June 13, 2022 Amarex Work Order (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))

EX-10.1 2 ex10-1.htm

 

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 ###-###-####

Fax: 724 ###-###-####

 

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 Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 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 Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 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 Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 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 Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 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
 Cost $
Category
Total $
A TRAVEL AND MEETINGS
  US Monitoring Visit Costs (Travel and Living)          
1 Airfare per flight  $    [***] 80  $    [***]  
2 Ground Transportation per day  $    [***] 120  $    [***]  
3 Parking per trip  $    [***] 80  $    [***]  
4 Hotel Accommodations per night  $    [***] 40  $    [***]  
5 Meals per day  $    [***] 120  $    [***]  $     [***]
B PRINTING & ASSEMBLY OF STUDY MATERIALS          
35 Investigator Study Binders Printing and Assembly per site  $    [***] 11  $    [***]  
36 Miscellaneous Printing/Copying per site per month  $    [***] 70  $    [***] $      [***]
C SHIPPING COSTS (CRFs, Study Binders, etc.)          
39 Overnight delivery (UPS/FedEx) per site per month  $    [***] 70  $    [***] $      [***]
E MISCELLANEOUS          
48 DSMB Honorarium per person per meeting  $    [***] 6  $    [***]  
51 Ad Hoc Electronic Data Transfers Over 12MB per transfer  $    [***] 11  $    [***]  
52 WebEx per month  $    [***] 11  $    [***] $      [***]
             
  TOTAL OF ESTIMATED PASS THROUGHS      $    [***]  

 

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 Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 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:

 

[***]

 

v

 

Amarex’s Response to AIM’s Request for Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 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

   

v

 

Amarex’s Response to AIM’s Request for Proposal6/13/2022
Amarex Clinical Research, LLC Confidential and Proprietary InformationPage 6