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Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 333-289359  ·  Started: 2025-08-13  ·  Last active: 2025-08-13
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2025-08-13
Emergent BioSolutions Inc.
Offering / Registration Process
File Nos in letter: 333-289359
CR Company responded 2025-08-13
Emergent BioSolutions Inc.
Offering / Registration Process
File Nos in letter: 333-289359
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 333-283150  ·  Started: 2024-11-18  ·  Last active: 2024-12-02
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2024-11-18
Emergent BioSolutions Inc.
File Nos in letter: 333-283150
Summary
Generating summary...
CR Company responded 2024-12-02
Emergent BioSolutions Inc.
File Nos in letter: 333-283150
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2021-12-09  ·  Last active: 2021-12-09
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2021-12-09
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2009-10-30  ·  Last active: 2021-11-12
Response Received 8 company response(s) High - file number match
UL SEC wrote to company 2009-10-30
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
CR Company responded 2009-11-13
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: October 29, 2009
Summary
Generating summary...
CR Company responded 2009-12-17
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: December 4, 2009
Summary
Generating summary...
CR Company responded 2014-12-22
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: December 16, 2014
Summary
Generating summary...
CR Company responded 2015-01-15
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: December 16, 2014
Summary
Generating summary...
CR Company responded 2018-12-17
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: December 12, 2018
Summary
Generating summary...
CR Company responded 2019-01-11
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
CR Company responded 2021-09-30
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: December 12, 2018 | January 11, 2019
Summary
Generating summary...
CR Company responded 2021-11-12
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
References: September 30, 2021
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2021-10-29  ·  Last active: 2021-10-29
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2021-10-29
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2021-08-18  ·  Last active: 2021-08-18
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2021-08-18
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2019-03-05  ·  Last active: 2019-03-05
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2019-03-05
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2018-12-12  ·  Last active: 2018-12-12
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2018-12-12
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): N/A  ·  Started: 2015-01-20  ·  Last active: 2015-01-20
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2015-01-20
Emergent BioSolutions Inc.
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2014-12-16  ·  Last active: 2014-12-16
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2014-12-16
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2010-01-19  ·  Last active: 2010-01-19
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2010-01-19
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 001-33137  ·  Started: 2009-12-04  ·  Last active: 2009-12-04
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2009-12-04
Emergent BioSolutions Inc.
File Nos in letter: 001-33137
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 333-155311  ·  Started: 2008-12-01  ·  Last active: 2008-12-09
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2008-12-01
Emergent BioSolutions Inc.
File Nos in letter: 333-155311
Summary
Generating summary...
CR Company responded 2008-12-09
Emergent BioSolutions Inc.
File Nos in letter: 333-155311
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 333-136622  ·  Started: 2006-09-11  ·  Last active: 2006-11-09
Response Received 1 company response(s) High - file number match
UL SEC wrote to company 2006-09-11
Emergent BioSolutions Inc.
File Nos in letter: 333-136622
Summary
Generating summary...
CR Company responded 2006-11-09
Emergent BioSolutions Inc.
File Nos in letter: 333-136622
Summary
Generating summary...
Emergent BioSolutions Inc.
CIK: 0001367644  ·  File(s): 333-136622  ·  Started: 2006-10-11  ·  Last active: 2006-10-11
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2006-10-11
Emergent BioSolutions Inc.
File Nos in letter: 333-136622
Summary
Generating summary...
DateTypeCompanyLocationFile NoLink
2025-08-13 Company Response Emergent BioSolutions Inc. DE N/A
Offering / Registration Process
Read Filing View
2025-08-13 SEC Comment Letter Emergent BioSolutions Inc. DE 333-289359
Offering / Registration Process
Read Filing View
2024-12-02 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2024-11-18 SEC Comment Letter Emergent BioSolutions Inc. DE 333-283150 Read Filing View
2021-12-09 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2021-11-12 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2021-10-29 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2021-09-30 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2021-08-18 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2019-03-05 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2019-01-11 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2018-12-17 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2018-12-12 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2015-01-20 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2015-01-15 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2014-12-22 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2014-12-16 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2010-01-19 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2009-12-17 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2009-12-04 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2009-11-13 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2009-10-30 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2008-12-09 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2008-12-01 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2006-11-09 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2006-10-11 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2006-09-11 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2025-08-13 SEC Comment Letter Emergent BioSolutions Inc. DE 333-289359
Offering / Registration Process
Read Filing View
2024-11-18 SEC Comment Letter Emergent BioSolutions Inc. DE 333-283150 Read Filing View
2021-12-09 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2021-10-29 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2021-08-18 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2019-03-05 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2018-12-12 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2015-01-20 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2014-12-16 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2010-01-19 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2009-12-04 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2009-10-30 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2008-12-01 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2006-10-11 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
2006-09-11 SEC Comment Letter Emergent BioSolutions Inc. DE N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2025-08-13 Company Response Emergent BioSolutions Inc. DE N/A
Offering / Registration Process
Read Filing View
2024-12-02 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2021-11-12 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2021-09-30 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2019-01-11 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2018-12-17 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2015-01-15 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2014-12-22 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2009-12-17 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2009-11-13 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2008-12-09 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2006-11-09 Company Response Emergent BioSolutions Inc. DE N/A Read Filing View
2025-08-13 - CORRESP - Emergent BioSolutions Inc.
CORRESP
 1
 filename1.htm

 CORRESP

 August 13, 2025
 Via EDGAR U.S. Securities and Exchange Commission
 Division of Corporation Finance 100 F Street, N.E.
 Washington, D.C. 20549

 Re:
 Emergent BioSolutions Inc.
 Registration Statement on Form S-3
 File No. 333-289359
 Filed August 7, 2025 Ladies and
Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Emergent BioSolutions Inc. hereby respectfully requests that
the effective date for the above-referenced registration statement be accelerated to 4:00 p.m., Eastern Time, on August 15, 2025, or as soon as practicable thereafter.
 Should you have any questions or comments regarding the foregoing, please contact Matthew C. Franker or Julie M. Plyler of
Covington & Burling LLP at (202) 662-5895 or (212) 841-1090, respectively.

 Respectfully,

 Emergent BioSolutions Inc.

 By:

 /s/ Jessica Perl

 Name:

 Jessica Perl

 Title:

 Senior Vice President, General Counsel and Corporate Secretary

 cc:
 Doris Stacey Gama
 Matthew C. Franker Julie M.
Plyler
2025-08-13 - UPLOAD - Emergent BioSolutions Inc. File: 333-289359
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 August 13, 2025

Richard S. Lindahl
Chief Financial Officer
Emergent BioSolutions Inc.
300 Professional Drive
Gaithersburg, MD 20879

 Re: Emergent BioSolutions Inc.
 Registration Statement on Form S-3
 Filed August 7, 2025
 File No. 333-289359
Dear Richard S. Lindahl:

 This is to advise you that we have not reviewed and will not review your
registration
statement.

 Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.

 Please contact Doris Stacey Gama at 202-551-3188 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Julie M. Plyler, Esq.
</TEXT>
</DOCUMENT>
2024-12-02 - CORRESP - Emergent BioSolutions Inc.
CORRESP
1
filename1.htm

CORRESP

 December 2, 2024

Via EDGAR

 U.S. Securities and Exchange Commission

Division of Corporation Finance

 100 F Street, N.E.

Washington, D.C. 20549

Re:
 Emergent BioSolutions Inc.

Registration Statement on Form S-1

File No. 333-283150

Filed November 12, 2024

 Ladies and
Gentlemen:

 Pursuant to Rule 461 under the Securities Act of 1933, as amended, the Emergent BioSolutions Inc. hereby respectfully requests
that the effective date for the above-referenced registration statement be accelerated to 4:00 p.m., Eastern Time, on December 4, 2024, or as soon as practicable thereafter.

Should you have any questions or comments regarding the foregoing, please contact Matthew C. Franker or Julie M. Plyler of
Covington & Burling LLP at (202) 662-5895 or (212) 841-1090, respectively.

Respectfully,

Emergent BioSolutions Inc.

By:

/s/ Jessica Perl

Name:

Jessica Perl

Title:

Senior Vice President, General Counsel and Corporate Secretary

cc:
 Tamika Sheppard

Matthew C. Franker

 Julie M.
Plyler
2024-11-18 - UPLOAD - Emergent BioSolutions Inc. File: 333-283150
November 18, 2024
Richard Lindahl
Executive Vice President, Chief Financial Officer and Treasurer
Emergent BioSolutions Inc.
300 Professional Drive
Gaithersburg, Maryland 20879
Re:Emergent BioSolutions Inc.
Registration Statement on Form S-1
Filed November 12, 2024
File No. 333-283150
Dear Richard Lindahl:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Matthew Franker
2021-12-09 - UPLOAD - Emergent BioSolutions Inc.
United States securities and exchange commission logo
December 9, 2021
Richard Lindahl
Chief Financial Officer
Emergent BioSolutions Inc.
400 Professional Drive Suite 400
Gaithersburg, Maryland
Re:Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
File No. 001-33137
Dear Mr. Lindahl:
            We have completed our review of your filings.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-11-12 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: September 30, 2021
CORRESP
1
filename1.htm

Document

November 12, 2021

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance Office of Healthcare & Insurance

100 F Street, N.E.

Washington, DC 20549-3561

Re:       Emergent BioSolutions Inc.

Form 10-K for the Fiscal Year Ended December 31, 2020

Form 10-Q for the Fiscal Quarter Ended June 30, 2021

File No. 001-33137

This letter sets forth the response of Emergent BioSolutions Inc. (“Emergent” or the “Company”) to the comments contained in your letter, dated October 29, 2021, relating to Emergent’s Form 10-K filed with the Commission on February 19, 2021 and Emergent’s Form 10-Q filed with the Commission on April 30, 2021. The comments of the Staff of the Commission (the “Staff”) are set forth in bold/italicized text below, and the Company’s response is set forth in plain text immediately beneath such comment.

Form 10-K for the Fiscal Year Ended December 31, 2020

Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Contract Development and Manufacturing Services, page 58

1.Refer to your response to comment 6 and the proposed disclosure in response to comment 4 with respect to the status of the AZ contract. You state that you are in negotiations with AZ to settle your contract and have not included revenue associated with the performance of any future services for AZ in the unsatisfied performance obligation disclosure. Please address the following:

a.As previously requested, please clarify in your proposed disclosure how your results of operations have been and are expected to be affected in the future for the renegotiation of the AstraZeneca contract. In this regard, we note the increase in selling, general and administrative expenses in the six months ended June 30, 2021 compared to the prior period of $15.2 million and the $12 million spent to remediate and strengthen the manufacturing process at the Bayview site referred to in your earnings call. In addition, it is unclear if there was any lost revenue and related cost of sales relating to the AZ contract.

b.Clarify in the filing the nature of the renegotiation, which appears to be a termination of the contract, and the status thereof. Specifically state that AZ's period of performance was from July 2020-September 2020 and you will not be recording any future revenues for the AZ contract.

c.Tell us why additional disclosure is not required in the notes to the financial statements.

We acknowledge the Staff's comments and have revised our disclosures in our Form 10-Q for the quarter ended September 30, 2021 filed on November 5, 2021 to include our accounting policy for CDMO arrangements that end in early termination as follows: "The Company’s CDMO customer contracts generally include provisions entitling the Company to a termination penalty when the contract is terminated prior to the contract’s nominal end date. The termination penalties in the customer contracts vary but are generally considered substantive for accounting purposes and create enforceable rights and obligations throughout the stated duration of the contract. The Company accounts for a contract cancellation as a contract modification. The determination of the contract termination penalty is based on the terms stated in the related customer agreement. As of the modification date, the Company updates its estimate of the transaction price, subject to constraints, and recognizes the amount over the remaining performance period or measure of progress under the arrangement."

We then further explain in the revenue footnote (Note 10) the status of the AstraZeneca ("AZ") arrangement as follows: "During the three months ended June 30, 2021, AZ instructed the Company to cease performing new manufacturing services. At that time the Company updated its estimated transaction price subject to constraints and measure of progress under the arrangement. The Company has completed the release of all previously manufactured batches for AZ and there are no remaining unsatisfied performance obligations included in the Company's unsatisfied performance obligation disclosure."

The period of performance for the AZ contract referenced in the Staff’s comment of July 2020 through September 2020 relates to the suite reservation and associated lease revenues.  The AZ contract’s total period of performance was from the second quarter 2020 through third quarter 2021.

To clarify the impact of AZ being removed from the Bayview facility we added the following disclosure in the inventory footnote (Note 3). "Inventories, net is stated at the lower of cost or net realizable value. During the nine months ended September 30, 2021, the Company recorded inventory write-offs at its Bayview facility of $41.5 million, which were directly or indirectly the result of the cross-contamination event at the Bayview facility identified during the three months ended June 30, 2021. The inventory write-off resulted from the Company's plan to discard raw materials and in-process batches that were deemed unusable. The charge was reflected as a component of cost of contract development and manufacturing."

The disclosure above aggregated both AZ and Johnson and Johnson ("JNJ') manufacturing materials, because neither customer exceeds 10% of revenues. Disclosures for AZ and JNJ are aggregated in our discussion of the results of operations as well. The discussion of CDMO revenues is as follows: "The increase in CDMO services revenue for the three months ended September 30, 2021 of $59.5 million is largely due to out-of-period adjustments (see Note 2) of $49.3 million along with incremental manufacturing activities. The increase for the nine months ended September 30, 2021 is due to the Company's partnerships with innovators, including JNJ and AZ, to address the COVID-19 pandemic. The AZ and JNJ arrangements were entered into during the second and third quarters of 2020 and the Company began servicing other innovator companies in 2021. Additionally, during the nine months ended September 30, 2021, there were out-of-period adjustments (see Note 2) of $28.8 million." Additionally, the Company included the following disclosure for CDMO expenses, "Cost of CDMO increased for the three and nine months ended September 30, 2021 as compared to the three and nine months ended September 30, 2020 due to an increase in CDMO service activities, increases in costs due to out-of-period adjustments (see Note 2) and additional costs to support remediation efforts for our COVID-19 manufacturing activities. Additionally, during the nine months ended September 30, 2021, the Company recorded inventory write-offs at its Bayview facility of $41.5 million, which were directly or indirectly the result of the cross-contamination event at the Bayview facility identified during the three months ended June 30, 2021."

The Company believes the above disclosures provide sufficient information for users of the financial statements about the status of the AZ arrangement.

Gross Profit Margin for Product Sales and CDMO services, page 59

2.We note your response to our prior comment 2 and your proposed disclosures. Your arguments, including your references to your prior response, focused on the manufacturing of bulk drug substances and drug products. Your recent revision of your revenue recognition policy for the drug substance batch production indicated a different pattern for control transfer under ASC 606. Furthermore, your business has also evolved to include a large portion of suite reservation operation, which appears to be bearing a significantly higher margin. Please tell us how you determined that disclosure of your costs related to the CDMO service was not required by Article 5 of Regulation S-X which requires separate disclosure of cost of tangible goods sold, cost of services, and expenses applicable to rental income if their related revenue is over 10% net sales and gross revenues. In addition, please clarify that you will separately present your leasing income on the face of the income statement.

We acknowledge the Staff's comments and have revised the presentation of the face of our statements of operations in our Form 10-Q for the quarter ended September 30, 2021 filed on November 5, 2021 to include the following presentation of:

a) CDMO lease revenues and CDMO services revenues subtotaled for total CDMO revenues, and

b) Cost of goods sold for products and cost of CDMO.

The Company has presented CDMO services and lease costs in aggregate given we operate an integrated manufacturing network, our leasing activities are not core to our business strategy, our current material lease revenues are temporary in nature, and the cost structure associated with our manufacturing facilities will remain with the Company even after the material lease revenues expire.  We anticipate that in 2022 our lease revenues will comprise 3-4% of total revenues, and as such we believe the disclosure of CDMO costs in aggregate is most useful.

Consolidated Financial Statements 17. Segment Information, page 105

3.We note your response to our prior comment 5. Please respond to the following comments relating to your segment presentation under ASC 280: Tell us how often the CODM meets with his/her direct reports, the financial information the CODM reviews to prepare for those meetings, the financial information discussed in those meetings, and who else attends those meetings.

a.If not already covered by your response to bullet 1, describe the information regularly provided to the CODM and how frequently it is prepared. More specifically, clarify if any business units performance results are presented, or discussed, as part of, or outside of the consolidated company-wide performance presentation that the CODM reviews.

b.Explain how budgets are prepared, who approves the budget at each step of the process, the level of detail discussed at each step, and the level at which the CODM makes changes to the budget.

c.Also describe the level of detail communicated to the CODM when actual results differ from budgets and who is involved in meetings with the CODM to discuss budget-to-actual variances.

Our chief operating decision maker ("CODM"), our President and Chief Executive Officer ('CEO"), has weekly or bi-weekly scheduled one-on-one meetings with each of his direct reports.  During those one-on-one meetings the CODM and his direct reports will discuss operational performance including new and potential business, manufacturing and quality performance, customer relations, human resource matters, communications, and other items. These one-on-one meetings do not routinely involve the review of financial information and generally do not involve the review of specific materials, but rather are meant to be a forum for the open exchange of information between the CODM and his direct reports on a variety of topics.  The following roles report directly to the CODM:

•Executive Vice President, Chief Operating Officer (“COO”)

•Executive Vice President, Chief Financial Officer & Treasurer (“CFO”)

•Executive Vice President, Corporate Development, External Affairs, and General Counsel

•Executive Vice President, Chief Medical Officer

•Executive Vice President, Chief Human Resources Officer

•Senior Vice President, Global Quality

The CODM is also the leader of the Executive Management Team ("EMT") which meets weekly and is comprised of the CODM and the direct reports listed above.  The EMT oversees general management of the business, advising the CODM on key matters, and providing strategic direction.  The routine weekly EMT meetings do not generally include discussion of financial performance; however, the EMT, including the CODM, receives a monthly financial report which contains historical and forecasted financial performance metrics, such as actual and forecasted revenues by product/service, as well as consolidated measures of profitability. This monthly financial report is prepared using consolidated financial information and does not contain any grouping or totaling of revenues, expenses, or profitability by business line, and does not contain information that would enable the calculation of profitability by business line. This monthly financial report is the primary information used by the CODM to allocate resources and assess performance. The monthly financial reporting includes a consolidated enterprise level analysis of the drivers for fluctuations compared to the most recent forecast. The fluctuation analysis references significant drivers of changes in consolidated performance, including products, functional departments, and unique transactions.

In addition to the monthly financial reporting reviewed by the CODM; on a quarterly basis, the Company conducts a Quarterly Business Review ("QBR") which is a series of meetings to review commercial, operational, and financial performance by business line.  Attendees at the QBR include the EMT (including the CODM), all senior vice presidents, and select other members of management as appropriate.  The content in the QBR materials includes discussion of recent business accomplishments and challenges, commercial opportunities, research and development updates, as well as a review of select financial metrics for each business line.  The financial metrics reviewed at the QBR include revenues by product/service, research and development expense ("R&D expense"), and selling, general and administrative expense ("SG&A expense") by business line.  The financial metrics do not include cost of goods or services or any metric of profitability or information such that profitability can be independently calculated.

Prior to commencing the annual budgeting process, the CODM and the EMT determine parameters and metrics at the consolidated level that serve as guiding principles to prepare the budget.  The finance organization, with leadership from the CFO, set financial targets for each business line and functional department to achieve based on recent performance and known trends.  Each business

line and functional department then creates their budget, which is then further revised based on a resource allocation exercise which is performed at the consolidated enterprise level to determine how to allocate investments and potential opportunities.  The CODM participates in that resource allocation exercise at the enterprise level.  The resource allocation exercise is a cross-business line exercise and resources are allocated to specific initiatives or projects rather than business lines. For example, while the business line leaders have autonomy for day-to-day decisions, major or strategic decisions and allocation of resources are made at the enterprise level by the CODM. Following CODM review, the budget is then finalized and a review is provided to the Board of Directors.

Additionally, we would like to clarify for the Staff that the Company implemented a new organizational structure in early October 2021 as disclosed in our Form 10-Q filing on November 5, 2021. The key components of the new business structure include a Government (MCM) line of products, Commercial line of products, and contract development and manufacturing offerings as well as the centralization of research and development (“R&D”) functions and capabilities at the enterprise level. The centralization of R&D at the enterprise level further illustrates the allocation of resources at the enterprise level with respect to our potential future growth through our R&D pipeline. The Company does not anticipate changes to the level of detail or metrics in the financial information to be provided to the CODM as part of this reorganization.

We respectfully remind the Staff of the following points referenced in our prior response letter dated September 30, 2021:

a.The business line leaders all report to the Company’s Executive Vice President and COO. The COO i
2021-10-29 - UPLOAD - Emergent BioSolutions Inc.
United States securities and exchange commission logo
October 29, 2021
Richard Lindahl
Chief Financial Officer
Emergent BioSolutions Inc.
400 Professional Drive Suite 400
Gaithersburg, Maryland
Re:Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Form 10-Q for the Fiscal Quarter Ended June 30, 2021
Response dated September 30, 2021
File No. 001-33137
Dear Mr. Lindahl:
            We have reviewed your September 30, 2021 response to our comment letter and have the
following comments.  In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional
comments.  Unless we note otherwise, our references to prior comments are to comments in our
August 18, 2021 letter.
Form 10-K for the Fiscal Year Ended December 31, 2020
Management's Discussion and Analysis of Financial Condition and Results of Operations Results
of Operations
Contract Development and Manufacturing Services, page 58
1.Refer to your response to comment 6 and the proposed disclosure in response to comment
4 with respect to the status of the AZ contract.  You state that you are in negotiations with
AZ to settle your contract and have not included revenue associated with the performance
of any future services for AZ in the unsatisfied performance obligation disclosure.  Please
address the following:

 FirstName LastNameRichard Lindahl
 Comapany NameEmergent BioSolutions Inc.
 October 29, 2021 Page 2
 FirstName LastNameRichard Lindahl
Emergent BioSolutions Inc.
October 29, 2021
Page 2
•As previously requested, please clarify in your proposed disclosure how your results
of operations have been and are expected to be affected in the future for the
renegotiation of the AstraZeneca contract.  In this regard, we note the increase in
selling, general and administrative expenses in the six months ended June 30, 2021
compared to the prior period of $15.2 million and the $12 million spent to remediate
and strengthen the manufacturing process at the Bayview site referred to in your
earnings call.  In addition, it is unclear if there was any lost revenue and related cost
of sales relating to the AZ contract.
•Clarify in the filing the nature of the renegotiation, which appears to be a termination
of the contract, and the status thereof.  Specifically state that AZ's period of
performance was from July 2020-September 2020 and you will not be recording any
future revenues for the AZ contract.
•Tell us why additional disclosure is not required in the notes to the financial
statements.
Gross Profit Margin for Product Sales and CDMO services, page 59
2.We note your response to our prior comment 2 and your proposed disclosures.  Your
arguments, including your references to your prior response, focused on the
manufacturing of bulk drug substances and drug products.  Your recent revision of your
revenue recognition policy for the drug substance batch production indicated a different
pattern for control transfer under ASC 606.  Furthermore, your business has also evolved
to include a large portion of suite reservation operation, which appears to be bearing a
significantly higher margin.  Please tell us how you determined that disclosure of your
costs related to the CDMO service was not required by Article 5 of Regulation S-X which
requires separate disclosure of cost of tangible goods sold, cost of services, and expenses
applicable to rental income if their related revenue is over 10% net sales and gross
revenues.  In addition, please clarify that you will separately present your leasing income
on the face of the income statement.
Consolidated Financial Statements
17. Segment Information, page 105
3.We note your response to our prior comment 5.  Please respond to the following
comments relating to your segment presentation under ASC 280:

•Tell us how often the CODM meets with his/her direct reports, the financial
information the CODM reviews to prepare for those meetings, the financial
information discussed in those meetings, and who else attends those meetings.
•If not already covered by your response to bullet 1, describe the information regularly
provided to the CODM and how frequently it is prepared. More specifically, clarify if
any business units performance results are presented, or discussed, as part of, or
outside of the consolidated company-wide performance presentation that the
CODM reviews.

 FirstName LastNameRichard Lindahl
 Comapany NameEmergent BioSolutions Inc.
 October 29, 2021 Page 3
 FirstName LastName
Richard Lindahl
Emergent BioSolutions Inc.
October 29, 2021
Page 3
•Explain how budgets are prepared, who approves the budget at each step of the
process, the level of detail discussed at each step, and the level at which the CODM
makes changes to the budget.
•Also describe the level of detail communicated to the CODM when actual results
differ from budgets and who is involved in meetings with the CODM to discuss
budget-to-actual variances.
            You may contact Li Xiao at (202) 551-4391 or Mary Mast at (202) 551-3613 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-09-30 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: December 12, 2018, January 11, 2019
CORRESP
1
filename1.htm

Document

September 30, 2021

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance Office of Healthcare & Insurance

100 F Street, N.E.

Washington, DC 20549-3561

Re:     Emergent BioSolutions Inc.

Form 10-K for the Fiscal Year Ended December 31, 2020

Form 10-Q for the Fiscal Quarter Ended June 30, 2021

File No. 001-33137

This letter sets forth the response of Emergent BioSolutions Inc. (“Emergent” or the “Company”) to the comments contained in your letter, dated August 18, 2021, relating to Emergent’s Form 10-K filed with the Commission on February 19, 2021 and Emergent’s Form 10-Q filed with the Commission on April 30, 2021. The comments of the Staff of the Commission (the “Staff”) are set forth in bold/italicized text below, and the Company’s response is set forth in plain text immediately beneath such comment.

Form 10-K for the Fiscal Year Ended December 31, 2020

Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations

Contract Development and Manufacturing Services, page 58.

1. You disclosed here that the increase in the 2020 CDMO service revenue was due to the Covid-19 related contracts and arrangements. Considering the significance of this item in 2020 and for the six months ended June 30, 2021, tell us how you have considered compliance with the disclosure requirement under Item 303 of Regulation S-K, which requires the disclosure of any significant components of revenues or expenses that, in the registrant's judgment, should be described in order to understand the registrant's results of operations, as well as any known trends or uncertainties that have had or that the registrant reasonably expects will have a material favorable or unfavorable impact on net sales or revenues or income from continuing operations. Please include revised disclosure to be included in future filings.

The Company considered Item 303 of Regulation S-K in the preparation of its Form 10-K and Form 10-Q, concluding that nearly all of the increase in CDMO services revenue was related to the Company’s COVID-19 related arrangements.  Notwithstanding, in response to the Staff’s comment, in the future the Company will provide quantification of the significant components of any material increase or decrease in revenues or expenses it believes necessary to understand the results of operations, as well as any known trends or uncertainties that have had or are reasonably expected to have a material favorable or unfavorable impact on net revenues, expenses or income from continuing operations. We have included below proposed disclosure based on the year ended December 31, 2020 compared to the year ended December 31, 2019:

“The increase in CDMO services revenue for the year ended December 31, 2020 of $370.5 million is primarily due to the Company's public-private partnership with BARDA in support of the US Government’s (“USG”) efforts to address the COVID-19 pandemic, which resulted in an increase of $253.3 million from BARDA as well as increases in aggregate sales from innovator manufacturers such as Johnson & Johnson (“JNJ”) and AstraZeneca (“AZ”), which collectively resulted in an increase in revenue of $96.7 million.”

The Company has included below proposed disclosure based on its discussion for the three and six months ended June 30, 2021 compared to the three and six months ended June 30, 2020:

“The increase in CDMO service revenue for the three and six months ended June 30, 2021 of $118.3 million and $280.4 million, respectively, is due to the Company’s public-private partnership with BARDA and innovator manufacturers, including AZ and JNJ, to address the COVID-19 pandemic. The BARDA increase was $25.8 million and $123.3 million for the three and six months ended June 30, 2021 respectively. The arrangements with innovator manufacturers, including AZ and JNJ, resulted in increases in revenues of $86.4 million and $152.9 during the three and six months ended June 30, 2021, respectively. The arrangements with BARDA and innovators responding to COVID-19 were primarily entered into during the second and third quarters of 2020.”

Gross Profit Margin for Product Sales and CDMO services, page 59.

2.Here you disclosed gross profit margin for product sales and CDMO services. Please respond to the following comments:

•The gross profit margin balance you presented on page 59 showed a significant increase from 55.9% in 2019 to 63.6% in 2020. Explain to us, and revise all future filings to disclose the reason for the significant increase, including the underlying drivers and any trends.

•During our prior review, you provided analysis and justifications for reporting a combined Cost of Product Sale and CDMO services as one line item in your statement of operations. Considering that now CDMO service increased to account for a significant share of your total revenue and costs, which also appears to have contributed to your margin improvement, please provide us with your analysis why it is appropriate to continue to report these costs as one line item.

In response to the Staff’s comment, the Company will include narrative descriptions for changes in gross margin, to the extent material, in all future filings.  The Company has included below the proposed disclosure based on its discussion for the year ended December 31, 2020 compared to the year ended December 31, 2019:

“The increase in gross margin percentage from 2019 to 2020 was primarily due to the operating leverage associated with both the Company’s public-private partnership with BARDA and new arrangements we entered into during 2020 with innovator manufacturers, such as AZ and JNJ, to address the COVID-19 pandemic.”

Management believes that the discussion of material changes in gross margin fluctuations will clarify the impact of product and CDMO sales on the Company’s operations.

The Company respectfully refers the Staff to its response No. 3 in its letter, dated January 11, 2019, responding to the SEC comment letter dated December 12, 2018, from the Staff’s prior review for the reasons why we present our cost of product sales and CDMO services as one line item in our statement of operations. The inputs and outputs in the manufacturing process are similar regardless of whether the Company is producing material for itself or external customers. The Company’s contract manufacturing business includes production of bulk drug substances and drug products. When producing bulk drug substances for customers, the Company procures raw materials and produces the contract manufacturing customer’s product from scratch and retains title and risk of loss to the product until it is delivered to the customer upon completion of the manufacturing process and the product has been approved by the Company’s quality

control review process.  For drug product customers, the Company receives work in process inventory from its clients and brings the product to a filled and finished state. The Company performs similar production activities for its own products and therefore does not view the costs associated with performing these activities for third-party customers as separate from the costs incurred to produce its own products. Often the Company uses excess capacity at facilities primarily used for its own products to perform contract manufacturing services. As a result, management views expenses associated with its manufacturing operations on an aggregate basis when analyzing the financial performance of its manufacturing facilities.  The financial reports provided to the chief operating decision maker (“CODM”) also present the expenses associated with product sales and CDMO services on a combined basis, further supporting the external presentation of these expenses on a combined basis. Furthermore, the Company communicates its gross margin goals to its investors on an aggregated basis believing this is the most useful measure of profitability of its manufacturing facilities.

Note 2. Summary of Significant Accounting Policies

Revenue Recognition - CDMO Services, page 81

3.Here you disclosed that you have determined that the technology transfer, stand-ready and suite-reservation performance obligations are satisfied over time, but only provided the method used to recognized revenue for the suite-reservation performance obligation. Please provide revised disclosure to be included in future filings of the method used to recognize the technology transfer and stand-ready performance obligations, and why the methods used provide a faithful depiction of the transfer of goods and services. Refer to ASC 606-10-50-18.

In response to the Staff’s comments, the Company will enhance its disclosure of the accounting policy for CDMO service revenue recognition in future filings as documented below:

“The Company performs CDMO services for third parties. Under these contracts, activities can include pharmaceutical product process development, drug substance manufacturing, drug product manufacturing services for injectable and other sterile products, process design, technology transfer, manufacturing validations, laboratory analytical development support, aseptic filling, lyophilization, final packaging, stability studies, and suite-reservations. These contracts vary in duration, activities, and number of performance obligations. Performance obligations identified under these arrangements may include drug substance and/or drug product manufacturing, technology transfer activities, and suite-reservations.

Drug substance and drug product manufacturing performance obligations are recognized as revenue over-time because the Company’s performance does not create an asset with an alternative use and the Company has an enforceable right to payment for performance completed as work is performed. In drug product arrangements, the customer typically owns and supplies the active pharmaceutical ingredient, or API, that is used in the manufacturing process; in drug substance arrangements, the customer provides certain seed material that is used in the manufacturing process. The transaction price is stated in the agreement as a fixed price per unit, with no contractual provision for a refund or price concession.  We use an input method to measure progress toward the satisfaction of the related performance obligations based on costs incurred as a percentage of total costs to complete which we believe best depicts the transfer of control of goods or services promised to our customers.

For arrangements where we have identified technology transfer activities to be a separate performance obligation, revenues are recognized over-time as the service is provided as there is no alternative future use to the Company for the asset created and the Company has an

enforceable right to payment for performance completed as of that date. The Company measures progress toward completion based on an input method using costs incurred to date as a percentage of total costs to complete the technology transfer activities.

Suite reservations are classified as leases because not only does the customer direct the use of the identified suite, but also obtains substantially all the economic benefits from the manufacturing capacity. If a customer reserves more than one suite, the allocation of contract value is based on relative selling price which varies due to size, location, capacity, production capability for drug product or drug substance, and the time of planned use. The associated revenue is recognized on a straight-line basis over the period of performance. For arrangements that contain both lease and non-lease components, consideration in the contract is allocated on a relative standalone selling price basis."

Note 3. Revenue Recognition, page 85

4.Considering their significance, please expand to provide, here or where appropriate, information of your CDMO contracts in sufficient detail to enable investors to understand the nature, amount, timing and uncertainty of revenue, cash flows arising from these contracts, including both qualitative and quantitative information, as required under ASC 606-10-50-1. At a minimum, please clarify to us, including proposed disclosure for future filings, the following:

•how you accounted for each component of each significant contract, including the BARDA contract entered into on May 24, 2020, and included in Exhibit 10.62, which consists of $542.7 million allocated to the reservation of manufacturing capacity and $85.5 million for accelerating the planned expansion of viral and non-viral drug product fill/finish capacity.

•Tell us your consideration of accounting for the reservation of the manufacturing capacity performance obligation in Task 1 of the May 2020 BARDA agreement as a lease. Tell us which contract(s) had a suite-reservation performance obligation referred to on page 86 and why. If the suite-reservation performance obligation relates to the BARDA agreement, please reconcile the amount allocated to the reservation of manufacturing capacity in Task 1 of the Task order ending in 007 to the amounts disclosed on page 86 for operating leases.

•Clarify if the reservation of manufacturing capacity, for which $542.7 million was valued as disclosed on page 13, includes the manufacturing activities performance obligation discussed in Task 1 in section C.3.1 of the BARDA agreement and, if so, why the $542.7 million is not allocated between the reservation of manufacturing capacity and manufacturing activities performance obligations. Refer to Section C.3.1 of the BARDA agreement.

•Clarify if you expensed the costs of the capacity expansion in Task 2 of section C.3.2 of the BARDA agreement as research and development or capitalized the amounts pursuant to ASC 730-10-25-2a. If you capitalized the costs, please tell us why you believe the costs have alternative future use. In this regard, we note the reference on page 13 to capital investment projects which appears to include the costs under the BARDA agreement.

•how you accounted for modifications of your original task orders, including modifications to the BARDA agreements to date.

•the basis for your accounting for the BARDA contract and each significant contract, including the Johnson & Johnson and AstraZeneca contracts, referencing the appropriate accounting literature.

•where you disclosed in your filing new tasks such as the BARDA agreement included in Exhibit 10.66 or any significant modifications to your agreements, other than in the Exhibits.

•If no additional disclosure is considered necessary in the body of the filing, please tell us why.

•Tell us if the reduction in price for your May 2020 task order ending in 007, discussed in Exhibit 10.10 of the June 30, 2021 10-Q, is material to your financial statements and, if so, why the terms of the modification are not disclosed.

•the nature of each performance obligation for each significant contract and when your performance obligations are satisfied. Refer to ASC 606-10-50-12.

•the amount of the transaction price allocated to performance obligations for each contract that are unsatisfied as of the end of the reporting period pursuant to ASC 606-10-50-13 and an explanation of when you expect to recognize the revenue.

•your consideration of providing disaggregated revenue by significant contract, contract-type, and prime vs subcontractor pursuant to ASC 606-10-50-5.

•why disclosure of the terms of the significant contracts is not required to be included in the filing.

•your consideration of including the reservation fee for the BARDA contract in your description of CDMO services throughout the filing, including pages 5 and 12. In this regard, the description appears inconsistent with the description on page 81 in the financial statements.

The Company has summarized below the accounting analysis of the arrangements for BARDA, JNJ and AZ which have had the
2021-08-18 - UPLOAD - Emergent BioSolutions Inc.
United States securities and exchange commission logo
August 18, 2021
Richard Lindahl
Chief Financial Officer
Emergent BioSolutions Inc.
400 Professional Drive Suite 400
Gaithersburg, Maryland
Re:Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Form 10-Q for the Fiscal Quarter Ended June 30, 2021
File No. 001-33137
Dear Mr. Lindahl:
            We have reviewed your filings and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2020
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Contract Development and Manufacturing Services, page 58
1.You disclosed here that the increase in the 2020 CDMO service revenue was due to the
Covid-19 related contracts and arrangements.  Considering the significance of this item in
2020 and for the six months ended June 30, 2021, tell us how you have considered
compliance with the disclosure requirement under Item 303 of Regulation S-K, which
requires the disclosure of any significant components of revenues or expenses that, in the
registrant's judgment, should be described in order to understand the registrant's results of
operations, as well as any known trends or uncertainties that have had or that the registrant
reasonably expects will have a material favorable or unfavorable impact on net sales or
revenues or income from continuing operations.  Please include revised disclosure to be
included in future filings.

 FirstName LastNameRichard Lindahl
 Comapany NameEmergent BioSolutions Inc.
 August 18, 2021 Page 2
 FirstName LastNameRichard Lindahl
Emergent BioSolutions Inc.
August 18, 2021
Page 2
Gross Profit Margin for Product Sales and CDMO services, page 59
2.Here you disclosed gross profit margin for product sales and CDMO services.  Please
respond to the following comments:

•The gross profit margin balance you presented on page 59 showed a significant
increase from 55.9% in 2019 to 63.6% in 2020.  Explain to us, and revise all future
filings to disclose the reason for the significant increase, including the underlying
drivers and any trends.
•During our prior review, you provided analysis and justifications for reporting a
combined Cost of Product Sale and CDMO services as one line item in your
statement of operations.  Considering that now CDMO service increased to account
for a significant share of your total revenue and costs, which also appears to
have contributed to your margin improvement, please provide us with your analysis
why it is appropriate to continue to report these costs as one line item.
Note 2. Summary of Significant Accounting Policies
Revenue Recognition - CDMO Services, page 81
3.Here you disclosed that you have determined that the technology transfer, stand-ready and
suite-reservation performance obligations are satisfied over time, but only provided the
method used to recognized revenue for the suite-reservation performance obligation.
Please provide revised disclosure to be included in future filings of the method used to
recognize the technology transfer and stand-ready performance obligations, and why the
methods used provide a faithful depiction of the transfer of goods and services.  Refer
to ASC 606-10-50-18.
Note 3. Revenue Recognition, page 85
4.Considering their significance, please expand to provide, here or where
appropriate, information of your CDMO contracts in sufficient detail to enable investors
to understand the nature, amount, timing and uncertainty of revenue, cash flows arising
from these contracts, including both qualitative and quantitative information, as
required under ASC 606-10-50-1.  At a minimum, please clarify to us, including proposed
disclosure for future filings, the following:

•how you accounted for each component of each significant contract, including the
BARDA contract entered into on May 24, 2020, and included in Exhibit 10.62, which
consists of $542.7 million allocated to the reservation of manufacturing capacity and
$85.5 million for accelerating the planned expansion of viral and non-viral drug
product fill/finish capacity.oTell us your consideration of accounting for the reservation of the
manufacturing capacity performance obligation in Task 1 of the May 2020
BARDA agreement as a lease.  Tell us which contract(s) had a suite-reservation
performance obligation referred to on page 86 and why.  If the suite-reservation

 FirstName LastNameRichard Lindahl
 Comapany NameEmergent BioSolutions Inc.
 August 18, 2021 Page 3
 FirstName LastNameRichard Lindahl
Emergent BioSolutions Inc.
August 18, 2021
Page 3
performance obligation relates to the BARDA agreement, please reconcile the
amount allocated to the reservation of manufacturing capacity in Task 1 of the
Task order ending in 007 to the amounts disclosed on page 86 for operating
leases.
oClarify if the reservation of manufacturing capacity, for which $542.7 million
was valued as disclosed on page 13, includes the manufacturing activities
performance obligation discussed in Task 1 in section C.3.1 of the BARDA
agreement and, if so, why the $542.7 million is not allocated between the
reservation of manufacturing capacity and manufacturing activities performance
obligations.  Refer to Section C.3.1 of the BARDA agreement.
oClarify if you expensed the costs of the capacity expansion in Task 2 of section
C.3.2 of the BARDA agreement as research and development or capitalized the
amounts pursuant to ASC 730-10-25-2a.  If you capitalized the costs, please tell
us why you believe the costs have alternative future use.  In this regard, we note
the reference on page 13 to capital investment projects which appears to include
the costs under the BARDA agreement.
•how you accounted for modifications of your original task orders, including
modifications to the BARDA agreements to date.
•the basis for your accounting for the BARDA contract and each significant contract,
including the Johnson & Johnson and AstraZeneca contracts, referencing the
appropriate accounting literature.
•where you disclosed in your filing new tasks such as the BARDA agreement included
in Exhibit 10.66 or any significant modifications to your agreements, other than in the
Exhibits.oIf no additional disclosure is considered necessary in the body of the filing,
please tell us why.
oTell us if the reduction in price for your May 2020 task order ending in 007,
discussed in Exhibit 10.10 of the June 30, 2021 10-Q, is material to your
financial statements and, if so, why the terms of the modification are not
disclosed.
•the nature of each performance obligation for each significant contract and when your
performance obligations are satisfied. Refer to ASC 606-10-50-12.
•the amount of the transaction price allocated to performance obligations for each
contract that are unsatisfied as of the end of the reporting period pursuant to ASC
606-10-50-13 and an explanation of when you expect to recognize the revenue.
•your consideration of providing disaggregated revenue by significant contract,
contract-type, and prime vs subcontractor pursuant to ASC 606-10-50-5.
•why disclosure of the terms of the significant contracts is not required to be included
in the filing.
•your consideration of including the reservation fee for the BARDA contract in your
description of CDMO services throughout the filing, including pages 5 and 12.  In
this regard, the description appears inconsistent with the description on page 81 in the
financial statements.

 FirstName LastNameRichard Lindahl
 Comapany NameEmergent BioSolutions Inc.
 August 18, 2021 Page 4
 FirstName LastName
Richard Lindahl
Emergent BioSolutions Inc.
August 18, 2021
Page 4

Consolidated Financial Statements
17. Segment Information, page 105
5.You state on page 7 that you are organized into four business units, however you have
only presented one reportable segment.  Please provide us an analysis of why you believe
additional segment disclosure is not required pursuant to ASC 280.
Form 10-Q for the Fiscal Quarter Ended June 30, 2021
Item 1. Risk Factors
Product Development and Commercialization Risks, page 39
6.You disclose in Risk Factors the FDA inspection on April 21, 2021 which discovered
cross-contamination of a single drug substance lot intended for further drug product
manufacturing and use in the Johnson & Johnson's COVID-19 vaccine.  Please provide
revised disclosure to be included in future filings for the following:

•Disclose in Management's Discussion and Analysis the effect the cross-
contamination had on your results of operations.
•Clarify on page 29 that the $41.5 million inventory write-off relates to the cross-
contamination issue.
•Provide additional disclosure relating to the status of the AstraZeneca contract as a
result of the cross-contamination issue and how your results of operations have been
and will be affected in the future.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            You may contact Li Xiao at (202) 551-4391 or Mary Mast at (202) 551-3613 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-03-05 - UPLOAD - Emergent BioSolutions Inc.
March 5, 2019
Richard S. Lindahl
Executive Vice President and Chief Financial Officer
Emergent BioSolutions Inc.
400 Professional Drive
Suite 400
Gaithersburg, MD 20879
Re:Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 23, 2018
File No. 001-33137
Dear Mr. Lindahl:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-01-11 - CORRESP - Emergent BioSolutions Inc.
CORRESP
1
filename1.htm

  FOIA Confidential Treatment Request

  Confidential Treatment Requested by Emergent BioSolutions Inc. Pursuant to 17 C.F.R. §200.83. A version of
      this letter submitted via EDGAR omits confidential information. Brackets ([     ]) denote the omission of the confidential information from the EDGAR submission of this letter.

  January 11, 2019

  VIA EDGAR
          SUBMISSION

  Securities and Exchange Commission

  Division of Corporation Finance

  Office of Healthcare & Insurance

  100 F Street, N.E.

  Washington, DC  20549-3561

  Re:       Emergent BioSolutions Inc.

  Form 10-K for the Fiscal Year Ended December 31, 2017

  Filed February 23, 2018

  Form 10-Q for the Quarterly Period Ended September 30, 2018

  Filed November 2, 2018

  Form 8-K

  Filed November 1, 2018

  File No. 001-33137

  This letter sets forth the response of Emergent BioSolutions Inc. (“Emergent” or the “Company”) to the comments contained
      in your letter, dated December 12, 2018, relating to Emergent’s Form 10-K filed with the Commission on February 23, 2018, Emergent’s Form 10-Q filed with the Commission on November 2, 2018, and Emergent’s Form 8-K filed with the Commission on
      November 1, 2018. The comments of the Staff of the Commission (the “Staff”) are set forth in bold/italicized text below, and the Company’s response is set forth in plain text immediately beneath such comment.

  Form 10-K for the Fiscal Year Ended December
          31, 2017

  Management's Discussion and Analysis of
          Financial Condition and Results of Operations

  Results of Operations

  Year ended December 31, 2017 Compared to Year
          Ended December 31, 2016

  Revenue

              1.

                Please tell us the following regarding your discussion of the changes in revenue:

              •

                How much of the increase in BioThrax
                      product sales relates to volume versus price.

              •

                What is meant by "timing of BioThrax
                      deliveries to SNS" and how it explains the increase in BioThrax sales.

              •

                The amount of other product sales by
                      product for 2017 and 2016.

              •

                The amount attributable to each bullet
                      with regard to the increase in other product sales.

              •

                The amount of expense incurred in 2017 and
                      2016 related to contracts and grants and where they are reflected in your financial statements.

    Also address the above bullets, as applicable, to your
        MD&A revenue discussion for the nine months ended September 30, 2018 compared to nine months ended September 30, 2017 in your Form 10-Q for the quarterly period ended September 30, 2018.

  In response to the Staff’s comment, the Company respectfully advises the Staff that substantially all of the Company’s
      sales of BioThrax® during the periods in question were made to the United States government (“USG”) under two long-term procurement contracts between the Company and the Centers for Disease Control (“CDC”) and Biomedical Advanced Research
      and Development Authority (“BARDA”) at a fixed price per dose.  The price per dose of BioThrax® in the two contracts is identical.  Therefore, the fluctuations in BioThrax® revenue are related to changes in volume depending on
      the timing of when the USG requests delivery of doses to the Strategic National Stockpile (“SNS”).  The SNS is a national repository of critical antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies maintained by
      the USG and it retains a threshold level of BioThrax® at any given time, as it deems necessary.  The Company will clarify in future Exchange Act periodic reports that BioThrax® product sales fluctuations are substantially due to
      changes in volume and those changes in volume are driven by the timing of deliveries and acceptance of product by the USG.

  For competitive and other reasons described herein, the Company has elected not to present revenue for each of its
      products on an individual basis.  Additionally, certain of the Company’s products are procured by the USG and other customers on an infrequent or periodic basis and therefore period to period fluctuations in sales may not be meaningful to the
      long-term financial profile of a product.  Furthermore, for fiscal years 2017, 2016, and 2015, no products other than BioThrax® had sales representing more than 10% of our total revenues.  BioThrax® product sales represented
      51%, 48%, and 60% of our total revenues for the fiscal years ended December 31, 2017, 2016, and 2015, respectively.  For the nine months ended September 30, 2018, BioThrax® product sales represented 28% of our total revenues and ACAM2000®
      product sales represented 23% of our total revenues.  For the nine months ended September 30, 2017, BioThrax® product sales represented 49% of our total revenues.  The Company has presented the table below for the purpose of responding to
      the Staff’s comment; however, the Company does not intend to present the below product sales revenue breakout in its future filings for the reasons mentioned above. The Company believes that presenting information in MD&A in a manner similar to
      the below could give investors a false impression, either favorably or unfavorably, about the Company’s results of operations and the financial profile of its products on an individual basis, particularly given the fact that many of its products are
      purchased on an irregular basis and therefore fluctuations period over period are not necessarily indicative of a product’s expected long-term performance.

  [INFORMATION REDACTED]

  In response to the Staff’s comments requesting quantification of movement in other product sales, the Company has
      re-presented such text with quantification included below for the year ended December 31, 2017 compared to the year ended December 31, 2016:

    “The increase in other product sales relates primarily to:

            •

              the timing of BAT® deliveries to the SNS ($28.4 million);

            •

              international sales for VIGIV and Trobigard™ ($25.3 million); and

            •

              sales of ACAM2000® and Raxibacumab, both acquired in October 2017 ($20.5 million).”

  Additionally, the Company has quantified the corresponding disclosure for the nine months ended September 30, 2018 and
      2017:

  “The increase in other product sales relates primarily to:

            •

              sales of ACAM2000® (which was acquired in October 2017) to the CDC ($116.7 million);

            •

              sales of Raxibacumab (which was acquired in October 2017) to BARDA ($39.6 million);

            •

              sales of Trobigard™ to the U.S. Department of State ($17.5 million);

            •

              sales of RSDL® to the DoD ($7.4 million); and

            •

              sales of Anthrasil® to the Canadian Defence Ministry ($7.0 million).

  These increases in other Products sales were partially offset by a decrease in BAT® sales
      ($18.9 million) primarily due to the timing of deliveries to the SNS.”

  In future filings under the Exchange Act, the Company confirms that it will include quantification of changes in Results
      of Operations similar to the above presentation.

  The revenues within our contracts and grants revenues primarily related to our cost-plus fixed fee contracts with the USG.
      The Company’s expenses associated with contracts and grants are primarily recorded within research and development expenses and represented 43% and 67% of total research and development expenses for the years ended December 31, 2017 and 2016,
      respectively.  Additionally, for the nine months ended September 30, 2018 and 2017 expenses associated with contracts and grants represented 34% and 46% of total research and development expenses, respectively.

  Cost of Product Sales and Contract
          Manufacturing

            2.

              Please tell us the amount attributable to each bullet with regard to the increase in cost of product sales and
                  manufacturing.

  In response to the Staff’s comments requesting quantification of the increase in cost of product sales and manufacturing,
      the Company has re-presented such text with quantification included below for the year ended December 31, 2017 compared to the year ended December 31, 2016:

  “Cost of product sales and contract manufacturing increased by $64.4 million, or 49%, to $195.7 million
      for 2017 from $131.3 million for 2016. The increase was primarily attributable to:

            •

              the timing of non-cash fair value adjustments to the contingent consideration liability (year over year increase of $8.2 million);

            •

              timing of BAT® sales to the SNS ($7.2 million);

            •

              timing of international sales for VIGIV and Trobigard™ ($13.7 million);

            •

              sales of the newly acquired ACAM2000® and Raxibacumab products ($18.5 million) (both acquired October 2017); and

            •

              increased costs associated with the expansion of our contract manufacturing business ($18.8 million).”

  In future filings under the Exchange Act, the Company confirms that it will include quantification of changes in Results
      of Operations similar to the above presentation.

  Consolidated Financial Statements

  Consolidated Statements of Operations

            3.

              Regarding the line item cost of product sales and contract manufacturing, please provide us the amounts included for
                  fiscal years December 31, 2016 and 2017 and the nine months ended September 30, 2018 for cost of product sales versus cost of contract manufacturing. Tell us how your current presentation that combines those items into one line item
                  complies with rule 5-03(b)2 of Regulation S-X.

  The Company respectfully advises the Staff that it uses the same manufacturing facilities and methods of production for
      its own products as well as for fulfillment of its contract manufacturing contracts.  Prior to completing two recent acquisitions in October 2018, the Company operated seven manufacturing facilities, five of which are multi-purpose as they perform
      manufacturing activities for its own marketed products as well as contract manufacturing customers.  The inputs and outputs in the manufacturing process are similar regardless of whether the Company is producing material for itself or external
      customers.  As a result, management views expenses associated with its manufacturing operations on an aggregate basis when analyzing the financial performance of its manufacturing facilities.  The Company’s contract manufacturing business includes
      performing “fill-finish” work for biologics products as well as producing bulk material for certain customers.  For “fill-finish” customers, the Company receives work in process inventory from its client and brings the product to filled and finished
      state and incurs costs to complete the manufacturing process.  Additionally, when producing bulk material for customers, the Company procures raw materials and produces the contract manufacturing customer’s product from scratch and retains title and
      risk of loss to the product until it is delivered to the customer upon completion of the manufacturing process and the product being approved by the Company’s quality control review process.  The Company performs similar production activities for its
      own products and therefore does not view the costs associated with performing these activities for third-party customers should be viewed separately from the costs incurred to produce its own products.  Furthermore, the Company has historically
      communicated its gross margin goals to its investors on an aggregated basis as it believes viewing overall gross margin is most useful to investors as the Company looks to optimize the profitability of its manufacturing facilities by producing its
      own products and utilizing excess capacity for contract manufacturing customers where possible.  As the Company expands its product portfolio, particularly with the recent acquisition of three marketed products during the fourth quarter of 2018, the
      Company expects that the contract manufacturing business will be less than 10% of total revenues in future periods and it is forecasted to be less than 10% of total revenues in fiscal year 2019.  As a result of these facts, the Company does not
      believe that expenses related to its contract manufacturing business represent “cost of services” per Rule 5-03(b)2 of Regulation S-X and believes its presentation of expenses to be in compliance with Regulation S-X as well as the most useful
      presentation of this expense to users of the financial statements.

  Notes to Consolidated Financial Statements

  2. Summary of Significant Accounting Policies

  Revenue Recognition

            4.

              Please provide us an accounting analysis that describes your accounting treatment (i.e. separation, measurement,
                  recognition and classification) for the March 16, 2017 contract and modification that you entered with BARDA. Provide reference to authoritative literature supporting your treatment.

  On September 30, 2016, the Company and BARDA entered into an agreement for the advanced development and delivery of
      NuThrax™ (“BARDA NuThrax™ Contract”). The BARDA NuThrax™ Contract consisted of a five-year base period of performance to develop NuThrax™ (contract value of [   ]) and to manufacture and deliver an initial 2.0 million NuThrax™ doses into the SNS
      after receiving Emergency Use Authorization (“EUA”) pre-authorization approval by US Food and Drug Administration (“FDA”) (contract value of [   ]). The BARDA NuThrax™ Contract also included procurement options (exercisable by BARDA) for the delivery
      of an additional 7.5 million to 50 million doses of NuThrax™ to the SNS, with a contract value of approximately $255 million up to approximately $1.3 billion, and options (also exercisable by BARDA) for an additional clinical study and post-marketing
      commitments with a contract value of $48 million.

  On March 16, 2017, the Company and
      BARDA entered into a new agreement for the delivery of BioThrax® to the SNS in exchange for $99.9 million (“BARDA BioThrax® Contract”). In connection with the signing of this agreement, the Company and BARDA
      also entered into a modification of the BARDA NuThrax™ Contract (“Modification
      to the BARDA NuThrax™ Contract”). The Modification to the BARDA NuThrax™ Contract increased the number of doses of NuThrax™ to be delivered under the base period from 2.0 million to 3.0 million, with no additional consideration to be
      provided to the Company, resulting in an implied discount on the initial doses
      to be delivered. Additionally, the Modification to the BARDA NuThrax™ Contract included a discount on the sales price for doses to be procured during the option period of up to $100 million.

  Accounting Standards Codification (“ASC”)
        605-25-25-3 states “…separate contracts with the same entity or related parties that are entered into at or near the same time are presumed to have been negotiated as a package and shall, therefore, be evaluated as a single arrangement in
        considering whether there are one or more units of accounting.” As the BARDA BioThrax® Contract and the Modification to the BARDA NuThrax™ Contract were entered into at the same time and the related terms of the agreements were negotiated as a package, the Company concl
2018-12-17 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: December 12, 2018
CORRESP
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                December 17, 2018

                  VIA EDGAR SUBMISSION

                  Securities and Exchange Commission

                  Division of Corporation Finance

                  100 F Street, NE

                  Washington, DC 20549

          Attention: Christine Torney, Staff Accountant

                RE:

                Emergent BioSolutions Inc.

                Form 10-K for the Fiscal Year Ended December 31, 2017

                Filed February 23, 2018

                Form 10-Q for the Quarterly Period Ended September 30, 2018

                Filed November 2, 2018

                Form 8-K filed November 1, 2018

                File No.
                      001-33137

              Ms. Torney:

          Emergent BioSolutions Inc. (the “Company”) is sending this letter to confirm the extension of time within which it will respond to the Staff’s comment
              letter dated December 12, 2018, relating to the Company's Annual Report on Form 10-K for the year ended December 31, 2017, Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 and Form 8-K, filed November 1, 2018.  As
              agreed, the Company will file its written response to the Staff's comment letter by no later than Friday, January 11, 2019.

          If you have any questions, or require any additional information, please contact Brian Millard, Vice President, Corporate Controller, Finance and
              Administration at (240) 631-3220.  Thank you for your assistance.

          Regards,

          By: /S/ RICHARD S. LINDAHL

              Richard S. Lindahl

              Executive Vice President,

              Chief Financial Officer and Treasurer

          CC: Jim B. Rosenberg, Senior Assistant Chief Accountant
2018-12-12 - UPLOAD - Emergent BioSolutions Inc.
December 12, 2018
Richard S. Lindahl
Executive Vice President and Chief Financial Officer
Emergent BioSolutions Inc.
400 Professional Drive
Suite 400
Gaithersburg, MD 20879
Re:Emergent BioSolutions Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed February 23, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 2, 2018
Form 8-K
Filed November 1, 2018
File No. 001-33137
Dear Mr. Lindahl:
            We have limited our review of your filings to the financial statements and related
disclosures and have the following comments.  In some of our comments, we may ask you to
provide us with information so we may better understand your disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2107
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Year ended December 31, 2017 Compared to Year Ended December 31, 2016
Revenue
1.Please tell us the following regarding your discussion of the changes in revenue:
•How much of the increase in Bio Thrax product sales relates to volume versus price.
•What is meant by "timing of Bio Thrax deliveries to SNS" and how it explains the

 FirstName LastNameRichard S. Lindahl
 Comapany NameEmergent BioSolutions Inc.
 December 12, 2018 Page 2
 FirstName LastNameRichard S. Lindahl
Emergent BioSolutions Inc.
December 12, 2018
Page 2
increase in Bio Thrax sales.
•The amount of other product sales by product for 2017 and 2016.
•The amount attributable to each bullet  with regard to the increase in other product
sales.
•The amount of expense incurred in 2017 and 2016 related to contracts and grants and
where they are reflected in your financial statements.
Also address the above bullets, as applicable, to your MD&A revenue discussion for the
nine months ended September 30, 2018 compared to nine months ended September 30,
2017 in your Form 10-Q for the quarterly period ended September 30, 2018.
Cost of Product Sales and Contract Manufacturing
2.Please tell us the amount attributable to each bullet with regard to the increase in cost of
product sales and manufacturing.
Consolidated Financial Statements
Consolidated Statements of Operations
3.Regarding the line item cost of product sales and contract manufacturing, please provide
us the amounts included for fiscal years December 31, 2016 and 2017 and the nine months
ended September 30, 2018 for cost of product sales versus cost of contract manufacturing.
Tell us how your current presentation that combines those items into one line item
complies with rule 5-03(b)2 of Regulation S-X.
Notes to Consolidated Financial Statements
2. Summary of Significant Accounting Policies
Revenue Recognition
4.Please provide us an accounting analysis that describes your accounting treatment (i.e.
separation, measurement, recognition and classification) for the March 16, 2017 contract
and modification that you entered with BARDA.  Provide reference to authoritative
literature supporting your treatment.
Form 8-K Dated November 1, 2018
Exhibit 99
5.Please refer to Compliance and Disclosure Interpretations: Non-GAAP Financial
Measures and specifically to the answers to questions 103.02 and 102.05. Tell us how
your presentation of EBITDA and adjusted EBITDA on a per share basis complies with
those answers.

 FirstName LastNameRichard S. Lindahl
 Comapany NameEmergent BioSolutions Inc.
 December 12, 2018 Page 3
 FirstName LastNameRichard S. Lindahl
Emergent BioSolutions Inc.
December 12, 2018
Page 3
Form 10-Q for the Quarterly Period Ended September 30, 2018
Notes to Condensed Consolidated Financial Statements
2. Revenue Recognition
6.Regarding your adoption of ASU 2014-09, please:
•Tell us why the adoption of ASC 606 resulted in a $42.4 million increase in deferred
revenue liability.
•Tell us whether you applied the guidance to all contracts at the date of initial
application or only to contracts that were not completed at the date of initial
application. Refer to ASC 606-10-65-1.h.
•Tell us whether you applied the practical expedient for contract modifications referred
to in ASC 606-10-65-1f(4) and, if so, whether you applied the guidance in ASC 606-
10-65-1.g.
•Provide us the disclosures required by ASC 606-10-65-1.i. and tell us why you did not
make these disclosures.
7.Regarding your application of ASC 606, please address the following:
•For each type of performance obligation you have, tell us whether it is recognized over
time or at a point in time and specifically how it is satisfied as well as the payment
terms.  For those recognized over time, tell us the method you use to recognize
revenue and why it represents a faithful depiction of the transfer of the goods or
services.
•In the third paragraph, you indicate that the Company's variable consideration
primarily includes consideration transferred under its development contracts with the
U.S. government as consideration received can vary based on developmental
progression of the product candidate(s). Please tell us more specifically about why this
consideration can vary and why you have not constrained it.
•In the fourth paragraph you indicate that revenue for long-term development contracts
is generally recognized based upon the cost-to-cost measure of progress, provided that
the Company meets the criteria associated with transferring control of the good or
service over time. Please tell us about any exceptions to your general recognition
policy.
•Regarding your disclosure in the eighth paragraph, tell us why with reference to
authoritative literature it is appropriate to recognize revenue for the CIADM contract
with Barda on a straight- line basis .
•Regarding your disclosure in the ninth paragraph, provide us an analysis with
reference to authoritative literature that supports your accounting for the modification
of the CIADM contract that reduced the optional periods to seven as a termination and
creation of a new contract to be accounted for prospectively.
            In closing, we remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or

 FirstName LastNameRichard S. Lindahl
 Comapany NameEmergent BioSolutions Inc.
 December 12, 2018 Page 4
 FirstName LastName
Richard S. Lindahl
Emergent BioSolutions Inc.
December 12, 2018
Page 4
absence of action by the staff.
            You may contact Christine Torney at 202-551-3652 or Jim Rosenberg at 202-551-3679
with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2015-01-20 - UPLOAD - Emergent BioSolutions Inc.
January 15, 2015

Via E -mail
Robert G. Kramer
Chief Financial Officer
Emergent BioSolutions, Inc.
2273 Research Boulevard
Suite 400
Rockville, MD 20850

Re: Emergent BioSolutions, Inc.
Form 10 -K for the Fiscal Year Ended December 31, 2013
Filed March 10, 2014
File No. 001 -33137

Dear M r. Kramer :

We have completed our review of your filing s.  We remind you that our comments or
changes to disclosure in response to our comments do not foreclose the Commission from taking
any action with respect to the company or the filing and the company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United  States.  We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the
information the Securities Exchange Act of 1934 and all applicable rules require.

Sincerely,

 /s/ Joel Parker

Joel Parker
Accounting Branch Chief
2015-01-15 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: December 16, 2014
CORRESP
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January 15, 2015

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention: Mr. Jim B. Rosenberg

                             Senior Assistant Chief Accountant

Re:

Emergent BioSolutions Inc.

Form 10-K for the Fiscal Year Ended December 31, 2013, Filed March 10, 2014

Form 10-Q for the Quarterly Period Ended September 30, 2014, Filed November 10, 2014

File No. 001-33137

Gentlemen:

We are submitting this letter in response to comments contained in a letter dated December 16, 2014 from Jim B. Rosenberg, Senior Assistant Chief Accountant, of the Staff (the "Staff") of the Securities and Exchange Commission to Emergent BioSolutions Inc. (the "Company").  The responses to these comments are set forth below and are keyed to the numbering of the comments and the headings used in the Staff's letter.

Form 10-K for the Fiscal Year Ended December 31, 2013

Management's Discussion and Analysis of Financial Condition and Results of Operations

Financial Operations Overview

Research and Development Expenses

1.

Please tell us why you believe classifying legal costs of pursuing patent protection of your intellectual property as research and development complies with ASC 730-10-55-2i.

Response:  The Company's disclosure in its Annual Report on Form 10-K for the year ending December 31, 2013 states that research and development expenses include "operating costs, such as the operating costs of facilities and the legal costs of pursuing patent protection of our intellectual property."  Upon further review, the Company has determined that legal costs of pursuing patent protection for its intellectual property are instead included in selling, general and administrative expenses within the Company's financial statements. The Company will correct this disclosure in its Annual Report on Form 10-K for the year ending December 31, 2014.

Form 10-Q for the Quarterly Period Ended September 30, 2014

Management's Discussion and Analysis of Financial Condition and Results of Operations

Contractual Obligations

2.

Please provide us proposed disclosure to be included in future filings to include the interest in connection with the convertible debt in the contractual obligations table.

Response: In response to the Staff's comment, the Company proposes to include revised and expanded disclosure substantially as set forth on Exhibit A hereto in its Annual Report on Form 10-K for the year ending December 31, 2014.

*            *            *

In connection with our responses to the Staff's comments, the Company hereby acknowledges that:

·

the Company is responsible for the adequacy and accuracy of the disclosure in the filings;

·

Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filings; and

·

the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

For the Staff's convenience, we also are delivering copies of this letter directly to Scott Wuenschell, Staff Accountant, and Joel Parker, Accounting Branch Chief.

If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (240) 631-3200 or facsimile at (301) 560-5049.  Thank you for your assistance.

Regards,

By: /S/ ROBERT G. KRAMER

Robert G. Kramer

Executive Vice President,

Chief Financial Officer and Treasurer

EXHIBIT A

Revised Contractual Obligations Table Disclosure

Payments due by period

Less than

1 to 3

4 to 5

More than

(in thousands)

Total

1 year

Years

Years

5 years

Contractual obligations:

2.875% Convertible Senior Notes due 2021 (Notes) (a)

$

250,000

$

-

$

-

$

-

$

250,000

Contractual interest due on Notes

43,701

7,188

14,376

14,376

7,761

Long-term indebtedness (excluding Notes)

1,000

-

-

-

1,000

Operating lease obligations

741

671

70

-

Total contractual obligations

$

295,442

$

7,859

$

14,446

$

14,376

$

258,761

(a) See Note ___ Long-term debt of the consolidated financial statements for additional information related to the Notes
2014-12-22 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: December 16, 2014
CORRESP
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December 22, 2014

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention: Scott Wuenschell, Staff Accountant

RE:

Emergent BioSolutions Inc.

Form 10-K for the Fiscal Year Ended December 31, 2013

Filed March 10, 2014

Form 10-Q for the Quarterly Period Ended September 30, 2014

Filed November 10, 2014

File No. 001-33137

 Mr. Wuenschell:

Emergent BioSolutions Inc. (the "Company") is sending this letter to confirm the extension of time within which it will respond to the Staff's comment letter dated December 16, 2014, relating to the Company's Annual Report on Form 10-K for the year ended December 31, 2013 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2014.  As agreed, the Company will file its written response to the Staff's comment letter by no later than January 15, 2015.

If you have any questions, or require any additional information, please contact Michael Darling, Vice President, Finance and Administration at (301) 795-1865.  Thank you for your assistance.

Regards,

By: /S/ ROBERT G. KRAMER

Robert G. Kramer

Executive Vice President,

 Chief Financial Officer and Treasurer

CC: Joel Parker, Accounting Branch Chief

       Jim B. Rosenberg, Senior Assistant Chief Accountant
2014-12-16 - UPLOAD - Emergent BioSolutions Inc.
December 16, 2014

Via E -mail
Robert G. Kramer
Chief Financial Officer
Emergent BioSolutions, Inc.
2273 Research Boulevard
Suite 400
Rockville, MD 20850

Re: Emergent BioSolutions, Inc.
   Form 10-K for the Fiscal Year Ended December 31 , 2013
   Filed March 10 , 2014
   Form 10 -Q for the Quarterly Period Ended September 30, 2014
   Filed November 10, 2014
File No. 001-33137

Dear M r. Kramer :

We have limited our review to only your financial statements and related disclosures and
do not intend to expand our review to other portions of your document s.  In our comment s, we
ask that you provide us information so we may better understand your disclosure s.

Please respond to this letter within 10 business days by providing the requested
information or by advising us when you will provide the requested response.   If you do not
believe  a comment appl ies to your facts and circumstances, please tell us why in you r
response.   Please furnish us a letter on EDGAR under the form type label CORRESP that keys
your response s to our commen ts.

After reviewing the information provided, we may raise additional comments and/or
request that you amend your filing.

Form 10 -K for the Fiscal Year Ended December 31, 2014
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Financial Operations Overview
Research and Development Expenses

1. Please tell us why you believe classifying legal costs of pursuing patent protection of
your intellectual property as research and development complies with ASC 730 -10-55-2i.

Robert G. Kramer
Emergent BioSolutions, Inc.
December 16, 2014
Page 2

 Form 10 -Q for the Quarterly Period Ended September 30, 2014
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Contractual Obligations

2. Please provide us proposed disclosure to be included in future filings to include the
interest in connection with the convertible debt in the contractual ob ligations table.

We urge  all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing s to be certain that the filing s include  the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require.   Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of t he disclosures they have made.

In responding to our comment s, please provide  a written statement from the company
acknowledging that:
 the company is responsible for the adequacy and accuracy of the disclosure in the filing s;
 staff comments or chan ges to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing s; and
 the company may not assert staff comments as a defense in any proceeding initia ted by
the Commission or any person  under the federal securities laws of the United States.

You may contact Scott Wuenschell , Staff Accountant, at (202) 551 -3467  or Joel Parker ,
Accounting Branch Chief, at (202) 551 -3651 if you have any questions regarding the comm ent.
In this regard, do not hesitate to contact me at (202) 551 -3679.

Sincerely,

 /s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief Accountant
2010-01-19 - UPLOAD - Emergent BioSolutions Inc.
Via Facsimile and U.S. Mail
Mail Stop 4720

         January 14, 2010

R. Don Elsey
Senior Vice President Finance, Chie f Financial Officer, and Treasurer
Emergent BioSolutions Inc.
2273 Research Boulevard, Suite 400
Rockville, Maryland 20850

Re: Emergent BioSolutions Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2008
Schedule 14A filed April 3, 2009
 File Number:  001-33137

Dear Mr. Elsey:

  We have completed our review of your  Form 10-K and related filings and have
no further comments at this time.            S i n c e r e l y ,
Joel Parker
        A c c o u n t i n g  B r a n c h  C h i e f
2009-12-17 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: December 4, 2009
CORRESP
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corresp

December 17, 2009

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

    Attention:

    Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

    Re:

    Emergent BioSolutions Inc.

Form 10-K for the Fiscal Year Ended December 31, 2008

Schedule 14A filed April 3, 2009

File No. 001-33137

Ladies and Gentlemen:

We are submitting this letter in response to comments contained in a letter dated December 4, 2009
from Jim B. Rosenberg, Senior Assistant Chief Accountant, of the Staff (the “Staff”) of the
Securities and Exchange Commission to R. Don Elsey, Senior Vice President Finance, Chief Financial
Officer and Treasurer of Emergent BioSolutions Inc. (the “Company”). The responses to these
comments are set forth below and are keyed to the numbering of the comments and the headings used
in the Staff’s letter.

Form 10-K for the Fiscal Year Ended December 31, 2008

Liquidity and Capital Resources

Contractual Obligations, page 89

    1.

    Refer to your response to prior comment ten. We note your response that you do not expect
that any (contingent contractual payments) would have an adverse effect on (your) financial
position, operations and capital resources because, if payable, (you) expect that the benefits
associated with the achievement of the relevant milestones or the achievement of revenue would
offset the burden of making the payments. Please note that such contractual obligations
should be disclosed on a gross basis without considering the offsetting effect of contingent
revenues or cash inflows. Please revise your disclosure to indicate your aggregate
contractual license and milestone payments.

    Response:

    In response to the Staff’s comment, the Company will include the requested
disclosure regarding aggregate contractual license and milestone payments in its Annual
Report on Form 10-K for the fiscal year ending December 31, 2009.

Schedule 14A filed April 3, 2009

Information About Executive And Director Compensation

Employment Agreements, page 23

    2.

    Please refer to your response to comment 14. You advise us that the agreement with Dr.
Lockhart need not be filed as an exhibit to your Form 10-K because it is unexecuted. However,
we note that the company is currently using this employment agreement to determine Dr.
Lockhart’s executive compensation. Please file this agreement as an exhibit. Since it is
nearing the end of your fiscal year, you may file this agreement as an exhibit to a Form 8-K,
and may note in the periodic report that the exhibit does not constitute a definitive
agreement.

    Response:

    The Company advises the Staff that, on December 4, 2009, the Company executed the
employment agreement with Dr. Lockhart. On December 10, 2009, the Company filed a
Form 8-K disclosing the execution of the agreement and including the agreement as an
exhibit to the Form 8-K.

*     *     *

2

For the Staff’s convenience, we also are delivering copies of this letter directly to Staci
Shannon, Staff Accountant, Mary Mast, Review Accountant, and Rose Zukin, Staff Attorney.

If you have any further questions or comments, or if you require any additional information, please
contact the undersigned by telephone at (301) 795-1800 or facsimile at (301) 795-1850. Thank you
for your assistance.

Very truly yours,

    /s/ R. Don Elsey

    R. Don Elsey

    Senior Vice President Finance,

Chief Financial Officer and Treasurer

3
2009-12-04 - UPLOAD - Emergent BioSolutions Inc.
Via Facsimile and U.S. Mail
Mail Stop 4720

         December 4, 2009

R. Don Elsey
Senior Vice President Finance, Chie f Financial Officer, and Treasurer
Emergent BioSolutions Inc.
2273 Research Boulevard, Suite 400
Rockville, Maryland 20850

Re: Emergent BioSolutions Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2008
Schedule 14A filed April 3, 2009
 File Number:  001-33137

Dear Mr. Elsey:

We have reviewed your November 13, 2009 response to our October 29, 2009
letter and have the following comments.  In our comments, we ask you to provide us with
information to better understand your disc losure.  Where it requests you to revise
disclosure, the information you provide should show us what the revised disclosure will
look like and identify the annual or quarterly filing, as applicable, in which you intend to
first include it.  If you do not  believe that revised disclosu re is necessary, explain the
reason in your response.  After reviewi ng the information provided, we may raise
additional comments and/or reques t that you amend the above filings.

Form 10-K for the Fiscal Year Ended December 31, 2008

Liquidity and Capital Resources
Contractual Obligations, page 89
1. Refer to your response to prior comment  ten.  We note your response that you do
not expect that any (contingent contr actual payments) would have an adverse
effect on (your) financial position, operati ons and capital resources because, if
payable, (you) expect that the benefits associated with the achievement of the
relevant milestones or the achievement of  revenue would offset the burden of
making the payments.  Please note that su ch contractual obligations should be
disclosed on a gross basis with out considering the offsetting effect of contingent revenues or cash inflows.  Please revise your  disclosure to indicate your aggregate
contractual license and milestone payments.

R. Don Elsey
Emergent BioSolutions Inc. December 4, 2009 Page 2
Schedule 14A filed April 3, 2009

Information About Executive And Director Compensation

Employment Agreements, page 23
2. Please refer to your response to comment 14.  You advise us that the agreement
with Dr. Lockhart need not be filed as an  exhibit to your Form 10-K because it is
unexecuted.  However, we note that the company is currently using this employment agreement to determine Dr. Lockhart’s executive compensation.  Please file this agreement as an exhibit.  Since it is nearing th e end of your fiscal
year, you may file this agreement as an e xhibit to a Form 8-K, and may note in
the periodic report that the exhibit does not constitute a definitive agreement.

* * * *

 Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response.  Pl ease furnish a cover le tter with your response
that keys your response to our comments.  De tailed cover letters gr eatly facilitate our
review.  Please furnish your letter on EDGAR under the form type label CORRESP.

Please contact Staci Shannon, Staff Account ant, at (202) 551-3374 or Mary Mast,
Review Accountant, at (202) 551-3613 if  you have any questions regarding the
processing of your response, as well as any que stions regarding the first comment.  You
may contact Rose Zukin, Staff Attorney, at  (202) 551-3239 with questions on the second
comment.  In this regard, do not hesi tate to contact me, at (202) 551-3679.

        S i n c e r e l y ,

        J i m  B .  R o s e n b e r g
Senior Assistant Chief
Accountant
2009-11-13 - CORRESP - Emergent BioSolutions Inc.
Read Filing Source Filing Referenced dates: October 29, 2009
CORRESP
1
filename1.htm

corresp

November 13, 2009

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention:

    Mr. Jim B. Rosenberg

    Senior Assistant Chief Accountant

    Re:

    Emergent BioSolutions Inc.

    Form 10-K for the Fiscal Year Ended December 31, 2008

    Schedule 14A filed April 3, 2009

    Form 10-Q for the Fiscal Quarter Ended June 30, 2009

    File No. 001-33137

Ladies and Gentlemen:

We are submitting this letter in response to comments contained in a letter dated October 29, 2009
from Jim B. Rosenberg, Senior Assistant Chief Accountant, of the Staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) to R. Don Elsey, Senior Vice President
Finance, Chief Financial Officer and Treasurer of Emergent BioSolutions Inc. (the “Company”). The
responses to these comments are set forth below and are keyed to the numbering of the comments and
the headings used in the Staff’s letter.

Form 10-K for the Fiscal Year Ended December 31, 2008

Item 1. Business

Manufacturing, page 21

    1.

