<PAGE>
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K/A
PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
----- -----
X ANNUAL REPORT
----- FOR THE FISCAL YEAR ENDED DECEMBER 31, 1996
-- or --
-----
TRANSITION REPORT
----- FOR THE TRANSITION PERIOD FROM ____ TO ____
-------------------------------
OSTEX INTERNATIONAL, INC.
NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER
0-25250
COMMISSION FILE NUMBER
STATE OF WASHINGTON
STATE OR OTHER JURISDICTION OF INCORPORATION OR ORGANIZATION
91-1450247
I.R.S. EMPLOYER IDENTIFICATION NUMBER
2203 AIRPORT WAY SOUTH, SUITE 400, SEATTLE, WASHINGTON 98134
206-292-8082
ADDRESS AND TELEPHONE NUMBER OF PRINCIPAL EXECUTIVE OFFICES
Securities registered pursuant to Section 12(b) of the Act:
(none) (none)
Title of Class Each Exchange on Which Registered
Securities registered pursuant to Section 12(g) of the Act:
COMMON STOCK, $.01 PAR VALUE
Title of Class
Indicate by checkmark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
---- ----
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein, and will not be contained,
to the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K.
X
----
<PAGE>
This amendment is filed to correct portions of the Exhibit Index and redactions
in exhibits 10.4A, 10.4B, 10.15A, and 10.15B.
(C) EXHIBIT INDEX (7)
Exhibit
Number Description
------- ---------------------------------------------------
3.1 Articles of Incorporation, as amended, dated January 1997.
(1)3.2 Bylaws, as amended
(1)4.1 Specimen Common Stock Certificate
Stock Purchase Agreements ("Terms and Provisions" included
in Exhibit 3.1)
(1)4.2A Series A Stock Purchase Agreement dated September 1989
(1)4.2B Series B Stock Purchase Agreement dated June 1992
(1)4.2C Series C Stock Purchase Agreement dated August 1993
(1)4.3 Form of CS First Boston Corporation Warrant
(1)4.4 Form of Invemed Associates, Inc. Warrant
(2)4.5 Shareholder Rights Agreement dated January 21, 1997
(1)10.1A Amended and Restated Stock Option Plan
(1)10.1B Form of Employee Stock Option Agreement
(1)10.1C Form of Director's Stock Option Agreement
(1)10.2 Directors' Nonqualified Stock Option Plan
(1)10.3 1994 Stock Option Plan
Agreements with Hologic, Inc.
(3)10.4A Co-Promotion and Sales Representation Agreement dated
January 14, 1997
(3)10.4B Joint Development, License and Supply Agreement dated
January 14, 1997
(1)10.5 Form of Indemnification Agreement with officers and
directors
(1)10.6 Form of Employee Confidentiality and Invention Agreement
Agreements with H. Raymond Cairncross
(1)10.7A Employment Agreement dated April 15, 1994
(1)10.7B Stock Option Agreements dated June 6, 1991, July 1, 1993,
July 1, 1994, April 15, 1994
(1)10.9 Asset Purchase and Sale Agreement dated May 31, 1994 with
Hybrilogic Corporation
(1)10.10 Cooperation Agreement dated August 11, 1993 with
Merck & Co., Inc.
Agreements with Mochida Pharmaceutical Co., Inc.
(1)10.12A Research and Development Agreement dated August 1992
(1)10.12B Osteomark License Agreement Dated August 1992
(1)10.12C Stock Purchase Agreement dated November 22, 1994
Agreements with The Washington Research Foundation
(1)10.13A Restated Exclusive License Agreement effective June 19,
1992 (Urinary Assay for Measuring Bone Resorption)
(1)10.13B Amendment to Restated Exclusive License Agreement effective
January 1, 1993
(1)10.13C Second Amendment effective June 2, 1994
(1)10.14 Exclusive License Agreement dated February 10, 1994 (O-CSF)
<PAGE>
Exhibit
Number Description
------- ---------------------------------------------------
Agreements with the University of Washington
(3)10.15A Research Agreement dated July 1, 1996 (Molecular Markers of
Connective Tissue Degradation)
(3)10.15B Research Agreement dated October 1, 1996 (Role of O-CSF in
Osteoclast Regulation)
(1)10.16A Know-How Transfer and Consulting Agreement dated
September 18, 1989 with David R. Eyre, Ph.D.
(1)10.16B Extension and Amendment dated May 1, 1992
(1)10.17 Amended and Restated Know-How Transfer and Consulting
Agreement dated February 22, 1993 with Minako Y. Lee, M.D.
(1)10.19 Osteomark EIA Exclusive Distribution License Agreement dated
March 28, 1994 with Technogenetics S.R.L. (division of
Recordati Pharmaceutical)
(1)10.20 Osteomark EIA Distribution License Agreement dated July 12,
1994 with BRAHMS Diagnostic (formerly Henning Berlin GMBH)
(1)10.21 Osteomark EIA Exclusive Distribution License Agreement dated
May 4, 1994 with Shield Diagnostics (Limited)
(1)10.22 Osteomark EIA Exclusive Distribution License Agreement dated
July 1, 1994 with DSL Diagnostic Products, Inc.
(dba INTER Medico)
(1)10.23 Osteomark Agreement dated February 12, 1993, as amended
May 10, 1994, with Nichols Institute Reference Laboratory
(1)10.24 Osteomark EIA Exclusive Distribution License Agreement dated
September 1, 1994 with Immuno Diagnostics
(1)10.25 License Agreement dated July 8, 1994 with Endrocrine
Sciences
(1)10.26 License Agreement dated August 1994 with Pacific Biometrics,
Inc.
Lease Agreements
(4)10.27A Lease Agreement dated October 2, 1995, with David A. Sabey
and Sandra L. Sabey
10.27B First Amendment of Lease dated October 15, 1996, with the
City of Seattle, successor-in-interest to David A. Sabey
and Sandra L. Sabey
Agreements with Johnson & Johnson Clinical Diagnostics, Inc.
(5)10.28A Distribution Agreement dated June 7, 1995
(5)10.28B Research, Development, License and Supply Agreement dated
June 7, 1995
(4)10.29 Clinical Laboratory Services License and Supply Agreement
dated October 25, 1995, with SmithKline Beecham Clinical
Laboratories, Inc.
<PAGE>
Exhibit
Number Description
------- ---------------------------------------------------
(4)10.30 Promotion Agreement dated September 20, 1995 with
Wyeth-Ayerst Laboratories
(6)10.31 Agreement with Laboratory Corporation of American Holdings
(LabCorp), dated January 11, 1996
13.0 Annual Report to stockholders for the year-ended
December 31, 1996
27.1 Financial Data Schedule
Notes to the Exhibits.
(1) Incorporated herein by reference from Item 16(a) of Registrant's Form S-1
Registration Statement as declared effective January 24, 1995 (No. 33-86118).
(2) Incorporated herein by reference from Form 8-A filed with the S.E.C.
in January 1997.
(3) Confidential treatment requested. Exhibit omits information that has
been filed separately with the Securities and Exchange Commission.
(4) Incorporated herein by reference from Form 10-K filed with the S.E.C
for the year ended December 31,1995.
(5) Incorporated herein by reference from Form 10-Q filed with the S.E.C
for the quarter ended June 30, 1995.
(6) Incorporated herein by reference from Form 10-Q filed with the S.E.C.
for the quarter ended March 31, 1996.
(7) Copies of exhibits may be obtained at prescribed rates from the Public
Reference Section of the Securities and Exchange Commission at 450 5th Street
NW, Room 1024, Washington, D.C., 20549.
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned.
OSTEX INTERNATIONAL, INC.
By /S/ THOMAS A. BOLOGNA
----------------------------
Thomas A. Bologna
President, Chief Executive Officer
and Member of the Board of Directors
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the
Registrant and in the capacities and on the dates indicated.
SIGNATURE CAPACITIES DATE
--------- ---------- ----
/S/ THOMAS A. BOLOGNA President, Chief Executive Officer
- ------------------------- and Member of the Board of Directors October 16, 1997
Thomas A. Bologna (principal executive officer)
/S/ Robert M. Littauer Senior Vice President, October 16, 1997
- ------------------------- Finance and Administration
Robert M. Littauer (principal financial and
principal accounting officer)
Note: Confidential treatment requested. Exhibit omits information that has
been filed separately with the Securities and Exchange Commission.
CO-PROMOTION AND SALES REPRESENTATION AGREEMENT
This Co-Promotion and Sales Representation Agreement (this "Agreement") is
entered into as of the 14th day of January, 1997 ("Effective Date"), by and
between
HOLOGIC, INC., a Delaware corporation having its principal place of business at
590 Lincoln Street, Waltham, MA 02154 ("Hologic" or "Company"), and
OSTEX INTERNATIONAL, INC., a Washington corporation having its principal place
of business at 2203 Airport Way South, Suite 400, Seattle, Washington 98134
("Ostex" or Representative).
1. FACTS
A. Hologic engages in the research, development, manufacture, sale, and
lease of diagnostic equipment and other products in the field of bone
metabolism, including its line of QDR bone densitometers. Hologic sells this
line of bone densitometers to physician offices, clinics, hospitals and other
medical settings to measure the density and strength of the subject's bones as
an aid in the diagnosis of osteoporosis and other bone diseases.
B. Ostex has developed its proprietary immunoassay Osteomark(R) to
determine the levels of the NTx epitope collagen metabolite resulting from bone
resorption ("NTx Assay"), which it has implemented and sells in a microtiter
format. ("Osteomark(R) Laboratory Test"). Ostex sells its Osteomark(R)
Laboratory Test to clinical laboratories, physician offices, clinics, hospitals
and other medical settings for the purpose of measuring the rate of bone
resorption or breakdown of the subject's bones as an aid in the management of
osteoporosis and other bone diseases.
C. The parties believe that their products are complementary to each
other, and wish to enter into this Co-Promotion and Sales Agency Agreement under
which (1) Ostex will act, in the Territory, as the sales agent for a package of
products consisting of a Strategic Alliance ("Fee Per Scan") Leasing Contract
for Hologic's QDR 4500 product and a certificate redeemable for performance of a
defined number of Osteomark(R) Laboratory Tests; and (2) the parties will
jointly promote their QDR and Osteomark(R) products in the Territory as an
integrated approach to the diagnosis and management of osteoporosis, will
establish a committee to coordinate their joint activities, and will take
certain other steps; all as described herein.
D. The parties have entered into simultaneously with this Agreement
that certain Joint Development, License and Supply Agreement providing for the
development and sale of an NTx Meter System for point of care use in accord with
the terms set out therein (the "Development Agreement").
<PAGE>
2. DEFINITIONS
(a) "Promotional Package," as used in this Agreement, means a package
consisting of a Strategic Alliance ("Fee Per Scan") Leasing Contract for the
Hologic QDR product and an Osteomark(R) Laboratory Certificate, as described in
Attachment A which is attached hereto and incorporated herein.
(b) "QDR Component" as used in this Agreement, means a Strategic
Alliance ("Fee Per Scan") Leasing Contract for the Hologic QDR product specified
in Attachment A hereto.
(c) "Osteomark(R) Laboratory Test" as used in this Agreement, means an
immunoassay to determine levels of the NTx epitope collagen metabolite resulting
from bone resorption ("NTx Assay"), as marketed and sold by Ostex in a
microtiter format to centralized laboratories ("Osteomark(R) Laboratory Test").
(d) "Osteomark(R) Laboratory Certificate" as used in this Agreement,
means a certificate redeemable for performance of a number of Osteomark(R)
Laboratory Tests, as described in Attachment A hereto.
(e) "Territory," as used in this Agreement means the United States
of America.
(f) "First Commercial Sale" means the first Sale of a NTx Meter System
pursuant to the Development Agreement for 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.
(g) "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.
<PAGE>
3. MARKETING COMMITTEE AND OTHER JOINT ACTIVITIES
(a) Immediately upon execution of this Agreement, the parties shall
form a marketing committee ("Marketing Committee") with two (2) named
representatives each from Hologic and Ostex, to oversee and coordinate the joint
marketing, promotional, sales, and other activities required or authorized by
this agreement. The Marketing Committee shall meet at least quarterly, and shall
attempt to operate by consensus, but failing consensus shall operate by majority
vote. All tie votes shall be finally resolved by a committee chairman. The
chairmanship shall alternate annually between representatives of the parties.
One of Hologic's representatives shall serve as chairman during the first year
of this Agreement, one of Ostex's the second year and so on. The Marketing
Committee may delegate certain of its functions to subcommittees or individual
members. Each party shall each cause its representatives on the Marketing
Committee to attempt to work to promote the goals of this Agreement, and most
particularly to advance the parties' mutual products and technologies as
complementary approaches for the diagnosis, management and treatment of
osteoporosis (the "Goals").
(b) Within thirty (30) days after the Effective Date, the Marketing
Committee shall prepare a written plan for the first year period of this
Agreement under which the parties shall undertake specified activities to
jointly promote the Goals and to support sales of the Promotional Package,
together with a proposed annual budget therefor, and an allocation of tasks
between the parties ("Marketing Plan"). At least sixty (60) days prior to the
end of the first year period of this Agreement, and each subsequent year period,
the Marketing Committee shall prepare a follow-on Marketing Plan to cover such
upcoming year. It is anticipated that said Marketing Plan shall include but not
be limited to (i) development and distribution of one or more joint brochures,
and possibly other materials, (ii) a program of joint advertising and public
relations, and (iii) a plan to promote the Goals with opinion leaders, and
generally, in the medical and managed care communities. For the first year
period, it is anticipated that the joint budget for such Marketing Plan shall
approximate XXXXXXXXXXXXXXXXXXXXXXX.
(c) Within sixty (60) days after the Effective Date, the Marketing
Committee shall also establish a plan and a budget under which the parties shall
collaborate to establish a database supporting the Goals, with the pre-approved
costs thereof to be shared equally by the parties and which database the parties
anticipate shall be owned jointly by the parties.
(d) Except as specified in Section 3(c) above, the parties shall share
the costs of all joint activities undertaken pursuant to the Marketing Plan (to
the extent approved in writing in advance by the Marketing Committee)
on the basis of XXX to Ostex, and XXX to Hologic. The Marketing Committee
shall establish an appropriate mechanism to implement such cost sharing,
under which each party shall be responsible for payment of specific costs for
specific joint activities and shall report such costs to the other party on a
periodic basis, and the parties shall reconcile and remit amounts payable to
each other on a quarterly basis, or on such other basis as the Marketing
Committee may determine. The parties specifically acknowledge that this cost
sharing arrangement is not intended to apply to either party's individual
marketing efforts relating to its own products, or to limit (or expand) either
party's rights to promote its technology or its approach to the diagnosis,
management and treatment of
<PAGE>
osteoporosis. For the purposes of this paragraph, costs to be shared exclude
employee compensation, fringe benefits and division or corporate overhead.
Sharable costs include but are not limited to agency fees relating to designing
and printing literature, payment to public relations firms, and spokesman
honoraria.
4. APPOINTMENT.
Hologic hereby appoints Ostex and Ostex hereby agrees to act as
Hologic's non-exclusive sales representative in the Territory for the purpose of
promoting, and soliciting orders for, the Promotional Package for the account of
Hologic at such prices and upon such terms and conditions as may be from time to
time specified by Hologic. Except as provided herein, Ostex shall have no other
right to promote or solicit orders for the Promotional Package for installation
outside of the Territory, or for any other Hologic product.
