Form 8-K
8-K — AIM ImmunoTech Inc.
Accession: 0001493152-26-036408
Filed: 2026-08-06
Period: 2026-07-31
CIK: 0000946644
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Entry into a Material Definitive Agreement
Item: Shareholder Nominations Pursuant to Exchange Act Rule 14a-11
Item: Financial Statements and Exhibits
Documents
8-K — form8-k.htm (Primary)
EX-10.1 (ex10-1.htm)
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0000946644
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2026-07-31
2026-07-31
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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): July 31, 2026
AIM
IMMUNOTECH INC.
(Exact
name of registrant as specified in its charter)
Delaware
001-27072
52-0845822
(state or other jurisdiction
(Commission
(IRS 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
(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))
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
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. ☐
Item
1.01 Entry into a Material Definitive Agreement.
On
July 31, 2026, AIM ImmunoTech Inc. (the “Company”) entered into a proposal (the “Proposal Agreement”) with Sterling
Pharma Solutions (the “Manufacturer”) that is related to the Master Service Agreement and a Quality Agreement entered into
between the Company and the Manufacturer in 2022. Pursuant to the Proposal Agreement, the Manufacturer agreed to manufacture further
batches of the polynucleotide drug substances PolyI and Poly C12U and transfer of associated test methods at the Manufacturer’s
Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen. The estimated cost to the Company under the Proposal
Agreement is approximately $1.5 million to be paid over a period of 12 months, as set forth in more detail in the Proposal
Agreement. The Company anticipates using the manufactured product for ongoing and future clinical trials, including potentially a Phase
3 clinical trial for metastatic pancreatic cancer.
The
foregoing summary of the Proposal Agreement does not purport to be complete and is qualified in its entirety by reference to the full
text of the Proposal Agreement, which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item
5.08 Shareholder Director Nominations.
Stockholders
who wish to nominate a director at the Company’s 2026 annual meeting of stockholders (the “2026 Annual Meeting”), or
to bring any other proposal before the 2026 Annual Meeting, that is not to be included in this year’s proxy materials pursuant
to Rule 14a-8, must do so in accordance with the Company’s Restated and Amended Bylaws, which require notice be received by the
Secretary at the Company’s principal executive offices not later than 5:00 p.m. local time on September 17, 2026 and not earlier
than August 18, 2026.
In
addition to satisfying the foregoing requirements, to comply with the universal proxy rules, stockholders who intend to solicit proxies
in support of director nominees other than the Company’s nominees must provide notice that sets forth the information required
by Rule 14a-19 under the Exchange Act no later than October 19, 2026.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit No.
Description
10.1
Proposal Agreement between the Company and the Manufacturer, dated July 31, 2026.
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document).
Cautionary
Note Regarding Forward-Looking Statements
This
Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
including with respect to the anticipated use of the manufactured products and any future clinical trial. These statements are subject
to risks and uncertainties that could cause actual results to differ materially, including but not limited to risks related to NYSE compliance,
clinical development, regulatory approval, and other factors described in the Company’s filings with the U.S. Securities and Exchange
Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company undertakes
no obligation to update any forward-looking statements.
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.
Date:
August 6, 2026
By:
/s/ Thomas K. Equels
Thomas K. Equels, CEO
EX-10.1
EX-10.1
Filename: ex10-1.htm · Sequence: 2
Exhibit
10.1
SPECIFIC TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE (1) SUCH TERMS ARE BOTH NOT MATERIAL AND ARE THE TYPE THAT
THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL, OR (2) DISCLOSURE OF SUCH INFORMATION WOULD CONSTITUTE A CLEARLY UNWARRANTED INVASION
OF PERSONAL PRIVACY. THESE REDACTED TERMS HAVE BEEN MARKED IN THIS EXHIBIT WITH THREE ASTERISKS AS [***].
