Solicitation_Post_0052.pdf

SEE ADDENDUM

(No Collect Calls)

W81XWH-17-R-0052 05-Jul-2015

b. TELEPHONE NUMBER

(301) 619-2359

8. OFFER DUE DATE/LOCAL TIME

09:00 AM 24 Jul 2017

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81XWH9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

JORGENSEN, RYAN

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

0010987391

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE W23MYC 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

FORT DETRICK-USAMRIID

MS JENNIFER L. AUDET

1425 PORTER STREET

FORT DETRICK MD 21702-5011

TEL: 301-619-0370 FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

$32,500,000

NAICS:

621511

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

PAGE 2 OF21

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81XWH-17-R-0052

Section SF 1449 - CONTINUATION SHEET

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job Small Molecule Synthesis

FFP

Small Molecule Synthesis work describe in the PWS.

FOB: Destination

PURCHASE REQUEST NUMBER: 0010987391

NET AMT

1001 1 Job OPTION Small Molecule Synthesis

FFP

Small Molecule Synthesis work describe in the PWS.

2001 1 Job OPTION Small Molecule Synthesis

FFP

3001 1 Job OPTION Small Molecule Synthesis

FFP

4001 1 Job OPTION Small Molecule Synthesis

FFP

PERFORMANCE WORK STATEMENT

Synthesis of Novel Therapeutic Candidates

PERFORMANCE WORK STATEMENT (PWS) (For Commercial Services)

1. INTRODUCTION

Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information—that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S.

Army Medical Research and Materiel Command at Fort Detrick, located in Frederick, MD.

The number of FDA approved therapeutics has increased over the past 10 years; however, there are still no approved therapeutic treatments for various biothreat agents, such as alphaviruses, Burkholderia pseudomallei, and Klebsiella pneumonia. Various programs at USAMRIID have focused on the screening of various novel small molecules as potential therapeutics to treat these biothreat agents. The purpose of this requirement is to identify a source to conduct synthesis of lead candidates to support further evaluation of these molecules in vivo.

2. BACKGROUND

USAMRIID has an extensive program focused on the development of therapeutic medical countermeasures against high priority biothreat agents, including alphaviruses, Burkholderia pseudomallei, and emerging threat pathogens.

This core team of individuals utilizes a pharmaceutical industry drug development model to design, screen and select those small molecules and multi-functional antibodies with the requisite properties to achieve regulatory approval from the US Food and Drug Administration (FDA). Key activities include the design of new chemical entities (NCEs), in vitro screening against a panel of biothreat agents and supporting activities, such as in vitro absorption, distribution, metabolism, and excretion (ADME), in vivo pharmacokinetics (pK), toxicology profiles, and proof-of-concept studies. In order to support these key activities, it will be necessary to synthesize newly designed NCEs and scale-up many of the lead candidate small molecules; therefore, establishing a service requirement for small molecule synthesis is important.

3. SCOPE

Over a course of a minimum of five years, USAMRIID is requiring synthesis of 190-300 novel small molecule inhibitor analogs, including nucleoside analogs and their corresponding monophosphate prodrugs. The synthesis process may require anywhere between 1 and 5 synthetic steps for non-nucleoside analogs, between 4 and 8 steps for nucleosides or between 6 and 10 steps for nucleoside monophosphate prodrugs. Additionally, based on the characteristics of the inhibitor, the quantity needed to be synthesized may be different for each small molecule candidate.

4. CONTRACTOR REQUIREMENTS

a. Contractor must have Standard Operating Procedures (SOP’s) in place for performing all relevant reaction, reaction workup, reaction product purification and product analysis processes;

b. Contractor shall provide a copy of their Quality Control Plan, including self-inspection plan, an internal staffing plan, and outline of the procedures that the offeror will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

c. Contractor must have a Chemical Hygiene Plan and all relevant safety SOP’s in place.

d. Contractor must have the proper facilities, infrastructure, instrumentation and equipment to carry out efficient syntheses, purifications and characterizations of target compounds.

e. For the synthesis of small molecules requiring 1-3 synthetic steps from a common intermediate, Contractor must have the capability to perform the synthesis of 20-50 analogs in parallel.

f. Contractor must have a demonstrated ability to perform multi-step synthesis, characterization and delivery of novel small molecules in a timely manner and of sufficient quantity and purity.

g. The Contractor should have multi-year experience for synthesizing novel small molecules.

h. The Contractor should employ a team of experienced synthetic chemists working on the bench, each with either a MS or PhD degree in Organic Chemistry and >2 years of industry experience. In addition, the chemistry team should be managed by a PhD Organic or Medicinal Chemist with at least 8 years of industry experience.

i. The Contractor must have access to the Organic/Synthetic chemistry literature and chemical databases such as Reaxys or SciFinder.

