SAINT LOUIS UNIVERSITY MODEL CLINICAL RESEARCH AGREEMENT
FOR SPONSOR-INITIATED PROTOCOLS
This Clinical Research Agreement (the "Agreement") entered into as of this day of
_______, 200_, (the "Effective Date") is by and between Saint Louis University a Missouri
benevolent corporation having its principal place of business located at 221 North Grand
Boulevard, St. Louis, Missouri 63103 ("The Institution"), and ________________ a corporation
organized under the laws of the State of _____________, having its principal offices located at
_________________ ("Sponsor").
WHEREAS, the Sponsor would like to enlist the assistance of the Institution to conduct a
clinical study, and such study is of mutual interest and benefit to the Institution and the Sponsor
and will further the instructional and research objectives of the Institution in a manner consistent
with its status as a tax-exempt, research and educational institution;
NOW, THEREFORE, in consideration of the premises and of the following mutual
promises, covenants, and conditions and any sums to be paid by the Sponsor to the Institution,
hereunder, the parties hereto agree as follows:
1.
STATEMENT OF WORK
a)
The Institution and the Institution's Principal Investigator agree to conduct a clinical
study on behalf of the Sponsor, entitled ____________ (the "Study"). The Sponsor's
protocol for this Study is attached as part of this agreement as EXHIBIT A. As required
by applicable Institution policies and with all federal law, this Study will be conducted
by the Institution in accordance with the conditions specified in the Statement of
Investigator, FDA Form 1572, signed by the Institution's Principal Investigator,
including but not limited to compliance with the Sponsor's procedures for Study
documentation and adverse event reporting. In addition, the Institution and the Sponsor
agree to comply with all federal, state, and local laws and regulations applicable to the
proper conduct of the Study.
b)
Institution shall conduct the Study in a timely manner and in strict accordance with
Agreement and Sponsor's Protocol, which must be approved by the Saint Louis
University Institutional Review Board (IRB) as a SLU IRB protocol, subject to
deviations required to protect Subject (a patient participating in the Study) safety.
Sponsor may modify the Protocol, effective upon notice to Institution and IRB approval.
Institution may not modify the Protocol. It may, however, propose Protocol changes to
Sponsor. It may also request exceptions to the Protocol, which must be approved by the
Sponsor and IRB.
c)
If Sponsor changes the Protocol, Institution may terminate Agreement if (a) in the
Principal Investigator's judgment, the changes have a negative impact on Subject safety
or welfare, or (b) the cumulative Protocol changes increase Institution's cost of
conducting the Study, and the parties are unable to agree on a revised Budget within 30
days. Both the Sponsor's Protocol and SLU IRB Protocol are incorporated in this
Agreement by reference.
d)
Institution makes NO WARRANTIES, EXPRESS, OR IMPLIED, CONCERNING
THE RESULTS OF THIS STUDY OR MERCHANTABILITY, OR FITNESS FOR A
PARTICULAR PURPOSE OF SUCH RESULTS. The Institution shall not be liable for
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any direct, consequential, or other and punitive damages suffered by Sponsor as a result
of this Study.
2.
PRINCIPAL INVESTIGATOR
This Study will be conducted under the direction of the Institution's 's Principal
Investigator ________________ ("Principal Investigator") who shall be responsible for
performing this Study and for direct supervision of any individual performing portions of
this Study at the Institution . In the event the Principal Investigator becomes unwilling or
unable to perform the duties required to conduct the Study under this Agreement, the
Institution and the Sponsor shall attempt to identify a qualified and mutually agreeable
replacement for the Institution's Principal Investigator. In the event a mutually acceptable
replacement cannot be identified and agreed upon, then the Study may be terminated by
either party hereto in accordance with Article 10 of this Agreement.
3.
PERFORMANCE PERIOD
a)
The effective period of this Agreement shall commence upon execution of this
Agreement and receipt of approval of the Study by the Saint Louis University IRB and
will continue until completion of the Study as required by the Protocol (including any
amendments thereto), unless this Agreement is terminated earlier pursuant to Article 10
hereof.
4.
