Exhibit
10.2


 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


(1)       hVIVO
Services Ltd


 


–
and –


 


 (2)     AIM
ImmunoTech Inc


 







 



 





Clinical
Trial Agreement


 












 



 




    	 



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


THIS
CLINICAL TRIAL AGREEMENT (the “Agreement”) is made by and between hVIVO Services Limited, a company registered
in England (company registration number 02326557) whose registered office is at QMB Innovation Centre, 42 New Road, London E1 2AX, UK
(“hVIVO”); and AIM ImmunoTech Inc., a company registered in Delaware USA, whose principle place of business
is at 2117 SW Highway 484 Ocala, FL 34473, USA (the “Sponsor”).


 


RECITALS:-


 


		(A)	The
                                            Sponsor is a company involved in the research and development of medicines for use in humans.



		(B)	hVIVO
                                            is a specialty biopharma company with discovery and clinical testing capabilities, pioneering
                                            a human disease models technology platform in respiratory and infectious diseases.



		(C)	The
                                            Sponsor wishes to access hVIVO’s human viral challenge model to conduct a clinical
                                            study in connection with Sponsor’s product Ampligen®, and hVIVO is willing to provide
                                            such access and associated services, in accordance with and subject to the provisions set
                                            forth in this Agreement.



		(D)	This
                                            Agreement shall supersede the Reservation and Start-Up Agreement, entered into by the Parties
                                            on 08 July 2021.



THE
PARTIES HERBY AGREE AS FOLLOWS:


 


1.
DEFINITIONS


 


In
this Agreement, the following terms shall have the following meanings:


 


	1.2             
    “Affiliate” 	in
    relation to a Party, means any entity that directly or indirectly controls, is controlled by, or is under common control with that
    Party, for so long as such control exists.  In the case of companies and corporations “control” and “controlled”
    means beneficial ownership of more than fifty percent (50%) of the voting stock, shares or equity in an entity.  In the
    case of any other legal entity, “control” and “controlled” shall exist through the ability to directly or
    indirectly control the management and/or business of the legal entity.
	 	 
	1.3             
    “Agreement”	means
    this agreement including any schedules attached to it.


 




    	2



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	1.4             
    “Applicable Law (s)”	means
                                            the laws, rules and regulations that are in force at the Effective Date or may come into
                                            force at any time after the Effective Date and which are applicable to the conduct of the
                                            Study, which may include:

                                                                     

    

    




 


	 	(a)	the
    European Union Directive 2001/20/EEC, Directive 2005/28/EEC and implementing and/or amending legislation and guidelines;
	 	 	 
	 	(b)	relevant
    laws and statutes of the UK including the Medicines Act 1968, the Medicines for Human Use (Clinical Trial) Regulations 2004, and
    all relevant guidance;
	 	 	 
	 	(c)	the
    International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all
    guidelines published or issued hereunder; and
	 	 	 
	 	(d)	the
    Data Protection Legislation



 


	 	For
    the avoidance of doubt, Sponsor acknowledges that hVIVO does not operate under the United States Food and Drug Administration (“FDA”)
    regulations.



 





	1.5             
    “Bed Day”	means
    each twenty-four (24) hour period for which a bed is reserved in hVIVO’s clinical facility for the conduct of the Clinical
    Phase of the Study. For example, a ten (10) day quarantine with ten (10) subjects would equal one hundred (100) Bed Days.
	 	 
	1.6             
    “Change Order” 	means
    a document, effective when signed by both Parties, detailing any agreed changes to the scope of the Study along with any associated
    changes to the budget, timelines, deliverables, responsibilities and payment schedule.
	 	 
	1.7             
    “Change Order Request”	shall
    have the meaning given to it in Clause 8.1.
	 	 
	1.8             
    “Clinical Phase”	means
    a fixed time period within the Study from the point of first subject enrolled to last subject discharged, not including any follow
    up period.



 



    	3



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	1.9             
    “Confidential Information”	means
    any and all information, data and material of any nature, including trade secrets, Technology, forecasts, analyses, evaluations,
    research, technical information, business information, financial information, business plans, and/or strategies, owned or controlled
    by either Party or its Affiliates, which either Party may receive or obtain in connection with any Study and/or this Agreement whether
    in writing, or in any other form. 
	 	 
	1.10         
    “Data Protection Legislation”	means
    all privacy laws applicable to any Personal Data processed under or in connection with this Agreement, including, without limitation,
    the Data Protection Act 2018 as amended, updated and re-enacted from time to time, the EC Directive on the protection of individuals
    with regard to the processing of personal data and on the free movement of such data (95/46/EC), the General Data Protection Regulation
    (EU) 2016/679 (GDPR) and all local laws or regulations giving effect to the Directive and Regulation (as any such legislation, directive
    or regulation may be amended, extended or re-enacted).
	 	 
	1.11         
    “Deliverables”	means
    the outputs to be delivered by hVIVO, as specified in Schedule 1.
	 	 
	1.12         
    “Effective Date”	means
    the date of the signature of the last Party to sign this Agreement.
	 	 
	1.13         
    “hVIVO Property”	means
    (i) property, materials and Technology owned by or licensed to hVIVO or its Affiliates prior to the Effective Date (including any
    information relating to the hVIVO’s human challenge model, methodologies or processes) and all improvements, modifications,
    or enhancements thereto; (ii) virus and viral inoculum; and (iii) any property, materials or Technology resulting from any violation
    by Sponsor, its officers, employees, agents and contractors of the limitation on uses of samples set forth in Clause 5.8.
    hVIVO Property does not include any Sponsor Property.



 



    	4



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	1.14         
                                            “Intellectual Property

                                                                                Rights”
                                            or “IPRs”
	means
    patents, any extensions of the exclusivity granted in connection with patents, trade secrets, trademarks, registered designs, trade
    names, service marks, applications for any of the foregoing (including provisionals, continuations, continuations-in-part and divisional
    applications), the right to apply for any of the foregoing, domain names, copyrights, moral rights, rights in and to databases (including
    rights to prevent the extraction or reutilization of information from a database), design rights, topography rights, and all rights
    or forms of protection of a similar nature or having equivalent or the similar effect to any of them which may subsist anywhere in
    the world, whether or not any of them are registered.
	 	 
	1.15         
    “Material Scope Reduction”	means
    a reduction in the required number of Study Subjects for the Clinical Phase, where such reduction is greater than or equal to ten
    (10) percent of the original number of Study Subjects.
	 	 
	1.16         
    “Non-Drug Data”	means
    all data generated from the Study Subjects, excluding Study Drug Data. Non-Drug Data expressly includes any data related to the Virus,
    and data from Study Subjects exposed to Virus prior to dosing of such Study Subjects with Study Drug.
	 	 
	1.17         
    “Non-Drug Samples”	means
    samples generated during the Study, with the exception of samples from Study Subjects who have been dosed with Study Drug.
	 	 
	1.18         
    “Party”	means
    the Sponsor or hVIVO and “Parties” shall mean both of them.
	 	 
	1.19         
    “Personnel”	any
    of the employees, sub-contractors, agents and/or other personnel of hVIVO or its Affiliates (including investigators, sub-investigators,
    clinical research coordinators and other personnel). This definition will include the Principal Investigator(s) where the context
    requires.


 




    	5



     


    





 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	1.20         
    “Postponement”	means
    any suspension, rescheduling or material delay (greater than one week) of part or all of the Clinical Phase of the Study, except
    where such suspension, rescheduling or material delay is due to (i) any circumstance within the reasonable control of hVIVO; or (ii)
    a Sponsor Force Majeure event.
	 	 
	1.21         
    “Principal Investigator”	means
    the individual named by hVIVO as the principal investigator and leader of that team of individuals, comprising Study Personnel.
	 	 
	1.22         
    “Protocol”	the
    protocol detailed in Schedule 1, as may be amended from time to time in accordance with this Agreement.
	 	 
	1.23         
    “Reasonable Endeavours”	means
    an obligation to do whatever should reasonably be done in the circumstances by a responsible and reasonably funded service provider
    (in the case of hVIVO) or a responsible customer receiving the Services (in the case of Sponsor) to fulfill the obligation concerned
    and the commitment to the other party.
	 	 
	1.24         
    “Regulatory Authority”	means
    any government authority, body or agency designated under the laws of the relevant country which is responsible for the regulation
    of clinical trials and/or activities undertaken in connection with clinical trials in the relevant country. This definition shall
    include the European Medicines Agency or the US Food and Drug Administration or any similar authority of any jurisdiction applicable
    to the Study where the context requires;
	 	 
	1.25         
    “Research Ethics Committee”	an
    independent body in the United Kingdom (or other applicable jurisdiction) whose responsibility it is to protect the rights, safety,
    and well-being of human subjects involved in a clinical trial.
	 	 
	1.26         
    “Services”	the
    services to be provided by hVIVO in respect of the Study, as described in Schedule 1.
	 	 
	1.27         
    “Site File”	means
    for the Study, the file maintained by the Principal Investigator containing the documentation specified in section 8 of ICH GCP (Good
    Clinical Practice) (edition CPMP/ICH/135/95) or otherwise required by Applicable Law.


 




    	6



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	1.28         
    “Sponsor Materials”	means
                                            intellectual property, property, materials and Technology owned by or licensed to Sponsor
                                            or its Affiliates prior to the Effective Date and all improvements, modifications, or enhancements
                                            thereto. “Sponsor Materials” also include materials which are to be provided
                                            to hVIVO in order to conduct the Study, including Study Drug, placebo and comparator (where
                                            applicable).

    

	 	 
	1.29         
    “Sponsor Property”	means
    Sponsor Materials and Technology and all improvements, modifications, or enhancements thereto, together with Study Data, Study Samples
    including Study Drug Samples and Non-Drug Samples, always excluding hVIVO Property.
	 	 
	1.30         
    “Standard Operating Procedures” or “SOPs”	means,
    in respect of the Study, the standard operating procedures, agreed to by the Parties prior to the commencement of the Study, under
    which the Study shall be conducted.
	 	 
	1.31         
     “Reservation and Start-Up Agreement”	means
    the agreement entered into by the Parties relating to Sponsor’s reservation of hVIVO’s facility and the initial activities
    conducted by hVIVO to the Sponsor in connection with the Study.
	 	 
	1.32         
    “Study”	means
    the specific investigation as described in the Protocol. 
	 	 
	1.33         
    “Study Completion”	means,
    for the purposes of this Agreement, completion of clinical study report.
	 	 
