Form 10-Q Emergent BioSolutions For: Mar 31
Certain identified information has been marked in the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the Company, if publicly disclosed. Double asterisks denote omissions.
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES 1 3 | |||||||||||
2. AMENDMENT/MODIFICATION NO. P0004 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ. NO. | 5. PROJECT NO. (If applicable) | ||||||||||
6. ISSUED BY | CODE | ASPR-BARDA | 7. ADMINISTERED BY (If other than Item 6) | CODE | ASPR-BARDA | ||||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 | ||||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. EMERGENT PRODUCT DEVLOPMENT GAITHE 300 PROFESSIONAL DR # 100 GAITHERSBURG MD 208793419 | X X | 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (See Item 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201600030C 10B. DATED (See Item 13) | |||||||||||
CODE 1365869 | FACILITY CODE | 09/30/2016 | |||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | |||||||||||||
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | |||||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (If required) See Schedule | |||||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | |||||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. | ||||||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | |||||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: | |||||||||||||
X | D. OTHER (Specify type of modification and authority) FAR 52.243-2 – Changes - Cost Reimbursement | ||||||||||||
E. IMPORTANT: Contractor is not, x is required to sign this document and return 2 copies to the issuing office. | |||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Tax ID Number: [**] DUNS Number: [**] The purpose of this modification is to modify ARTICLES B.5. ADVANCE UNDERSTANDINGS and G.3. KEY PERSONNEL. Funds Obligated Prior to this Modification: $464,692,203 Funds Obligated with Mod #4: $0 Total Funds Obligated to Date: $464,692,203 Expiration Date: September 29, 2021 (unchanged) Period of Performance: 09/30/2016 to 09/29/2021 | |||||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | |||||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Abigail Jenkins SVP Business Unit Head, Vaccines | 16A. NAME OF CONTRACTING OFFICER CHRISTOPHER SCOTT | ||||||||||||
15B. CONTRACTOR/OFFEROR /s/ Abigail Jenkins (Signature of person authorized to sign) | 15C. DATE SIGNED Mar 2, 2020 | 16B. UNITED STATES OF AMERICA BY /s/ Christopher Scott (Signature of Contracting Officer) | 16C. DATE SIGNED 3/3/20 | ||||||||||
NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)
Previous Edition Unusable Prescribed by GSA
FAR (48 CFR) 53.243
ARTICLE B.5. ADVANCE UNDERSTANDINGS is hereby modified as follows:
m. Shipment to the Strategic National Stockpile and Storage
Emergent shall develop a delivery schedule that is in agreement with BARDA. Delivery estimates are dependent on product release. Shipping will be FOB destination.
At least [**] before each scheduled shipment by the Contractor, the Contractor shall provide the following to the Contracting Officer and COR:
i. | Packing Slip |
ii. | Certificate(s) of Analysis |
iii. | Confirm the number of pallets, vials and doses to be loaded |
iv. | Diagram of product shipment pallet (how many vials per box, per pallet) |
The Contractor will assume responsibility for the cost of shipping and transport of finished product to the SNS for long-term storage once usable product requirements have been met. The USG will assume responsibility for long-term storage of the finished product, and emergency distribution of the finished product. The USG shall incur only the storage costs while the product is held within the USG’s control. The product shall be stored in compliance with cGMP at the Contractor’s facility until the delivery of finished product to the SNS.
The Contractor shall ensure that vaccine delivery follows cGMPs to maintain the integrity of the product en route. The Contractor shall file the necessary documentation to the FDA/CBER for the safe movement of the product to include any protocol deviations en route.
The Contractor shall be responsible for the secure and segregated storage of held intermediates and the FDP prior to lot release and subsequent arrival at the SNS. The Contractor will agree upon a delivery schedule. [**] advance notice is required prior to shipment to the SNS. However, while the product is in long-term storage with the USG (i.e., in the SNS), the Contractor shall continue to be responsible for all quality control/quality assurance monitoring and subsequent reporting necessary to insure appropriate storage conditions of the product until said product is licensed.
