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AIM ImmunoTech Inc. – ‘10-K’ for 12/31/21 – ‘EX-10.82’

On:  Thursday, 3/31/22, at 1:05pm ET   ·   For:  12/31/21   ·   Accession #:  1493152-22-8324   ·   File #:  1-27072

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  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 3/31/22  AIM ImmunoTech Inc.               10-K       12/31/21   90:9.3M                                   M2 Compliance LLC/FA

Annual Report   —   Form 10-K

Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-K        Annual Report                                       HTML   1.77M 
 2: EX-4.23     Instrument Defining the Rights of Security Holders  HTML     36K 
 3: EX-10.78    Material Contract                                   HTML     59K 
 4: EX-10.79    Material Contract                                   HTML     48K 
 5: EX-10.80    Material Contract                                   HTML     26K 
 6: EX-10.81    Material Contract                                   HTML    113K 
 7: EX-10.82    Material Contract                                   HTML     58K 
 8: EX-21       Subsidiaries List                                   HTML     24K 
 9: EX-23.1     Consent of Expert or Counsel                        HTML     24K 
10: EX-31.1     Certification -- §302 - SOA'02                      HTML     29K 
11: EX-31.2     Certification -- §302 - SOA'02                      HTML     29K 
12: EX-32.1     Certification -- §906 - SOA'02                      HTML     25K 
13: EX-32.2     Certification -- §906 - SOA'02                      HTML     25K 
19: R1          Cover                                               HTML     94K 
20: R2          Consolidated Balance Sheets                         HTML    122K 
21: R3          Consolidated Balance Sheets (Parenthetical)         HTML     39K 
22: R4          Consolidated Statement of Comprehensive Loss        HTML     91K 
23: R5          Consolidated Statement of Changes in Stockholders'  HTML     61K 
                Equity                                                           
24: R6          Consolidated Statements of Cash Flows               HTML    128K 
25: R7          Business                                            HTML     35K 
26: R8          Summary of Significant Accounting Policies          HTML     68K 
27: R9          Marketable Securities                               HTML     72K 
28: R10         Patents, Trademark Rights                           HTML     38K 
29: R11         Accrued Expenses                                    HTML     33K 
30: R12         Stockholders? Equity                                HTML    383K 
31: R13         Segment and Related Information                     HTML     31K 
32: R14         Research, Consulting and Supply Agreements          HTML     37K 
33: R15         401(k) Plan                                         HTML     29K 
34: R16         Employment Agreements                               HTML     57K 
35: R17         Leases                                              HTML     49K 
36: R18         Income Taxes (FASB ASC 740 Income Taxes)            HTML     61K 
37: R19         Note Payable                                        HTML     43K 
38: R20         Certain Relationships and Related Transactions      HTML     29K 
39: R21         Concentrations of Risk                              HTML     30K 
40: R22         Fair Value                                          HTML    146K 
41: R23         Financing Obligation Arising from Sale Leaseback    HTML     32K 
                Transaction                                                      
42: R24         Subsequent Events                                   HTML     33K 
43: R25         Summary of Significant Accounting Policies          HTML     99K 
                (Policies)                                                       
44: R26         Summary of Significant Accounting Policies          HTML     32K 
                (Tables)                                                         
45: R27         Marketable Securities (Tables)                      HTML     72K 
46: R28         Patents, Trademark Rights (Tables)                  HTML     38K 
47: R29         Accrued Expenses (Tables)                           HTML     31K 
48: R30         Stockholders? Equity (Tables)                       HTML    314K 
49: R31         Leases (Tables)                                     HTML     30K 
50: R32         Income Taxes (FASB ASC 740 Income Taxes) (Tables)   HTML     49K 
51: R33         Fair Value (Tables)                                 HTML    130K 
52: R34         Business (Details Narrative)                        HTML     25K 
53: R35         Schedule of Property and Equipment (Details)        HTML     39K 
54: R36         Summary of Significant Accounting Policies          HTML     47K 