5. OBLIGATIONS OF OSTEX.
Ostex shall:
(a) Use reasonable efforts to promote sales of and to secure and
present to Hologic orders for the Promotional Package in the Territory, in
accord with the directions of the Marketing Committee described below. It is
anticipated that Ostex will inform and assign all of its sales people in the
Territory to represent the Promotional Package, will provide appropriate
training in conjunction with Hologic, will use its usual marketing efforts to
promote the Promotional Package, and will inform and involve Hologic's sales
force as reasonably necessary and appropriate to obtain such orders.
(b) Meet the performance goals set out in Exhibit B hereto.
(c) Provide to the Marketing Committee on or before the fifteenth
calendar day of each calendar quarter, a written Business Report containing (i)
a summary of marketing and promotional activities related to the Promotional
Package undertaken during the prior quarter (ii) an order forecast listing
prospective customers, products, quantity, and dollar volume of orders under
consideration, and indicating timing and probability of each prospect; and (iii)
an identification of any actions required to obtain such orders. The Marketing
Committee will agree on a format and reporting form for said information and
forward such to Ostex at least 30 days prior to the first reporting date.
(d) Not incur any liability on behalf of Hologic, nor in any way pledge
or purport to pledge Hologic's credit; nor describe or hold itself out as an
employee of Hologic, nor describe itself other than as a representative for
Hologic for the performance of functions specified in, and pursuant to, this
Agreement; nor make any claims, warranties or representations with respect to
the QDR Component except as previously approved in writing by Hologic; and
<PAGE>
(e) Not advertise the Promotional Packages or distribute any printed
matter referring to the Promotional Package or to the QDR Component without the
Marketing Committee's specific prior approval in writing. All advertising by
Ostex shall be without recourse to Hologic for any expense incurred unless such
expense shall have been specifically authorized in writing by the Marketing
Committee.
6. OBLIGATIONS OF HOLOGIC.
Hologic shall:
(a) Be solely responsible for the actual sales of the Promotional
Package, as well as all installation, in-service application customer training,
support, warranty, and after-warranty service of all units of the QDR Component
ordered by reason of this Agreement. Hologic reserves the right, in its absolute
and sole discretion, at any time and from time to time, to decline the
acceptance of any order transmitted to it by Ostex or through Ostex's efforts.
All credit appraisal of potential customers, risk of credit extended to such
customers and collections pursuant to such credit extensions shall be the sole
responsibility of Hologic. In no event shall Ostex accept any order or otherwise
attempt to bind Hologic for the sale of any Promotional Package(s) unless
specifically asked by Hologic, in writing, to do so. All remittances by the
customer shall be made directly to the order of Hologic and transmitted by the
customer directly to Hologic.
(b) Provide to the Marketing Committee on or before the fifteenth
calendar day of each calendar quarter, a written Business Report containing (i)
a summary of marketing and promotional activities related to the Promotional
Package undertaken during the prior quarter (ii) an order forecast listing
prospective customers, products, quantity, and dollar volume of orders under
consideration, and indicating timing and probability of each prospect; and (iii)
an identification of any actions required to obtain such orders.
(c) Upon request, provide reasonable training to Ostex's sales force
respecting the QDR Component and the Promotional Package, and participate with
Ostex in training for Ostex's sales force respecting the Goals. Hologic shall
also invite and permit Ostex to provide reasonable similar training to Hologic's
sales force respecting the Osteomark(R) Laboratory Test and the Goals.
(d) Upon request, provide reasonable sales and account support to
Ostex's sales force as appropriate to promote the Promotional Package and the
Goals, and to obtain orders therefor. Said sales and account support shall
include but not be limited to maintenance of one or more telephone help lines to
answer Ostex sales questions about the QDR Component, development with Ostex of
appropriate instructional handouts, proforma financial statements and other
promotional materials, and direct assistance with any slow-moving sales; all as
agreed by the parties through the Marketing Committee.
<PAGE>
(e) Reserve the right, in its absolute and sole discretion, at any time
and from time to time to recommend to the Marketing Committee, to discontinue,
modify, alter or improve the Promotional Package, always providing Ostex with
reasonable notice thereof.
(f) Notify Ostex of current prices relating to Promotional Packages,
and any changes in the prices therefor. At no time shall the title to any
Promotional Packages be transferred to or vested in Ostex, but shall remain in
Hologic at all times until transferred to a customer.
7. COMMISSIONS.
(a) Hologic shall pay to Ostex, in full compensation for its services
performed pursuant hereto, the commissions provided for in Attachment B hereto.
Commissions shall be payable upon Hologic receipt of the associated lease
installment or price due. Payment shall be made on or before the forty fifth
(45th) day following the end of the first three month period of the term of the
Fee Per Scan Lease Contract described in Exhibit A hereto.
8. INDEPENDENT CONTRACTOR - EXPENSES.
(a) Each party is engaged in business as an independent sales
representative, and the parties acknowledge and agree that each party, in the
performance of its duties and obligations pursuant to this Agreement, shall be
acting as an independent contractor and not as an employee of the other.
(b) Except as otherwise specifically provided in this Agreement, each
party shall bear all expenses incurred by it in acting hereunder, including
(without limiting the generality of the foregoing) all office expenses,
traveling and entertainment expenses, postage and salaries of salesmen and other
personnel, as well as all advertising and promotional expenses.
9. TERM AND TERMINATION.
(a) This Agreement shall be effective as of the date hereof and shall
extend for a period extending until First Commercial Sale of an NTx Meter System
pursuant to the Joint Development, License and Supply Agreement simultaneously
entered into between the parties. The parties may extend this Agreement by
mutual consent in writing at any time prior to its expiration, and will
negotiate in good faith to extend this co-promotion effort to cover the NTx
Meter Test which is the subject of the associated Development Agreement.
(b) Either party may terminate this Agreement, entirely in its
discretion and without liability therefor, by giving to the other party ninety
(90) days advance written notice, or upon written notice if the Joint
Development, License, and Supply Agreement is terminated for any reason.
<PAGE>
(c) Either party may terminate this Agreement for material defaults of
the other party, effective thirty (30) days following written notice to the
defaulting party, unless within said thirty (30) days, the party receiving the
notice remedies the default.
(d) Hologic may terminate this Agreement, effective on sixty (60) days
notice (and opportunity to cure), in the event that Ostex has not presented
orders for an average of three (3) Promotional Packages (or QDR Systems) per
month during each month of the Agreement, beginning after the first three months
thereof.
(e) Notwithstanding the foregoing, either party may terminate this
Agreement upon notice, effective immediately, in the event of the bankruptcy or
insolvency of the other party, or if the other party enters into a composition
with its creditors.
(f) In the event of the termination of this Agreement by Hologic, Ostex
shall be entitled to receive commissions for Promotional Packages sold within
thirty (30) days following the termination of this Agreement.
(g) Upon termination of this Agreement, each party shall promptly
return all technical information and literature relating to the other party's
component of the Promotional Packages, including price lists, samples, documents
and papers.
(h) At any time following ninety (90) days after the Effective Date,
either party may notify the other that this Agreement is not fulfilling the
notifying party's business goals, and ask that this Agreement be modified to
meet these goals. In this case, the parties shall meet and negotiate in good
faith to modify this agreement appropriately. At this time the parties may agree
to convert this Agreement to provide that Ostex will provide lead generation
services rather than act as a sales representative providing orders, with
appropriate adjustments to fees and the program as a whole.
10. WARRANTIES AND LIABILITIES; INDEMNITY
(a) Except as expressly set forth in each party's warranty and sales
literature accompanying its component of the Promotional Packages (and
accordingly subject to all conditions and limitations set forth therein), EACH
PARTY MAKES, AND THE OTHER PARTY AND ITS CUSTOMERS RECEIVE, NO WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION NO WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR AGAINST INFRINGEMENT.
(b) Ostex hereby agrees to indemnify, defend and hold harmless Hologic
from and against all liability, damages or loss and from any claims,
proceedings, suits, demands, recoveries or expenses arising out of, based on, or
allegedly caused by, or in connection with any product manufactured by Ostex and
distributed pursuant to this Agreement (other than the QDR Product), including
<PAGE>
but not limited to performance of an Ostex Laboratory Test upon redemption of a
Osteomark(R) Laboratory Certificate ("Ostex Product"), or any product claim made
or allegedly made in connection therewith. This indemnity shall not apply to any
product claim made by Hologic with respect to an Ostex Product , which claim is
not contemporaneously made by Ostex, or approved in writing by the Marketing
Committee or Ostex.
(c) Hologic hereby agrees to indemnify, defend and hold harmless Ostex
from and against all liability, damages or loss and from any claims,
proceedings, suits, demands, recoveries or expenses arising out of, based on, or
allegedly caused by, or in connection with any product manufactured by Hologic
and distributed pursuant to this Agreement (other than an Ostex Product),
including but not limited to the QDR Component and Hologic's line of QDR bone
densitometers ("Hologic Product"), or any product claim made or allegedly made
in connection therewith. This indemnity shall not apply to any product claim
made by Ostex with respect to an Hologic Product , which claim was not
contemporaneously made by Hologic, or approved in writing by the Marketing
Committee or Hologic. Hologic further indemnifies and holds Ostex harmless from
any third-party claims arising from or relating to any financial default by a
customer of a Hologic Product.
11. LIMITATION OF LIABILITY.
IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR THE
OTHER PARTY'S DIRECTORS, OFFICERS, CONSULTANTS, EMPLOYEES, AGENTS,
REPRESENTATIVES OR CUSTOMERS FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL LOSSES
OR DAMAGES, IRRESPECTIVE OF THE CAUSE THEREOF.
12. DEFENSE OF THIRD-PARTY CLAIMS AND INDEMNITY.
(a) 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 that is founded, in whole or in part, on an allegation that the
Hologic Product infringes any trade secret, patent, or copyright belonging to a
third party, 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 12, 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. 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 Ostex Product, or if Ostex or WRF, or their Affiliates
have any interest in the claim, suit or other legal proceeding, or any license
to any right so asserted.
<PAGE>
(b) 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 that is founded, in whole or in part, on an allegation that the
Ostex Product infringes any trade secret, patent, or copyright belonging to a
third party, 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 12, 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 Ostex Product, or if in the opinion of Ostex the Ostex
Product is 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 Ostex Product, (ii) replace or modify the
Ostex Product so that it becomes non-infringing, or (iii) if neither (i) or (ii)
are reasonably available, accept return of the Ostex Product held in inventory
by Hologic and those laboratories which have entered into agreements to accept
Osteomark(R) Laboratory Certificates, 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 any claim is based
on any use of the Hologic Product, or if Hologic, or its Affiliates have any
interest in the claim, suit or other legal proceeding, or any license to any
right so asserted.
13. NON ASSIGNMENT.
This Agreement shall be binding upon and inure to the benefit
of the parties hereto and their respective successors and assigns; provided that
any assignment or transfer of this Agreement or any of the rights or obligations
hereunder by either party without the written consent of the other shall be void
and of no effect. Such written consent shall not be unreasonably withheld.
14. CONFIDENTIALITY PROVISIONS.
(a) Recipient shall not at any time, during and for a period of three
(3) 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
<PAGE>
utilize reasonable procedures to safeguard Confidential Information, including
releasing Confidential Information only to its employees on a "need to know"
basis. Nothing in this Agreement shall prevent Recipient from disclosing
Confidential Information to government agencies for regulatory purposes.
(b) 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.
(c) The parties acknowledge that: (a) the covenants set forth in this
Section 14 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 14; 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 14 if Recipient fails to perform in accordance
herewith.
15. NOTICES.
Any notice required or permitted to be given under this Agreement shall
be in writing and shall be sufficiently given when delivered in person or
deposited in the United States mail (registered or certified) postage prepaid,
addressed as follows:
If to Hologic, addressed to:
HOLOGIC, Inc.
590 Lincoln Street
Waltham, MA 02154 (USA)
Attention Mark Duerst, Vice-President - Sales & Marketing
Copy to Steven L. Nakashige, President and COO
If to Ostex, addressed to:
Ostex, International, Inc.
2203 Airport Way South, Suite 400,
Seattle, Washington 98134
Attention: Jeffrey J. Miller, Ph.D., Senior Vice President,
Corporate Development
Copy to: Robert Glaser, President and COO
or to such other addresses as may be specified from time to time in a written
notice given by such party. Both parties agree to acknowledge receipt of any
notice delivered in person.
<PAGE>
16. TRADEMARKS AND TRADE NAMES.
(a) No provision of this Agreement shall be interpreted or construed as
conferring upon any party any right to use in labeling, advertising, marketing,
publicizing or otherwise promoting the Promotional Package, any name, trade
name, trademark, or other designation (or derivation thereof) of any other party
hereto or WRF or the University of Washington, respectively, except as expressly
provided under this Section 16.
(b) Hologic shall incorporate into the packaging of each and every
Osteomark(R) Laboratory Certificate marketed, promoted, sold, and/or distributed
under this Agreement, and in addition to its own trademarks and names, such
Ostex trademarks or statements as Ostex shall reasonably request. Ostex hereby
grants Hologic 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 Ostex; provided, however, that each
such use of such statement and/or trademark be accompanied by a printed notice
identifying Ostex as the owner thereof. Hologic furthermore shall have the right
to display its own name, trade names, and/or trademarks. Hologic shall not use
any Ostex trademark with respect to products not covered by this Agreement.
(c) 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.
(d) 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 Exhibit C; (b) Ostex is named as applicant in
those applications indicated by Exhibit C 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 an third party.
(e) Ostex acknowledges that Hologic is the sole owner of the trademarks
and trade names which designate and identify the QDR Component of the
Promotional Package and business (the "Marks").
(f) Ostex agrees that it may only use those Marks which identify the
Promotional Packages it is authorized to sell and then only to further the
promotion and sale of the Promotional Packages such Marks identify. Ostex may
only use such Marks in their standard form and style as they appear upon the
<PAGE>
Promotional Packages or as instructed in writing by Hologic. No other letter(s),
word(s), design(s), symbol(s), or other matter of any kind shall be superimposed
upon, associated with or shown in such proximity to the Marks so as to tend to
alter or dilute them.
(g) In all advertisement, sales and promotional literature or other
printed matter in which any of such Marks appear, Ostex must identify itself by
full name and address and state its relationship to Hologic. Every such Mark
used or displayed by Ostex must be identified as a Mark owned by Hologic, in a
form and manner approved by Hologic. Each party shall have the right to review
and approve any promotional literature or other printed matter in which such
party's trademarks appear.
(h) Upon expiration or in the event of any termination of this
Agreement, each party shall promptly discontinue every use of the trademarks or
any other confusingly similar word or symbol of the other.
(i) No public announcements or similar publicity with respect to this
Agreement shall be made by either party without the other party's prior written
approval and neither party may make any announcements regarding any of the other
party's products without the prior written consent of the other party. Such
prior written approval and prior written consent shall not be unreasonably
withheld. Nothing in this Section 16(i), however, shall prevent either party
from making such public announcements as such party's legal obligations require.
In such event, the party who is required to make the public announcement will
allow the other party to review the announcement sufficiently in advance in
order to provide suggestions on the form and substance of the announcement.
17. MISCELLANEOUS.
(a) Section headings as to the contents of particular paragraphs are
for convenience only and are in no way to be construed as part of this
Agreement, or as a limitation of the scope of the particular paragraph to which
they refer.
(b) Any waiver by either party of any provision of this Agreement shall
not be construed or deemed to be a waiver of any other provision of this
Agreement nor a waiver of a subsequent breach of the same provision.
