Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions.
EX-10.2 8 exhibit10_2.htm
EXHIBIT 10.2
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. 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: $198,705,042 Expiration Date: September 29,2021 Period of Performance: 09/30/2016 to 09/29/2021 | ||||||||||
| Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||
| 15A. NAME AND TITLE OF SIGNER (Type or print) | 16A. NAME OF CONTRACTING OFFICER CHRISTOPHER SCOTT | |||||||||
| 15B. CONTRACTOR/OFFEROR (Signature of person authorized to sign) | 15C. DATE SIGNED | 16B. UNITED STATES OF AMERICA By (Signature of Contracting Officer) | 16C. DATE SIGNED | |||||||
NSN 7540-01-152-8070 STANDARD FORM 30 (Rev. 10-83)
Previous edition unusable Prescribed by GSA
FAR (48 CFR) 53.243
ARTICLE B.2. BASE PERIOD is hereby modified as follows:
| CLIN | Period of Performance | Supplies/ Services | Total Est. Cost | Fixed Fee (7%) | Total Cost Plus Fixed Fee | |||||||||
| COST REIMBURSEMENT | ||||||||||||||
| 0001 (Base) | 09/30/2016 – 09/29/2021 | Licensure, approval, and clearance of product through the FDA | [ | **] | [ | **] | [ | **] | ||||||
| FIRM FIXED PRICE | ||||||||||||||
| CLIN | Period of Performance | Supplies/ Services | Units (# of Doses) | Unit Price ($) | 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 ($) |
| 0004A (Option Quantity) | [**] | Additional Surge Capacity (EUA) | 7,500,000 to [**] | [**] | [**] |
| 0004B (Option Quantity) | [**] | Additional Surge Capacity (Licensure) | 7,500,000 to [**] | [**] | [**] |
| 0004C (Option Quantity) | [**] | Additional Surge Capacity (EUA) | [**] | [**] | [**] |
| 0004D (Option Quantity) | [**] | Additional Surge Capacity (Licensure) | [**] | [**] | [**] |
| 0004E (Option Quantity) | [**] | Additional Surge Capacity (EUA) | [**] | [**] | [**] |
| 0004F (Option Quantity) | [**] | Additional Surge Capacity (Licensure) | [**] | [**] | [**] |
| 0004G (Option Quantity) | [**] | Additional Surge Capacity (EUA) | [**] | [**] | [**] |
| 0004H (Option Quantity) | [**] | Additional Surge Capacity (Licensure) | [**] | [**] | [**] |
[**]
ARTICLE B.5. ADVANCE UNDERSTANDINGS is hereby modified as follows:
h. Option CLINS
If procurement for CLIN 4 occurs after FY 2018, the following chart illustrates the dose prices to be used:
| Units (# of Doses) | FY 2019 Unit Price ($) | FY 2020 Unit Price ($) | FY 2021 Unit Price ($) |
| 7,500,000 to [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
| [**] | [**] | [**] | [**] |
[**]
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 |
| 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 |
| 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
