bardassleditsv4






                                                                                                                                                                                                Exhibit 10.1                                            Confidential Materials Omitted – To be filed separately with the                   Securities and Exchange Commission upon request. Double asterisks denote omissions.                                                                                                                                                                                                                    1      1   .       CONTRACT ID CODE                       PAGE OF PAGES   AMENDMENT  OF  SOLICITATION/MODIFICATION OF CONTRACT                                                                                                                        I                                                                                                                                                                                       1      I            5   2. AMENDMENT/MODIFICATION NO.                                   3. EFFECTIVE DATE                           4.  REQUISITION/PURCHASE       REQ.  NO                   1 5. PROJECT NO, (If applicable)   P00003                                                          See Block 16C                              OS244568   6. ISSUED BY                                          CODE                                                                   ASPR-BARDA                                   7. ADMINISTERED BY (If  other than Item 6)                 CODE   IASPR-BARDA                ASPR-BARDA                                                                                                   ASPR-BARDA   20 0 Independence Ave., S.W.                                                                                 200 Independence Ave., S.W.   Room 640-G                                                                                                   Room 638-G   Washington DC 20201                                                                                          Washington DC 20201                                                                                                                               8. NAME AND ADDRESS OF CONTRACTOR (No., Street, county, State and ZIP                                      (√)  9A AMENDMENT OF SOLICITATION NO      Code)                                                                                                                                                                                                                                                                                                                                       EMERGENT PRODUCT  DEVELOPMENT GAITHESBURG                                                                        9B. DATED (SEE ITEM 11)                                                                                                                  INC.                                                                                                                                                                                                                           EMERGENT PRODUCT DEVELOPMENT GAITHE                                                                              10A M ODIFICATION OF CONTRACT/ORDER NO.                                                                                                               X   HHS0100201600030C  300 PROFESSIO NAL DR# 100  GAITHERSBURG MD  208793419                                                                                                                                1OB. DATED (SEE ITEM 13)   CODE        1365869                                             FACILITY CODE                                     09/30/2016                                                                      11. THIS ITEM ONLY APPUES 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 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 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 )                                            Net Increase:                                                  $260,988,090   [**]                                                                                                                                                                                                                                                    13. THIS ITEM ONLY APPLIES TO MODIFICATION 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 CONTRACTIORDE R IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office,                        appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)                      C. THIS SUPPLEMENTALAGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:         X          FAR 52.217 -7 Option for Increased Quantity - Separately Priced Line Item                     D. OTHER (Specify type of modification and authority)                                                                                                                                                                                                                                               E. IMPORTANT:  Contractor                       is not,        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.3. OPTION PRICES, B.5, ADVANCE  UNDERSTANDINGS, C. 1. STA TEMENT OF WORK, G.3. KEY PERSONNEL, and SECTION J - LIST OF  ATTACHMENTS.  Funds Obligated Prior to this Modification: $203,704, 113  Funds Obligated with Mod #3: $260,988 ,090  Total Funds Obligated to Date: $464,692,203  Continued ...                provided herein, all terms and conditions or the document referenced in Item 9 A or 1 0A , as heretofore changed, remains unchanged ed and in full force and effect.                                                                                                                                CHRISTOPHER SCOTT                                                                                     15C. DATE SIGNED                                                                                         16C . DATE SIGNED          ADAM HAVEY, EVP                                                                                                                                                                     07/30/2019                   ( Srgnat ure of person authorized to s,gn)                                                  16 B. UNITED STATES OF AMERICA (Signature of Contracting                                                                                                               Officer) 





 