5. TECHNICAL / PERFORMANCE REQUIREMENTS

BASE PERIOD (08/01/2017 – 07/31/2018)

Objective: Contractor shall synthesize novel small molecules defined by USAMRIID. USAMRIID will provide the Contractor with the structures of compounds to be synthesized over 3-4 iterative cycles per performance period.

The synthesis, purification, characterization and delivery of novel small molecules including some nucleoside analogs will occur in three (3) major Milestones.

The requirements for the services, data and materials to be provided by the Contractor are expected to meet the following performance characteristics for the following milestones for each performance period:

Milestone 1: Small molecule synthesis – synthesis of up to 100 novel small molecules (10-25 mg each at ≥95% purity; 1-4 synthetic steps from a common intermediate). All products analyzed/characterized by LCMS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data.

Milestone 2: Re-synthesis of novel small molecules – re-synthesis of up to 4 non-nucleoside small molecules (500 mg - 1 g each at ≥95% purity; 2-5 synthetic steps). Re-synthesis of up to 2 nucleosides or nucleoside monophosphate prodrugs (500 mg – 1 g each at ≥95% purity; 4-10 synthetic steps). All products analyzed/characterized by HPLC, MS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data.

Milestone 3: Synthesis of nucleoside analogs and/or corresponding monophosphate prodrugs – synthesis of up to 10 nucleoside and/or nucleoside monophosphate prodrug analogs (10-25 mg each at >95% purity; 4-10 synthetic steps).

All products analyzed/characterized by LCMS and 1H NMR and delivered as dry solids in glass vials along with their corresponding spectral data.

OPTION PERIODS (Years 2, 3, 4, and 5) (12 months each)

Objective: Contractor shall continue to provide support for the synthesis, purification, characterization and delivery of novel small molecules defined by USAMRIID as outlined in the base year and repeated for each additional performance year. The number of nucleoside analogs for milestones 2 and 3 may be increased by USAMRIID in the Option Periods.

USAMRIID will use the novel small molecules and nucleoside analogs to:

• Evaluate the in vitro inhibitory effects against Burkholderia pseudomallei (Bp), Klebsiella pneumonia (Kp), and various viral targets including Alphaviruses.

• Evaluate the in vitro ADME properties of active compounds.

• Evaluate the in vivo PK and tolerability of active compounds.

• Evaluate the in vivo efficacy and protection against Burkholderia pseudomallei (Bp), Klebsiella pneumonia (Kp), and various viral targets including Alphaviruses.

6. DELIVERABLES

a. The Contactor shall synthesize up to 115 candidate small molecules including nucleoside analogs and their corresponding monophosphate prodrugs, in the 9 month base period, as described in Technical/Performance Requirements: Section 5. Up to 340 small molecules to be synthesized within the first three years.

b. The Contractor shall meet the three (3) Milestones of this requirement as detailed in Technical/Performance Requirements: Section 5 in the base period and option years.

c. Contractor shall ship all completed synthesized final products to USAMRIID on a monthly basis, and provide to USAMRIID a corresponding monthly report in electronic form of all synthesized small molecules produced during that month. The report shall include general synthesis protocols and spectral data (LCMS and 1H NMR) for each final product and their corresponding intermediates.

d. Purity of all delivered small molecule final products will be ≥95%.

e. The Contractor shall confirm that all synthesized small molecules are characterized (LCMS and 1H NMR) before being shipped to USAMRIID for testing.

f. Data: The Contractor shall provide the compilation of all electronic and/or hard copy data to the USAMRIID Project Lead/PI and COR on an annual basis no later than fifteen (15) calendar days from the end date of the period of performance.

