Section_J.1_HIV_Task_Order.pdf

1. THIS CONTRACT IS A RATED ORDER RATING PAGE OF PAGES

UNDER DPAS (15 CFR 700)

2. CONTRACT NUMBER 3. SOLICITATION NUMBER 4. TYPE OF SOLICITATION 5. DATE ISSUED 6. REQUISITION/PURCHASE NUMBER

SEALED BID (IFB)

NEGOTIATED (RFP)

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

9. Sealed offers in original and _____________________________ copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in until local time _______________________ (Hour) (Date)

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L. All Offers are subject to all terms and conditions contained in this solicitation.

A. NAME B. TELEPHONE (NO COLLECT CALLS) C. E-MAIL ADDRESS

AREA CODE NUMBER EXT.

(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE PART II - CONTRACT CLAUSES

A SOLICITATION/CONTRACT FORM I CONTRACT CLAUSES

B SUPPLIES OR SERVICES AND PRICES/COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

C DESCRIPTION/SPECS./WORK STATEMENT J LIST OF ATTACHMENTS

D PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS

E INSPECTION AND ACCEPTANCE

F DELIVERIES OR PERFORMANCE

G CONTRACT ADMINISTRATION DATA L INSTR., CONDS., AND NOTICES TO OFFERORS

H SPECIAL CONTRACT REQUIREMENTS M EVALUATION FACTORS FOR AWARD

K REPRESENTATIONS, CERTIFICATIONS AND OTHER

STATEMENTS OF OFFERORS

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted, the offeror will furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule following the terms of this solicitation.

13. DISCOUNT FOR PROMPT PAYMENT 10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) 30 CALENDAR DAYS (%) CALENDAR DAYS (%) (See Section I, Clause No. 52-232-8)

14. ACKNOWLEDGEMENT OF AMENDMENTS AMENDMENT NO. DATE AMENDMENT NO. DATE

(The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated:

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ADDRESS

OF OFFEROR

(Type or print)

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ABOVE - ENTER SUCH ADDRESS IN SCHEDULE

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IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

(Signature of Contracting Officer)

(REV. 9-97)

10. FOR INFORMATION CALL: Email

11. TABLE OF CONTENTS

STANDARD FORM 33

SOLICITATION, OFFER AND AWARD

SOLICITATION

OFFER (Must be fully completed by offeror)

AWARD (To be completed by Government)

1 N/A 50

SOL-OAA-12-000128

X

U.S. AGENCY FOR INTERNATIONAL DEVELOPMENT

OFFICE OF ACQUISITION AND ASSISTANCE

M/OAA/GH SA-44 Building 301 4th Street, SW.

WASHINGTON, DC 20547

See Section L

See Section L

Paul Burford GHcommodityIDIQ@usaid.gov

X 1

X 6-8

X 9-22

X 23-24

X 25

X 26-27

X 28-31

X 32-43

X 44-50

$.00

Christopher J. Egaas

Contracting Officer

HIV/AIDS Task Order

Contents

ACRONYMS

SECTION B – SUPPLIES OR SERVICES AND PRICE/COSTS

B.1. PURPOSE

B.2. ORDER TYPE

B.3. ESTIMATED COST, FIXED FEE AND OBLIGATED AMOUNT

B.4. PRICE SCHEDULE

B.5. LABOR

B.6. ALLOWABLE COSTS

B.7. PAYMENT

SECTION C – STATEMENT OF WORK

C.1. STATEMENT OF WORK

C.2. OBJECTIVE 1: GLOBAL COMMODITY PROCUREMENT AND LOGISTICS

C.3. OBJECTIVE 2: SYSTEMS STRENGTHENING – SUPPLY CHAIN TECHNICAL

ASSISTANCE

C.4. OBJECTIVE 3: GLOBAL COLLABORATION

SECTION D – PACKAGING AND MARKING

D.1. AIDAR 752.7009 MARKING (JAN 1993)

D.2. BRANDING POLICY

D.3. PACKAGING AND PACKING PROVISIONS

SECTION E – INSPECTION AND ACCEPTANCE

E.1. NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

E.2. INSPECTION AND ACCEPTANCE

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

F.2. PLACE OF PERFORMANCE

F.3. REPORTING REQUIREMENTS

F.4. PERSONNEL

F.5. WORK WEEK

SECTION G – CONTRACT ADMINISTRATION DATA

G.1. NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

G.2. PAYMENT AND VOUCHERS

G.3. CONTRACTING OFFICER

G.4. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

G.5. CONTRACTOR’S PRIMARY POINT OF CONTACT

G.6. PAYING OFFICE

G.7. ACCOUNTING AND APPROPRIATION DATA

G.8. CONTRACTOR'S PAYMENT ADDRESS

G.9. TECHNICAL DIRECTIONS / RELATIONSHIP WITH USAID

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

H.2. AIDAR 752.225-70 SOURCE AND NATIONALITY REQUIREMENTS (FEB 2012)

H.3. AIDAR 752.7004 EMERGENCY LOCATOR INFORMATION (JUL 1997)

H.4. AIDAR 752.7007 PERSONNEL COMPENSATION (JUL 2007)

H.5. ADDITIONAL REQUIREMENTS FOR PERSONNEL COMPENSATION

H.6. INFORMATION SYSTEM SECURITY

H.7. DEFENSE BASE ACT (DBA) INSURANCE

H.8. AUTHORIZED GEOGRAPHIC CODE

H.9. LOGISTIC SUPPORT

H.10. LANGUAGE REQUIREMENTS

H.11. NONEXPENDABLE PROPERTY PURCHASES AND INFORMATION

TECHNOLOGY RESOURCES

H.12. EXECUTIVE ORDERS ON TERRORISM FINANCING

H.13. FOREIGN GOVERNMENT DELEGATIONS TO INTERNATIONAL CONFERENCES

(JAN 2002)

