CLINICAL STUDY AGREEMENT
This Clinical Study Agreement (“Agreement”), effective on the last day of signature
herein (the "Effective Date) is made by and between ______________________________,
located at ______________________________ (“Sponsor”) and Oregon Health & Science
Institution, located at 3181 SW Sam Jackson Park Road, Portland, Oregon 97239 (“Institution”).
Collectively the Sponsor and Institution may be referred to as “the Parties,” or individually as “a
Party.”
WHEREAS, Sponsor has requested Institution and the Principal Investigator to conduct a
human clinical study at the facilities of Institution;
WHEREAS, Institution has the appropriate facilities and personnel with the requisite
skill, experience, and knowledge, including without limitation ______________________(the
“Principal Investigator”), to undergo the study, and desires to do so. The portion of the clinical
study to be performed by Institution under this Agreement is referred to herein as the “Study.”
WHEREAS, the Study contemplated by this Agreement is of mutual interest and benefit
to Institution and Sponsor, and will further the instructional and research objects of Institution in
a manner consistent with its status as an educational and health care institution;
NOW THEREFORE, in consideration of the premises and the mutual promises and certifications
expressed herein, the Parties hereto agree as follows:
1.
Performance of the Study
A.
The Study is to be performed as described in the Protocol entitled:
"___________________________,” under the direction of the Principal Investigator. Sponsor
and Institution do not represent or guarantee that any specific results shall be achieved from the
performance of the Protocol.
B.
Institution shall use reasonable efforts to perform the Study substantially in
accordance with the terms and conditions of this Agreement and the Protocol. Principal
Investigator, while not a party to this Agreement, has by signing below as “read and
acknowledged by” acknowledges the terms and conditions of this Agreement that bear on the
Principal Investigator’s duties and activities in relation to the Study.
C.
Institution understands that Principal Investigator is essential to the Study, and
Institution shall not substitute another person to perform the duties of Principal Investigator
without the prior written consent of Sponsor. If the Principal Investigator becomes unable or
unwilling to fulfill his or her duties, Institution shall promptly nominate one or more qualified
successor(s) to serve as Principal Investigator, if possible. If, despite such nomination by
Institution, a successor acceptable to both Sponsor and Institution is not found within thirty (30)
days, either Party may terminate this Agreement and the Study in accordance with Section 13.B.
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D. As required by federal law, this Study will be conducted in accordance with the
conditions specified in the Statement of Investigator, Form 1572 of the United States Food and
Drug Administration (“FDA”), signed by the Principal Investigator, including but not limited to
compliance with Sponsor's procedures for Study documentation, data recording and reporting,
and adverse event reporting.
2.
Compliance with Applicable Laws
A.
Institution and Sponsor agree to abide by all applicable, including international,
federal, state, and local, laws and regulations as they relate to their responsibilities herein and
associated with the conduct of the Study.
B.
Institution agrees to conduct the Study and maintain records and data during and
after the term of this Agreement in compliance with all applicable federal, state, and local legal
and regulatory requirements (together, "Laws"), including without limitation, any requirements
of the FDA and the United States Drug Enforcement Administration. Without limiting the
foregoing, Institution agrees (i) to comply with all informed consent requirements, whether state,
federal or local, including but not limited to 21 C.F.R. 50.20, et seq, (ii) to cause the Principal
Investigator and all Sub-Investigators to comply with all financial disclosure requirements,
whether state, federal or local, including but not limited to 21 C.F.R. 54, et seq. and to accurately
complete all forms, certifications and other documents reasonably requested by Sponsor in
connection with Sponsor’s obligations under such financial disclosure or other Laws.
C.
To the extent any work under this Agreement requires Institution or its employees
to obtain genetic information from an individual or from any individual's sample, Sponsor and
Institution acknowledge that Oregon's Genetic Privacy law (ORS 192.531 – 192.549) will apply
and that its requirements shall be observed by both Institution and Sponsor in the course of
carrying out their responsibilities under the Agreement.
D.
