**Exhibit 10.45.1**

 

**PharmAthene, Inc.**

**Confidential Materials Omittedand Filed Separately with the Securities and Exchange Commission**

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|  | AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT  ID CODE N/A Page 1 of 32 2. AMENDMENT/MODIFICATION NO. Modification 0016 3.  EFFECTIVE DATE See Item 16 4. REQUISITION/PURCHASE REQ. NO N/A 5. PROJECT NO.  (If applicable) N/A 6. ISSUED BY CODE N/A 7. ADMINISTERED BY (IF OTHER THAN  ITEM 6) CODE N/A U.S. DEPT OF HEALTH & HUMAN SERVICES ASPR/BARDA 330  INDEPENDENCE AVESW, ROOM G640 WASHINGTON, D.C. 20201 See Item 6 8. NAME AND  ADDRESS OF CONTRACTOR (No., Street, County, State, and Zip Code) PharmAthene  UK, Limited VIN: (1148448) Johnson Matthey Building PO Box 88, Haverton Hill  Road Billingham, TS 23 1 XN UK  9A.  AMENDMENT OF SOLICITATION NO. 9B. DATED (SEE ITEM 11) 10A. MODIFICATION OF  CONTRACT/ORDER NO. HHS0100200900103C CODE: N/A FACILITY CODE: N/A 10B. DATED  (SEE ITEM 11) 9/1/2003 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF  SOLICITATIONS  The above numbered,  solicitation is amended as set forth in Item 14. The hour and date specified  for receipt of Offers  is extended  is not extended. Offers must acknowledge  receipt of this amendment prior to the hour and date specified in the  solicitation or as amended by one of the following methods: (a) By completing  Items 8 and 15, and returning copies of the amendment; (b) By acknowledging  receipt of this amendment on each copy of the offer submitted; or (c) By  separate letter or telegram which includes a reference to the solicitation  and amendment numbers, FAILURE OF YOUR 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)  CAN:    Appropriation:   O.C.    Obiligation 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF  CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO., AS DESCRIBED IN ITEM 14  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: FAR 1.602-1,  52,243-2 Changes – Cost Reimbursement – Alt V (APR 1984) D. OTHER (Specify  type of modification and authority) E. IMPORTANT: Contractor  is NOT is required to sign this document  and return 1 copy to the issuing office. 14. DESCRIPTION OF  AMENDMENT/MODIFICATION (Organized by UCF section headings, including  solicitation/contract subject matter where feasible. The purpose of this  modification is to reduce the Scope of Work performed under this control. The  total estimated to complete remains unchanged at $32,458,052. Period of  Performance is changed from 6/30/2011 to 3/31/2011. Total Funds Currently  Allotted Cost Fco Total Prior to this MOD: This Modification Revised Total  $117,736,200.00 Contract Funded through date: 3/31/2011. Except as provided  hereto, 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 VICE PRESIDENT 16A. NAME AND TITLE OF  CONTRACTING OFFICER Darrick A. Eady, Contracting Officer 15B.  CONTRACTOR/OFFEROR VICE PRESIDENT (Signature of person authorized to sign)  15C. DATE SIGNED 10/9/09 16B. UNITED STATES OF AMERICA (Signature of  Contracting Officer) 16C. DATE SIGNED 10/9/09 NSN 7540-01-152-8070 STANDARD  FORM 30 (REV. 10-83) Previous Edition Unusable Prescribed by GSA FAR (48 CFR)  53.243 |
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|  | 2 Contract No: HHSO100200900103C Modification No: 0016 SECTION B  – SUPPLIES OR SERVICES AND PRICE/COSTS ARTICLE B.2. ESTIMATED COST AND FIXED  FEE has been modified to read as follows. a. The estimated cost for this  contract is b. The Fixed fee for this contract is $ The fixed fee shall be  paid in installments based on the negotiated milestones set forth in ARTICLE  B.4.h. and subject to the withholdings provisions of the ALLOWABLE COST AND  PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II,  Article 1.1 of this contract. Payment of fixed fee shall not be made in less  than monthly increments. c. The Government’s obligation, represented by the  sum of the estimated cost plus fixed fee is $117,736,200. d. Total funds  currently available for payment and allotted to this contract modification  are of which represents the estimated costs, and of which is this fixed fee.  These funds cover the start dates for Milestones 1, 2, 3, 4, 5, 6, Program  Management and EVMS. For further provision on funding, see the LIMITATIONS OF  COSTS clause referenced in PART II, ARTICLE 1.2. Authorized Substitutions of  Clauses. e. It is estimated that the amount currently allotted will cover  performance of contract through June 30 of 2011. ARTICLE B.4. ADVANCE  UNDERSTANDINGS, in accordance FAR 52.244-2 (approval of subcontractor) paragraph  a, b, c, d, e, f, Subcontracts have been deleted in it entirety and replaced  with the following. Any future subcontract awards or modification to existing  subcontracts that fall within the requirements of FAR Section 52.244-2 shall  not proceed without the prior written approval of the Contracting Officer  upon review of the supporting documentation and the draft subcontract as  required by the Subcontract clause in this contract. After written approval  of the Subcontract by the Contracting Officer, a copy of the signed, approved  subcontract shall be provided to the Contracting Officer. a. A firm-fixed  price subcontract between PharmAthene and for an amount not to exceed or  continued development of rPA vaccine is hereby approved by the Contracting  Officer. The period of performance is (04/01/2009 to 12/31/2010). This  approval includes the following scope of work: V9-Final |
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|  | 3 MS1; BDS Stability HPPS Analysis, On-going Stability Lot  B2272/008, Time Points T=24 and T=36 months (WBS 1.1.1) FDP Stability CD, SDS-PAGE,  Fluorescence Analysis, On-going Stability Lot 907616, Time Points 18, 21, 24,  27, 30, 33, and 36 months (WBS 1.2.1) MS4; Reference standard Lot B2272-007,  2009 re-qualification HPPS assay (WBS 4.1.5) Reference standard Lot  B2272-012, 2009 Qualification HPPS assay (WBS 4.1.5) Reference standard Lot  B2272-012, 2010 re-qualification HPPS assay (WBS 4.1.5) MS6; Support for  technology transfer of BDS and assays to Diosynth (WBS 6.10) Shipment and  disposal (WBS 6.1) MS7; Report activity progress to timeline and impact of  variances to schedule at the milestone level (EVMS) b. A firm-fixed price  subcontract between PharmAthene and for an amount not to exceed hereby  approved by the Contracting Officer. The period of performance is (04/01/2009  to 12/31/2010). This approval encompasses the following scope of work: MS2;  Immunopotency development studies (WBS 2.2.2) MS7; Report activity progress  to timeline and impact of variances to schedule at the milestone level (EVMS)  c. A firm-fixed price subcontract between PharmAthene and for an amount not  to exceed is hereby approved by the Contracting Officer. The period of  performance is (04/01/2009 to 12/31/2010). This approval encompasses the  following scope of work: MS1; Shipping (WBS 1.2.10) MS7; Report activity progress  to timeline and impact of variances to schedule at the milestone level (EVMS)  d. A firm-fixed price subcontract between PharmAthene and for an amount not  to exceed hereby approved by the Contracting Officer. The period of  performance is (04/01/2009 to 12/31/2010). This approval encompasses the  following scope of work: MS1; Storage (WBS 1.2.9) MS7; Report activity  progress to timeline and impact of variances to schedule at the milestone  level (EVMS)  |
