Combined_Syn-Sol_TPN_and_Other_Sterile_Compounding_Products.pdf

Combined Synopsis/Solicitation Number NIH-CC-19-011876 - 503A and 503B

Outsourcing Facility to Supply TPN and other Sterile Compounded Products

National Institutes of Health Clinical Center

Materials Management and Environmental Services Department

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and

Solicitation for Commercial Items,” as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. The solicitation is being issued using simplified acquisition procedures under the authority of FAR 13.5 Test Program for Certain Commercial Items.

The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2019-03, Effective 12 June 2019.

The associated North American Industrial Classification System (NAICS) code for this procurement is

325412, Pharmaceutical Preparation Manufacturing, with a small business size standard of 1250 employees.

This acquisition is open to capable businesses of any size. Responses are due by 11:00 a.m., July 24, 2019.

Questions may be submitted by email to the Contract Specialist (Lisa.Schaupp@nih.gov) through July 16, 2019 by 3;00 p.m. E.T.. Answers will be posted by 5:00 p.m. E.T. July 17, 2019.

The National Institute of Health, Office of Purchasing and Contracts, is seeking a 503A and 503B FDA approved Outsourcing Facility capable of independently fulfilling compounding requests for select non patient-specific sterile compounded products, patient specific total parenteral nutrition and renal replacement therapy that meet the quality expectations to provide to National Institutes of Health Clinical

Center (NIH CC) patients on an ongoing basis. Services must be provided in accordance with the specifications of the Performance Work Statement (PWS). Please see the Statement of Work attached herein for details of the requirement.

PRICE SCHEDULE: NOTICE FOR MINIMUM AND MAXIMUM ORDER AMOUNTS FOR THE

CONTRACT ORDERING PERIOD.

The guaranteed minimum award amount for this contract is $90.00. The maximum aggregate value of orders that can be placed under this contract over a 60 month period is $3.25 million. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

All business capable, registered with the FDA, and experienced as 503B and/or 503A Outsourcing

Facilities are invited submit offers. As one part of the offer, the contractor must provide pricing in the attached pricing tables for the following Period of Performance.

Line

Item

Description – Total

Parenteral Nutrition and

Other Compounded Sterile

Products for the NIH Clinical

Center

Estimated Ordering

Period

Estimated Minimum

Order/

Estimated Maximum

Order

Base Period: Sterile

Compounded Products 8/15/2019 to 8/14/2020 $90.00 / $650,000

Option Period One (1): Sterile

Compounded Products 8/15/2020 to 8/14/2021 $90.00 / $650,000

Option Period Two (2): Sterile

Compounded Products 8/15/2021 to 8/14/2022 $90.00 / $650,000

Option Period Three (3) Sterile

Compounded Products 8/15/2022 to 8/14/2023 $90.00 / $650,000

Option Period Four (4): Sterile

Compounded Products 8/15/2023 to 8/14/2024 $90.00 / $650,000

STATEMENT OF WORK

Table of Contents

PART 1 – GENERAL INFORMATION

PART 2 - GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

PART 3 - CONTRACTOR FURNISHED ITEMS AND SERVICES

PART 4 - DEFINITIONS & ACRONYMS

STERILE COMPOUNDING PHARMACEUTICAL OUTSOURCING

PART 1 – GENERAL INFORMATION

This Statement of Work (SOW) issued by National Institute of Health, Clinical Center describes the goals expected to be achieved with regard to inspection, compounding, and delivery.

1.1 Introduction

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 institute and centers, the NIH provides leadership and financial support to researches in all fifty states and throughout the world.

The Clinical Center at the NIH in Bethesda, Maryland, is the nation’s largest hospital devoted to clinical research. It is a national resource that makes it possible to rapidly translate scientific observations and laboratory discoveries into new approaches for diagnosing, treating, and preventing disease. Approximately 1,500 studies are in progress at the NIH Clinical Center. About half the studies are the first tests of new medications or medical treatments in patients

1.2 Current Environment:

The Department of Pharmacy’s primary operating objective is to support and conduct research by providing safe, high quality care – one patient – one medication at a time. The secondary operating objective is standardize, improve effectiveness (service, outcomes), and reduce waste.