Institution and Sponsor hereby certify that they are not, and their principals are not,
debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a(a)
and (b), or sanctioned by a Federal Health Care Program (as defined in 42 U.S.C. Sec. 1320 a7b(f)), including, but not limited to the federal Medicare or a state Medicaid program, or debarred,
suspended, excluded or otherwise declared ineligible from any Federal agency or program. In
the event that during the term of this Agreement, either party (i) becomes debarred, suspended,
excluded, sanctioned, or otherwise declared ineligible; or (ii) receives notice of an action or
threat of an action with respect to any such debarment, suspension, exclusion, sanction, or
ineligibility, the Party shall immediately notify the other Party. Both Parties also agree that, in the
event that either Party becomes debarred, suspended, excluded, sanctioned, or otherwise declared
ineligible, either Party has the right to immediately terminate this Agreement without any further
action or notice by either Party.
3.
Responsibilities of Institution
A.
Prior to commencing the Study, Institution shall be responsible for obtaining
approval of the Protocol, Informed Consent Form (“ICF”) and Study advertisements, if any, from
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the appropriate Institution Review Board (“IRB”), ethics committee or from any other group
formally designated by Institution to review and approve the Study. In the event the IRB
requires the implementation of revisions to the Protocol or ICF, such revisions shall not be
implemented until Sponsor has been notified and has given its written approval. The Protocol
and/or ICF shall not be revised without the prior written agreement of Sponsor and the IRB.
B.
Institution shall be responsible for obtaining any ICF documents signed by or on
behalf of each human subject (“Subject”) participating in the Study. Such ICF document shall be
approved by Sponsor and the IRB, prior to the Subject's participation in the Study.
C.
No modifications shall be made to the Protocol unless agreed upon in writing by
Sponsor, Institution, and the Principal Investigator. All amendments to the Protocol shall be
documented and dated as provided in the Protocol. IRB approval must be obtained before the
modifications are implemented, and the Principal Investigator will submit the Protocol
modifications to the IRB. Sponsor will submit Protocol modifications to the FDA. If either
Institution or Sponsor desires a change to the Protocol to comply with Applicable Standards or to
protect the safety, rights, or welfare of Subject(s), and the other Party does not agree to such
change, then either Party may terminate this Agreement and the Study in accordance with
Section 13.
D.
Institution acknowledges the applicability to the Study of federal, state, and local
confidentiality laws and regulations (the “Privacy Rules”), including without limitation the
privacy standards and other requirements relating to protected health information as defined in
the Health Insurance Portability and Accountability Act of 1996 and implementing regulations,
as amended from time to time. Institution will, in accordance with the Privacy Rules, assure that
all Subjects give appropriate written authorizations and fully consent to all uses and disclosures
contemplated under the Protocol and this Agreement of any and all protected health information
regarding such Subjects. In addition to, Institution and Sponsor hereby agree as follows:
(i)
(ii)
(iii)
Institution represents that it is a “Covered Entity” under the provisions of the
Health Insurance Portability and Accountability Act of 1996 and the regulations
promulgated there under (“HIPAA”). Institution and Principal Investigator shall
handle all Study Data in accordance with HIPAA requirements.
Sponsor represents that no component of Sponsor that will be performing any of
Sponsor’s obligations under this Agreement is a “Health Care Component” of a
“Hybrid Entity” as those terms are defined for purposes of HIPAA at 45 C.F.R.
Parts 160, 164. Therefore, in performing its obligations under this Agreement,
Sponsor is not governed by HIPAA. The performance of Sponsor’s obligations
hereunder does not cause it to become a “Business Associate” of a Covered Entity
under HIPAA.
Institution and Sponsor agree, in the event of any amendment to HIPAA, to
negotiate changes to this Section that Institution believes may be necessary to
enable it to comply with HIPAA, as amended, in connection with the performance
of its obligations or activities pursuant to this Agreement.
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E.
Institution and Principal Investigator shall retain all records of the Study, records
of the data, and either the original or copies of all ICF documents for the period of time specified
in the FDA regulations or in the applicable legal or regulatory requirements, whichever is longer.
Institution agrees to make these and any related medical records available (with appropriate
protection of patient confidentiality) for review and/or copying, if requested by Sponsor, its
designees, or by representatives of the FDA or any other regulatory agency.
