emergentbiosolutionshhso






Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is  the type of information that the registrant treats as private or confidential. Double asterisks denote omissions.        AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES   1 4  2. AMENDMENT/MODIFICATION NO.   P00011  3.  EFFECTIVE DATE  See Block 16C  4. REQUISITION/PURCHASE NO.   OS285761  5. PROJECT NO. (If applicable)    6. ISSUED BY CODE  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)      9A. AMENDMENT OF SOLICITATION NO.  EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.  EMERGENT PRODUCT DEVELOPMENT GAITHE  300 PROFESSIONAL DR # 100  GAITHERSBURG MD 208793419      9B. DATED (SEE ITEM 11)     x 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 electronic communication which includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGMENT 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 letter or electronic communication, provided each letter or electronic  communication 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)   Net Increase: $398,550,000.00  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) Mutual Agreement of the Parties  E. IMPORTANT:  Contractor                   is not,  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 B.3 OPTION PRICES, B.5 ADVANCE  UNDERSTANDINGS, C.3 STATEMENT OF WORK, and SECTION J LIST OF ATTACHMENTS  Funds Obligated Prior to this Modification:  $722,692,203  Funds Obligated with Mod #11:  $398,550,000  Total Funds Obligated to Date:  $1,121,242,203  Expiration Date: May 31, 2025  Period of Performance: 09/30/2016 to 05/31/2025  Continued ...       Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect.  15A. NAME AND TITLE OF SIGNER (Type or print)  Adam Havey EVP, COO  16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)  JILL M. JOHNSON  





 






    15B. CONTRACTOR/OFFEROR  /s/Adam Havey     (Signature of person authorized to sign)  15C. DATE SIGNED  Sep 30, 2021  16B. UNITED STATES OF AMERICA    /s/Jill M. Johnson - S   (Signature of Contracting Officer)  16C. DATE SIGNED  2021.09.30  Previous edition unusable  STANDARD FORM 30 (REV. 11/2016)    Prescribed by GSA FAR (48 CFR) 53.243  





 






      CONTINUATION SHEET  REFERENCE NO. OF DOCUMENT BEING CONTINUED  HHSO100201600030C/P00011  PAGE  2  OF  4  NAME OF OFFEROR OR CONTRACTOR  EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. 1365869   ITEM NO.  (A)  SUPPLIES/SERVICES  (B)  QUANTITY  (C)  UNIT  (D)  UNIT PRICE  (E)  AMOUNT  (F)  10  Add Item 10 as follows:  CLIN 0010 Additional Surge Capacity (EUA)  Accounting Info:  2021.1991073.26088 Appr. Yr.: 2021 CAN: 1991073  Object Class: 26088  Funded: $[**]  Accounting Info:  2021.1990178.26088 Appr. Yr.: 2021 CAN: 1990178  Object Class: 26088  Funded: $[**]      398,550,000.00    OPTIONAL FORM 336 (4-86)  Sponsored by GSA FAR (48  CFR) 53.110  NSN 7540-01-152-8067  





 






HHSO100201600030C P00011   Page 4 of 4      The purpose of this modification is to modify ARTICLES B.3 OPTION PRICES, B.5  ADVANCE UNDERSTANDINGS, C.1 STATEMENT OF WORK and SECTION J – LIST  OF ATTACHMENTS.  ARTICLE B.3. OPTION PRICES - CLIN 0010 is modified as follows:  CLIN Period of  Performance  Supplies/Services Doses Price per  Dose  Total Cost Additional  Doses****  CLIN 0010  (Option  Quantity)***  09/30/2021 -  03/31/2023  Additional Surge  Capacity (EUA)  4,737,000* [**] [**]  Dose number  TBD  10,263,000 [**] [**]  TOTAL 15,000,000 [**] $398,550,000  (Funded)    [**]. As of the signing of this Modification to the Contract, 20,263,000 doses have been  delivered. With the exercising of CLIN 0010, 4,737,000 doses of the 15,000,000 doses will be  priced at a $[**] and will fulfill Contractor’s per dose cumulative reduction obligation regarding  the first 25 million doses procured under the options. All doses will be billed at the price of  $[**].  **Under CLIN 0010, a total of 15,000,000 doses are expected to be procured at the unit prices  stated above and may include the delivery of [**] and Additional Doses as set forth herein. CLIN  0010 pricing includes the $[**] within its agreed upon pricing for 4,737,000 doses delivered.  ***CLIN 0010 is funded   **** Additional Doses may be delivered to BARDA as consideration under the provision Article  B.5.I. In the event Contractor delivers doses [**] (See Article B.5.I), Contractor will provide a  [**]% dose-replacement equivalent of additional doses to the Government. As set forth in Article  B.5.I, 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 Contractor 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.  • For CLINs 0004, 0006 and 0010, BARDA agrees to allow delivery of and may  accept doses [**] 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 [**]. Contractor shall provide the Additional  





 






HHSO100201600030C P00011   Page 5 of 4      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.  SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT  ARTICLE C.1. STATEMENT OF WORK  Independently and not as an agent of the Government, the Contractor shall furnish all necessary  services, qualified personnel, material, equipment, and facilities not otherwise provided by the  Government as needed to perform the Statement of Work dated September 30, 2021, set forth in  SECTION J – List of Attachments, attached hereto and incorporated into this Prime Contract.  SECTION J – LIST OF ATTACHMENTS is hereby modified as follows:  1. Statement of Work, dated September 30, 2021, 10 pages  2. AV7909 Target Delivery Schedule (CLIN 0010)  Q4 2021 Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023  Oct-Dec Jan-Mar Apr-Jun Jul-Sep Oct-Dec Jan-Mar  [**] Doses [**] Doses [**] Doses [**] Doses [**] Doses [**] Doses    All other terms and conditions of this contract remain unchanged.  End of Modification #11  





 






  September 30, 2021  Page 1    ATTACHMENT 1: STATEMENT OF WORK  NEXT GENERATION ANTHRAX VACCINE  RFP 16-100-SOL-0015  AV7909 Anthrax Vaccine  1.0 Contractual Statement of Work  Preamble to the Statement of Work  Independently and not as an agent of the Government, the Contractor shall be required to furnish  all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise  provided by the Government, as needed to perform the Statement of Work submitted in response  to RFP 16-100-SOL-00015.  1.1 Scope  The scope of work for this contract includes AV7909 development activities through licensure  that fall into the following areas: program management, nonclinical, clinical, regulatory, and  chemistry, manufacturing, and controls (CMC). The scope of work also includes activities to  support post-marketing requirements.  1.2 Objective  The objective of this Statement of Work (SOW) is to conduct all necessary activities to advance  the development of AV7909 through Biologics License Application (BLA) submission and  approval and post-marketing requirements. Activities to meet the objective of this SOW fall in  seven separate contract line item number (CLIN):  • CLIN 0001 – Approval of Emergency Use Authorization (EUA), licensure, approval, and  clearance of product through the FDA (Base)  • CLIN 0001A – Conduct of a Phase 2 clinical [**] study or other studies required by the  FDA [**] (Option)  • CLIN 0012 – Include doxycycline arm in the conduct of the Phase 2 clinical drug-drug  interaction study and qualify a redundant contract filler (Base)  • CLIN 0002 – Initial purchase, storage, and delivery of product (Base)  • CLIN 0003 – Phase 4 post marketing requirements (Option)  • CLIN 0004 – Surge Capacity – Additional procurement of product (EUA) (Option) –  [**] to [**]1  • CLIN 0006 – Surge Capacity – Additional procurement of product (EUA) (Option) –  [**] to [**] doses  • CLIN 0010 – Surge Capacity - Additional procurement of product (EUA) (Option) – [**]  or more doses  1.3 CLIN 0001 - Approval of Emergency Use Authorization (EUA), licensure, approval,  and clearance of product through the FDA (Base)    [**]  





 






  September 30, 2021  Page 2    This section identifies representative tasks and sub-tasks for CLIN 0001 with associated WBS  code for each task or subtask.  [**] Program Management  Emergent shall provide program management activities. The activities shall include but are not  limited to:  • Identification of and management to, distinct stages of the product development pathway  that are gates for Go/No Go decisions for advancing to the next stage of the Integrated  Product Development Plan.  • Establishment of and tracking of milestones and timelines for the initiation conduct, and  completion of product development activities for each stage with a budget (in direct  costs) linked to each stage.  • Ongoing evaluation of qualitative and quantitative criteria and accompanying data used  to assess the scientific merit and technical feasibility of proceeding to the next stage of  product development.  • Maintaining and managing staff (in-house and contracted) to assure the necessary  expertise and dedicated effort to perform the work.  • Directing and overseeing subcontractors and consultants to assure successful  performance of planned activities within the cost and schedule constraints of the contract.  • Conducting performance measurement that shall include establishing an initial plan;  defining measurable parameters; defining how these parameters relate to cost and  schedule impacts; their approach in providing a detailed schedule that generates a critical  path for the project; and a description of the cost-accounting system used or intended to  be used based on budget estimates to monitor all costs related to the contract award for  both Emergent and subcontractors on a real time basis.  • Manage contract activities in accordance with Earned Value Management. In this regard,  Emergent shall:  o Provide an Integrated Master Project Plan (including tabular and Gantt forms) to  BARDA that clearly indicates the critical path to support product approval. The  Integrated Master Project Plan shall outline key, critical path milestones, with  “Go/No-Go” decision criteria and a contract Work Breakdown Structure (due  within 90 days of contract award with updates as requested by the Contracting  Officer’s Representative (COR).  o Submit an updated Integrated Master Schedule in an approved format.  o Use principles of Earned Value Management System (EVMS) in the management  of this contract.  o Submit a plan for a Performance Measurement Baseline Review (PMBR)  electronically via email to the Contracting Officer (CO) and COR for a PBMR to  occur within 90 days of contract award.  • Develop and maintain a risk management plan.  • Participate in regular meetings to coordinate and oversee the contracting effort.  [**] Non-Clinical Toxicology  





 






  September 30, 2021  Page 3    Emergent shall conduct safety and toxicology of AV7909 using animal models following Good  Laboratory Practice guidelines (GLP: as defined in the U.S. Code of Federal Regulations, 21CFR  Part 58), as appropriate. The activities shall include but are not limited to:  • [**]  [**] Non-Clinical Efficacy  Emergent shall conduct efficacy, pharmacokinetics/pharmacodynamics, bioavailability,  solubility, formulation, dose, route and schedule of the medical countermeasure using both in  vitro and animal models following Good Laboratory Practice guidelines (GLP: as defined in the  U.S. Code of Federal Regulations, 21 CFR Part 58), as appropriate. The activities shall include  but are not limited to:  • [**]  [**] Clinical Evaluation  Emergent shall design and conduct Phase 2 and Phase 3 clinical studies in accordance with all  Federal regulations and Good Clinical Practice (GCP) guidelines. The activities shall include but  are not limited to:  • [**]  [**] Regulatory Activities  Emergent shall conduct all required regulatory activities to support submission of BLA licensure  for AV7909. The activities shall include but are not limited to:  • [**]  [**] - Chemistry and Manufacturing Controls (CMC)  Emergent shall complete the manufacturing activities necessary to support BLA submission. The  activities shall include but are not limited to:  • [**]  1.4 CLIN 0001A - Conduct of a Phase 2 clinical [**] study or other studies required by the  FDA [**] (Option)  This section identifies representative tasks and sub-tasks for CLIN 0001A with associated WBS  code for each task or subtask.  [**] Program Management  Emergent shall provide program management activities. The activities shall include but are not  limited to:  • Identification of and management to, distinct stages of the product development pathway  that are gates for Go/No Go decisions for advancing to the next stage of the Integrated  Product Development Plan.  





 






  September 30, 2021  Page 4    • Establishment of and tracking of milestones and timelines for the initiation conduct, and  completion of product development activities for each stage with a budget (in direct  costs) linked to each stage.  • Ongoing evaluation of qualitative and quantitative criteria and accompanying data used  to assess the scientific merit and technical feasibility of proceeding to the next stage of  product development.  • Maintaining and managing staff (in-house and contracted) to assure the necessary  expertise and dedicated effort to perform the work.  • Directing and overseeing subcontractors and consultants to assure successful  performance of planned activities within the cost and schedule constraints of the contract.  • Conducting performance measurement that shall include establishing an initial plan;  defining measurable parameters; defining how these parameters relate to cost and  schedule impacts; their approach in providing a detailed schedule that generates a critical  path for the project; and a description of the cost-accounting system used or intended to  be used based on budget estimates to monitor all costs related to the contract award for  both Emergent and subcontractors on a real time basis.  • Manage contract activities in accordance with Earned Value Management. In this regard,  Emergent shall:  o Provide an Integrated Master Project Plan (including tabular and Gantt forms) to  BARDA that clearly indicates the critical path to support product approval. The  Integrated Master Project Plan shall outline key, critical path milestones, with  “Go/ No Go” decision criteria and a contract Work Breakdown Structure (due  within 90 days of contract award with updates as requested by the Contracting  Officer’s Representative (COR).  o Submit an updated Integrated Master Schedule in an approved format.   o Use principles of Earned Value Management System (EVMS) in the management  of this contract.  o Submit a plan for a Performance Measurement Baseline Review (PMBR)  electronically via email to the Contracting Officer (CO) and COR for a PBMR to  occur within 90 days of contract award.  • Develop and maintain a risk management plan.  • Participate in regular meetings to coordinate and oversee the contracting effort.  [**] Clinical Evaluation  Emergent shall design and conduct a Phase 2 clinical study in accordance with all Federal  regulations and Good Clinical Practice (GCP) guidelines unless other studies are required by the  FDA [**]. The activities shall include, but are not limited to:  • [**] - AVA.214 Phase 2 [**] Study  [**] - Chemistry and Manufacturing Controls (CMC)  Emergent shall complete the manufacturing activities necessary to support AVA.214 Phase 2  [**] Study. The activities below are specific to conducting a Phase 2 [**] clinical study. If the  FDA requires an alternate strategy for [**], the activities below may no longer be applicable.  Upon new guidance from the FDA, Emergent will update the SOW accordingly.  





 






  September 30, 2021  Page 5    • [**]  1.5 CLIN 0012 – Include doxvcvcline arm in the conduct of the Phase 2 clinical drug-drug  interaction study and qualify a redundant contract filler (Base)  This section identifies representative activities of CLIN 0012 associated with CLIN0001 subtask  [**] - AVA.210 Phase 2 [**] and [**] Chemistry and Manufacturing Controls:  • [**]  1.6 CLIN 0002 - Initial purchase, storage, and delivery of product (Base)  Under the Base Period funding Emergent shall manufacture, fill, and deliver 3,000,000 doses  procured in fiscal year 2019 as an initial procurement to the Strategic National Stockpile (SNS).  Emergent is approved to use management reserve funding for shipping costs associated with  these deliveries.  1.7 CLIN 0003 - Phase 4 post marketing requirements (Option)  [**].  Program Management  Emergent shall provide program management activities. The activities shall include but are not  limited to:  • Identification of and management to, distinct stages of the product development pathway  that are gates for Go/No Go decisions for advancing to the next stage of the Integrated  Product Development Plan.  • Establishment of and tracking of milestones and timelines for the initiation conduct, and  completion of product development activities for each stage with a budget (in direct  costs) linked to each stage.  • Ongoing evaluation of qualitative and quantitative criteria and accompanying data used  to assess the scientific merit and technical feasibility of proceeding to the next stage of  product development.  • Maintaining and managing staff (in-house and contracted) to assure the necessary  expertise and dedicated effort to perform the work.  • Directing and overseeing subcontractors and consultants to assure successful  performance of planned activities within the cost and schedule constraints of the contract.  • Conducting performance measurement that shall include establishing an initial plan;  defining measurable parameters; defining how these parameters relate to cost and  schedule impacts; their approach in providing a detailed schedule that generates a critical  path for the project; and a description of the cost-accounting system used or intended to  be used based on budget estimates to monitor all costs related to the contract award for  both Emergent and subcontractors on a real time basis.  • Manage contract activities in accordance with Earned Value Management. In this regard,  Emergent shall:  o Provide an Integrated Master Project Plan (including tabular and Gantt forms) to  BARDA that clearly indicates the critical path to support product approval. The  Integrated Master Project Plan shall outline key, critical path milestones, with  “Go/No Go” decision criteria and a contract Work Breakdown Structure (due  





 






  September 30, 2021  Page 6    within 90 days of contract award with updates as requested by the Contracting  Officer’s Representative (COR).  o Submit an updated Integrated Master Schedule in an approved format.   o Use principles of Earned Value Management System (EVMS) in the management  of this contract.  o Submit a plan for a Performance Measurement Baseline Review (PMBR)  electronically via email to the Contracting Officer (CO) and COR for a PBMR to  occur within 90 days of contract award.  • Develop and maintain a risk management plan.  • Participate in regular meetings to coordinate and oversee the contracting effort.  [**]  1.8 CLIN 0004 through 11 - Surge Capacity – Additional procurement of product (Option)  Emergent shall deliver up to 25 million dose regimens (equivalent to 50 million doses of  AV7909). This option may be triggered after EUA pre-authorization approval by FDA, which is  currently linked to release of PPQ lots, and deliveries will start within [**] after trigger.  Under CLIN 0004, Emergent shall manufacture, fill, and deliver 10,263,000 doses procured in  fiscal year 2019 as an initial procurement to the Strategic National Stockpile (SNS). [**].  Under CLIN 0006 Emergent shall manufacture, fill, and deliver 10,000,000 doses procured from  August 1, 2020 through July 31, 2021, as an additional procurement to the SNS. [**].  Under CLIN 0010 Emergent shall manufacture, fill, and deliver 15,000,000 doses procured from  September 30, 2021 through March 31, 2023, as an additional procurement to the SNS. [**].  For CLINs 0004, 0006 and 0010, 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 [**].  For delivery to the SNS, Emergent shall comply with the relevant associated activities and  deliverables as outlined in the Quality Agreement (attached) as signed by Emergent, BARDA,  and the SNS. Emergent shall provide appropriate documentation to BARDA for quality  assurance of the final drug product delivered to the SNS and invoice appropriately.  1.9 Reporting Requirements and Deliverables Reports  As part of the work to be performed under this contract, Emergent will prepare and deliver the  following reports throughout the period of performance.  Monthly Technical Progress Reports  On the fifteenth (15) day of each month for the previous calendar month, Emergent will submit  to the COR and the CO a Technical Progress Report covering the previous calendar month. The  first reporting period consists of the first full month of performance plus any fractional part of  the initial month. Thereafter, the reporting period will consist of each calendar month. The  frequency of Technical Progress Reporting will be determined by the CO and COR during  negotiations of the contract. The format and type of Technical Progress Report and Executive  Summary will be provided by the COR. The Technical Progress Reports will summarize  





 






  September 30, 2021  Page 7    progress for the reporting period, such as: management and administrative updates, technical  progress, issues, proposed work, manufacturing and supply chain management, and a summary  of invoices. A Technical Progress Report will not be required for the period when the same  month Annual Progress Reports or a Final Report are due. Emergent will submit one copy of the  Technical Progress Report electronically via e-mail to the CO and COR.  Annual Progress Reports  On the thirtieth (30th) calendar day following the last day of each reporting period, Emergent  will submit to the COR and the CO an Annual Progress Report. The first reporting period  consists of the first full year of performance plus any fractional part of the initial year.  Thereafter, the reporting period shall consist of each calendar year. Annual Progress Reports will  summarize progress for the reporting period, such as: management and administrative updates,  technical progress, issues, proposed work, manufacturing and supply chain management, and a  summary of invoices. An Annual Progress Report will not be required for the period when the  Final Technical Progress Report is due.  Draft Final Report and Final Report  Emergent will submit the Draft Final Progress Report forty-five (45) calendar days prior to the  expiration date of the contract and the Final Progress Report on or before the expiration date of  the contract. These reports will include a summation of the work performed and results obtained  for execution of various studies or technical work packages during the entire contract period of  performance. This report will be in sufficient detail to describe comprehensively the results  achieved. An electronic copy of the Draft Final Report and Final Report will be submitted to the  COR and CO.  FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions  With regard to interactions with the FDA, Emergent shall:  • Forward the initial draft minutes to BARDA within five business days of any formal  meeting with the FDA or other regulatory agency, and forward the final minutes when  available.  • Forward the initial draft minutes to BARDA within five business days of any informal  meeting with the FDA or other regulatory agency, and forward the final minutes when  available and if applicable.  • Forward the dates and times of any meeting with the FDA and other regulatory agencies  to BARDA as soon as the meeting times are known and make arrangements for  appropriate BARDA staff to attend the meetings.  • Provide BARDA the opportunity to review and comment upon any documents to be  submitted to the FDA or other regulatory agency. Emergent will provide BARDA with  five (5) business days in which to review and provide comments prior to Emergent’s  submission to the FDA.  Emergent will notify the COR and CO within 24 hours of all FDA arrivals to conduct site  visits/audits by any regulatory agency and provide the USG with an exact copy (non-redacted) of  the FDA Form 483 and the Establishment Inspection Report (EIR). Emergent will provide the  COR and CO copies of the plan for addressing areas of non-conformance to FDA regulations for  Good Laboratory Practice (GLP) guidelines as identified in the audit report, status updates  





 






  September 30, 2021  Page 8    during the plans execution, and a copy of all final responses to the FDA. Emergent will also  provide redacted copies of any FDA audits received from subcontractors that occur as a result of  this contract or for this product. Emergent will make arrangements with the COR for the  appropriate BARDA representative(s) to be present during the final debrief by the regulatory  inspector.     





 






  September 30, 2021  Page 9    Key Deliverables  A summary of Key Deliverables for this contract follow  No. Deliverable Description Due Date  01 Monthly  Progress Report  Shall include a description of the  activities during the reporting period  and the activities planned for the  ensuing reporting period. The first  reporting period consists of the first  full month of performance plus any  fractional part of the initial month.  Thereafter, the reporting period shall  consist of each calendar month.  Due on or before the 15th day  of each month following the  end of each reporting period.  Monthly progress reports are  not required in the same month  Annual Progress reports or a  Final Report are due.  02 Annual Progress  Report  Shall include a summation of the  activities during the reporting period,  and the activities planned for the  ensuing reporting period. The first  reporting period consists of the first  full year of performance plus any  fractional part of the initial year.  Thereafter, the reporting period shall  consist of each calendar year.  Due on or before the 30th  calendar day following the end  of each reporting period.  03 Draft Final  Progress Report  To include a summation of the work  performed and results obtained for  execution of various studies or  technical work packages during entire  contract period of performance. Shall  be in sufficient detail to describe  comprehensively the results achieved.  Due 45 Calendar days prior to  the expiration date of the  contract.  04 Final Progress  Report  To include a summation of the work  performed and results obtained for  execution of various studies or  technical work packages during entire  contract period of performance. Shall  be in sufficient detail to describe  comprehensively the results achieved.  Due on/before the expiration  date of the contract.  05  FDA/Regulatory  Agency  Correspondence  and Meeting  Minutes  The Contractor shall forward initial  draft minutes and final draft minutes of  any formal or informal meeting with  the FDA or other regulatory agency.  The contractor shall forward the dates  and times of any meeting with the  FDA and other regulatory agencies as  soon as the meeting times are known  and make arrangements for appropriate  BARDA staff to attend the meetings.  The Contractor shall provide BARDA  the opportunity to review and comment  upon any documents to be submitted to  the FDA or other regulatory agency.  Due within 5 business days of  each meeting for Contractor’s  minutes, upon receipt of  minutes from FDA/regulatory  agency, and upon request from  the COR or Co-COR.  





 






  September 30, 2021  Page 10    No. Deliverable Description Due Date  The Contractor shall forward SOPs  upon request from the COR. The  contractor shall notify the COR and  CO within 24 hours of all FDA arrivals  to conduct site visits/audits by any  regulatory agency, and provide copies  of any associated reports,  documentation, or communication.  06  Integrated  Master Project  Plan (Critical  Path Milestones,  Work  Breakdown  Structure, Risk  Mitigation  Plan/Matrix)  The contractor shall provide an  Integrated Master Plan (including  tabular and Gantt forms) to BARDA  that clearly indicates the critical path to  annual deliverables (key, critical path  milestones, with “Go/No Go” decision  criteria) and Work Breakdown  Structure (WBS) elements that shall be  discernable and consistent. The  contractor shall develop and maintain a  risk management plan that highlights  potential problems and/or issues that  may arise during the life of the  contract, their impact on cost, schedule  and performance, and appropriate  remediation plans.  Due within 90 days of contract  award. Updates are due as  requested by the COR or Co- COR.  07 Technology  Packages  Technology packages developed under  the contract that includes complete  protocols must be submitted at the  request of the BARDA COR.  Due upon request from the  COR or Co-COR.  08 Experimental  Protocols  The Contractor shall submit to the  COR all study/experiment/test plans,  designs, and protocols prior to  execution for BARDA approval or  upon request by the COR or Co-COR  when required.  Due upon request from the  COR or Co-COR.  09 Annual/Final  Invention Report  All reports and documentation required  by FAR Clause 52.227-11, Patent  Rights-Ownership by the Contractor,  including, but not limited to, the  invention disclosure report, the  confirmatory license, and the  Government support certification. If no  invention is disclosed or no activity has  occurred on a previously disclosed  invention during the applicable  reporting period, a negative report shall  be submitted to the CO.  Annual Invention Report Due  on or before the 30th calendar  day after the completion of each  reporting period. Final  Invention Report due on or  before the expiration of the  contract.  10 Publications  Any manuscript or scientific meeting  abstract containing data generated  Due within 30 calendar days for  manuscripts prior to publication  





 






  September 30, 2021  Page 11    No. Deliverable Description Due Date  under this contract must be submitted  to COR for review prior to submission.  and 15 calendar days for  abstracts.  11 Press Releases  The Contractor agrees to accurately  and factually represent the work  conducted under this contract in all  press releases. The Contractor shall  ensure the CO has received and  approved an advanced copy of any  press release not less than five (5)  business days prior to the issuance of  any potential press release.  Reports/Notices due for  approval to the CO not less than  five (5) business days prior to  the issuance of any potential  press release.  12 Security Report  The contractor shall report to the  government any activity or incident  that is in violation of established  security standards or indicates the loss  or theft of government products  Due within 24 hours after  occurrence of an activity or  incident.  13  Earned Value  Management  System  Requirements  Subject to the requirements under FAR  52.234-4 Earned Value Management  System, the Contract shall use  principles of Earned Value  Management System (EVMS) in the  management of this contract (include  this plan as part of the monthly, annual,  and final reports). The Contractor shall  also submit a Performance  Measurement Baseline Review plan  electronically via email to the CO and  COR for a PMBR to occur within 90  days of contract award, and an  Integrated Master Schedule  electronically via email as outlined in a  format agreed upon by BARDA to the  COR and CO. The Offeror shall deliver  an Earned Value Contract Performance  Report on a monthly basis.  As detailed in Section F.3.2  Subpart F.    





 






       Milestone  #  WBS  # Milestone Deliverables Summary (Details  as specified in the Deliverables) Quantity  Estimated  Completion  Date  CLIN 0001  &   CLIN 0012  1 [**] [**] [**]  1 Electronic Copy to  Contract Officer  Representative  (COR);  1 Electronic Copy to  Contracting Officer  (CO)  12/19/2017  2 [**] [**] [**] See Above 1/18/2018  3 [**] [**] [**] See Above 5/24/2018  4 [**] [**] [**] See Above 11/6/2018  5 [**] [**] [**] See Above 11/8/2018  8 [**] [**] [**] See Above 3/21/2021  9 [**] [**] [**] See Above 8/18/2020  10 [**] [**] [**] See Above 12/31/2021  11 [**] [**] [**] See Above 5/12/2021  12 [**] [**] [**] See Above 12/15/2021  CLIN 0002 16 -  Completion of delivery  of 3 million doses of  AV7909  Delivery of 3 million doses of  AV7909 See Above 10/24/2019