CLINICAL STUDY AGREEMENT
Exhibit
10.2
THIS
Clinical
Study Agreement (this “Agreement”)
is
entered into as of the
execution
date of the last party to sign below (the “Effective
Date”),
by
and between Protalex,
Inc.,
a
corporation organized and existing under the laws of the State of Delaware,
with
an address at 000 Xxxxx Xxxxxx Xxxxx, Xxx Xxxx, XX 00000 (“SPONSOR”)
and
PAREXEL
International LLC,
a
limited liability company organized and existing under the laws of the State
of
Massachusetts, with an address at 000 Xxxx Xxxxxx, Xxxxxxx, XX 00000
(“PAREXEL”).
WHEREAS,
SPONSOR
conducts business in the research, development, manufacture and sale of
pharmaceutical products, including, a product known as [*********]1 (the
“Study
Drug”);
and
WHEREAS,
PAREXEL
is in the business of providing services in the management and conduct of
clinical trials for pharmaceutical products and related activities;
and
WHEREAS,
SPONSOR
desires to retain PAREXEL to assist SPONSOR by assuming certain
responsibilities, providing certain agreed-upon services, and conducting
a
clinical trial study pursuant to the Protocol, as it may be amended or
supplemented hereafter, from time to time, as agreed to by the parties in
writing and in accordance with this Agreement (the “Study”);
and
WHEREAS,
PAREXEL
has established a clinical pharmacology research unit located on the
7th
floor of
The Harbor Hospital Center, 0000 Xxxxx Xxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000
(“PAREXEL-BALTIMORE
CPRU”),
dedicated to conducting clinical studies on behalf of third party
sponsors.
NOW,
THEREFORE,
for
valuable consideration and intending to be legally bound, subject to the
terms
and conditions stated herein, the parties agree as follows:
A. Definitions.
In
addition to the terms defined elsewhere herein, as used in this Agreement
the
following terms shall have the meanings set forth in this Section A unless
the
context clearly dictates otherwise:
1. “Act”
shall
mean shall mean that federal statute enacted in 1938 as Public Law 75-717,
as such may have been amended, and which is contained in Title 21 of the
U.S. Code of Federal Regulations, Section 301 et
seq.
and the
rules and regulations promulgated thereunder.
2. “GCP”
shall
mean current Good Clinical Practice as promulgated under and in accordance
with
the Act, Title 21 of the U.S. Code of Federal Regulations, Part 312, the
Guidelines on Principles of Good Clinical Practice in Conduct of EU Clinical
Trials as promulgated under European Directive 2001/20/EC and ICH E6, as
may be
applicable and appropriate under the circumstances, as each may be amended
from
time to time, or any successors thereto.
3. “EMEA”
means
the European Medicines Evaluation Agency, or any successor entity
thereto.
4. “FDA”
means
the United States Food and Drug Administration or any successor entity
thereto.
_______________
1
[*****]
denotes sections of the document which have been redacted in connection
with a
request for confidential treatment.
1
5. “IRB”
means
an appropriate Human Subject Institutional Review Board or equivalent body
organized in accordance with the Act, having jurisdiction over the institution
in which the Study will be conducted.
6. “Principal
Investigator”
means
PAREXEL’s employee, [*****************] or his successor appointed in accordance
with the terms of this Agreement.
7. “Regulatory
Authorities”
shall
mean: (a) the FDA, EMEA (where applicable and appropriate) and any and all
national, multi-national (as used in this Agreement including without limitation
the European Union), or other governmental or industry agency or body with
authority over the manner in which the Study is conducted in a country; and
(b)
any and all national or multi-national authority responsible for granting
regulatory approval to market a drug product in a particular country or
multi-national group or union of countries.
B. Engagement.
SPONSOR
hereby engages PAREXEL and PAREXEL hereby accept SPONSOR’s engagement to assist
SPONSOR by (i) assuming certain responsibilities and providing certain
agreed-upon services in connection with the Study as detailed in Attachment
B
annexed
hereto; and (ii) conducting the Study, the full scope of which is defined
in and
will be performed in accordance with the [*******************] entitled
[*******************] (the “Protocol”)
and
any amendments or supplements thereto agreed in writing by SPONSOR and PAREXEL.
A copy of the Protocol is attached hereto as Attachment
A.
C. CRO
Services
1. Scope
of Work.
PAREXEL
hereby agrees to perform the particular tasks as set out in Attachment
B
annexed
hereto and made a part hereof (the “Services”)
in
accordance with: (i) all applicable statutes, rules and regulations which
may
include, without limitation, the Act, the Declaration of Helsinki, and FDA,
and
any proposed regulations provided to PAREXEL by SPONSOR; (ii) the Protocol;
(iii) the mandates of the PAREXEL-BALTIMORE CPRU’s IRB; and (iv) any other
written instructions from SPONSOR. Further, PAREXEL will perform the Services
in
a competent and professional manner, consistent with the current industry
standards for clinical research and GCP.
2. Change
in Scope.
If at
any time while the Services are being performed hereunder SPONSOR requests
a
change in the scope of the Services or the assumptions under which the parties
created the Services Budget or timeline prove to be materially inaccurate
(any
such occurrence, a “Change
in Scope”),
SPONSOR and PAREXEL will jointly review such proposed Change in Scope and
PAREXEL shall provide SPONSOR with information on any corresponding increase
or
decrease in the Services Budget and a revised time estimate for performing
the
changed or additional services. Changes in Scope must be approved by SPONSOR
and
PAREXEL, in writing, prior to commencement of any services arising from such
changes. Any work performed in connection with a Change in Scope that has
not
been reviewed and approved, in writing, by SPONSOR will not be reimbursed.
In
the event that a Change in Scope is agreed to between the parties, an amended
or
supplemental Attachment
B
(as
appropriate) shall be prepared and executed by the parties in accordance
with
provisions of this Agreement.
3. Regulatory
Matters.
(a) PAREXEL
acknowledges and agrees that the responsibility for the respective Services
included on Attachment
B
are
being transferred to PAREXEL in accordance with Title 21 of the U.S. Code
of
Federal Regulations (the “CFR”)
Section 312.52. SPONSOR shall retain those responsibilities not specifically
listed in Attachment
B.
