SSJ-BioProfile FLEX2-redacted.pdf

For All Actions At or Below the Simplified Acquisition Threshold FAR Part 16, COVID -19

Control No: JA20-04-0312

Version – March 2020 FOR OFFICIAL USE

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

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

2. Description of Action: WRAIR has a requirement for BioProfile® FLEX2 instrument which is required to perform metabolite analysis and cell counting which is critical for making in process decisions about bioreactor cell cultures during manufacturing of GMP grade material for the COVID-19 vaccine product

Nature: ☒New Requirement ☐ Follow-on Requirement

Contract Vehicle: ☒ Purchase Order Number: TBD____________

☐ 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: ________

FY: 2020________

Name of Proposed Contractor(s) and Address:

Nova Biomedical_____________________________ 200 Prospect Street___________________________ Waltham, MA 02454-9141______________________

Brand Name Buy: ☒ Yes ☐ No

3. Description of Services or Supplies: This is a new requirement to acquire a chemistry/cell viability modular instrument required to perform metabolite analysis and cell counting which is critical for making in process decisions about bioreactor cell cultures during the manufacturing of GMP grade vaccine products. This equipment is required for the GMP manufacture of the MRDC SARS-CoV2 vaccine candidate being developed at WRAIR.

Period of Performance: 15 May 2020 Total Value: $ 127,500.00

4. Authority: Select the appropriate authority below:

☒ 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.

The WRAIR Pilot Bioproduction Facility (PBF) 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. PBF is also required to comply with Department of Defense 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, PBF has an urgent need for a chemistry/cell viability modular instrument. This system and subsequent service is required in order to protect the public from the spread of (or isolate people infected with) COVID-19.

SARS-CoV-2 - the causative agent of coronavirus disease 2019 (COVID-19) - was detected in Wuhan, China in December 2019 and has infected more than 1.4 Million individuals globally and caused over 80,000 deaths including over 12,000 within the United States. The COVID-19 outbreak was declared a Pandemic by the World Health Organization on 11 March 2020. 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. 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 diagnosis of nearly 1000 SARS-CoV-2 infected U.S. Service Members 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 metabolite analysis and cell counting capabilities critical for making in process decisions about bioreactor cell cultures during the manufacturing process of the SARS-CoV2 vaccine product. If we are unable to utilize the authority cited, the PBF is at risk of being unable to provide support for the manufacturing of the vaccine product.

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that this instrument is 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.

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 from 15 MAR 2020 through 18 MAR 2020 by the requiring activity and contracting team: Stasya Zarling Bejma, Kasey Carroll, and Christine Helman. 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 closes 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.

Nova Biomedical is the only known company capable of providing the BioProfile® FLEX2 instrument which is required to perform metabolite analysis and cell counting which is critical for making in process decisions about bioreactor cell cultures during manufacturing of GMP grade material for the COVID-19 vaccine product.

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.

To date there is no treatment or vaccination for MRDC SARS-CoV2 which leads to the COVID-1 disease. Therefore, it is imperative that the instruments needed to develop a vaccine with a goal of initiating First in Human Phase I clinical trials in August 2020 are procured expeditiously.

Nova Biomedical is the manufacturer and sole distributor of the industry leading cell culture metabolite analyzer.

The following websites were queried and none of them could provide the required instrument within the required timeframe.

• GSA Advantage

• VWR, a supplier of BioProfile® consumables, does not sell the unit.

This instrument and the subsequent Installation Qualification (IQ) and Operational Qualification (OQ) services must be delivered on 30 April 2020 or the government, service members and the American public face increased risk prolonged exposure to this fatal disease and rising mortality rates.

8. Other Facts: Not Applicable.

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 Stasya Zarling Bejma Program Manager, PBF

10. Contracting Officer Certification/Approval: I hereby determine that the anticipated 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.

________________________________ Date: See electronic signature Christine Helman Contracting Officer