PAYMENT AND OTHER SUPPORT
a)
In consideration of conducting the Study hereunder, the Sponsor shall pay the Institution
up to total sum of ($_________ ) for the entire Study. Payment shall be made to the
Institution in accordance with the budget attached as EXHIBIT B of this Agreement.
b)
All payments to be made by the Sponsor to the Institution hereunder shall be made
payable to Saint Louis University (Tax I.D. Number: 43-0654872) in United States
dollars.
c)
The Sponsor will be assessed an Institutional Review Board (IRB) Processing Fee for
new clinical Study agreements. Fees will also be assessed for annual review and
substantive amendments reviewed by the IRB. The sponsor is to provide the billing
address for parties responsible for paying fees related to IRB review. Within thirty (30)
days after Sponsor's/CRO’s receipt of an itemized invoice, IRB Fee payments are to be
made payable to Saint Louis University Institutional Review Board and directed as
follows:
Saint Louis University
Institutional Review Board
3556 Caroline Street, C110
St. Louis, MO 63104
Address Where IRB Invoices Should Be Sent:
_________________
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_________________
_________________
_________________
Payments associated with study related costs should be sent to:
Saint Louis University
__________________
__________________
__________________
d)
For purposes of identification, each payment shall include Sponsor's name, the
protocol number of the Study and the name of the Institution's Investigator. Sponsor
shall return a copy of the Institution's invoice with each payment.
e)
The Institution agrees to provide all mutually agreed upon personnel, facilities, patients
and other study-related resources to perform the Institution's responsibilities under
protocol for the Study. The Sponsor agrees to provide the Institution with the required
quantities of properly labeled study medications for the Study, (including any needed
replacement study medications and proper handling and storage instructions for study
medications), case report forms and Study support services (e.g., laboratory services) as
specified in the Study Protocol.
f)
The Institution shall retain title to any equipment purchased with Study funds provided
by the Sponsor under this Agreement.
5.
RECORDKEEPING, REPORTING, ACCESS, INSPECTIONS
a)
Completed Case Report Form shall mean a case report that has been completed in
accordance with all United States Food and Drug Administration ("FDA) regulations for
a patient who properly qualified for, participated in, and completed the Study in
accordance with all applicable protocol requirements for the Study.
b)
Principal Investigator agrees to timely complete all case report forms required under the
Study and to deliver these forms and any other necessary data related to the Study to
representatives of the Sponsor at periodic monitoring visits in St. Louis. All such
information and material will become the property of the Sponsor and may be freely
utilized by the Sponsor at the Sponsor's sole discretion. Principal Investigator further
agrees to reasonably assist the Sponsor's representatives in resolving any discrepancies or
errors in case report forms and in performing random audits of original case records,
laboratory reports and/or other raw data sources underlying Study data recorded on the
case report forms. The Sponsor will send copies of the final corrected case report forms
to the Principal Investigator when the corrected case forms are available.
c)
Institution may submit Study data using the electronic system provided by the Sponsor.
Sponsor warrants to Institution that this system complies with U.S. 21 CFR Part 11and
HIPAA. Institution will comply with Sponsor's Instructions, U.S. 21 CFR Part 11, and
HIPAA. Institution will prevent unauthorized access to the data.
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d)
Authorized representatives of the Sponsor or its designee and government regulatory
authorities to the extent required by law shall have the right, upon providing a reasonable
advance notice to Institution and during regular business hours, examine and inspect the
facilities being used to conduct the Study, and review all records, procedures, and other
materials (including Case Report Forms and subject medical records) related to the
Study, and have access to the participating investigators to discuss the Study. If
Institution is found to be deficient in any manner by Sponsor, Sponsor will give notice to
Institution, and will give Institution thirty (30) days to correct or implement effort to
correct deficiency. After thirty (30) days, Sponsor shall terminate Institution's continued
participation in the Study if reasonable best efforts to correct the deficiency are
ineffectual. It is further agreed that if either Party is notified that the Sponsor or the Study
is to be the subject of an audit, such Party shall promptly inform the other Party. If a
formal response to any audit is required, Institution agrees to permit representatives of
Sponsor to review and comment on such response.
e)
Institution shall retain in a safe and secure location one copy of all printed and electronic
data and reports resulting from the Study for the longer of (a) two years after the last
marketing authorization for the Study Drug or Study Device has been approved or
Sponsor has discontinued research on the Study Drug or Study Device or b) such longer
period as required by regulatory requirements. Sponsor will notify Institution within 30
days after this retention requirement has expired. Sponsor will reimburse site for any
subsequent storage costs and other related costs plus administrative fees. When
Institution destroys records, it will do so in a matter that ensures that their confidentiality
is protected.