Except
for those responsibilities specifically transferred from SPONSOR to PAREXEL
by
Attachment
B,
SPONSOR
shall at all times be the “sponsor” of the Study pursuant to the terms of the
Act and the regulations of the FDA, as promulgated in Title 21 of the
CFR
2
(b) Federal
regulations require approval (and continuing review) of the Study at
PAREXEL-BALTIMORE CPRU by an IRB. PAREXEL shall ensure that the Principal
Investigator signs the Statement of Investigator form (Form
FDA
1572) representing
that the Principal Investigator has complied with such regulations.
(c) PAREXEL
shall ensure that the Principal Investigator obtains written informed consent
given by, or for, each subject enrolled in the Study. Each signed original
informed consent should remain in the subject’s record and a copy made available
for SPONSOR’S inspection.
(d) PAREXEL
shall report all adverse drug experiences (whether serious or not) incurred
during or as the result of the Study to SPONSOR in accordance with the Protocol
and applicable regulations including, where required, immediate telephone
reporting and will promptly provide SPONSOR with all relevant information
in
their possession or control as may be needed to reasonably assist SPONSOR,
at
SPONSOR’s sole expense, in the identification and resolution of problems or
unexpected occurrences involving the Study Drug or its use in the
Study.
4. Credentials
of Principal Investigator.
With
respect to the Principal Investigator, PAREXEL shall ensure that he or she:
(i)
has an unrestricted license to practice in the state where he or she will
conduct the Study; (ii) has never had his or her license revoked in any
jurisdiction; (iii) has never been disbarred by the FDA or subject to any
other
disciplinary action by the FDA or any other regulatory agency; and (iv) has
malpractice insurance in an amount no less than [***********].
D. Clinical
Study
1. Principal
Investigator; Subinvestigators.
(a) The
Principal Investigator will serve as the principal Study investigator, will
supervise the conduct of the Study, and may, in accordance with applicable
law
and the Protocol, appoint such other individuals as he may deem appropriate
as
subinvestigators to assist in the conduct of the Study (any such individual,
a
“Subinvestigator”).
The
Principal Investigator shall be solely responsible for leading, and approving
any action of, any Subinvestigator(s) or other support staff providing services
hereunder. The Principal Investigator, any Subinvestigator and all support
staff
shall comply with the terms of this Agreement to the same extent as PAREXEL.
PAREXEL shall inform each such person of his/her obligations hereunder and
shall
obtain his/her agreement to abide by the terms and conditions of this Agreement.
PAREXEL shall have ultimate supervision over the Principal Investigator and
any
each Subinvestigator and accordingly shall be responsible for any breach
hereof
by the Principal Investigator, any Subinvestigator or any support staff hired
by
PAREXEL and involved in the conduct of the Study.
(b) If
the
Principal Investigator should become unable or unwilling for any reason to
complete the Study, PAREXEL shall consult with SPONSOR regarding the appointment
of a new investigator and if both parties cannot agree on a substitute, all
further enrollment of subjects into the Study shall immediately cease and
SPONSOR shall have the option to terminate the Study upon written notice
to
PAREXEL. In
the
event SPONSOR so terminates the Study, SPONSOR shall pay PAREXEL, net thirty
(30) days from the date of PAREXEL’S invoice, for all Services performed,
pass-through expenses incurred, and non-cancelable expenses incurred up to
and
including the effective date of termination. For the avoidance of doubt,
no
termination pursuant to this Section D-1(b) shall trigger any penalty payments
under Section F-5(b).
3
2. Conduct
of the Clinical Trial.
(a) PAREXEL
and Principal Investigator each represent that they: (i) have the requisite
and
necessary experience, equipment, facilities and personnel to conduct the
Study
in accordance with the Protocol; (ii) are not parties to any other agreement
that would materially conflict with, or prevent their ability to perform
their
respective Services under this Agreement; and (iii) shall use their respective
commercially reasonable efforts to perform the Study in a professional manner
and to complete the Study within the time period specified in the
Protocol.
(b) The
Principal Investigator or his/her designee shall submit the Protocol for
review
and approval to the appropriate review authorities, including, among others,
an
IRB having jurisdiction over the facilities in which the Study will be
conducted. The Study shall be conducted in accordance with the Protocol as
approved by the IRB, as the same may be changed from time to time in accordance
with prudent research practices, all changes being subject to SPONSOR’s prior
written approval before implementation within the Study. PAREXEL shall provide
SPONSOR with written evidence of review and approval of the Study by the
IRB
prior to the initiation of the Study, and if applicable, the IRB’s continuing
review and approval of the Study.
(c) PAREXEL
and Principal Investigator warrant and represent that they shall conduct
the
Study in accordance with: (i) the terms of the Protocol, (ii) all written
instructions from SPONSOR, (iii) GCP, and (iv) all applicable laws, rules,
regulations and other governmental requirements. These obligations shall
include:
(i) on
behalf
of PAREXEL, the Principal Investigator and any Subinvestigators or their
respective designees shall, in compliance with applicable governmental
requirements and the Protocol, prepare, document and maintain records and
case
histories on case report forms (“CRFs”),
retain such data and records after completion of the Study, and obtain advance
informed consent from each of the subjects (or their duly authorized
representatives) participating in the Study;
(ii) the
Principal Investigator and any Subinvestigators or their respective designees
shall notify SPONSOR of any adverse reaction (whether serious or not) incurred
during or as the result of the Study as soon as reasonably possible after
the
occurrence of the such event, and provide a written confirmation report of
such
event promptly thereafter;
(iii) upon
reasonable advanced, written notice and during PAREXEL’s normal business hours,
PAREXEL and Principal Investigator shall permit representatives of SPONSOR,
that
are not competitors of either PAREXEL or PAREXEL’s affiliates to examine their
respective facilities used to perform the Services hereunder, to validate
CRFs
against original data in their files, to make copies of records relating
to the
Services and/or Study and monitor the Services performed hereunder, and to
determine the adequacy of the facilities and whether the Study is being
conducted in compliance with this Agreement, the Protocol and relevant
governmental requirements, provided that (i) such representative first signs
PAREXEL’s non-disclosure agreement (in the form substantially attached hereto as
Attachment
E)
and
(ii) such audit does not interrupt the normal business operation of PAREXEL
or
the Principal Investigator.