1.3 Objective:

To contract with a source for select patient-specific sterile compounded products including specific parenteral nutrition and renal replacement therapy that meets the quality expectations to provide to National Institutes of

Health Clinical Center (NIH CC) patients on an ongoing basis.

1.4 Scope of Work – 503A

The Contractor shall provide patient-specific sterile compounded pharmaceutical products for patients in the NIH CC (see Exhibit A) on an as needed basis. The preparation of all sterile products shall be in compliance with all United States Pharmacopeia (USP) Chapter <797>, USP Chapter <800>, FDA 503a regulations, and all relevant FDA Guidance. The Contractor shall

1.4.1 Maintain an active license by the appropriate state board of pharmacy in which the pharmacy is geographically located.

1.4.2 Legally authorized to ship prescriptions into the state of Maryland.

1.4.3 Provide all inspection reports and responses as requested.

1.4.4 Provide immediate disclosure of any disciplinary or punitive action by any regulatory agency (e.g., FDA warning letter, state board of pharmacy).

1.4.5 Provide proof of performing comprehensive investigations of out-of-limit findings, as recommended by USP chapter <797>, to determine root cause, followed by corrective and preventative actions. The outsourcer shall provide documented processes and procedures (including shipping validation studies) to ensure that preparations leaving the site retain their integrity and stability through the shipping cycle.

1.4.6 Accommodate an onsite audit arranged for and paid by the NIH.

1.4.7 Maintain registration with the Drug Enforcement Administration (DEA) as required and appropriate.

1.4.8 Provide proof of performing all tests necessary for the release of products and provide the names of their qualified vendors for these tests.

1.4.9 Provide all batch records as requested by the government.

1.4.10 Provide the following information upon request:

1.4.10.1 A brief history of the company including mission statement and a list of leadership positions and qualification

1.4.10.2 An organization chart

1.4.10.3 Description of facilities

1.4.10.4 Discussion of services available

1.4.10.5 Catalog of products available

1.4.10.6 Ability to handle hazardous, potent, or controlled drugs

1.4.10.7 Custom requests as required.

1.4.10.8 List of qualified vendors for testing (e.g. potency, dissolution, microbial assessments)

1.4.10.9 List of SOPs

1.4.10.10 Standard quality agreement template

1.4.10.11 Proof that all pharmacists working for the outsourcer shall be licensed in the state where they are practicing.

1.4.10.12 If required in the state where the compounding center resides, proof that all pharmacy technicians shall be licensed or registered in the state where they are practicing.

1.4.10.13 A certificate of analysis and potency testing of all bulk ingredients used.

1.4.10.14 Proof of compliance with all rules and regulations inherent in the Drug Supply Chain

Security Act (DSCSA).

1.4.10.15 Quality control history and quality assurance trend reports.

1.4.10.16 Documentation confirming staff competency (i.e., observation documentation on garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to and on an ongoing basis on the compounding of actual drug preparations.

1.4.10.17 Documentation confirming that the outsourcer tests aseptic techniques by preparing media fill tests.

1.4.10.18 Documentation that confirms that pharmacists and pharmacy technicians are qualified according to USP <797> requirements BEFORE the compounding of actual drug preparations.

1.4.10.19 Evidence that supports the Beyond Use Date assigned to each product.

1.4.10.20 Evidence of performing routine surface microbiological and fungal environmental monitoring to minimize contamination on a minimum of a weekly basis.

1.4.11 Provide quality packaging and labeling in accordance with NIH CC requirements. (e.g. drug name differentiation in the form of TALLMAN lettering, visual cues to differentiate drug names and concentrations, auxiliary labeling to indicate contraindicated routes of administration).

1.4.11.1 Tamper-evident options which may include overwrap, shrink wrap, tamper-evident foil, and/or tamper-evident caps.

1.4.11.2 A variety of container types for the compound products (e.g., syringes, minibags, pump-specific cassettes) to meet the specific needs of the NIH CC based on Contractor catalog.

1.4.11.3 Next day delivery, trackable by signature-receipt upon request.

1.4.12 Maintain Contingency Plans. Business continuity plans shall be in place in the event of a natural or man-made disaster or public health emergency.

1.4.13 Have the ability to compound controlled substances.

1.4.14 Guarantee timeframes for compounded sterile preparations.

1.4.15 Provide evidence that current production capacity is able to meet the requirements of NIH CC.

1.4.16 Provide a mechanism to immediately respond to customer service issues or questions 24 hours a day, 7 days a week.

1.4.17 Maintain a written Disaster Emergency plan for the provision of services in the event of loss of utilities.

1.4.18 Meet all requirements of and be in full compliance with the Drug Supply Chain Security Act (DSCSA).

The outsourcer shall comply with the provisions of the DSCSA for the tracing of products through the pharmaceutical distribution supply chain and all documentation requirements therein.

1.4.19 Provide Total Parenteral Nutrition (TPN) compounded and delivered within four (4) hours of request.

1.4.20 Provide custom Continuous Renal Replacement Therapy (CRRT) and delivered within four (4) hours of request. Up to twice a day delivery may be needed for the custom CRRT.

1.4.21 Deliver all completed compounding other than TPN and CRRT within 24 hours of request.

1.5 Scope of Work – 503B

The Contractor shall provide non patient-specific sterile compounded pharmaceutical products for patients in the NIH CC (see Exhibit A) on an as needed basis. The preparation of all sterile products shall be in compliance with all United States Pharmacopeia (USP) Chapter <797>, USP Chapter <800>, FDA 503b regulations, and all relevant FDA Guidance. The Contractor shall use the appropriate USP grade bulk ingredients and obtained from a current Good Manufacturing Practice (cGMP) compliant supplier. The Contractor shall

1.5.1 Be registered with the FDA as a 503B outsourcing facility.

1.5.2 Provide all inspection reports and responses as requested.

1.5.3 Provide immediate disclosure of any disciplinary or punitive action by any regulatory agency (e.g., FDA warning letter, state board of pharmacy).

1.5.4 Provide proof of performing comprehensive investigations of out-of-limit findings, as recommended by USP chapter <797>, to determine root cause, followed by corrective and preventative actions. The outsourcer shall provide documented processes and procedures (including shipping validation studies) to ensure that preparations leaving the site retain their integrity and stability through the shipping cycle.

1.5.5 Accommodate an onsite audit arranged for and paid by the NIH.

1.5.6 Maintain a state pharmacy license where the compounding center resides.

1.5.7 Maintain registration with the Drug Enforcement Administration (DEA) as required and appropriate.

1.5.8 Provide proof of performing all tests necessary for the release of products and provide the names of their qualified vendors for these tests.

1.5.9 Provide all batch records as requested by the government.

1.5.10 Provide the following information upon request:

1.5.10.1 A brief history of the company including mission statement and a list of leadership positions and qualification

1.5.10.2 An organization chart

1.5.10.3 Description of facilities

1.5.10.4 Discussion of services available

1.5.10.5 Catalog of products available

1.5.10.6 Ability to handle hazardous, potent, or controlled drugs

1.5.10.7 Custom requests as required.

1.5.10.8 List of qualified vendors for testing (e.g. potency, dissolution, microbial assessments)

1.5.10.9 List of SOPs

1.5.10.10 Standard quality agreement template

1.5.10.11 Proof that all pharmacists working for the outsourcer shall be licensed in the state where they are practicing.

1.5.10.12 If required in the state where the compounding center resides, proof that all pharmacy technicians shall be licensed or registered in the state where they are practicing.

1.5.10.13 A certificate of analysis and potency testing of all bulk ingredients used.

1.5.10.14 Proof of compliance with all rules and regulations inherent in the Drug Supply Chain

Security Act (DSCSA).

1.5.10.15 Quality control history and quality assurance trend reports.

1.5.10.16 Documentation confirming staff competency (i.e., observation documentation on garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures) is evaluated prior to and on an ongoing basis on the compounding of actual drug preparations.

1.5.10.17 Documentation confirming that the outsourcer tests aseptic techniques by preparing media fill tests.

1.5.10.18 Documentation that confirms that pharmacists and pharmacy technicians are qualified according to USP <797> requirements BEFORE the compounding of actual drug preparations.

