JA Curative COVID-19 PCR Test_Bridge_for_redact_Redacted.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

FOR OFFICIAL USE ONLY

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I. Agency and Contracting Activity.

The Department of the Air Force (DAF) Rapid Capabilities Office (RCO) is the responsible office for executing this contracting action.

II. Nature and/or description of the action being approved.

This action will be awarded as a new contract, via FAR Part 12 Acquisition of Commercial Items, as a sole source contract that contains Firm Fixed Price (FFP) and Firm Fixed Price Level of Effort (FFP LOE) contract line items

(CLINS).

III. Description of supplies/services required to meet agency needs (including the estimated value).

The government requires the immediate provision of domestically provided COVID-19 rapid testing services to include, but not limited to, test kits, laboratory testing, rapid test site setup, and associated logistics. It is critically important that the Department of Defense (DoD) receive testing capacity to support no less than 50,000 COVID-10 tests per day starting by the end of July 2020. The DoD, based on pandemic conditions, may increase the scope of the testing services, to increase mission assurance. The value of this contract is estimated at $48,000,000.00 with Operations and Maintenance (O&M) funding. Funds are anticipated from other agencies such as Department of Homeland Security (DHS), via the Economy Act.

The period of performance is estimated to be 6 months.

IV. Statutory authority permitting other than full and open competition.

10 USC 2304(c)(2) as implemented by FAR 6.302-2 Unusual and compelling urgency: A delay in providing the DoD with SARS-COV-2 collection kits to test the DoD military, civilians, contractors, and their dependents will significantly increase the risk of serious injury to the DoD community as undiagnosed individuals unknowingly spread the COVID-19 virus to additional people. During the month of July 2020, as states and municipalities seek to re-open local economies, the infection rate of SARS-CoV-2 has increased to the highest level in the United States, since the pandemic started. The DoD population is equally susceptible to the rise in infection rates as DoD personnel and their families are embedded with society. The increase in DoD testing has overwhelmed the incumbent DoD testing capacity (i.e. Medical groups) to the point where a contractor supplied test is required. To save lives, reduce the spread of SAR-CoV-2, and protect DoD mission readiness, additional testing supplies from a new source are needed immediately.

Prior to July 2020, the DoD had sufficient testing resources for clinical symptomatic uses as reported by the COVID-19 Task Force (CVTF). As the infection rates grew throughout July, medical facilities could no longer count on suppliers to meet the clinical demands. This unforeseen spike in clinical cases coupled with supplier unreliability caused the CVTF on 16 July 2020 to seek alternative sources for 250,000 tests to meet the immediate clinical need.

Current estimate is that the 250,000 tests will last 90 days.

V. Demonstration that the contractor's unique qualifications or the nature of the acquisition requires use of the authority cited above (applicability of authority).

Curative, Inc. is the only company positioned to respond with new SARS-COV-2 testing capacity within days rather than months. This is because of four facts: First, Curative has manufactured and retains a stockpile of approximately 1.5M collection kits for immediate delivery to the Military Treatment Facilities (MTFs). Second, prior DoD investment has stood up a High Capacity Lab in Washington, D.C. capable of processing 50,000 tests/day.

Third, software interfaces have been developed and validated between Curative and the DoD Electronic Health Record (EHR) system as demonstrated at pilot sites. Finally, DoD has completed an Independent Validation and

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Verification (IV&V) of the Curative Oral Fluid Swab (OFS) vs the Nasopharyngeal Swab (NP) which showed the tests are equivalent. Therefore, Curative is the only available source able to respond to the government's urgent requirement.

Immediacy of fulfilling test kit orders:

The U.S. is experiencing a shortage of test kits due to a lack of critical components, specifically magnetic silica beads. Many test kits require items such as swabs and analyzers, which are among a few vital components for COVID-19 tests that the COVID-19 Joint Acquisition Task Force identified in April 2020 to have a critical shortage, which is expected to persist through 2021. This critical shortage limits several COVID-19 test kit supplier's abilities to scale to meet the DoD and DHS's requirements. Curative has approximately 1.5M collection kits available for the DoD immediately upon contract award. Over the last month, more than 2.2M collection kits have been produced with a demonstrated daily production of more than 110,000/day, therefore meeting any DoD requirements. To fulfill the orders, Curative has a proprietary ecommerce solution that allows for Military Treatment Facilities (MTFs) to order directly from Curative via the online portal, upon receiving approval from the Program Office based on the allocations of kits directed by Senior Leaders. Curative has developed an orthogonal supply chain in which alternative materials and sources were qualified and validated by the FDA. As such, Curative has already secured resources for the first 3 million collection kits, and equipment sufficient for a testing capacity of 150,000 tests per day. Curative continuously monitors the supply chain for potential limitations and takes action to overcome these challenges.

