syn_sol.pdf

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH

THE FORMAT IN 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. THIS SOLICITATION IS BEING ISSUED

USING SIMPLIFIED ACQUISITION PROCEDURES UNDER THE AUTHORITY OF FAR SUBPART 13.5 TEST

PROGRAM FOR CERTAIN COMMERCIAL ITEMS.

This solicitation is a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular 2005-80 effective March 2, 2015.

The associated North American Industrial Classification System (NAICS) code for this procurement is 325414 with a small business size standard of 500 employees. This acquisition is 100% set-aside for small business. Simplified acquisition procedures will be utilized.

In accordance with the clause at 52.219-14 Limitation on Subcontracting, the small business prime Contractor must perform 50% of the labor with their personnel.

The National Institute of Standards and Technology (NIST)/Biomanufacturing Initiative includes development of a suite of fundamental measurement science, standards, and reference data to enable more accurate and confident characterization of key attributes of protein drugs. As part of that project, NIST has acquired a large quantity of IgG1k monoclonal antibody intended for development into a NIST Reference Material. This material will be released with physicochemical data as well as quantitative data traceable to fundamental units of measurement, and is expected to be utilized as a system suitability tool in the biopharmaceutical industry.

The Contractor shall thaw three (3) one liter containers (individually) of Bulk and dilute this material to 1/10 its original concentration to prepare “Reference Material”.

Each individual diluted Bulk must be aliquotted into 10,000 (±300) units of 800 µL each, for a total of 30,000 (±1000) units of 800 µL each.

OPTION LINE ITEM

Line items 0003 and 0004 are option line items. Quoters must provide a firm-fixed price for both option line items. Prices for the option line items shall remain valid in accordance with the following:

Line Item 0003 - Option Line Item – 90 days from the date of award;

Line Item 0004 – Option Line Item – 120 days from the date of award.

If exercised, it is anticipated that the period of performance would be extended 30 days from the date the option is exercised. The Government may exercise option line items, at its discretion if it is determined to be in the Government’s best interest to do so.

Options will be exercised by the issuance of a purchase order modification (Standard Form

30).

Responsible quoters shall provide pricing for all of the following line items.

LINE ITEM 0001 – BASE LINE ITEM: PRE-FILL DEVELOPMENT STUDY. QTY 1 JOB. The Contractor shall furnish all personnel, facilities, materials and services necessary to successfully complete the Pre-Fill Development Study in accordance with the statement of work.

LINE ITEM 0002 – BASE LINE ITEM: MATERIAL FILL. QTY 1 JOB. The Contractor shall furnish all personnel, facilities, materials and services necessary to successfully complete

Generation 1 material fill, and deliver all required deliverables and successfully meet all of the technical requirements for the required end product as required by the statement of work.

LINE ITEM 0003 – OPTION LINE ITEM: Quantity 1 JOB, Pre-Fill Development Study. The

Contractor shall furnish all personnel, facilities, materials and services necessary to successfully complete the Pre-Fill Development Study in accordance with the statement of work.

LINE ITEM 0004 – OPTION LINE ITEM: Quantity 1 JOB, Pre-Fill Development Study. The

Contractor shall furnish all personnel, facilities, materials and services necessary to successfully complete the Pre-Fill Development Study in accordance with the statement of work.

REFERENCE THE ATTACHED STATEMENT OF WORK FOR ALL TECHNICAL REQUIREMENTS AND DELIVERABLES.

PAYMENT SCHEDULE. Partial payments will be authorized based on completion of deliverables. The Government will establish a payment schedule at the time of award or after award. Payments will be based upon successful completion of required deliverables.

It is anticipated that at least 40% of the total amount of the contract will be held until all work is successfully completed.

EVALUATION CRITERIA AND BASIS FOR AWARD

The Government intends to award a purchase order resulting from this solicitation to the responsible quoter whose quotation, conforming to the solicitation, results in the best value to the Government, price and other factors considered.

