Document:

emergentbiosolutionsh657

  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 10.8    ORDER FOR SUPPLIES OR SERVICES PAGE OF PAGES  IMPORTANT:  Mark all packages and papers with contract and/or order numbers. 1 17  1. DATE OF ORDER 2. CONTRACT NO. (if any) 6. SHIP TO  04/02/2020 HHSO100201200004I a. NAME OF CONSIGNEE  3. ORDER NO. 4. REQUISITION/REFERENCE NO. Multiple Destinations  75A50120F33006 OS256855  5. ISSUING OFFICE (Address correspondence to) b. STREET ADDRESS  ASPR-BARDA  200 Independence Ave., S.W.  Room 640-G  Washington DC 20201    c. CITY d. STATE e. ZIP CODE  7. TO: f. SHIP VIA  a. NAME OF CONTRACTOR   EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC 8. TYPE OF ORDER  b. COMPANY NAME  a. PURCHASE  REFERENCE YOUR:   b. DELIVERY    Except for billing instructions  on the reverse, this delivery  order is subject to  instructions contained on  this side only of this form  and is issued subject to the  terms and conditions of the  above-numbered contract.  c. STREET ADDRESS  EMERGENT MANUFACTURING OPERATIONS B  5901 E LOMBARD ST   Please furnish the following on the  terms and conditions specified on both  sides of this order and on the attached  sheet, if any, including delivery as  indicated.  d. CITY e. STATE f. ZIP CODE  BALTIMORE MD 212246824  9. ACCOUNTING AND APPROPRIATION DATA 10. REQUISITIONING OFFICE  2020.199COV2.25103 BARDA  11. BUSINESS CLASSIFICATION (Check appropriate box(es)) 12. F.O.B. POINT   a. SMALL      b. OTHER THAN SMALL      c. DISADVANTAGED      d. WOMEN-OWNED      e. HUBZone    f. SERVICE-DISABLED  g. WOMEN-OWNED SMALL BUSINESS (WOSB)  h. EDWOSB    VETERAN-OWNED ELIGIBLE UNDER THE WOSB PROGRAM   13. PLACE OF 14. GOVERNMENT B/L NO. 15. DELIVER TO F.O.B.  POINT ON OR BEFORE  (Date)  16. DISCOUNT TERMS  a. INSPECTION b. ACCEPTANCE  10/02/2021   Destination Destination     17. SCHEDULE (See reverse for Rejections)  ITEM NO.  (a)  SUPPLIES OR SERVICES  (b)  QUANTITY  ORDERED  (c)  UNIT  (d)  UNIT  PRICE  (e)  AMOUNT  (f)  QUANTITY  ACCEPTED  (g)   Tax ID Number:  [**]  DUNS Number:  [**]  A detailed breakdown of CLIN  costs is reflected in Section B  of this task order.  Appr. Yr.:  2020 CAN:  199COV2  Object Class: 25103  Continued . . .         SEE BILLING  INSTRUCTIONS  ON REVERSE  18. SHIPPING POINT 19. GROSS SHIPPING WEIGHT 20. INVOICE NO.         $[**]  17(h)  TOTAL  (Cont.  pages)      21. MAIL INVOICE TO:  a. NAME   PSC/FMS  b. STREET ADDRESS PSC_invoices@psc.hhs.gov  (or P.O.Box)        $[**]  17(i)  GRAND  TOTAL  c. CITY d. STATE e. ZIP CODE      22. UNITED STATES OF   AMERICA BY (Signature)   Crystal R. Reed- tweedy-S  23. NAME (Typed)   CRYSTAL R. REED-TWEEDY  TITLE:  CONTRACTING/ORDERING OFFICER        Digitally signed by Crystal R.   Reed-tweedy-S  Date: 2020.04.02 13:38:13 -04’00’  

 

    AUTHORIZED FOR LOCAL REPRODUCTION OPTIONAL FORM 347 (Rev.. 2/2012)  PREVIOUS EDITION NOT USABLE Prescribed by GSA/FAR 48 CFR 53.213(f)  

 