	1.34         
    “Study Data”	means
    all reportable data generated from the Study Subjects, i.e., Study Drug Data and Non-Drug Data. 
	 	 
	1.35         
    “Study Drug” 	means
    Ampligen®, also known as rintatolimod, the medicinal product to be used in the Study. Ampligen and rintatolimod shall have the
    same meaning in this Agreement.


 




    	7



     


    


 





EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	1.36         
    “Study Drug Data”	means
    all data generated from the Study Subjects following dosing of such Study Subjects with Study Drug and is documented in the case
    report forms or is otherwise reportable to Sponsor under the terms of the Protocol and this Agreement.
	 	 
	1.37         
    “Study Drug Samples”	means
    samples generated during the Study from Study Subjects who have been dosed with Study Drug.
	 	 
	1.38         
    “Study Samples”	means
    all samples generated from the Study Subjects, i.e., Study Drug Samples and Non-Drug Samples. Study Samples include, at least, all
    nasal washes and serum samples from Study Subjects.
	 	 
	1.39         
    “Study Records”	means
    files and documents (electronic or otherwise) which (i) individually and collectively permit evaluation of the conduct of a trial
    and the quality of the data produced; and (ii) detail the Services performed.
	 	 
	1.40         
    “Study Site”	means
    the premises in which the Study will be conducted. For the avoidance of doubt, this includes the site where the Study Drug is administered
    to a Study Subject and, where the context requires, the quarantine facility where the Study Subjects are infected with the virus
    inoculum. 
	 	 
	1.41         
    “Study Subject”	means
    a person recruited to participate in the Study.
	 	 
	1.42         
    “Table of Responsibilities”	means
    the table allocating responsibilities of both Parties in relation to the Study, as set out in Schedule 1.
	 	 
	1.43         
    “Technology”	means
    all technical and other information which is not in the public domain (other than as a result of a breach of confidence), including
    information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, procedures,
    designs for experiments and tests and results of experimentation and testing processes, specifications and techniques, laboratory
    records, clinical data, minutes of meetings, status reports, clinical trial reports, manufacturing data and information contained
    in submissions to regulatory authorities, whether or not protected by Intellectual Property Rights.


 


	1.44         
    “Virus”	means
    hVIVO’s virus, A/Perth/16/2009 (H3N2) and human rhinovirus (HRV-16).



 






    	8



     


    

 





EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT HAS BEEN
OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II) WOULD
BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 

	1.45	Any
                                            reference to a statute or statutory provision is a reference to it as it is in force for
                                            the time being, taking account of any amendment, extension, or re-enactment and includes
                                            any subordinate legislation for the time being in force made under it.



	1.46	The
                                            headings to clauses are inserted for convenience only and shall not affect the interpretation
                                            or construction of this Agreement.



	1.47	Unless
                                            the context otherwise requires, words denoting the singular shall include the plural and
                                            vice versa and the masculine includes the feminine and vice versa.



	1.48	In
                                            this Agreement, “including” means including without limitation; “includes”
                                            and “include” shall be construed accordingly.



	2.	COMPLIANCE



	2.1	The
                                            Parties shall adhere to the prevailing industry professional and ethical standards in the
                                            conduct of the Study and shall comply with all Applicable Laws.



	2.2	Sponsor
                                            and hVIVO shall comply with the Association of the British Pharmaceutical Industry guidelines
                                            that relate to compensation of Study Subjects. hVIVO shall be solely responsible for the
                                            compensation of Study Subject. A copy of the British Pharmaceutical Industry guidelines shall
                                            be provided by hVIVO to Sponsor.



	3.	APPROVALS



	3.1	hVIVO,
                                            on behalf of the sponsor, shall apply for all approvals from each Regulatory Authority in
                                            respect of the Study and shall use its best endeavours to procure the grant of all such approvals.
                                            Unless otherwise agreed in writing by the Parties, all approvals from the Regulatory Authorities
                                            shall be applied for and issued in the name of the Sponsor. hVIVO shall keep Sponsor fully
                                            informed of the progress of any submissions made to the Regulatory Authority and provide
                                            Sponsor, as soon as reasonably practicable, copies of any correspondence between the Regulatory
                                            Authority and hVIVO in respect of such submissions. 





    	9



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	3.2	If
                                            a Regulatory Authority issues any notification to hVIVO in respect of submissions made to
                                            the Regulatory Authority in respect of the Study, hVIVO shall notify the Sponsor in sufficient
                                            time to allow the Sponsor to consider and respond to such notification. The Sponsor shall
                                            have the sole right to determine any response to any such notification from the Regulatory
                                            Authority and hVIVO shall not respond to any such notification without the prior written
                                            approval of the Sponsor. Nothing in this Clause 3.2 shall prevent hVIVO from responding
                                            to any notification from the Regulatory Authority to the extent that (i) such notification
                                            relates to hVIVO business other than the conduct of the Study; or (ii) hVIVO is obliged to
                                            do so in order to comply with any and all Applicable Laws.



	3.3	Unless
                                            otherwise agreed in writing by the Parties, hVIVO shall ensure that (i) the Principal Investigator
                                            submits an application in respect of the Study to the Research Ethics Committee and (ii)
                                            if a favourable opinion is issued by the Research Ethics Committee, the Principal Investigator
                                            complies with the terms of the said opinion. In addition, hVIVO shall ensure that the Principal
                                            Investigator keeps the Parties fully informed of the progress of all Research Ethics Committee
                                            submissions and provides the Sponsor with all correspondence relating to such submissions,
                                            should the Sponsor make such a request 



	3.4	The
                                            Sponsor shall not supply the Study Drug to hVIVO until the Sponsor has obtained all required
                                            documentation from the Regulatory Authority and also received a favourable opinion from the
                                            Research Ethics Committee. hVIVO shall ensure that neither administration of the Study Drug
                                            to any Study Subject nor any other clinical intervention mandated by the Protocol in any
                                            Study Subject takes place until it is satisfied that the approval from the Regulatory Authority
                                            and the favourable opinion from the Research Ethics Committee have been obtained. 



	4.	hVIVO’S
                                            OBLIGATIONS



	4.1	hVIVO
                                            shall perform the Services in accordance with:



		4.1.1	this
                                            Agreement;



		4.1.2	the
                                            Protocol;



		4.1.3	the
                                            conditions set by the Regulatory Authority and the Research Ethics Committee in respect of
                                            the Study;



		4.1.4	the
                                            SOPs which will be shared with the Sponsor; and 



		4.1.5	Applicable
                                            Law.





    	10



     


    

 






EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	4.2	hVIVO
                                            shall ensure that the Principal Investigator (i) performs all duties in accordance with this
                                            Agreement, the Protocol and all Applicable Laws; (ii) is aware of, acknowledges and agrees
                                            to the obligations applicable to the Principal Investigator as set out in this Agreement;
                                            (iii) is under an obligation to assign all Sponsor Property to Sponsor.



	4.3	hVIVO
                                            shall notify the Sponsor if the Principal Investigator (i) is debarred; (ii) ceases to be
                                            employed or engaged by hVIVO for any reason; or (iii) is otherwise unavailable to continue
                                            as Principal Investigator, and shall provide a replacement investigator of appropriate experience,
                                            seniority and qualification. 



Infectivity
Rate and Recruitment of Study Subjects


 


	4.4	Prior
                                            to the commencement of the Study, hVIVO shall provide Sponsor with hVIVO’s estimate
                                            of the likely infectivity rate of the virus inoculum for the Study (the “Predicted
                                            Infectivity Rate”). The Sponsor acknowledges that hVIVO may in certain circumstances
                                            be subject to confidentiality obligations in relation to viral infectivity rates that hVIVO
                                            predicted for other clinical studies. While hVIVO shall use reasonable endeavours to estimate
                                            the infectivity rate of the virus inoculum, the Sponsor acknowledges and agrees that (i)
                                            hVIVO cannot guarantee that the Predicted Infectivity Rate shall be achieved during the Study
                                            as a result of inherent, natural variations of infectivity; and (ii) Sponsor’s acceptance
                                            of, reliance on, or use of the Predicted Infectivity Rate shall be at Sponsor’s sole
                                            risk. Sponsor hereby agrees to release, waive and forever discharge any demands, claims,
                                            suits or actions against hVIVO arising out of or in connection with Sponsor’s acceptance,
                                            reliance on, or use of the Predicted Infectivity Rate.



	4.5	hVIVO
                                            shall use commercially reasonable efforts to recruit and screen the number of individuals
                                            that in the sole discretion of hVIVO, taking into account the study-specific inclusion and
                                            exclusion requirements set forth in the Protocol, will be sufficient to provide the requisite
                                            number of Study Subjects. 



	4.6	hVIVO
                                            shall ensure that the informed consent form is approved by Sponsor before its use.



	4.7	hVIVO
                                            shall, or ensure that the Principal Investigator shall, obtain the required informed consent
                                            of each of the Study Subjects participating in the Study, by way of obtaining completed informed
                                            consent forms from the aforementioned Study Subjects, in a form agreed by the Parties. 



	4.8	The
                                            Sponsor agrees that where, the Sponsor recommends to hVIVO that hVIVO includes one or more
                                            specific individuals in the group of volunteers to be screened for eligibility to serve as
                                            Study Subjects, and such individual(s) after undergoing screening is/are deemed not to be
                                            eligible to participate in the Study, the Sponsor shall reimburse hVIVO for any prior written
                                            Sponsor approved reasonable costs incurred by hVIVO when processing such volunteers.
















    	11



     


    

 






















EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Use
of Affiliates and Third-Party Subcontractors by hVIVO


 


	4.9	hVIVO
                                            may subcontract the provision of any Services to its Affiliates or subcontractors, provided
                                            that hVIVO shall remain responsible for all acts or omissions of its Affiliates and subcontractors
                                            in connection with the performance of the Services, as if said acts or omissions were its
                                            own. hVIVO shall ensure, before engaging its Affiliates or subcontractors, that the Affiliates
                                            or subcontractors is under an obligation to assign all Sponsor Property to Sponsor. Notwithstanding
                                            the foregoing, for the avoidance of doubt, hVIVO shall not be responsible for acts or omissions
                                            of subcontractors that are selected by the Sponsor for use in provision of Services in connection
                                            with the Study. 
	 	 
	4.10	Any
                                            failure of hVIVO to perform its obligations or any delay by hVIVO in performing its obligations
                                            shall not be considered a breach of such obligations to the extent that such failure or delay
                                            was caused by any act or omission of the Sponsor, including the Sponsor’s failure to
                                            provide, in a timely manner, documents, materials or information necessary for hVIVO to perform
                                            its obligations under this Agreement.
	 	 