g. Summary Reports will be provided by the Contractor within fifteen (15) days after the completion of each Milestone as detailed in Section 5.

h. The COR is required to submit to the Contract Specialist and Contracting Officer a monthly report concerning performance of services rendered under this contract based on Paragraph 7: Quality Assurance Surveillance Plan, as described in Attachment A.

i. The Contractor shall report contract�related information in accordance with the Contractor Manpower Reporting (CMR) clause by 31 October of each year to the CMR website at: https://cmra.army.mil

7. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The QASP is a tool used by the Government (i.e. COR) as a way to assess contractor performance. The following performance based service acquisition items will be monitored under this QASP and shall be uploaded to the Virtual Contractor Enterprise (VCE) at https://cor.army.mil on a monthly basis by the COR:

Surveillance Activity Checklist Contract No. XXXXXXXXX Contract Requirement Method of Surveillance Standard Acceptable Quality Level Incentive Milestone 1: Small molecule synthesis Biweekly teleconf, Monthly report of synthesis With ≥95% purity; endotoxin and contaminant free. At the minimum quantity described in Section 5; milestone 1.

Favorable Past Performance Rating Milestone 2: Re-synthesis of novel small molecules Biweekly teleconf, Monthly report of synthesis Synthesize up to 6 candidate small molecules with ≥95% purity; endotoxin and contaminant free. At the minimum quantity described in Section 5; Milestone 2. Favorable Past Performance Rating Milestone 3: Synthesis of nucleoside analogs and/or corresponding monophosphate prodrugs Biweekly teleconf, Monthly report of synthesis Synthesize up to 10 nucleoside analogs and/or their corresponding prodrug analogs with ≥95% purity; endotoxin and contaminant free. At the minimum quantity described in Section 5; Milestone 3. Favorable Past Performance Rating Timely receipt of synthesized compounds Evaluation of deliverable deadlines Receipt of required material Monthly Favorable Past Performance Rating Timely receipt of Summary Reports Evaluation of deliverable deadlines Review of Monthly Reports After the completion of each Milestone Favorable Past Performance Rating

8. PERIOD OF PERFORMANCE

The anticipated period of performance is 01 01 August 2017 through 31 July 2022

(4) renewal option years (12 months each).

9. PLACE OF PERFORMANCE

The place of performance is the Contractor’s facility; no work is required to be conducted at USAMRIID by the Contractor.

10. GOVERNMENT FURNISHED INFOMRATION, FACILITIES,SUPPLIES, AND SERVICES

a) USAMRIID will make available to the contractor the structures of small molecules to be synthesized. If needed, USAMRIID will provide potential synthetic routes for their preparation.

b) All structural, synthetic and biological information and data that is either shared or generated through this contract remains the sole property of the US Government and must not be shared with a third party.

11. SECURITY AND SAFEGUARD METHODS

a) The contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The contractor shall ensure the confidentiality, integrity, and availability of Government data is in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFARS Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management.

12. ANTITERRORISM / OPERATIONS SECURITY REQUIREMENTS

Documented in file

13. TRAVEL

The Government authorizes up to two (2) annual trips to meet with USAMRIID personnel to discuss service details for the base year and one (1) annual trip for each option year thereafter. Meeting location will be at USAMRIID (Fort Detrick) in Frederick, MD. All Contractor personnel must be a U.S. citizen or provide documentation of clearance to enter USAMRIID (i.e. Passport and/or VISA information, citizenship, etc.). Government allowable travel costs shall be reimbursed in accordance with the Joint Travel Regulations.

14. CONTRACTOR MANPOWER REPORTING

Input for Contract Services information in the web site operated and maintained by the Assistant Secretary of the Army (Manpower & Reserve Affairs). See the "Contractor Manpower Reporting" clause for specific reporting information. 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. The contractor shall provide evidence of compliance with the CMR requirement to the Contractor Officer's Representative, Contract Specialist, and Contracting Officer no later than 15 November of each calendar year.

