Combined_Syn-Sol_Liquid_Handling_System__QUOTES_DUE_August_06 _2015.pdf

NIH-CC-15-011971

NATIONAL INSTITUTES OF HEALTH, CLINICAL CENTER,

Pharmacokinetics Research Lab, Pharmacy Department

Liquid Handling system for Solid-Phase Extraction (SPE) and Solid Liquid

Extraction (SLE) Sample Processing

Combined Synopsis/Solicitation

Office of Purchasing and Contracts

July 27, 2015

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) 2005-83, effective July 2, 2015.

Combined Synopsis/Solicitation NIH-CC-15-011971

Liquid Handling system for Solid-Phase Extraction (SPE) and Solid Liquid Extraction

(SLE) Sample Processing

This combined synopsis/solicitation is set aside for Small Business only. Only Small Businesses under the associated the associated North American Industrial Classification System (NAICS) code are invited to submit quotes. The associated NAICS code for this procurement is 334616 with a small business size standard of 500 employees.

The National Institutes of Health, Office of Purchasing and Contracts, is seeking a vendor to provide a Liquid

Handling System for use in developing rugged, robust, and reliable solid-phase extraction (SPE) and solid-liquid extraction (SLE) methods in both 96-well plate format as well as 1-ml, 3-ml, or 6-ml cartridge format. The extraction methods will be subsequently utilized to extract and process human biological samples from ongoing clinical research studies being conducted in collaboration with NIAID, NIDDK, NCI, and NICHD. See Liquid

Handling System Statement of Work attached herein.

All Contractors operating as small businesses are encouraged to provide a quotation/offer for Brand Name or

Equal equipment listed in the tables below.

Line

Item Description Qty U/I U/P Total ($)

0001 Extrahera Liquid Handling System 1 EA $_______ $_______

0002 Configuration Kit 96 1 EA $_______ $_______

0003 Vacuum Pump ME1C,100-230 VAC, 50-60 hz 1 EA $_______ $_______

0004 Configuration Kit 24 Positions 1 EA $_______ $_______

0005 Column Rack 96 x 1ml (tabless) 1 EA $_______ $_______

0006 Column Rack 24 x 1ml 1 EA $_______ $_______

0007 Column Rack 24 x 3ml 1 EA $_______ $_______

0008 Column Rack 24 x 6ml (tabless) 1 EA $_______ $_______

0009 Sample Rack 16 x 100 mm 24 positions 1 EA $_______ $_______

0010 Collection Rack 12 x 75 mm, 24 Positions 1 EA $_______ $_______

0011 1000 ul Clear Pipet Tips (960/box) 2 BOX $_______ $_______

0012 Sample Collections Plates, 2 ml (50/pk) 1 PACKAGE $_______ $_______

First Year Maintenance Package for Liquid

Handling system, 110 volt

1 EA $_______ $_______

0014 SPE Dry 96 Sample Concentrator System 1 EA $_______ $_______

TOTAL Total excluding Options $_______

Option 1: Extended Maintenance Package (12 months)

1 EA $_______ $_______

Option 2: Extended Maintenance Package (12 months)

1 EA $_______ $_______

Option 3: Extended Maintenance Package (12 months)

1 EA $_______ $_______

Option 4: Extended Maintenance Package (12 months)

1 EA $_______ $_______

TOTAL Total including all Options $_______

STATEMENT OF WORK

Background

The Clinical Pharmacokinetics Research Lab (CPRL) participates and collaborates in the design and analysis of clinical studies with various NIH institutes. The CPRL develops and validates bioanalytical assays for the testing of human samples and determination of drug levels for subsequent pharmacokinetic analysis.

The Liquid Handling System will be used to develop rugged, robust, and reliable solid-phase extraction (SPE) and solid-liquid extraction (SLE) methods in both 96-well plate format as well as 1-ml, 3-ml, or 6-ml cartridge format.

The extraction methods will be subsequently utilized to extract and process human biological samples from ongoing clinical research studies being conducted in collaboration with NIAID, NIDDK, NCI, and NICHD.

Scope of Work

The CPRL needs a Liquid Handling System that has the following:

Instrument shall be capable of processing samples using 96-well plates, as well as 1-ml, 3-ml, and 6-ml

SPE and SLE cartridges.

Instrument shall have a positive pressure manifold integrated into the dispensing bulkhead.

