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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

 

Amarex’s Response to AIM’s Request for Proposal

4 August 2020

Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 2

 

 

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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:

 

● 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 InformationPage 3

 

 

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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 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 InformationPage 4

 

 

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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) *** ***

 

*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 InformationPage 5

 

 

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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

 

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 InformationPage 6

 

 

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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 InformationPage 7

 

 

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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 InformationPage 8

 

 

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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  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 InformationPage 9

 

 

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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.:

 

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

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