QASP

QUALITY ASSURANCE SURVEILLANCE PLAN

For Synthesis of Novel Therapeutic Candidates Contract Number: W81XWH-XX-C-XXXX Contractor Name: ENTER AT TIME OF AWARD

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

• What will be monitored

• How monitoring will take place

• Who will conduct the monitoring

• How monitoring efforts and results will be documented

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

FAR 52.246-5 Inspection of Services – Cost-Reimbursement, applies to this effort

2. AUTHORITY

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

3. ROLES AND RESPONSIBILITIES:

The following personnel shall oversee and coordinate surveillance activities.

3.1. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: TO BE ENTERED AT TIME OF AWARD Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: TO BE ENETRED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

3.2. Contracting Officer’s Representative (COR) – The COR will be located at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The COR will be responsible for technical administration of the contract, and shall assure proper Government surveillance of the contractor’s performance with the assistance of two Contracting Officer’s Technical Representatives (COTRs). The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned COR: LTC Todd Kijek Title: Molecular and Translational Sciences Division Chief Telephone: 301-619-8256 Email: todd.m.kijek.mil@mail.mil

3.3. Contracting Officer’s Technical Representative (COTR) – There will be one COTR responsible for assisting the COR in technical administration of the contract, and they shall assist the COR in assuring proper Government surveillance of the contractor’s performance. The COTRs may include performance monitors, inspectors, technical experts, or other who provide information the helps the COR monitor contractor performance.

A COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action. The COTR is as follows:

Assigned COTR: TO BE ENTERED AT TIME OF AWARD Title: TO BE ENTERED AT TIME OF AWARD Telephone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

3.4. Contractor Representatives – The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract.

Program Manager Name: TO BE ENTERED AT TIME OF AWARD Title/Role: TO BE ENTERED AT TIME OF AWARD Telephone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

Task Manager Name: TO BE ENTERED AT TIME OF AWARD Title/Role: TO BE ENTERED AT TIME OF AWARD Telephone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

Other Key Contract Personnel - TO BE ENTERED AT TIME OF AWARD

4. PERFORMANCE REQUIREMENTS AND METHOD OF SURVEILLANCE

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

4.1. Contract Surveillance:

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The CORs contribution is their professional, non-adversarial relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance. Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

4.2. Methods of Surveillance:

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

• Review of Summery Reports (various)

• Receipt of vaccine and control product (various)

• Receipt of raw data files and analyzed data (various)

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

• DIRECT OBSERVATION - Can be performed periodically or through 100% surveillance.

• MANAGEMENT INFORMATION SYSTEMS (MIS) - Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.

• PERIODIC INSPECTION - Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

o Analysis of contractor's progress reports - Evaluate cost, schedule, etc.

o Performance reporting.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

4.3. Surveillance Matrix:

The Surveillance Matrix Table 1 is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Table 1. Surveillance Matrix for Arenavirus Mechanism of Action Evaluation Surveillance Activity Checklist Contract No. XXXXXXXXX Contract Requirement Method of Surveillance Standard Acceptable Quality Level Incentive Milestone 1: Small molecule synthesis Biweekly teleconf, Monthly report of synthesis With ≥95% purity; endotoxin and contaminant free. At the minimum quantity described in Section 5; milestone 1.

Favorable Past Performance Rating Milestone 2: Re-synthesis of novel small molecules Biweekly teleconf, Monthly report of synthesis With ≥95% purity; endotoxin and contaminant free. At the minimum quantity described in Section 5; Milestone 2.

Favorable Past Performance Rating Milestone 3: Synthesis of nucleoside analogs and/or corresponding monophosphate prodrugs Biweekly teleconf, Monthly report of synthesis With ≥95% purity; endotoxin and contaminant free. At the minimum quantity described in Section 5; Milestone 3. Favorable Past Performance Rating Timely receipt of synthesized compounds Evaluation of deliverable deadlines Receipt of required material Monthly Favorable Past Performance Rating Timely receipt of Summary Reports Evaluation of deliverable deadlines Review of Monthly Reports After the completion of each Milestone Favorable Past Performance Rating

5. RATINGS:

Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance.

The Government performs surveillance, using this QASP, to determine the quality of the contractor's performance as it relates to the performance element standards. The matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of contractor’s performance, the following performance ratings may be used.