(iv) PAREXEL
and the Principal Investigator or his designee will promptly provide SPONSOR
with all information in their possession or control as may be needed to
reasonably assist SPONSOR, at SPONSOR’s sole expense, in the identification and
resolution of problems or unexpected occurrences involving the Study Drug
or its
use in the Study; and
(v) Principal
Investigator or his designee will keep appropriate records of the Study Drug
received, dispensed, used, and returned in accordance with applicable law
and
the Protocol.
4
3. Periodic
Reports.
The
Principal Investigator shall keep SPONSOR advised of the status of the Study
through the submission of periodic reports as deemed necessary by SPONSOR,
the
frequency and format of which shall be mutually agreed. A final report shall
be
submitted by the Principal Investigator and presented to SPONSOR.
4. Study
Supplies.
(a) SPONSOR
shall provide PAREXEL with a sufficient quantity of the Study Drug to conduct
the Study, as well as any other compounds, materials and information which
the
Protocol specifies SPONSOR shall deliver or which SPONSOR deems necessary
to
conduct the Study in accordance with the Protocol (all such items, “Study
Materials”).
(b) All
Study
Drug, and Study Materials are and shall remain the sole property of SPONSOR.
PAREXEL, the Principal Investigator and each Subinvestigator shall take all
reasonable steps to handle, store, use and dispose of the Study Drug and
any
Study Materials in accordance with the Protocol. PAREXEL, the Principal
Investigator and each Subinvestigator shall not release any Study Drug to
any
third party, with the exception of Study subjects, (including without limitation
any governmental agency, any other investigator or any other third party)
without the prior written express approval from SPONSOR, except in cases
where
they are required by law to release the Study Drug to a regulatory agency
acting
within the scope of its regulatory authority, in which case, PAREXEL, and
the
Principal Investigator/Subinvestigator will promptly notify SPONSOR of such
action.
5. Financial
Reporting.
So that
SPONSOR may fulfill its certification and other financial disclosure obligations
to the FDA under 21 CFR Part 54 and such other laws and regulations as may
from
time to time be or become applicable with respect thereto, the Principal
Investigator and any Subinvestigators shall provide such financial disclosures
to SPONSOR as SPONSOR may reasonably request and that are directly related
to
the Services performed by PAREXEL hereunder, on such forms as SPONSOR may
supply
or as SPONSOR may approve. All such financial disclosures made by PAREXEL
shall
be maintained by SPONSOR as confidential and shall only be disclosed to the
FDA
or such other applicable government agency. During the time the Study is
being
conducted and for one (1) year thereafter, the Principal Investigator and
any
Subinvestigators shall update such forms promptly and provide the same to
SPONSOR as may be reasonably requested by SPONSOR.
6. Termination
of the Study.
(a) An
early
termination of the Study shall be permitted upon prior written notice to
the
appropriate party, specifying the exact reason for such termination, as
follows:
(i) by
either
party, immediately, if such party believes a termination is necessary to
protect
the safety or welfare of the Study subjects or upon termination of the Study
at
the direction of a regulatory agency; and
(ii) by
SPONSOR, at any time upon thirty (30) days notice, for scientific reasons,
as
solely determined by SPONSOR or if the purpose of the Study has, for any
reason,
become obsolete or no longer has any validity or purpose; or for any other
reason which SPONSOR deems appropriate.
(b) Within
thirty (30) days following the completion or premature termination of the
Study,
PAREXEL shall furnish SPONSOR with all completed CRFs not already returned
to
the SPONSOR, any unused CRFs, and all data, reports and other information
generated in relation to the Study, as well as all Study Drug and Study
Materials provided by SPONSOR, unless SPONSOR directs otherwise in writing.
The
SPONSOR shall inform PAREXEL in writing when to dispose of any unused Study
Drug
or Study Materials and will approve of said process as furnished by PAREXEL
prior to this taking place. SPONSOR will bear the cost of all data management
activities required to produce portable data formats outside of PAREXEL’s
standard.
5
(c) For
the
avoidance of doubt, termination pursuant to Section D-6(a)(i) shall not trigger
any penalty payments under Section F-5(b).
E. Compensation
1. Fee.
(a) In
full
consideration for PAREXEL’s Services under Section B and the performance of the
Study (including, without limitation, the costs of the Principal Investigator’s,
any Subinvestigators’ and other support staff’s services hereunder), SPONSOR
shall pay PAREXEL a clinical fee (the “Fee”)
in
accordance Attachment
C,
plus
SPONSOR shall reimburse PAREXEL for: (i) all pass-through costs incurred
in the
performance of the Services, and (ii) the
pass-through cost
of
medical care or additional diagnostic procedures associated with adverse
reactions that are attributable to the administration of the Study Drug and
arise in the course of the Study as performed in adherence to the Protocol.
(b) All
payments are due net thirty (30) days from receipt of PAREXEL’S invoice.
(c) PAREXEL
will accomplish and complete the Services and the Study within the Fee set
forth
above, and will not commit to any expenses in excess of such maximum amount
without SPONSOR’s prior written consent. Each party agrees to discuss budgetary
matters with the other party as either party may request from time to
time.
2. Method
of Payment.
All
payments of the Fee require submission of an invoice therefore from PAREXEL
to
SPONSOR and shall be made by check, which will be made payable to:
[*******************]
and
shall
be sent to:
[*******************]
Tax
ID #:
[*******************]
3. Accounting
Records.
PAREXEL
shall maintain complete and accurate accounting records in respect of the
Services and performance of the Study in accordance with generally accepted
accounting principles consistently applied. During the term of this Agreement
and for a period of three (3) years following the termination or expiration
of
this Agreement, upon SPONSOR’s written request, a copy of these records shall be
provided to SPONSOR, at SPONSOR’s sole expense.
