HIV PrEP - RFP__12_18_19.pdf

REVISED

December 18, 2019

You are invited to submit a proposal in accordance with the requirements of this Solicitation No.

75R60220R00001 and Federal Acquisition Regulation (FAR) Part 15. The purpose of this requirement is to provide access to Pre-Exposure Prophylaxis (PrEP) for qualified eligible patients in the U.S. PrEP as a prevention is critical to the Department’s mission to End the HIV Epidemic in 10 years. The period of performance will be a 12-month base period plus four (4) 12-month option periods. The NAICS code for this requirement is 541611, Administrative Management and General Management Consulting Services with a size standard of $16.5M and Product Service Code Q517, Medical-Pharmacology. It is anticipated that various types of awards such as cost-sharing hybrid contract inclusive of Firm Fixed Price and Cost award may result from this solicitation.

QUESTIONS

Questions or issues for which you require clarification or correction by the Government must be submitted via email to ctaylor@hrsa.gov. In order to allow a reply to be provided to all prospective Offerors before submission of their proposal, your questions must be received no later than 12:00 p.m.

Eastern Standard Time (EST) on January 10, 2020. Questions received after the due date and time will not be considered. NO EXCEPTIONS.

ELECTRONIC PROPOPSAL SUBMISSION

Your Request for Proposal (RFP) shall be prepared in accordance with Sections L and M and the "Statement of Objectives". This RFP does not commit the Government to pay any costs for the preparation and submission of a proposal nor does it commit the Government to make an award. Your proposal shall be received by the Contracting Officer as soon as possible, but no later than February 13, 2020 at 2:00 p.m., EST via e-mail at ctaylor@hrsa.gov.

In the rare event of an e-mail malfunction (ctaylor@hrsa.gov), Offerors shall immediately notify the Contracting Officer or Contract Specialist via telephone prior to the solicitation closing date and time.

Failure to do so will automatically deem an Offeror’s quote as late. Failure to submit a complete proposal prior to the solicitation closing date and time will render the quote late and unacceptable.

Your proposal must provide a contact name and number, your company name and complete address, including street, city, county, state, zip code, e-mail address, Tax Identification Number (TIN), and Dun & Bradstreet Number (DUNS). The TIN must match the name of the vendor to whom the payments will be made. Please note that FAR 52.204-6 Contractor Identification Number Data Universal System (DUNS Number). If you do not have a DUNS number, please contact Dun and Bradstreet at 1-866-705- 5711 or via the Internet at http://www.dnb.com.

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Health Resources and Services Administration Office of Acquisitions Management and Policy 5600 Fishers Lane, Room 14W29 Rockville, MD 20857 mailto:ctaylor@hrsa.gov http://www.dnb.com/

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation# 75R60220R00001

The Contractor must be registered in the SAM database at www.sam.gov. "Registered in the SAM database" means that (1) the Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database; and (2) The Government has validated all mandatory data fields and has marked the record "Active". If you are not registered in the SAM, you may obtain information on registration and annual confirmation requirements via the internet at http://www.sam.gov or at 1-207-438-1690.

By submission of an offer, the Offeror acknowledges the requirement that a prospective awardee shall be registered in the System Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. If not registered in the SAM, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. SAM requires any prospective awardee to have a DUNS number and be registered in the SAM database prior to award, during performance, and through final payment of any award resulting from this solicitation.

It is brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to expenditure of public funds in connection with this proposed acquisition.

Requests for additional information concerning this RFP should be referred to Carolyn C. Taylor at ctaylor@hrsa.gov or 301-443-6508.

Sincerely yours, /s/

Carolyn C. Taylor Contract Specialist http://www.sam.gov/

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

SECTION A – STANDARD FORM (SF) 33

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SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Purpose of Contract

The purpose of this contract is to develop and implement a solution to distribute pre-exposure prophylaxis (PrEP) medication to qualified eligible patients in the U.S. PrEP medications and the PrEP regimen are critical elements of the Ending the HIV Epidemic in America. Offerors are permitted to submit proposals on a cost reimbursement or fixed price basis, or a combination thereof, although the Government will apply a preference for fixed price proposals.

In addition, the Government strongly prefers that cost proposals should be based on non-drug price based pricing—e.g., pricing not based on percentages of Wholesale Acquisition Cost (WAC) or other similar references. Rather, the Government strongly prefers that pricing should be based on serving populations, in increments, of up to 200,000 patients per year.

