N62645-10-R-0001_CombinedSynopsisSolicitation_7Amendment0003.doc

N62645-10-R-0001

**SOLICITATION AMENDMENT 0001**

The proposal submission due date is extended to 15 January 2010, 05:00PM EST.*

**SOLICITATION AMENDMENT 0002**

The proposal submission due date is extended to 20 January 2010, 05:00PM EST.*

**SOLICITATION AMENDMENT 0003**

The purpose of this amendment is to answer questions from the solicitation. Section C – Statement of Work, Section L – Instructions to Offerors and the CLIN Structure have been updated (changes are in RED). Attachment 01: Pricing Sheet has also been added. There are no other changes.

SECTION C - STATEMENT OF WORK

LABORATORY TESTING SUPPLIES FOR

NAVAL MEDICAL CENTER SAN DIEGO, California

The Contractor shall provide a price for each test that can be performed on its equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego.

All responsible offers shall meet the following mandatory salient characteristics:

- The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation and reporting of a test result, (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance (minimum of 2 per year) and emergency repairs) and (d) training for Government personnel (the per test price shall not include costs for collection devices).

- The per test price shall include delivery, installation, and removal of equipment and shall be provided at no additional charge.

- The per test price shall include costs covering service, which shall be available five (5) days a week, Monday thru Friday between the hours 0800 to 1700 hours local time with 24 hour telephone technical support.

- The per test price shall include costs covering hardware and software upgrades as needed.

- The per test price shall include costs covering upgrades to new technological improvements in test methodology, i.e. enhanced SDA chemistry, automated sample processing.

- The contractor shall provide a fully automated system (all analytical steps performed onboard instrument). The automation platform shall be a single platform able to sample directly from patient collection tubes without removing caps and automatically dispense all reagents, perform all automated steps for Nucleic Acid Amplification (NAAT) Technology to detect Neisseria Gonorrhoeae and Chlamydia Trachomatis, analyze and verify results that will be transmitted to the instrument computer which then utilizes an interface to transmit the results to the DOD Composite Health Care System (CHCS) Laboratory Information System. Specimen flow from start to finish shall be fully automated to include waste collection.

- The contractor shall provide a system that includes the following procedures: Sample preparation, Separation Suspension, Reagent Preparation, Hybridization, Separation, and Detection.

- The contractor shall provide a system that has the capability to expand the test menu (run additional tests such as those being developed by the company or pending FDA clearance).

- The contractor shall provide a system with a minimum specimen throughput of greater than 300 Neisseria Gonorrhoeae and Chlamydia Trachomatis specimens per eight (8) hour shift.

- The contractor shall provide a system that uses Nucleic Acid Amplification (NAAT) Technology performing simultaneous amplification and detection of target DNA or rRNA.

- The contractor shall provide a system that analyzes endocervical and vaginal samples, urine samples for both males and females, and male urethral swabs.

- The contractor shall provide a system that can screen both organisms at the same time using the same specimen.

- The contractor shall provide equipment that has an analytical sensitivity cut-off of 350 Net RLU.

- The contractor shall provide a system that allows for confirmatory testing of all positive Neisseria Gonorrhoeae and Chlamydia Trachomatis.

- The contractor shall provide collection devices to collect specimens to be delivered at the delivery points identified below.

- The contractor shall provide specimen storage capacity shall have a stability of up to 30 days in a transport container with preservative media, as appropriate, for urine and swab specimens when stored at 2-30 degrees Celsius. Specimens must be able to be kept at -20 degrees Celsius for up to 90 days if the time of transport/storage exceeds 30 days.

- The contractor shall use a closed primary testing container with pierceable caps to prevent specimen contamination and false positive or negative results.

- The contractor shall provide a system that can read Code 39 barcodes.

- The contractor shall provide a system that has bi-directional interface with HLA 2, Composite Healthcare System (CHCS), Laboratory Information Systems (LIS). This system shall be capable of receiving and transmitting results directly to the LIS, eliminating the need to manually enter results.

- Supplies/Items that require special handling, e.g. refrigeration, time sensitive, open immediately etc, shall be marked in a clear manner with a label that is easily read, understandable and larger than 3"x 3" (9 sq inches). The label shall be placed in three (3) or more locations on the container (top & sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

- Reagents shall be delivered with a minimum of six months of shelf life.

