BARDA CSS No. 75A50121R00021.pdf

COMBINED SYNOPSIS / SOLICITATION

75A50121R00021

TITLE: COVID-19 Pharmaceutical Consumables Expansion and Acceleration: Single Use 2D and 3D Bags and Single Use Assemblies

(i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75A50121R00021 and the solicitation is issued as a request for proposal

(RFP). This acquisition is for a commercial services and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items, and FAR Part 12—Acquisition of Commercial Items, FAR Subpart 18.202(d), and is expected to exceed the simplified acquisition threshold.

(iii) This is a competitive combined synopsis/solicitation. Award(s) will be made to the offerors whose proposal(s) successfully address each of the identified requirements, and for which the proposed price is determined to be fair, reasonable and realistic.

(iv) The Government is soliciting sources identified and determined capable while conducting

Market Research.

(v) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03, dated February 16, 2021.

(vi) The associated NAICS code is 339112 and the Small Business size standard is 1000 employees. This requirement is competitive and is not set aside for small businesses.

DESCRIPTION

The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to expand and accelerate domestic pharmaceutical consumables manufacturing capacity for dingle Use 2D and 3D Bags and Single Use Assemblies.

See attached Statement of Objectives for complete requirement details.

EVALUATION AND AWARD

(vii) The Government anticipates including a 9-month period of performance (through December

2021) for the effort to expand manufacturing capacity. Once the manufacturing capacity is established and validated, the Contractor will sustain the expanded manufacturing capacity and provide the Government a price preference and priority placement for 10 years.

(viii) The Government plans to award a purchase order resulting from this solicitation. The resulting award will be made to the responsible Offeror whose offer will be most advantageous to the Government, price and other factors considered. The factors listed below shall be used to evaluate proposals. Comparative evaluations will be conducted if multiple proposals are received.

(a) Technical Capability

(b) Price

(c) Past Performance

SUBMISSION INSTRUCTIONS

(ix) All responses to this RFP must be received by 3:00pm Eastern Time on Tuesday, February 23, 2021 and must reference the solicitation number cited above. Responses must be submitted via email to Jeffrey Schmidt at Jeffrey.schmidt2@hhs.gov

(x) This is an RFP. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this proposal or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by Offeror. Any representations and/or certifications attached to this RFP must be completed by the Offeror.

(xi) Responses to this RFP must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size.

(xii) Responses to this RFP must include separate technical and cost volumes.

(xiii) TECHNICAL VOLUME: The Technical Volume shall include a detailed work plan indicating how each aspect of the objectives are to be accomplished. The technical volume should be in as much detail as you considered necessary to fully explain your proposed technical approach or method. In addition, the technical volume must include:

(a) Technical rationale, technical approach, and plan for accomplishment of goals and objectives in support of requirements and proposed deliverables. Include in this section all proprietary claims to the results, property, intellectual property, or systems supporting and/or necessary for the effort in question. If there are no proprietary claims, this should be stated.

(b) A clearly defined organization chart for the program team which includes, as applicable: (1) the programmatic relationship of team member; (2) the unique capabilities of team members; (3) the task of responsibilities of team members; (4) the teaming strategy among the team members; and (5) the key personnel to be involved in the effort.

(c) Discussion concerning any potential likelihood to leverage the effort for use among other

Government organizations of interest if/as may be appropriate, along with any details concerning current use by other non-federal parties.

(d) Statement of Work (SOW) - In plain English, clearly define:

(1) The objective of the proposed contract.

(2) A detailed description of the proposed approach to accomplish the stated objective.

(3) The measurable milestones involved & associated completion criteria for each involved.

(4) All deliverables (reporting, data, reports, etc.) to be provided to the Government in support of the proposed tasks/activities.

(5) Description of the facilities to be used for the contracted effort.

(6) Capital and Commercial equipment to be purchased to achieve the contract objective.

