April 7, 2022 Amarex Work Order (portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))
Exhibit 10.1
Response to AIM ImmunoTech’s
Request for Proposal for Trial Services to Support a Phase II Pancreatic Cancer Study
March 30, 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: April 8, 2022
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 Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 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 Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma.” The study will be conducted at up to 30 sites in the United States and Europe. This proposal covers 20 sites in the US. It is assumed that not all 20 sites will start at once, and that as the course of the trial goes on, certain sites will be closed out early if they have no active patients left. Discussions around adding European sites to the project can be addressed in an amendment to this proposal. For the time being, it is assumed one site will be included in the Netherlands. DSMB meetings have been estimated to occur every 4 months. 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 1. Study Parameters Used to Prepare This Proposal
| STUDY PARAMETERS | ||
| Number of US sites | [***] | |
| Number of Dutch sites | [***] | |
| Number of countries participating in study | [***] | |
| Number of subjects randomized/enrolled | [***] | |
| SITE MONITORING AND AUDITING | ||
| Number of qualification sites | [***] | |
| Number of site initiation visits | [***] | |
| Number of interim monitoring sites | [***] | |
| Number of closeout visits | [***] | |
| IRB MANAGEMENT | ||
| Number of Local IRB to manage | [***] | |
| Number of Central IRB to manage | [***] | |
| Number of DSMB meetings to review data | [***] | |
| Number of statistical tables per DSMB | [***] | |
| Number of statistical listings per DSMB | [***] |
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 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.
| MEDICAL MONITORING | ||
| Estimated number of SAEs | [***] | |
| Estimated number of reportable events | [***] | |
| DATA MANAGEMENT | ||
| Estimated Number of Adverse Events, Concomitant Medications, and Medical Histories to code | [***] | |
| Number of unique pages in eCRF book | [***] | |
| Number of central labs & vendors | [***] | |
| BIOSTATISTICS | ||
| Number of stat. tables for final analysis (uniques/replicates) | [***] | |
| Number of listings for final analysis (uniques/replicates) | [***] | |
| Number of graphs for final analysis (unique/replicate) | [***] | |
| CLINICAL STUDY REPORT WRITING | ||
| Write final clinical trial report | [***] | |
| PROJECT MANAGEMENT | ||
| Number of months for project setup | [***] | |
| Number of months for enrollment | [***] | |
| Number of months for follow-up (treatment period) | [***] | |
| Number of months of active study phase for monitoring | [***] | |
| Number of months for close out | [***] | |
| Number of months of project management (including set up and close out) | [***] |
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 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.
Study Tasks
Clearly-defined roles 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 2, below.
Table 2. Study Tasks
| Service | Not Required | Amarex | AIM | |||
| PROJECT MANAGEMENT | ||||||
| Meetings, Training, and Study Start Up | ||||||
| Prepare for and Attend Kick-off Meeting & Study Start-Up | X | |||||
| Prepare for and Attend Project Team Training | 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 Initial Drug Shipments | X | |||||
| Set up of WebView IRT™ product supply tracking and email alert system. Track drug shipments to sites, drug supply depots, auto-email requests for resupply based on randomization. Require acknowledgement email from drug depot. | X | |||||
| Maintenance for WebView IRT™ Resupply and Tracking | 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 |
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 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.
| Program Edit Checks | X | |||||
| Set Up Data Transfer from Vendors | X | |||||
| Receive and Reconcile Headers of Clean Data from Vendors | 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 | |||||
| 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 | |||||
| WEBVIEW 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 | ||||||
| Submit and Obtain Initial Approval of Local IRB | X | |||||
| Submit and Obtain Initial Approval of Central IRB | X | |||||
| Obtain Initial Approval for Sites Affiliated with the Central IRB | X | |||||
| Review and Approve IRB Informed Consent Comments | X | |||||
| Review and Approve Site Informed Consent Prior to IRB Submission | X | |||||
| Site Regulatory Document Collection | ||||||
| Set Up Trial Master File | X |
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 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.