H.14. 752.7032 INTERNATIONAL TRAVEL APPROVAL AND NOTIFICATION

REQUIREMENTS (JAN 1990)

H.15. USAID DISABILITY POLICY (DEC 2004)

H.16. COMPLIANCE WITH SECTION 508 OF THE REHABILITATION ACT OF 1973, AS

AMENDED

H.17. LOGISTIC SUPPORT GOVERNMENT FURNISHED FACILITIES OR PROPERTY 38

H.18. RIGHT TO PROCURE FROM OTHER SOURCES

H.19. REPORTING OF FOREIGN TAXES (JULY 2007)

H.20. NONDISCRIMINATION (JUNE 2012)

H.21. SUBCONTRACTING PLAN AND THE SF 294 - SUBCONTRACTING REPORT FOR

INDIVIDUAL CONTRACTS AND SF 295 - SUMMARY CONTRACTING REPORT

H.22. SMALL DISADVANTAGED BUSINESS (SDB) PARTICIPATION PROGRAM

TARGET

H.23. SUBCONTRACTING CONSENT

H.24. CONSCIENCE CLAUSE IMPLEMENTATION (FEBRUARY 2012)

H.25. CONDOMS (JUNE 2005)

H.26. PROHIBITION ON THE PROMOTION OR ADVOCACY OF THE LEGALIZATION

OR PRACTICE OF PROSTITUTION OR SEX TRAFFICKING (APRIL 2010)

PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

I.1. NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

I.2. IFAR 52.222-50 COMBATING TRAFFICKING IN PERSONS (FEB 2009)

I.3. 52.203-13 CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT (APR 2010)

…………………………………………………………………………………………………..46

ACRONYMS

ACT Artemisinin-based combination therapy APS Annual program statement CDC Centers for Disease Control CHAI Clinton Health Access Initiative DIFD Department for International Development (United Kingdom) GH Global health ITN Insecticide treated net LLIN Long-lasting insecticide treated net NGO Non-governmental organization IPTp Intermittent preventive treatment for pregnant women IDIQ Indefinite Delivery, Indefinite Quantity contract PMI President’s Malaria Initiative QA Quality assurance RFTOP Request for task order proposal RDT Rapid diagnostic test TOCOR Task order contracting officer’s representative USAID United States Agency for International Development USG United States Government WHO World Health Organization

SECTION B – SUPPLIES OR SERVICES AND PRICE/COSTS

B.1. PURPOSE

The purpose of this Task Order, awarded under the Global Health Supply Chain Management Indefinite Delivery, Indefinite Quantity (IDIQ) Contract, is to advance the President’s Emergency Plan for AIDS Relief (PEPFAR) goals of moving towards an AIDS-Free Generation and strengthening health systems; by improving the availability of health commodities and the provision of technical assistance. This TO will be managed by the Bureau for Global Health’s Office of HIV/AIDS (OHA).

The IDIQ requirements and terms are not repeated within this TO but are additive to the terms of this TO; therefore, this document is a streamlined representation of PEPFAR’s unique needs.

The combination of the IDIQ and TO terms and conditions represent the full set of contractual requirements from the PEPFAR program.

B.2. ORDER TYPE

This is a cost plus fixed fee, term type contract. For the consideration set forth in the contract, the Contractor shall provide the deliverables or outputs described in Section C and comply with all contract requirements.

B.3. ESTIMATED COST, FIXED FEE AND OBLIGATED AMOUNT

(a) The estimated amount for the performance of the work required hereunder, exclusive of any fixed fee is $__________. The fixed fee is $__________. The estimated cost plus fixed fee is

(b) Within the estimated cost plus fixed fee specified in paragraph (a) above, the amount currently obligated and available for reimbursement of allowable costs incurred by the Contractor (and payment of fee) for performance hereunder is $__________. The Contractor shall not exceed the aforesaid obligated amount.

(C) Funds obligated hereunder are anticipated to be sufficient through TBD.

B.4. PRICE SCHEDULE

The total Summary budget is:

Line Item Year 1 Year 2 Year 3 Year 4 Year 5 TOTAL

1. TOTAL LABOR

Headquarters Labor Direct Salaries $ HQ Consultants $ Total HQ Labor Costs $ Field Labor Direct Salaries $ Field Consultants $ Total Field Labor Costs $

TOTAL LABOR $

2. FRINGE BENEFITS

HQ Fringe $ Field Fringe

TOTAL FRINGE

BENEFITS

3. SUBCONTRACTS

HQ Subcontracts $ Field Subcontracts $

TOTAL SUBCONTRACTS $

4. TRAVEL, TRANSPORTATION & PER DIEM

HQ Travel & Per Diem Field Travel & Per Diem Total Travel, Transportation & Per Diem

5. ALLOWANCES $

6. OTHER DIRECT

COSTS

Sub-Total Direct Costs $ $ $ $ $ $

7. INDIRECT COSTS

Overhead G&A (If Any)

TOTAL INDIRECT COSTS $

Sub-Total (Direct + Indirect) $ $ $ $ $ $

8. FIXED FEE % % % % % $

9. COMMODITY PROCUREMENT

HIV/AIDS products 345M 355M 366M 377M 388M $1,831M Cost Recovery on Commodities

Sub-Total Commodity Procurement

TOTAL CPFF $ $ $ $ $ $

B.5. LABOR

The following is the price schedule per year, please note that CLINs contain multiple positions/individuals per Labor Category (chart filled upon award):

CLIN Labor Category Daily Rate Level of Effort Total 0001 A $ $ 0001 B $ $ 0001 C $ $ 0001 D $ $ 0001 E $ $ 0001 F $ $

B.6. ALLOWABLE COSTS

The U.S. dollar costs allowable must be limited to reasonable, allocable, and allowable costs determined in accordance with FAR 52.216-7, Allowable Cost and Payment, and FAR 52.216-8, Fixed Fee, if applicable: AIDAR 752.7003, Documentation for Payment; OMB Circular 1-21, Cost Principles for Educational Institutions and OMB Circular A-122, Cost Principles for Non-profit organizations.