(c) This Agreement, in conjunction with the Joint Development, License
and Supply Agreement, constitutes the entire understanding and agreement between
the parties and supersedes all prior negotiations, understandings and agreements
between Hologic and Ostex. There are no understandings, representations or
warranties of any kind, express or implied, oral or written, not expressly set
forth herein or in the Joint Development, License and Supply Agreement. No
amendment or modification of any provision of this Agreement shall be valid or
of any force or effect, unless made by written instrument signed by the
respective duly authorized representatives of Hologic and Ostex, specifying the
exact nature of such amendment or modification.
<PAGE>
(d) 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.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
as of the day and year first above written by their respective authorized
officials.
OSTEX INTERNATIONAL, INC.
By /S/ JEFFREY J. MILLER PH.D.
Jeffrey J. Miller, Ph.D.,
Senior Vice President,
Corporate Development
HOLOGIC, INC.
By /S/ S. DAVID ELENBOGEN
S. David Ellenbogen
Chairman and CEO
<PAGE>
EXHIBIT A
PROMOTIONAL PACKAGE DESCRIPTION
QDR 4500C System Strategic Alliance ("Fee Per Scan") Leasing Contract as
described in the attached Attachment A-1. (No modifications to this lease
contract can be accepted.)
Osteomark(R) Laboratory Certificate, comprising a certificate for a specified
number of free tests at a specified laboratory or laboratories ( to be mutually
agreed by Hologic and Ostex) with a value of XXXXXXX.
<PAGE>
Attachment A-1
- -16-
HOLOGIC STRATEGIC ALLIANCE PROGRAM
EXHIBIT A-1
LEASING CONTRACT
Owner: Hologic, Inc. Customer (Name): __________________
590 Lincoln Street Street Address: ________________
Waltham, MA 02154 City/State/Zip: ______________________
(617) 890-2300 Phone: ______________________
Contact: ______________________
________ QDRAE 4500C Hologic QDR "ACCLAIM' Series" Bone Densitometer
________ QDR-1000plus Hologic QDR Bone Densitometer
Tax Exempt# ______ Customer P.O. #__________________ Date: ____________
<TABLE>
<CAPTION>
STRATEGIC ALLIANCE PROGRAM SUMMARY
<S> <C> <C> <C>
Line Definitions QDR 4500C QDR-1000plus
1. Usage Fee: $50 per study $50 per study
2. Trial period (no minimums): Six months Six months
3. Deposit (credited against usage): $5,000 $3,000
4. Deferred Billing Credit for first 100 scans Credit for first 60 scans
5. Minimums after six months: 30 scans per month 25 scans per month
6. Minimums after 12 months: 35 scans per month 30 scans per month
7. Conversion to own: Anytime Anytime
8. Conversion to lease: Anytime Anytime
9. Upgrade options: Available to any ACCLAIM Available to any ACCLAIM
</TABLE>
Customer Acceptance Hologic, Inc. Acceptance
Customer: _____________________ Signature: _____________________________
Signature: __________________ Name/Title: ____________________________
Name/Title: __________________ Date: _____________________________
Date: _____________________________
Equipment Location:
The equipment is to be delivered and installed at the following location:
Address: _____________________________
City: _____________________________
State _____________________________
Zip _____________________________
Installation Contact Person/phone: __________________________________________
- --------------------------------------------------------------------------------
<PAGE>
HOLOGIC, INC.
590 Lincoln Street, Waltham, MA 02154
Tel: 617.890.2300
Fax: 617.890.0008
TERMS AND CONDITIONS
1. Lease of Equipment. Upon execution of this Equipment Lease Agreement (the
"Agreement"), Customer agrees to lease from Hologic, Inc. ("Hologic") the
equipment set forth above (the "Equipment"), subject to the terms and conditions
set forth in this Agreement, for a term commencing upon installation of the
Equipment and, unless such lease (the "Lease") is sooner terminated as provided
herein, terminating sixty (60) months from the date of installation.
2. Deposit. In consideration of Hologic entering into this Agreement, Customer
has paid to Hologic a non-refundable deposit plus applicable taxes, if any.
During the first six months of this Agreement ('Trial Period"), this deposit is
creditable against the Patient Studies performed by the Customer (the first 100
scans for a QDR 4500C and 60 scans for a QDR-1000plus).
3. Lease Payments. Subject to the credits granted in Section 2, Customer shall
pay Hologic as Lease payments hereunder, an amount equal
to $50.00 for each patient study performed by Customer (or any affiliate of
Customer) using a bone densitometer plus taxes and, to the extent
applicable, service fees and other charges as provided herein. A "Patient Study"
means a sequence of one or more scans performed on a patient on the Equipment or
any other bone densitometer owned, leased or operated by Customer or any of its
affiliates. Technically unacceptable scans may be credited if Customer provides
Hologic with copies of such studies on diskette accompanied by a brief
description of the nature of the deficiency.
Customer agrees to provide to Hologic, not later than the eighth (8th) day of
each month, a copy of the count report, produced by the software included within
each system, of the Patient Studies performed by the Equipment during the
preceding month and a count report of the number of any other Patient
Studies performed during the preceding month. The lease payment shall be
calculated by multiplying the number of patient Studies by $50.00 and adding all
applicable taxes. A late fee equal to five percent (5%) of the total lease
payment due will be applied to delinquent payments (payments received by Hologic
after the thirtieth (30th) day of the month).
In the first 12 months, the lease payments due are based on the assumption
that the Customer will perform at least the Minimum Monthly Scans (30 Patient
Studies per month for a QDR 4500C and 25 for a QDR-1000plus) for a minimum lease
payment of at least $1,500 ( for a QDR 4500C) or $1,250 (for a QDR-1000plus) per
month (plus applicable taxes)(the "Monthly Minimum"). The Monthly Minimum will
be waived for the first six months. After 12 months, the lease payments due are
based upon the assumption that Customer will perform at least (I) for a QDR
4500C-35 Patient Studies per month (the "Minimum Monthly Scans") for a minimum
lease payment of at least $1,750 per month (plus applicable taxes) (the "Monthly
Minimum") or (ii) for a QDR-1000plus - 30 Patient Studies per month (the"Minimum
Monthly Scans") for a minimum lease payment of at least $1,500 per month (plus
applicable taxes) (the "Monthly Minimum"). If Customer has not conducted the
Minimum Monthly scans in any month, beginning after the first six months of
usage (the "Trial Period"), Customer may nevertheless elect to pay the Monthly
Minimum. If Customer (a) has not paid the Monthly Minimum commencing with the
seventh full month after the date of installation, or (b) fails to perform any
of it obligations hereunder and such failure shall continue for ten days after
written notice, it is agreed that Hologic shall be entitled without notice to
Customer and with or without legal process, take immediate possession- session
of such Equipment without liability to Hologic by reason of such entry or taking
possession, and terminate the Lease.
4. Conversion of Agreement. At any time, Customer may convert this Lease into an
Operating Lease or a Full Payout Lease, provided that Customer is then in full
compliance with the terms and conditions hereof. This right of conversion only
applies to Hologic administered or authorized lease programs. If the Customer
converts to one of the following lease options within the first six months from
the date of installation, Hologic will defer the commencement of payments
required under the Lease for 90
PERSONAL GUARANTY
In order to induce Hologic to enter into this Lease with Customer, the
undersigned, jointly and severally, hereby irrevocably and unconditionally,
guaranty without deduction or diminution by reason of counterclaim, offset, or
defense, the prompt and complete payment under, whenever due, and performance of
this Lease to Hologic or its assigns, including any and all modifications,
additions, supplements and amendments thereof, as will as all of Customer other
leases with Hologic that have commencement dates not later than ten (10) days
after Hologic receives written notice from the undersigned of their desire not
to guaranty any additional leases. The undersigned warrant and guaranty that
this Lease has been properly executed by Customer, and agree. that this guaranty
shall be of full force and effect irrespective of any invalidity or
unenforceability of the Lease or any provisions thereof, or the existence,
validity or value of any security. The undersigned hereby waive presentment
notice of acceptance hereof, all notices of any kind to which we may be
entitled, and all defenses of guarantor or surety. The undersigned consent that
from time to time, without notice to or further consent from the undersigned and
without releasing or affecting the undersigned's liability thereunder, the time
for payment or performance under this lease may be extended or accelerated in
whole or part, any security therefore may be exchanged, released, enforced sold,
leased or otherwise dealt with, the provision of any documents may be canceled,
modified or waived, any other guarantors may be released, and any indulgence may
be granted to Customer, as Hologic may in its sole discretion determine. The
obligation and liability of each undersigned is direct, continuing and
unconditional, shall not be diminished or affected whether or not the Equipment
is repossessed, and Hologic shall not be required to proceed against Customer or
resort to any other right or remedy before proceeding against the undersigned
under this guaranty. No payment by the undersigned, except payment in full of
all liabilities hereunder shall entitle the undersigned to be subrogated to any
of the rights or remedies of Hologic under this Lease. The undersigned warrant
they have read this Lease and hereby waive any and all rights to a trial by
jury, and agree to the venue and jurisdiction contained therein, and agree that
only full payment and performance of the Lease can discharge the undersigned's
liability. This guaranty shall be binding upon the undersigned and the heirs,
representatives, successors and assigns of the undersigned, in favor of Hologic
and Lessor's successors and assigns. This guaranty cannot be terminated or
changed orally and no provision hereof may be modified or waived except in
;writing.
x________________________________
(GUARANTOR'S SIGNATURE) AN INDIVIDUAL
- -----------------------
DATE
X________________________________
(GUARANTOR'S SIGNATURE) AN INDIVIDUAL
- -----------------------
DATE
HOLOGIC, INC.
590 Lincoln Street, Waltham, MA 02154
Tel: 617.890.2300
Fax: 617.890.0008
days.
<PAGE>
An "Operating Lease means a fixed rent lease with 60 monthly payments in
the fixed amount of the initial Monthly Minimum ($1,500 for a QDR 4500C and
$1,250 for a QDR-1000plus), beginning on the date of conversion, with an option
for Customer to acquire the Equipment at the end of such term for its fair
market value, as determined by Hologic.
A "Full Payout Lease" means a new lease whereby Customer would finance a
deemed unamortized contract price for the Equipment plus the residual value of
the Equipment, as determined by Hologic based upon Hologic's amortization
schedule for this Agreement, over a five (5) year term at then current interest
rates, with an option for Customer to acquire the Equipment at the end of such
term for XXXXXXX. During the first 12 months of this agreement (from date of
installation) the fixed monthly lease payment shall be XXXXXXX for a QDR 4500C
and XXXXXXX for a QDR-1000plus.
In connection with any such conversion, Hologic may require Customer to enter
into a new lease with standard terms and conditions. Conversion of the Lease is
conditioned upon a then current approval of Customer by Hologic.
5. Purchase Option. At any time, during the first 12 months from the date
of installation, Customer shall have the right, upon written notice to Hologic,
to purchase the Equipment at a purchase price of XXXXXXX for a QDR 4500c and
XXXXXXX for a QDR-1000plus. On or after the first anniversary date from the date
of installation, Customer shall have the right, upon written notice to Hologic,
to purchase the Equipment at a purchase price equal to the sum of (a) the
present value of the total lease payments to be due to
Hologic over the term of this Agreement, assuming that Customer had converted
the Agreement into an Operating Lease, plus (b) the present value of the
estimated residual value of the Equipment at the end of the five year lease
term. The present value of the lease payments, the estimated residual value and
the present value of such residual value shall be determined by Hologic based
upon its amortization schedule for this Agreement. Customer shall have the
further right, at the end of the term of the Agreement, upon written notice to
Hologic, to purchase the Equipment at its fair market value, as determined by
Hologic.
6. Training. Hologic shall be responsible for the initial installation of the
Equipment at Customer's premises and for training Customer's designated
equipment operator in use of the Equipment.
7. Equipment Service and Maintenance. Subject to Section 8, costs and expenses
relating to service and maintenance of the Equipment will be the responsibility
of Hologic, provided that Customer has not defaulted on any of its obligations
under this Agreement. Following the conversion of this Agreement to an Operating
Lease, a Full Payout Lease or purchase, all costs and expenses associated with
equipment service and maintenance shall be the responsibility of Customer. A
full year of equipment service and maintenance will be provided free of charge
from the date of conversion to a lease or purchase, for all conversions within
six months of the date of installation.
8. Use and Alteration. Customer shall use the Equipment solely in the conduct of
its business, in the manner and for the use contemplated by the manufacturer
thereof, and in compliance with all laws, rules and regulations of every
governmental authority having jurisdiction over the Equipment and with the
provisions of all policies of insurance carried by Customer. Customer will not
make any alterations or additions to the Equipment or move the Equipment from
the installation site. During the term of the Lease, Customer shall be entirely
responsible for daily maintenance and cleaning of the Equipment and for any loss
or damage to the Equipment except for ordinary wear and tear. Customer agrees to
cause the Equipment to be operated in accordance with all manufacturer's manuals
or instructions. While the Equipment is in Customer's possession, Customer
shall bear the entire risk of loss, theft, destruction or damage to the
Equipment. Upon Hologic's request, Customer will permit Hologic to have access
to the Equipment at all reasonable times for the purpose of inspection and
examination.
9. Customer Representations. Customer hereby represents, warrants and covenants
that with respect to this Agreement hereunder: (a) The execution, delivery and
performance thereof by the Customer have been duly authorized by all necessary
corporate action; (b) The individual executing such was duly authorized to do
so; and (c) This Agreement constitutes the legal, valid and binding obligations
of the Customer enforceable in accordance with their respective terms.
10. Events of Default. Customer shall be in default under @ Agreement upon the
happening of any of the following events or conditions (herein called "Events of
Default"): (a) Customer shall find to make any payment due hereunder within
thirty (30) days after the same is due and payable; (b) Customer shall fail to
perform any other covenant or agreement to be performed by it under this
Agreement, and such failure shall continue for ten (10) days after written
notice thereof by Hologic to Customer; (c) any representation, warranty,
certification or statement made or furnished to Hologic herein, or in connection
herewith, by or on behalf of Customer proves to have been false in any material
respect when made or furnished; or (d) Customer shall make an assignment for the
benefit of creditors, or bankruptcy, arrangement, reorganization, liquidation,
insolvency, receivership or dissolution proceeding shall be instituted by or
against Customer and shall be consented to or be pending and not dismissed for a
period of thirty (30) days.
11. Remedies of Hologic. Upon the occurrence of any Event of Default, and at any
time thereafter so long as the same shall be continuing and shall not have been
remedied, Hologic may, at its option, declare this Agreement to be in default
and, at any time thereafter, may exercise one or more of the following remedies,
as Hologic in its sole discretion shall elect: (a) accelerate and cause to
become immediately due and payable all amounts payable hereunder and, including
if the Agreement has been converted to an Operating Lease or a Full Payout
Lease, all payments due thereunder; (b) terminate this Agreement as to any and
all Equipment upon written notice to Customer, without prejudice to any other
remedies hereunder; (c) enter upon the premises where any Equipment is located,
and, without notice to Customer and with or without legal process, take
immediate possession of such Equipment without liability to Hologic by reason of
such entry or taking possession, and without such action constituting a
termination of this Agreement unless Hologic notifies Customer in writing to
such effect; and (d) proceed by appropriate action either at law or in equity to
enforce performance by Customer of the applicable covenants of this Agreement or
to recover damages for the breach thereof. Hologic shall also be entitled to
recover as damages for the loss of the bargain and not as a penalty, an amount
equal to the sum of the following amounts: (i) all unpaid monthly payments owing
for the Equipment through the last day of the month in which such Equipment is
either sold, released or otherwise disposed of, and (ii) expenses paid or
incurred by Hologic in connection with the repossession, attempted repossession,
holding, repair and subsequent sale, release or other disposition of any
Equipment, including commissions and attorneys' fees. None of Hologic's remedies
under this Agreement are intended to be exclusive, but each shall be cumulative
and in addition to
HOLOGIC, INC.