1.5.10.19 Evidence that supports the Beyond Use Date assigned to each product.

1.5.10.20 Evidence of performing routine surface microbiological and fungal environmental monitoring to minimize contamination on a minimum of a weekly basis.

1.5.11 Provide quality packaging and labeling in accordance with NIH CC requirements and cGMP. (e.g. drug name differentiation in the form of TALLMAN lettering, visual cues to differentiate drug names and concentrations, auxiliary labeling to indicate contraindicated routes of administration).

1.5.11.1 Tamper-evident options which may include overwrap, shrink wrap, tamper-evident foil, and/or tamper-evident caps.

1.5.11.2 A variety of container types for the compound products (e.g., syringes, minibags, pump-specific cassettes) to meet the specific needs of the NIH CC based on Contractor catalog.

1.5.11.3 Next day delivery, trackable by signature-receipt upon request.

1.5.12 Maintain Contingency Plans. Business continuity plans shall be in place in the event of a natural or man-made disaster or public health emergency.

1.5.13 Have the ability to compound controlled substances.

1.5.14 Guarantee timeframes for compounded sterile preparations.

1.5.15 Provide evidence that current production capacity is able to meet the requirements of NIH CC.

1.5.16 Provide a mechanism to immediately respond to customer service issues or questions 24 hours a day, 7 days a week.

1.5.17 Maintain a written Disaster Emergency plan for the provision of services in the event of loss of utilities.

1.5.18 Meet all requirements of and be in full compliance with the Drug Supply Chain Security Act (DSCSA).

The outsourcer shall comply with the provisions of the DSCSA for the tracing of products through the pharmaceutical distribution supply chain and all documentation requirements therein.

1.6 Delivery Schedule

TPN/CRRT

1.4.19

Contractor must deliver compounded TPN daily ARO by 6 p.m. ET. Government will enter order by 2:00 p.m. ET.

CRRT

1.4.20

Contractor must deliver compounded custom CRRT up to twice daily ARO by 12 p.m. and 6 p.m. ET. Government will enter order by 8 a.m. and/or by 2:00 p.m. ET.

All other medications 1.4.21

Delivery within 48 hours of receipt of order.

Emergency Orders 1.4.11.3

Next day delivery, trackable by signature-receipt.

1.7 Contract Type and Period of Performance

A Firm Fixed Price Indefinite Delivery/Indefinite Quantity Contract is contemplated for one 12-month base period and four (4) twelve month option periods to extend the ordering period of performance.

The Period of Performance is estimated to begin sometime in August 2019 and run through August 2024.

Estimated Periods of Performance is as follows.

Base Period: 8/15/2019 – 8/14/2020 Option Period One (1): 8/15/2020 - 8/14/2021 Option Period Two (2): 8/15/2021 - 8/14/2022 Option Period Three (3): 8/15/2022 - 8/14/2023 Option Period Four (4): 8/15/2023 - 8/14/2024

1.8 Recognized Holidays: Work may occur on Federal Holidays. Delivery of products may occur all hours and across all days.

The ten holidays observed by the Federal Government are as follows:

New Year’s Day Memorial Day Columbus Day Christmas Day

Martin Luther King

Day

Independence Day Veterans Day

President's Day Labor Day Thanksgiving Day

Also, any other day declared by the President of the United States to be a National or Federal holiday.

1.9 Hours of Operation: The NIH CC operates 365 days per year, 24 hours per day including all holidays.

Maintenance Support must be provided across all days and hours (365x24x7).

1.10 Delivery Acceptance Hours: Delivery of requested compounds shall be available twenty four hours per day, seven days per week. The NIH Clinical Center accepts deliveries 24/7. All deliveries after hours will be to the central unit dose pharmacy.

1.11 Delivery Acceptance Destination: The Compounded Sterile Products (CSP) must be delivered to:

National Institutes of Health

Department of Pharmacy

9000 Rockville Pike

ATTN: Pharmacy Procurement

Bethesda, MD 20892

After normal business hours Delivery Acceptance Destination:

Department of Pharmacy

9000 Rockville Pike

ATTN: Pharmacist on Duty

A CSP shall not be considered delivered unless: (1) it is delivered in a proper dose administration and shipping system; (2) the medication arrives at the specified point of destination; (3) The CSP is delivered on time.

