Last_Mile_Solicitation_Final.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

ASPR-BARDA

Washington DC 20201 Room 638-G 200 Independence Ave., S.W.

ASPR-BARDA

OS CODE 16. ADMINISTERED BYCODE

X

X

446110

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORASPR-BARDA

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

04/29/2019 1500 ET

03/29/2019

240-401-5253Caleb Owen (No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

19-100-SOL-00017

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 77 OS235377OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

Washington DC 20201 200 Independence Ave. S.W.

Office of the Secretary Office of the Secretary

15. DELIVER TO

Washington DC 20201 Room 640-G 200 Independence Ave., S.W.

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$27.50

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

ASPR-BARDA

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The Department of Health and Human Services (HHS)/the Assistant Secretary for Preparedness and Response (ASPR)/the Division of the Strategic National Stockpile (SNS) has a requirement for mail-order pharmacy delivery of antibiotics for post exposure prophylaxis (PEP) to an affected metropolitan area. The Government is requesting proposals in response to this solicitation.

Proposals should be prepared in accordance with the objectives in Section C, and the instructions found in Sections L and M below.

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

SHERICA G. TESHOME

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

1 ASPR-19-00767 Expedited Mail-Order

Pharmaceutical Delivery

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

77 2 of

PART I – THE SCHEDULE

Section B – Supplies or Service and Cost/Price

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This Solicitation (19-100-SOL-0017) is for the acquisition of mail-order pharmacy delivery of antibiotics and post exposure prophylaxis (PEP) to United States’ metropolitan areas.

ARTICLE B.2. CONTRACT TYPE

The Government anticipates the award of multiple, definitized Firm-Fixed Price Contracts. However, the Offeror may propose other contract types if it believes them to be most beneficial to the Government.

B.3 CLIN STRUCTURE

This CLIN structure is a suggestion and is not required. Please propose a CLIN structure that you feel best fits the Government’s requirement as the ultimate CLIN structure is dependent on each proposed solution.

Base Period (3 Months)

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE NOT TO EXCEED

0001 Proof Of Concept

Non-Severable

JOB $ $

Option Period 1 (12 Months)

0002 Readiness and Delivery Services

0002-01 Readiness and Delivery Services:

Chicago

Period of Performance: 12-Months

EA $ $

0002-02 Readiness and Delivery Services: Los Angeles

Period of Performance: 12-Months

EA $ $

0002-03 Readiness and Delivery Services: New York City

Period of Performance: 12-Months

EA $ $

0002-04 Readiness and Delivery Services: San Francisco

Period of Performance: 12-Months

EA $ $

0002-05 Readiness and Delivery Services:

Denver

Period of Performance: 12-Months

EA $ $

0002-06 Readiness and Delivery Services:

Kansas City

Period of Performance: 12-Months

EA $ $

0002-07 Readiness and Delivery Services:

National Capital Region (District of Columbia, Virginia, and Maryland)

Period of Performance: 12-Months

EA $ $

Option Period 2 (12 Months)

0003 Readiness and Delivery Services

0003-01 Readiness and Delivery Services:

Chicago

Period of Performance: 12-Months

EA $ $

0003-02 Readiness and Delivery Services: Los Angeles

Period of Performance: 12-Months

EA $ $

0003-03 Readiness and Delivery Services: New York City

Period of Performance: 12-Months

EA $ $

0003-04 Readiness and Delivery Services: San Francisco

Period of Performance: 12-Months

EA $ $

0003-05 Readiness and Delivery Services:

Denver

Period of Performance: 12-Months

EA $ $

0003-06 Readiness and Delivery Services:

Kansas City

Period of Performance: 12-Months

EA $ $

0003-07 Readiness and Delivery Services:

National Capital Region (District of Columbia, Virginia, and Maryland)

Option Period 3 (12 Months)

0004 Readiness and Delivery Services

0004-01 Readiness and Delivery Services:

Chicago

Period of Performance: 12-Months

EA $ $

0004-02 Readiness and Delivery Services: Los Angeles

Period of Performance: 12-Months

EA $ $

0004-03 Readiness and Delivery Services: New York City

Period of Performance: 12-Months

EA $ $

0004-04 Readiness and Delivery Services: San Francisco

Period of Performance: 12-Months

EA $ $

0004-05 Readiness and Delivery Services:

