JEFO_Emergent_Signed.doc.pdf

1. Identification of the Agency and Contracting Activity.

a. Federal Agency and Contracting Activity.

Department of Health and Human Services (DHHS)

Office of the Secretary (OS) Office of the Assistant Secretary for Preparedness and Response (ASPR)

b. Sponsoring Organization.

Biomedical Advanced Research and Development Authority

(BARDA) Pharmaceutical Countermeasures Infrastructure Division

(PCI)

c. Project Officer Information.

Timothy Belski ill Federal

Building

200 C Street SW

Washington, DC 20024

Timothy.Belski@hhs.go v 202.205.4235

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

a. Acquisition purpose and objectives.

The objective of this task order is to reserve and expand the capacities and capabilities established at Emergent CIADM.

b. Project background.

BARDA established a Center for Innovation in Advanced Development and Manufacturing (CIADM) with Emergent BioSolutions as public-private partnerships to ensure domestic vaccine manufacturing surge capacity to address national preparedness and response priorities.

HHS/BARDA requires the services of Emergent to provide core advanced development ("industrialization") and manufacturing services to other commercial partners under contract to the U.S. Government (USG) for development of biopharmaceuticals against public health threats.

Additionally, HHS/BARDA requires Emergent to provide manufacturing facilities utilizing flexible manufacturing and modem platform technologies to produce vaccines for outbreaks of an emerging infectious

JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY

mailto:Timothy.Belski@hhs.gov mailto:Timothy.Belski@hhs.gov pathogens.

In December 2019, a novel (new) coronavirus known as SARS-CoV-2

(“the virus”) was first detected in Wuhan, Hubei Province, People’s

Republic of China, causing outbreaks of the coronavirus disease COVID-

19 that has now spread globally. The Secretary of Health and Human

Services (HHS) declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 1, 2020, the President of the United

States, pursuant to sections 01 and 301 of the National Emergencies Act

(50 U.S.C. 1601 et seq.) and consistent with section 1135 of the Social

Security Act (SSA), as amended (42 U.S.C. 1320b-5), proclaimed that the

COVID-19 outbreak in the United States constitutes a national emergency.

Under the President’s Operation Warp Speed Mission, HHS is leading a whole of nation effort with the primary goal to execute on a well-defined portfolio of COVID-19 vaccine candidates to maximize probability of having one or more safe and effective vaccines as fast as possible for mass distribution. As such, it is a national security concern to quickly make available safe and effective COVID-19 vaccines. To this end, BARDA must reserve existing manufacturing capacity and expand manufacturing capacity in order to ensure adequate domestic capabilities are established and ready.

3. Description of the Requirement:

a. Project title.

Emergent CIADM Manufacturing Capacity Reservation and Expansion

b. Project description.

BARDA is seeking to reserve and expand pharmaceutical manufacturing capacity as soon as possible and reserve this capacity through December 31, 2021 for drug substance and drug product manufacturing. Under the President's Operation Warp Speed

Mission, HHS is leading a whole of nation effort with the primary goal to execute on a well-defined portfolio of COVID-19 vaccine candidates to maximize probability of having one or more safe and effective vaccines as fast as possible for mass distribution. The reserved capacity shall include the facilities and equipment renovated/constructed/purchased as well as services supported through the HHS/BARDA CIADM contracts (IDIQ type contracts).

The reservation shall exclude the performance of any work in the reserved capacity without the explicit, written approval from the

USG during the reservation period. In addition, the USG seeks to expand the pharmaceutical manufacturing capacity for drug product manufacturing at our CIADM facilities. The new capacity must be operational no later than December 31, 2021. For the purposes of this task, capacity expansion may include: procurement, installation, and commissioning/qualification/validation of new equipment;

construction activities associated with expansion of existing facilities/capacities.

Several technically superior vaccine candidates are being targeted by the U.S. Government for accelerated development. As such, large scale manufacturing must be reserved now by for use by BARDA to direct rapid technical transfer and parallel mass-production efforts.

As more organizations and companies seek commercial vaccine manufacturing capacity for both COVID-19 and other vaccine products, this capacity is becoming much more limited. BARDA is acting proactively to secure this critical manufacturing infrastructure before other market forces capture it. In addition, the capacity being secured under this action is with a teaming partner well-known to BARDA and has a favorable past performance record, thereby reducing technical and business risk to the government.

c. Requirement type.

X Services

Supplies/equipment

Information technology

(IT)

Other (specify):

d. Type of action.

X New requirement

Follow-on

e. Proposed order type.

X Firm-fixed-price

Time and materials

Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements):

Cost Reimbursement:

f. Acquisition identification number.

Requisition number OS258575

g. Total estimated dollar value and performance/delivery period.