                                          REFERENCE NO. OF DOCUMENT BEING CONTINUED                                               AGE   OF    CONTINUATION SHEET HHSO1002 0 l 600030C/P00003                                                                 2        5                                                                                                                                   NAME OF OFFEROR OR CONTRACTOR  EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC. 1365869             ITEM NO.                           SUPPLIES/SERVICES                       QUANTI UNIT        UNIT               AMOUNT                                                                               TY                PRICE     (A)                                     (B)                                      (D)                               (F)                                                                                 (C)              (E)                                                                                                                      Expiration Date: September 29,2021 (Unchanged)                                                           Delivery:      07/30/2019                                                                                                                                                                                         Delivery Location Code: HHS             HHS                                                                                                      200 Independence Avenue, SW                                                                                                                                                                                       Washington DC 20201 US                                                                                                                                                                                                                               Appr. Yr.: 2019 CAN: 1990051 Object Class: 26088                                                         FOB: Destination                                                                                                                                                                                                  Period of Performance: 09/30/2016 to 09/29/2021                                                                                                                      Change Item 4 to read as follows (amount shown is                                                                                                                                                                 the obligated amount).                                                                            260,988,090.00   4              CLIN 0004- Option Funding to support procurement of              AV7909 Anthrax Vaccine to the Strategic National              Stockpile.    NSN 7540-01-152-8067                                                                                    OPTIONAL FORM 336 (4-86)                                                                                                          Sponsored by GSA                                                                                                          FAR (48 CFR) 53.110 





 






                                                         ARTICLE B.3. OPTION PRICES are hereby modified as follows:              CUN        Period of        Supplies/Services                        Doses          Price per      Total Cost                 Performance                                                                Dose   CLIN 0004     07/29/19 -      Additional Surge Capacity                10[**]*         $[**]        $260,988,090    (Option -    09/29/21        (EUA)                                 Funded\***                                                                                   *25 million doses procured under the options will be reduced by $[**] per dose           (regardless of the year these doses may be procured).           **Under this option 10[**]doses are expected to be procured at the unit price of           $[**]. (This is the unit price of $[**] negotiated for surpassing the [**] million dose           threshold and inclusive of $[**] per dose reduction.) If fully delivered there will be [**]           doses that will be applicable for the $[**] per dose reduction in future procurement           options                   **CLIN 0004 is funded with this modification                   ARTICLE B.5. ADVANCE UNDERSTANDINGS is hereby modified as follows:                       k.  Terms and conditions for payment                           Subject to the availability of funds the government intends to procure 3,000,000 doses of                   AV7909 as outlined in the base period of the contract at a unit price of $[**]per dose                   and an additional 10[**]doses under an option exercised in FY2019 at a unit price of                   $[**]per dose. This Advance Understanding counts as COA approval for the delivery of                   3,000,000 doses funded in the Base Period.                           Invoices shall be submitted upon delivery of product to government specified locations                   and government acceptance of product. A delivery schedule along with expected doses                   to be delivered will be included as an attachment to this option.                       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 [**] month expiration dating 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 no older than                   [**] months from the date of manufacture stamped on the vial label.                       o   BARDA does agree to a one-time exception to the [**]-month 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.                       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 48 hours before each scheduled shipment by the Contractor, the Contractor                   shall provide the following to the Contracting Officer and COR:                                i. Packing Slip                                                           3 





 






                                                             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 FOP prior to lot release and subsequent arrival at the SNS. The          Contractor will agree upon a delivery schedule. Thirty days 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 ensure          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.                  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 the  necessary services, qualified personnel, material, equipment, and facilities not otherwise provided  by the Government as needed to perform the Statement of Work dated July, 30 2019 set forth in  SECTION J - List of Attachments, attached hereto and made a part of the contract.                  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 30 days 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                                                  4                                                  





 






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          SECTION J - LIST OF ATTACHMENTS is hereby modified as follows:              1. Statement of Work, dated July 30, 2019, 11 pages              9.  Quality Agreement              10. AV7909 Delivery Schedule                                         Q3 2019                         Q4 2019                                          Total                 August        September  October       November     December     Q1 2020    Q2 2020       Doses  Doses                                                       [**]       [**]          [**]         [**]      [**]     [**][**] Delivered:    [**]          [**]          [**]      [**]          [**]         [**]       [**]       [**]  Base Doses  [**]            [**]                                                                     [**]  Option                                    [**]      [**]          [**]         [**]       [**]       [**]  Doses                                  2H 2019 Delivery                                                  1H 2020 Delivery  [**]                                                              [**]                                                                                                                                                                                                   All other terms and conditions of this contract remain unchanged.                                                   End of Modification #3                                                    5          





