emergent600030cmodificat






      Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) is the type of  information that the registrant treats as private or confidential.  Double asterisks denote omissions.  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES   1 6  2. AMENDMENT/MODIFICATION NO.   0001  3.  EFFECTIVE DATE  See Block 16C    4. REQUISITION/PURCHASE NO.     5. PROJECT NO. (If applicable)    6. ISSUED BY CODE ASPR-BARDA 7. ADMINISTERED BY (If other than Item 6)   CODE ASPR-BARDA  ASPR-BARDA  200 Independence Ave., S.S.  Room 640-G  Washington, DC 20201  ASPR-BARDA  200 Independence Ave., S.S.  Room 638-G  Washington, DC 20201  8.  NAME AND ADDRESS OF CONTRACTOR (No., Street, county, State and ZIP Code)     (x) 9A. AMENDMENT OF SOLICITATION NO.    EMERGENT PRODUCT DEVELOPMENT GAITHERSBURG INC.   EMERGENT PRODUCT DEVELOPMENT GAITHE  300 PROFESSIONAL DR # 100  GAITHERSBURG MD 208793419      9B. DATED (SEE ITEM 11)     x 10A. MODIFICATION OF CONTRACT/ORDER NO.  HHSO100201600030C   10B. DATED (SEE ITEM 13)  CODE    1365869 FACILITY CODE       09/30/2016  11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS  □ The above numbered solicitation is amended as set forth in Item 14.  The hour and date specified for receipt of Offers                     □ is extended, □ is not extended.  Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:  (a) By completing  Items 8 and 15, and returning ____ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or  (c) By separate letter or  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)    See Schedule  13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.  IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.  CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER  NO. IN ITEM 10A.    B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office,  appropriation date, etc) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).   C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:        X  D. OTHER (Specify type of modification and authority)    FAR 52.243-2 Changes – Cost Reimbursement  E. IMPORTANT:  Contractor   □ is not, ⊠ is required to sign this document and return     2    copies to the issuing office.  14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)  Tax ID Number:  [**]  DUNS Number:  [**]  The purpose of this modification is to modify ARTICLES B.2 BASE PERIOD, B.3. OPTION PRICES,  B.5. ADVANCE UNDERSTANDINGS, and SECTION 1 - CONTRACT CLAUSES.    Funds Obligated Prior to this Modification: $198,705,042  Funds Obligated with Mod #1: $0  Total Funds Obligated to Date: $198,705,042    Expiration Date: September 29,2021  Period of Performance: 09/30/2016 to 09/29/2021  Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.  15A. NAME AND TITLE OF SIGNER (Type or print)  Barbara Solow                                      SVP Research and Development  16A. NAME OF CONTRACTING OFFICER   CHRISTOPHER SCOTT  15B. CONTRACTOR/OFFEROR  /s/ Barbara Solow       (Signature of person authorized to sign)  15C. DATE SIGNED    Mar 14, 2017  16B. UNITED STATES OF AMERICA  By  /s/ Christopher Scott     (Signature of Contracting Officer)  16C. DATE SIGNED    3/16/17  NSN 7540-01-152-8070 STANDARD FORM 30 (Rev. 10-83)  Previous edition unusable  Prescribed by GSA    FAR (48 CFR) 53.243 





 






  2    ARTICLE B.2. BASE PERIOD is hereby modified as follows:    CLIN Period of  Performance  Supplies/ Services Total Est. Cost Fixed Fee  (7%)  Total Cost Plus  Fixed Fee      COST REIMBURSEMENT      0001  (Base)  09/30/2016 –  09/29/2021  Licensure, approval, and clearance  of product through the FDA  [**] [**] [**]      FIRM FIXED PRICE      CLIN Period of  Performance  Supplies/ Services Units (# of  Doses)  Unit Price ($) Total ($)  0002  (Base)  09/30/2016 –  09/29/2021  Initial Purchase, Storage, and  Delivery of Product  3,000,000 [**] [**]  Total  CLINS  1&2  09/30/2016 –  09/29/2021  See Above Descriptions   $198,705,042  (Funded)  [**]    ARTICLE B.3. OPTION PRICES is hereby modified as follows:    CLIN Period of  Performance  Supplies/ Services Total Est. Cost Fixed Fee Total Cost  Plus Fixed  Fee ($)      COST REIMBURSEMENT     0001A  (Option  Quantity)  [**] Phase II [**] Study or  studies required by the FDA [**]  [**] [**] [**]  CLIN Period of  Performance  Supplies/ Services Total Est. Cost Fixed Fee Total Cost  Plus Fixed  Fee ($)      FIXED PRICE     0003  (Option  Quantity)  [**] Phase IV post marketing  commitments /Requirements  (This is an option that may or  may not be exercised during the  base period as determined by  the need and as established by  the FDA)  N/A N/A [**]    CLIN Period of  Performance  Supplies/ Services Units (# of  Product)  FY 2018  Unit Price  ($)  Total ($)  0004A  (Option  Quantity)  [**] Additional Surge Capacity (EUA)       7,500,000 to  [**]  [**] [**]  