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|  | 4 A firm-fixed price subcontract between PharmAthene an for an  amount not to exceed hereby approved by the Contracting Officer. The period  of performance is (04/01/2009 to 12/31/2010). This approval encompasses the  following scope of work: MS1; FDP stability sterility testing, time point 24  and 36 months (WBS 1.2.1) FDP CTM l00ug dose stability sterility testing,  time point 12 months (WBS 1.2.2) FDP CTM 50ug dose stability sterility  testing, time point 12 months (WBS 1.2.3) High phosphate diluent CTM  stability sterility testing, time point 12 months (WBS 1.2.6) Sample storage  (WBS 1.2.11) MS3; FDP CTM 100ug dose GMP documents, media fill, raw material  procurement & release, development, lot manufacture, lot testing, and  release (WBS 3.1) FDP CTM 50ug dose GMP documents, raw material procurement &  release, development, lot manufacture, lot testing, and release (WBS 3.2)  High phosphate diluent CTM lot manufacture, lot testing, and release (WBS  3.4) FDP VMP (WBS 3.6) Storage (WBS 3.7) MS4; FDP Phosphate Analysis  Development and Validation (WBS 4.2.2) MS7; Report activity progress to  timeline and impact of variances to schedule at the milestone level (EVMS) f.  A firm-fixed price subcontract between PharmAthene and for an amount not to  exceed hereby approved by the Contracting officer. The period of performance  is (04/01/2009 to 12/31/2009). This approval encompasses the following scope  of work: MS3; Order and ship Alhydrogel (WBS 3.5) g. A firm-fixed price  subcontract between PharmAthene and for an amount not to exceed is hereby  approved by the Contracting Officer. The period of performance is (04/01/2009  to 12/31/2010). This approval encompasses the following scope of work: MS3;  Mixing Study Protocol(s) (WBS 3.5.3) Process Solution Protocol(s) (WBS 3.5.4)  Demonstration Batch Protocol(s) (WBS 3.5.10) FDP Master Validation Plan (WBS  3.6.2) FDP Draft Process Validation Protocol (WBS 3.6.3) FDP  Leachables/Extractables Studies (WBS 3.6.7) MS6; BDS Master Validation Plan  (WBS 6.6) Support technology transfer to Diosynth (WBS 6.11) |
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|  | 5 A firm-fixed price subcontract between PharmAthene and for an  amount not to exceed is hereby approved by the Contracting Officer. The  period of performance is (04/01/2009 to 9/30/2009). This approval encompasses  the following scope of work: MS3; Test and release Alhydrogel for 2009, provide  CoA (WBS 3.5) i. A firm-fixed price subcontract between PharmAthene and Inc  for an amount not to exceed hereby approved by the Contracting Officer. The  period of performance is (04/01/2009 to 3/31/2010). This approval encompasses  the following scope of work: MS2; MCLA 2nd degraded material study, analysis  and report on data from HPA (WBS 2.1.1) MCLA installation at HPA (WBS 2.1.1)  MCLA operation efficiency studies, analysis and report on data from HPA (WBS  2.1.1) MCLA validation protocol (WBS 2.1.1) MCLA interim specification DOE  settings to HPA, analysis and report on data from HPA (WBS 2.1.1) MCLA  validation studies, analysis and report of results (WBS 2.1.1) MS7; Report  activity progress to timeline and impact of variances to schedule at the milestone  level (EVMS) j. A firm-fixed price subcontract between PharmAthene and for an  amount not to exceed is hereby approved by the Contracting Officer. The  period of performance is (04/01/2009 to 12/31/2010). This approval  encompasses the following scope of work: MS4; consulting services for assay  development MS6; consulting services for process transfer to Diosynth MS7;  Report activity progress to timeline and impact of variances to schedule at  the milestone level (EVMS) k. A firm-fixed price subcontract between  PharmAthene and for an amount not to exceed is hereby approved by the  Contracting Officer. The period of performance is (04/01/2009 to 12/31/2010).  This approval encompasses the following scope of work: MSI; BDS stability  physical and chemical testing, Lot B2272/008, Storage, Appearance, pH,  SDSPAGE, IEF, TVC, Time Points T=24 and 36 months (WBS 1.1.1) FDP stability  physical and chemical testing, Lot 907616, Storage, Appearance, pH, UBA,  Osmolality, Time Points T=18 and 21 months (WBS 1.2.1) FDP stability physical  and chemical testing, Lot 907616, Storage, Appearance, pH, UBA, Osmolality,  SDS Des, Time Points T=24, 27, 30, 33 and 36 months (WBS 1.2.1) |
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|  | 6 FDP CTM l00ug dose stability physical and chemical testing,  Storage, Appearance, pH, UBA, Osmolality, SDS Des, Time Points T=0, 3, 6, 9  and 12 months (WBS 1.2.2) FDP CTM 50ug dose stability physical and chemical  testing, Storage, Appearance, pH, UBA, Osmolality, SDS Des, Time Points T=0,  3, 6, 9 and 12 months (WBS 1.2.3) High phosphate diluent CTM stability  physical and chemical testing, Storage, Appearance, pH, Osmolality, Time  Points T=0, 3, 6, 9 and 12 months (WBS 1.2.6) Sample storage (WBS 1.2.10)  MS4; BDS stability appearance, A280, SDS-PAGE, TVC, and IEF assay validation  (WBS 4.2.2) Reference standard Lot B2272-007, 2009 re-qualification (WBS  4.1.5) Reference standard Lot B2272-012, 2009 Qualification (WBS 4.1.5)  Reference standard Lot B2272-012, 2010 re-qualification (WBS 4.1.5) MS7;  Report activity progress to timeline and impact of variances to schedule at  the milestone level (EVMS) l. A firm-fixed price subcontract between  PharmAthene and for an amount not to exceed is hereby approved by the  Contracting Officer. The Period of performance is (04/01/2009 to 12/31/2010).  This approval encompasses the following scope of work: MS2; MCLA installation  at HPA (WBS 2.1.1) MCLA HPA software validation protocol, execution, and  report (WBS 2.1.1) MS7; Report activity progress to timeline and impact of  variances to schedule at the milestone level (EVMS) m. A firm-fixed  pricesubcontract between PharmAthene and for an amount not to exceed is  hereby approved by the Contracting Officer. The period of performance is  (10/01/2009 to 3/31/2011). Award of the subcontract shall not proceed without  the prior written approval of the Contracting Officer upon review of the  supporting documentation and the draft subcontract as required by the  Subcontracts clause of the General Clauses incorporated in this contract.  After written approval of the subcontract by the Contracting Officer, a copy  of the signed, approved subcontract shall be proved to the Contracting  Officer. This approval will encompass the following scope of work: MS4; HPPS  release and stability assay validation (WBS 4.1.3) LC-MS/MS Method  Development and validation Activities (WBS 4.1.4) MS6; Upstream process  transfer and development (WBS 6.5) Downstream process transfer and  development (WBS 6.5) Transfer of Analytical method (WBS 6.4) Transfer of  validated assays (WBS 6.4) 140L demonstration batches (WBS 6.5) Scale-up,  pre-production, and 3000L run (WBS 6.7) 3000L GMP run (WBS 6.8) Validation  master plan (WBS 6.6) Analytical method validation (WBS 6.4) |
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|  | 7 Small Scale Process Characterization (6.12) MS7; Report  activity progress to timeline and impact of variances to schedule at the  milestone level (EVMS) A firm-fixed price subcontract between PharmAthene and  for an amount not to exceed is hereby approved by the Contracting Officer.  The period of performance is (04/01/2009 to 12/31/2010). This approval encompasses  the following scope of work: MS1; BDS stability challenge potency testing,  Lot B2272/008, Time Points T=24 and 36 months (WBS 1.l.l) FDP stability  challenge potency testing, Lot 907616, Time Points T=18, 21, 24, 27, 30, 33  and 36 months (WBS 1.2.1) FDP CTM l00ug dose stability challenge potency  testing, Time Points T=0, 3, 6, 9 and 12 months (WBS 1.2.2) FDP CTM 50ug dose  stability challenge potency testing, Time Points T=0, 3, 6, 9 and 12 months  (WBS 1.2.3) MS2; FDP Mouse Challenge Potency Assay Development Plan and  Studies (WBS 2.2.1) MS3; FDP CTM l00ug dose mouse challenge potency testing,  Time Point T=0 months (WBS 3.1) FDP CTM 50ug dose mouse challenge potency  testing, Time Point T=0 months (WBS 3.2) MS7; Report activity progress to  timeline and impact of variances to schedule at the milestone level (EVMS) o.  A firm-fixed price subcontract between PharmAthene and for an amount not to  exceed hereby approved by the Contracting Officer. The period of performance  is (04/01/2009 to 9/30/2009). This approval encompasses the following scope  of work: MS6; MSDS (WBS 6.5) MS7; Report activity progress to timeline and  impact of variances to schedule at the milestone level (EVMS) A firm-fixed  price subcontract between PharmAthene and for an amount not to exceed $ is  hereby approved by the Contracting Officer. The period of performance is  (04/01/2009 to 12/31/2010). This approval encompasses the following scope of  work: MS2; Immunopotency development studies (WBS 2.2.2) MS3; FDP CTM l00ug  dose general safety testing (WBS 3.1) FDP CTM 50ug dose general safety  testing (WBS 3.2) MS7; Report activity progress to timeline and impact of  variances to schedule at the milestone level (EVMS) |