B.2 Compensation Cost/Price

[The Compensation section will be completed at time of award based on negotiated price structure.]

For further provisions on funding, see the clause FAR 52.232.20, Limitation of Cost (APR 1984), which is hereby incorporated by reference.

B.3 Allowable Costs

Costs shall be determined to be allowable in accordance with FAR 52.216-7, Allowable Cost and Payment, 52.216-8, Fixed Fee, and 52.216-12, Cost-Sharing Contract-No Fee.

B.4 Direct Costs

The Contractor will be reimbursed for costs as described below, incurred directly and specifically in the performance of this contract, claimed by the Contractor, and accepted by the Contracting Officer:

1. Salaries and wages of the Contractor's employees directly employed in performing the work required by this contract, including related fringe benefits if treated as a direct cost; otherwise, fringe benefits may be claimed as part of indirect costs below.

2. Materials and services required in the performance of this contract, after deducting all discounts for the purchase of such materials and services.

3. Consultant fees or other payments to consultants required in the performance of this contract, provided, that such fees or payments shall not exceed the daily rate of $850 per day, exclusive of travel costs, without the written approval of the Contracting Officer.

4. Travel and subsistence expenses exclusively in direct performance of this contract. The

Contractor shall be reimbursed for transportation costs and travel allowances in accordance with the established Travel policy of the Contractor, but subject to the following limitations:

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

a. Such transportation cost shall not be reimbursed in an amount greater than the cost of first class rail or of economy air travel. Travel allowances for per diem shall be reimbursed in accordance with the Contractor's established Travel policy, but in no event shall such allowances exceed the prevailing Government rate except within the corporate limits of those cities and other specified areas where higher ceiling rates have been established by the General Services Administration for Civil Service employees in travel status.

b. The Contractor shall be reimbursed for the cost of travel performed by its personnel in a privately owned automobile not to exceed the cost by the most direct economy air route between the points so traveled. If more than one person travels in such automobile, no additional charge will be made by the Contractor for such travel between such points.

Reimbursement shall be in accordance with the Contractor’s established travel policy, but in no event shall such allowances exceed the prevailing Government rate (as set by Federal Travel Regulations–see www.gsa.gov).

c. HRSA will not reimburse travelers for unauthorized or excess expenses.

B.5 Prior Authorization of Certain Direct Costs

Purchase orders and subcontracts are governed by FAR Clause 52.244-2, Subcontracts (OCT 2010) of the General Provisions except as may be indicated herein.

The Contractor shall not be allowed the following costs without the prior written approval of the Contracting Officer. Incurrence of such costs with the intent of claiming reimbursement as direct costs under this contract shall be at the Contractor's own risk, if without such prior written authorization:

a. Purchase or rental of any item of equipment including furniture or office equipment regardless of cost.

b. Any rental or purchase agreement for real or personal property, or any term contract for maintenance.

c. Travel for general meetings directly related with the performance of this contract.

d. Rearrangement, alterations or relocation of facilities.

B.6 Indirect Costs

1. The allowable indirect costs under this contract shall be established in accordance with the terms and conditions of this contract and FAR 52.216-7, Allowable Cost and Payment (AUG 2018).

2. Pending the establishment of the negotiated indirect cost rates, the provisional rates below are approved for billing purposes only.

http://www.gsa.gov/

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

TYPE PROVISIONAL CEILING BASE

Fringe Benefits Total direct costs excluding capital expenditures and Sub awards.

Overhead Salaries and wages excluding vacation, holiday, sick leave pay and other paid absences

G&A

3. The final indirect cost rates applicable to this contract shall not exceed the ceiling rates listed above;

however, that in the event the rates are determined by the cognizant negotiated indirect cost official on the basis of actual allowable costs are less than the ceiling rate agreed to herein, then the lower rates as established by such cognizant official shall apply.

4. If the Contractor does not have a current rate agreement within the first 90 days after the effective date of this contract, the Contractor shall initiate a request for indirect cost rate agreement from the following:

Hruta Virkar National Institutes of Health 6011 Executive Blvd Room 549C-1 Rockville, MD 20852 301-496-4137 hruta.virkar@nih.gov

5. Notwithstanding the foregoing, the Contractor shall, in the case of an upward adjustment of the provisional rates, comply with the requirements of clause FAR 52.232-20 “Limitation of Cost”.

mailto:hruta.virkar@nih.gov

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

SECTION C – DESCRIPTION/SPECIFICATIONS/ STATEMENT OF WORK

C.1 Performance Work Statement

Independently and not as an agent of the Government, the Contractor shall furnish all personnel, material, facilities, services, and equipment as needed to perform the services under this contract and as set forth in Section J (Attachment A).