F.
Institution and/or Principal Investigator shall provide to Sponsor interim reports,
including case report forms (CRFs), concerning the progress of the Study in accordance with the
Protocol and any other reasonable schedule proposed by Sponsor. Institution and Principal
Investigator shall use the reporting form specified in the Protocol and otherwise as requested by
Sponsor. In addition, Institution and the Principal Investigator shall promptly report to Sponsor
any serious adverse events that occur during the Study, in accordance with the Protocol.
G.
Sponsor will at its expense provide Institution with the required quantity of the
Study Drug/Device know as ____________ (“Study Drug/Device”) in amounts sufficient to
undergo the Study and appropriately formulated and configured in accordance with the Protocol.
The Study Drug/Device are to be used with caution and prudence in adherence to the Protocol.
The Institution will at all times maintain control of the Study Drug/Devices in accordance with
the Protocol. Institution agrees that the Study Drug and the Devices provided by Sponsor for use
in the Study will be used for clinical research purposes only and in the course of conducting of
the Study. Institution shall store the Study Drug and the Devices in a secure location. Institution
agrees that all Study Drug and the Devices provided by Sponsor for use in the Study shall be and
remain the sole and exclusive property of Sponsor. Neither Institution nor the Principal
Investigator shall use the Study Drugs or the Devices provided by Sponsor for use in the Study
for any commercial purposes. Upon completion or discontinuance of the Study or the
termination or expiration of this Agreement, all remaining Study Drug/Device shall be accounted
for and returned to Sponsor, at Sponsor’s expense, together with the inventory records pertaining
to the Study Drug/Device, Confidential Information (defined herein) and any other records, data,
and materials which are the property of Sponsor, except as required per law or regulation for the
Institution to retain.
4.
Regulatory Inspections/Audits
A.
During the term of this agreement the Institution agrees and shall cause the
Principal Investigator to permit representatives of Sponsor and/or the FDA to examine at any
reasonable time during normal business hours and at mutually convenient times where possible
the facilities where the Study is being conducted and to have access to the results of the Study
including but not limited to original patient records and any other relevant information necessary
to confirm that the Study is being conducted in conformance with the Protocol and with all
applicable laws and regulations.
B.
Principal Investigator and/or Institution shall, as soon as reasonably possible and
if legally permissible, notify Sponsor if FDA or any other regulatory agency schedules an
inspection or audit, or if without scheduling, begins an inspection or audit. Sponsor shall have
the right to be present at any such inspection if legally permissible or allowable by the regulatory
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agency, and shall participate in preparing any responses thereto which may be required. Sponsor
agrees to reimburse the Institution for its time in preparation of, and attendance at, such
inspection or audit, as set forth in the Budget and Payment Schedule as attached (Exhibit A).
C.
If legally permissible or allowable by the regulatory agency, Principal
Investigator and Institution agree to provide Sponsor with any inspection report provided by the
FDA or by any other regulatory agency within (30) days from receipt of such report.
5.
Payment
A.
In consideration for conducting the Study, the Sponsor shall pay Institution for all
services required under this Study as described in Exhibit A, attached and incorporated by
reference as part of this Agreement.
B.
Payment shall be made to Oregon Health & Science University, and mailed to
Oregon Health & Science University, ATTN: Sponsored Projects Administration, 2525 S.W.
First Avenue, Suite 220, Portland, Oregon 97201. Institution’s federal tax identification number
(TIN) is 93-1176109.
C.
Institution shall submit invoices to Sponsor in sufficient detail. Invoices shall be
sent to Sponsor to the attention of _____________:
6.
Confidentiality
A.