Denver

Period of Performance: 12-Months

EA $ $

0004-06 Readiness and Delivery Services:

Kansas City

Period of Performance: 12-Months

EA $ $

0004-07 Readiness and Delivery Services:

National Capital Region (District of Columbia, Virginia, and Maryland)

Option Period 4 (12 Months)

0005 Readiness and Delivery Services

0005-01 Readiness and Delivery Services:

Chicago

Period of Performance: 12-Months

EA $ $

0005-02 Readiness and Delivery Services: Los Angeles

Period of Performance: 12-Months

EA $ $

0005-03 Readiness and Delivery Services: New York City

Period of Performance: 12-Months

EA $ $

0005-04 Readiness and Delivery Services: San Francisco

Period of Performance: 12-Months

EA $ $

0005-05 Readiness and Delivery Services:

Denver

Period of Performance: 12-Months

EA $ $

0005-06 Readiness and Delivery Services:

Kansas City

Period of Performance: 12-Months

EA $ $

0005-07 Readiness and Delivery Services:

National Capital Region (District of Columbia, Virginia, and Maryland)

Option Period 5 (9 Months)

0006 Readiness and Delivery Services

0006-01 Readiness and Delivery Services:

Chicago

Period of Performance: 9-Months

EA $ $

0006-02 Readiness and Delivery Services: Los Angeles

Period of Performance: 9-Months

EA $ $

0006-03 Readiness and Delivery Services: New York City

Period of Performance: 9-Months

EA $ $

0006-04 Readiness and Delivery Services: San Francisco

Period of Performance: 9-Months

EA $ $

0006-05 Readiness and Delivery Services:

Denver

Period of Performance: 9-Months

EA $ $

0006-06 Readiness and Delivery Services:

Kansas City

Period of Performance: 9-Months

EA $ $

0006-07 Readiness and Delivery Services:

National Capital Region (District of Columbia, Virginia, and Maryland)

Period of Performance: 9-Months

SECTION C – Description/Specification/Statement of Objectives

1. Background

The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities’ ability to withstand adversity, strengthening our health and response systems, and enhancing national health security.

The Division of Strategic National Stockpile (DSNS) is responsible for stockpiling and deploying pharmaceuticals and medical supplies needed during a public health response. During a public health emergency, federal supplies of medications used to treat or prevent illness may need to be distributed and dispensed to people throughout the country. Currently, distribution and dispensing/administration of pharmaceuticals from the Strategic National Stockpile (SNS) relies on the public health system (state and local health departments).

2. Scope

DSNS is requiring mail-order pharmacy delivery of antibiotics for post exposure prophylaxis (PEP) to an affected metropolitan area. It is believed that mail-order pharmacy providers have existing infrastructure that could be leveraged in partnership with the Government during such an event and is requesting offerors provide innovative proposals to achieve the Government’s overall requirement.

3. Objectives

The Government is seeking to utilize the services of mail-order pharmacy providers to deliver antibiotics for post exposure prophylaxis during an infectious disease emergency in designated U.S. cities.

The cities to be covered by this service are Chicago, Los Angeles, New York City, San Francisco, Denver, Kansas City, and the National Capital Region, which include populations in District of Columbia, Virginia, and Maryland. Other cities may be added as the Government sees benefit for these services.

The antibiotics to be delivered are: ciprofloxacin HCI 500mg tablets and doxycycline hyclate 100mg tablets.

During an infectious disease emergency, the Government plans to respond in two phases.

Phase 1: Within 24 hours of receiving Government owned antibiotics, the vendor shall deliver either ciprofloxacin HCI 500Mg tablets unit of use 20-count bottles or doxycycline hyclate 100mg unit of use 20-count bottles to households in their existing customer base. Each recipient will receive either doxycycline or ciprofloxacin. The Government would like a solution in which the offeror obtains information from existing customers regarding household occupants in advance so there is the ability to dispense these antibiotics to all individuals at an address. Phase 1 product delivery is an urgent requirement that must occur within 48 hours of the Governments’ decision to deploy and therefore the Government is looking for efficiencies and innovative solutions to achieving this requirement (such as Vendor Managed Inventory, Government Owned/Provided Product Stored On-Site, etc.)

