Limiting-Competition-under-SAT_ACC_Pichia_RCT Redacted.pdf

Control No: JA-22-Edg-340 Pichia Pastoris

Research Corporation Technologies

Memorandum for Record Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: ACC-APG-Edgewood Division Ft Detrick Branch 110 Thomas Johnson Drive Suite 240 Frederick, MD 21702 DoDAAC: W911SR

2. Description of Action: Execution of a new firm fixed price, single source, purchase order with non-profit organization, Research Corporation Technologies (RCT) to secure proprietary licensing rights of the Pichia Pastoris strains, vectors, derivatives, and related materials. This licensing agreement shall support existing and future research efforts under the Botulinum Toxin (BOT) vaccine (VAC) program. The Government customer for this action is the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) Joint Program Manager for Chemical, Biological, Radiological, and Nuclear Medical, BIO2 Program Office.

2.a. Nature: New Requirement Follow-on Requirement 2.b. Contract Vehicle: Purchase Order Number: W911SR-22-P-0013 2.c. Pricing/Contract Type: Firm Fixed Price 2.d. Funds: Other Funds: Government Fiscal Year 2022 Army RDT&E 2.e. Name of Proposed Contractor(s) and Address:

Research Corporation Technologies Inc. (RCT) 6440 North Swan Road, Suite 200 Tucson, Arizona 85718

UNIQUE ENTITY ID: VZMHFLXBW5K1

CAGE: 9AQ89

2.f. Brand Name Buy: Yes No

3. Description of Services or Supplies: Purchase licensing rights for the use of Pichia Pastoris cell lines (physical materials), transformed cell lines (physical materials) and any knowledge utilized to create derivative cell lines. RCT owns Pichia Pastoris base strains, transformed cell lines and derivative cell lines that may result from research efforts that relied upon RCT's base strains/cell lines. This action includes continuing use of Pichia Pastoris base strains, transformed cell lines and derivative cell lines previously developed by Dynport Vaccine Company (DVC) on behalf of and at the expense of the United States Government (USG) under Contract, DAMD17-98-C-8024. From 2000 to 2021, research and development Contract, DAMD17-98-C-8024 Pichia Pastoris cell lines for work towards the development of a botulinum toxin (BOT) vaccine (VAC) approved by the United States Food and Drug Administration (FDA). Optional periods for additional license renewals have not been included due to the unknown future of the BOT VAC research efforts beyond 2023. Total estimated value is $30,000.00 comprised of $15,000.00 to initiate the transfer and $15,000.00 for the annual minimum royalty fee. $15,000.00 is due upon execution of the Contract and $15,000.00 is due if/when a transfer to a new commercial vendor occurs. The licensing agreement rights had previously been held in part by DVC under an existing contract (DAMD17-98-C-8024) that has since been terminated for work under the Botulinum Toxin Developmental Vaccine Program.

Research Corporation Technologies

3.a. Period of Performance: 1 year after date of contract award (ADC) 3.b. Total Value: $ 30,000.00

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

5. Reasons for Authority Cited: RCT is the only reasonable source capable of providing the required supplies or services. See below for information that supports unique capabilities and support for the lack of competition.

In 2000, at the onset of the Vaccine Botulinum (VAC BOT) program, Research

Pichia Pastoris cell line was selected for research use as the only cell line used to support development of the botulinum vaccine. Only Research Corporation Technologies Inc. (RCT) provides a license agreement for the specific strains of Pichia pastoris, derivatives, and materials used for research purposes, only. A previous contract between JPEO CRBN Medical and Dynport Vaccine Corporation ended in 2021 required use of the same strains from the same company for research efforts towards development of a Botulinum vaccine. Without this license agreement with RCT, the Government future Botulinum research efforts would be limited in scope and scale.

A description of the detrimental effects/serious injury to the mission of the requiring activity or to the Government, financial or otherwise that will result if this justification is not approved and the product or service cannot be provided by the intended sole source Contractor, RCT is provided below:

The loss of this license with RCT would result in substantial schedule delays and duplicative costs. If the Government decided to proceed without this license agreement with RCT and DVC fails to pay the $30k annual fee (no longer contractually obligated to pay) than the license will terminate and DVC would need to destroy (and certify destruction) of all RCT strains, vectors, derivatives, and related materials in its possession. If the license agreement is allowed to lapse and then require re-initiation, later, than a larger upfront fee and annual fee may be realized. Without the current license agreement continued, then the strains would need to be transformed again and another master cell bank would need to be made. Tasks related to this re-work are estimated to be much more expensive than any license transfer/renewal difference. Any research and development progress made on the BOT VAC program by Dynport require duplication of existing costs and effort. If a full and open competitive effort to procure a similar license agreement from a company other than RCT for use of Pichia lines and derivatives from 2000 to 2021 would no longer be available for Government use. Cell bank derivatives created Government work/time just to be equivalent to the licensing rights provided by RCT.

Duplicative research and development costs and significant schedule delays would result from a new competitive solicitation to any company aside from RCT.

Research Corporation Technologies

6. Publicizing Contract Actions: For this FAR Part 13 action, the public display and synopsis requirements of FAR 5.101 and FAR 5.203, apply and have been satisfied by publishing special notice, W911SR-22-RCTL to the System for Award Management (SAM) website on 22 June 2022. This special notice provided additional market research to determine whether any other entity may be able to satisfy this requirement and to provide notice of the intent to sole source this requirement. The special notice became inactive on 08 July 2022. To date no responses have been received in response to this notice.

6.a. In accordance with FAR 13.105(c) this document shall be approved, signed, and redacted, prior to posting to the SAM website.

7. Market Research: Market research demonstrated that only RCT can provide a capable of providing the unique subscription services that include access to proprietary information required by the Government.

8. Other Facts: Prime Contractor, Dynport Vaccine Company maintained the same license agreement with RCT from 2000-2021 under the previously awarded R&D contract, DAMD17-98-C-8024. The RCT product/license agreement for (Pischia Pastoris) was purchased by DVC on behalf of the Government during the development of the botulinum vaccine, this license grants continued use of the products necessary for program development.

Research Corporation Technologies

Approvals

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name: Wai Kwan Chung Title: Assistant Program Manager JPM CBRN Medical

Signature:

X Wai Kwan Chung

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: Richard W. Totten Title: Contracting Officer

Signature:

X Richard W. Totten