1.12 Special Qualifications: The contractor shall perform the required work in accordance with all applicable USP <797>, USP <800>, National Institute of Occupational Safety and Health (NIHOSH), and The Joint Commission Standards.

1.13 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The NIH CC Contracting Officer, NIH CC Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the NIH CC Contracting Officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.14 NIH CC Contracting Officer's Representative: The NIH CC COR is a specialist from the NIH CC Pharmacy Department whose role is to define, plan, track and manage the project.

The following individual is designated as the NIH CC COR: To Be Determined After Award

1.15 Executive Management Oversight: Executive Management oversight for this project is provided by the NIH CC Chief Pharmacy and the NIH CC Operations Chief.

PART 2 - GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

1. GOVERNMENT FURNISHED ITEMS AND SERVICES:

The Government does not plan to furnish equipment or services for this contract.

PART 3 - CONTRACTOR FURNISHED ITEMS AND SERVICES

1. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

The Contractor shall provide:

A. The following products in approximate monthly quantities. Fulfillment only as formally ordered by website request. Additional products may be requested from Contractor Catalog.

Line Item

Description Unit of Issue

Unit Price Average (not minimum) Qty

Total $

0001 Morphine 1mg/mL – 50mL in 0.9% NaCl in Bag

20/Week

0002 Morphine 1mg/mL – 100mL in 0.9% NaCl in Bag

20/Week

0003 Hydromorphone 1mg/ml

– 50mL in 0.9%1/ NaCl in Bag

60/Week

0004 Fentanyl 1,250 mcg in a total volume of Bupivacaine 0.125% 250mL

35/Week

0005 Phenylephrine HCl (USP) (40 mg/ml) 0.9% Sodium Chloride (USP) 250-mL (bag)

50/Week

0006 Ephedrine Sulfate (USP) (5 mg/mL) 10mL (BD Syringe)

50/Week

0007 Fentanyl Inj 500 mcg in a total volume of 0.9% Sodium Chloride Inj 50 mL, Concentration: 10 mcg/mL

10/Week

0008 Total Parenteral Nutrition (TPN)

8 bags/day

0009 Continual Renal Replacement Therapy

(CRRT)

orders/Month

PART 4 - DEFINITIONS & ACRONYMS

4.1 DEFINITIONS:

4.1.1 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

4.1.2 CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

4.1.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the NIH CC Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

4.1.4 DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

4.2 ACRONYMS:

4.2.1 ACRF. The Ambulatory Care Research Facility (ACRF).

4.2.2 CRC. The Mark O. Hatfield Clinical Research Center (CRC).

4.2.3 CSP. Compounded Sterile Products (CSP)

(End Performance Work Statement)

PROVISIONS AND CLAUSES

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items Oct 2018

CLAUSES INCORPORATED BY FULL TEXT

ADDENDUM TO 52.212-4

(v) The non-FAR Part 12 discretionary FAR, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found.

CLAUSES AND PROVISIONS INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 Covenant Against Contingent Fees MAY 2014

52.203-7 Anti-Kickback Procedures MAY 2014

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights And Requirement To

Inform Employees Of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content

Paper

MAY 2011

52.204-7 System for Award Management OCT 2018

52.204-16 Commercial and Government Entity Code Reporting JUL 2016

52.204-18 Commercial And Government Entity Code Maintenance JUL 2015

52.209-7 Information Regarding Responsibility Matters OCT 2018

52.209-11 Representation by Corporations Regarding Delinquent Tax

Liability or a Felony Conviction under any Federal Law

FEB 2016

52.217-5 Evaluation of Options JUL 1990

52.229-3 Federal State and Local Taxes FEB 2013

52.232-1 Payments APR 1984

52.232-17 Interest MAY 2014

52.232-23 Assignment of Claims MAY 2014

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984

52.237-3 Continuity of Services JAN 1991

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.245-1 Government Property AUG 2010

52.245-9 Use And Charges AUG 2010

52.253-1 Computer Generated Forms JAN 1991

352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

DEC 2015

352.223-70 Safety and Health DEC 2015

352.227-70 Publications and Publicity DEC 2015

352.237-74 Non-Discrimination in Service Delivery DEC 2015

CLAUSES AND PROVISIONS INCORPORATED BY FULL TEXT

52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates award of a Firm Fixed Priced Indefinite Delivery Indefinite Quantity with economic price adjustment contract resulting from this solicitation.

