Exhibit
10.78


 





 


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.


 


Amendment
01 to Project AIM02


Statement
of Work and Budget for


 


Original
Amarex Project No.:


AIM02_Phase
1 & 2


 


Prepared
for:


AIM
ImmunoTech Inc.


2117
SW Highway 484


Ocala,
FL 34473


 


Prepared
by:


Amarex
Clinical Research, LLC


20201
Century Boulevard


Germantown,
MD 20874


Phone:
(301) 528-7000


Fax:
(301) 528-2300


 


Amendment
Date: December 30, 2020


 




 





This Amendment 1 to the Amarex Project AIM02 is prepared for the
exclusive use of AIM, for the work indicated herein. It is proprietary and not to
be copied or distributed outside of AIM.




 





 













    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 1




     


    

 





1.
Terms and Conditions


 






 


Made
this 30th day of December, 2020 (the “Effective Date”) to the Project Agreement made on the 6th day of
August, 2020 (the “Agreement) by and between:


 


AIM
Immunotech Inc., a corporation with its principal place of business at 2117 SW Highway 484, Ocala, FL 34473 (hereinafter “AIM”),
AND


 


Amarex
Clinical Research, LLC, a for-profit Maryland limited liability company with its principal place of business at 20201 Century
Boulevard, Germantown, Maryland 20874. (hereinafter “Amarex”).


 


WHEREAS
AIM has requested and Amarex has agreed to provide certain Services in addition to those in the Agreement relating to additional
services.


 


NOW
THEREFORE, the parties hereby agree to amend the Agreement as follows:


 


		1.	Amarex
                                         agrees to provide the Services as listed in Section 2, Project Statement of Work.
	 	 	 
		2.	AIM
                                         agrees to pay Amarex the costs noted in Section 4, Amendment Budget.
	 	 	 
		3.	AIM
                                         will pay the costs associated with the Amendment according to Section 5, Payment Schedule.



 


This
Amendment may be signed in any number of counterparts, which, when taken together, will constitute one and the same Amendment.


 


IN
WITNESS WHEREOF, the authorized representatives of the parties have duly executed this agreement as of the Effective Date.


 


FOR
AND BEHALF OF:


 


	For and on behalf of AIM Immunotech Inc.:	 	For
    and on behalf of Amarex Clinical Research, LLC:
	 	 	 
	Print
    Name: 	Peter
    W. Rodino	 	Print
    Name: 	Kazem
    Kazempour
	 	 	 	 	 
	Signature:
    	/s/
    Peter W. Rodino	 	Signature:
    	/s
    /Kazem Kazempour
	 	 	 	 	 
	Title:
    	COO	 	Title:
    	President
    and CEO (Member)
	 	 	 	 	 
	Date:	1/5/2021	 	 Date:	1/6/2021


 




    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 2




     


    




 


2.
Project Statement of Work


 






 


Amarex
will support AIM in clinical trial work, to include:


 


	 	●	Monitoring
    of the Phase I Unit in the Netherlands by a local Dutch monitor.
	 	 	 
	 	●	Setup
    and maintenance of a shadow TMF, and investigator site files can be provided if the Phase I Unit does not do this itself.
    Training of a backup CRA can be conducted, if needed.


 





Assumptions


 


	Activity
    / resource	 	Unit
	Patients,
    territories and sites	 	 
	Enrolled
    patients 	 	40
	Sites
    	 	1
	Countries
    	 	1
    (NL)
	CRAs	 	1

        (backup
        CRA training billed if required)

	Study
    duration (months)	 	 
	Set
    up duration	 	1.0
	Conduct
    	 	5
	Closure
    duration	 	1.0
	Meetings
    and visits	 	 
	KO
    TC	 	1
	Investigator
    meetings 	 	NA
    
	Sponsor/CRO
    Study Team Teleconferences	 	9x
        1hr TCs in total

        Fortnightly
        during set up

        Monthly
        during Conduct

        Fortnightly
        during closure

	Site
    visits	 	 
	PSVs	 	0
	SIVs	 	1
	MVs
    - Conduct 	 	6
    (1x 1 day visit and 5x 2 day visits)
	COVs	 	1


 


3.
Timelines


 






 


Amarex
will begin working upon approval of this Amendment.