Liquid Handling system shall have the following pipetting specifications:

Up to 1000 µL in one aliquot

At 50 µL: ±2.0% accuracy and 1.0% CV*

At 100 µL: ±2.0% accuracy and 1.0% CV*

At 500 µL: ±1.5% accuracy and 1.0% CV*

At 1000 µL: ±1.0% accuracy and 1.0% CV*

Instrument shall have five auto-dispensing solvent lines for efficient and flexible solid-phase extraction method development.

Instrument should have five auto-dispensing solvent lines for efficient and flexible solid-phase extraction method development.

System must have vacuum assisted waste lines to ensure sample waste path does not backup during sample processing.

Extrahera Liquid Handling system must be fully compatible with existing legacy RapidTrace solid-phase extraction (SPE) modules for seamless SPE method transfer using 1-ml SPE cartridges.

Customer training on Biotage Extrahera Liquid Handling systems must be available and shall cover general maintenance of instrument as well as sample extraction methods setup.

Sample extraction method development and training for care of instrument should be included to minimize disrepair of instrument due to extraction method design errors and inadequate maintenance.

Solid-phase extraction (SPE) and solid-liquid extraction (SLE) consumables should be provided during method design training and testing of instrument.

Service and Maintenance Requirements:

One preventive maintenance (PM) service must be included as part of the plan, and the PM should include replacement of all parts and testing of instrument as indicated by the Caliper Life Sciences service preventive maintenance protocol.

Instrument must come with a 1-year service plan, and repair must be completed using only original quality parts which should be covered under service plan.

Repair and/or preventive maintenance (PM) must be completed within 72 hours of initial service call.

Service engineers must have complete systems-certified training on the Liquid Handling System.

Parts must be available for next day delivery in case initial service call misdiagnoses instrument problem, and subsequently, repair must be completed the following day.

Customer technical support and application support on the Liquid Handling instrument must be available during normal business hours via phone.

Software applications specialists must be available during business hours via phone.

Period of Performance of Warranty:

Estimated Base Period: 08/20/2015 – 08/19/2016

Est. Option Period 1: 08/20/2016 – 08/19/2017

Est. Option Period 2: 08/20/2017 – 08/19/2018

Est. Option Period 3: 08/20/2018 – 08/19/2019

Est. Option Period 4: 08/20/2019 – 08/19/2020

Delivery of Equipment shall be within 30 days of Order

Destination:

National Institutes of Health, Clinical Center

Pharmacy Department

10 Center Drive

Bethesda, MD 20892

(End of Statement of Work)

PROVISIONS AND CLAUSES

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items May 2015

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 INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 Covenant Against Contingent Fees MAY 2014

52.203-6 Restrictions On Subcontractor Sales To The Government (Sep 2006)

Alternate 1

SEP 2006

52.203-7 Anti-Kickback Procedures MAY 2014

52.203-8 Cancellation, Rescission, And Recovery Of Funds For Illegal Or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity 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

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards JUL 2013

52.204-18 Commercial And Government Entity Code Maintenance JUL 2015

52.209-6 Protecting the Government's Interest When Subcontracting With

Contractors Debarred, Suspended, or Proposed for Debarment

AUG 2013

52.219-6 Notice of Total Small Business Set Aside NOV 2011

52.222-55 Minimum Wages Under Executive Order 13658 DEC 2014

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011

52.223-6 Drug Free Workplace MAY 2001

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 APR 2012

52.245-9 Use And Charges APR 2012

52.253-1 Computer Generated Forms JAN 1991

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations JAN 2010

352.223-70 Safety and Health JAN 2006

352.227-70 Publications and Publicity JAN 2006

352.231-71 Pricing Of Adjustments JAN 2001

352.242-73 Withholding of Contract Payments JAN 2006 352.270-7 Accessibility of Meetings, Conferences and Seminars to Persons with

Disabilities

JAN 2010

52.211-6 -- Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

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

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the

Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the

Contractor within the term of the Contract.

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 60 months.

(End of Clause)

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 re-representation and submit it to the contracting office, along with the contract number and the date on which the re-representation 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)

52.232-25 -- Prompt Payment (Jul 2013)

(a) Invoice payments—

(5) Computing penalty amount. The Government will compute the interest penalty in accordance with the

Office of Management and Budget prompt payment regulations at 5 CFR part 1315.

(i) For the sole purpose of computing an interest penalty that might be due the Contractor, Government acceptance is deemed to occur constructively on the 15th day (unless otherwise specified in this contract) after the Contractor delivers the supplies or performs the services in accordance with the terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor compliance with a contract provision. If actual acceptance occurs within the constructive acceptance period, the Government will base the determination of an interest penalty on the actual date of acceptance. The constructive acceptance requirement does not, however, compel Government officials to accept supplies or services, perform contract administration functions, or make payment prior to fulfilling their responsibilities.

52.252-2 -- Clauses Incorporated By Reference (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference

(hyperlink).

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR FAR Supplement (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

INVOICE REQUIREMENTS

1) One invoice per delivered period (itemized)

2) Purchase Order number

3) Contractor DUNS number

4) Delivery Dates

5) Work performed

6) Total for entire invoice

A. The contractor shall submit the original and a copy of the invoices concurrently as follows:

a. An original mailed to the following designated payment office:

National Institutes of Health

Office of Financial Management

Commercial Accounts, Room 4B-432

2115 East Jefferson Street MSC 8500

Bethesda, Maryland 20892-8500

b. One copy e-mailed to the Contracting Officer’s Representative at:

National Institutes of Health

Department of Pharmacy

10 Center Dr, MSC 1196

Building 10, Room 1C166

Bethesda, Maryland 20892

Email: (To be announced at time of award)

(End of Addendum to 52.212-4)

PROVISIONS INCORPORATED BY REFERENCE

52.212-1 Instructions to Offerors--Commercial Items APR 2014

INSTRUCTIONS TO OFFERORS:

Addendum to FAR 52.212-1, Acceptance of Terms and Conditions

This is an Open-Market Combined Synopsis/Solicitation for equipment as defined herein. Offers will be reviewed exclusively based upon information submitted. If the information submitted does not address all the technical characteristics required in this combined solicitation-synopsis, the offer will be rejected. The Government intends to award a Fixed Price Contract as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL offers shall include a statement regarding the terms and conditions herein as follows:

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included

In the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s)

Please note that this procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits an offer based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Contract, not the terms and conditions of the offeror’s FSS or GWAC contract, and the statement required above shall be included in the offer.

(End of Addendum to FAR 52.212-1)

Addendum to FAR 52.212-1, Proposal Preparation Instructions

FAR 52.212-1 is hereby amended to reflect the changes shown below as to the specific paragraph revised.

Paragraph (b) Submission of Offers. The following amends this paragraph with respect to the information and documents required for submission in response to this solicitation.

(1) ELECTRONIC OFFERS. The offeror shall submit electronic offers in response to this solicitation unless otherwise specified herein. The offer must arrive by the time specified in the solicitation to the following email address: Lisa.Schaupp@nih.gov .

(2) PROCESS FOR AWARD. Award will be made to the Best Value Offeror consistent with the evaluation criteria discussed at FAR 52.212-2 and Addendum to FAR 52.212-2.

a) Selection of an offeror for contract award will be based on an evaluation of proposals against three factors.

The factors in order of importance are: technical, price, and past performance. Although technical factors are of paramount consideration in the award of the contract, both past performance and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

b) Offerors are advised that award will be made to that offeror whose proposal provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with mailto:Lisa.Schaupp@nih.gov obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become a significant determining factor for award of a contract as proposals become more equal based on the other factors. In any event the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered.

c) The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria provided in the solicitation.

(3) BASIS FOR AWARD. Award will be made to the offeror that proposes: a technical proposal conforming to the requirements of the solicitation; has an acceptable record of past performance; its price is determined to be fair and reasonable by the contracting officer; and the contracting officer determines the offeror is responsible in accordance with FAR Part 9. The Contracting Officer intends to award without discussions, but reserves the right to do so in his or her sole discretion.

(4) The Government may reject a proposal if it is found that any information that has a negative impact on the offeror's past performance record has been deleted, misrepresented, or withheld.

(5) Offers shall remain valid for a period of 90 days from the date offers are due.

(6) Quotation shall include Certifications and Representations, Technical, Past Performance, and Price as separate parts in the submission.

CERTIFICATIONS & REPRESENTATIONS:

Provide pricing for each Contract Line Item Numbers (CLINS).

52.212-3 - Offeror Representations and Certifications -- Commercial Items(MAR 2015)

Proof of Brand Name or Equal

QUOTATION COMPOSITION:

PART I: TECHNICAL

FACTOR 1: TECHNICAL CAPABILITY - The offeror shall provide sufficient information to demonstrate its understanding of the requirements, providing a concise, detailed, and thorough discussion of its technical capability to successfully provide the equipment and services as required in this solicitation.