 






                                                                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 three separate contract  line item number (CUN):      •   CLIN 0001 - Approval of Emergency Use Authorization (EUA), licensure, approval,          and clearance of product through the FDA (Base)      •   CUN 000IA - Conduct of a Phase 2 clinical [**] study or other studies required by the FDA for          the establishment of a [**] specification (Option)      •   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 (Option)         1.3 CLIN 0001 - Approval of Emergency Use Authorization (EUA), licensure, approval. and  clearance of product through the FDA (Base)         This section identifies representative tasks and sub-tasks for CUN 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.      July 30, 2019                                                                     





 






    •  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 90days                 of contract award.      •   Develop and maintain a risk management  plan.      •   Participate in regular meetings to coordinate and oversee the contracting effort.         [**] Non-Clinical Toxicology    Emergent shall conduct safety and toxicology of AV7909 using animal models following Good  Laboratory Practice guidelines (OLP: 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 (OLP: 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:                             July 30, 2019                                                                     





 






               [**]      [**] 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:         [**]    [**]    [**] 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        July 30, 2019                                                                     





 






                                                  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; defming          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 90days                 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 for the  establishment of [**] specification. The activities shall include, but are not limited to:         [**]    [**] 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 establishment of [**], the activities below may no longer be applicable. Upon new  guidance from the FDA, Emergent will update the SOW accordingly.         [**]         1.5 CLIN 0002 - Initial purchase, storage, and delivery or 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.                July 30, 2019                                                                               





 






                                          1.6   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:             0   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).             0   Submit an updated Integrated Master Schedule in an approved  format.             0    Use principles of Earned Value Management System (EVMS) in the management of this                 contract.             0    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.              [**]                          July 30,  2019                                                                             





 






                                                  1.7 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 [**] months after trigger.          Under CLIN 4 Emergent shall manufacture, fill, and deliver 10[**]doses procured in fiscal year 2019 as   an  initial  procurement  to  the  Strategic  National  Stockpile  (SNS).  Emergent  will  be  responsible  for   shipping and transport of filled and finished AV7909 product to the SNS and the costs associated with the   delivery.          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.         1.8 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 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        July 30, 2019                                                                              





 






                                           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 during the plan’s 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.               July 30, 2019                                                                              





 






Key Deliverables  A summary of Key Deliverables for this contract follow [*]                                                                                                                                        July 30, 2019                                                                         





 






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                                              Milestone #  WBS #  Milestone          Deliverables           Quantity  Estimated                                                       Summary (Details as               Completion                                                       specified in the                  Date                                                       Deliverables)                                                                                                                               [**]          [**]         [**]      [**]       [**]     [**]                [**]          [**]       [**]         [**]         [**]       [**]       [**]                [**]          [**]                                    CLIN 0001                                                [**]       [**]          [**]        [**]       [**]     [**][**]   [**]                [**]          [**]       [**]         [**]         [**]       [**]       [**]                [**]                                                                     [**]                                                [**]       [**]          [**]        [**]       [**]     [**][**]   [**]                [**]          [**]       [**]         [**]         [**]       [**]       [**]                [**]                                                                     [**]                                                [**]       [**]          [**]        [**]       [**]     [**][**]   [**]                [**]          [**]       [**]         [**]         [**]       [**]       [**]                [**]                                                                     [**]                                                [**]       [**]          [**]        [**]       [**]     [**][**]   [**]                [**]          [**]       [**]         [**]         [**]       [**]       [**]  CLIN 0002     [**]          --         Completion   Delivery of [**]        [**]       [**]                                         of delivery  3 million                                         of 3 million doses of                                         doses of     AV7909                                         AV7909                     July 30, 2019