8-K
AIM ImmunoTech Inc. (AIM)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported)
June13, 2022
AIM
IMMUNOTECH INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-27072 | 52-0845822 |
|---|---|---|
| (state<br> or other jurisdiction | (Commission | (I.R.S.<br> Employer |
| of<br> incorporation) | File<br> Number) | Identification<br> No.) |
| 2117 SW Highway 484, Ocala FL | 34473 | |
| --- | --- | |
| (Address<br> of principal executive offices) | (Zip<br> Code) |
Registrant’s
telephone number, including area code: (352) 448-7797
AIM ImmunoTech Inc.
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities
registered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.001 per share | AIM | NYSE<br> American |
Item1.01 Entry into a Material Definitive Agreement.
On June 13, 2022, we executed a work order with Amarex Clinical Research LLC (“Amarex”) our contract research organization, pursuant to which Amarex will manage the clinical trial entitled: “A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ampligen® in Patients with Post-COVID Conditions,” once FDA authorization to proceed is received. The study will be conducted at up to 10 sites in the United States. We are sponsoring the study. Per the work order, we anticipate that the study will cost approximately $4.4 million which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations. A copy of the Amarex work order is filed herewith as Exhibit 10.1.
CautionaryStatement
This Current Report on Form 8-K and the exhibit filed herewith, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether the Study concerning the efficacy and safety of Ampligen® in patients with Post-COVID Conditions or other current or planned clinical trials will be successful, yield favorable data or not require additional funding, and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Even if Ampligen® proves effective in treating Post-COVID Conditions, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive, major pharma companies may be working to develop their own disease treatments. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the presentation. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. In addition, many countries, including Argentina, are dealing with COVID-19 outbreaks and have made that their primary focus. We believe that this may be delaying our commercialization of Ampligen® in Argentina until COVID-19 is more under control. We cannot assure that our potential foreign operations will not be adversely affected by these risks.
Item9.01. Financial Statements and Exhibits.
(d)Exhibits.
| Exhibit No. | Description |
|---|---|
| 10.1 | June 13, 2022 Amarex Work Order (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10)). |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AIM<br> IMMUNOTECH INC. | ||
|---|---|---|
| June<br> 17, 2022 | By: | /s/ Thomas K. Equels |
| Thomas<br> K. Equels, CEO |
Exhibit10.1
EXPLANATORYNOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Response to AIM ImmunoTech’s
Request for Proposal for Trial Services to
Support a Phase II Study of Ampligen in Patients
with Post-COVID Conditions
June 13, 2022
EXPLANATORYNOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IF 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 13, 2022
Preparedfor:
AIM ImmunoTech Inc
783 Jersey Avenue
New Brunswick, NJ 08901
Phone: 352-260-7797
Fax: 724-260-6742
Preparedby:
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 | 6/13/2022 |
| --- | --- | | Amarex Clinical Research, LLC Confidential and Proprietary Information | Page i |
EXPLANATORYNOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Our Understanding of AIM’s Needs
Based on our discussions with AIM, Amarex understands that AIM plans to conduct a trial entitled: “A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ampligen^®^ in Patients with Post-COVID Conditions.” The study will be conducted at up to 10 sites in the United States. No interim analysis is planned.