      ORDER FOR SUPPLIES OR SERVICES  SCHEDULE - CONTINUATION  PAGE OF   2  IMPORTANT: Mark all packages and papers with contract and/or order numbers.  DATE OF ORDER CONTRACT NO. ORDER NO.  04/02/2020 HHSO100201200004I 75A50120F33006  ITEM No.  (a)  SUPPLIES/SERVICES  (b)  QUANTITY  (c)  UNIT  (d)  UNIT  PRICE  (e)  AMOUNT  (f)  QUANTITY  ACCEPTED  (g)   Period of Performance: 04/02/2020 to  10/02/2021        1 ASPR- 2 0- 01770 -- Award of a Task  Order to  Emergent Product Development under  Emergent's current CIADM IDIQ contract  (HHSO100201200004I) to support  Development of a COVID-19 Therapeutic  Medical Countermeasure (COVID-HIG)  Delivery Location Code : HHS /OS/ ASPR  HHS/OS/ASPR  200 C St SW  WASHINGTON DC 20201 US  Amount : $[**]     [**]   2 OPTIONAL- Support of additional  clinical trial, including the supply of  at least [**] doses, plus storage and  shipping as required  Amount: $[**] (Option Line Item)  Delivery Location Code: HHS  HHS  200 Independence Avenue, SW  Washington DC 20201 US  Amount: $[**]  The total amount of award: $[**].  The obligation for this award is shown  in box 17(i).                                                             0.00           TOTAL CARRIED FORWARD TO 1ST PAGE (ITEM 17(H))  $[**]   AUTHORIZED FOR LOCAL REPRODUCTION OPTIONAL FORM 348 (Rev.. 4/2006)  PREVIOUS EDITION NOT USABLE Prescribed by GSA FAR (48 CFR) 53.213(f)  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 4 of 18    B. COST / PRICE SCHEDULE  Cost-Plus-Fixed Fee CLINS  Base CLIN Table  CLIN ITEM DESCRIPTION Cost Fee ([**]%) Cost Plus Fixed Fee  0001  • Collection of human plasma  containing antibodies to SARS-  CoV-2 sufficient to supply at least  [**] doses of drug product.  • cGMP manufacture of at least [**]  doses of drug product for use in a  controlled clinical trial;  manufacturing approach must be  amenable to commercial-scale  production within potential EUA  timeframe estimated to be [**];  stability testing as needed to support  clinical use.  • Development and  validation/qualification of assays as  required for screening, stability  testing, and manufacturing.  • Supportive nonclinical studies as  required for development of drug  product.  • Regulatory filings to FDA,  including formal interactions (e.g.,  Pre-IND) as necessary, IND  submission, and EUA submission  within targeted [**] of task order  award.  • Support of clinical trial through  drug supply, including storage and  shipping as required.  • Program management and reporting  as required.  [**] [**] [**]       

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 5 of 18    Option CLIN Table  CLIN ITEM DESCRIPTION Cost Fee ([**]%) Cost Plus Fixed Fee  0002  • Support of additional clinical trial,  including the supply of at least  [**] doses, plus storage and  shipping as required.  • Program management and  reporting as required.  [**] [**] [**]    Total Not to Exceed Amount $[**]    C. STATEMENT OF OBJECTIVES  C.1 Background  In December 2019, a novel (new) coronavirus known as SARS-CoV-2 (“the virus”) was  first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of  the coronavirus disease CO VID-19.  As a result of the virus’ global spread, HHS declared a  public health emergency for the U.S. on January 31, 2020 to aid the nation’s healthcare  community in responding to COVID-19.  On March 13, 2020, the President proclaimed that  the COVID-19 outbreak in the U.S. constitutes a national emergency.  Currently, there are no FDA-approved therapeutics for the treatment of COVID-19.  There is  great interest in evaluating the use of convalescent plasma and plasma-derived products as  therapeutics for COVID-19, given their historical use as treatments in other outbreaks.   Notably, the FDA recently published guidance on the investigational use of COVID-19  convalescent plasma under emergency INDs.  As part of the HHS’ response to COVID-19, BARDA is seeking solutions for the  manufacture and development of plasma-derived polyclonal antibody-based COVID-19  therapeutics for clinical evaluation, with potential for commercial-scale manufacture under  EUA.  C.2 Scope of Work (SOW)/Objectives  Independently and not as an agent of the US Government (USG), the Contractor shall  furnish all the necessary services, qualified personnel, materials, supplies, equipment and  facilities not otherwise provided by the USG as needed to perform the work described  below.     

