THE GENERAL HOSPITAL CORPORATION
CLINICAL TRIAL AGREEMENT
(Investigator-Initiated)
This Clinical Trial Agreement
("Agreement") is made as of the 28 day of
September, 2009 ("Effective Date") between CytoDyn, Inc., a
publicly traded
corporation organized under the laws of Colorado with its principal
place of
business at 1511 Third Street, Santa Fe, New Mexico 87505
("Company"), and The
General Hospital Corporation d/b/a Massachusetts General Hospital,
a
not-for-profit corporation organized under the laws of
Massachusetts with its
principal place of business at 55 Fruit Street, Boston, MA
02114
("Institution"), each referred to herein individually as a "Party"
and
collectively as the "Parties."
The Parties to this Agreement
share a common mission of improving the
public health by engaging in research for the purpose of
discovering and making
available to the public new and improved medical drugs, devices,
procedures, and
information. In connection with this mission, Institution, through
Eric
Rosenberg, M.D. ("Principal Investigator"), having particular
expertise and
opportunity, proposes to provide, and Company desires to have,
further research
conducted on Company's drug described below.
Accordingly, for good and
valuable consideration, the sufficiency of
which is hereby acknowledged, the Parties agree as follows:
Section 1: Study Performance
----------------------------
1.1 Conduct
of Study in Accordance with Protocol; Priority of Terms.
Subject to the initial and continuing approvals described in
Section 1.2 below,
Institution, through Principal Investigator, agrees to conduct an
ex-vivo study
of Cytolin(R) brand of S6FI monoclonal antibodies ("Study Drug") in
accordance
with the study protocol entitled "An observational study to
determine the
in-vitro immunologic and virology activity of Cytolin," attached to
this
Agreement as Exhibit A and herein incorporated by reference
("Study"). The
Parties agree that the Study will be performed in strict accordance
with the
Study protocol entitled above, and any subsequent amendments
thereto (the" Study
Protocol"). In the event of any conflict between the Protocol and
the provisions
of the main body of this Agreement, the Protocol shall govern with
respect to
scientific and subject consent issues, and the provisions of the
main body of
this Agreement shall govern with respect to all other issues. In
the event of
any conflict between the Study informed consent form and the
provisions of this
Agreement with respect to any commitment by Company to cover costs
associated
with subject injuries, the broader commitment (the commitment that
is more
protective of human subjects) shall control.
1.2 Study
Review and Approvals. The Study shall be conducted by
personnel, agents, vendors, or consultants of Institution under the
direction of
the Principal Investigator at Institution or additional facilities
with the
prior approval and ongoing review of all appropriate and necessary
review
authorities. Institution, through Principal Investigator, shall
provide Company
with written evidence of review and approval of this Study by
Institution's
Institutional Review Board ("IRB") prior to the initiation of the
Study and
shall inform Company of the IRB's continuing reviews of the Study
promptly after
each such review takes place, which shall be at least once per
year. Initiation
of the Study Protocol shall not begin until IRB approval
<PAGE>
is obtained. In accordance with the obligations under the Food and
Drug
Administration Amendment Act of 2007 ("the Act"), Company agrees to
fully
register this Study with the public registry clinicaltrials.gov
before
enrollment of the first patient at Institution and comply with all
of the Act's
requirements thereafter.
1.3
Completion of the Study. For purposes of this Agreement,
Company
and Institution shall consider the Study to be complete and
concluded at all
sites at such time as the occurrence of final data lock or earlier
termination
by a Data Safety Monitoring Board or as otherwise specified in the
Protocol
("Study Conclusion").
1.4
Provision and Use of Study Drug. Company shall be responsible
for
providing and delivering to Institution, at no charge, such
quantities of the
Study Drug in bags for in vitro use as needed for conducting the
Study in
accordance with the Study Protocol, along with the results of
safety testing for
the lot of Study Drug provided, and conducted according to
currently published
standards. Institution acknowledges receipt of the latter. Company
understands
that Institution and Principal Investigator are relying on timely
delivery of
the Study Drug in order for Institution to perform its obligations
under this
Agreement. Institution understands that the ability of the Company
to provide
the drug depends upon Institution providing shipping and delivery
requirements.
Institution, through Principal Investigator, will safeguard such
Study Drug with
the degree of care used for its own property and shall return or
otherwise
dispose of any remaining Study Drug at the Study Conclusion in
accordance with
the Study Protocol. Institution and Principal Investigator shall
not use any
Study Drug for any purpose other than the Study, unless otherwise
agreed.