590 Lincoln Street, Waltham, MA 02154
Tel: 617.890.2300 Fax: 617.890.0008
any other remedy referred to herein or otherwise available to Customer in law or
in equity. Customer waives any and all rights to notice and to a judicial
hearing with respect to the repossession of the equipment by Hologic in the
event of a default hereunder by Customer.
12. Title. Tide to the Equipment leased to Customer pursuant to the
terms hereof is and will remain at all times vested in Hologic or its
designee, unless and until Customer exercises its option to purchase the
Equipment pursuant to Section 5.
13. Assignment. Without Hologic's prior written consent, Customer will not
assign any of Customer's rights hereunder or sublet or transfer the Equipment.
Hologic may, at any time, mortgage, grant a security interest in, transfer, sell
or assign this Agreement or any Equipment or any payments due or to become due
hereunder, without notice to Lessee. Customer agrees that in the event of any
such assignment and written notice thereof to Customer, Customer will accept and
comply with the directions and demands of Hologic's assignee. THE RIGHTS OF ANY
SUCH ASSIGNEE SHALL NOT BE SUBJECT TO ANY DEFENSE, COUNTERCLAIM OR SET-OFF WHICH
CUSTOMER MAY HAVE AGAINST HOLOGIC.
14. Insurance; Taxes. Customer agrees that it shall obtain and maintain property
damage and liability insurance and keep the Equipment insured for its full
replacement value, name Hologic as an additional insured with respect thereto
and, upon the request of Hologic, will provide a certificate of insurance
acceptable to Hologic evidencing such insurance coverage. Customer agrees to pay
for, or reimburse Hologic for payment of, all sales, use, privilege, excise,
personal property or other taxes imposed or levied with respect to the Equipment
or by reason of the furnishing of the Equipment hereunder.
15. Termination. The lease may be terminated by Customer, prior to purchase of
the Equipment or conversion into an Operating Lease or a Full Payout Lease upon
ninety (90) days prior written notice to Hologic. In the event of such
termination, Customer agrees to pay for all Patient Studies performed up to the
date of termination, including any applicable taxes thereon. In consideration of
the financial accommodations made by Hologic to Customer under the leasing
program set forth in this Agreement, in the event of such a termination by
Customer or a termination of the Lease by Hologic, as a result of Customer
default or failure of Customer to pay the Monthly Minimum, Customer agrees that
for a period of twelve (12) months after such termination, or the fifth
anniversary of the date of this Agreement, whichever occurs first,
Customer shall pay Hologic a minimum termination fee equal to
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx (or any of its affiliates)
performed Patient Studies during such period; provided however no termination
fee shall be due if neither Customer nor any of its affiliates perform Patient
Studies during the termination period.
16. Indemnification. Customer agrees to defend, indemnify and hold Hologic
harmless from and against any and all claims, damages, costs, expenses
(including attorney's fees), losses and liabilities of every kind and nature in
any way arising out of or in connection with (i) the failure of any of
Customer's representations or warranties contained herein to be true, complete
and correct as of the date hereof and at all times during the term of the
Agreement, or (ii) the breach by Customer of any provision of Agreement, or
(iii) the figure of Customer to pay any amounts owed under this Agreement as and
when the same shall become due or (iv) failure to maintain the Equipment as
provided in Section 8 or (v) the use of the Equipment other than, in accordance
with Hologic's instructions for use.
17. Further Assurances. Customer will promptly execute and deliver to Hologic
such further documents and assurances and take such further action as Hologic
may from time to time reasonably request in order to more effectively carry out
the purpose of this Agreement and to protect the rights and remedies of Hologic
hereunder, including, without limitation, the execution and delivery of
financing, statements under the Uniform Commercial Code.
18. Proprietary Software. It is recognized that during the term of this
Agreement, computer software will be delivered to Customer on a licensed basis
in printed form, or in any of several possible machine-readable forms. Such
computer software is and shall remain the sole property of Hologic. The grant to
Customer of rights to the software extends solely a non-exclusive, single-use
royalty-free license to use software for the sole purpose of performing and
analyzing scans acquired in the normal course of its business, using the
Equipment and for no other purpose. Such software is valuable to Hologic and
shall be treated as confidential and proprietary information subject to the
confidentiality provisions hereof. Customer will have no right to sell, assign,
transfer, copy or sublicense the software, without the prior written consent of
Hologic.
19. Confidential Information. All drawings, diagrams, specifications, devices
and other materials furnished by Hologic and identified as confidential relating
to use and service of the Equipment and the information therein, including, but
not limited to, Customer Manual provided to it by Hologic in connection with the
Equipment, is proprietary and confidential to Hologic. Such materials have been
developed at great expense and they contain trade secrets of Hologic. Customer
may not reproduce or distribute such materials except to Customer's employees
who may use the articles as part of their duties. Customer agrees that it will
keep confidential and not disclose or divulge any of such materials or the
information therein to any unauthorized person for any purpose whatsoever
without the prior written consent of Hologic.
20. Disclaimers; Warranties. CUSTOMER ACKNOWLEDGES AND AGREES THAT HOLOGIC MAKES
NO EXPRESS OR IMPLIED WAR- RANTIES ARISING OUT OF OR RELATED TO CUSTOMER'S USE
OR OPERATION OF THE EQUIPMENT. IN NO EVENT SHALL HOLOGIC BE LIABLE FOR ANY
INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR
ASSOCIATED WITH THE EQUIPMENT OR THE LEASE THEREOF EVEN IF ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
21. Entire Agreement; Governing Law. This Agreement constitutes the entire
agreement between the parties. This Agreement shall be deemed a contract made
under the laws of the Commonwealth of Massachusetts shall be construed under and
governed by the laws thereof. The invalidity or unenforceability of any
provision of this Agreement shall not affect the validity or enforceability of
any other provision hereof. Customer waives any right to a trial by jury in any
action to enforce or defend any matter arising from or related to this
Agreement.
22. Amendment; Waiver. No term or provision of this Agreement may
be changed, waived, amended, discharged or terminated except by a written
instrument executed by the parties hereto.
HOLOGIC
590 Lincoln Street, Waltham, MA 02154
Tel: 617.890.2300 Fax: 617.890.0008
<PAGE>
EXHIBIT B
COMMISSION
An amount equal to the Patient Study or other lease payment amounts (i.e.
$50 per Patient Study) payable to Hologic or credited to deposits held by
Hologic pursuant to the Strategic Alliance Leasing Contract during the first
three month period commencing with the beginning of the term of said Contract,
not including deposits paid or due, or taxes and to the extent applicable,
service fees and other charges provided for in said contract, and provided that
if the Lease Contract is converted to a sales contract during said period
Hologic will pay an additional finders fee of XXXXXXX.
Note: During the term of this Agreement, Hologic will also provide finders fees
and sales assistance fees pursuant to its then-current Policy for Non-Exclusive
Distribution and Finder's Fees (current version attached) for sales of all QDR
4500 model Systems in the Territory as a result of qualified leads provided by
Ostex.
PERFORMANCE GOALS
Three (3) Promotional Packages per month.
<PAGE>
HOLOGIC, INC.
POLICY FOR FINDER'S FEE ELIGIBILITY
January 13, 1997
SALES REPRESENTATIVES
Under this form of relationship, the Sales Representative presents to
Hologic contracts with Hologic approved sales prospects, which are not being
solicited by Hologic's direct sales force or another Sales Representative.
Hologic coordinates the activities of its Sales Representatives and sales force
by requiring that sales prospects be registered. Hologic may approve a proposed
sales prospect, disapprove it, or disapprove the prospect but offer to pay a
sales assistance fee. Normally, Hologic will not approve a sales prospect if
either Hologic's sales force, or another ISO is pursuing the prospect. If
Hologic is pursuing the prospect directly, Hologic may pay a sales assistance
fee. Once Hologic has approved a proposed prospect, the Sales Representative is
eligible for a commission whether the prospect places an approved order through
the Sales Representative, or directly with Hologic, but not if a sale is made
through an Hologic Distributor. Hologic's registration process, and its
commission and sales assistance policies are described in more detail in the
next section.
SALES COMMISSIONS (FINDER'S FEES)AND SALES ASSISTANCE FEES
REGISTRATION OF PROSPECTS
Hologic requires formal registration of prospects to become eligible for a
commission or sales assistance fee. A registration form has been attached for
use in this process. Prospect registrations are to be filed with the Hologic
Regional Sales Manager for your area. Status of prospect shall be confirmed with
you, in writing, within 72 hours of receipt of registration form. Registrations
remain "active" for six months from date of receipt and approval by Hologic.
Prospects must be re-registered for consideration beyond this period. Hologic
reserves the right to reject prospects from any of the programs listed above at
its sole discretion.
COMMISSIONS/FINDERS FEES
Once a prospect has been registered, Finder's fees are paid once a sale has
been successfully completed including full collection of all amounts due. Fees
are paid according to the schedule listed below:
QDR 1000 XXXXXXX
QDR 4500C XXXXXXX
QDR 4500W XXXXXXX
QDR 4500SL XXXXXXX
QDR 4500A XXXXXXX
Hologic shall reduce Finder's fees by XXX in instance that purchase is made
as a part of an established national buying contract with Hologic. Fees may also
be reduced or renegotiate in the instance of multiple system purchases by a
customer, and may be increased in situations where the Sales Representative
commits to a marketing plan and substantial minimum sales quota.
SALES ASSISTANCE FEE
In the instance where a sales lead is provided to Hologic and Hologic
determines that this lead is already an "active prospect" in contact with
Hologic's direct sales organization, the independent sales organization can
still earn a fee through active support of Hologic I its sales efforts. To be
eligible for these fees, the sales organization must provide Hologic's prospect
with a written recommendation and endorsement of Hologic's products. If Hologic
is successful in completing the sale (including collection) with this registered
prospect, the sales organization shall receive a sales assistance fee of XXXXXXX
for its help with the account.
<PAGE>
CUSTOMER LETTERS
The Finder's Fee and Sales Assistance Fee programs require that the
independent sales organization take active measures in support of the sale
between the registered prospect and Hologic. These active measures must include
the sending of at least one "consultative sales letter" supporting the purchase
of Hologic's equipment to the prospect. A copy of this letter, issued on the
ISO's letterhead is to be provided to Hologic as a part of the prospect
registration process (see below). Hologic has provided you with example letters
for this purpose as a portion of this package. Independent sales organization
will not be eligible for fees if this requirement has not been fulfilled.
CHECKLIST OF ACTIVITIES REQUIRED OF SALES ORGANIZATION TO EARN FEES
Hologic has attempted to keep the process for earning sales fees simple yet
fully documented for the protection of the independent sales organization. For
this procedure to work properly, Hologic's insists that all procedures be
followed.
FINDER'S FEE PROGRAM STEPS
1. Complete Prospect Registration Form;
2. Supply registration form to Hologic's Regional Sales Manager for your
area (see map);
3. Obtain prospect status from Hologic (generally within 72 hours)confirming
it is not an active Hologic prospect;
4. ISO issues "customer letter" to prospect, with copy to Hologic (completing
prospect registration form)
5. Hologic and ISO coordinate account follow-up
6. Hologic issues quotation to prospect
7. ISO and Hologic cooperate in management and communicating account status
8. Order issued to Hologic by prospect
9. Prospect completes payments on purchase as required
10. Fees issued to ISO
SALES ASSISTANCE FEE PROGRAM STEPS
1. Complete Prospect Registration Form;
2. Supply registration form to Hologic's Regional Sales Manager for your area
(see map);
3. Obtain prospect status from Hologic (generally within 72 hours)confirming
it is not an active Hologic prospect;
4. Independent Sales Organization issues "customer letter" to prospect with
copy to Hologic (completes prospect registration process)
5. Hologic issues any quotations required (note that these may have already
been issued)
6. Independent sales organization and Hologic cooperate in management and
communicating account status
7. Order issued to Hologic by prospect
8. Prospect completes payments on purchase as required
9. Fees issued to independent sales organization
<PAGE>
PROSPECT REGISTRATION FORM
Prospect Name ____________________
Address ____________________
--------------------
City ____________________
State ____________________
Zip ____________________
Phone ____________________
FAX ____________________
OTHER CONTACTS AT ACCOUNT: (examples: partners, secretaries, business managers,
administrators, purchasing agents)
Name / Phone:
ACCOUNT BACKGROUND AND INTEREST
(Supply a short summary of account activity to date)
COMPETITION
BUDGET INFORMATION
<PAGE>
SAMPLE CUSTOMER LETTER
Dear Customer:
Thank you for inquiring about bone densitometry equipment with our firm. I have
taken the liberty of investigating these products for you and would like to
share some information with you that may assist in your selection. As you know,
our firm has a sales agency relationship with Hologic, and can introduce you to
this company.
The bone densitometry business is dominated by only a couple of companies.
Hologic, Inc. of Waltham, MA (800-343-9729) is the leader in this field (60%
market share). Their equipment is considered to be the most technically advanced
and easiest to use. Their equipment has been selected by nearly all of the
pharmaceutical companies for development of the new osteoporosis drugs including
Merck's Fosamax trials. Hologic equipment has also been used in the NIH
sponsored Study of Osteoporotic Fractures (SOF), the largest osteoporosis trial
in the world, and in the NHANES study which has established the reference data
that the industry is using in its standardization efforts.
Hologic offers a full product line of both pencil and fan beam scanners
available at most price points. We would highly recommend that you consider the
fan beam products which are of the latest design. The pencil beam units are
inexpensive but are based on 8 year old technology that is incapable of
providing many of the new advances. Although Hologic equipment is typically
slightly higher in price than their competitors, we believe it is money well
spent and easily justified through savings in tech time, marketing advantages
offered and long term costs of ownership. The latest developments in the field
are available on the Hologic equipment including:
Fan Beam Technology - Offers faster scan times (30 sec. on all patients), high
resolution images, enhanced precision, significant operational conveniences and
modular product design.
Internal Reference System - The system constantly calibrates itself on a pixel
by pixel basis. No operator calibration (or mistakes) are possible. This assures
consistency in data upon upgrade or repair.
Supine Lateral Scanning - Many luminaries now suggest lateral spine scans in
patients over age 65 where artifacts lead to false negative findings with
traditional AP scans in as many as 30-40% of patients. Lateral scans may also
provide earlier diagnostic capability and earlier information concerning
response to treatment since they focus on trabecular regions of the spine. If
you decide that you want laterals, do not settle for the decubitis options which
suffer from substantial precision problems. Note too that with the modular
design of the 4500 family, laterals can always be added at a later date.
Single Energy Imaging - This is brand new to low end densitometers. High end fan
beam system have offered imaging / morphometry options in the past but Hologic
has recently made this available on all fan beam systems. The 7 second full
spine scan gives a nice image at very low dose and may be useful in spotting
artifacts (wedge fractures) that could artificially elevate spine density.
Although these images will not replace films, they do provide quantitative
morphometry capability and could be used to "screen" candidates for further
evaluation through use of films. Imaging will probably be expanded to other
applications soon and fan beam systems are required for this capability.
Modular Product Design - This is one of the best features of the Hologic
products. The field is changing very rapidly and Hologic has made a point of not
forcing decisions upon buyers nor making their equipment obsolete. Their
philosophy is to allow you to buy only what you need now and to add to that as
needs dictate. They have eliminated the financial penalty associated with
upgrades using other manufacturer's equipment and the significant data concerns
if equipment is to be exchanged.