| 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 | |||||
| Travel Time for Monitoring Visits | X | |||||
| SAFETY | ||||||
| Set Up Tracking System and SAE Start Up | X | |||||
| Prepare Safety Management Plan | X | |||||
| Prepare Medical Monitoring Plan | X | |||||
| Set Up EDC Safety Reporting Module | X | |||||
| Collect, Process, Evaluate SAE or Pregnancy, and Prepare Narrative | X | |||||
| Prepare CIOMS or MedWatch Form | X | |||||
| Prepare SAE Follow up Reports | X | |||||
| Medical Monitoring (24/7) | X | |||||
| Distribute SAE "Dear Dr." Letters to Sites | X | |||||
| Submit Safety Reports to Regulatory Authorities | X | |||||
| Prepare and Submit Full Annual Report for IND (includes TLGs and up to 1 round of edits) | X | |||||
| Set Up of Coding System to Code AEs, ConMeds, and Histories | X | |||||
| Prepare Medical Coding Plan (includes up to 2 rounds of edits) | X | |||||
| Code Adverse Events, Medications, and Histories (Using MedDRA and WHO Drug ATC Level) | X |
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 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.
| DATA SAFETY MONITORING BOARD (DSMB) | ||||||
| Establish and Manage 3-Member DMC | X | |||||
| Develop DSMB Charter (includes up to 1 round of edits) | X | |||||
| Organize, Conduct and Participate in DSMB Meetings | X | |||||
| Prepare Statistical Analysis Plan for DSMB | X | |||||
| Program Tables, Listings and Graphs for DSMB | X | |||||
| Prepare Statistical Report for DSMB Meetings | X | |||||
| RANDOMIZATION AND ENROLLMENT | X | |||||
| Develop WebView IRT™ Enrollment/Randomization Module | X | |||||
| Generate WebView IRT™ Randomization Code and Plan | X | |||||
| Conduct WebView IRT™ Enrollment/Randomization Maintenance | X | |||||
| BIOSTATISTICS | ||||||
| Prepare Statistical Analysis Plan (includes list of TLGs in Amarex standard format, and data set conventions) | X | |||||
| Program Tables, Listings and Graphs for Final Analysis | X | |||||
| Conduct QC Audit of Stats | X | |||||
| Production and Review of Tables, Listings, and Graphs for Final Analysis (per unique display) | X | |||||
| Production and Review of Tables, Listings, and Graphs for Final Analysis (per replicate display) | X | |||||
| Base ADaM CDISC Conversion (mapping and programming) | 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 Subject Narratives for CSR | 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 |
X* - Regulatory work is covered under a separate agreement.
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 6 |
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)
US
| 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 | $ | [***] | [***] | $ | [***] | |||||||||||||
| 16 | Prepare for and Attend Project Team Training | per day | $ | [***] | [***] | $ | [***] | |||||||||||||
| Communication and Tracking | ||||||||||||||||||||
| 17 | Coordinate Amarex's Internal Project Team | per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| 18 | Communicate with Sponsor (includes standard teleconferences with activities reports and emails) | per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| 19 | Manage Central Labs/Vendors | per lab-vendor/per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| 20 | Tracking Systems Setup | fixed fee | $ | [***] | [***] | $ | [***] | |||||||||||||
| 27.1 | Management of Payments to Sites, IRBs, Labs, and/or Vendors | per payment / site, IRB or vendor | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| 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 | $ | [***] | [***] | $ | [***] | |||||||||||||
| 60 | Maintenance for WebView IRT Product Resupply and Tracking | per site per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| 63 | Support Initial Drug Shipments | per site per shipment | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| E | DATA MANAGEMENT SERVICES | |||||||||||||||||||
