EXHIBIT 10.28
CLINICAL TESTING AGREEMENT
This Clinical Testing Agreement (hereinafter, "Agreement") is entered into
and effective as of February 24,1997 by and between Discovery Laboratories,
Inc., a Company having its principal place of business at 000 Xxxxxxx Xxxxxx,
00xx Xxxxx, Xxx Xxxx, XX 00000 (hereinafter, "Sponsor") and the University of
Utah (Tax ID #00-0000000), a body politic and corporate of the State of Utah, on
behalf of the University of Utah School of Medicine, located at 00 Xxxxx Xxxxxxx
Xxxxx, Xxxx Xxxx Xxxx, Xxxx 00000 (hereinafter, "University").
RECITALS
WHEREAS, Sponsor wishes to have certain clinical testing services
performed in accordance with the scope of work outlined in this Agreement; and
WHEREAS, the performance of such clinical testing is consistent,
compatible and beneficial to the academic role and mission of University as an
institution of higher education; and
WHEREAS, University is qualified, having personnel and adequate facilities
and equipment, and desires to provide and conduct such clinical testing services
performed in accordance with the approved protocol and scope of work outlined
herein.
AGREEMENT
NOW, THEREFORE, for and in consideration of the mutual covenants,
conditions, and undertakings herein set forth, the parties agree as follows:
1.0 Scope of Work:
1.1 Services. University agrees to perform for Sponsor certain
testing services (hereinafter, the "Services"), described in the Institutional
Review Board (IRB) approved study protocol entitled, Treatment of Cystic
Fibrosis Lung Disease by Inhalation of SuperVent(TM) Aerosol Solutions [the
normal volunteer portion (Part A) of this study], a copy of which has been
provided to the University by Sponsor and which is incorporated herein as
Exhibit A and summarized as Exhibit B.
1.2 Performance and Modification of Services. The Services shall be
performed under the direction and supervision of Xxxxx X. Xxxxxxxx, M.D.,
Principal Investigator (hereinafter, "PI"), Department of Medicine. Services
shall be performed by PI, following prior written approval and ongoing review of
a duly constituted IRB. Any modification to the study protocol, recommended by
the PI and/or IRB, prior to initiation of Services or during the performance of
Services shall be brought to the attention of Sponsor. Services may not be
altered without written approval of Sponsor and a subsequent review and approval
by the IRB, as required.
1.3 Enrollment, Data and Review of Services Rendered. University
shall enroll a minimum of [***] evaluable, normal volunteers, pursuant to Part A
of the study protocol and provide to Sponsor no less than [***] complete and
accurate case report forms (CRFs), containing analyzable data, within thirty
(30) days of study completion. Personnel from Sponsor shall visit University
periodically to monitor and determine performance status of the Services,
adherence to the study protocol and retrieve complete and accurate CRFs.
[***] Confidential treatment requested.
1.4 Access to and Retention of Records. Data and records compiled by
University under this Agreement, including source documentation and study
participant forms, shall be available to Sponsor and any regulatory agency, such
as the U.S. Food and Drug Administration or the like for comparison with
subject/patient CRFs. University agrees to retain medical records and source
documentation, including a copy of all CRFs, for a period of fifteen (15) years.
1.5 Conflicts. In the event of conflict between terms of the
Agreement and the actual study protocol, the terms of the study protocol will
control in all matters affecting the conduct of the Services.
2. Term: The term of this Agreement shall commence upon the effective date
hereof and shall continue until November 30,1997, unless extended or renewed by
mutual consent of the parties.
3. Compensation and Payment:
3.1 Compensation. Sponsor shall pay to University [***]
(hereinafter, "Compensation") for performance of Services under this Agreement.
The budget for providing the Services is outlined and set forth in Exhibit C,
which is attached hereto and incorporated herein by this reference.
3.2 Payment. [***] Completeness and accuracy of CRFs will be
determined by Sponsor during Sponsor's in-process and end of study audits, which
University gives Sponsor the right and support to conduct. Sponsor will use
reasonable efforts to initiate and conclude the end of study audit 30 days
following receipt of complete CRFs.
3.3 Compensation Checks. Compensation checks shall be payable to
"The University of Utah" and shall be delivered to Xxxx X. Xxxxxxxx, Manager,
Research Accounting, 000 Xxxx Xxxxxxxx, Xxxxxxxxxx xx Xxxx, Xxxx Xxxx Xxxx,
Xxxx, 00000.