    We note that you have entered into a Product Supply Agreement with Talecris Biotherapeutics,
whereby you have agreed to obtain all manufacturing requirements for your anthrax immune
globulin therapeutic candidate exclusively from Talecris, and have also agreed to pay Talecris
royalties on net sales on a country-by-country basis for commercial product manufactured by
Talecris under the contract. Please disclose a range of royalty rates (for example,
“low-single-digits,” “high-single-digits,” etc.) payable to Talecris. Your disclosure should
disclose any differences in the royalty range based on the country in which the sales may
occur.

    Response:

    In response to the Staff’s comment, the Company proposes to include disclosure of
the range of royalty rates under this agreement in its Annual Report on Form 10-K for
the fiscal year ending December 31, 2009 (the “2009 Form 10-K”).

Intellectual Property and Licenses, page 24

    2.

    We note your description of your license agreements with USAMRIID, OETC, and HPA. Please
expand your description of these agreements to disclose the following information:

Securities and Exchange Commission

November 13, 2009

Page 2

    •

    All material rights and obligations of the company and the other party;

    •

    The range of royalty rates (for example, “low-single-digits,” “high-single-digits,”
etc.);

    •

    The aggregate amount of milestone or other payments payable or receivable to each
party, and the amounts paid to date; and

    •

    Duration and termination provisions.

    Response:

    In response to the Staff’s comment, the Company proposes to include revised and
expanded disclosure substantially as set forth on Exhibit A hereto in its 2009 Form
10-K.

    3.

    We note your statement on page 28 that you have paid minimum contractual commitments of $1.0
million under each of the two development agreements to which you are a party with HPA. If
you have additional payment obligations to HPA, please disclose the aggregate amount of
expected payments under each development agreement.

    Response:

    The Company advises the Staff that there are currently no outstanding amounts due
or future required payments under either development agreement. The Company may decide
in the future to use HPA to perform additional work under one or both of the
development agreements; however, until the Company determines to perform such
additional work, it is not capable of estimating future amounts that may be paid under
either of the agreements.

    4.

    We note your disclosure on page 28 that you acquired a license agreement with StMUGV, under
which you are required to pay StMUGV a percentage of the net revenue or license fees that you
receive from products developed using the MVA platform technology that are used for research
or other purposes, and a percentage of the license fees that you receive from products
developed using MVA that are licensed as starting material for the production of a smallpox
vaccine. Please expand your description of this agreement to state the royalty range (for
example, “low-single-digits,” “high-single-digits,” etc.) payable to StMUGV.

    Response:

    In response to the Staff’s comment, the Company proposes to include disclosure of
the range of royalty rates under this agreement in its 2009 Form 10-K.

    5.

    We note that you have described the material terms of the license agreement with StMUGV, but
have not filed the license agreement as an exhibit. Please file the agreement as an exhibit
to your Form 10-K, or provide us with a legal analysis as to why you are not required to file
the agreement as an exhibit pursuant to Item 601(b)(l0) of Regulation S-K.

    Response:

    The Company advises the Staff that the license agreement with StMUGV is included
as Exhibit 10.20 to the
2008 Form 10-K.

Item 1A. Risk Factors

“If we are unable to protect the confidentiality of our proprietary information and know-how...,” page 64

    6.

    We note that the only intellectual property protection for BioThrax, other than the BioThrax
trademark, is confidentiality regarding your manufacturing capability and specialty know-how,
which you protect, in part, with confidentiality agreements with your employees, consultants and

Securities and Exchange Commission

November 13, 2009

Page 3

    third parties. Please provide us with a supplemental copy of the standard confidentiality
agreement you enter into with your employees. We may have further comment.

    Response:

    Under separate cover, the Company is supplementally providing the Staff with the
Company’s standard form of confidentiality agreement with its employees.

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities

    7.

    We note that you have not provided the performance graph required by Item 201(e) of
Regulation S-K in either your Form 10-K or in your definitive proxy statement, or in your
Annual Report to Shareholders. If you have not included the performance graph in your filed
materials, please confirm that you will include this information in your Form 10-K for the
next fiscal year, or in your 2010 proxy statement.

    Response:

    The Company advises the Staff that the performance graph required by Item 201(e)
of Regulation S-K was set forth on page 135 of the Company’s 2008 Annual Report to
Stockholders, consistent with Instruction 7 to Item 201(e). The Company further
confirms that it will likewise include the performance graph in its 2009 Annual Report
to Stockholders. For the Staff’s convenience, the Company is supplementally providing
the Staff with a copy of the Company’s 2008 Annual Report to Stockholders under
separate cover.

Item 7.
Management’s Discussion and Analysis of Financial Condition and
Results of Operations

Financial Operations Overview

Revenues, page 80

    8.

    We note your disclosure that in September 2007 and September 2008, you received two
development contracts from the National Institute of Allergy and Infectious Disease, valued at
up to $9.5 million and $30 million, respectively. Please disclose when and how these amounts
will become receivable.

    Response:

    In response to the Staff’s comment, the Company proposes to include revised and
expanded disclosure substantially as set forth on Exhibit B hereto in the Revenue
Recognition section of Management’s Discussion and Analysis in its 2009 Form 10-K.

    Additionally, the Company advises the Staff that in its Quarterly Report on
Form 10-Q for the period ended September 30, 2009, filed on November 5,
2009, the Company has included additional disclosure of period of
performance with regard to its contracts and grants, and that the Company
will continue to disclose such information.

    9.

    Please file the development contracts with NIAID as exhibits to your Form 10-K, or provide us
with a legal analysis as to why you are not required to file the agreements as exhibits
pursuant to Item 601(b)(l0) of Regulation S-K.

Securities and Exchange Commission

November 13, 2009

Page 4

    Response:

    The Company advises the Staff that in the Company’s view the development contracts
with NIAID are not material contracts that are required to be filed pursuant to Item
601(b)(10) of Regulation S-K. The Company believes that its development contracts
with NIAID are of the type that ordinarily accompany the kind of business conducted by
the Company and were entered into in the ordinary course of business. In addition, the
Company does not believe that the Company’s business is substantially dependent on
either of these agreements or that the agreements are material in light of the
substantial revenues that the Company has generated from BioThrax product sales, which
it uses to fund product development. The Company believes that in total, its contracts
and grants revenue does not represent a material source of revenue for the years ended
2006, 2007 and 2008. The Company’s average annual product sales revenue for the past
three full fiscal years is approximately $162.3 million. Total average annual contracts
and grants revenue for these same three full fiscal years is approximately $9.1
million, or 5.3% of total revenues for the three year period. Accordingly, the Company
respectfully submits that the agreements with these third parties are not required to
be filed as exhibits to its Annual Report on Form 10-K.

Liquidity and Capital Resources

Contractual Obligations, page 89

    10.

    You note on page 26 that you consider three existing licenses to be material to your current
product portfolio or development pipeline, and they include licenses with USAMRIID, OETC, and
HPA. Please include in the contractual obligation table the cash obligations under all
material license and collaboration agreements. Where uncertainties prevent making a
reasonable estimate of the obligations, explain the uncertainties in a note to the table
indicating aggregate license and milestone payments, their timing, events triggering their
payment and expected effects on financial position, operations and capital resources.
Additionally, disclose any significant terms in the notes to the financial statements, as
required.

    Response:

    In response to the Staff’s comment, the Company proposes to include revised and
expanded disclosure substantially as set forth on Exhibit C hereto in the footnote to
the contractual obligation table in its 2009 Form 10-K. The Company also
advises the Staff that the Company has evaluated its prior disclosure with
respect to the terms of its three material licenses, and believes that no
additional disclosure of significant terms is required in the notes to the
financial statements.

Exhibit Index

    11.

    We note that you have described the material terms of the following related party agreements,
but have not filed the agreements as exhibits:

    •

    2009 Marketing Arrangement with an entity controlled by family members of the Chief
Executive Officer to market and sell BioThrax; and

    •

    Consulting Arrangement with a member of the Company’s Board of Directors.

Securities and Exchange Commission

November 13, 2009

Page 5

    Please file these agreements as exhibits to your Form 10-K, or provide us with a legal
analysis as to why you are not required to file the agreements as exhibits pursuant to Item
601(b)(10)(ii)(A) of Regulation S-K.

    Response:

    The Company advises the Staff that the Marketing Agreement is included as Exhibit
10.27 and the Consulting Services Agreements are included as Exhibits 10.24 and 10.25
to the Company’s 2008 Form 10-K.

    12.

    Please identify the member of the company’s Board of Directors with whom the company entered
into a consulting arrangement, as disclosed on page 118. Please refer to Item 404(a)(l) of
Regulation S-K. It does not appear that you are describing the related party consulting
agreement with The Hauer Group, as you indicate on page 118 that the company paid
approximately $218,000 under the unnamed consulting arrangement at issue during the year ended
December 31, 2008, while you disclose on page 11 of the definitive proxy statement that the
company paid The Hauer Group approximately $180,000 in 2008 in connection with the Consulting
Agreement to which it is a party.

    Response:

    The Company advises the Staff that the reference on page 118 of the Company’s 2008
Form 10-K is a reference to the Consulting Services Agreement with The Hauer Group.
The $218,000 amount in the 2008 Form 10-K inadvertently included $38,000 in fees paid
to Jerome Hauer for his services as a director. The $180,000 amount disclosed in the
definitive proxy statement is the actual amount paid to the Hauer Group in 2008
pursuant to the consulting arrangement.

Schedule 14A filed April 3, 2009

Information About Executive And Director Compensation

Compensation Discussion and Analysis

Elements of Executive Compensation, page 17

    13.

    We note your disclosure on page 17 that adjustments to base salary are based in part upon
each executive officer’s individual performance. We further note that the base salaries of
your named executive officers increased in 2008. Please confirm that you will expand your disclosure
to discuss the material factors that the Compensation Committee considered in adjusting base
salaries in next year’s Compensation Discussion and Analysis.

    Response:

    The Company confirms that it will expand its disclosure in next year’s
Compensation Discussion and Analysis with respect to the material factors that the
Compensation Committee considers in adjusting base salaries.

Employment Agreements, page 23

    14.

    We note that you have described the material terms of the company’s employment agreement with
Dr. Lockhart, but have not filed the employment agreement as an exhibit. Please file the
agreement as an exhibit to your Form 10-K.

    Response:

    The Company advises the Staff that the agreement with Dr. Lockhart described in
the Company’s definitive proxy statement was not executed by the parties at

Securities and Exchange Commission

November 13, 2009

Page 6

    the time the definitive proxy statement was filed and did not constitute a
definitive agreement. The agreement currently remains unexecuted. The Company further
advises the Staff that notwithstanding that the agreement has not been executed, the
Company has paid Dr. Lockhart compensation to date as summarized in the Company’s
public disclosure. The Company proposes to either (i) include a written description of
the draft agreement, containing substantially the same information as previously disclosed in
the definitive proxy statement, as an exhibit to the Company’s 2009 Form 10-K, or (ii)
if the agreement is executed by the parties, file the definitive written contract as an
exhibit to the Company’s 2009 Form 10-K.

Information Relating to Option Exercises, page 25

    15.

    We note your disclosure on page 25 regarding the exercise of stock options during the fiscal
year ended December 31,2009 for each named executive officer. However, your disclosure does
not address any vesting of stock during the last completed fiscal year. Please advise whether
the company had any vesting of stock.

    Response:

    The Company advises the Staff that there was no vesting of stock awards during the
fiscal year ended December 31, 2008, nor does the Company have outstanding any stock
awards with respect to which Item 402(g)(2)(iv) or
(v) of

Regulation S-K would apply.

Form 10-Q for the Fiscal Quarter Ended June 30, 2009

Notes to Consolidated Financial Statements

1. Summary of significant accounting policies

Note receivable, page 7

    16.

    Please tell us how you concluded that your note receivable with PS
2009-10-30 - UPLOAD - Emergent BioSolutions Inc.
Via Facsimile and U.S. Mail
Mail Stop 4720

         October 29, 2009

R. Don Elsey
Senior Vice President Finance, Chie f Financial Officer, and Treasurer
Emergent BioSolutions Inc.
2273 Research Boulevard, Suite 400
Rockville, Maryland 20850

Re: Emergent BioSolutions Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2008
Schedule 14A filed April 3, 2009
Form 10-Q for the Fiscal Quarter Ended June 30, 2009
 File Number:  001-33137

Dear Mr. Elsey:

We have reviewed your filings and have the following comments.  In our
comments, we ask you to provide us with  information to better understand your
disclosures.  Where a comment requests you to revise disclosure, the information you
provide should show us what the revised disc losure will look like and identify the annual
or quarterly filing, as appli cable, in which you intend to fi rst include it.  If you do not
believe that revised disclosure  is necessary, explain the reason in your response.  After
reviewing the information provided, we may raise additional comments and/or request
that you amend your filings.

 Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure  requirements and to  enhance the overall
disclosure in your filings.  We look forward to working with you in these respects.  We
welcome any questions you may have about our  comments or on any other aspect of our
review.  Feel free to call us at the telephone numbers listed at the end of this letter.

Form 10-K for the Fiscal Year Ended December 31, 2008

Item 1.  Business
Manufacturing, page 21
1. We note that you have entered into a Pr oduct Supply Agreement with Talecris
Biotherapeutics, whereby you have ag reed to obtain all manufacturing
requirements for your anthra x immune globulin therapeu tic candidate exclusively
from Talecris, and have also agreed to pay Talecris royalties on net sales on a

R. Don Elsey
Emergent BioSolutions Inc.
October 29, 2009
Page 2
country-by-country basis for commercia l product manufactured by Talecris under
the contract.  Please disclose a range of royalty rates (for example, “low-single-
digits,” “high-single-digits,” etc.) payabl e to Talecris.  Your  disclosure should
disclose any differences in  the royalty range based on the country in which the
sales may occur.

Intellectual Property an d Licenses, page 24

2. We note your description of your license agreements with USAMRIID, OETC,
and HPA.  Please expand your description of these agreements to disclose the
following information:

• All material rights and obligations of  the company and the other party;
• The range of royalty rates (for exampl e, “low-single-digi ts,” “high-single-
digits,” etc.);
• The aggregate amount of milestone or othe r payments payable or receivable to
each party, and the amounts paid to date; and
• Duration and termination provisions.
3. We note your statement on page 28 that  you have paid minimum contractual
commitments of $1.0 million under each of the two development agreements to
which you are a party with HPA.  If you have additional payment obligations to
HPA, please disclose the aggregate am ount of expected payments under each
development agreement.
4. We note your disclosure on page 28 that  you acquired a license agreement with
StMUGV, under which you are required to  pay StMUGV a percentage of the net
revenue or license fees that you receive  from products developed using the MVA
platform technology that are used for resear ch or other purposes, and a percentage
of the license fees that you receive fro m products developed using MVA that are
licensed as starting material for the production of a smallpox vaccine.  Please expand your description of this agreement to  state the royalty range (for example,
“low-single-digits,” “high-single-digi ts,” etc.) payable to StMUGV.
5. We note that you have described the materi al terms of the license agreement with
StMUGV, but have not filed the license agre ement as an exhibit.  Please file the
agreement as an exhibit to your Form 10-K, or provide us with a legal analysis as
to why you are not required to file the ag reement as an exhibit pursuant to Item
601(b)(10) of Regulation S-K.

R. Don Elsey
Emergent BioSolutions Inc.
October 29, 2009
Page 3  Item 1A.  Risk Factors

“If we are unable to protect the confidentia lity of our proprietary information and know-
how . . .,” page 64

6. We note that the only intellectual property  protection for BioThrax, other than the
BioThrax trademark, is confidentiality regarding your manuf acturing capability
and specialty know-how, which you protec t, in part, with confidentiality
agreements with your employees, consultants and third parties.  Please provide us
with a supplemental copy of the standard  confidentiality agre ement you enter into
with your employees.  We may have further comment.

Item 5.  Market for Registrant’s Common E quity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
7. We note that you have not provided th e performance graph required by Item
201(e) of Regulation S-K in either your Form 10-K or in your definitive proxy
statement, or in your Annual Report to Sh areholders.  If you have not included the
performance graph in your filed material s, please confirm that you will include
this information in your Form 10-K for th e next fiscal year, or in your 2010 proxy
statement.

