Court filing

Maloney-Clyburn to Emergent BioSolutions — Investigation Launch Letter (April 19, 2021)

Record facts

Court	Committee on Oversight and Reform / Select Subcommittee on the Coronavirus Crisis
Filed	2021-04-19

Full text

April 19, 2021

Mr. Robert G. Kramer

Mr. Fuad El-Hibri
President and Chief Executive Officer

Executive Chairman
Emergent BioSolutions, Inc.

Emergent BioSolutions, Inc.
400 Professional Drive, Suite 400

400 Professional Drive, Suite 400
Gaithersburg, MD 20879

Gaithersburg, MD 20879

Dear Mr. Kramer and Mr. El-Hibri:

The Oversight Committee and the Select Subcommittee on the Coronavirus Crisis are
investigating whether Emergent BioSolutions, Inc. (Emergent) leveraged its relationship with a
key Trump Administration official to secure and profit from federal contracts, despite a track
record of increasing prices without justification and failing to meet contract requirements, and
whether these actions impeded our nation’s response to the coronavirus crisis.

Specifically, we are investigating reports that Emergent received multi-million-dollar
contracts to manufacture coronavirus vaccines despite a long, documented history of
inadequately trained staff and quality control issues. Emergent received $628 million in
June 2020 to establish the primary U.S. facility for manufacturing vaccines developed by
Johnson & Johnson and AstraZeneca.1 Dr. Robert Kadlec, who served as Assistant Secretary for
Preparedness and Response under President Trump and previously worked as a consultant for
Emergent, appears to have pushed for this award despite indications that Emergent did not have
the ability to reliably fulfill the contract.

A series of issues came to light last month after public reporting revealed quality control
issues at Emergent’s Baltimore plant. During the manufacturing process, your company
contaminated millions of doses of Johnson & Johnson’s one-shot coronavirus vaccine with
ingredients from the AstraZeneca vaccine.2 Emergent was forced to destroy up to 15 million
tainted doses of the Johnson & Johnson vaccine, with another 62 million doses in jeopardy until
it can be determined that they were not affected. The plant also had to destroy millions of doses
of AstraZeneca’s coronavirus vaccine between October 2020 and January 2021 due to suspected
contamination.3 The Food and Drug Administration (FDA) is currently reviewing Emergent’s
manufacturing problems, and Emergent announced on April 19, 2021, that it has agreed with

1 U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted, New York Times (Apr. 6,
2021) (online at www.nytimes.com/2021/04/06/us/covid-vaccines-emergent-biosolutions.html).
2 Johnson & Johnson Confirm Vaccine Production Problems at Emergent Plant in Baltimore, Washington
Post (Apr. 1, 2021) (online at www.washingtonpost.com/business/2021/03/31/vaccine-johnson-johnson-emergent/).
3 U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted, New York Times (Apr. 6,
2021) (online at www.nytimes.com/2021/04/06/us/covid-vaccines-emergent-biosolutions.html); J&J Takes Over
Plant Where Contractor Ruined 15 Million Vaccine Doses, New York Magazine (Apr. 6, 2021) (online at
https://nymag.com/intelligencer/2021/04/j-and-j-takes-over-vaccine-plant-where-15m-doses-were-ruined.html).

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 2

FDA to halt the manufacturing of new material at its Baltimore plant “pending completion of the
inspection and remediation of any resulting findings.”4

Thankfully, these serious errors have not impacted the safety or efficacy of coronavirus
vaccines available to Americans. The Johnson & Johnson coronavirus vaccine doses that have
been delivered and used nationwide were produced at a different Johnson & Johnson facility.
Because FDA has not certified the Baltimore plant, vaccines manufactured at the facility have
not been distributed to the public.5 As a result, the contaminated doses from Emergent’s
Baltimore plant have not been delivered to the American public. We commend the Biden
Administration for moving swiftly to address the manufacturing problems by directing Johnson
& Johnson to assume full responsibility for vaccine manufacturing at your company’s plant.6
Nevertheless, we remain concerned about the circumstances that led to the award of this contract
under the prior Administration and whether Emergent’s manufacturing errors could hinder
vaccination efforts that are critical to saving lives and ending the coronavirus crisis.

