75A50223R00003 Amendment 0001.pdf

(x)

75A50223R00003 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

WASHINGTON DC 20201

ASPR-HQ

HEADQUARTERS CONTRACTING

ASST SEC FOR PREPAREDNESS AND RESPONSE

US DEPT OF HEALTH & HUMAN SERVICES

ASPR-HQ

WASHINGTON DC 20201

ASPR-ORM-HQ

HEADQUARTERS CONTRACTING

ASST SEC FOR PREPAREDNESS AND RESPONSE

US DEPT OF HEALTH & HUMAN SERVICES

ASPR-ORM-HQ

07/25/20230001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

07/25/2023

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of Amendment 0001 is to correct and change the submission deadline for questions in response to the solicitation.

1. The due date for questions is hereby changed to August 8th, 2023 at 1:00 PM ET. All questions must be submitted electronically by email to IBMSCC-Submissions@hhs.gov.

2. All other terms and conditions remain the same.

Period of Performance: 09/22/2023 to 09/21/2026

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

ROGER N. HENRIQUEZ

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

08/01/2023

COMBINED SYNOPSIS SOLICITATION

I. This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. The procedures from FAR Parts 12, 15, and 19 are being utilized as part of the Request for Proposal (RFP). This announcement constitutes the only solicitation; proposals are being requested.

II. The solicitation number is 75A50223R00003 which is a Request for Proposal (RFP). The solicitation document and incorporated provisions and clauses are currently in effect through Federal Acquisition Circular 2023-04 effective June 2, 2023.

III. Contract Type will be Firm Fixed Price (FFP).

NOTICE TO Offerors: This acquisition is being posted as a Partial Set-Aside for Small Business in accordance with FAR 19.502-3 NAICS Code: 325220 - Artificial and Synthetic Fibers and Filaments Manufacturing. The size standard is 1,000 employees.

Product Service Code: AN35 – Health R&D SVCS; Consumer & Occupational Health & Safety; R&D Facilities& Major Equipment

IV. a. The Office of Industrial Base Management and Supply Chain (IBMSC), of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary and Administration for Strategic Preparedness and Response (ASPR), has a requirement to establish a sustainable, competitive manufacturing capacity for the production of manmade fibers.

b. The Government intends to evaluate offers and award a contract(s) without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government. Notwithstanding the Government’s intent to award multiple contracts as a result of the solicitation, the Government expressly reserves the right to conduct discussions and to award one, multiple, or no contracts, if it is determined to be in the Government’s best interest.

c. Award is anticipated for a total MMF capability expansion of 60k to 150K MTA. However, the total number of awards are subject to change based on the proposals received and the final award numbers will be determined based on the best interest of the Government. The number of awards is estimated at the time of issuance of this RFP and does not represent the guarantee that any contract awards will be made. This requirement is a partial set-aside.

V. See Sections B and C below for description of requirements.

VI. The period of performance is anticipated to total 3 years.

VII. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Mar 2023), applies to this acquisition.

VIII. The provision 52.212-2, Evaluation-Commercial Products and Commercial Services (Nov 2021), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services (Dec 2022), with its offer. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that effect in accordance with this clause).

IX. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Dec 2022), applies to this acquisition.

X. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (Jun 2023), applies to this acquisition and FAR clauses applicable include, but are not limited to: 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See Sections D through I.

XI. There are no special contract requirements or terms and conditions related to contract financing arrangements.

XII. 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.

XIII. Offers are due no later than August 25, 2023, at 5:00 PM ET with the Subject Line RFP 75A50223R00003, by email to IBMSCC-Submissions@hhs.gov.

The offeror’s complete proposal (including all information required to be submitted as part of the offeror’s Volume A -Technical Proposal, to include Statement of Work (SOW), and Volume B - Price/Business Proposal) must be received by the date and time specified for receipt of offers. Technical proposals are to be no more than 60 pages in length. This page limit does not include cover pages, table of contents, Cross Reference Matrix, or resumes. If the Offeror includes appendices with information not expressly allowed herein, the Offeror should note that such information will not be evaluated. There is no page limit for the Price Proposal. The Price Proposal shall include details for all resources required to accomplish the requirements for the base and any option periods.