	5.	THE
                                            SPONSOR’S OBLIGATIONS 
	 	 
	5.1	Sponsor
                                            assigns to hVIVO to fulfill all regulatory obligations unless otherwise stated in this agreement.
                                            Sponsor warrants that it will cooperate with hVIVO in taking any actions that hVIVO reasonably
                                            believes are necessary to comply with the regulatory obligations. Notwithstanding the foregoing,
                                            Sponsor hereby acknowledges and accepts that it shall remain the ultimate responsible party
                                            for the quality and integrity of all Study Data and for the Study as a whole as per Applicable
                                            Laws. The Parties acknowledge and agree that Sponsor shall at all times be deemed to be the
                                            “sponsor” of the Study pursuant to the terms of all Applicable Laws.
	 	 
	5.2	The
                                            Sponsor shall perform its obligations under this Agreement in accordance with:



		5.2.1	this
                                            Agreement;



		5.2.2	the
                                            Protocol;



		5.2.3	the
                                            conditions set by the Regulatory Authority and the Research Ethics Committee in respect of
                                            the Study;



		5.2.4	the
                                            SOPs; and 



		5.2.5	Applicable
                                            Law.



	5.3	The
                                            Sponsor shall provide hVIVO, in a timely manner, all documents, data and information in the
                                            Sponsor’s possession or control that (i) are reasonably necessary for hVIVO to conduct
                                            the Study, including without limitation evidence of any approvals from any applicable Regulatory
                                            Authority; and (ii) are reasonably required by hVIVO to access, use and exploit Non-Drug
                                            Data and hVIVO Samples.








    	12



     


    







 





EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	5.4	The
                                            Sponsor shall provide hVIVO, free of charge, any Sponsor Materials in such quantities as
                                            are required for the Study. Title and risk in Sponsor Materials shall at all times remain
                                            with Sponsor. Sponsor, at its sole discretion, is responsible for maintaining adequate insurance
                                            to cover any loss, damage or theft of Sponsor Materials. The Sponsor shall comply with all
                                            Applicable Laws that relate to the shipment of the Sponsor Materials.
	 	 
	5.5	The
                                            Sponsor shall provide hVIVO with all information in its possession or control relating to
                                            known or potential hazards associated with the use of the Sponsor Materials which is reasonably
                                            required to enable hVIVO to comply with the Health and Safety at Work Act 1974 and any other
                                            Applicable Law. With respect to the Study Drug, Sponsor shall provide batch certificates
                                            and release certificates, from a suitably qualified person within the United States, certifying
                                            that the Study Drug can be used in the Study. Sponsor assigns release of the Study Drug within
                                            the UK to hVIVO.
	 	 
	5.6	Should
                                            Sponsor either: (i) ship, mail or have delivered, any materials or documents to hVIVO; or
                                            (ii) request that hVIVO, ship, mail or have delivered any materials or documents to Sponsor
                                            or any third party; Sponsor alone shall be responsible for such items in transit before they
                                            arrive at their destination, including any cost of insurance, risk in transit and risks
                                            associated with customs delays.
	 	 
	5.7	The
                                            Sponsor shall, if, as and when required by any Applicable Law:
	 	 



		5.7.1	submit
                                            information about the Study for listing in a free, publicly accessible clinical trial registry
                                            within twenty-one (21) days (or within such time as specified by Applicable Law at the time)
                                            of initiation of enrolment of the Study Subjects; and



		5.7.2	shall
                                            publish the results of the Study on a free, publicly accessible clinical trial results database
                                            within one (1) year (or within such time period as specified by any Applicable Law at the
                                            time) of the Study Drug being approved and made commercially available in any country, or
                                            for a post-approval clinical trial, within one (1) year (or within such time period as specified
                                            by the relevant Applicable Law at the time) of completion the clinical trial. In respect
                                            of a clinical trial that is under review by peer-reviewed journals that prohibit disclosure
                                            of results pre-publication, the results will be posted at the time of publication.








    	13



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	5.8	Sponsor
                                            shall only use Study Samples for Protocol specified analyses and re-analyses to determine
                                            and to secure Intellectual Property Rights to the effects of Study Drug on a Study Subject,
                                            as provided for in the Protocol and not for any other purpose whatsoever, including without
                                            limitation, further exploratory studies. Notwithstanding the foregoing, in no event shall
                                            Sponsor use the Study Samples to attempt to (i) reverse engineer or determine in any way
                                            the chemical or biological structure or genetic sequence of the Virus; (ii) determine the
                                            progression or characteristics of infection or disease resulting from exposure of a human,
                                            including the Study Subject, to the Virus; (iii) determine the nature of the interaction
                                            of the Virus with human tissue or fluids; or (iv) conduct research on Study Samples which
                                            is not related to the determination of the effect of Study Drug on a Study Subject.
	 	 
	5.9	In
                                            no event shall hVIVO use the Study Samples or Sponsor Material to attempt to (i) reverse
                                            engineer or determine in any way the chemical or biological structure of the Sponsor Material;
                                            (ii) determine the distribution and size of the Sponsor Material; or (iii) conduct research
                                            on Study Samples containing Sponsor Material, or Sponsor Material which is not specified
                                            in the protocol and which is not directly related to the determination of the effect of Study
                                            Drug on a Study Subject.
	 	 
	5.10	Sponsor
                                            and hVIVO acknowledge and agree that:



		5.10.1	Sponsor
                                            shall, as soon as reasonably practicable, provide hVIVO with details of any third-party vendors
                                            that Sponsor wishes to engage in relation to the Study who would require access to hVIVO
                                            Property or Confidential Information.



		5.10.2	hVIVO,
                                            should it have commercially reasonable grounds to do so (for example where the third party
                                            vendor is a competitor or potential competitor of hVIVO), shall have the right to object
                                            to the choice of such third-party vendors and in such an event, shall provide Sponsor with
                                            the reason(s) for said objection.



		5.10.3	hVIVO
                                            shall, as soon as reasonably practicable, provide Sponsor with details of any Affiliates
                                            or Subcontractors that hVIVO wishes to engage in relation to the Study who would require
                                            access to Sponsor Property or Confidential Information.



		5.10.4	Sponsor,
                                            should it have commercially reasonable grounds to do so (for example, where the Affiliates
                                            or Subcontractors is a competitor or potential competitor of Sponsor), shall have the right
                                            to object to the choice of such Affiliates or subcontractors.






		5.10.5	The
                                            Parties shall enter into discussions to find an amicable way of overcoming any objection
                                            made by hVIVO to Sponsor’s choice of third party vendors or by Sponsor to hVIVO’s
                                            choice of Affiliates or Subcontractors.



		5.10.6	In
                                            the event that the Parties cannot reach agreement, hVIVO or Sponsor shall have the right
                                            to terminate this Agreement at any time, upon provision of written notice to each other.








    	14



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	6.	INSPECTIONS



	6.1	hVIVO
                                            shall permit representatives of the Sponsor who are authorized to carry out an independent
                                            examination of the Study, to visit the Study Site to observe the conduct of the Study by
                                            hVIVO or its Personnel and to examine any procedures relating to the Study. Each such audit
                                            or inspection shall be conducted upon reasonable prior notice to hVIVO and during regular
                                            business hours. Sponsor will comply with all reasonable rules and requirements of hVIVO with
                                            respect to its presence at hVIVO’s facility in connection with such audits, and all
                                            information made available to Sponsor in connection with such audit will be deemed Confidential
                                            Information of hVIVO. After the first such audit, should Sponsor request any further audits,
                                            hVIVO reserves the right to charge for the time of the hVIVO personnel involved in the additional
                                            audits, provided such audits are not “for cause”. 



	6.2	The
                                            Parties acknowledge that either Party may respond independently to any correspondence or
                                            inquiry from the Regulatory Authorities in which such Party or its Affiliates is named. Each
                                            Party shall promptly notify the other Party if either Party receives notice of or otherwise
                                            becomes aware of any proposed investigation, intended or actual inspection, written enquiry
                                            and/or visit to the Study Site by any Regulatory Authority in connection with the Study and
                                            forward to the other Party copies of any correspondence with any such Regulatory Authority
                                            relating to the Study.



	6.3	Each
                                            Party shall keep the other Party fully informed of the progress of any inspection, investigation
                                            or examination by the Regulatory Authority and shall inform the other Party of the results
                                            of such inspection, investigation or examination, to the extent the result directly concerns
                                            or affects the past or future performance by either Party of its obligations under this Agreement.



 


	7.	INFORMATION
                                            SHARING AND PHARMACOVIGILANCE



	7.1	Each
                                            Party shall promptly report to the other Party any new information arising during the Study
                                            which, in its reasonable opinion, could affect (i) the safety of any Study Subject or hVIVO
                                            Personnel and/or (ii) the Study Subjects’ consent or their willingness to continue
                                            participation in the Study. In such circumstances hVIVO shall (i) revise the informed consent
                                            forms and any other written information provided to Study Subjects and obtain Sponsor’s
                                            approval of revised documentation before its use and shall submit the same to the relevant
                                            Research Ethics Committee for approval; and/or (ii) notify the Study Subjects of such new
                                            information. 








    	15



     


    


 





EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	7.2	If
                                            hVIVO reasonably believes that the Study should be discontinued on safety or ethical grounds,
                                            hVIVO shall provide Sponsor a written statement of its reasons. The Parties will discuss
                                            in good faith and attempt to resolve any issues by modification of the Protocol. In the event
                                            that such modification cannot be achieved, or hVIVO’s reasonable concerns are not addressed,
                                            hVIVO may terminate this Agreement, upon provision of written notice to Sponsor.



	7.3	hVIVO
                                            shall notify the Sponsor of any suspected unexpected serious adverse reaction (“SUSAR”)
                                            arising during the Study in accordance with the procedure specified in the Protocol.



	7.4	hVIVO
                                            shall promptly notify Sponsor of all serious adverse events (“SAE”), as specified
                                            in the Protocol. Following such notification, hVIVO shall provide the Sponsor with a detailed
                                            written report in relation to the SAE. Additionally, hVIVO shall report to Sponsor any adverse
                                            events and/or laboratory abnormalities as required by the Protocol.