(7) Estimated direct labor hours (including labor categories) to be performed to achieve the proposed objective.

(xiv) COST VOLUME: The cost volume shall contain enough information to allow the Government to perform a basic analysis of the propose cost or price of the work. The Government anticipates issuing a firm fixed price contract with payable milestones based on explicit milestone achievement criteria. The Cost Volume shall provide other than cost or pricing data in sufficient detail to substantiate the price proposed (e.g., realism and reasonableness). It is CRITICAL that the offeror’s cost proposal contain ALL prices and costs associated with each milestone. The proposal elements for each milestone must be supported by 3rd party vendor quotes, labor categories, labor hours, rates, applied fringe, overhead, G&A and profit. The breakdown shall include total proposed price, inclusive of all major cost items, as follows:

(a) Direct Labor – including individual labor categories with associated labor categories, labor hours and direct labor rates.

(b) Indirect Costs – Including Fringe Benefits, Overhead, General and Administrative (G&A)

Expense, Cost of Money, Fee, etc. (must show base amount and rate).

(c) Subcontractors – List all subcontractors. For reach subcontractor, include total subcontract cost and build-out for all direct labor, indirect costs, travel, materials, and other direct costs.

(d) Travel – Provide the purpose of the trip, number of trips, number of days per trip, departure and arrival destinations, number of people, etc.

(e) Other Direct Costs (ODCs) – Itemized by cost category, with sufficient backup documentation to support proposed costs.

(f) Equipment Purchases – Itemized list with associated costs, including quantities, unit prices, proposed vendors (if known), and the basis of estimate (e.g., quotes, prior purchases, catalog price lists, etc.); any item that exceeds $10,000 must be supported with back-up documentation such as a copy of catalog price lists or quotes prior to purchase.

(g) Materials – Itemized list with associated costs, including quantities, unit prices, proposed vendors (if known), and the basis of estimate (e.g., quotes, prior purchases, catalog price lists, etc.); any item that exceeds $10,000 must be supported with back-up documentation such as a copy of catalog price lists or quotes prior to purchase.

(h) The source, nature, and amount of proposed costs to be billed to the Government.

(i) Any Forward Pricing Rate Agreement (FPRA), other rate agreements, other documentation concerning approved rates, or any other such documentation that may assist in expediting negotiations (if available).

(j) Proposers with a DCAA-approved cost accounting system must submit appropriate DCAA documentation that provides evidence of government approval of the cost accounting system.

COST INFORMATION SHALL BE PROVIDED IN MS EXCEL FORMAT WITH ACCESS TO ALL

CALULATIONS AND FORMULAS.

(xv) The Government anticipates requesting clarifying information after receipt and evaluation of your proposal.

(xvi) The Government reserves the right to enter into discussions.

(xvii) For information about this RFP, contact Jeffrey Schmidt, Contracting Officer, at 202-205-0260 or jeffrey.schmidt2@hhs.gov.

mailto:jeffrey.schmidt2@hhs.gov.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xviii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference(Feb 1998). This solicitation incorporates one or more solicitation provisions 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. The Offeror is cautioned that the listed provisions may include blocks that must be completed by the Offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the Offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at www.acquisition.gov.

The following provisions apply to this acquisition and are incorporated by reference:

(a) The provision at FAR 52.204-7, System for Award Management (Oct 2018).

(b) The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul

2016).

(c) The provision at 52.204-26, Covered Telecommunications Equipment or Services-

Representation (Oct 2020).

(d) The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Oct 2018).

(e) The provision at FAR 52.212-2 Evaluation—Commercial Items (Oct 2014).

(f) The provision at 52.212-3, Offeror Representations and Certifications—Commercial Items

(Dec 2019).