B.7. PAYMENT

The paying office is (See Section G)

[END OF SECTION B]

SECTION C – STATEMENT OF WORK

C.1. STATEMENT OF WORK

C.1.1. Background

The President's Emergency Plan for AIDS Relief (PEPFAR) started as a commitment of $15 billion over five years in 2003 to fund the global HIV/AIDS pandemic. PEPFAR is the largest initiative ever established by a country to a specific disease. The program initially aimed to provide antiretroviral treatment (ART) to 2 million HIV-infected people in resource-limited settings. With the reauthorization of PEPFAR in 2008, there was a shift away from focus countries and a greater emphasis was placed on building health systems in partnership with countries ensuring long-term sustainability.

The release of the Obama Administration’s PEPFAR Blueprint for Creating an AIDS-free Generation strongly reaffirmed the United States’ commitment to such goals (http://www.pepfar.gov) and put a greater emphasis on making antiretroviral treatment available to even more people. Over the past decade, PEPFAR has made strategic investments in collaborative networks that provide technical support, strengthen host country management, and build robust leadership and capacity in communities living with and affected by HIV/AIDS around the world. PEPFAR is making antiretrovirals widely available, with approximately six million people on this life-saving treatment (by 2013).

Behind PEPFAR’s successes in preventing the spread of HIV and treating infected individuals, is a tremendous amount of USAID funded procurement and supply chain strengthening.

USAID established the Supply Chain Management System (SCMS) contract to meet the procurement and supply chain technical assistance needs of PEPFAR. SCMS provides global procurement and delivery of health commodities to HIV/AIDS programs around the world, as well as providing supply chain technical assistance. The flagship SCMS contract purchased over three quarters of all the antiretroviral (ARV) drugs procured by PEPFAR and SCMS has purchased $1.5 billion worth of health commodities since its inception.

C.1.2. TASK ORDER OVERVIEW

USAID has restructured its entire portfolio of supply chain related projects into the new Global Health Supply Chain Program. The services that are offered by SCMS and DELIVER have been consolidated into one IDIQ within the Global Health Supply Chain Program. This HIV/AIDS TO will accelerate the work started by SCMS. As described in the GH Supply Chain IDIQ, the objectives of this TO are as follows:

• Objective 1: Improve the provision of health commodities through global commodity procurement and logistics.

http://www.pepfar.gov/

• Objective 2: Strengthen in-country supply chain systems through supply chain technical assistance.

• Objective 3: Global collaboration to engage strategically to improve long term global supply of health commodities.

In addition to this TO and the other TOs under this IDIQ, USAID anticipates awarding a Multiple Award IDIQ for technical assistance (TA). USAID Missions and PEPFAR teams in country will be given flexibility in how they invest PEPFAR resources. HIV/AIDS funding is largely controlled at the country level, by USG inter-agency PEPFAR teams. Funding for activities will be established with individual Missions or USAID Washington on an annual basis. The Contractor will be approached by USAID Missions when they elect to use this TO for procurement or TA services, to develop budgets that will be financed by PEPFAR Country Operational Plan budgets or other annual, country-level appropriations.

Prior to the flagship SCMS project, many governments with large-scale USG funded HIV/AIDS programs reported variability in pricing, late deliveries, low visibility of international shipments and other procurement and logistics challenges for HIV related commodities. These challenges threatened the expansion of HIV/AIDS prevention, care and treatment programs. Over the past seven years, the strategic sourcing of HIV commodities at the global level has allowed PEPFAR to deliver over $1.5 billion worth of commodities to patients in need. The continuation of this important global HIV supply chain is critical.

The Contractor must operate a global supply chain and provide technical assistance on behalf of USAID Missions, Bureaus, operating units, other USG agencies, Public International Organizations, local and international non-Governmental organizations, private sector entities, and/or Partner Countries, hereinafter referred to as “clients” (as described in Objective 1). External buy-in from sources outside USAID is encouraged.

The demand for technical assistance services will also continue to grow. The contract must be able to provide a broad range of technical assistance services for the benefit of HIV/AIDS programs and other disease programs that will be initiated by USAID Missions and by headquarters. The Contractor must build on existing evidence-based strategies and local capacities, while producing measurable results (as described in Objective 2).

C.2. OBJECTIVE 1: GLOBAL COMMODITY PROCUREMENT AND LOGISTICS

The Contractor must be prepared to perform the following tasks under Objective 1.

C.2.1 Health Commodity Procurement

The Contractor should anticipate managing HIV/AIDS and related commodity procurement volume in the range of $350-$500 million on an annual basis. The exact type and value of the commodities cannot be predicted at this time. However, the commodities that are likely to be bought in largest volumes are:

• antiretrovirals (ARVs);

• laboratory diagnostics, equipment and consumables;

• drugs to treat opportunistic infections;

• other commodities as approved by USAID; and

• HIV rapid test kits (these products will be purchased under a separate contract that is set-aside for small businesses, but may be required in some instances when that contractor is unable to provide rapid test kits).

During the life of this TO, advanced treatment and diagnostic tools will emerge and the Contractor is expected to procure these products (e.g. pharmaceuticals and diagnostics).