4.0 Reporting Requirements: University shall document and maintain all
data and other records, such as source documents, collected in connection with
providing the Services hereunder as required by the study protocol, federal
regulations, and this Agreement.
5.0 Equipment and Other Study Materials. All equipment, instruments and
materials purchased or used by the University in connection with performance of
the Services shall at all times remain under the sole control and ownership of
University. All equipment, instruments, and study materials, including study
drug, manufactured for or purchased by Sponsor for use by the University in
connection with performance of the Services shall at all times remain under the
control and ownership of the Sponsor and shall be returned to Sponsor at
Sponsor's request.
[***] Confidential treatment requested.
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6.0 Publication:
6.1 Significant Results. In furtherance of University's role as a
public institution of higher education it is necessary that significant results
of research and testing activities be reasonably available for publication by
the University, and Sponsor acknowledges that University may publish the results
of research and testing conducted in connection with this Agreement.
6.2 Consent to Publish. Notwithstanding the foregoing, University
agrees that it shall not publish the results of research and testing conducted
in connection with this Agreement, without the prior written consent of Sponsor,
until the expiration of six (6) months following the first to occur of either
the termination of this Agreement or submission to Sponsor of at least ten (10)
complete and accurate CRFs, pursuant to Sections 1 and 4, hereof.
6.3 Waiver of Six-Month Waiting Period. In the event University
wishes to publish research and testing results prior to the expiration of the
above described six (6) month period, University shall first provide to Sponsor
written notice of University's intent to publish and a draft of such
publication. Sponsor shall have sixty (60) days after receipt of the draft of
such publication to (1) request in writing the removal of portions deemed by
Sponsor to contain confidential or patentable material owned by Sponsor, (2)
request a delay in submission of the draft for publication pending Sponsor's
application(s) for patent protection, relating to any invention or inventions
made under this Agreement, (3) request a delay in submission of the draft for
publication pending Sponsor's submission of data and results of Services to the
U.S. FDA or the like. In any event, University shall have no obligation to delay
publication of the draft for longer than eight (8) months following delivery of
University's notice to Sponsor of intent to publish. If University does not
receive Sponsor's written response to the notice of intent to publish within the
sixty (60) day period, then Sponsor shall be deemed to have consented to such
publication.
6.4 Proprietary Information. Information supplied to University by
Sponsor and identified by Sponsor as proprietary information shall not be
included in any material published by University without prior written consent
of Sponsor.
7. Confidentiality: Sponsor acknowledges that University is a governmental
entity and thus subject to the Utah Government Records Access and Management
Act, Sec. 63-2-101 et. seq., Utah Code Xxx. (1993 and Supp. 1995) ("GRAMA") and
Section 53B 16-301 et. seq., Utah Code Xxx. (1993 and Supp. 1995). Pursuant to
GRAMA and Section 53B-16-301 et. seq., this Agreement, and confidential
information provided pursuant hereto, may be subject to public disclosure. Any
person who provides University with records that such person believes should be
protected from disclosure for business reasons must, pursuant to Section
63.2-308 of GRAMA and Section 53B-16-304, provide University with a written
claim of business confidentiality and a concise statement of reasons supporting
such claims.
8. Indemnification:
8.1 Indemnification by University. University is a governmental
entity and is subject to the Utah Governmental Immunity Act, Section 63-30-1 et
seq., Utah Code Xxx. (1993 and Supp. 1995) (the "Act"). Section 63-30-34 of this
Act expressly limits judgment against the University, its officers and employees
to $250,000.00 per person and $500,000.00 per occurrence for bodily injury and
death and to $100,000.00 per occurrence for property damage. Subject to the
provisions of the Act, University shall indemnify, defend and hold harmless
Sponsor, its directors, officers, agents and employees against any actions,
suits, proceedings, liabilities and damages that may result solely from
negligent acts or omissions of University, its officers, agents or employees in
connection with this Agreement. Nothing in this Agreement shall be construed as
a waiver of any rights or defenses applicable to University under the Act,
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including without limitation, the provisions of Section 63-30-34 regarding
limitation of judgments. University shall give Sponsor timely notice of any
claim or suit instituted of which it has knowledge that in any way, directly or
indirectly, affects or might affect Sponsor, and Sponsor shall have the right at
its own expense to participate in the defense of the same.
