Emergent BioSolutions, Inc, Operation Warp Speed - $628M TCV Dr Kadlec should hire an attorney FORTHWITH

I heard Congress sent you an “invitation” to provide testimony and requested a bunch of documents and communications between your Company and the Former Administration. Good Luck

HHS and Emergent Bio Background:

On June 1, 2020 Health and Human Services announced a new task order with a value of $628,250,000.00

HHS Adds $628 Million to Contract with Emergent BioSolutions to Secure CDMO Manufacturing Capacity for Operation Warp Speed

Health and Human Services announced a task order with Emergent BioSolutions to advance manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics. The task order is worth approximately $628 million and falls under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of HHS’s Office of the Assistant Secretary for Preparedness and Response.

Under the task order, Emergent will commit contract development and manufacturing organization (CDMO) drug substance and drug product manufacturing capacity valued at approximately $542.75 million for production of COVID-19 vaccine candidates through 2021, in addition to an investment of approximately $85.5 million for the rapid expansion of Emergent’s viral and non-viral CDMO fill / finish capacity for vaccine and therapeutic manufacturing.

The Contract Vehicle Number -HHSO100201200004I and task order number 75A50120F33007¹ which was further aggregated in to the following components;

1. ASPR-20-02178 -- Emergent CIADM -Manufacturing Capacity Reservation and Expansion (1 of 3) Delivery: 12/31/2021

2. ASPR-20-02178 -- Emergent CIADM -Manufacturing Capacity Reservation and Expansion (2 of 3) Delivery: 12/31/2021

3. ASPR-20-02178 -- Emergent CIADM Manufacturing Capacity Reservation and Expansion (3 of 3) Delivery 12/31/2021

With a total contract value (TCV) of: $628,250,000.00.

Under the terms and conditions of the behemoth award:

• B.1.1 total fixed price of this task order (sum of Task 1 and Task 2) is $628,250,000.00

• B.1.2 total fixed price of Task 1: Capacity Reservation is $542,750,000.00

• B.1.3 total fixed price of Task 2: Pharmaceutical Manufacturing Capacity Expansion is $85,500,000.00

The contract monthly aggregate payout includes twenty (20) monthly payment installments of $27,137,500.00 irrespective if Emergent adheres to the stringent T’s and C’s of the contact - specifically the “deliverables”²

And yes I understand that most do not read Government contracts or the various SEC disclosures, like it or not I happen to do this everyday for my employer/client and I just can’t understand why so many ignore the facts in the public domain - for example (it’s literally right there in the contract/SEC disclosures) link to highlighted and annotated Emergent & HHS contact - via SEC-EXHIBIT 10.4, found on my public drive

EMERGENT BIOSOLUTIONS INC. SEC-FORM 8-K

When a publicly traded company has an “event” by SEC law they are required to file a disclosure. On April 19, 2021 Emergent filed a FORM-8-K because an “event” occurred. The disclosure reads in part (this is VERY IMPORTANT and why I consistently state it is imperative to read the SEC filings)

Item 8.01 Other Events;

Emergent BioSolutions Inc. (“Emergent” or the “Company”) has entered into agreements related to the manufacturing of bulk drug substance for various COVID-19 vaccine candidates at its Bayview facility in Baltimore, Maryland. On April 12, 2021, the U.S. Food and Drug Administration (the “FDA”) initiated an inspection of the Bayview facility. On April 16, 2021, at the request of the FDA, Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility and to quarantine existing material manufactured at the Bayview facility pending completion of the inspection and remediation of any resulting findings.

Select Subcommittee on COVID-19

On April 19, 2021 the subcommittee sent a letter to the top executives of Emergent BioSolutions, Inc. - Officially announcing the Select Subcommittee was launching an investigation into whether the company leveraged its relationship with a key Trump Administration official

to profit from federal contracts despite a track record of raising prices and failing to meet contract requirements, and whether these actions impeded our nation’s response to the coronavirus crisis. 

The Select Subcommittee on COVID-19 explicitly stated:

…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.  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.

As for recent reports, which detailed a series of issues, concerning various quality control and staffing at Emergent’s Bayview Baltimore plant. Which directly impacted the production of Johnson & Johnson vaccine. As previously noted in Emergent Bio’s April 19, 2021 SEC-FORM-8-K filing, the FDA asked and Emergent agreed to pause vaccine manufacturing at the plant and to quarantine the materials used until the investigation concludes. No really it’s right there in Emergent’s SEC-FORM-8-K

but wait…there’s MORE… the Select Subcommittee also announced they are investigating Emergent’s actions to unduly influence anthrax vaccine assets currently stockpiled in the Strategic National Stockpile. 

Chairs’ letter to Mr. Kramer and Mr. El-Hibri seeking documents and information from Emergent. The first paragraph is one helluva salvo;

And like everything with the Trump Administration - the apparent and significant “conflict of interest” once again rears its ugly head - Dr. Robert Kadlec has a ton of explaining to do because you can’t serve two masters. If true that Dr Kadlec “push for the award” which was nearly 3/4 of a billion dollars.

“…your company contaminated millions of doses of Johnson & Johnson’s one-shot coronavirus vaccine with ingredients from the AstraZeneca vaccine. 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”

A 800% price increase for Anthrax vaccine:

As previously mentioned the Select Subcommittee on COVID-19 also formally announced an investigation into Emergent’s anthrax vaccine currently in our

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.

Dr Kaldec should hire an attorney forthwith;

He was nominated by Trump to head up the ASPR - prior to his Senate Confirmation - Dr Kadlec served as a managing director of RPK Consulting LLC³.

For now you should be adequately informed - I also created an Emergent share folder on my public drive which includes all of the documents in today’s article but I’ve also supplemented the various communications regarding Dr Kadlec starting in 2017 via the footnote⁴, found below.

It also might be beneficial to reread these precious articles too:

• https://file411.substack.com/p/congressman-tim-ryan-announces-new

• https://file411.substack.com/p/trump-pence-kushner-and-azar-covid

• https://file411.substack.com/p/the-select-subommittee-on-the-coronavirus

1. You can find the HHS Contract Award via USASpending.gov, last visited April 19, 2021

2. I personally find it easier to read a Company’s Security & Exchange Commission https://www.sec.gov Filings. Or by going to the Company’s Investor Relations Page https://investors.emergentbiosolutions.com last visited April 19, 2021 ,

3. See Virginia State Corporation Commission August 2011 Articles of Incorporation for RPK Consulting LLC, uploaded to my public drive

4. Select Subcommittee Releases New Evidence of Trump Administration’s Failure to Address Supply Shortages - March 20, 2020, Mr. Navarro wrote to then-Director of the Biomedical Advanced Research and Development Agency (BARDA) Rick Bright and HHS Assistant Secretary Dr. Robert Kadlec:  “My head is going to explode if this contract does not get immediately approved.  This is a travesty.  I need PHLOW noticed by Monday morning.  This is being screwed up.  Let’s move this now.  We need to flip the switch and they can’t move until you do.  FULL funding as we discussed.” 

March 2020 - Dr. Robert Kadlec Assistant Secretary, Preparedness and Response
Department of Health and Human Services - written testimony

March 21, 2020: Letter to Secretary Alex Azar and Dr. Rober Kadlec, Department of Health and Human Services

March 19, 2020: Letter to Secretary Alex Azar (HHS) and Dr. Robert Redfield (CDC)

March 17, 2020: Letter to Donald J. Trump, President of the United States

March 17, 2020: Letter to Donald J. Trump, President of the United States

February 2018 - Cummings Presses Gowdy to Subpoena Pentagon Documents on Hurricane Response ... to the hurricanes: On October 26, 2017, Robert Kadlec