emergentbiosolutionshb12






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.  Exhibit 10.2      AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES   1 2  2. AMENDMENT/MODIFICATION NO.   P00008  3.  EFFECTIVE DATE  See Block 16C  4. REQUISITION/PURCHASE 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)     (x) 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)    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 ARTICLE C.1 STATEMENT OF WORK and SECTION J LIST OF ATTACHMENTS.    Funds Obligated Prior to this Modification: $722,692,203  Funds Obligated with Mod #8: $ 0  Total Funds Obligated to Date: $722,692,203    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 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect.  15A. NAME AND TITLE OF SIGNER (Type or print)  Kelly Warfield VP, Vaccines R&D  16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)  SABRINA J. MCINTYRE  





 






  15B. CONTRACTOR/OFFEROR         (Signature of person authorized to sign)  15C. DATE SIGNED    Mar 18, 2021  16B. UNITED STATES OF AMERICA      Sabrina J. Mcintyre -S   (Signature of Contracting Officer)  16C. DATE SIGNED  Previous edition unusable STANDARD FORM 30 (REV. 11/2016)    Prescribed by GSA FAR (48 CFR) 53.243  Electronically signed by: Kelly Warfield  Reason: I approve this document  Date: Mar 18, 2021 09:10 EDT   Digitally signed by Sabrina J. Mcintyre -S  Date: 2021.03.22 17:57;58-04’00’  





 






HHSO100201600030C P00008 Page 3      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  service, qualified personnel, material, equipment, and facilities not otherwise provided by the Government  as needed to perform the Statement of Work set forth in SECTION J – List of Attachments, attached  hereto and made a part of the contract.    SECTION J – LIST OF ATTACHMENTS is hereby modified as follows:  1. Statement of Work, dated March 11, 2021, 10 pages    All other terms and conditions of this contract remain unchanged.  End of Modification #8  





 






  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  Preamable 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 [**] the Phase 2 clinical [**] 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 (Option)  • CLIN 0006 – 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 CLIN 0001 with associated WBS  code for each task or subtask.  





 






  Page 2    [**] 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:  ○ 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).  ○ Submit an updated Integrated Master Schedule in an approved format.  ○ Use principles of Earned Value Management System (EVMS) in the  management of this contract.  ○ 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.  





 






  Page 3    [**] Non-Clinical Toxicology  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  





 






  Page 4    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:  ○ 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).  ○ Submit an updated Integrated Master Schedule in an approved format.  ○ Use principles of Earned Value Management System (EVMS) in the  management of this contract.  ○ 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:  





 






  Page 5    • [**] – 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.  • [**]  1.5 CLIN 0012 – Include [**] the Phase 2 clinical [**]  study and [**] contract filler (Base)  This section identifies representative activities of CLIN 0012 associated with CLIN000l 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.  





 






  Page 6    • 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:  ○ 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).  ○ Submit an updated Integrated Master Schedule in an approved format.  ○ Use principles of Earned Value Management System (EVMS) in the  management of this contract.  ○ 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.  [**].   For CLINs 0004 and 0006, BARDA may accept [**] 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  





 






  Page 7    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 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.  





 






  Page 8    • 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 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.  





 






  Page 1    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. 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.  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.  06  Integrated Master  Project Plan  (Critical Path  Milestones, Work  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,  Due within 90 days of contract  award. Updates are due as  requested by the COR or Co- COR.  





 






  Page 2    No. Deliverable Description Due Date  Breakdown  Structure, Risk  Mitigation Plan/  Matrix)  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.  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 under this contract  must be submitted to COR for review prior to  submission.  Due within 30 calendar days for  manuscripts prior to publication  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  As detailed in Section F.3.2  Subpart F.  





 






  Page 3    No. Deliverable Description Due Date  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.      





 






       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)  [**]  2 [**] [**] [**] See Above [**]  3 [**] [**] [**] See Above [**]  4 [**] [**] [**] See Above [**]  5 [**] [**] [**] See Above [**]  8 [**] [**] [**] See Above [**]  9 [**] [**] [**] See Above [**]  10 [**] [**] [**] See Above [**]  11 [**] [**] [**] See Above [**]  12 [**] [**] [**] See Above [**]  CLIN 0002 16 - Completion of delivery of 3  million doses of AV7909  Delivery of 3 million doses of  AV7909 See Above [**]