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

SECTION D – PACKAGING AND MARKING

All reports and documents shall have, at a minimum in the document header, the contract number, and the Contracting Officer Representative (COR) name. All reports and documents shall have, at a minimum in the document footer, the author in the lower left corner, the page # of total # of pages in the center bottom of the page, and the date and /or version of the document (not the auto date) in the lower right corner.

The Contractor shall deliver all items at the time indicated in the Deliverables Schedule.

All deliverable reports are to carry at the top of the first page the following information:

1. Contract number

2. Deliverable item number

3. Deliverable item delivery due date

4. Date of submission

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

SECTION E – INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE

The Contracting Officer Representative (COR), as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractor’s performance, evaluating the quality of services provided by the Contractor and performing final inspection and acceptance of all deliverables. Each task order issued under this contract will provide the COR’s contact information.

E.2 FAR 52.246-4 Inspection of Services—Fixed Price (AUG 1996)

(a) Definition. “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may—

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

E.3 FAR 52.246-5 Inspection of Services – Cost Reimbursement (APR 1984)

(a) Definition. "Services," as used in this clause, includes services performed, workmanship, and material furnished or used in performing services.

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination Solicitation#

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all places and times during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If any of the services performed do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, for no additional fee. When the defects in services cannot be corrected by re-performance, the Government may:

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce any fee payable under the contract to reflect the reduced value of the services performed.

(e) If the Contractor fails to promptly perform the services again or take the action necessary to ensure future performance in conformity with contract requirements, the Government may-

(1) By contract or otherwise, perform the services and reduce any fee payable by an amount that is equitable under the circumstances; or

(2) Terminate the contract for default.

E.4 Quality Assurance Surveillance Plan (QASP)

The Government will monitor the Contractor’s performance under this contract in accordance with the QASP.

Ending the HIV Epidemic: Pre-Exposure Prophylaxis (PrEP) Implementation and Dissemination

Solicitation# 75R60220R00001

SECTION F – DELIVERIES OR PERFORMANCE

F.1 Period of Performance

The period of performance shall be a base period of 12 months and four (4) 12-month option periods.

The option periods under this contract may be exercised in accordance with FAR 52.217-9, Option to Extend the Term of the Contract (MAR 2000). The period of performance under this contract shall commence with the effective date of the contract.

F.2 Place of Performance

The place of performance for this contract will be at the contractor site.

F.3 Observance of Federal Holidays

New Year’s Day January 1st Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursdays in November Christmas Day December 25th Inauguration Day Every fourth year, Washington, DC

No on site services shall be performed, nor shall HHS reimburse a contractor for work performed on Federal legal holidays, holidays set forth by Presidential Executive Order and any other Government closures, including closures for inclement weather, unless otherwise provided for in the terms of the contract. The contractor may not bill for hours not worked.

F.4 Schedule of Deliverables

The contractor shall ensure all products and services delivered under this contract are compliant with HHS Section 508 requirements in accordance with the Health and Human Services Acquisition Regulation (HHSAR). These Section 508 Standards were issued by the United States Access Board (https://www.access-board.gov/) and published in the Federal Register, on January 18, 2017, as the final rule (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule). The final rule updates the Section 508 Standards along with accessibility guidelines for telecommunication products and equipment covered by section 255 of the Communications Act.

The Section 508 Standards applicable to this contract are:

https://www.access-board.gov/ https://www.access-board.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule

Section 508 Standards and Guidelines (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines)

• Web Content Accessibility Guidelines (WCAG) 2.0 o Success Criteria, Level A and AA

• Chapter 3: Functional Performance Criteria (FPC)

• Chapter 4: Hardware (If Applicable)

• Chapter 5: Software

• Chapter 6: Support Documentation and Services

Regardless of format, all digital content or communications materials produced as a deliverable under this contract must conform to applicable HHS Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. The contractor is responsible for remediating all deliverables that do not comply with the applicable requirements as identified in the HHS Section 508 checklists.