Performance Rating Criteria Exceptional Performance meets contractual requirements and exceeds many to the Government’s benefit. The element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Satisfactory Performance meets contractual requirements. The element being assessed contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The element being assessed contains a serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

6. DOCUMENTING PERFORMANCE:

6.1. Acceptable Performance - The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

6.2. Unacceptable Performance - When unacceptable performance occurs, the COR shall inform the contractor.

This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

7. FREQUENCY OF MEASUREMENT:

7.1. Frequency of Measurement - During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

7.2. Frequency of Performance Assessment Meetings - The COR shall meet with the contractor quarterly to assess performance and shall provide a written assessment.

PERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACT/TASK ORDER NUMBER 2. CONTRACTOR 3. TYPE OF SERVICES

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE 5. COR PHONE 6. SUSPENSE

DATE

I. PERFORMANCE

7. 0 DEFICIENCY (CHECK ALL BOXES THAT APPLY)

0 NEW

0 REPEAT

0 NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF DEFICIENCY BOX WAS CHECKED) 10. DETAILED

PERFORMANCE ASSESSMENT

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE 0 CONCUR 0 NON-CONCUR

12. CORRECTIVE ACTION ESTIMATED COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE

OR REASON FOR NON-CONCURRENCE OF COR CITED DEFICIENCY

III. ACTION CORRECTED

14. 0 CONCUR 0 NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS

CUSTOMER COMPLAINT RECORD

DATE/TIME OF COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION

BUILDING NUMBER

INDIVIDUAL

PHONE NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

CORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR

2. CONTRACT NUMBER

3. TYPE OF SERVICES

4. FUNCTIONAL AREA

5. SUSPENSE DATE

6. CONTROL NUMBER

7. DEFICIENCY 0 MAJOR 0 MINOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE

SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE

SIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT

RECURRENCE

11. COR DETERMINATION

0 ACCEPTED 0 REJECTED

12. CLOSE DATE

EVALUATION CRITERIA

EVALUATION CRITERIA

For Synthesis of Novel Therapeutic Candidates

A. BASIS FOR AWARD

The award will be made based on the best overall (i.e., best value) proposal that is determined to be the most beneficial to the Government, with appropriate consideration given to the following evaluation factors:

Technical Capability Quality Control Plan Past Performance Price

Technical Capability and Quality Control Plan are equal in importance and are considered more important than Past Performance. The Subfactors 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 Quality Control Plan factors.

If upon final evaluation, an offeror is deemed “Unacceptable” or “High Risk” for any individual non-price factor, they shall be excluded from award consideration.

B. EVALUATION CRITERIA

1. The non-price evaluation factors (Technical Capability and Quality Control Plan) will each receive a rating of Excellent, Good, Acceptable, Marginal, or Unacceptable.

Technical Capability – is a demonstration that which the offeror understands the requirement and a detailed explanation of how the offeror intends to successfully perform the requirement. That is, an understanding of the tasks required and to be performed as well as methodology and flexibility in performing the requirement within the timeframe allotted.

Quality Control Plan (QCP) – is a demonstration of how offeror complies with the quality standard established in the PWS. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures will use to maintain quality, timeliness, responsiveness, customer satisfaction.

The following rating definitions will be used:

• Excellent – The offeror’s proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. This clearly achievable 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.

• 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.

• 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.

• Marginal – The proposal that satisfies all of the Government's requirements with minimum detail to indicate feasibility of approach and shows a minimal understanding of the problem with an overall high degree of risk in meeting the Government's requirement.

• 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 non-cost evaluation factor Past Performance, will receive a rating of Low Risk, Moderate Risk, High Risk, or Unknown Risk.

Past Performance – Relevancy in nature (i.e. similar in scope and magnitude/size) and regency (usually within the last 3 years).

The following rating definitions will be used:

• Low Risk – Little doubt exists, based on the offeror's performance record that the offeror can perform the proposed effort.

• Moderate Risk – Some doubt exists, based on the offeror's performance record, that the offeror can perform the proposed effort.

• High Risk – Significant doubt exists based on the offeror's performance record that the offeror can perform the proposed effort.

• Unknown Risk – Little or no relevant performance record identifiable; equates to an unknown risk rating having no positive or negative evaluation significance.

