Document:

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.

 

EXHIBIT
10.5

 

 

 

Response
to AIM ImmunoTech’s Request for 

Proposal for Services to Support a Phase I/II Clinical Trial for Ampligen in Healthy Volunteers

 

 

 

August
4, 2020

 

 

 

 

 

     

     

    

 

 

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.

 

Important
Information

 

This
proposal for a Project Work Order is provided to AIM ImmunoTech, Inc (AIM) for the purpose of its evaluation and the information
contained herein is not intended to be used by (AIM) for any other purpose than the subject of this proposal. (AIM) agrees not
to voluntarily disclose any of the information contained herein to any third party without the prior written consent of Amarex
Clinical Research, LLC (Amarex).

 

This
proposal document is subject to negotiation and, when the final version is signed by both parties, shall create a Project Work
Order with legal obligations on the part of both parties.

 

Proposal
Expiration Date: August 22, 2020

 

Prepared
for:

 

AIM
ImmunoTech Inc

2117
SW Highway 484

Ocala,
FL 34473

 

Prepared
by:

 

Amarex
Clinical Research, LLC

20201
Century Boulevard, Suite 450

Germantown,
MD 20874

Phone:
(301) 528-7000

Fax:
(301) 528-2300

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 2

     

    

 

 

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

(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.

 

Key
Study Assumptions

 

Amarex
understands that AIM would like to conduct a Phase I/II study in healthy volunteers of Ampligen to prevent COVID-19 infection.

 

Amarex
will provide:

 

	●	Project
    Management
	●	Data
    Management
	●	Clinical
    Site Management
	●	Randomization
	●	Statistics
	●	Safety
    and Pharmacovigilance
	●	Data
    Management Committee (DMC)
	●	Medical
    Writing

 

As
previously discussed, Amarex has identified a clinical site that will be able to handle the Phase I portion of the study. The
site also believes they will be able to handle the Phase II portion of the study, as long as the enrollment is around 150 subjects.
Additional sites may be added at AIM’s discretion. It is assumed that all lab work can be managed and run through the site.
Costs provided by the site and their projected enrollment times have been included in this proposal. The storage of serum samples
is not included in the budget.

 

This
proposal is based on the information provided by AIM and is subject to change based on the finalized protocol. We have assumed
that the Phase I will have 4 cohorts with 6 subjects each conducted in parallel, with 3 active cohorts and 1 placebo cohort. It
is assumed the subjects will receive treatments over a 28 day period. A follow up period of 28 days will occur after last treatment.
A DMC will occur after the last treatment visit is complete to determine if the Phase II should commence. Amarex will conduct
a remote initiation and interim monitoring visits during this Phase.

 

The
Phase II estimates 3 cohorts of 50 subjects each, 2 active cohorts and 1 placebo. An initial DMC will be held after the first
6 subjects in each cohort are enrolled and treated. Once the DMC clears the study to continue, the remaining 132 subjects will
be enrolled across the 3 cohorts. It is anticipated that some of the interim monitoring visits will be held at the site for this
part of the study. The schedule of events is expected to be nearly identical between the two Phases, and therefore no additional
programming would be needed to setup the EDC for the Phase II portion. A final analysis has been quoted in the budget below, but
it is understood that AIM may like to conduct another analysis for sample size purposes prior to closing enrollment.

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

Study
Parameters

 

 

 

 Following
is a list of study parameters Amarex has used in order to prepare this proposal response:

 

Table
3. Study Parameters Used to Prepare This Proposal

 

	STUDY
    PARAMETERS	Phase
    I 	Phase
    II
	Number
    of sites	***	***
	Number
    of countries participating in study	***	***
	Number
    of subjects screened	***	***
	Number
    of subjects randomized/enrolled	***	***
	SITE
    MONITORING AND AUDITING	***	***
	Number
    of site qualification visits	***	***
	Number
    of site initiation visits	***	***
	Number
    of interim monitoring visits	***	***
	Number
    of site closeout visits	***	***
	Number
    of study sites audited	***	***
	COMMITTEE
    FORMATION, INVESTIGATOR MEETING	 
	Number
    of DMC meetings to review data	***	***
	Number
    safety listings for DMC meetings (uniques/replicates)	***	***
	Number
    of Investigator meetings	***	***
	MEDICAL
    MONITORING	 	 
	Estimated
    number of SAEs 	***	***
	Estimated
    number of reportable events	***	***
	DATA
    MANAGEMENT	 	 
	Estimated
    Number of Adverse Events and Concomitant Medications to code	***	***
	Number
    of unique pages in eCRF	***	***
	Number
    of central labs	***	***
	BIOSTATISTICS	 	 
	Number
    of stat. tables for interim analysis (uniques/replicates)	***	***
	Number
    of listings for interim analysis (uniques/replicates)	***	***
	Number
    of graphs for interim analysis (uniques/replicates)	***	***

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

	Number
    of stat. tables for final analysis (uniques/replicates)	***	***
	Number
    of listings for final analysis (uniques/replicates)	***	***
	Number
    of graphs for final analysis (uniques/replicates)	***	***
	CLINICAL
    STUDY REPORT WRITING	 	 
	Write
    interim clinical trial report	***	***
	Write
    final clinical trial report	***	***
	PROJECT
    MANAGEMENT	 	 
	Number
    of months for project setup	***	***
	Number
    of months for enrollment/treatment	***	***
	Number
    of months for follow-up	***	***
	Number
    of months for close out	***	***
	Number
    of months of project management (including set up and close out)	***	***

 

*More
sites may be added to the Phase II, if desired. Additional sites will increase the Phase II cost, and an amendment can be signed
to make any such adjustments.

 

**Assumes
DMC after Phase I will review the Interim Analysis report.

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

Study
Roles and Responsibilities

 

Clearly-defined
roles and responsibilities are essential to project success, and Amarex will work closely with AIM to make sure all project tasks
are covered. It is our current understanding that the tasks associated with this trial are assigned as shown in Table 1, below.

 

Table
1. Study Tasks and Responsibilities

 

	Service	NA	Amarex	AIM
	PROJECT
    MANAGEMENT	 	 	 
	Meetings,
    Training, and Study Start Up	 	 	 
	Prepare
    for and Attend Kick-off Meeting & Study Start-Up	 	X	 
	Communication
    and Tracking	 	 	 
	Coordinate
    Amarex’s Internal Project Team	 	X	 
	Communicate
    with Sponsor 

    (includes standard teleconferences with activities reports, emails, faxes)	 	X	 
	Manage
    Central Labs/Vendors	X	 	 
	Tracking
    Systems Setup	 	X	 
	Management
    of Payments to Sites, IRBs, and/or Vendors	 	X	 
	REGULATORY
    SERVICES	X	 	 
	PRODUCT
    MANAGEMENT	 	 	 
	Support
    Drug Shipments	 	X	 
	DATA
    MANAGEMENT SERVICES	 	 	 
	Data
    Management	 	 	 
	Develop
    Data Management Plan	 	X	 
	Standard
    Data Cleaning (Run edit checks; generate, process, and track data queries)	 	X	 
	Develop
    Edit Specifications	 	X	 
	Data
    Operations	 	 	 
	Program
    Edit Checks	 	X	 
	Set
                                         Up Transfer of Final SAS Data to Sponsor

        (in
        Amarex’s format)
	 	X	 
	Perform
                                         Data Transfer to Sponsor

        (Including
        export of final SAS Analysis Datasets)
	 	X	 
	EDC
    Support	 	 	 
	Conduct
    Electronic Data Capture Site Training	 	X	 

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

	Prepare
    EDC Manual and Completion Instructions (includes up to 1 round of edits)	 	X	 
	Prepare
    User Acceptance Testing (UAT) Management Plan	 	X	 
	Conduct
    QC of EDC Database	 	X	 
	Provide
    Electronic Data Capture Help Desk	 	X	 
	EDC
    PROGRAMMING	 	 	 
	Development
    of CRF Screen Shots	 	X	 
	EDC
    Programming	 	X	 
	EDC
    Maintenance	 	X	 
	CLINICAL
    SITE SERVICES	 	 	 
	Site
    Identification and Contracting	 	 	 
	Prepare
    Site Identification Plan	X	 	 
	Perform
    Site Identification	X	 	 
	Present
    Sites for Site Qualification Visits	X	 	 
	Develop
    Site Contracts (includes up to 2 rounds of edits)	 	X	 
	Negotiate
    Site Contract CTAs	 	X	 
	Negotiate
    Site Contract Budgets	 	X	 
	IRB
    and Ethics Committee Management	 	X	 
	Site
    Regulatory Document Collection	 	 	 
	Set
    Up Trial Master File	 	X	 
	Set
    Up, File, and Track Investigator/Site Regulatory Files	 	X	 
	Conduct
    Ongoing Regulatory Document Collection, Review, Tracking, and Maintenance of Trial Master File	 	X	 
	Monitoring
    Services	 	 	 
	Prepare
    Study Operations Manual (includes up to 2 rounds of edits)	 	X	 
	Prepare
    Monitoring Guidelines (includes up to 2 round of edits)	 	X	 
	Perform
    Site Management	 	X	 
	Prepare
    for Site Visit 	 	X	 
	Prepare
    Documents for Site Initiation	 	X	 
	Conduct
    Site Qualification Visits	 	X	 
	Conduct
    Study Initiation Visits	 	X	 
	Conduct
    Interim Monitoring Visits	 	X
    	 
	Conduct
    Close Out Visits	 	X	 

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

	SAFETY	 	 	 
	Set
    Up Tracking System and SAE Start Up	 	X	 
	Prepare
    Safety Management Plan	 	X	 
	Collect,
    Process, Evaluate, Prepare Narrative, and Report SAEs (CIOMS or MedWatch)	 	X	 
	Medical
    Monitoring (24/7)	 	X	 
	Distribute
    SAE “Dear Dr.” Letters to Sites	 	X	 
	Submit
    Safety Reports to Regulatory Authorities	 	X	 
	Reconcile
    Safety Database with Clinical Database	 	X	 
	DATA
    MONITORING COMMITTEE (DMC)	 	 	 
	Establish
    and Manage 3-Member DMC	 	X	 
	Develop
    DMC Charter (includes up to 1 round of edits)	 	X	 
	Organize,
    Conduct and Participate in DMC Meetings	 	X	 
	Prepare
    Statistical Analysis Plan for DMC	X	 	 
	Program
    Tables, Listings and Graphs for DMC	 	X	 
	Prepare
    Statistical Report for DMC Meetings	 	X	 
	RANDOMIZATION
    AND ENROLLMENT	 	X	 
	BIOSTATISTICS	 	 	 
	Review
    the Protocol and Prepare Statistical Analysis Plan (1 draft and 1 final, mock templates for TLGs, and data set conventions)	 	X	 
	Program
    Tables, Listings and Graphs for Interim and Final Analysis	 	X	 
	Conduct
    QC Audit of Stats	 	X	 
	Production
    and Review of Tables, Listings, and Graphs for Interim and Final Analysis	 	X	 
	MEDICAL
    WRITING	 	 	 
	Prepare
                                         Interim Clinical Study Report

        (non-ICH
        Format) - includes up to one round of edits
	 	X	 
	Prepare
    Final Clinical Study Report Shell 

    (ICH Format) - includes up to one round of edits	 	X	 
	Prepare
    Final Clinical Study Report (ICH Format) with Appendices - includes up to two rounds of edits	 	X	 
	Conduct
    QC Audit of Clinical Study Report	 	X	 

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

Proposed
Amarex Direct Services Budget

 

***

Estimated
Pass-Through Costs

***

Estimated
Third Party Costs

 

***

Payment
Schedule for Services

The
payment terms and obligations for the services outlined in this proposal are as follows:

 

	Payment
    Description	 	Percentage
    Due	 	Phase
    I Amount	 	 	Phase
    II Amount	 
	Execution of Project Work
    Order	 	20%	 	$	***	 	 	$	***	 
	Monthly Unit-Based Billing	 	Balance Due	 	$	***	 	 	$	***	 
	TOTAL	 	 	 	$	514,391.29	 	 	$	650,247.87	 

 

The
Execution payment will be credited back to AIM as monthly invoices hit certain milestones against the expected total cost of Amarex
services. Milestones will be on the *** totals have been billed to AIM. AIM will be billed each month for units of service performed
in that month. If the study is terminated early, AIM will only be responsible for the units of work performed, and any remaining
funds from the execution fee that have not been applied will be refunded to AIM.

 

Payment
Schedule for Pass-Through Expenses

Pass-through
expenses such as approved travel, document shipping and printing, and other reasonable expenses will be invoiced to AIM at cost.
These expenses will be supported by acceptable documentation or actual receipts and will be invoiced on a monthly basis.

 

Payment
Terms

		***	

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 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.

 

Project
Work Order Signatures

 

In
Witness Whereof, AIM ImmunoTech Inc. and Amarex Clinical Research, LLC agree to all items and payment terms and conditions presented
in this Project Work Order as indicated by the signatures below of their respective duly authorized representatives as of the
“Effective Date”, appearing below.

 

ACKNOWLEDGED,
ACCEPTED, AND AGREED TO:

 

	For
                                         and on behalf of AIM ImmunoTech

        Inc.:
	 	For
                                         and on behalf of Amarex Clinical 

        Research,
        LLC:

	Print
    Name: 	 Peter
    Rodino 	 	Print
    Name: 	Kazem
    Kazempour
	Signature:
    	 /s/
    Peter Rodino 	 	Signature:
    	/s/
    Kazem Kazempour
	Title:
    	 COO
    and General Counsel 	 	Title:
    	President
    and CEO (Member)
	Effective Date:	 08/06/20 
	 	Effective Date:	 

 

    	Amarex’s Response to AIM’s Request for Proposal	4 August 2020

	Amarex Clinical Research, LLC Confidential and Proprietary Information	Page 10Exhibit (10)(a)

    

    

    

    

    

    

    Consent of Independent Registered Public Accounting Firm

    

    

    

    

    We consent to the reference to our firm under the caption “Independent Registered Public Accounting Firm” in
      Post-Effective Amendment No. 79 to the 1933 Act Registration Statement (Form N-4 No. 333-40937) and Amendment No. 781 to the 1940 Act Registration
      Statement (Form N-4 No. 811-08517), and to the use therein of our reports dated (a) March 13, 2020, with respect to the consolidated financial statements of The Lincoln National Life Insurance Company and (b) April 15, 2020, with respect to the financial statements of Lincoln National Variable Annuity
      Account N for the registration of interests in a separate account under individual flexible payment deferred variable annuity contracts.

    

    

    

    

    

    

    

    

    /s/ Ernst & Young LLP

    Philadelphia, Pennsylvania

    August 14, 2020

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