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