3. Price will not receive a rating.

C. TRADE-OFF ANALYSIS

1. When making the source selection decision, the award is not necessarily 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 (i.e. Technical Capability, Quality Control Plan and Past Performance), and the offered price as independent variables. This analysis necessitates tradeoffs be made between the non-price strengths and weaknesses, risks, and price offered in each proposal. The Source Selection Authority (SSA) will consider the strengths and weaknesses identified for each factor during the evaluation process and assess their impact on the acquisition objectives. The SSA will assess the best mix of price and non-price benefits. 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.

2. 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.

3. The SSA must document his/her rationale for selecting the successful offeror(s) in an independent, standalone document. The source selection decision document should explain how the successful proposal(s) compared to other offerors’ proposals based on the evaluation factors and sub factors in the solicitation and should discuss the judgment used in making tradeoffs. In the event that the SSA disagrees with a finding(s) of the Source Selection Evaluation Board (SSEB), the SSA’s rationale shall be part of the decision document.

4. When the SSA determines that the best value proposal is other than the lowest-priced proposal, the document must explicitly justify paying a price premium regardless of the superiority of the proposal's non-cost rating. The justification must clearly state what benefits or advantages the Government is receiving for the added price and why it is the Government's interest to expend the additional funds. This justification is required even when the solicitation indicates that non-cost factors are more important than cost price. When the SSA determines the non-cost benefits offered by the higher-priced, technically superior proposal are not worth the price premium, an explicit justification is also necessary.

MINIMUM ESSSENTIAL CRITERIA

Minimum Essential Characteristics For Synthesis of Novel Therapeutic Candidates

1. Contractor must have a demonstrated ability to synthesize, purify, and characterize novel small molecules.

2. Contractor should have multi-year experience in synthesizing novel small molecules.

3. Contractor should have multi-year experience in performing multi-step syntheses, characterization, and delivery of novel small molecules in a timely manner.

4. Contractor must be able to deliver small molecule final products with no less than ≥95% purity.

5. Contractor must be able to provide small molecule final products that are free endotoxin and contaminants.

6. Contractor must have CURRENT Standard Operating Procedures (SOPs) for all relevant process to synthesize, purify and characterize novel compounds.

7. Contractor shall have a Quality Control Plan, including self-inspection plan, an internal staffing plan, and outline of the procedures that the Offeror will use to maintain quality, timeliness, responsiveness, and customer satisfaction.

8. Contractor shall have a Chemical Hygiene Plan and CURRENT safety SOP’s.

9. Contactor must have all relevant safety and biosafety SOPs in place.

10. Contractor must have the proper facilities, infrastructure, instrumentation, and equipment to carry out efficient syntheses, purifications, and characterizations of novel small molecules.

11. Contactor must have the capability to synthesize up to 115 candidate small molecules including nucleoside analogs and their corresponding monophosphate prodrugs, in the 9 month base period and up to 340 small molecules to be synthesized within the first three years.

12. Contractor shall ship all completed synthesized final products to USAMRIID on a monthly basis, and provide to USAMRIID a corresponding monthly report in electronic form of all synthesized small molecules produced during that month.

13. Contractor shall provide a technical data report to include general synthesis protocols and spectral data (LCMS and 1H NMR) for each final product and their corresponding intermediates.

14. Contractor should have access to the Organic/Synthetic chemistry literature and chemical databases such as Reaxys and SciFinder.

15. Contractor shall provide all electronic and/or hard copy data and materials to USAMRIID.

16. Contractor should provide a validation plan for both assays and processes with timelines (including justifications for the timeline) as part of the submission should also be provided.

17. Progress must be monitored quarterly and annually. USAMRIID reserves the right to review all vendors for sufficiency.