	7.5	The
                                            Sponsor, or hVIVO on the sponsor’s behalf, shall notify the Regulatory Authority and
                                            the Research Ethics Committee of any SUSAR which occurs during the Study and is fatal or
                                            life-threatening within seven (7) days of being notified by hVIVO or the Principal Investigator
                                            and any SUSAR which is not fatal or life-threatening within fifteen (15) days of being notified
                                            by hVIVO or the Principal Investigator, unless a shorter period is required by any Applicable
                                            Law, in which case the time required by any Applicable Law will apply. 



	7.6	hVIVO
                                            shall promptly notify the Sponsor of any serious breach of the Protocol or good clinical
                                            practice (including ICH GCP). For the purposes of this provision, a serious breach is a breach
                                            which is likely to effect to a significant degree: (i) the safety or physical or mental integrity
                                            of the Study Subjects; or (ii) the scientific value of the Study. The Sponsor shall notify
                                            the Regulatory Authority of the serious breach as soon as it becomes aware of it and in any
                                            event no later than seven (7) days after receiving notification of the serious breach. 



	7.7	Either
                                            Party shall promptly advise the other Party of adverse reactions or side-effects related
                                            to the Study Drug which may become known to either Party during the course of the Study.



	7.8	The
                                            Sponsor shall inform hVIVO and the Principal Investigator of the name and telephone number
                                            of the person who will be available as the Sponsor’s point of contact. The Sponsor
                                            shall also provide hVIVO and Principal Investigator with an emergency telephone number to
                                            enable SUSAR event reporting at any time.






	8.	CHANGES
                                            TO STUDIES



	8.1	Either
                                            Party may request changes to the Protocol or changes to this Agreement, each a “Change
                                            Order Request”.





    	16



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	8.2	When
                                            a Change Order Request is made by either Party, hVIVO shall, as soon as is reasonably practicable,
                                            provide Sponsor with details of the impact which the proposed amendment will have on the
                                            Study including impact on costs and/or timelines. The Parties shall negotiate in good faith
                                            thereafter to agree the Change Order. 



	8.3	hVIVO
                                            shall not be obligated to provide Services modified by a Change Order Request until a Change
                                            Order is fully executed. In the event that any Change Order Request which materially affects
                                            hVIVO’s ability to perform the ongoing Services is not agreed within thirty (30) days
                                            of the Change Order Request being made, hVIVO reserves the right to suspend performance of
                                            any portion of the affected Services. Notwithstanding the foregoing, hVIVO, at its sole discretion,
                                            may agree to continue with the amended Services pending Change Order execution, provided
                                            Sponsor provides email approval of the additional services and commitment to pay the associated
                                            costs. Sponsor acknowledges and agrees that any such email provided by Sponsor’s personnel
                                            will be legally binding on Sponsor.



	9.	COMPLETION
                                            OF THE STUDY



	9.1	At
                                            Study Completion:



		9.1.1	The
                                            responsible Party (as defined in Schedule 1) shall notify the Regulatory Authority
                                            and Research Ethics Committee in respect of the completion of the Study, as required by Applicable
                                            Law and the Protocol.



		9.1.2	hVIVO
                                            is responsible for the study database, and hVIVO shall provide to Sponsor copies of the Drug
                                            and Non-Drug Data.



		9.1.3	hVIVO
                                            shall, at the Sponsor’s behest, ensure that any unused or partially used Study Drug
                                            in the control or possession of hVIVO, its Affiliates and subcontractors and/or any Personnel
                                            is either returned to the Sponsor or destroyed in accordance with the Protocol. Sponsor shall
                                            bear the costs of any such return or destruction.



		9.1.4	Each
                                            Party shall promptly destroy or deliver to the other Party any non-electronic forms of Confidential
                                            Information of the other Party that it is holding, except that each Party shall be entitled
                                            to retain one (1) copy of the other Party’s Confidential Information to the extent
                                            necessary for the Party to comply with its legal obligations. 
	 	 	 
	 	9.1.5	hVIVO
                                            will store Study Samples for a period of three (3) months following final laboratory data
                                            upload being the date on which the final laboratory data transfer occurs.





    	17



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 



		9.1.5.1	Study
                                            Drug Samples. Prior to the conclusion of the three (3) month period, hVIVO shall contact
                                            Sponsor for instructions as to whether (i) to destroy the Study Drug Samples, (ii) ship them
                                            to Sponsor, or (iii) extend the period of storage, in each case at Sponsor’s cost.
                                            In the event that Sponsor fails to respond within 30 days, hVIVO shall ship the Study Drug
                                            Samples to Sponsor and notify by providing shipping details (including Courier and tracking
                                            numbers) to AIM no later than at time of shipment and invoice Sponsor for the cost of shipment.
                                            In case Sponsor chooses to extend the period of storage, the parties will enter a separate
                                            agreement to that effect.



		9.1.5.2	Non-Drug
                                            Samples. At the conclusion of the three (3) month period, hVIVO shall ship the Non-Drug
                                            Samples to Sponsor and invoice Sponsor for the cost of shipment. In case Sponsor chooses
                                            to extend the period of storage, the parties will enter a separate agreement to that effect.



		9.1.6	hVIVO
                                            shall send Sponsor a copy of the Study Records and also retain Study Records for a period
                                            of five (5) years from the date of completion of the Study. At the conclusion of the five
                                            (5) year period, hVIVO shall notify Sponsor. Should Sponsor require continued archiving,
                                            Sponsor shall notify hVIVO and the Parties will enter into a separate Archiving Contract,
                                            detailing the responsibilities of each Party and the fees payable by Sponsor. In the absence
                                            of such notification, hVIVO may at its sole discretion destroy the Study Records, provided
                                            however that hVIVO has provided thirty (30) days notice to the Sponsor of its intent to destroy
                                            the Study Records. On written request by the Sponsor, the Study Records will be destroyed,
                                            at the Sponsor’s cost, provided that the destruction of such Study Records is consistent
                                            with the archive and data storage requirements under the Applicable Laws.



	10.	PAYMENTS



	10.1	In
                                            consideration of hVIVO providing the Services, the Sponsor shall pay hVIVO the sums set out
                                            in the budget, in accordance with the invoicing schedule (both attached in Schedule 2).



	10.2	In
                                            order to ensure the health and safety of the participating Study Subjects, the Sponsor agrees
                                            to pay the cost of any emergency and/or acute medical care, treatment, consultation, tests,
                                            and procedures (together “Emergency Care”) incurred by or in connection
                                            with Study Subjects that may become necessary during the conduct of the Study. The Sponsor
                                            recognises that although hVIVO and/or the Principal Investigator shall make every effort
                                            to notify the Sponsor before incurring costs in relation to such Emergency Care, it may not
                                            always be possible for hVIVO to provide such advance notice to the Sponsor. Where in the
                                            reasonable opinion of hVIVO and/or the Principal Investigator, one (1) or more Study Subjects
                                            require additional medical care, treatment, consultation, tests and procedures on a non-emergency
                                            basis (“Non-Emergency Care”), hVIVO shall notify the Sponsor in advance.
                                            The Sponsor shall only reimburse hVIVO for any Non-Emergency Care for which it has provided
                                            hVIVO with prior written approval, or which is to be provided to Study Subjects under the
                                            terms of the Protocol and/or any informed consent form. hVIVO will submit invoices relating
                                            to the Emergency Care and Non-Emergency Care, including any third-party invoices, to the
                                            Sponsor which the Sponsor shall pay in accordance with the provisions of this Clause 10.





    	18



     


    

 



EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential



 


	10.3	All
                                            sums stated in this Agreement are stated exclusive of any value added tax (VAT) or any other
                                            sales tax or duties where applicable. hVIVO shall present the Sponsor with a VAT invoice
                                            for all such VAT payments which shall be paid by the Sponsor to hVIVO in addition to the
                                            charges specified under this Agreement. Before execution of this Agreement, hVIVO shall provide
                                            the Sponsor with a good faith estimate of any value added tax (VAT) that may occur under
                                            this Agreement.



	10.4	The
                                            Sponsor shall pay hVIVO within thirty (30) days of the date of an invoice. If payment is
                                            not made within the thirty (30) day period hVIVO reserves the right to (i) charge interest
                                            on a daily basis on the amount outstanding at the expiry of the thirty (30) day period at
                                            a rate that is the higher of the interest rate of the Bank of England Base Rate plus 5% and
                                            the statutory interest for late payments as specified in the Late Payment of Commercial Debts
                                            (Interest) Act (1998); and/or (ii) suspend performance of the Services until such time as
                                            the outstanding amount is paid in full.



	10.5	Payment
                                            shall be made in British pounds sterling by BACS payable to hVIVO Services Ltd or directly
                                            to the following bank account (or the bank account specified by the in writing from time
                                            to time):



[***]


 


	10.6	If
                                            any deductions or withholdings in respect of duties, taxes, taxation or charges otherwise
                                            of a taxation nature are required to be made under any Applicable Law in relation to sums
                                            payable to hVIVO under this Agreement, hVIVO will include said taxes in invoices to Sponsor
                                            and Sponsor shall be responsible for and promptly pay said taxes to hVIVO or the appropriate
                                            taxing authority without any deduction to any amount or fees owed by Sponsor to hVIVO.



	11.	INTELLECTUAL
                                            PROPERTY



	11.1	The
                                            Sponsor grants to hVIVO and its Affiliates, between the Effective Date and the Termination
                                            of this Agreement, a worldwide, non-exclusive, royalty-free license to use the Sponsor Property
                                            relevant to the Study solely for the purpose of conducting the Study and fulfilling its obligations
                                            in respect of the Study as specified in this Agreement.





    	19



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	11.2	hVIVO
                                            acknowledges and agrees that the Sponsor shall own all right, title and interest in all Sponsor
                                            Property which includes all Study Drug and Non-Study Drug data generated from this study
                                            (including all related Intellectual Property Rights and including Intellectual Property Rights,
                                            to the extent related to the Study Drug, that is developed or invented during this Study).
                                            hVIVO, including its Affiliates and subcontractors, assign, and agree to assign, all of their
                                            rights, title and interest in Sponsor Property to Sponsor. hVIVO agrees not to use any Affiliates,
                                            Personnel or Subcontractors who is not under an obligation to assign all Sponsor Property
                                            to Sponsor. hVIVO, including its Affiliates agree that any materials, compositions, medicaments,
                                            methods including methods of treatment, and processes involving the use of Study Drug belongs
                                            to Sponsor.



	11.3	If
                                            requested by Sponsor, hVIVO will assist Sponsor, at a pre-approved Sponsor’s cost,
                                            in applying for Intellectual Property Rights related to Sponsor Property. Such assistance
                                            may include, for example, signing assignments and declarations for filing in various countries
                                            and during prosecution.