We have also found Hologic's service to be reputable. The DXA equipment seems
quite reliable but 800 "HELP " lines and next day on site service is available.
Hologic is the only company that does all of their own service using factory
- -direct Hologic personnel.
We hope that this information is useful. [ADD APPROPRIATE FOLLOW-UP LANGUAGE]
Sincerely,
<PAGE>
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 2203 Airport Way South, Suite 400, Seattle, Washington
98134 ("Ostex"), and HOLOGIC, INC., a Delaware corporation having its principal
place of business at 590 Lincoln Street, Waltham, MA 02154 ("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 Dr. David Eyre 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").
D. Serex, Inc., a New Jersey Corporation with its principal place of
business at 230 West Passaic Street, Mayfield, New Jersey 07607 ("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
<PAGE>
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 ("SARA 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-ray bone 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 SARA 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 SARA 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 SARA 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:
<PAGE>
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 Dr. David Eyre, 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.
<PAGE>
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 SARA 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.
<PAGE>
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
SARA 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.
<PAGE>
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.
<PAGE>
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 SARA 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
<PAGE>
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
<PAGE>
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
<PAGE>
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 SARA 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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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
<PAGE>
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.
<PAGE>
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
<PAGE>
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
<PAGE>
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 SARA Format or adaptation
of the NTx Assay Technology for use with the SARA 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
<PAGE>
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
<PAGE>
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 SARA 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
<PAGE>
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.
<PAGE>
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
<PAGE>
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,
<PAGE>
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
SARA 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 SARA 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
<PAGE>
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 SUE. 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
<PAGE>
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
<PAGE>
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
<PAGE>
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.
<PAGE>
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.
<PAGE>
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
<PAGE>
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).
<PAGE>
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.
<PAGE>
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.
2203 Airport Way South
Suite 400
Seattle, Washington 98134
Attention: Jeffrey J. Miller, Ph.D.,
Senior Vice President, Corporate Development
Copy to: Robert Glaser, President and COO
if to Hologic:
Hologic, Inc.
590 Lincoln Street,
Waltham, MA 02154
Attention: Joel Weinstein, Vice President -
Business Development
Copy to: S. David Ellenbogen, 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
<PAGE>
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
<PAGE>
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/ JEFFREY J. MILLER, PH.D.
Jeffrey J. Miller, Ph.D.,
Senior Vice President,
Corporate Development
HOLOGIC, INC.
By /S/ S. DAVID ELLENBOGEN
S. David Ellenbogen
Chairman and CEO
<PAGE>
ATTACHMENT D
SEREX PATENT RIGHTS
See Attached List as of 12/26/95 which represents Hologic's current knowledge
(to be updated and confirmed)
<PAGE>
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
<PAGE>
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 _________
<PAGE>
<TABLE>
<CAPTION>
OSTEX INTERNATIONAL, INC.
TITLE Lot No. Doc No. Rev. Page
NTx Concentrate 2007 G 23 of 24
_______________________________________________________________________
-------ATTACHMENT 3-------
QC DATA SHEET
<S> <C> <C> <C> <C> <C> <C>
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
</TABLE>
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 pmol.ml 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: _________
<PAGE>
ATTACHMENT 6.2
MARKETING PLAN (TO BE APPENDED PER SECTION 6.2)
<PAGE>
ATTACHMENT 7.2.4
Product Specifications - NTx Meter Strips and NTx Meters
See Attached - Subject to Modification
<PAGE>
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.
<PAGE>
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, F.Hoffman-LaRoche 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.
<PAGE>
ATTACHMENT 16.5
HOLOGIC TRADEMARK FILINGS
MARK 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
<PAGE>
Note: Confidential treatment requested. Exhibit omits information that has
been filed separately with the Securities and Exchange Commission.
RESEARCH AGREEMENT
THIS RESEARCH AGREEMENT is effective this 1st day of July, 1996, by and
between OSTEX INTERNATIONAL, INC., a Washington corporation, having its
principal place of business at 2203 Airport Way South, Suite 400, Seattle,
Washington 98134 ("Ostex"), and the UNIVERSITY OF WASHINGTON, having its
principal office at Seattle, Washington 98195 ("University").
RECITALS
A. Ostex has an ongoing interest in research technology (including
inventions, processes, formulae and the like, whether or not patentable, and
property eligible for copyright protection) for measuring the rate of human
tissue resorption based on the quantitation of specific marker peptides derived
from cross-linking sequences in collagen, entitled "Molecular Markers of
Connective Tissue Degradation," as more particularly described in that certain
proposal attached as EXHIBIT A (the "Technology");
B. The Technology has been assigned by the University to the Washington
Research Foundation ("WRF") pursuant to Section 3.3 of that certain Technology
Administration Agreement, dated January 1, 1985, between the University and WRF,
as amended (the "UW Agreement"). Pursuant to that certain Restated Exclusive
License Agreement between Ostex and WRF, effective June 29, 1992, as amended
(the "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 Technology;
C. Ostex entered into a Research Agreement dated July 26,
1989 and amended November 1, 1992 pursuant to which initial funding was
provided by Ostex for research with respect to the Technology;
D. It is in the mutual interest of Ostex and University
that research be continued with respect to the Technology, in accordance
with a research program to be conducted and funded pursuant to this Agreement
(the "Research Program"); and
E. Ostex is willing to fund the conduct of the Research Program, at and
through the University of Washington, Department of Biological Structure, and
the University desires to obtain such funding, all subject to and in accordance
with the terms of conditions set forth in this Agreement.
AGREEMENTS
In consideration of the covenants and promises contained herein and for
good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties hereto agree as follows:
1. SCOPE/SCHEDULE
The Research Program shall be conducted in accordance with the Research
Proposal attached hereto as EXHIBIT A and made a part hereof, or mutually
agreeable written modifications thereof. The Research Program shall be carried
out during the Program Period (as defined below), unless sooner terminated or
extended as herein provided.
2. PROGRAM PERIOD
The Program Period shall be from XXXXXXXXXXXXXXXXX, and it may be
extended
by mutual written consent of the parties not less than thirty (30) days prior to
the termination of the then current Program Period.
3. OSTEX'S PRINCIPAL OBLIGATIONS
Ostex shall pay University a total of XXXXXXXXXXXXXXX to cover all
direct and indirect costs of the Research Program asset forth in the Budget
included in the Research Proposal attached hereto as
EXHIBIT A and incorporated herein.
4. PAYMENT
Ostex will provide University funds for the costs of the research
performed under this Agreement as specified in the Budget. Ostex shall pay
University as follows upon receipt of invoices from University:
PAYMENT DATE AMOUNT
1 XXXX XXXX
2 XXXX XXXX
3 XXXX XXXX
4 XXXX XXXX
5 XXXX XXXX
6 XXXX XXXX
7 XXXX XXXX
8 XXXX XXXX
9 XXXX XXXX
10 XXXX XXXX
11 XXXX XXXX
12 XXXX XXXX
Total XXXX
<PAGE>
University will submit its customary statement of expenses incurred under this
Agreement within thirty (30) days after the end of each six-month period.
5. PRINCIPAL INVESTIGATOR
For the purpose of this Agreement and pursuant to University policy,
David R. Eyre is designated the Principal Investigator ("Principal
Investigator") who shall be responsible for direction and content of the
Research Program, including budgeting and revisions to the Budget necessary to
accomplish the Research Program. Should the Principal Investigator leave the
University or otherwise become unavailable during the Program Period, University
may nominate a replacement. If Ostex does not accept the replacement, the
Research Program and Budget may be modified to reflect a reduced scope of work
or terminated on sixty (60) days' notice at the option of Ostex unless an
arrangement acceptable to Ostex can be made to subcontract with the departed
Principal Investigator or his new institution to continue the work on the
Research Program.
6. CONFIDENTIALITY
Neither party shall furnish any confidential and/or proprietary
information of a third party to the other party in connection with this
Agreement. Any such information which either party wishes to furnish to the
other party shall be the subject of a separate confidentiality agreement between
the parties.
7. DATA REPORTS AND FACILITIES
7.1 University shall, in accordance with established
University practice, keep complete, accurate, and authentic accounts, notes,
data, and records of the work performed under this Agreement and shall provide
Ostex with semi-annual reports within thirty (30) days following the end of each
six-month period commencing on the date of this Agreement. University shall also
submit to Ostex a written comprehensive final report within ninety (90) days of
termination of the Research Program.
7.2 At the discretion and convenience of the Principal
Investigator, during the course of the Research Program, Ostex's representatives
and others designated by Ostex may be present as observers while various tests,
inspections and other aspects of the Research Program are being conducted.
Ostex's representatives may consult informally with the Principal Investigator
regarding the Research Program both personally and by telephone. Further, Ostex,
at its expense, shall have the right to send one Ostex employee to work and be
trained at the Department of Orthopedics at the University. University
acknowledges and agrees that the Principal Investigator may serve as a member of
the board of directors and/or as a consultant (but not an officer) of Ostex
during the term of this Agreement.
7.3 From its own resources and those provided under this
Agreement, University agrees to make available laboratory facilities and
equipment for the Research Program.
8. INVENTION RIGHTS
8.1 University acknowledges and agrees that (i) all Technology
made, developed or conceived on or before the date of this Agreement has been
assigned to WRF pursuant to Section 3.3 of the UW Agreement, and no commitments
have been made with respect to such Technology pursuant to Section 3.2 of the UW
Agreement, (ii) all Technology made, developed or conceived after the date of
this Agreement will be submitted to WRF pursuant to Section 3.1 of the UW
Agreement, (iii) no commitment will be made pursuant to Section 3.1 of the UW
Agreement with respect to Technology made, developed or conceived after the date
of this Agreement unless Ostex agrees to such commitment in writing, and (iv)
University shall not terminate, amend, waive or enforce the UW Agreement (or any
rights or obligations thereunder) in any manner that could adversely affect
Ostex's rights under this Agreement unless Ostex agrees in writing to such
termination, amendment, waiver or enforcement.
8.2 University shall have no right, title or interest in any
Technology made, developed or conceived by employees or consultants of Ostex
entirely without use of University facilities.
9. PUBLICATION
University will be free to publish the results of research conducted
under this Agreement within a reasonable period of time. University will provide
copies of manuscripts to Ostex prior to their submission for publication or
their presentation. In order to full protect the rights of University and Ostex,
any contemplated publication or other dissemination containing details of an
invention, whether or not patentable, will be withheld until a patent
application is filed or other appropriate steps to protect commercial value have
been completed. Such withholding shall be kept to a minimum and will not exceed
six (6) months, except by mutual agreement between Ostex and University.
10. INDEMNIFICATION
University and Ostex each agree to indemnify and to hold harmless the
other party from damage to persons or property resulting from any act or
omission on the part of itself, its employees, its agents, or its officers.
11. NOTICES
Whenever any notice is to be given hereunder, it shall be in writing
and shall be deemed received, if delivered by courier on a business day, on the
day delivered, or on the fifth business day following mailing, if sent by
first-class, certified or registered mail, postage prepaid, to the following
addresses:
University: Director, Grant and Contract Services
3935 University Way N.E., JM-24
Seattle, Washington 98195
Ostex: Ostex International, Inc.
2203 Airport Way South, Suite 301
Seattle, Washington 98134
12. TERMINATION
12.1 This Agreement may be terminated by University at any
time or by Ostex at any time on or after XXXXXXXX. Sixty (60) days' prior
written notice is needed from one party to the other if either party
determines, in its discretion, that the Research Program is no longer
academically, technically or commercially feasible. Upon receipt or delivery of
such notice of termination, University shall exert its best efforts to limit or
terminate any outstanding financial commitments for which Ostex is to be liable,
and Ostex shall reimburse University (to the extent not previously paid) for all
costs incurred by it for the Research Program, including, without limitation,
all uncancellable obligations. University shall furnish, within sixty (60) days
of the effective date of termination, a final report of all costs incurred and
all funds received and shall reimburse Ostex for payments which may have been
advanced in excess of total costs incurred with no further obligations to Ostex.
12.2 Notwithstanding paragraph 12.1, in the event that either
party shall be in default of any of its obligations under this Agreement and
shall fail to remedy such default within thirty (30) days after written notice
thereof, the party not in default shall have the option of terminating this
Agreement by giving written notice of termination to the defaulting party.
12.3 Termination of this Agreement shall not affect the rights
and obligations of the parties accrued prior to termination or the rights and
obligations set forth in Article 8.
13. WARRANTS AND COVENANTS BY UNIVERSITY
13.1 University hereby warrants that it has the right and
authority to enter into this Agreement and that the representatives whose
signatures appear hereunder are duly authorized by University to enter into this
Agreement on behalf of University.
13.2 University covenants that it will not knowingly enter
into agreements with any industrial and/or commercial funding source other than
Ostex inconsistent with its obligations under this Agreement.
14. APPLICABLE LAW
This Agreement shall be governed by the laws of the State of
Washington.
15. ARBITRATION AND JURISDICTION
15.1 At the request of either party, any controversy, claim,
or dispute arising out of or relating to any provision of this Agreement shall
be settled by arbitration to be conducted in Seattle, Washington. Such
arbitration shall be in accordance with the rules applied by the American
Arbitration Association. Judgment upon any award rendered through arbitration
may be entered into any court of competent jurisdiction.
15.2 Ostex and University agree to submit to jurisdiction
in Seattle, Washington.
16. PARTIES BOUND
This Agreement, including the indemnification provisions, shall be
binding upon and inure to the benefit of the parties hereto, their respective
successors, assigns, legal representatives and heirs. Ostex may assign this
Agreement to any successor to all or substantially all of the assets and
business of Ostex. This Agreement shall not otherwise be assignable by either
party without the prior written consent of the other party.
17. NO ORAL MODIFICATION
No change, modification, extension, termination or waiver of this
Agreement, or any of the provisions herein contained, shall be valid unless made
in writing and signed by duly authorized representatives of the parties hereto.
18. SURVIVORSHIP
Sections 8 and 9 of this Agreement shall survive any expiration or
termination of this Agreement.
19. USE OF NAMES
Neither party will use the name of the other party or its employees in
any advertisement, press release or publicity with respect to the Technology
without the prior written approval of the other party. University shall have the
right to acknowledge Osteonix's support of the research performed under this
Agreement in scientific publications and other scientific communications.
IN WITNESS WHEREOF, the undersigned have entered into this Agreement as
of the date first set forth above.
UNIVERSITY: OSTEX:
By /S/ DONALD W. ALLEN By ROBERT J. GLASER
------------------------------- ----------------
Donald W. Allen, Director Robert J. Glaser, COO
Grant and Contract Services
Date: 11/21/96 Date: 10/23/96
University of Washington
Seattle, Washington 98105
To: Ostex International, Inc.
Type of Support Requested: Research Grant (continuation)
Title of Project: Molecular Markers of Connective Tissue
Degredation
Principal Investigator: David R. Eyre
Amount Requested: XXXXXX (including indirect costs)
Funding Period; XXXXXXXXXX
University office to be Grant & Contract Services
contacted regarding 3935 University Way NE, Box 355754
negotiation of award: Seattle, Wa 98195
Tel: 206-543-4043
Official authorized to
give University approval: /S/ DONALD W. ALLEN
-------------------------
Donald W. Allen, Director
Grant & Contract Services
RESEARCH PROPOSAL
Title: Molecular Markers of Connective Tissue Degradation
Funding Period: XXXXXXXXXXXXXXXXXX
PI: David R. Eyre
Orthopaedic Research Laboratories
University of Washington
Box 356500
Seattle, WA 98195-6500
Sponsor: Ostex International, Inc.
