A02-FAR-Part6-JA-ESKAPEE PathogensRedacted.pdf

Control No: JA-20-07-00146 Contractor: Green Mountain Antibodies Inc.

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: This Research and Development (R&D) requirement is in support of the Walter Reed Army Institute of Research (WRAIR) for developing, assessing and delivery of antibodies against ESKAPEE pathogens.

Authority: 10 U.S.C. 2304(c)(1) as implemented by FAR Part 6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

Amount: $

Prepared by: Dr. Schroeder Noble DSN:

COR, Research Chemist Date: 06 AUG 20

Email: Schroeder.m.noble.civ@mail.mil

Contracting Officer: Sharew Hailu DSN:

Contracting Officer Date: 06 AUG 20

Email: sharew.hailu.civ@mail.mil

Technical: Dr. Daniel V. Zurawski DSN:

Microbiologist Date: 06 AUG 20

Email: Daniel.v.zurawski.civ@mail.mil

Requirements: Dr. Schroeder Noble DSN:

COR, Research Chemist Date: 06 AUG 20

Email: Schroeder.m.noble.civ@mail.mil

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager:

Typed Name: Dr. Schroeder Noble

DSN:

Signature:

8/7/2020

X Schroeder M. Noble Right-Click "Signature Setup"

Signed by: NOBLE.SCHROEDER.M.1289823413

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

Legal Counsel:

Typed Name:

DSN:

Signature:

X Right-Click "Signature Setup"

Command Advocate for Competition:

Typed Name: Erin Cross

DSN: 3

Signature:

X Right-Click "Signature Setup"

STRUNCK.THOM

AS.FRANCIS.108

7094355

Digitally signed by

STRUNCK.THOMAS.FRANCIS.

1087094355 Date: 2020.08.07 17:06:23 -04'00'

CROSS.ERIN.KATHE

RINE.1380799002

Digitally signed by

CROSS.ERIN.KATHERINE.1380799

Date: 2020.08.10 16:37:10 -04'00'

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler Street, Fort Detrick, MD 21702.

2. Description of Action: The Walter Reed Army Institute of Research (WRAIR) Bacterial Disease Branch’s (BDB) Wound Infections Department (WID) requests a Firm Fixed Price (FFP) Research and Development (R&D) contract with Green Mountain Antibodies located at 1 Mill Street Suite 143, Burlington, VT 05401. The Government projects award for September 2020 and FY2020 MIDRP/DHP RDTE funds will be used.

3. Description of Supplies/Services: This requirement is for the procurement of the technical expertise and scientific services to develop antibodies against the Enterococcus species, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter species and Escherichia coli (ESKAPEE) pathogens in support of the WID, BDB, and WRAIR. To meet the objectives, the Green Mountain Antibodies Inc. shall provide antibodies against protein targets found on the surface of ESKAPEE pathogens for research and testing in WRAIR’s humanized mice to most effectively replicate how the bacterial species would effect a wounded Solider

Base Period: 9/30/2020 to 9/29/2021 Value:

Option Period 1: 9/30/2021 to 9/29/2022 Value: $ Option Period 2: 9/30/2022 to 9/29/2023 Value:

Option Period 3: 9/30/2023 to 9/29/2024 Value:

Option Period 4: 9/30/2024 to 9/29/2025 Value: $ FAR Clause 52.217-8 9/30/2025 to 3/30/2026 Value: $ Total: $

4. Authority Cited: 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited:

WRAIR requires Green Mountain Antibodies Inc. to provide ESKAPEE antibody development and assessment, in support of its research study through other than full and open competition. Only one responsible source, Green Mountain Antibodies Inc., and no other contractor will satisfy agency requirements due its unique capability.

Unique Capability: The antibody development and assessment requires the use of humanized mice or BALB/c, which refers to Bagg Albino (inbred research mouse strain) provided by WRAIR. Green Mountain Antibodies Inc. is the only source capable of providing human monoclonal antibodies for research and testing in WRAIR’s humanized mice. WRAIR requires the use of humanized mice to most effectively replicate how the bacterial species would effect a wounded Solider as well as develop human monoclonal antibodies, which is a product and prototype for clinical trials. Green Mountain

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

Antibodies, Inc. is the only company that will accept and provide the antibody development and assessment on the humanized mice required for this mission.