6.
PROPRIETARY INFORMATlON AND CONFlDENTIALlTY
a)
The Institution shall not disclose to any third party or use for any purposes other than the
performance of this Study, any of the Sponsor's trade secrets, or other proprietary
information, which has been reduced to writing and marked as "Confidential," and
disclosed to the Institution by the Sponsor pursuant to this Agreement (collectively,
"Proprietary Information"), without the Sponsor's prior written consent, except as
otherwise specified in this Agreement. The Institution shall protect the Sponsor's
Proprietary Information with the same level of care the Institution uses to protect its own
confidential information, and in no event shall it use less than a reasonable degree of
care. The Institution’s obligation of non-disclosure and non-use of the Sponsor's
proprietary information shall not apply to the following:
i)
information that it is or becomes publicly available through no fault of the
Institution; or
ii)
Information that the Institution can demonstrate was in its possession at
the time of disclosure by the Sponsor and that was not acquired, directly or
indirectly, from the Sponsor; or
iii)
Information that is independently developed by the Institution without use
of any Sponsor's Proprietary Information; or
iv)
Information that becomes available to the Institution from a third party
that is not legally prohibited from disclosing such information, provided
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such information was not acquired directly or indirectly from the Sponsor;
or
v)
Information that is approved for release by written authorization of the
Sponsor; or
vi)
Sponsor's Proprietary Information that exists five (5) years following the
date of termination of all activities required under the Study Protocol; or
vii)
Proprietary Information that is required to be released by any
governmental agency or court having competent jurisdiction, provided
that the Institution notify the Sponsor in writing prior to releasing such
Proprietary Information.
b)
In the event that the Institution finds that it is necessary to disclose Proprietary
Information to a proper authority in confidence in order to permit the Institution to defend
its research against an allegation of fraud or misconduct, the Institution shall promptly
notify the Sponsor in writing. The Institution shall timely apprise the Sponsor of the
Institution's activities in defense against any such allegations relating to the Study.
c)
Institution and the Principal Investigator shall return Proprietary Information to the
Sponsor to the extent possible within a reasonable period of time following the
termination of the Study or following receipt of a written request for Proprietary
Information from the Sponsor at Sponsor's expense.
d)
In the event Sponsor shall come into contact with Research Subject's medical records,
Sponsor shall hold in confidence the identity of the patient and shall comply with all
applicable law(s) regarding the confidentiality of such records.
7.
HIPAA
Institution and Principal Investigator will comply with applicable laws and regulations
governing the privacy and security of Subject information, including the Health Insurance
Portability and Accountability Act (HIPAA). Institution will obtain written authorization
from Subjects or Institution IRB waivers to use and disclose their information to the
extent necessary to conduct the Study and provide Study data to Sponsor. These
authorizations or waivers will allow disclosures to Sponsor to the extent necessary for
Sponsor to comply with this Agreement, applicable laws, regulations and legal
requirements. Even if not a HIPAA Covered Entity, Sponsor:
a. Will not use Subject information except for purposes of the Study and as authorized
by Subject.
b. Will not disclose Subject identifying information or disclose Subject private
information to any third-party unless required to do so by law, regulation, government
order, or pursuant to a written request by the Subject.
c. Will not remove Subject information from Institution.
d. Will not attempt to contact any Subjects.
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8.
STUDY DATA AND RESULTS
The Institution and Sponsor respectively shall jointly own study data that Institution
generates by performing this Study, including all Study results. Data shall include all
Study results, which includes information entered onto patient case report forms. The
Sponsor shall have the sole right to use such Data for all commercial purposes, and the
Institution's use shall be limited to those instances dealing with patient care and
treatment, teaching, academic research and publication. The Sponsor shall have sole
ownership of the original copies of all patient case report forms; however, the Institution
shall have the right to retain one copy of each form for documentation and other
authorized purposes.
9.