Institution agrees to and shall ensure its employees, including the Principal
Investigator, keep confidential any Sponsor confidential and proprietary information directly
related to the conduct of the Study and supplied to it in writing by and marked confidential by
Sponsor (“Confidential Information”). Such Confidential Information will not be included in
any published material without prior approval by Sponsor. The obligations of this Section shall
not apply to:
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
information that is or becomes known publicly through no fault of the Institution
or Principal Investigator;
information learned by Institution or Principal Investigator through a third party
entitled to disclose it;
information developed by Institution or Principal Investigator independently of
information obtained from Sponsor as shown by written records;
information already known to Institution or Principal Investigator before
Sponsor’s disclosure as shown by witnessed prior written records;
information required to be disclosed to by law, including the Oregon Public
Records Law, to comply with government regulations, subpoenas or court orders,
provided Sponsor receives reasonable notice of such demand whenever possible;
information required to be disclosed by the FDA, the IRB or other government
agency, or necessary to be released to support the medical care of the Subject; or
information that Sponsor in writing agrees may be disclosed.
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B.
Furthermore, Institution may disclose Confiential Information to a Study subject’s
healthcare provider(s) or third-party payor(s) to the extent reasonably necessary 1) to determine
the appropriate medical treatment for such subject or 2) for the purpose of facilitating third-party
payment for such medical treatment; provided, however, that Institution shall (a) ensure that any
healthcare provider or third-party payor to which it releases Confidential Information is aware of
the confidential nature; and (b) disclose only the minimum amount of Confidential Information
reasonably required to determine the appropriate medical treatment of the subject or facilitate
third-party payment for such medical treatment.
C.
The obligation of the Institution under this Article shall survive and continue for
five (5) years after termination of this Agreement.
D.
In the event Sponsor shall come into contact with patient medical records,
Sponsor shall hold in confidence the identity of the patient and shall comply with all applicable
laws regarding the confidentiality of such records.
E.
In the event the Institution or Principal Investigator finds it necessary to disclose
Information to a proper authority to permit the Institution to defend its research against an
allegation of fraud, the Institution or Principal Investigator shall first notify Sponsor and the
Institution and Sponsor shall attempt to agree to a mutually satisfactory way to disclose such
Information as necessary for this limited purpose.
7.
Ownership of Study Results and Medical Records
A.
Title to the Study Drugs or Devices and the detailed testing protocols provided by
Sponsor shall as between the Parties hereto remain with Sponsor. Subject to Section 7(b) with
respect to the ownership of original medical records, Institution agrees that all data, analyses,
information, and materials prepared or derived as a direct result of the Study required to be
provided to the Sponsor per this Agreement and in accordance with the Protocol, whether
preliminary or final (the “Study Results”), shall be the property of Sponsor. All Study Results
may be used and/or transferred by Sponsor for any lawful purpose with no further payment to the
Institution. Institution may without royalty obligation utilize the Study Results for patient care
and for its own internal teaching, research, and educational purposes, consistent with the research
and public health mission of the Institution, and for publication to the extent permitted under
Section 8 herein.
B.
Institution shall own its original medical records and related documentation.
CRFs and summaries submitted to Sponsor shall be the property of Sponsor, and Institution will
be entitled to retain copies thereof.
8.
Publication
A.
Institution and Principal Investigator shall not authorize the publication or
presentation of Study Results without Sponsor’s prior review and comment of the proposed
publication or presentation. Institution agrees to provide any proposed publication to Sponsor
thirty (30) days prior to submission, for confidential review for the inclusion of Confidential
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Information, and to determine whether patentable inventions of discoveries are disclosed therein.
Sponsor shall respond in writing within thirty (30) days with either approval of the proposed
material for publication or a specific state of (a) concern based upon the need to seek patent
protection or (b) any reasonable basis for concern to edit or remove Confidential Information,
prior to submission for publication. Should the documents contain any patentable information, at
Sponsor’s request, Institution shall withhold submission and/or publication for an additional
sixty (60) days to allow Sponsor to pursue U.S. patent filings.
B.
If the Study is part of a multi-center study, Institution and Principal Investigator
agree that their first publication shall be made in conjunction with the presentation of a joint,
multi-center publication of the Study results from all appropriate sites. If such a multi-center
publication is not submitted within twelve (12) months after conclusion or termination of the
Study at all sites, or after the Sponsor confirms there will be no joint, multi-center publication,
but not longer than twelve (12) months after conclusion of the Study at all sites, Institution and
Principal Investigator may publish individually in accordance with this Section.
C.