While the TO is not strictly limited to procuring HIV/AIDS commodities, procurement for malaria and family planning programs will generally be done by separate TOs under the

IDIQ.

The Contractor will not receive a fee on the cost of commodities that it procures and distributes. The Contractor may recover cost of headquarters procurement teams (the level of effort) as a direct cost.

This task includes, but is not limited to, the following activities:

C.2.1.1. Health Commodity Strategic Sourcing

As stated in the IDIQ requirements and in addition:

The Contractor must implement strategic sourcing plans and maintain a procurement operation that achieves best value on health commodity procurement. For the purpose of this TO, best value represents the lowest possible landed-cost for acceptable health commodities that can be delivered within the timeframes required by clients and in accordance with Automated Directives Systems (ADS) chapter 312. The Contractor must anticipate managing HIV/AIDS and health commodity procurement volume in the range of $350-$500 million annually. An illustrative list of commodities can be seen in the IDIQ Section J.8.

The Contractor must ensure that it continually has an updated understanding of which ARVs and rapid test kits are pre-qualified and the impact of the availability of active pharmaceutical ingredient on the supply of finished formulations from manufacturers and the emergence of new drugs and point of care (POC) diagnostics. The Contractor must also be capable of following the evolution of scientific literature on HIV diagnosis, care and treatment that will help the contractor predict changes to product sourcing. The Contractor will play a key role in introducing new commodities into public health programs and must maintain flexibility in its procurement processes to allow for timely changes. In addition, the Contractor must keep abreast of product and industry specific changes in the market. The Contractor must also balance the interests of driving prices lower and keeping suppliers in the market to mitigate the risk of supply disruptions where competition is already limited to a few generic manufacturers (this is particularly true for ARVs). Issues related to the financing, supply, demand, new technology and policy issues related to ensuring the long-term availability and introduction of commodities, must be understood by the Contractor.

Procurement of laboratory and diagnostic commodities will be an important activity under this TO. An understanding of maintenance contracts, which can be negotiated as part of the purchase price of lab equipment, or can be purchased separately, may be required of the Contractor in some countries.

Sourcing locally will also be an important task within this TO, particularly where procuring commodities locally achieves the best value for USAID by lowering the landed cost of products, shortening lead-times to meet program needs or transferring risk of managing inventory to vendors. Currently, lab consumables and reagents represent the largest category of locally sourced HIV-commodities. The Contractor must be capable of ensuring locally sourced commodities are procured according to USAID contracting statutes and regulations.

C.2.1.2. Health Commodity Selection

As stated in the IDIQ requirements and in addition:

The Contractor must meet USAID’s ADS 312 requirements for the purchase of commodities.

HIV-specific ADS requirements currently dictate that USAID GH/OHA/SCH must approve all HIV-related pharmaceutical purchases, with a few specific exceptions. More information on the pre-qualification requirements and a list of pre-qualified sources can be found at http://www.usaid.gov/sites/default/files/documents/1864/ADS312AdditionalHelpDocument.

pdf.

Under the USAID ADS, laboratory reagents and diagnostic tests are considered pharmaceuticals; however, laboratory equipment and consumables are not. During the period of performance of this TO USAID ADS changes may be made and the Contractor is expected to understand changes to this important USAID ADS language and submit requests in accordance with any such revisions.

C.2.1.3. Health Commodity Procurement and Subcontractor Management

The Contractor must leverage economies of scale under this TO when practicable, by pooling procurements across countries to achieve the best possible pricing from suppliers (and freight, as detailed in the logistics section of this TO). Pricing for health commodities purchased in large volumes is expected to be equal or lower than prices achieved by private sector buyers and other donors.

The Contractor must provide and operate a health commodity procurement management system that is capable of efficient and accurate processing of all procurements and subcontracts under this TO. The Contractor must analyze partnership and sourcing opportunities with different sources of supply including manufacturers, and internationally-recognized wholesalers/procurement agents to determine the best procurement channels. The Contractor is responsible for the timely and efficient delivery of the commodity as specified in the purchase request and for ensuring and enforcing contractual remedies, if conditions are not met. The Contractor must collaborate with the Quality Assurance Contractor (also to be awarded under the Global Health Supply Chain Program) to ensure that they are buying and delivering a product meeting USAID quality standards.

USAID expects the Contractor’s approach to be flexible, efficient, reliable, comprehensive and cost-effective. The Contractor is responsible for the timely delivery of quality assured commodities as specified in the purchase request and for ensuring and enforcing contractual remedies with suppliers (if the established contractual conditions regarding these elements are not met).

C.2.1.4. Commodity Procurement Risk Management.

As stated in the IDIQ requirements and in addition:

The Contractor must have a supplier risk strategy that helps mitigate risks to the continuous flow of commodities to clients. Risks that impact procurement, shipping, warehousing, distribution, maintenance (for equipment) or any other aspect of the supply chain must be detailed in contingency plans and risk profiles that are delivered to USAID, for the following products:

• ARVs

• HIV rapid test kits (in the event that the Single Award IDIQ for Rapid Test Kit

Procurement is unable to procure)

• CD4 reagents

• Viral load reagents

• Lab equipment

The Contractor must undertake risk mitigation strategies at the global level, which may include but are not limited to security measures, inventory counts, the use of tracer products, minimizing warehousing and transfer points for commodities. The Contractor must promptly report to USAID any suspected instances of irreconcilable inventory, loss, theft, deterioration, and diversion/misappropriation of commodities funded under this TO.