PUBLICATION/PRESENTATIONS
a)
The Institution and the Principal Investigator are free to publish, present, or use any
results arising out of this Study for their own instructional, research, or publication
objectives, provided that such publication does not disclose any of the Sponsor's
Proprietary Information, as defined in this Agreement. The Institution and the Principal
Investigator agree to submit a confidential draft of any proposed publication or a
summary of any intended public disclosure to the Sponsor at least thirty (30) days prior to
submission for publication, presentation, or use and agrees, at the request of the Sponsor,
to withhold any such submission for an additional period, not to exceed ninety (90) days
to allow the Sponsor to file patent applications or to take any other action designed to
protect its patent rights. If the Sponsor informs the Institution that the manuscript or
disclosure contains Proprietary Information, the Principal Investigator shall modify or
delete such Proprietary Information and the Principal Investigator and the Sponsor shall
use their best efforts to provide scientifically meaningful equivalent information for use
in such disclosure.
b)
Notwithstanding anything herein to the contrary, if this Study is part of a multi-center
Study, the Institution and the Principal investigator agree that the first publication of the
results of the Study shall be made in conjunction with the presentation of a joint, multicenter publication of the Study results, with the investigators from all appropriate sites
contributing data, analyses, and comments. If such a multi-center publication is not
submitted within twelve (12) months after the conclusion of the Study at all sites, the
Institution and/or Principal Investigator may publish the results from the Institution's site
individually, subject to the Sponsor's rights under Article 8 (a) of this Agreement.
c)
Registration. In connection with any data or other information generated from the
services conducted hereunder by the INSTITUTION or INVESTIGATOR, SPONSOR
shall have the right to publish, post or register such data and information (without
approval from the INSTITUTION or INVESTIGATOR) on ClinicalTrials.gov or other
public web based data entry system in accordance with the International Committee of
Medical Journal Editors (ICMJE) and/or The Food and Drug Administration
Amendments Act of 2007 (“FDAAA”) or other applicable laws. SPONSOR shall be
exclusively responsible for registering the Study and posting the Study results in
accordance with FDAAA and for updating and/or amending such clinical trial
registration and posting as appropriate. DO NOT USE WITH INVESTIGATORINITIATED OR NIH-FUNDED STUDY CONTRACTS
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10.
INTELLECTUAL PROPERTY
a)
It is expressly agreed that neither the Sponsor nor the Institution transfer by operation
of this Agreement to the other party hereto any patent right, copyright, or other
proprietary right that either party owns as of the commencement of this Study, except
as specifically set forth herein.
b)
The Institution agrees that any inventions, discoveries, or improvements (hereinafter
"Sponsor's (“Inventions") arising out of work performed hereunder that are
dependent on the Sponsor's patent claims, proprietary information, or are expressly
anticipated by the Study protocol shall be owned by the Sponsor and shall be promptly
disclosed by the Institution's Principal Investigator to the Sponsor, unless the study has
been initiated by the Institution.
c)
The Institution shall own all other inventions developed or partially developed under
this Agreement solely by the Institution. Sponsor and Institution shall jointly own any
Inventions developed jointly by one or more employees of the Sponsor and the
Institution under this Agreement. The Institution shall grant the Sponsor an exclusive
option to negotiate with the Institution to obtain an exclusive, royalty bearing,
worldwide license, including the right to sublicense, to make, have made, use, and sell
commercial products incorporating such sole Institution Inventions or Institution's
rights in joint inventions providing that the Sponsor agrees to pay for all costs relating
to the filing, prosecution and maintenance of the Institution patents on inventions
made by the Institution during the Study. The Sponsor may exercise its exclusive
license option in writing at any time during the Study period (including any mutually
agreed extensions thereof) and for a period of one hundred and eighty (180) days
following the date that the confidential written invention disclosure is submitted to the
Sponsor by the Institution. Beginning on the date of the Sponsor's written notice of
exercise of its exclusive license option with regard to any particular Institution owned
Invention, the Institution and Sponsor will have a period of six (6) months in which to
negotiate in good faith the terms and conditions of a commercially reasonable
exclusive license agreement satisfactory to both parties. Upon the expiration of the
exclusive option period or the six-month exclusive license negotiation period, the
Institution shall have no further obligation to the Sponsor under this Agreement with
regard to any Institution owned Inventions made during the Study.
d)
If the Sponsor elects not to exercise its option as described above or decides to
discontinue the financial support for the filing, prosecution and maintenance of the
Institution's patent rights, the Institution shall be free to file or continue prosecution or
maintain any such application(s), and to maintain any protection issuing thereon in the U.