Prepared
for
Prepared
by
AIM Immunotech
Inc
Sterling
Pharma Solutions
Judy
Boan
Business
Development Director
Ali Afnan
Phone:
[***]
Email:
[***]
Email:
[***]
Proposal:
HEBA_7869_v3.D.24072026
24th
July 2026
Revision
history
Date
Proposal
Number
Revision
Description
24th
July 2026
HEBA_7869_v3.D.23072026
Revised
to include full release testing for CDP, IDP and UDP; to reduce cGMP to one batch; [***].
1st
July 2026
HEBA_7869_v2.D.01072026
Revised
to include HEBA_8437 Analytical method Validation scope of work. Revision of section 3.1 based on some work already completed in
HEBA_7633_v2. Itemized
capex
included and other minor updates.
15th
January 2026
HEBA_7869_v1.D.15012026
Original
proposal
CONFIDENTIAL
Page 2 of 20
Table
of contents
Revision
history
2
Table
of contents
3
1.
Company Summary
5
2.
Executive summary
5
3.
Research and Development Plan
6
3.1
Polyl
and Poly C12U process development
6
3.2
Polyl
and Poly C12U non-GMP demonstration batches
7
3.3
Polyl
Stage 1 and Poly C12U Analytical Method Implementation and Validation
8
4.
Manufacturing plan
10
4.1
cGMP
Manufacture of Polymer Solutions
11
5.
Pricing and invoicing
13
6.
Project Management
16
6.1
Communication
management plan
16
6.2
Schedule
16
6.3
High
level initial assumptions/tentative schedule:
17
7.
Signature page
18
Further
information
19
Appendix
A: Terms and Conditions
20
CONFIDENTIAL
Page 3 of 20
Scheme
1. Synthesis of PolyI
Scheme
2. Synthesis of Poly C12U
CONFIDENTIAL
Page 4 of 20
1. Company Summary
Sterling
Pharma Solutions has over 50 years’ experience of supporting our customers globally with projects from pre-clinical to commercial
manufacture. Each year we develop, scale up and manufacture to cGMP over 150 stages of chemistry. In the last four years we have supported
our customers through clinical supply and launch with 16 new chemical entities.
Differentiated
by the three core characteristics of service, passion, and science, we are more than a traditional CDMO. We are a PDMO®, or partnership
development and manufacturing organization. That means we are uniquely responsive to your needs, committed to your product, and capable
of adding a deep level of scientific value.
Whilst
science can be complex, we believe partnerships should be simple.
To watch a short animation about Sterling please click here.
2. Executive summary
AIM
Immunotech Inc (“AIM Immunotech”) has requested that Sterling Pharma Solutions (“Sterling”) provide a proposal
for the manufacture of further batches of the polynucleotide drug substances PolyI and Poly C12U. The syntheses of PolyI and Poly C12U
are depicted in Schemes 1 and 2.
This
proposal is based on manufacture of the polymers in aqueous frozen solution at the Dudley site.
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CONFIDENTIAL
Page 5 of 20
3 Research and Development Plan
3.1
Polyl and Poly C12U process development
Efforts
will initially focus on the following development and optimization activities. The investigation work will commence following evaluation
and confirmation of suitability of the analytical methods to support this work. Sterling would be pleased to discuss and further refine
or adjust the activities captured in this section:
Polyl
●
Experiments to investigate root causes of batch failures for polymer size and inosine diphosphate content:
○
[***]
○
[***]
○
Experiments to confirm
optimized yield, polymer size, and IDP removal (2 experiments)
Poly
C12U
●
Experiments to investigate root causes of batch failures for polymer size and cytidine diphosphate:
○
[***]
○
[***]
○
Experiments to confirm
optimized yield, polymer size, and CDP removal (2 experiments)
Assumptions:
1.
Allocate
12 calendar weeks [***] to execute the Polyl and Poly C12U process
development and optimization scope. This assumes multiple FTE’s, chemists and analysts, will be used.
2.