C.2.1.5. Health Commodity Supplier Forecasting

Under this TO, the Contractor must maintain and communicate with USAID on commodity forecasts for the following product categories at the global level:

• ARVs

• HIV rapid test kits (in the event that the Single Award IDIQ for HIV/AIDS Rapid Test

Kit Procurement is unable to procure)

• CD4 reagents

• Viral load reagents

The forecasts must factor in aggregated forecasts for individual countries. The Contractor must review forecasts retrospectively with USAID to monitor their accuracy, and improve accuracy by adopting new methodologies or revising existing methodologies. The Contractor must work proactively to ensure upstream suppliers of active pharmaceutical ingredients (or other product components) can meet demand.

C.2.1.6. Health Commodity Customer Demand Forecasting

As stated in the IDIQ requirements and in addition:

The Contractor must coordinate commodity procurements and deliveries with other international donors, particularly the Global Fund, and partner country counterparts. The Contractor must seek HIV-related forecast and supply planning data from other partners in country, including host country governments, the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), the Clinton Health Access Initiative, UNITAID and others. The Contractor must maintain a global-level capability to aggregate procurement forecasts and supply plans for multiple countries to avoid HIV-commodity shortages or over-stocks.

C.2.1.7. Product Registration

As stated in the IDIQ requirements and in addition:

The Contractor must maintain a current listing of HIV-related health commodities registered in each country.

C.2.1.8. Health Commodity Supplier Performance Management

As stated in the IDIQ requirements.

C.2.1.9. Performance Management and KPIs

C.2.1.10. Coordinated Health Commodity Procurement

C.2.1.11. Continuous Improvement.

C.2.2 Logistics. Logistics services for commodity delivery

C.2.2.1 Customer Order Fulfillment

The Contractor must undertake all steps necessary to support country programs to place and fulfill orders. The Contractor must develop a system to continuously measure customer satisfaction with high quality customer service. USAID may request the Contractor to assist HIV/AIDS programs to identify the types and quantities of commodities to be procured, and timing of deliveries with funds other than PEPFAR or USAID. The Contractor will also work closely with in-country HIV/AIDS staff to develop commodity procurement/order plans for commodity needs.

The Contractor must be fully responsible for the timely procurement, delivery, and management of commodities, per agreed cost and shipment date as provided under this TO.

The Contractor must further be responsible for redressing any failures to meet terms and conditions of commodity delivery through, without limitation, adequate supervision and management of vendors and/or subcontractors, insurance claims, ensuring adequate contractual remedies, and enforcing contractual remedies on vendor subcontracts.

C.2.2.2 Warehousing and Inventory Management

As stated in the IDIQ requirements and in addition:

The Contractor must establish implement and continuously maintain inventory strategies for HIV-related commodities procured under this TO. The inventory strategies must strike the right balance between cost (inventory, operating, transportation, etc.) and service (lead time, response time to emergency requests, stock-outs, etc.). The Contractor may use strategies, such as operating Regional Distribution Centers, to lower the cost through bulk transportation to regional points while also reducing the lead-times on orders. The Contractor must continuously review its inventory stock strategy and maintain the ability to adjust the number, size, price, and location of its warehousing facilities to ensure best value for the USG. The Contractor must assume full responsibility for the management of commodities held as central stock, if any, including but not limited to maintaining processes, procedures and reporting to safeguard and account for stock inventory.

C.2.2.3 Freight Forwarding and Transportation

As stated in the IDIQ requirements and in addition:

USAID requires the Contractor to document and certify delivery of all commodities to previously-identified consignees through a reporting and verification system. The Contractor must maintain this documentation on file and keep it available for USAID or external review.

Specifically, USAID requires the Contractor to ensure control and produce, within reason, all related documentation for every step within the supply chain for which the Contractor or its Subcontractor bears responsibility and has assumed chain of custody. The Contractor shall negotiate and place insurance policies to cover damaged or lost products as appropriate. The Contractor must promptly inform and reimburse USAID for commodity damage or loss incurred while within Contractor or Subcontractor control. The Contractor must maintain all procurement records. The Contractor must maintain all records and other evidence sufficient to reflect all costs claimed to have been incurred in the performance of this TO. The

Contractor must retain all of this documentation and submit for USAID or external review (e.g., for audit purposes), if requested.

C.2.2.4 In- Country Commodity Distribution.

The Contractor must be capable of distributing products from the central level down to the point of use in select countries (e.g. clinic, hospital, lab, etc.), where PEPFAR has elected to invest in operating an in-country supply chain system. The Contractor shall undertake risk mitigation strategies at the country level, which may include but are not limited to security measures, inventory counts, the use of tracer products, minimizing warehousing and transfer points for commodities. The Contractor must promptly report to USAID any suspected instances of irreconcilable inventory, loss, theft, deterioration, and diversion/misappropriation of commodities funded under this TO. The Contractor must support country programs in developing and implementing innovative risk mitigation strategies.

C.2.2.5 Financial Management.

As stated in the IDIQ requirements.

C.2.2.6 Continuous Improvement.

C.2.3 Health Commodity Quality Assurance. Provide Health Commodities That Meet Required Quality Requirements

The Contractor is responsible for incorporating the appropriate health commodity quality assurance (QA) and quality control (QC) processes into their global supply chain. In collaboration with USAID’s QA Contractor or USAID designee, the Contractor is responsible for maintaining the appropriate documentation supporting the quality of health commodities procured under this TO. This activity includes, but is not limited to, the following elements:

C.2.3.1. Collaboration with QA Contractor and other USAID Designee.

C.2.3.2. Adherence to USAID’s Quality Assurance Requirements.

C.2.3.3. Managing Product Recalls.

C.2.3.4. In-House QA Capability.

No in-house QA capability is needed under this TO.

C.2.4 Data Visibility. Provide Appropriate Visibility of Data

C.2.4.1. Information Systems Capabilities.

As stated in the IDIQ requirements.

C.2.4.2. Data.

As stated in the IDIQ requirements.

C.2.4.3. Data Standards.