S. and in any foreign country at the Institution's sole expense. In the event that the
Sponsor acquires an exclusive license or right under this Agreement, the Sponsor hereby
grants to the Institution a nonexclusive worldwide perpetual license to have and to use the
exclusively licensed Institution intellectual and tangible property for noncommercial
academic research and teaching purposes.
11.
TERMINATION
a)
This Agreement may be terminated for cause by the Sponsor, or by the Institution, upon
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provision to the other party of at least thirty (30) days prior written notice that references
a material breach of any of the terms and conditions of this Agreement. If said material
breach is not satisfactorily remedied within the thirty (30)-day notice period, or
substantial steps to cure the breach within 60 days, this agreement shall then terminate
upon the expiration of said notice period.
b)
In addition, either party may terminate the Agreement by giving written notice to the
other party if any of the following reasons occur:
i)
If the authorization to perform the Study in the United States is not
granted or is withdrawn by the FDA;
ii)
If the emergence of any adverse reaction or side effect with the Study drug
administered is of such magnitude to support termination of the Study;
iii)
If the Principal Investigator conducting the Study is unwilling or unable to
continue performing the Study and a mutually acceptable successor is not
available.
iv)
If upon notice of other party that it has been declared insolvent, ceases or
threatens to cease to carry on its business, or an administrator or receiver
has been appointed over all or part of its assets.
c)
If this Agreement is terminated prior to the expiration of the Study period and the
Sponsor has not yet remitted payment for the full estimated project cost to the
Institution, the Sponsor shall still be held responsible for all non-cancelable Institution
costs and expenses and for any non-refundable fixed costs payments included in Exhibit
B, incurred prior to the date of such early termination and the Sponsor shall remit full
payment for such costs and expenses within thirty (30) days of the date of termination of
the study. In no event shall the Sponsor be obligated to pay the Institution more than the
total amount set forth in Exhibit B of this agreement. Any unobligated funds paid to the
Institution by the Sponsor shall be returned to the Sponsor by the Institution within sixty
(60) days following the Institution's receipt of the Sponsor's written request for such
unobligated funds.
d)
Immediately upon receipt of a written notice of termination by the Institution, the
Principal Investigator shall promptly stop entering Research Subjects into the Study
Protocol and shall cease conducting procedures on Research Subjects already entered
in the Study Protocol as directed by Sponsor, and to the extent medically permissible.
The Institution shall furnish to the Sponsor all case report forms, either completed or
uncompleted, up to the date of the Study termination, as well as all other Study
materials, including but not limited to the Study product.
12.
INDEMNIFICATION
a)
The Sponsor hereby agrees to indemnify, defend and hold harmless the Institution as
well as its trustees, officers, employees, affiliates and agents. If research occurs at
Saint Louis University Hospital or other Tenet owned facilities, indemnification
will include affiliated entities, specifically including but not limited to Saint Louis
University Hospital, its parent, and related entities and employees thereof
participating in the study, from any loss, expense (including reasonable attorney
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fees), cost, liability, damage or claim including any liability, loss, personal injuries,
death, or property damage arising out of: 1)the negligence or wrongful acts or
omissions of the Sponsor, its employees, and agents, 2) any defect, deficiency,
malfunction, hazard or adverse reactions in or resulting from the Protocol or any
equipment and supplies provided or manufactured by the Sponsor in connection with
this study, and, 3) any material breach of the Sponsor obligations pursuant to this
Agreement, provided that the Study is performed by the Institution in complete
compliance with this Agreement and Study Protocol attached hereto. Nothing
contained herein shall impose any obligations or liability on the Sponsor to the extent
any loss is caused in whole or in part by the intentional misconduct or gross
negligence or wrongful acts or omissions of the Institution, its employees, trustees or
agents and affiliated entities of Saint Louis University. The Institution will notify the
Sponsor within (forty-eight) 48 hours of any complaint, claim or injury to any subject
arising out of or in the course of the Institution's activities in connection with the Study
hereunder, and the Sponsor shall have sole control of the defense or settlement of such
complaint or claim. The Institution shall fully cooperate with the Sponsor in defending
the claims and will make no compromise or settlement without the prior written
approval of the Sponsor.