The
IDP, [***] enzyme, CDP, [***], and UDP will be provided by AIM Immunotech free of charge.
3.
Laboratory work to investigate
the C to U ratio in Poly C12U was approved by AIM Immunotech and carried out by Sterling (Reference HEBA_7633_v2.D.12032026).
4.
Upon successful completion
AIM will review within 5 business days and provide decision on path forward.
Deliverables:
1.
Provision of any available samples
of Polyl and Poly C12U from development work.
2.
Development report.
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of page intentionally left blank.
CONFIDENTIAL
Page 6 of 20
3.2
Polyl and Poly C12U non-GMP demonstration batches
Sterling
will manufacture a non-GMP demonstration batch of each process in laboratory glassware of 20 liters, to verify the performance of each
process and control strategy, as well as to verify the validity of the assumptions made below.
Assumptions:
1.
Allocate 3
calendar weeks to manufacture the non-GMP demonstration batch of Polyl.
2.
Allocate 3 calendar weeks
to manufacture the non-GMP demonstration batch of Poly C12U.
3.
[***]
4.
The process details and
target specifications will be mutually agreed upon between Client and Sterling prior to the demonstration batches.
5.
Upon successful completion
AIM will review within 5 business days and provide decision on path forward.
Deliverables:
1.
Non-GMP batches
of Polyl and Poly C12U, on a commercially reasonable effort basis, process and target specifications will be agreed between AIM Immunotech
and Sterling prior to the execution of the demo batches.
2.
Updated Development Report.
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of page intentionally left blank.
CONFIDENTIAL
Page 7 of 20
3.3
Polyl Stage 1 and Poly C12U Analytical Method
Implementation and Validation.
Sterling
will implement AIM Immunotech provided phase appropriate analytical methods for the PolyI and Poly C12U products. and will utilize AIM
Immunotech provided fit for purpose analytical reference standards. The development and validation of several methods has also been identified
as a project requirement (Table 1).
Assumptions:
1.
A
total of [***] have been identified for the analytical validation activities shown in Table 1. Multiple FTE’s will be
used to complete the work in approximately [***].
Table
1. Analytical validation requirements
Item
Method
- analysis
Qualification
level
Development
time (days)
Validation
time (days)
Comments
CDP,
IDP, UDP
Appearance
N/A
[***]
[***]
No
validation required for appearance.
CDP,
IDP, UDP
KF
Development
and Verification
[***]
[***]
(USP)
CDP,
IDP, UDP
Elemental
Impurities (Heavy metals and
As)
Development
and Verification
[***]
[***]
(USP)
CDP,
IDP, UDP
HPLC
– Purity Impurities
Identification
Validation
[***]
[***]
Validation
required using customer supplied method
[***]
[***]
[***]
Development
and Validation
[***]
[***]
Specification
to be confirmed. Method to be developed and validated using customer supplied method [***]
[***]
Development
and Validation
[***]
[***]
Endotoxin
Outsourced
[***]
[***]
To
be performed at either Lucideon or Wickham
[***]
[***]
Development
and Validation
[***]
[***]
Methods
to be developed and validated [***]
[***]
Development
and Validation
[***]
[***]
[***]
Development
and Validation
[***]
[***]
IPC
(Polymerisation)
[***]
Validation
[***]
[***]
Validation
required using customer supplied method [***]
Molecular
Weight
Validation
[***]
[***]
Method
developed at Sterling, requires to be validated based on [***]. Validation will be
covered by release testing
validation
IPC
[***]
Polymer
Concentration
Development
and Validation
[***]
[***]
Method
to be developed and validated based on a [***]
Protein
Concentration
Validation
[***]
[***]
Validation
required using customer supplied method [***]
CONFIDENTIAL
Page 8 of 20
Item
Method
- analysis
Qualification
level
Development
time (days)
Validation
time (days)
Comments
Release
Testing
Molecular
Weight
Validation
[***]
[***]
Validation
required using customer supplied method [***]
TOTAL
[***]
[***]
Assumptions:
1.