Phase 2: Within 144 hours of receipt of Government owned antibiotics the vendor shall deliver either ciprofloxacin HCI 500Mg tablets unit of use 100-count bottles or doxycycline hyclate 100mg tablets unit of use 100-count bottles to households in their existing customer base. Each recipient will receive either doxycycline or ciprofloxacin. With a broader time frame to deliver under Phase 2, the Government believes the best solution is for the DSNS to deliver product directly to the vendor’s distribution sites for further shipment. Nonetheless, the Government is open to alternate solutions that may be of greater value (Vendor Managed Inventory, Government Owned/Provided Product Stored On-Site, etc.).

The Government will provide direction on which of the two products each individual shall receive. The vendor shall apply Governmental recommendations/guidance to the patient profiles to determine if they should receive the recommended antibiotics. Should the offeror propose dispensing of Government Owned Product in either Phase, offeror shall discuss their ability and processes for dispensing FDA Shelf-Life Extended Product (SLEP).

3.1 Proof of Concept

In order to determine the feasibility of this requirement, the Government is requiring a proof of concept. The offeror shall provide a detailed description of such concept including measurables and defining what success of a concept would be. In addition but not limited to, the offeror shall address the following:

a. The proof of concept test shall be for residential delivery of antibiotics for post exposure prophylaxis (PEP) during a public health emergency to current customers in 7 metropolitan cities (Chicago, Los Angeles, New York City, San Francisco, Denver, Kansas City, and the National Capital Region which include populations in District of Columbia, Virginia, and Maryland).

b. The test shall include a physical demonstration; however, it is not required that any actual product be delivered.

c. Describe the methods or processes to track customer level information, and ability to add triage protocols (series of 4-6 questions provided by CDC) to help determine what drugs each person should receive.

d. Describe the methods or processes for transportation carriers to deliver these antibiotics during a public health emergency to areas with potential environmental contamination.

e. The test shall ultimately prove the offeror’ s ability to quickly receive, process, and deliver potentially large volumes of product to their customer base within set timelines found in 3.2.b.

3.2 Readiness

At a minimum, the offeror shall:

a. Describe how they will maintain a readiness level to receive and respond to a notice to dispense from DSNS 24/7/365, and dispense product as directed and within specified timeframes.

b. Include a description of methods or processes demonstrating the ability to interrupt routine business operations to receive shipments of government owned pharmaceuticals (ie.

antibiotics), and deliver to current customers (and family members) to each of the following metropolitan areas Chicago, Los Angeles, New York City, San Francisco, Denver, Kansas City, and the National Capital Region which include populations in District of Columbia, Virginia, and Maryland within specified timeframes.

1. 24 hours of receipt of government owned pharmaceuticals

2. 144 hours of receipt of government owned pharmaceuticals

c. Describe ability to store government owned pharmaceuticals under current Good

Manufacturing Practices conditions, including current storage capacity and surge capacity.

3.3 Additional Items of Request

The offeror shall:

a. Provide the number of current members/beneficiaries in each of these metropolitan cities:

Chicago, Los Angeles, New York City, San Francisco, Denver, Kansas City, and the National Capital Region which include populations in District of Columbia, Virginia, and Maryland.

b. Provide description of additional methods and processes that would expedite residential delivery of antibiotics to each of the metropolitan areas identified.

c. As the Government begins to implement this requirement, additional cities may be added later as requiring this vital service.

d. Description of methods or processes to potentially expand drug residential delivery beyond current customers in each of the metropolitan cities to include select population groups identified by the Government at time of event.

3.4 Yearly Exercises:

In the event that the government does not initiate the deployment of product, the government anticipates a yearly exercise that may or may not be announced in advance. These exercises will help ensure the readiness of both the Contractor and the Government. The exercises may or may not involve the physical movement of product. The possible exercises this contract may be involved with are 1) a readiness call to determine when the product could begin deployment along with estimated timeline; 2) a staging call in which product is packaged and loaded, awaiting transport; 3) a deployment call in which an order is issued and product is shipped.

*Product used for these exercises will be mock material and not actual product.