F.5 Reporting Requirements and Deliverables

1. The Contractor shall submit the items in quantities and during the time periods indicated above to the following address or electronically as mutually agreed:

[To be completed at time of award]

2. The Contractor shall submit each deliverable items individually per the deliverable schedule.

FAR Clause Title Date

52.242-15 Stop-Work Order AUG 1989 52.242-15 Stop-Work Order, Alternate I APR 1984 52.242-17 Government Delay of Work APR 1984 https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

SECTION G – CONTRACT ADMINISTRATION DATA

G.1 DESIGNATION OF CONTRACTING OFFICER REPRESENTATIVE (COR)

The person identified below is hereby designated as the Contracting Officer Representative (COR) for this contract. The responsibility of the COR is to assist in the technical monitoring and administration of the contract. To this end, the COR may provide technical direction to the contractor as described in Sections G.2 and G.3.

TBD at time of award (Name) (Office/Division) Washington. DC Phone Number: __________ Fax Number: ____________ Email: ________________

G.2 CONTRACTING OFFICER’S REPRESENTATIVE’S AUTHORITY

Technical Direction – The COR is authorized to provide the contractor with information, direction, and coordination within the confines of the contractual work description.

This includes providing technical direction to the Contractor to guide the contract effort in order to accomplish the contractual performance work statement. This may include the interpretation of specifications or technical portions of the work description, and where required by the contract, review and approval of product deliverables of the Contractor to the Government under the contract.

G.3 RESTRICTIONS ON THE CONTRACTING OFFICER’S REPRESENTATIVE’S

AUTHORITY

The COR has no authority to make any commitments or changes that affect price, quality, quantity, delivery, or other terms and conditions of the contract nor in any way direct the contractor or its subcontractors to operate in conflict with the contract terms and conditions.

The COR is not authorized to provide technical direction outside the parameters of the performance work statement as stated in the Contract.

The COR may not issue any direction to the Contractor that:

1. Solicits a proposal, OR

2. Constitutes an assignment of additional work outside the performance work statement of this

Contract, OR

3. In any manner causes an increase in the total contract cost or the time required for contract performance, or

4. Changes any of the express terms, conditions, or specifications of the Contract (e.g., changes in the price or scope of work, instructions to start or stop work, approval of any actions that will result in additional charges to the government).

If the contractor is unclear whether a technical direction is within the parameters of the performance work statement, it must contact the Contracting Officer, who is the only individual authorized to determine whether a technical direction is within the parameters of the performance work statement.

G.4 KEY PERSONNEL

The following individuals are designated as Personnel and considered to be essential to the work being performed under this contract:

Pursuant to the Key Personnel clause (HHSAR 352.242-70) referenced in Section I of this contract, the following individual(s) is (are) designated as Key Personnel and considered to be essential to the work being performed under this contract:

[To be completed at time of award]

The person identified as the Program Manager shall direct the necessary work and services toward fulfillment of the contractual requirements. Prior to removing, replacing, or diverting the specified individual(s), the Contractor shall notify the Contracting Officer in writing and reasonably in advance, and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the contract. No diversion shall be made by the Contractor without the written consent of the Contracting Officer, provided that the Contracting Officer may ratify in writing changes made due to events beyond the control of the Contractor, and such ratification shall constitute the consent of the Contracting Officer required by this clause. Examples of events beyond the control of the Contractor are: (1) prolonged sickness, (2) termination of employment, and (3) death. Key personnel, with the consent of the Contracting Officer, may be amended from time to time during the course of the contract to either add or delete personnel, as appropriate.

G.5 STAFFING REQUIREMENTS

The general responsibilities of all contract personnel are as follows:

1. Consistently exhibit teamwork and provides best value for customers by improving the quality of customer interaction and communication, and internally improving communication to increase the quality and value of service provided.

2. Demonstrate proactive behavior, provides timely responsiveness, and exhibits a sense of ownership and commitment in all dealings.

3. Consistently perform timely follow through to ensure quality completion of customer actions.

Actively engages in customer partnering sessions and lessons learned sessions. On a regular basis, shows initiative in problem identification and resolution.

4. Maintain the integrity and security of federally-owned property, including equipment, supplies, and information technology related hardware, software and data.

4. Effectively plan, organize, and prioritize work to accommodate agreed to dates/timelines as noted in the task order, and produce clear and effective results of acceptable quality.

5. Refer new or unusual circumstances in a timely manner to the COR for guidance.

G.6 ELECTRONIC FUNDS TRANSFER

The Contractor shall designate a financial institution for receipt of electronic funds transfer payments.

Contractors are encouraged to periodically review their file for accuracy and are required to re-reregister before their expiration date, which is the same date as their CCR expiration date. SAM will notify users by e-mail that their file is due to expire beginning 60 days prior to expiration, then 30 days and finally 15 days before expiration.