F. General
1. Inspections.
PAREXEL
shall promptly notify SPONSOR of any request received by PAREXEL or Principal
Investigator from any applicable regulatory or other governmental agency
to
inspect or otherwise gain access to the information, data or materials
pertaining to the Services performed by PAREXEL under Section B of this
Agreement, or in connection with the conduct of the Study hereunder. PAREXEL
shall promptly notify SPONSOR of such requests prior to permitting any third
party access unless prior notice is not reasonably practical. Upon reasonable
advanced written notice and during PAREXEL’s normal business hours, PAREXEL
agrees to permit inspection of such information, data and materials by
authorized representatives of such agencies as required by law. PAREXEL will
provide SPONSOR with copies of such notice(s) and related correspondence.
PAREXEL will notify SPONSOR of the results of any such inspection. At SPONSOR’s
request when reasonably necessary and appropriate and at a mutually agreeable
time, PAREXEL will accompany SPONSOR, at SPONSOR’s sole expense, to such
agencies to discuss relevant aspects of PAREXEL’s Services performed
hereunder.
2. Confidentiality.
(a) In
preparation for, and during the course of, the Services or Study, it may
be
necessary for SPONSOR to disclose to PAREXEL, the Principal Investigator
and
Subinvestigators (whether
written, oral, electronic, or otherwise)
non-public technical and business information regarding such Study and PAREXEL
may otherwise receive, access or develop such information in the course of
performing the Services under this Agreement which information may include,
but
shall not be limited to, trade secrets, know-how, proprietary information,
protocols, data, formulae, processes, techniques and information relating
to
SPONSOR’s past, present and future research and development activities (the
“Confidential
Information”)
For
purposes of clarity, the parties agree that all information relating to the
Study Drug, the Study and all Inventions (as defined in Section F-4(b)) will
constitute Confidential Information. PAREXEL agrees to: (1) use such
Confidential Information only in connection with the legitimate purposes
of this
Agreement; (2) disclose such Confidential Information only to those who have
a
need to know it and are obligated to keep same in confidence; and (3) safeguard
such Confidential Information with reasonable care. The confidentiality
obligations of this Agreement shall also apply to any proprietary, trade
secret
or other confidential information which are disclosed to PAREXEL or the
Principal Investigator/Subinvestigators by SPONSOR subsequent to the execution
of this Agreement. PAREXEL and the Principal Investigator acknowledge that
in
the event of a breach of this Section E2: (i) SPONSOR may suffer irreparable
damage that may not be fully remedied by damages, (ii) SPONSOR shall be entitled
to seek injunctive relief against any such breach in court, and (iii) any
action
taken by SPONSOR shall in no way be construed to limit or otherwise restrict
its
rights to seek other damages or relief available under this Agreement or
applicable law.
6
(b) The
foregoing obligations shall not apply to any portion of the Confidential
Information which PAREXEL or the Principal Investigator can reasonably
demonstrate is:
(i) information
that is in the public domain at the time of disclosure hereunder or generation
in the Study, or that which subsequently enters the public domain through
no
breach of this Agreement;
(ii) information
which PAREXEL can demonstrate was already legally in its the possession prior
to
disclosure hereunder or generation in the Study, excluding information provided
by SPONSOR to PAREXEL pursuant to a confidentiality agreement prior to such
disclosure;
(iii) information
which is provided to PAREXEL or the Principal Investigator, without restriction
as to confidentiality or use, by a third party lawfully entitled to possession
of such Confidential Information and who does not violate any contractual,
legal
or fiduciary obligation to SPONSOR by providing such Confidential Information
to
PAREXEL or the Principal Investigator;
(iv) information
which is required by is required by law, rule, regulation, or court of competent
jurisdiction to be disclosed; provided that PAREXEL or the Principal
Investigator give the SPONSOR prompt notice thereof; or
(v) information
which is independently developed by or on behalf of PAREXEL or its affiliates
without use of the Confidential Information.
(c) PAREXEL
may disclose the Confidential Information to those of its affiliates, employees,
agents, and subcontractors requiring legitimate access thereto for the purpose
of performing the Services under this Agreement and conducting the Study.
Each
such recipient shall be subject to written agreements containing confidentiality
provisions that are applicable to the Confidential Information and that are
substantively similar to the provisions of this Section F-2. The obligations
set
forth in this Section F-2 shall extend to copies, if any, of Confidential
Information made by PAREXEL, and to documents prepared by PAREXEL, the Principal
Investigator, and all employees, agents, and subcontractors, to the extent
they
embody or contain Sponsor Confidential Information, and to any electronic
data
files to the extent they contain Confidential Information.
(d) PAREXEL
shall, and shall cause the Principal Investigator and any Subinvestigators
to
comply, and shall require any of the persons or entities performing the Study
on
the PAREXEL’s behalf to comply, with all applicable U.S. federal and state laws
and regulations governing patient privacy and confidentiality of health
information, including without limitation the federal Health Insurance
Portability and Accountability Act of 1996 (“HIPAA”)
and
its implementing regulations. PAREXEL, the Principal Investigator and any
Subinvestigators shall take all actions reasonably necessary to comply with
such
laws and regulations, including agreeing to amend this Agreement as necessary
for compliance. PAREXEL shall, and shall cause the Principal Investigator
and
any Subinvestigators to obtain written authorization from Study subjects
as
necessary to permit regulatory agencies, affiliated IRBs and privacy boards,
the
SPONSOR, its affiliates, agents, and employees, other research sites that
may be
involved in the Study, health care providers who may provide services to
such
subjects, and laboratories and other individuals and organizations that may
analyze the subjects’ medical information in connection with the Study to have
full access to and use of the subjects’ Protected Health Information, as defined
in HIPAA and its implementing regulations and official guidance promulgated
thereunder. A sample of such a written authorization is attached hereto as
Attachment D.
If the
form of written authorization differs from the Attachment D
sample,
it shall be submitted to the SPONSOR, or its designated representative, for
review and approval prior to submission to the IRB, if applicable, and the
Study
subjects.
7
(e) The
terms
of this Section F-2, and the parties’ obligations hereunder, shall survive
termination or expiration of this Agreement and the completion of PAREXEL’s
Services hereunder.
3. Publication;
Publicity.