	11.4	Sponsor
                                            grants hVIVO, a worldwide, non-exclusive, irrevocable, fully paid up, royalty-free license
                                            to use the Non-Drug Data solely (i) to the extent necessary for hVIVO to understand, develop
                                            and analyze its Human Challenge Model(s), and (ii) for the purpose of documenting the safety
                                            and efficacy of the virus, including but not limited to the ethical and regulatory virus
                                            dossier package; any such use subject always to the terms of the Informed Consent. hVIVO
                                            agrees that any Intellectual Property Rights comprising Sponsor Property or the use of Sponsor
                                            Property belongs to Sponsor.



	11.5	Sponsor
                                            grants hVIVO, a worldwide, non-exclusive, fully paid up, royalty-free license to use the
                                            Study Drug Data solely to the extent necessary for hVIVO to understand, develop and analyze
                                            its Human Challenge Model(s), any such use subject always to the terms of the Informed Consent.
                                            hVIVO agrees that any Intellectual Property Rights comprising Sponsor Property or the use
                                            of Sponsor Property belongs to Sponsor.



	11.6	Sponsor
                                            acknowledges and agrees that hVIVO shall own all right, title and interest in all hVIVO Property
                                            (including any and all related Intellectual Property Rights) except for Sponsor Materials.
                                            Nothing contained in this Agreement shall be interpreted to grant Sponsor any title, interest,
                                            license or other rights to or in the Virus. Nothing contained in this Agreement shall be
                                            interpreted to grant hVIVO any title, interest, license or other rights to or in Sponsor
                                            Material including, at least, Ampligen; double stranded RNA; therapeutic double stranded
                                            RNA; compositions comprising the same (Ampligen, double stranded RNA; therapeutic double
                                            stranded RNA); medicaments comprising the same; treatments comprising the same; methods comprising
                                            the same; or methods of manufacturing the same.





    	20



     


    


 





EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	12.	DATA
                                            PROTECTION AND CONFIDENTIALITY



Data
Protection


 


	12.1	Both
                                            parties will comply with the Data Protection Legislation (as defined in Schedule 4).
                                            This Clause 12 and the requirements in Schedule 4 are in addition to and do
                                            not relieve, remove or replace a party’s obligations under the Data Protection Legislation.



	12.2	The
                                            parties acknowledge and agree that, notwithstanding any other provision contained in this
                                            Agreement, they are Joint Controllers with respect to any personal data collected or otherwise
                                            obtained in connection with the Study.



	12.3	The
                                            Parties shall comply with the data processing requirements in Schedule 4 which defines
                                            the principles and procedures that the parties shall adhere to.



	12.4	The
                                            Parties shall adhere to the principle of medical confidentiality in relation to Study Subjects.
                                            hVIVO shall not disclose Study Subjects Personal data (as defined in the Data Protection
                                            Legislation) to the Sponsor except where permitted by Applicable Law and where strictly necessary,
                                            for example where required to satisfy the requirements of the Protocol for the purpose of
                                            monitoring or adverse event reporting, or in relation to a claim or proceeding brought by
                                            a Study Subject in connection with the Study. Neither Party shall disclose the identity of
                                            Study Subjects to third parties without prior written consent of the Study Subject, except
                                            in accordance with any Applicable Law, or in relation to a claim or proceeding brought by
                                            the Study Subject in connection with the Study. 



	12.5	Without
                                            prejudice to Section 6.1 of Schedule 4, hVIVO shall act as the primary contact
                                            for the Study Subjects as outlined in the Informed Consent Form. 



	12.6	hVIVO
                                            shall ensure that all Study Data transferred to Sponsor or its designee or any third party
                                            pursuant to this Agreement is pseudonymised and sent to Sponsor or its designee or any third
                                            party without any additional information that would enable it to be re-identified by the
                                            recipient(s). 



	12.7	If
                                            a Data Protection Representative is required for the Study, the Parties shall enter a separate
                                            agreement pertaining to the appointment of such Data Protection Representative on Sponsor’s
                                            behalf.





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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Confidential
Information


 


	12.8	The
                                            Parties shall ensure that only those of their Personnel directly concerned with carrying
                                            out each Party’s obligations under this Agreement shall have access to the Confidential
                                            Information of the other Party. Each Party undertakes to treat as strictly confidential and
                                            not to disclose to any third party any Confidential Information of the other Party, save
                                            where disclosure is required by a Regulatory Authority or by law or allowed under this Agreement.
                                            The Party required to make a disclosure required by a Regulatory Authority or by law shall
                                            inform the other within a reasonable time prior to being required to make the disclosure,
                                            of the requirement to disclose and the information required to be disclosed. Each Party undertakes
                                            not to make use of any Confidential Information of the other Party, other than in accordance
                                            with performance of obligations under this Agreement, without the prior written consent of
                                            the other Party.



	12.9	The
                                            obligations of confidentiality set out in Clause 12.7 shall not apply to Confidential
                                            Information of a disclosing Party which is: (i) published or becomes generally available
                                            to the public other than as a result of a breach of the undertakings hereunder by the receiving
                                            Party; (ii) prior to its receipt, in the possession of the receiving Party without any obligations
                                            of confidentiality or restrictions on its use as evidenced by contemporaneous written evidence;
                                            (iii) independently developed by or on behalf of the receiving Party by individuals that
                                            do not have any knowledge of the information and/or materials of the Party disclosing the
                                            Confidential Information; or (iv) obtained by the receiving Party from a third party not
                                            subject to a duty of confidentiality to the Party that owns the Confidential Information.



	12.10	Where
                                            the Sponsor visits or inspects the facilities of hVIVO (including the Study Site) in accordance
                                            with the provisions of Clause 6, the Sponsor shall treat any information of hVIVO
                                            that comes to its knowledge during such visit or inspection as the Confidential Information
                                            of hVIVO subject to the provisions of this Clause 12. 



	12.11	It
                                            is acknowledged and agreed between the Parties that the hVIVO Property, and particularly
                                            any information relating to the viral challenge model, other models, methodologies or processes
                                            of hVIVO comprises business critical and commercially sensitive information of hVIVO and
                                            that no disclosure of such information may be made by Sponsor without the prior written consent
                                            of hVIVO. Any unauthorised disclosure may result in hVIVO protecting its rights by obtaining
                                            an injunction and/or claiming damages.



	12.12	The
                                            provisions of this Clause 12 shall apply to any Confidential Information disclosed
                                            by either Party under the Reservation and Start-Up Agreement.






	12.13	This
                                            Clause 12 shall survive termination or expiry of this Agreement. 



	13.	PUBLICATIONS
                                            AND PUBLICITY



	13.1	Each
                                            Party shall be permitted to present at conferences, symposia and professional meetings, and
                                            to publish in journals, theses or dissertations, or otherwise of their own choosing, in relation
                                            to the Study (each, a “Publication”). 



	13.2	Sponsor
                                            shall note the participation of the Principal Investigator and/or other representatives of
                                            hVIVO in all Sponsor Publications by acknowledgement or co-authorship, as appropriate.





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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	13.3	hVIVO
                                            shall note the participation of the AIM representatives who have contributed to the study
                                            design and protocol development and/or review in all hVIVO Publications by acknowledgement
                                            or co-authorship, as appropriate. 



	13.4	Each
                                            Party shall submit a Publication to the other Party for review and comment at least sixty
                                            (60) days (or the time limit specified in the Protocol if longer) prior to publication.



	13.5	Each
                                            Party agrees that all reasonable comments made by the other Party in relation to possible
                                            compromise of Confidential Information and/or IPRs will be addressed and incorporated prior
                                            to publication. This Clause 13 does not limit in any way the obligations of either
                                            Party with respect to the Confidential Information of the other Party.



	13.6	Either
                                            Party shall be entitled to make a reasoned request that a Publication be delayed for a period
                                            of up to six (6) months from the date of first submission in order to enable the Party to
                                            take steps to protect its Intellectual Property Rights. A Party shall not unreasonably withhold
                                            or delay its consent to a further request for an exceptional additional delay if the Party
                                            requesting the delay has reasonable grounds to believe its Intellectual Property Rights might
                                            otherwise be compromised or lost.



	13.7	Once
                                            a Party has produced a publication in accordance with the process described above, any subsequent
                                            publication which includes materially the same data and/or information shall not require
                                            further review or consent by the other Party. 



	13.8	For
                                            the avoidance of doubt, hVIVO shall not require the Sponsor’s consent nor shall the
                                            above requirements apply to any publication of hVIVO Property or anonymized Non-Drug Data
                                            in so far as such publication does not include any reference to the Sponsor, any Study identifier,
                                            or any Property or other Confidential Information of the Sponsor, other than the anonymized
                                            Non-Drug Data. 



	13.9	Neither
                                            Party may use the other Party’s name in any form of advertising, promotion or publicity,
                                            including press releases, without the prior written consent of the other Party. This term
                                            does not restrict a Party’s ability to use the other Party’s name in filings
                                            with the Securities and Exchange Commission, FDA, MHRA or other governmental agencies, when
                                            required to do so.



	13.10	Each
                                            Party agrees that it will not disclose the terms of this Agreement to any third party without
                                            the written consent of the other Party, which shall not unreasonably be withheld taking into
                                            account all relevant circumstances and the legitimate interests of both parties, provided
                                            that nothing in this Agreement shall prevent either Party from disclosing the terms of this
                                            Agreement to any Regulatory Authority (for any purpose connected to the Study or the Study
                                            Drug) or as required to comply with any Applicable Laws or any order of any court of competent
                                            jurisdiction.














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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	14.	WARRANTIES



	14.1	Each
                                            Party warrants to the other that: (i) it has the full power and right to enter into this
                                            Agreement; and (ii) it does not have any prior or ongoing obligations and/or commitments
                                            to a third party that might interfere and/or conflict with the performance of the Study or
                                            that Party’s obligations under this Agreement. 



	14.2	hVIVO
                                            warrants that, any employees of hVIVO involved in the Study (including the Principal Investigator)
                                            will have the expertise relevant to the Study and will have the training, licenses, approvals
                                            or certifications necessary for conducting the Study and hVIVO shall ensure that all such
                                            training, licenses, approvals and/or certifications are properly maintained throughout the
                                            Study. 



	14.3	hVIVO
                                            warrants that to the best of its knowledge the individuals employed by hVIVO or with whom
                                            hVIVO has contracted to participate in the performance of the Services have not been debarred
                                            or suspended from providing, and otherwise have all necessary registrations to provide, the
                                            Services (or the relevant part thereof that they are engaged to provide) under any Applicable
                                            Law. 