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|  | 8 A firm-fixed price subcontract between PharmAthene and for an  amount not to exceed is hereby approved by the Contracting Officer. The  period of performance is (04/01/2009 to 12/31/2010). This approval  encompasses the following scope of work: MS1; BDS stability MCLA testing, Lot  B2272/008, Time Point T=36 months (WBS l.l.1) MS2; MCLA Assay development and  validation (WBS 2.1.1) MS4; Reference standard re-qualification (WBS 4.1.5)  MS6; Operation of Process at Intermediate Scale, MCLA testing (WBS 6.5)  Process Scale up Campaign (3 runs), MCLA testing (WBS 6.7) MS7; Report  activity progress to timeline and impact of variances to schedule at the  milestone level (EVMS) A firm-fixed price subcontract between PharmAthene and  for an amount not to exceed is hereby approved by the Contracting Officer.  The period of performance is (04/01/2009 to 12/31/2010). This approval  encompasses the following scope of work: MS1; BDS stability physical and  chemical testing, Lot B 2272/008, Time Points T=24 and 36 months (WBS 1.1.1)  FDP stability physical and chemical testing, Lot 907616, Time Points T=18, 21,  24, 27, 30, 33 and 36 months (WBS 1.2.1) FDP CTM l00ug dose stability  physical and chemical testing, Time Points T=0, 3, 6, 9 and 12 months (WBS  1.2.2) FDP CTM 50ug dose stability physical and chemical testing, Time Points  T=0, 3, 6, 9 and 12 months (WBS 1.2.3) MS4; Reference standard  re-qualification (WBS 4.1.5) MS7; Report activity progress to timeline and  impact of variances to schedule at the milestone level (EVMS) s. A firm-fixed  price subcontract between PharmAthene an amount not to exceed hereby approved  by the Contracting Officer. The performance is (04/01/2009 to 12/31/2010).  This approval encompasses the following scope of work: MS4; Reference  standard re-qualification (WBS 4.1.5) MS7; Report activity progress to  timeline and impact of variances to schedule at the milestone level (EVMS) |
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|  | 9 A firm-fixed price subcontract between PharmAthene and or an  amount not to exceed is hereby approved by the Contracting Officer. The  period of performance is (04/01/2009 to 12/31/2010). This approval encompasses  the following scope of work: MS6; Office space for PTN RTP support team MS7;  Report activity progress to timeline and impact of variances to schedule at  the milestone level (EVMS) A firm-fixed price subcontract between PharmAthene  an for an amount not to exceed is hereby approved by the Contracting Officer.  The period of performance is (04/01/2009 to 12/31/2010). This approval  encompasses the following scope of work: MSI; BDS stability challenge potency  statistics, Lot B 2272/008, Time Points T=24 and 36 months (WBS 1.1.1) FDP  stability challenge potency statistics, Lot 907616, Time Points T=18, 21, 24,  27,30, 33 and 36 months (WBS 1.2.1) FDP CTM l00ug dose stability challenge  potency statistics, Time Points T=0, 3, 6, 9 and 12 months (WBS 1.2.2) FDP CTM  50ug dose stability challenge potency statistics, Time Points T=0, 3, 6, 9  and 12 months (WBS 1.2.3) MS2; MCLA validation study statistics (WBS 2.1.1)  FDP Mouse Challenge Potency Assay Development Plan and Study statistics (WBS  2.2.1) MS3; FDP CTM l00ug dose mouse challenge potency statistics (WBS 3.1)  FDP CTM 50ug dose mouse challenge potency statistics (WBS 3.2) MS7; Report  activity progress to timeline and impact of variances to schedule at the  milestone level (EVMS) A firm-fixed price subcontract between PharmAthene and  for an amount not to exceed is hereby approved by the Contracting Officer.  The period of performance is (04/01/2009 to 12/31/2010). This approval  encompasses the following scope of work: MSI; BDS, FDP and sample storage  (WBS 1.2.11) MS7; Report activity progress to timeline and impact of  variances to schedule at the milestone level (EVMS) ARTICLE B.4. ADVANCE  UNDERSTANDINGS, paragraph h Milestones have been modified to reflect the  current change in the scope of work. The Contractor’s Technical Proposal  dated March 24, 2009, as amended by MOD 0016. submitted in response to this  change is hereby incorporated into the contract by reference. The Contractor  shall perform the remaining work substantially as set forth in this technical  proposal. In the event of a conflict between Section C, and the Contractor’s  Technical Proposal, Section C will take precedence. |
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|  | 10 The Contractor shall complete the work in accordance with the  Statement of Work and the contract milestones set forth below. Contractor  shall submit all Milestone-associated documents in draft form, subject to  BARDA review and approval before finalization and acceptance. The  distribution of the fixed fee shall be paid in milestone based installments  and payment of this fee shall be determined by the Project Officer’s written  certification that the milestone has been satisfactory performed and that the  technical requirements have been met regarding the completion of the  following milestones. Upon notification that the Milestone and all of its  subparts have been satisfactorily completed, the Contractor may bill fee as  cost incurred. If the Contractor meets the milestones earlier than the dates  set forth below, then the fee will be paid at the earlier date after  completion of the milestone. Milestone WBS Brief Description Deliverable Date  Deliverable Estimated Cost Fixed Fee Total CPFF BDS Stability 1.1.1 Ongoing  BDS Stability 07/31/2010 BDS B2272-008 T=36 months Certificate of Analysis  1.2.1 Ongoing FDP Stability 11/30/2010 FDP 907616, Up to T=36 months  Certificate of Analysis 1 1.2.2 Clinical Batch 1 (2009) l00ug/dose 12/31/2010  FDP, up to T=12 months Certificate of Analysis 12.3 Clinical Batch 2 (2009)  50ug/dose 12/31/2010 FDP, up to T=12 months Certificate of Analysis 1.2.5  Ongoing Diluent Stability 11/15/2009 Diluent lot 803634, Final Study Report  1.2.7 Clinical diluent stability 11/30/2010 Diluent, up to T=12 months  Certificate of Analysis Estimated Cost Fixed Fee Total CPFF Milestone Potency  Assay Deliverable Date eliverable 2 2.1.1 MCLA Assay development and  validation 03/31/2010 MCLA assay Validation Report |
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|  | 11 2.2.1 Challenge Assay 8/31/2010 Challenge Assay Development  Report (work to dale) 2.2.2 Immunopotency 12/31/2010 Immunopotency Assay  Development Report (work to date) Estimated Cost Fixed Fee Total CPFF  Milestone FDP Manufacture Deliverable Date Deliverable 3.1 Clinical Batch I  (l00ug/dosc) 11/30/2009 Certificate of Analysis and Disposition Cert for each  Batch 3 3.2 Clinical Batch 2 (50ug/dose) 12/15/2009 Certificate of Analysis  and Disposition Cert for each Batch 3.4 30L High Phosphate Diluent  Manufacture 11/15/2009 Certificate of Analysis and Disposition Certificate  Estimated Cost Fixed Fee Total CPFF Milestone Assay Development and  Validation Deliverable Date Deliverable 4 4.1.3 BDS stability assay  validation for Appearance, A280, SDS- PAGE, TVC, IEF 4/30/2010 Approved  validation report for all assays combined or approved validation reports for  each assay |