Sponsor agrees to ensure that the Study is fully registered on a publicly accessible
internet site in accordance with the requirements of the International Committee of Medical
Journal Editors (ICMJE) and to provide proof of such registration to Institution prior to
execution of this Agreement.
D.
Should findings from the Study potentially directly affect the safety or medical
care of the Study participants, Sponsor will communicate to Institution such findings for
dissemination to Study participants.
9.
Publicity
No party to this Agreement shall use the name of any other Party hereto or the name of any
employee in connection with any advertising or promotion of product or service without the prior
written consent of such Party.
10.
Intellectual Property
Any and all discoveries, developments, improvements, processes, compositions of matter,
formulations, or methods of use or delivery related to the Study Drug/Device or Confidential
Information, conceived and first reduced to practice by Principal Investigator, or any person
acting under the direction of or on behalf of Institution or Principal Investigator, as a part of the
direct conduct of the Study ("Invention") shall be promptly disclosed in writing to the Sponsor
by Institution. If such Inventions are, under applicable law, the property of Institution, the
Sponsor shall have the right of first refusal to obtain an exclusive, worldwide, royalty-bearing
license to make, have made, use, and sell the invention or products incorporating the Invention.
11.
Indemnification and Subject Injury Reimbursement
A.
Sponsor agrees to defend, indemnify and hold harmless the Institution, and the
Institution’s officers, agents and employees, including the Principal Investigator, and the IRB,
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(“Indemnitees”) from any and all losses, costs, liabilities, demands, claims, lawsuits, actions,
damages, and expenses (including reasonable attorneys’ fees) (“Losses”) arising out of or in
connection with the performance of the activities pursuant to the Protocol.
B.
The obligation to defend, indemnify and hold harmless shall apply only if the
Institution notifies Sponsor within a reasonable time following receipt of claim of any Loss(es)
and Institution’s determination that Sponsor is involved in such Loss(es), and if such Loss(es) is
a lawsuit, permits the Sponsor and its attorneys and personnel, at their discretion and cost, to
handle and control the defense of such claims or suits, including pretrial, trial or settlement, and
fully cooperates with and assists Sponsor and its attorneys in such defense. Provided, however,
Sponsor and its attorneys will work with Institution’s legal representative to ensure Institution’s
concerns are reasonably met and/or that the indemnification obligation is fully tendered to
Sponsor. Sponsor further agrees that it will not settle or compromise any such claim or suit
without the prior written consent of Institution.
C.
The Sponsor shall promptly reimburse Institution for reasonable and necessary
medical expenses incurred by Subjects for medical care, including hospitalization, in the
diagnosis and treatment of adverse reactions arising from or contributed to by research
procedures or the Study Drug/Device following their administration or use in accordance with
the Protocol, which are not attributable to the negligence or misconduct of any person in the
employment of Institution. The term "adverse reactions" does not mean the natural progression
of an underlying or pre-existing condition or events that would have been expected from the
standard treatment using currently approved therapies for the Subject’s condition.
12.
Insurance
Sponsor shall carry the following:
(i)
(ii)
Commercial General Liability insurance with a minimum limit of not less than
$5,000,000 per occurrence and $10,000,000 General Aggregate for each annual
policy term for Bodily Injury and Property Damage and $10,000,000
Products/Completed Operations Aggregate for each annual policy term. It shall
include contractual liability coverage for the indemnity provided under this
contract.
Professional Liability insurance with a combined single limit of not less than
$5,000,000 per occurrence and $10,000,000 annual aggregate for damages caused
by error, omission or negligent acts by the sponsor, its employees, directors or
officers. Any deductible shall not exceed $25,000 each claim, incident or
occurrence.
These insurance policies, which cannot be excess to a self-insurance program, are to be
issued by an insurance company authorized to do business in the State of Oregon, and must also
have an A.M. Best rating of A (IX) or better. If written on a claims-made basis, the commercial
general and professional liability insurance shall be maintained for a period of not less than two
years following termination of this sponsored study. Institution and its officers and employees
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shall be included as an additional insured in these insurance policies. All applicable policies
shall be endorsed so that coverage is primary and non-contributory.