FORMATTING AND PAGE LIMITATIONS

A. Formatting for proposals

• Proposals should not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

• Font size should be 11 points.

B. Page limitations:

The technical proposal should be no more than 60 pages in length including the Statement of Work. This page limit does not include cover pages, table of contents, cross reference Matrix, resumes, appendixes and attachments. If the Offeror includes appendixes with information not expressly allowed herein, the Offeror should note that such information may not be evaluated.

• There is no page limit for the business proposal.

• Proposal pages should be numbered “Page 1 of 60, “Page 2 of 60” etc.

Only Electronic submissions will be accepted and shall be submitted via email to IBMSCC- Submissions@hhs.gov. All submissions must include the solicitation number and the word “SUBMISSION”. It is recommended that offerors limit email submissions to 2MB. If submissions are going to exceed this size, it is recommended that offerors submit them as clearly titled and numbered separate emails or as a zip file. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

All questions regarding this RFP must be submitted electronically by email to IBMSCC- Submissions@hhs.gov no later than 1:00 PM ET August 8, 2023. For proper submission of questions, include the solicitation number and the word “QUESTION” in the subject of the email. The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting. Please be advised that the Government reserves the right to transmit those questions and answers of a common interest to all prospective offerors. The Government also reserves the right to respond or not respond to any questions at its discretion.

The point of contact for information regarding this combined synopsis/solicitation are:

Krystal Creaser mailto:IBMSCC-Submissions@hhs.gov mailto:IBMSCC-Submissions@hhs.gov mailto:IBMSCC-Submissions@hhs.gov%20no%20 mailto:IBMSCC-Submissions@hhs.gov%20no%20

Contract Specialist Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA)Assistant Secretary for Preparedness and Response

(ASPR)

U.S. Department of Health and Human Services (HHS) Email: IBMSCC-Submissions@hhs.gov

Roger Henriquez Contracting Officer Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA)Assistant Secretary for Preparedness and Response

(ASPR)

U.S. Department of Health and Human Services (HHS) Email: IBMSCC-Submissions@hhs.gov

SECTION B - SUPPLIES OR SERVICES AND

PRICES/COSTS

B.1 Contract Line Items

TBD based on proposals received.

This is a requirement for non-severable services.

* NOTE: The Government may make multiple awards under this solicitation. In which case, each individual vendor’s award will show only the items awarded to them.

SECTION C - STATEMENT OF OBJECTIVES (SOO)

Section One: General Information and Description of Services

1.1 General Information/Scope

The recent COVID-19 Public Health Emergency has illuminated the importance of increasing the United States domestic Man-Made Fibers (MMF) manufacturing expansion and capacity capabilities, ensuring the U.S possesses a reliable domestic MMF supply chain during periods of global uncertainty, which occurred since the beginning of the COVID-19 pandemic. The current assessment revealed that ’MF's annual production domestic capacity runs at a steady state of 31.2K Metric Tons Annually (MTA), and the peak annual demand is 68.4K MTA.

The United States Government (USG)’ has a requirement for manufacturing capacity sufficient to manufacture 60,000 to 150,000 metric tons annually, through which improvements in production scale, efficiency, and process optimization/quality/sustainability (e.g., automation, polymer chemistry, biodegradability, innovation, etc.) will tilt the competitive balance to ensure that the U.S. possesses a constant and reliable domestic MMF source.

The Request for Proposal (RFP) and Statement of Objectives for commercial sustainment have been updated with new evaluation criteria. The criteria include Innovation, Scalability, Sustainability, and Global Competitiveness, which were absent in the previously canceled solicitation. Every vendor must submit a 5-year Strategic Business Plan detailing their company's long-term growth, profitability, and sustainability to qualify.

1.1.1. Period of Performance (PoP): 36 Months after Contract Award.

1.2 Description of Services

1.2.1 Contract and Project Management

1.2.2 The Contractor shall develop and deliver to the USG Point of Contact (POC) List* for approval a Contractor Statement of Work (CSOW), a Contractor Work Breakdown Structure (CWBS), an Integrated Master Schedule (IMS) and other documents supporting and defining the Contractor’s proposed effort two days before the scheduled Kick-Off Meeting.

1.2.2.1 The Contractor shall manage the project from contract award through completion. The Contractor shall develop and maintain processes to evaluate and monitor progress made by the Contractor in accomplishing the requirements of this Statement of Objectives (SOO). The Contractor shall develop, maintain, and deliver a Project Progress Report two business days before the scheduled Kick-Off Meeting.

The Contractor shall include information, timelines, graphs, data points, financial forecasts, etc., once mailto:IBMSCC-Submissions@hhs.gov monthly as instructed by the USG and required by this contract.

1.2.2.2 The Contractor shall develop and maintain a Risk Registry Report and deliver the Risk Registry Report on the 3rd Tuesday of every month to 1) identify materialized risk factors impacting the project, 2) aligned mitigation strategies, and 3) status of mitigation strategy. The Contractor shall include information, timelines, graphs, data points, etc., as instructed by the USG and within this contract.

1.2.2.2.1 Immediate Risk Reporting

The Contractor shall report the following identified risks to the individuals identified on the USG POC LIST* by the end of the next business day from the time that risk is known:

- Suppliers can no longer produce equipment/material that will affect the Industrial Base Expansion (IBx) effort.

- Any shortages in materials/equipment that will affect the IBx effort.

- Orders that are being backfilled or not being shipped due to vendor competing priorities.

- Any intermediary suppliers/distributors experiencing delays in the shipment of materials/supplies.

- Any natural or manufactured disaster that disrupts the supply chain affecting the delivery of materials/supplies.

- Any suppliers are refusing to fill orders due to not having a priority rating from Defense Priorities and Allocations System / Health Advanced Research Projects Agency (DPAS)/ (HARPA).

- Any suppliers that are redirecting supplies to other higher priority efforts due to not having a rating from DPAS/HARPA.

- Any other supply chain limitation not addressed above may affect the timeliness, quality, and or cost of the IBx effort.

1.2.2.3 The Contractor shall notify the individuals identified on the USG POC LIST* at least two weeks before the following. The notification shall include the location, dates, and times, along with a POC and Access Instructions should the USG choose to verify:

a. Requirements to sustain production machines to include serviceability, maintenance, and quality systems requirements for the period of performance. The manufacturer should propose at what percentage of production capacity it can operate up to 150,000 MTA of MMF production to sustain them during low demand or non-emergency periods.

b. Manufacturers’ recommendations to maintain the capacity to produce MMF at their maximum monthly production rate within 120 days of USG notification and provide options to operate MMF production at lower volume during low demand or non-medical emergency periods.

c. Manufacturer shall provide evidence of commercial viability. The USG’s goal is to ensure that the manufacturer is not wholly dependent upon USG investment, intervention, or MMF production only.

d. The USG reserves the right to witness any testing or demonstration of capacity.

1.2.2.4 Meetings

Meetings held in a virtual environment shall be readily accessible to the USG, with screen-sharing presentation and discussion capability. The following meeting schedules may be altered based on the mutual Contractor and USG agreement. Ad hoc meetings may be required to address issues affecting the project.

1.2.2.4.1 Kick-Off Meeting

The Contractor shall conduct a Kick-Off Meeting 12 business days after receipt of the contract award. The exact time and place (physical or virtual) of this meeting will be mutually agreed upon by the Contractor and the USG. The Contractor shall coordinate with the USG on the agenda. The agenda shall be distributed via email per the USG POC List at least two business days before the scheduled Kick-Off Meeting.

Contractor Format Acceptable upon USG approval.

The purpose of the Kick-Off Meeting is to review the Project Progress Report and any other mutually agreed-upon agenda topics.

1.2.2.4.2 Status Meetings

The Contractor shall initially conduct Monthly Status Meetings until such a time that a determination is made that these meetings be held more or less frequently, as determined by the USG. Status Meetings shall be held in person or virtual. Meeting Minutes shall be prepared and submitted via the USG POC List NLT 2 business days after the Monthly Status Meetings. Contractor Format Acceptable upon USG approval.

1.2.3 The Contractor shall have the capacity to manufacture 60,000 to 150,000 MTA of MMF manufacturing capabilities, through which improvements in production scale, efficiency, and process optimization/quality/sustainability (e.g., automation, polymer chemistry, biodegradability, innovation, etc.)

will tilt the competitive balance to ensure that the U.S. possesses a constant and reliable domestic MMF source.