8.2 Indemnification by Sponsor. Sponsor shall indemnify, defend and
hold University, its directors, officers, agents and employees against any
actions, suits, proceedings, liabilities and damages arising from proper use of
drugs or treatments in accordance with the approved protocol in performing the
Services, or from the negligent acts or omissions of Sponsor, its directors,
officers, agents or employees in connection with this Agreement. Sponsor shall
give University timely notice of any claim or suit instituted of which its has
knowledge that in any way, directly or indirectly, affects or might affect
University, and University shall have the right at its own expense to
participate in the defense of the same.
9.0 Injury to Participants:
9.1 Sponsor's Obligations. Without limiting the indemnification
obligations otherwise set forth in this Agreement, Sponsor agrees that in the
event any person or persons participating in the testing in accordance with the
approved study protocol conducted in connection with this Agreement
("Participant") at any time suffers any injury, illness or adverse medical
condition as a result of the Participant's involvement in the testing, Sponsor
shall pay, and hold University harmless from all reasonable medical expenses and
hospital costs which may result from the Participant's involvement in the
testing and which are (1) not otherwise covered by insurance owned by the
Participant or (2) not due to negligent acts or omissions by the University.
Sponsor's obligations under this paragraph shall be continuing and shall survive
the completion of Services and the termination of this Agreement.
9.2 University's Obligations. Without limiting the indemnification
obligations otherwise set forth in this Agreement, University agrees that in the
event any person or persons participating in the testing in accordance with the
approved study protocol conducted in connection with this Agreement
("Participant") at any time suffers any injury, illness or adverse medical
condition as a result of negligent acts or omissions, University shall pay and
hold Sponsor harmless from all reasonable medical expenses and hospital costs
which may result from the Participant's involvement in the testing and which are
not otherwise covered by insurance owned by the Participant. University's
obligations under this paragraph shall be continuing and shall survive the
completion of Services and the termination of this Agreement.
10.0 Compliance with Laws: In performance of the Services, University
shall comply with all applicable federal, state and local laws, codes,
regulations, rules and orders. University shall obtain, at its own expense as a
part of the price for Services, all required government licenses, permits and
approvals for the performance of the Services; with the exception that Sponsor
shall obtain all necessary approvals from appropriate and qualified IRBs for
testing of human subjects and all other licenses, permits and approvals which
the Protocols specify will be obtained by Sponsor. University warrants that
neither it or any person associated with the performance of the Services,
pursuant to this Agreement, has been debarred by the U.S. FDA from the conduct
of clinical trials of drugs, biologics or medical devices in human subjects.
11.0 Relationship of Parties: In assuming and performing the obligations
of this Agreement, University and Sponsor (collectively, the "Parties";
individually, the "Party") are each acting as independent Parties and neither
shall be considered or represent itself as a joint venture, partner, agent or
employee of the other. Neither Party shall include the name or any trademark of
the other Party in any advertising, sales promotion or other publicity matter
without the prior written approval of the other Party.
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12.0 Termination:
12.1 Notice of Termination. This Agreement may be terminated by
either Party at any time and from time to time, by giving written notice thereof
to the other Party. Such termination shall be effective thirty (30) days after
receipt of such notice.
12.2 Obligations of the University. Termination by either Party
shall not relieve the University of its obligations accrued hereunder, prior to
such termination, to provide Sponsor with (a) copies of all data, records,
including source documents, and test results, (b) information, data and test
results that is required be captured and made part of the CRFs by University,
(c) a complete and accurate accounting of the drug (test article) supply and (d)
all used or unused portions of the drug supply, raw materials, reagents, vials,
stoppers, closures, unused nebulizers and all compressors provided University
for the performance of Services, pursuant to this Agreement. University agrees
to comply with its obligations herein within thirty (30) days following receipt
of such notice of termination by either Party.
12.3 Obligations and Liabilities of the Parties. Termination shall
not relieve either Party of (a) any obligation or liability accrued hereunder
prior to such termination, or (b) rescind or give rise to any right to rescind
any payments made prior to the time of such termination.
13.0 Uncontrollable Forces: Neither Sponsor nor University shall be
considered to be in default of this Agreement if delays in or failure of
performance shall be due to uncontrollable forces, the effect of which, by the
exercise of reasonable diligence, the non performing Party could not avoid. The
term "uncontrollable forces" shall mean any event which results in the
prevention or delay of performance by a Party of its obligations under this
Agreement and which is beyond the control of the non performing Party. It
includes, but is not limited to, fire, flood, earthquakes, storms, lightning,
epidemic, war, riot, civil disturbances, sabotage, inability to procure permits,
licenses, or authorizations from any state, local or federal agency or person
for any of the supplies, materials, accesses, or services required to be
provided by either Sponsor or University under this Agreement, strikes, work
slowdowns or other labor disturbances and judicial restraint.