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 6 of 18    The Contractor shall:  • Collect human plasma containing antibodies to SARS-CoV-2 sufficient to supply at least  [**] doses of drug product.  • Manufacture at least [**] doses of cGMP drug product for use in a controlled clinical  trial using an approach amenable to commercial-scale production within potential EUA  timeframe of [**], plus stability testing as required for clinical use.  The clinical trial is  anticipated to start within [**] of contract award.  • Develop and validate/qualify assays required for screening, manufacturing, and stability  testing as necessary.  • Conduct supportive nonclinical studies as required for development of drug product.  • Prepare and submit regulatory filings to FDA, including IND submission, and conduct  formal meetings (e.g., Pre-IND) with FDA as necessary.  EUA submission is targeted  within [**] of task order award.  • Support clinical trial(s) through the delivery of cGMP drug product (includes storage  and shipping) and all supporting information as required.  • Provide program management and reporting as required.  C.3 (SOW) Tasks  TASKS  The Contractor shall perform the following Tasks:  CLIN 0001: Manufacture and Development of Human Immune Globulin Drug  Product from Human Plasma for Clinical Evaluation  A. Collection of Human Plasma Containing Antibodies to SARS-CoV-2  The Contractor shall collect human plasma containing antibodies to SARS-CoV-2 which  will include utilizing FDA-approved plasma collection centers in the U.S. Collection  may rely on a [**].  The volume of plasma collected shall be sufficient to supply at least  [**] doses of final human immune globulin drug product.  B. Manufacture of at Least [**] doses of Human Immune Globulin Drug Product  The Contractor shall use the collected plasma to manufacture at least [**] doses of fill- finished human immune globulin final drug product under cGMP conditions.  The  manufacturing approach used should be scalable based on the availability and timing of  plasma collections, with potential to scale-up to commercial manufacturing within a  potential EUA timeframe of [**] from task order award.  A manufacturing process used  previously for FDA-approved human immune globulin products is preferred as a means  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 7 of 18    of reducing technical and regulatory risk.  The process should include purification and  viral inactivation/removal as necessary.  BARDA anticipates that the purified product  will be formulated as a liquid formulation.  The [**] doses of fill-finished drug product must be made available for clinical  evaluation; the clinical trial is expected to start within [**] of task order award.  The  Contractor must oversee storage and shipping of plasma, intermediates, and drug product  between facilities as required.  The Contractor must also conduct stability testing as  required to support clinical use of the product.  C. Development and Validation/Qualification of Assays to Support Screening and  Manufacturing  The Contractor shall develop assays as needed to support cGMP manufacturing,  including (but not limited to) in-process, release, and stability assays.  Potency assays  specific to SARS-CoV-2 will need to be developed based on either wildtype SARS- CoV-2 (will require [**]) or pseudotype virus (will require [**]).  The assays must be  qualified and/or validated as appropriate using available reference standards or positive  controls.  This shall include the production of all analytical documentation, training and  facility readiness required to support on-going testing.  In the event that assays are to be  subcontracted, the Contractor shall provide copies of the Supply and Quality  Agreements between the Prime Contractor and Subcontractor for review prior to  approval.  D. Conduct Supportive Nonclinical Studies as Required for Development of Drug Product  The Contractor shall conduct nonclinical studies to support the development of the  human immune drug product, including any as specified by FDA.  Supportive efficacy  studies in animal models (e.g., mice or ferrets) may also be warranted (for example, for  the submission of an EUA to FDA).  In the event that studies are to be subcontracted, the  Contractor shall provide copies of the Subcontractor Agreements between the Prime  Contractor and Subcontractor for review prior to approval.  E. Prepare and Submit Regulatory Filings to FDA (including IND Submission and EUA  Submission)  The Contractor shall prepare and submit regulatory filings to the FDA as required for the  development and clinical use of the human immune globulin drug product, including the  submission of an IND.  Preliminary discussions, including (but not limited to) Pre-IND  meetings, may be necessary to ensure FDA concurrence with regulatory strategy.   Following the conduct of a clinical trial(s) using the drug product, the Contractor should  also be prepared to support an expedited EUA submission within [**] of task order  award.  F. Support clinical trial through the delivery of cGMP drug product and all supporting  information as required.  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 8 of 18    The Contractor shall support the conduct of a clinical trial evaluating the safety and  efficacy of the human immune globulin drug product.  BARDA anticipates that the  clinical trial will be conducted in partnership with another entity (e.g., The National  Institutes of Health), who will oversee the clinical operations of the trial; the Contractor  is not expected to manage the clinical operations of the trial.  The Contractor is expected  to support the clinical trials through the supply of clinical trial material as necessary  (includes storage and shipping as necessary), while also providing all documentation and  information as required by the study sponsor.  G. Provide program management and reporting as required  This task shall reimburse the cost for managing the contract in connection with the  deliverables described in section F2.  Schedule of Deliverable below.  The following are  examples of those typically required: project plans, tech transfer plans, protocols,  validation reports, [**] and final reports.  Additionally, regular update meetings, ad hoc  meetings, periodic site visits and [**] site visits shall be included.  OPTIONAL TASKS  CLIN 0002 (Option): Support for Additional Clinical Trial  A. Support clinical trial through the delivery of cGMP drug product and all supporting  information as required.  The Contractor shall support the conduct of an additional a clinical trial evaluating the  safety and efficacy of the human immune globulin drug product.  The Contractor is  expected to support the clinical trials through the supply of clinical trial material (at least  [**] doses) as necessary (includes storage and shipping as necessary), while also  providing all documentation and information as required by the study sponsor  B. Provide program management and reporting as required  This task shall reimburse the cost for managing the contract in connection with the  deliverables described in section F2.  Schedule of Deliverable below.  The following are  examples of those typically required: project plans, tech transfer plans, protocols,  validation reports, [**] and final reports.  