Client methods
for implementation are assumed to be scientifically sound and compatible with Sterling analytical instrumentation and quality systems.
Method implementation consists of a system set-up, verification of system performance, and analysis of a representative sample.
2.
Method development will
involve development or optimization of AIM Immunotech provided analytical methods and verification of suitability for the phase of
the project.
3.
Validation of methods will
be carried out as appropriate for late phase and commercial use in accordance with ICH Q2(R2). Validations will include studies such
as specificity, linearity, range, limit of quantification, limit of detections, solution stability, intermediate precision, robustness
(up to two parameters), and relative response factor determinations (up to three related substances), where applicable.
4.
Samples of raw materials,
in-process controls, isolated intermediates, and final product will be supplied from chemistry development runs, demonstration batch,
or by AIM Immunotech, whatever is deemed most practical and appropriate, for analytical method implementation, verifications, and
validations, where applicable.
5.
Sterling assumes that AIM
Immunotech will provide all required analytical reference standards. Sterling assumes that the reference standards have been appropriately
tested and qualified for their intended use and will be provided with current CoAs.
6.
Reference standard qualifications
and re-qualifications are not included in the scope of this proposal.
7.
[***]
8.
[***]
9.
Upon successful completion
AIM will review within 5 business days and provide decision on path forward.
Deliverables:
1.
Method implementation reports.
2.
Method development reports.
3.
Finalized validation/verification protocols and reports.
4.
Finalized analytical methods.
5.
An electronic copy of raw analytical data upon request.
CONFIDENTIAL
Page 9 of 20
4.
Manufacturing plan
Sterling
strives for right-first-time execution with a focus on safety and quality. The technical transfer from development to manufacture is
performed through a series of governance processes and continued technical, EHS and quality management before, during and after manufacturing.
The estimated production and material resources are based upon the learnings from laboratory familiarization work, including the activities
listed below.
The
following manufacturing support activities are included:
●
Documentation:
Generation of the necessary master production and testing records will be performed. These will be provided for review and/or
approval of the AIM Immunotech and developed in conjunction with AIM Immunotech. Timelines are dependent upon timely review and approval
of these documents in support of manufacturing.
●
Technical management:
Technical support during the campaign will be provided for the standard transfer and management of the production activities.
This will include support from the technical staff (chemistry, analytical and engineering teams) to perform process and method training
to all involved operations staff.
●
Stewardship: Sterling’s
EHS, technical services, and quality department personnel will ensure compliance with global regulatory frameworks with respect to
manufacturing operations and workplace safety. This includes, but is not limited to, the review of toxicological information, occupational
health review of processes and ingredients, health-based exposure limit (“HBEL”) determinations, maximum carry over calculations
for cross-contamination and a site risk assessment.
●
Cleaning: Development
and validation of appropriate methods for the cleaning and verification of the equipment from production residues will be performed
in support of this process. Additionally, all cleaning of the equipment is included in the standard manufacturing support package.
Cleaning process validation is not included in the scope of this proposal. In support of this, a material questionnaire may be provided
for a cleaning limit assessment.
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of page intentionally left blank.
CONFIDENTIAL
Page 10 of 20
4.1
cGMP Manufacture of Polymer Solutions
Manufacture
of the polymer solutions will be carried out in Sterling’s GMP Pilot Plant facility, located at the Dudley, UK site. A reactor
stream featuring [***] liter vessels will be assigned, with the additional equipment required for the processes. In each case
the target batch size will be preparation of [***] liters of solution containing [***] of polymer. All steps will be carried
out under cGMP conditions. Completed batches of polymer solution will be held in suitable containers and frozen for storage and onward
transportation for lyophilization.