| Data Management | ||||||||||||||||||||
| 65 | Develop Data Management Plan | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 73 | Standard Data Cleaning (Run edit checks; generate, process, and track data queries) | per query | $ | [***] | [***] | $ | [***] | |||||||||||||
| 78 | Develop Edit Specifications | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| Data Operations | ||||||||||||||||||||
| 86 | Program Edit Checks | per edit check | $ | [***] | [***] | $ | [***] | |||||||||||||
| 88 | Set Up Data Transfer from Vendors | fixed cost/per vendor | $ | [***] | [***] | $ | [***] | |||||||||||||
| 89 | Receive and Reconcile Headers of Clean Data from Vendors | per transfer/per vendor | $ | [***] | [***] | $ | [***] | |||||||||||||
| 91 | Set Up Transfer of Final SAS Data to Sponsor (in Amarex's format) | per dataset | $ | [***] | [***] | $ | [***] | |||||||||||||
| 92 | Perform Data Transfer to Sponsor (Including export of final SAS Analysis Datasets) | per transfer | $ | [***] | [***] | $ | [***] | |||||||||||||
| EDC Support | ||||||||||||||||||||
| 95 | Conduct Electronic Data Capture Site Training | per training | $ | [***] | [***] | $ | [***] | |||||||||||||
| 96 | Prepare EDC Manual and Completion Instructions (includes up to 1 round of edits) | per manual | $ | [***] | [***] | $ | [***] | |||||||||||||
| 97 | Prepare User Acceptance Testing (UAT) Management Plan | per document | $ | [***] | [***] | $ | [***] | |||||||||||||
| 98 | Conduct QC of EDC Database | per subject enrolled | $ | [***] | [***] | $ | [***] | |||||||||||||
| 99 | Provide Electronic Data Capture Help Desk | per month | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| WEBVIEW EDC PROGRAMMING | ||||||||||||||||||||
| 101 | Development of CRF Screen Shots | per unique page | $ | [***] | [***] | $ | [***] | |||||||||||||
| 102 | WebView EDC Programming (Initiation) | per study | $ | [***] | [***] | $ | [***] | |||||||||||||
| 103 | WebView EDC Programming (UAT 1) | per study | $ | [***] | [***] | $ | [***] |
| ||||||||||||
| 104 | WebView EDC Programming (System Activation) | per study | $ | [***] | [***] | $ | [***] | |||||||||||||
| 105 | WebView EDC Maintenance | per month | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 7 |
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 $ | ||||||||||||||
| F | CLINICAL SITE SERVICES | |||||||||||||||||||
| Site Identification and Contracting | ||||||||||||||||||||
| 106 | Prepare Site Identification Plan | per plan | $ | [***] | [***] | $ | [***] | |||||||||||||
| 107 | Perform Site Identification and Present Sites for Site Qualification Visits | per site recommended | $ | [***] | [***] | $ | [***] | |||||||||||||
| 108 | Develop Site Contracts (includes up to 2 rounds of edits) | per contract | $ | [***] | [***] | $ | [***] | |||||||||||||
| 109 | Negotiate Site Contract CTAs | per site | $ | [***] | [***] | $ | [***] | |||||||||||||
| 110 | Negotiate Site Contract Budgets | per site | $ | [***] | [***] | $ | [***] | |||||||||||||
| IRB and Ethics Committee Management | ||||||||||||||||||||
| 112 | Submit and Obtain Initial Approval of Local IRB | per submission per Local IRB | $ | [***] | [***] | $ | [***] | |||||||||||||
| 113 | Submit and Obtain Initial Approval of Central IRB | per submission per Central IRB | $ | [***] | [***] | $ | [***] | |||||||||||||
| 114 | Obtain Initial Approval for Sites Affiliated with the Central IRB | per submission per site | $ | [***] | [***] | $ | [***] | |||||||||||||
| 116 | Review and Approve IRB Informed Consent Comments | per IRB | $ | [***] | [***] | $ | [***] | |||||||||||||
| 117 | Review and Approve Site Informed Consent Prior to IRB Submission | per site | ||||||||||||||||||
| Site Regulatory Document Collection | $ | [***] | ||||||||||||||||||
| 120 | Set Up Florence Trial Master File | per study | $ | [***] | [***] | $ | [***] | |||||||||||||
| 121 | Set Up Investigator/Site Regulatory Files | per site | $ | [***] | [***] | $ | [***] | |||||||||||||
| 122 | Conduct Ongoing Regulatory Document Collection, Review, and Maintenance of eTMF | per site/per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| Monitoring Services | ||||||||||||||||||||
| 123 | Prepare Study Operations Manual (includes up to 2 rounds of edits) | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 124 | Prepare Monitoring Guidelines (includes up to 2 round of edits) | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 125 | Perform Site Management | per site/per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| 127 | Prepare Documents for Site Initiation | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 128 | Conduct Site Qualification Visits (includes prep and visit report in Amarex format) | per one-day visit | $ | [***] | [***] | $ | [***] | |||||||||||||
| 129 | Conduct Study Initiation Visits (includes prep and visit report in Amarex format) | per one-day visit | $ | [***] | [***] | $ | [***] | |||||||||||||
| 130 | Conduct Interim Monitoring Visits (includes prep and visit report in Amarex format) | per one-day visit | $ | [***] | [***] | $ | [***] | |||||||||||||
| 131 | Conduct Close Out Visits (includes prep and visit report in Amarex format) | per one-day visit | $ | [***] | [***] | $ | [***] | |||||||||||||
| 133 | Travel Time for Monitoring Visits | per trip | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| G | SAFETY | |||||||||||||||||||
| 143 | SAE Start Up | fixed fee | $ | [***] | [***] | $ | [***] | |||||||||||||
| 144 | Prepare Safety Management Plan (includes up to 1 round of edits) | per plan | $ | [***] | [***] | $ | [***] | |||||||||||||
| 145 | Prepare Medical Monitoring Plan (includes up to 1 round of edits) | per plan | $ | [***] | [***] | $ | [***] | |||||||||||||
| 146 | Set Up WebView EDC Safety Reporting Module | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 148 | Collect, Process, Evaluate SAE/UADE or Pregnancy, and Prepare Narrative | per event | $ | [***] | [***] | $ | [***] | |||||||||||||
| 149 | Prepare CIOMS or MedWatch Form | per reportable event | $ | [***] | [***] | $ | [***] | |||||||||||||
| 150 | Prepare SAE/UADE Follow up Reports | per update | $ | [***] | [***] | [***] | ||||||||||||||
| 152 | Medical Monitoring Support Line (24/7) | per month | $ | [***] | [***] | $ | [***] | |||||||||||||
| 154 | Distribute SAE/UADE "Dear Dr." Letters to Sites | per letter per site | $ | [***] | [***] | $ | [***] | |||||||||||||
| 155 | Submit Safety Reports to Regulatory Authorities | per reportable event per country | $ | [***] | [***] | $ | [***] | |||||||||||||
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 8 |
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.
| 156 | Prepare and Submit Full Annual Report for IDE/IND (includes TLGs and up to 1 round of edits) | per submission | $ | [***] | [***] | $ | [***] | |||||||||||||
| 159 | Set Up of Coding System to Code AEs, ConMeds, and Histories | fixed cost | $ | [***] | [***] | $ | [***] | |||||||||||||
| 160 | Prepare Medical Coding Plan (includes up to 2 rounds of edits) | per plan | $ | [***] | [***] | $ | [***] | |||||||||||||
| 161 | Code Adverse Events, Medications, and Histories (Using MedDRA and WHO Drug ATC Level) | per term | $ | [***] | [***] | $ | [***] | $ | [***] |
| AMAREX DIRECT SERVICES FEES | ||||||||||||||||||||
| Bid ID | Service | Unit Description | Unit Cost $ | No. Units | Total Cost $ | Category Total $ | ||||||||||||||
| H | DATA SAFETY MONITORING BOARD (DSMB) | |||||||||||||||||||
| 163 | Establish and Manage 3-Member DSMB | fixed cost | $ | [***] | [***] | $ | [***] | |||||||||||||