Clinical Laboratory Improvement Amendments (CLIA) lab:

Under the prior Blanket Purchase Agreement, a Clinical Laboratory Improvement Amendments (CLIA) lab was established in Washington D.C. with more than 125 personnel and a testing capacity of 50,000 tests per day. The lab is authorized by the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or current revision of Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff issued by FDA This lab contains exclusive access for the DoD. Curative's lab approach is unique in that Curative has developed a high-throughput automated testing process that enables a 24-hour turnaround time from sample receipt with an ability for an individual laboratory to process 50,000 tests per day. This highly automated testing provides increased accuracy, is reliable, and scalable with investment. Curative to bring a 50,000 tests per day lab to Washington D.C. Three days from contract award, the lab was validated within FDA guidelines and policies with an initial operating capability of 10,000 tests per day.

Curative had demonstrated >25,000 tests per day and is prepared to execute 50,000 tests per day to meet DoD's requirement. DoD reference labs are unable to gain supplies and handle the increased test volume. The Curative testing solution does not require utilization of current DoD labs to process the samples. This means that Curative does not increase shortages on the DoD or commercial supply chain. The Curative lab does not compete for the same supplies or overwhelm the current DoD testing processing system. Due to this alternative lab approach, Curative will reduce pressure off current DoD labs which may allow for resource distribution of testing supplies to those MTFs with in-house capabilities and increasing infection rates. This is the exact use case asked for by the COVID-19 Task Force (CVTF) and Air Force Surgeon General (AF/SG) as DoD reference labs are unable to gain supplies and handle the increased test volume. Curative's laboratories are the only facilities currently available with trained staff capable of conducting the analysis of the FDA approved Curative-Korva SARS-CoV-2 assays that meet the DoD's requirements without significant delays.

Medical Records Integration:

Through the previous BPA contract the DoD worked with Curative to create a data integration, protection, and patient record keeping system/process for the COVID-19 testing process. Originally the DoD awarded a BPA that developed and deployed a connection between the Curative lab and DoD medical systems (i.e. Composite Health Care System (CHCS) and Military Health System Genesis) by interfacing through LabCorp. This approach allows for anonymous lab ordering to Curative while populating patient records with the results via known interfaces.

Curative's software for assigning the collection kit to the patient was also deployed into Tricare Online (TOL) via

March 2020 FOR OFFICIAL USE ONLY Page 6 of 7 conducted utilizing historical sales data on the same or similar items.

In addition, commercially available PCR tests exist for other illnesses, as well as for COVID-19. Proposed prices will be evaluated based on market research including comparison to commercial vendors, and other agency pricing on similar buys.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market research is continuous as new FDA Emergency Use Authorizations (EUA) are issued weekly. The DoD has assembled multiple expert bodies to review and assess new technologies for COVID-19 testing which includes the Joint Acquisition Task Force (JATF) Screening and Diagnostics (S&D) and the COVID-19 Acquisition Task Force (DAF ACT). A specialized research team, , supports the continuous monitoring of new products and updates forecast models to support decision makers.

pulled all FDA EUA PCR based tests, reviewed RFIs via the AFWERX portal, and combined the results with the JATF S&D. This market research identified multiple PCR manufacturers who did not respond to the Sources Sought posting on 27 May 2020, these PCR manufactures do have the capability of meeting the 50,000 tests per day requirement. However, considering the impacts in the global supply chain, the additional manufacturers have limitations in their ability to provide the DoD approximately 50,000 tests per day out of their total production capacities.

While multiple manufacturers state a production capacity of greater than 50,000 tests per day, there are limiting factors for all companies other than Curative that prevent the companies from fulfilling the Government's requirement. The primary constraints of other vendors that manufacture PCR tests are (1) supply chains using foreign sources with inconsistent reliability given the global competitive market for such tests and resources and/or

(2) production capacities, which meet the Government's requirement of 50,000 tests per day, yet, the DoD is unable to take all resources form the civil sector. For the second constraint, market research identified two vendors (Abbott and Rutgers) that would have to allocate 100% of their current production capacity to meet this requirement and two vendors (Abbott and Cephid) with Federal/DoD contracts that manufacture more than 50,000 tests per day, but do not have additional capacity to fulfill the DoD's immediate requirement. Based on the team's findings, Curative, Inc. was the only source capable of meeting the DoD's requirements for current production capacity.

In addition to these groups, a Sources Sought (SS) was posed to ensure the industry could respond directly to the DoD requirements. Based on the all the team's findings, Curative, Inc. is the only source capable of meeting the DoD's requirements.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

N/A

X. List of any sources that expressed, in writing, an interest in the acquisition.

Based on responses to the Source Sought Synopsis, when eliminating duplicate submissions, 25 vendors identified themselves as interested parties in writing. These include:

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XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

The events of the COVID-19 pandemic that led to this requirement were unprecedented and put unforeseen stress on a specific market segment that has struggled to manage the surge of medical facilities in need of test kits. Adequate competition exists during periods not subject to a pandemic. After this period of unprecedented need and urgency has ended, the Contracting Officer and the Requiring Activity will re-evaluate to ensure this effort is returned to Full and Open Competition.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.