Company represents and warrants that it is in compliance with
federal, state,
and local laws and regulations relating to the manufacture and
formulation of
any investigational drug and to other materials supplied, and with
other
applicable legal requirements.,
1.5
Compliance with Applicable Laws and Regulations. Parties agree
to
conduct the Study in accordance with all applicable local, state,
and federal
laws and regulations.
Section 2: Material Subject Information
---------------------------------------
2.1 Company
agrees to notify Principal Investigator in writing
promptly and at least within fifteen (15) days of information (such
as Study
results) that could affect the safety or medical care of current or
former
subjects, affect current subjects' willingness to continue
participation,
influence the conduct of the Study, or alter the IRB's approval.
Company and
Institution shall comply with their respective reporting
requirements to
regulatory authorities, including, for example, the Food and
Drug
Administration, the Office for Human Research Protections, and
other authorities
as required. Institution, through the Principal Investigator and/or
IRB as
appropriate, shall be responsible for informing subjects of the
above important
information they learn from Company in accordance with the
IRB-approved informed
consent form and Company shall not contact them. No other provision
of this
Agreement shall be construed to override the provisions of this
Section 2.1.
Clinical Trial Agreement
Page 2 of 19
<PAGE>
Section 3: Study Data/Results
-----------------------------
3.1
Provision of Data/Results; Provision of Abstracts/Manuscripts].
(a)
Institution shall own the data resulting from the Study.
Institution shall provide copies of the data produced in the
performance of the
Study to Company. Company may use the Study data in accordance with
Section 3.2.
(b) All data
from laboratory analyses for Institution's Study subjects
which are performed off-site, and all other subject-specific data
generated by
Company or its agents for Institution's Study subjects, if
Institution does not
receive such data directly from the off-site laboratory or other
source, shall
be provided by Company to Institution upon the Study Conclusion. If
the Study is
blinded, Company shall also provide the randomization codes for
Institution's
Study subjects upon the Study Conclusion.
3.2 Use of
Data/Results. Institution shall comply in all material
respects with all applicable federal, state and local laws and
regulations
regarding the privacy of individually identifiable health
information (including
its collection, use, storage, and disclosure), including, but not
limited to,
the Health Insurance Portability and Accountability Act of 1996
("HIP AA") and
the regulations promulgated thereunder, as may be amended from time
to time.
Company agrees to collect, use, store, and disclose individually
identifiable
health information collected or produced in the Study only for the
purpose of
the Study and related studies (that is, other studies of the Study
Drug, alone
or in combination with other drugs, or other studies that relate to
the medical
condition or disease area under investigation in the Study), and
for the purpose
of complying with applicable law, provided that all such uses are
disclosed in
the IRB-approved informed consent form. If Institution's
IRB-approved informed
consent form so states, Company may use information that is not
identifiable
under any applicable U.S. laws for any research and development
purpose. Company
will use all reasonable efforts to protect the privacy and security
of
individually identifiable health information and will require its
business
partners to do so also. Company will not contact any Study
subjects, unless
permitted by the informed consent form. No other provision in this
Agreement
shall be construed to override the provisions of this Section
3.2.
3.3 Use of
Specimens/Tissue. Company will collect, use, store, and
disclose any specimens/tissue it receives only in accordance with
the Protocol
and informed consent form, and in any event will not collect, use,
store, or
disclose any individually identifiable health information attached
to or
contained within the specimens/tissue in any manner that would
violate Section
3.2 of this Agreement.