b)
When the Study is to involve blood or other clinical specimens that are to be shipped to
the Sponsor or Sponsor's agent in connection with a research project, the Institution will
provide any blood/clinical specimens as required pursuant to the above-referenced
research project to the Sponsor "as is" and makes no representation or warranty (express
or implied) that the specimens are free from harmful biological or infectious agents or
organisms and are otherwise merchantable or fit for a particular purpose or use. The
Sponsor agrees to assume the risk of all liability in connection with its use of said
specimens and, further agrees to indemnify, defend and hold the Institution, its
employees and agents harmless from any claims, liabilities, damages, and expenses
(including reasonable attorney's fees) arising as a result of any injury or damages relating
to the shipment, handling, use, or subsequent transfer of the specimens by the Sponsor
and its employees or agents.
c)
The Sponsor acknowledges that this Agreement does not confer upon the Sponsor any
right of claim of indemnification by the Institution, either expressed or implied.
Deviations from the terms of the Protocol that may arise out of necessity do not
constitute negligence or willful malfeasance provided that the Institution shall notify the
Sponsor within forty-eight (48) of any such deviations.
d)
In the event a claim or action is or may be asserted against the Institution or its affiliated
entities, the Institution shall have the right to select and to obtain representation by
separate legal counsel. If the Institution exercises such right, all costs and expenses
incurred by Institution for such separate counsel shall be borne by Institution, and/or its
affiliated entities.
13.
INSURANCE
a)
The Institution warrants and represents that the Institution has the following insurance or
self- insurance in amounts no less than that specified for each type:
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(a) Professional liability insurance with combined limits of not less than
$1,000,000 per occurrence and $3,000,000 in aggregate.
b)
Such insurance protection is applicable to officers, employees, and agents while acting
within the scope of their employment by the Institution. The Institution has no liability
insurance policy as such that can extend protection to any other person. Upon request, the
Institution will provide evidence of its self-insurance.
c)
Sponsor represents and agrees that it will carry general liability and product liability
insurance coverage with limits of at least one million dollars ($1,000,000) per occurrence
combined single limit and ten million dollars ($10,000,000) annual aggregate, and upon
request agrees to furnish a certificate of insurance acceptable to Institution indicating the
required coverage. Sponsor warrants that the insurance covers the Study and is not
materially encumbered by existing claims. Sponsor agrees to maintain such coverage for
the duration of this Agreement and if the policy is claims-made, for two-years thereafter.
Sponsor will notify Institution within twenty (20) days of any notice of cancellation or
non-renewal, or material change in, or claim against, its insurance coverage. Insurance
carriers will have an AM Best rating of A-VII or better.
14.
SUBJECT INJURY
a)
The Sponsor shall reimburse for all reasonable and necessary medical expenses incurred
by Research Subjects for any medical care, including hospitalization, in the treatment of
adverse reactions arising directly or indirectly from study drugs or devices following their
administration or use In accordance with the Protocol, which expenses are not covered by
the Research Subject's medical or hospital insurance coverage or other third party payor
and are in no way attributable to the gross negligence or willful misconduct of any person
in the employment of the Institution. Natural progression of an underlying pre-existing
condition does not constitute an adverse reaction. In addition, adverse reactions do not
include those resulting solely from the Institution's negligence. Sponsor shall have no
other duty to provide any other type of compensation to the Research Subjects.
b)
As soon as any Study Personnel concludes that a death, other Serious Adverse Event
(SAE), Unexpected Adverse Event (UAE), or other event specified in the Protocol
probably occurred during the Study, regardless of cause. Institution will report the event
within 24 hours to Sponsor by telephone, and follow-up with a written report of the even
to Sponsor within 48 hours of concluding that such event probably occurred. Institution
shall comply with other Sponsor and IRB reporting instructions. It will not delay the
report because of incomplete information, which can be supplied later.