We are also investigating Emergent’s actions to unduly influence the assets currently
stockpiled in the Strategic National Stockpile (SNS), which is critical to providing for the
emergency health security of the United States in the event of a public health emergency or
bioterrorist attack.7 Emergent is the sole supplier of the SNS’s stockpile of anthrax vaccine.
Emergent has raised the government purchasing price of the anthrax vaccine by 800% since
acquiring the drug in 1998. As a result, through most of the last decade, nearly half of the SNS’s
budget has been spent purchasing Emergent’s anthrax vaccine. These spiraling costs contributed
to shortages of critical supplies, including ventilators, reusable respirator masks, and other
personal protective equipment, which severely impacted the government’s ability to respond to
the coronavirus crisis.

Emergent Received Lucrative Contracts Despite a Track Record of Failures

In June 2012, the Department of Health and Human Services (HHS) awarded a
$163 million contract to Emergent to retrofit and expand its Baltimore manufacturing plant.
Through this public-private partnership, the federal government hoped to increase its ability to
rapidly manufacture vaccines in the event of an infectious disease outbreak or biological attack.8

4 Emergent BioSolutions, Form 8-K (Apr. 19, 2021) (online at
https://investors.emergentbiosolutions.com/node/20371/html).
5 Id.; J&J Takes Over Plant Where Contractor Ruined 15 Million Vaccine Doses, New York Magazine
(Apr. 6, 2021) (online at https://nymag.com/intelligencer/2021/04/j-and-j-takes-over-vaccine-plant-where-15m-
doses-were-ruined.html).
6 U.S. Taps Johnson & Johnson to Run Troubled Vaccine Plant, New York Times (Apr. 3, 2021) (online at
www.nytimes.com/2021/04/03/us/politics/emergent-vaccine-plant-johnson-johnson.html).
7 Congressional Research Service, National Stockpiles: Background and Issues for Congress (June 15,
2020) (online at https://crsreports.congress.gov/product/pdf/IF/IF11574).
8 Federal Vaccine Development Sites Ill-Suited to Counter COVID-19 Epidemic, Washington Post (Mar.
15, 2020) (online at www.washingtonpost.com/investigations/federal-vaccine-development-sites-ill-suited-to-
counter-covid-19-epidemic/2020/03/15/34e8586c-63c4-11ea-acca-80c22bbee96f_story.html).

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 3

The contract required Emergent to demonstrate that it could produce 50 million doses of a
pandemic influenza vaccine within four months, and partner with a company developing a flu
vaccine candidate to gain manufacturing approval from FDA by June 2020.9

In 2017, Dr. Kadlec was nominated by President Trump and confirmed by the Senate to
lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). Until 2015,
Dr. Kadlec provided consulting services to Emergent through his company, RPK Consulting.10
Following Dr. Kadlec’s confirmation, Emergent received millions of dollars in federal contracts
from ASPR, including contracts for the SNS that were awarded without competitive bidding.11
Emergent encouraged oversight of the SNS to be transferred from the Centers for Disease
Control and Prevention (CDC) to ASPR, under Dr. Kadlec’s control.12

In 2019, ASPR commissioned a review of the company’s progress under the 2012
contract, which determined that Emergent’s ability to deliver in a pandemic remained largely
unproven.13 Emergent ultimately failed to meet the contract’s June 2020 deadline. An FDA
inspection of the Baltimore plant in April 2020 revealed that Emergent did not have the
necessary personnel to produce a coronavirus vaccine.14 A separate inspection in June 2020
found that Emergent’s plan for manufacturing urgently needed coronavirus vaccines was
inadequate due to poorly trained staff and quality control problems.15

Even in light of these failures, the Trump Administration awarded an additional
$628 million to Emergent in June 2020 to manufacture coronavirus vaccines.16 Dr. Kadlec has

9 U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted, New York Times (Apr. 6,
2021) (online at www.nytimes.com/2021/04/06/us/covid-vaccines-emergent-biosolutions.html).
10 Before Pandemic, Trump’s Stockpile Chief Put Focus on Biodefense. An Old Client Benefited,
Washington Post (May 4, 2020) (online at www.washingtonpost.com/investigations/before-pandemic-trumps-
stockpile-chief-put-focus-on-biodefense-an-old-client-benefited/2020/05/04/d3c2b010-84dd-11ea-878a-
86477a724bdb_story.html); Robert Kadlec, the Trump Administration’s Top Official for Addressing Biological
Threats, Awarded a $2 Billion Contract to a Company He Used to Advise, Business Insider (May 5, 2020) (online at
www.businessinsider.com/trump-official-awarded-2-billion-contract-to-a-former-employer-2020-5).
11 Before Pandemic, Trump’s Stockpile Chief Put Focus on Biodefense. An Old Client Benefited,
Washington Post (May 4, 2020) (online at www.washingtonpost.com/investigations/before-pandemic-trumps-
stockpile-chief-put-focus-on-biodefense-an-old-client-benefited/2020/05/04/d3c2b010-84dd-11ea-878a-
86477a724bdb_story.html).
12 Id.; How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile, New York Times
(Mar. 6, 2021) (online at www.nytimes.com/2021/03/06/us/emergent-biosolutions-anthrax-coronavirus.html).
13 Id.
14 Senior Trump and Biden Officials Knew for Months About Problems at Vaccine Plant, Politico (Apr. 6,
2021) (online at www.politico.com/news/2021/04/06/emergent-biosolutions-coronavirus-vaccines-479447).
15 Top Official Warned that COVID Vaccine Plant Had to Be ‘Monitored Closely’, New York Times (Apr.
7, 2021) (online at www.nytimes.com/2021/04/07/us/emergent-biosolutions-coronavirus-vaccine.html).
16 Department of Health and Human Services, Press Release: HHS Adds $628 Million to Contract with
Emergent BioSolutions to Secure CDMO Manufacturing Capacity for Operation Warp Speed (June 1, 2020) (online
at www.hhs.gov/about/news/2020/06/01/hhs-adds-628-million-contract-emergent-biosolutions-secure-

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 4

reportedly said he knew this was a risky decision.17 Emergent’s coronavirus manufacturing deals
are worth up to $1.5 billion.18 Emergent also has separate agreements with Johnson & Johnson
and AstraZeneca worth another $875 million.19

FDA continues to investigate Emergent’s manufacturing problems. We are concerned by
the costs to taxpayers and the potential impact on our nation’s vaccination efforts caused by
Emergent’s failed attempts to manufacture these vaccines.

Undue Influence and Unjustified Pricing Led to Critical Supply Shortages

We are also concerned that Emergent may have used its political connections to acquire
lucrative manufacturing contracts and significantly increase its profits, while failing to deliver on
these contracts. In 1998, Emergent, which was previously organized under the name BioPort,
purchased the license to the anthrax vaccine from the State of Michigan for $25 million.20 The
anthrax vaccine, BioThrax, is the only FDA-licensed vaccine for the prevention of anthrax
infection. BioThrax received initial approval in 1970 and the price of this vaccine has increased
substantially over the years.21 When the company acquired the license to BioThrax in 1998, the
price of a dose of the vaccine averaged about $3.35. By 2010, according to data from Emergent,
the company had increased the price it charges to the government to about $28 per dose. It is
now over $30 per dose.22 Average wholesale prices for BioThrax are even higher, reaching
$90 per dose.23

Over the last 12 years, the federal government has implemented changes to storage and
dosing for the anthrax vaccine that should have reduced both the number of doses needed to
respond to an emergency and the cost of supplying BioThrax to the government. In 2009, FDA
changed its guidelines to extend the shelf life of BioThrax from three years to four years.24 In

manufacturing-capacity-operation-warp-speed.html).
17 U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted, New York Times (Apr. 6,
2021) (online at www.nytimes.com/2021/04/06/us/covid-vaccines-emergent-biosolutions.html).
18 Id.
19 Id.
20 How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile, New York Times (Mar.
6, 2021) (online at www.nytimes.com/2021/03/06/us/emergent-biosolutions-anthrax-coronavirus.html).
21 U.S. Food and Drug Administration, Anthrax (Feb. 2, 2018) (online at www.fda.gov/vaccines-blood-
biologics/vaccines/anthrax).
22 How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile, New York Times (Mar.
6, 2021) (online at www.nytimes.com/2021/03/06/us/emergent-biosolutions-anthrax-coronavirus.html).
23 Johns Hopkins Medicine POC-IT Guides, Johns Hopkins ABX Guide: Anthrax Vaccine (July 3, 2020)
(online at www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540030/all/Anthrax_vaccine).
24 Emergent BioSolutions, Press Release: Emergent BioSolutions Receives FDA Approval Extending Shelf
Life of BioThrax (Anthrax Vaccine Adsorbed) to 4 Years (June 10, 2009) (online at
https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-receives-fda-
approval-extending-shelf-life).

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 5

2019, CDC put forward recommendations of the Advisory Committee on Immunization
Practices to space out anthrax vaccine booster shots from one year to three years.25

Emergent used these changes to justify an increase in the price of vaccines sold to the
government. The Washington Business Journal reported that the “shelf life extension also
allows Emergent to charge more for future doses of the vaccine delivered to the government’s
stockpile.”26 According to an Emergent press release, the change in shelf life not only enabled
the company to receive an additional payment of approximately $30 million for doses previously
delivered to the SNS, but also resulted in an immediate price increase for the future delivery of
anthrax doses under both the then-current contract and the follow-on multi-year contract.27

Although anthrax infection is still a danger, the last time it appeared in the intelligence
community’s annual Worldwide Threat Assessment was in 2012. At that time, then-Director of
National Intelligence James R. Clapper stated, “we assess the anthrax threat to the United States
by lone actors is low.”28

In 2020, Emergent continued development of a new anthrax vaccine called NuThrax.29
Even though Emergent’s new anthrax vaccine was unlicensed and had not yet been approved,
Dr. Kadlec’s office awarded your company roughly $3 billion in long-term contracts for anthrax
and other bioterrorism threats in the months before the coronavirus pandemic.30 We are
concerned that Emergent’s demands and financial interests—rather than legitimate threat-based
assessments—drove the type and amount of assets maintained in the SNS under the prior
Administration.

During the Trump Administration and Dr. Kadlec’s tenure with ASPR, Emergent’s
anthrax vaccine contracts put an enormous strain on the budget for the SNS, contributing to

25 Centers for Disease Control and Prevention, Use of Anthrax Vaccine in the United States:
Recommendations of the Advisory Committee on Immunization Practices, 2019 (Dec. 13, 2019) (online at
www.cdc.gov/mmwr/volumes/68/rr/rr6804a1.htm).
26 Emergent BioSolutions Anthrax Vaccine Gets a Boost, Washington Business Journal (June 10, 2009)
(online at www.bizjournals.com/washington/stories/2009/06/08/daily54.html).
27 Emergent BioSolutions, Press Release: Emergent BioSolutions Receives FDA Approval Extending Shelf
Life of BioThrax (Anthrax Vaccine Adsorbed) to 4 Years (June 10, 2009) (online at
https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-receives-fda-
approval-extending-shelf-life).
28 Senate Select Committee on Intelligence, Unclassified Statement for the Record of Director James R.
Clapper, Office of the Director of National Intelligence, Hearing on the Worldwide Threat Assessment of the U.S.
Intelligence Community (Jan. 31, 2012) (online at
www.dni.gov/files/documents/Newsroom/Testimonies/20120131_testimony_ata.pdf).
29 BARDA Upgrades Emergent Pact with $258M Option for Anthrax Vaccine Stores, Fierce Pharma (July
14, 2020) (online at www.fiercepharma.com/manufacturing/barda-upgrades-emergent-pack-258-million-option-for-
anthrax-vaccine-stores).
30 How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile, New York Times (Mar.
6, 2021) (online at www.nytimes.com/2021/03/06/us/emergent-biosolutions-anthrax-coronavirus.html).

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 6

critical supply shortages that impacted the nation’s ability to respond to other threats. In 2020,
the government spent more than $370 million on Emergent’s anthrax vaccine. Dr. Kadlec
admitted that spending on your company’s anthrax vaccines limited the federal government’s
ability to prepare for other disasters, saying: “If I could spend less on anthrax replenishment, I
could buy more N95s. I could buy more ventilators. I could buy more of other things that quite
frankly I didn’t have the money to buy.”31 It appears that the SNS shortages of basic medical
supplies during the coronavirus pandemic last year are directly related to Emergent’s outsized
influence over the price and procurement of its anthrax vaccines.

Increased Profits and Executive Compensation

Emergent’s profits rose significantly during the Trump Administration and Dr. Kadlec’s
tenure with ASPR. In 2020, Emergent’s profits soared while the United States was in the depths
of a global pandemic. By the fourth quarter of 2020, Emergent’s total revenues were $583
million, an increase of 62% over the same period in 2019. Product sales for anthrax vaccines
more than doubled from $173 million to $374 million over the same time period.32 Emergent’s
President and Chief Executive Officer Robert G. Kramer boasted to investors last month that
profitability for 2020 was “off-the-chart successful.”33

Corporate compensation at Emergent has also soared. According to the New York Times,
in 2020, “Emergent’s stock performed so well that its founder and chairman cashed in shares and
options worth over $42 million, more than he had redeemed in the previous five years combined,
corporate filings show.”34 In addition to this windfall for Emergent’s Executive Chairman, Fuad
El-Hibri, Mr. Kramer’s annual compensation increased by 51% between 2019 and 2020.
Emergent’s most recent annual proxy disclosure shows that in 2020 Mr. Kramer received
$893,000 in salary, a $1.2 million bonus, $2.1 million in stock awards, and $1.4 million in stock
options. At $5.7 million, his total annual compensation for 2020 is more than 43 times the total
compensation for the median employee at Emergent.35

*
*
*

For these reasons, please produce the following information and documents by May 3,
2021:

31 Id.
32 Emergent BioSolutions, Emergent BioSolutions Reports Financial Results for Fourth Quarter and Full
Year 2020 (Feb. 18, 2021) (online at https://investors.emergentbiosolutions.com/news-releases/news-release-
details/emergent-biosolutions-reports-financial-results-fourth-quarter-2).
33 U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted, New York Times (Apr. 6,
2021) (online at www.nytimes.com/2021/04/06/us/covid-vaccines-emergent-biosolutions.html).
34 How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile, New York Times (Mar.
6, 2021) (online at www.nytimes.com/2021/03/06/us/emergent-biosolutions-anthrax-coronavirus.html).
35 Emergent BioSolutions, 2020 Proxy Statement (Apr. 9, 2021) (online at
https://investors.emergentbiosolutions.com/node/20351/html).

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 7

1.
All contracts between Emergent BioSolutions or any of its subsidiaries or
affiliates, and the Department of Health and Human Services between 2015 and
the present;

2.
All inspection, audit, or risk assessment reports related to manufacturing, quality,
or compliance at Emergent BioSolutions’ Baltimore plant from 2017 through the
present, including with respect to disinfection and contamination protocols, staff
training and competence, and ability to comply with contract terms;

3.
All documents and communications related to the suspected contamination of
coronavirus vaccines at Emergent BioSolutions’ Baltimore plant, including but
not limited to the discovery of the suspected contamination, any testing or
investigation related thereto, and any determination related to destroying vaccine
doses;

4.
A detailed description of the causes of the suspected contamination of coronavirus
vaccines at Emergent BioSolutions’ Baltimore plant, the status of any
investigation into the suspected contamination of coronavirus vaccines at
Emergent BioSolutions’ Baltimore plant, and any findings, outcomes, or
recommendations resulting from that investigation;

5.
All documents and communications related to any financial or reputational
consequences resulting from delay of the production of any coronavirus vaccine,
waste or spoilage of vaccine components, or failure to fulfill any obligation under
any contract to manufacture any coronavirus vaccine or component thereof;

6.
All documents and communications with Robert Kadlec between November 9,
2016, and January 20, 2021;

7.
All agreements between Emergent BioSolutions, or any of its subsidiaries or
affiliates, and Robert Kadlec, RPK Consulting, or any agent or affiliate thereof,
and a summary of all payments under those contracts;