The offeror shall submit with their proposal:

Proof that the Extrahera Lliquid Handling system or equal was manufactured, tested, and certified by

Biotage, LLC or equal, within the past 6 months.

Past Performance information on at leats two recent and relevant contracts.

One-year (12 month) warranty shall cover parts and service for the Extrahera Liquid Handling system including the management systems software.

Drawings and Specifications of the machine proposed if other than the brand name.

Submissions shall meet, at least, the criteria described in the Statement of Work above.

PART II: PAST PERFORMANCE.

Offerors shall submit past performance information on at least two (2) but not more than four (4) recent and relevant contracts (within the past three years from the date of the solicitation). If more than four contract references are submitted, only the first four will be evaluated. References may include performance on contracts for Federal, State and local Governments as well as private commercial firms of similar size and scope.

Section 1 – Contract Description Information:

Offeror’s CAGE Code and DUNS Number. Point of Contact (POC) (name, and current address, e-mail address, and telephone and fax numbers). Contracting activity/Administration and current address, Contracting Officer or

Technical Representative Name, e-mail address, telephone and fax numbers. Contract Number and, in the case of

Indefinite Delivery type contracts, GSA contracts, and Blanket Purchase Agreements, include Delivery Order

Numbers also; Awarded price; Final or projected final price; Original/Final delivery schedule, including dates of start and completion of delivery.

Section 2 – Performance (See FAR Provision 52.212-2 Addendum Government intends to evaluate.)

Offerors shall provide a specific narrative explanation of each contract listed in Section 1 above describing recency and relevancy of the requirements in this solicitation.

For any contracts that did not/do not meet original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The

Offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

PART III: PRICE.

Offerors shall provide pricing for all item/s specified on each Contract Line Item Number (CLIN) of the solicitation.

Para (g) Contract award. This paragraph is amended to state that the Government may conduct discussions prior to contract award.

Para (j) Data Universal Numbering System (DUNS)/CAGE Code. This paragraph is amended to state that the offeror shall obtain these Codes and include them in the proposal and confirm Registration in System for Award

Management and the Online Representations and Certifications, if you are a US firm. Award cannot and shall not be made to an offeror without these codes.

Para (m) Proposal Preparation Costs. This solicitation does not commit the Government to pay any costs incurred in the submission of an offer, in making any necessary studies for the preparation thereof, or for any visit(s) the

Contracting Officer may request for the purpose of clarification of the offer.

Para (n) The offeror is responsible for ensuring that its proposal is complete. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of any stated claims.

The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to perform the requirement. The offeror shall assume that the

Government has no prior knowledge of their experience and will base its evaluation solely on the information presented in the offeror's proposal.

Para (o) Protests received at a level higher than the contracting officer will be referred to the contracting officer.

Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for appeals or independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

Para (p) The non-FAR Part 12 discretionary FAR, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Addendum to FAR 52.212-1)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See Addendum to 52.212-2

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

ADDENDUM TO 52.212-2

Paragraph (a) is hereby supplemented with the following:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Award will be made using the best value source selection process.

Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate the proposal and award a contract without discussions.

In the evaluation of all Offerors’ proposals, appropriate consideration is given to three (3) evaluation factors:

Technical, Past Performance and Price are in descending order of importance. Technical is more important than past performance. Technical and Past Performance, when combined, are significantly more important than Price. The importance of price in the evaluation will increase with the degree of equality among quotations of the non-price factors.

To receive consideration for award, a rating of no less than “ACCEPTABLE” must be achieved for the technical capability evaluation factor. For Past Performance, the offeror must receive a rating of no less than

‘SATISFACTORY confidence’ to be considered for award. However, offerors which receive an unknown

(neutral) past performance rating will be considered for award.

EVALUATION FACTORS -- THE FOLLOWING FACTORS WILL BE EVALUATED:

PART I: TECHNICAL

Factor 1: Technical Capability reflects the Government’s confidence in the offeror’s ability, as demonstrated in its proposal, to perform the requirements as stated in this Solicitation.

Factor 2: The Offeror’s proposal will be evaluated for the degree to which it describes the automated vial filling system proposed as it represents required parameters in the Statement of Work. The Offeror’s documentation of a cGMP-compliant facility to support sterile testing, IQ/OQ documentation, FDA Form 483 within the past three years, FDA Establishment Inspection Report, Pre-Approval Facility Inspection, facility and product flow diagrams, and documentation of the proposed manufacturing facility’s current possession of and validity of a U.S. FDA facility registration will also be evaluated.