- Upon expiration of the contract or termination of this contract for any reason, the government shall immediately turn over to the contractor possession of the equipment, including cabling, wiring, attachments and accessories thereto, and all operating manuals along with maintenance and service records relating there to the contactor, in the same good condition and repair as when received, ordinary wear and tear expected.

- The governement shall not be held liable for loss, damage, destruction, or theft of contractor property except when the loss, damage, destruction, or theft is the result of willful misconduct or lack of good faith on part of the governement.

- Regulatory Requirements: The equipment and reagents for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing, and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment and reagents shall be in compliance with OSHA requirements.

All equipment and accessories shall be new from the manufacturer. Used or refurbished equipment, or equipment obtained from a third party shall not be accepted.

Delivery times at Naval Medical Center San Diego shall be Monday thru Friday between 0800 and 1530 hours local time.

Exact delivery schedule shall be listed in each delivery order. Delivery points for the collection devices include the following locations:

Naval Medical Center-San Diego

Commanding Officer

Materials Management

Naval Medical Center

34800 Bob Wilson Drive

San Diego, CA 92134

Naval Hospital Camp Pendleton

Commanding Officer

Laboratory Department

Box 555191

Camp Pendleton, CA 92055-5191

Naval Hospital Bremerton

Commanding Officer

Laboratory Department

1 Boone Road

Bremerton, WA 98312-1898

Naval Hospital Oak Harbor

Commanding Officer

Laboratory Department

3475 North Saratoga Street

Oak Harbor, WA 98278

Naval Hospital Lemoore

Commanding Officer

Laboratory Department

937 Franklin Ave

Lemoore, CA 93246

Naval Hospital Twentynine Palms

Commanding Officer

Laboratory Department

Box 788250 MCAGCC

Twentynine Palms, CA 92278-8250

US Naval Hospital Guam

Commanding Officer

Laboratory Department

Agana, GU 96538-9340

U.S. Naval Medical Clinic Pearl Harbor Commanding Officer Laboratory

Department Bldg 1407 Makalapa Road Pearl Harbor, HI 96860-5058

US Naval Hospital Okinawa

Commanding Officer

Laboratory Department

PSC 482

FPO AP 96362-1600

U. S. Naval Hospital, Yokosuka, Japan

COMMANDING OFFICER

Laboratory Department

PSC 475, Box 1

FPO AP 96350-1600

The Contractors is hereby advised that the United States Government and agencies are exempted from state and local government tax by virtue of article 6 of the United States Constitution. No exemption certificate is required.

SECTION F - PERFORMANCE

a. Period of Performance

Performance is anticipated from 01 February 2010 through 30 January 2015, for a total of five years including option periods.

b. Place of Performance

National Naval Medical Center San Diego 34800 Bob Wilson Drive

San Diego, California 92134

SECTION G - CONTRACT ADMIN

Contract Administration Data

1. POC

(a) The name, address and telephone number of the Contract Specialist responsible for administering this contract is:

NAVAL MEDICAL LOGISTICS COMMAND

Code 02/Shannon Lertora

693 Neiman Street

Fort Detrick, MD 21702

Telephone: (301) 619‑0287 [no collect calls]

(b) Unless otherwise stated herein, any correspondence or discussion regarding this contract will be directed to the Contract Specialist in (a) above.

(c) Each delivery order will specify a Point of contact.

2. INVOICING INSTRUCTIONS

See Invoicing Instructions.

3. DESIGNATION OF ORDERING ACTIVITIES

The following requiring activities are hereby named to place delivery orders.

Contracting Officer

Naval Medical Logistics Command

693 Neiman Street

Frederick, MD 21702-9203

Warranted Contracting Officer as designated in writing by the PCO at NMLC

Naval Medical Center San Diego

34800 Bob Wilson Drive, Suite 8

San Diego, CA 92134-5000

The activities’ ordering offices are responsible for issuing and administering any orders placed hereunder. Ordering officers have no authority to modify any provision of the basic contract. Any deviations from the terms of the basic contract must be submitted and approved by the Contracting Officer for contractual action.