H. Raymond Cairncross
Chairman and CEO
2203 Airport Way South
Seattle, WA 98134
SUMMARY
This is a continuation research proposal for an existing project,
"Molecular Markers of Connective Tissue Degredation", funded from July 1, 1989
to the present.XXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
<PAGE>
BUDGET
Molecular Markers of Connective Tissue Degradation
(continuation project, XXXX)
XXXXXXXXXXXX
Personnel Position Effort Salary Fringe Total
- -------------- ----------- ------- ------ ------ ------
Lynne Atley, Ph.D. Post-doctoral fellow 100% XXX XXX XXX
Michael Harkey, Ph.D. Research Associate 50% XXX XXX XXX
MaryAnn Weis, B.S. Manager-Research 25% XXX XXX XXX
Ping Shao, B.S. Res. Technologist 100% XXX XXX XXX
Kristin Vosberg, B.S. Res. Technologist 100% XXX XXX XXX
Layne Norland, D.V.M. Graduate Student 100% XXX XXX XXX
Secretary 30% XXX XXX XXX
------
XXX
EQUIPMENT
Micro-titer plate washer, XXXX; water baths, XXXX; Microcentrifuge, XXXX;
Pulsed power supply, XXXX; Controlled environment shaker XXXX; Gel
electophoresis system XXXX; Purchase of HPLC system for peptide
fractionation, XXXX XXXX
SUPPLIES
XXXXXXXXXXXXXXXX
XXXXXXXXXXX and supplies
XXXXXXXXXXX and supplies
General chemicals and biochemicals
Plasticware, glassware and disposable XXXX
TRAVEL
Investigators to acedemic scientific meetings XXXX
DISCRETIONARY BUDGET(64 series, separate account)
To sponsor research seminars, conferences, meals, travel and
entertainment expenses for visiting scientists, seminar speakers
and visitors to the University on Ostex-related business XXXX
OTHER
XXXXXXXXXXXX
XXXXXXXXXXXX. Shared
Costs of service contracts on major equipment, equipment
repairs and replacement, photographic services, publication
costs, computer charges, copying, postage, courier services
and telephone charges. XXXX
------
Total Direct XXXX
(XX of modified total direct costs) UW indirect costs XXXX
--------
XXX Total XXXX
<PAGE>
BUDGET FOR ENTIRE PROPOSED PROJECT-PERIOD
XXXX XXXX XXXX
XXXX XXXX XXXX
XXXX XXXX XXXX
XXXX XXXX XXXX
-------- ----- ---------
Salaries (+fringe benefits) XXXX XXXX XXXX
Equipment XXXX XXXX XXXX
Supplies XXXX XXXX XXXX
Travel XXXX XXXX XXXX
Discretionary XXXX XXXX XXXX
Other XXXX XXXX XXXX
-------- ------ ---------
Total direct costs XXXX XXXX XXXX
UW indirect costs XXXX XXXX XXXX
(XX of MTDC) --------- ------ ---------
Total XXXX XXXX XXXX
<PAGE>
BUDGET JUSTIFICATION
The principal investigator, David Eyre, Ph.D., will direct the work
scientifically. Lynne Atley, who spent 6 months with us in 1994 as a visiting
scholar, will complete her Ph.D. requirements in Melbourne (University of
Melbourne) by April 1996 and join us as a post-doctoral fellow. She trained
under Drs. John Wark and Peter Ebeling with her thesis research on bone turnover
markers, and is keen to expand her knowledge of collagen biochemistry and work
on novel markers of skeletal metabolism. Working 100% on this project, her
efforts will focus on XXXXXXXXXXXXXXXXXXXXXas well as the application of the new
collagen-based markers (types II and III) in clinical XXXXXXX. Michael Harkey,
Ph.D. is a molecular biologist studying the XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
MaryAnn Weis, B.S. the laboratory's chief technician and research manager, runs
the gas-phase protein sequencer (a core resource for all the scientific aims)
and also has taken over project duties on O-CSF from Patricia Woods, B.S., who
left the laboratory in December 1995. Ping Shao, B.S., has worked full time on
the project for over four years. She has considerable experience in
XXXXXXXXXXXXX and in the running of immunoassays, including responsibility for
all NTx assays that we run in collaboration with outside investigators. Her
responsibility going forward will be the XXXXXXXXXXXXXXXX. Kristin Vosberg,
B.S., has worked full time on the project for over two years. Her experience is
in preparing antisera, running immunoassays including Western blots and in the
preparation and analysis of XXXXXXXXX. Her responsibility going forward will be
the development and XXXXXXXXXXXX. Layne Norland, D.V.M., is studying for a
Masters degree in the Dept. of Comparative Medicine. His research project is a
collaboration with our laboratory, to investigate whether XXXXXXXXXXXXXXXXX.
<PAGE>
A. SPECIFIC AIMS
The primary focus of this project will continue to be...
One Page Redacted
XXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
B. PROGRESS REPORT
The aims for the last three years in summary were to:
One half page redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
PROGRESS
Two pages redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
C. RESEARCH PLAN
The scientific strategy is to ...
Four and one half pages redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
<PAGE>
D. PUBLICATIONS
The following papers and abstracts of meeting presentations from the Orthopedic
Research Laboratories have resulted from or are related to this project.
Articles
1. Niyibizi C, Bonadio J, Byers PH, Eyre DR. Incorporation of type I collagen
molecules that contain a mutant a2(l) chain (Gly580-greater than Asp) into
bone matrix in a lethal case of osteogenesis imperfecta. J ' Bioi.
Chem. 267:23108-23112,1992.
2. Bogaert R, Tiller GE, Weis MA, Gruber HE, Rimoin DL, Cohn DH, Eyre DR.
Substitution of glutamate for glycine 853 of the triple helical domain of type
11 collagen produces hypochondrogenesis. J. Biol. Chem. 267:22522-22526, 1992.
3. Harris ST, Gertz BJ, Eyre DR, Genant HK, Chesnut CH Ill. The effect of
short-term treatment with alendronate upon vertebral density and biochemical
markers of bone remodeling. J. Clin. Endocrinol. Meth. 76:1399-1407, 1993.
4. Ezzat S, Melmed S, Endrew D, Eyre DR, Singer FR. Biochemical assessment of
bone formation and resorption in acromegaly. J. Clin. Endocrinol. Metab.
76:1452- 1457, 1993.
5. Bolien AM, Eyre DR. Direct extraction of gelatinases
from rat bone. Connect. Tiss. Res. 29:223-230, 1993.
6. Gerstenfeld LC, Riva A, Hodgens K, Eyre DR, Landis WJ. Post-translational
control of collagen fibrillogenesis in a mineralizing chick osteoblast culture
system. Bone Miner. Res. 8:1031-1043, 1993.
7. Gertz BJ, Shao P, Hanson DA, Quan H, Harris ST, Genant HK, Chesnut CH 111,
Eyre DR. Monitoring bone resorption in early postmenopausal women by an
immunoassay for cross-linked collagen peptides in urine. J. Bone Miner Res.
9:135- 142, 1994.
8. Eyre, DR. New Molecular Markers of Bone Metabolism. Ther. Res. 15:1 00-1 1 1,
1994.
9. Bollen A-M, Eyre DR. Bone resorption rates in children monitored by the
urinary assay of collagen type I cross-linked peptides. Bone 15:31-34, 1994.
10. Bell NH, Hollis BW, Shary J, Eyre DR, Eastell R, Colwell A, Russell GRG.
Diclofenac sodium is as effective as premarin in inhibiting bone resorption in
postmenopausal women. Am. J. Med. 96:349-353, 1994.
11. Brenner RE, Vetter U, Bollen A-M, Mike M, Eyre DR. Bone resorption
assessed by immunoassay of urinary cross-linked collagen peptides in patients
with osteogenesis imperfecta. J. Bone Miner. Res. 9:933-937, 1994.
12. Blumsohn A, Herrington K, Hannon RA, Shao P, Eyre DR, Eastell R. The effect
of calcium supplementation on the circadian rhythm of bone collagen degradation.
J. Clin. Endocrinol. Metab. 79:730-735, 1994.
13. Niyibizi C, Eyre DR. Structural characteristics of cross-linking sites in
type V collagen of bone: Chain specificity's and heterotypic links to type I
collagen. Eur. J. Biochem. 224:934-950, 1994.
14. Bogaert R, Wilkin D, Wilcox WR, Lachman R, Rimoin D, Cohn DH, Eyre DR.
Expression in cartilage of a 7-amino acid deletion in type 11 collagen from two
unrelated individuals with Kniest dysplasia. Am. J. Hum. Genet. 55:1128-1136,
1994.
15. Bockman RS, Wilhelm F, Siris E, Singer F, Chausmer A, Sitton R, Kotier J,
Bosco BJ, Eyre DR, Levenson D. A multicenter trial of low-dose gallium nitrate
in patients with advanced Paget's disease of bone. J. Clin. Endocrincl. Metab-
80:595-602, 1995.
<PAGE>
16. Eyre DR, Wu J-J. Collagen structure and cartilage matrix integrity. J.
Rheumatol. 22(Suppl. 43):82-85, 1995.
17. Eyre DR. The specificity of collagen cross-links as markers of bone and
connective tissue degradation. Acta Orthop. Scand. 66(Suppi. 266):166-170, 1995.
18. Key Jr. LL, Rodriguez RM, Willi SM, Wright NM, Hatcher HC, Eyre DR, Cure JK,
Griffin PP, Ries WL. Long term treatment of osteopetrosis with recombinant human
interferon gamma: An 18 month clinical trial. N. Engl. J. Med.
332(24):1594-1599, 1995.
19. Wu J-J, Eyre DR. Structural analysis of cross-linking domains in cartilage
type Xi collagen: Insights on polymeric assembly. J. Biol. Chem.
270(32):18865-18870, 1995.
20. Tiller GE, Polumbo PA, Weis MA, Lachman RS, Cohn DH, Rimoin DL, Eyre DR.
Dominant mutations in the type 11 collagen gene (COL2Al) produce
spondyloepimetaphyseal dysplasia (SEMD), Strudwick type. Nature Genet.
11(l):87-89, 1995.
21. Steinmann B, Eyre DR, Shao P. Urinary pyridincline cross-links in
Ehlers-Danlos Syndrome type VI. Am. J. Hum. Genet. 1995; 57:1505-1508.
22. Bolien A-M, Martin MD, Leroux BG, Eyre DR. Circadian variation in urinary
excretion of bone collagen cross-links. J. Bone Miner. Res. 1995; 10(12):1885-
1890.
23. Diab M, Wu J-J, Eyre DR. Collagen type IX from human cartilage: A structural
profile of intermolecular cross-linking sites. Biochem. J. 3 14:327-332, 1996.
Abstracts
1 . Diab M, Shapiro F, Eyre DR. Abnormality of type IX collagen in diastrophic
dysplasia. Trans. Ortho. Res. Cos. (San Francisco (1 8)S 1): 1 20, 1993.
2. Caulfield MP, Morgan C, Carlton E, Brickman AS, Clemens JD, Eyre DR, Pandian
MR. Comparison of an immunoassay for cross-linked N-telopeptide of bone collagen
with HPLC detection of pyridinolines. The Endocrine Society, 1993.
3. Dickson IR, Arora MK, Coombes RC, Shao P, Eyre D. Pyridinolines and cross-
linked type 1 collagen N-telopeptides as markers of bone metastases in breast
cancer. J. Bone Miner. Res. 8(Sl):S288, 1993.
4. Lee MY, Woods PE, Lottsfeldt JL, Ramesh N, Osborne WRA, Eyre DR. Isolation
and molecular characterization of a murine osteoclast colony stimulating factor
(0- CSF). J. Bone Miner. Res. 8(Sl):Sl44, 1993.
5. Blumsohn A, Al-Dehaimi AW, Herrington K, Shao P, Eyre DR, Eastell R. Effect
of timing of calcium supplementation on the circadian rhythm of bone collagen
degradation. J. Bone Miner. Res. 8(Sl):Sl58, 1993.
6. Rodriguez RR, Ries WL, Eyre DR, Key LL. Type I collagen cross-linked N-
telopeptide excretion by osteopetrotic patients during interferon gamma therapy:
A correlation with bone biochemical and densitometric markers. J. Bone Miner.
Res. 8(Sl):S291, 1993.
7. Ebeling PR, Atley LM, Eyre DR, Guthrie J, Dennerstein L, Wark JD. Sensitivity
of type I collagen N-telopeptide cross-links in detecting early menopausal
changes in bone tumover. Proc. ANZ Bone Miner. Soc. A2, 1993.
<PAGE>
8. Ebeling PR, Atley LM, Eyre DR, Shao P, Guthrie J, Dennerstein L, Wark JD.
Sensitivity of collagen N-telopeptide cross-links and osteocalcin in detecting
early menopausal changes in bone tumover. Abstract presented at the 4th
lntemational symposoium on Osteoporosis in Hong Kong, March 1993.
9. Fiedelius C, Eyre DR, Christiansen C. Urinary type I collagen cross-linked N-
telopetides: A new marker for bone resorption. Poster presented at the 4th
International Symposium on Osteoporosis in Hong Kong, March 1993.
10. Eyre DR, Bogaert R, Diab M, Hanson D, Knigge P, Niyibizi C, Weis MA, Wu ii.
Studies on the molecular structure of collagen heteropolymers in bone and
cartilage. Presented at the 5th International Conference on Osteogenesis
Imperfecta, September 27-30, 1993, Oxford, England.
11. Kanthawatana S, Eyre DR, Hendeles L. The effect of short course of oral
prednisone on a biochemical marker of bone resorption. Xllth Intemational
Congress of Pharmacology. Montr6al, Qu6bec, July 1994.
12. Apone S, Fevold K, Lee M, Eyre D. A rapid method for quantifying osteoclast
activity in vitro. J. Bone Miner. Res. 9(Sl):Al2O, p. S178, 1994.
13. Clemens JD, Herrick- M, Singer FR, Rosen HN, Shao P, Eyre DR. Cross-linked
N- telopeptides of type I collagen in human serum as a biochemical marker of
bone resorption. J. Bone Miner. Res. 9(Sl):A5-72, p. S228, 1994.
14. Prior JC, Eyre Dr, Ebeling PR, Wark, JD. Trabecular bone loss after
premenopausal oophorectomy is not prevented by con'ugated estrogen or
medroxyprogesterone--a double-blind, randomized 1-year study. J. Bone Miner.
Res. 9(Sl):C294, p. S394, 1994.
15. Key LL, Rodriguez RM, Hatcher H, Eyre DR, Ries WL. Long term treatment of
osteopetrotic patients with interferon gamma. J. Bone Miner. Res. 9(Sl):72, p.
S138, 1994.
16. Sowers M-F, Eyre, D, Hollis, BW. Changes in bone tumover markers and bone
density with lactation. J. Bone Miner. Res. g(Sl):A512, p. S2p7, 1994.
17. Jackson G, Hollis BW, Eyre DR, Baylink DJ, Bell NH. Effects of race and
calcium intake on bone markers and calcium metabolism in young adult men. J.
Bone Miner. Res. 9(S 1):Al 78, p. S 1 85, 1994.
18. Ebeling PR, Eyre DR, Gurthrie J, Dennerstein L, Wark JDF. Prediction of
early menopausal bone loss by biochemical markers of bone turnover. Amer. Soc.
Bone Miner. Res., Kansas City, MO, September 1994.
19. Wu JJ, Murray J, Eyre DR. Evidence foi copolymeric cross-linking between
types 11 and Ill collagens in human articular cartilage. ORS, Atlanta, 1996.
