Research, Consulting and Supply Agreements

3 Months Ended

Mar. 31, 2023

Research Consulting And Supply Agreements

Research, Consulting and Supply Agreements

Note 13: Research, Consulting and Supply Agreements

The following represent companies with which AIM has active contracts that it paid toward in Q1 2023.

Amarex Clinical Research LLC

AIM has multiple contracts with Amarex Clinical Research LLC (“Amarex”) In the first Q1 2023, we paid $520,800 related to these ongoing agreements:

● Pancreatic Cancer - In April 2022, AIM executed a work order with Amarex pursuant to which Amarex will manage a Phase 2 clinical trial in locally advanced pancreatic cancer patients designated AMP-270. Per the work order, AIM anticipates that the study will cost approximately $8.2 million, which includes pass through costs of approximately $1.0 million and excludes certain third-party and investigator costs and escalations. AIM anticipates that the study will take approximately 4.6 years to complete.

○ In Q1 2023, we paid approximately $309,400 related to this agreement.

● Post-COVID Conditions - On June 13, 2022, AIM executed a work order with Amarex, pursuant to which Amarex will manage a Phase 2 trial in patients with Post-COVID Conditions. It is planned that the study will be conducted at up to 10 sites in the United States. AIM is sponsoring the study. AIM anticipates that the study will cost approximately $4.4 million, which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations.

○ In Q1 2023, we paid approximately $211,400 related to this agreement.

hVIVO Services Limited

In July 2021, the Company executed a Reservation and Start-Up Agreement (the “Agreement”) with hVIVO Services Limited (“hVIVO”), and subsequently signed a clinical trial agreement (“CTA”) in September. For the year ended December 3, 2021, the Company had incurred an expense and paid hVIVO approximately $2,340,000 for services incurred in 2021. In March 2022, the Company announced that it had officially withdrawn its application from the Medicines and Healthcare Regulatory Agency and terminated its agreement with hVIVO and incurred a cancelation fee of $60,000 which was paid in the first quarter 2022.

Impatients N.V.

In 2016, the Company entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”), a Netherlands-based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related to ME/CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing EAP activities. The agreement was automatically extended for a period of 12 months on May 20, 2021; automatically extended again for an additional period of 12 months on May 20, 2022; and will be automatically extended again on May 20, 2023.

○ In Q1 2023, we paid $8,000 related to this agreement.

Jubilant HollisterStier

Jubilant HollisterStier (“Jubilant”) is AIM’s authorized CMO for Ampligen for the approval in Argentina. In 2017, the Company entered into a purchase order with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Since the 2017 engagement of Jubilant, four lots of Ampligen consisting of more than 16,000 units have been manufactured and released in year 2018. The first lot was designated for human use in the United States in the cost recovery CFS program and for expanded oncology clinical trials. The second lot has been designated for these programs in addition to commercial distribution in Argentina for the treatment of CFS. In March 2023, we submitted a work order for a total of $1,432,257.

○ In Q1 2023, there were no payments related to this agreement.

Pharmaceutics International Inc.

In December 2020, AIM added Pharmaceutics International Inc. (“Pii”) as a “Fill & Finish” provider to enhance the Company’s capacity to produce the drug Ampligen. This addition amplifies AIM’s manufacturing capability by providing redundancy and cost savings. The contracts augment AIM’s existing fill and finish capacity. As agreed to in the Master Services Agreement, the terms of each of AIM’s projects with Pii will be negotiated separately and defined in individual Service Contracts. For the year ended December 31, 2022, the Company has incurred an expense and paid Pii approximately $278,000.

○ In Q1 2023, we paid approximately $9,300 related to this agreement.

Polysciences Inc.

In April 2021, the Company approved a proposal from Polysciences Inc. (“Polysciences”) for the manufacture of our Poly I and Poly C12U polynucleotides and associated test methods at Polysciences’ Warrington, PA location to enhance our capacity to produce the polymer precursors to the drug Ampligen. The Company is working with Polysciences to negotiate and finalize both a Service Agreement and a Quality Agreement. For the year ended December 31, 2021, the Company has incurred an expense and paid Polysciences approximately $250,000. For the three months ended March 31, 2022, the Company paid Polysciences $103,000.

○ In Q1 2023, there were no payments related to this agreement.

Yamasa Corporation

The Company has utilized Yamasa Corporation (“Yamasa”) for the production of raw materials required to create polymer precursors to manufacture the drug Ampligen. In March 2023, we submitted a work order for $327,730 related to the purchase of these raw materials from Yamasa. These raw materials will be used in the manufacture of polymer precursors at Sterling.

○ In Q1 2023, there were no payments related to Yamasa.

Sterling Pharma Solutions

On December 5, 2022, the Company entered into a Master Service Agreement and a Quality Agreement with Sterling Pharma Solutions (“Sterling”) for the manufacture of the Company’s Poly I and Poly C12U polynucleotides and transfer of associated test methods at Sterling’ Dudley, UK location to produce the polymer precursors to manufacture the drug Ampligen.

○ In Q1 2023, there were no payments related to this agreement.