If requested by Institution, Sponsor shall furnish acceptable insurance certificates to
Institution prior to performing the services under this contract. The certificate will specify all of
the parties who are additional insureds, and, if requested, Sponsor will also provide a copy of the
additional insured endorsement. If requested, complete policy copies shall be provided to
Institution. Sponsor shall be financially responsible for all pertinent deductibles or self-insured
retentions.
There shall be no cancellation, material change, reduction of limits or intent not to renew the
insurance coverage(s) without thirty (30) days written notice from Sponsor or its insurer(s) to
Institution.
13.
Term, Termination, Survivorship
A.
This Agreement shall become effective when it has been signed by duly
authorized representatives of both Parties and shall continue in force until the Study had been
completed to the reasonable satisfaction of Sponsor, unless terminated in accordance with this
Section. Institution and Principal Investigator shall use their reasonable best efforts to complete
the Study as set forth in the Protocol.
B.
Termination
(i)
(ii)
(iii)
C.
Sponsor and Institution may terminate this Agreement for any reason upon
thirty (30) days prior written notice.
Termination for Cause. Either Party may terminate this Agreement if the
other Party breaches any of its obligations or provisions of the Agreement;
provided, however, that the defaulting Party shall be given no less than
thirty (30) days prior written notice of such default and the opportunity to
cure the default during such period.
Sponsor or Institution may terminate this Agreement immediately if it
reasonably determines that such action is necessary to protect the safety,
rights, or welfare of the Subject(s) or such action is necessary for safety
reasons relating to the use of the Study Drug/Device provided by the
Sponsor, or relating to the conduct of the Study, or if the FDA, IRB, or
other regulatory agency with authority over the conduct of this Study
requests that the Study be terminated.
Early Termination Procedures
(i)
Upon receipt of notice of termination in writing from Sponsor, Institution
and the Principal Investigator shall immediately stop entering patients into
the Study and, to the extent medically permissible, cease administering the
Study Drug and conducting procedures on Subjects already entered into
the Study.
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(ii)
(iii)
(iv)
Institution and Principal Investigator shall use all reasonable efforts, upon
the request of Sponsor, to complete reports for all Subjects that have been
entered into the Study as of the termination date of this Agreement.
Sponsor shall pay Institution amounts earned through termination of this
Agreement, including non-cancelable obligations, in accordance with
Exhibit A.
Termination of this Agreement shall not affect any rights or remedies of
either Party at law or in equity
D.
The provisions of Sections 6, 7, 8, and 11 shall survive the expiration or early
termination of this Agreement of Study indefinitely unless stated otherwise.
14.
General Provisions
A.
Entirety of Agreement. Section and clause headings are used herein solely for
convenience of reference and are not intended as substantive parts of the Parties’ agreement.
This Agreement incorporates the Exhibits referenced herein. This written Agreement constitutes
the entire agreement between the Parties concerning the subject matter, and supersedes all other
or prior agreements or understandings, whether written or oral, with respect to that subject
matter. This Agreement may be amended or modified only in writing signed by both Parties. In
the case of conflict between the terms of this Agreement and the Protocol or other attachments or
Study-related documents, the terms of this Agreement shall control.
B.
Notice(s). Any notice required or permitted by this Agreement shall be in writing
and shall be deemed given as of the date it is (a) delivered by hand or (b) sent by registered or
certified mail, postage prepaid, return receipt requested, and addressed to the party to receive
such notice at the following address, or such other address as is subsequently agreed to in
writing.
If to Sponsor:
If to Institution:
For Administrative Matters:
Oregon Health & Science University
3303 SW Bond Avenue
Portland, Oregon 97239
Attn: Diane Brownlee
Mail Code: CH15T
Phone: 503-494-0323
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For Technical Matters:
Oregon Health & Science University
______________________
Portland, Oregon 97239
Attn: ____________________
Mail Code: __________
Phone:
Fax:
For Legal Matters:
Oregon Health & Science University
3181 SW Sam Jackson Park Road
Portland, Oregon 97239
Attn: Office of General Counsel
Mail Code: L585
C.
No Partnership, Independent Contractor. The Institution agrees and the Principal
Investigator acknowledges that services provided under this Agreement will be as independent
contractors and not as an employee, agent, joint venturer or partner of Sponsor. No Party shall
have the authority to bind any other party in respect whatsoever to third parties.
