SSJ_Micro Flow FINAL redacted.pdf

Control No: JA-20-04-0298

Version – March 2020 FOR OFFICIAL USE

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold For COVID-19

1. Contracting Activity: The Contracting Activity is the United States Army Medical Research Acquisition Activity (USAMRAA) 820 Chandler St, Fort Detrick MD 21702.

2. Description of Action: Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility (PBF) requests a firm-fixed price contract with ProteinSimple.

Nature: ☒New Requirement ☐ Follow-on Requirement

Contract Vehicle: ☐ Purchase Order Number _______________________________

☐ Blanket Purchase Agreement (BPA) Number _______________ ☐ Order/BPA# _______ against FSS Contract #_____ _________ ☐ Order #___________ against Multiple Award IDIQ Contract Name or

☐ Order #_______ against a single award IDC Contract

☐ Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: ☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid

Funds: ☐ Operations & Maintenance, Army (OMA) ☒ Other Funds: RDT&E

FY: 20

Name of Proposed Contractor(s) and Address:

ProteinSImple 3001 Orchard Parkway San Jose, CA 95134

Brand Name Buy: ☐ Yes ☒ No

3. Description of Services or Supplies:

This is a new requirement to acquire a micro-flow imaging system. This system will be used to satisfy the FDA requirement for sub-visible particle determination of biologic materials in addition to giving us the capability of monitoring the protein over time during stability testing to watch for fragmentation and/or aggregation. This equipment is required for the release testing of the MRDC SARS-CoV2 vaccine candidate being developed at WRAIR.

Period of Performance: 15 April 2020 Total Value: $144,562.00

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.

Or, ☐ FAR 8.405-6(a)(1)(i)(A) Urgency

Or, ☐ FAR 16.505(b)(2)(i)(A) Urgency

5. Reasons 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") in response to the COVID-19 pandemic on 13 March 2020.

WRAIR has a public responsibility to comply with the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) guidance to prevent further spread of COVID-19.

They are also required to comply with Department of Defense and U.S. Army Europe guidance to implement plans to ensure compliance with directed force health protection measures throughout the area of operations in order to prevent an outbreak of COVID-19 within U.S. personnel (service members, civilians, contractors, and dependents) or confine it to as small a population as possible. In order to comply and put protective measures in place, The WRAIR Pilot Bioproduction Facility (PBF) has an urgent need for micro-flow imaging system. These supplies are required in order to protect the public from the spread of (or isolate people infected with) COVID-19. This requirement is required to perform release testing of the SARS-CoV2 vaccine drug substance and drug product prior to use in human clinical trials.

Every day that passes, confirmed COVID-19 cases spike and the death toll increases. It is imperative that these supplies are obtained as quickly as possible to protect public health. The U.S. Government cannot apply standard procurement times to an acquisition of this urgent nature. Even the short time-lines of 30- 60 days to award, could result in hundreds of thousands more being infected and thousands more dying.

There is currently no available vaccine to prevent SARS-CoV2 infection. The WRAIR is currently developing a new vaccine product as part of the MRDC effort. The WRAIR Pilot Bioproduction Facility (PBF) has been tasked with the manufacturing of this novel vaccine with a goal of initiating First in Human Phase I clinical trials by August 2020. The identification of 77 SARS-CoV-2 infected U.S.

citizens and two U.S. Service Members (1 in South Korea, 1in Italy) has critically underscored the mission essential requirement for an effective vaccine for the prevention of SARS-CoV2 infection or reduction in COVID-19 morbidity and mortality.

The equipment described in this request is required to perform release testing of the SARS-CoV2 vaccine drug substance and drug product prior to use in human clinical trials. If we are unable to procure the micro-flow imaging system, the PBF is at risk of being unable to provide support for the release testing of the vaccine product.

6. Publicizing Contract Actions: In accordance with FAR 5.202(a)(2), this action will not be synopsized. The purpose of this procurement is to provide the Army with the necessary equipment to promptly assist in the manufacturing and release testing of the COVID-19 vaccine.

7. Market Research: Market research was conducted in March 2020 by the requiring activity and contracting team. Market research was minimal due to the urgent nature of this emergency procurement and the lack of requirements package and historical data for this requirement.

In December of 2019 an outbreak of COVID-19 was reported in Wuhan City, Hubei Province, China. The World Health Organization (WHO) states COVID-19 is the infectious disease caused by the most recently discovered coronavirus. They also state in humans, several coronaviruses are known to cause respiratory infections, ranging from the common cold to more severe diseases, such as COVID-19. The WHO states:

“Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. People with fever, cough and difficulty breathing should seek medical attention.”

The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020, stating it is a “public health crisis”. The following is information from the WHO website. The WHO is recommending all countries activate and scale up their emergency response mechanisms utilizing a four-pronged approach.

First, prepare and be ready. In other words, prepare your people and your health facilities. Second, detect, prevent, and treat. Utilize surveillance to find, isolate, test and treat every case in order to break the chain of transmission. Third, reduce and suppress. Reduce transmission by finding and isolating as many cases as possible and quarantining their closest contacts. Protect health facilities, old age homes, and other vital areas. They recommend testing all suspected cases. Fourth, innovate and improve. Find new ways to prevent infection, save lives, and minimize impact. Utilize personal protective equipment. Utilize the WHO training programs, technical guidance, studies, protocols, and preparedness and response plans.

On January 31, 2020, the United States Department of Health and Human Services Secretary Alex M.

Azar II declared a public health emergency (PHE) for the United States to aid the nation’s health care community in responding to COVID-19. On 13 March 2020, the President of the United States of America declared COVID-19 an emergency IAW 42 U.S.C. 5122 (the Robert T. Stafford Disaster Relief and Emergency Assistance Act) which allows for Special Emergency Procurement Authority IAW 41 U.S.C.1903. On 18 March 2020, the President invoked his authority IAW the Defense Production Act.

The Act allows the President, where necessary to promote the national defense, may require acceptance and performance of contracts orders by any person he finds to be capable of performing them.

ProteinSimple is the only known company capable of providing the MFI5100 system which is required for determination of sub-visible particles required by the FDA for release testing of the MRDC SARS- CoV2 vaccine drug substance and drug product.

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.

________________________________ Date: See electronic signature Richard Millward Associate Director

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 and comparing prices to prices previously paid.

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.

________________________________ Date: See electronic signature Courtney Piar Contracting Officer