Item 7.  Management’s Discussion and Analys is of Financial Condition and Results of
Operations
Financial Operations Overview
Revenues, page 80
8. We note your disclosure that in September 2007 and September 2008, you
received two development contracts from the National Institute of Allergy and Infectious Disease, valued at up to  $9.5 million and $30 million, respectively.
Please disclose when and how these amounts will become receivable.
9. Please file the development contracts with NIAID as exhibits to your Form 10-K,
or provide us with a legal analysis as  to why you are not required to file the
agreements as exhibits pursuant to  Item 601(b)(10) of Regulation S-K.

Liquidity and Capital Resources

Contractual Obligations, page 89
10. You note on page 26 that you consider thr ee existing licenses to be material to
your current product portfolio or developm ent pipeline, and they include licenses
with USAMRIID, OETC, and HPA.  Please include in the contractual obligation
table the cash obligations under all material license a nd collaboration agreements.
Where uncertainties prevent making a reas onable estimate of the obligations,

R. Don Elsey
Emergent BioSolutions Inc.
October 29, 2009
Page 4
explain the uncertainties in a note to th e table indicating aggregate license and
milestone payments, their timing, events triggering their payment and expected
effects on financial position, operations and capital resources.  Additionally,
disclose any significant terms in the notes to the financial statements, as required.

Exhibit Index

11. We note that you have described the materi al terms of the following related party
agreements, but have not filed the agreements as exhibits:

• 2009 Marketing Arrangement with an enti ty controlled by family members of
the Chief Executive Officer to market and sell BioThrax; and
• Consulting Arrangement with a memb er of the Company’s Board of
Directors.

Please file these agreements as exhibits to  your Form 10-K, or provide us with a
legal analysis as to why you are not require d to file the agreements as exhibits
pursuant to Item 601(b)(10)(ii)(A) of Regulation S-K.
12. Please identify the member of the compa ny’s Board of Directors with whom the
company entered into a consulting arrange ment, as disclosed on page 118.  Please
refer to Item 404(a)(1) of Regulation S- K.  It does not appear that you are
describing the related party consulting  agreement with The Hauer Group, as you
indicate on page 118 that the company paid approximately $218,000 under the unnamed consulting arrangement at issu e during the year ended December 31,
2008, while you disclose on page 11 of th e definitive proxy statement that the
company paid The Hauer Group approximately $180,000 in 2008 in connection with the Consulting Agreement to which it is a party.

Schedule 14A filed April 3, 2009

Information About Executive And Director Compensation

Compensation Discussion and Analysis
Elements of Executive Compensation, page 17
13. We note your disclosure on page 17 that ad justments to base salary are based in
part upon each executive officer’s individua l performance.  We further note that
the base salaries of your named execu tive officers increased in 2008.  Please
confirm that you will expand your disclosure to discuss the material factors that
the Compensation Committee considered in ad justing base salaries in next year’s
Compensation Discussion and Analysis.

R. Don Elsey
Emergent BioSolutions Inc.
October 29, 2009
Page 5  Employment Agreements, page 23

14. We note that you have described the mate rial terms of the company’s employment
agreement with Dr. Lockhart, but have not filed the employment agreement as an exhibit.  Please file the agreemen t as an exhibit to your Form 10-K.

 Information Relating to Op tion Exercises, page 25

15. We note your disclosure on page 25 regardi ng the exercise of stock options during
the fiscal year ended December 31, 2009 for each named executive officer.  However, your disclosure does not addre ss any vesting of stock during the last
completed fiscal year.  Please advise whether the company had any vesting of
stock.

Form 10-Q for the Fiscal Quarter Ended June 30, 2009

Notes to Consolidated Financial Statements

1.  Summary of significant accounting policies
Note receivable, page 7
 16. Please tell us how you concluded that your  note receivable with PSC was not
impaired as of June 30, 2009, and that it is probable you will co llect all principal
and interest due according to the terms of the contract.  In this regard, specifically
tell us how you considered the following factors identified in your disclosure on
page 14:

• PSC failed to repay the loan by the end of the forbearance period;
• You sought an order requiring PSC to  provide you with possession of the
collateral, as you are not in po ssession of such  collateral; and
• You, along with several other PSC cred itors, filed a peti tion for bankruptcy
against PSC.

* * * *
 Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response.  Please furnish a cover letter with your
response that keys your response to our co mments.  Detailed cover letters greatly
facilitate our review.  Please furnish your  letter on EDGAR under the form type label
CORRESP.
 We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings to be certain that  the filings includes all information required
under the Securities Exchange Act of 1934 and that they have provided all information

R. Don Elsey
Emergent BioSolutions Inc.
October 29, 2009
Page 6  investors require for an informed invest ment decision.  Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy  of the disclosures they have made.
 In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:

• the company is responsible for the adequacy and accuracy of the disclosure in
the filings;
• staff comments or changes to disclosure  in response to staff comments do not
foreclose the Commission from taking a ny action with respect to the filings;
and
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any pers on under the federal s ecurities laws of
the United States.

In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filings or in response to our comments on your filings.
 Please contact Staci Shannon, Staff Account ant, at (202) 551-3374 or Mary Mast,
Review Accountant, at (202) 551-3613 if  you have any questions regarding the
processing of your response, as well as any questions regarding comments on the
financial statements and related matters.  Y ou may contact Rose Zukin, Staff Attorney, at
(202) 551-3239 with questions on the remain ing comments.  In this regard, do not
hesitate to contact me, at (202) 551-3679.
        S i n c e r e l y ,

        J i m  B .  R o s e n b e r g
Senior Assistant Chief
Accountant
2008-12-09 - CORRESP - Emergent BioSolutions Inc.
CORRESP
1
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corresp

EMERGENT BIOSOLUTIONS INC.

2273 Research Boulevard, Suite 400

Rockville, MD 20850

December 9, 2008

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention: Michael Rosenthall, Esq.

Re: Emergent BioSolutions Inc.

Registration Statement on Form S-3

File No. 333-155311

Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Emergent BioSolutions Inc. (the
“Company”) hereby requests acceleration of the effective date of its Registration Statement on Form
S-3 (File No. 333-155311), as amended (the “Registration Statement”), so that it may become
effective at 4:30 p.m. Eastern time on December 10, 2008, or as soon as practicable thereafter.

The Company hereby acknowledges that:

    (i)

    should the Securities and Exchange Commission (the “Commission”) or the staff, acting
pursuant to delegated authority, declare the Registration Statement effective, it does not
foreclose the Commission from taking any action with respect to the Registration Statement;

    (ii)

    the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the Registration Statement effective, does not relieve the Company from its full
responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and

    (iii)

    the Company may not assert staff comments and the declaration of effectiveness as a defense
in any proceeding initiated by the Commission or any person under the federal securities laws
of the United States.

    Very truly yours,

    By:
    /s/ Daniel J. Abdun-Nabi

    Name:
    Daniel J. Abdun-Nabi

    Title:
    President and Chief Operating Officer
2008-12-01 - UPLOAD - Emergent BioSolutions Inc.
Mail Stop 6010
December 1, 2008
 Fuad El-Hibri Chief Executive Officer Emergent BioSolutions Inc. 2273 Research Boulevard, Suite 400 Rockville, MD 20850
Re: Emergent BioSolutions Inc.
  Registration Statement on Form S-3
Filed November 12, 2008
  File No. 333-155311

Dear Mr. El-Hibri:

We have limited our review of your filing to those issues we have addressed in
our comments.  Where indicated, we think you should revise your document in response
to these comments.  If you disagree, we w ill consider your explanation as to why our
comment is inapplicable or a revision is unneces sary.  Please be as detailed as necessary
in your explanation.  In some of our comme nts, we may ask you to provide us with
information so we may better understand your  disclosure.  After reviewing this
information, we may raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure  requirements and to  enhance the overall
disclosure in your filing.  We look forward to  working with you in these respects.  We
welcome any questions you may have about our  comments or any other aspect of our
review.  Feel free to call us at the telephone numbers listed at the end of this letter.
 General

1. We note that your registration statement doe s not disclose details of the private
placement transaction(s) in which the sh ares you now seek to register were
initially sold.  Please revise the disclosu re in your Form S-3 to include a complete
description of those privat e placement transaction(s).
 2. We note the selling shareholders are the beneficial owners of approximately 47%
of the company’s outstanding shares of common stock.  Give n the beneficial
ownership of the selling shareholders and th e fact that the selling shareholders are
affiliates of the company, it appears that the transaction may be considered to be a primary offering.  Please tell us your ba sis for determining the transaction is

appropriately characterized as  a transaction that  is eligible to be made under Rule
415(a)(1)(i).  See Telephone Interpretati ons Manual Interpretation D.29.   Please
include in this analysis your basis for determining that each affiliated selling
shareholder is not an underwriter.  Pl ease provide a separate analysis for each
affiliated selling shareholder.

* * *

As appropriate, please amend your regist ration statement in response to these
comments.  You may wish to provide us w ith marked copies of the amendment to
expedite our review.  Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information.  Detailed cover
letters greatly facilitate our review.  Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Act of 1933 and that they have  provided all information investors require
for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’ s disclosure, they are responsible for the
accuracy and adequacy of the disclosures they have made.
Notwithstanding our comments, in the even t the company requests acceleration of
the effective date of the pending registration statement, it should furnish a letter, at the
time of such request , acknowledging that:

‚ should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose th e Commission from taking any action with
respect to the filing;
 ‚ the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective,  does not relieve the company from its full responsibility
for the adequacy and accuracy of the disclosure in the filing; and
 ‚ the company may not assert staff comments a nd the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
  In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the

securities specified in the above registration statement.  We will act  on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement.  Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration.  Please provide this request at least two business days in a dvance of the requested effective date.
 Please contact Mike Rosenthall at (2 02) 551-3674 or myself at (202) 551-3715
with any questions.

     S i n c e r e l y ,          J e f f r e y  R i e d l e r
Assistant Director
  cc: Brian A. Johnson, Esq.  Wilmer Cutler Pickering Hale and Dorr LLP  399 Park Avenue  New York, NY 10022  Fax: 212-230-8888   Denise Esposito, Esq.
 Senior Vice President, Legal Affa irs, General Counsel and Secretary
 Emergent BioSolutions Inc.  2273 Research Boulevard, Suite 400
Rockville, MD 20850 Fax: 301-795-1899
2006-11-09 - CORRESP - Emergent BioSolutions Inc.
CORRESP
1
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corresp1

November 9, 2006

VIA EDGAR AND FACSIMILE

    Emergent BioSolutions, Inc.

300 Professional Drive, Suite 250

Gaithersburg, MD 20879

    Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

    t 301 944 0290

f 301 944 0173

www.emergentbiosolutions.com

Attention: Song P. Brandon, Esq.

    Re:

    Emergent BioSolutions Inc.

    Registration Statement on Form S-1

    File No. 333-136622

    Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Emergent BioSolutions Inc., a
Delaware corporation (the “Company”), hereby requests acceleration of the effective date of its
Registration Statement on Form S-1 (File No. 333-136622), as amended (the “Registration
Statement”), so that it may become effective at 5:00 p.m. Eastern time on November 14, 2006, or as
soon thereafter as practicable.

The Company hereby acknowledges that:

    (i)

    should the Securities and Exchange Commission (the “Commission”) or the staff, acting
pursuant to delegated authority, declare the Registration Statement effective, it does not
foreclose the Commission from taking any action with respect to the Registration Statement;

    (ii)

    the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the Registration Statement effective, does not relieve the Company from its full
responsibility for the adequacy and accuracy of the disclosure in the Registration Statement;
and

    iii)

    the Company may not assert staff comments and the declaration of
effectiveness of the Registration Statement as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.

    Very truly yours,

EMERGENT BIOSOLUTIONS INC.

    By:
    /s/ Daniel J. Abdun-Nabi

    Daniel J. Abdun-Nabi

    Senior Vice President Corporate Affairs,

General Counsel and Secretary
2006-10-11 - UPLOAD - Emergent BioSolutions Inc.
Mail Stop 6010

        October 11, 2006

Fuad El-Hibri
Chief Executive Officer
Emergent BioSolutions Inc.
300 Professional Drive, Suite 250
Gaithersburg, Maryland  20879

 Re: Emergent BioSolutions Inc.
  Amendment No. 1 to the Registration Statement on Form S-1
  Filed September 25, 2006
  File No. 333-136622

Dear Mr. El-Hibri:

 We have reviewed your filing and have th e following comments.  Where indicated, we
think you should revise your document in response to these comments.  If you disagree, we will
consider your explanation as to why our commen t is inapplicable or a revision is unnecessary.
Please be as detailed as necessa ry in your explanation.  In some  of our comments, we may ask
you to provide us with information so we may better understand your disclosure.  After
reviewing this information, we may raise additional comments.

 Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements and to enhance the overall disclosure in
your filing.  We look forward to working with you in these respects.  We welcome any questions
you may have about our comments or any other aspect of our review.  Feel fr ee to call us at the
telephone numbers listed at the end of th is letter.

Form S-1/#1

Our Business, page 1

1. We note your response to comment 10. Please te ll us if the IND filed by Microscience
and that which is currently held by Emergent Product Development UK is for an IND
filed with the FDA in the United States or wi th a similar agency in a foreign country.

 1

Our Strategy, page 3

2. We note your response to comment 12 and reis sue the comment. The discussion of the
risks and obstacles you will face in implementing your strategy should be as prominent as
the discussion of your strategy.  Please revi se the discussion of the risks you face to
include a similar level of detail fo r each of the risks you identify.

We will not be able to commercialize our pr oduct candidates if our preclinical development
efforts are not successful, …, page 20
3. We note your statement in your response to comment 27 that you have had discussions
with the FDA relating to the design of your Ph ase I clinical trial.  Did the FDA indicate
that it would not require a Phase II clinical trial?

Use of Proceeds, page 45

4. We note your response to comment 50 and your revised disclosure. However, our
comment sought for you to provide disclosure  on how much you anticipate spending for
each product candidate and where in the develo pment process you expect to be after the
expenditure of these proceeds. Therefore, our comment is reissued in part. Please revise
this section accordingly. Please also provide the approximate timing of these expenditures.

License Agreements, page 111

5. We note your response to comment 63. We not e your revised disclo sure that you have
paid $1.0 million minimum contractual commitments for each of the two developmental
agreements you entered with HPA. Please di sclose any amounts you have paid HPA to
date with respect to the license agreements you have with them. You also indicate that
with respect to the license ag reement with HPA that if you fa il to file an IND within a
certain time period under either of your license agreement with HPA that you are
obligated to pay HPA an annual fee until an  IND has been filed. Please disclose the
annual fee amount, if such amount is material.

Typhoid Vaccine, page 96
Hepatitis B therapeutic vaccine, page 98
Group B streptococcus, page 100
Chlamydia vaccine, page 102
Meningitis B vaccine, page 94
6. We note your response to comment 69.  To the ex tent that the data from your clinical
trials was analyzed for immunogenicity, the resu lts of these analyses should be disclosed
with the related p values and statements that  they are merely indications of efficacy and
not sufficient to enable a product to proceed  to Phase II clinical development.

 2

Management’s discussion and analysis of financial condition
Critical accounting policies and estimates
Revenue recognition, page 56

7. We have reviewed your response to commen t number 54.  Please disclose within your
document similar information regarding the FDA review process as you have presented
within your response.  In a ddition, please disclose the number of instances, if any, that
the FDA has denied sale of BioThrax and the effect on the financial statements of such
denial.  Lastly, please descri be to us, and disclose, the poi nt at which you capitalize cost
as inventory.  Given that you are unable to sell BioThrax until you have received FDA
approval, please tell us how these costs meet the definition of an asset as described in
paragraph 26 of CON 6.  Specifically, addre ss your ability to es timate the likelihood of
obtaining FDA approval in determining whether there is a future economic benefit.