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<br> of sites | 10 |
| Number<br> of countries participating in study | 1 |
| Number<br> of subjects screened | 170 |
| Number<br> of subjects randomized/enrolled | 80 |
| Number<br> of subjects completed | 80 |
| SITE MONITORING AND AUDITING | |
| Number<br> of qualification sites | 20 |
| Number<br> of site initiation visits | 10 |
| Number<br> of interim monitoring sites | 40 |
| Number<br> of closeout visits | 10 |
| IRB MANAGEMENT | |
| Number<br> of Local IRB to manage | 10 |
| Number<br> of Central IRB to manage | 1 |
| Number<br> of DSMB meetings to review data | 1 |
| Number<br> of statistical tables per DSMB | 10/10 |
| Number<br> of statistical listings per DSMB | 10/10 |
| MEDICAL MONITORING | |
| Estimated<br> number of SAEs | 5 |
| Estimated<br> number of reportable events | 1 |
| DATA MANAGEMENT | |
| Estimated<br> Number of Adverse Events, Concomitant Medications, and Medical Histories to code | 2,210 |
| Number<br> of unique pages in eCRF book | 20 |
| Number<br> of central labs & vendors | 2 |
| BIOSTATISTICS | |
| Number<br> of stat. tables for final analysis (uniques/replicates) | 30/20 |
| Number<br> of listings for final analysis (uniques/replicates) | 30/20 |
| Number<br> of graphs for final analysis (unique/replicate) | 5/0 |
| CLINICAL STUDY REPORT WRITING | |
| Write<br> final clinical trial report | Yes |
| PROJECT MANAGEMENT | |
| Number<br> of months for project setup | 2 |
| Number<br> of months for enrollment | 4 |
| Number<br> of months for follow-up (treatment period) | 3 |
| Number<br> of months of active study phase for monitoring | 7 |
| Number<br> of months for close out | 2 |
| Number<br> of months of project management (including set up and close out) | 11 |
| Amarex’s Response to AIM’s Request for Proposal | 6/13/2022 |
| --- | --- | | Amarex Clinical Research, LLC Confidential and Proprietary Information | Page 1 |
EXPLANATORYNOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Proposed Amarex Direct Services Budget
(US Dollars)
| AMAREX DIRECT SERVICES FEES | |||||
|---|---|---|---|---|---|
| Bid ID | Service | Unit Description | Unit Cost $ | No. Units | Total<br> <br> Cost |
| B | PROJECT MANAGEMENT | ||||
| Meetings, Training, and Study Start Up | |||||
| 11 | Prepare<br> for and Attend Kick-off Meeting & Study Start-Up | per<br> protocol | $ [***] | 1 | [***] |
| 16 | Prepare<br> for and Attend Project Team Training | per<br> day | $ [***] | 1 | [***] |
| Communication and Tracking | |||||
| 17 | Coordinate<br> Amarex's Internal Project Team | per<br> month | $ [***] | 11 | [***] |
| 18 | Communicate<br> with Sponsor <br><br> (includes standard teleconferences with activities reports and emails) | per<br> month | $ [***] | 11 | [***] |
| 19 | Manage<br> Central Labs/Vendors | per<br> lab-vendor/per month | $ [***] | 14 | [***] |
| 20 | Tracking<br> Systems Setup | fixed<br> fee | $ [***] | 1 | [***] |
| 27.1 | Management<br> of Payments to Sites, IRBs, Labs, and/or Vendors | per<br> payment / site, IRB or vendor | $ [***] | 61 | [***] |
| D | PRODUCT MANAGEMENT | ||||
| 59 | Set<br> up of WebView IRT product supply tracking and email alert system. Track drug shipments to sites, supply depots, auto-email<br> requests for resupply based on randomization. Require acknowledgement email from supply depot. | per<br> project | $ [***] | 1 | [***] |
| 60 | Maintenance<br> for WebView IRT Product Resupply and Tracking | per<br> site per month | $ [***] | 20 | [***] |
| 63 | Support<br> Initial Drug / Device Shipments | per<br> site per shipment | $ [***] | 10 | [***] |
| E | DATA MANAGEMENT SERVICES | ||||
| Data Management | |||||
| 65 | Develop<br> Data Management Plan | per<br> project | $ [***] | 1 | [***] |
| 73 | Standard<br> Data Cleaning (Run edit checks; generate, process, and track data queries) | per<br> query | $ [***] | 800 | [***] |
| 78 | Develop<br> Edit Specifications | per<br> project | $ [***] | 1 | [***] |
| 79 | Conduct<br> QC Audit of Interim Clinical Database <br><br> (5% of pts (min 5 max 50) for all data per lock) | per<br> subject | $ [***] | 2 | [***] |
