W911SR-21-R-BMRC Solicitation.pdf

CODE

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until local time

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A X B X C

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EX

X G F 50 - 53

54 - 66 X H 67 - 73

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA FAR (48 CFR) 53.214(c)

1 73

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W911SR 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

1 - 3 4 - 7

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

8 - 23 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 26 - 28 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 29 - 30 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

31 - 48

PART II - CONTRACT CLAUSES

USA CONTRACTING CMD-APG. - W911SR

EDGEWOOD CONTRACTING DIVISION

8456 BRIGADE STREET

BLDG E4215

ABERDEEN PROVING GROUND MD 21010-5401

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

14 Jul 2021

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W911SR21RBMRC

Section A - Solicitation/Contract Form

EXECUTIVE SUMMARY

A.1 The U.S. Army Combat Capabilities Development Command, Chemical Biological Center, BioSciences Division (DEVCOM CBC BSD) requires a contract to provide qualified surety and non-surety laboratory technical experience, expertise, technical laboratory work, and administrative support for applied and basic research. This effort will encompass the detection, identification, growth, purification, analysis and detoxification of known and new biological pathogens, naturally occurring and synthetic toxins, biologically active compounds, biomanufacturing studies of biological and chemical products and organophosphorus chemical warfare nerve agents that have high potential for use as warfare and terror.

A.2 This is a Request for Proposal (RFP). The Government intends to award a single-award Indefinite Delivery/Indefinite Quantity (IDIQ) for the requirements listed within this solicitation.

A.3 All questions regarding this solicitation shall be submitted in writing to the email address listed below by 12:00 p.m. (Noon), Eastern Daylight Time (EDT) on 06 August 2021. Questions should be submitted using the attached Excel spreadsheet labeled “Solicitation Questions Template.” The answers to all questions will be posted at one time, after the Government team has had a chance to adequately address them. NOTE:

A.4 The point of contact for this solicitation is:

Mr. Nicholas Granata Jr, Contracting Officer Army Contracting Command, Aberdeen Proving Ground, Edgewood Contracting Division (ACC

APG ECD)

8456 Brigade Street, Aberdeen Proving Ground, MD 21010 Nicholas.granata.civ@mail.mil

A.5 Pursuant to the Federal Acquisiton Regulation (FAR) Clause 52.215-1, “Instructions to Offerors- Competitive Acqusition”, the Government intends to evaluate proposals and award a contract without discussions with Offerors. The Procuring Contracting Officer may ultimately decide to hold discussions with Offerors in the competitive range if it is deemed to be in the best interest of the Government.

A.6 It is anticipated that the contract resulting from this solicitation will have a 36 month ordering period. The period of performance will be specified in each issued Task Order. One executable task order will be issued under this contract.

A.7 Upon execution of the contract, the first task order will be issued as Cost Plus Fixed Fee (CPFF), which will represent the guaranteed minimum under this contract vehicle. The anticipated ceiling of this contract vehicle is $24,868,845.00.

A.8 Period of Performance. The period of performance will be specified in each Task Order. No task orders will be issued under this contract, nor any new work added to any previously issued task order, after the end of the ordering period. Performance may begin at any time during the ordering period.

Any extension to performance periods in individual Task Orders will be made by the Contracting Officer in writing in accordance with appropriate authority (e.g., changes clause etc.). The Contractor shall not perform beyond the current period of performance for which the Contractor has authority, nor will the Government be liable for costs incurred by the Contractor for performing in a period without authorization.

A.9 This requirement is being solicited as a total Small Business Set-Aside. Offers will be solicited from only small business concerns and any award resulting from this solicitation will be made to a small business pursuant to FAR 52.219-6.

A.10 All proposals must be signed, dated, and submitted no later than 5:00 P.M. (EDT) on 14 August 2021, per instructions listed in this solicitation.

A.11 All proposals from responsible sources will be fully considered. Offerors that are not registered in the System for Award Management (SAM) database at the time of proposal submission will not be considered responsible. Offerors may register with SAM online at the following website:

www.sam.gov.

Section B - Supplies or Services and Prices

MINIMUM GUARANTEE

B.1 Contract Limitations

B.1.1 The guareenteed minimum of this contract will be satisfied via the first executable Task Order to be issued at award of the contract.

B.1.2 Pursuant to FAR 52.216-22, “Indefinite Quantity” of this contract, the contract minimum quantity will be satisfied via the first executable Task Order. The maximum quantity is the total “not to exceed” the amount of $24,868,845.00 for the cumulative sum of all orders to be issued under this Indefinite Delivery Indefinite Quantity (IDIQ) contracting vehicle. This maximum amount set forth herein is the total available for all orders issued under the IDIQ vehicle. The maximum amount may only be exceeded with prior written approval of the Contracting Officer.

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Job CBDBR Services/Tasks CPFF

CPFF

The contractor, as an independent contractor, and not as an agent for the Government shall provide all labor, materials, and equipment (except those specifically designated as Government-furnished) to perform as detailed in the Performance Work Statement (PWS), Section C and the terms and conditions of the contract.

FOB: Destination

PSC CD: AJ12

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

0002 1 Job Travel/Materials and ODC's

COST

Travel and Other Direct Costs and their resulting indirect expenses will be on a cost-reimbursement basis, and are non-fee bearing, will be reviewed, approved and conducted IAW FAR 31.205-46; reimbursable IAW the Joint Travel Regulations (JTR) at https://www.defensetravel.dod.mil/site/travelreg.cfm.

0003 12 Months CBDBR Services/Tasks FFP Base Year

FFP

The contractor, as an independent contractor, and not as an agent for the Government shall provide all labor, materials, and equipment (except those specifically designated as Government-furnished) to perform as detailed in the Performance Work Statement (PWS), Section C and the terms and conditions of the contract.

NET AMT

0004 36 Months Data Deliverables

FFP

The contractor shall prepare and deliver Contract Data Requirements Lists (CDRLs) as set forth in the Performance Work Statement (PWS) located in Section C and associated CDRL's, DD Form 1423, found in Section J.

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0005 36 Months

Contractor Manpower Reporting

FFP

The contractor, as an independent contractor and not as an agent of the Government shall report ALL contractor labor hours in accordance with paragraph C.3.14 of the Performance Work Statement required for performance of services provided under this contract for the U.S. Army Combat Capabilities Development Command, Chemical Biological Center (DEVCOM CBC) via a secure data collection site. The contractor is required to fill in all required data fields completely using the following web address: http://www.sam.gov. For instructions for reporting, please select “Help” from the main navigation menu and then select "User guides", where the “Quick Start Guide for Service Contract Reporting” can be found for the instructions to complete the required report. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), this runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2021. If further assistance is required, Contractors may direct questions to the Federal Service Desk which is located at www.fsd.gov.

FOB: Destination

PSC CD: AJ12

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0006 1 Job

Contractor Acquired Property

CPFF

This CLIN is created for reporting purposes only. Contractor Acquired Property (CAP) is anticipated and will be evaluated/determined at the TO level. All CAP meeting the Item Unique Identification and Valuation (IUID) criteria IAW DFARS 211.274-2, will be marked and reported appropriately upon delivery pursuant to DFARS 252.211-7003 FOB: Destination

PSC CD: AJ12

ESTIMATED COST

0007 Job CBDBR Total Contract

CPFF

The purpose of this CLIN is to establish the total estimated value of CBDBR.

This CLIN is created for reporting purposes only. The maximum value (ordering ceiling) of the Indefinite Delivery, Indefinite Quantity (IDIQ) contract is $24,868,845.00.

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

Performance Work Statement For the “Chemical, Biological Defense and Biomanufacturing Research”

Effort

C.1.0 Scope. The U.S. Army Combat Capabilities Development Command, Chemical Biological Center, Biosciences Division (DEVCOM CBC BSD) has been tasked to support National Chemical, biological, radiological and nuclear (CBRN) defense programs aimed at defeating chemical and biological threats by providing laboratory technical experience and expertise, technical laboratory work, programmatic support for applied and basic research and administrative support. This effort will encompass the detection, identification, growth, purification, analysis and detoxification of known and new biological pathogens, naturally occurring and synthetic toxins, biologically active compounds, biomanufacturing of biological and chemical products and organophosphorus chemical warfare nerve agents that have high potential for use as warfare and terror.