8.
All documents and communications related to the calculation of compensation for
each of the following executives for each of the past five years, including but not
limited to any determination of whether the executive has satisfied requirements
for incentive-based compensation; any description of the reasons for the year-to-
year changes in compensation; and any related communications and approval
documentation regarding the compensation:

a.
Fuad El-Hibri, Executive Chairman of the Board of Directors; and
b.
Robert Kramer, President and Chief Executive Officer;

9.
All documents reflecting Emergent BioSolution’s policies, procedures, and
practices related to executive compensation;

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 8

10.
The dates, times, locations, and attendees of any meetings between
representatives of Emergent BioSolutions or any of its subsidiaries or affiliates,
and officials from the Department of Health and Human Services or Operation
Warp Speed, between 2017 and the present;

11.
For each calendar year from 2015 through the present, provide the following for
the anthrax vaccine:

a.
total gross sales;
b.
number of units sold;
c.
cost of goods sold; and
d.
total sales net of any rebates, discounts, and all other price concessions,
including the type, amount, and recipient of each discount or concession;

12.
An organizational chart for Emergent BioSolutions, and a list of each Emergent
business unit, component, or division involved in the pricing of the anthrax
vaccine and organizational charts for those entities;

13.
A list of all third-party entities that have been contracted to provide services
related to the marketing, manufacturing, pricing, or lobbying of the anthrax
vaccine, and a description of the services provided by the third-party entity;

14.
All internal and external presentations, analyses, or other documents prepared for
or provided to Emergent BioSolutions’ Board of Directors, any subcommittee of
the Board of Directors, or any corporate officers, discussing:

a.
pricing strategies, pricing changes, or methods, approaches, or strategies
to lobby or solicit for increased or continued purchases of the anthrax
vaccine or agreements to manufacture coronavirus vaccines by the federal
government;

b.
manufacturing, quality, and compliance risks related to the operation of
Emergent BioSolution’s Baltimore plant or the company’s production of
coronavirus vaccines, including with respect to disinfection and
contamination protocols, staff training and competence, and ability to
comply with contract terms;

15.
All documents related to changes or improvements in the production,
manufacturing, or development of the anthrax vaccine;

16.
A searchable, sortable, downloadable spreadsheet that contains the following
information for each contract between Emergent BioSolutions, or any of its
subsidiaries or affiliates, and the federal government related to the anthrax
vaccine or any coronavirus vaccine from 2015 to present:

Mr. Robert G. Kramer
Mr. Fuad El-Hibri
Page 9
a.
contract number;
b.
date of contract;
c.
contracting entity;
d.
manufacturing cost per unit or dose;
e.
contract price per dose; and
f.
total contract value.
The Committee on Oversight and Reform is the principal oversight committee of the
House of Representatives and has broad authority to investigate “any matter” at “any time” under
House Rule X. The House of Representatives established the Select Subcommittee on the
Coronavirus Crisis “to conduct a full and complete investigation” of “issues related to the
coronavirus crisis,” including the “preparedness for and response to the coronavirus crisis,
including the development of vaccines and treatments” and “executive branch policies,
deliberations, decisions, activities, and internal and external communications related to the
coronavirus crisis.”36
An attachment to this letter provides additional instructions for responding to this request.
If you have any questions regarding this request, please contact Committee staff at (202) 225-
5051. Thank you for your prompt attention to this request.
Sincerely,
_______________________
_______________________
Carolyn B. Maloney
James E. Clyburn
Chairwoman
Chairman
Committee on Oversight and Reform
Select Subcommittee on the
Coronavirus Crisis
Enclosure
cc:
The Honorable James Comer, Ranking Member
Committee on Oversight and Reform
The Honorable Steve Scalise, Ranking Member
Select Subcommittee on the Coronavirus Crisis
36 H.Res. 8, sec. 4(f), 117th Cong. (2021); H.Res. 935, 116th Cong. (2020).

Responding to Oversight Committee Document Requests

1.
In complying with this request, produce all responsive documents that are in your
possession, custody, or control, whether held by you or your past or present agents,
employees, and representatives acting on your behalf. Produce all documents that you
have a legal right to obtain, that you have a right to copy, or to which you have access, as
well as documents that you have placed in the temporary possession, custody, or control
of any third party.