The following will be used to evaluate quotations:

Technical Capability

Experience

Past Performance

Price

Technical Capability, Experience, and Past Performance, when combined, shall be equal in importance to price.

TECHNICAL CAPABILITY

Technical capability shall be evaluated to determine the Contractor’s ability to successfully complete the project. Documentation will be evaluated to determine the feasibility and likelihood for success of the proposed technical approach.

In determining best value, stronger consideration will be given to quoters whose feasible and likely to be successful technical approach includes an increased level of automation and/or engineering controls for the fill of generation 1 material with conditions as specified below. These conditions are intended to minimize risk of potential aggregation or degradation of the product.

1. Vial to vial reproducibility of both homogeneity and volume are of critical importance to this procurement. The technical approach clearly documents that it will ensure vial to vial reproducibility; and/or

2. The use of robotic liquid handling, robotic capping, and robotic labeling of the vials.

EXPERIENCE

Experience shall be evaluated to determine the degree of and relevance of experience the

Contractor possesses in completing the same or similar projects.

PAST PERFORMANCE

Evaluation of Past Performance shall be based on the references provided and/or the quoter’s recent and relevant procurement history with NIST, its’ affiliates, and/or other relevant references. Past performance evaluation shall determine the overall quality of the services and/or end products provided by the Contractor.

Quoters with no relevant past performance will receive a neutral rating.

PRICE

Price shall be evaluated for all quoters whose quotations are determined technically acceptable. Price will be evaluated to determine whether that total price is consistent with the technical portion of the quotation and is a fair and reasonable overall price to the Government.

ADDENDUM TO 52.212-1 – INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

(a) General Instructions

Quotations are required to conform to solicitation provisions and be prepared in accordance with this section. To aid in evaluation, the quotation must be clearly and concisely written as well as being neat, indexed (cross-indexed as appropriate) and logically assembled. All pages of each part shall be appropriately numbered and identified with the name of the offeror, the date, and the solicitation number.

Quoters shall submit one original of their quotation, marked as such, and two copies of the technical and price quotations. Only one copy of the business portion of the quotation is required to be submitted.

Quoters are not required to submit more than one copy of any portion of the quotation if the quotation is being submitted via email.

Quotations must be received not later March 31, 2015, at 3:30 PM Eastern Time. E-mail quotations are acceptable. Fax quotations shall not be accepted. E-mail quotations are considered received when the e-mail enters into the electronic inbox of Carol Wood.

Only information received on or before the due date and time shall be considered for award. Any quotation, or part thereof, received after the due date and time, will be deemed late and will not considered for award.

Each volume shall be clearly marked by volume number and title.

(b) Overall Arrangement of the Quotation

(1) BUSINESS QUOTATION

(A) The business quotation consists of the actual offer to enter into a contract to perform the required work. It also includes identification of technical data to be withheld; and any other administrative information.

(B) Format and Content. The business quotation shall include the following documents (in the order listed):

(i) Use of the Form – The Standard Form 1449, must be executed fully and used as the cover sheet (or first page) of Volume I. Include one (1) originally signed copy of the form in the Original Volume I. The Standard Form 1449 is available for download at www.acquisition.gov/far;

(ii) Acceptance Period - The acceptance period for the quotation shall not be less than 120 days;

(iii) Concurrence with all terms and conditions of the solicitation.

(iv) The Dun and Bradstreet Number for the quoter’s active registration at the

System for Award Management, (www.SAM.Gov) website.

(iv) If the quoter’s representations and certifications do not reflect the

NAICS code governing this solicitation, quoters must submit documentation of their business size under the NAICS code governing this solicitation.

(v) Signature Authority - The person signing the form must have the authority to commit the quoter to all of the provisions of the solicitation, fully recognizing that the Government has the right, by terms of the solicitation, to make an award without further discussion if it so elects.

(2) TECHNICAL QUOTATION

In order that the technical quotation may be evaluated strictly on the merit of the material submitted, no price information shall be included.