Prior
to manufacture Sterling will prepare the following documentation, which will be sent to AIM Immunotech for review and approval:
●
Process Record Sheets (PRS)
●
Final product analytical monographs
The
asset and batch plan are detailed in the table below and estimated plant occupancy is reflected in the pricing and invoicing section.
Table
2. Asset strategy for the GMP manufacturing campaign
Product
Asset
(litres)
Batch
size (kg of solution)
Number
of Batches
Estimated
Occupancy
Time
(days)1
Polyl
[***]
[***]
1
[***]
days
Poly
C12U
[***]
[***]
1
[***]
days
1Estimated
cycle times include commissioning and cleaning time.
Assumptions:
1.
The
[***] IDP, [***] kg [***] enzyme, [***] CDP, [***], and [***] UDP will be provided
by AIM Immunotech free of charge.
2.
Process validation is not
required at this stage of the project.
3.
The
products will be provided as [***] in Nalgene PPCO [***] container.
4.
[***] will be carried
out by a third party contracted by Aim Immunotech.
5.
The manufacturing includes
full release testing for CDP, IDP and UDP.
Deliverables:
1.
One cGMP batches
each of Poly I and Poly C12U solution on commercially reasonable efforts basis (Sterling will follow approved procedures).
2.
Report of analysis, BSE/TSE
statement, and certificate of compliance for each batch.
3.
An electronic copy of each
executed batch record.
4.
Campaign report.
CONFIDENTIAL
Page 11 of 20
Table
3. Investment requirements for the GMP manufacturing campaign
Process
Step
Requirement
Capital
estimate ($)
Ultrafiltration/
Diafiltration
New
ultrafiltration rig with associated pump, pipework, instrumentation and membranes
$[***]
Packaging
New
flexible isolator for polymer solution discharges
$[***]
General
Project
management
$[***]
Total
$[***]
Storage
and shipment agreement:
Storage
is free for up to two months from the date of manufacture. Storage beyond two months will be billed at the end of each month at a rate
listed in the below table.
Table
4. Product storage
Storage
condition
Price
per pallet storage per month
Monitored
room temperature
$[***]
Controlled
room temperature (15-30°C)
$[***]
Controlled
cold storage (2-8°C) or hazardous material storage
$[***]
Controlled
cold storage (-20°C)
$[***]
Controlled
substance (controlled storage)
$[***]
Storage
of materials in advance of three months from the date of manufacture will incur an additional Value Added Tax (VAT) charge, which is
required by UK Government, of 20% of the goods’ sales value. This will be passed through at cost. Recovery of any VAT charged to
the Client is the responsibility of the Client.
Preparation
of a single bulk shipment of each lot of material manufactured under this Proposal is included in the total price. Bulk shipments of
material will be dispatched under Incoterms FCA 2020 (Sterling Dudley), or will be charged back at [***].
Preparation
of bulk material for shipment will be billed per request at a rate of $[***] each. This rate includes the time required to weigh,
sample and label the material in a GMP compliant environment. Multiple preparations from the same bulk, if requested and sampled simultaneously,
will incur a single $[***] preparation charge. Each shipment will also be back charged at [***].
Preparation
of laboratory samples for shipment will be billed at a rate of $[***] per sample, per shipment, plus freight costs and a [***].
CONFIDENTIAL
Page 12 of 20
Pricing and invoicing
Sterling
has made various estimates and assumptions in preparing this Proposal, including the value and volume of materials to be used and the
amount of time above activities will utilise its facilities and personnel. Based on such estimates and assumptions, the Pricing Summary
below provides the indicative price to provide the development, testing, and manufacturing activities by Sterling with supporting materials,
supplies, and waste included unless explicitly listed otherwise. Sterling will endeavor to ensure the price quoted below is the maximum
price and will regularly review and monitor any potential for increased costs, however, some variables are not within Sterling’s
control and therefore if the estimates and assumptions can be demonstrated to be inaccurate, Sterling reserves the right to update the
Pricing Summary, discuss with AIM Immunotech and invoice AIM Immunotech accordingly. Further if additional or out of scope activities
and/or materials are required due to unforeseen outcomes or at the request of AIM Immunotech, Sterling will discuss with AIM Immunotech
and provide a change order to support that work or activity.