4. CONTENT OF DELIVERY ORDERS

Delivery orders shall contain the following "minimum" information:

1. Date of order.

2. Contract number and order number.

3. Item number and description, quantity, and unit price.

4. Delivery date and place of delivery.

5. Accounting and appropriation data.

7. Payment office address.

8. Invoicing instructions.

5. ORDERING

The Contracting Officer will order tests against the contract through issuance of Delivery Orders via a DD Form 1155 or SF 1449 signed by the Contracting Officer. Delivery Orders will be executed in writing by the Contracting Officer and transmitted either via facsimile, electronically via e-mail, or Medical Acquisition Portal (MAP). MAP is a secure, automated web-based application that facilitates the acquisition and management of services.

6. COMMUNICATIONS

(a) Except as specified in paragraph (b) below, no order, statement, or conduct of Government personnel who visit the contractor's facility or in any other manner communicate with contractor personnel during the performance of this contract shall constitute a change under the "Changes" clause of this contract.

(b) The contractor shall not comply with any order, direction or request of Government personnel unless it is issued in writing and signed by the Contracting Officer, or is pursuant to specific authority otherwise included as a part of this contract.

(c) The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract and, notwithstanding provisions contained elsewhere in this contract, the said authority remains solely the Contracting Officer's. In the event the contractor effects any change at the direction of any person other than the Contracting Officer, the change will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in charges incurred as a result thereof.

SECTION L - INSTRUCTIONS

Instructions to Offerors This section specifies the format and content that offerors shall use in this Request for Proposal (RFP). The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors shall submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified. Any proposal which does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration. A complete proposal, including Technical Approach (written) and Price shall be submitted by the closing date specified in the solicitation.

Technical Approach (Written) Instructions

Offerors shall provide sufficient written technical documentation (including, but not limited to: product literature, specifications, features or operator manuals) to allow for thorough evaluation of proposal. Additionally, the vendor shall fully explain their ability to meet the mandatory salient characteristics and Statement of Work (SOW) in a point-by-point narrative form. The offeror shall demonstrate the conformity of the proposed requirement to meet the mandatory salient characteristics and SOW. The offeror shall provide a table of contents or some similar means for the government to find the specific answers required by the solicitation, without having to search the entire proposal for a specific answer. The offerors shall provide sufficient information to document conformance to the salient characteristics.

Page limit for written technical approach: 30 pages in addition to the FDA certification documentation

Price Proposal Instructions

Offeror shall specify the cost per test price, CLIN total price, and total contract price (all five years including option periods). Shipping shall be FOB Destination. The government anticipates award of a firm fixed price requirements contract. Offerors shall submit firm fixed pricing for all above requirements. Include commercial price lists and if applicable, any FSS schedule numbers and pricing. Include any applicable discounts to the Government. Price Proposals shall be separated from the written technical proposal.

Other Administrative Instructions

Offerors shall provide company details, specifically:

Complete company name and address:

Fax number:

Phone Number:

Tax Identification Number (TIN):

CAGE Code:

DUNS number:

Place of Manufacture:

Submission of Proposal

Proposals shall be submitted by email only as a MS Word or Adobe PDF attachments to Shannon Lertora at Shannon.Lertora@med.navy.mil. Proposals are due by 05:00 PM EST on 20 JANUARY 2010. Any questions shall be addressed to Shannon Lertora, by email only, no later than 05:00 PM EST on 18 JANUARY 2010. No phone calls accepted.

SECTION M - EVALUATION FACTORS

The Government intends to award a contract resulting from this solicitation to the responsible offeror whose offer is the lowest price technically acceptable offer to the Government. Award shall be made on the basis of the lowest evaluated price meeting or exceeding the non-cost factor (technical conformance to the requirements of the solicitation). Evaluation of price will be based on the offeror’s total price for all line items. This acquisition is being conducted under simplified acquisition procedures (IAW FAR 12.6, 13.5 and 16.5). Past Performance is not an evaluation factor for this acquisition.

The following factors shall be used to evaluate offers:

1. Technical Features Meeting/Exceeding Minimum Requirements

The offeror shall submit a proposal that meets the requirement for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis in accordance with the Statement of Work (SOW) in Section C. The proposal shall be evaluated based on adherence to the salient characteristics, as well as the ability to meet the SOW.