(xix) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more 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 www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

(a) The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

(b) The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul

2016)

(c) The clause at FAR 52.204-24, Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment (Oct 2020)

(d) The clause at FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and

Video Surveillance Services or Equipment (Aug 2020)

(e) The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items(Oct 2018)

(f) The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015) http://www.acquisition.gov/ http://www.acquisition.gov/

(xx) The following provisions and clauses apply to this acquisition and are attached in full text:

(a) Statement of Objectives

(b) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Mar 2020)

(c) BARDA Fixed Price Invoice Instructions

(xxi) There following additional contract requirement(s) or terms and conditions are applicable to this acquisition:

(a) Pricing: The contractor agrees that it shall not offer, sell or otherwise provide the services funded by the Government’s investment to any entity at a price lower than that offered to the Government for the duration of the contract, including any exercised options.

(b) Precedence. For the term of the contract, the contractor agrees that upon Presidential

Declaration of a Public Health Emergency that Government orders will be provided precedence for completion over and above any other orders, up to the stated capacity, whether orders are DPAS rated or treated by the recipient as such.

(c) Service Contract Act. The Service Contract Act is applicable to the expansion efforts of this acquisition. Wage determinations for offerors’ respective geographic areas can be found at beta.sam.gov.

(xxii) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.”

Attachment 1 – Statement of Objectives Solicitation No. 75A50121R00021

B. Schedule

B.1 General. This contract shall be executed in accordance with FAR 12 Acquisition of Commercial Items using Simplified Acquisition Procedures (FAR 13) as a Firm Fixed Price (FFP) contract with milestone payments. See FAR 32.1004.

B.2 Milestone Payment Schedule

The Government will make milestone payments to the contractor upon receipt and approval of properly submitted invoice(s) and documentation demonstrating completion of the following milestone events:

Payable Milestone Event Milestone Date

(to be filled in by Offeror)

Fixed Payment Amount

(To be filled in by Offeror)

Total Milestone Payments $XXX NOT TO EXCEED $15,000,000.00

B.3. Contract Line Items (CLIN)

CLIN 1000: Expansion of US manufacturing capability for COVID-19 vaccine consumable products to meet urgent COVID-19 and future pandemic capacity demands in accordance with the Statement of Objectives outlined in Section C below.

CLIN 2000: Monthly progress reports.

CLIN 3000: Quarterly In-Process Reviews (IPR) Hosted at the contractor’s facilities.

CLIN 4000: Final Report that details the findings and issues of the completed project.

CLIN 5000: 10 year ordering period: For a period of 10 years after completion of CLINs 1000-4000, the contractor shall provide the Government with preferred pricing and precedence for orders from BARDA and/or BARDA authorized 3rd parties in response to a Presidential Declaration of Public Health Emergency as described in the Contract terms and conditions.

C. Statement of Objectives

C.1. General Objectives.

The contractor shall expand existing US based manufacturing capacity for COVID-19 vaccine consumables products. The contractor shall identify, develop and qualify new manufacturing capacity for utilization with USG (BARDA and affiliate partners) COVID-19 vaccines. Expansion of existing domestic capacity shall be through expansion of the Contractor’s existing domestic facilities and establishment of new facilities.

C.2 Specific Objectives.

C.2.1. The contractor shall develop a long-term vaccine consumables manufacturing capacity and production solution to provide a long-term capacity and production capability that enables surge manufacturing capacity of drug substance including COVID-19 and future pandemic or other critical situations. The contractor shall develop and implement plans to realize and execute a significant increased capacity production request in the shortest possible timeframe at domestic sites.

C.2.2. The contractor shall undertake all necessary activities to build out and expand capacity at its domestic consumables manufacturing facilities.