Section 4: Publication
----------------------
4.1
Principal Investigator shall be free to publish the
data/results
from the Study in accordance with this Section 4.1.] Principal
Investigator
shall be free to publish the data/results of the Study subject only
to the
provisions of Section 8 regarding Company's Proprietary
Clinical Trial Agreement
Page 3 of 19
<PAGE>
Information. The Institution shall require Principal Investigator
to furnish
Company with a copy of any proposed publication prior to submission
for
publication, at least thirty (30) days prior to submission for
manuscripts and
at least seven (7) days prior to submission for abstracts. Company
shall be
entitled to review such proposed publications solely for the
purpose of
identifying Company Proprietary Information, which shall be removed
from the
publication upon Company's request; and to identify any patentable
Inventions,
which shall be addressed as described below; and to provide any
other comments
Company desires to provide, provided that Principal Investigator
shall have no
obligation to address any such additional comments. At the
expiration of such
thirty (30) day or seven (7) day period, Principal Investigator may
proceed with
submission for publication provided that any identified Company
Proprietary
Information has been removed; and provided further that upon notice
by Company
that Company reasonably believes a patent application claiming an
Invention (as
defined in Section 5) should be filed prior to such publication,
in
Institution's discretion such submission shall be delayed for up to
an
additional thirty (30) days or until any patent application or
applications have
been filed, whichever shall first occur. In no event shall the
submission of
such publication of results be delayed for more than sixty (60)
days for
manuscripts and for more than thirty-seven (37) days for abstracts
from the date
such proposed publication was provided to Company; at the end of
said sixty (60)
or thirty-seven (37) days, the Principal Investigator shall be free
to publish
such results as proposed.
Section 5: Inventions/Intellectual Property
-------------------------------------------
5.1 The
Principal Investigator and any other investigators
(hereinafter "Institution Investigator") who shall conceive and
reduce to
practice an invention, solely or jointly, in the performance of the
Study as
outlined in the Protocol (hereinafter referred to as "Invention")
shall promptly
report such Invention to Institution and shall assign all of his or
her rights,
title and interest in the Invention to Institution. Institution
shall promptly
advise Company in writing of each Invention disclosed to
Institution and shall
discuss with Company whether a patent application or applications
(hereinafter
referred to, together with any patents issued thereon, as "Patent
Rights")
pertaining to such Invention should be filed and in which
countries. In the
event of joint inventorship between Company personnel and
Institution
Investigator, Company personnel shall assign all of their rights,
title and
interest in the Invention ("Joint Invention") to Company, and
Institution
Investigator shall assign all of their rights, title and interest
in the Joint
Invention to Institution, and the Joint Invention will be deemed to
be jointly
owned. If both parties mutually agree that Patent Rights should be
filed,
applications assigned solely to Institution shall be filed by
Institution, and
applications owned jointly by Institution and Company shall be
filed as mutually
agreed upon by the parties. In the event Company is not interested
in having
Patent Rights filed with respect to a particular Invention, Company
shall advise
Institution of such fact within ninety (90) days from the date on
which the
Invention was disclosed to Company by Institution and Institution
shall be free
to file and prosecute Patent Rights on such Invention (including
Institution's
rights in any Joint Invention) at its own expense and to license
such Patent
Rights to any other party.
5.2 All
patent costs pertaining to any Patent Rights filed by mutual
agreement of Company and Institution, including preparation,
filing,
prosecution, issuance and maintenance costs, shall be borne by
Company.
Clinical Trial Agreement
Page 4 of 19
<PAGE>
5.3 As to
any Patent Rights assigned in whole or in part to
Institution and filed by mutual agreement of the parties, Company
shall have for
the three (3) months next following the filing of such Patent
Rights in the
United States Patent and Trademark Office the option to negotiate a
world-wide,
royalty bearing, exclusive license under the rights assigned by an
Institution
Investigator to Institution therein with the right to sublicense.
It is
understood that Institution will reserve the right to use any
Invention for
research, clinical and educational purposes, and that if federal
funding has
supported the Invention, Company's license will be subject to the
rights,
conditions and limitations imposed by United States law with
respect to Subject
Inventions (as defined in 35 U.S.C. Section 202 et seq., as
amended), including
without limitation the royalty-free non-exclusive license granted
to the United
States Government with respect to such Subject Inventions (see 35
USC Section
202 et seq., as amended, and regulations pertaining thereto).
5.4 This
option is to be exercised by written notice to Institution
during said three month period and the negotiation, during the
three (3) months
next following such notice, of a license agreement containing
license terms
standard for agreements between universities and industry including
without
limitation clauses providing for payment of reasonable royalties
and other
compensation to Institution, objective, time-limited due diligence
provisions
for the development, commercialization and marketing of a product
embodying the
Invention and product liability indemnification and insurance
requirements which
are acceptable to Institution's liability insurance carrier. In the
absence of
such notice by Company and agreement on license terms, Institution
may grant a
license to such Patent Rights to any other party.
5.5 All
information given to Company by Institution in accordance with
Sections 5.1, 5.2, 5.3, and 5.4 will be held in confidence by
Company so long as
such information remains unpublished or publicly undisclosed by
Institution.