2. Price (all CLINs shall be priced)

The offeror’s initial proposal shall contain the offeror’s best terms from a price and technical standpoint.

I. Completeness. The offeror has submitted a cost per test price, CLIN total price, and total contract price (all five years including option periods), completed all required representations and certifications, and acknowledgement of any amendments.

II. Reasonableness. The Government's determination that the proposed price is fair and reasonable based on price analysis. The degree to which the offeror’s proposed price represents a fair and reasonable price will be evaluated using the techniques in FAR 15.305(1), which provides that comparison of the proposed prices will usually satisfy the requirement for price analysis.

The Government intends to evaluate offers and award a contract without discussions. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to make no award of a contract as a result of this solicitation.

Competitive Range. In accordance with FAR 15.306(c), “Competitive Range,” the Government will evaluate all proposals, and if discussions are to be conducted, the Government will establish a competitive range. Based on the ratings of each proposal against all evaluation criteria, the Contracting Officer may further reduce the competitive range for purposes of efficiency.

Discussions may be in person, by telephone or in writing at the discretion of the Contracting Officer.

INVOICING INSTRUCTIONS

Invoicing Instructions and Payment for Services

Invoices for supplies rendered under this Contract shall be submitted electronically through Wide Area Work Flow – Receipt and Acceptance (WAWF):

The vendor shall self-register at the web site https://wawf.eb.mil. Vendor training is available on the internet at http://wawftraining.com.

A separate invoice will be prepared for every pay period. Do not combine the payment claims for services provided under this contract.

Select the 2-in-1 Invoice within WAWF as the invoice type. The 2-in-1 Invoice prepares the Material Inspection and Receiving Report, DD Form 250, and invoice in one document.

Back up documentation (such as timesheets, etc.) can be included and attached to the invoice in WAWF.

Attachments created in any Microsoft Office product are attachable to the invoice in WAWF.

The following information regarding Naval Medical Center San Diego is provided for completion of the invoice in WAWF:

Issuing Office DODAAC: N62645

Admin DODAAC: N62645

Acceptor DODAAC: N00259

LPO DODAAC: N00259

Pay DODAAC: HQ0248

The contractor shall submit invoices for payment per contract terms.

The Government shall process invoices for payment per contract terms.

The point of contact for WAWF at the Naval Medical Center San Diego is HM3 Mikkell Burley at (619) 532-9234, Mikkell.Burley@med.navy.mil (PRIMARY).

For training materials, instructions for setting up WAWF, and step-by-step instructions for the (Invoice 2-in-1 Services Only) Invoice, please visit the following web site: http://www.acquisition.navy.mil/navyaos/content/view/full/99/ For any other questions, please contact the WAWF helpdesk at 1-866-618-5988 or cscassig@ogden.disa.mil or the WAWF Implementation Team at wawf@med.navy.mil.

ANSWERS TO QUESTIONS

Amendment 0002 to N62645-10-R-0001-0002

13 January 2010

Answers to Questions Received

Question 1: The FDA cleared package inserts for vendors of this type of equipment / test exceed 30 pages. May they be included as an attachment without violating the 30 page limit of the Technical Approach listed in Section L?

Answer 1: Section L Instructions to Offerors, Technical Approach (Written) Instructions has been updated.

Question 2: Currently we ship FOB destination prepaid and added to invoice for all reagents and will line item this accordingly. Is this to be included as part of the Cost per test rather than a separate line item?

Answer 2: Yes, the cost for shipping shall be included as part of the cost per test rather than a separate line item.

Question 3: Section 5, Ordering, seems to indicate that the Contracting Officer will place multiple orders for tests on an as needed basis during the term of the contract or option period. Is this correct? Or will the entire amount listed under the CLIN be delivered at one time?

Answer 3: The Contracting Officer will place multiple orders for tests on an as needed basis during the term of the contract or option period.

Question 4: The solicitation requests, on page 1, "a price for each test that can be performed on its equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis". On Page 7 item # 0001 lists an estimated quantity of 34,500 tests. Does this indicate 34,500 Neisseria Gonorrhoeae and 34,500 Chlamydia Trachomatis tests, or does this mean 17,250 tests of each for a total of 35,000 tests? This is extremely important for calculating the overall estimate for each CLIN.