G.7 EVALUATION OF CONTRACTOR’S PERFORMANCE final evaluation of

Interim and final evaluation of Contractor performance (including options) on this contract shall be conducted in accordance with FAR Subpart 42.15 and HHSAR 342.7001(d) and entered into the Contractors Performance Assessment Reporting System (CPARS) (see Section J, List of Attachments, Attachment CD.

The Government will conduct an evaluation of Contractor’s performance based on the completion of the tasks stated in the PWS. HRSA documents contractor performance using the Contractor Performance Assessment Rating System (CPARS) (www.cpars.gov). The evaluation shall be conducted by the COR and be comprised of an evaluation of contractor performance completed by the Contractor and Federal staff, and a review of progress reports and financial reports.

G.8 BILLING INSTRUCTIONS

See Attachment B.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1 FOOD

Food (including but not limited to meals, light refreshments, and beverages) is not to be provided and is an unallowable cost.

H.2 EQUIPMENT

The Contractor shall not use federal funding available through this contract for costs incurred for services or equipment which are reimbursable as part of another government contract. The federal funding available through this contract shall not be used to reimburse the contractor for the purchase of computer hardware and/or software without prior Contracting Officer approval.

H.3 CONFIDENTIALITY AGREEMENT REQUIREMENT

The Contractor shall implement a confidentiality agreement related to all data provided by the Government staff. All Contractor staff that work with the Federal Government and are provided information and access to databases shall sign such an agreement and a copy of the signed agreement for each relevant staff member shall be submitted to the COR prior to receipt of relevant documents.

H.4 TRAVEL REIMBURSEMENT

Any travel reimbursement under this contract shall be performed in accordance with Federal Travel Regulations.

H.5 PROHIBITION AGAINST PERSONAL SERVICES

The Contractor shall not perform personal services as defined under FAR 2.101 under this contract.

Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government will not supervise or direct Contractor employees in the performance of their assignments. If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently-governmental functions under this contract. No Contractor employee shall represent or give the appearance that he/she is a Government employee, agent or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following these requirements.

H.6 POST-AWARD ORGANIZATIONAL CONFLICT OF INTEREST

General: The Contractor shall have programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.

Disclosure: The Contractor shall report all actual and potential conflicts of interest pertaining to this contract to the Contracting Officer, including those that would be caused by a contemplated modification to this contact or another contract. Such reports shall be in writing (including by email). Upon request, the Contractor shall respond to a Contracting Officer's request for an OCI mitigation plan.

Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer shall take action which may include requesting a mitigation plan from the Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503 as applicable.

H.7 EQUAL EMPLOYMENT OPPORTUNITY POSTERS

In order to comply with the notice posting requirements of FAR clause 52.222-26 Equal Opportunity as incorporated into the contract, the contractor shall obtain the posters from the following link:

https://wwwl .eeoc.gov/employers/poster.cfm.

H. 8 LIMITATION ON GILEAD MAP ENROLLEES

Patients receiving Product under Gilead’s (Medication Assistant Program) MAP during the 12 months before their application to receive PrEP under the Gilead Donation Agreement shall not receive donated Product under the Donation Agreement. Instead, the Contractor shall direct those patients to MAP to receive free Product. And if the patient is a QEP under the Donation Agreement, that patient shall receive free Product under MAP. In the event a patient who had previously enrolled in Gilead’s MAP is no longer eligible for MAP but otherwise qualifies as a QEP under the Donation Agreement, such patient shall be permitted to enroll in the HHS Donation Program.

SECTION I – CONTRACT CLAUSES

L.1 FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CONTRACT

CLAUSES

FAR 52.252-2 Clauses Incorporated by Reference (FEB 1998)

The 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. In addition, the full text of a clause may be accessed electronically at http://www.acquisition.gov/far/.

Clause No. Title Date

52.202.1 Definitions Nov 2013

52.203.3 Gratuities Apr 1984

52.203.5 Covenant Against Contingent Fees May 2014

52.203.6 Restrictions on Subcontractor Sales to the Government Sep 2006 52.203-7 Anti-Kickback Procedures. May 2014 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal May 2014 or Improper Activity.

52.203-10 Price or Fee Adjustment for Illegal or Improper Activity. May 2014 52.203-11 Certification and Disclosure Regarding Payments to Influence

Certain Federal Transactions Sep 2007

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

52.203-13 Contractor Code of Business Ethics and Conduct. Oct 2015 52.203-17 Contractor Employee Whistleblower Rights and Requirement Apr 2014 To Inform Employees of Whistleblower Rights.