20. lchimura S, Wu JJ, Eyre DR. A sensitive method for collagen type IX peptide-
mapping in human cartilage. ORS, Atlanta, 1996.
21. Wang C, Eyre DR, Clark R, Kleinberg D, lranmanesh A, Dudley RE, Berman N,
Swerdloff RS. Sublingual testosterone replacement decreases bone resorption and
increase bone formation markers in hypogonadal men. Int. Congress of
Endocrinol., 1996.
<PAGE>
University of Washington Hazardous Materials Use
Complete and Return to
Environmental Health and Safety GS-05
A. Principal Investigator: David R. Eyre. Ph.D.
B. Department: Orthopaedics
C. Building: Health Sciences Room #: BB1052
D. Phone No.: 543-4700
E. Mail Stop: Box 356500
F. Co-investigator(s) _________________________ ______________________
========================= ======================
G Title of Project or Proposal.
Molecular Markers of Connective Tissue Degradation
<TABLE>
<CAPTION>
Yes No
<S> <C> <C>
1. Will Hazardous Materials be used or stored in your laboratory? x
2. Have you and your employees received Hazard Communication training? x
3. Will your research include the use of substances of high acute toxicity, x
reproductive toxins, carcinogens, mutagens, or teratogens?
4. Is there a chemical inventory available for your laboratory? x
5. Do you have access to a computer that is in or near your laboratory for the
purpose of accessing networked safety information? x
6. Are you familiar with the UW's Hazardous Waste Disposal Guidelines? x
7. Doe your laboratory contain the following?
</TABLE>
A. X FIRE EXTINGUISHERS?
B. X FLAMMABLE LIQUID STORAGE CABINETS?
C. X BIOLOGICAL SAFETY CABINETS?
D. X FUME HOODS (ANY TYPE)?
E. _ RESPIRATORS AND REPLACEMENT CARTRIDGES?
F. X PROTECTIVE GLOVES (LATEX, NITRILE, VINYL, ETC.)?
G. X COMPRESSED GASES?
H. X EYE WASHES?
I. X EMERGENCY SHOWER WITHIN 100 FT. OF THE LAB?
J. X ROOM WINDOWS THAT OPEN?
8. Please list on the back of this form any special hazards or precautions
associated with the use of chemicals in your research?
<PAGE>
University of Washington Biohazard Activity Review
Complete and Return to
Environmental Heath and Safety Box 354400
A. Principal Investigator: David R. Eyre. Ph.D.
B. Department: Orthopaedics
C. Building: Health Sciences LAB Room #: BB1052, 1054, 1032
D. Phone No.: 543-4700
E. Box: 356500 E-Mail: [email protected]
F. Co-investigator(s) _________________________ ______________________
========================= ======================
G Title of Project or Proposal.
Molecular Markers of Connective Tissue Degradation
__ Check here if project is non-competitive renewal and skip to Section M
Yes No
H. Is your lab engaged in the following areas of biohazard activity?
1. Activities involving non-human primates, including blood, tissues and/or
body fluids from non-human primates. __ x
2. Activities involving other animals or animal blood and tissues:
Animal Type: XXXXXX
a. Commercially raised laboratory animals. x __
b. Feral (wild caught) animals. __ x
3. Activities involving human blood, tissues, body fluids and excreta.
a. Have all personnel received Hepatitis B vaccinations?
(See UW Exposure Control Plan or call 543-7278 for
more information.) x __
b. Does the laboratory have an exposure control plan?
(if yes, answer Section I. below.) x __
4. Activities involving contact with cultures or specimens which may contain
microorganisms (including viruses). Culture Type: ___________ __ x
5. Activities involving recombinant DNA. (All projects involving recombinant
DNA must be registered with the UW Recombinant DNA Committee,
regardless of containment level. See Section III., pages 2-5 of the
"University
Biohazard Safety Manual" or call EH&S at 543-7278 regarding non-competitive
grant renewals.) __ x
I. Does your laboratory exposure control plan cover:
1. Procedures on use of personal protective equipment and
clothing? x __
2. Procedures for handling hypodermic needles, glass, pipettes
and biological wastes? x __
3. Immunization and medical surveillance program(s)? x __
4. Personnel training? x __
If the answer to any or part of section H. is "Yes" , please complete the next
page.
<PAGE>
University of Washington
Biohazard Activity Review
Page 2 of 2
Another
J. Does this project require the use of? In Lab* Location
1. Laminar flow biological safety cabinets. x __
2. Centrifuge x __
3. Autoclave x __
4. Sonication Equipment x __
*equipment located in rooms listed on first page.
K. Submit the following with this form.
1 . A copy of the GC-1 form.
2. An assessment of the possible risks from biohazards and a
brief summary of the biosafety
precautions followed.
3. Any comments received from departmental review of the project.
4. A summary of the proposed project written in lay terms and/or
a copy of the application
being submitted for grant support
L. If Class III agents* are involved submit the following additional information
with this form:
1. A resume of the training and experience of each person who
will participate in the project
2. A description of laboratory facilities available including
containment equipment such as biological safety cabinets, etc.
Include a statement by Environmental Heath and Safety
assessing the adequacy of containment facilities.
+ Consult UW Biosafety Manual for classification of agents.
Note: Work with Class IV agents will not be approved at the
University of Washington as appropriate facilities are not
available.
M. If this is a non-competitive renewal of funded grant and there are no
significant changes in the project from
the original submittal, submit the following:
a. A copy of the new GC-1 form.
b. a brief summary of the new year's proposed activity.
For more information contact
EH&S Biosafety Specialist at 543-7278
<PAGE>
Form HS SR-1 trev
BOX FOR COMMITTEE USE ONLY
MASTER ___
COMMITTEE ___
REVIEWER ___
INVESTIGATOR X
25-763-E
APPLICATION NUMBER
UNIVERSITY OF WASHINGTON
HUMAN SUBJECTS DIVISION BOX 355752
STATUS REPORT: Application no. 24-112-E
__ DO NOT RENEW. Complete items 1-6 of Status Report and return form.
XX RENEW WITH MINOR OR NO CHANGES. Complete items 1-10 of Status Report;
- -- submit one original plus three (3) copies of this form.
RENEW WITH CHANGES IN PROCEDURES, POPULATION, OR PURPOSE: Complete
and submit nine (9) copies of a new HSRC application (UW 13-11) and
this Status Report (items 1-10).
Investigator's name, position, division and department, mail stop and telephone
number:
David R. Eyre, Ph.D., Professor, Dept. of Orthopaedics, Box 356500, 543-4700
Title of Human Subjects Application:
Connective Tissue Research XXXXXXXXXXXXXXXXXXXXXXXXXXXX
Brief summary of findings to date (add sheets if necessary):
SEE ATTACHED
4. Number and types of adverse events. complaints, and withdrawals and
how they were handled (add sheets if necessary):
NONE.
5. No. of subjects enrolled in study to date:
XX Normals/Controls XX Patients/Cases
6. No. of subjects added during past year of approval:
XX Normals/Controls XX Patients/Cases
7. No. of subjects continuing participation: N/A See attached.
XX Normals/Controls XX Patients/Cases
8. How many new subjects will join the study over the next year?
XX Normals/Controls XX Patients/Cases
9. Do you propose any minor changes in this study or consent form?
X No. ___ Yes. If yes, describe (add sheets if necessary).
Submit 4 copies of revised consent form and other materials, if appropriate.
10. Provide information for all funding, awarded or proposed for this activity
(add sheets if necessary).
Type: XX research grant, __ contract, __ fellowship, __training grant,
__ other, explain:
Name of principal investigator: David R. Eyre, Ph.D.
Name of agency: SEE ATTACHED. Agency's no. (if assigned):
Title of proposal: SEE ATTACHED SEE ATTACHED
Inclusive dates: from SEE ATTACHED, through ________________
Submitted through Grant and Contract Services? __ No XX Yes __ VAMC __Other:
HSRC Chair's signature: ____________________ Date June 08, 1995 Approve XX
Disapprove __
Subject to the following conditions:
Period of approval is one year, from 06-08-95 through 06-07-96.
* VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED *
<PAGE>
Washington, Comparative Medic 01/30/1996
- - Protocol Description
Eyre, David R. BOX 356500
PROTOCOL: 2547-03 Last Update: 01/30/1996
Immunoassay Assessment of Type I and Type II Collagen Degradation in the
Received: 11/15/1995 Approved: 11/16/1995 Sig. Chg.: 01/25/1996
Expires: 11/15/1996 Vet Appr.: 01/25/1996
Funding sources: Ostex International
PI: Eyre, David R. Mail: BOX 356500 S/D: / Orthopaedics
Contacts: Function Phone Emergency
Norlund, Layne C 543-0474/ 685-8932
Species: 11 XXXXXXXXXXX Strain: XXXXXXX
Vivarium: 01 Lab Room: 01 G609,D604 Oper. Room:
1 2 3 4 Total
Approved: X X X X XXX
Ordered: XXX X X X XXX
Adjusted: XX X X X XX
Remaining: XX X X X XX
Y-Drug administration Y-Blood sampling Y-Euthanasia
Y-Collection of tissue Y-Withhold meds
NO CONDITIONS
Protocol Summary:
21. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
<PAGE>
Note: Confidential treatment requested. Exhibit omits information that has
been filed separately with the Securities and Exchange Commission.
Research Agreement
Dr. Minako Y. Lee
RESEARCH AGREEMENT
This RESEARCH AGREEMENT is entered into as of the 1st day of September,
1996, by and between OSTEX INTERNATIONAL, INC., a Washington corporation, having
its principal place of business at 2203 Airport Way South, Suite 400, Seattle,
Washington 98134 ("Ostex"), and the UNIVERSITY OF WASHINGTON, having its
principal office at Seattle, Washington 98195 (the "University").
RECITALS
A. Ostex has an ongoing interest in certain research technology
(including inventions, processes, formulae and the like, whether or not
patentable, and property eligible for copyright protection) entitled "Role of
O-CSF in Osteoclast Regulation," as more particularly described in "Exhibit A"
attached hereto (the "Technology").
B. The Technology has been assigned by the University to the Washington
Research Foundation ("WRF") pursuant to Section 3.3 of that certain Technology
Administration Agreement, dated January 1, 1985, between the University and WRF,
as amended (the "UW Agreement"). Pursuant to that certain Exclusive License
Agreement between Ostex and WRF, dated October 20, 1989 (the "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 Technology.
C. Ostex and the University entered into a Research Agreement dated
November 1, 1992, pursuant to which Ostex funded the first two years of a
research program to be conducted by the University relating to the Technology
(the "Research Program").
D. It is in the mutual interest of Ostex and the University that the
Research Program be continued pursuant to this Agreement.
E. Ostex is willing to fund the XXXXXXXXXXX of the Research Program at
and through the University of Washington, Department of Biological
Structure, and the University desires to obtain such funding, all subject to and
in accordance with the terms and conditions set forth in this Agreement.
<PAGE>
AGREEMENTS
In consideration of the covenants and promises contained herein and for
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties hereto agree as follows:
1. SCOPE AND SCHEDULE
The Research Program shall be conducted in accordance with the research
proposal attached hereto as "Exhibit A" and incorporated herein by this
reference (the "Research Proposal"), and in accordance with mutually agreeable
written modifications thereof. The Research Program shall be carried out during
the Program Period (as defined below), unless sooner terminated or extended as
herein provided.
2. PROGRAM PERIOD
The Program Period initially will be XXXX in duration; commencing XXXX
and expiring XXXX, provided, however, that the parties may by mutual
agreement reached no less than thirty (30) days prior to expiration XXXXXXX,
extend the Program Period forXXXXXXXXXXXXXXXXXXXXXX to commence XXXX and expire
XXXX.
3. OSTEX'S PRINCIPAL OBLIGATIONS
3.1 During XXXXXXXXX of the Program Period, Ostex shall pay
the University the sum of XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX to cover
all direct and indirect costs of the corresponding portion of the Research
Program, as set forth in the budget section of the Research Proposal.
3.2 In the event that the Program Period is extended beyond
XXXXXXX in accordance with Section 2 above, Ostex shall during XXXXXXX pay the
University the sum of XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX to cover all
direct and indirect costs of the corresponding portion of the Research Program,
as set forth in the budget section of the Research Proposal.
4. PAYMENT TERMS
4.1 During XXXXXXX of the Program Period, Ostex shall, upon
receipt of invoices from the University, pay the University the amount specified
in Section 3.1 above, in accordance with the following schedule:
PAYMENT DATE PAYMENT AMOUNT
-XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXX
XXXXXXXXXX
- XXXXXXXXXXXXXXXXXXXXXXXXXXX XXX
- XXXXXXXXXXXXXXXXXXXXXXXXXXX XXX
- XXXXXXXXXXXXXXXXXXXXXXXXXXX XXX
<PAGE>
4.2 In the event that the Program Period is extended beyond
XXXXXXX, Ostex shall, upon receipt of invoices from the University, pay the
University during XXXXXXX the amount set forth in Section 3.2 above, in
accordance with the following schedule:
PAYMENT DATE PAYMENT AMOUNT
- XXXXXXXXXXXXXXXXXXXXXXXXX XXX
- XXXXXXXXXXXXXXXXXXXXXXXXX XXX
- XXXXXXXXXXXXXXXXXXXXXXXXX XXX
- XXXXXXXXXXXXXXXXXXXXXXXXX XXX
4.3 The University shall submit its customary statement of
expenses incurred under this Agreement within thirty (30) days after the end of
each six-month interval of the Program Period.
5. PRINCIPAL INVESTIGATOR
For purposes of this Agreement, and pursuant to University policy, Dr.
Minako Y. Lee is designated the principal investigator of the Research Program
("Principal Investigator"). The Principal Investigator shall be responsible for
the direction and content of the Research Program, including budgeting and
budget revisions necessary to accomplish the objectives of the Research Program.
Should the Principal Investigator leave the employ of the University or
otherwise become unavailable to fulfill her obligations as Principal
Investigator during the Program Period, the University may nominate a
replacement for the position of Principal Investigator. If such replacement is
not acceptable to Ostex, the Research Program and budget contained in the
Research Proposal may be modified to reflect a reduced scope of work, or, at the
option of Ostex, may be terminated upon sixty (60) days' notice, unless
arrangements acceptable to Ostex can be made to subcontract with the departed
Principal Investigator, or the institution at which she is then employed, to
continue the work described in the Research Proposal.
6. CONFIDENTIALITY
Neither party shall furnish to the other any confidential or
proprietary information of any third party in connection with this Agreement.
Any such information which one party wishes to furnish to the other shall be the
subject of a separate confidentiality agreement between the parties.
7. DATA REPORTS AND FACILITIES
7.1 The University shall, in accordance with established
University practice, keep complete, accurate, and authentic accounts, notes,
<PAGE>
data, and records of the work performed under this Agreement and shall provide
Ostex with reports within thirty (30) days following the end of each six-month
interval of the Program Period. The University shall furthermore submit to Ostex
a written and comprehensive final report within ninety (90) days after
termination of the Research Program.
7.2 At the discretion and convenience of the Principal
Investigator during the course of the Research Program, Ostex's representatives
and others designated by Ostex may be present as observers while various tests,
inspections and other aspects of the Research Program are being conducted.
Ostex's representatives may consult informally with the Principal Investigator
regarding the Research Program both personally and by telephone. The University
acknowledges and agrees that the Principal Investigator may serve as a
consultant to Ostex during the term of this Agreement.
7.3 From its own resources and those provided under this
Agreement, the University agrees to make available laboratory facilities and
equipment for the Research Program.