2.
Requested documents, and all documents reasonably related to the requested documents,
should not be destroyed, altered, removed, transferred, or otherwise made inaccessible to
the Committee.

3.
In the event that any entity, organization, or individual denoted in this request is or has
been known by any name other than that herein denoted, the request shall be read also to
include that alternative identification.

4.
The Committee’s preference is to receive documents in electronic form (i.e., CD,
memory stick, thumb drive, or secure file transfer) in lieu of paper productions.

5.
Documents produced in electronic format should be organized, identified, and indexed
electronically.

6.
Electronic document productions should be prepared according to the following
standards:

a.
The production should consist of single page Tagged Image File (“TIF”), files
accompanied by a Concordance-format load file, an Opticon reference file, and a
file defining the fields and character lengths of the load file.

b.
Document numbers in the load file should match document Bates numbers and
TIF file names.

c.
If the production is completed through a series of multiple partial productions,
field names and file order in all load files should match.

d.
All electronic documents produced to the Committee should include the following
fields of metadata specific to each document, and no modifications should be
made to the original metadata:

BEGDOC, ENDDOC, TEXT, BEGATTACH, ENDATTACH, PAGECOUNT,
CUSTODIAN, RECORDTYPE, DATE, TIME, SENTDATE, SENTTIME,
BEGINDATE, BEGINTIME, ENDDATE, ENDTIME, AUTHOR, FROM, CC,
TO, BCC, SUBJECT, TITLE, FILENAME, FILEEXT, FILESIZE,
DATECREATED, TIMECREATED, DATELASTMOD, TIMELASTMOD,

INTMSGID, INTMSGHEADER, NATIVELINK, INTFILPATH, EXCEPTION,
BEGATTACH.

7.
Documents produced to the Committee should include an index describing the contents
of the production. To the extent more than one CD, hard drive, memory stick, thumb
drive, zip file, box, or folder is produced, each should contain an index describing its
contents.

8.
Documents produced in response to this request shall be produced together with copies of
file labels, dividers, or identifying markers with which they were associated when the
request was served.

9.
When you produce documents, you should identify the paragraph(s) or request(s) in the
Committee’s letter to which the documents respond.

10.
The fact that any other person or entity also possesses non-identical or identical copies of
the same documents shall not be a basis to withhold any information.

11.
The pendency of or potential for litigation shall not be a basis to withhold any
information.

12.
In accordance with 5 U.S.C.§ 552(d), the Freedom of Information Act (FOIA) and any
statutory exemptions to FOIA shall not be a basis for withholding any information.

13.
Pursuant to 5 U.S.C. § 552a(b)(9), the Privacy Act shall not be a basis for withholding
information.

14.
If compliance with the request cannot be made in full by the specified return date,
compliance shall be made to the extent possible by that date. An explanation of why full
compliance is not possible shall be provided along with any partial production.

15.
In the event that a document is withheld on the basis of privilege, provide a privilege log
containing the following information concerning any such document: (a) every privilege
asserted; (b) the type of document; (c) the general subject matter; (d) the date, author,
addressee, and any other recipient(s); (e) the relationship of the author and addressee to
each other; and (f) the basis for the privilege(s) asserted.

16.
If any document responsive to this request was, but no longer is, in your possession,
custody, or control, identify the document (by date, author, subject, and recipients), and
explain the circumstances under which the document ceased to be in your possession,
custody, or control.

17.
If a date or other descriptive detail set forth in this request referring to a document is
inaccurate, but the actual date or other descriptive detail is known to you or is otherwise
apparent from the context of the request, produce all documents that would be responsive
as if the date or other descriptive detail were correct.

18.
This request is continuing in nature and applies to any newly-discovered information.
Any record, document, compilation of data, or information not produced because it has
not been located or discovered by the return date shall be produced immediately upon
subsequent location or discovery.

19.
All documents shall be Bates-stamped sequentially and produced sequentially.

20.
Two sets of each production shall be delivered, one set to the Majority Staff and one set
to the Minority Staff. When documents are produced to the Committee, production sets
shall be delivered to the Majority Staff in Room 2157 of the Rayburn House Office
Building and the Minority Staff in Room 2105 of the Rayburn House Office Building.