| Data Operations | |||||
| 86 | Program<br> Edit Checks | per<br> edit check | $ [***] | 200 | [***] |
| 88 | Set<br> Up Data Transfer from Vendors | fixed<br> cost/per vendor | $ [***] | 2 | [***] |
| 89 | Receive<br> and Reconcile Headers of Clean Data from Vendors | per<br> transfer/per vendor | $ [***] | 14 | [***] |
| 91 | Set<br> Up Transfer of Final SAS Data to Sponsor <br><br> (in Amarex's format) | per<br> dataset | $ [***] | 40 | [***] |
| 92 | Perform<br> Data Transfer to Sponsor <br><br> (Including export of final SAS Analysis Datasets) | per<br> transfer | $ [***] | 1 | [***] |
| EDC Support | |||||
| 96 | Prepare<br> EDC Manual and Completion Instructions (includes up to 1 round of edits) | per<br> manual | $ [***] | 1 | [***] |
| 97 | Prepare<br> User Acceptance Testing (UAT) Management Plan | per<br> document | $ [***] | 1 | [***] |
| 98 | Conduct<br> QC of EDC Database | per<br> subject enrolled | $ [***] | 80 | [***] |
| 99 | Provide<br> Electronic Data Capture Help Desk | per<br> site/per month | $ [***] | 70 | [***] |
| WEBVIEW EDC PROGRAMMING | |||||
| 101 | Development<br> of CRF Screen Shots | per<br> unique page | $ [***] | 20 | [***] |
| 102 | WebView<br> EDC Programming (Initiation) | per<br> study | $ [***] | 1 | [***] |
| 103 | WebView<br> EDC Programming (UAT 1) | per<br> study | $ [***] | 1 | [***] |
| 104 | WebView<br> EDC Programming (System Activation) | per<br> study | $ [***] | 1 | [***] |
| 105 | WebView<br> EDC Maintenance | per<br> month | $ [***] | 9 | [***] |
| F | CLINICAL SITE SERVICES | ||||
| Site Identification and Contracting | |||||
| 106 | Prepare<br> Site Identification Plan | per<br> plan | $ [***] | 1 | [***] |
| 107 | Perform<br> Site Identification and Present Sites for Site Qualification Visits | per<br> site recommended | $ [***] | 15 | [***] |
| 108 | Develop<br> Site Contracts (includes up to 2 rounds of edits) | per<br> contract | $ [***] | 1 | [***] |
| 109 | Negotiate<br> Site Contract CTAs | per<br> site | $ [***] | 10 | [***] |
| 110 | Negotiate<br> Site Contract Budgets | per<br> site | $ [***] | 10 | [***] |
| IRB and Ethics Committee Management | |||||
| 112 | Submit<br> and Obtain Initial Approval of Local IRB | per<br> submission per Local IRB | $ [***] | 10 | [***] |
| 113 | Submit<br> and Obtain Initial Approval of Central IRB | per<br> submission per Central IRB | $ [***] | 1 | [***] |
| 116 | Review<br> and Approve IRB Informed Consent Comments | per<br> IRB | $ [***] | 11 | [***] |
| 117 | Review<br> and Approve Site Informed Consent Prior to IRB Submission | per<br> site | $ [***] | 10 | [***] |
| Site Regulatory Document Collection | |||||
| 120 | Set<br> Up Trial Master File | per<br> study | $ [***] | 1 | [***] |
| 121 | Set<br> Up Investigator/Site Regulatory Files | per<br> site | $ [***] | 10 | [***] |
| 122 | Conduct<br> Ongoing Regulatory Document Collection, Review, Tracking, and Maintenance of Trial Master File | per<br> site/per month | $ [***] | 70 | [***] |
| Monitoring Services | |||||
| 123 | Prepare<br> Study Operations Manual (includes up to 2 rounds of edits) | per<br> project | $ [***] | 1 | [***] |
| 124 | Prepare<br> Monitoring Guidelines (includes up to 2 round of edits) | per<br> project | $ [***] | 1 | [***] |
| 125 | Perform<br> Site Management | per<br> site/per month | $ [***] | 90 | [***] |
| 127 | Prepare<br> Documents for Site Initiation | per<br> project | $ [***] | 1 | [***] |
| 128 | Conduct<br> Site Qualification Visits (includes prep and visit report in Amarex format) | per<br> one-day visit | $ [***] | 20 | [***] |
| 129 | Conduct<br> Study Initiation Visits (includes prep and visit report in Amarex format) | per<br> one-day visit | $ [***] | 10 | [***] |
| 130 | Conduct<br> Interim Monitoring Visits (includes prep and visit report in Amarex format) | per<br> one-day visit | $ [***] | 40 | [***] |
| 131 | Conduct<br> Close Out Visits (includes prep and visit report in Amarex format) | per<br> one-day visit | $ [***] | 10 | [***] |
| 133 | Travel<br> Time for Monitoring Visits | per<br> trip | $ [***] | 80 | [***] |
All values are in US Dollars.
