A02-Limiting Competition_Redacted.pdf

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Control Number: JA-24-07-1626

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Source Selection Information - See FAR 2.101 and 3.104-4

JAN 2024

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition

Threshold

1. Contracting Activity: The U.S. Army Medical Research Acquisition Activity (USAMRAA), 808 Schreider, Fort Detrick, MD, 21702 on behalf of the U.S.

Army Medical Research Institute of Chemical Defense (USAMRICD), Building E2900, 8350 Ricketts Point Rd, APG-EA, MD 21010.

2. Description of Action: Anti-Carfentanil monoclonal antibody (mAb) for use in Non-Human Primates

Nature of Requirement ☒ New Requirement

☒ Purchase Order ☐ Blanket Purchase Agreement (BPA) ☐ Order against BPA # Click or tap here to enter text.

☐ Order against Multiple Award IDIQ Contract # Click or tap here to enter text.

☐ Order against Single Award IDIQ Contract # Click or tap here to enter text.

☐ Order against FSS Contract # Click or tap here to enter text.

☐ Follow-on Requirement to Contract/Order # Click or tap here to enter text.

☐ Modification against existing Contract/Order #Click or tap here to enter text.

Contract Type ☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid Click or tap here to enter text.

Funding ☒ Research, Development, Test & Evaluation (RDT&E) ☐ Other - Click or tap here to enter text.

Fiscal Year: 2023-2024

Name of Proposed Contractor(s) and Address Celltheon Corporation 32890 Alvarado Niles Road, Suite 826, Union City, CA 94587

UEI: XBBJYPDQAU19 CAGE: 71G96

3. Description of Services or Supplies:

Synthesis of >4 grams of anti-carfentanil monoclonal antibody (mAb) to be used in non-human primates. The total mass of the mAb will then be diluted into phosphate buffered saline (pH 7.4) to yield a concentration of >75 mg/ml. The resulting solution will be safe to use in non-human primates (such as African green monkeys).

Delivery Date: 06/01/2025. This includes the lead time required for these items to be made and delivered therefore, the award has to be placed before September 2024.

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4. Authority:

☒ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name, or industrial mobilization).

5. Reasons for Authority Cited:

The mAb will be used to support an NIH Interagency Agreement (IAA) research study that is in collaboration with the University of Washington specifically testing the anti-fentanyl mAb synthesized by Celltheon. Additionally, Celltheon utilizes at least 2 proprietary methods to create their mAbs. Based on the NIH-IAA research milestones to test anti-carfentanil, only the anti-carfentanil mAb from Celltheon will meet the Government’s need. Any other mAb would fail to meet the promised objective of the research. Specifically, the proposal requires the use of the same production/synthesis platform used by Celltheon and Dr. Pravetoni to ensure that systematic replication is achieved (direct comparison to prior research results) and that Dr.

Myers and Dr. Pravetoni can interpret the data obtained. The proposal requires use of previously developed monoclonal antibody technology and direct work with the collaborating laboratory at the University of Washington. Relevant sections of the approved and funded NIH-IAA research proposal are captioned here:

Having successfully completed these efficacy assessments with standard fielded opioid antagonists, we will then evaluate the best available novel opioid countermeasure. In this regard, Dr. Marco Pravetoni has developed monoclonal-antibody (mAb) therapies capable of rapidly detoxifying opioids in vivo. We intend to examine suitable carfentanil mAbs as rescue therapy and compare them to standard therapy, as shown in Table 1.

Table 1. Overview of exposure and treatment conditions.

Carfentanil Exposure (2.0 x MED)

NMF LOW NMF HIGH mAb 1

NLX LOW NLX HIGH mAb 2

External Collaboration(s) and Justifications Dr. Marco Pravetoni, University of Washington, will serve as a collaborator and subject-matter consultant. Dr. Pravetoni will provide the best candidate monoclonal-antibody therapy. He will also aid in the analysis and reporting of data resulting from Aim 2.

6. Publicizing Contract Actions:

The public display and synopsis requirements of FAR 5.101 and FAR 5.203:

☒ Apply and will be followed.

7. Market Research:

The standard government tools and markets were used and searched to discover if any existing avenues were available to USAMRICD. Queries into UNICOR, GSA, and Ability One yielded no significant results for “anti-carfentanil monoclonal antibody”.

Further research showed that due to Celltheon’s proprietary technology used for synthesizing their mAbs and that the reference study used Celltheon, no other manufacturer would meet the requirements USAMRICD. Celltheon has maintained frozen cell banks of the stable pools from prior work with Dr. Pravetoni for completing this production request.

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Other Facts:

a. Procurement history. N/A

b. Other facts. N/A