                (Details Narrative)                                              
55: R37         Schedule of Available for Sale (Details)            HTML     68K 
56: R38         Schedule of Equity Securities (Details)             HTML     30K 
57: R39         Marketable Securities (Details Narrative)           HTML     30K 
58: R40         Schedule of Patents, Trademark Rights (Details)     HTML     33K 
59: R41         Schedule of Amortization of Patents and Trademarks  HTML     40K 
                (Details)                                                        
60: R42         Patents, Trademark Rights (Details Narrative)       HTML     27K 
61: R43         Schedule of Accrued Expenses (Details)              HTML     35K 
62: R44         Schedule of Options and Equity Estimated Based on   HTML     37K 
                Weighted Average Assumptions (Details)                           
63: R45         Schedule of Stock Option Activity (Details)         HTML    142K 
64: R46         Schedule of Unvested Stock Option Activity          HTML     75K 
                (Details)                                                        
65: R47         Schedule of Warrants Outstanding and Exercisable    HTML     69K 
                (Details)                                                        
66: R48         Stockholders? Equity (Details Narrative)            HTML    243K 
67: R49         Research, Consulting and Supply Agreements          HTML     36K 
                (Details Narrative)                                              
68: R50         401(k) Plan (Details Narrative)                     HTML     31K 
69: R51         Employment Agreements (Details Narrative)           HTML     57K 
70: R52         Schedule of Operating lease Future Payments         HTML     38K 
                (Details)                                                        
71: R53         Leases (Details Narrative)                          HTML     65K 
72: R54         Schedule of Components of Net Deferred Tax Assets   HTML     48K 
                and Liabilities (Details)                                        
73: R55         Schedule of Effective Tax Rate and Statutory Tax    HTML     51K 
                Rate (Details)                                                   
74: R56         Income Taxes (FASB ASC 740 Income Taxes) (Details   HTML     44K 
                Narrative)                                                       
75: R57         Note Payable (Details Narrative)                    HTML     67K 
76: R58         Certain Relationships and Related Transactions      HTML     33K 
                (Details Narrative)                                              
77: R59         Schedule of Assumptions to Estimate Fair Value of   HTML     87K 
                Warrants (Details)                                               
78: R60         Schedule of Range of Probabilities (Details)        HTML     31K 
79: R61         Schedule of Assets and Liabilities Measured at      HTML     38K 
                Fair Value on a Recurring Basis (Details)                        
80: R62         Schedule of Changes in Level 3 Liabilities          HTML     30K 
                Measured at Fair Value on a Recurring Basis                      
                (Details)                                                        
81: R63         Schedule of Assets and Liabilities Measured at      HTML     39K 
                Fair Value on a NonRecurring Basis (Details)                     
82: R64         Schedule of Assets and Liabilities Measured at      HTML     33K 
                Fair Value on a NonRecurring Basis (Details)                     
                (Parenthetical)                                                  
83: R65         Fair Value (Details Narrative)                      HTML     36K 
84: R66         Financing Obligation Arising from Sale Leaseback    HTML     45K 
                Transaction (Details Narrative)                                  
85: R67         Subsequent Events (Details Narrative)               HTML     41K 
88: XML         IDEA XML File -- Filing Summary                      XML    150K 
86: XML         XBRL Instance -- form10-k_htm                        XML   2.11M 
87: EXCEL       IDEA Workbook of Financial Reports                  XLSX    103K 
15: EX-101.CAL  XBRL Calculations -- aim-20211231_cal                XML    195K 
16: EX-101.DEF  XBRL Definitions -- aim-20211231_def                 XML    724K 
17: EX-101.LAB  XBRL Labels -- aim-20211231_lab                      XML   1.31M 
18: EX-101.PRE  XBRL Presentations -- aim-20211231_pre               XML    984K 
14: EX-101.SCH  XBRL Schema -- aim-20211231                          XSD    194K 
89: JSON        XBRL Instance as JSON Data -- MetaLinks              430±   591K 
90: ZIP         XBRL Zipped Folder -- 0001493152-22-008324-xbrl      Zip    355K 