Stock-based compensation, page 58

8. Refer to your response to previous comment 54.  We continue to believe that you have
used an “independent valuation specialist” as an expert to help determine the fair value of
your equity securities.  Please name the independent valuation sp ecialists and provide
written consents, as appropriate, or provide to us a more robust and detailed analysis of Rule 436, including considera tion of footnote 60 of the AICPA Practice Aid, which
supports management’s current determination th at the independent valu ation specialist is
not an expert.

Financial operations overview
Revenues, page 60
9. We note your added disclosures regarding your expectation of successful delivery of the
required 1 million doses of BioThrax to the DoD during the three month period ended
September 30, 2006.  Please update your disc losures to indicate whether you were
successful in delivering these doses.  If you were unable to deliver th e doses as required,
please disclose the implications of non-perfor mance, including any effect on the financial
statements that will be reflected in the September 30, 2006 financial statements.
10. Given the wide disparity in the price per dose charge under the HHS and DoD contracts,
please revise your disclosure to discuss significant changes in pri ce separate from your
current discussion of volume.

Contractual Obligations, page 73
11. We have reviewed your response to commen t number 58.  Please disclose within the
footnote to the table, the material royalties and milestones related to current development
programs that the Company estimated are not probable to occur and the basis for management’s decision.

 3

Selling Shareholders, page 157
12. We note your response to comment 74 and your  response that Microscience Investment
“may” be an affiliate of a broker-dealer.  Please determine if Microscience Investment is
an affiliate of a broker-dealer and if they are considered an affiliate of a broker-dealer, please revise your disclosure to include the following representations:

• The selling security holder purchased in the ordinary course of business; and
• At the time of the purchase, the selli ng security holder had no agreements or
understanding to distri bute the securities.

If you are unable to make these statements in  the prospectus, please revise the prospectus
to state the seller sharehol der is an underwriter.

Nature of the business and organization, page F-7
13. We have reviewed your response to commen t number 78.  Please note that Article 11-
01(d) of Regulation S-X states that a “pre sumption exists that a separate entity, a
subsidiary, or a division is a business.”  Additionally, in appears based upon your response that Microscience possessed physical facilities, employee base, operating rights,
and production techniques. Accordingly, please provide additional information as to why financial statements for Microscience have not been provided in accordance with Rule 3-
05 of Regulation S-X.  Please note that the determination of a business under EITF 98-3
and SFAS 141 is irrelevant to this analysis.

Exhibits

14. We note that a number of your agreements will be filed by amendment, including the form of underwriting agreement. Please file as  promptly as possible all exhibits as we
will need to review them prio r to granting effectiveness of the registration statement. In
that regard, to the extent you are able to provide us with a supplemental copy of the
underwriting agreement, this may expedite our review of your filing.

* * *

 4

As appropriate, please amend your registration statement in response to these comments.
You may wish to provide us with marked copies  of the amendment to expedite our review.
Please furnish a cover letter with  your amendment that keys your responses to our comments and
provides any requested supplemental information.  Detailed cover letters greatly facilitate our
review.  Please furnish your letter to us vi a EDGAR under the form type label CORRESP. Please
understand that we may have additional comm ents after reviewing your amendment and
responses to our comments.

You may contact Todd Sherman at (202) 551-3665 or Kevin Woody, Accounting Branch
Chief at (202) 551-3629 if you have questions re garding comments on the financial statements
and related matters.  Please contact Song Brandon at (202) 551-3621, Suzanne Hayes, Legal
Branch Chief at (202) 551-3675, or me at  (202) 551-3715 with any other questions.

        S i n c e r e l y ,

        J e f f r e y  R i e d l e r
        A s s i s t a n t  D i r e c t o r

cc: David Redlick
 Brian A. Johnson
 Wilmer Cutler Hale and Dorr LLP
 1875 Pennsylvania Ave., NW
 Washington, DC 20006

 5
2006-09-11 - UPLOAD - Emergent BioSolutions Inc.
Mail Stop 6010          September 9, 2006   Fuad El-Hibri Chief Executive Officer Emergent BioSolutions Inc.  300 Professional Drive, Suite 250 Gaithersburg, Maryland  20879
 Re: Emergent BioSolutions Inc.
  Registration Statement on Form S-1   Filed August 14, 2006   File No. 333-136622
Dear Mr. El-Hibri:
  We have reviewed your filing and have the following comments.  Where indicated, we think you should re vise your document in response to these comments.  If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary.  Please be as deta iled as necessary in your explanation.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing th is information, we may raise additional
comments.   Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure  requirements and to  enhance the overall
disclosure in your filing.  We look forward to  working with you in these respects.  We
welcome any questions you may have about our  comments or any other aspect of our
review.  Feel free to call us at the telephone numbers listed at the end of this letter.
 FORM S-1

 General

 1. Please note that we have received your  request for confidential treatment for
certain of your exhibits.  In that regar d, please be advised th at comments related
to your request for confidential treatment w ill be delivered under separate cover.
We will not be in a position to consider a request for acceleration of effectiveness

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 2
of this registration statement until we resolve all issues concerning the
confidential treatment request.

2. Please provide updated interim financial in formation in accordance with Item 3-
12 of Regulation S-X.
 Comments Applicable to the Entire Prospectus

3. Please provide us proofs of all graphic,  visual, or photographic information you
will provide in the printed prospectus prior to its use, for example in a preliminary
prospectus.  Please note we may have comments re garding these materials.

4. Please note that when you file a pre- effective amendment containing pricing-
related information, we may have additiona l comments.  As you are likely aware,
you must file this amendment prio r to circulating the prospectus.

5. Please note that when you file a pre-eff ective amendment that  includes your price
range, it must be bona fide.  We interpre t this to mean your range may not exceed
$2 if you price below $20 and 10% if you price above $20.
 Summary, page 1

6. In instances where you have stated that Bi oThrax is safe and effective, please
revise to state that it is su fficiently safe and effective.

7. You indicate on page 1 that a study by th e Institute of Medicine supported the
FDA ruling that BioThrax is safe and effective for the prevention of anthrax
infection by all routes of exposure, including inhalation. Pl ease provide us a
marked copy of this source to support your statement.

8. We note the statistical information you include on pages 2 and 76-77 regarding
the data obtained from Frost & Sullivan. Please provide us with copies of this
source in which you obtained the statistical  figures.  The copy should be marked
to indicate the information supporting your statements.

9. If any of the data from Frost & Sullivan were derived from studies or reports that
were performed on your behalf, please so indicate and file any appropriate third
party consents.
 Our Business, page 1

10. We note that you have completed Phase I cl inical trials for your typhoid vaccine.
Please tell us if the IND filed with th e FDA was filed by you or another party.
Additionally, tell us the product name  used in the IND that was filed.

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 3

11. Are you planning to conduct clinical trials for your hepatitis B therapeutic vaccine
or Group B streptococcus vaccine in the US?
 Our Strategy, page 3

12. We note your summary of the primary goals for your company for the future.
Please balance the discussion of your stra tegy in the summary with an equally
prominent discussion of obstacles and risk s in implementing the stated goals.
 The Offering, page 5

13. Please revise to include disclosure rela ting to the rights which are being offered
with the common stock.
 Risk Factors, page 8

14. Please include a separate risk factor disc losing the possibility that the issuance of
the preferred stock purchase ri ghts might prevent a change  in control in instances
where some shareholders may believe the ch ange in control may be in their best
interests.
 “We have derived substantially all of our re venue from sales of our . . . .,” page 8

15. Please revise your risk factor header and discussion to clearly state that BioThrax
is currently your only product ava ilable for commercial sale.

16. Please revise to include a separate sta nd alone risk factor disclosing the ongoing
legal proceedings and the effects they  may have on your sales to the US
government.
 “Our U.S. government contracts for BioThrax ® require annual funding . . . .,” page 9

17. This risk factor appears to be discussi ng three separate risks factors, the risks
associated with Congressional appropria tions that the fundi ng of governmental
programs are subject to; the risks permitting unilateral termination of government contracts; and the risk associated wi th specific procurement regulations in
conducting business with the government.  Pleas e ensure that each risk factor only
discusses one risk factor and move the discussion pertaining to unilateral
termination by the government to the risk factor entitled “Unfavorable provisions
in government contracts may harm our business . . . .” on page 10 and the discussion regarding governmental oversight  as a new separate risk factor.

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 4

“The pricing under our fixed price government  contracts is based on . . . .,” page 1
0

18. If in the past your estimated costs were not accurate and therefore, you were not
able to earn an adequate return on your contract, if such impact was material,
please describe the incidence and furthe r describe the impact it had on your
operations.
 “We have a limited operating history and may no t maintain profitability . . . .,” page 11

19. If there were any material factors that resulted in losses for the three months
ended March 31, 2006, please explain.  If  these factors involved increased
expenses that are likely to recur, please  identify them and discuss their impact
going forward.
 “We may need additional funding and may be unabl e to raise capital when . . . .,” page 12

20. You indicate that you are committed to substantial capital expenditures in
connection with the expansion of your Lans ing, Michigan facility  as well as for
the planned build out of two buildings in  Frederick, Maryland. Please quantify the
approximate amount of expenditure you are committed for in connection with these expansions. Please provide similar in formation in the risk factor entitled
“We have initiated a manufact uring facility expansion pr ogram. . . .” on page 13.
 “BioThrax and our immunobiotic product candida tes are difficult to . . . .,” page 13

21. If your financial condition has historically been materially impacted by lot
failures, product recalls or other acceptance criteria, please describe the situation
and further describe the imp act it had on your operations.

“Disruption at, damage to or destruction of  our manufacturing facilities . . . .,” page 14

22. If you have experienced any of the situati ons described in your bullet point list,
please revise to describe the situation you experienced and the consequences.  It
may be necessary to include such discussi on as a separate risk  factor discussion.
 “If third parties do not manufacture our product candidates in sufficient . . . .,” page 15

23. Please identify the third parties that manufactur e the supplies of your
immunobiotic product candidates for your pr eclinical and clinical developments
needs. If any of these parties have faile d to meet your preclinical and development
needs, please discuss the failure  and the effects of the failure.

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 5
24. Please identify the third party who provi des you with services related to your
purification and fractionation of plas ma for your anthrax immune globulin
candidate.
 “Our use of hazardous materials, chemicals, b acteria and viruses requires . . . .,” page 16

25. If you have been in violation of the envir onmental laws or been the subject of any
investigations for violations in the past, pl ease revise to include this information.
26. Please state whether you currently have reas onably adequate insurance to insulate
yourself from damage claims arising fr om your use of hazardous materials and
quantify the extent of your insurance coverage.

“We will not be able to commercialize our product candidates if our  . . . .,” page 17

27. You indicate in the first full paragra ph following the bullet points that you
anticipate that the FDA will not require you to conduct a Phase II clinical trial for
the botulinum toxoid vaccine before pe rmitting you to initiate a donor stimulation
program for your botulinum immune globu lin candidate. Please provide the basis
for your believe that the FDA will not requ ire to conduct a Phas e II clinical trial
related to your botulinum immune globulin candidate.
 “If we fail to achieve significant sales of Bi oThrax to customers in  . . . .,” page 19

28. Please identify the potential customers you are targeting the BioThrax product.
Please also identify the type of custom ers who are currently purchasing your
BioThrax product, other than the U.S. government.

29. Please disclose when your new Lansing facility will be completed.
 “The commercial success of BioThrax and any products we develop…,” page 19

30. Please explain the meaning of the term “recombinant.”

31. To the extent that there have been repo rts of any material side effects from
BioThrax or any of your products in devel opment, please revise to include this
information.
 “We have a small marketing and sales group.  If  we are unable to expand . . . .,” page 21

32. To the extent known, please disclose th e projected time frame of your hiring the
additional marketing personnel and the approximately how many employees you
plan to hire.

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 6
33. If you have had problems attracting or retaining qualified marketing and sales
employees, please revise to describe  the problems you have experienced.
 “We face substantial competition…,” page 21

34. Much of the detail included in this disc ussion is more approp riate for the Business
section.  Please revise the discussion to include a level of detail that helps readers
understand the risk and consequences.  Move the detailed discussion to the
Business section.
 “Legislation and contractual provisions limiting or restricting liability . . . .,” page 23

35. You indicate that you have applied to th e Department of Homeland Security for
liability protection for sales of BioThra x. Please disclose when you submitted the
application and when you expect to h ear from the Department of Homeland
Security.
 “Product liability lawsuits could cause us to incur substantial liabilities  . . . .,” page 24

36. You indicate that the lawsuits claim da mages resulting from personal injuries
allegedly suffered because of the BioThrax vaccination. Please specify what type of personal injuries the lawsuits claims  arose from the use of your BioThrax
vaccination.  Additionally, disclose the amount of damages they are seeking.
 “If we fail to attract and keep senior mana gement and key scientific. . . .,” page 27

37. If you have experienced difficulties hiring or  retaining employees, please describe
these difficulties. Similarly, if you have r eason to expect that you may experience
difficulties due to shortages of qualified people or other reasons, please discuss these expectations and the conditions  that create the expectations.
 “We rely on property and equipment owned by the Department of Defense . . . ., page 28

38. Please disclose the fee you currently pa y to the government for use of their
equipment, if such amount is material.
 “If third parties on whom we rely for clinical  trials do not perform as . . . .,” page 33

39. Please identify the third parties on whom  you “heavily” rely for the successful
execution of your clinical trials. To the extent you have any agreements with such parties, please describe the agreements  in your Business section and file the
agreement as an exhibit. If you do not believe such agreements are material to you, please provide us with a detailed an alysis explaining why you do not believe
such agreements are material to you.

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 7

40. You indicate that you expect to rely on the data from the development efforts of
CDC, assuming CDC consents  to such use and the study is completed. Please
expand your disclosure by describing how frequent your contact with the CDC is
and what information you are privy to, if any.

41. Please remove the discussi on relating to your plans to  expand your internal
clinical development and regulatory capabi lities and the risk that you may not be
able to recruit appropriate ly trained personnel to your infrastructure to a new
separate risk factor discussion.
 “We may fail to protect our intellectual pr operty rights, which would . . . .,” page 33

42. To the extent you are aware that you have any intellectual proper ty that is being
infringed upon or that you have been notif ied of a third party's belief that you are
infringing on their intellectual property, pleas e revise to disclose  the situation and
potential consequences.

43. Please disclose who has the obligations to take necessary actions to protect
patents under your license and collaborati on agreements. If you do not have the
obligation to take action, do you have the ri ght to take necessary actions if the
other party does not?
 “If we infringe or are alleged to infringe intellectual property ri ghts . . . .,” page 35

44. If you or your collaborators were ever require d to pay license fees  or royalties, or
both as a result of patent infringement cl aims or to avoid potential claims, please
so indicate and provide a desc ription of the circumstances.
 “Fuad El-Hibri, our president, chief executive  officer and chairman of . . . .,” page 37

45. Please revise your risk factor heading to include the fact that  Mr. El-Hibri will
also control the outcome for the election of directors. We note you have provided
this disclosure in your risk factor discussion.
 “If you purchase shares of our common stock in this offering, you will . . . .,” page 38

46. Please revise this risk factor to state th at shareholders will co ntribute ___% of the
total amount to fund BioSolutions bu t will own only ___% of the shares
outstanding.

Fuad El-Hibri
Emergent BioSolutions Inc.  September 9, 2006 Page 8

“A significant portion of our total outstanding shares are restricted from . . . .,” page 39

47. Please disclose the total number of shares that will available for immediate sale in
the market. Please also disclose the percen tage that the shares will represent of
your total outstanding shar es after the offering.

48. Please also disclose the total amount bene ficially owned by Mr . El-Hibri and the
percentage that his shares represent of  your total outstanding after the offering.
We note you have provided this information in the risk factor entitled “Fuad El-
Hibri, our president, chief executive o fficer and chairman . . . .,” page 37.

49. Please indicate how many s