| Amarex’s Response to AIM’s Request for Proposal | 6/13/2022 |
| --- | --- | | Amarex Clinical Research, LLC Confidential and Proprietary Information | Page 2 |
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 IF PUBLICLY DISCLOSED.
| AMAREX DIRECT SERVICES FEES | |||||
|---|---|---|---|---|---|
| Bid ID | Service | Unit Description | Unit Cost $ | No. Units | Total<br> <br> Cost |
| G | SAFETY | ||||
| 143 | Set<br> Up Tracking System and SAE/UADE Start Up | fixed<br> fee | $ [***] | 1 | [***] |
| 144 | Prepare<br> Safety Management Plan (includes up to 1 round of edits) | per<br> plan | $ [***] | 1 | [***] |
| 145 | Prepare<br> Medical Monitoring Plan (includes up to 1 round of edits) | per<br> plan | $ [***] | 1 | [***] |
| 146 | Set<br> Up WebView EDC Safety Reporting Module | per<br> project | $ [***] | 1 | [***] |
| 148 | Collect,<br> Process, Evaluate SAE/UADE or Pregnancy, and Prepare Narrative | per<br> event | $ [***] | 5 | [***] |
| 149 | Prepare<br> CIOMS or MedWatch Form | per<br> reportable event | $ [***] | 1 | [***] |
| 150 | Prepare<br> SAE/UADE Follow up Reports | per<br> update | $ [***] | TBD | [***] |
| 153 | Revise<br> SAE/UADE Narratives for DSMB Meetings | per<br> event/per meeting | $ [***] | 7 | [***] |
| 154 | Distribute<br> SAE/UADE "Dear Dr." Letters to Sites | per<br> letter per site | $ [***] | 10 | [***] |
| 155 | Submit<br> Safety Reports to Regulatory Authorities | per<br> reportable event per country | $ [***] | 1 | [***] |
| 159 | Set<br> Up of Coding System to Code AEs, ConMeds, and Histories | fixed<br> cost | $ [***] | 1 | [***] |
| 160 | Prepare<br> Medical Coding Plan (includes up to 2 rounds of edits) | per<br> plan | $ [***] | 1 | [***] |
| 161 | Code<br> Adverse Events, Medications, and Histories<br><br> (Using MedDRA and WHO Drug ATC Level) | per<br> term | $ [***] | 2210 | [***] |
| H | DATA SAFETY MONITORING BOARD (DSMB) | ||||
| 163 | Establish<br> and Manage 3-Member DSMB | fixed<br> cost | $ [***] | 1 | [***] |
| 164 | Develop<br> DSMB Charter (includes up to 1 round of edits) | per<br> project | $ [***] | 1 | [***] |
| 165 | Organize,<br> Conduct and Participate in DSMB Meetings | per<br> meeting | $ [***] | 2 | [***] |
| 166 | Prepare<br> Statistical Analysis Plan for DSMB | per<br> project | $ [***] | 1 | [***] |
| 167 | Program<br> and Produce Unique Tables for DSMB | per<br> unique table | $ [***] | 10 | [***] |
| 168 | Program<br> and Produce Replicate Tables for DSMB | per<br> replicate table | $ [***] | 10 | [***] |
| 169 | Program<br> and Produce Unique Listings for DSMB | per<br> unique listing | $ [***] | 10 | [***] |
| 170 | Program<br> and Produce Replicate Listings for DSMB | per<br> replicate listing | $ [***] | 10 | [***] |
| 172 | Prepare<br> Statistical Report for DSMB Meeting (open and closed session reports, includes up to 1 round of edits) | per<br> meeting | $ [***] | 1 | [***] |
| I | RANDOMIZATION AND ENROLLMENT | ||||
| 176 | Develop<br> WebView IRT Enrollment/Randomization Module | per<br> project | $ [***] | 1 | [***] |