The Contractor, via this contract with the USG, will be expected to comply with a written Quality Agreement (attached) as to the manner in which the product will be stored within the specific USG stockpile facility (ies) that have been identified post contract award. In addition, this Quality Agreement will outline the responsibilities of both the Contractor and the USG (i.e., SNS- Quality Control). These documents shall be drafted and signed by both parties prior to the transport and storage of the product.
BARDA will not accept considerations for stability failures/reduced shelf-life. Any lots deemed non-conforming will be placed in quarantine and must be replaced by Emergent. If there is an indication of trending stability issues then an investigation will need to be opened and deliveries suspended until resolved. Notwithstanding anything to the contrary herein, until the Contractor receives concurrence by the FDA, the USG may accept any lots produced following Contractor’s implementation of new spore dose challenge levels in [**] as part of potency release testing. Should the FDA not concur that the new spore dose challenge levels are acceptable to release and use of the material under either Emergency Use Authorization or licensure, Contractor will be responsible for replacing any such lots with new lots, acceptable to the FDA, at no cost to the USG.
ARTICLE G.3. KEY PERSONNEL is hereby modified as follows:
The key personnel specified in this contract are considered to be essential to work performance. At least [**] prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.
The following individuals are considered to be essential to the work being performed hereunder:
Name | Position |
[**] | [**] |
[**] | [**] |
[**] | [**] |
[**] | [**] |
[**] | [**] |
[**] | [**] |
[**] | [**] |
*Bold indicated changes in this modification
All other terms and conditions of this contract remain unchanged.
End of Modification #4
Certain identified information has been marked in the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the Company, if publicly disclosed. Double asterisks denote omissions.
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES 1 3 | |||||||||||
2. AMENDMENT/MODIFICATION NO. P00005 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ. NO. | 5. PROJECT NO. (If applicable) | ||||||||||
6. ISSUED BY | CODE | ASPR-BARDA | 7. ADMINISTERED BY (If other than Item 6) | CODE | ASPR-BARDA | ||||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 | ||||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. EMERGENT PRODUCT DEVLOPMENT GAITHE 300 PROFESSIONAL DR # 100 GAITHERSBURG MD 208793419 | X X | 9A. AMENDMENT OF SOLICITATION NO. 9B. DATED (See Item 11) 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201600030C 10B. DATED (See Item 13) | |||||||||||
CODE 1365869 | FACILITY CODE | 09/30/2016 | |||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | |||||||||||||
The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | |||||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (If required) See Schedule | |||||||||||||
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | |||||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. | ||||||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | |||||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: | |||||||||||||
X | D. OTHER (Specify type of modification and authority) FAR 43.103(a) (3) Mutual Agreement of the Parties | ||||||||||||
E. IMPORTANT: Contractor is not, x is required to sign this document and return 1 copies to the issuing office. | |||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Tax ID Number: [**] DUNS Number: [**] The purpose of this modification is to modify ARTICLES B.3. OPTION PRICES, B.5. ADVANCE UNDERSTANDINGS, F.3 DELIVERIES, G.1 CONTRACTING OFFICER, and G.4. INVOICE SUBMISSION. Funds Obligated Prior to this Modification: $464,692,203 Funds Obligated with Mod #5: $0 Total Funds Obligated to Date: $464,692,203 Expiration Date: September 29, 2021 (Unchanged) Period of Performance: 09/30/2016 to 09/29/2021 | |||||||||||||
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | |||||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Abigail Jenkins SVP BU HEAD, Vaccines | 16A. NAME OF CONTRACTING OFFICER SABRINA J. MCINTYRE | ||||||||||||
15B. CONTRACTOR/OFFEROR /s/ Abigail Jenkins (Signature of person authorized to sign) | 15C. DATE SIGNED Apr 10, 2020 | 16B. UNITED STATES OF AMERICA BY /s/ Sabrina Mcintyre (Signature of Contracting Officer) | 16C. DATE SIGNED 4/10/20 | ||||||||||
STANDARD FORM 30 (REV. 11/2016)
Previous Edition Unusable Prescribed by GSA
FAR (48 CFR) 53.243
The purpose of this modification is to modify ARTICLES B.3 OPTION PRICES, B.5 ADVANCE UNDERSTANDINGS, F.3 DELIVERIES, G.1 CONTRACTING OFFICER, and G.4. INVOICE SUBMISSION.