1.2.4 To meet the requirements, the capability must be fully functional. All equipment must be commissioned, qualified, and validated, trained staff must be in place, and all necessary utilities, services, and raw materials must be available for MMF production. The Contractor must demonstrate the required capability before completing the final milestone.

Upon completion of the contract, the Contractor shall be able to produce an IBx capable of producing 60,000 to 150,000 MTA of MMF upon notification from the Government Procurement Contracting Officer (PCO); the Contractor shall ramp up to a maximum production capacity of 60,000 to 150,000 metric tons of MMF per year within 120 days. Program Management, Administration, and Reporting Requirements:

1.2.4.1 Program Management, Administration, and Reporting Requirements:

1.2.4.2 The Contractor shall provide the overall program management functions required to execute this SOO for the duration of the contract. A designated Program Manager (PM) shall lead the day-to-day management of program activities required to meet delivery schedules defined in the contract.

1.2.4.3 The Contractor shall propose how they will identify and actively manage project risks, including, but not limited to, supply chain risks.

1.2.4.4 The Contractor shall notify the Government, as soon as possible, where it may be able to assist in risk mitigation.

1.2.4.5 The Contractor shall identify technology improvements to machinery, when available or as needed, to the government to determine possible investment opportunities to improve capacity and capability.

1.2.4.6 The Contractor shall insure, maintain, operate, validate, and service all equipment and tooling acquired by the Contractor funded by this award as required to have the capacity sufficient to manufacture 60,000 to 150,000 MTA of MMF. The Contractor will ensure that the facility is in a state of readiness to meet the 120 days ramp-up requirement.

1.2.4.7 To the extent applicable, The Contractor shall implement and maintain the proper current good manufacturing practices (cGMP) and quality management systems.

1.2.4.8 The Contractor shall implement and maintain a robust cybersecurity program.

1.2.4.9 If applicable, provide legal segregation of the business from any foreign partners or assets.

1.2.4.10 The Contractor shall propose a workforce management plan, e.g., how the workforce will train, maintain, etc., that reflects the ability to meet the Statement of Objectives.

1.2.4.11 The Contractor shall manage, including flow-down requirements, partnerships, subcontractors, or other business arrangements needed to complete expanded production and qualification of the tool/equipment to be produced. This would also include operational agreements with any foreign suppliers, etc.

1.2.4.12 The Contractor shall provide a monthly production progress meeting and corresponding report that addresses all the above, including the monthly production numbers and immediate updates for any technical or otherwise impediments that could adversely affect the performance schedule.

1.2.4.13 The Contractor shall develop and submit a Testing Plan that details the methods/processes they will use to demonstrate the IBx capacity preservation to produce 60,000 to 150,000 MTA of MMF for the USG’s approval.

1.2.4.14 The Contractor shall detail and deliver a Testing Report with the IBx capacity preservation testing results IAW the USG approved Testing Plan.

1.2.4.15 The Contractor shall develop innovative methods for enhancing safety measures for healthcare professionals and fostering healthy competition among local suppliers and their foreign counterparts.

1.2.4.16 The Contractor shall develop innovative capabilities for developing and fielding new MMF that offers enhanced quality and protection to frontline medical workers and provides domestic sources a competitive advantage over overseas supplies The Offeror is required to confirm that there are no existing, essential patents that would impede their ability to operate freely. Additionally, they must propose a strategy to ensure that any patents or intellectual property that are gained because of the project remain within the United States. The Government places a particular emphasis on advancements related to automation, polymer chemistry, continuous polymerization, durability, reusability, comfort, and increased biodegradability in various environments such as landfills, soil, seawater, and wastewater. Proposals that include any of these advancements should also provide a detailed description of relevant testing, validation, and other assurances of successful implementation and execution.

1.2.4.17 The Contractor shall submit all requested and required reports as outlined under this contract.

1.2.4.18 Data – Not Separately Priced

Milestones and several milestones are TBD pending Contractor data.