‘EX-10.82’   —   Material Contract


This Exhibit is an HTML Document rendered as filed.  [ Alternative Formats ]



 

Exhibit 10.82

 

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.

 

PHARMACEUTICS INTERNATIONAL, INC. SERVICES CHANGE ORDER

 

Initiation Date

2/28/2022

Project Number:

27AIM01

Change Order Number:

                                          1

 

AIM ImmunoTech Inc. Contact:

Victoria Scott, Director of Quality & Regulatory Affairs

 

Corporate Address:

2117 SW Highway 484

Ocala, FL 34473

Corporate Phone 352-448-7797

Corporate Fax: 352-480-4620

Email: Victoria.Scott@AIMimmuno.com

 

Pii Contact:

Luis Molina, Director, Business Management

 

Corporate Address:

10819 Gilroy Road

Hunt Valley, MD 21031

Corporate Phone: 410-584-0001

Email: lmolina@pharm-int.com

 

Change Order Title: Manufacture placebo feasibility batch; Method transfer for in-process assay – Ampligen sterile solution

 

I. Change in Scope and Associated Costs

 

Activity COST Total Cost

 

AIM ImmunoTech Inc. (“Client”) has requested Pii provide method transfer services for in-process assay.

AIM ImmunoTech has authorized Pii to issue this Change Order, which covers the activities/deliverables and any equipment/material listed in the following sections.

   

 

Section 1: Method transfer for in-process assay.

 

$[***] $[***]

Section 2: Manufacture of Placebo Feasibility cGMP Batch.

  Pii will manufacture one (1) placebo feasibility batch with NO filling and Compounding and Filtration only.    

  Tests to be performed $[***] $[***]

 

pH

   
 

osmolality

   
         

Section 3: Materials Testing Charge – Estimate only (Actuals will be billed)    
API:    
  Full release testing will be charged at $[***] / lot    
  ID release at $[***] / lot    

 

27AIM01 CO1 March 25, 2022 Page 1 of 4
  CONFIDENTIAL  

 

 C: 
 

 

 

    Note: For the engineering trial mentioned in section 2, water will be used as the testing material    
Excipients:    
  USP/NF and EP/JP full release testing will be charged at $8,500 / lot    
  PII will use stock excipients where applicable and may opt to charge on a per kg basis    
  ID release at $[***] / lot    
Packaging Components:    
  USP/NF full release testing will be charged at $[***] / lot    
  PII will use stock components where applicable and may opt to charge on a per unit basis    
  ID release at $[***] / lot    
Note:    
  Any outsourced testing not conducted at Pii for API, Excipients, or Packaging Components will be invoiced as a pass through + handling costs as per the terms of the agreement.  
    Sub-Total: $[***]
   

Estimated Costs for Pass Through:

(For budgeting purposes only based on 20% of subtotal; actuals will be billed as noted herein)

 

$[***]

 

In addition to the above costs:

 

  Client shall pay to Pii upon receipt of Pii’s invoice by Client for all non-capital materials (excipients, packaging components, HPLC columns, analytical standards, microbial testing and tooling) used in the study at cost plus 10%. Pii shall obtain Client’s prior written approval for any expenditure greater than $5,000. For high priced items more than $5,000, Pii will charge cost plus 5% to Client . Pii shall invoice Client for all reasonable and normal out-of-pocket travel-related expenses, including airfare, room & board, car rental and the like, of Pii during any technology transfer phase or project update meetings requested in advance by Client.
  Any excipients, materials or components ordered as specialized items (not standard stock items) for use in the project will be invoiced in full to Client. A handling fee will apply as noted above. Payment is due within 45 days of receipt of invoice by Client.
  Materials Usage and Testing will be per the terms of the original agreement (“Materials Charges and Testing (Estimate Only)” of Section III: Cost)
  Any OOS investigation and testing that is not considered to be Pii laboratory error will be billed at a rate of $300/hour.
  Any remaining stock of specialized items ordered on behalf of Client or shipped to Pii by Client will be shipped to Client upon notification by Pii. Client will be solely responsible for cost of shipment and a shipment preparation fee of $1,500 will be applied.
  ●  Shipments outside of Agreement work scope will be invoiced as per the following:

  a) Shipment requests with three (3) day notice or more will be charged at $500 plus shipping costs and a 10% service charge on shipping.
  b) Shipment requests with two (2) day notice will be charged at $1,000 plus shipping costs and a 10% service charge on shipping.
  c) Shipment requests with twenty-four (24) hour notice will be charged at $1,500 plus shipping costs and a 10% service charge on shipping.

 

27AIM01 CO1 March 25, 2022 Page 2 of 4
  CONFIDENTIAL  

 

 C: 
 

 

 

II. Payment Schedule

 

Milestones Activity Amount Due

Change Order

Initiation

Change Order Initiation (Non-refundable)- 27AIM01 CO1 – Manufacture placebo feasibility batch; Method transfer for in-process assay – Ampligen sterile solution.

 

Please remit payment upon receipt of Pii invoice.

$[***]

  Completion of Analytical Method for In-Process Assay  
       
1 Provision of Draft of the Method Transfer Report sent to AIM ImmunoTech, Inc. for the in-process Assay $[***]
       
2

Completion of Manufacturing of Placebo Feasibility Batch

 

$[***]
  R&D reviewed executed Feasibility Batch Record sent to AIM ImmunoTech, Inc.  
Total $$[***]

 

27AIM01 CO1 March 25, 2022 Page 3 of 4
  CONFIDENTIAL  

 

 C: 
 

 

 

III. Signatures

 

This Agreement is Change Order No. 1 to Service Agreement No. 27AIM01 executed by AIM ImmunoTech Inc. and Pii dated December 22, 2020.

 

Pii Signatory   Signature and Date
     
John Guthrie   /s/ John Guthrie March 8, 2022
Chief Financial Officer      
       
Client Signatory (Client Representative)      
       
Ellen M. Lintal   /s/ Ellen M Lintal March 8, 2022
Chief Financial Officer      

 

Purchase Order Number: __________________

(Provided by Client if necessary)

 

27AIM01 CO1 March 25, 2022 Page 4 of 4
  CONFIDENTIAL  

 

 C: 
 

 

 


Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘10-K’ Filing    Date    Other Filings
Filed on:3/31/2210-Q
3/25/22
3/8/22
For Period end:12/31/21
12/22/208-K
 List all Filings 


6 Subsequent Filings that Reference this Filing

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 4/19/24  AIM ImmunoTech Inc.               S-1                    6:628K                                   M2 Compliance LLC/FA
 4/01/24  AIM ImmunoTech Inc.               10-K       12/31/23   84:8.7M                                   M2 Compliance LLC/FA
 3/31/23  AIM ImmunoTech Inc.               10-K       12/31/22   87:8.7M                                   M2 Compliance LLC/FA
 8/15/22  AIM ImmunoTech Inc.               10-Q        6/30/22   72:6M                                     M2 Compliance LLC/FA
 7/01/22  AIM ImmunoTech Inc.               S-8         7/01/22    4:143K                                   M2 Compliance LLC/FA
 5/13/22  AIM ImmunoTech Inc.               10-Q        3/31/22   68:5.6M                                   M2 Compliance LLC/FA


55 Previous Filings that this Filing References

  As Of               Filer                 Filing    For·On·As Docs:Size             Issuer                      Filing Agent

 1/21/22  AIM ImmunoTech Inc.               S-3                    5:822K                                   M2 Compliance LLC/FA
11/15/21  AIM ImmunoTech Inc.               10-Q        9/30/21   69:5.9M                                   M2 Compliance LLC/FA
 8/16/21  AIM ImmunoTech Inc.               10-Q        6/30/21   69:10M                                    M2 Compliance LLC/FA
 5/17/21  AIM ImmunoTech Inc.               10-Q        3/31/21   73:4.7M                                   M2 Compliance LLC/FA
 3/31/21  AIM ImmunoTech Inc.               10-K       12/31/20   94:7.6M                                   M2 Compliance LLC/FA
 1/22/21  AIM ImmunoTech Inc.               8-K:4,9     1/16/21    2:35K                                    M2 Compliance LLC/FA
11/12/20  AIM ImmunoTech Inc.               10-Q        9/30/20   68:4.1M                                   M2 Compliance LLC/FA
 8/14/20  AIM ImmunoTech Inc.               10-Q        6/30/20   72:4.9M                                   M2 Compliance LLC/FA
 4/27/20  AIM ImmunoTech Inc.               8-K:1,9     4/27/20    2:74K                                    M2 Compliance LLC/FA
 4/06/20  AIM ImmunoTech Inc.               8-K:1,7,9   4/06/20    3:119K                                   M2 Compliance LLC/FA
 3/26/20  AIM ImmunoTech Inc.               8-K:1,7,9   3/26/20    3:233K                                   M2 Compliance LLC/FA
12/11/19  AIM ImmunoTech Inc.               8-K:1,2,9  12/11/19    4:336K                                   M2 Compliance LLC/FA
 9/27/19  AIM ImmunoTech Inc.               8-K:1,8,9   9/27/19    5:739K                                   M2 Compliance LLC/FA
 9/24/19  AIM ImmunoTech Inc.               S-1/A       9/23/19    6:1.1M                                   M2 Compliance LLC/FA
 8/26/19  AIM ImmunoTech Inc.               8-K:5,8,9   8/22/19    3:81K                                    M2 Compliance LLC/FA
 8/23/19  AIM ImmunoTech Inc.               8-K:5,8,9   8/22/19    3:60K                                    M2 Compliance LLC/FA
 8/14/19  AIM ImmunoTech Inc.               10-Q        6/30/19   66:4.8M                                   M2 Compliance LLC/FA
 6/05/19  AIM ImmunoTech Inc.               8-K:5,9     6/03/19    2:773K                                   M2 Compliance LLC/FA
 5/02/19  AIM ImmunoTech Inc.               8-K:1,9     5/02/19    2:72K                                    M2 Compliance LLC/FA
 3/15/19  AIM ImmunoTech Inc.               8-K:1,9     3/13/19    2:58K                                    M2 Compliance LLC/FA
 3/08/19  AIM ImmunoTech Inc.               8-K:5,8,9   3/05/19    3:404K                                   M2 Compliance LLC/FA
 2/27/19  AIM ImmunoTech Inc.               8-K:8,9     2/26/19    4:304K                                   M2 Compliance LLC/FA
 2/06/19  AIM ImmunoTech Inc.               S-1/A                 16:2M                                     M2 Compliance LLC/FA
11/14/18  AIM ImmunoTech Inc.               10-Q        9/30/18   64:4.8M                                   M2 Compliance LLC/FA
10/04/18  AIM ImmunoTech Inc.               8-K:1,2,3,910/04/18    4:348K                                   M2 Compliance LLC/FA
 8/03/18  AIM ImmunoTech Inc.               DEF 14A     8/03/18    1:1.8M                                   M2 Compliance LLC/FA
 4/20/18  AIM ImmunoTech Inc.               8-K:1,3,7,9 4/20/18    6:896K                                   M2 Compliance LLC/FA
 3/30/18  AIM ImmunoTech Inc.               10-K       12/31/17   88:14M                                    M2 Compliance LLC/FA
 3/22/18  AIM ImmunoTech Inc.               8-K:1,9     3/22/18    4:328K                                   M2 Compliance LLC/FA
11/14/17  AIM ImmunoTech Inc.               8-A12B                 2:423K                                   M2 Compliance LLC/FA
 8/29/17  AIM ImmunoTech Inc.               8-K:5,8,9   8/22/17    4:76K                                    M2 Compliance LLC/FA
 8/23/17  AIM ImmunoTech Inc.               8-K:1,3,9   8/23/17    4:301K                                   M2 Compliance LLC/FA
 6/01/17  AIM ImmunoTech Inc.               8-K:1,3,9   6/01/17    4:333K                                   M2 Compliance LLC/FA
 5/15/17  AIM ImmunoTech Inc.               10-Q        3/31/17   61:3.4M                                   M2 Compliance LLC/FA
 5/08/17  AIM ImmunoTech Inc.               8-K/A:1,9   1/17/17    2:313K                                   M2 Compliance LLC/FA
 2/03/17  AIM ImmunoTech Inc.               8-K:1,3,7,9 2/01/17    6:468K                                   S2 Filings LLC/FA
 1/17/17  AIM ImmunoTech Inc.               8-K:1,9     1/17/17    2:217K                                   S2 Filings LLC/FA
 9/01/16  AIM ImmunoTech Inc.               8-K:1,3,7,9 9/01/16    6:419K                                   S2 Filings LLC/FA
 8/29/16  AIM ImmunoTech Inc.               10-Q/A      3/31/16    5:409K                                   S2 Filings LLC/FA
 8/15/16  AIM ImmunoTech Inc.               10-Q        6/30/16   55:3.1M                                   S2 Filings LLC/FA
 6/27/16  AIM ImmunoTech Inc.               DEF 14A     6/27/16    1:731K                                   S2 Filings LLC/FA
 6/10/16  AIM ImmunoTech Inc.               8-K:5,9     6/09/16    2:124K                                   S2 Filings LLC/FA
 5/16/16  AIM ImmunoTech Inc.               10-Q        3/31/16   52:2.9M                                   S2 Filings LLC/FA
 3/01/16  AIM ImmunoTech Inc.               8-K:5,9     2/29/16    2:39K                                    S2 Filings LLC/FA
 2/04/16  AIM ImmunoTech Inc.               8-K:5,8,9   1/26/16    4:68K                                    S2 Filings LLC/FA
11/16/15  AIM ImmunoTech Inc.               10-Q        9/30/15   67:4.5M
 8/12/15  AIM ImmunoTech Inc.               10-Q        6/30/15   64:4.5M
 3/19/15  AIM ImmunoTech Inc.               10-K       12/31/14   85:14M
 3/14/14  AIM ImmunoTech Inc.               10-K       12/31/13   96:16M
 8/15/12  AIM ImmunoTech Inc.               8-K:1,9     8/14/12    3:39K                                    Toppan Merrill/FA
 3/14/12  AIM ImmunoTech Inc.               10-K       12/31/11   48:5.4M                                   Toppan Merrill/FA
11/09/11  AIM ImmunoTech Inc.               10-Q        9/30/11   39:4.3M                                   Toppan Merrill/FA
 9/16/11  AIM ImmunoTech Inc.               DEF 14A    10/13/11    1:1.5M                                   Toppan Merrill/FA
 3/12/10  AIM ImmunoTech Inc.               10-K       12/31/09   11:2.5M                                   Toppan Merrill/FA
 4/03/06  AIM ImmunoTech Inc.               10-K       12/31/05    3:626K                                   Toppan Merrill/FA
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