(a) The
right
to publish any part of the results (including, without limitation, all Study
Data (as defined in Section F-4(a) generated during the Study) of the Study
shall rest solely with SPONSOR. Except as to PAREXEL Works, PAREXEL, Principal
Investigator and any Subinvestigator each agree that it/he/she will not publish,
or otherwise publicly disclose any data or results generated during the Study,
or any information owned or generated by any source in the course of the
Services provided hereunder without the prior written permission of Sponsor.
(b) No
party
shall use the name, symbols or marks of any other party in any publicity,
advertising or announcement without the other party's prior written approval.
PAREXEL shall not originate any publicity, press release or other public
announcement, written or verbal, whether to the public press or otherwise,
relating to this Agreement, the Protocol, the Study conducted hereunder,
or to
any amendment(s) thereto without the express written consent of
SPONSOR.
4. Ownership;
Inventions
(a) All
CRFs
and other reports submitted to SPONSOR and all information, documents and
raw
data collected or generated in connection with this Agreement (“Study
Data”),
excluding patient records or any other third party proprietary information
shall
be the sole property of SPONSOR and may be used by SPONSOR for any purpose
without further obligation or liability to PAREXEL.
(b) PAREXEL,
the Principal Investigator, any Subinvestigators and all other Study personnel
engaged to perform the Study under this Agreement shall promptly disclose
to
SPONSOR any and all discoveries or inventions that are conceived or first
reduced to practice or demonstrated to have utility by them in the performance
of the Study (“Inventions”).
All
right, title and interest in and to all Inventions, whether or not patentable
or
subject to copyright, shall be the exclusive property of SPONSOR, and PAREXEL,
the Principal Investigator, any Subinvestigators or other Study personnel
shall
assign, and hereby assigns, to the SPONSOR all of its, his or her rights
and
interests in and to all Inventions, and shall cooperate with the SPONSOR
in all
reasonable respects to assure that ownership of all Inventions accrues to
the
SPONSOR including, but not limited to, signing applications for letters patent,
trademarks and copyrights, assignments, or other necessary or similar documents.
PAREXEL represents and warrants that all its employees (including, without
limitation, the Principal Investigator, any Subinvestigators and all other
Study
personnel engaged to perform the Study) are required to execute assignment
of
inventions agreements on behalf of PAREXEL, upon hiring by PAREXEL.
8
(c) Notwithstanding
Section F-4(b) above, SPONSOR acknowledges that all confidential or proprietary
testing methods, practices, computer programs, techniques, processes, tools,
or
equipment, and other materials and ideas developed by or for PAREXEL and
solely
used by PAREXEL in performance of the Services under this Agreement, which
are
not either supplied to PAREXEL by Sponsor or related in any way to the Study,
Study Drug, Study Materials or other SPONSOR product, technology or know-how
(the “PAREXEL
Developments and Processes”),
other
than any of such PAREXEL Developments and Processes which relate exclusively
to
the matters or substances studied hereunder, and except to the extent any
of
such PAREXEL Developments and Processes contain information of SPONSOR required
to be kept confidential hereunder, shall be and remain the sole property
of
PAREXEL. Further, SPONSOR agrees that any discoveries, improvements,
enhancements, modifications, or inventions to the PAREXEL Developments and
Processes made during the course of this Agreement shall be the sole property
of
PAREXEL. All
proprietary ideas, methods, inventions, discoveries, information, reports
and
other proprietary or protectable matters relating to SPONSOR's products and
their applications shall be and remain the sole property of
SPONSOR.
5. Term
and Termination
(a) This
Agreement shall be effective as of the Effective Date and, unless earlier
terminated as set forth below or extended upon written agreement signed by
the
parties, shall expire on September 5, 2006.
(b) SPONSOR
may terminate this Agreement without cause upon [*******************] prior
written notice to PAREXEL. In the event of any such termination SPONSOR agrees
to pay to PAREXEL the payments according to the following cancellation terms:
(i) SPONSOR
agrees to pay PAREXEL a termination penalty of [*******************] plus
all
labor-related and direct costs incurred in connection with PAREXEL’s services
performed through the date of termination. In the event that the SPONSOR
postpones the study, the SPONSOR also agrees to pay PAREXEL a postponement
penalty of [*******************]. If PAREXEL cannot accommodate a new study
date
within thirty (30) days of the previously agreed upon time, then SPONSOR
will
not be required to pay the postponement penalty.
(c) Either
party hereto may terminate this Agreement, upon thirty (30) days written
notice,
if the other party materially fails to abide by the terms of this Agreement
and
such material failure remains uncured during such thirty (30)-day period.
In
the
event of such termination, SPONSOR shall pay PAREXEL for all Services performed
in accordance with this Agreement, plus all pass-through expenses incurred,
net
thirty (30) days from the date of PAREXEL’s invoice.
(d) Termination
or expiration of this Agreement shall not affect any rights or obligations
which
have accrued prior thereto. No termination of this Agreement, however
effectuated, shall release the parties hereto from their rights and obligations
under Sections X-0, X-0, X-0(x), X-0, X-0, X-0, X-0(x), X-0, F-10, F-11,
F-13
and F-14.
6. Independent
Contractors.
PAREXEL’s relationship to SPONSOR under this Agreement is that of an independent
contractor, and PAREXEL has no authority to bind or act on behalf of SPONSOR.
PAREXEL represents that Principal Investigator’s relationship to PAREXEL and
PAREXEL-BALTIMORE CPRU is that of an employee.
9
7. Assignment.
PAREXEL
may not assign this Agreement to any other party, without SPONSOR's prior
written consent. Any attempted assignment without SPONSOR’s prior written
consent shall constitute a material breach of this Agreement.
8. Debarment.
PAREXEL
hereby certify that it, PAREXEL-BALTIMORE CPRU, and its employees (including,
without limitation, the Principal Investigator, any Subinvestigators and
support
staff) that it and they have not and will not use in any capacity the services
of any individual, corporation, partnership or association which has been
debarred under 21 U.S.C. §335(a) or (b), disqualified as a clinical investigator
under the provisions of 21 CFR §312.70, or disqualified as an institutional
review board or an institution under the provisions of 21 CFR §56.121. In the
event that PAREXEL or the Principal Investigator becomes aware of any debarment,
threatened debarment, disqualification or threatened disqualification of
any
individual, corporation, partnership, or association providing services to
PAREXEL or to the Principal Investigator which relates to the Services under
this Agreement, PAREXEL and/or the Principal Investigator, as the case may
be,
shall notify SPONSOR promptly.
9. Indemnity
(a) SPONSOR
shall indemnify, defend and hold harmless PAREXEL and its respective
subsidiaries, affiliates, officers, agents, directors, employees (individually,
a “PAREXEL
Indemnitee”
and
collectively the “PAREXEL
Indemnitees”)
against and from any loss, damage, cost and/or expense including reasonable
attorneys’ fees (collectively, “Damages”)
that
they may suffer as the result of claims, demands, suits, or judgments
(“Claims”)
which
may be made or instituted against them by a third party based upon the
following: [*******************] Sponsor’s indemnification obligations hereunder
shall not apply to the extent such Claims are caused by:
[*******************]
(b) PAREXEL
shall indemnify, defend and hold harmless SPONSOR, its affiliates, and their
respective directors, officers, employees and agents (individually, a
“Sponsor
Indemnitee”
and
collectively the “Sponsor
Indemnitees”)
from,
against, for and in respect of any and all Damages that they may suffer as
the
result of Claims which may be made or instituted against them by a third
party
based upon:
[*******************]
(c) PAREXEL’s
indemnification obligations hereunder
shall not apply to the extent such Claims are attributable to:
[*******************]
(d) It
is a
condition under this Section F-9 that any person seeking indemnity under
this
Agreement must: (a) promptly notify the indemnifying party in writing as
soon as
it/him/her becomes aware of Claims against it/him/her, provided however,
that
failure to provide such prompt notification shall not be grounds to deny
a claim
of indemnification if the indemnifying party is not prejudiced by such delayed
notice; (b) authorize and permit the indemnifying party to carry out the
sole
management, defense and disposition of such Claims, provided
that the
indemnifying party may not settle any Claims without the indemnified party’s
prior written consent (which shall not be unreasonably withheld or delayed)
if
such settlement would involve and admission of liability or wrongdoing on
the
part of the indemnified party; and (c) fully cooperate with the indemnifying
party regarding such Claims (including access to pertinent records and
documentation and provision or relevant testimony). Subject to the foregoing,
each indemnified party may participate in such Claims at its/him/her own
expense
and cost. No indemnified party may settle any Claim against it/him/her for
which
it may or intends to seek indemnification hereunder from an indemnifying
party
without such indemnifying party’s prior written consent, or such indemnifying
party’s indemnification obligation as to such Claim shall be null and void;
provided,
that, where
an
indemnified party affords an indemnifying party the opportunity to take over
the
defense of a Claim and the indemnifying party has notified the indemnified
party
in writing that it believes the Claim does not fall within any indemnification
obligations hereunder, then the indemnified party shall be entitled thereafter
to settle such Claim without the indemnifying party’s consent and shall be
entitled to reimbursed by the indemnifying party for the amount of such
settlement (and reasonable attorney’s fees and cost of litigation related
thereto) if it is decided subsequently by a court of competent jurisdiction
that
the Claim did in fact fall within the indemnification obligation.
10
10. Subject
Injury Reimbursement.
The
SPONSOR shall pay the cost of medical treatment of any injury or illness
sustained by a Study subject as the result of the administration of the Study
Drug in accordance with the Protocol, but only to the extent that said subject’s
insurance or other third-party insurance is insufficient to cover said
costs.
11. Disclaimer;
Limitation on Liability.
(a) SPONSOR
acknowledges that the results of the Study and Services to be provided hereunder
are inherently uncertain and that, accordingly, there can be no assurance,
representation, or warranty by PAREXEL that the product covered by this
Agreement can, either during the term of this Agreement or thereafter, be
successfully developed or, if so developed, will receive the required approval
by the U.S. Food and Drug Administration or other regulatory body.
(b) PAREXEL,
and the Principal Investigator make no representations, conditions, or
warranties, either express or implied, with respect to the any particular
result
of the Study except that PAREXEL and the Principal Investigator shall have
results of the Study reported completely, accurately and in a timely manner
and
shall at all times comply with GCP and all applicable laws and regulations,
including without limitation the Act and regulations of the FDA, as may be
amended.
(c) IN
NO
EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY SPECIAL, INDIRECT,
EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING ANY LOST PROFIT
OR
LOST SAVINGS, EVEN IF SUCH PARTY HAS BEEN ADVISED, KNOWS OR SHOULD KNOW OF
THE
POSSIBILITY OF SUCH DAMAGES; [*******************].
12. Delays;
Force Majeure.
(a) SPONSOR
acknowledges that PAREXEL will require documents, drug supplies, data, records,
and cooperation of the SPONSOR in order to properly perform the Study and
Services hereunder and that PAREXEL is not responsible for errors, delays
or
other consequences arising from the failure of SPONSOR to provide such
documents, drug supplies, data, records or cooperation.
(b) Both
parties acknowledge that neither party will be responsible to the other party
for any default under this Agreement by reason of accidents, strikes, riots,
wars, fire, terrorist acts, acts of God, acts in compliance with any law,
or any
other cause beyond its reasonable control (“Force
Majeure”).
If
due performance of this Agreement by either party is affected in whole or
in
part by reason of any Force Majeure event, it shall give prompt notice thereof
to the other party. A party claiming the benefit of Force Majeure shall use
commercially reasonable efforts to avoid or overcome the causes affecting
performance. In the event that any such Force Majeure continues in excess
of one
(1) month, the party not affected by the event of Force Majeure shall have
the
right to terminate this Agreement upon written notice to the other specifying
the effective date of termination. In the event of such termination, SPONSOR
shall pay PAREXEL for all Services performed and pass-through expenses incurred
through the effective date of termination. For the avoidance of doubt, no
termination pursuant to this Section F-12(b) shall trigger any penalty payments
under Section F-5(b).