Milestone Description Date

Section Two: Services Summary

2.1 Services Summary

The Services Summary (SS) aims to define performance evaluation. The following SS chart lists the Statement of Objective Requirements the USG will survey and document. The USG will survey all the requirements of this contract. The absence of any SOO requirement from the SS does not detract from its enforceability nor limit the rights or remedies of the USG and sets forth the maximum allowable deviation from the statement of objective for that service.

2.2 Services Summary Table

SS# Statement Objective SOO Paragraph

Objective Threshold

1 Contractor Statement of Work; Contractor Work Breakdown Structure; Integrated Master Schedule

1.2.2 One - (2) business days before

the scheduled Kick-Off Meeting

2 Project Progress Report

1.2.2.1

(2) business days before the scheduled Kick-Off Meeting and the monthly status meetings

3 Risk Registry Report

1.2.2.2 3rd Tuesday of every month

4 Immediate Risk Reporting 1.2.2.2.1 Report Immediate Risks by the end of the next business day

5 Meeting Minutes 1.2.2.4.2 NLT 2 business days after the Monthly Status Meetings

6 Testing Plan 1.2.3.14 Draft/Final IAW Contractor approved PWS

7 Testing Report 1.2.3.15 Draft/Final IAW Contractor approved PWS

8 Monthly Status Meetings 1.2.3.12 Meetings will be held monthly, as needed.

Section Three: Government Furnished Property, Equipment, and Services

3.1 Government Furnished Services/Property

The USG does not intend to provide services or Government Property in connection with this effort.

3.2 Priority Access

By entering this contract, the Contractor agrees to be legally bound to provide the U.S. Government with Priority Access for a 10-year period, starting from the completion of the capacity/expansion project that is the subject of this contract, notwithstanding the conclusion of any other commitments at the end of this contract's period of performance.

"Priority Access" is defined for this contract as: "upon a determination by the HHS Secretary that the MMF production is needed to prepare for or respond to disease, health condition or other threat to the public health that causes a public health emergency or a credible risk of such an emergency, the U. S. Government has priority access to [CAPACITIES THAT THE U.S. GOVERNMENT WILL RECEIVE PRIORITY ACCESS TO] over any other non-rated DPAS)/ HRPAS contract or orders, and, to assure such priority, shall be required to accept and perform such DPAS/HRPAS rated contracts or orders in preference to any other non-rated DPAS/HRPAS rated contracts/orders during these ten years."

If the Contractor novates or otherwise transfers responsibility for performance under this contract and the commitments herein to any other entity, the Priority Access requirement shall follow the transfer, and this language concerning Priority Access shall be included in any transfer agreement and affirmed by the transferee. The parties agree to negotiate in good faith for continued U.S. Government Priority Access, as defined herein, to extend beyond these ten years.

APPENDIX 1 Acronyms Glossary ASPR – Administration for Strategic Preparedness and Response cGMP – current Good-Manufacturing Practices CSOW – Contractor Statement of Work CWBS – Contractor Work Breakdown Structure DPAS – Defense Priorities and Allocations System HARPA – Health Advanced Research Projects Agency IBMSC – Industrial Base Management and Supply Chain IBx – Industrial Base Expansion IMS – Integrated Master Schedule MMF – Man-Made Fibers MTA – Metric Ton Annually PCO – Procurement Contracting Officer POC – Point of Contact PPE – Personal Protective Equipment PWS – Performance Work Statement SOO – Statement of Objectives SS – Services Summary USG – United States Government

APPENDIX 2 Definitions Ad Hoc Meetings - One-off, unplanned gatherings that focus on a specific topic of discussion.

Capable of producing – The capacity or ability to produce the contracted product.

Complete and Demonstrate – To prove or make evidence by reasoning or evidence.

Contractor Statement of Work – A document describing the work requirements for a specific project and its performance and design expectations.

Contractor Work Breakdown Structure – Defines the scope of the effort and how the contractor will accumulate costs. Aligns responsibility with accountability within the Contractors’ team’s organization and establishes the single numbering system that serves as the thread for the overall business information framework.

Innovation – A process by which a domain, product, or service is renewed and brought up to date by applying new processes, introducing new techniques, or establishing successful ideas to create new value.

Integrated Master Schedule – A time-based schedule containing the networked, detailed tasks necessary to ensure successful contract execution.