Answer 4: Section C Statement of Work has been updated. The estimated tests for each period of performance shall be used to test for both Neisseria Gonorrhoeae and Chlamydia Trachomatis simultaneously using the same specimen.

Question 5: I do not see that transport and collection devices, used to collect the patient specimen, are included in the SOW price per test definition. These items, such as swabs or urine collection tubes, are typically not purchased by the lab, but are purchased through the prime vendor by each individual clinic or location. Should collection and transport swabs and tubes be included in the CLIN estimated total, or anywhere else on the response?

Answer 5: See the revised CLIN structure.

Question 6: Will collection devices for endocervical and vaginal swabs, urine for both male and female, and male urethral swabs be part of the bid as separate line items or will they be priced separately to individual accounts/clinics worldwide that send testing to Naval San Diego?

Answer 6: See the revised CLIN structure.

Question 7: Quotes are provided on a cost per kit basis. All cost of the system use are included in the cost per kit with the exception of collection devices priced separately. There are no additional charges. Is this acceptable and if not - how then is a Cost per Test computed?

Answer 7: See the revised CLIN structure. In addition, please complete Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.

ATTACHMENT 01: PRICING SHEET

CLIN 0001AA:

Cost per Test __________

Number of Tests per Kit __________

Cost per Kit __________

CLIN 1001AA:

CLIN 2001AA:

CLIN 3001AA:

CLIN 4001AA:

CLIN 5001AA:

BASE PERIOD

FFP

Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis and collection devices for the Naval Medical Center San Diego.

Period of Performance 01 February 2010 - 30 September 2010

FOB: Destination

ESTIMATED

NET AMT

0001AA

Kit

Cost Per Test Fee

Estimated 34,500 Test Volume Per Base Period

Period of Performance 01 February 2010 - 30 September 2010

** See Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.**

Price for each test that can be performed on contractor provided equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego in accordance with the Statement of Work. Ownership of the equipment will remain with the contractor.

ESTIMATED

0001AB

Collection Device

Period of Performance 01 February 2010 - 30 September 2010

ESTIMATED

FFP

Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis and collection devices for the Naval Medical Center San Diego.

Period of Performance 01 October 2010 - 30 September 2011

ESTIMATED

1001AA

Kit

FFP

Estimated 62,100 Test Volume Per Option Period

Period of Performance 01 October 2010 - 30 September 2011

** See Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.**

Price for each test that can be performed on contractor provided equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego in accordance with the Statement of Work. Ownership of the equipment will remain with the contractor.

ESTIMATED

1001AB

FFP

Period of Performance 01 October 2010 - 30 September 2011

ESTIMATED

FFP

Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis and collection devices for the Naval Medical Center San Diego.

Period of Performance 01 October 2011 - 30 September 2012

ESTIMATED

2001AA

Kit

FFP

Estimated 74,520 Test Volume Per Option Period

Period of Performance 01 October 2011 - 30 September 2012

** See Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.**

Price for each test that can be performed on contractor provided equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego in accordance with the Statement of Work. Ownership of the equipment will remain with the contractor.

ESTIMATED

2001AB

FFP

Period of Performance 01 October 2011 - 30 September 2012

ESTIMATED

FFP

Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis and collection devices for the Naval Medical Center San Diego.

Period of Performance 01 October 2012 - 30 September 2013

ESTIMATED

3001AA

Kit

FFP

Estimated 89,424 Test Volume Per Option Period

Period of Performance 01 October 2012 - 30 September 2013

** See Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.**

Price for each test that can be performed on contractor provided equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego in accordance with the Statement of Work. Ownership of the equipment will remain with the contractor.

ESTIMATED

3001AB

FFP

Period of Performance 01 October 2012 - 30 September 2013

ESTIMATED

FFP

Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis and collection devices for the Naval Medical Center San Diego.

Period of Performance 01 October 2013 - 30 September 2014

ESTIMATED

4001AA

Kit

FFP

Estimated 89,424 Test Volume Per Option Period

Period of Performance 01 October 2013 - 30 September 2014

** See Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.**

Price for each test that can be performed on contractor provided equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego in accordance with the Statement of Work. Ownership of the equipment will remain with the contractor.