18. The Contractor should employ a team of experienced synthetic chemists working on the bench, each with either a MS or PhD degree in Organic Chemistry and >2 years of industry experience. In addition, the chemistry team should be managed by a PhD Organic or Medicinal Chemist with at least 8 years of industry experience.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A Government 1001 N/A N/A N/A Government 2001 N/A N/A N/A Government 3001 N/A N/A N/A Government 4001 N/A N/A N/A Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 POP 01-AUG-2017 TO

31-JUL-2018

N/A FORT DETRICK-USAMRIID

MS JENNIFER L. AUDET

1425 PORTER STREET

FORT DETRICK MD 21702-5011

301-619-0370

W23MYC

1001 POP 01-AUG-2018 TO

31-JUL-2019

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-AUG-2019 TO

31-JUL-2020

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-AUG-2020 TO

31-JUL-2021

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-AUG-2021 TO

31-JUL-2022

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013 52.203-3 Gratuities APR 1984 52.203-5 Covenant Against Contingent Fees MAY 2014 52.203-6 Restrictions On Subcontractor Sales To The Government SEP 2006 52.203-7 Anti-Kickback Procedures MAY 2014 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

APR 2014

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreeements or Statements

JAN 2017

52.204-3 Taxpayer Identification OCT 1998 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2016 52.204-8 Annual Representations and Certifications JAN 2017 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

OCT 2016

52.204-13 System for Award Management Maintenance OCT 2016 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-21 Basic Safeguarding of Covered Contractor Information Systems

JUN 2016

52.204-22 Alternative Line Item Proposal JAN 2017 52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.209-7 Information Regarding Responsibility Matters JUL 2013 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.215-1 Instructions to Offerors--Competitive Acquisition JAN 2017 52.215-2 Audit and Records--Negotiation OCT 2010 52.215-8 Order of Precedence--Uniform Contract Format OCT 1997 52.217-5 Evaluation Of Options JUL 1990 52.219-28 Post-Award Small Business Program Rerepresentation JUL 2013 52.222-3 Convict Labor JUN 2003 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-35 Equal Opportunity for Veterans OCT 2015 52.222-36 Equal Opportunity for Workers with Disabilities JUL 2014 52.222-37 Employment Reports on Veterans FEB 2016 52.222-40 Notification of Employee Rights Under the National Labor

Relations Act

DEC 2010

52.222-50 Combating Trafficking in Persons MAR 2015 52.222-54 Employment Eligibility Verification OCT 2015 52.222-60 Paycheck Transparency (Executive Order 13673) OCT 2016 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.227-1 Alt I Authorization And Consent (Dec 2007) - Alternate I APR 1984 52.227-11 Patent Rights--Ownership By The Contractor MAY 2014 52.229-3 Federal, State And Local Taxes FEB 2013 52.232-2 Payments Under Fixed-Price Research And Development

Contracts

APR 1984

52.232-9 Limitation On Withholding Of Payments APR 1984 52.232-23 Assignment Of Claims MAY 2014 52.232-25 Prompt Payment JAN 2017 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

JUL 2013

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-1 Disputes MAY 2014 52.233-2 Service Of Protest SEP 2006 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-13 Bankruptcy JUL 1995 52.243-1 Alt V Changes--Fixed-Price (Aug 1987) - Alternate V APR 1984 52.244-5 Competition In Subcontracting DEC 1996 52.244-6 Subcontracts for Commercial Items JAN 2017 52.246-7 Inspection Of Research And Development Fixed Price AUG 1996 52.246-25 Limitation Of Liability--Services FEB 1997 52.249-5 Termination For Convenience Of The Government

(Educational And Other Nonprofit Institutions)

AUG 2016

52.249-9 Default (Fixed-Priced Research And Development) APR 1984 52.252-1 Solicitation Provisions Incorporated By Reference FEB 1998 52.252-2 Clauses Incorporated By Reference FEB 1998 52.252-5 Authorized Deviations In Provisions APR 1984 52.252-6 Authorized Deviations In Clauses APR 1984 52.253-1 Computer Generated Forms JAN 1991 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7001 Prohibition On Persons Convicted of Fraud or Other Defense- Contract-Related Felonies

DEC 2008

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7002 Payment For Subline Items Not Separately Priced DEC 1991 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7004 Alt A System for Award Management Alternate A FEB 2014 252.204-7006 Billing Instructions OCT 2005 252.204-7007 Alternate A, Annual Representations and Certifications JAN 2015 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.225-7048 Export-Controlled Items JUN 2013 252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business Concerns

SEP 2004

252.227-7013 Rights in Technical Data--Noncommercial Items FEB 2014 252.227-7016 Rights in Bid or Proposal Information JAN 2011 252.227-7017 Identification and Assertion of Use, Release, or…