As stated in the IDIQ requirements.

C.2.4.4. Data Loss Prevention.

As stated in the IDIQ requirements.

C.2.4.5. Updates to Information Systems.

As stated in the IDIQ requirements.

C.2.4.6. Data Ownership.

As stated in the IDIQ requirements.

C.2.4.7. Support Existing Tools.

As stated in the IDIQ requirements.

C.2.4.8. Product Ordering & Tracking.

C.3. OBJECTIVE 2: SYSTEMS STRENGTHENING – SUPPLY CHAIN TECHNICAL ASSISTANCE.

This TO defines in-country supply chain systems broadly and includes public, private, and non-profit sector-run supply chains.

C.3.1. Strategic Planning: Provide Strategic Planning and Design Assistance

C.3.1.1. SUPPLY CHAIN STRATEGIC PLAN DEVELOPMENT.

As stated in the IDIQ requirements.

C.3.1.2. STRATEGIC IMPLEMENTATION.

C.3.2. In- Country Logistics

C.3.2.1. Commodity Quantification and Forecasting.

As stated in the IDIQ requirements and in addition:

C.3.2.2. Health Commodity Supply Planning.

As stated in the IDIQ requirements.

C.3.2.3. Procurement.

As stated in the IDIQ requirements.

C.3.2.4. Health Commodity Warehousing and Inventory Management.

As stated in the IDIQ requirements.

C.3.2.5. Health Commodity Distribution and Transportation.

As stated in the IDIQ requirements and in addition:

For this HIV/AIDS TO, it is important to note that clearance of HIV rapid test kits (purchased by a separate USAID contract) will need to be cleared and distributed; and the Contractor may be called on by USAID Missions or the USG to clear and distribute HIV rapid test kits.

C.3.2.6. Health Care Waste Management.

As stated in the IDIQ requirements and in addition:

Health commodity waste management may include the following types of waste: sharps (e.g.

used needles), non-sharps, gauze, blood/IV lines, gloves, infusion sets, scalpels, blades, and broken glass, expired drugs, laboratory reagents, and cleaning solvents. Poor management of health care waste exposes healthcare workers, waste handlers and the community to infections, toxic effects and injuries. Activities under this TO have the potential to affect the environment. The Contractor must be capable of providing assistance and must apply practices which incorporate appropriate health and safety measures and environmental safeguards, including proper disposal of medical waste. This must be done, at a minimum, in accordance with international norms as spelled out by WHO and must also meet the requirements of local policies and laws. The Contractor must be ready to advise (or operate) reverse logistics systems to routinely handle waste for health facilities.

C.3.2.7. Commodity Quality Assurance.

As stated in the IDIQ requirements and in addition:

The Contractor must be ready to provide technical assistance related to product quality assurance. It is envisioned that the full range of technical assistance described in the IDIQ will only be used as a last resort under the HIV/AIDS TO. The illustrative activities described below are those that are required for this HIV/AIDS TO, and must be undertaken with full consultation and collaboration with other USAID implementing partners to avoid duplication. Illustrative activities related to commodity quality assurance include the following:

• Technical assistance regarding proper sampling and testing, and pre-shipment inspections may be required as part of the overall product quality process.

• Technical assistance to the national drug regulatory authority or national entity responsible for in-country supply chains.

• Technical assistance with post-market surveillance activities.

• Technical assistance and/or review of the internal control systems of the supply chain handling USG or other donor product to minimize leakage or diversion of product.

C.3.2.8. Appropriate Pharmaceutical and Commodity Selection.

The Contractor must provide technical assistance to help select the appropriate pharmaceuticals, laboratory products, and other commodities to support a partner country’s programs and adhere to treatment protocols. For this TO, the introduction and scale-up of new initiatives, such as PMTCT Option B+ and Voluntary Medical Male Circumcision (VMMC) will be important. USAID expects further changes as the epidemiology of HIV/AIDS changes, and new diagnostic tools and treatments are introduced. USAID requires the Contractor to be prepared to support local supply chains to adapt to these new challenges and potential changes in epidemiology so that beneficiaries receive access to appropriate diagnosis and treatment.

C.3.2.9. Identification of Barriers to Commodity Importation.

As stated in the IDIQ requirements and in addition:

The Contractor must be ready to provide technical assistance associated with the review of tariff and regulatory barriers to the importation of the needed health commodities, identifies these problems to the attention of appropriate local and USG officials, and assists in devising solutions to reduce/minimize these barriers. The Contractor must also assist, at the request of USAID Missions, in the smooth importation of HIV rapid test kits procured by a separate USAID contract.

C.3.2.10. Commodity Loss Prevention.

As stated in the IDIQ requirements.

C.3.2.11. Product Recalls.

As stated in the IDIQ requirements.

C.3.2.12. Commodity Supply Chain Design.

As stated in the IDIQ requirements.

C.3.2.13. Data Collection and Information Systems.

As stated in the IDIQ requirements.

C.3.2.14. Construction.

C.3.3. Capacity-Building.

C.3.4. Enabling Environments. Strengthen Enabling Environments to Improve Supply Chain Performance.

C.3.4.1. Commodity Financing

As stated in the IDIQ requirements.

C.3.4.2. Human Resources.

As stated in the IDIQ requirements.

C.3.4.3. Governance and Leadership.

As stated in the IDIQ requirements.

C.3.4.4. Policy.

C.4. OBJECTIVE 3: GLOBAL COLLABORATION

The Contractor must provide leadership, guidance and technical assistance to ensure the long-term global supply and in-country availability of both existing and new HIV/AIDS health commodities. The global market for HIV/AIDS and health commodities has seen many technical breakthroughs in the past eight years but has also been affected by instability, price changes and periodic shortages of key products, which impact the ability of HIV programs to rapidly implement key interventions. This instability impacts the upstream supplier base in terms of market dynamics, supply, and quality issues for key commodities such as ARVs and diagnostics, in current and future program efforts; and can ultimately lead to interruptions of life-saving commodities for patients. The Contractor must take steps with the international stakeholders (e.g. GFATM, CHAI, etc) to avoid such interruptions.

