution term of
this Agreement, Ostex shall supply and Hologic or its designated manufacturer(s)
shall keep sufficient inventory of Critical Reagents to carry out reasonable
demand or orders for NTx Meter Strip(s) without undue delay.
3.7 FACILITIES STANDARDS. At all times during the term of this
Agreement, Hologic and its designated manufacturer(s) shall provide or cause to
be provided such warehousing and transport facilities as are both commercially
reasonable and adequate under the applicable regulations, product requirements,
and industry standards of all relevant jurisdictions under this Agreement.
4. PRODUCT MANAGEMENT COMMITTEE. Within thirty (30) day of the
Effective Date, the parties shall form a Product Management Committee consisting
of two (2) named representatives each from Hologic and Ostex respectively, and
one (1) named representative (non-voting) from Serex, which committee shall have
the responsibility to oversee and coordinate development, marketing,
promotional, Sales, and distribution efforts and other activities required or
permitted by this Agreement respecting the NTx Meter System. The committee shall
meet at least once per quarter, at locations and at times to be agreed, and
shall undertake the responsibilities set out in this Agreement, as well as the
obligation to regularly review development status, marketing and sales
forecasts, actual sales performance, competitive activities, and promotional
plans. The committee shall attempt to operate by consensus, and shall take no
action without approval of a majority of voting members. The committee may
delegate certain of its functions to subcommittees or individual members. Each
party shall cause its members to work diligently to promote the commercial
success of the NTx Meter System. Either party may change its representatives
assigned to said committee by fifteen (15) days advance written notice provided
pursuant to SECTION 21 of this Agreement.
5. ROLE OF THE PARTIES IN THE DEVELOPMENT AND REGULATORY APPROVAL
OF THE NTX METER SYSTEM.
5.1 GOALS. The parties have established the development goals
set out herein, which goals are anticipated to be accomplished within the
general time periods set out therein, as said development goals may be specified
in more detail or amended from time to time, provided that Hologic shall use and
shall cause Serex to use its best commercial efforts to complete development of
the NTx Meter System and to obtain regulatory
approval thereof for XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
5.2 CONSULTATION AND AVAILABILITY OF OSTEX KNOW-HOW. Each
party shall perform the activities assigned to it, and shall make available key
employees to provide consultation, advice, assistance, and scientific direction
in furtherance of the objectives of this Agreement. Without limiting the
generality of the foregoing, Ostex shall make available to Hologic and to Serex
personnel trained in and knowledgeable of the WRF 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.
5.3 SEREX ROLE. Hologic shall cause Serex to use its best
commercial efforts, pursuant to the Hologic/Serex Agreement, to (a) integrate
the Ostex NTx Assay Technology to work with the XXXX Format to create the NTx
Meter Strip; (b) cooperate with Hologic to develop the NTx Meter; and (c)
cooperate with Hologic and Ostex in the conduct of clinical trials and the
obtaining of regulatory approvals for the NTx Meter System as a whole.
5.4 HOLOGIC ROLE. Pursuant to the Hologic/Serex
Agreement, Hologic shall (a) cooperate with Serex in connection with, and
continue to fund, development of the NTx Meter Strip
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX;
(b) arrange, manage and fund development of the NTx Meter
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX; and (c)
arrange, manage, and fund conduct of clinical trials and the obtaining of
regulatory approvals for the NTx Meter System XXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
5.5. OSTEX ROLE.
5.5.1 GENERALLY. Pursuant to SECTIONS 2.1 and
3.1 of this Agreement, Ostex shall
--------- -------------
(a) provide the license and Critical Reagents specified therein; (b) cooperate
with Hologic to develop the NTx Meter and (c) cooperate with Hologic and Serex
in the conduct of clinical trials and the obtaining of regulatory approvals for
the NTx Meter System.
5.5.2 OSTEX FUNDING. In addition, Ostex shall
reimburse Hologic for XXXXXXXXXXXX of Hologic's funding paid out
in support of Serex's development efforts, Meter
development, support of clinical trials and regulatory approval, upon
receipt of Hologic's invoice to Ostex for the previous calendar quarter's
expenses, to a maximum of XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
(the "Maximum Cost") which is one-hundred ten percent (110%) of the total of the
amounts set out in SECTION 5.4 above. If at any time, it appears that the cost
of the Serex development effort for the NTx Meter System will exceed said
Maximum Cost, the parties will meet and use their best efforts to negotiate, in
good faith, an appropriate
agreement to allocate any such excess. Failing agreement, either party may
terminate this Agreement without penalty upon thirty (30) days advance written
notice to either party, provided that the other party may agree during such
notice period to reimburse the entire excess, in which case royalties payable
pursuant to SECTIONS 7.3 and 7.4 shall be adjusted to reflect the overall
percentage of funding paid by each party during the period beginning January 1,
1997.
5.5.3 ACCESS TO CLINICAL DATA. Ostex shall
provide Hologic and Serex with full access to all clinical trial data and
regulatory submissions, and make available all urine samples, collected by Ostex
that pertain to the NTx Assay Technology and to the activities of Hologic and
Serex under this Agreement. It is acknowledged that such information will be
subject to the confidentiality provisions set out in this Agreement 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.
5.5.4. TECHNICAL SUPPORT. Ostex shall assist
Hologic and Serex, at either's
reasonable request, in the technical training of a mutually determined number of
Hologic and/or Serex'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 business, and Hologic
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, WRF Bone Resorption Technology and Ostex Intellectual Property.
6. ROLE OF THE PARTIES IN MANUFACTURE AND COMMERCIALIZATION
OF NTX METER TEST.
6.1 MANUFACTURING. Pursuant to the Hologic/Serex Agreement,
Hologic shall, within a reasonable time period following FDA approval, develop
the capacity to manufacture or have manufactured reasonable commercial
quantities of the NTx Meter and NTx Meter Strips. Hologic may have Serex and/or
third parties manufacture and package the NTx Meter Strips (provided that they
have agreed to be bound by the terms of this Agreement, including its provisions
relating to confidentiality), and may manufacture the NTx Meter itself or
utilize third parties to do so, provided that Hologic shall first furnish Ostex
with evidence demonstrating any such third party's capability to manufacture
such NTx Meter Strips or NTx Meters pursuant to GMP and all applicable
regulatory requirements.
6.2 COMMERCIALIZATION. Six months prior to the anticipated
First Commercial Sale of NTx Meter Systems under this Agreement, but in no event
longer than 24 months from the effective date of this Agreement, Hologic and
Ostex, acting through the Product Management Committee, shall agree on a
marketing plan for said NTx Meter Systems for the following twelve months (a
"Marketing Year") that will be appended to this Agreement as ATTACHMENT 6.2. The
parties anticipate that such Attachment will cover marketing activities and will
require each party to spend, individually, XXXXXXXXXXXXXXXXXXXXXX of anticipated
total Gross Sales by both parties together of NTx Meter Strips and NTx Meters
for such year (as this number is determined by the Product Management Committee)
on marketing activities therefor. The Product Management Committee shall agree
on a new marketing plan for each subsequent Marketing Year during the term of
this Agreement; provided that such marketing plan shall not require either party
to spend XXXXXXXXXXXXXXXXX of that party's individual Gross Profit received
from its Sales of NTx Meter Systems during the immediately preceding Marketing
Year (not including royalties received from the other party pursuant to SECTIONS
7.3 or 7.4 hereof), provided further that if the Product Management Committee is
not able to agree on a marketing plan for any such subsequent Marketing Year,
the marketing plan (including budgetary allocations) for the immediately
preceding Marketing Year shall be repeated with expenditures equivalent to the
dollar expenditures of such preceding Marketing Year. If either party does not
spend the amount so designated pursuant to the marketing plan for any Marketing
Year of this Agreement, the other party shall, in addition to any other remedy
provided under this Agreement, be entitled to take a credit against royalties
payable by it for the subsequent Marketing Year equal to the shortfall. Said
Product Management Committee will also establish for each Marketing Year of the
term a designated quantity of NTx Meter Strips to be purchased by each party
pursuant to this Agreement, and distributed as "promotional samples" without
customer charge, and without royalty to either party. For the first Marketing
Year, the parties expect to designate not less than 30% of the anticipated
production of NTx Meter Strips as such "promotional samples" provided that this
percentage may be revised by the Product Management Committee in light of market
conditions and strategy, allocated 50% to each party or as otherwise agreed.
