CLINICAL LABORATORY AGREEMENT
THIS CLINICAL LABORATORY AGREEMENT ("Agreement") is made as of this 7th day of
March, 1996 by and between, Xxxxx-Xxxxx Pharmaceutical Research, a division of
Xxxxxx-Xxxxxxx Company, a Delaware corporation with offices at 000 Xxxxx Xxxx,
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000 ("Warner") and Pacific Biometrics, Inc. ("PBI"
or "Laboratory"), located at 0000 Xxxxxxxx Xxx. Xxxx, Xxxxxxx, XX 00000.
WHEREAS, Warner desires Laboratory to perform certain clinical laboratory
services in conjunction with the clinical study being conducted by or on behalf
of Warner in accordance with Warner's protocol number CI 981-70: An assessment
of the cost-effectiveness of treating to NCEP goals with atorvastatin as
compared to fluvastatin, lovastatin, and simvastatin in patients with risk
factors for CHD a copy of which is attached hereto as Exhibit A and incorporated
herein by reference (the "Protocol"); and
WHEREAS, Laboratory desires to perform such clinical laboratory services;
THEREFORE, in consideration of the mutual promises contained herein, the parties
agree as follows:
1.0 OWNERSHIP OF DATA AND PUBLICATION:
Laboratory agrees that all data, materials, plans, reports, ideas, inventions
and discoveries generated during or as a result of the performance of the
Services (as defined herein) shall be the exclusive property of Warner, and
Laboratory agrees to execute any documents or undertake any further actions
requested by Warner to evidence transfer of title thereto.
2.0 SCOPE OF SERVICES:
Laboratory shall perform and complete the clinical laboratory services described
in and in accordance with the Protocol and Schedule A which are attached hereto
and incorporated herein by reference. Such services are hereinafter referred to
as the "Services." Laboratory shall exercise its reasonable and diligent efforts
and professional expertise in performing the Services. Laboratory shall not
perform any services other than as specifically set forth on the schedule of
services and payments contained in Schedule A without the prior written consent
of Warner in the form of Exhibit B (a "Consent", a copy of which is attached
hereto), signed by all of the following four individuals: (1) the Xxxxx-Xxxxx
Senior Director of Clinical Research Administration; (2) the Xxxxx-Xxxxx
Director of Planning and Contracting; (3) the Xxxxx-Xxxxx Senior Vice President
of Worldwide Clinical Research; and (4) an authorized representative of the
Laboratory. No payments shall be made by Warner to Laboratory for any services
performed by
Laboratory unless such services are specifically enumerated in Exhibit A and
Schedule A or are specifically approved by a fully executed Consent.
3.0 TIME SCHEDULE:
The parties agree that time is of the essence, and Laboratory shall perform and
complete the Services and provide Warner with all data, information and reports
required hereunder in accordance with the time schedule set forth in Schedule A,
including, without limitation, providing in a timely manner to Warner as
required in Schedule A, the data and reports required hereunder in a form
acceptable to Warner.
4.0 FINANCIAL ARRANGEMENTS:
In consideration for the Services to be performed by Laboratory, Warner shall
pay Laboratory in accordance with the fee schedule set forth in Schedule A. In
no event shall the total fees paid to Laboratory exceed the total budget amount
set forth in Schedule A.
All payments due hereunder shall be contingent upon continued completion of the
Services, including, without limitation, delivering all reports with respect
thereto (a) in accordance with this Agreement, (b) to the reasonable
satisfaction of Warner and (c) in accordance with the time schedule set forth in
Schedule A. All invoices for payment shall be forwarded to the following
individual:
Xxxxxx Xxxxx
Xxxxx-Xxxxx Pharmaceutical Research Division
0000 Xxxxxxxx Xxxx
Xxx Xxxxx, XX 00000
5.0 AUTHORITY:
Laboratory hereby represents and warrants that it has the power and authority to
undertake the contractual commitments set forth in this Agreement and that its
execution of this Agreement and its performance of the Services shall not
constitute a breach or default under any agreement which Laboratory has entered
into with any third party.
6.0 PERFORMANCE COVENANTS:
Laboratory shall render the Services in accordance with professional standards
currently prevailing in its industry and will produce and provide services,
expertise, materials, plans, reports, data and information which are accurate,
of the highest quality and suitable for inclusion in Warner's drug marketing
registrations. Laboratory shall only assign personnel to perform Services who
shall have the skills necessary to efficiently and professionally fulfill the
performance covenant contained in the preceding sentence. In carrying out its
responsibilities under this Agreement, Laboratory covenants to perform the
Services and maintain records and data during and after the term of this
Agreement in compliance with all applicable laws, rules and regulations.
-2-
7.0 TERM:
The term of this Agreement shall commence on the date hereof and shall
continue until six (6) months after the earlier of (a) the date the Services
are finally completed and all final reports and data are furnished to Warner or
(b) the date on which this Agreement is terminated as provided herein. The
representations, warranties and covenants contained in this Agreement, as well
as those rights and obligations contained in the terms of this Agreement which
by their intent or meaning have validity beyond the term hereof, including,
without limitation, Sections 1, 9, 10 and 11, shall survive the termination or
expiration of this Agreement.
8.0 TERMINATION:
This Agreement shall automatically and immediately terminate upon the occurrence
of a "Termination Event." A "Termination Event" shall mean the voluntary or
involuntary filing of a petition for bankruptcy, insolvency or placing in
receivership of Laboratory. This Agreement may be terminated by Warner at any
time in the exercise of its sole discretion upon thirty (30) days prior written
notice to Laboratory. Upon receipt of notice, Laboratory agrees to promptly
terminate conduct of the Services. In the event of termination hereunder, other
than as a result of a material breach by Laboratory, Warner shall pay Laboratory
for any Services performed by Laboratory prior to receipt of the notice of
termination or the occurrence of a Termination Event, whichever is earlier. Any
unexpended funds previously paid by Warner to Laboratory shall be immediately
refunded to Warner. Either party may also terminate this Agreement on thirty
(30) days prior written notice in the event the other party breeches this
Agreement, unless such other party cures breech within such thirty (30) day
period.
9.0 CONFIDENTIALITY:
Both during and after the term of this Agreement, Laboratory shall not disclose
to any third party and shall otherwise maintain in confidence and use only for
the purposes contemplated in this Agreement (a) all data, information,
materials, plans, reports and ideas which are disclosed by or on behalf of
Warner to Laboratory and (b) all data, information, materials, plans, reports
and ideas which are generated as a result of the performance of Services. The
preceding obligations shall not apply to data, information, materials, plans,
reports and ideas which have entered the public domain through no fault of
Laboratory or where Warner gives its prior written consent to its use or
disclosure. Laboratory agrees to return all such data, information, materials,
plans, reports and ideas and all copies or reproductions thereof and all notes,
reports, excerpts, and extracts relating thereto, to Warner immediately upon the
expiration or termination of this Agreement or at an earlier date at the request
of Warner.
10.0 INDEMINITY:
Laboratory shall defend, indemnify, and hold Warner and its officers, directors,
employees and affiliates harmless from, against, for and in respect of any and
all damages, liabilities, losses, costs, and expenses (including, without
limitation, reasonable attorneys fees and amounts paid in settlement) arising
out of or relating to any suit, action, or
-3-
proceeding brought by a third party regarding the data, information, materials,
plans, reports or ideas produced hereunder or the performance of the Services,
provided, however, that Laboratory shall not be liable for any damages, losses,
costs or expenses arising solely out of the willful misconduct of Warner.
11.0 AUDIT:
Warner is hereby granted the right to examine Laboratory's relevant raw data,
records, facilities and other information during normal business hours. Warner
is hereby further granted the right to discuss with any Laboratory officers,
employees, agents or representatives any aspect of this Agreement or the
Services, both during and after the term of this Agreement, solely to permit
Warner to confirm that the Services are or have been performed in compliance
with all applicable laws, rules and regulations and the terms and conditions of
this Agreement.
12.0 ASSIGNMENT:
This Agreement shall not be assigned by either party hereto without the prior
written consent of the other party, except that Warner may assign this Agreement
in whole or in part to any of its affiliates who shall be substituted directly
in whole or in part for it hereunder. Except as otherwise provided herein, this
Agreement shall be binding upon and shall inure to the benefit of the parties
hereto and their respective successors and permitted assigns.
13.0 NOTICES:
Any notice or report required or permitted to be given or made under this
Agreement by one of the parties hereto to the other shall be in writing and sent
to the other party by hand or mailed by first class (postage prepaid) or by
facsimile copy at its address indicated below or to such other address as the
addressee shall have theretofore furnished in writing to the addressor:
If to Warner:
Xxxxx-Xxxxx Pharmaceutical Research Division
Xxxxxx-Xxxxxxx Company
0000 Xxxxxxxx Xxxx
Xxx Xxxxx, XX 00000
Attention: Xxxxx Xxxxxx
Director, Planning and Contracting
Fax: 000-000-0000
with a copy to:
Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, XX 00000
Attention: Counsel, Pharmaceuticals, North America
Fax: 000-000-0000
-4-
If to Laboratory:
Pacific Biometrics, Inc.
0000 Xxxxxxxx Xxx. Xxxx
Xxxxxxx, XX 00000
Attention: Xxxxxxxxx Xxxx Xxxxx, Ph.D.
Vice President, Director of Laboratories
Fax: 000-000-0000
14.0 GOVERNING LAW:
This Agreement shall be governed by and construed in accordance with the laws of
the State of Michigan without reference to conflicts of laws rules or
principles.
15.0 ENTIRE AGREEMENT:
The terms and provisions contained in this Agreement constitute the entire
agreement between the parties and supersede all previous communications,
representations, agreements or understandings, either oral or written between
the parties hereto with respect to the subject matter hereof, and no agreement
or understanding varying or extending this Agreement shall be binding upon
either party hereto unless in a writing which specifically refers to this
Agreement and which is signed by duly authorized officers or representatives of
the respective parties. The provisions of the Agreement not specifically amended
thereby shall remain in full force and effect.
16.0 NON-WAIVER:
Any waiver of the terms of this Agreement must be in writing signed by the
waiving party. The waiver by either of the parties to this Agreement of any
breach of any provision hereof by the other party shall not be construed to be a
waiver of any succeeding breach of such provision or a waiver of the provision
itself.
17.0 SEVERABILITY:
If and to the extent that any court or tribunal of competent jurisdiction holds
any of the terms, provisions or conditions or parts thereof of this Agreement,
or the application hereof to any circumstances, to be invalid or to be
unenforceable in a final nonappealable order, the remainder of this Agreement
and the application of such term, provision or condition or part thereof to
circumstances other than those as to which it is held invalid or unenforceable
shall not be affected thereby, and each of the other terms, provisions and
conditions of this Agreement shall be valid and enforceable to the fullest
extent of the law.
18.0 AGENCY:
The relationship of the parties under this Agreement is that of independent
contractors. Neither party shall be deemed to be the agent of the other, nor
shall the parties be deemed
-5-
to be partners or joint venturers, and neither is authorized to take any action
binding upon the other.
19.0 USE OF NAMES:
Laboratory shall not use the name of Warner or any of Warner's affiliates,
employees, or subsidiaries or reference any of Warner's products in any
Laboratory promotions, public statements or public disclosures without the prior
express written consent of an authorized representative of Warner.
20.0 U.S. GENERIC DRUG ENFORCEMENT ACT:
Laboratory represents that it and its employees, affiliates and agents have
never been (a) debarred or (b) convicted of a crime for which a person can be
debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Act of
1992 ("Section 306(a) or (b)"). Laboratory represents that it has never been
and, to the best of its knowledge after due inquiry, none of its employees,
affiliates or agents has ever been (a) threatened to be debarred or (b) indicted
for a crime or otherwise engaged in conduct for which a person can be debarred,
under Section 306(a) or (b). Laboratory agrees that it will promptly notify
Warner in the event of any such debarment, conviction, threat or indictment. The
terms of the preceding sentence shall survive the termination or expiration of
this Agreement.
21.0 COUNTERPARTS AND HEADINGS:
This Agreement may be executed in any number of counterparts, each of which
shall be deemed to be an original and all of which together shall be deemed to
be one and the same instrument. All headings in this Agreement are inserted for
convenience of reference only and shall not affect its meaning or
interpretation.
IN WITNESS WHEREOF, Warner and Laboratory have executed this Agreement as of the
day and year first above written.
PACIFIC BIOMETRICS, INC XXXXXX-XXXXXXX COMPANY
/s/ Xxxxxxxxx Xxxx Xxxxx /s/ Xxxxxx Xxxxx
Xxxxxxxxx Xxxx Xxxxx, Ph.D. Xxxxxx Xxxxx, M.D.
Vice President, Director of Senior Vice President,
Laboratories Worldwide Clinical Research
/s/ Xxxxxx Xxxxxxxxx
Xxxxxx Xxxxxxxxx, Ph.D.
Chairman, Pharmaceutical Research and
Development
-6-