Any
third-party services and shipping handled by Sterling not explicitly listed below will be passed through at cost plus a handling fee.
Table
5. Pricing summary
Scope
of work – milestone
Total
Anticipated
Timing
1.
Polyl process development (Section 3.1)
$[***]
[***]
Polyl
development
$[***]
Materials
$[***]
2.
Polyl C12U process development (Section 3.1)
$[***]
[***]
Pol.y
C12U development
$[***]
Materials
$[***]
3.
Polyl non-GMP demonstration batch (Section 3.2)
$[***]
[***]
Demonstration
batch Polyl
$[***]
Process
Materials
$[***]
Ultrafiltration
equipment [***]
$[***]
4.
Polyl C12U non-GMP demonstration batch (Section 3.2)
$[***]
[***]
Demonstration
batch Poly C12U
$[***]
Process
Materials
$[***]
Ultrafiltration
equipment [***]
$[***]
5.
Polyl Stage 1 and Poly C12U Analytical Method Implementation and Validation (Section 3.3)
$[***]
[***]
Analytical
method implementation and validations
$[***]
Materials
$[***]
CONFIDENTIAL
Page 13 of 20
Scope
of work – milestone
Total
Anticipated
Timing
6.
Capital expenditure to support manufacture of cGMP batches
$[***]
[***]
Capital
expenditure (Table 3)
$[***]
7.
Manufacture of cGMP batches of Polyl (Section 4.1)1
$[***]1
[***]
Polyl
manufacture
$[***]
Polyl
materials
$[***]
8.
Manufacture of cGMP batches of Polyl C12U (Section 4.1)1
$[***]1
[***]
Poly
C12U manufacture
$[***]
Poly
C12U materials
$[***]
Estimated
total
$1,446,2002
1The
total value (manufacturing and materials) represented in these lines shall be considered the value used in the calculation of the “Cancellation
Fee” as captured in the Terms and Conditions (attached hereto) 2This pricing is based upon a GBP (£) to USD ($) conversion
rate of x1.33; a mutually agreed currency adjustment will be applied for any fluctuations above agreed limits (e.g. supplementary invoices/credit
notes, alternatively pricing will be based on the exchange rate on the date invoices are raised).
Table
6. Price component summary
Price
component
Total
1)
Sterling services
$[***]
2)
Materials
$[***]
3)
Capital expenditure
$[***]
Estimated
total
$1,446,200
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CONFIDENTIAL
Page 14 of 20
Table
7. Invoice schedule for scope of work
Scope
of work – milestone
Total
Invoicing
milestone
1.
Project initiation deposit
$[***]
[***]
2.
Second deposit
$[***]
[***]
3.
Polyl process development (Section 3.1)
$[***]
[***]
4.
Polyl C12U process development (Section 3.1)
$[***]
[***]
5.
Polyl non-GMP demonstration batch (Section 3.2)
$[***]
[***]
6.
Poly C12U non-GMP demo batch (Section 3.2)
$[***]
[***]
7.
Analytical method development and validation (Section 3.3)
$[***]
[***]
8.
Capital expenditure to support manufacture
$[***]
[***]
9.
Manufacture of cGMP batches Polyl (Section 4.1)
$[***]
[***]
10.
Manufacture of cGMP batches Poly C12U (Section 4.1)
$[***]
[***]
Estimated
total
$1,446,200
Scope
changes:
All
changes from this scope of work will be documented by Sterling and approved by AIM Immunotech prior to commencement of any such additional
work.
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of page intentionally left blank.