 




    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 3




     


    

 





4.
Amendment Budget


 






 





Services

 


	CLINICAL SITE SERVICES	 
	Bid ID	 	Service	 	Unit Description	 	 	Unit Cost $	 	 	No. 
 Units
	 	 	Total 
 Cost $ 
	 	 	 	Category 
 Total $ 
	 
	 	 	Study start-up (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	1	 	Study familiarisation	 	Once	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	2	 	Study KO meeting (TC)	 	Once	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	3	 	Preparation of PM Plans	 	Plans	 	 	$ [***]	 	 	4	 	 	$ [***]	 	 	 	 	 
	4	 	Site initiation	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	5	 	In-house SCRA activities - set up including site communication	 	Site / months	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	6	 	Sponsor TCs - set up	 	Alternate Weeks	 	 	$ [***]	 	 	2	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Conduct (5 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	7	 	Monitoring Visits	 	IMV	 	 	$ [***]	 	 	6	 	 	$ [***]	 	 	 	 	 
	8	 	In-house SCRA activities - conduct 
including site communication	 	cohorts	 	 	$ [***]	 	 	4	 	 	$ [***]	 	 	 	 	 
	9	 	Sponsor TCs - Conduct	 	monthly	 	 	$ [***]	 	 	5	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Study closure (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	10	 	Close-Out	 	COVs	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	11	 	In-house SCRA activities - closure 
including site communication	 	Site / months	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	12	 	Sponsor TCs - closure	 	Alternate Weeks	 	 	$ [***]	 	 	2	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	TOTAL	 	 	 	 	 	 	 	 	 	 	$ [***]	 	 	 	 	 



 


Optional
Services


 


	OPTIONAL SERVICES	 
	Bid ID	 	Service	 	Unit Description	 	Unit Cost $	 	 	No. 
 Units
	 	Total 
 Cost $ 
	 	 	Category 
 Total $ 
	 
	 	 	Study start-up (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	13	 	Backup CRA familiarization and training	 	per CRA	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	14	 	Set up shadow TMF	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	 	 
	15	 	Set up ISFs	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Conduct (5 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	16	 	Maintenance of TMF - Conduct	 	Site / months	 	 	$ [***]	 	 	5	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	Study closure (1 months)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	17	 	Return of TMF to sponsor	 	Sites	 	 	$ [***]	 	 	1	 	 	$ [***]	 	 	 	$ [***]	 



 




    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 4




     


    

 








Estimated
Pass-Through


 


	Estimated Pass-Through Costs	 
	Bid ID	 	Service	 	Unit Description	 	 	Unit Cost $ 	 	 	No. 
 Units
	 	 	Total 
 Cost $ 
	 	 	 	Category 
 Total $ 
	 
	1	 	Printing/Shipping	 	site months	 	 	$ [***]	 	 	7	 	 	$ [***]	 	 	 	 	 
	2	 	Communications	 	TCs	 	 	$ [***]	 	 	9	 	 	$ [***]	 	 	 	$ [***]	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	ESTIMATED TOTAL	 	 	 	 	 	 	 	 	 	 	$ [***]	 	 	 	 	 



 


5.
Payment Schedule


 






 


	Payment Description	 	Percentage Due	 	Amount
	Monthly Unit-Based Billing	 	TBD	 	TBD



 


AIM
will be billed according to the same terms and provisions as outlined in the Agreement.


 




    	Amarex Confidential and Proprietary
	
	Amendment 01 to AIM02 Contract	12/30/20

	Additional Services	Page 5