Additionally, regular update meetings, ad hoc  meetings, periodic site visits and [**] site visits shall be included.  D. PACKAGING AND MARKING (if applicable)  All deliverables shall be preserved, packaged, and packed in accordance with normal commercial  practices to meet the packaging requirements of the carrier, including that, which is necessary, to  prevent deterioration and damages due to the hazard of shipping, handling, and storing.  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 9 of 18    E. INSPECTION AND ACCEPTANCE  Inspection and acceptance of all work, performance, reports and other deliverables, under this task  order, will be performed at the Contractor’s facility or approved subcontractor facility, by the  Contracting Officer or the duly authorized representative of the Government.  The Contracting Officer’s Representative (COR) is a duly authorized representative of the  Government and is responsible for the inspection and acceptance of all items/activities to be  delivered and or completed under this task order.  F. PERFORMANCE / DELIVERABLES  F.1 Period of Performance  The period of performance for all optional tasks, if exercised, will fall within the Task Order award  date through eighteen (18) months.  Therefore, the entire period of performance for this task order will be eighteen (18) months  from task order issuance.  Period of performance for CLINs with stability testing beyond this date  will be adjusted as needed to accommodate completion.  The location of performance should be at the CIADM Contractor’s U.S.-based facility, unless  otherwise authorized by the Contracting Officer.  Subcontractors may be offered for specific tasks  (alternate facilities); however, the CIADM Contractor’s capability and capacity, as outlined in the  CIADM base contract, is the USG’s preferred location for executing the majority of this work    F.2 Schedule of Deliverables  Task Deliverable Title Format Deliverable Due Dates  CLIN0001/CLIN0002     CLIN0001/CLIN0002 Regular update  teleconferences  BARDA and Contractor  to determine format  First meeting will be [**]  post kick off meeting,  subsequent meetings will  be at a frequency (as short  as every [**]) to be agreed  by the Contractor and  BARDA  CLIN0001/CLIN0002 Meeting agenda and minutes  for teleconferences  Contractor-determined  format  Agenda – draft [**] before  teleconference; Minutes –  draft within [**] of  teleconference  CLIN0001/CLIN0002 [**] Status Report BARDA-provided  template [**], on [**] following period  CLIN0001/CLIN0002 Integrated Master Schedule Contractor-determined  format  Within [**] of contract  award, updated [**]  CLIN0001/CLIN0002 Incident Report Contractor-determined  format  Notification of incident  within [**]. Draft report  within [**] of incident, final  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 10 of 18    Task Deliverable Title Format Deliverable Due Dates  report within [**] of  resolution  CLIN0001/CLIN0002 Quality Assurance Plan Contractor-determined  format  Draft – [**]  Final – [**]   post contract award  CLIN0001/CLIN0002 Risk Management Plan / Risk  Register  Contractor-determined  format  Within [**] of contract  award; Risk Register  updated [**]  CLIN0001/CLIN0002  Detailed data regarding  locations where work will be  performed  Contractor-determined  format  Within [**] of contract  award, updated [**]  CLIN0001/CLIN0002  Detailed spreadsheet on critical  project materials that are  sourced from a location other  than the United States,  Contractor-determined  format  Within [**] of contract  award, updated [**]  CLIN0001/CLIN0002 Final Task Order Report and  Assessment  Contractor-determined  format  Draft – [**]  Final – [**]  post completion of task  CLIN0001/CLIN0002  Continuity of Operations Plan  (to continue operations in the  event of a declared pandemic  emergency)  Contractor-determined  format  Draft – [**]  Final – [**] \post award of  contract  CLIN0001     CLIN0001 Plasma Collection Plan  (including list of sources)  Contractor-determined  format  Draft – [**]  Final – [**]   post award of CLIN0001  CLIN0001 Reports for Plasma Collection Contractor-determined  format  Draft – [**]  Final – [**]   post completion of task  CLIN0001 Final Manufacturing Report Contractor-determined  format  Draft – [**]  Final – [**]   post completion of task  CLIN0001 Analytical Verification Protocols Contractor-determined  format  Draft – [**] prior to planned  execution  Final – [**] after protocol  execution  CLIN0001 Analytical Reports Contractor-determined  format  Draft – [**]  Final – [**]   post completion of task  CLIN0001 Validation Protocols Contractor-determined  format  Draft – [**] prior to planned  execution  Final – [**] after protocol  execution  CLIN0001 Validation Reports Contractor-determined  format  Draft – [**]  Final – [**]   post completion of task  CLIN0001 Fill / Finish Strategy Report Contractor-determined  format  Draft – [**]  Final – [**]   post award of CLIN0001  CLIN0001  Nonclinical Protocols (BARDA  approval needed prior to study  execution)  Contractor-determined  format  Draft – [**] prior to planned  execution  Final – [**] after study  execution  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 11 of 18    Task Deliverable Title Format Deliverable Due Dates  CLIN0001 Nonclinical Reports Contractor-determined  format  Draft – [**]  Final – [**]   post completion of task  CLIN0001  Regulatory Submissions to  FDA (e.g., Meeting Requests,  Briefing Books, etc.)  Contractor-determined  format  Draft – [**] prior to  submission to FDA (or as  agreed-to by the COR)  Final – [**] post submission  to FDA  CLIN0001 Investigation New Drug (IND)  Application  Contractor-determined  format  Draft – [**] prior to  submission to FDA (or as  agreed to by the COR),  within [**] post award of  CLIN0001  Final – [**] post submission  to FDA  CLIN0001  Information supporting  Emergency Use Authorization  (EUA) Request  BARDA-determined  format  Within [**] of BARDA’s  request  CLIN0001  Documentation of drug product  as requested by Sponsor of  Clinical Trial  Determined by Sponsor  of clinical trial  Final – [**] post submission  to trial sponsor  CLIN0001  Documentation of delivery of  batch of fill-finished drug  product for clinical trials  Determined by Sponsor  of clinical trial  Final – [**] post submission  to trial sponsor  CLIN0001  Confirmation of cumulative  availability of at least [**] doses  of fill-finished drug product  Contractor-determined  format  Final – [**] post completion  of task  CLIN0002 (Option)     CLIN0002 (Option)  Regulatory Submissions to  FDA (e.g., Meeting Requests,  Briefing Books, etc.)  Contractor-determined  format  Draft – [**] prior to  submission to FDA  Final – [**] post submission  to FDA  CLIN0002 (Option)  Documentation of drug product  as requested by Sponsor of  Clinical Trial  Determined by Sponsor  of clinical trial  Final – [**] post submission  to trial sponsor  CLIN0002 (Option)  Documentation of delivery of  batch of fill-finished drug  product for clinical trials  Determined by Sponsor  of clinical trial  Final – [**] post submission  to trial sponsor  CLIN0002 (Option)  Confirmation of cumulative  availability of at least [**]  (additional) doses of fill- finished drug product  Contractor-determined  format  Final – [**] post completion  of task       