The following adjectival ratings will be used in evaluating each offeror’s technical proposal.

Color Rating Description

Blue Outstanding

Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

Purple Good

Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

Green Acceptable

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Yellow Marginal

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths. Risk of unsuccessful performance is high.

Red Unacceptable Proposal does not meet requirements and contains one or more deficiencies. Proposal is un-awardable.

PART II: PAST PERFORMANCE

The past performance evaluation results is an assessment of the offeror’s probability of meeting the minimum past performance solicitation requirements. This assessment is based on the offeror’s record of relevant and recent past performance information that pertain to the products and/or services outlined in the solicitation requirements.

Offerors are cautioned that in conducting present and past performance evaluations, the Government may use data provided in the offeror's proposal, any other source available to the Government and data obtained from other sources to include, but not limited, to data independently obtained from other Government and commercial sources.

After the Government has evaluated Offerors’ past performance for recency and relevancy, the Government will evaluate Quality of Performance (how well the contractor has performed on contracts).

The Government will assign an Unknown /Neutral rating, meaning the rating is treated neither favorably nor unfavorably, to Offerors with no recent/relevant past performance record or the offeror’s performance record is not available or the information is inadequate such that no meaningful confidence assessment rating can be reasonably assigned.

In this context:

“Offeror” refers to the proposed prime contractor and all proposed major subcontractors or team members. A major subcontractor or team member is defined as one who will be providing at least 25 percent of the contract effort. In either case, the contract or delivery order of the proposed prime contractor and proposed major subcontractors will be assessed individually and the results will then be assessed in their totality to derive the prime offeror’s past performance rating. The Government may consider the offeror’s past performance as an entire team including subcontractors, joint ventures and/or teaming partners, aggregately, rather than an individual contractor basis.

“Recency” - To be recent, the performance effort must have occurred within 3 years from the date of issuance of this solicitation.

“Relevancy” – Relevant performance includes products or services that are the same or similar in scope, magnitude and complexity to the effort described in the solicitation.

The following ratings shall be used in assessing an offeror’s Past Performance Relevancy

Rating Description

Very Relevant Present/past performance effort involved essentially the same scope and magnitude of effort and complexities this solicitation requires.

Relevant Present/past performance effort involved similar scope and magnitude of effort and complexities this solicitation requires.

Somewhat Relevant Present/past performance effort involved some of the scope and Magnitude of effort and complexities this solicitation requires.

Not Relevant

Present/past performance effort involved little or none of the scope and magnitude of effort and complexities this solicitation requires.

The following ratings shall be used for the Performance Confidence Assessment.

Performance Confidence

Assessments

Rating Description

Substantial Confidence Based on the offeror’s recent/relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.

Satisfactory Confidence Based on the offeror’s recent/relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort.

Limited Confidence Based on the offeror’s recent/relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.

No Confidence Based on the offeror’s recent/relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.

Unknown Confidence (Neutral) No recent/relevant performance record is available or the offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.

Note: In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305 (a)(2)(iv)). Therefore, the offeror shall be determined to have “unknown” past performance and their performance confidence assessment rating will be “unknown confidence (neutral).”

PART III: PRICE

Price will be evaluated separately from the technical and past performance factors and will be evaluated for fairness and reasonability in terms of the Government’s requirement.

(End of Addendum)

OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS

The offeror makes the following Representations and Certifications as part of its proposal (check/complete all appropriate boxes or blanks on the following pages).

(Name of Offeror)

(Signature of Authorized Individual) (Date)

(Typed Name of Authorized Individual)

Note: The penalty for making false statements in offers is prescribed in 18 U.S.C. 1001.

FAR Clause 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL

ITEMS (March 2015)

An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certifications electronically via the system for Award management (SAM) Website accessed through http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically, the offeror shall complete only paragraphs (c) through (p) of this provision.

(a) Definitions. As used in this provision--

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

http://www.acquisition.gov/

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395 (b), applies in accordance with the rules and definitions of 6 U.S.C.

(c).

Manufactured end product means any end product in product service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Substinence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan

Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the

Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

Sensitive technology--

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic

Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern--

(1) Means a small business concern--

(i) Not less than 51 percent of which is owned by one or more service--disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

Small business concern means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

Small disadvantaged business concern, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States;

and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

Veteran-owned small business concern means a small business concern--

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned business concern means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

Women-owned small business concern means a small business concern--

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

(b) (1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAM website.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website at http://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR

52.212-3, Offeror Representations and Certifications--Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except…