	15.	INDEMNITY
                                            AND LIABILITY



Indemnity
to hVIVO


 


	15.1	The
                                            Sponsor shall indemnify, defend and hold harmless hVIVO, its Affiliates and subcontractors,
                                            and their Personnel, directors and officers (each, a “hVIVO Indemnified Party”)
                                            against any and all losses, damages, penalties, expenses and/or costs (including reasonable
                                            legal and expert costs, expenses and any settlements or ex gratia payments) (collectively
                                            “Losses”) resulting or arising from or otherwise incurred by hVIVO Indemnified
                                            Party, in connection with: (i) any actions, litigation, claims and/or proceedings made or
                                            brought by a third party (including by or on behalf of Study Subjects or their dependents)
                                            (collectively “Third Party Claims”); or (ii) any regulatory investigation
                                            brought by the Regulatory Agency, in each case arising out of or in relation to the conduct
                                            of the Study and/or the performance of hVIVO of its obligations under this Agreement.



	15.2	The
                                            indemnity provided by the Sponsor under Clause 15.1 shall not apply to the extent
                                            that the Loss is caused by the:



		15.2.1	grossly
                                            negligent act or omission of, or breach of statutory duty, by a hVIVO Indemnified Party;
                                            or



		15.2.2	failure
                                            of hVIVO to conduct the Study, in accordance with the Protocol.





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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Indemnity
to the Sponsor


 


	15.3	hVIVO
                                            shall indemnify, defend and hold harmless the Sponsor, its Affiliates, and their employees,
                                            directors and officers (each, a “Sponsor Indemnified Party”) against Losses
                                            resulting or arising from or otherwise incurred by the Sponsor Indemnified Party, in connection
                                            with any Third Party Claims arising out of or in relation to the willful misconduct or gross
                                            negligence of hVIVO in the performance of its obligations under this Agreement or the conduct
                                            of any Study.



	15.4	The
                                            indemnity provided by hVIVO under Clause 15.3 shall not apply to the extent that the
                                            Loss is caused by the:



		15.4.1	grossly
                                            negligent act or omission of, breach of statutory duty, or willful misconduct by a Sponsor
                                            Indemnified Party; or



		15.4.2	failure
                                            of a Sponsor Indemnified Party to conduct the Study in accordance with the Protocol.



	15.5	Each
                                            Party shall indemnify, hold harmless and defend the other Party against any and all claims,
                                            demands, actions, awards, judgments, settlements, costs, expenses, liabilities, damages and
                                            losses arising from indemnifying party’s failure to comply with the Data Protection
                                            Legislation.



Indemnification
Procedure


 


	15.6	A
                                            Person seeking recovery under this Clause 15 (the “Indemnified Party”)
                                            in respect of a Claim shall give prompt notice of such Third Party Claim to the Party from
                                            which indemnification is sought (the “Indemnifying Party”) and, provided that
                                            the Indemnifying Party is not contesting its obligation under this Clause 15, shall
                                            permit the Indemnifying Party to control any litigation relating to such Third Party Claim
                                            and the disposition of such Third Party Claim; provided that the Indemnifying Party shall
                                            (a) act reasonably and in good faith with respect to all matters relating to the settlement
                                            or disposition of such Third Party Claim as the settlement or disposition relates to such
                                            Indemnified Party and (b) not settle or otherwise resolve such claim without the prior written
                                            consent of such Indemnified Party (which consent shall not be unreasonably withheld, conditioned
                                            or delayed taking into account all relevant circumstances and the legitimate interests of
                                            both parties). Each Indemnified Party shall cooperate with the Indemnifying Party in its
                                            defense of any such Third Party Claim in all reasonable respects and shall have the right
                                            to be present in person or through counsel at all legal proceedings with respect to such
                                            Third Party Claim. 





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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Limitation
of Liability


 


	15.7	Nothing
                                            in this Agreement is intended to restrict or exclude the liability of any Party in relation
                                            to death or personal injury caused by the gross negligence of that Party or its Personnel
                                            or to restrict or exclude any other liability of either Party which cannot be so restricted
                                            or excluded in law.



	15.8	In
                                            no circumstances shall hVIVO have any liability to Sponsor, howsoever arising and in each
                                            case whether direct or indirect for any:



		(i)	loss
                                            of bargain, revenue, profit or anticipated savings.



		(ii)	loss
                                            of production or use. 



		(iii)	loss
                                            of business or business opportunity.



		(iv)	loss
                                            of goodwill or reputation. 



		(v)	loss
                                            or waste of staff and/or management time. 



		(vi)	replacement
                                            or replacement cost of Sponsor Materials. 



		(vii)	action,
                                            inaction, error or omission of any third-party delivery services or carriers.



		(viii)	special,
                                            indirect or consequential loss or damage of any nature. 



	15.9	Subject
                                            to Clause 15.6 and without prejudice to the limitation of liability set out in Clause
                                            15.7, in no event shall the aggregate liability of hVIVO (including its liability under
                                            the indemnity in Clause 15.3) exceed the amount of fees payable by the Sponsor to
                                            hVIVO in respect of the Study. 



Insurance


 


	15.10	Each
                                            Party shall maintain during the term of this Agreement adequate insurance consistent with
                                            industry practice and if applicable with all legal or regulatory obligations as may be required
                                            to fulfill its obligations under this Agreement and insure its foreseeable risks related
                                            to this Agreement. This will include but not be limited to the specific requirements detailed
                                            hereinafter.



	15.11	hVIVO
                                            shall maintain professional liability insurance in respect of its liability under the Study
                                            in relation to acts or omission of hVIVO, its employees and the Principal Investigator, of
                                            a value not less than the sum of £[***] GBP. At the Sponsor's request, hVIVO will provide
                                            a copy of such insurance coverage to the Sponsor.



	15.12	The
                                            Sponsor will take out clinical trial insurance sufficient to cover any claims arising under
                                            the Study and such cover shall be of a value not less than £[***] GBP in respect of
                                            any one occurrence or series of occurrences arising from one event, and shall name hVIVO
                                            as an additional insured party. The Sponsor shall provide hVIVO with copies of insurance
                                            certificates together with a written statement that the policies to which they refer (i)
                                            remain in full force and effect, (ii) provide adequate cover for the intended Study and (iii)
                                            do not exclude any of the anticipated Study Subjects. On request, Sponsor will provide copies
                                            of the full insurance policies for hVIVO to review, in order for hVIVO to fulfill its expected
                                            regulatory due diligence. The terms of any insurance or the amount of cover shall not relieve
                                            the Sponsor of any liabilities under this Agreement.











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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


	16.	TERM
                                            AND TERMINATION



	16.1	This
                                            Agreement shall commence on the Effective Date and, unless earlier terminated in accordance
                                            with provisions of this Agreement, will terminate six (6) months after Study Completion.
                                            



	16.2	Either
                                            Party may terminate this Agreement without cause at any time during the term of the Agreement
                                            on provision of sixty (60) day’s written notice to the other Party.



	16.3	Either
                                            Party may terminate this Agreement upon provision of written notice:



		16.3.1	if
                                            the other Party commits a material breach of this Agreement, and where such breach is capable
                                            of remedy, fails to remedy such breach within twenty-eight (28) days of receiving notice
                                            in writing to do so.



		16.3.2	if
                                            the other Party is declared insolvent or has an administrator or receiver appointed over
                                            all or any part of its assets or ceases or threatens to cease to carry on its business; 



		16.3.3	pursuant
                                            to the provisions of Clause 18.7 (Force Majeure); or



		16.3.4	if
                                            a Regulatory Authority directs that the Study be terminated or revokes or cancels any approval
                                            required to conduct the Study.



		16.3.5	if
                                            the Parties fail to reach agreement in relation to a Change Order submitted by either Party
                                            in accordance with the provisions of Clause 8.



		16.4	hVIVO
                                            may terminate this Agreement subject to the provisions of Clause 5.10, or Clause
                                            7.2 herein.



	17.	CONSEQUENCES
                                            OF TERMINATION 



	17.1	Upon
                                            termination of this Agreement by either Party for any reason, the relevant post-completion
                                            obligations of the Parties set out in Clause 9.1 shall apply.



	17.2	Upon
                                            termination of this Agreement by either Party for any reason other than termination pursuant
                                            to Clause 16.3.1 or 16.3.2:



		17.2.1	the
                                            Parties shall promptly discuss a close-out schedule in relation to the Study and hVIVO shall
                                            cease performing any work that is not necessary for the orderly close-out of the Study or
                                            not required by the Applicable Law;





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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


		17.2.2	Sponsor
                                            shall pay hVIVO:



		(i)	all
                                            fees, costs and expenses incurred up to the date of termination.



		(ii)	all
                                            third party costs and/or expenses and all out of pocket costs, charges and/or expenses incurred
                                            by hVIVO as a result of termination.



		(iii)	hVIVO’s
                                            reasonable out of pocket costs incurred for the purposes of completing activities set out
                                            in the close-out schedule referred to in Clause 17.2.1, including those that are in
                                            connection with the fulfillment of any legal or regulatory requirements relating to such
                                            close-out activities.



		(iv)	all
                                            expenditure falling due for payment after the date of termination which arises from commitments
                                            reasonably and necessarily incurred by hVIVO for the performance of the Study prior to the
                                            date of termination.



		(v)	a
                                            cancellation charge equating to any unused Bed Day fees. 



hVIVO
will prepare an invoice detailing the total amount due minus any payments already made by Sponsor. Sponsor will pay said invoice within
thirty (30) days of receipt. In the event that the amount already paid by Sponsor exceeds the total amount due, hVIVO shall issue a credit
note and refund the overpayment within 30 days of issue of credit note.


 


	17.3	If
                                            following termination or expiry of this Agreement, hVIVO has ongoing obligations under this
                                            Agreement and the cost of performing those obligations increases as a result of changes in
                                            the Applicable Laws, hVIVO shall notify the Sponsor of such increases and the Sponsor shall
                                            reimburse hVIVO for such additional costs on reasonable commercial terms.



		17.4	Expiry
                                            or termination of this Agreement shall be without prejudice to any rights or remedies that
                                            Parties may have in law or equity in relation to the expired or terminated Agreement. 



		17.5	Clauses
                                            1, 2.2, 3.2, 4.4, 4.9, 5.1, 5.3, 5.6, 6.2, 6.3, 7.7, 9, 10.2 to 10.6, 11, 12, 13, 15, 17
                                            and 18 shall continue in full force and effect on termination or expiry of this Agreement.



