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THE GENERAL HOSPITAL CORPORATION CLINICAL TRIAL AGREEMENT

Clinical Trial Agreement

THE GENERAL HOSPITAL CORPORATION CLINICAL TRIAL AGREEMENT | Document Parties: CYTODYN INC You are currently viewing:
This Clinical Trial Agreement involves

CYTODYN INC

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Title: THE GENERAL HOSPITAL CORPORATION CLINICAL TRIAL AGREEMENT
Governing Law: Massachusetts     Date: 9/29/2009

THE GENERAL HOSPITAL CORPORATION CLINICAL TRIAL AGREEMENT, Parties: cytodyn inc
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                        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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