The quotation must be typed, on 8-1/2" by 11" paper, not exceeding 20 pages, single sided, single spaced, exclusive of experience and past performance references.

For the purpose of evaluation of Technical Capability, the technical quotation must include:

-Methodology and instrumentation proposed to be used for dilution, fill, freeze, and storage of Generation 1 RM;

-Containers proposed to be used for storage of Generation 1 RM including composition, closure system, etc. Specific manufacturer and product number of containers is preferred. The quotation must clearly demonstrate that the proposed containers will meet or exceed the salient characteristics identified in the statement of work;

-Estimated time of each step including estimated temperature of each step;

-Methodology and instrumentation proposed to be used for freeze and storage of

Homogenized Bulk.

-Methodology and instrumentation proposed to be used to satisfy analytical testing requirements of concentration as outlined in the statement of work.

-A discussion of the specific engineering controls and/or increased levels of automation that will meet the special consideration identified under the Technical Capability evaluation factor.

For the purpose of evaluation of Experience, the technical quotation must include:

Descriptions of projects the quoter, including any proposed subcontractor(s)/ consultants, as applicable, have performed in the past 3 years that will demonstrate the

Contractor’s experience with mAb therapeutics, and experience packaging monoclonal antibodies in accordance with the specifications identified in the statement of work.

Project descriptions must indicate the customer or company name and the actual tasks performed by the Contractor. Documentation must be directly related to the project being described.

For the purpose of evaluation of Past Performance, the technical quotation must include, but is not limited to:

Past performance information regarding relevant contracts over the past three years with

Federal, state, or local governments, and/or commercial customers.

http://www.sam.gov/

If the quoter intends to subcontract with another firm(s) for part of this requirement, that firm’s past performance information shall also be provided. If the firm has no relevant past performance, it shall include a statement to that effect in its proposal.

The Government reserves the right to consider data obtained from sources other than those described by the quoter in their quotation.

For each contract, the quoter shall provide the following information:

Contract number;

Description and relevance to solicitation requirements include dollar value.

Documentation shall not exceed ½ page in length;

Period of Performance – indicate by month and year the start and completion (or

“ongoing”) dates for the contract;

Reference Contact - identify the name and address of the client with current telephone number and email address of a point of contact of the client responsible for the contract;

Contracting Office – If a Government contract (Federal or state), identify the Procuring

Contracting Officer (PCO), administrative Contracting Officer (ACO), and Contracting

Officer’s Representative (COR), and their names, current telephone numbers and email addresses.

Problems Encountered – include information regarding information regarding any problems encountered on the contracts described above and corrective actions taken to resolve those problems.

(3) PRICE QUOTATION

The price quotation must include a total firm fixed price for each line item.

The firm fixed price must be broken down to illustrate costs associated for each line item in accordance with the quoter’s methodology. The breakdown must then be compiled into a summary which shows the total of all labor (by labor category) and other direct costs for all proposed tasks.

The Government reserves the right to require submission of the following detailed information to support the firm fixed price quotation as applicable:

(a) Direct Labor: Labor category, number of hours, hourly rate and total.

The Service Contract Act does not cover bona fide executive, administrative, or professional employees. If Contractor employees performing under this requirement fall within this exemption, offerors must state the applicable exemption. Reference Fact

Sheet 17a at http://www.dol.gov/whd/regs/compliance/fairpay/fs17a_overview.pdf.

If the Service Contract Act applies to employees performing under this contract, the Contractor must provide a copy of the applicable wage determination with their quotation.

(b) Other Direct Costs: The amount proposed for duplication or reproduction, meetings and conferences, postage, communication and any other applicable items. Travel, subsistence and local transportation shall be supported with a breakdown which includes:

number of trips anticipated, cost-per-trip-per-person, destination(s) proposed, number of person(s) scheduled for travel, mode of transportation, and mileage allowances if privately-owned vehicles will be used. Costs for travel shall not exceed those allowed by the Federal Travel Regulation.

http://www.dol.gov/whd/regs/compliance/fairpay/fs17a_overview.pdf

(c) Materials: Cost breakdown of materials or equipment must be supported with the methodology used and vendor quotations supplied as applicable.