15.
NOTICES
a)
With the exception of Study funds paid by the Sponsor pursuant to Article 4 hereof, all
notices required or permitted to be given under this Agreement shall be in writing and
shall be sufficient if delivered personally, sent by prepaid air courier, sent by mail or
sent by telefax transmission, as addressed as follows:
If to the Sponsor:
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Phone:
Fax:
If to the Institution:
Office of Research Services Administration
Saint Louis University
3556 Caroline Street, Suite 120
St. Louis, MO 63104
Attn: Todd Wakeland, J.D.
Phone: 314-977-7436 Fax: Fax: 314-977-7730
b)
Notices relating exclusively to medical or scientific issues shall be sent to the Principal
Investigator (with a copy to the Institution if such notices cover a change in the Study
Protocol):
If to the Principal Investigator:
c)
Any such communication shall be deemed to have been given when delivered if
personally delivered, on the business day after dispatch if sent by air courier, on the third
business day following the date of mailing if sent by mail and on the date of telefax if
sent by telefax transmission.
16.
INDEPENDENT CONTRACTORS
The relationship of the Sponsor to the Institution and its Principal Investigator shall be
that of an Independent Contractor and neither party shall have authority to make any
statements, representations or commitments of any kind, or to take any action which shall
be binding on the other party, except as may be explicitly provided for herein or
authorized in advance in writing by the other party.
17.
USE OF OTHER PARTIES' NAMES
a)
Neither party shall use the other party's name, nor issue any public statement about this
Agreement, including its existence, without the prior written permission of the other
party, except as required by law (and, in such case, only with prior written notice given to
the other party). Under no circumstances may Sponsor use the name, symbols or marks of
Institution in connection with any product advertisement. Such prior permission shall not
be unreasonably withheld.
b)
The parties agree that in order for the Institution and Principal Investigator to satisfy its
reporting obligations, it may identify or disclose their participation in the Study
(including the name of the sponsor, name of the Study, and protocol number) as required
by law, Court order, or state regulation, and in documents such as the investigator
curriculum vitae's, internal Institutional reports, external grant applications, and
governmental reports and filings.
18.
PHARMACY
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The Sponsor acknowledges and agrees that the Institution requires that all investigational
drugs shall be delivered to the Saint Louis University Hospital Pharmacy or Cardinal
Glennon Children's Hospital Pharmacy (hereinafter "Pharmacy") and that the Institution
shall have the authority to require that any investigational drugs be stored and dispensed
by Pharmacy. Such drugs shall be sent or delivered to:
Attention:
19.
RETURN OF UNUSED MATERIALS
Within thirty (30) days following termination or completion of the research, all unused
compounds, drugs, devices, case reports, whether or not completed, and other related
materials that were furnished to the Institution by or on behalf of the Sponsor shall be
destroyed or returned to the Sponsor at the Sponsor's request and expense.
30) days after Sponsor's receipt of an itemized invoice.
20.
CHANGES TO THE PROTOCOL
The Sponsor may at any time modify the Protocol by written notice to the Institution,
after approval by the Principal Investigator and by the Institutional Review Board (IRB).
The Sponsor will be assessed an additional processing fee if full IRB review is necessary.
Administrative changes will not be assessed a fee. No other financial adjustments shall be
made because of such modification unless the parties hereto amend this Agreement in
writing accordingly.
21.
CONFLICT OF INTEREST
The Institution policy requires that persons engaged in Sponsored research must disclose
potential financial conflicts of interest with such research, including certain consulting,
stock ownership, or other relationships with a company which sponsors such research,
and that the Institution must take measures to eliminate or minimize any effects of such
potential conflicts on the objectivity of such research. The Principal Investigator agrees
to comply with Institution policy and requirements governing conflict of interest, and
any federal and government guidelines.
22.
CONFORMANCE WITH LAW AND ACCEPTED PRACTICE
a)
The Institution shall perform the research in conformance with generally accepted
standards of Good Clinical Practice as set forth in Title 21 of the U.S. Code of Federal
Regulations, with the Protocol, and with all applicable local, state, federal and foreign
laws and regulations governing the performance of clinical investigations including but
not limited to the Federal Food, Drug and Cosmetic Act and regulations of the FDA and
comparable foreign agencies.