Green Mountain Antibodies Inc. is the only source that has been able to fulfill WRAIR’s requirements for antibodies against protein targets found on the surface of ESKAPEE pathogens for research and testing in WRAIR’s in vitro assays and animal models, specifically humanized mice, for the past 10 years. During this time, Green Mountain Antibodies Inc. has developed four (4) monoclonal antibodies with WRAIR. Although four (4) monoclonal antibodies have already been developed, WRAIR has more assays and scientific steps to fully assess these antibodies through Green Mountain Antibodies Inc. to fulfill its mission to develop a clinical trial ready product.

Green Mountain Antibodies, Inc. is the only source capable to continue to provide support of these efforts in order to ensure the continuity of research knowledge. Award to Green Mountain Antibodies Inc. will allow continued research efforts with WRAIR’s original products to include a larger scale purification for the antibodies already generated and further characterization to include epitope mapping, antibody sequencing, and animal work, all of which are required for intellectual property for the US Army. One of the antibodies ( has been patented after further characterization was completed, however, the other three antibodies still need to undergo further evaluation before it is suitable for patent filing. Green Mountain Antibodies, Inc. has the capability to support WRAIR’s effort by using pre-existing research data, processes, techniques, and previous antigens/antibodies to meet objectives. Awarding to any other source would impact the integrity of the current data, disrupt the research process, and ultimately the timeline for products that will lead to additional US Army patents for which Green Mountain Antibodies Inc. has waived its rights. Competition of this requirement would not recoup the cost, work or knowledge, developed over the last ten years.

(a) Alternatives: The Government looked at three potential alternatives including suspending operations, hiring in-house personnel/expertise, and replacing existing system, all of which are not options to meet this requirement.

WRAIR needs the pathogens research to be conducted for antibody development and suspending operations is not a possibility. WRAIR does not have any in-house technical personnel with experience or equipment to develop and provide human antibodies against protein targets found on the surface of ESKAPEE pathogens for research and testing. Antibodies Incorporated and Bio X Cell were identified as alternative contractors;

however, these firms do not provide the historical knowledge of WRAIR, nor do they provide human monoclonal antibodies with the flexibility to work with humanized mice that is required by WRAIR for human product development.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective Competition: A Sources Sought was posted to Beta.SAM.gov for 8 days from 21 May 2020 to 29 May 2020, no responses or inquiries were received.

Because this is a sole source action, effective competition is not applicable.

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

b. Subcontracting Competition: This is a single source award to Green Mountain Antibodies, Inc. and is designated as a small business. As such, subcontracting competition is not applicable.

7. Actions to Increase Competition: Competition of the requirement is not possible since the proposed contractor, Green Mountain Antibodies, Inc. is the only source that has the capability to provide monoclonal antibody development and assessment on the humanized mice provided by WRAIR required for this research. The Government will continue to seek out potential sources that are capable providing these services.

8. Market Research:

The requirement for ESAKAPEE research at WRAIR was initiated in 2010. WRAIR conducted market research from the onset of the research, contacting over 30 companies to potentially meet the requirement, however, responses found that all were unwilling to utilize WRAIR’s humanized mice in their laboratory and/or refused any animals provided from an outside organization.

Market research was conducted by WRAIR from 10 March 2020 to -17 March 2020 through online searches as well as consulting with technical experts who have industry knowledge. As a result, WRAIR found two potential contractors that could meet portions of the requirement; and as both could provide mouse antibodies. However, these firms do not provide the flexibility to work with humanized mice to develop human antibodies that is required by WRAIR for human product development.

In accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 205.205-71, DFARS 206.302-1(d), and DFARS Procedures, Guidance and Information (PGI) 206.302-1(d), a sources sought was posted by the Contracting Office on Beta.SAM.gov for 8 days from 21 May 2020 to 29 May 2020, however no responses or inquiries were received.

Notice of Intent to Sole Source was posted on Beta.SAM.gov for 15 days from 8 July 2020 to 23 July 2020. The Contracting Office received an inquiry from however, it was determined that the company is unable to raise monoclonal antibodies, as required by WRAIR, but rather polyclonal. Additionally, r stated to have only conducted research on regular mice and other mammals but had no experience with humanized mice and could not support the requirement of this research.