ESTIMATED

4001AB

FFP

Period of Performance 01 October 2013 - 30 September 2014

ESTIMATED

FFP

Neisseria Gonorrhoeae and Chlamydia Trachomatis testing on a cost per test basis and collection devices for the Naval Medical Center San Diego.

Period of Performance 01 October 2014 - 31 January 2015

ESTIMATED

5001AA

Kit

FFP

Estimated 29,808 Test Volume Per Option Period

Period of Performance 01 October 2014 - 31 January 2015

** See Attachment 01: Pricing Sheet to include Cost per Test, Number of Tests per Kit and Cost per Kit.**

Price for each test that can be performed on contractor provided equipment for Neisseria Gonorrhoeae and Chlamydia Trachomatis testing at the Naval Medical Center San Diego in accordance with the Statement of Work. Ownership of the equipment will remain with the contractor.

ESTIMATED

5001AB

FFP

Period of Performance 01 October 2014 - 31 January 2015

ESTIMATED

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

30-SEP-2010

RECEIVING OFFICER

LOADING DOCK 1

34800 BOB WILSON DR.

SAN DIEGO CA 92134-5000

619-532-6078

N00259

30-SEP-2010

SEE DO/TO

SEE DO/TO MD

N00000

30-SEP-2011

RECEIVING OFFICER

LOADING DOCK 1

34800 BOB WILSON DR.

SAN DIEGO CA 92134-5000

619-532-6078

N00259

30-SEP-2011

SEE DO/TO

SEE DO/TO MD

N00000

30-SEP-2012

RECEIVING OFFICER

LOADING DOCK 1

34800 BOB WILSON DR.

SAN DIEGO CA 92134-5000

619-532-6078

N00259

30-SEP-2012

SEE DO/TO

SEE DO/TO MD

N00000

30-SEP-2013

RECEIVING OFFICER

LOADING DOCK 1

34800 BOB WILSON DR.

SAN DIEGO CA 92134-5000

619-532-6078

N00259

30-SEP-2013

SEE DO/TO

SEE DO/TO MD

N00000

30-SEP-2014

RECEIVING OFFICER

LOADING DOCK 1

34800 BOB WILSON DR.

SAN DIEGO CA 92134-5000

619-532-6078

N00259

30-SEP-2014

SEE DO/TO

SEE DO/TO MD

N00000

31-JAN-2015

RECEIVING OFFICER

LOADING DOCK 1

34800 BOB WILSON DR.

SAN DIEGO CA 92134-5000

619-532-6078

N00259

31-JAN-2015

SEE DO/TO

SEE DO/TO MD

N00000

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (AUG 2009)

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision.

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

"Emerging small business" means a small business concern whose size is no greater than 50 percent of the numerical size standard for the NAICS code designated.

"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.

Inverted domestic corporation means a foreign incorporated entity which is treated as an inverted domestic corporation under 6 U.S.C. 395(b), i.e., a corporation that used to be incorporated in the United States, or used to be a partnership in the United States, but now is incorporated in a foreign country, or is a subsidiary whose parent corporation is incorporated in a foreign country, that meets the criteria specified in 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in Federal Supply Classes (FSC) 1000-9999, except--

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

(2) Federal Supply Group (FSG) 87, Agricultural Supplies;

(3) FSG 88, Live Animals;

(4) FSG 89, Food and Related Consumables;

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

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

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

(8) FSC 9610, Ores;

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

(10) FSC 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.

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.

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; or

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

(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 Online Representations and Certifications Application (ORCA) website.

(2) The offeror has completed the annual representations and certifications electronically via the ORCA website at http://orca.bpn.gov. After reviewing the ORCA 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 for paragraphs ----------.

(Offeror to identify the applicable paragraphs at (c) through (n) of this provision that the offeror has completed for the purposes of this solicitation only, if any.)

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on ORCA.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it ( ) is, ( ) is not a small business concern.

(2) Veteran-owned small business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents as part of its offer that it ( ) is, ( ) is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. (Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.) The offeror represents as part of its offer that it ( ) is, ( ) is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents, for general statistical purposes, that it ( ) is, ( ) is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents that it ( ) is, ( ) is not a women-owned small business concern.

Note: Complete paragraphs (c)(6) and (c)(7) only if this solicitation is expected to exceed the simplified acquisition threshold.

(6) Women-owned business concern (other than small business concern). (Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents that it ( ) is, a women-owned business concern.

(7) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:

(8) Small Business Size for the Small Business Competitiveness Demonstration Program and for the Targeted Industry Categories under the Small Business Competitiveness Demonstration Program. (Complete only if the offeror has represented itself to be a small business concern under the size standards for this solicitation.)

(i) (Complete only for solicitations indicated in an addendum as being set-aside for emerging small businesses in one of the designated industry groups (DIGs).) The offeror represents as part of its offer that it ( ) is, ( ) is not an emerging small business.

(ii) (Complete only for solicitations indicated in an addendum as being for one of the targeted industry categories (TICs) or designated industry groups (DIGs).) Offeror represents as follows:

(A) Offeror's number of employees for the past 12 months (check the Employees column if size standard stated in the solicitation is expressed in terms of number of employees); or

(B) Offeror's average annual gross revenue for the last 3 fiscal years (check the Average Annual Gross Number of Revenues column if size standard stated in the solicitation is expressed in terms of annual receipts).

(Check one of the following):

Average Annual

Number of Employees Gross Revenues

___ 50 or fewer ___ $1 million or less

___ 51 - 100 ___ $1,000,001 - $2 million

___ 101 - 250 ___ $2,000,001 - $3.5 million

___ 251 - 500 ___ $3,500,001 - $5 million

___ 501 - 750 ___ $5,000,001 - $10 million

___ 751 - 1,000 ___ $10,000,001 - $17 million

___ Over 1,000 ___ Over $17 million

(9) (Complete only if the solicitation contains the clause at FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns or FAR 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting, and the offeror desires a benefit based on its disadvantaged status.)

(i) General. The offeror represents that either--

(A) It ( ) is, ( ) is not certified by the Small Business Administration as a small disadvantaged business concern and identified, on the date of this representation, as a certified small disadvantaged business concern in the database maintained by the Small Business Administration (PRO-Net), and that no material change in disadvantaged ownership and control has occurred since its certification, and, where the concern is owned by one or more individuals claiming disadvantaged status, the net worth of each individual upon whom the certification is based does not exceed $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); or

(B) It ( ) has, ( )( has not submitted a completed application to the Small Business Administration or a Private Certifier to be certified as a small disadvantaged business concern in accordance with 13 CFR 124, Subpart B, and a decision on that application is pending, and that no material change in disadvantaged ownership and control has occurred since its application was submitted.

(ii) Joint Ventures under the Price Evaluation Adjustment for Small Disadvantaged Business Concerns. The offeror represents, as part of its offer, that it is a joint venture that complies with the requirements in 13 CFR 124.1002(f) and that the representation in paragraph (c)(9)(i) of this provision is accurate for the small disadvantaged business concern that is participating in the joint venture. (The offeror shall enter the name of the small disadvantaged business concern that is participating in the joint venture: ____________.)

(10) HUBZone small business concern. (Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.) The offeror represents, as part of its offer, that--

(i) It ( ) is, ( ) is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material change in ownership and control, principal office, or HUBZone employee percentage has occurred since it was certified by the Small Business Administration in accordance with 13 CFR part 126; and

(ii) It ( ) is, ( ) is not s joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for the HUBZone small business concern or concerns that are participating in the joint venture. (The offeror shall enter the name or names of the HUBZone small business concern or concerns that are participating in the joint venture:____________.) Each HUBZone small business concern participating in the joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Certifications and representations required to implement provisions of Executive Order 11246--

(1) Previous Contracts and Compliance. The offeror represents that--

(i) It ( ) has, ( ) has not, participated in a previous contract or subcontract subject either to the Equal Opportunity clause of this solicitation, the and

(ii) It ( ) has, ( ) has not, filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that--

(i) It ( ) has developed and has on file, ( ) has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR Subparts 60-1 and 60-2), or

(ii) It ( ) has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $100,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Act Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American Act --Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American Act--Supplies.”

(2) Foreign End Products:

Line Item No.:---------------------------------------------------------

Country of Origin:-----------------------------------------------------

(List as necessary)

(3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.

(g)(1) Buy American Act-Free Trade Agreements-Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end…