D.
Enrollment Incentives. Notwithstanding any other provision in this agreement,
there shall be no funds or remuneration of any kind associated with the work under this
agreement that has not been incorporated in this agreement by an amendment between the parties
and administered through Institution's Sponsored Projects Administration. Further, such
"finder's fees", "referral fees", "enrollment incentives" or other funding or remuneration
arrangements shall only be allowed where they are provided in return for actual and significant
work related to the Study and are proportional to the time and effort required.
E.
Assignment. This Agreement may not be assigned by either Party.
F.
Severability. The provisions of this Agreement shall be deemed severable.
Therefore, if any part of this Agreement is rendered void, invalid or unenforceable, such
rendering shall not affect the validity and enforceability of the remainder of this Agreement
unless the part or parts which are void, invalid or unenforceable as aforesaid shall substantially
impair the value of the whole agreement to either Party.
G.
No Waiver. Either party's failure to require the other Party to comply with any
provision of this Agreement shall not be deemed a waiver of such provision or any other provision
of this Agreement.
H.
Oregon.
Applicable Law. This Agreement shall be governed by the laws of the State of
I.
Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed an original and all of which together shall constitute one instrument.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized representatives.
Agreed to By:
SPONSOR
Signature:
___________________________
Name:
___________________________
Title:
___________________________
Date:
___________________________
Agreed to By:
INSTITUTION
Signature:
___________________________
Name:
Diane Brownlee
Title:
Contracts Manager, Clinical Trials Office
Date:
___________________________
Read and Acknowledged By Principal Investigator:
Signature:
___________________________
Printed Name:
_____________________________
Date:
___________________________
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EXHIBIT A
STUDY BUDGET AND PAYMENT SCHEDULE
A.
follows:
Payment Schedule:
Sponsor shall reimburse Institution for such services as
(1) Payment in the amount of $__________ representing Institution’s IRB initial
review and Study set-up costs, thirty (30) days after execution of this Agreement.
No portion of this payment is refundable.
(2) Advanced Payment in the amount of $_______, representing ____ completed
Subjects.
(3) Subsequent payments shall be paid on the following schedule. Payments will be
made within sixty (60) days of the completed milestone indicated below. Late
payments will be assessed a fee of ten percent (10%) of the amount due
(Insert Milestone Schedule)
(4) If milestone schedule is based on monitoring visits conducted by the Sponsor or
collection of Case Report Forms (CRFs) by the Sponsor, payments must be made
at least quarterly, regardless of the frequency of monitoring visits or collection of
CRFs.
(5) In the event there is any excess funds remaining from the Advanced Payment
required in (2) above, Institution shall refund funds in excess of costs incurred to
Sponsor sixty (60) days after Study termination.
(6) The following fees will be paid by the Sponsor as incurred:
IRB annual review fee of $1,320.00
IRB review fees of $825.00 for all amendments to the Study
B.
Study Cancellation. In the event Sponsor cancels the Study, Sponsor shall
reimburse the Institution as follows:
(1) If prior to Protocol submission to Institution’s IRB, payment of the study start-up
costs; or
(2) Subsequent to Protocol submission to Institution’s IRB, payment of the study startup costs, IRB Initial Review Fee and, as applicable, all additional fees and costs set
forth in Exhibit A, including reimbursement for all Subject visits through the date
of cancellation and all non-cancelable charges incurred by Institution.
C.
Audits. In the event the Institution is notified that the FDA wishes to conduct an
audit as a result of this Study, Sponsor shall compensate the Institution at the rate of $_____ per
hour for preparation and appearance at such audit.
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D.
Payment Information: Payee under this Agreement is: Oregon Health & Science
University. Payments shall be mailed to:
Oregon Health & Science University
Attn: Sponsored Projects Administration
2525 SW First Avenue, Suite 220
Portland, Oregon 97201
The Institution's Federal Tax ID # is_________________. Payment documents must
include the Principal Investigator's name, the Study or Protocol Number and invoice number if
provided by Institution to Sponsor.
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