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|  | 12 4.2.1 FDP Phosphate release and stability method development  and validation 02/15/2010 Approved validation report 4.2.2 FDP  characterization method development 10/31/2010 Approved method development  report(s) Estimated Cost Fixed Fee Total CPFF Milestone Regulatory  Deliverable Date Deliverable 5 5.1.2 Submission 2 -CMC update 12/31/2009  Submission package to FDA 5.2 2009 Annual Report 08/30/2009 Annual Report  Submitted to FDA Estimated Cost Fixed Fee Total CPFF Milestone Tech Transfer  Deliverable Date Deliverable 6 6.5 Process Transfer Initiated 11/1/2009 Contract  signed 6.5 Process Transfer midpoint 12/31/2009 2 months from contract signed  6.5 Fermentation Process Transfer Complete 2/28/2010 4 months from contract  signed 6.5 Purification Process Transfer and Development Complete 3/31/2010  Demonstration run vial crack 6.4 Analytical method transfer initiated  11/30/2009 Contract signed 6.4 Analytical method transfer and qualification  complete 05/30/2010 Vial crack for 1st demonstration run 6.4 Transfer of  11/30/2009 Contract Signed |
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|  | 13 validated assays initiated 6.4 Transfer of validated assays  complete 05/31/2010 Vial crack for 3rd demonstration run 6.5 Demonstration  run #l complete 04/30/2010 bulk fill complete 6.5 Demonstration run #2  complete 05/31/2010 bulk fill complete 6.5 Demonstration run #3 complete  05/31/2010 bulk fill complete 6.7 cGMP pre-production started 04/30/2010 3  months before planned start of engineering run 6.7 Pre-production and  facility setup complete 07/31/2010 Engineering run vial crack 6.7 Start of  1st. engineering run 07/31/2010 Vial crack 6.7 Completion of 1st engineering  run 30 days after start Bulk fill complete 6.7 Start of 2nd engineering run  08/30/2010 Vial crack 6.7 Completion of 2nd engineering run 30 days after  start Bulk fill complete 6.8 Start of cGMP run 10/31/2010 Vial crack 6.8  Completion of cGMP run 30 days after start Bulk fill complete 6.8 cGMP run  tested 12/31/2010 CoA 6.6 Validation master plan work initiated 10/31/2010  Bulk fill complete cGMP run 6.6 Validation master plan complete 02/28/2011  Validation master plan approved 6.4 Start Analytical method validation  08/30/2010 initiated 6.4 Complete Analytical method validation 02/28/2011  Reports approved 6.12 Small Scale Process Characterization 3/31/11 Reports  Approved |
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|  | 14 Other Cost Areas Estimated Cost Fixed Fee Total Cost Program  Management General Program Management $906,928 $499,105 $0.0 $499,105 Earned  Value Management Estimated Cost Fixed Fee Total Cost Estimated Program Cost  $25,250,793 $3,687,259 $28,938,052 Estimated Incurred Cost in Performance  (NIAID Contract N01-AI-30052) prior to April 1, 2009 that were not previously  billed Estimated Cost Fixed Fee Total Cost $3,520,000 Estimated Contract  PRICE $32,458,052 ARTICLE B.4 –Advance Understanding is hereby modified to  add paragraph (p) (q), (r), (s), and (t), p. Site Visits and Inspections At  the discretion of the USG and independent of activities conducted by the  Contractor, with ten (10) business days notice to the Contractor, the USG  reserves the right to conduct site visits and inspections on an as needed  basis, including collection of product samples and key intermediates held by  the Contractor, or sub-contractors. In the case of subcontractor visits and  inspections that are independent of activities conducted by the Contractor,  the USG shall demonstrate cause for such visit and/or inspection. These site  visits shall be coordinated through the Prime Contractor. Under  time-sensitive or critical situations, the USG reserves the right to suspend  the 10 day notice to the Contractor. The areas covered under the site visits  and audits could include, but are not limited to: security, regulatory and  quality systems, and cGMP/GLP/GCP compliance.  |
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|  | 15 The USG will conduct cGMP inspections of all manufacturing  facilities (including sub-contractor facilities) under this contract within  six (6) months of contract award. Formal cGMP inspections will occur on an  annual basis, or as needed, if cause dictates. The Contractor shall provide a  written response including appropriate corrective actions within twenty (20)  business days after receipt of audit or inspection report, or request for  information and clarification from the USG. q. People in Plant For a duration  of its choosing, the USG may place, one or more persons in the Contractor’s  or Subcontractor’s facility (PIP) with a seven (7) days advance notice to the  Contractor. In the case of subcontractor visits, the USG shall coordinate  these activities through the Contractor. The People in Plant (PIP) will have  necessary training prior to being placed in the Contractor’s facility. The  PIP are restricted to observing, verifying, and surveying the Contractor’s or  subcontractor’s performance and work environment, in adherence to the  applicable regulations and the Scope of Work under this contract. r. Subject  Matter Experts The Contractor shall acquire the services of qualified Subject  Matter Experts (SMEs), as needed, for additional oversight to achieve  compliance with FDA regulations in the areas of quality assurance and related  to activities in areas of manufacturing, clinical, non-clinical, assay  development, storage and distribution, and other relevant aspects within the  Scope of Work under this contract. These SMEs shall be approved by the  Contracting Officer prior to being hired. s. Material Transport and Delivery The  USG must pre-approve all plans and Standard Operating Procedures (SOPs)  related to the distribution, transport, delivery and acceptance of vaccine  materials including but not limited to cell banks (master and or working),  BDS, FDP and critical reagents. Pre-approvals shall be based on generally  accepted and current industry best practices. Documents for pre-approval  include, but are not limited to: qualification and validation plans for  temperature-controlled packaging of said materials; qualification of vehicles  and shipping procedures, instructions, choice of temperature recording  methods (and associated limits) and procedures for handling deviations and  excursions, and communication plans. t. Access to Documentation a. The  Contractor shall provide the USG with access, as requested, to documentation  and data generated during this contract in accordance with |
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|  | 16  the SOW, including but  not limited to: Contractor efforts; communications and correspondence with  regulatory agencies and bodies to include audit observations, inspection  reports, and Contractor’s commitments and responses; Subcontractor  documentation including protocols for pre-approval and, QA reviewed raw data  from studies and final technical reports. The Contractor shall provide this  documentation within a reasonable amount of time. The Contractor shall  provide BARDA with a minimum of 5 business days to provide feedback. In the  case of lengthy or complex submissions, BARDA reserves the right to require  additional time for review. The Contractor shall review and approve any  request for information generated outside of this contract under previous  USG-funded efforts. U. Program Management a. Condition of Payment for Risk  Mitigation Management Activities. During the course of this development effort,  if the Contractor perceives a risk that is likely or will cause a negative  consequence to the development effort, the Contractor shall notify the  Project Officer and Contracting Officer. The Contractor shall present a risk  mitigation plan that contains the following elements. • Statement of the  problem: This should be based on the risk assessment and should indicate the  source of the problem. • Indicate the impact cost and schedule. A statement,  of the additional funds or other unprogrammed resources required to  accomplish the plan. If no additional resources are required, so state. If  known or projected, indicate the source(s) of these funds/resources. •  Selected Approach: A clear statement of which option (or options) was  selected and why. This could include the results of a trade off study if  appropriate. It should also include any additional description of that option  necessary to make the selected approach clear. • Present an updated project  schedule: chart which shows start and end dates for each action Before  commencing, the project plan must be approved by the Contractor Officer.  |
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|  | 17 SECTION C -DESCRIPTION/SPECIFICATIONS/WORK STATEMENT ARTICLE  C. l. STATEMENT OF WORK. Paragraph a, has been modified as set forth below:  Independently and not as an agent of the USG, the Contractor shall furnish  all the necessary services, qualified personnel, material equipment, and  facilities, not otherwise provided by the USG as needed to accomplish the  tasks and milestones in the Statement of Work, Section J, Attachment 1,  attached hereto and made a part of this contract modification. Performance  and expenditures under this modification shall be consistent with the work  plans schedule and budget described in the Contractor’s March 24, 2009 Scope  of Work, as amended by MOD 0016 as amended by this contract modification  0016, which would include answers provided in response to Technical and  Administrative Questions. All work included in Section J, Attachment 1, dated  September 30, 2003 and any amendments thereto through Modification 0016  associated with process development and validation, engineering runs  sufficient to ensure production of at least 3 cGMP consistency lots suitable  for Phase 3 trials, initial Phase 2 clinical trials and such other efforts  that are not included in the above Statement of Work has been terminated  and/or deleted at the request of the USG. ARTICLE C.2. REPORTING  REQUIREMENTS. Paragraph b is hereby deleted in its entirety and replaced with  the following: a. Monthly Technical Progress Reports. On the tenth of each  month, the Contractor shall submit a Monthly Technical Progress Report for  the previous calendar month, to the Project Officer and the Contracting  Officer. The Contractor shall submit one copy of the Monthly Technical  Progress Report electronically via e-mail. Report documents sent by e-mail  shall be submitted in MSWord, MSExcel, MSProject, or compatible versions.  Such reports shall include the following specific information: The contract  number and title, the period of performance being reported, the Contractor’s  name and address, the author(s), and the date of submission. These reports  are subject to the technical inspection and requests for clarification by the  Project Officer. These reports shall be brief and factual and provide the  following information in no more than 15 pages: (1) The Monthly Technical  Progress report shall address each of the below items and be cross-referenced  to the WBS in the Gantt chart and Project Plan. • An Executive Summary in MS  PowerPoint format, highlighting the progress, |
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|  | 18 issues, and relevant activities in manufacturing,  non-clinical, regulatory, and security. The Executive summary should be  limited to 2-3 slides and highlight only critical issues for that reporting  period and resolution approach. • Progress in meeting contract milestones-  broken out by subtasks within each milestone, overall project assessment,  problems encountered and recommended solutions. The reports shall detail the  planned progress and actual progress during the period covered, explaining  occurrences of any differences between the two, and the corrective steps and  actions are planned, if behind schedule. • The reports shall also include a  three month rolling forecast of key planned activities, referencing the  WBS/Project Plan. • The project’s plans and schedule must reflect up to date  FDA regulatory requirements and guidance. • Estimated and Actual Expenses  (applicable until the EVMS reports are submitted) a. This report shall also  contain a narrative statement as to whether there is any discrepancy at this  time between the % of work completed and the cumulative costs incurred to  date. Section IV of this report shall also contain estimates for the  Subcontractors’ expenses from the Contract No. HHSO100200900103C previous month  if the Subcontractor did not submit a bill in the previous month. These shall  be listed for each Subcontractor. If the Subcontractor(s) was not working or  did not incur any costs in the previous month, then a statement to this  effect should be included in this report for those respective subcontractors  (2) Earned Value Management a. In lieu of a formal Integrated Baseline  Review, 60 days after contract modification Contractor shall deliver a  submission to include: a description of the work scope through Work  Authorization Documents (WADs); Integrated Master Schedule (IMS) with the  inclusion of agreed major milestones and control account plans (CAP) for all  control accounts; baseline revision documentation and program log(s); and  risk register. BARDA will review documentation and provide written comments  and questions to Contractor, who shall provide a written response back to  BARDA within 20 days. b. The Contractor shall deliver the Integrated Master  Schedule statused with performance data and should include actual  start/finish and projected start/finish dates. The statused schedule should  be delivered 10 days after reporting month end. Contractor shall deliver a  program level Integrated Master Schedule that rolls up all time-phased WBS  elements down to the activity level. This IMS shall include the dependencies  that exist between tasks. |
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|  | 19 c. The Contractor shall deliver an Earned Value Contract  Performance Report (EV-CPR) on a monthly basis per the instruction in  DI-MGMT-81466A (see http://www.acq.osd.mil/pm/). Contractor shall provide  preliminary EV-CPR, Format l, on the 15th day after end of Contractor  reporting period and final EV-CPR and Format 5 on the 20th day after end of  Contractor reporting period. The USG shall use best efforts to respond within  5 business days. (3) Milestone Reports As specified in Section B.4.h, the  Contractor shall provide a Milestone Report with final versions of key  project documentation, after the completion of each Milestone unless  otherwise agreed upon by the Project Officer and the Contracting Officer. All  documents related to Milestone deliverables shall be submitted to BARDA in  draft form for review and comments prior to submittal in final form in the  final Milestone Report. Milestone reports and monthly reports may be combined  if agreed by the Project Officer and the Contracting Officer. (4) Annual  Report The Contractor shall be required to submit to the Project Officer and  Contracting officer an annual technical progress report within 15 days after  the anniversary of the contract award date. (5) Weekly teleconferences The  Contractor shall participate in weekly teleconferences with BARDA to discuss  the performance of the contract. The Contractor shall record, maintain and  provide draft meeting minutes to the Project Officer for approval within 3  days after teleconference. The Project Officer will approve the final  version. The Contractor shall distribute final approved version within 3  business days after receipt of BARDA approval. (6) Interactions with  Regulatory Agencies b. The Contractor shall notify the Project Officer and  Contracting officer of all site visits/audits by any regulatory agency,  within 24 hours of receipt of notice. In the event of an FDA inspection which  occurs as a result of this contract and for this product, or for any other  FDA inspection that has the reasonable potential to impact the performance of  this contract, the Contractor will provide the USG with an exact copy of the  FDA Form- 482, Form 483, and the Establishment Inspection report (EIR) within  24 hours of receipt. c. The Contractor shall include BARDA representatives in  all scheduled meetings and teleconferences with any regulatory agency. The  Contractor shall provide both the meeting minutes and finalized meeting  minutes related to any meeting with regulatory agencies. |
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|  | 20 d. The Contractor shall provide BARDA the opportunity to  review and comment upon any documents required to be submitted to regulatory  agencies. These shall include documents that are generated as result of this  contract or documents that have the reasonable potential to impact the  performance of this contract. The Contractor shall provide BARDA with a  minimum of 5 business days to provide feedback comments. In the case of  lengthy or complex submissions, BARDA reserves the right to require  additional time for review. (7) Final Report The Contractor shall submit five  (5) copies of a comprehensive Final Report, with four (4) copies to the  Project Officer and one (1) copy to the Contracting Officer. This final  report shall detail, document and summarize the results of the entire  contract work for the period covered. This report shall be in sufficient  detail to explain comprehensively the results achieved under all milestones. |
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|  | 21 SECTION F - DELIVERIES OR PERFORMANCE ARTICLE F. l.  DELIVERIES OR PERFORMANCE, paragraph b is modified to read as follows: The  items specified below as described in Section C, ARTICLE 2 will be required  to be delivered F.O.B. Destination as set forth in FAR 52.247-45.  Addressee   Deliverable Item  Delivery  Time  Quantity Andre Early Contracting  Officer US Department of Health and Human Services Assistant Secretary for  Preparedness and Response Biomedical Advance Research & Development  Authority 330 Independence Avenue, SW Room G640 Washington, DC 20201 Email:  darrick.early@hhs.gov  Monthly Progress  Reports Milestone Reports (after completion) EVMS •Initial documentation for  PMB •Integrated Master Schedule •EV-CPR Milestone Report Annual Report Draft  Weekly Teleconference Meeting Minutes Final Weekly Teleconference Meeting  Minutes Final Report Interaction with Regulatory Agencies Government  Furnished Properly Report  10th of EA  Month 10th of EA Month w/in 60 days of Contract Mod 10th of EA Month (after  reporting Month end Preliminary by 15th day, final by the 20th day after  reporting month end By 10th day after completion of Milestone W/in 15  business days of Anniversary of contract award W/in 3 business days following  teleconference W/in 3 business days following receipt of BARDA Comments By the  Expiration of the Contract In accordance with Section C.2.6 W/in 15 days of  Anniversary date of contract award  1  original 1 original 1 original 1 original l original 1 original 1 original l  original 1 original l original 1 original l original  Lucy Mac Gabhann Project Officer US  Department of Health and Human Services Assistant Secretary for Preparedness  and Response Biomedical Advance Research & Development Authority 330  Independence Avenue, SW Room G640 Washington, DC 20201 Email:  Lucy.macgabhann@hhs.gov  Monthly  Progress Reports Milestone Reports (after completion) EVMS •Initial  documentation for PMB •Integrated Master Schedule •EV-CPR Milestone Report  Annual Report Draft Weekly Teleconference Meeting.  10th of EA Month 10th of EA Month w/in 60  days of Contract Mod 10th of EA Month (after reporting Month end Preliminary  by 15th day, final by the 20th day after reporting month end By 10th day  after completion of Milestone W/in 15 business days of Anniversary of  contract award W/in 3 business days following teleconference  1 original 1 original 1 original 1 original  l original 1 original 1 original l original |
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|  | 22 Minutes  Final Weekly Teleconference meeting Minutes Final Report Interaction with  Regulatory Agencies Government Furnished Property Report  W/in 3 business days following receipt of  BARDA comments By the Expiration of the Contract In accordance with Section  C.2.6 W/in 15 business days of Anniversary date of contract award  1 original 4 original 1 original 1 original

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|  | 23 SECTION G – CONTRACT ADMINISTRATION DATA ARTICLE G.l. PROJECT  OFFICER is hereby modified to read as follows: The following Project Officer  will represent the Government for the purpose of this contract: FROM: Gopa  Raychaudhuri, Project Officer, NIH/NIAID TO: Lucy G. Mac Gabhann, Project  Officer, BARDA Performance of the work hereunder shall be subject to the  technical directions of the designated Project Officer for this contract. As  used herein, technical directions are directions to the Contractor, which  fill in details, suggests possible lines of inquiry, or otherwise completes  the general scope of work set forth herein. These technical directions must  be within the general scope of work, and may not alter the scope of work or  cause changes of such a nature as to justify an adjustment in the stated  contract price/cost, or any stated limitation thereof. In the event that the  Contractor feels that full implementation of any of these directions may  exceed the scope of the contract, he or she shall notify the originator of  the technical direction and the Contracting Officer in a letter separate of  any required report(s) within two (2) weeks of the date of receipt of the  technical direction and no action shall be taken pursuant to the direction.  If the Contractor fails to provide the required notification within the said  two (2) week period that any technical direction exceeds the scope of the  contract, then it shall be deemed for purposes of this contract that the  technical direction was within the scope. No technical direction, nor its  fulfillment, shall alter or abrogate the rights and obligations fixed in this  contract. The Government Project Officer is not authorized to change any of  the terms and conditions of this contract. Changes shall be made only by the  Contracting Officer by properly written modification(s) to the contract. Any  changes in Project Officer delegation will be made by the Contracting Officer  in writing with a copy being furnished to the Contractor. (End of Clause)  ARTICLE G.2. KEY PERSONNEL is hereby modified to read as follows: The  personnel specified in this contract modification are considered to be  essential to the work being performed hereunder and that the Government  recognizes that some of the named individuals may or may not charge directly  to this Program. Prior to removing any of the specified individuals to other  programs on a full time basis, the Contractor shall notify the Contracting  Officer reasonably in advance and shall submit justification (including  proposed substitutions) in sufficient detail to permit evaluation of the  impact on the program. No changes shall be made by the Contractor without the  written consent of the Contracting Officer; provided that the Contracting  Officer may ratify in writing such diversion and such ratification shall constitute  the consent of the Contracting Officer |
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|  | 24 required by this clause. The contract may be modified from  time to time during the course of the contract to either add or delete  personnel, as appropriate.  Senior  Vice-President of Operations Vice President of Regulatory Affairs and Quality  Chief Scientific Officer Vice President of Manufacturing and Supply Chain  Program Director Senior Director of Operations: Research Triangle Park Site  Medical Director Head of Operations Head of Quality Senior Director of Final  Drug Product Head of Vaccines Quality Director of Vaccines Technical  Development VP of Bioanalysis  ARTICLE  G.4 – INDIRECT RATES, is hereby modified to read as follows: (a) Subject to  the provisions of the clause entitled “Allowable cost and Payment” in Section  I, Contract Clauses, allowable indirect cost under this contract shall be  obtained by applying the approved DCAA and/or negotiated indirect cost rates  below to the base, (b) The Contractor shall be reimbursed for allowable  indirect rates as the following rate(s)   Type  Calendar Year 2009  Calendar Year 2010  Base Fringe (US) Fringe (UK) Overhead (US)  Overhead (UK) G & A Fee |
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|  | 25 SECTION H- SPECIAL CONTRACT REQUIREMENTS ARTICLE H. 10.  ANIMAL WELFARE is hereby deleted in its entirety and replaced with the  following: Information on Compliance with Animal Care Requirements  Registration with the U. S. Dept. of Agriculture (USDA) is required to use  regulated species of animals for biomedical purposes. The USDA office contact  information is available at http://www.aphis.usda.gov/ac/acorg.html. They are  responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et.  seq.), http://www.nal.usda.gov/awic/legislat/awa.htm. The Public Health  Service (PHS) Policy is administered by the Office of Laboratory Animal  Welfare (OLAW) http://grants 2.nih.gov/grants/olaw/olaw.htm. An essential  requirement of the PHS Policy  http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every  institution using live vertebrate animals must obtain an approved assurance  from OLAW before they can receive funding from any component of the U. S.  Public Health Service. The PHS Policy requires that Assured institutions base  their programs of animal care and use on the Guide for the Care and Use of  Laboratory Animals http://www.nap.edu/readingroom/books/labrats/ and that  they comply with the regulations (9 CFR, Subchapter A)  http://www.nal.usda.gov/awic/legislat/usdalegl.htm issued by the U.S.  Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may  differ from USDA regulations in some respects. Compliance with the USDA  regulations is an absolute requirement of this Policy. The Association for  Assessment and Accreditation of Laboratory Animal Care International (AAALAC)  http://www.aaalac.org is a professional organization that inspects and  evaluates programs of animal care for institutions at their request. Those  that meet the high standards are given the Accredited status. As of the 2002  revision of the PHS Policy, the only accrediting body recognized by PHS is  the AAALAC. While AAALAC Accreditation is not required to conduct biomedical  research, it is highly desirable. AAALAC uses the Guide as their primary  evaluation tool. They also use the Guide for the Care and Use of Agricultural  Animals in Agricultural Research and Teaching. It is published by the  Federated of Animal Science Societies http://www.fass.org. |
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|  | 26 ARTICLE H. 14. PRESS RELEASES deleted in its entirety and  replaced with the following: a. Press Releases -Pursuant to Public Law(s)  cited in paragraph (2), below, the Contractor shall clearly state, when  issuing statements, press releases, requests for proposals, bid solicitations  and other documents describing projects or programs funded in whole or in  part with Federal money: the percentage of the total costs of the program or  project which will be financed with Federal money; the dollar amount of  Federal funds for the project or program; and the percentage and dollar  amount of the total costs of the project or program that will be financed by  nongovernmental sources. b. Public Law and Section No. Fiscal Year  Period Covered P.L. 109-149, Title V,  section 506, as Directed by P.L. 110-5, Div. B, title I, 2009 10/1/08 -  9/30/09 Section 104. ARTICLE H.15. Reporting Matters Involving Fraud, Waste,  and Abuse, has been deleted in its entirety and replaced with the following:  Anyone who becomes aware of the existence or apparent existence of fraud,  waste and abuse in BARDA funded programs is encouraged to report such matters  to the HHS Inspector General’s Office in writing or on the Inspector  General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477).  All telephone calls will be handled confidentially. The e-mail address is  Htips@os.dhhs.gov and the mailing address is: Office of Inspector General  Department of Health and Human Services TIPS HOTLINE P.O. Box 23489  Washington, D.C. 20026 ARTICLE H. 16. ANTI-LOBBYING, has been deleted in its  entirety are placed with the following: Prohibition on the Use of  Appropriated Funds for Lobbying Activities HHSAR 352.270-10 Anti – Lobbying  (Jan 2006) The Contractor is hereby notified of the restrictions on the use  of Department of Health and Human Service’s funding for lobbying of Federal,  State and Local legislative bodies. Section 1352 of Title 31, United Stated  Code (Public Law 101-121, effective 12/23/89), among other things, prohibits  a recipient (and their subcontractors) of a Federal contract, grant, loan, or  cooperative agreement from using appropriated funds (other than profits |
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|  | 27 from a federal contract) to pay any person for influencing or  attempting to influence an officer or employee of any agency, a Member of  Congress, an officer or employee of Congress, or an employee of a Member of  Congress in connection with any of the following covered Federal actions; the  awarding of any Federal contract; the making of any Federal grant; the making  of any Federal loan; the entering into of any cooperative agreement; or the  modification of any Federal contract, grant, loan, or cooperative agreement.  For additional information of prohibitions against lobbying activities, see  FAR Subpart 3.8 and FAR Clause 52.203-12. In addition, the current Department  of Health and Human Services Appropriations Act provides that no part of any  appropriation contained in this Act shall be used, other than for normal and  recognized executive-legislative relationships, for publicity or propaganda  purposes, for the preparation, distribution, or use of any kit, pamphlet,  booklet, publication, radio, television, or video presentation designed to  support, or defeat legislation pending before the Congress, or any State or  Local legislature except in presentation to the Congress, or any State or  Local legislative body itself as stated in P.L. 109-149, Title V, section  503(a), as directed by P.L. 110-5, Div. B, Title I, section 104. The current  Department of Health and Human Services Appropriations Act also provides that  no part of any appropriation contained in this Act shall be used to pay the  salary or expenses of any contract or grant recipient, or agent acting for  such recipient, related to any activity designed to influence legislation or  appropriations pending before the Congress, or any State or Local legislature  as stated in P.L. 109-149, Title V, section 503(b), as directed by P.L.  110-5, Div. B, Title I, section 104. (End of Clause) ARTICLE 22 -  DISSEMINATION OF INFORMATION, is hereby added and shall read as follows:  After the execution of Modification 16, information first produced under this  contract shall not be released or publicized without the prior written  consent of the Contracting Officer, which approval shall not be unreasonably  withheld, conditioned, or delayed; provided, however, that no such consent is  required to comply with any law, rule, regulation, court ruling or similar  order; for submission to any government entity’ for submission to any  securities exchange on which the Contractor’s (or its parent corporation’s)  securities may be listed for trading; or to third parties relating to securing,  seeking, establishing or maintaining regulatory or other legal approvals or  compliance, financing and capital raising activities, or mergers,  acquisitions, or other business transactions. (End of Clause) |