23.
DEBARMENT CERTIFICATlON
a)
Neither the Institution nor any Person employed thereby directly in the performance of
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the Research has been debarred under section 306(a) or (b) of the Federal Food, Drug and
Cosmetic Act and no debarred person will in the future be employed by the Institution in
connection with any work to be performed for or on behalf of Sponsor which may later
become part of any application for approval of a drug or biologic by the FDA, if at any
time after execution of this contract, the Institution becomes aware that the Institution or
any person employed thereby is, or is in the process of being debarred, the Institution
hereby certifies that the Institution will so notify the Sponsor within 15 days.
b)
Either party of this Agreement shall not assign hereunder any rights and obligations
hereunder without the prior written consent of the parties hereto. Any party may assign
this Agreement to an affiliated organization or in connection with the merger,
consolidation or sale of all or substantially all of its assets, upon 30 days' prior written
notice to the other party. An "affiliated organization" is an organization controlled by, in
control of, or under common control with the assigning party, and that agrees to assume
all responsibilities and obligations under this Agreement. Any other assignment of this
Agreement, and the associated rights and obligations, requires the prior written consent of
the other party.
24.
COMPLETE AGREEMENT AND MODIFICATION
This Agreement constitutes the entire agreement among the parties pertaining to the
Protocol and supersedes all prior agreements and understandings, whether oral or written.
No modification, amendment or waiver of this Agreement shall be binding unless
executed in writing by the parties. If a provision of the Study Conduct Article of the
Agreement conflicts with a provision of the Protocol, the Protocol takes precedence on
matters of medicine, science and conduct of the study. If a court of competent jurisdiction
finds any provision of this Agreement legally invalid or unenforceable then 1) such
finding will not affect the validity or enforceability of this Agreement, and 2) the parties
will negotiate to revise the provision to make it valid and enforceable. If the parties
cannot agree on such revisions, the Agreement will be performed in the absence of such
provision. If such performance is impossible, this Agreement will terminate upon 30 days
written notice by one party to the other party.
25.
WAIVER
No waiver of any term or provision of this Agreement whether by conduct or otherwise
in any one or more instances shall be deemed to be, or construed as, a further or
continuing waiver of any such term or provision, or of any other term or provision, of
this Agreement.
26.
CONTINUING OBLIGATION
Termination of this Agreement by either party shall not affect the rights and obligations
of the parties accrued prior to the effective date of the termination. The rights and duties
under Articles 5, 6, 7, 8, 9, I1, 13, 16, 21, 22 and 27 survive the termination or
expiration of this Agreement.
27.
GOVERNING LAW & JURISDICTION
This Agreement shall be governed by and construed in accordance with the laws of the
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State of Missouri (notwithstanding any conflict of laws provisions which would serve to
defeat application of Missouri substantive law). Each of the parties hereto agrees to
venue in and submits to the exclusive jurisdiction of the state and/or federal courts
located within the State of Missouri for any suit, hearing or other legal proceeding of
every nature, kind and description whatsoever in the event of any dispute or controversy
arising hereunder or relating hereto, or in the event any ruling, finding or other legal
determination is required or desired hereunder.
28.
FORCE MAJEURE
Neither party will be liable for failure or delay in performing its obligations under this
Agreement if the failure or delay is required to (a) comply with a governmental law,
regulation or order (not the result of its own conduct) or (b) is caused by other
circumstances beyond the control of such party, that could not have been avoided by that
party's due care, and are not specified elsewhere in this Agreement. A party claiming
force majeure will notify the other party in writing, with an explanation, within three
days. It will use its efforts to resume and complete the performance of its obligations
under this Agreement. If efforts will not enable resumption or completion, the party may
terminate this Agreement.
In Witness Whereof, the parties have caused this Agreement to be executed by their duly
authorized representatives as of the Effective Date hereof.
For SAINT LOUIS UNIVERSITY
By:
For SPONSOR
_____________________
By:
Johnny Kidd
Grants Administrator
Office of Research Services Administration
Date: _____________________
______________________
Name:
Title:
Date: ______________________
Read and Understood by Principal Investigator:
_______________________
Name:
Date: _______________________
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