Exhibit 10.45.1


 


PharmAthene, Inc.


Confidential Materials Omitted
and Filed Separately with the Securities and Exchange Commission


 




	
  

  	
  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 

  






 















	
  

  	
  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

  






 















	
  

  	
  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)  

  






 















	
  

  	
  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) 

  






 















	
  

  	
  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) 

  






 















	
  

  	
  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) 

  






 















	
  

  	
  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) 

  






 















	
  

  	
  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) 

  






 















	
  

  	
  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. 

  






 















	
  

  	
  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 

  






 















	
  

  	
  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 

  






 















	
  

  	
  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 

  






 















	
  

  	
  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 

  






 















	
  

  	
  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. 
  

  






 















	
  

  	
  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 

  






 















	
  

  	
  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.  

  






 















	
  

  	
  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, 

  






 















	
  

  	
  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.

  






 















	
  

  	
  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.

  






 















	
  

  	
  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. 

  






 















	
  

  	
  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

  






 















	
  

  	
  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

   

  






 















	
  

  	
  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

  






 















	
  

  	
  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

  






 















	
  

  	
  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.

  






 















	
  

  	
  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

  






 















	
  

  	
  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) 

  






 















	
  

  	
  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 

  






 















	
  

  	
  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.

  






 















	
  

  	
  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 

  






 















	
  

  	
  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. 

  






 















	
  

  	
  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.