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|  | 28 ARTICLE 23 - IDENTIFICATION AND DISPOSITION OF DATA, is  hereby added and shall read as follows: The Contractor will be required to  provide certain data generated under this contract to the Department of  Health and Human Services (HHS). The Contractor shall consent to USG review  of data produced outside of this contract. The data must be deemed relevant  to this contract and statement of work. The Contractor shall keep copies of  all data required by the Food and Drug Administration (FDA) relevant to this  contract for the time specified by the FDA. SECTION I- CONTRACT CLAUSES The  following contract clause has been incorporated into this contract. FAR  Clause No.  Date  Title 52.245-1  JUN 2007   Government Property 52.245-9   June 2007  Use and Charges |
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|  | 29 SECTION J - LIST OF ATTACHMENTS ATTACHMENT 1 – Statement of  Work, is deleted in its entirety and replaced as follows. All other  milestones are no longer required. Independently and not as an agent of the  USG, the Contractor shall furnish all the necessary services, qualified  personnel, material equipment, and facilities, not otherwise provided by the  USG as needed to accomplish the tasks and milestones in the Statement of  Work, Section J, Attachment 1, attached hereto and made a part of this  contract. Performance and expenditures under this modification shall be  consistent with the work plans schedule and budget described in the  Contractor’s March 24, 2009 Scope of Work as amended by MOD 0016, which would  include answers provided in response to Technical and Administrative  Questions. a. Execute a stability testing program to ensure the safety,  sterility, potency and integrity of the vaccine used in clinical trials and  non-clinical studies, to support all regulatory requirements including: IND  amendments; data to support the product’s use under Emergency Use  Authorization (EUA), BLA submission and product licensure and post-licensure  tasks as appropriate. b. Develop, qualify and validate product release and  stability indicating assays including potency assays; in-process assays (as  appropriate); product characterization methods; and reagents for use in  clinical and pivotal studies that shall ultimately support the product’s use  under EUA, BLA submission and product licensure. c. Manufacture, fill and  finish the Final Drug Product and companion diluents to be used in clinical  trials and non-clinical studies to support the product’s use under EUA, BLA  submission and product licensure. Contractor shall ensure all relevant data,  including that from the subcontractor, is submitted to the FDA in accordance  with the licensure strategy. d. Plan and execute a Technology Transfer of  Bulk Drug Substance production, including, but not limited to, relevant  knowledge of the process including batch records, test records and other  documentation, analytical methods, raw material information and master and  seed stocks, to a qualified cGMP compliant Contract Manufacturing  Organization (CMO) with experience producing FDA-licensed vaccines and  biologies. Execute scale-up and production of at least one cGMP lot at  full-scale. e. Execute a Performance Measurement System that meets the Seven  Principles of Earned Value Management. The Seven Principles are: I.  Plan all work scope for the program to  completion. II.  Break down the program  work scope into finite pieces that can be assigned to a responsible person or  organization for control of technical, schedule, and cost objectives. |
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|  | 30 III.  Integrate program  work scope, schedule, and cost objectives into a performance measurement  baseline plan against which accomplishments may be measured. Control Changes  to the baseline. IV.  Use actual cost  incurred and recorded in accomplishing the work performed. V.  Objectively assess accomplishments at the  work performance level. VI.  Analyze  significant variances from the plan, forecast impacts, and prepare an  estimate at completion based on performance to date and work to be performed.  VII.  Use Performance Measurement  System information in the company’s management processes. f. The Contractor  shall structure their Performance Measurement and Earned Value Management  Systems using a discernable and consistent deliverable-based Work Breakdown  Structure consistent with the rPA Work Breakdown Structure format provided by  BARDA. g. The Contractor and BARDA shall mutually agree upon cost, schedule  and technical plan baselines (Performance Measurement Baseline). These  baselines shall be the basis for monitoring and reporting progress throughout  the life of the contract. MILESTONES Consistent with the requirements  described in the SOW above, the Contractor will submit a proposed plan, and  execute this plan to accomplish the following milestones. Unless otherwise  agreed, all milestones will conclude with delivery of an acceptable final  milestone report to BARDA. The report shall document the details and data  completed under each milestone, including all pertinent final technical  reports related to work accomplished |
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|  | 31 New MS #  Previous MS  #  Previous Milestone Title  Scope of previous milestone 1  16   Develop and manage a stability plan for Drug Substance and Drug  Product  Work carried out under this  Milestone has included all BDS and FDP stability program activities 2  4   Assay development, qualification and validation  Recent work carried out under this  milestone has included assay development of BDS and FDP potency assays i.e.  MCLA, challenge potency and immunopotency 3   6, 11  Milestone 6: Final Drug  product - process technology transfer, development and pre-validation  Milestone 11: Fill 750,000 doses as part of a process validation campaign and  fill 750,000 doses as part of a consistency campaign  Work under Milestone 6 has included FDP  manufature for clinical studies and pre process validation activities Work  under Milestone 11 to date has included some preparatory activities for the  FDP process validation campaign including Raw Materiel purchases and supplier  Audits. 4  12  Release of 3 process validation cGMP lots,  deliver or store 750,000 doses  This  milestone included a Sub-milestone relating to establishment of assays,  therefore all activities relating to release, stability and characterisaiton  assay development and validation have been allocated to this Milestone 5  15   Complete Regulatory Plan  Work  allocated to this Milestone has included preparation and review of regulatory  submissions 6  None  BDS Technology Transfer activities are new  activities and have not been previously associated with a specific NIH  Milestone. Previously all BDS manufacturing activities ware captured under  Milestone 10: rPA bulk drug substance manufacture for process validation and  consistency lot production. The following Work Plan describes the remaining  activities associated with contract HHSO100200900103C, this updated Plan  reflects the activities that have been selected to be undertaken under this  contract. |
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|  | 32 h.  Meetings and  Conferences: In accordance with the responsibilities to oversee the contract  effort, the Project Officer, shall direct the need for meetings and  conferences. The Contractor shall coordinate and participate in regular  meetings and conference and include all relevant Contractors and  subcontractor personnel. Such meetings may cover areas, but are not limited  to, the technical, regulatory and ethical aspects of the program, preclinical  and clinical study designs, assay development and validation. The meeting may  involve BARDA technical consultants and Subject Matter Experts to discuss  technical data provided by the Contractor. |
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