August 6, 2020, Project Work Order with Amarex Clinical Research LLC. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))

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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 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

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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:

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.

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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

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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.

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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

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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:

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.

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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: