Exhibit
        10.2


      


      CLINICAL
        STUDY AGREEMENT

      


      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 145 Union Square Drive, New Hope, PA 18938 (“SPONSOR”)
        and
PAREXEL
        International LLC,
        a
        limited liability company organized and existing under the laws of the State
        of
        Massachusetts, with an address at 200 West Street, Waltham, MA 02451
        (“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, 3001 South Hanover Street, Baltimore, MD 21225
        (“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 D-3, D-6, D-7(b), E-4, F-2, F-4, F-5(d), F-9, 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

      200
        West
        Street

      Waltham,
        MA 02451

      ATTN:
        General Counsel

      


      


      To
        SPONSOR:

      


      [*******************]

      [*******************]

      Protalex,
        Inc.

      145
        Union
        Square Drive

      New
        Hope,
        PA 18938 

      


      


      To
        PAREXEL-BALTIMORE CPRU:

      


      [*******************]

      [*******************]

      Harbor
        Hospital Center 

      PAREXEL-BALTIMORE
        CPRU, 7th
        Floor

        
3001
        South Hanover Street

      Baltimore,
        MD 21225 

      


      


      To
        PRINCIPAL INVESTIGATOR

      


      [*******************]

      [*******************]

      Harbor
        Hospital Center 

      PAREXEL-BALTIMORE
        CPRU, 7th
        Floor

        3001
        South Hanover Street

      Baltimore,
        MD 21225 

      


      


      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, 200 West Street, Waltham, MA 02451 (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: 
                _______________________________________________________

    

      
        
           

        

        
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