FBODaily.com | FedBizOpps: PRESOL | B | HUMAN FIBROBLAST IN VITRO - COPY OF SYNOPSIS

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 02, 2013 FBO #4177
SOLICITATION NOTICE

B -- HUMAN FIBROBLAST IN VITRO - COPY OF SYNOPSIS

Notice Date: 4/30/2013
Notice Type: Combined Synopsis/Solicitation
NAICS: 541690 — Other Scientific and Technical Consulting Services
Contracting Office: Other Defense Agencies, TRICARE Management Activity, USUHS CONTRACTING OFFICE, 4301 JONES BRIDGE ROAD, Bethesda, Maryland, 20814-4799, United States
ZIP Code: 20814-4799
Solicitation Number: HT9404-13-Q-0660
Archive Date: 6/18/2013
Point of Contact: Christina Johnson, Phone: 3012953069, Zamora Olin, Phone: 301-295-3922
E-Mail Address: christina.johnson@usuhs.edu, Zamora.Olin@usuhs.edu
(christina.johnson@usuhs.edu, Zamora.Olin@usuhs.edu)
Small Business Set-Aside: Total Small Business
Description: COPY OF SYNOPSIS This requirement is set-aside for small businesses. The Uniformed Services University of the Health Sciences (USUHS), located on the Walter Reed National Military Medical Center (WRNMMC) Campus, Bethesda, MD, intends to solicit proposals to expand human fibroblasts in-vitro for re-introduction into human subjects. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued. The solicitation number is HT9404-13-Q-0660, and it is being issued as a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-66, effective April 1, 2013. E-mail or mailed offers are acceptable. Facsimile offers will not be accepted. In accordance with FAR Subpart 16.4, this is a firm-fixed price contract. This requirement is unrestricted and will be competed as full and open competition. The following North American Industry Classification System (NAICS) codes are applicable: 541690 - Other Scientific and Technical Consulting Services with a size standard of $7.0 millions of dollars 541712 - Research and Development in the Physical, Engineering, and Life Sciences with a size standard of 500 employee I. PRICE SCHEDULE: The contractor should provide pricing as set up below: Contract Line Number (CLIN), description, and unit of issue. CLIN 0001 Analysis Sample Number and Qty. Per Sample Cost Total Cost Fibroblasts Lots Analysis for three (3) patients 6 lots $ $ CLIN 0002 (OPTION) Fibroblasts Lots Analysis for seven to ten (7-10) patients 14-20 lots $ $ Contract Total $ USUHS intends to purchase CLIN 0001 and may purchase CLIN 0002 which is an option and will be separately funded. The Government reserves the right to initiate deliverance by an issuance of a modification specifying the actual delivery date and the appropriate fund citation of the current fiscal year. II. STATEMENT OF WORK 1.0 General Information: 1.0.1 Contractor must provide and maintain all management, supervision, manpower, equipment, supplies, licenses, permits, insurance, shipment and any other resources necessary to accomplish the services described and required within the statement of work (SOW). 1.0.2 The projected period of performance for CLIN 0001 will be in effect for one (1) year. Services shall commence on October 1, 2013 through September 30, 2014. The total period of the initial contract shall not exceed one (1) year. Option CLIN 0002 may be initiated during the initial performance window for FY 2013 or in further FY periods. 1.1 Introduction The Government has generated a protocol to expand autologous human fibroblasts in vitro for re-introduction into human donors. This protocol is specific for an autologous fibroblast product and is being developed under an open Investigational New Drug (IND) Application with the Food and Drug Administration (FDA). The protocol has been generated and all processes have been optimized and reviewed. The Government will supply the contractor with the harvested human donor skin. The contractor will expand the fibroblasts for the harvested human skin in a Good Laboratory Practice or Good Manufacturing Practice facility that meets FDA requirements as outlined in the Governments' pre-IND meeting with the FDA. The expanded cells will need to be free of adventitial agents, sterile, and pure as outlined in the pre-IND materials. The cells will then be provided to the Army for autologous re-introduction into healthy autologous donors. 2.0 Technical Requirements The contractor will expand the fibroblasts according to an established protocol. This initial task of generating six (6) lots must be accomplished for each lot within 30 to 90-day period after receiving each lot. The number of lots can be modified upon mutual agreement, if required by the project needs. Upon review of the work performed during the initial 365-day period, the contractor may generate the product on a per-lot basis. The total anticipated number of lots required is 20-26. 1. Given the site limitations of the skin harvest site, a 4 mm skin punch biopsy or smaller is required. The fibroblasts lots will have the following characteristics: a. One (1) 4 mm skin punch biopsy will be obtained from each human subject from two different anatomical sites for a total of two (2) skin samples. b. Each skin punch biopsy sample will need to be expanded separately, i.e. reflect a unique lot number, for a target dose of 40 million cells suspended in 0.7-1 ml of vehicle volume for administration to the patient. The two products expanded from different sites will need to be separately identified (i.e. unique lot numbers). A separate vial containing at least 10 million cells in vehicle for each harvested site will need to be provided for further laboratory testing to assess the potency of each of the two products for each patient. This sample be used for in vitro studies only and will not be administered to the patient. c. Each individual skin biopsy can be manipulated or divided (if necessary) by the contractor to reach the target dose of 40 million cells in 0.7-1 ml of vehicle. Any deviations will need to be noted and included in the CMC of the Government Sponsor's IND. d. For each patient, a 0.7-1 ml aliquot of vehicle must be provided for the purpose of control. This vehicle will be injected into the skin of the patient at a different location. 