Project – Collaborative enterprise carefully planned to achieve a particular end state.

Project Progress Report - A document that explains in detail how much progress the Contractor has made toward the completion of the project.

Kick-Off Meeting - A meeting convened by the Contractor to discuss and finalize the work SOO and PWS procedures with the Contractor.

Man-Made Fiber – a fiber that is artificial and not of natural origin.

Operational Capability – The ability of a system to perform in the intended operational environment, particularly concerning meeting the contract’s requirements.

Risk Registry Report - The document used to identify potential risks contains the results of the qualitative risk analysis, quantitative risk analysis, and risk response planning.

Status Meetings - A meeting where personnel discuss the current stage(s) of the project they are working on.

Testing - A single or multipurpose integrated test unit engineered, designed, fabricated, or modified to accomplish special-purpose testing in performing a contract.

USG POC List – United States Government Point of Contract list is a group of government employees and department(s) that handles communications with the Contractor. ** The USG POC List is a living document that changes periodically. Revisions will be sent to the contractor when revisions occur. The Contractor shall reference the most recent revision of the USG POC List.

Virtual - A web conference, contrary to an in-person event.

SECTION D-PACKAGING, MARKING AND SHIPPING

This Section is not applicable to this requirement.

SECTION E- INSPECTION AND ACCEPTANCE

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 this/these address(es): http://www.acquisition.gov (End of Clause)

FAR SOURCE TITLE AND DATE

52.212-4 Contract Terms and Conditions—Commercial Products and

Commercial Services (Dec 2022)

52.212-4 (Alt. 1) Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2021)

SECTION F- DELIVERIES AND PERFORMANCE

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 this/these address(es):

http://www.acquisition.gov

52.242-15 Stop-Work Order (Aug 1989)

F.1 Deliverables

(a) At a minimum, the Contractor shall provide a quarterly report and a status report, after the close of each quarter’s business. Reports shall reflect, at a minimum, call/order, number date of order, total dollar amount of each call/order number, total net sales, and amounts. Reports shall be sent to the designated Project Officer/COR by e-mail or as otherwise instructed by the Government’s Contracting Officer. Reports are due fifteen (15) days after the end of each quarter.

(b) Additional deliverables must be proposed by Offeror.

http://www.acquisition.gov/

F.2 Delivery Schedule:

Offeror must propose detailed delivery/milestone schedule.

F.3 Period of Performance

The period of performance for this contract will be TBD. (It is anticipated that the Period of Performance is likely to total 3 years.)

F.4 Place of Performance

Anywhere in the 50 United States, or the U.S. Territories: Offeror must provide specific location information.

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR personnel:

Contract Specialist Krystal Creaser Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA)Assistant Secretary for Preparedness and Response

(ASPR)

U.S. Department of Health and Human Services (HHS) Email: IBMSCC-Submissions@hhs.gov

Contracting Officer Roger Henriquez Industrial Base Management Supply Chain (IBMSC) Contracting Office of the Head of Contracting Activity (OHCA)Assistant Secretary for Preparedness and Response

(ASPR)

U.S. Department of Health and Human Services (HHS) Email: IBMSCC-Submissions@hhs.gov

Contracting Officer’s Representative (COR)/Technical Point of Contact (POC)

TBD

Office of Industrial Base Management and Supply Chain (IBMSC) U.S. Department of Health and Human Services (HHS)

G.2 ELECTRONIC INVOICING AND PAYMENT REQUIREMENTS - INVOICE

PROCESSING PLATFORM (IPP)

All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business

Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St.

Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

• If your company is already registered to use IPP, you will not be required to re-register.

• If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

Additional Office of the Assistant Secretary for Preparedness and Response (ASPR) requirements:

(i) The contractor shall submit monthly invoices under this contract unless otherwise agreed upon by all parties. For indefinite delivery and blanket purchase agreement vehicles, separate invoices must be submitted for each order.

(ii) Invoices must break-out price/cost by contract line- i t e m number (CLIN) as specified in the pricing section of the contract.

(iii) Invoices must include the Dun & Bradstreet Number (DUNS) of the Contractor.