Firm fixed price = $628,250,000.00

Period of performance: June 1,2020 December 31, 2021

4. Market Research.

BARDA is maintaining contacts with contract manufacturing organizations

(CMO's) in the pharmaceutical industry to ascertain the available capacity to manufacture vaccines for COVID-19 response. Discussions with Emergent have revealed that they are in discussions with multiple vaccine developers interested in reserving the capacity at the CIADM facility through December 2021. If this is to occur, BARDA would not be in a position to manufacture vaccines in a relevant time frame to the President's Operation Warp Speed, which seeks to provide 300 million vaccine doses as soon as possible.

5. Identification of the justification rationale [see 16.505(b)(2)] for exceptions to the fair opportunity process.

Only One Source. FAR Subpart 16.505(b)(2)(i)(B) Only one of the multiple- award, indefinite delivery contract’s awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

a. Name and address of the proposed contractor.

Emergent BioSolutions

Inc. 400 Professional Drive Suite 400 Gaithersburg, MD 20879

b. Nature of the acquisition and proposed contractor unique qualifications.

BARDA supports the HHS Center for Innovation in Advanced

Development and Manufacturing (CIADM) program through a multiple award IDIQ contract with two contractors/service providers:

Emergent BioSolutions, Inc. (Emergent) and Texas A&M University

System (TAMUS).

The HHS CIADM program supports the country’s advanced development activities for chemical, biological, radiological, and nuclear (CBRN)-related products and BARDA provides guidance and management oversight in terms of specific product objectives. The CIADM program is also intended to enable the Government to reserve and require manufacturing capacity necessary to manufacture vaccines in the event of pandemic.

Several technically superior vaccine candidates are being targeted by the

U.S. Government for accelerated development including the need to manufacture, at a commercial scale, adenovirus (“Ad”) vectored vaccines such vaccines require Bio-Safety Level (BSL) 2, or higher, containment.

As more organizations and companies seek commercial vaccine manufacturing capacity for both COVID-19 and other vaccine products, this capacity is becoming much more limited. As such, large scale manufacturing must be reserved now by for use by BARDA to direct rapid technical transfer and parallel mass-production efforts.

Of the two CIADM contractors, only Emergent is capable of manufacture, at a commercial scale, adenovirus (“Ad”) vectored vaccines in the near term (within the next six months) at an acceptable volume (greater than 2,000L).

In addition, only Emergent has the fill/finish capacity for the

“Ad” vectored vaccine campaign that is contemplated. Award to Emergent is necessary and in the best interests of the

Government.

6. Determination by the Contracting Officer that the anticipated cost to be fair and reasonable.

The Contracting Officer has determined the anticipated price is fair and reasonable.

To determine price reasonableness, the Contracting Officer: (1) compared the proposed price with the Independent Government Cost Estimate (IGCE); and (2) relied on a comparison of the proposed prices to historical prices paid.

The IGCE was developed using prior historical rates and information. BARDA has a history of issuing cost plus fixed fee task orders to Emergent which allowed

BARDA to estimate price based on actual amount for similar work. In developing the IGCE, BARDA included an increase over actual, historical costs to account for BARDA’s plan to request a firm fix price proposal.

The proposed price was less than the total price in the IGCE.

7. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

a. Removal of barriers to competition.

The BARDA CIADM program consists of one multiple award IDIQ contract with two contractors/service providers: Emergent BioSolutions, Inc. and Texas A&M University System (TAMUS).

BARDA intends to issue a task order to TAMUS for similar services to acquire available/surge capacity. As such, the two companies under the multiple award IDIQ program are planned to receive task orders for similar, but tailored services.

b. Listing of sources, if any, that expressed an interest, in writing, in the acquisition.

Emergent

BioSolutions Inc.

400 Professional

Drive Suite 400 Gaithersburg, MD 20879

8. Program office certification.

CERTIFICATION: This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information an exception to fair opportunity, are accurate and complete.

Official Name & Title Signature Date

Project Officer Timothy T. Belski

Head of the Sponsoring

Program Office* Michael Angelastro

*The Head of the Sponsoring program is the individual at least one level above

9. Contracting Officer Certification and Approval Signature(s).

Official Name & Title Signature Date

Contracting Officer

Jeffrey Schmidt, CCO, MCM Support Services BARDA

Chief of the Contracting

Officer

Joffrey Benford, BARDA CMA Director Joffrey Q. Digitally signed by

Joffrey Q. Benford -S

Benford -S Date: 2020.05.21 11:42:29 -04'00'

Head of the Contracting

Activity

Schuyler T. Digitally signed by

Schuyler T. Eldridge IV -S

Eldridge IV -S Date: 2020.05.21 18:27:15 -04'00'

Competition Advocate Digitally signed by Adam S.

Adam S. Devore -S Devore -S Date: 2020.05.21 15:43:05 -04'00'

HHS Senior

Procurement Executive

Jun 1, 2020