Section 6: Use of Name
----------------------
6.1 Except
for disclosure by Institution of Company's support for the
Study in publications, for purposes of recruitment/consent of Study
subjects,
and by either Party for purposes of meeting any applicable
requirements for the
registration of the Study or of Study results with a publicly
accessible or
other clinical trial registry, and for satisfying the Company's
obligation to
report its financial commitments to Institution in cash or in kind
and related
material events in an 8K filed with the Securities and Exchange
Commission
within four days of the date this Agreement is executed, neither
Party to this
Agreement shall use the name of the other Party or of any staff
member,
employee, student, or agent of the other Party or any adaptation,
acronym or
name by which the other Party is commonly known, in any
advertising, promotional
or sales literature or in any publicity without the prior written
approval of
the Party or individual whose name is to be used., which approval
shall not be
unreasonably withheld.
Section 7: Study Records
------------------------
7.1
Institution shall make Study records (including minimum
necessary
portions of
Clinical Trial Agreement
Page 5 of l9
<PAGE>
medical records) available to Company representatives upon
reasonable request
for comparison with case report forms. Any audits conducted by
Company will be
undertaken in conjunction with Institution, at reasonable times and
with
reasonable prior notice, and pursuant to guidelines established by
Institution
in order to assure patient confidentiality. Each of Company and
Institution
shall retain records of the Study, including in Institution's case
either the
original or a copy of all volunteer consent forms, in conformance
with federal
regulations applicable to it. . Institution shall also make such
records
available upon request for review by representatives of the U.S.
Food and Drug
Administration. Company acknowledges that Company may not direct
the manner in
which Institution fulfills its obligations to permit inspection by
governmental
entities. It shall not be a breach of this Agreement for
Institution to comply
with the demands and requests of any governmental entity in
accordance with
Institution's judgment or to fail to inform and consult with the
Company before
complying with such demand or request.
Section 8: Proprietary Information
----------------------------------
It is anticipated that in the performance of this Agreement,
Principal
Investigator, Company and Institution may need to disclose to each
other
information, which is considered confidential. The rights and
obligations of the
parties with respect to such information are as follows:
8.1
"Disclosing Party" shall mean a party that discloses
Proprietary
Information (as defined in paragraph 8.2 below) under this
Agreement. "Receiving
Party" shall mean a party that receives Proprietary Information
under this
Agreement.
8.2
"Proprietary Information" refers to information of any kind,
other
than data from or results of the Study, which is obtained by
Receiving Party
from Disclosing Party, which, by appropriate marking, is identified
as
confidential and proprietary at the time of disclosure. In the
event that
Proprietary Information must be provided visually or orally,
obligations of
confidence shall attach only to that information which is confirmed
by
Disclosing Party in writing within thirty (30) working days as
being
confidential.
8.3 Period
of Restriction. For a period of five (5) years after the
Effective Date of this Agreement and indefinitely with respect to
any
individually identifiable health information, institutional billing
information
and institutional financial information disclosed by Institution to
Company,
Receiving Party agrees to use reasonable efforts, no less than the
protection
given their own confidential information, to use Proprietary
Information
received from Disclosing Party and accepted by Receiving Party only
in
accordance with this Section 8.
8.4 Use of
Proprietary Information. Receiving Party agrees to use
Disclosing Party's Proprietary Information solely for the purposes
of conducting
the Study, obtaining any required review of the Study or its
conduct, or
ensuring proper medical treatment of any patient or subject.
Receiving Party
agrees to make Proprietary Information available only to those
personnel and
agents at Receiving Party and those consultants and vendors who
require access
to it in the performance of this Study and to inform them of the
confidential
nature of such information.
8.5 Release
of Proprietary Information. Except as provided herein,
Receiving Party
Clinical Trial Agreement
Page 6 of 19
<PAGE>
agrees to keep all Proprietary Information confidential unless
Disclosing Party
gives specific written consent for release.
8.6 Notice
of Unauthorized Disclosure. Receiving Party shall notify,
and shall require any recipient to notify, Disclosing Party of any
disclosure
not authorized hereunder of which it becomes aware. In such
situations,
Receiving Party shall take and shall require each such recipient to
take
reasonable steps to prevent any further disclosure or unauthorized
use.
8.7
Exclusions. No Receiving Party shall be required to treat any
information as Proprietary Information under this Agreement in the
event:
(i) it is
publicly available prior to the date of the Agreement or
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