8. INVENTION RIGHTS
8.1 The University acknowledges and agrees that: (i) all
Technology made, developed or conceived on or before the date of this Agreement
has been assigned to WRF pursuant to Section 3.3 of the UW Agreement, and no
commitments have been made with respect to such Technology pursuant to Section
3.2 of the UW Agreement; (ii) all Technology made, developed or conceived after
the date of this Agreement will be submitted to WRF pursuant to Section 3.1 of
the UW Agreement; (iii) no commitment will be made pursuant to Section 3.1 of
the UW Agreement with respect to Technology made, developed or conceived after
the date of this Agreement unless Ostex agrees to such commitment in writing;
and (iv) the University shall not terminate, amend, waive or enforce the UW
Agreement, or any rights or obligations thereunder, in any manner that could
adversely affect Ostex's rights under this Agreement unless Ostex agrees in
writing to such termination, amendment, waiver or enforcement.
8.2 The University shall have no right, title or interest in
any Technology made, developed or conceived by employees or consultants of Ostex
entirely without the use of University facilities.
9. PUBLICATION
The University will not be restricted hereunder from publishing the
results of research conducted under this Agreement within a reasonable period of
time following their availability. The University will provide a copy of all
manuscripts to Ostex prior to their presentation or submission for publication.
In order to protect fully the rights of the University and of Ostex, any
contemplated publication or other dissemination containing details of an
invention, whether or not patentable, will be withheld until a patent
<PAGE>
application is filed or other appropriate steps to protect commercial value have
been completed. Such withholding shall be kept to a minimum and will not exceed
six (6) months, except by mutual agreement between Ostex and the University.
10. INDEMNIFICATION
The University and Ostex each agree to indemnify and hold the other
party harmless from damage to persons or property resulting from any act or
omission on the part of itself, its employees, its agents, or its officers.
11. NOTICES
Any notice to be given hereunder shall be in writing and shall be
deemed received by the addressee on the day delivered if delivered by courier on
a business day, or on the fifth business day following mailing if sent by
first-class, certified or registered U.S. mail, postage prepaid, to the
following address:
if to the University: Director, Grant and Contract Services
3935 University Way, N.E., JM-24
Seattle, Washington 98195
if to Ostex: Ostex International, Inc.
2203 Airport Way South, Suite 301
Seattle, Washington 98134
Attention: President
12. TERMINATION
12.1 This Agreement shall terminate upon the expiration of the
Program Period as defined in Section 2 above; provided, however, that this
Agreement may be terminated by either party prior to expiration of the Program
Period upon sixty (60) days' prior written notice, if such party determines, in
its discretion, that the Research Program is no longer feasible or desirable
academically, technically, or commercially. Upon receipt or delivery of such
notice of termination, the University shall exert its best efforts to limit or
terminate any outstanding financial commitments for which Ostex is responsible
hereunder, and Ostex shall reimburse the University, to the extent not
previously reimbursed, for all costs incurred by the University for the Research
Program, including, without limitation, all obligations not cancelable. The
University shall furnish, within sixty (60) days of the effective date of
termination, a final report of all costs incurred and all funds received and
shall reimburse Ostex for payments which may have been advanced in excess of
total costs incurred, with no further obligations to Ostex.
12.2 Notwithstanding paragraph 12.1 above, in the event that
either party shall be in default of any of its obligations under this Agreement
<PAGE>
and shall fail to cure such default within thirty (30) days after receiving
written notice thereof, the party not in default shall have the option of
terminating this Agreement by giving written notice of termination to the
defaulting party, which shall be effective thirty (30) days after delivery.
12.3 Termination of this Agreement shall not affect the rights
and obligations of the parties accrued prior to termination, or the rights and
obligations set forth in Section 8 above.
13. WARRANTS AND COVENANTS BY UNIVERSITY
13.1 The University hereby warrants that it has the right and
authority to enter into this Agreement and that the representatives whose
signatures appear hereunder are duly authorized by the University to enter into
this Agreement on behalf of the University.
13.2 The University covenants that it will not knowingly enter
into any agreement with any industrial or commercial funding source other than
Ostex if such agreement would be inconsistent with the University's obligations
hereunder.
14. GOVERNING LAW
This Agreement shall be governed by and construed in accordance with
the laws of the State of Washington.
15. ARBITRATION AND JURISDICTION
15.1 At the request of either party, any controversy, claim,
or dispute arising out of or relating to any provision of this Agreement shall
be settled by arbitration to be conducted in Seattle, Washington. Such
arbitration shall be conducted in accordance with the rules applied by the
American Arbitration Association. Judgment upon any award rendered through
arbitration may be entered into any court of competent jurisdiction.
15.2 Ostex and the University agree to submit to
jurisdiction in Seattle, Washington.
16. SUCCESSORS AND ASSIGNS
This Agreement, including the indemnification provisions hereof, shall
be binding upon and inure to the benefit of the parties hereto, their respective
successors, assigns, and legal representatives. Ostex may assign this Agreement
to any successor to all or substantially all of its business and assets. This
Agreement shall not otherwise be assignable by either party without the prior
written consent of the other.
<PAGE>
17. NO ORAL MODIFICATION
No change, modification, extension, termination or waiver of this
Agreement, or any provision herein contained, shall be valid unless made in
writing and signed by duly authorized representatives of the parties hereto.
18. SURVIVAL
Sections 8 and 9 of this Agreement shall survive any expiration or
other termination of this Agreement.
19. USE OF NAMES
Neither party will use the name of the other party or its employees in
any advertisement, press release or publicity with respect to the Technology
without the prior written approval of the other party. The University shall have
the right to acknowledge Ostex's support of the research performed under this
Agreement in scientific publications and other scientific communications.
EFFECTIVE as of the day and year first set forth above.
UNIVERSITY: OSTEX:
By /S/ DANALD A. ALLEN By /S/ JOHN M. BRENNEMAN
Donald W. Allen, Director, John M. Brenneman, Director of Finance
Grant and Contract Services
11/21/96 10/22/96
Date of signature Date of signature
<PAGE>
EXHIBIT A
Continuation of Research proposal:
Role of O-CSF in Osteoclast Regulation
For XXXXXXXXXXXXXXXXXXXXXXXXXXX
Submitted to:
OSTEX International Inc.
2203 Airport Way, S., Suite 301
Seattle, WA. 98l34
Tel: (206) 292-8082
Fax: (206) 292-8625
Principal Investigator:
Minako Y. Lee, ,M.D.
Research Associate Professor
Department of Biological Structure
SM-20
University of Washington
Seattle, WA. 98195
Tel: (206) 685-1514
Fax:(206) 543-1524
1
Lee, Minako Y.
<PAGE>
Budget Request for XXXX X XXXXXXXXXXXXXXXXXX
DETAILED BUDGET FOR THE FIRST 12 MONTHS
Personnel:
Name Role % Salary Fringe Total
M. Y. Lee P.I 40% XXX XXX XXX
Y Igarashi Senior Fellow 30% XXX XXX XXX
L. Ferguson Res Tech I 100% XXX XXX XXX
Q. Dang Hourly XXX XXX XXX
Subtotal personnel: XXX
Equipments:
Microcentrifuge XXXX, Tissue homogenizer XXXX XXX
Supplies:
XXXXXXXXXXXXXXX XXX
XXXXXXXXXXXXXXX XXX
XXXXXXXXXXXXXXX XXX
XXXXXXXXXXXXXXX XXX
XXXXXXXXXXXXXXX XXX
Others XXXX, equipment repair, service: XXX
publication: XXX, photocopies, postage: XXXX XXX
XXXXXXXXXXXXXXX XXX
Housing in XXXXXXXXXXXXXXX XXX
Subtotal for supplies: XXX
Total direct costs: XXX xxxxxx Indirect Costs: xxxxxx
xxxxxx xxxxxx Indirect Costs: xxxxxx
Total direct costs for the next XXXX period xxxxxx Indirect Costs: xxxxxx
Total direct and indirect for next XXXX period: XXXX
<PAGE>
xxxxxx xxxxxx
Personnel
Salaries xxxxxx xxxxxx
Fringe xxxxxx xxxxxx
Total xxxxxx xxxxxx
Equipment xxxxxx xxxxxx
Supplies xxxxxx xxxxxx
Total xxxxxx xxxxxx
BUDGET JUSTIFICATION:
We are requesting salaries for personnel who will be working on the
proposed project at a % effort as indicated. Dr. Lee will spend xxx of her time
as P.I. A proposed salary is commensurate with her experience and academic
level. Dr. Igarashi, Ph.D. in biochemisty, is an associate professor in
Biochemistry at Dokkyo University School of Medicine, Japan. He came to our
laboratory in April 95 as a visiting scholar to work for 2 years. He is a well
experienced biochemist in protein purification and molecular biology, and his
contribution is very helpful to our program. He will work with us on
XXXXXXXXXXXX. He needs 30% of his salary support in next year. Ms. Ferguson will
provide technical assistance in XXXXX involved in the proposal. Mr. Dang will
XXXXXXX.
Fringe benefit is calculated at 22% for PI, 25% for the fellow, and 30% for the
research technologist, according to the institutional regulation. Annual
inflation rate is calculated at 4%.
Indirect cost rate is as per current agreement between University of Washington
and OSTEX International Inc.
<PAGE>
Research Proposal: Role of O-CSF in Osteoclast Regulation
A) SPECIFIC AIMS
One half page redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
B) BACKGROUND AND SIGNIFICANCE:
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
responsible for bone resorption. It is now well established that
Ostoeclasts are derived from a hematopoietic stem cell population and
multinucleated functional osteoclasts are formed by the fusion of mononuclear
precursor cells (1,2). Although it has been clearly shown that osteotropic
hormones such as 1,25 dihydroxyvitamin D3 (vitamin D3) or parathyroid hormone
(PTH) play important roles in the process of functional osteoclast formation
(3), mechanisms of immature osteoclast development in the bone marrow is still
poorly understood. Nonetheless, recent studies have gradually revealed that more
and more complex mechanisms are involved in differentiation of immature
osteoclasts from the heterogenous hematopoietic cell population. Involvement of
not only various interleukins, colony stimulating factors (CSF), growth factors,
and/or hormones but also soluble receptors of cytokines (4) and marrow stromal
cell elements have been suggested to play roles at various stages of osteoclast
development (3).XXXXXXXXXXXXXXXXXXXXXXXXXXX
The remaining page unsder background and significance is redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
<PAGE>
C) PROGRESS REPORT/ PRELIMINARY STUDIES
Following studies have been conducted in collaboration with laboratories of
Dr. David Eyre, Department of Orthopedics, Dr. William Osborne, Department of
Pediatrics, both at the University of Washington, and Dr. Stephen Apone, Ostex
International. Inc.
Two pages redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PRELIMINARY STUDIES
Two and one half pages redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
<PAGE>
Publications:
M.Y.Lee, P.E.Woods, J.L.Lottsfeldt, N.Ramesh, W.R.A.Osborne, D.R.Eyre: Isolation
and molecular characterization of a murine osteoclast colony stimulating factor
(O-CSF). J Bone Mineral Research 8: S144, 1993.
T.H.Lee, K.L.Fevold, Y.Muguruma, J.L.Lottsfeldt, M.Y.Lee. Relative roles of
osteoclast colony-stimulating factor and macrophage colony stimulating factor in
the course of osteoclast development. Exp Hematol 22:66-73, 1994.
Stephen Apone, Karen Fevold, Minako Lee, David Eyre: A rapid method for
quantifying osteoclast activity in vitro. J Bone Mineral Research 9:S178, 1994.
Y.Hayase, M.Y.Lee: Osteoclast progenitors develop from primitive hematopoietic
stem cells. Exp Hematol 22:(8), 755, 1994.
Y.Mugururna, M.Y.Lee: Osteoclast progenitors express c-Kit, but their
differentiation appears independent of stem cell factor. Abstract submitted to
the annual meeting for the American Society of Hematology, 1995.
L.E.Purton, M.Y.Lee,B.Torok-Storb. Normal human peripheral blood mononuclear
cells mobilized with granulocyte colony-stimulating factor contain osteoclast
progenitors. Abstract submitted to the annual meeting for the American Society
of Hematology, 1995.
<PAGE>
D) Research plan:
Four pages redacted
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
<PAGE>
WORK SCHEDULE:
Aim 1 XXXXXXXXXXXXXXXXXXXX
Aim 2 XXXXXXXXXXXXXXXXXXXX
Aim 3 XXXXXXXXXXXXXXXXXXXX
References:
1. SudaT. et al., Modulation of osteoclast differentiation. Endocrine
Reviews. 13:66-80,1992
2. Nijweide,PJ. and GroothR. Ontogeny of the osteoclast. In Biology and
Physiology of the Osteoclast. Rifkin, BR and Gay CV eds. p82-97. CRC press,
Boca Raton, Florida 1992
3. Chambers,TJ. Regulation of osteoclast development and function. ibd.
p 106-128.
4. Tamura, T. et al., Soluble interleukin-6 receptor triggers osteoclast
formation by interleukin 6. Proc. Natl Acad. Sci. 90:11924-1928, 1993
5. Lee, MY., Eyre, DR., Osborne, WRA. Isolation of a murine osteoclast
colony stimulating factor. Proc. Natl. Acad. Sci. 88:8500-8504,1991
6. Lee, MY.,
Lottsfeldt, JL. Fevold, KL. Identification and characterization of osteoclast
progenitors by clonal analysis of hematopoietic cells. Blood 80:1710-1716, 1992
7. Metcalf,D. Hematopoietic regulators. Redundancy or Subtlety? Blood
82:35l5-3523, 1993
8. Kaushansky, K., Lin,N. and Adamson,J: Interleukin 1 stimulates
fibroblasts to synthesize granulocyte-macrophage and granulocyte colony
stimulating factors. Mechanisms for the hematopoietic response to inflammation.
J Clin Invest 81: 92-97, 1988
9. Thomson, B.M., Saklatvala, J. and Chambers,
T.J: Osteoblasts mediate interleukin 1 stimulation of bone resorption by rat
osteoclasts. J Exp Med 164: 104-112, 1986
10. Lee,TH., Fevold,KL., Muguruma,Y.,
Lottsfeldt,JL., Lee,MY. Relative roles of osteoclast colony-stimulating factor
and macrophage colony-stimulating, factor in the course of osteoclast
development. Exp Hematol 22:66-73. 1994
11. de-la-Mata,J., et al., Interleukin-6
enhances hypercalcemia and bone resorption mediated by parathyroid
hormone-related protein in vivo. J.Clin Invest. 95:2846-2852, 1995
12. KodamaH., et al., Congenital osteoclast deficiency in osteopetrotic
(op/op) mice is cured by injections of macrophage colony-stimulating
factor. J. Exp. Med. 173:269-272, 1991
13. Jilka,R., et al., Increased osteoclast development after
estrogen loss: mediation by interleukin-6. Science 257:88-91, 1992
14.Horowits,MC. Cytokines and estrogen in bone: Anti-osteoporotic effects.
Science 260:626-627, 1993
15. Rifkin,DB and Moscatelli, D. Recent developments in the
cell biology of basic fibroblast growth factor. J.Cell Biol 109: 1-6, 1989
16.Apone,S., Fevold,K., Lee,M., Eyre,D. A rapid method for quantifying
osteoclastactivity in vitro. J Bone Min Res 9:S178, 1994
17. Muguruma,Y. and Lee, MY.Osteoclast progenitors express c-Kit, but
their differentiation appears independent of SCF. (submitted) 15
<PAGE>
FOUR EXPRESSION GRAPHS REDACTED ON THIS PAGE