6.3 Supply of Critical Reagents. Ostex shall use its best
commercial efforts to supply the need of Hologic and its designated
manufacturer(s) for Critical Reagents as necessary to meet the demand for NTx
Meter Systems, in accordance with purchase orders received by Ostex from Hologic
and its designated manufacturer(s), and in SECTIONS 6.3.1 AND 6.3.2 below.
6.3.1 FORECAST OF DEMAND. Within sixty days of
the start of each calendar quarter, Hologic or its designated
manufacturer(s) shall deliver to Ostex a "rolling" forecast of quantities of
Critical Reagents to be purchased by Hologic and its designated manufacturer(s)
and supplied by Ostex during each month of 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 months thereof. The forecasted demand for
the first subsequent quarter shall be relied on by Ostex for purposes of its
manufacturing and supply obligations hereunder, but Hologic and its designated
manufacturer(s) may vary from its initial forecast for such quarter by no more
than twenty-five percent (25%). The forecasted demand for the final two quarters
of each Rolling Forecast shall be used by Ostex for planning purposes, but
Hologic and its designated manufacturer(s) shall not be bound by its initial
forecast(s), nor shall Hologic or its designated manufacturer(s) be liable to
Ostex with respect to any changes thereto.
6.3.2 ALLOCATION OF PRODUCTION. In the event
that Ostex does not meet the demand for Critical Reagents ordered pursuant
to SECTION 6.3.1, Ostex shall allocate overall production of Critical Reagents
(whether manufactured or purchased, and whether for Ostex's internal
manufacturing or for Sale) such that Hologic and its designated manufacturer(s)
receives the same proportion of the amount of the Critical Reagents it has
ordered (pursuant to SECTION 6.3.1 hereto) as Ostex allocates to its own
manufacture of products utilizing the NTx Assay Technology, or to its otherwise
most favored non-end-user customer, whichever proportion is greater (measured as
a proportion of total units of production), provided that Ostex shall not be
required to sell to Hologic and its designated manufacturer(s) any more than
thirty percent (30%) of its total production of any Critical Reagent during any
quarter.
6.3.3 EXERCISE OF MANUFACTURING OPTION. In
the event that Ostex does not for any
reason, for a period of thirty (30) days, meet (through internal or third-party
manufacture), Hologic's demand for Critical Reagents which comply with SECTION
3.4 hereof, ordered pursuant to SECTION 6.3.1 hereof, Hologic shall be entitled,
upon fifteen (15) days written notice, to exercise the option to manufacture
such Critical Reagents described in SECTION 2.2 hereof. Any Hologic exercise of
said option shall not relieve Ostex of its obligations pursuant to this SECTION
6.3. Upon any Hologic exercise of said option, Ostex shall provide to Hologic
subject to the provisions of SECTION 10 of this Agreement, all information
necessary to so manufacture such Critical Reagents, provided that Hologic shall
not disclose to Serex any Confidential Information so disclosed without the
prior written approval of Ostex which approval may be conditioned or withheld at
Ostex's sole discretion.
6.4 PUBLICATIONS. Each party shall, throughout the term of
this Agreement, use its continuing commercially reasonable efforts to develop
documentation and publish scientific articles directly or indirectly supporting
the clinical utility of the NTx Meter System. Such publications will be
submitted to the other party for review and approval prior to publication, and
shall be subject to the requirements of SECTION 16.2 hereof regarding the use of
trademarks.
7. ROLE OF THE PARTIES IN THE SALES OF THE NTX METER TEST.
7.1 The parties' general agreement is that Hologic and Ostex
shall each sell NTx Meter Strips and NTx Meters as they see fit, and shall share
the profits associated therewith in accord with the reciprocal royalty
mechanisms more specifically described in this Section.
7.2 OSTEX PURCHASE OF NTX METER STRIPS AND METERS Hologic
shall use its commercially reasonable efforts to supply the need of Ostex to
meet the demand for NTx Meter Strips and NTx Meters, in accordance with purchase
orders received by Hologic from Ostex, and in accordance with the rolling
forecast and allocation provisions specified in Sections 7.2.10 and 7.2.11
below.
7.2.1 Ostex shall pay Hologic a non-royalty
transfer price for NTx Meter Strips and
NTx Meters sold pursuant to this Section equal to XXXXXXXXXXXXXXX therefor
(including any extra charge for Ostex-requested modifications to standard
packaging as may be agreed).
7.2.2 Payment for each shipment of NTx Meter
Strips and NTx Meters shall be made by
Ostex within 30 days of the date of invoice, it being agreed that such invoice
shall not be dated prior to shipment of the NTx Meter Strips and NTx Meters to
which such invoice relates.
7.2.3 THIRD-PARTY MANUFACTURING ON BEHALF OF
HOLOGIC. In the event that Hologic
licenses a third party to manufacture NTx Meter Strips or NTx Meters to be
supplied to Ostex under this Agreement, Hologic shall ensure and provide
evidence to Ostex demonstrating that such third-party manufacturer complies with
good manufacturing practices (GMP) and all applicable governmental regulations
relating thereto and is either in compliance with or working toward compliance
with the quality standards established by the International Standards
Organization, Rules 9000 et seq. and amendments or successors thereto ("ISO
9000").
7.2.4 PRODUCT WARRANTY; QUALITY CONTROL. Hologic
warrants to Ostex that all NTx
Meter Strips and NTx Meters sold by Hologic to Ostex hereunder shall (i) comply
with the product specifications attached hereto as ATTACHMENT 7.2.4 when used in
accord with applicable Hologic instructions, as modified by mutual agreement of
the parties, (ii) be free from defects in material, workmanship and design, 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, Hologic
warrants that all NTx Meter Strips and NTx Meters manufactured and supplied for
the United States market under this Agreement shall be manufactured, tested,
documented, packaged, and transported in compliance with GMP requirements of the
FDA including, without limitation, 21 CFR Part 820 and any amendments or
successors thereto; and that all NTx Meter Strips and NTx Meters 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 Hologic facilities, books, and records to
confirm such compliance. Hologic further represents that 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 within one year of receipt that any product supplied
pursuant to this Agreement fails to meet these specifications and warranties,
Hologic shall, as Ostex's sole remedy for such failure, replace said product
(returned by Ostex to the factory pursuant to Hologic's reasonable standard
return procedures) with product which conforms to the above specifications and
warranties, provided that Hologic shall not be obligated to replace NTx Meter
Strips distributed as "Promotional Samples" which pass Hologic quality assurance
tests and comply with all FDA and other governmental regulations relating to
such Promotional Samples. These warranties shall not apply to any item that is
subjected to abuse, stress, or misuse; or used in any manner inconsistent with
applicable Hologic instructions; or insofar as any such warranty violation is
caused by Ostex's violation of its warranties set out in SECTION 3.4 hereof.
7.2.5 CUSTOMS AND TAXES. With respect to
international shipments of any goods
purchased, sold, distributed, or otherwise transferred hereunder, including the
Critical Reagents, the purchasing party shall be responsible for clearing all
such goods through customs and shall pay any and all taxes and/or duties imposed
by any governmental authority in connection therewith.
7.2.6 DELIVERY. All NTx Meter Strips and NTx
Meters purchased by Ostex under this
Agreement shall be shipped FOB manufacturer's dock.