3.0 Deliverables 1. Human fibroblasts lots either from an adult donor or fetal foreskin will be sent to the Contractor to: a. Demonstrate that the existing protocol documentation is adequate to expand the fibroblasts as outlined in the Chemistry Manufacturing and Controls (CMC) section of the draft IND or provide a Cross-reference Letter from the contractor for the Government Sponsor to include in their IND. b. Provide data from the initial skin expansion to the Government for incorporation into the Government Sponsor's final FDA IND submission and/or or provide IND support such as a Cross-reference Letter for an existing FDA evaluated product. The Government will retain all cellular material and data from the initial expansion to include all remaining expanded fibroblasts. The Government cannot proceed with payment for expansion of skin fibroblast lots until the Government's IND is complete. c. Determine a per-sample fee for expansion of autologous fibroblasts from skin biopsies to include transport of the skin biopsy specimen to the contractor's lab, expansion of the fibroblasts, testing of the fibroblasts for sterility and purity, placement in an appropriate freezing media, and transport back to the Government for grafting into the autologous donor. d. Expand fibroblasts from a 4 mm skin biopsy as directed by the Government for additional on-going studies. The Government cannot proceed with the collection of skin biopsies for fibroblast expansion until the Government Sponsor's IND is complete. 4. Optional assays that the contractor could perform include quantitative RT-PCR studies on skin samples from the donor, routine hemotoxylin and eosin staining, and immunostaining of donor skin tissue, in-vitro cell-culture assays to assess expression of specific skin markers. 4.0. Laboratory Quality Assurance (QA) and Quality Control (QC) The contractor shall meet the following requirements for laboratory QA and QC: 1. Make available necessary information on techniques and materials to be used in the assays and the quality control procedures as required by the FDA and for the Government Sponsor's IND. Reference ranges for laboratory values will be included along with any appropriate documentation to support the choice of the ranges. Abnormal range codes must be included. Any relevant analytical comments should also be included. 2. Maintain records for reporting results and document quality control information according to FDA requirements, which at a minimum will include the following: a. Quality control information relevant to this project. b. Quality control results that can be linked to each lot by the identification number provided for each lot. c. A laboratory log containing a record of the status of all specimens upon arrival, date of receipt, deviations from protocol or good laboratory practice; e.g., proper labeling and packaging, an account of all vials, etc. d. A laboratory log containing a record of all handling, storage and manipulation of specimens, which might affect the quantitative results reported; e.g., freezing, thawing of specimens, spilled, contaminated. e. A quality assurance system by which random or systematic error may be detected and monitored. 3. Link all specimens to: a. Analytic batch, date of analysis, analyst, and instrument (especially if multiple instruments are available for the same assay type (e.g., HPLC instruments) b. Quality control values measured as part of each batch, expected control values, lot number of the controls and the manufacturer and date of expiration of control materials. If control materials are prepared in house, a description of the procedure used for creating the controls, date created, and summary data regarding characterization of controls. c. Standard materials used and changed over time to provide long-term comparability of values. d. Reagents by batch, reagent's expiration dates, and date of change of reagents. Reagents should be identified by lot number and manufacturer. e. All repeated values and reasons for test repeats recorded. 4. Participate in a Proficiency Testing program through independent laboratories such as the College of American Pathologists or a comparable program. 5. Be CLIA-certified or equivalent certification. Maintain this certification for the length of the contract. 6. Apply Westgard rules, if applicable, to the QC for the test methods used. 7. Be able to document a between-run, among-run CV for measurements performed. CVs must be within published acceptable ranges for laboratory assays. 4.1. Laboratory Results and Quality Control Management Any unsatisfactory blind quality control specimen performance will be investigated by the PATH COR(Contract Officer's Representative) at the FDA and reported to Westat's laboratory for internal investigation. Documentation shall be provided to ensure that the Contractor laboratory has corrected the cause of the unsatisfactory performance test results. If the error is determined to be technical or methodological error, the laboratory shall submit all quality control data from the batch of specimens which included the incorrect result. Quality surveillance and monitoring of results is on-going and will be used to determine the significance of failed quality control results, failed blind QC results, batch inconsistency, and delays in resulting and changes in quality that will affect the outcome of the Study. When one QC sample is determined to be out of the 3 SD range, or more than one QC sample is 2 SD out of range, the Contractor must investigate the failure(s) and document the cause of the problem that led to the unacceptable result(s). The investigation and documentation should include: 1. How the problem was investigated - a written summary of the steps the laboratory took to determine the nature of the problem. 2. A written conclusion as to the cause of the unacceptable result(s). 3. Specific corrective action (the changes the laboratory implemented) taken to prevent recurrence of the problem. 4. Evidence (actions taken) that the problem was successfully corrected. 5. Evidence of the laboratory director's review of the investigation. 5.0 Reporting Requirements A summary report for each lot prior to administration to the patient will be provided to the Government that is compliant with FDA reporting requirements. If the report indicates that the lot is not appropriate for human use, the Government will not be responsible for payment for this lot or additional lots from the same subject. 6.0 Ownership of Work Product The USUHS will exclusively own and hold title to all property rights in the work produced under this contract, as well as all documents, information, and records provided to the contractor pursuant to the contract. The contractor Supplier will not represent or claim that it has acquired any right, title, or interest in the work produced or supplied under this contract. Neither the supplier nor its personnel may sell, publish, copy, lend, display, or distribute the work produced or supplied under this contract to any person, without the prior written approval of the Contracting Officer ("CO"). Upon the completion or termination of the contract, or at the USUHS's request, the contractor and its personnel must promptly deliver to the USUHS all work produced or samples supplied under this contract, including raw information and drafts, whether or not complete. III. CLAUSES INCORPORATED BY REFERENCE 52.202-1 Definitions JAN 2012 52.203-3 Gratuities APR 1984 52.203-6 Alt I Restrictions on Subcontractor Sales to the Government OCT 1995 52.203-12 Limitation On Payments To Influence Certain Federal Transactions OCT 2010 52.204-2 Security Requirements AUG 1996 52.204-4 52.204-7 Printed or Copied Double Sided on Postconsumer Fiber Content Paper Central Contractor Registration MAY 2011 FEB 2012 52.215-8 Order of Precedence--Uniform Contract Format OCT 1997 52.222-22 52.222-25 52.222-50 Previous Contracts and Compliance Reports Affirmative Action Compliance Combating Trafficking in Persons FEB 1999 APR 1984 FEB 2009 52.223-6 Drug-Free Workplace MAY 2001 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving AUG 2011 52.227-1 Authorization and Consent DEC 2007 52.229-3 52.232-1 Federal, State, and Local Taxes Payments APR 2003 APR 1984 52.232-9 Limitation On Withholding Of Payments APR 1984 52.232-11 52.233-1 Extras Disputes APR 1984 JUL 2002 52.233-4 52.237-1 Applicable Law for Breach of Contract Claim Site Visit OCT 2004 APR 1984 52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984 52.242-13 Bankruptcy JUL 1995 52.249-4 Termination For Convenience Of The Government (Services) (Short Form) APR 1984 52.251-1 Government Supply Sources APR 2012 252.201-7000 Contracting Officer's Representative DEC 1991 252.204-7000 Disclosure Of Information DEC 1991 252.204-7004 Central Contractor Registration (Alternate A SEP 2007 252.204-7006 Billing Instructions OCT 2005 252.223-7006 Prohibition On Storage And Disposal Of Toxic And Hazardous Materials APR 1993 252.226-7001 Utilization of Indian Organizations and Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns SEP 2004 252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment MAR 1998 52.246-4 Inspection of Services-Fixed-Price AUG 1996 IV. CLAUSES INCORPORATED BY FULL TEXT 52.212-2 Evaluation-Commercial Items. COMMERCIAL ITEMS (JAN 1999) (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: Contractors must address the evaluation factor 1, Technical Capability, within 15 pages in length. Evaluation factors are listed in their order of importance, with the most important being listed first. Evaluation Factors: 1. Technical Capability Provide information that demonstrates an understanding the requirements by including at a minimum: an established scientific track record with the Food and Drug Administration (FDA), provide a Cross Reference Letter for the fibroblast expansion process for an applicable FDA-reviewed product, if available, and a management approach/plan to provide the necessary information for the Chemistry Manufacturing and Controls section of the Government Sponsor's IND. 2. Delivery: Provide the logistics of transporting the fibroblasts lots from the USUHS to the contractor's site and back to the USUHS. The contractor must address the recommended device the Government should use to deliver the cells to the skin and whether the product will need to be transferred to a device or will the product come pre-loaded in a device. 3. Past Performance The Government is requesting offerors submit additional relevant and similar references that demonstrate capabilities in your organization's ability to fulfill the requirements of this procurement. Past performance should be no more than three (3) years old. The Government will determine the extent to which an offeror's experience is similar in size, scope and complexity to the Government's requirements under this solicitation. Offerors must provide a minimum of three customer references on contracts of similar complexity, scope, dollar amount and type. The following information must be provided for each customer reference: ● Name of agency and/or business and address ● Name of current point of contact, including telephone number and e-mail address ● Contract number ● Contract value ● Contract performance period ● Brief description of services provided 4. Price Offerors must offer on all items included in the Price Schedule, in order to be considered for award. Price evaluation will be based on the cumulative total of all items included in the Price Schedule. Technical, delivery and past performance, when combined, are more important to price. (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. (End of provision) 52.212-4 Contract Terms and Conditions-Commercial Items. (FEB 2012) (a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights- (1) Within a reasonable time after the defect was discovered or should have been discovered; and (2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item. (b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract. (c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties. (d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract. (e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference. (f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence. (g) Invoice. (1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include- (i) Name and address of the Contractor; (ii) Invoice date and number; (iii) Contract number, contract line item number and, if applicable, the order number; (iv) Description, quantity, unit of measure, unit price and extended price of the items delivered; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading; (vi) Terms of any discount for prompt payment offered; (vii) Name and address of official to whom payment is to be sent; (viii) Name, title, and phone number of person to notify in event of defective invoice; and (ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract. (x) Electronic funds transfer (EFT) banking information. (A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract. (B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration, or 52.232-34, Payment by Electronic Funds Transfer-Other Than Central Contractor Registration), or applicable agency procedures. (C) EFT banking information is not required if the Government waived the requirement to pay by EFT. (2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315. (h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings. (i) Payment.- (1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract. (2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315. (3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause. (4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made. (5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall- (i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the- (A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment); (B) Affected contract number and delivery order number, if applicable; (C) Affected contract line item or subline item, if applicable; and (D) Contractor point of contact. (ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer. (6) Interest. (i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in Section 611 of the Contract Disputes Act of 1978 (Public Law 95-563), which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid. (ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract. (iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if- (A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days; (B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or (C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2). (iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment. (v) Amounts shall be due at the earliest of the following dates: (A) The date fixed under this contract. (B) The date of the first written demand for payment, including any demand for payment resulting from a default termination. (vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on- (A) The date on which the designated office receives payment from the Contractor; (B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or (C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor. (vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract. (j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon: (1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or (2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination. (k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties. (l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided. (m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience. (n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession. (o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract. (p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items. (q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract. (r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. 3701, et seq., Contract Work Hours and Safety Standards Act; 41 U.S.C. 51-58, Anti-Kickback Act of 1986; 41 U.S.C. 265 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. 423 relating to procurement integrity. (s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order: (1) The schedule of supplies/services. (2) The Assignments, Disputes, Payments, Invoice, Other Compliances, and Compliance with Laws Unique to Government Contracts paragraphs of this clause. (3) The clause at 52.212-5. (4) Addenda to this solicitation or contract, including any license agreements for computer software. (5) Solicitation provisions if this is a solicitation. (6) Other paragraphs of this clause. (7) The Standard Form 1449. (8) Other documents, exhibits, and attachments. (9) The specification. (t) Central Contractor Registration (CCR). (1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the CCR database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the CCR database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the CCR database to ensure it is current, accurate and complete. Updating information in the CCR does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document. (2)(i) If a Contractor has legally changed its business name, "doing business as" name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in FAR Subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day's written notification of its intention to (A) change the name in the CCR database; (B) comply with the requirements of Subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor must provide with the notification sufficient documentation to support the legally changed name. (ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the CCR information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the "Suspension of Payment" paragraph of the electronic funds transfer (EFT) clause of this contract. (3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the CCR record to reflect an assignee for the purpose of assignment of claims (see Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the CCR database. Information provided to the Contractor's CCR record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the "Suspension of payment" paragraph of the EFT clause of this contract. (4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via CCR accessed through https://www.acquisition.gov or by calling 1-888-227-2423 or 269-961-5757. (End of clause) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. (AUG 2012) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). _X__Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). __ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) _X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Aug 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Jul 2010) (Pub. L. 111-5). _X_ (6) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note). __ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Feb 2012) (41 U.S.C. 2313). _X_ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). __ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). _X_ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JAN 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (11) [Reserved] _X_ (12)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644). __ (ii) Alternate I (Nov 2011). __ (iii) Alternate II (Nov 2011). __ (13)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-7. __ (iii) Alternate II (Mar 2004) of 52.219-7. _X_ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)). __ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (15 U.S.C. 637(d)(4)). __ (ii) Alternate I (Oct 2001) of 52.219-9. __ (iii) Alternate II (Oct 2001) of 52.219-9. __ (iv) Alternate III (Jul 2010) of 52.219-9. _X_ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)). _X_ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). __ (18) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (19)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). __ (ii) Alternate I (June 2003) of 52.219-23. __ (20) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (21) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f). _X_ (23) 52.219-28, Post Award Small Business Program Representation (Apr 2012) (15 U.S.C. 632(a)(2)). __ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (15 U.S.C. 637(m)). __ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)). _X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (27) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126). _X_ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X_ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212). _X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). _X_ (32) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212). _X_ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X_ (34) 52.222-54, Employment Eligibility Verification (JUL 2012). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (37)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423). __ (ii) Alternate I (DEC 2007) of 52.223-16. _X_ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513). __ (39) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (40)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (May 2012) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, and 112-42). __ (ii) Alternate I (Mar 2012) of 52.225-3. __ (iii) Alternate II (Mar 2012) of 52.225-3. __ (iv) Alternate III (Mar 2012) of 52.225-3. __ (41) 52.225-5, Trade Agreements (MAY 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (42) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (45) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). _X_ (47) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (48) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (51)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). __ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: __ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 351, et seq.). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). __ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). __ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) [Reserved] (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (JUL 2012). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of clause) 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. (End of clause) 52.217-7 OPTION FOR INCREASED QUANTITY - SEPARATELY PRICE LINE ITEM (MAR 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. 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 address: http://farsite.hill.af.mil. (End of clause) VI. QUESTIONS Questions regarding this solicitation that requires clarification or additional information must be submitted in writing via e-mail to Christina Johnson at christina.johnson@usuhs.edu by May 13, 2013. The e-mails must reference solicitation number, HT9404-13-Q-0660 (subject header). Questions will not be answered over the phone. All questions will be addressed by an amendment to the solicitation. Questions received after May 13, 2013, 10:00 AM EST, will not be answered and will be considered late. All questions must reference the page number, section, and/or paragraph of the solicitation. It will be the responsibility of the contractor to check the website, http://www.fbo.gov, for any issuance of any amendments and/or updates to this requirement. VII. PROPOSAL SUBMISSION Email or mailed proposals will be accepted at christina.johnson@usuhs.edu. Facsimile proposals will not be accepted. Proposals submitted in this format will be rejected. Firms are advised that access onto the WRNNMC base and on base parking is restricted; therefore delivery in person is not advised. The Government will not consider proposals delayed at the security posts nor be responsible to provide base access. Proposals can be mailed to the following designated office: Uniformed Services University of the Health Sciences Contracting Directorate 4301 Jones Bridge Road Bldg. A, Rm. 1040C Bethesda, MD 20814-4799 Attn: Ms. Christina Johnson HT9404-13-Q-0660 Proposals are due on June 3, 2013 at 12:00 PM eastern local time. Late proposals will not be considered. It is the contractor's responsibility to ensure that proposals and completed past performance questionnaires arrive to the designated office by the closing date and time. All quoters are advised that registration in the System for Award Management (SAM) (https.//www.sam.gov) is mandatory. All contractors doing business with the Federal Government must be registered in the database. Quoters should include their Data Universal Numbering System (DUNS) number in their quotes. The CO will verify registration prior to award. Please ensure that a business size is listed for this requirement's applicable NAICS codes - 541690 and/or 541712. FAILURE TO COMPLETE THE REGISTRATION PROCEDURES OUTLINED IN THIS PROVISION MAY RESULT IN ELIMINATION FROM CONSIDERATION FOR AWARD.
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Place of Performance: Address: BETHESDA, MD, United States
Record: SN03048838-W 20130502/130430234829-beab636645a36dc8f26cfdd0905e43c6 (fbodaily.com)
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