JA 9-28-2021 Redacted.pdf

CUI

Control Number:

Justification Review Document FAR 6.302-2 Other than Full and Open Competition

Unusual and Compelling Urgency for COVID-19

Program/Equipment: Joint Program Executive Office – Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), the Assistant Secretary for Preparedness and Response (ASPR), Biomedical and Advanced Research and Development Authority (BARDA), Manufacture and Distribution of Therapeutics in Response to the Coronavirus Disease 2019 (COVID-19) Pandemic.

Authority: 10 United States Code (U.S.C.) 2304(c)(2) as implemented by Federal Acquisition Regulation (FAR) 6.302-2 – Unusual and Compelling Urgency

Amount: $3,780,000,000

Prepared by:

Typed Name: DSN:

Title: Contract Specialist Date: 25 August 2021 E-mail:

Typed Name: DSN:

Title: Contract Specialist Date: 25 August 2021 E-mail:

Contracting Officer:

E-Mail: Date Reviewed: 25 August 2021

Technical Representative:

Title: Biologist/Project Officer Date Reviewed: 25 August 2021

Requirements Representative:

Title: Therapeutics Branch Chief Date Reviewed: 25 August 2021

Justification and Approval FAR 6.302-2 Other than Full and Open Competition

Unusual and Compelling Urgency for COVID-19

1. Contracting Activity: Army Contracting Command – Joint COVID-19 Response

Division

2. Description of Action: Army Contracting Command - Joint COVID-19 Response Division (ACC-JCRD), on behalf of JPEO-CBRND, requests approval to immediately award a modification to contract W15QKN-21-C-0014 with Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd., Tarrytown, NY 10591, to manufacture and distribute up to 1,800,000 doses of an antibody therapeutic (REGEN- COV) to treat COVID-19 in the general United States (U.S.) population as soon as possible. The anticipated contract type is Firm Fixed Price. The requirement and funding are from the U.S. Department of Health and Human Services (HHS). This effort is entered into by the Department of Defense (DoD) and ACC-JCRD on behalf of BARDA, in accordance with the Memorandum of Understanding between HHS and the DoD regarding DoD Acquisition Support, signed 20 May 2021. The DoD will be the contracting agency. The U.S. Government (USG) set aside funds specifically to develop therapeutics, treatments, and vaccines against COVID-19. Those set aside funds, Public Health and Social Services Emergency Funds (five year funds), are being used to support this effort.

3. Description of Supplies/Services: HHS and the DoD require the ability to procure mass quantities of COVID-19 therapeutics to support military locations and personnel throughout the Continental United States and outside the Continental United States. In addition, the USG requires the ability to procure mass quantities of COVID-19 therapeutics for the U.S. population. To advance the U.S. response to COVID-19, requirements and technology continue to be identified that are crucial to addressing the Public Health Emergency (PHE). Procurement of the products and technology leading to obtaining sufficient therapeutic doses to treat the U.S. population will enable the U.S.

to bring to bear the most effective measures to defeat the threat of COVID-19.

Regeneron's COVID-19 antibody therapeutic is the most promising therapeutic candidate identified by HHS. Based on the successful technology developed by Regeneron, they were one of the first amongst industry to progress a candidate to Phase 3 clinical trials, allowing for rapid scale up of their manufacturing processes. On 21 November 2020, Regeneron announced their antibody cocktail of REGN10987 (casirivimab) and REGN10933 (imdevimab), known as REGEN-COV, a promising therapy being investigated for use against COVID-19, received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Under a separate prototype Other Transaction Agreement (OTA), Regeneron has

The Exceptional Circumstances Determination to exceed the 12-month statutory limitation pursuant to FAR 6.302-2(d)(1)(ii) was approved by the Head of Contracting Activity on 2 September 2021.

4. Authority Cited: 10 U.S.C. Section 2304(c)(2), as implemented by FAR 6.302-2, "Unusual and Compelling Urgency."

5. Reason for Authority Cited: 41 U.S.C. § 1903, Special Emergency Procurement Authority, is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. § 5121- 5207 (the "Stafford Act"), and the American Rescue Plan Act of 2021, in response to the COVID-19 pandemic on 13 March 2020. Considering unvaccinated personnel predominately, confirmed COVID-19 cases continue to increase with a concomitant increase in the death toll. FAR 6.302-2 allows for other than full and open competition based on urgent and compelling circumstances. This action satisfies the requirements of FAR 6.302-2 because of (a) the urgent threat COVID-19 poses to both national security and the public health and

(b) the prospect that the Regeneron antibody therapeutic, if contracted for now and in this manner, could be available in significant quantities to reduce spread, sickness, and death caused by the SARS-CoV-2 virus, and reduce an overworked healthcare system by preventing hospitalizations. By any measure, the urgent and compelling nature of this requirement is met and justified by the subsequent explanation:

The USG cannot adopt standard procurement times to an acquisition of this urgent nature. Even under the best of circumstances, a short timeline of 30-60 days to award a contract is unacceptable, and failure could result in many more with advanced stages of sickness and increased deaths. Efforts to alleviate the COVID-19 pandemic threat will require multiple, simultaneous efforts, all supporting availability of vaccines and therapeutics, to include development and production. Failure to have the therapeutics ready and available to the U.S. population as soon as possible will risk resurgence of the COVID-19 hospitalizations and increased mortality to affected individuals.

6. Efforts to Obtain Competition: The USG has not sought competition for this particular contract action due to the unusual and compelling urgency to obtain sufficient therapeutics for the U.S. population in response to the unprecedented threat represented by COVID-19. This instant contract action has not been synopsized based upon the exception at FAR 5.202(a)(2). As stated above, the USG cannot adopt standard procurement times to an acquisition of this urgent nature. There are currently no available fully FDA-approved treatments against COVID-19. Failure to expeditiously obtain and have available FDA authorized therapeutics to the U.S. population could lead to grievous harm to military services members, their dependents, and U.S. citizens.

7. Actions to Increase Competition: Based upon market research, there are currently other companies capable of developing and delivering safe and effective therapeutics against COVID-19 in sufficient quantities to protect the citizens of the U.S., its service members and their families, but only in the future.

Once multiple FDA authorized therapeutics are available in the marketplace, the USG will be able to use competitive processes to obtain future quantities of COVID-19 therapeutics. Historically, the procurement vehicles to develop and deliver therapeutics have been entered into using competition. Once the acute need to have sufficient quantities of therapeutics available for the U.S. citizens is satisfied, future contract actions will return to the use of competitive processes for replenishing the supply of the therapeutics.

8. Market Research: The USG, in partnership with BARDA, has various methods by which to stay connected to industry and to leverage current research and development to meet mission needs. BARDA conducts in-depth market research through Tech Watches, BARDA Industry Days, interviews with individuals knowledgeable of industry trends and requirements, and through in-depth market research of companies or product-specific research. This in-depth market research was conducted beginning in January 2020, and is ongoing to determine the availability of capable sources to develop, produce, and deliver a significant number of therapeutic product doses.

There are several manufacturers with varying therapeutic technologies,

9. Interested Sources: To date, no other companies have written to express an interest in this procurement.

10. Other Facts:

a. Procurement history.

(1) Contract W15QKN-21-C-0014; Delivery of 1,250,000 doses of Regeneron antibody therapeutic, awarded on 12 January 2021.

(2) Competitive Status: Sole-source commercial procurement

(3) Authority Previously Cited: 10 U.S.C. 2304(c)(2) as implemented by FAR 6.302-2

(4) Summary of Paragraph 7 of the previous Justification and Approval: There are multiple other companies capable of developing and delivering safe and effective therapeutics against COVID-19 in sufficient quantities to protect the citizens of the U.S.

Therefore, Regeneron is the only source capable of providing an antibody therapeutic that will meet the Government’s needs.

(5) Changed Circumstances: As COVID-19 cases continue to rise, the PHE persists, and the Government has a public responsibility to comply with the World Health Organization and the U.S. Centers for Disease Control and Prevention guidance, in order to prevent further spread of COVID-19 as expeditiously as possible.

(6) Unusual Patterns: N/A

(7) Significant Changes: The previous Justification and Approval was based on the urgent threat COVID-19 poses to both national security and the public health and the prospect that the Regeneron antibody therapeutic, if contracted for immediately, could be available in significant quantities to reduce spread, sickness and death caused by the SARS-CoV-2 virus.

(1) OTA Prototype Project MCDC2008-005; Large-Scale Manufacturing of Antibodies

Directed to SARS-CoV-2, awarded on 06 July 2020.

(2) Competitive Status: Full and open competition.

(3) Authority Previously Cited: N/A

(4) Summary of Paragraph 7 of the previous Justification and Approval: N/A

(5) Changed Circumstances: As the PHE persists, the Government has a public responsibility to comply with the World Health Organization and the U.S. Centers for Disease Control and Prevention guidance, in order to prevent further spread of COVID-19 as expeditiously as possible.

(6) Unusual Patterns: No unusual patterns identified.

(7) Significant Changes: No Justification and Approval was previously required.

b. Other facts. N/A