7.2.7 INVENTORY. At all times during the
distribution term of this Agreement,
Hologic shall supply and Ostex shall keep sufficient inventory of NTx Meter
Strips and NTx Meters to carry out reasonable demand for orders therefor without
undue delay.
7.2.8 FAILURE OF PAYMENT. In the event that
Ostex fails to comply with the payment
terms of this Section, Hologic shall have the right, in addition to all other
rights available under this Agreement, to suspend further shipment of NTx Meter
Strips and NTx Meters until such breach is cured.
7.2.9 FACILITIES STANDARDS. At all times
during the term of this Agreement, Ostex
shall provide or cause to be provided such warehousing and transport facilities
as are both commercially reasonable and adequate under the applicable
regulations, product requirements, and industry standards of all relevant
jurisdictions under this Agreement.
7.2.10 FORECAST OF DEMAND. Within thirty days of
the start of each calendar quarter,
Ostex shall deliver to Hologic a "rolling" forecast of the quantities of NTx
Meter Strips and NTx Meters to be purchased by Ostex and supplied by Hologic
during each month of 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 NTx Meter Strips and
NTx Meters over the first three months thereof. The forecasted demand for the
first subsequent quarter shall be relied on by Hologic for purposes of its
manufacturing and supply obligations hereunder, but Ostex may vary from its
initial forecast for such quarter by no more than twenty-five percent (25%). The
forecasted demand for the final two quarters of each Rolling Forecast shall be
used by Hologic for planning purposes, but Ostex shall not be bound by its
initial forecast(s), nor shall Ostex be liable to Hologic with respect to any
changes thereto.
7.2.11 ALLOCATION OF PRODUCTION. In the event
that Hologic does not meet the demand
for NTx Meters or NTx Meter Strips ordered pursuant to SECTION 7.2.10, Hologic
shall allocate overall production thereof such that Ostex receives the same
proportion of the amount of the NTx Meters and NTx Meter Strips it has ordered
(pursuant to SECTION 7.2.10 hereto) as Hologic allocates for its direct sale, or
to its otherwise most favored non-end-user customer, whichever proportion is
greater (measured as a proportion of total units of production), provided that
Hologic shall not be required to sell to Ostex and any more than fifty percent
(50%) of its total production during any quarter.
7.3 OSTEX ROYALTY ON SALES OF NTX METER STRIPS AND NTX METERS.
Subject to the terms of SECTION 7.5 hereof, Ostex shall pay to Hologic a
royalty equal to XXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. Ostex shall make the royalty
payments required by this Section not later than forty-five (45) calendar days
following the end of each calendar quarter. At such time, Ostex shall also
provide Hologic with a full accounting of units disposed of, Gross Sales, Net
Sales, COGS, and Gross Profits attributable thereto for said quarter.
7.4 HOLOGIC ROYALTY ON SALES OF NTX METER STRIPS AND NTX
METERS. Subject to the terms of SECTION 7.5 hereof, Hologic shall pay
to Ostex a royalty equal to XXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX., provided that Hologic shall not
be required to make any royalty payment with respect to dispositions of NTx
meter technology incorporated into or sold as a package with or part of, other
Hologic equipment, XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. Hologic shall make the
royalty payments required by this Section not later than forty-five (45)
calendar days following the end of each calendar quarter. At such time, Hologic
shall also provide Ostex with a full accounting of units disposed of, Gross
Sales, Net Sales, COGS, and Gross Profits attributable to its Sales of NTx Meter
Strips, NTx Meters, and NTx meter technology (but not other Hologic equipment
into which said technology may be incorporated or packaged) for said quarter.
7.5 ADJUSTMENT TO ROYALTIES. Following the end of the first
year period beginning with the First Commercial Sale, and each subsequent year
period, if either party's Gross Sales of NTx Meter Strips for the prior
year period was not equal to or greater than XXXXXXXXXXX XXXXXXXXXXXXXXX by both
parties of such NTx Meter Strips, the royalty payable on said NTx Meter Strips
for the following year period by "the party with the larger Sales" shall be
adjusted downward by XXXXXXXXXXXXXXXXXXXX that the total Sales of NTx Meter
Strips by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX of such NTx Meter Strips, unless
"the party with the larger Sales" waives this adjustment.
7.6 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 Meter Strips or the NTx
Meter or the Critical Reagents (whether incorporated in NTx Meter Strips or in
any other product, including but not limited to the OsteomarkAE Laboratory Test)
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 NTx
Meter Strip or NTx Meter involved in the incident, as appropriate.
7.7 PRODUCT RECALL. If either party believes that a product
recall 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 insofar as such recall relates to Critical Reagents
(except printing and mailing costs incurred to notify customers of such recall),
shall be borne by Ostex. All out of pocket costs of a required or agreed recall
except insofar as such recall relates to Critical Reagents or the NTx Assay
Technology ( except printing and mailing costs incurred to notify customers of
such recall), shall be borne by Hologic. 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 or the NTx Assay
Technology were in violation of applicable law or the terms of this contract,
Hologic may obtain reimbursement by Ostex of all reasonable out of pocket costs
and expenses of such recall (except for printing and mailing costs incurred to
notify customers of such recall), or (ii) the fact that any NTx Meter or NTx
Meter Strip(s) were otherwise in violation of applicable law or the terms of
this contract, Ostex may obtain reimbursement by Hologic of all reasonable out
of pocket costs and expenses of such recall (except for printing and mailing
costs incurred to notify customers of such recall. Each party shall maintain
complete and accurate records of all product sold by it for such periods as
required by law. Nothing in this Section shall be construed to modify or limit
any legal obligation of either party with respect to any recall.
7.8 CORRECTIVE ACTION. If any government agency with
jurisdiction shall request or order any corrective action with respect to any
Critical Reagent, or NTx Meter or NTx Meter Strips, 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 (i) constitutes a
breach by a party of any of its warranties, representations or covenants
contained herein, or (ii) a party knew or should have known would require such
corrective action; 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.
8. BOOKS AND RECORDS; AUDITS. Each party to this Agreement shall
maintain accurate books and records with respect to all Critical Reagents and
NTx Meters and NTx Meter Strips. Upon the request of the other party, each party
will provide the requesting party or its independent public accountant with
access, 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 amounts owed. 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
the laws of Massachusetts, whichever rate is lower. All fees for such audits
shall be borne by the requesting party unless the audit shows an under reporting
of amounts due of five percent (5%) or more, in which case the costs of said
audit shall be borne by the party being audited.
9. 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 to the extent that such rights
relate exclusively to the NTx Assay Technology; and (b) vest solely in Serex to
the extent that such rights relate exclusively to the XXXX Format or adaptation
of the NTx Assay Technology for use with the XXXX Format; and (c) vest solely in
Hologic to the extent that such rights relate exclusively to the NTx Meter or
use of NTx Meter Strips with the NTx Meter; and (d) in all other cases vest in
the party or parties of the inventor.
10. OBLIGATION NOT TO DISCLOSE CONFIDENTIAL INFORMATION. Recipient
shall not at any time, and shall cause Serex (in the case of Hologic) and its
permitted assigns and sublicensees (in the case of either party) 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 other party without the express prior written consent of that
other party. 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 to whom disclosure is necessary or appropriate for the Recipient to
undertake its responsibility pursuant to this Agreement. Nothing in this
Agreement shall prevent Recipient from disclosing Confidential Information to
government agencies for regulatory purposes.
10.1 RECIPIENT'S OWN USE OF CONFIDENTIAL INFORMATION.
Recipient shall not make any use, directly or indirectly, of any Confidential
Information of the other party except in the ordinary course of business
pursuant to this Agreement or any other specific, written agreement entered into
between Ostex and Hologic.
10.2 SPECIFIC PERFORMANCE. The parties acknowledge that: (a)
the covenants set forth in this SECTION 10 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 10; 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 10
if Recipient fails to perform in accordance herewith.
