EMERGENT BIOSOLUTIONS INC. Form 8-K (April 19, 2021)

Summary

A Form 8-K current report of Emergent BioSolutions Inc. dated April 19, 2021, signed by Richard S. Lindahl, Executive Vice President, Chief Financial Officer and Treasurer. Under Item 8.01 the company states that it has entered into agreements related to manufacturing bulk drug substance for various COVID-19 vaccine candidates at its Bayview facility in Baltimore, Maryland. It reports that the Food and Drug Administration began an inspection of the facility on April 12, 2021. On April 16, 2021, at the agency's request, the company agreed not to start manufacturing any new material there and to quarantine existing material pending completion of the inspection and remediation of any resulting findings.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 19, 2021

EMERGENT BIOSOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware | 001-33137 | 14-1902018
(State or other jurisdiction | (Commission File Number) | (IRS Employer
of incorporation) | Identification No.)

400 Professional Drive , Suite 400 ,

Gaithersburg , Maryland 20879

(Address of principal executive offices, including zip code)

( 240 ) 631-3200

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class | Trading Symbol(s) | Name of each exchange on which registered
Common Stock, Par Value $0.001 per share | EBS | New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EMERGENT BIOSOLUTIONS INC.
Dated: April 19, 2021 | By: | /s/ RICHARD S. LINDAHL
Name: Richard S. Lindahl Title: Executive Vice President, Chief Financial Officer and Treasurer

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