(d) Consultants: If consultants are proposed, state the amount of service estimated to be required and the consultant's quoted daily or hourly rate. Include

Consulting Agreements entered into between consultant(s) and the offeror, or invoices submitted by consultant(s) for similar services previously provided to the offeror.

(e) Subcontracts: If proposed, cost information for each subcontractor shall be furnished in the same format and level of detail as prescribed for the prime offeror.

SECURITY REQUIREMENTS

Because of heightened security, e-mail, FED-EX, UPS or similar delivery methods are the preferred method of delivery of quotations.

If quotations are hand delivered, delivery must be made on or before the actual due date through Gate A, and a 48 hour (excluding weekends and holidays) prior notice must be made to Carol Wood in the Acquisition Management Division via e-mail, carol.wood@nist.gov.

Notice must include the company name, name of the individual making the delivery, and the country of citizenship of the individual. A US citizen must deliver the quotation due to timeline associated with the clearance process for non-US citizens to obtain entry to the

NIST site. Please ensure that the individual making the delivery brings state issued photo identification and a current vehicle registration, or they will be denied access to the facility.

NIST IS NOT RESPONSIBLE FOR LATE DELIVERY DUE TO THE ADDED SECURITY MEASURES. In addition, quoters who do not provide a 48 hour notification in order to coordinate entrance to the NIST campus assume the risk of not being able to deliver quotations on time. The Government is not responsible for the amount of time required to clear unannounced visitors, visitors without proper identification and without complete information that would allow delivery (i.e. point of contact, telephone POC, building, room number, etc.)

PROVISIONS AND CLAUSES

The full text of a FAR provision or clause may be accessed electronically at www.acquisition.gov.

The following provisions apply to this acquisition:

52.212-1, Instructions to Offerors – Commercial with the Addendum to 52.212-1;

52.212-3, Offeror Representations and Certifications – Commercial Items;

52.217-5, Evaluation of Options;

52.225-4, Buy American—Free Trade Agreements—Israeli Trade Act Certificate.

In accordance with FAR 52.212-3 Offeror Representations and Certifications – Commercial

Items, offerors must complete annual representations and certifications on-line at www.SAM.Gov. If paragraph (j) of the provision applies, a written submission is required;

The following clauses apply to this acquisition:

52.212-5 Contract Terms and Conditions – Commercial Items;

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Items including subparagraphs:

52.203-6, Restrictions on Subcontractor Sales to the Government

52.209-6,Protecting the Government’s Interests when Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment

52.219-6, Notice of Total Small Business Set-Aside

52.219-8, Utilization of Small Business Concerns http://www.acquisition.gov/ http://www.sam.gov/ https://acquisition.gov/far/current/html/52_200_206.html#wp1137622 https://acquisition.gov/far/current/html/52_207_211.html#wp1140926 https://acquisition.gov/far/current/html/52_217_221.html#wp1136004

52.219-14, Limitations on Subcontracting

52.222-3, Convict Labor

52.222-19, Child Labor--Cooperation with Authorities and Remedies

52.222-21, Prohibition of Segregated Facilities

52.222-26, Equal Opportunity

52.222-35, Equal Opportunity for Veterans

52.222-37, Employment Reports on Veterans

52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act 52.225-13, Restrictions on Certain Foreign Purchases

52.232-33, Payment by Electronic Funds Transfer-System for Award Management

52.217-7, Option to Extend Services;

52.217-9, Option to Extend the Term of the Contract;

52.227-14, Rights in Data—General;

52.245-1, Government Furnished Property;

52.247-34, FOB Destination; and

Department of Commerce Agency-Level Protest Procedures Level above the Contracting

Officer is also incorporated. It can be downloaded at www.nist.gov/admin/od/contract/agency.htm.

http://www.nist.gov/admin/od/contract/agency.htm