11. SEREX DEVELOPMENT OF PLP TEST. Both parties acknowledge that Serex
has developed the PLP Assay, which determines the levels of a peptide linked
pyridinoline resulting from bone resorption, under the Hologic/Serex Agreement.
Notwithstanding any other provision of this Agreement, nothing shall prevent
Serex and/or Hologic from continuing this development or commercializing or
selling any results thereof, or from using any information provided or gained as
a result of this Agreement, or any derivative thereof, including Ostex Know-How
and Confidential Information, in the course of these activities, provided that
Hologic and Serex otherwise comply with the requirements of SECTION 10 hereof,
and provided always that Serex and Hologic shall not be entitled to use for said
purposes any intellectual property received pursuant to Hologic's election to
manufacture of Critical Reagents pursuant to SECTION 2.2 hereof. This provision
shall not be construed to provide Hologic or Serex with any right to use any
Ostex Patent Rights for any purpose not specifically permitted by this
Agreement, or to extend any Ostex Intellectual Property to cover the PLP Assay.
12. TERM AND TERMINATION.
12.1 INITIAL LICENSE TERM, AUTOMATIC RENEWAL. This Agreement
shall be in full force and effect as of the date first written above and
shall remain in effect XXXXXXXXXXXXthereafter unless sooner terminated pursuant
to this Section 12. On the XXXXXX and subsequent anniversaries of the date
hereof, the term of this Agreement shall (subject to SECTION 12.5 below) be
automatically continued for a period of XXXXXXXXXXXXXXXXXXX, unless either
Hologic delivers to Ostex, or Ostex delivers to Hologic, at least ninety (90)
days prior to such anniversary date, a written
notice of its intent to disengage for cause based upon failure of such other
party to use commercially reasonable efforts toward the achievement of market
objectives for NTx Meter Systems, in light of factors to include, without
limitation, profits, sales volume, market development, and the capture of market
share. In such event, if the parties are unable through good-faith negotiations
to agree to terms and conditions for further extension of the term hereof, this
Agreement and all license rights granted hereunder shall terminate as of the
anniversary date to which the notice of intent to disengage applies, without
liability of either party to the other in consequence of such termination.
12.2 TERMINATION BY OSTEX. Ostex shall have the right to
terminate this Agreement immediately upon notice in the event that: (a) Hologic
fails to complete development of the NTx Meter or to cause Serex to complete
development of the NTx Meter Strip in accord with the specifications set out in
ATTACHMENT 7.2.4 XXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXX, or to obtain regulatory
approval therefor for the United States within
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX; or (b) Hologic materially breaches or fails
to perform in a timely manner any of its material duties or obligations
hereunder, and such breach shall remain uncured, or the failure to perform shall
continue, for at least sixty (60) days after Ostex has given notice of such
breach or failure. Without limiting the generality of the foregoing, a "material
breach" or "failure to perform" shall include without limitation, any failure to
remit payments, or failure to comply with any financial reporting requirement,
or failure to maintain Hologic's rights pursuant to the Hologic/Serex
Agreement..
12.3 TERMINATION BY HOLOGIC. Hologic shall have the right to
terminate this Agreement immediately upon notice in the event that (a) Hologic
fails to complete development of the NTx Meter or to cause Serex to complete
development of the NTx Meter Strip in accord with the specifications set out in
ATTACHMENT 7.2.4 XXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXX, or to obtain regulatory
approval therefor for the United States within XXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX for any reason other than as a result of
Hologic's material breach of its obligations under this Agreement; or (b) Ostex
has materially breached or failed to perform in a timely manner any of its
material duties or obligations hereunder, and such breach shall remain uncured,
or the failure to perform shall continue, for at least sixty (60) days after
Hologic has given notice of such breach or failure to Ostex. Without limiting
the generality of the foregoing, a "material breach" or "failure to perform"
shall include without limitation, any failure to remit payments, or failure to
comply with any financial reporting requirement, or failure to maintain Ostex's
rights pursuant to the WRF/Ostex Exclusive License Agreement.
12.4 TERMINATION FOR TECHNICAL DEFECT.
12.4.1 BY OSTEX. If within ninety (90) days of
the Effective Date, Ostex determines
that a material technical deficiency exists in the XXXX Format which is likely
to prevent Serex or Hologic from completing development of an NTx Meter Strip
which meets the Product Specifications described in ATTACHMENT 7.2.4 within the
time period set out in SECTION 12.2(A) above, Ostex shall provide a notice
thereof to Hologic which describes in detail said purported deficiency and the
impact thereof on the specifications and/or time frame for development. Upon
receipt of such notice, Hologic shall conduct a though review of the subject
matter of said notice, provide to Ostex a detailed report of how Hologic or
Serex plan to resolve the issues raised and to meet the relevant specifications
and/or time frame, and meet with Ostex to review said report. If Hologic fails
to provide said report within fifteen (15) business days following receipt of
such notice, Ostex may within ten business days following the final due date of
such report, terminate this Agreement upon written notice without liability of
any sort.
12.4.2 BY HOLOGIC. If within ninety (90)
days of the Effective Date, Hologic
determines that a material technical deficiency exists in the NTx Assay
Technology or Critical Reagents which is likely to prevent Serex or Hologic from
completing development of an NTx Meter Strip which meets the Product
Specifications described in ATTACHMENT 7.2.4 within the time period set out in
SECTION 12.2(A) above, Hologic shall provide a notice thereof to Ostex which
describes in detail said purported deficiency and the impact thereof on the
specifications and/or time frame for development. Upon receipt of such notice,
Ostex shall conduct a though review of the subject matter of said notice,
provide to Hologic a detailed report of how Ostex plans to resolve the issues
raised and to meet the relevant specifications and/or time frame, and meet with
Hologic to review said report. If Ostex fails to provide said report within
fifteen (15) business days following receipt of such notice, Hologic may within
ten business days following the final due date of such report, terminate this
Agreement upon written notice without liability of any sort.
12.4 BANKRUPTCY OF A PARTY.
12.4.1 OSTEX BANKRUPTCY. All rights and licenses
granted under or pursuant to this
Agreement by Ostex to Hologic are, and shall otherwise be deemed to be, for
purpose of Section 365(n) of Title 11, U.S. Code (the "Bankruptcy Code"),
licenses of rights to "intellectual property" as defined under Section 101(60)
of the Bankruptcy Code. The parties agree that Hologic, as a licensee of such
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code.
12.4.2 HOLOGIC BANKRUPTCY. All rights and
licenses granted under or pursuant to this
Agreement by Hologic to Ostex are, and shall otherwise be deemed to be, for
purpose of Section 365(n) of Title 11, U.S. Code (the "Bankruptcy Code"),
licenses of rights to "intellectual property" as defined under Section 101(60)
of the Bankruptcy Code. The parties agree that Ostex, as a licensee of such
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code.
12.5 RESERVED
12.6 MAXIMUM TERM. Notwithstanding any provision of this
Agreement to the contrary, the license granted with respect to the Ostex Patent
Rights under SECTION 2 above shall terminate upon expiration of the last
remaining Ostex Patent Right. Upon such expiration, Hologic shall be deemed to
have a perpetual, worldwide, royalty free license to manufacture, make, have
manufactured or made, use, market, sell, and distribute NTx Meter Strips
worldwide except Japan for any application.
12.7 RIGHTS AND DUTIES UPON TERMINATION.
12.7.1 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.
12.7.2 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.
12.7.3 NTX METER STRIPS REMAINING. Upon
termination of this Agreement, Hologic shall
have the right to sell NTx Meter Strips then remaining in its possession or to
be manufactured using Critical Reagents then held in inventory, and Ostex may
sell NTx Meter Strips then remaining in its possession, within a reasonable time
after termination hereof; provided, however, that all such Sales shall be
subject to the royalty provisions of this Agreement, notwithstanding
termination. Alternatively, Hologic may return Critical Reagents remaining in
inventory and in good condition to Ostex for a refund of the original transfer
price (or for credit toward any amounts due).