| 177 | Generate<br> WebView IRT Randomization Code and Plan | per<br> project | $ [***] | 1 | [***] |
| 178 | Conduct<br> WebView IRT Enrollment/Randomization Maintenance | per<br> month | $ [***] | 7 | [***] |
| J | BIOSTATISTICS | ||||
| 182 | Prepare<br> Statistical Analysis Plan (includes list of TLGs in Amarex standard format, and data set conventions) | per<br> project | $ [***] | 1 | [***] |
| 189 | Program<br> Tables for Final Analysis (unique tables) | per<br> unique table | $ [***] | 30 | [***] |
| 190 | Program<br> Tables for Final Analysis (replicate tables) | per<br> replicate table | $ [***] | 20 | [***] |
| 191 | Program<br> Listings for Final Analysis (unique listings) | per<br> unique listing | $ [***] | 30 | [***] |
| 192 | Program<br> Listings for Final Analysis (replicate listings) | per<br> replicate listing | $ [***] | 20 | [***] |
| 193 | Program<br> Graphs for Final Analysis (unique graph) | per<br> unique graph | $ [***] | 5 | [***] |
| 195 | Conduct<br> QC Audit of Stats | per<br> lock | $ [***] | 1 | [***] |
| 198 | Production<br> and Review of Tables, Listings, and Graphs for Final Analysis (per unique display) | per<br> unique display | $ [***] | 65 | [***] |
| 199 | Production<br> and Review of Tables, Listings, and Graphs for Final Analysis (per replicate display) | per<br> replicate display | $ [***] | 40 | [***] |
| Other | |||||
| 202 | Base<br> ADaM CDISC Conversion (mapping and programming) | per<br> conversion | $ [***] | 1 | [***] |
| K | MEDICAL WRITING | ||||
| 211 | Prepare<br> Final Clinical Study Report Shell <br><br> (ICH Format) - includes up to one round of edits | per<br> report | $ [***] | 1 | [***] |
| 212 | Prepare<br> Subject Narratives for CSR | per<br> narrative | $ [***] | 8 | [***] |
| 213 | Prepare<br> Final Clinical Study Report (ICH Format) with Appendices - includes up to two rounds of edits | per<br> report | $ [***] | 1 | [***] |
| 214 | Conduct<br> QC Audit of Clinical Study Report | per<br> report | $ [***] | 1 | [***] |
| M | GENERAL & ADMINISTRATIVE EXPENSES | ||||
| 221 | G&A<br> Expenses | per<br> month | $ [***] | 11 | [***] |
| TOTAL OF ACTIVITY-BASED COSTING | [***] |
All values are in US Dollars.
| Amarex’s Response to AIM’s Request for Proposal | 6/13/2022 |
| --- | --- | | 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 IF PUBLICLY DISCLOSED.
The unit costs provided in the budget are discounted according to certain economies of scale. A reduction of tasks or units could result in higher unit costs for remaining tasks or units.
Additional units in excess of those planned above will be billed at the same unit rate as shown above.
Amarex budgets services by ‘tasks’ as opposed to by hours. Each task has a fixed unit price associated with it and an estimated number of units proposed for the project. Please examine the estimated number of units for each task carefully to make sure they agree with your expectation. Amarex reserves the right to increase its rates on an annual basis. This increase will not exceed 5% per year.