C.4.1. Global Strategic Engagement

The Contractor must engage with relevant global partners to ensure that there is appropriate strategic coordination and the ability to leverage activities for the furtherance of the program.

At the global level, the Contractor must attend and/or be a member of key strategic meetings that HIV/AIDS and PEPFAR specific. Examples include meetings related to health commodity procurement, forecasting and quantification, and distribution, system design, supply chain management systems, infrastructure, commodity security and capacity building.

In these meetings, it is incumbent upon the Contractor to share lessons learned and best practices in supply chain management and commodity security.

C.4.2. Global Market Dynamics

C.4.2.1. Global Market Intelligence.

As stated in the IDIQ requirements.

C.4.2.2. Strategies and Information Sharing.

As stated in the IDIQ requirements.

C.4.2.3. Analyzing Global Data and Reporting.

As stated in the IDIQ requirements.

C.4.2.4. New Technologies and Products.

C.4.3. Advocacy: Continued Awareness Raising and Advocacy to Improve the

Availability of Health Commodities

C.4.4. Coordination. Effective Coordination withal USAID Funded Supply Chain Activities within the IDIQ

C.4.5. Knowledge Management and Communication

C.4.6. TRANSITION FROM DELIVER TASK ORDER

[END OF SECTION C]

SECTION D – PACKAGING AND MARKING

D.1. AIDAR 752.7009 MARKING (JAN 1993)

(a) It is USAID policy that USAID-financed commodities and shipping containers, and project construction sites and other project locations be suitably marked with the USAID emblem. Shipping containers are also to be marked with the last five digits of the USAID financing document number. As a general rule, marking is not required for raw materials shipped in bulk (such as coal, grain, etc.), or for semi-finished products which are not packaged.

(b) Specific guidance on marking requirements should be obtained prior to procurement of commodities to be shipped, and as early as possible for project construction sites and other project locations. This guidance will be provided through the cognizant technical office indicated on the cover page of this contract, or by the Mission Director in the cooperating country to which commodities are being shipped, or in which the project site is located.

(c) Authority to waive marking requirements is vested with the Regional Assistant

Administrators, and with Mission Directors.

(d) A copy of any specific marking instructions or waivers from marking requirements is to be sent to the Contracting Officer; the original should be retained by the Contractor.

D.2. BRANDING policy

(a) In accordance with ADS 320 “Branding and Marking”, this Task Order incorporates USAID’s policy directives and required procedures on branding and marking of USAID-funded programs, projects, activities, public communications, and commodities with the USAID identity.

Markings under this contract shall comply with the USAID “Graphic Standards Manual" available at www.usaid.gov/branding or any successor branding policy.

(b) The Contractor must use the Branding Implementation Plan (BIP) and Marking Plan (MP) that was approved for the IDIQ.

Desired level of visibility: USAID identity must be prominently displayed in commodities of equipment; infrastructure projects; printed, audio; Visual or electronic public communications; studies, reports, publications, websites, and promotional and informational products; and events.

Organization to

Be acknowledged: The branding may acknowledge other organizations deemed as partners of an event or deliverable.

http://www.usaid.gov/branding

The Marking Plan must enumerate all of public communications, commodities, infrastructure projects, program materials, events, deliverables, and other items that shall be marked with the USAID identity or brand.

D.3. PACKAGING AND PACKING PROVISIONS

Packaging, packing and marking shall be in accordance with all applicable FDA regulations or the manufacturer’s current public sector packaging for overseas distribution, Packaging and packing must ensure the safety, efficacy and quality of the product and be appropriate for distribution to harsh climates under less than ideal transport and storage conditions.

[END OF SECTION D]

SECTION E – INSPECTION AND ACCEPTANCE

E.1. NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

The following contract clauses pertinent to this section are hereby incorporated by reference (by Citation Number, Title, and Date) in accordance with the clause at FAR 52.252-2 "CLAUSES INCORPORATED BY REFERENCE" in Section I of this contract. Full text of the FAR clauses is available at https://www.acquisition.gov/far/ and full text of the AIDAR clauses is available at http://www.usaid.gov/ads/policy/300/aidar and http://www.usaid.gov/ads/policy/300/300.

NUMBER TITLE DATE

FEDERAL ACQUISITION REGULATION (48 CFR Chapter 1)

52.246-3 INSPECTION OF SUPPLIES—COST-REIMBURSEMENT MAY 2001

52.246-5 INSPECTION OF SERVICES—COST REIMBURSEMENT APR 1984

52.246-16 RESPONSIBILITY FOR SUPPLIES APR 1984

E.2. INSPECTION AND ACCEPTANCE

USAID inspection and acceptance of services, reports and other required deliverables or outputs shall be subject to the performance standards set forth in Sections C and F. Inspection and acceptance shall take place at:

United State Agency for International Development Bureau of Global Health, RRB 3rd Floor 1300 Pennsylvania Avenue, NW Washington DC 20523 or at any other location where the services are performed and reports and deliverables or outputs are produced or submitted. Inspection of all deliverables required hereunder shall be made by the Contracting Officer’s Representative (COR), designated in Section G, who has been delegated authority to inspect and accept all services, reports and other required deliverables. Acceptance of services, reports and other deliverables by the COR shall form the basis for payments to the Contractor.