12.7.4 SURVIVAL OF TERMS. Notwithstanding
any other provision herein to the
contrary, SECTIONS 3.4, 7.2.4, 7.3, 7.4, 7.6-7.8, 8-13, 16.4, 16.5, and 18-28 of
this Agreement shall survive any termination or expiration hereof.
13. REPRESENTATIONS, WARRANTIES AND INDEMNITIES.
13.1 BY OSTEX. Ostex represents and warrants to Hologic
as follows:
13.1.1 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. As of the Effective Date of the Agreement, Ostex is in
full compliance with the WRF/Ostex Exclusive License Agreement and has not been
notified of any assertion that it is in default of said WRF/Ostex Exclusive
License Agreement or that WRF plans to terminate any Ostex rights thereunder.
Ostex shall immediately notify Hologic if it receives any notice that it is in
default of said WRF/Ostex Exclusive License Agreement or that WRF plans to
terminate any Ostex right thereunder.
13.1.2 OSTEX PATENT RIGHTS AND OSTEX KNOW-HOW.
As of the Effective Date of the
Agreement, and except as described in ATTACHMENT 13.1.2 to this Agreement, (a)
Ostex has sole and exclusive rights to the Ostex Patent Rights and all rights
necessary to convey Ostex Know-How to Hologic and Serex; (b) the Ostex Patent
Rights, to the best knowledge of Ostex are valid and enforceable, and do not
infringe on the proprietary rights of any third party: (c) Ostex is not aware of
any "prior art" or other claim which would invalidate any part or all of the
Ostex Patent Rights; or any claim that Ostex does not have all rights to use and
permit Hologic and Serex to use the Ostex Know-How for all purposes permitted by
this Agreement; (d) Ostex is not aware of any unexpired patent or pending patent
application of a party not a party to this agreement which has claims which
cover any part of the Ostex Know-How or Ostex Patent Rights; and (e) Ostex has
taken all necessary actions to maintain all Ostex Patent Rights in full force
and effect.
13.1.3 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.
13.1.4 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.
13.2 BY HOLOGIC. Hologic represents and warrants to Ostex
as follows:
13.2.1 ORGANIZATION AND AUTHORITY. As of the
Effective Date of the Agreement,
Hologic is duly organized, validly existing and in good standing under the laws
of Delaware, USA 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 Hologic, 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 Hologic in accordance with its terms. Except as have been or
will be obtained by Hologic, 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 As of the Effective
Date of the Agreement, Hologic is in full compliance with the Hologic/Serex
Agreement and has not been notified of any assertion that it is in default of
said Hologic/Serex Agreement or that Serex plans to terminate any Hologic rights
thereunder. Hologic shall immediately notify Ostex if it receives any notice
that it is in default of said Hologic/Serex Agreement or that Serex plans to
terminate any Hologic right thereunder.
13.2.2 SEREX PATENT RIGHTS. As of the Effective
Date of the Agreement, (a) Hologic
is not aware of any "prior art" which would invalidate any part or all of the
XXXX patents; and (b) Hologic is not aware of any unexpired patent or pending
patent application of a party not a party to this agreement which has claims
which cover any part of the XXXX patents.
13.2.2.1HOLOGIC PATENT RIGHTS AND HOLOGIC
KNOW-HOW. As of the Effective Date
of the Agreement, (a) Hologic has sole and exclusive rights to the Hologic
Patent Rights and all rights necessary to convey Hologic Know-How to Ostex; (b)
the Hologic Patent Rights, to the best knowledge of Hologic are valid and
enforceable, and do not infringe on the proprietary rights of any third party;
(c) Hologic is not aware of any "prior art" or other claim which would
invalidate any part or all of the Hologic Patent Rights; or any claim that
Hologic does not have all rights to use and permit Ostex to use the Hologic
Know-How for all purposes permitted by this Agreement; (d) Hologic is not aware
of any unexpired patent or pending patent application of a party not a party to
this Agreement which has claims which cover any part of the Hologic Know-How or
Hologic Patent Rights; and (e) Hologic has taken all necessary actions to
maintain all Hologic Patent Rights in full force and effect.
13.2.3 NO DEFAULT. The execution, delivery and
performance of this Agreement by
Hologic 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 Hologic is a party or by
which it is bound.
13.2.4 HOLOGIC'S DISCLAIMER OF OTHER
WARRANTIES. Hologic 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, HOLOGIC 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
13.3 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 13, 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
13.4 GOVERNMENTAL COMPLIANCE. Each party shall obtain and
maintain all required licenses, permits, certificates and authorizations needed
to perform its obligations under this Agreement, including without limitation
those required for said party's appointment as sublicensee, for the
effectiveness of this Agreement in all jurisdictions where said party operates,
for the import and for the export of NTx Meter Systems, and for the marketing,
distribution and Sale of NTx Meter Systems. Each party shall be solely
responsible for compliance with any foreign exchange controls affecting its
activities.
14. THIRD-PARTY INFRINGEMENT.
14.1 NOTICE OF 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 Patent Rights of a party licensed
hereunder relating to the Field of Use, said party (the "Notifying Party") shall
immediately report such information to the other party to this Agreement and
shall provide in such report 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. At such time as the party owning or
controlling the infringed patents ("Aggrieved Party") shall, in its sole
judgment, be satisfied that there exists a reasonable likelihood of
infringement, Aggrieved Party shall take such steps, including notification, to
place the putative infringer on notice of Aggrieved Party's claims. The form of
the notification and the manner and nature of any communications between
Aggrieved Party and the alleged infringer shall be within the sole discretion of
Aggrieved Party.
14.2 RIGHT TO XXX. If, sixty (60) days after receipt of notice
of a perceived third-party infringement, such third party infringement continues
and the Aggrieved Party has not commenced legal action or presented to the
Notifying Party a plan acceptable to the Notifying Party to enjoin or otherwise
to resolve such infringement, then the Notifying Party shall be entitled, at its
own expense and for its own benefit, to commence an action in its own name. In
the event that the Aggrieved Party initiates such action, the Aggrieved Party
shall be entitled to retain all damages awarded therein. In the event that the
Notifying Party initiates such action, the Notifying Party shall be entitled to
retain one half of all damages awarded therein attributable to the Field of Use,
after payment of all reasonable legal expenses of such litigation. In the event
that the rules then obtaining shall require the naming of the owner of said
Patent Rights for purposes of such infringement action, the Notifying Party
shall be entitled to name the Aggrieved Party, or to cause the Aggrieved Party
to consent to be named, as a party plaintiff in such action; and failing such
cooperation the Notifying Party shall be entitled to reduce royalties payable to
the Aggrieved Party by fifty percent (50%). Each party shall assist the other
party and reasonably cooperate in any such action at said party's request.
15. DEFENSE OF THIRD-PARTY CLAIMS.
15.1 HOLOGIC DEFENSE OF THIRD-PARTY CLAIMS AND INDEMNITY. In
the event that any claim, suit, or other legal proceeding is threatened or
commenced against Ostex or WRF that is founded, in whole or in part, on an
allegation that the NTx Meter or NTx Meter Strip infringes any trade secret,
patent, or copyright belonging to a third party (other than WRF), Ostex will
give Hologic prompt written notice of such legal proceeding and Hologic may
elect to assume sole control of the defense to or settlement of such dispute.
Ostex shall cooperate fully with Hologic in any defense, settlement or
compromise made by Hologic. Ostex shall not enter into any settlement agreement
or other voluntary resolution of any such claim, suit, or other legal proceeding
without obtaining Hologic's prior written consent thereto. If Ostex has complied
fully with the procedures set forth in this SECTION 15.1, Hologic will indemnify
and hold Ostex harmless from and against any loss, cost, damage, or other
expenses incurred by Ostex as a result of such claim, suit or legal proceeding.
If a final injunction is obtained against Ostex's use of the NTx Meter or NTx
Meter Strips, or if in the opinion of Hologic the subject NTx Meter or NTx Meter
Strips are likely to become the subject of a successful claim of infringement,
Hologic may, at its option and expense, (i) procure for Ostex the right to
continue distributing and/or using the NTx Meter or NTx Meter Strips, (ii)
replace or modify the NTx Meter or NTx Meter Strips so that it (they) become
non-infringing, or (iii) if neither (i) or (ii) are reasonably available, accept
return of the NTx Meter or NTx Meter Strips held by Ostex and its distributors
in inventory, and terminate this Agreement without further obligation or
liability. This indemnification provision shall be null and void and Hologic
shall have no liability to the extent that any claim is based on any use of the
NTx Assay Technology, Critical Reagents or Ostex Intellectual Property or if the
NTx Meter or NTx Meter Strips have been modified or tampered with in any way
without the express written consent of Hologic, or if Ostex has any interest in
the claim, suit or other legal proceeding, or any license to any right so
asserted.
15.2 OSTEX DEFENSE OF THIRD-PARTY CLAIMS AND INDEMNITY. In the
event that any claim, suit, or other legal proceeding is threatened or commenced
against Hologic or Serex that is founded, in whole or in part, on an allegation
that the NTx Assay Technology, Critical Reagents or Ostex Intellectual Property
as used in the NTx Meter System infringes any trade secret, patent, or copyright
belonging to a third party (other than Serex), Hologic 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. Hologic shall cooperate
fully with Ostex in any defense, settlement or compromise made by Ostex. Hologic
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 Hologic has complied fully with the procedures set
forth in this SECTION 15.2, Ostex will indemnify and hold Hologic harmless from
and against any loss, cost, damage, or other expenses incurred by Hologic as a
result of such claim, suit or legal proceeding. If a final injunction is
obtained against Hologic's use of the NTx Assay Technology, Critical Reagents or
Ostex Intellectual Property as used in the NTx Meter Systems, or if in the
opinion of Ostex the NTx Assay Technology, Critical Reagents or Ostex
Intellectual Property are likely to become the subject of a successful claim of
infringement, Ostex may, at its option and expense, (i) procure for Hologic the
right to continue distributing and/or using the NTx Assay Technology, Critical
Reagents or Ostex Intellectual Property in the NTx Meter System, (ii) replace or
modify the NTx Assay Technology, Critical Reagents or Ostex Intellectual
Property so that it (they) become non-infringing, or (iii) if neither (i) or
(ii) are reasonably available, accept return of the NTx Assay Technology,
Critical Reagents or Ostex Intellectual Property used in the NTx Meter Systems
held by Hologic and its distributors in inventory, and terminate this Agreement
without further obligation or liability. This indemnification provision shall be
null and void and Ostex shall have no liability to the extent that NTx Assay
Technology, Critical Reagents or Ostex Intellectual Property have been modified
or tampered with in any way without the express written consent of Ostex, or if
Hologic or Serex have any interest in the claim, suit or other legal proceeding,
or any license to any right so asserted.
15.3 ROYALTY PAYMENTS. Except as provided above, any
entitlement to terminate royalties shall occur only upon a final adjudication of
the invalidity or non-enforceability of the patents, copyrights or trade secrets
in question. For such purposes, final adjudication shall mean an adjudication or
determination by a trial court or a court of appeal, which adjudication or
determination shall be final, binding and not further appealable, whether by its
terms or by the passage of time.
16. USE OF TRADEMARKS AND TRADE NAMES.
16.1 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 NTx
Meter Systems, any name, trade name, trademark, or other designation (or
derivation thereof) of the other party hereto or WRF or the University of
Washington, or Serex, except as expressly provided under this SECTION 16.
16.2 USE OF NAMES AND MARKS IN LABELING. As a part of the
marketing plan prepared pursuant to SECTION 6.2 hereof, the parties shall agree
upon appropriate trademark(s) to be used in connection with NTx Meter Strips
marketed, promoted, sold, and/or distributed under this Agreement. In the
absence of such agreement, the parties agree that Hologic shall affix to the
outer packaging of, and shall include on the package insert for, any NTx Meter
Strips marketed, promoted, sold, and/or distributed by Hologic under this
Agreement, and in addition to its own trademarks and names, one or more labels
displaying with equal prominence to said Hologic trademarks or names, the
statement "An OsteomarkAE Assay" or such other trademark or statement as Ostex
shall reasonably request, and Ostex shall affix to the outer packaging of, and
shall include on the package insert for, any NTx Meter Strips marketed,
promoted, sold, and/or distributed by Ostex under this Agreement, and in
addition to its own trademarks and names, displaying with equal prominence to
said Ostex trademarks or names such other trademark or statement as Hologic
shall reasonably request. Ostex shall also have the right to review and approve
all claims relating to the intended use of NTx Meter Strips contained in package
inserts and other promotional materials, which approval shall not be
unreasonably withheld. Each party hereby grants to the other party a
non-transferable, non-exclusive license, concurrent with the term of this
Agreement, to use such statement and/or trademark accordingly and in
substantially the same manner as used by its owner; provided, however, that each
such use of such statement and/or trademark be accompanied by a printed notice
identifying the owner as the owner thereof. Neither party shall use any
trademark of the other party with respect to products not covered by this
Agreement. In the event that particular NTx Meter Strips do not meet the
specifications or quality standards required under SECTIONS 3.4 or 7.2.4 above,
either party may cause the other party to remove all trademarks of said party
from such NTx Meter Strips and shall have the right to cancel the foregoing
grant of license to use such trademarks, unless the other party promptly meets
such specifications or quality standards. Each party shall have the right to
receive and approve the use of its marks in any proposed product literature,
advertising material or material for publication. In all such materials unless
otherwise specifically agreed in advance in writing, the immunoassay performed
by the NTx Meter Strips shall be identified as "An OsteomarkAE Assay."
16.3 TRADEMARK REGISTRATION. Ostex and Hologic shall each be
responsible for the registration, maintenance and enforcement of their
respective names, trade names, and trademarks; provided, however, that each
party shall aid the other in the enforcement of that party's rights by
monitoring for, and notifying said party of, any unauthorized use of any of said
party's trademarks. 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.
16.4 OSTEX REPRESENTATIONS AND WARRANTIES. Ostex represents
and warrants, as of the date of this Agreement, that: (a) Ostex is the owner and
registrant of the trademarks issued registrations as indicated by ATTACHMENT
16.4; (b) Ostex is named as applicant in those applications indicated by
ATTACHMENT 16.4 as pending; and (c) to the best of its knowledge, none of the
Ostex trademarks infringes upon the trademark, trade name, or other proprietary
rights of a third party. In the event that any action or proceeding is initiated
against Ostex, Hologic, or any other licensee or distributor of Ostex in any
country alleging that the trademark "Osteomark" infringes the trademark rights
of the third party initiating such action or proceeding, Hologic may continue to
market NTx Meter Strips within such country without the trademark "Osteomark"
affixed thereto (but with such other trademark as Ostex may reasonably specify)
pending resolution of the dispute as to trademark rights.
16.5 HOLOGIC REPRESENTATIONS AND WARRANTIES. Hologic
represents and warrants, as of the date of this Agreement, that: (a) Hologic is
the owner and registrant of the trademarks issued registrations as indicated by
ATTACHMENT 16.5; (b) Hologic is named as applicant in those applications
indicated by ATTACHMENT 16.5 as pending; and (c) to the best of its knowledge,
none of the Hologic trademarks infringes upon the trademark, trade name, or
other proprietary rights of an third party. In the event that any action or
proceeding is initiated against Hologic, Ostex, or any other licensee or
distributor of Hologic in any country alleging that any Hologic trademark
infringes the trademark rights of the third party initiating such action or
proceeding, Ostex may continue to market NTx Meter Strips within such country
without said Hologic trademark affixed thereto (but with such other trademark as
Hologic may reasonably specify) pending resolution of the dispute as to
trademark rights.