11
13. Communications.
Any
notice or other administrative communication required or permitted under
this
Agreement shall be by first class mail, postage prepaid, certified mail,
return
receipt requested, and will be deemed given as of the date it is received
by the
receiving party at the address(es) as follows:
To
PAREXEL:
PAREXEL
International LLC
000
Xxxx
Xxxxxx
Xxxxxxx,
XX 00000
ATTN:
General Counsel
To
SPONSOR:
[*******************]
[*******************]
Protalex,
Inc.
000
Xxxxx
Xxxxxx Xxxxx
Xxx
Xxxx,
XX 00000
To
PAREXEL-BALTIMORE CPRU:
[*******************]
[*******************]
Harbor
Hospital Center
PAREXEL-BALTIMORE
CPRU, 7th
Floor
0000
Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
To
PRINCIPAL INVESTIGATOR
[*******************]
[*******************]
Harbor
Hospital Center
PAREXEL-BALTIMORE
CPRU, 7th
Floor
0000
Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
14. Miscellaneous
Provisions.
(a) This
Agreement, together with all attachments, contains the entire understanding
of
the parties with respect to the subject matter herein and supersedes all
previous agreements and undertakings with respect thereto. In the event of
a
conflict between the terms and conditions of this Agreement and those of
the
Protocol and any attachment, the terms and conditions of this Agreement shall
control. This Agreement may be modified only by written agreement signed
by
the parties.
12
(b) Each
party to this Agreement agrees to comply with all applicable laws and
regulations relating to performance of their respective responsibilities
under
this Agreement including but not limited to laws and regulations administered
by
the FDA as well as the federal false claims statute (31 USC 3729) and
anti-kickback statute (42 U.S.C. 1320a-7(b)) and the related safe harbor
regulations. Accordingly, no part of any consideration paid hereunder is
a
prohibited payment for the recommending or arranging for the referral of
business or the ordering of items or services. Further the parties understand
and agree that neither this Agreement nor any consideration paid hereunder
is
contingent upon PAREXEL’s use or purchase of any of SPONSOR’s products. PAREXEL
agrees that it will not seek or collect, and will not assist a Study subject
in
seeking or collecting, reimbursement from any health insurance plan, PPO,
or
governmental medical plan or other government provided health coverage available
to the Study subject for any medical expenses paid by SPONSOR pursuant to
this
Agreement.
(c) This
Agreement shall be construed under, and the rights and the obligations of
the
parties shall be determined by and in accordance with, the laws of the State
of
Pennsylvania, without regard or giving effect to its conflict of laws
principles.
(d) In
the
event that any provision of this Agreement is deemed by a court of competent
jurisdiction to be in violation of any federal, state or local statutes,
laws,
rules or regulations, or is otherwise declared invalid or unenforceable by
such
court, the parties agree to negotiate in good faith a valid, legal and
enforceable substitute provision that most nearly reflects the original intent
of the parties and all other provisions hereof shall remain in full force
and
effect in such jurisdiction and shall be liberally construed in order to
carry
out the intentions of the parties hereto
as
nearly as may be possible.
(e) The
waiver by either party of any breach, term, provision or condition of this
Agreement shall not be deemed or construed as a further or continuing waiver
of
any such breach, term, provision or condition or a waiver of any other or
subsequent breach, term, provision or condition contained in this
Agreement.
IN
WITNESS WHEREOF
the
parties hereto have caused this Agreement to be executed in duplicate by
their
duly authorized representatives as of on
the
Effective Date.
| PAREXEL INTERNATIONAL LLC | PROTALEX, INC. |
| By: __________________________________________________________ | By: _______________________________________________________ |
| Name:__________________________________________________________ | Name: _______________________________________________________ |
| Title: __________________________________________________________ | Title: _______________________________________________________ |
| Date: __________________________________________________________ | Date: _______________________________________________________ |
Attachment
A: Protocol
Attachment
B: CRO Responsibilities & Checklist
Attachment
C: Study Budget and Payment Schedule
Attachment
D: HIPAA Authorization Language
Attachment
E: Nondisclosure Agreement
13
Exhibit
10.2
ATTACHMENT
A
PROTOCOL
[*******************]2
____________
2
[*****]
denotes this document has been redacted in connection with a request
for
confidential treatment.
14
Exhibit
10.2
ATTACHMENT
B
CRO
SERVICES AND CHECKLIST
[*******************]3
____________
3 [*****] denotes these documents have been redacted in connection with a request for confidential treatment.
15
Exhibit 10.2
ATTACHMENT
C
STUDY
BUDGET
[*******************]4
____________
4
[*****]
denotes this document has been redacted in connection with a request
for
confidential treatment.
16
Exhibit
10.2
ATTACHMENT
D
HIPAA
Authorization Agreement
Permission
to Review, Use and Release Information about You for Protocol
[*****************]
INTRODUCTION
You
are
being asked to read, review, and sign this authorization agreement as a result
of a federal law on the privacy of identifiable health information. The law
is
called the federal Health Insurance Portability and Accountability Act (HIPAA).
It requires that research subjects get written notification about the
collection, use and disclosure (sharing) of health information that can identify
them. In addition, it requires researchers (like the study doctor) to ask
research subjects for permission to use and disclose identifiable health
information for the purpose of this research study.
Signing
this authorization agreement authorizes the study doctor and study staff
to
collect health information that can identify you and to use and disclose
this
information to the parties specifically named in this authorization agreement.
EXPLANATION
OF AUTHORIZATION
Information
used and disclosed may include the entire research record, supporting
information from your medical records, results of laboratory, diagnostic,
or
other tests, and clinical and research observations made during your
participation in the research study.
As
part
of this study, the study doctor and staff will record health information
about
you that contains your name and other items that can be used to identify
you.
The health information identifying you will remain in the research records
indefinitely. In addition, the records may be kept indefinitely. Authorized
representatives of Protalex Inc, PAREXEL International, Chesapeake Research
Review, Inc. (a Research Ethics Review Board that reviews this study), the
Food
and Drug Administration (FDA) and other US governmental agencies, and possibly
governmental agencies of other countries, will be given access to these records
on request and may copy them. Copies of the study records that do not include
your name but may be traced back to you may be given to Protalex Inc., PAREXEL
International, Chesapeake Research Review, Inc., and laboratories working
with
the sponsor on this study. The sponsor may send a copy of the records to
the FDA
or other regulatory agencies such as governmental agencies in other countries.
By signing this form you are authorizing this use and disclosure.
Because
of the need to release information to these and other parties, absolute
confidentiality cannot be guaranteed. After its release, information that
can
identify you may no longer be protected by federal privacy rules. However,
information will be collected and shared following professional standards
of
confidentiality.
This
Authorization is valid once it is signed and dated by you. This Authorization
has no expiration date, unless governed by state law, which requires a specific
date of expiration. If state law applies, the authorization will expire December
31, 2054.
Information
and results from this study may be presented at meetings or published in
journals. Your name, and information that can easily be traced back to you,
will
not be included in presentations and publications.
17
SUSPENSION
OF YOUR RIGHT TO ACCESS PERSONAL INFORMATION
Your
research records may be used to make health care decisions about you. Under
federal privacy rules you have a right to inspect and obtain a copy of your
personal health information, including personal health information maintained
in
the study records. However, the right to inspect and obtain your personal
health
information in the study records will be suspended during the study to keep
from
spoiling the study results. Your right of access to the study records will
be
reinstated after the research is completed.
If
there
is a medical need during your participation, study records may be made available
to you, or to medical professionals who are caring for you, as needed for
your
care.
VOLUNTARY
PARTICIPATION
Your
authorization to use and disclose your identifiable health information for
the
purpose of this research study is voluntary. However, if you do not provide
your
written authorization for the use and disclosure of your identifiable health
information, you cannot participate in this research study.
In
addition, your participation in the overall research study is entirely
voluntary. You may refuse to participate or may quit at any time during the
study. All you have to do is tell the study doctor.
If
you
decide to stop participating in the research study, you may also end your
authorization allowing the researchers to collect, use and disclose any
additional health information that could identify you. To end your
authorization, you must notify the study doctor of your decision in writing.
If
you end your authorization, no new health information that can identify you
will
be gathered from you or your existing medical records. However, information
that
is in your study records at the time that your authorization is ended cannot
be
removed.
You
may
freely ask questions about this authorization agreement now or at any time.
If
anything causes you concern, or you have questions you may contact the study
doctor or study staff at the telephone number printed on the first page of
this
form.
STATEMENT
OF AUTHORIZATION
I
have
read this authorization agreement and its contents were explained. My questions
have been answered. I voluntarily authorize study staff to collect, use and
disclose my health information as specified in this authorization agreement.
I
will receive a signed and dated copy of this authorization agreement for
my
records. By signing this authorization agreement I am not giving up any of
my
legal rights.
____/____/____
Signature
of Research Subject Date
___________________________________ _______:______
Printed
Name of Research Subject Time
18
STATEMENT
OF PERSON EXPLAINING AUTHORIZATION
I
have
carefully explained to the subject the nature and purpose of the authorization
agreement. I have been available to answer any questions that the subject
has
regarding this authorization agreement.
____/____/____
Signature
of Person Explaining Authorization Date
___________________________________ _______:______
Printed
Name of Person Explaining Authorization Time
19
ATTACHMENT
E
NON-DISCLOSURE
AGREEMENT
This
Agreement made the _____ day of ___________________, 2005, between [COMPANY
NAME], [ADDRESS], [ADDRESS] (hereinafter referred to as "COMPANY") and PAREXEL
International Corporation, 000 Xxxx Xxxxxx, Xxxxxxx, XX 00000 (hereinafter
referred to as "PAREXEL").
Pursuant
to the Clinical Study Agreement between PAREXEL and Protalex, Inc. dated
October
___, 2005 (“Service Agreement”), COMPANY is examining PAREXEL’s facilities used
to perform the services under the Service Agreement. All information provided
by
PAREXEL to COMPANY and all information accessed by COMPANY in the course
of such
examination shall be subject to the following terms and conditions:
|
1.
|
COMPANY
hereto understands that the PAREXEL’s relationship with its clients,
officers and employees is one of confidence and that during COMPANY’s
examination of PAREXEL’s facilities used to perform the services under the
Service Agreement, COMPANY may receive or access, or may have already
received, have knowledge of, information which relates to the business,
operations, products, or plans of PAREXEL or of its clients and
which is
not known to the general public (hereinafter "Confidential Information").
COMPANY will not at any time, without the express prior written
consent of
PAREXEL, either during the term of this Agreement, the Service
Agreement
or at any time thereafter, (a) disclose any Confidential Information
to
any other person or entity, or (b) use any Confidential Information
for
the COMPANY’s own benefit or the benefit of any other person or
entity.
|
|
The
foregoing obligations shall not apply to
information:
|
|
a)
|
which
was rightfully known to COMPANY prior to receipt from
PAREXEL;
|
|
b)
|
which
is or lawfully becomes generally available to the
public;
|
|
c)
|
which
is lawfully acquired from third parties who have a right to disclose
such
information;
|
|
d)
|
which
PAREXEL releases in a written agreement from a confidential status;
or
|
|
e)
|
which
COMPANY is required by law to release, provided COMPANY provides
prompt
written notice of such requirement allowing PAREXEL to seek a protective
order.
|
|
2.
|
Upon
termination of this Agreement or the request of PAREXEL, COMPANY
shall
promptly return all materials disclosed to it in connection with
this
Agreement, including all copies, extracts and derivations
thereof.
|
|
3.
|
Neither
this Agreement nor the disclosure by PAREXEL of Confidential Information
to COMPANY shall be deemed by implication or otherwise to vest
in COMPANY
any rights, licenses or patents in or to the Confidential
Information.
|
|
4.
|
COMPANY’s
obligations hereunder shall survive any termination or expiration
of this
Agreement.
|
|
5.
|
This
Agreement will be governed by and construed in accordance with
the laws of
the Commonwealth of
Massachusetts.
|
| PAREXEL INTERNATIONAL LLC | COMPANY |
| By: __________________________________________________________ | By: _______________________________________________________ |
| Name:__________________________________________________________ | Name: _______________________________________________________ |
| Title: __________________________________________________________ | Title: _______________________________________________________ |
| Date: __________________________________________________________ | Date: _______________________________________________________ |
20