(End of Provision)

52.216-2 -- Economic Price Adjustment -- Standard Supplies.

As prescribed in 16.203-4(a), insert the following clause. The clause may be modified by increasing the 10 percent limit on aggregate increases specified in subparagraph (c)(1), upon approval by the chief of the contracting office.

Economic Price Adjustment -- Standard Supplies (Jan 1997) http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/16.htm#P93_16805

(a) The Contractor warrants that the unit price stated in the Schedule for _________ [offeror insert Schedule line item number] is not in excess of the Contractor’s applicable established price in effect on the contract date for like quantities of the same item. The term “unit price” excludes any part of the price directly resulting from requirements for preservation, packaging, or packing beyond standard commercial practice. The term “established price” means a price that --

(1) Is an established catalog or market price for a commercial item sold in substantial quantities to the general public; and

(2) Is the net price after applying any standard trade discounts offered by the Contractor.

(b) The Contractor shall promptly notify the Contracting Officer of the amount and effective date of each decrease in any applicable established price. Each corresponding contract unit price shall be decreased by the same percentage that the established price is decreased. The decrease shall apply to those items delivered on and after the effective date of the decrease in the Contractor’s established price, and this contract shall be modified accordingly.

(c) If the Contractor’s applicable established price is increased after the contract date, the corresponding contract unit price shall be increased, upon the Contractor’s written request to the

Contracting Officer, by the same percentage that the established price is increased, and the contract shall be modified accordingly, subject to the following limitations:

(1) The aggregate of the increases in any contract unit price under this clause shall not exceed 10 percent of the original contract unit price.

(2) The increased contract unit price shall be effective --

(i) On the effective date of the increase in the applicable established price if the

Contracting Officer receives the Contractor’s written request within 10 days thereafter; or

(ii) If the written request is received later, on the date the Contracting Officer receives the request.

(3) The increased contract unit price shall not apply to quantities scheduled under the contract for delivery before the effective date of the increased contract unit price, unless failure to deliver before that date results from causes beyond the control and without the fault or negligence of the Contractor, within the meaning of the Default clause.

(4) No modification increasing a contract unit price shall be executed under this paragraph (c) until the Contracting Officer verifies the increase in the applicable established price.

(5) Within 30 days after receipt of the Contractor’s written request, the Contracting

Officer may cancel, without liability to either party, any undelivered portion of the contract items affected by the requested increase.

(d) During the time allowed for the cancellation provided for in subparagraph (c)(5) of this clause, and thereafter if there is no cancellation, the Contractor shall continue deliveries according to the contract delivery schedule, and the Government shall pay for such deliveries at the contract unit price, increased to the extent provided by paragraph (c) of this clause.

(End of Clause)

52.216-18 – Ordering (Oct 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from date of award through expiration date of the contract.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

52.216-19 -- ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $90.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $650,000;

(2) Any order for a combination of items in excess of $650,000; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the

Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph

(b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within Two (2) days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

52.216-22 -- Indefinite Quantity (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the

Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period;

provided, that the Contractor shall not be required to make any deliveries under this contract after August 14, 2025.

(End of Clause)

52.216-27 -- Single or Multiple Awards (Oct 1995)

The Government may elect to award a single delivery order contract or task order contract or to award multiple delivery order contracts or task order contracts for the same or similar supplies or services to two or more sources under this solicitation.

(End of Provision)

52.217-5 -- Evaluation of Options (Jul 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

52.217-6 -- Option for Increased Quantity (Mar 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within [insert in the clause the period of time in which the Contracting Officer has to exercise the option]. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause)

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 [insert in the clause the period of time in which the Contracting Officer has to exercise the option]. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

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 any time prior to the expiration of the contract; 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 66 months.

52.219-28 -- Post-Award Small Business Program Re-representation (Jul 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code

_____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

(a) During the term of this contract, the Contractor shall post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR

471.2(d) and (f).