(iv) Invoices that include or labor hours CLINS must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

(v) Invoices that include cost-reimbursement CLINs must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem http://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

(End)

SECTION H—SPECIAL CONTRACT REQUIREMENTS

H.1 – CONTRACTING OFFICER

The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

H.2 – CONTRACTING OFFICER’S REPRESENTATIVE

Performance of work under this contract is subject to the technical direction of the COR identified in Section G.1 Administration or a representative designated by the contracting officer in writing. The term “technical direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, and/or fills in details and otherwise serves to ensure that tasks outlined in the contract are accomplished satisfactorily. Technical direction must be within the scope of the contract specification(s)/work statement. The COR does not have authority to issue technical direction that:

i. Constitutes additional work outside the contract specification(s)/work statement;

ii. Constitutes a change as defined in the “Changes” clause of this contract;

iii. Causes an increase or decrease in the contract price, or the time required for contract performance

iv. Interferes with the contractor’s right to perform under the terms and conditions of the contract; or

v. Directs, supervises or otherwise controls the actions of the contractor’s employees.

Technical direction may be oral or in writing. The COR must confirm oral direction in writing within five workdays, with a copy to the contracting officer. The contractor shall proceed promptly with performance resulting from the technical direction issued by the COR, if the opinion of the contractor, any direction of the COR or the designated representative falls within the limitations above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government workday.

Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subjected the terms of the “Disputes” clause of this contract.

The COR is responsible for confirming the inspection/acceptance of product delivered prior to payment of invoices.

H.3 – CONTRACTOR PUBLICITY

The Contractor, or any entity or representative acting on behalf of the Contractor, may not refer to the equipment or services furnished pursuant to the provisions of this contract in any news release or commercial advertising, or in connection with any news release or commercial advertising, without first obtaining explicit written consent to do so from the Contracting Officer. Should any reference to such equipment or services appear in any news release or commercial advertising issued by or on behalf of the Contractor without the required consent, the Government will consider institution of all remedies available under the contract and applicable law.

H.4 – PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds, until reviewed and approved by the Contracting Officer. For avoidance of doubt, proposals to this RFP may include projected costs to support items below as they relate to the overall scope of work; however, written approval from the Contracting Officer prior to the contractor incurring those costs and/or entering into binding agreements for such items will be required for the duration of the Period of Performance. These costs include the following:

1) Acquisition, by purchase or lease, of any interest in real property

2) Rearrangement or alteration of facilities

3) Purchase of lease of any item of general-purpose office furniture or office equipment regardless of dollar value

4) Accountable Government Property

5) Overtime

6) General scientific meetings/conferences

7) Travel costs that include foreign travel

8) Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements)

9) Costs to be paid for the performance of a fixed-price subcontract that exceeds $250,000.00

10) Refreshments and Meal Expenditures

11) Promotional Items

12) Printing

H.5 – Foreign Transfer of Assets or Technology This clause shall remain in effect during the term of the Contract and for five (5) years thereafter.

Definitions AFFILIATES: Associated business concerns, non-profit organizations, or individuals if, directly or indirectly, (1) either one controls or can control the other; or (2) a third-party controls or can control both.

ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable of being conveyed between economic or Governmental entities that is the focus/scope of development by the U.S. Government (“USG”) and Contactor in this Contract.

ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable of being conveyed between economic or Governmental entities that is the focus/scope of development by the U.S. Government (the “USG”) and Contactor in this Contract.

FOREIGN FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of a country other than the United States of America (U.S.), its territories, or possessions. The term includes, for purposes of this Contract, any agency or instrumentality of a foreign government; and firms, institutions or business organizations which are owned or substantially controlled by foreign governments, firms, institutions, or individuals.

TECHNOLOGY: Technical Data, Computer Software, manufactured materials and Subject Inventions funded by the USG under this Contract. Technology also includes contractor know how and personnel expertise, as well as other Assets necessary to assure successful completion of this Contract.

U.S. FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of the United States, its territories, or possessions. The term includes, for purposes of this Contract, any agency or instrumentality of the USG; and firms, institutions or business organizations which are owned or substantially controlled by U.S. citizens, firms, institutions, governmental agencies or individuals.