| 164 | Develop DSMB Charter (includes up to 1 round of edits) | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 165 | Organize, Conduct and Participate in DSMB Meetings | per meeting | $ | [***] | [***] | $ | [***] | |||||||||||||
| 167 | Program and Produce Unique Tables for DSMB | per unique table | $ | [***] | [***] | $ | [***] | |||||||||||||
| 168 | Program and Produce Replicate Tables for DSMB | per replicate table | $ | [***] | [***] | $ | [***] | |||||||||||||
| 169 | Program and Produce Unique Listings for DSMB | per unique listing | $ | [***] | [***] | $ | [***] | |||||||||||||
| 170 | Program and Produce Replicate Listings for DSMB | per replicate listing | $ | [***] | [***] | $ | [***] | |||||||||||||
| 172 | Prepare Statistical Report for DSMB Meeting (open and closed session reports, includes up to 1 round of edits) | per meeting | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| I | RANDOMIZATION AND ENROLLMENT | |||||||||||||||||||
| 176 | Develop WebView IRT Enrollment/Randomization Module | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 177 | Generate WebView IRT Randomization Code and Plan | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 178 | Conduct WebView IRT Enrollment/Randomization Maintenance | per month | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| J | BIOSTATISTICS | |||||||||||||||||||
| 182 | Prepare Statistical Analysis Plan (includes list of TLGs in Amarex standard format, and data set conventions) | per project | $ | [***] | [***] | $ | [***] | |||||||||||||
| 189 | Program Tables for Final Analysis (unique tables) | per unique table | $ | [***] | [***] | $ | [***] | |||||||||||||
| 190 | Program Tables for Final Analysis (replicate tables) | per replicate table | $ | [***] | [***] | $ | [***] | |||||||||||||
| 191 | Program Listings for Final Analysis (unique listings) | per unique listing | $ | [***] | [***] | $ | [***] | |||||||||||||
| 192 | Program Listings for Final Analysis (replicate listings) | per replicate listing | $ | [***] | [***] | $ | [***] | |||||||||||||
| 193 | Program Graphs for Final Analysis (unique graph) | per unique graph | $ | [***] | [***] | $ | [***] | |||||||||||||
| 195 | Conduct QC Audit of Stats | per lock | $ | [***] | [***] | $ | [***] | |||||||||||||
| 198 | Production and Review of Tables, Listings, and Graphs for Final Analysis (per unique display) | per unique display | $ | [***] | [***] | $ | [***] | |||||||||||||
| 199 | Production and Review of Tables, Listings, and Graphs for Final Analysis (per replicate display) | per replicate display | $ | [***] | [***] | $ | [***] | |||||||||||||
| Other | ||||||||||||||||||||
| 202 | Base ADaM CDISC Conversion (mapping and programming) | per conversion | $ | [***] | [***] | $ | [***] | $ | $ [***] | |||||||||||
| K | MEDICAL WRITING | |||||||||||||||||||
| 211 | Prepare Final Clinical Study Report Shell (ICH Format) - includes up to one round of edits | per report | $ | [***] | [***] | $ | [***] | |||||||||||||
| 212 | Prepare Subject Narratives for CSR | per narrative | $ | [***] | [***] | $ | [***] | |||||||||||||
| 213 | Prepare Final Clinical Study Report (ICH Format) with Appendices - includes up to two rounds of edits | per report | $ | [***] | [***] | $ | [***] | |||||||||||||
| 214 | Conduct QC Audit of Clinical Study Report | per report | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| M | GENERAL & ADMINISTRATIVE EXPENSES | |||||||||||||||||||
| 221 | G&A Expenses | per month | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| N | ADDITIONAL SERVICES | |||||||||||||||||||
| 253 | Identify, Contract, and Setup Vendor | per vendor | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| Executive Discount ([***]%) | $ | ([***]]) | ||||||||||||||||||
| TOTAL OF ACTIVITY-BASED COSTING | $ | [***]
| ||||||||||||||||||
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 9 |
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.
