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)
June 13, 2022
AIM IMMUNOTECH INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-27072 | 52-0845822 | ||
(state or other jurisdiction | (Commission | (I.R.S. Employer | ||
of incorporation) | File Number) | Identification No.) |
2117 SW Highway 484, Ocala FL | 34473 | |
(Address of principal executive offices) | (Zip 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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement 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 of each class | Trading Symbol | Name of each exchange on which registered | ||
Common Stock, par value $0.001 per share | AIM | NYSE American |
Item 1.01 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.
Cautionary Statement
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.
Item 9.01. 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 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 IMMUNOTECH INC. | ||
June 17, 2022 | By: | /s/ Thomas K. Equels |
Thomas K. Equels, CEO |
Exhibit 10.1
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.
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
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.
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
Prepared for:
AIM ImmunoTech Inc
783 Jersey Avenue
New Brunswick, NJ 08901
Phone: 352-260-7797
Fax: 724-260-6742
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 | 6/13/2022 |
Amarex Clinical Research, LLC Confidential and Proprietary Information | Page i |
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.
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 of sites | 10 |
Number of countries participating in study | 1 |
Number of subjects screened | 170 |
Number of subjects randomized/enrolled | 80 |
Number of subjects completed | 80 |
SITE MONITORING AND AUDITING | |
Number of qualification sites | 20 |
Number of site initiation visits | 10 |
Number of interim monitoring sites | 40 |
Number of closeout visits | 10 |
IRB MANAGEMENT | |
Number of Local IRB to manage | 10 |
Number of Central IRB to manage | 1 |
Number of DSMB meetings to review data | 1 |
Number of statistical tables per DSMB | 10/10 |
Number of statistical listings per DSMB | 10/10 |
MEDICAL MONITORING | |
Estimated number of SAEs | 5 |
Estimated number of reportable events | 1 |
DATA MANAGEMENT | |
Estimated Number of Adverse Events, Concomitant Medications, and Medical Histories to code | 2,210 |
Number of unique pages in eCRF book | 20 |
Number of central labs & vendors | 2 |
BIOSTATISTICS | |
Number of stat. tables for final analysis (uniques/replicates) | 30/20 |
Number of listings for final analysis (uniques/replicates) | 30/20 |
Number of graphs for final analysis (unique/replicate) | 5/0 |
CLINICAL STUDY REPORT WRITING | |
Write final clinical trial report | Yes |
PROJECT MANAGEMENT | |
Number of months for project setup | 2 |
Number of months for enrollment | 4 |
Number of months for follow-up (treatment period) | 3 |
Number of months of active study phase for monitoring | 7 |
Number of months for close out | 2 |
Number 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 |
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.
Proposed Amarex Direct Services Budget
(US Dollars)
AMAREX DIRECT SERVICES FEES
|
||||||
Bid ID | Service | Unit Description | Unit Cost $ | No.
Units |
Total
Cost $ |
Category
Total $ |
B | PROJECT MANAGEMENT | |||||
Meetings, Training, and Study Start Up | ||||||
11 | Prepare for and Attend Kick-off Meeting & Study Start-Up | per protocol | $ [***] | 1 | $ [***] | |
16 | Prepare for and Attend Project Team Training | per day | $ [***] | 1 | $ [***] | |
Communication and Tracking | ||||||
17 | Coordinate Amarex's Internal Project Team | per month | $ [***] | 11 | $ [***] | |
18 | Communicate
with Sponsor (includes standard teleconferences with activities reports and emails) |
per month | $ [***] | 11 | $ [***] | |
19 | Manage Central Labs/Vendors | per lab-vendor/per month | $ [***] | 14 | $ [***] | |
20 | Tracking Systems Setup | fixed fee | $ [***] | 1 | $ [***] | |
27.1 | Management of Payments to Sites, IRBs, Labs, and/or Vendors | per payment / site, IRB or vendor | $ [***] | 61 | $ [***] | $ [***] |
D | PRODUCT MANAGEMENT | |||||
59 | Set up of WebView IRT product supply tracking and email alert system. Track drug shipments to sites, supply depots, auto-email requests for resupply based on randomization. Require acknowledgement email from supply depot. | per project | $ [***] | 1 | $ [***] | |
60 | Maintenance for WebView IRT Product Resupply and Tracking | per site per month | $ [***] | 20 | $ [***] | |
63 | Support Initial Drug / Device Shipments | per site per shipment | $ [***] | 10 | $ [***] | $ [***] |
E | DATA MANAGEMENT SERVICES | |||||
Data Management | ||||||
65 | Develop Data Management Plan | per project | $ [***] | 1 | $ [***] | |
73 | Standard Data Cleaning (Run edit checks; generate, process, and track data queries) | per query | $ [***] | 800 | $ [***] | |
78 | Develop Edit Specifications | per project | $ [***] | 1 | $ [***] | |
79 | Conduct
QC Audit of Interim Clinical Database (5% of pts (min 5 max 50) for all data per lock) |
per subject | $ [***] | 2 | $ [***] | |
Data Operations | ||||||
86 | Program Edit Checks | per edit check | $ [***] | 200 | $ [***] | |
88 | Set Up Data Transfer from Vendors | fixed cost/per vendor | $ [***] | 2 | $ [***] | |
89 | Receive and Reconcile Headers of Clean Data from Vendors | per transfer/per vendor | $ [***] | 14 | $ [***] | |
91 | Set
Up Transfer of Final SAS Data to Sponsor (in Amarex's format) |
per dataset | $ [***] | 40 | $ [***] | |
92 | Perform
Data Transfer to Sponsor (Including export of final SAS Analysis Datasets) |
per transfer | $ [***] | 1 | $ [***] | |
EDC Support | ||||||
96 | Prepare EDC Manual and Completion Instructions (includes up to 1 round of edits) | per manual | $ [***] | 1 | $ [***] | |
97 | Prepare User Acceptance Testing (UAT) Management Plan | per document | $ [***] | 1 | $ [***] | |
98 | Conduct QC of EDC Database | per subject enrolled | $ [***] | 80 | $ [***] | |
99 | Provide Electronic Data Capture Help Desk | per site/per month | $ [***] | 70 | $ [***] | $ [***] |
WEBVIEW EDC PROGRAMMING | ||||||
101 | Development of CRF Screen Shots | per unique page | $ [***] | 20 | $ [***] | |
102 | WebView EDC Programming (Initiation) | per study | $ [***] | 1 | $ [***] | |
103 | WebView EDC Programming (UAT 1) | per study | $ [***] | 1 | $ [***] | |
104 | WebView EDC Programming (System Activation) | per study | $ [***] | 1 | $ [***] | |
105 | WebView EDC Maintenance | per month | $ [***] | 9 | $ [***] | $ [***] |
F | CLINICAL SITE SERVICES | |||||
Site Identification and Contracting | ||||||
106 | Prepare Site Identification Plan | per plan | $ [***] | 1 | $ [***] | |
107 | Perform Site Identification and Present Sites for Site Qualification Visits | per site recommended | $ [***] | 15 | $ [***] | |
108 | Develop Site Contracts (includes up to 2 rounds of edits) | per contract | $ [***] | 1 | $ [***] | |
109 | Negotiate Site Contract CTAs | per site | $ [***] | 10 | $ [***] | |
110 | Negotiate Site Contract Budgets | per site | $ [***] | 10 | $ [***] | |
IRB and Ethics Committee Management | ||||||
112 | Submit and Obtain Initial Approval of Local IRB | per submission per Local IRB | $ [***] | 10 | $ [***] | |
113 | Submit and Obtain Initial Approval of Central IRB | per submission per Central IRB | $ [***] | 1 | $ [***] | |
116 | Review and Approve IRB Informed Consent Comments | per IRB | $ [***] | 11 | $ [***] | |
117 | Review and Approve Site Informed Consent Prior to IRB Submission | per site | $ [***] | 10 | $ [***] | |
Site Regulatory Document Collection | ||||||
120 | Set Up Trial Master File | per study | $ [***] | 1 | $ [***] | |
121 | Set Up Investigator/Site Regulatory Files | per site | $ [***] | 10 | $ [***] | |
122 | Conduct Ongoing Regulatory Document Collection, Review, Tracking, and Maintenance of Trial Master File | per site/per month | $ [***] | 70 | $ [***] | |
Monitoring Services | ||||||
123 | Prepare Study Operations Manual (includes up to 2 rounds of edits) | per project | $ [***] | 1 | $ [***] | |
124 | Prepare Monitoring Guidelines (includes up to 2 round of edits) | per project | $ [***] | 1 | $ [***] | |
125 | Perform Site Management | per site/per month | $ [***] | 90 | $ [***] | |
127 | Prepare Documents for Site Initiation | per project | $ [***] | 1 | $ [***] | |
128 | Conduct Site Qualification Visits (includes prep and visit report in Amarex format) | per one-day visit | $ [***] | 20 | $ [***] | |
129 | Conduct Study Initiation Visits (includes prep and visit report in Amarex format) | per one-day visit | $ [***] | 10 | $ [***] | |
130 | Conduct Interim Monitoring Visits (includes prep and visit report in Amarex format) | per one-day visit | $ [***] | 40 | $ [***] | |
131 | Conduct Close Out Visits (includes prep and visit report in Amarex format) | per one-day visit | $ [***] | 10 | $ [***] | |
133 | Travel Time for Monitoring Visits | per trip | $ [***] | 80 | $ [***] | $ [***] |
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
Cost $ |
Category
Total $ | |
G | SAFETY | ||||||
143 | Set Up Tracking System and SAE/UADE Start Up | fixed fee | $ [***] | 1 | $ [***] | ||
144 | Prepare Safety Management Plan (includes up to 1 round of edits) | per plan | $ [***] | 1 | $ [***] | ||
145 | Prepare Medical Monitoring Plan (includes up to 1 round of edits) | per plan | $ [***] | 1 | $ [***] | ||
146 | Set Up WebView EDC Safety Reporting Module | per project | $ [***] | 1 | $ [***] | ||
148 | Collect, Process, Evaluate SAE/UADE or Pregnancy, and Prepare Narrative | per event | $ [***] | 5 | $ [***] | ||
149 | Prepare CIOMS or MedWatch Form | per reportable event | $ [***] | 1 | $ [***] | ||
150 | Prepare SAE/UADE Follow up Reports | per update | $ [***] | TBD | [***] | ||
153 | Revise SAE/UADE Narratives for DSMB Meetings | per event/per meeting | $ [***] | 7 | $ [***] | ||
154 | Distribute SAE/UADE "Dear Dr." Letters to Sites | per letter per site | $ [***] | 10 | $ [***] | ||
155 | Submit Safety Reports to Regulatory Authorities | per reportable event per country | $ [***] | 1 | $ [***] | ||
159 | Set Up of Coding System to Code AEs, ConMeds, and Histories | fixed cost | $ [***] | 1 | $ [***] | ||
160 | Prepare Medical Coding Plan (includes up to 2 rounds of edits) | per plan | $ [***] | 1 | $ [***] | ||
161 | Code
Adverse Events, Medications, and Histories (Using MedDRA and WHO Drug ATC Level) |
per term | $ [***] | 2210 | $ [***] | $ [***] | |
H | DATA SAFETY MONITORING BOARD (DSMB) | ||||||
163 | Establish and Manage 3-Member DSMB | fixed cost | $ [***] | 1 | $ [***] | ||
164 | Develop DSMB Charter (includes up to 1 round of edits) | per project | $ [***] | 1 | $ [***] | ||
165 | Organize, Conduct and Participate in DSMB Meetings | per meeting | $ [***] | 2 | $ [***] | ||
166 | Prepare Statistical Analysis Plan for DSMB | per project | $ [***] | 1 | $ [***] | ||
167 | Program and Produce Unique Tables for DSMB | per unique table | $ [***] | 10 | $ [***] | ||
168 | Program and Produce Replicate Tables for DSMB | per replicate table | $ [***] | 10 | $ [***] | ||
169 | Program and Produce Unique Listings for DSMB | per unique listing | $ [***] | 10 | $ [***] | ||
170 | Program and Produce Replicate Listings for DSMB | per replicate listing | $ [***] | 10 | $ [***] | ||
172 | Prepare Statistical Report for DSMB Meeting (open and closed session reports, includes up to 1 round of edits) | per meeting | $ [***] | 1 | $ [***] | $ [***] | |
I | RANDOMIZATION AND ENROLLMENT | ||||||
176 | Develop WebView IRT Enrollment/Randomization Module | per project | $ [***] | 1 | $ [***] | ||
177 | Generate WebView IRT Randomization Code and Plan | per project | $ [***] | 1 | $ [***] | ||
178 | Conduct WebView IRT Enrollment/Randomization Maintenance | per month | $ [***] | 7 | $ [***] | $ [***] | |
J | BIOSTATISTICS | ||||||
182 | Prepare Statistical Analysis Plan (includes list of TLGs in Amarex standard format, and data set conventions) | per project | $ [***] | 1 | $ [***] | ||
189 | Program Tables for Final Analysis (unique tables) | per unique table | $ [***] | 30 | $ [***] | ||
190 | Program Tables for Final Analysis (replicate tables) | per replicate table | $ [***] | 20 | $ [***] | ||
191 | Program Listings for Final Analysis (unique listings) | per unique listing | $ [***] | 30 | $ [***] | ||
192 | Program Listings for Final Analysis (replicate listings) | per replicate listing | $ [***] | 20 | $ [***] | ||
193 | Program Graphs for Final Analysis (unique graph) | per unique graph | $ [***] | 5 | $ [***] | ||
195 | Conduct QC Audit of Stats | per lock | $ [***] | 1 | $ [***] | ||
198 | Production and Review of Tables, Listings, and Graphs for Final Analysis (per unique display) | per unique display | $ [***] | 65 | $ [***] | ||
199 | Production and Review of Tables, Listings, and Graphs for Final Analysis (per replicate display) | per replicate display | $ [***] | 40 | $ [***] | ||
Other | |||||||
202 | Base ADaM CDISC Conversion (mapping and programming) | per conversion | $ [***] | 1 | $ [***] | $ [***] | |
K | MEDICAL WRITING | ||||||
211 | Prepare
Final Clinical Study Report Shell (ICH Format) - includes up to one round of edits |
per report | $ [***] | 1 | $ [***] | ||
212 | Prepare Subject Narratives for CSR | per narrative | $ [***] | 8 | $ [***] | ||
213 | Prepare Final Clinical Study Report (ICH Format) with Appendices - includes up to two rounds of edits | per report | $ [***] | 1 | $ [***] | ||
214 | Conduct QC Audit of Clinical Study Report | per report | $ [***] | 1 | $ [***] | $ [***] | |
M | GENERAL & ADMINISTRATIVE EXPENSES | ||||||
221 | G&A Expenses | per month | $ [***] | 11 | $ [***] | $ [***] | |
TOTAL OF ACTIVITY-BASED COSTING | $ [***] |
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
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.
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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 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 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 Description | Percentage Due | Amount | ||
Execution of Project Work Order | 20% | $ [***] | ||
Monthly Unit-Based Billing | Balance Due | $ [***] | ||
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 are due 30 days after delivery of an invoice. |
■ | Late payment fee: 1% per month interest on all past due, unpaid balances. |
■ | Amarex Clinical Research, LLC Tax ID: [***] |
■ | Please include Invoice numbers on all payments |
■ | Payments will be sent to Amarex’s partner company NSF International |
■ | Payments will be wire transferred to the NSF International bank account at: |
[***]
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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 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 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 |