PROTOCOL: 981-53
CLINICAL LABORATORY AGREEMENT
THIS CLINICAL LABORATORY AGREEMENT ("Agreement") is made as of this 08 day
of March, 1995 by and between Xxxxxx-Xxxxxxx Company, a Delaware corporation
located at 000 Xxxxx Xxxx, Xxxxxx Xxxxxx, Xxx Xxxxxx 00000 ("Warner") and
Pacific Biometrics, Inc , a Seattle corporation located at 0000 Xxxxxxxx Xxxxxx
Xxxx, Xxxxxxx, XX 00000 ("Laboratory").
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 981-53 and entitled "A
3-year, population-based, randomized, open-label study comparing the effect of
aggressive lipid lowering with atorvastatin versus usual care in
hypercholesterolemic patients with coronary artery disease at risk of adverse
outcomes" 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:
Section 1. 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 suggested by Warner to evidence
transfer of title thereto.
Section 2. Scope of Services. Laboratory shall perform and complete the
clinical laboratory services described in and in accordance with the Protocol
and Exhibit B which is 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
Exhibits A and B. without the prior written consent of Warner in the form of
Exhibit C (a "Consent", a copy of which is attached hereto), signed by all of
the following four individuals: (1) the Warner study manager; (2) the Warner
Director of CRD Finance; (3) the Warner technical operations representative; 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 Exhibits A or B or are specifically
approved by a fully executed Consent.
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Section 3. 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 Exhibit B, including, without limitation, providing in a
timely manner to Warner as required in Exhibit B, the data and reports required
hereunder in a form acceptable to Warner.
Section 4. Financial Arranqements. In consideration for the Services to be
performed by Laboratory, Warner shall pay Laboratory in accordance with the fee
schedule set forth in Exhibit B, provided, however, that upon complete execution
of this Agreement, Warner shall promptly pay to Laboratory the sum of
seventy-five thousand ($75,000) Dollars (the "Initial Payment") The Initial
Payment shall be credited against all fees accrued by Laboratory subsequent to
the date hereof. In no event shall the total fees paid to Laboratory exceed the
total budget amount set forth in Exhibit B.
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
Exhibit B.
Section 5. 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.
Section 6. 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.
Section 7. 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,
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Sections 1, 9, 10 and 1l, shall survive the termination or expiration of this
Agreement.
Section 8. Termination. This Agreement shall, at the option of Warner,
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 fifteen (15) 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.
Section 9. 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.
Section 10. Indemnity. 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 Laboratory's negligent
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.
Section 11. 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
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been performed in compliance with all applicable laws, rules and regulations and
the terms and conditions of this Agreement.
Section 12. 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.
Section 13. 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: President
with a copy to:
Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, XX 00000
Attention: Counsel, Pharmaceuticals, North America
If to Laboratory:
Pacific Biometrics, Inc.
0000 Xxxxxxxx Xxxxxx Xxxx
Xxxxxxx, XX 00000
Attention: Xxxxxxxxx Xxxx Xxxxx, Ph.D., Vice President
Director of Laboratories
Section 14. 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.
Section 15. 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
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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.
Section 16. Non-waiver. Any waiver of the terms of this Agreement must be
in a 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.
Section 17. 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.
Section 18. 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 to be partners or joint venturers,
and neither is authorized to take any action binding upon the other.
Section 19. 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.
Section 20. 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.
Section 21. Counterparts and Headings. This Agreement may be executed in
any number of counterparts, each of which shall be
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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 Clinical
Laboratory Agreement as of the day and year first above written.
Pacific Biometries, Inc.
By: /s/ Xxxxxxxxx Xxxx Xxxxx
Name: Xxxxxxxxx Xxxx Xxxxx, Ph.D.
Title: Vice President
Director of Laboratories
XXXXXX-XXXXXXX COMPANY
By: ______________________________________
Name: ____________________________________
Title: ___________________________________