21.
Upon completion of the production, submit a written certification, signed by you or your
counsel, stating that: (1) a diligent search has been completed of all documents in your
possession, custody, or control that reasonably could contain responsive documents; and
(2) all documents located during the search that are responsive have been produced to the
Committee.

Definitions

1.
The term “document” means any written, recorded, or graphic matter of any nature
whatsoever, regardless of how recorded, and whether original or copy, including, but not
limited to, the following: memoranda, reports, expense reports, books, manuals,
instructions, financial reports, data, working papers, records, notes, letters, notices,
confirmations, telegrams, receipts, appraisals, pamphlets, magazines, newspapers,
prospectuses, communications, electronic mail (email), contracts, cables, notations of any
type of conversation, telephone call, meeting or other inter-office or intra-office
communication, bulletins, printed matter, computer printouts, teletypes, invoices,
transcripts, diaries, analyses, returns, summaries, minutes, bills, accounts, estimates,
projections, comparisons, messages, correspondence, press releases, circulars, financial
statements, reviews, opinions, offers, studies and investigations, questionnaires and
surveys, and work sheets (and all drafts, preliminary versions, alterations, modifications,
revisions, changes, and amendments of any of the foregoing, as well as any attachments
or appendices thereto), and graphic or oral records or representations of any kind
(including without limitation, photographs, charts, graphs, microfiche, microfilm,
videotape, recordings and motion pictures), and electronic, mechanical, and electric
records or representations of any kind (including, without limitation, tapes, cassettes,
disks, and recordings) and other written, printed, typed, or other graphic or recorded
matter of any kind or nature, however produced or reproduced, and whether preserved in
writing, film, tape, disk, videotape, or otherwise. A document bearing any notation not a
part of the original text is to be considered a separate document. A draft or non-identical
copy is a separate document within the meaning of this term.

2.
The term “communication” means each manner or means of disclosure or exchange of
information, regardless of means utilized, whether oral, electronic, by document or
otherwise, and whether in a meeting, by telephone, facsimile, mail, releases, electronic

message including email (desktop or mobile device), text message, instant message,
MMS or SMS message, message application, or otherwise.

3.
The terms “and” and “or” shall be construed broadly and either conjunctively or
disjunctively to bring within the scope of this request any information that might
otherwise be construed to be outside its scope. The singular includes plural number, and
vice versa. The masculine includes the feminine and neutral genders.

4.
The term “including” shall be construed broadly to mean “including, but not limited to.”

5.
The term “Company” means the named legal entity as well as any units, firms,
partnerships, associations, corporations, limited liability companies, trusts, subsidiaries,
affiliates, divisions, departments, branches, joint ventures, proprietorships, syndicates, or
other legal, business or government entities over which the named legal entity exercises
control or in which the named entity has any ownership whatsoever.

6.
The term “identify,” when used in a question about individuals, means to provide the
following information: (a) the individual’s complete name and title; (b) the
individual’s business or personal address and phone number; and (c) any and all
known aliases.

7.
The term “related to” or “referring or relating to,” with respect to any given subject,
means anything that constitutes, contains, embodies, reflects, identifies, states, refers to,
deals with, or is pertinent to that subject in any manner whatsoever.

8.
The term “employee” means any past or present agent, borrowed employee, casual
employee, consultant, contractor, de facto employee, detailee, fellow, independent
contractor, intern, joint adventurer, loaned employee, officer, part-time employee,
permanent employee, provisional employee, special government employee,
subcontractor, or any other type of service provider.

9.
The term “individual” means all natural persons and all persons or entities acting on
their behalf.

File and source

File: CONGRESS_Maloney-Clyburn_to-Emergent-BioSolutions_Investigation-Launch-LETTER_2021-04-19.pdf
Size: 250,233 bytes
SHA-256: 37aaa81b56d9b8db97879b3c08a5885d60e7650454937a5a6901dacbace0d412
Our copy: CONGRESS_Maloney-Clyburn_to-Emergent-BioSolutions_Investigation-Launch-LETTER_2021-04-19.pdf
Original: No public link identified.