(1) Physical posting of the employee notice shall be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the

National Labor Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor shall also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in (b)(3) of this section, must read, ``Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers.''

(b) This required employee notice, printed by the Department of Labor, may be--

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202)

693-0123, or from any field office of the Office of Labor-Management Standards or Office of Federal

Contract Compliance Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart

A, 29 CFR Part 471.

(d) The Contractor shall comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the

Contractor may be suspended or debarred in accordance with 29 CFR 471.14 and subpart 9.4. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 471, which implements Executive

Order 13496 or as otherwise provided by law.

(f) Subcontracts. (1) The Contractor shall include the substance of this clause, including this paragraph

(f), in every subcontract that exceeds $10,000 and will be performed wholly or partially in the United

States, unless exempted by the rules, regulations, or orders of the Secretary of Labor issued pursuant to section 3 of Executive Order 13496 of January 30, 2009, so that such provisions will be binding upon each subcontractor.

(2) The Contractor shall not procure supplies or services in a way designed to avoid the applicability of

Executive Order 13496 or this clause.

(3) The Contractor shall take such action with respect to any such subcontract as may be directed by the

Secretary of Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance.

(4) However, if the Contractor becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the

Secretary of Labor, to enter into such litigation to protect the interests of the United States.

(End of clause)

52.232-19 -- AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

Funds are not presently available for performance under this contract beyond September 30, 2019. The

Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond September 30, 2019, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting

Officer.

52.233-2 -- SERVICE OF PROTEST (SEP 2006)

(a) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office

(GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from:

Susan Nsangou, Chief Contracting Officer

NIH Clinical Center Office of Purchasing and Contracts

6707 Democracy Blvd Suite 106

(b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO.

52.237-1 -- Site Visit (Apr 1984)

Offerors or quoters are urged and expected to inspect the site where services are to be performed and to satisfy themselves regarding all general and local conditions that may affect the cost of contract performance, to the extent that the information is reasonably obtainable. In no event shall failure to inspect the site constitute grounds for a claim after contract award.

52.237-2 -- Protection of Government Buildings, Equipment, and Vegetation (Apr 1984)

The Contractor shall use reasonable care to avoid damaging existing buildings, equipment, and vegetation on the Government installation. If the Contractor’s failure to use reasonable care causes damage to any of this property, the Contractor shall replace or repair the damage at no expense to the Government as the

Contracting Officer directs. If the Contractor fails or refuses to make such repair or replacement, the

Contractor shall be liable for the cost, which may be deducted from the contract price.

(End of Clause)

52.246-2 -- Inspection of Supplies -- Fixed-Price.

As prescribed in 46.302, insert the following clause:

Inspection of Supplies -- Fixed-Price (Aug. 1996)

(a) Definition. “Supplies,” as used in this clause, includes but is not limited to raw materials, components, intermediate assemblies, end products, and lots of supplies.

(b) The Contractor shall provide and maintain an inspection system acceptable to the

Government covering supplies under this contract and shall tender to the Government for acceptance only supplies that have been inspected in accordance with the inspection system and have been found by the Contractor to be in conformity with contract requirements. As part of the http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/46.htm#P110_15832 system, the Contractor shall prepare records evidencing all inspections made under the system and the outcome. These records shall be kept complete and made available to the Government during contract performance and for as long afterwards as the contract requires. The Government may perform reviews and evaluations as reasonably necessary to ascertain compliance with this paragraph. These reviews and evaluations shall be conducted in a manner that will not unduly delay the contract work. The right of review, whether exercised or not, does not relieve the

Contractor of the obligations under the contract.

(c) The Government has the right to inspect and test all supplies called for by the contract, to the extent practicable, at all places and times, including the period of manufacture, and in any event before acceptance. The Government shall perform inspections and tests in a manner that will not unduly delay the work. The Government assumes no contractual obligation to perform any inspection and test for the benefit of the Contractor unless specifically set forth elsewhere in this contract.

(d) If the Government performs inspection or test 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. Except as otherwise provided in the contract, the Government shall bear the expense of Government inspections or tests made at other than the Contractor’s or subcontractor’s premises; provided, that in case of rejection, the Government shall not be liable for any reduction in the value of inspection or test samples.