 






  3      0004B  (Option  Quantity)  [**] Additional Surge Capacity  (Licensure)  7,500,000 to  [**]  [**] [**]  0004C  (Option  Quantity)  [**] Additional Surge Capacity (EUA) [**] [**] [**]  0004D  (Option  Quantity)  [**] Additional Surge Capacity  (Licensure)  [**] [**] [**]  0004E  (Option  Quantity)  [**] Additional Surge Capacity (EUA) [**] [**] [**]  0004F  (Option  Quantity)  [**] Additional Surge Capacity  (Licensure)  [**] [**] [**]  0004G  (Option  Quantity)  [**] Additional Surge Capacity (EUA) [**] [**] [**]  0004H  (Option  Quantity)  [**] Additional Surge Capacity  (Licensure)  [**] [**] [**]    [**]    ARTICLE B.5. ADVANCE UNDERSTANDINGS is hereby modified as follows:    h. Option CLINS    If procurement for CLIN 4 occurs after FY 2018, the following chart illustrates the dose  prices to be used:    Units (# of Doses) FY 2019 Unit  Price ($)  FY 2020 Unit  Price ($)  FY 2021 Unit  Price ($)  7,500,000 to  [**]  [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]  [**] [**] [**] [**]    [**] 





 






  4    The USG reserves the right to re-negotiate the option CLINS based on availability of  funds and feedback received from the FDA.      SECTION I - CONTRACT CLAUSES    ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY  1998) is hereby modified to add FAR 52.219-9 as follows:    This contract incorporates the following clauses by reference, with the same force and effect as if  they were given in full text. Upon request, the Contracting Officer will make their full text available.  Also, the full text of a clause may be accessed electronically at these addresses:  https://www.acquisition.gov/FAR/ . HHSAR Clauses at:  http://www.hhs.gov/policies/hhsar/subpart352.html .    General Clauses for Cost-Reimbursement/Fixed Price Research and Development Contract    (1) FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:      Reg Clause Date Clause Title  FAR 52.202-1 Nov 2013 Definitions  FAR 52.203-3 Apr 1984 Gratuities  FAR 52.203-5 May 2014 Covenant Against Contingent Fees  FAR 52.203-6 Sep 2006 Restrictions on Subcontractor Sales to the Government  FAR 52.203-7 May 2014 Anti-Kickback Procedures  FAR 52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity  FAR 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity  FAR 52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal Transactions  FAR 52.203-13 Oct 2015 Contractor Code of Business Ethics and Conduct  FAR 52.203-14 Oct 2015 Display of Hotline Poster(s)    FAR    52.203-17    Apr 2014 Contractor Employee Whistleblower Rights and Requirement To Inform  Employees of Whistleblower Rights  FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper  FAR 52.204-7 Jul 2013 System for Award Management  FAR 52.204-10 Oct 2015 Reporting Executive Compensation and First-Tier Subcontract Awards  FAR 52.204-13 Jul 2013 System for Award Management Maintenance    FAR    52.209-6    Oct 2015 Protecting the Government's Interests When Subcontracting With Contractors  Debarred, Suspended, or Proposed for Debarment  FAR 52.209-10 Nov 2015 Prohibition on Contracting with Inverted Domestic Corporations  FAR 52.210-1 Apr 2011 Market Research  FAR 52.215-2 Oct 2010 Audit and Records – Negotiation  FAR 52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format  FAR 52.215-10 Aug 2011 Price Reduction for Defective Cost or Pricing Data  FAR 52.215-11 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data—Modifications.  FAR 52.215-12 Oct 2010 Subcontractor Certified Cost or Pricing Data  FAR 52.215-13 Oct 2010 Subcontractor Certified Cost or Pricing Data—Modifications  FAR 52.215-15 Oct 2010 Pension Adjustments and Asset Reversions  FAR 52.215-17 Oct 1997 Waiver of Facilities Capital Cost of Money    FAR    52.215-18    Jul 2005 Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than  Pensions  FAR 52.215-19 Oct 1997 Notification of Ownership Changes    FAR    52.215-21    Oct 2010 Requirements for Certified Cost or Pricing Data and Data Other Than Certified  Cost or Pricing Data -Modifications  FAR 52.215-23 Oct 2009 Limitations on Pass-Through Charges  FAR 52.216-7 Jun 2013 Allowable Cost and Payment  FAR 52.216-8 Jun 2011 Fixed Fee  FAR 52.219-8 Oct 2014 Utilization of Small Business Concerns  





 