Netherlands
| CLINICAL SITE SERVICES | ||||||||||||||||||||
| Bid ID | Service | Unit Description | Unit Cost $ | No. Units | Total Cost $ | Category Total $ | ||||||||||||||
| Study start-up (1 months) | ||||||||||||||||||||
| 1 | Study familiarisation | Once | $ | [***] | [***] | $ | [***] | |||||||||||||
| 2 | Study KO meeting (TC) | Once | $ | [***] | [***] | $ | [***] | |||||||||||||
| 3 | Preparation of PM Plans | Plans | $ | [***] | [***] | $ | [***] | |||||||||||||
| 4 | Site initiation | Sites | $ | [***] | [***] | $ | [***] | |||||||||||||
| 5 | In-house SCRA activities - set up including site communication | Site / months | $ | [***] | [***] | $ | [***] | |||||||||||||
| 6 | Sponsor TCs - set up | Alternate Weeks | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| Conduct (5 months) | ||||||||||||||||||||
| 7 | Monitoring Visits | IMV | $ | [***] | [***] | $ | [***] | |||||||||||||
| 8 | In-house SCRA activities - conduct including site communication | Site / months | $ | [***] | [***] | $ | [***] | |||||||||||||
| 9 | Sponsor TCs - Conduct | monthly | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| Study closure (1 months) | ||||||||||||||||||||
| 10 | Close-Out | COVs | $ | [***] | [***] | $ | [***] | |||||||||||||
| 11 | In-house SCRA activities - closure including site communication | Site / months | $ | [***] | [***] | $ | [***] | |||||||||||||
| 12 | Sponsor TCs - closure | Alternate Weeks | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| TOTAL | $ | [***] | ||||||||||||||||||
| OPTIONAL SERVICES | ||||||||||||||||||||
| Bid ID | Service | Unit Description | Unit Cost $ | No. Units | Total Cost $ | Category Total $ | ||||||||||||||
| Study start-up (1 months) | ||||||||||||||||||||
| 13 | Backup CRA familiarization and training | per CRA | $ | [***] | [***] | $ | [***] | |||||||||||||
| 14 | Set up shadow TMF | Sites | $ | [***] | [***] | $ | [***] | |||||||||||||
| 15 | Set up ISFs | Sites | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| Conduct(5 months) | ||||||||||||||||||||
| 16 | Maintenance of TMF - Conduct | Site / months | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| Study closure (1 months) | ||||||||||||||||||||
| 17 | Return of TMF to sponsor | Sites | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| Ad Hoc | ||||||||||||||||||||
| 18 | Ad hoc project support | per hour | $ | [***] | TBD | TBD | TBD | |||||||||||||
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.
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 10 |
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.
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 | $ | [***] | [***] | $ | [***] | |||||||||||||
| 2 | Ground Transportation | per day | $ | [***] | [***] | $ | [***] | |||||||||||||
| 3 | Parking | per trip | $ | [***] | [***] | $ | [***] | |||||||||||||
| 4 | Hotel Accommodations | per night | $ | [***] | [***] | $ | [***] | |||||||||||||
| 5 | Meals | per day | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| B | PRINTING & ASSEMBLY OF STUDY MATERIALS | |||||||||||||||||||
| 36 | Miscellaneous Printing/Copying | per site per month | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| C | SHIPPING COSTS (CRFs, Study Binders, etc.) | |||||||||||||||||||
| 39 | Overnight delivery (UPS/FedEx) | per site per month | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
| E | MISCELLANEOUS | |||||||||||||||||||
| 48 | DSMB Honorarium | per person per meeting | $ | [***] | [***] | $ | [***] | |||||||||||||
| 51 | Ad Hoc Electronic Data Transfers Over 12MB | per transfer | $ | [***] | [***] | $ | [***] | |||||||||||||
| 53 | Florence eTMF Annual Study Fee | per study per year | $ | [***] | [***] | $ | [***] | |||||||||||||
| 54 | Florence eTMF Annual Entity User Fee | per entity per year | $ | [***] | [***] | $ | [***] | $ | [***] | |||||||||||
TOTAL OF ESTIMATED PASS THROUGHS | $ | 1,027,000.00 | ||||||||||||||||||
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.
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 11 |
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.
Third Party Costs
Third party costs are not included in this proposal. They can be further discussed with AIM.
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 12 |
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 | [***] | % | $ | [***] | ||||
| Monthly Unit-Based Billing | Balance Due | $ | [***] | |||||
| TOTAL | $ | 7,186,493.11 | ||||||
Optional services will be billed on a monthly basis, as needed.
The Execution fee will be credited back as follows: $[***] will be credited when the total service invoicing reaches each of the following amounts $[***], $[***], and $[***].
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: |
JP Morgan Chase
New York, NY, USA
Acct. No.: [***]
ABA No.: 021000021
SWIFT Code: CHASUS33
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 13 |
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: | Peter W. Rodino, III | Print Name: | Kazem Kazempour | |
| Signature: | /s/ Peter W. Rodino | Signature: | /s/ Kazem Kazempour | |
| Title: | COO & General Counsel | Title: | President and CEO (Member) | |
| Effective Date: | April 7, 2022 | Effective Date: | April 7, 2022 | |
Amarex’s Response to AIM’s Request for Proposal Amarex Clinical Research, LLC Confidential and Proprietary Information | 3/30/2022 Page 14 |