(e)

(1) When supplies are not ready at the time specified by the Contractor for inspection or test, the Contracting Officer may charge to the Contractor the additional cost of inspection or test.

(2) The Contracting Officer may also charge the Contractor for any additional cost of inspection or test when prior rejection makes reinspection or retest necessary.

(f) The Government has the right either to reject or to require correction of nonconforming supplies. Supplies are nonconforming when they are defective in material or workmanship or are otherwise not in conformity with contract requirements. The Government may reject nonconforming supplies with or without disposition instructions.

(g) The Contractor shall remove supplies rejected or required to be corrected. However, the

Contracting Officer may require or permit correction in place, promptly after notice, by and at the expense of the Contractor. The Contractor shall not tender for acceptance corrected or rejected supplies without disclosing the former rejection or requirement for correction, and, when required, shall disclose the corrective action taken.

(h) If the Contractor fails to promptly remove, replace, or correct rejected supplies that are required to be removed or to be replaced or corrected, the Government may either

(1) by contract or otherwise, remove, replace, or correct the supplies and charge the cost to the Contractor or

(2) terminate the contract for default.

Unless the Contractor corrects or replaces the supplies within the delivery schedule, the Contracting Officer may require their delivery and make an equitable price reduction. Failure to agree to a price reduction shall be a dispute.

(i)

(1) If this contract provides for the performance of Government quality assurance at source, and if requested by the Government, the Contractor shall furnish advance notification of the time --

(i) When Contractor inspection or tests will be performed in accordance with the terms and conditions of the contract; and

(ii) When the supplies will be ready for Government inspection.

(2) The Government’s request shall specify the period and method of the advance notification and the Government representative to whom it shall be furnished. Requests shall not require more than 2 workdays of advance notification if the Government representative is in residence in the Contractor’s plant, nor more than 7 workdays in other instances.

(j) The Government shall accept or reject supplies as promptly as practicable after delivery, unless otherwise provided in the contract. Government failure to inspect and accept or reject the supplies shall not relieve the Contractor from responsibility, nor impose liability on the

Government, for nonconforming supplies.

(k) Inspections and tests by the Government do not relieve the Contractor of responsibility for defects or other failures to meet contract requirements discovered before acceptance. Acceptance shall be conclusive, except for latent defects, fraud, gross mistakes amounting to fraud, or as otherwise provided in the contract.

(l) If acceptance is not conclusive for any of the reasons in paragraph (k) hereof, the

Government, in addition to any other rights and remedies provided by law, or under other provisions of this contract, shall have the right to require the Contractor

(1) at no increase in contract price, to correct or replace the defective or nonconforming supplies at the original point of delivery or at the Contractor’s plant at the Contracting

Officer’s election, and in accordance with a reasonable delivery schedule as may be agreed upon between the Contractor and the Contracting Officer; provided, that the

Contracting Officer may require a reduction in contract price if the Contractor fails to meet such delivery schedule, or

(2) within a reasonable time after receipt by the Contractor of notice of defects or nonconformance, to repay such portion of the contract as is equitable under the circumstances if the Contracting Officer elects not to require correction or replacement.

When supplies are returned to the Contractor, the Contractor shall bear the transportation cost from the original point of delivery to the Contractor’s plant and return to the original point when that point is not the Contractor’s plant. If the Contractor fails to perform or act as required in (1) or (2) above and does not cure such failure within a period of 10 days (or such longer period as the Contracting Officer may authorize in writing) after receipt of notice from the Contracting Officer specifying such failure, the Government shall have the right by contract or otherwise to replace or correct such supplies and charge to the Contractor the cost occasioned the Government thereby.

(End of Clause)

52.246-15 -- Certificate of Conformance.

As prescribed in 46.315, insert the following clause in solicitations and contracts for supplies or services when the conditions in 46.504 apply:

Certificate of Conformance (Apr 1984)

(a) When authorized in writing by the cognizant Contract Administration Office (CAO), the

Contractor shall ship with a Certificate of Conformance any supplies for which the contract would otherwise require inspection at source. In no case shall the Government’s right to inspect supplies under the inspection provisions of this contract be prejudiced.