CONFIDENTIAL
Page 15 of 20
6
Project Management
Sterling
will appoint a dedicated project manager to manage the project through all project stages. Standardized tools, techniques, detailed processes
and procedures will be used to track, monitor, and communicate project progress throughout the lifecycle of the contract.
6.1
Communication management plan
Upon
initiation, a detailed communication management plan will be created to support the project. This is expected to include, but is not
limited to the following:
1.
Regularly scheduled team teleconferences
2.
Meeting minutes
3.
Weekly written updates
4.
Development/campaign final report
5.
Team and escalation communication matrix
These
processes will support, but not replace, formal communication outlined in the quality agreement.
This
communications management plan sets the communications framework for this project. It will serve as a guide for communications throughout
the life of the project and will be updated as communication requirements change. This plan identifies and defines the roles of the project
team members as they pertain to communications. It also includes a communications matrix which maps the communication requirements of
this project, and communication conduct for meetings and other forms of communication.
The
assigned project manager will take the lead role in ensuring effective communications on this project. The communications matrix will
be used as the guide for what information to communicate, who is to do the communicating, when to communicate it, and to whom to communicate.
6.2
Schedule
Based
on the information provided by Client, assumptions made by Sterling, and the consultation of subject matter experts, a tentative schedule
has been prepared to highlight significant milestones surrounding the proposal. Post-acceptance of this proposal, the assumptions will
be reviewed and the schedule will be updated to reflect current timing and milestones accordingly. Any delay to the items indicated in
the table below will have a direct impact to the overall timeline and delivery of the bulk API.
CONFIDENTIAL
Page 16 of 20
6.3 High
level initial assumptions/tentative schedule:
The
Gantt chart provided in this proposal is based off of assumptions (development time, cycle time, yields, etc.) derived from the information
provided by the client and assumes approval by Client within 30 days. Should capacity or availability of resources change due to signature
of other projects prior to execution of this proposal Sterling will notify Client and discuss any potential impacts.
[*** the blacked out portions
of the image below have been redacted]
CONFIDENTIAL
Page 17 of 20
7 Signature page
This
proposal shall become binding on the parties if signed by an authorized representative of AIM Immunotech and returned to Sterling within
30 days of the date hereof.
Acceptance:
If
acceptable, please indicate by signing below and issuing a purchase order or payment method referencing this proposal number.
An
authorized representative of Sterling will sign upon proposal receipt from AIM Immunotech to formally accept the proposal.
By
signing this proposal, the parties acknowledge the services provided hereunder shall be subject to the Terms and Conditions in Appendix
A.
Sterling
AIM Immunotech
Inc
Mathew Minardi
Peter Rodino
Printed name of authorized representative
Printed name of authorized representative
/s/ Mathew Minardi
/s/ Peter Rodino
Signature
Signature
President
Americas/APAC and COC
General Counsel & COO
Title
Title
7/31/2026
7/31/2026
Date
Date
Purchase order number
CONFIDENTIAL
Page 18 of 20
Further
information
About
Sterling
Our
facilities
Partnership
development and manufacturing organisation (PDMO) Our heritage
Executive
team
Small
Molecule Services
API
Development
API
Manufacturing
CMC
Solid
state chemistry
Milling
and micronisation
ADCs
ADC
Development
ADC
Analytical Services
Technologies
Hazardous
chemistry
Diazomethane
Hazard
evaluation
Chiral
chemistry
Controlled
substances
Continuous
processing/flow
Biocatalysis
Highly
Potent API (HPAPI)
Fluorination
Knowledge
Hub
All
resources
Quality
and regulatory
HSE
Latest
news
CONFIDENTIAL
Page 19 of 20
Appendix
A: Terms and Conditions
https://www.sterlingpharmasolutions.com/core/wp-content/uploads/2026/03/Sterling-Proposal-TCs-Dudley-Cramlington-Jan-2026.pdf
Remainder
of page intentionally left blank.
CONFIDENTIAL
Page 20 of 20
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