14.0 Miscellaneous:
14.1 Assignment. Neither Party shall assign or transfer any interest
in this Agreement, nor assign any claims for money due or to become due under
this Agreement, without the prior written consent of the other Party.
14.2 Principal Investigator and Protocol Coordinator. The Principal
Investigator and Protocol Coordinator have been selected by the Sponsor to be
Xxxxx X. Xxxxxxxx, M.D. and Xxxxx Xxxx, R.N., respectively. Replacements or
successors require prior written approval of the Sponsor.
14.3 Entire Agreement. This Agreement, with its Exhibits A and B,
constitutes the entire agreement between the Parties regarding the subject
matter hereof and supersedes any other written or oral understanding of the
parties. This Agreement may not be modified except by written instrument
executed by both parties.
14.4 Successors and Assigns. This Agreement shall be binding upon
and inure to the benefit of the parties, their successors and permitted assigns.
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14.5 Notices. Except as provided in Section 3 hereof, regarding
payment of invoices, any notice or other communication required or permitted to
be given to either Party hereto shall be in writing and shall be deemed to have
been properly given and effective: (a) on the date of delivery if delivered in
person during recipient's normal business hours; or (b) on the date of delivery
if delivered by courier, express mail service or first-class mail, registered or
certified, return receipt requested. Such notice shall be sent or delivered to
the respective addresses given below, or to such other address as either Party
shall designate by written notice given to the other Party as follows:
In the case of Sponsor:
Discovery Laboratories, Inc.
000 Xxxxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxx X. Xxxxxxxxx, Vice President
In the case of University:
University of Utah
Office of Sponsored Research
1C47 School of Medicine
00 Xxxxx Xxxxxxx Xxxxx
Xxxx Xxxx Xxxx, XX 00000
Attn: Xxx X. Xxxxxxxx, Manager Sponsored Projects
14.6 Governing Law. This Agreement shall be interpreted and
construed in accordance with the laws of the State of Utah, without application
of any principles of choice of laws.
14.7 Non waiver. A waiver by either Party of any breach of this
Agreement shall not be binding upon the waiving Party unless such waiver is in
writing. In the event of a written waiver, such a waiver shall not affect the
waiving Party's rights with respect to any other or further breach.
14.8 Execution by Counterpart. This Agreement may be executed
separately or independently in any number of counterparts, each and all of which
together shall be deemed to have been executed simultaneously and for all
purposes to be one Agreement.
14.9 Attorney Fees. The prevailing Party in any action or suit to
enforce the terms or conditions of this Agreement shall be entitled to recover
its costs of court and reasonable attorney's fees incurred in enforcing the
terms or conditions of this Agreement.
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their duly authorized representatives effective as of the day and
year first written above.
UNIVERSITY OF UTAH ("University")
By: /s/ [ILLEGIBLE], ACTING FOR
------------------------------
(signature)
Name: Xxxxxx X. Xxxxx
----------------------------
(please print)
Title: Director, Sponsored Projects
Date: FEB 6 1997
DISCOVERY LABORATORIES, INC. ("Sponsor")
By: /s/ Xxxxx Xxx, M.D.
------------------------------
(signature)
Name: Xxxxx Xxx, M.D.
----------------------------
(please print)
Title: President and CEO
Date:_____________________________
PRINCIPAL INVESTIGATOR FOR UNIVERSITY
By: /s/ Xxxxx X. Xxxxxxxx. M.D.
------------------------------
(signature)
Name: Xxxxx X. Xxxxxxxx. M.D.
----------------------------
(please print)
Title: Associate Professor
Date: 2/6/97
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EXHIBIT A - Clinical Protocol
Treatment of Cystic Fibrosis Lung Disease by Inhalation of Supervent(TM)
Aerosol Solution
EXHIBIT B - Summary Clinical Protocol - Part A
[***]
[***] Confidential treatment requested.
9
EXHIBIT C - Budget for Performance of Services
[***]
[***] Confidential treatment requested.
10
[***]
[***] Confidential treatment requested.
11
[***]
[***] Confidential treatment requested.
12
[***]
[***] Confidential treatment requested.
13
[***]
[***] Confidential treatment requested.
14
[***]
[***] Confidential treatment requested.
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