C.1.1 Background. DEVCOM CBC BSD at Aberdeen Proving Ground Edgewood Area (APG EA) is responsible for basic research, advanced development, testing, and evaluation of technology in microbiological, biochemical, chemical and analytical fields of science, which support a broad range of research studies that include chemical and biological detection technology and sensors, immunosensor assay development, validation, production of biological reference material and biological reagents, production of tri-service biomaterials and commodity chemicals with downstream processing and data management. Furthermore, the DEVCOM CBC BSD maintains a formal Quality Management System to support its International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) certification for quality analytical and operational processes.

The DEVCOM CBC BSD will support the current capability primarily through the conduct of chemical and biological surety and non-surety laboratory expertise. The majority of the effort shall be performed in the laboratories at DEVCOM CBC BSD. In accordance with these assignments, the DEV COM CBC BSD provides the following:

a. Research and Development programs in the areas of biomanufacturing, microbiological, biochemical, chemical and computational fields, which support a diverse base of research topics, to include pathogen studies, decontamination, toxic small molecules, threat characterization, sensor and assay development/evaluation and the production of biologically derived materials to include both biological material and chemical commodities.

C.1.2 Objective. The objective of this contract is to obtain qualified non-surety and surety laboratory, technical, programmatic, and administrative services in support of the DEVCOM CBC BSD mission relating to CBRN detection, decontamination, threat characterization, biomanufacturing, and other basic and applied research and development efforts to meet DEVCOM CDC’s customer requirements.

C.2.0 Applicable Documents.

C.2.1 QMS-QA-01 R2 DB Laboratory Quality Assurance Plan, current version (Available upon award)

C.2.2 Biosciences SOPS, IOPS, test plans, CBC Biosafety manual, current version etc. (Available upon award)

C.2.3 SOP Guidebook, Preparation of Standing Operating Procedures, current version

C.2.4 AR 50-6, Chemical Surety, current version.

https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN3125_AR50-6_WEB_FINAL.pdf

C.2.5 AR 190-59, Chemical Agent Security Program, current version https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/r190_59.p df

C.2.6 AR 385-10, The Army Safety Program, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN16777_ARN16343_AR385_10_FINAL.p df

C.2.7 AR 25-2 Army Regulation (AR 25-2 “Army Cybersecurity”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN17503_AR25_2_Admin_FINAL.p df

C.2.8 AR 2014-5 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=104095

C.2.9 AR 381-12 C.2.17 Army Regulation (AR 381-12 “Threat Awareness and Reporting Program”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/AR%20381- 12%20FINAL%20WEB.pdf

C.2.10 AR 190-17 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=1002302

C.2.11 AR 50-1 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=82123

C.2.12 AR 190-59 https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/r190_59.pdf

C.2.13 AR 11-34 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r11_34.pdf

C.2.14 530-1 C.2.18 Army Regulation (AR 530-1 “Operations Security”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r530_1.pdf

C.2.15 AR 190-13 https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/ARN21433_R190_13_FINAL.pdf

C.2.16 DA Pam 40-8, Occupational Health Guidelines for the Evaluation and Control of Occupational Exposure to Nerve Agents GA, GB, GD, and VX, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN6941_PAM_40_Final.pdf

C.2.17 DA Pam 40-173, Occupational Health Guidelines for the Evaluation and Control of Occupational Exposure to Mustard Agents H, HD, and HT, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p40_173.pdf

C.2.18 DA Pam 385-61, Toxic Chemical Agent Safety Standards, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN12692_PAM385-61_WEB_FINALL.pdf

C.2.19 DODI 5220.22M (National Industry Security Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/522022M.pdf

C.2.20 DA PAM 385-10 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p385_10.pdf