At this time, market research conducted found only one source, Green Mountain Antibodies Inc., with the capability to meet WRAIR’s continued need to developing and assessing antibodies against ESKAPEE using humanized mice.

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

9. Interested Sources:

inquired on the requirement, however it was not able to meet the development of monoclonal antibodies for humanized mice.

See paragraph 6 for the synopsis information to date, no other sources have written to express an interest in this acquisition.

10. Other Facts:

a. Procurement History:

The study started with basic research in 2010 to understand how the pathogens worked and changed over a course of time. During the basic science phase, funding was limited and only small buys were made each year using Government Purchase Card (GPC). In 2012 the research had reached a point where WRAIR required the use of humanized mice and targeted antibody development and assessment. As the research evolved and efforts increased, WRAIR met these objectives under IDIQ W81XWH-11-D-0021.

(1) Contract numbers and dates of the last several contracts for these same requirements.

These services were procured as ODCs (Subcontract) under W81XWH-11-D-0021- 0057 for the following three projects

Hcp Project o Initiated 25 Jan 2013 for immunization/hybridomas development as well as sub-cloning and supernatant delivery DmpW2 Project o Initiated 22 Dec 2015 for immunization/hybridomas development as well as sub-cloning and supernatant delivery

BauA Project o Initiated 23 Feb 2016 for immunization/hybridomas development as well as sub-cloning and supernatant delivery

(2) The competitive status of these actions.

Initial procurement at the onset of the research was executed through GPC. As the research evolved, efforts were procured using a Single Award IDIQ (W81XWH-11-D- 0021) Task Order awarded to Clinical Research Management (CRM). Green Mountain Antibodies Inc. supported WRAIR as a subcontractor under the Task Order.

The IDIQ was competitively awarded, receiving 4 offers from the following contractors;

CRM, General Dynamics Information Technology (GDIT), Ke’aki Technologies, and Henry M. Jackson Foundation. No set-aside was used.

(3) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

These services were accomplished under a Single Award IDIQ Task Order, W81XWH-11-D-0021-0057, where Green Mountain Antibodies Inc. was a subcontractor. The IDIQ has since expired, however, WRAIR requires Green Mountain Antibodies Inc. to continue its development of antibodies in support of its mission.

11. Technical 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: Dr. Daniel V. Zurawski Date: 07-AUG-20 Title: Microbiologist Signature:

8/7/2020

X Daniel V. Zurawski Right-Click "Signature Setup"

Signed by: ZURAWSKI.DANIEL.V.1282209000

12. 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: Dr. Schroeder Noble Date:

Title: Program Manager Signature:

8/7/2020

X Schroeder M. Noble Right-Click "Signature Setup"

Signed by: NOBLE.SCHROEDER.M.1289823413

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: cost analysis price analysis should cost IGCE audit: other: Historical Data

As a part of this basis, certified cost or pricing data:

will be required.

will not be required and the following exception applies (FAR 15.403):

Prices that will be agreed upon are based on adequate price competition.

Prices that will be agreed upon are based on prices set by law or regulation.

A commercial item is being acquired.

A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

The contract action is a modification to a contract or subcontract for commercial item(s).

The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name: Sharew Hailu Date:

Title: Contracting Officer Signature:

X Right-Click "Signature Setup"

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Sharew Hailu Date:

Title: Contracting Officer Signature:

X Right-Click "Signature Setup"

HAILU.SHARE

W.1410278207

Digitally signed by

HAILU.SHAREW.1410278207

Date: 2020.08.07 14:51:15 -04'00'

HAILU.SHARE

W.1410278207

Digitally signed by

HAILU.SHAREW.1410278207

Date: 2020.08.07 14:52:41 -04'00'

Program/Equipment: WRAIR’s, BDB, Wound Infections Department (WID)

Version – September 2018 FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement of the technical expertise and support services to develop antibodies against the ESKAPEE pathogens for the estimated amount of $ n an other than full and open competition basis pursuant to the authority of 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements, subject to availability of funds, and provided that the services or property herein described have otherwise been authorized for acquisition.

Erin Cross Date:

Command Advocate for Competition Signature:

X Right-Click "Signature Setup"

CROSS.ERIN.KA

THERINE.13807

99002

Digitally signed by

CROSS.ERIN.KATHERINE.13

80799002 Date: 2020.08.10 16:37:38 -04'00'