17. ASSIGNMENT AND SUBLICENSE.
17.1 BY HOLOGIC. Except as specifically permitted by this
Agreement, Hologic shall not assign, sublicense, delegate, or in any other
manner transfer any of its rights, privileges, obligations or duties under this
Agreement to any non-Affiliate 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 Hologic, or any third-party
acquisition of a majority of the business interests or voting shares of Hologic,
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 Hologic to assign, sublicense, delegate or
otherwise transfer any right, privilege, obligation or duty under this Agreement
other than in accordance with this SECTION 17 shall be void and shall, at the
option of Ostex, be cause for immediate termination of this Agreement and all
licenses granted hereunder. Transfers of any rights hereunder by Hologic to an
Affiliate shall be permitted only after the delivery to Ostex of reasonable
evidence that such Affiliate has agreed in writing to be bound by the terms of
this Agreement.
17.2 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 non-Affiliate third party without the prior written consent of
Hologic, which consent may be withheld in Hologic'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 17 shall be void and shall,
at the option of Hologic, be cause for immediate termination of this Agreement
and all licenses granted hereunder. Transfers of any rights hereunder by Ostex
to an Affiliate shall be permitted only after the delivery to Hologic of
reasonable evidence that such Affiliate has agreed in writing to be bound by the
terms of this Agreement.
18. ARBITRATION.
18.1 AGREEMENT TO SETTLE DISPUTES BY ARBITRATION. At the
request through notice of either Ostex or Hologic, 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 Hologic, or in
Boston, Massachusetts, 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.
18.2 APPOINTMENT OF ARBITRATORS. Within thirty (30) days after
the delivery pursuant to SECTION 18.1 above of a notice of request for
arbitration, Hologic and Ostex shall each appoint one 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
NTx Meter Systems. 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.
18.3 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 SECTION 19.3 below.
18.4 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.
18.5 PROTECTIVE ORDER. In the event of arbitration and at the
request of either Ostex or Hologic, 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.
18.6 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.
18.7 RIGHTS OF THIRD PARTIES. Notwithstanding the agreement to
arbitrate any dispute between Ostex and Hologic, in the event that a controversy
or claim between Ostex and Hologic 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.
18.8 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.
19. ATTACHMENTS. The Attachments listed below are incorporated
by reference into this Agreement
and shall for all purposes be deemed part hereof:
Attachment D Serex Patent Rights
Attachment 3.4 Ostex Critical Reagent Specifications
Attachment 6.2 Marketing Plan (To be Appended per SECTION 6.2)
Attachment 7.2.4 Product Specifications - NTx Meter Strips and NTx
Meters
Attachment 13.1.2 Ostex Patent Rights and Know-How - Exceptions to
Warranty
Attachment 16.4 Ostex Trademark Filings
Attachment 16.5 Hologic Trademark Filings
20. 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).
21. 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 Meter
Systems, the parties agree as follows:
21.1 OSTEX LIABILITY. Ostex shall be liable for and shall
indemnify and hold Hologic harmless against any liability, damages or loss and
from any claims, suits, proceedings, demands, recoveries or expenses in
connection with (i) any Critical Reagents or NTx Assay Technology licensed or
sold by Ostex to Hologic or its designated manufacturers pursuant to this
Agreement arising out of, based on, or caused by product claims whether written
or oral, made or alleged to be made, by Ostex in its advertising, publicity,
promotion, or Sale of the Critical Reagents or NTx Assay Technology where such
product claims were not approved by Hologic, including without limitation
expenses of total or partial product recalls as described in SECTION 7.7 hereof,
or (ii) any breach by Ostex of any of its representations or warranties
contained herein or (iii) any of its negligent or willful acts or omissions.
Hologic shall promptly notify Ostex of any such demand or claim which comes to
its attention.
21.2 HOLOGIC LIABILITY. Hologic shall be liable for and shall
indemnify and hold Ostex harmless against any liability, damages or loss and
from any claims, suits, proceedings, demands, recoveries or expenses in
connection with (i) any NTx Meters or NTx Meter Strips sold by Hologic to Ostex
pursuant to this Agreement arising out of, based on, or caused by product claims
whether written or oral, made or alleged to be made, by Hologic in its
advertising, publicity, promotion, or Sale of the NTx Meters or NTx Meter Strips
where such product claims were not approved by Ostex, including without
limitation expenses of total or partial product recalls as described in SECTION
7.7 hereof, or (ii) any breach by Hologic of any of its representations or
warranties contained herein or (iii) any of its negligent or willful acts or
omissions. Ostex shall promptly notify Hologic of any such demand or claim which
comes to its attention.
21.3 CONSEQUENTIAL, INCIDENTAL, AND PUNITIVE DAMAGES.
Notwithstanding any other provision of this Agreement, 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), regardless of
whether such other party has been informed of the possibility that such damages
may occur.
22. 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: Xxxxxxx X. Xxxxxx, Ph.D.,
Senior Vice President, Corporate Development
Copy to: Xxxxxx Xxxxxx, President and COO
if to Hologic:
Hologic, Inc.
000 Xxxxxxx Xxxxxx,
Xxxxxxx, XX 00000
Attention: Xxxx Xxxxxxxxx, Vice President -
Business Development
Copy to: S. Xxxxx Xxxxxxxxxx, Chairman and CEO
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 21 designate a
substitute address for receipt of future notices.
23. GOVERNING LAW. All claims or controversies asserted by Ostex
against Hologic or Serex shall be construed and enforced in accordance with the
laws of the Commonwealth of Massachusetts. 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
Hologic or Serex), shall be brought and tried in the State or Federal Courts
located in Massachusetts. All claims or controversies asserted by Hologic
against Ostex or WRF shall be construed and enforced in accordance with the laws
of the State of Washington. Any judicial action by Hologic relating to the
relationship between the parties pursuant to this Agreement, or goods purchased
or licensed hereunder (together with any counterclaims asserted by Ostex or
WRF), 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 18 shall be governed by and construed
in accordance with the Federal Arbitration Act.
24. INTEGRATION. 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
Agreement, and, neither party makes any covenant or other commitment to the
other concerning its future action. Accordingly, this Agreement, in conjunction
with the Co-Promotion Agreement:- (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 forth in this
Agreement 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 Agreement 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.
25. MODIFICATION. No modification to this Agreement shall be
enforceable unless made in writing
and signed by an authorized representative of each party.
26. 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.
27. 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.
28. 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 17
above.
29. NONCOMPETITION. During the term of this Agreement, Hologic shall
not enter into or maintain any marketing, licensing, or development agreement or
relationship (whether directly or by reason of any merger, acquisition,
consolidation or otherwise) with any company (other than Serex) which competes
with Ostex to develop biochemical markers of bone resorption, and Ostex shall
not enter into or maintain any marketing, licensing, or development agreement or
relationship (whether directly or by reason of any merger, acquisition,
consolidation or otherwise) with any company which competes with Hologic to
develop devices to measure bone mass or other structural characteristics. If
Hologic violates this provision, Ostex as its sole remedy for such violation may
at its option and upon 30 days notice, terminate this Agreement. If Ostex
violates this provision, Hologic as its sole remedy for such violation may at
its option and upon 30 days notice, terminate this Agreement.
30. STANDSTILL PROVISION. During the term of this Agreement, Hologic
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; 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 Hologic or Serex, respectively,
without the prior written consent of Hologic'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.
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.
OSTEX INTERNATIONAL, INC.
By /S/ XXXXXXX X. XXXXXX, PH.D.
Xxxxxxx X. Xxxxxx, Ph.D.,
Senior Vice President,
Corporate Development
HOLOGIC, INC.