52.203-18 Prohibition on Contracting with Entities that Require Certain Jan 2017 Internal Confidentiality Agreements or Statements-Representation 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Jan 2017 Agreements or Statements 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber May 2011 Content Paper.

52.204-7 System for Award Management Oct 2016 52.204-9 Personal Identity Verification of Contractor Personnel. Jan 2011 52.204-10 Reporting Executive Compensation and First-Tier Oct 2016 Subcontract Awards.

52.204-13 System for Award Management Maintenance. Oct 2016 52.204-14 Service Contract Reporting Requirements Oct 2016 52.204-18 Commercial and Government Entity Code Maintenance Jul 2016 52.204-19 Incorporation by Reference of Representations and Certifications Dec 2014 52.204-21 Basic Safeguarding of Covered Contractor Information Systems Jun 2016 52.204-22 Alternative Line Item Proposal Jan 2017 52.209-6 Protecting the Government’s Interest When Subcontracting Oct 2015 http://www.acquisition.gov/far/ with Contractors Debarred, Suspended, or Proposed for Debarment.

52.209-9 Updates of Publicly Available Information Regarding Oct 2018 Responsibility Matters.

52.209-10 Prohibition on Contracting with Inverted Domestic Corporations Nov 2015 52.210-1 Market Research Apr 2011 52.215-2 Audit and Records—Negotiation Oct 2010 52.215-8 Order of Precedence—Uniform Contract Format Oct 1997 52.215-10 Price Reduction for Defective Certified Cost or Pricing Data Aug 2011 52.215-11 Price Reduction for Defective Certified Cost or Pricing Data Aug 2011 —Modification 52.215-12 Subcontractor Certified Cost or Pricing Data Oct 2010 52.215-13 Subcontractor Certified Cost or Pricing Data—Modifications Oct 2010 52.215-15 Pension Adjustments and Asset Reversions Oct 2010 52.215-18 Reversion or Adjustment of Plans for Postretirement July 2005 Benefits (PRB) Other Than Pensions 52.215-19 Notification of Ownership Change Oct 1997 52.215-20 Requirements for Certified Cost or Pricing Data Oct 2010 52.215-21 Requirements for Certified Cost or Pricing Data and Data Oct 2010 Other Than Certified Cost or Pricing Data—Modifications

– Alternate III 52.215-23 Limitations on Pass-Through Charges Oct 2009 52.216-7 Allowable Cost and Payment Aug 2018 52.216-8 Fix Fee Jun 2011 52.216-12 Cost-Sharing Contract – No Fee Apr 1984 52.219-8 Utilization of Small Business Concerns Oct 2018 52.219-9 Small Business Subcontracting Plan Aug 2018 52.219-16 Liquidated Damages—Subcontracting Plan Jan 1999 52.222-3 Convict Labor June 2003 52.222-21 Prohibition of Segregated Facilities Apr 2015 52.222-26 Equal Opportunity Sept 2016 52.222-35 Equal Opportunity for Veterans Oct 2015

52.222.36 Equal Opportunity for Workers with Disabilities Jul 2014 52.222-37 Employment Reports on Veterans Feb 2016 52.222-40 Notification of Employee Rights Under the National Labor Dec 2010 Relations Act 52.222-50 Combating Trafficking in Persons Jan 2019 52.222-54 Employment Eligibility Verification Oct 2015 52.223-6 Drug-Free Workplace May 2001 52.223-18 Encouraging Contractor Policies to Ban Text Messaging Aug 2011 While Driving 52.224-1 Privacy Act Notification Apr 1984 52.224-2 Privacy Act Apr 1984 52.224-3 Privacy Training Jan 2017 52.227-14 Rights in Data—General May 2014 52.227-16 Additional Data Requirements June 1987

52.228-7 Insurance–Liability to Third Persons Mar 1996 52.230-2 Cost Accounting Standards Oct 2015 52.230-3 Disclosure and Consistency in Cost Accounting Practices Oct 2015 52.230-6 Administration of Cost Accounting Standards. June 2010 52.232-9 Limitation on Withholding of Payments Apr 1984 52.232-17 Interest May 2014 52.232-18 Availability of Funds Apr 1984 52.232-20 Limitation of Cost Apr 1984 52.232-22 Limitation of Funds Apr 1984 52.232-23 Assignment of Claims May 2014 52.232-25 Prompt Payment Jan 2017 52.232-33 Payment by Electronic Funds Transfer— Oct 2018 System for Award Management.