 






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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 





		18.	GENERAL


 


No
Agency


 











		18.1	The
                                            Parties are independent contractors and nothing in this Agreement will create or imply any
                                            agency relationship between the Parties, nor will the Agreement be deemed to constitute a
                                            joint venture or partnership between the Parties. Neither Party will have authority to bind
                                            the other in any manner whatsoever.












Agreement


 


		18.2	This
                                            Agreement constitutes the entire agreement and understanding of the Parties relating to the
                                            Study and supersedes any other prior agreement or understanding between the Parties.



		18.3	The
                                            Parties acknowledge that by entering into this Agreement they do not rely on any statement,
                                            representation, warranty, course of dealing, custom or understanding except for those expressly
                                            set out in this Agreement.



		18.4	The
                                            Parties irrevocably and unconditionally waive any rights and/or remedies they may have to
                                            the fullest extent permitted by law (including the right to claim damages and/or to rescind
                                            this Agreement) in respect of any misrepresentation other than a misrepresentation which
                                            is expressly set out in this Agreement or a misrepresentation which was made fraudulently.



		18.5	Except
                                            as expressly set forth in this Agreement, neither Party grants to the other by implication,
                                            estoppel or otherwise, any right, title, license or interest in any Intellectual Property
                                            Right owned by either Party.



		18.6	No
                                            change shall be made to this Agreement except in writing and signed by the duly authorised
                                            representatives of both Parties.



Force
Majeure


 


		18.7	Neither
                                            Party shall be liable to the other Party or shall be in default of its obligations hereunder
                                            if such default is the result of war, hostilities, terrorist activity, revolution, civil
                                            commotion, strike (other than that of the Party’s workforce), epidemic, accident, fire,
                                            wind, flood or because of any act of God or other similar cause beyond the reasonable control
                                            of the Party affected and which by the exercise of reasonable diligence, said party is unable
                                            to foresee, prevent or provide against. The Party affected by such circumstances shall promptly
                                            notify the other Party in writing when such circumstances cause a delay or failure in performance
                                            (a “Delay”) and also when they cease to do so. In the event of a Delay
                                            lasting for four (4) weeks or more the non-affected Party shall have the right to terminate
                                            this Agreement immediately by giving notice in writing to the other Party.





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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Inconsistency


 


		18.8	To
                                            the extent that there are any inconsistencies between the provisions of the Protocol and
                                            the provisions of this Agreement:



		(i)	the
                                            provisions of Protocol shall prevail in matters of medicine, subject safety and conduct of
                                            the clinical trial, to the extent that the relevant provisions of the Protocol are in accordance
                                            with all Applicable Laws.



		(ii)	this
                                            Agreement takes precedence in other conflicts, in particular any conflicts with respect to
                                            general legal terms and conditions and specifically Intellectual Property and ownership rights.



Assignment


 





		18.9	Neither
                                            Party may assign its rights or obligations under this Agreement or any part thereof without
                                            the prior written consent of the other Party, such consent not to be unreasonably withheld
                                            or delayed taking into account all relevant circumstances and the legitimate interests of
                                            both parties, except that either Party may assign this Agreement and the rights, obligations
                                            and interests of such Party, (i) in whole or in part, to any of its Affiliates, or (ii) in
                                            whole, but not in part, to any purchaser of all of its assets or all of its assets to which
                                            this Agreement relates or shares representing a majority of its common stock voting rights
                                            or to any successor corporation resulting from any merger, consolidation, share exchange
                                            or other similar transaction.



Further
Assurance


 


		18.10	Each
                                            Party shall, as and when requested by the other Party and at the cost of the requesting Party,
                                            perform all acts and execute all documents as may be reasonably necessary to give effect
                                            to the provisions of this Agreement. 



Notices


 





		18.11	Notice
                                            hereunder must be in writing and given to the other Party by hand delivery; by first class
                                            mail, postage prepaid; by air courier or by overnight courier to the postal address set forth
                                            above or to such other address as either Party may designate. Notices shall be deemed to
                                            have been received when (a) if delivered by hand, on the date of delivery if delivered by
                                            hand prior to 5:00 pm on a business day, otherwise on the next business day following the
                                            date of delivery; (b) if sent by first class mail or air courier, three (3) business days
                                            after deposit in the mail (excluding the day of posting); or (c) if sent by overnight courier,
                                            the next business day. For purposes of this Agreement, “business days” means
                                            each Monday through Friday except for such days deemed to be a legal holiday in the United
                                            Kingdom.











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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Severability


 





		18.12	If
                                            any provision of the Agreement is held to be invalid, void or unenforceable, then the remaining
                                            provisions of this Agreement shall continue in full force and effect. The judicial or other
                                            competent authority making such determination shall have the power to limit, construe or
                                            reduce the duration, scope, activity and/or area of such provision, and/or delete specific
                                            words or phrases as necessary to render, such provision enforceable.



Waiver


 


		18.13	No
                                            failure or delay by either Party in exercising any right or remedy conferred on such Party
                                            by this Agreement shall operate as a waiver of such right or remedy, nor shall any single
                                            or partial exercise of any such right nor any single failure to do so, preclude any other
                                            or future exercise of it, or the exercise of any other right under this Agreement. 



		18.14	No
                                            printed standard terms appearing on any purchase order, invoice, or other documentation relating
                                            to Services shall be effective in adding to or changing the terms of this Agreement. 



Governing
Law, Dispute Resolution and Jurisdiction


 


		18.15	In
                                            the event of a dispute arising under this Agreement, authorised representatives of the Parties
                                            will discuss and meet as appropriate to try to resolve the dispute within twenty-one (21)
                                            days of being requested in writing by any Party to do so. If the dispute remains unresolved,
                                            it will then be referred to a senior manager from each of the Parties who will use reasonable
                                            endeavours to resolve the dispute within a further fourteen (14) days.



		18.16	If
                                            the dispute remains unresolved at the conclusion of the process described in Clause 18.15,
                                            then the parties may (but for the avoidance of doubt are not obligated to) refer such matter
                                            for settlement by arbitration administered by the International Chamber of Commerce (“ICC”)
                                            under its International Rules of Arbitration, and judgment on the award rendered by the arbitrator
                                            shall be binding and may be entered in any court having jurisdiction thereof. Such arbitration
                                            shall be conducted in English by one arbitrator mutually acceptable to the parties selected
                                            in accordance with ICC Rules.



		18.17	The
                                            laws of England and Wales shall govern the interpretation, construction and validity of this
                                            Agreement and the Parties hereby submit to the exclusive jurisdiction of the courts of London,
                                            England.






Non-Solicitation



 


		18.18	Neither
                                            Party may, during the term of this Agreement and for one (1) year thereafter, approach, induce
                                            with offers of employment or engage as a contractor, subcontractor, employer, joint venturer
                                            or otherwise, whether directly or indirectly, any of the employees of the other Party that
                                            it may come into contact with in performing its duties under this Agreement or a Work Order,
                                            without first obtaining the prior written agreement of the other Party.





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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


Third
Party Rights


 


		18.19	The
                                            Contracts (Rights of Third Parties) Act 1999 and any legislation amending or replacing this
                                            Act shall not apply in relation to this Agreement and nothing in this Agreement shall confer
                                            on any third party the right to enforce any provision of this Agreement.



 


Counterparts


 


		18.20	This
                                            Agreement shall not be effective until signed by a duly authorized representative of each
                                            Party. This Agreement may be executed and delivered electronically in Portable Document Format
                                            (PDF) and/or in any number of counterparts, each of which when executed and delivered shall
                                            constitute an original of this Agreement, but all the counterparts shall together constitute
                                            the same agreement. If this Agreement is executed in counterparts, it shall not be effective
                                            unless and until each Party has executed a counterpart.



 


IN
WITNESS WHEREOF, the Parties have executed this Agreement to be effective as of the Effective Date.


 


	hVIVO
    Services Ltd	 	AIM
    ImmunoTech Inc.


 


	Signature	/s/
    Dori Kadmon	 	Signature	/s/
    Thomas K Equels
	Name	Dori
    Kadmon	 	Name	Thomas
    K. Equels
	Title	Head
    of Legal	 	Title	Chief
    Executive Officer
	Date	September
    24, 2021	 	Date	September
    27, 2021


 




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WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 





SCHEDULE
1


 


DELIVERABLES,
PROTOCOL, ASSUMPTIONS AND RESPONSIBILITIES


 


		1.	DELIVERABLES



As
a result of performing the Services, the deliverables to be provided by hVIVO under this Agreement are as follows, subject to the assumptions
detailed in Section 3 below:


 


		1)	Final
                                            agreed protocol



		2)	Ethics
                                            submission package



		3)	64
                                            subjects inoculated



		4)	A
                                            quality controlled data set with all queries resolved



		5)	Clinical
                                            Study Report



 


		2.	PROTOCOL



Incorporated
by reference.


 


	Protocol
    Title	 	A
    Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Prophylactic Efficacy, Safety, and Tolerability of Ampligen®
    in Healthy Adult Participants Subsequently Challenged with Either Influenza A/Perth/16/2009 (H3N2) Virus or Human Rhinovirus-16
    (HRV-16)
	Protocol
    Number	 	AMP-COV-101
	Version	 	1.0
	Date	 	27
    Aug 2021


 


		3.	ASSUMPTIONS



	Screening
    Assumptions	 	 
	Anticipated
    Serosuitability rate*	 	[***]%
	Start
    of V2 Screening 	 	October
    2021
	Estimated
    No. of Screening visits	 	200
	 	 	 
	Quarantine
    Phase Assumptions	 	 
	

    Start of Challenge Phase (date from which subjects may be admitted)	 	November
    2021
	Duration
    of Challenge Phase	 	2
    months
	Number
    of Subjects in Challenge Phase	 	64
	Subject
    Participation Fee (Challenge Phase)	 	£[***]
	Project
    Management Assumptions	 	 
	Number
    of Sponsor/hVIVO Face to Face Project Meetings	 	NA
	Frequency
    of Sponsor/hVIVO Conference Calls	 	1
    per week
	Data
    Assumptions	 	 
	No
    of Data Transfers	 	1


 


*Sponsor
acknowledges and agrees that the serosuitablity rate is not within hVIVO’s control. Serosuitability will be monitored on a weekly
cycle. If the average combined serosuitability rate drops below [***]%, hVIVO may initiate a Change Order Request reflecting changes
to the Services necessitated by the change in such assumption.