By /S/ S. XXXXX XXXXXXXXXX
S. Xxxxx Xxxxxxxxxx
Chairman and CEO
ATTACHMENT D
SEREX PATENT RIGHTS
See Attached List as of 12/26/95 which represents Hologic's current knowledge
(to be updated and confirmed)
PATENTS
(a list to be updated to the date of this Amendment)
1. US Patent No. 5,451,504 (Serial No. 07/737,091).
Method and Device for Detecting the Presence of an Analyte in a Sample
2. US Serial No. 08/047,156
An Integrated Packaging Holder Device for Immunochromatographic Assays in
Flow-Through or Dipstick Formats and foreign counterparts thereof and continuing
application US Serial No. 08/539,170 (continuation of 08/047,156)
3. US Serial No. 08/196,092 and foreign Counterparts
4. US Serial No. 08/493.420 and foreign counterparts
5. US Serial No. 08/192,778
ATTACHMENT 3.4
Ostex Critical Reagent Specifications
OSTEX INTERNATIONAL, INC.
TITLE Lot No. Doc No. Rev. Page
Ion Exchange 1H11 2020 B 16 of 16
Purified
_______________________________________________________________________
7.0 Quality Control Testing
7.1 XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
_______________________________________________________________________
Test Acceptance Pass/ Initials/
Parameter Method Criteria Results Fail Date
_______________________________________________________________________
7.2 XXXXX 0004 XXXXX _____ ____ ____
7.3 XXXXX 0006 XXXXX _____ ____ ____
7.4 XXXXX XXX XXXXX _____ ____ ____
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXX results
_________________________________________________________________________
Record reviewed by_________________________ ___________________
Quality Control Date
Record reviewed by_________________________ ___________________
Quality Assurance Date
Released _________________________________ Not Released _________
OSTEX INTERNATIONAL, INC.
TITLE Lot No. Doc No. Rev. Page
NTx Concentrate 2007 G 23 of 24
_______________________________________________________________________
-------ATTACHMENT 3-------
QC DATA SHEET
Volume NTx nromal NTx Total Protein Protein Specific Activity
(ml) BCE step 3.1 nanamol (ml) step 8.3 Total mg - (nmol/ml)/
(ml) protein (mg/ml mg/mlprotein
nmol/ml BCE Vol (ml))
____ ______ ________ _____ ________ __________
7.3.4 XXXX Step 7.3.3
7.10 XXXX Step 7.9
7.22 XXXX Step 7.20
7.28 XXXX Step 7.27
Total Nanomole yield = (total nmoles step 7.3.4) x 100=___________%
-----------------------------
(total nmoles step 7.28)
QC materials used
Osteomark kit PN 9006 or 9006 LN _____, clibrator diluent PN 2022 LN____
PBS PN 2003 LN ___. Gold 300 xxxx.xx NTx in PBS 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(C)is greater than
20%, repeat steps 8.1.3 to 8.1.5)
(H) Average (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 aloquots: _________
Volume of alquots: __________
Total volume to inventory:________
Total nanomoles BCE to Inventory: _________
ATTACHMENT 6.2
MARKETING PLAN (TO BE APPENDED PER SECTION 6.2)
ATTACHMENT 7.2.4
Product Specifications - NTx Meter Strips and NTx Meters
See Attached - Subject to Modification
Product Specifications - NTx Meter Strips and NTx Meters
Hologic Point-of-Care Bone Resorption Test
DRAFT Specifications (Goals)
1. The test is being designed so as to qualify for XXXXX.
2. Specimens = XXXX.
3. The method of XXXXXXXX must be simple, clean, nearly foolproof, and
designed "to render the likelihood of erroneous results negligible." XXXXX
4. There will be XXXXX.
5. The target time to run the tests, from the beginning of application of the
specimen to the strips, is XXXXX.
6. The XXXXX limits of the XXXXX. The test should cover XXXXX.
7. The XXXXX limits of the XXXXX. The test should cover XXXXX.
8. For both tests, XXXXX.
9. XXXXX. There will be approximately the dame as those of comparable tests
currently commercially available.
10. Substances typically or occasionally found in XXX should not interfere
with test performance. Though the list remains to be specified, probable
candidates for inclusion are: XXXXX.
TEST FORMAT
11. Initiation of any timing should be simple. (E.G.,XXXXX).
12. Once the (timed) test begins, and until it concludes, XXXX should be
required.
CONTROLS
13. XXXXX will be supplied to users, with appropriate instructions for use.
The goal is to have XXXX, and controls XXXX which are to be run as infrequently
as possible, while providing acceptable levels of control.
METER FUNCTION
14. The meter will detect XXXX from each strip, and then using XXXX will
calculate concentrations and the XXXX.
15. The result reported by the meter will be the XXXXX.
16. XXXXX.
17. The meter will XXXXX as required. XXXXXX.
ERROR CONDITIONS
18. XXXXX.
19. If the meter detects a XXXX, no test result will be reported, and the
meter will indicate XXXX.
20. Application of an XXXXXXX will detedted by the meter, and no test result
will be reported.
METER MAINTENANCE
21. The XXXX of the meter will be cleanable using XXXX.
22. If a meter malfunctions, it will be returned to the manufacturer for
repair, and a replacement meter will be given to the user.
METER POWER, RELIABILITY
23. The meter will be powered by XXXX. Target XXXX lifetime is XXXXX.
24. Meter XXXXXXXXXXXXX in production.
STABILITY
25. Target strip stability at launch XXXX.
METER REGULATORY REQUIREMENTS
26. The meter will be manufactured according to XXXXX.
27. The meter will have the XXXX.
28. The meter will meet XXXX limits XXXX and XXXX limits XXXXX.
ATTACHMENT 13.1.2
OSTEX PATENT RIGHTS AND KNOW-HOW - EXCEPTIONS TO WARRANTY
Pursuant to paragraph 14.1, the WRF and Ostex on June 12, 1996, filed a civil
action for patent infringement against Osteometer Biotech A/S and Diagnostic
Systems Laboratories, Inc. in the U.S. District Court of the Western District of
Washington at Seattle (Civil Action No. C96-0910WD). The patent in suit, U.S.
Patent No. 5,455,179, claims a method of monitoring degradation of type I
collagen using an antibody that binds to carboxy-terminal telopeptide
metabolites of type I collagen in urine and other body fluids. Plaintiffs claim
that the CrossLaps ELISA Kit manufactured and distributed by the defendants
infringes the `179 patent. Defendants have counterclaimed that the `179 patent
is invalid, not infringed, and unenforceable. Osteometer has also denied
jurisdiction. The case is set for trial commencing 12/2/97.
Ostex is also defending two of its European patents in opposition
proceedings in the European Patent Office. European Patent No. 394,296 has been
opposed by Osteometer Biotech A/S, X.Xxxxxxx-XxXxxxx AG, and Metra Biosystems,
Inc. European Patent No. 502,928 has been opposed by Osteometer Biotech A/S,
Metra Biosystems, Inc., and Boehringer Mannheim GMBH.
ATTACHMENT 16.5
HOLOGIC TRADEMARK FILINGS
XXXX REGISTRATION NO. ISSUE DATE NOTES
---- ---------------- ---------- -----
ACCLAIM 1,70,513 4/23/96 X-Ray Technology, Inc.
CER 1,751,849 2/9/93 _
HOLOGIC 1,652,292 7/30/91 _
XXXXXXX XXXXXXXXXXXX XXXXX XXXXXXXXX.
XXXXXXX XXXXXXXXXXXX XXXXX XXXXXXXXX
QDR 1,510,840 11/1/88 Assigned to X-Ray Technology,
QDR-1000 1,506,996 10/4/88 Assigned to X-Ray Technology,
Inc. 11/4/91
SAHARA 2,008,809 10/15/96 _
XXXXXXX XXXXXXXXXXX XXXXXX XXXXXXXXXX
UBA 1,529,557 3/14/89 _
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