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 12 of 18    Meetings  Routine Update Teleconferences  The CIADM shall participate in regular teleconferences with USG to discuss the performance of the  task order.  The frequency will be agreed upon by the CIADM and USG and may be dependent on  the activities during that time of the task order.  Typically, these meetings are held [**] or [**].  The  CIADM shall keep meeting minutes and forward a finalized copy to the Contracting Officer (CO)  and Contracting Officer’s Representative (COR) for approval within [**] after each teleconference,  or as otherwise authorized by the Contracting Officer.  Person-in-Plant  CIADM shall accommodate up to [**] BARDA personnel at any given time throughout the  performance of this task order.  On-site BARDA personnel will provide oversight of the work and  real-time technical direction per guidance from the BARDA program office in Washington, D.C.  Periodic Site Visits  The CIADM shall accommodate for periodic site visits by USG on an ad hoc basis.  The CIADM  shall keep meeting minutes and forward a finalized copy to the Contracting Officer and COR for  approval within [**] after each site visit, or as otherwise authorized by the CO.  [**] Site Visits  The CIADM shall provide formal presentations summarizing all work accomplished in the previous  calendar quarter at the CIADM’s site on a [**] basis.  The CIADM shall keep meeting minutes and  forward a finalized copy to the CO and COR for approval within [**] after each site visit, or as  otherwise authorized by the CO.  Kick-Off Meeting  The Contractor shall participate in a kick-off meeting, within [**] of task order award; content,  format and location to be determined by the USG and the Contractor.  The Contractor shall keep  meeting minutes and forward a finalized copy to the Contracting Officer and COR for approval  within [**] after the meeting is held, or as otherwise authorized by the Contracting Officer.     

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 13 of 18    G. CONTRACT ADMINISTRATION  G.1 Government Personnel  (a) Contracting Officer  [**]  ASPR/BARDA/CMA  O’Neill House Office Building  Washington, DC 20015  Email: [**]  Phone: [**]  The Contracting Officer is the only individual who can legally commit the Government to the  expenditure of public funds.  No person other than the Contracting Officer can make any changes to  the terms, conditions, general provisions or other stipulations of this Task Order.  The Contracting Officer is also the only individual with authority to act as agent of the Government  under this Task Order, with authority to (1) direct or negotiate any changes in the statement of  work, (2) modify or extend the period of performance, (3) authorize reimbursement to the  Contractor for any costs incurred during the performance of this Task Order and/or (5) otherwise  change any terms and conditions of this Task Order.  (b) Contracting Officer’s Representative  [**]  ASPR/BARDA  24H26, O’Neill House Office Building   Washington, DC 20515   Email: [**]  Phone: [**]  [**]  ASPR/BARDA  O’Neill House Office Building  Washington, DC 20515  Email: [**]  Phone: [**]     

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 14 of 18    G.2 Invoicing Instructions  Invoices for payment shall be submitted as two (2) hard copies and one (1) electronic copy to the  following address, and shall include SF-1034.  In addition, for Cost Plus Fixed Fee (CPFF) CLINs,  the CIADM shall provide supporting documentation with the invoice to support all claimed costs.   This includes an itemized breakdown of all associated costs such as labor classification, labor hours,  labor rate, indirect costs, timecards, etc.  This shall be provided for the CIADM (prime contractor)  and all subcontractors.  Further invoicing details are included in Section G of the base CIADM  contract.  [**]  ASPR/BARDA/CMA  O’Neill House Office Building   Washington, DC 20515  Email: [**]  Phone: [**]  The Government may request additional information (timecards, receipts, etc.) to support costs  claimed in the Contractor’s invoices.  G.3 Evaluation of Contractor Performance  (a) Purpose:  In accordance with FAR 42.1502(a), past performance evaluations shall be  prepared at least [**] and at the time the work under a contract or order is completed, via  CPARS, the Government-wide evaluation tool (www.cpars.gov).  (b) Evaluators:  The performance evaluation will be completed jointly by the Contracting  Officer’s Representative and the Contracting Officer.  (c) Performance Evaluation Factors:  Per FAR 42.1503(b)(2), evaluation factors for each  assessment shall include, at a minimum:  technical (quality of product or service); cost  control; schedule/timeliness; management and business relations; small business  subcontracting; other (as applicable).  (d) Contractor Review:  A copy of the evaluation will be electronically sent to the  Contractor as soon as practicable after completion of the evaluation.  The Contractor  shall submit comments, rebutting statements, or additional information to the  Contracting Officer within [**] after receipt of the evaluation.  (e) Resolving Disagreements between the Government and the Contractor:  Disagreements  between the parties regarding the evaluation will be reviewed at a level above the  Contracting Officer.  The ultimate conclusion on the performance evaluation is a  decision of the contracting agency.  Copies of the evaluation, Contractor’s response, and  review comments, if any, will be retained as part of the evaluation.  (f) Release of Contractor Performance Evaluation Information:  The completed evaluation  will not be released to other than Government personnel and the Contractor whose  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 15 of 18    performance is being evaluated.  Disclosure of such information could cause harm both  to the commercial interest of the Government and to the competitive position of the  Contractor being evaluated, as well as impede the efficiency of Government operations.  (g) Source Selection Information:  Departments and agencies may share past performance  information with other Government departments and agencies when requested to support  future award decisions.  The information may be provided through interview and/or by  sending the evaluation and comment document to the requesting source selection  official.  (h) Retention Period:  The agency will retain past performance information for a maximum  period of [**] after completion of contract performance for the purpose of providing  source selection information for future contract awards.    H. SPECIAL REQUIREMENTS  H.1 Intellectual Property  Execution of a task order may require a relationship between HHS, the firm that possesses rights to  specific Intellectual Property (IP) required for the development effort (the “MCM IP Holder”), and  the firm providing the Core Services under the task order (the “CIADM”).  The relationship must  reflect the Parties’ rights to all IP developed and/or IP used in performance of the task order, and be  consistent with HHS’ IP rights per the Federal Acquisition Regulations (FAR) clauses described in  the base contract.  Prior to any performance of work, the MCM IP Holder and/or the CIADM shall  provide the Contracting Officer with a written description of all IP necessary to develop (the  “Description”).  The Description must identify the basis for offering HHS less than unlimited rights  to any pre-existing IP identified in the Description that will be utilized in performance of the task  order.  The Description shall also include written verification of the rights provided to HHS to any  and all IP utilized or developed during performance of the task order as specified under FAR Clause  52.227-11, FAR Clause 52.227-11 as amended in any applicable subcontract and/or teaming  agreement related to performance of the task order, FAR Clause 52.227-14 and FAR Clause 52.227- 14 as amended in any applicable subcontract and/or teaming agreement (the “FAR Clauses”).  The MCM IP Holder and the CIADM will remain free to negotiate any agreement of their own  regarding their use of any of the IP utilized or developed during performance of an task order, so  long as the negotiated agreement complies with the requirements under the FAR Clauses, and the  terms contained in the agreement do not otherwise adversely affect the performance of work under  the task order.  The agreement shall be furnished to the Contracting Officer within [**] after the  agreement is finalized.  In addition, this task order incorporates FAR Clause 52.227-1 Authorization  and Consent (DEC 2007) and FAR Clause 52.227-3 Patent Indemnity (APR 1984).     