 


 




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NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


TABLE
OF RESPONSIBILITIES


 





Roles
and Responsibilities


 


	 	 	Area	 	Activity	 	AIM
    Immuno TechInc	 	hVIVO	 	n/a



  


[***]


 




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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


SCHEDULE
2


 


BUDGET
AND INVOICING SCHEDULE


 


		1.	BUDGET



The
budget herein is provided on a fixed price basis, subject to the Protocol, Assumptions and Responsibilities detailed in Schedule 1.


 


In
the event of a material change in the scope of the Study, the Assumptions, the Responsibilities or the Protocol, hVIVO may initiate a
Change Order Request pursuant to Clause 8.1. Sponsor shall only be liable for any fees and charges in excess of those set forth
in the budget in the event that there is a material change in the scope of the Study, the Assumptions, the Responsibilities or the Protocol.


 




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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


INVOICING
SCHEDULE


 


	Total
    Study Budget	 	[***]
	Start
    Up Agreement Fees (paid)	 	-£[***]
	Remainder
    to Pay	 	£[***]


 


The
remaining fees will be invoiced according to the following schedule:


 


	Milestone
    payments	 	%	 	Contract	 	Advance
    Fees	 	Net
    Payment
	SUA
    Activities (Paid)	 	 	 	 	 	£[***]	 	£[***]
	Quarantine
    Booking Fee (Paid)	 	 	 	 	 	£[***]
    	 	£[***]
    
	On
    contract signature	 	[***]%	 	£[***]	 	[***]	 	£[***]
	Commencement
    of Screening	 	[***]%	 	£[***]	 	 	 	£[***]
	1st
    Inoculation	 	[***]%	 	£[***]	 	 	 	£[***]
	30th
    Inoculation	 	[***]%	 	£[***]	 	[***]	 	£[***]
	Last
    Inoculation	 	[***]%	 	£[***]	 	[***]	 	£[***]
	Data
    Lock	 	[***]%	 	£[***]	 	 	 	£[***]
	Clinical
    Study Report or 60 Days after 1st Draft)	 	[***]%	 	£[***]	 	 	 	£[***]
	Total	 	100%	 	£[***]	 	£[***]
    	 	£[***]


 





Key
Assumptions


 


	Data
    Management is based on initial quote and is confirmed on finalisation of Statistical Analytical Plan
	 
	IMP
    Destruction will be a pass through and is not included
	 
	Clinical
    Monitoring will contracted directly by client
	 
	Data
    & Legal Services assumed to run from Nov 21 (Protocol approval) to Jul 22 inclusive (CSR)
	 
	Medical
    Monitor is not included





 




    	36



     


    

 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


SCHEDULE
3


 


POSTPONEMENT
AND MATERIAL SCOPE REDUCTION


 


The
date of the Clinical Phase forming part of the Study, as agreed by the Parties is as set out in Schedule 1. Sponsor acknowledges
and agrees that hVIVO will incur expenses and lost revenue because of any Postponement or Material Scope Reduction that occurs before
or during the Clinical Phase. Therefore, in such an event, without prejudice to any other right or remedy of hVIVO, the Sponsor shall
pay hVIVO compensation for unused Bed Days as detailed below:


 


	Event	 	Compensation
	Postponement
    notified less than 12 weeks prior to, or after initiation of, the Clinical Phase	 	[***]%
    of unused Bed Day Fees
	Postponement
    notified more than 12 weeks prior to initiation of Clinical Phase	 	[***]%of
    unused Bed Day Fees
	Material
    Scope Reduction notified less than 12 weeks prior to, or after initiation of, the Clinical Phase	 	[***]%
    of unused Bed Day Fees
	Material
    Scope Reduction notified more than 12 weeks prior to initiation of Clinical Phase	 	[***]%
    of unused Bed Day Fees


 


In
addition to the Postponement Charge, Sponsor shall pay:


 


		

                                                                                (i)
	hVIVO’s
                                            fees and expenses associated with the Postponement and the rescheduling of the Clinical Phase;



		(ii)	any
                                            non-reimbursable third-party costs that hVIVO has incurred or is committed to incur in relation
                                            to the postponed Clinical Phase.



		(iii)	any
                                            additional fees and fees related to services performed that would need to be repeated in
                                            relation to the rescheduled Clinical Phase; 



		(iv)	hVIVO
                                            shall use Reasonable Endeavours to minimize such costs. hVIVO shall submit an itemized invoice
                                            to the Sponsor identifying all of the costs, charges and expenses to be reimbursed.



In
the event of a Postponement hVIVO shall, within a reasonable time frame, assess such Postponement with respect to (i) the timing of event;
and (ii) the impact on hVIVO’s business and may at its sole discretion, choose to waive part or all of the compensation payments
due.


 


The
Parties shall use Reasonable Endeavours to negotiate a rescheduled date for initiation or resumption of the Clinical Phase. The Clinical
Phase shall be deemed be rescheduled when the Parties have agreed upon a Change Order pursuant to the provisions of Clause 8.
If (i) such Change Order is not agreed within twelve (12) weeks of the date of Postponement; or (ii) the rescheduled date proposed by
Sponsor is not within one year of the original date of initiation of the Clinical Phase, hVIVO may terminate this Agreement upon written
notice to Sponsor.


 















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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential





SCHEDULE
4


 


DATA
PROTECTION


 


		1.	Definitions
                                            and Purpose



		1.1	Unless
                                            otherwise defined elsewhere in this Agreement, capitalized terms in this Schedule shall have
                                            the definitions given to them in the Data Protection Legislation.



		1.2	This
                                            Schedule sets out the framework for the collecting and sharing of Personal Data between the
                                            parties as Joint Controllers. It defines the principles and procedures that the parties shall
                                            adhere to and the responsibilities the parties owe to each other.



		2.	Compliance
                                            with legislation



		2.1	Each
                                            party shall maintain valid and up to date registrations or notifications required to process
                                            the Personal Data.



		2.2	Each
                                            party warrants and undertakes that, in respect of Personal Data collected or shared by that
                                            party:



		2.2.1	those
                                            Personal Data have been collected, processed and transferred in accordance with the Data
                                            Protection Legislation;



		2.2.2	the
                                            Data Subjects have been provided with all information required by the Data Protection Legislation;
                                            and,



		2.2.3	where
                                            necessary, it has obtained, recorded and can produce evidence of freely given, specific,
                                            informed, unambiguous and explicit consent from Data Subjects for their Personal Data including
                                            their Special Category Personal Data to be processed in order to fulfil the Purpose. 



		3.	Obligations



		3.1	Each
                                            party shall have in place appropriate technical and organisational measures to protect the
                                            Personal Data against accidental or unlawful destruction or accidental loss, alteration,
                                            unauthorised disclosure or access, and which provide a level of security appropriate to the
                                            risk represented by the processing and the nature of the data to be protected.



		3.2	The
                                            parties agree to provide reasonable and prompt assistance as is necessary to each other to
                                            enable them to comply with the Data Protection Legislation.



		3.3	Each
                                            party will inform the other immediately upon becoming aware of any actual or threatened data
                                            breach involving the Personal Data. Any such notification shall contain at least the nature
                                            of, the likely consequences of, and the measures taken or proposed to be taken to mitigate,
                                            the data breach. Information shall also contain the required elements as defined under Articles
                                            33 and 34 of GDPR. Any liability for the data breach will be determined in accordance with
                                            Article 82 of GDPR





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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


		3.4	Each
                                            party will provide clear and comprehensive privacy notices to Data Subjects whose data is
                                            collected by that party. Such privacy notices will comply with any requirements for information
                                            to be provided to Data Subjects under the Data Protection Legislation.



		4.	Transfers



Neither
party shall transfer any Personal Data outside of the European Economic Area unless such transfer is subject to appropriate safeguards
so as to ensure both parties’ compliance with the Data Protection Legislation.


 


		5.	Sub-Processors



		5.1	Where
                                            a party is to engage a sub-contractor to process the Personal Data on its behalf as a data
                                            processor (or sub-processor) that party must comply with, and ensure that such sub-contractor
                                            also complies with, the Data Protection Legislation. Each party shall be fully liable for
                                            the acts and/or omissions of its sub-contractors (including data processors and/or sub-processors)
                                            as though they were that party's acts or omissions.



		5.2	A
                                            party shall only use data processors (or sub-processors) providing sufficient guarantees
                                            to implement appropriate technical and organisational measures in such a manner that the
                                            processing will meet the requirements of the Data Protection Legislation and ensure the protection
                                            of the rights of the data subjects.



		5.3	Each
                                            party shall have in place procedures so that any third party it authorises to access the
                                            Personal data, including data processors, will respect and maintain the confidentiality of
                                            the Personal Data. Any person acting under the authority of either party shall be obligated
                                            to process the Personal Data only on instructions from that party.



		6.	Data
                                            subject rights



		6.1	Each
                                            party will be responsible for responding to Subject Access Requests received by that party.
                                            



		6.2	Each
                                            party will maintain a record of Subject Access Requests, the decisions made and any information
                                            that was exchanged. Records will include copies of the request for information, details of
                                            the data accessed and where relevant, notes of any meeting, correspondence or phone calls
                                            relating to the request.



		6.3	Each
                                            party will be responsible for the rectification of any inaccurate or incomplete Personal
                                            Data held by that party.





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EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.


 


Confidential


 


		6.4	Each
                                            party will be responsible for the erasure of Personal Data held by that party where erasure
                                            is required under Data Protection Legislation (including without limitation, the requirements
                                            of Article 17 GDPR).



		6.5	Each
                                            party will be responsible for the restriction of processing of Personal Data held by that
                                            party where such restriction is required under Data Protection Legislation (including without
                                            limitation, the requirements of Article 18 GDPR).



		6.6	Each
                                            party will be responsible for providing Personal Data held by that party to Data Subjects
                                            or third parties where such provision is required under Data Protection Legislation (including
                                            without limitation, the requirements of Article 20 GDPR).



		6.7	Each
                                            party will be responsible for responding to any objections that party receives from Data
                                            Subjects to the processing of Personal Data carried on by that party.



		6.8	Each
                                            party will notify the other without undue delay, if:



		6.8.1	they
                                            are informed of any inaccurate or incomplete Personal Data;



		6.8.2	they
                                            become aware of an obligation to erase Personal Data;



		6.8.3	they
                                            become aware of an obligation to restrict the processing of Personal Data; or



		6.8.4	they
                                            receive an objection to the processing of Personal Data from a Data Subject on any grounds.








    	40