4. Order Information

Offerors may propose on one or multiple cities. The Government reserves the right to award multiple awards however we will only issue one award per city. Each city will be awarded one proof of concept to one awardee. The Government reserves the right to award a solution to Phase 1, Phase 2, or Both in each city. The Government will not award Phase 1 to Vendor A and Phase 2 to Vendor B.

SECTION D – PACKAGING, MARKING AND SHIPPING

ARTICLE D.1. POSTAGE AND FEES

All postage and fees related to submitting information, including forms, reports, etc., to the

Contracting Officer or the Contracting Officer Representative shall be the responsibility of the

Contractor. All items to be delivered under the contract shall be preserved, packaged, and packed in accordance with normal commercial practices to meet the packing requirements of the carrier and ensure safe delivery at the intended destination.

ARTICLE D.2. MARKING

All information submitted to the Contracting Officer or the Contracting Officer’s Representative under this contract shall be clearly marked to show the following information on the cover:

Name of the contractor

Contract Number

Consignee’s Name and Address

The title of the deliverables

Date of the Deliverables

ARTICLE D.3. GOVERNMENT ADDRESS

ASPR will inform the Contractor of the address where to ship any purchased equipment or supplies.

Addresses may vary depending on where the items are needed

Section E – Inspection and Acceptance

ARTICLE E.1. FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

This section or other parts of this contract may incorporate 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 address: https://www.acquisition.gov/far/

FAR 52.246-2 – Inspection of Supplies – Fixed Price (August 1996)

FAR 52.246-4 -- Inspection of Services- Fixed Price (August 1996)

Inspection and acceptance of the product, and documentation called for herein shall be accomplished by the Government COR. The COR will review, examine, and verify that all services and deliverables fulfill and are in compliance with the requirements and standards as stated in this contract. Technical inspection and acceptance will take place at:

Location to be Determined at time for award

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the CO’s duly authorized representative within 30 days of receipt.

ARTICLE E.2. CONTRACTOR’S PERFORMANCE

At the COR’s discretion, he/she and the Contractor’s program manager will meet to evaluate the manner in which the Contractor is performing in accordance with the contract requirements and standards such as: good workmanship, the Contractor’s record of forecasting and controlling cost; the Contractor’s adherence to contract schedule, Contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction, and generally, the Contractor’s business like concern for the interest of the customer. The Contracting Officer may attend these meetings. Formal performance reviews will be conducted at least annually on or about the anniversary date of the contract.

ARTICLE E.3. BASIS OF ACCEPTANCE

The Contractor’s performance and the quality of services provided hereunder shall be subject to final inspection and acceptance by the Contracting Officer in conjunction with the Contracting Officer’s Representative (COR). The Basis for Acceptance shall be compliance with the requirements set forth within the Statement of Objectives, Contractor’s Proposal and other terms and conditions of the Contract.

Deliverable items rejected under the contract shall be corrected in accordance with the applicable clauses.

https://www.acquisition.gov/far/ https://www.acquisition.gov/far/

SECTION F – DELIVERIES/PERFORMANCE

ARTICLE F.1. FAR 52.252-2 – Clauses Incorporated by Reference (JUN 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. Full text may be accessed electronically at https://www.acquisition.gov/far/index.html

FAR 52.242-15 STOP-WORK ORDER (AUG 1989)

FAR 52.242-17 GOVERNMENT DELAY OF WORK (APR 1984)

FAR 52.247-34 F.O.B. DESTINATION (Nov 1991)

ARTICLE F.2. PERIOD OF PERFORMANCE

The period of performance of the base period shall be one (3) three month trial period, four twelve (12) month option periods, and one, final nine (9) month option period consisting of a total period of performance of (5) five years if all options are exercised. All options are to be exercised at the sole discretion of the Government.

ARTICLE F.3. DELIVERABLES AND DELIVERY SCHEDULE

Deliverable Frequency Medium/Format/# of Copies

Submit To

Kick Off Meeting Within 5 days of award WORD Copy via e-mail COR/All

Attendees Proof of Concept

Report

Within 30 days from commencement of proof of concept, vendor shall provide a final proof of concept report

Via email COR

Quarterly

Readiness Report By the 15th of every third month Via email COR

Deployment

Report

Within 24 hours of deployment. 1 copy submitted via email

COR

ARTICLE F.4. REPORTS/DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this contract, and upon delivery and acceptance of the items described above in F.3.

The Contractor shall be responsible for submission of all reports and deliverables. The approved file formats for all deliverables shall be specified in the award document.

https://www.acquisition.gov/far/index.html

ARTICLE F.5. NON-DISCLOSURE AGREEMENT (NDA)

Offerors may be required to sign a Non-Disclosure Agreement (NDA) prior to beginning any work under any resulting contract.

ARTICLE F.6. OBSERVANCE OF LEGAL HOLIDAYS

The Department of Health and Human Service observes the following days as holidays:

New Year’s Day

Martin Luther King’s Birthday

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

Inauguration Day

(Every 4 Years, Washington DC only)

Any other day designated by Federal law, Executive Order, or Presidential Proclamation. When any such day falls on a Saturday, Friday is taken as the observation day. When the holiday falls on a Sunday, then Monday is the observation day. Observance of such days by Government personnel shall not be cause for additional period of performance or entitlement to compensation except as set forth in the contract. If the Contractor’s personnel work on a holiday, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost.

ARTICLE F.7 NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the

Contracting Officer, and the COR, in writing, giving pertinent details, provided, however, that this data shall be informational only in character and that this provision shall not be construed as a waiver by the Government of any delivery schedule date, or any rights or remedies provided by law or under this contract.

SECTION G- CONTRACT ADMINISTRATION

ARTICLE G.1. CONTRACTING OFFICER (CO)

The Contracting Officer is:

Sherica Teshome

HHS/ASPR/ORM

Sherica.Teshome@hhs.gov

(202) 205-5919

The Contracting Officer (CO) 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. Any other commitment, either explicit or implied, is invalid.

The CO is the only person with authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work;

(2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any prices incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; or (6) otherwise change any terms and conditions of this

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

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Contracting Officer’s Representative (COR) is:

TBD

As delegated by the CO, the COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

ARTICLE G.3. CONTRACTOR POINT OF CONTACT

The Contractor’s Point of Contact is:

mailto:Sherica.Teshome@hhs.gov

TBD.

ARTICLE G.4. PAYMENT BY ELECTRONIC FUNDS TRANSFER

The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract.

ARTICLE G.5. INVOICE SUBMISSION

The Contractor shall deliver invoices electronically and simultaneously to: PSC, the Contracting

Officer Representative, the Contracting Officer and Contract Specialist electronically. Unless otherwise specified by the Contracting Officer, all invoices shall be addressed as follows:

The Contractor agrees to include, as a minimum, the following information on each invoice:

Contractor’s Name & Address

Contractor’s Banking Information (where payment is to be remitted)

Contractor’s Tax Identification Number (TIN)

Contract Number

Requisition

Number Invoice

Number Invoice

Date

Contract Line Item Number

Quantity Unit Price & Extended Amount for each line item Total Amount of Invoice (to include the accumulative total(s), the period of performance of the contract and the period of performance of the billing period)

Name, title and telephone number of person to be notified in the event of a defective invoice

Payment Address, if different from the information in (b) (1).

The invoice shall be signed by a person authorized to bind the Contractor. The Contractor shall not submit an invoice prior to delivery of goods or services.

ARTICLE G.6. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

ARTICLE G.7. STANDARDS OF CONDUCT

In performing this contract, Contractor personnel may be required to interact with high-level

Government and non-government officials. The Contractor shall ensure that all its personnel conduct their work in a professional and responsible manner.

ARTICLE G.8. EVALUATION OF CONTRACTOR PERFORMANCE

Purpose: In accordance with FAR 42.1502, the Contractor’s performance will be periodically evaluated by the government in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

Performance Evaluation Period: The Contractor’s performance will be evaluated at least annually.

Evaluators: The performance evaluation will be completed jointly by the Contracting Officer’s

Representative and the Contracting Officer.

Performance Evaluation Factors: The Contractor's performance will be evaluated in accordance with

SECTION M, Attachment #1, Contract Performance Evaluation Report and the Contractor Performance Assessment Reporting System (CPARS).

Contractor Review: A copy of the evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

Resolving Disagreements between the Government and the Contractor: Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency. Copies of the evaluation, Contractor's response, and review comments, if any, will be retained as part of the evaluation.

Release of Contractor Performance Evaluation Information: The completed evaluation will not be released to other than Government personnel and the Contractor whose performance is being evaluated.

Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the contractor being evaluated, as well as impede the efficiency of

Government operations.

Source Selection Information: Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

Retention Period: The agency will retain past performance information for a maximum period of 3 years after completion of contract performance for the purpose of providing source selection information for future contract awards.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. CONFLICT OF INTEREST

The Contractor warrants that to the best of its knowledge and belief except as otherwise disclosed, no actual or apparent organizational or employee conflict of interest exists as defined below: a situation in which the nature of work under a Government contract and a Contractor's organization and any of its affiliate organizations or their successors in interest (hereinafter collectively referred to as the

"Contractor"), financial, contractual or other interests are such that the appearance of the Contractor's objectivity in performing the contract work may be impaired, may otherwise result in a biased work product, or may result in the contractor being given an unfair competitive advantage; or a financial interest or relationship, professional or otherwise, of an employee, subcontractor employee, or consultant (hereinafter referred to as "employee") with an entity that may actually impair or have the appearance of impairing the objectivity of the employee in performing the contract work, or an employee has had, currently has, or is reasonably expected to have, official responsibilities with an outside organization, or some other financial interest or business affiliation, such that a reasonable person with knowledge of the relevant facts might question the employee's objectivity/impartiality in performing the contract.

For purposes of paragraphs a(i) - (a)(iii), the financial interests and business affiliations of the employee's spouse, minor children, and business partners are imputed to the employee.

The Contractor agrees that if changes in their organization or employees have occurred that give rise to the appearance of a conflict of interest since submission of their final proposal revision (FPR) and contract award or occur during the performance of this contract, it shall make an immediate and full disclosure to the Contracting Officer and Contracting Officer's Technical Representative (COR) in writing.

Such disclosure should include a description of the circumstances, and a description of any action which the Contractor has taken or proposes to take to avoid, neutralize, or mitigate any actual or apparent conflict of interest.

The Contractor has an ongoing responsibility to notify the Government Contracting Officer and COR in writing if any actual or apparent conflict of interest arises during the period of performance of the contract. The written notification must provide details of the conflict of interest and any planned mitigation.

The Contractor agrees to immediately notify the Contracting Officer and the COR of (1) any actual or apparent personal conflict of interest with regard to any of its employees working on, having published, or having access to information regarding this contract, or (2) any such information regarding this contract, when such conflicts have been reported to the contractor.

The Contractor agrees to notify the Contracting Officer and COR prior to incurring costs for that employee's work when an employee may have a conflict of interest. In the event that the conflict of interest does not become known until after performance on the contract begins, the Contractor shall immediately notify the Contracting Officer and COR of the conflict of interest. The employee shall recuse himself/herself from work on this contract when an actual or apparent conflict has been identified until such time as it is determined that the conflict does not exist or it is resolved. The Contractor shall continue performance of this contract until notified by the Contracting Officer of the appropriate action to be taken.

The provisions of this clause shall be included in all subcontracts and consulting agreements to avoid, neutralize, or mitigate actual or apparent conflicts of interest.

ARTICLE H.2. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR 16.505(b)(8), the following individual has been designated as the

HHS/ASPR Ombudsman for task order and delivery order contracts:

Cassandra Freeman

HHS/ASPR/MFHC

200 C Street, S.W.

Washington, D.C. 20201

Cassandra.Freeman@hhs.gov

ARTICLE H.3. CONFIDENTIALITY OF INFORMATION

Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the

Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

If it is established elsewhere in this contract, that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

Confidential information, as defined in this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the

Contracting Officer prior to any release, disclosure, dissemination, or publication.

Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and legal officials.

ARTICLE H.4. ACCESS TO DOCUMENTATION/DATA

The Government shall have physical and electronic access to all documentation and data generated under mailto:Cassandra.Freeman@hhs.gov mailto:Cassandra.Freeman@hhs.gov this contract, including: all data documenting Contractor performance, all data generated, all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. The Government shall acquire unlimited rights to all data funded under this contract.

ARTICLE H.5. IDENTIFICATION AND DISPOSITION OF DATA

HHS reserves the right to review any other data determined by HHS to be relevant to this contract.

ARTICLE H.6. DISSEMINATION OF INFORMATION

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR and CO, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

ARTICLE H.7. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.8. PUBLICATION AND PUBLICITY

The Contractor shall not release any reports, manuscripts, press releases, or abstracts about the work being performed under this contract without written notice in advance to the Government, for additional information see HHSAR 352.227-70 Publications and Publicity (Dec 2015).

Unless authorized in writing by the CO, the contractor shall not display the HHS logo including Operating

Division or Staff Division logos on any publications.

The Contractor shall not reference the products(s) or services(s) awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies HHS approval or endorsement of the product(s) or service(s) provided.

The Contractor shall include this clause in all subcontracts where the subcontractor may propose publishing the results of its work under the subcontract.

ARTICLE H.9. REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in ASPR-funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800- 4478477). All telephone calls will be handled confidentially. The mailing address is:

U.S. Department of Health and Human Services

Office of Inspector General

ATTN: OIG HOTLINE OPERATIONS

P.O. Box 23489

Washington, DC 20026

ARTICLE H.10. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES

The Contractor is hereby notified of the restrictions on the use of HHS funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of

Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions: the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 – Limitations on the Payment of Funds to Influence Federal Transactions and FAR Clause 52.203-12 (Oct 2010).

In addition, the current HHS Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes; for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress; or any State or Local legislative body itself.

The current HHS Appropriations Act also provides that no part of any appropriation contained in this

Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

SECTION I – CONTRACT CLAUSES

ARTICLE I.1 FEDERAL ACQUISITION REGULATIONS (FAR) (48 CFR Chapter 1 CONTRACT CLAUSES)

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.

Full text of the FAR clauses may be accessed electronically at: https://www.acquisition.gov/far/index.html

FAR Clauses

FAR 52.202-1 Nov 2013 Definitions

FAR 52.203-3 Apr 1984 Gratuities

FAR 52.203-5 May 2014 Covenant Against Contingent Fees

FAR 52.203-7 May 2014 Anti-Kickback Procedures

FAR 52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

FAR 52.203-10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity

FAR 52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal Transactions

FAR 52.203-14 Oct 2015 Display of Hotline Poster(s)

FAR 52.203-17 Apr 2014 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights

FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

FAR 52.204-6 April 2008 Data Universal Numbering System (DUNS) Number

FAR 52.204-9 Jan 2011 Personal Identity Verification of Contractor Personnel

FAR 52.204-13 Oct 2016 System for Award Management Maintenance

FAR 52.204-19 Dec 2014 Incorporation by Reference of Representations and Certifications

FAR 52.209-7 Jul 2013 Information Regarding Responsibility Matters

FAR 52.216-7 Jun 2013 Allowable Cost and Payment

FAR 52.225-25 Aug 2018 Prohibition on Contracting with Entities Engaging in Sanctioned Activities Relating to Iran—Representation and Certification

FAR 52.227-1 Dec 2007 Authorization and Consent

FAR 52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright Infringement

FAR 52.227-14 May 2014 Rights in Data – General

FAR 52.232-11 Apr 1984 Extras

FAR 52.232-38 Jul 2013 Submission of Electronic Funds Transfer Information with Offer

FAR 52.232-39 Jun 2013 Unenforceability of Unauthorized Obligations https://www.acquisition.gov/far/index.html

FAR 52.242-13 Jul 1995 Bankruptcy

FAR 52.253-1 Jan 1991 Computer Generated Forms

HHSAR CLAUSES

HHSAR 352.215-70 Dec 2015 Late Proposals and Revisions

HHSAR 352.203-70 Dec 2015 Anti-Lobbying

HHSAR 352.208-70 Dec 2015 Printing and Duplication

HHSAR 352.224-70 Dec 2015 Privacy Act

HHSAR 352.224-71 Dec 2015 Confidential Information

HHSAR 352.227-70 Dec 2015 Publications and Publicity

HHSAR 352.239-73 Dec 2015 Electronic and Information Technology Accessibility Notice

HHSAR 352.270-9 Dec 2015 Non-Discrimination for Conscience

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

ITEMS (JAN 2018)

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

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

(4) 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:

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct

1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, 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.)

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_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L.

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

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.

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

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41

U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved]

__ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

_X_ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (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 (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

_X_ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

_X_ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C.

657 f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-

Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns

Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

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