  5    FAR 52.219-9 Nov 2016 Small Business Subcontracting Plan  FAR 52.219-28 July 2013 Post-Award Small Business Program Representation  FAR 52.222-1 Feb 1997 Notice to the Government of Labor Disputes  FAR 52.222-2 Jul 1990 Payment for Overtime Premiums  FAR 52.222-3 Jun2003 Convict Labor  FAR 52.222-21 Apr 2015 Prohibition of Segregated Facilities  FAR 52.222-26 Apr 2015 Equal Opportunity  FAR 52.222-35 Oct 2015 Equal Opportunity for Veterans  FAR 52.222-36 Jul 2014 Equal Opportunity for Workers with Disabilities  FAR 52.222-37 Feb 2016 Employment Reports on Veterans  FAR 52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor Relations Act    FAR    52.222-43    May 2014 Fair Labor Standards Act and Service Contract Labor Standards—Price  Adjustment (Multiple Year and Option Contracts)  FAR 52.222-50 Mar 2015 Combating Trafficking in Persons  FAR 52.222-54 Oct 2015 Employment Eligibility Verification  FAR 52.223-6 May 2001 Drug-Free Workplace  FAR 52.223-18 Aug 2011 Encouraging Contractor Policy to Ban Text Messaging While Driving  FAR 52.224-1 April 1984 Privacy Act Notification  FAR 52.224-2 April 1984 Privacy Act  FAR 52.225-13 Jun 2008 Restrictions on Certain Foreign Purchases  FAR 52.227-1 Dec 2007 Authorization and Consent, Alternate 1 (APR 1984)  FAR 52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright Infringement  FAR 52.227-3 Apr 1984 Patent Indemnity  FAR 52.227-11 May 2014 Patent Rights – Ownership by the Contractor  FAR 52.227-14 May 2014 Rights in Data - General  FAR 52.227-16 Jun 1987 Additional Data Requirements  FAR 52.228-7 Mar 1996 Insurance – Liability to Third Persons  FAR 52.229-3 Feb 2013 Federal, State and Local Taxes  FAR 52.230-2 Oct 2015 Cost Accounting Standards  FAR 52.230-6 June 2010 Administration of Cost Accounting Standards  FAR 52.232-1 Apr 1984 Payments  FAR 52.232-2 Apr 1984 Payments under Fixed-Price Research and Development Contracts  FAR 52.232-8 Feb 2002 Discounts for Prompt Payment  FAR 52.232-9 Apr 1984 Limitation on Withholding of Payments  FAR 52.232-11 Apr 1984 Extras  FAR 52.232-17 May 2014 Interest  FAR 52.232-20 Apr 1984 Limitation of Cost  FAR 52.232-23 May 2014 Assignment of Claims  FAR 52.232-25 Jul 2013 Prompt Payment  FAR 52.232-33 Jul 2013 Payment by Electronic Funds Transfer--System for Award Management  FAR 52.233-1 May 2014 Disputes  FAR 52.233-3 Aug 1996 Protest After Award, Alternate I  FAR 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim  FAR 52.242-1 Apr 1984 Notice of Intent to Disallow Costs  FAR 52.242-3 May 2014 Penalties for Unallowable Costs  FAR 52.242-4 Jan 1997 Certification of Final Indirect Costs  FAR 52.242-13 Jul 1995 Bankruptcy  FAR 52.243-1 Aug 1987 Changes - Fixed-Price Alternate V (Apr 1984).  FAR 52.243-2 Aug 1987 Changes—Cost-Reimbursement Alternate V (Apr 1984).  FAR 52.243.6 Apr 1984 Change Order Accounting  FAR 52.243-7 Apr 1984 Notification of Changes  FAR 52.244-2 Oct 2010 Subcontracts, Alternate 1 (Jun 2007)  FAR 52.244-5 Dec 1996 Competition in Subcontracting  FAR 52.244-6 Apr 2015 Subcontracts for Commercial Items  FAR 52.245-1 Apr 2012 Government Property  FAR 52.245-9 Apr 2012 Use and Charges  





 






  6    FAR 52.246-7 Apr 1996 Inspection of Research and Development – Fixed-Price  FAR 52.246-8 May 2001 Inspection of Research and Development – Cost-Reimbursement  FAR 52.246-23 Feb 1997 Limitation of Liability.  FAR 52.246-25 Feb 1997 Limitation of Liability—Services  FAR 52.248-1 Oct 2010 Value Engineering  FAR 52.249-2 Apr 2012 Termination for the Convenience of the Government (Fixed-Price)  FAR 52.249-6 May 2004 Termination (Cost-Reimbursement)  FAR 52.249-8 Apr 1984 Default (Fixed-Price Supply and Service)  FAR 52.249-9 Apr 1984 Default (Fixed-Price Research and Development)  FAR 52.249-14 Apr 1984 Excusable Delays  FAR 52.253-1 Jan 1991 Computer Generated Forms        All other terms and conditions of this contract remain unchanged.    End of Modification #1