[END OF SECTION E]

http://www.usaid.gov/ads/policy/300/300

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

The resulting Task Order described here is expected to operate for five (5) years:

Specific dates TBD at time of award

The total period of performance will not exceed five years.

F.2. PLACE OF PERFORMANCE

The contractor will have a headquarters in Washington, DC. The contractor will have warehouse locations in ___TBD_____.

The contractor will perform the services of this Task Order in multiple countries based on global commodity demand.

F.3. REPORTING REQUIREMENTS

The contractor will submit Task Order reports in accordance with the Supply Chain Indefinite Delivery, Indefinite Quantity Contract. In addition, the following report is required for this TO:

a. Global Price Report: The contractor must report annually on the cost of major products and product lines, the cost of products by manufacturer and country. Raw data for such reports are not for public consumption; however, the contractor will assist in publishing summary level reports for public consumption. An example of such reports is the annual “OGAC ARV Price Survey” and can be seen in the IDIQ Section J.10.

F.4. PERSONNEL

F.4.1 KEY PERSONNEL

Task Order Key Personnel (A different individual must fill these positions for each Task Order).

a. Task Order Director – Task Order Director(s) serve as the main point of contact for each TO and share responsibility for the success of the program with the IDIQ Director. The Task Order Director(s) also serve as the main point of contact disease-specific programs within USAID and they must maintain an understanding of logistics and systems strengthening activities.

b. Finance Manager – Finance Manager (s) serve as the main point of contact for financial management issues related to each TO.

c. Procurement and Logistics Manager – Procurement and Logistics Manager (s) serve as the main point of contact for procurement issues related to each TO.

d. Systems Strengthening Manager – Systems Strengthening Manager (s) serve as the main point of contact for systems strengthening issues related to a specific disease or

TO.

e. Global Collaboration Manager (for HIV/AIDS TO only) – the Global

Collaboration Manager under the HIV TO serves as the main point of contact for Objective 3 activities. This role will be shared by other members of the teams under the other TOs.

F.5. WORK WEEK

Personnel under this Task Order are authorized to work a five-day (5-day) work week.

No overtime or premium pay is authorized.

[END OF SECTION F]

SECTION G – CONTRACT ADMINISTRATION DATA

G.1. NOTICE LISTING CONTRACT CLAUSES INCORPORATED BY REFERENCE

The following AIDAR clause pertinent to this section is hereby incorporated by reference (by Citation Number, Title, and Date).

NUMBER TITLE DATE

752.7003 DOCUMENTATION FOR PAYMENT NOV 1998

G.2. PAYMENT AND VOUCHERS

The Contractor may submit vouchers for payment monthly or bi-monthly. Under the cost reimbursement portion of the contract, the Contractor may invoice for costs incurred at the time of invoice.

G.3. CONTRACTING OFFICER

TBD

U.S. Agency for International Development Office of Acquisition and Assistance Attn: USAID/OAA/GH, Room #: TBD 1300 Pennsylvania Avenue, NW Washington, DC 20523-7900

G.4. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

TBD

U.S. Agency for International Development 1300 Pennsylvania Avenue, NW Washington, DC 20523-7900

A COR Designation Letter will be signed by the TOCOR and TOCO at the time of award. A copy will be given to the contractor.

G.5. CONTRACTOR’S PRIMARY POINT OF CONTACT

The Contractor’s Primary Point of Contact is [name and position to be inserted at award] who can be reached at telephone no. [to be inserted at award] or email [to be inserted at award].

G.6. PAYING OFFICE

The Contractor must submit invoices to the payment office indicated on the Cover Page of each Task Order. Generally, this will be the USAID Washington Office/Bureau or the USAID overseas field Mission from which the funds for the Task Order are provided or, for Missions without their own Controller, the regional office responsible for that Mission.

Invoices for USAID Washington Office/Bureau shall be submitted to the payment office at the following email address:

EI@usaid.gov.

Include Subject Line: Contractor Name, Award #, Invoice #

G.7. ACCOUNTING AND APPROPRIATION DATA

Budget Fiscal: (Data to be inserted at award) Operating Unit:

Strategic Objective:

Team/Division:

Benefiting Geographic Area:

Expanded Object Class Code (EOCC):

Amount Obligated:

G.8. CONTRACTOR'S PAYMENT ADDRESS

[To be inserted at award]

G.9. TECHNICAL DIRECTIONS / RELATIONSHIP WITH USAID

(a) Technical Directions is defined to include:

(1) Written directions to the Contractor which fill in details, suggest possible lines of inquiry, or otherwise facilitate completion of work;

(2) Provision of written information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work statement;

(3) Review and, where required, provide written approval of technical reports, drawings, specifications, or technical information to be delivered. Technical directions must be in writing, and must be within the scope of work detailed in Section C.

(b) The Contracting Officer, by separate designation letter, authorizes the COR to take any or all action with respect to the following which could lawfully be taken by the Contracting Officer, except any action specifically prohibited by the terms of this contract:

mailto:EI@usaid.gov

(1) Assure that the Contractor performs the technical requirements of the contract in accordance with the contract terms, conditions, and specifications.

(2) Perform, or cause to be performed, inspections necessary in connection with (a) above and require the Contractor to correct all deficiencies; perform acceptance for the Government.

(3) Maintain all liaison and direct communications with the Contractor. Written communications with the Contractor and documents shall be signed as "Contracting Officer's Representative" with a copy furnished to the Contracting Officer.

(4) Issue written interpretations of technical requirements of Government drawings, designs, and specifications.

(5) Monitor the Contractor's production or performance progress and notify the

Contractor in writing of deficiencies observed during surveillance, and direct appropriate action to effect correction. Record and report to the Contracting Officer incidents of faulty or nonconforming work, delays or problems.

(6) Obtain necessary security clearance and appropriate identification if access to