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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

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Important Information
This proposal for a Project Work Order is provided to AIM ImmunoTech, Inc (AIM) for the purpose of its evaluation and theinformation 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 Inc2117 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
Amarex Clinical Research, LLC Confidential and Proprietary Information

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-5.htm

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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:
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●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 haveassumed that the Phase I will have 4 cohorts with 6 subjects each conducted in parallel, with 3 active cohorts and 1 placebo cohort. Itis assumed the subjects will receive treatments over a 28 day period. A follow up period of 28 days will occur after last treatment. ADMC will occur after the last treatment visit is complete to determine if the Phase II should commence. Amarex will conduct a remoteinitiation 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 6subjects in each cohort are enrolled and treated. Once the DMC clears the study to continue, the remaining 132 subjects will beenrolled across the 3 cohorts. It is anticipated that some of the interim monitoring visits will be held at the site for this part of thestudy. 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 understoodthat AIM may like to conduct another analysis for sample size purposes prior to closing enrollment.
Amarex’s Response to AIM’s Request for Proposal
Amarex Clinical Research, LLC Confidential and Proprietary Information

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-5.htm

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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
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
Amarex Clinical Research, LLC Confidential and Proprietary Information

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-5.htm

Phase I
***
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Phase II
***
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***
***
***
***
***
***
***
***

***
***
***

***
***
***

***
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***
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***
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***

***
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***

***
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***
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***
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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)

***
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***
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***
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***
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***
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*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
Amarex Clinical Research, LLC Confidential and Proprietary Information

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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
ServicePROJECT MANAGEMENT
Meetings, Training, and Study Start Up
Prepare for and Attend Kick-off Meeting & Study Start-Up
Communication and Tracking
Coordinate Amarex’s Internal Project Team
Communicate with Sponsor(includes standard teleconferences with activities reports, emails, faxes)
Manage Central Labs/Vendors
Tracking Systems Setup
Management of Payments to Sites, IRBs, and/or Vendors
REGULATORY SERVICES
PRODUCT MANAGEMENT
Support Drug Shipments
DATA MANAGEMENT SERVICES
Data Management
Develop Data Management Plan
Standard Data Cleaning (Run edit checks; generate, process, and track data queries)
Develop Edit Specifications
Data Operations
Program Edit Checks
Set Up Transfer of Final SAS Data to Sponsor(in Amarex’s format)
Perform Data Transfer to Sponsor(Including export of final SAS Analysis Datasets)
EDC Support
Conduct Electronic Data Capture Site Training
Amarex’s Response to AIM’s Request for Proposal
Amarex Clinical Research, LLC Confidential and Proprietary Information

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-5.htm

NAAmarex

AIMX
X
X
X
X
X
X
X

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

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-5.htm

X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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SAFETYSet Up Tracking System and SAE Start UpPrepare Safety Management Plan
Collect, Process, Evaluate, Prepare Narrative, and Report SAEs (CIOMS or MedWatch)
Medical Monitoring (24/7)
Distribute SAE “Dear Dr.” Letters to Sites
Submit Safety Reports to Regulatory Authorities
Reconcile Safety Database with Clinical Database
DATA MONITORING COMMITTEE (DMC)
Establish and Manage 3-Member DMC
Develop DMC Charter (includes up to 1 round of edits)
Organize, Conduct and Participate in DMC Meetings
Prepare Statistical Analysis Plan for DMC
Program Tables, Listings and Graphs for DMC
Prepare Statistical Report for DMC Meetings
RANDOMIZATION AND ENROLLMENTBIOSTATISTICS
Review the Protocol and Prepare Statistical Analysis Plan (1 draft and 1 final, mock
templates for TLGs, and data set conventions)
Program Tables, Listings and Graphs for Interim and Final Analysis
Conduct QC Audit of Stats
Production and Review of Tables, Listings, and Graphs for Interim and Final Analysis
MEDICAL WRITING
Prepare Interim Clinical Study Report(non-ICH Format) - includes up to one round of edits
Prepare Final Clinical Study Report Shell(ICH Format) - includes up to one round of edits
Prepare Final Clinical Study Report (ICH Format) with Appendices - includes up to tworounds of edits
Conduct QC Audit of Clinical Study Report
Amarex’s Response to AIM’s Request for Proposal
Amarex Clinical Research, LLC Confidential and Proprietary Information

https://www.sec.gov/Archives/edgar/data/946644/000149315220015932/ex10-5.htm

X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X

X
X
X
X
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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
Execution of Project Work Order
Monthly Unit-Based Billing
TOTAL

Percentage Due
20%Balance Due$$$

Phase I Amount******
514,391.29$$$

Phase II Amount******
650,247.87The Execution payment will be credited back to AIM as monthly invoices hit certain milestones against the expected total cost ofAmarex 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 toAIM 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
Amarex Clinical Research, LLC Confidential and Proprietary Information

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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.:
Print Name:Peter Rodino
Signature:/s/ Peter Rodino
Title:
COO and General Counsel
Effective Date: 08/06/20

For and on behalf of Amarex ClinicalResearch, LLC:
Print Name:
Kazem Kazempour
Signature:/s/ Kazem Kazempour
Title:
President and CEO (Member)
Effective Date:

Amarex’s Response to AIM’s Request for Proposal
Amarex Clinical Research, LLC Confidential and Proprietary Information

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