General

The Parties agree that research findings and technological developments made under this Contract constitute an investment by the USG on behalf of its citizens in the interest of their economic and national health security. These investments are made for the primary benefit of the citizenry of the U.S. with those same benefits potentially accruing to the people of all nations. Therefore, the USG has a fiduciary responsibility to protect the full invested value of the Assets and Technology developed under this Contract. The USG is also cognizant of the duty the Contractor has to its shareholders and other stakeholders with a vested interest in the economic success of the Contractor. At times both parties are aware their respective interests may diverge. Therefore, in the course of conducting business though the Contract, access to technology developments under this Contract by Foreign Firms or Institutions must be carefully considered.

Export Controls

Contractor agrees to comply with all applicable laws regarding export controls and not to export any Asset or Technology to any U.S. embargoed countries.

Post-award Transfer of Ownership of Assets or Technology

The Contractor shall provide notice to the Contracting Officer and COR within three (3) business days of any discussions of a proposed transfer of ownership or establishment of a licensing agreement of any Asset or Technology funded under this Contract from the Contractor to a Foreign Firm or Institution. Notice will also be given within three (3) business days of any discussions of a proposed transfer of operational, corporate, or economic control of Assets and Technology funded under this Contract to Foreign Firms or Institutions. This Article shall not apply to transfers by the Contractor to Affiliated entities of the Contractor, as well as technology transfers for the purposes of manufacturing in accordance with the Statement of Work.

Prior to transferring any Asset funded by the USG under this Contract, the Contractor should carefully review the USG rights under FAR Subpart 42.12 pertaining to Novation, specifically FAR section

42.1204. That provision provides that the USG may recognize a third-party assignment only if the transfer of Assets and Technology is determined to be in the USG’s interests. The Contractor should be aware that the USG is under no obligation to recognize a successor in interest. If the Contracting Officer determines that a transfer of Assets and Technology may have adverse consequences to the economic well-being or national health security interests of the U.S., the Contractor, and the Contracting Officer shall jointly endeavor to find alternatives to the proposed transfer which obviate or mitigate potential adverse consequences of the transfer, but which may provide substantially equivalent benefits to the Contractor.

In addition to the USG licensing rights to subject inventions and technical data funded under this Contract, see FAR clause 52.227-11 (Patent Rights-Ownership by the Contractor) and FAR Clause 52.227-14 (Rights in Data - General), the USG shall have a first right of refusal for the purchase of the Asset and/or Technology funded under the Contract. The USG may waive this first right of refusal in writing submitted to the Contractor within ninety (90) calendar days of the initial notification to the USG of the Contractor’s intent to conduct any form of Asset or corporate transfer.

Except for transfers to affiliates of the Contractor, including those entities necessary to complete the Statement of Work, the Contractor shall provide written notice to the Contracting Officer and COR of the scheduled transfer to a Foreign Firm or Institution at least ninety (90) calendar days prior to the scheduled date of transfer. Such notice shall cite this Article and shall specifically identify the Asset or Technology proposed for the transfer and the general terms of the transfer. No transfer shall take place without written concurrence from the Contracting Officer.

Transfer to a Prohibited Source

In the event of a transfer of an Asset and/or Technology by the Contractor to a Foreign Firm or Institution which is identified as a Prohibited Source pursuant to Federal Acquisition Regulation Subpart 25.7: (a) the Government may terminate this contract for cause and (b) the license rights to the technical data and subject invention under the relevant FAR IP Clauses (FAR Clause 52.227-11 and FAR Clause 52-227-14) shall survive the termination. Upon request of the USG, the Contractor shall provide written confirmation of such licenses.

Lower Tier Agreements

The Contractor shall include this Article, suitably modified, to identify the Parties, in all subcontracts or lower tier agreements, regardless of tier.

SECTION I – CONTRACT CLAUSES

I.1 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 this/these address(es):

http://www.acquisition.gov https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018)

52.204-16 Commercial and Government Entity Code Reporting (Aug 2020)

52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)

52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

52.209-7 Information Regarding Responsibility Matters (Oct 2018)

52.209-12 Certification Regarding Tax Matters (Oct 2020)

52.211-17 Delivery of Excess of Quantities (Sep 1989)

52.212-4 Contract Terms and Conditions-Commercial Commercial Products and Commercial Services (Dec 2022)

52.216-4 Economic Price Adjustment –…