Modification No. 1, effective March 16 2017, to the BARDA AV7909 Contract

Contract Categories: Business Finance - Modification Agreements
EX-10.2 3 emergent600030cmodificat.htm EX-10.2 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: . HHSAR Clauses at: . 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