52.232-39 Unenforceability of Unauthorized Obligations. Jun 2013 52.232-40 Providing Accelerated Payments to Small Business Dec 2013 Subcontractors 52.233-1 Disputes May 2014 Alternate I Dec1991 52.233-3 Protest after Award Aug 1996 Alternate I June 1985 52.233-4 Applicable Law for Breach of Contract Claim Oct 2004 52.237-3 Continuity of Services Jan 1991 52.239-1 Privacy or Security Safeguards Aug 1996 52.242-1 Notice of Intent to Disallow Costs Apr 1984 52.242-3 Penalties for Unallowable Costs May 2014 52.242-4 Certification of Final Indirect Costs Jan 1997 52.242-5 Payments to Small Business Subcontractors. Jan 2017 52.242-13 Bankruptcy July 1995 52.243-1 Changes-Fixed Price Aug 1987 52.243-2 Changes—Cost Reimbursement Aug 1987 Alternate I Apr 1984 52.244-2 Subcontracts Oct 2010 52.244-5 Competition in Subcontracting Dec 1996 52.244-6 Subcontracts for Commercial Items Nov 2017 52.245-1 Government Property Jan 2017 52.246-25 Limitation of Liability—Services Feb 1997 52.249-2 Termination for Convenience of the Government (Fixed-Price) Apr 2012 52.249-6 Termination (Cost-Reimbursement) May 2004 52.249-8 Default (Fixed Price Supply and Service) Apr 1984 52.249-14 Excusable Delays Apr 1984 52.253-1 Computer Generated Forms. Jan 1991

FAR 52.222-2 Payment for Overtime Premiums July 1990

(a) The use of overtime is authorized under this contract if the overtime premium does not exceed 1 and ½ of regular pay or the overtime premium is paid for work—

(1) Necessary to cope with emergencies such as those resulting from accidents, natural disasters, breakdowns of production equipment, or occasional production bottlenecks of a sporadic nature;

(2) By indirect-labor employees such as those performing duties in connection with administration, protection, transportation, maintenance, standby plant protection, operation of utilities, or accounting;

(3) To perform tests, industrial processes, laboratory procedures, loading or unloading of transportation conveyances, and operations in flight or afloat that are continuous in nature and cannot reasonably be interrupted or completed otherwise; or

(4) That will result in lower overall costs to the Government.

(b) Any request for estimated overtime premiums that exceeds the amount specified above shall include all estimated overtime for contract completion and shall—

(1) Identify the work unit; e.g., department or section in which the requested overtime will be used, together with present workload, staffing, and other data of the affected unit sufficient to permit the Contracting Officer to evaluate the necessity for the overtime;

(2) Demonstrate the effect that denial of the request will have on the contract delivery or performance schedule;

(3) Identify the extent to which approval of overtime would affect the performance or payments in connection with other Government contracts, together with identification of each affected contract; and

(4) Provide reasons why the required work cannot be performed by using multi shift operations or by employing additional personnel.

FAR 52.244-2 Subcontracts Oct 2010

(a) Definitions. As used in this clause— “Approved purchasing system” means a Contractor’s purchasing system that has been reviewed and approved in accordance with Part 44 of the Federal Acquisition Regulation (FAR). “Consent to subcontract” means the Contracting Officer’s written consent for the Contractor to enter into a particular subcontract.

“Subcontract” means any contract, as defined in FAR Subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contractor a subcontract. It includes, but is not limited to, purchase orders, and changes and modifications to purchase orders.

(b) When this clause is included in a fixed-price type contract, consent to subcontract is required only on unpriced contract actions (including unpriced modifications or unpriced delivery orders), and only if required in accordance with paragraph (c) or (d) of this clause.

(c) If the Contractor does not have an approved purchasing system, consent to subcontract is required for any subcontract that—

(1) Is of the cost-reimbursement, time-and-materials, or labor-hour type; or

(2) Is fixed-price and exceeds—

(i) For a contract awarded by the Department of Defense, the Coast Guard, or the National Aeronautics and Space Administration, the greater of the simplified acquisition threshold or 5 percent of the total estimated cost of the contract; or

(ii) For a contract awarded by a civilian agency other than the Coast Guard and the National Aeronautics and Space Administration, either the simplified acquisition threshold or 5 percent of https://www.acquisition.gov/sites/default/files/current/far/html/FARTOCP44.html#wp226845 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%202_1.html#wp1145507 the total estimated cost of the contract.