ARTICLE B.3. OPTION PRICES are hereby modified as follows:
CLIN | Period of Performance | Supplies/Services | Doses | Price per Dose | Total Cost | Additional Doses**** |
CLIN 0004 (Option - Funded)*** | [**] - 09/29/21 | Additional Surge Capacity (EUA) | [**] | [**] | [**] | Dose number TBD |
[**].
***CLIN 0004 is funded
****Additional Doses may be delivered to BARDA as consideration under the provision in Article B.5.I. In the event that EBS delivers doses [**] (see Article B.5.I), Emergent will provide a [**]% dose-replacement equivalent of additional doses to the Government. As set forth in Article B.5.l, BARDA may accept [**] if such doses are delivered along with the appropriate number of additional doses (“Additional Doses”). Additional Doses shall be calculated as [**]% of the number of delivered [**].
ARTICLE B.5. ADVANCE UNDERSTANDINGS is hereby modified as follows:
I. Stability
BARDA understands that the stability testing is ongoing to support long-term stability of AV7909. The contractor will continue to perform ICH compliant stability studies on AV7909. While EBS and BARDA believe that a [**] will be achieved, this cannot be confirmed until FDA licensure of the vaccine.
For the agreed upon price, AV7909 will be delivered to the SNS that is [**] from the date of manufacture stamped on the vial label.
• | BARDA does agree to a [**] to the [**] limitation to allow delivery of approximately [**] doses of AV7909 that were initially manufactured as PPQ material intended for qualification of a Redundant Fill Site at PAR. |
• | For CLIN 0004, BARDA agrees to allow delivery of and may accept doses dated [**] if such doses are delivered along with the appropriate number of additional doses (“Additional Doses”). Additional Doses shall be calculated as [**]% of the number of delivered [**]. EBS shall provide the Additional Doses as consideration for BARDA’s acceptance of [**] with a [**] for storage in the Strategic National Stockpile. The Additional Doses will be included with delivery of the [**] at no additional cost to BARDA or the US Government. |
ARTICLE F.3. DELIVERIES is hereby modified as follows:
Email Addresses: CO - [**]
COR - [**]
ARTICLE G.1. CONTRACTING OFFICER is hereby modified as follows:
The following Contracting Officer (CO) will represent the Government for the purpose of this contract:
[**]
HHS/OS/ASPR/BARDA
200 C St. SW
O’Neill House Office Building
Washington, DC 20515
[**]
ARTICLE G.4. INVOICE SUBMISSION is hereby modified as follows:
g. | Invoices shall be delivered electronically to the Contracting Officer (CO), the Contracting Officer’s Representative (COR), PSC, and e-Room electronically. Unless otherwise specified by the Contracting Officer, all deliverables, invoices, and reports furnished to the Government under the resultant contract shall be addressed as follows: |
All other terms and conditions of this contract remain unchanged.
End of Modification #5
EXHIBIT 31.1
CERTIFICATION
I, Robert G. Kramer, Sr., certify that:
(1) I have reviewed this Quarterly Report on Form 10-Q of Emergent BioSolutions Inc.;
(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4) The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
(5) The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information, and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: April 30, 2020
/s/ROBERT G. KRAMER, SR.
Robert G. Kramer, Sr.
Chief Executive Officer
EXHIBIT 31.2
CERTIFICATION
I, Richard S. Lindahl, certify that:
(1) I have reviewed this Quarterly Report on Form 10-Q of Emergent BioSolutions Inc.;
(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4) The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
(5) The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information, and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: April 30, 2020
/s/RICHARD S. LINDAHL
Richard S. Lindahl
Chief Financial Officer
EXHIBIT 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Emergent BioSolutions Inc. (the "Company") for the period ended March 31, 2020 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, Robert G. Kramer, Sr., Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: April 30, 2020
/s/ROBERT G. KRAMER, SR.
Robert G. Kramer, Sr.
Chief Executive Officer
EXHIBIT 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Emergent BioSolutions Inc. (the "Company") for the period ended March 31, 2020 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, Richard S. Lindahl, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: April 30, 2020
/s/RICHARD S. LINDAHL
Richard S. Lindahl
Chief Financial Officer