December 30, 2020 Amendment to Project Work Order with Amarex Clinical Research LLC. (Portions of this Agreement have been redacted in compliance with Regulation S-K Item 601(b)(10))
Exhibit 10.78
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 IN PUBLICLY DISCLOSED.
Amendment 01 to Project AIM02
Statement of Work and Budget for
Original Amarex Project No.:
AIM02_Phase 1 & 2
Prepared for:
AIM ImmunoTech Inc.
2117 SW Highway 484
Ocala, FL 34473
Prepared by:
Amarex Clinical Research, LLC
20201 Century Boulevard
Germantown, MD 20874
Phone: (301) 528-7000
Fax: (301) 528-2300
Amendment Date: December 30, 2020
This Amendment 1 to the Amarex Project AIM02 is prepared for the exclusive use of AIM, for the work indicated herein. It is proprietary and not to be copied or distributed outside of AIM.
Amarex Confidential and Proprietary | |
| Amendment 01 to AIM02 Contract | 12/30/20 |
| Additional Services | Page 1 |
1. Terms and Conditions
Made this 30th day of December, 2020 (the “Effective Date”) to the Project Agreement made on the 6th day of August, 2020 (the “Agreement) by and between:
AIM Immunotech Inc., a corporation with its principal place of business at 2117 SW Highway 484, Ocala, FL 34473 (hereinafter “AIM”), AND
Amarex Clinical Research, LLC, a for-profit Maryland limited liability company with its principal place of business at 20201 Century Boulevard, Germantown, Maryland 20874. (hereinafter “Amarex”).
WHEREAS AIM has requested and Amarex has agreed to provide certain Services in addition to those in the Agreement relating to additional services.
NOW THEREFORE, the parties hereby agree to amend the Agreement as follows:
| 1. | Amarex agrees to provide the Services as listed in Section 2, Project Statement of Work. | |
| 2. | AIM agrees to pay Amarex the costs noted in Section 4, Amendment Budget. | |
| 3. | AIM will pay the costs associated with the Amendment according to Section 5, Payment Schedule. |
This Amendment may be signed in any number of counterparts, which, when taken together, will constitute one and the same Amendment.
IN WITNESS WHEREOF, the authorized representatives of the parties have duly executed this agreement as of the Effective Date.
FOR AND BEHALF OF:
| For and on behalf of AIM Immunotech Inc.: | For and on behalf of Amarex Clinical Research, LLC: | |||
| Print Name: | Peter W. Rodino | Print Name: | Kazem Kazempour | |
| Signature: | /s/ Peter W. Rodino | Signature: | /s /Kazem Kazempour | |
| Title: | COO | Title: | President and CEO (Member) | |
| Date: | 1/5/2021 | Date: | 1/6/2021 | |
Amarex Confidential and Proprietary | |
| Amendment 01 to AIM02 Contract | 12/30/20 |
| Additional Services | Page 2 |
2. Project Statement of Work
Amarex will support AIM in clinical trial work, to include:
| ● | Monitoring of the Phase I Unit in the Netherlands by a local Dutch monitor. | |
| ● | Setup and maintenance of a shadow TMF, and investigator site files can be provided if the Phase I Unit does not do this itself. Training of a backup CRA can be conducted, if needed. |
Assumptions
| Activity / resource | Unit | |
| Patients, territories and sites | ||
| Enrolled patients | 40 | |
| Sites | 1 | |
| Countries | 1 (NL) | |
| CRAs | 1 (backup CRA training billed if required) | |
| Study duration (months) | ||
| Set up duration | 1.0 | |
| Conduct | 5 | |
| Closure duration | 1.0 | |
| Meetings and visits | ||
| KO TC | 1 | |
| Investigator meetings | NA | |
| Sponsor/CRO Study Team Teleconferences | 9x 1hr TCs in total Fortnightly during set up Monthly during Conduct Fortnightly during closure | |
| Site visits | ||
| PSVs | 0 | |
| SIVs | 1 | |
| MVs - Conduct | 6 (1x 1 day visit and 5x 2 day visits) | |
| COVs | 1 |
3. Timelines
Amarex will begin working upon approval of this Amendment.
Amarex Confidential and Proprietary | |
| Amendment 01 to AIM02 Contract | 12/30/20 |
| Additional Services | Page 3 |
4. Amendment Budget
Services
| 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 | $ [***] | 1 | $ [***] | |||||||||||||
| 2 | Study KO meeting (TC) | Once | $ [***] | 1 | $ [***] | |||||||||||||
| 3 | Preparation of PM Plans | Plans | $ [***] | 4 | $ [***] | |||||||||||||
| 4 | Site initiation | Sites | $ [***] | 1 | $ [***] | |||||||||||||
| 5 | In-house SCRA activities - set up including site communication | Site / months | $ [***] | 1 | $ [***] | |||||||||||||
| 6 | Sponsor TCs - set up | Alternate Weeks | $ [***] | 2 | $ [***] | $ [***] | ||||||||||||
| Conduct (5 months) | ||||||||||||||||||
| 7 | Monitoring Visits | IMV | $ [***] | 6 | $ [***] | |||||||||||||
| 8 | In-house SCRA activities - conduct including site communication | cohorts | $ [***] | 4 | $ [***] | |||||||||||||
| 9 | Sponsor TCs - Conduct | monthly | $ [***] | 5 | $ [***] | $ [***] | ||||||||||||
| Study closure (1 months) | ||||||||||||||||||
| 10 | Close-Out | COVs | $ [***] | 1 | $ [***] | |||||||||||||
| 11 | In-house SCRA activities - closure including site communication | Site / months | $ [***] | 1 | $ [***] | |||||||||||||
| 12 | Sponsor TCs - closure | Alternate Weeks | $ [***] | 2 | $ [***] | $ [***] | ||||||||||||
| TOTAL | $ [***] | |||||||||||||||||
Optional Services
| 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 | $ [***] | 1 | $ [***] | |||||||||||||
| 14 | Set up shadow TMF | Sites | $ [***] | 1 | $ [***] | |||||||||||||
| 15 | Set up ISFs | Sites | $ [***] | 1 | $ [***] | $ [***] | ||||||||||||
| Conduct (5 months) | ||||||||||||||||||
| 16 | Maintenance of TMF - Conduct | Site / months | $ [***] | 5 | $ [***] | $ [***] | ||||||||||||
| Study closure (1 months) | ||||||||||||||||||
| 17 | Return of TMF to sponsor | Sites | $ [***] | 1 | $ [***] | $ [***] | ||||||||||||
Amarex Confidential and Proprietary | |
| Amendment 01 to AIM02 Contract | 12/30/20 |
| Additional Services | Page 4 |
Estimated Pass-Through
| Estimated Pass-Through Costs | ||||||||||||||||||
| Bid ID | Service | Unit Description | Unit Cost $ | No. Units | Total Cost $ | Category Total $ | ||||||||||||
| 1 | Printing/Shipping | site months | $ [***] | 7 | $ [***] | |||||||||||||
| 2 | Communications | TCs | $ [***] | 9 | $ [***] | $ [***] | ||||||||||||
| ESTIMATED TOTAL | $ [***] | |||||||||||||||||
5. Payment Schedule
| Payment Description | Percentage Due | Amount | ||
| Monthly Unit-Based Billing | TBD | TBD |
AIM will be billed according to the same terms and provisions as outlined in the Agreement.
Amarex Confidential and Proprietary | |
| Amendment 01 to AIM02 Contract | 12/30/20 |
| Additional Services | Page 5 |