(d) If the Contractor has an approved purchasing system, the Contractor nevertheless shall obtain the Contracting Officer’s written consent before placing any subcontracts (e)(1) The Contractor shall notify the Contracting Officer reasonably in advance of placing any subcontract or modification thereof for which consent is required under paragraph (b), (c), or (d) of this clause, including the following information:

(i) A description of the supplies or services to be subcontracted.

(ii) Identification of the type of subcontract to be used.

(iii) Identification of the proposed subcontractor.

(iv) The proposed subcontract price.

(v) The subcontractor’s current, complete, and accurate certified cost or pricing data and Certificate of Current Cost or Pricing Data, if required by other contract provisions.

(vi) The subcontractor’s Disclosure Statement or Certificate relating to Cost Accounting Standards when such data are required by other provisions of this contract.

(vii) A negotiation memorandum reflecting—

(A) The principal elements of the subcontract price negotiations;

(B) The most significant considerations controlling establishment of initial or revised prices;

(C) The reason certified cost or pricing data were or were not required;

(D) The extent, if any, to which the Contractor did not rely on the subcontractor’s certified cost or pricing data in determining the price objective and in negotiating the final price;

(E) The extent to which it was recognized in the negotiation that the subcontractor’s certified cost or pricing data were not accurate, complete, or current; the action taken by the Contractor and the subcontractor; and the effect of any such defective data on the total price negotiated;

(F) The reasons for any significant difference between the Contractor’s price objective and the price negotiated; and

(G) A complete explanation of the incentive fee or profit plan when incentives are used. The explanation shall identify each critical performance element, management decisions used to quantify each incentive element, reasons for the incentives, and a summary of all trade-off possibilities considered.

(2) The Contractor is not required to notify the Contracting Officer in advance of entering into any subcontract for which consent is not required under paragraph (b), (c), or (d) of this clause.

(f) Unless the consent or approval specifically provides otherwise, neither consent by the Contracting Officer to any subcontract nor approval of the Contractor’s purchasing system shall constitute a determination—

(1) Of the acceptability of any subcontract terms or conditions;

(2) Of the allowability of any cost under this contract; or

(3) To relieve the Contractor of any responsibility for performing this contract.

(g) No subcontract or modification thereof placed under this contract shall provide for payment on a cost-plus-a-percentage-of-cost basis, and any fee payable under cost-reimbursement type subcontracts shall not exceed the fee limitations in FAR 15.404-4(c)(4)(i).

(h) The Contractor shall give the Contracting Officer immediate written notice of any action or suit filed and prompt notice of any claim made against the Contractor by any subcontractor or vendor that, in the opinion of the Contractor, may result in litigation related in any way to this contract, with respect to which the Contractor may be entitled to reimbursement from the Government.

(i) The Government reserves the right to review the Contractor’s purchasing system as set forth in FAR Subpart 44.3.

(j) Paragraphs (c) and (e) of this clause do not apply to the following subcontracts, which were evaluated during negotiations:

https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2015_4.html#wp1208557 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2044_3.html#wp1074685

I.2. OPTIONS

FAR 52.217-7 Option for Increased Quantity – Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within thirty (30) days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

FAR 52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within sixty days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed fifty-four months.

FAR 2.252-6 Authorized Deviations in Clauses (Apr 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter

1) clause with an authorized deviation is indicated by the addition of “(DEVIATION)” after the date of the clause.

(b) The use in this solicitation or contract of any Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of “(DEVIATION)” after the name of the regulation.

Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter 3) (http://www.hhs.gov/regulations/hhsar/)

Clause No. Title Date

352.203-70 352.211-1

352.211-3 352.208-70

Anti-Lobbying Public Accommodations and Commercial Facilities Paperwork Reduction Act Printing and Duplication

DEC 2015

352.224-70 Privacy Act DEC 2015 http://www.hhs.gov/regulations/hhsar/)

352.227-70 Publications and Publicity DEC 2015 352.231-70 Salary Rate Limitation DEC 2015 352.219-70 352.219-71 352.233-71

Mentor Protégé program Mentor-Protégé Program Reporting Litigation and Claims

DEC 2015

JAN 2010

DEC 2015

352.239-74 Electronic and Information Technology Accessibility

352.224-71 Confidential Information (DEC 2015)

(a) Confidential Information, as used in this clause, 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.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected…