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DETAILED IDENTIFICATION ASSAY SERVICES Federal contract opportunity
Solicitation number
W81XWH-13-T-0003
Issued by
Department of the Army Medical Command

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Section SF 1449 - CONTINUATION SHEET

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Each

DETAILED IDENTIFICATION ASSAY SERVICES

FFP

THE CONTRACTOR SHALL PROVIDE RESEARCH AND DEVELOPMENT SERVICES FOR CONDUCTING DETAILED IDENTIFICATION ASSAYS FOR BACTERIAL ISOLATES AS WELL AS GENERATING A RAPID TEST THAT PREDICTS EFFECTIVE ANTIBIOTIC TREATMENT.

SEE THE PERFORMANCE WORK STATEMENT FOR SPECIF INFORMATION.

FOB: Destination

MILSTRIP: W23MYC2145N239

PURCHASE REQUEST NUMBER: W23MYC2145N239

NET AMT

ITEM NO
SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1
Each

CONTRACTOR MANPOWER REPORTING

FFP

ANNUAL CONTRACTOR MANPOWER REQUIREMENT IN ACCORDANCE WITH USAMRAA CLAUSE 52.004-4000

FOB: Destination

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN
INSPECT AT
INSPECT BY
ACCEPT AT
ACCEPT BY
0001
Destination
Government
Destination
Government
0002
Destination
Government
Destination
Government

DELIVERY INFORMATION

CLIN
DELIVERY DATE
QUANTITY
SHIP TO ADDRESS
UIC
0001
POP 10-DEC-2012 TO

09-DEC-2013

N/A
FORT DETRICK

FORT DETRICK

1425 PORTER ST.

FREDERICK MD 21702

W23MYC

0002
09-DEC-2013
1
(SAME AS PREVIOUS LOCATION)

W23MYC

CLAUSES INCORPORATED BY REFERENCE

52.212-1
Instructions to Offerors--Commercial Items
FEB 2012
52.212-4
Contract Terms and Conditions--Commercial Items
FEB 2012
52.217-8
Option To Extend Services
NOV 1999
52.225-13
Restrictions on Certain Foreign Purchases
JUN 2008
52.233-4
Applicable Law for Breach of Contract Claim
OCT 2004
52.243-1
Changes--Fixed Price
AUG 1987
52.247-34
F.O.B. Destination
NOV 1991
52.249-8
Default (Fixed-Price Supply & Service)
APR 1984
52.253-1
Computer Generated Forms
JAN 1991
252.201-7000
Contracting Officer's Representative
DEC 1991
252.203-7002
Requirement to Inform Employees of Whistleblower Rights
JAN 2009
252.204-7001
Commercial And Government Entity (CAGE) Code Reporting
AUG 1999
252.204-7003
Control Of Government Personnel Work Product
APR 1992
252.232-7003
Electronic Submission of Payment Requests and Receiving Reports
JUN 2012

CLAUSES INCORPORATED BY FULL TEXT

CONTRACTOR MANPOWER REPORTING (CMR) - (ACCOUNTING FOR CONTRACT SERVICES) (APR 2011) (USAMRAA)

The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the contractor will report ALL contractor manpower (including sub-contractor manpower) required for performance of this contract. The contractor is required to completely fill in all the information in the format using the following web address: https://cmra.army.mil. The required information includes: (l) Contract Number; (2) Delivery Order Number (If applicable); (3) Task Order Number (If applicable); (4) Requiring Activity Unit Identification Code (UIC); (5) Command; (6) Contractor Contact Information; (7) Federal Service Code (FSC); (8) Direct Labor Hours; (9) Direct Labor Dollars; and, (10) Location. In the event the Contracting Officer's Representative (COR)/Contracting Officer's Technical Representative (COTR) has not entered their data requirements first, the contractor must also enter the COR/COTR required data with the exception of fund cite, obligations, and disbursement data. The CMRA help desk can be reach at 703-695-5103 or 703-695-5058 for any technical questions. The help desk can also be contacted via email: contractormanpower@hqda.army.mil. As part of its quote or offer, the contractor will also provide the estimated total cost (if any) incurred to comply with this reporting requirement. The reporting period will be the period of performance not to exceed 12 months ending 30 September of each government fiscal year and must be reported by 31 October of each calendar year.

ARMY ELECTRONIC INVOICING INSTRUCTIONS (FEB 2006)

Contractor shall submit payment request using the following method(s) as mutually agreed to by the Contractor, the Contracting Officer, the contract administration office, and the payment office.

__X_____ Wide Area Workflow (WAWF) (see instructions below)

________ Web Invoicing System (WInS)(https://ecweb.dfas.mil)

________ American National Standards Institute (ANSI) X.12 electronic data interchange (EDI) formats (http://www.X12.org and http://www.dfas.mil/ecedi)

________ Other (please specify)____________________________________

DFAS POC and Phone:____1-800-553-0527________________________________________

WAWF is the method to electronically process vendor request for payment. This application allows DOD vendors to submit and track Invoices and Receipt/Acceptance documents electronically.

Contractors using WAWF shall:

(i) register to use WAWF at https://wawf.eb.mil and

(ii) ensure an electronic business point of contact (POC) is designated in the Central Contractor Registration site at http://www.ccr.gov within ten (10) calendar days after award of this contract/order.

WAWF Instructions

Questions concerning payments should be directed to the Defense Finance and Accounting Service (DFAS)

Defense Finance and Accounting Services

DFAS ROME

325 Brooks Road

Customer Svc.

Rome NY 13441-4527

1-800-553-0527

Please have your purchase order/contract number ready when calling about payments.

You can easily access payment and receipt information using the DFAS web site at http://www.dfas.mil/money/vendor. Your purchase order/contract number or invoice number will be required to inquire about the status of your payment.

The following codes and information will be required to assure successful flow of WAWF documents.

TYPE OF DOCUMENT

________ Commercial Item Financing ________Construction Invoice (Contractor Only)

________ Invoice (Contractor Only)

________ (Invoice and Receiving Report COMBO)

___X_____ Invoice as 2-in-1 (Services Only)

________ Performance Based Payment (Government Only)

________ Progress Payment (Government Only)

________ Cost Voucher (Government Only)

________ Receiving Report (Government Only)

________ Receiving Report With Unique Identification (UID) Data (Government Only)

UID is a new globally unique “part identifier” containing data elements used to track DoD parts through their life cycle.

________ Summary Cost Voucher (Government Only)

VENDOR’S CAGE CODE: ___________

ISSUE BY DODAAC: W81XWH

ADMIN BY DODAAC: W81XWH

INSPECT BY DODAAC: W23MYC

ACCEPT BY DODAAC:

W23MYC

SHIP TO DODAAC: W23MYC

PAYMENT OFFICE FISCAL STATION CODE: _________

EMAIL POINTS OF CONTACT LISTING: See Additional Information section in the award.

USAMRAA.BLUE@AMEDD.ARMY.MIL

52.212-2 EVALUATION--COMMERCIAL ITEMS (JAN 1999)

A. EVALUATION CRITERIA

The award will be made based on the best value, competitive source selected proposal that is determined to be the most beneficial to the Government, with appropriate consideration given to the following evaluation factors: Technical Capability, Personnel Qualifications, Corporate Experience, Past Performance, and Price. Technical Capability and Personnel Qualifications are equal in importance and are considered more important than Corporate Experience and Past Performance. Corporate Experience and Past Performance are of equal importance. The Sub factors under each factor are of equal importance; However, price may become the deciding factor if proposals are evaluated and determined to be technically equivalent. To receive consideration for award, a rating of no less than "Acceptable" must be achieved for the Technical Capability and Personnel Qualifications factors. If upon final evaluation, an offeror is deemed "Unacceptable" or "High Risk" for any individual non-price factor, they may be excluded from award consideration.

1. PROPOSAL EVALUATION

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 non-price factors considered.

b. These principal non-price factors will be evaluated in each offeror's proposal and are deemed critical in evaluating technical proposals: technical approach, management approach, and past performance.

c. Any proposals that are unrealistic in terms of technical or schedule commitments or unrealistically high or low in cost and/or price will be deemed reflective of an inherent lack of technical competence or indicative of the offeror's failure to comprehend the complexity and risk of the contract requirements, and may be grounds for rejection of the proposal.

2. FACTORS FOR AWARD

a. TECHNICAL CAPABILITIES - Sub factors: Management Approach, Quality Control Plan and Training, Emergency & Occupational Health & Safety Program are of equal importance.

i. The Vendor shall demonstrate their ability to provide all labor, materials, and equipment to complete the tasks listed in the Performance Work Statement (PWS).

ii. Pricing shall be provided by the offeror for:

1. Developing detailed identification assays for bacterial isolates as well as generating a rapid test that predicts effective antibiotic treatment to include:

a. Selecting informative candidate oligonucleotides using previously conducted bioinformatic analyses and preliminary screening data for the target organism to identify candidate oligonucleotides.

i. Conduct literature searches to identify relevant antibiotic resistance and virulence factors and select oligonucleotides from genetic elements to include on the custom screening array design.

b. Identifying oligonucleotides that specifically hybridize to their respective targets and not closely related organisms or human background.

i. Oligonucleotides that have high selectivity will be used as the basis for development of multiplexed molecular assays for each of the target organisms.

ii. Test candidate oligonucleotides on the array against the eight target organisms, as well as against near neighbors and human DNA (background).

iii. Amplified material will be hybridized to the custom array containing all candidate oligonucleotides for all target organisms. Experiments will include 3 types of internal controls.

c. Developing both a multiplexed PCR-based molecular assay as well as a solution based real-time PCR multiplexed assay.

i. Highly discriminating species-level sequences will be selected to serve as oligonucleotides probes for the target organism.

ii. 2 — 4 oligonucleotides probes will be selected to identify genetic elements associated with virulence or antibiotic resistance.

iii. Pricing for this contract will not include an option year.

b. PERSONNEL QUALIFICATIONS — Sub factors: Key Personnel are of equal importance.

i. Provide well defined organizational structure chart showing levels of management personnel authority, including names of individuals involved specifically with this services. Describe ability to attract and retain high quality staff by providing a copy of the organizational recruitment and retention plan, and a detailed description of the organization's turnover rate by year for the last three years segregated into "management" and "nonmanagement" categories.

1. Key Personnel - The Offeror shall employ only qualified personnel to complete work as per the PWS, and provide proof of qualifications by submission of resumes with position description, training certificates and certifications and references if available on all proposed contract employees.

2. Personnel will have experience with bioinformatics, microarrays and molecular assay development to allow for the extrapolation of past efforts to future projects.

c. CORPORATE EXPERIENCE: The Offeror shall provide evidence of performance in selecting informative candidate oligonucleotides, identifying oligonucleotides that specifically hybridize to their respective targets, and developing both a multiplexed PCR-based molecular assay as well as a solution based real-time PCR multiplexed assay. Records maintenance and consulting service reports with a proven capability to maintain supporting documentation as required by the PWS will also be evaluated.

d. PAST PERFORMANCE: The Government will assess the degree of relevancy and success in past performance efforts in the past 3 years of a similar scope, size, complexity, and subject matter in accordance with the solicitation. This criterion is also assessed by the performance risk associated with an offeror's likelihood of success in performing the solicitation's requirements and quality as indicated by that offeror's record of current or past performance with the same or similar requirements. The Government will assess each Offeror's general corporate background, and recent success in managing similar or related work. Also, they will assess each Offeror's problems encountered in the performance of similar services and the description of how the problem(s) was/were resolved.

e. PRICE: The offeror shall provide their cost structure for performing the service. Price shall be evaluated to determine that proposed prices are fair and reasonable. Prices will be examined to determine appropriateness based on adequate price competition. Proposed prices will be compared with each offeror and will be used to determine which proposal offers the greatest value to the Government. This decision shall be based on a comparative assessment of proposals against all technical evaluation criteria in the solicitation and on the rationale for any business judgments and tradeoffs made, including benefits associated with additional costs. Offeror's are cautioned that the award may not necessarily be made to the lowest price offered.

B. EVALUATION CRITERIA

1. The evaluation factors will receive a rating of excellent, good, acceptable, or unacceptable. The following rating definitions will be used:

a. EXCELLENT: The offeror's proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior accomplishment of all requirements and objectives. This clearly attainable approach includes numerous advantageous characteristics of substance, and essentially no disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions, which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear, precise, fully supported, and demonstrate a clear understanding of the requirements.

b. GOOD: The proposal demonstrates a sound approach, which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions, which are considered feasible and practical. These solutions further demonstrate an understanding of the requirements.

c. ACCEPTABLE: The proposal demonstrates an approach, which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions are further considered to reflect moderate risk in that they are somewhat clear and precise, partially supported, and demonstrate a general understanding of the requirements.

d. UNACCEPTABLE: The proposal demonstrates an approach, which is based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has numerous disadvantages of substance, and advantages, which, if they exist, are far outweighed by disadvantages. Collectively, the advantages and disadvantages will not result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions, which are not feasible and practical. The solutions are further considered to reflect very high risk in that they lack any clarity or precision, are unsupported, and do not demonstrate an understanding of the requirement.

2. The evaluation factors will receive a rating of low risk, moderate risk, high risk, or unknown risk. The following rating definitions will be used:

a. LOW RISK: Little doubt exists, based on the offeror's performance record that the offeror can perform the proposed effort.

b. MODERATE RISK: Some doubt exists, based on the offeror's performance record, that the offeror can perform the proposed effort.

c. HIGH RISK: Significant doubt exists based on the offerors performance record that the offeror can perform the proposed effort.

d. UNKNOWN RISK: Little or no relevant performance record identifiable; equates to an unknown risk rating having no positive or negative evaluation significance.

3. The price evaluation factor will not receive a rating.

C. TRADE-OFF ANALYSIS

a. When making the source selection decision, the award will not necessarily be made to the lowest priced offer; however, the trade-off process does not preclude eventual selection of the lowest priced, acceptable offer as providing the best value. By applying trade-off analysis, each offer will be considered by examining the proposal attributes of each of the non-price factors, and the offered price as independent variables. This analysis necessitates tradeoffs be made between the non-price strengths and weaknesses, risks, and the price offered in each proposal. The Source Selection Authority will consider the strengths and weaknesses identified for each factor during the evaluation process and assess their impact on the acquisition objectives. The award is then made to the offeror who proposes the combination of factors which represents the best value based on the trade-off analysis.

b. The source selection decision document will describe the rationale for making the best-value award decision. If the lowest priced, acceptable offer is not selected, or the superior technical proposal is not selected the justification for making such a determination will be included in the source selection decision document.

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

E. 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)

52.212-5 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)).

___ 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 (SEP 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)).

_X__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUL 2010) (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). (Applies to contracts over $30,000). (Not applicable to subcontracts for the acquisition of commercially available off-the-shelf items).

___ (7) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (section 740 of Division C of Public Law 111-117, section 743 of Division D of Public Law 111-8, and section 745 of Division D of Public Law 110-161).

___ (8) 52.219-3, Notice of Total HUBZone Set-Aside or Sole-Source Award (JAN 2011) (15 U.S.C. 657a).

_X__ (9) 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).

___ (10) [Reserved].

___ (11)(i) 52.219-6, Notice of Total Small Business Set-Aside (JUNE 2003) (15 U.S.C. 644).

___ (ii) Alternate I (OCT 1995) of 52.219-6.

___ (iii) Alternate II (MAR 2004) of 52.219-6.

___ (12)(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__ (13) 52.219-8, Utilization of Small Business Concerns (JAN 2011) (15 U.S.C. 637 (d)(2) and (3)).

___ (14)(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.

___ (15) 52.219-14, Limitations on Subcontracting (DEC 1996) (15 U.S.C. 637(a)(14)).

___ (16) 52.219-16, Liquidated Damages--Subcontracting Plan (JAN 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (17)(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.

___ (18) 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).

___ (19) 52.219-26, Small Disadvantaged Business Participation Program--Incentive Subcontracting (OCT 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (20) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (MAY 2004) (U.S.C. 657 f).

___ (21) 52.219-28, Post Award Small Business Program Rerepresentation (APR 2009) (15 U.S.C. 632(a)(2)).

___ (22) 52.219-29 Notice of Total Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (APR 2011).

___ (23) 52.219-30 Notice of Total Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (APR 2011).

_X__ (24) 52.222-3, Convict Labor (JUNE 2003) (E.O. 11755).

___ (25) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (JUL 2010) (E.O. 13126).

___ (26) 52.222-21, Prohibition of Segregated Facilities (FEB 1999).

_X__ (27) 52.222-26, Equal Opportunity (MAR 2007) (E.O. 11246).

_X__ (28) 52.222-35, Equal Opportunity for Veterans (SEP 2010) (38 U.S.C. 4212).

_X__ (29) 52.222-36, Affirmative Action for Workers with Disabilities (OCT 2010) (29

U.S.C. 793).

__X__ (30) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

____ (31) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

___ (32) 52.222-54, Employment Eligibility Verification (JAN 2009). (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.)

___ (33) (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.)

___ (34) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b) ___ (35)(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. .

___ (36) 52.223-18, Contractor Policy to Ban Text Messaging while Driving (SEP 2010) (E.O. 13513).

___ (37) 52.225-1, Buy American Act--Supplies (JUNE 2003) (41 U.S.C. 10a-10d).

___ (38)(i) 52.225-3, Buy American Act--Free Trade Agreements--Israeli Trade Act (JUN 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138).

___ (ii) Alternate I (JAN 2004) of 52.225-3.

___ (iii) Alternate II (JAN 2004) of 52.225-3.

___ (39) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X__ (40) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (41) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (42) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (43) 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)) ___ (44) 52.232-30, Installment Payments for Commercial Items (OCT 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

_X__ (45) 52.232-33, Payment by Electronic Funds Transfer--Central Contractor Registration (OCT 2003) (31 U.S.C. 3332).

___ (46) 52.232-34, Payment by Electronic Funds Transfer--Other than Central Contractor Registration (MAY 1999) (31 U.S.C. 3332) ___ (47) 52.232-36, Payment by Third Party (FEB 2010) (31 U.S.C. 3332).

___ (48) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

___ (49)(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: (Contracting Officer check as appropriate.)

____ (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 U.S.C. 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 (SEP 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 1998) (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 (JAN 2009).

(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)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

WWW.ARNET.GOV

(End of clause)

252.212-7001 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS APPLICABLE TO DEFENSE ACQUISITIONS OF COMMERCIAL ITEMS (JUN 2012)

(End of clause)

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

CONTRACT FOR SERVICES: TO CONDUCT DETAILED IDENTIFICATION ASSAYS FOR BACTERIAL ISOLATES AS WELL AS GENERATING A RAPID TEST THAT PREDICTS EFFECTIVE ANTIBIOTIC TREATMENT.

1.0

PURCHASE, SERVICES, PERFORMANCE WORK STATEMENT (PWS), AND SCOPE

1.1 This contract shall provide for services rendered to Employees of the Bacteriology Division to select and evaluate informative candidate oligonucleotides and develop a Luminex-based multiplexed molecular assay that will assist in predicting effective antibiotic treatment.

1.2 The Contractor shall comply with Federal, State and Local laws, and regulations and standards applicable to the performance of this contract such as, but no limited to: Code of Federal Regulation (CFR), National Fire Protection Association Standards (NFPA), Underwriter's Laboratories Standards for Safety (UL), Occupational and Safety Health Act (OSHA), including

Lockout/Tag-out, American Society of Mechanical Engineers (ASME), the Food and Drug Administration (FDA), and Canadian Standards Association (CSA). The Contractor shall provide Material Safety Data Sheets (MSDS) to the Contracting Officer's Representative (COR) for all chemicals, fluids, solutions or materials contemplated for use in the performance of the contract as outlined in Title 29 CFR (Code of Federal Regulation) 1910 (General Industry Standards) and Title 40 CFR, Protection of the Environment. All materials shall be approved by the authorized Government Representative prior to introducing the material into USAMRIID. .

a. If a conflict in regulations occurs, the most stringent regulation shall apply.

b. Smoking is prohibited in any area of USAMRIID.

c. Eating and drinking is permitted only in designated areas upon approval of the Contracting Officer's Representative (COR).

1.3 The Contractor shall not accept any instruction issued by any person other than the Government

Contracting Officer (KO), or the Contracting Officer's Representative (COR) as long as it does not alter, change, or affect the legal terms of the contract.

1.4 The Contractor shall provide all the necessary trained and experienced personnel to develop a multiplexed molecular PCR based assay using the Luminex xMAP open architecture beaded array platform, as well as a real-time multiplexed molecular assay.

1.5 The period of performance for this project will be 1 year and will be required to be reported in the

Contracting Manpower Reporting Application (CMRA).

1.6 The Contractor shall have the ability and resources for telephonic, facsimile, and e-mail communications with the Government to transact business and discuss matters relating to the performance of this contract.

1.7 Equipment listed in this contract will be serviced and maintained to meet or exceed the original equipment manufacturers (OEM's) published specifications.

1.8 Acronyms and Definitions used in the text of this PWS are at Technical Exhibit 1 (TE-1).

1.9 Publications and Documents required for the completion of this contract are listed in Technical

Exhibit 2 (TE-2)

1.10 The Contractor may be required to maintain or establish a quality management system to ensure that the quality of the services, material provided, and documentation meet or exceed the specifications, terms, and conditions of this contract. At the discretion of the Government, an inspection of the contractor maintained quality management system may be conducted by the

COR or KO. Upon request of the Contracting Officer's Representative (COR), the Contractor shall participate in the quality assurance inspections. Further, the Contractor's quality management system may be required to meet the requirements of the International Organization for Standardization (ISO) 09001/9002 or ISO/IEC 17025, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

2.0

GOVERNMENT RESPONSIBILITY, PROPERTY, MATERIALS, AND SERVICES

2.1 Government property and materials made available to the Contractor under the terms of this contract shall be for used only to meet the performance requirements of this contract.

2.2 The Government, at its election, may furnish consumable or expendable supplies consumed during a normal procedural sequence when necessary for the completion of the required services. Consumable or expendable supplies may only be provided for work accomplished at the Government site. The Contractor must identify any and all other materials that are considered consumable or expendable and the Government must agree to provide said consumable and/or expendable. supplies.

2.3 The Government will provide the Contractor with all Government required forms and make available all Government publications referenced in this Performance Work Statement (PWS) when not normally available to the public or the Contractor. Final determination of availability rests with the Government.

2.4 The Government will not be responsible for damage or loss of the Contractor's materials or personal belongings, brought onto Government property, due to fire, theft, accident, or other disaster.

3.0 GOVERNMENT POINTS OF CONTACT (POC'S)

3.1 The Government KO will identify the Government's POC's and their responsibilities. The

Government COR(s) will be designated, in writing, to the Contractor and their scope of authority will be set forth therein.

3.2 Normal business hours for USAMRIID operations are from 0800 thru 1600, Monday through

Friday, Federal Holidays excluded.

4.0 CONTRACTOR POINTS OF CONTACT (POC'S)

4.1 The name and telephone number of the Contractor's POCs will be provided to the Government no later than the post orientation conference.

4.2 The Contractor shall provide, in writing, the name and telephone number, facsimile and email of a primary and alternate individual to act as their representative for the scheduling and coordination of calls, and to be responsible for the coordination of the contract with the Government. The Contracting Officer (KO) and Contracting Officer's Representative (COR) shall immediately be notified in writing whenever changes are made.

5.0 CONTRACTOR FURNISHED PROPERTY AND MATERIAL

5.1 Only the material referenced in paragraph 2, above will be furnished by the Government. All other material required in the performance of this contract shall be furnished by the Contractor.

5.2 The Contractor shall provide all service literature, and reference publications to be used by contractor personnel as required for the completion of the services in accordance with this PWS

5.3 The Contractor shall provide the COR or POC with reports at the beginning, at regular intervals during and also upon completion of the project. The reports shall include, but not be limited to: The Contract Number (PO), a detailed description of the service(s) performed, the completion date and time, and labor hours expended.

5.4 The Contractor shall provide all supporting documentation not provided with the report within three (3) work days of the service completion date.

6.0

CONTRACTOR RESPONSIBILITY

6.1 The Contractor shall provide to the Government detailed identification assays for bacterial isolates as well as generating a rapid test that predicts effective antibiotic treatment.

a. The Contractor will select informative candidate oligonucleotides using previously conducted bioinformatic analyses and preliminary screening data for the target organism to identify candidate oligonucleotides.

6.1.a.1 Conduct literature searches to identify relevant antibiotic resistance and virulence factors and select oligonucleotides from genetic elements to include on the custom screening array design.

b. Identify oligonucleotides that specifically hybridize to their respective targets and not closely related organisms or human background.

6.1.b.1 Oligonucleotides that have high selectivity will be used as the basis for development of multiplexed molecular assays for each of the target organisms.

6.1.b.2 Test candidate oligonucleotides on the array against the eight target organisms, as well as against near neighbors and human DNA (background).

6.1.b.3 Amplified material will be hybridized to the custom array containing all candidate oligonucleotides for all target organisms. Experiments will include 3 types of internal controls.

c. Develop both a multiplexed PCR-based molecular assay as well as a solution based real-time PCR multiplexed assay.

6.1.c.1 Highly discriminating species-level sequences will be selected to serve as oligonucleotides probes for the target organism.

6.1.c.2 2 — 4 oligonucleotides probes will be selected to identify genetic elements associated with virulence or antibiotic resistance.

6.2 All test, measurement or diagnostic equipment (TMDE) used in the performance of this contract will be routinely calibrated and the calibration traceable to a national standard (NIST). The calibration shall not have expired when used to trouble-shoot, verify or calibrate the equipment being serviced.

6.3 Reports shall be provided to the COR by the Contractor during the initial submission, and then by monthly status reports with both electronic and hard copies.

6.4 The Contractor shall not be penalized financially or otherwise for delays caused by the

Government.

6.5 The Contractor shall provide to the COR, for each billing period, their invoice for payment. The invoice may be used by the Government to aid in verifying the Contractor's performance.

6.6 Contractor shall request payment and invoice via Wide Area Work Flow (WAWF) per the following schedule: IN ARREARS

TECHNICAL EXHIBIT -1

(TE-1)

ACRONYMS

ASME: American Society of Mechanical Engineers

BMBL: Biosafety in Microbiological and Biomedical Laboratories (BMBL, published by the US Department of Health and Human Services/CDC-NIH), CFR: Code of Federal Regulations

CMRA: Contract Manpower Reporting Application

COR: Contracting Officers Representative.

CSA: Canadian Standards Association

DTRA: Defense Threat Reduction Agency

ECG/EKG: Electrocardiogram

FDA: Food and Drug Administration FSE: Field Service Engineer.

GIS: General Industry Standards GLP: Good Laboratory Practices GMP: Good Manufacturing Practices IND: Investigational New Drug

ISO: International Organization for Standardization

KO: Contracting Officer.

KR: Contractor.

MMCN: Material management Control Number.

MSDS: Material Safety Data Sheet. NAC: National Agency Check.

NACLAC: National Agency Check with Law and Credit Coverage.

NFPA: National Fire Protection Association.

NHP: Non-Human Primate

NIST: National Institute of Standards and Technology.

OEM: Original Equipment Manufacturer

OSHA: Occupational Safety and Health Administration.

POC: Point of Contact.

SIP: Special Immunizations Program. SOW: Statement of Work.

TMDE: Test Measurement and Diagnostic Equipment.

TMTI: Transformational Medical Technologies Initiative

UL: Underwriters Laboratories Inc.

USAMRIID: United States Army Medical Research Institute of Infectious Diseases.

WAWF: Wide Area Work Flow.

DEFINITIONS

CONTRACTING OFFICER (KO): A Government employee with the expressed authority to enter into, administer, and/or terminate contracts, and to make related determinations and findings.

CONTRACTING OFFICERS REPRESENTATIVE (COR): A Government employee, appointed and delegated with certain duties and responsibilities in writing by the KO, normally to provide technical direction, clarification and guidance, and for monitoring and ensuring satisfactory performance of the contract.

POINT OF CONTACT (POC): A person who is authorized by the KO as their representative at the work site who has the authority to request services and performance of the contractor against this contract. The COR has this authority as well.

QUALITY CONTROL PLAN (QCP): The Contractor's written plan will ensure the performance of the services required by the contract are met or exceeded. At a minimum the Contractor's Quality Control Plan will include:

1. Suggested inspection intervals and checklists to be used by the contractors QA inspector.

2. Contractor's management and supervision process.

TECHNICAL EXHIBIT — 2

(TE-2)

PUBLICATIONS AND DOCUMENTS

Documents applicable to this contract are listed below. The documents have been coded as advisory (A) or mandatory (M). The Contractor shall follow those coded as mandatory, but only to the extent specified in this specification when the document is referenced herein. Army publications will be available at the start of the contract. The Contractor will be notified of pertinent supplements or amendments to mandatory publications issued during the life of the contract. Supplements or amendments will be incorporated by a contract modification issued by the Contracting Officer.

OTHER REGULATORY DOCUMENTS: (A)

21 CFR Codes of Federal Regulations, Title 21, Food and Drugs, Part 0800 to 1299 (Includes Regulations for the Administration and Enforcement of the Radiation Control for Health and Safety Act of 1968)

QUALITY ASSURANCE SURV

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

NOTOCORD, INC.

2.1. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). The purpose of this section is to define performance evaluation procedures. The Surveillance Plan describes what the government will survey. The absence of any contract requirement from the QASP shall not detract from its enforceability nor limit the rights or remedies of the government under any other provision of this contract, including the clauses entitled, "Inspection of Services" and "Default." The government has the right to inspect all services required in the contract.

2.1.1. The Performance Requirement is set forth in Column #1. 2.1.2. The Performance Standard is set forth in Column #2.

2.1.3. The Acceptable Quality Level for each Requirement is set forth in Column #3.

2.1.4. The Surveillance Method and Frequency for each requirement is set forth in Column #4.

2.2. GOVERNMENT QUALITY ASSURANCE. Contractor performance will be compared to the Contract Performance Standards and the QASP. The government may use a variety of surveillance methods to evaluate the contractor's performance to determine if it meets the contract standards. The methods used on the contract are:

2.2.1. One Hundred Percent Inspection of the output items. 2.2.2. Periodic Inspection of the processes or output items. 2.2.3. Customer Complaints

2.2.4 Random Sampling

2.3. PERFORMANCE EVALUATION. Performance of a service will be an evaluation to determine whether or not it meets the performance threshold of the contract. When the performance threshold is not met, a Contract Discrepancy Report (CDR) will be issued to the contractor by the Contracting Officer's Representative (COR). The contractor shall respond to the CDR by completing the form and returning it to the COR within 15 calendar days of receipt.

2.4. QUALITY ASSURANCE SURVEILLANCE PLAN TABLE

Performance
Performance
Acceptable Quality
Method of

Surveillance and

Requirement
Standard
Level

Frequency

Select Informative candidate oligonucleotides Contractor Is Responsible For Coordinating And Ensuring PWS Compliance

100% Compliance
COR Observation

Identify oligonucleotides that specifically hybridize to their respective targets Contractor Is Responsible For Coordinating And Ensuring PWS

Compliance

100% Compliance
COR Observation

Develop a multiplexed PCR-based molecular assay Contractor Is Responsible For Coordinating And Ensuring PWS Compliance

100% Compliance
Review Of Records, Reports, and Data with COR Observation and Technical Inspection

Develop a solution based real-time PCR multiplexed assay Contractor Is Responsible For Coordinating And Ensuring PWS Compliance

100% Compliance Review Of Records, Reports, and Data with COR Observation and Technical Inspection

Contractor Will Maintain a Single Project Schedule From Which Various Project Reports Shall Be Produced Initial, Monthly, and Quarterly Status

Reports With a Minimum Of Three (3)

Phone Conferences.

Reports shall include

Both Electronic And

Hard Copies

100% Compliance.
Status Reports with

COR Observation

Provide Invoices to COR For Payment.

Invoices May Be Used To Aid In Verifying Performance In Accordance With The Performance Work Statement.

100% Compliance
Proper Documentation Provided Initially and Then Quarterly With COR Observation

File details come from the government source that posted it. Updated .