C.2.3. Manufacturing capacity expansion shall be for vaccine consumables products including, but not limited to:

o 2-D Single Use Bags o 3-D Single Use Bags o Single Use Assemblies (tubes and associated connectors required for drug manufacturing)

C.2.4. Manufacturing capacity expansion shall be capable of supporting projected 3rd party demand for consumables products from current BARDA sponsored COVID-19 vaccine developers now through 2023, to specifically include the current surge requirement for the US domestic response to COVID-19. The current anticipated required consumable products capacity expansion increase is shown below:

ANTICIPATED SURGE CAPACITY DEMAND FOR CONSUMABLES

Location

Product Required Expansion Ready By

3-D Single Use Bags From 0 to 600 bags/wk From 600-1200 bags/wk

Jun 2021 Sep 2021

Single Use Assemblies From 1300 assemblies/wk to 1700 assemblies/wk Mar 2021 Location

Product Required Expansion Ready By

2-D Single Use Bags From 0 to 1,200 Bags/wk From 1,200 to 2,400 bags/wk

Sep 2021 Dec 2021

3-D Single Use Bags From 0 to 1,200 bags/wk From 1,200 to 2,400 bags/wk

Sep 2021 Dec 2021

Single Use Assemblies From 0 to 4,800 assemblies/wk From 4,800 to 9,600 assemblies/wk

Sep 2021 Dec 2021

C.2.5. The contractor shall ensure compliance with all Federal safety and health regulations and ensure Food and Drug Administration (FDA) approval upon completion of the effort for all of the new capacity. BARDA will support the contractor’s requests for assistance in navigating and streamlining federal requirements to the maximum practical extent.

C.2.6. Future Consumables Product Pricing. Upon completion of this effort, the contractor agrees that it shall not offer, sell or otherwise provide the services funded by the Government’s investment to any entity at a price lower than that offered to the Government. In the event that Contractor provides the above referenced services at a lower unit price than that price sold to the Government, Contractor shall immediately notify the OTAO in writing of the lower price. For prior purchases, the Contractor shall reimburse the Government the difference between the lower price provided to the other customer(s) and the price provided to the Government, multiplied by the volume/quantity provided. Such reimbursement shall occur within thirty days

(30) of the Contractor discovering that the lower price was given to another customer. Notwithstanding the foregoing, the parties may agree to apply the difference in price paid by the other customer(s) and Government into additional quantities/volume required by the Government.

C.2.7 Precedence. Upon completion of the effort, the contractor agrees that upon Presidential Declaration of a Public Health Emergency that Government orders will be provided precedence for completion over and above any other orders. Fulfillment of orders shall commence within two (2) months of notification. These requirements apply regardless of a DO or DX rating under the Defense Production Act

C.2.8 Reservation of Supply. In addition to priority access for the Government, the Contractor agrees to set aside a reservation of in response to the current domestic US public health emergency. This reservation will be accessible to the Government and/or third parties purchasing pursuant to a Government contract for the benefit of the Government (see generally FAR Part 51).

C.3. Schedule Objectives.

The schedule for this effort shall be from date of award (anticipated February 2021) through XXX. However, more rapid acceleration is highly desired by the Government in order to meet critical COVID- 19 response needs. As incremental capabilities become available from different activities, they shall be placed online as quickly as possible and made available to USG BARDA to meet critical national COVID-19 demands.

C.4. Overall Management Objectives.

The contractor shall be responsible for overall management and oversight of the work necessary to achieve the objectives of this agreement. The contractor shall provide the overall management, integration, and coordination of all agreement activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all agreement activities.

The contractor shall establish project milestones for each facility/capability for which expansion and/or development is planned. Incremental progress against each milestone shall be provided to BARDA in accordance with established deliverables (see C.7 below). Any changes or deviations planned or incurred by the contractor in pursuing the objectives of this agreement shall be reported to BARDA. While primary responsibility for management and execution of the effort resides with the contractor, BARDA shall have input to the milestone review process and any changes to the objectives of the agreement. BARDA shall have the responsibility for communicating to the contractor any changes in USG MCM strategies that may impact this agreement.

C.5. Risk Management Objectives.

The contractor shall identify all anticipated project risks categorized as moderate or high and report them to BARDA in accordance with reporting requirements (see C.7 below). The contractor shall manage all project risks using its in-house risk management capabilities, and report to BARDA changes to all identified risks as they occur/arise. BARDA shall be permitted to participate in the risk management and mitigation processes associated with this project.

C.6. Intellectual Property.

Intellectual Property rights for all technology developed under this agreement shall reside with the contractor, with the exception of information contained in specified deliverables, which shall be subject to distribution within US Government agencies and their contractors (Distribution Statement C). See C.7 below.

C.7. Deliverables.

C.7.1. Monthly Progress Reports. Submitted monthly no later than the 10th of the month. Recipient format acceptable. Electronic submission acceptable in MS Office or PDF format. Financial information shall be MS Excel format. Monthly reports shall NOT be marked proprietary and shall have Distribution Statement C (US Government and their contractors). Each monthly report shall, at a minimum, contain the following:

• Summary of monthly progress for each of the contractor’s facilities/capabilities associated with this effort.

• Summary of progress towards established milestones for each facility/capability.

• Identification of any milestone that is slipping or missed, and discussion of path forward to bring milestone back to schedule, and impact on other milestones.

• Summary of risks, discussion of potential impacts and efforts to mitigate.

• Summary of overall schedule and changes from previous month.

• Financial summary of contractor costs incurred by month to date, invoices submitted, and

Government payments made.

C.7.2. Quarterly in Process Reviews. Scheduled as needed, generally not more frequently than quarterly, at the contractor’s facilities. Duration: 8 hours max. Face to face review of previous quarter’s activities.

Informative in nature to keep BARDA apprised of project progress and to discuss issues that may require joint resolution, such as milestone changes, political impacts on objectives, schedule, funding.

C.7.3. Final Report. Final Report shall NOT be marked proprietary, and shall have Distribution Statement C.

Final report summarizing stated objectives and the progress that was achieved in meeting those objectives;

summary of risks incurred, impacts and mitigation; quantitative discussion of vial production throughput improvements achieved; financial summary of project; schedule summary for project, comparing original schedule to final schedule; recommendations for path forward as applicable.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

ITEMS (Nov 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section

743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-6

(2) 52.203-13

(3) 52.203-15

(4) 52.204-10

(5)

(6) 52.204-14

(7) 52.204-15

(8) 52.209-6

(9) 52.209-9

(10)

(11) 52.219-3

[Contracting officer check as appropriate.]

Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)).

Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.

109-282) (31 U.S.C. 6101 note).

[Reserved].

Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

111-117, section 743 of Div. C).

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C.657a).

(ii) Alternate I (Mar 2020) of 52.219-3.

(12) 52.219-4

(13)

(14) 52.219-6

(15) 52.219-7

(16) 52.219-8

(17) 52.219-9

(18) 52.219-13

(i), Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(ii) Alternate I (Mar 2020) of 52.219-4.

(i) Notice of Total Small Business Set-Aside (Nov 2020) of 52.219-6 (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-6.

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-7.

Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

(i), Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).

(ii) Alternate I (Nov 2016) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Jun 2020) of 52.219-9.

(v) Alternate IV (Jun 2018) of 52.219-9.

(i) Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

(ii) Alternate I (Mar 2020) of 52.219-13.

(19) 52.219-14

(20) 52.219-16

(21) 52.219-27

(22) 52.219-28

(23) 52.219-29

(24) 52.219-30

(25) 52.219-32

(26) 52.219-33

Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657 f).

Post Award Small Business Program Rerepresentation (Nov 2020) (15 U.S.C. 632(a)(2)). May require contractor completion.

(ii) Alternate I (Mar 2020) of 52.219-28.

Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).

Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

Nonmanufacturer Rule (Mar 2020)(15 U.S.C. 637(a)(17)).

(27) 52.222-3 Convict Labor (June 2003) (E.O. 11755).

(28)

(29)

✔ (30)

✔ (31)

(32)

(33)

(34)

✔ (35)

(36)

(37)

(38)

(39)

(40)

(41)

(42)

(43)

✔ (44)

(45)

52.222-19

52.222-21

52.222-26

52.222-35

52.222-36

52.222-37

52.222-40

52.222-50

52.222-54

52.223-9

52.223-11

52.223-12

52.223-13

52.223-14

52.223-15

52.223-16

52.223-18

52.223-20

Child Labor—Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126).

Prohibition of Segregated Facilities (Apr 2015).

(i) Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26. If this is checked, some terms have been waived.

(i) Equal Opportunity for Veterans (Jun 2020)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35. If this box is checked, some terms have been waived.

(i) Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36. If this box is checked, some terms have been waived.

Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(i) Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). Alt I requires CO completion.

Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(i) Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Requires CO completion.

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Alt I requires contractor certification.

Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). Requires contractor completion.

Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

(i), Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(i) Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

(i), Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

Aerosols (JUN 2016) (E.O. 13693).

(46) 52.223-21

(47) 52.224-3

(48) 52.225-1

(49) 52.225-3

(50) 52.225-5

(51) 52.225-13

(52) 52.225-26

(53) 52.226-4

(54) 52.226-5

Foams (JUN 2016) (E.O. 13693).

(i), Privacy Training (JAN 2017) (5 U.S.C. 552a).

(ii) Alternate I (JAN 2017) of 52.224-3.

Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

(i), Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

(ii) Alternate I (May 2014) of 52.225-3.

(iii) Alternate II (May 2014) of 52.225-3.

(iv) Alternate III (May 2014) of 52.225-3.

Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). Requires CO completion.

Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

(55) 52.229-12 Tax on Certain Foreign Procurements—Notice and Representation (Jun 2020)

(57)

(58)

(59)

(59)

(61)

(61)

(63)

(63)

52.232-29

52.232-30

52.232-33

52.232-34

52.232-36

52.239-1

52.242-5

52.247-64

Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C.

3332).

Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). Requires CO completition.

Payment by Third Party (May 2014) (31 U.S.C. 3332).

Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

(i), Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.

1241(b) and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

(1) 52.222-41 Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(2) 52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). Requires CO completion.

(3) 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4) 52.222-44 Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(5) 52.222-51 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C.

chapter 67).

(6) 52.222-53 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain

Services—Requirements (May 2014) (41 U.S.C. chapter 67).

(7) 52.222-55 Minimum Wages Under Executive Order 13658 (Nov 2020).

(8) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(9) 52.226-6 Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C.4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C.793).

(x) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C.4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78 and E.O 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain

Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section

862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241

(b) and 10 U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

BARDA FIXED PRICE INVOICE INSTRUCTIONS

(a) Invoice Submission.

(1) The Contractor shall submit invoices in accordance with the payment schedule included in the contract.

(2) A proper invoice, shall be sent electronically, via email, to the Program Officer, Contracting Officer and PSC mailboxes below:

(i) Program Officer

(ii) Contracting Officer

(iii) PSC_Invoices@psc.hhs.gov

(3) The subject line of your email invoice submission shall contain the contract number, order number (if applicable), and the number of invoices. The Contractor shall send one email per contract per month. The email may have multiple invoices for the contract.

Invoices must be in the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF or TIFF or Word).

(4) Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

(5) All calls concerning contract payment shall be directed to the Program Officer.

(6) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

(b) Invoice Elements.

(1) The Contractor shall submit an electronic invoice to the email addresses designated above. A proper invoice must include the following items:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice;

and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice.

(B) In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this order will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer - System for Award Management.

(2) Additionally, the Program Support Center (PSC) requires:

mailto:PSC_Invoices@psc.hhs.gov mailto:PSC_Invoices@psc.hhs.gov

(i) the invoice to break-out price/cost by contract line item number (CLIN) as specified in the pricing section of the contract

(ii) the invoice to include the Dun & Bradstreet Number (DUNS) of the Contract