Estimated Pass-Through Costs
| ESTIMATED PASS THROUGH COSTS | |||||
|---|---|---|---|---|---|
| Bid ID | Expense | Unit Description | Unit Cost $ | No. Units | Total<br> Cost |
| A | TRAVEL AND MEETINGS | ||||
| US Monitoring Visit Costs (Travel and Living) | |||||
| 1 | Airfare | per<br> flight | $ [***] | 80 | [***] |
| 2 | Ground<br> Transportation | per<br> day | $ [***] | 120 | [***] |
| 3 | Parking | per<br> trip | $ [***] | 80 | [***] |
| 4 | Hotel<br> Accommodations | per<br> night | $ [***] | 40 | [***] |
| 5 | Meals | per<br> day | $ [***] | 120 | [***] |
| B | PRINTING & ASSEMBLY OF STUDY MATERIALS | ||||
| 35 | Investigator<br> Study Binders Printing and Assembly | per<br> site | $ [***] | 11 | [***] |
| 36 | Miscellaneous<br> Printing/Copying | per<br> site per month | $ [***] | 70 | [***] |
| C | SHIPPING COSTS (CRFs, Study Binders, etc.) | ||||
| 39 | Overnight<br> delivery (UPS/FedEx) | per<br> site per month | $<br> [***] | 70 | [***] |
| E | MISCELLANEOUS | ||||
| 48 | DSMB<br> Honorarium | per<br> person per meeting | $ [***] | 6 | [***] |
| 51 | Ad<br> Hoc Electronic Data Transfers Over 12MB | per<br> transfer | $ [***] | 11 | [***] |
| 52 | WebEx | per<br> month | $ [***] | 11 | [***] |
| TOTAL OF ESTIMATED PASS THROUGHS | [***] |
All values are in US Dollars.
Pass-through expenses, such as: approved travel, document shipping and printing, and other project related out-of-pocket expenses incurred by Amarex in the conduct of the study will be invoiced to AIM at the actual cost. These expenses will be supported by acceptable documentation or actual receipts.
Third Party Costs
Third party costs are not included in this proposal.They can be further discussed with AIM.
v
| Amarex’s Response to AIM’s Request for Proposal | 6/13/2022 |
| --- | --- | | Amarex Clinical Research, LLC Confidential and Proprietary Information | Page 4 |
EXPLANATORYNOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Payment Schedule and Terms
Payment Schedule for Services
The payment terms and obligations for the services outlined in this proposal are as follows:
| Payment<br> Description | Percentage<br> Due | Amount |
|---|---|---|
| Execution<br> of Project Work Order | 20% | $<br> [***] |
| Monthly<br> Unit-Based Billing | Balance<br> Due | $<br> [***] |
| TOTAL | $ [***] |
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
| ■ | Payments<br> are due 30 days after delivery of an invoice. |
|---|---|
| ■ | Late<br> payment fee: 1% per month interest on all past due, unpaid balances. |
| --- | --- |
| ■ | Amarex<br> Clinical Research, LLC Tax ID: [***] |
| --- | --- |
| ■ | Please<br> include Invoice numbers on all payments |
| --- | --- |
| ■ | Payments<br> will be sent to Amarex’s partner company NSF International |
| --- | --- |
| ■ | Payments<br> will be wire transferred to the NSF International bank account at: |
| --- | --- |
[***]
v
| Amarex’s Response to AIM’s Request for Proposal | 6/13/2022 |
| --- | --- | | Amarex Clinical Research, LLC Confidential and Proprietary Information | Page 5 |
EXPLANATORYNOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELYHARMFUL IF 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: | Thomas K Equels | Print Name: | Kazem Kazempour |
| Signature: | /s/Thomas K Equels | Signature: | /s/Kazem Kazempour |
| Title: | Chief Executive Officer | Title: | President and CEO (Member) |
| Effective Date: | June 14, 2022 | Effective Date: | June 13, 2022 |
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| Amarex’s Response to AIM’s Request for Proposal | 6/13/2022 |
| --- | --- | | Amarex Clinical Research, LLC Confidential and Proprietary Information | Page 6 |