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 16 of 18    H.2 Key Personnel  Key personnel specified in this task order are considered to be essential to work performance.  At  least [**] prior to the Contractor voluntarily diverting any of the specified individuals to other  programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a  justification for the diversion or replacement, and a request to replace the individual.  The request  must identify the proposed replacement and provide an explanation of how the replacement’s skills,  experience and credentials meet or exceed the requirements of the contract (including, when  applicable, Human Subjects Testing requirements).  If the employee of the Contractor is terminated  for cause or separates from the Contractor voluntarily with less than [**] notice, the Contractor  shall provide the maximum notice practicable under the circumstances.  The Contractor shall not  divert, replace or announce any such change to key personnel without the written consent of the  Contracting Officer.  The task order will be modified to add or delete key personnel as necessary to  reflect the agreement of the parties.  The following individuals are determined to be key personnel.  The offeror may list other  individual(s) it deems would fall under the Key Personnel category, for USG evaluation.    Name Title  [**] [**]  [**] [**]  [**] [**]  [**] [**]  [**] [**]    H.3 Personnel Qualifications  The offeror shall provide curriculum vitae (CV) for each individual specified in its proposal as key  personnel.  The CV shall clearly describe the individual’s knowledge, work experiences,  registrations, and certifications, and applicable experience.  The CV shall include a summary  describing the individual’s involvement in similar work.  H.4 Consultants and Sub-Contractors  If the Contractor determines that the use of Subcontractors or Consultants is needed, the Contractor  is directed to submit a Contracting Officer’s Authorization request.  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 17 of 18    H.5 No Personal Services or Inherently Governmental Function  Pursuant to FAR 37.1, no personal services shall be performed under this contract.  All work  requirements shall flow only from the COR to the Contractor’s Project Manager.  No Contractor  employee will be directly supervised by the Government.  All employee assignments, and daily  work direction, shall be given by the applicable Contractor supervisor.  If the Contractor believes  any Government action or communication has been given that would create a personal services  relationship between the Government and any Contractor employee, the Contractor shall promptly  notify the Contracting Officer of this communication or action.  Pursuant to FAR 7.5, the Contractor shall not perform any inherently governmental actions under  this contract.  No Contractor employee shall hold him or herself out to be a Government employee,  agent, or representative.  No Contractor employee shall state orally or in writing at any time that he  or she is acting on behalf of the Government, hi all communications with third parties in connection  with this contract, Contractor employees shall identify themselves as Contractor employees and  specify the name of the company for which they work.  In all communications with other  Government Contractors in connection with this contract, the Contractor employee shall state that  they have no authority to in any way change this contract and that if the other Contractor believes  this communication to be a direction to change their contract, they shall notify the Contracting  Officer for that contract and not carry out the direction until a clarification has been issued by the  Contracting Officer.  The Contractor shall ensure that all of its employees working on this contract are informed of the  substance of this article.  Nothing in this article shall limit the Government’s rights in any way  under the other provisions of this contract, including those related to the Government’s right to  inspect and accept the services to be performed under this contract.  The substance of this article  shall be included in all subcontracts at any tier.    H.6 ADDITIONAL TERMS AND CONDITIONS  The terms and conditions applicable to this Task Order Award are as follows:  References:  • Base Contract Number: HHSO 1002012000041  • Task Order (TO) Award Number: 75A50120F33006  • HHS reserves the right to exercise priorities and allocations authority with respect to this  task order, to include rating this order in accordance with 45 CFR Part 101, Subpart A— Health Resources Priorities and Allocations System.  Documents Incorporated By Reference:  1. Proposal dated March 20, 2020  2. Revised price proposal dated March 31, 2020  

 

Task Order: 75A50120F33006  (Contract No. HHSO100201200004I)    Page 18 of 18    I. FAR/HHSAR CONTRACT CLAUSES  I.1 52.232-2 Clauses Incorporated by Reference  All clauses incorporated in the base contract are in full effect at the task order level.  This section or  other parts of this TOR may incorporate one or more clauses by reference, with the same force and  effect as if they were given in full text.  Upon request, the Contracting Officer will make their full  text available.  In addition, the full text of a clause may be accessed electronically at this address:  https://www.acquisition.gov/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.  Exhibit 10.9  Electronically signed by Syed T Husain  Reason: I approve this document  Date: April 7, 2021 00:00 EDT  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES  1 2 2. AMENDMENT/MODIFICATION NO. P00001 3. EFFECTIVE DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. OS273315 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE ASPR/BARDA 7. ADMINISTERED BY (If other than Item 6)    CODE ASPR-BARDA02  ASPR/BARDA  200 Independence Ave., S.W.  Room 640-G  Washington DC 20201  ASPR-BARDA  330 Independence Ave, SW, Rm G640  Washington DC 20201  8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (x) 9A. AMENDMENT OF SOLICITATION NO.  EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC  EMERGENT MANUFACTURING OPERATIONS B  5901 E LOMBARD ST  BALTIMORE MD 212246824  9B. DATED (SEE ITEM 11)  x 10A. MODIFICATION OF CONTRACT/ORDER NO.  HHSO100201200004I  75A50120F33006  10B. DATED (SEE ITEM 13)  CODE    1410445 FACILITY CODE  04/02/2020  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: $[**]  2020.199COV2.25103 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 data, 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: FAR. 52.232-20, (i) Limitation of cost of funds.  D. OTHER (Specify type of modification and authority) 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:  [**] This is Modification No. P00001 to Contract No. 75A50120F33006. The purpose of this modification is to add funds to cover plasma acquisition costs for the manufacture of anti-SARS-CoV-2 hyperimmune globulin. Accordingly, the following changes are made to the contract: A. Add Supplemental Funds to CLIN 0001 in the amount $[**] in supporting manufacturing of hyperimmune globulin for NIH-sponsored clinical trials. B. The value if CLIN 0001 was $[**], increased by $[**], as a result of this modification, new total for CLIN 0001 is now $[**]. C. Replace Contract Officer (CO) under section (G) Contract Administration, G.1.(a) government Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.  15A. NAME AND TITLE OF SIGNER (Type or print).  Syed T Husain SVP and CDMO BU Head  16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)  MONICA WATSON  15B. CONTRACTOR/OFFEROR  /s/ Syed T Husain  (Signature of person authorized to sign)  15C. DATE  SIGNED  Apr 7, 2021  16B. UNITED STATES OF AMERICA  /s/ Monica Watson  (Signature of Contracting Officer)  16C. DATE SIGNED  STANDARD FORM 30 (Rev. 11/2016)  Digitally signed by Monica Watson -S  Date: 2021.04.12 15:44:23 -04’00’  

 

    Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243  

 

      CONTINUATION  SHEET  REFERENCE NO. OF DOCUMENT BEING CONTINUED  HHSO100201200004I/75A50120F33006/P00001  PAGE OF   2 2  NAME OF OFFEROR OR CONTRACTOR  EMERGENT MANUFACTURING OPERATIONS BALTIMORE LLC 1410445  ITEM No.  (A)  SUPPLIES/SERVICES  (B)  QUANTITY  (C)  UNIT  (D)  UNIT  PRICE  (E)  AMOUNT  (F)                          1  personnel. Contract Officer [**] is being replaced by  [**]  D:  All other terms and conditions remain the same.  Appr. Yr.: 2020 CAN:  199COV2 Object Class: 25103  Period of Performance: 04/02/2020 to 10/02/2021    Change Item 1 to read as follows (amount shown is  the obligated amount) :      ASPR-20-01770 – Award of a Task Order to Emergent  Product Development under Emergent's current  CIADM IDIQ contract (HHSO100201200004I) to  support Development of a COVID-19 Therapeutic  Medical Countermeasure (COVID-HIG)                                                                                       [**]  NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)   Sponsored by GSA FAR (48 CFR) 53.110

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