C.21.DA PAM 385-69 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p385_69.pdf

C.22 29 CFR 1910.134 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134

C.23 Radiation Safety Program for DEVCOM CBC

C.24 DOD 8570.01 (Certification Requirements) https://public.cyber.mil/cw/cwmp/dod-approved-8570-baseline-certifications/

C.25 DOD 8570.01M (Information Assurance Workforce Improvement Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf

C.3.0 Requirements. The Contractor, as an independent entity and not as an agent of the Government, shall provide the necessary resources (except those specifically designated as Government-furnished) to accomplish tasks of the type set forth below. The anticipated work requires specialized facilities, equipment and procedures, and Contractor personnel will be required to perform work on site at DEVCOM CBC, Aberdeen Proving Ground, contractor facilities, or other anticipated Government approved cites. The Contractor must have an active Personnel Reliability Program with DEVCOM CBC and provide a fully qualified Personnel Reliability Program (PRP) staff with requisite experience on day one of contract award to perform the tasks under the paragraph C.3.3 in this PWS.

C.3.1 Key Personnel. The Contractor shall provide a Program Manager (PM) who shall be available during normal duty hours (0900 to 1700) in order to perform overall management of the contract. The PM shall be the Contractors primary point of contact and shall have the authority to act or make decisions on all matters on behalf of the Contractor. The Contractor shall designate an alternate who shall be authorized to make decisions in the absence of the PM. The Contractor shall staff the total number of key personnel or other supervisory, management and/or administrative personnel they deem necessary to successfully manage the proposed level of effort for this requirement. Qualifications of key personnel shall meet or exceed the resumes submitted as part of the proposal. If Contractor proposes above the minimum qualifications for Key Personnel and/or if the person proposed is different from the person provided, the person provided must meet the Contractors proposed qualifications. The Contractor shall include the substance of this requirement in any subcontract which is awarded under this contract. No substitutions in key personnel shall be made except in accordance with (IAW) this paragraph. All proposed substitutions must be submitted in writing to the Contracting Officer (KO) 30 days or180 days if security clearance is to be obtained, in advance of the proposed substitutions. All requests for substitutions must include a resume for the proposed substitute. The COR will review the proposed substitute resume to ensure Contract requirements are met. Should the Contractor fail to provide an acceptable substitute as determined by the KO, this contract may be terminated for default. Key personnel with minimum qualifications for this contract are detailed in the Table below:

TABLE 1 – Qualifications for Key Personnel Labor Category Education/experience/ requirements

Program Manager

A minimum of a Bachelor’s degree in Science, Technology, or Engineering with a minimum of 10 years of experience supervising and managing personnel in a technical field set forth in the PWS dealing with research, development, testing and evaluation (RDTE) activities in a collaborative engagement.

Principle Investigator (PI) -Senior Scientist/Engineer

A minimum of a Bachelor’s degree in Science, Technology or Engineering with five (5) years of experience in research and development capabilities as set forth in the PWS dealing with RDTE activities in a collaborative engagement.

Subject Matter Expert (SME)

A minimum of a PhD degree in Science, Technology, Data Management, Information Management or Information Technology Support with ten (10) years of experience in cooperative biological engagement support associated with CBRNE research and technology and/or biomanufacturing as set forth in the PWS dealing with RDTE activities in a collaborative engagement.

Staff Support- Level III

Position requires a minimum of a BA / BS with at least 6 (six) years of administrative experience in supporting RDTE activities in a collaborative engagement in one or more of the following areas: Administration, Communications, Technical Writing, Protocol, Quality Assurance, and/or Documentation Management

Staff Support- Level II

Position requires a BA or BS with at least 3 (three) years of RDTE activities in a collaborative engagement administrative experience in one or more of the following areas: utilization Microsoft Office Suite; editing of technical reports;

facilitation of meetings, and/or development of corporate communications

Technical Support-Level III

Position requires at least a BS in Science, Technology or Engineering with 5 (five) years of demonstrated experience in one or more of the following specific technical focus areas: Chemistry, Molecular Biology, Microbiology, Biodefense, Biochemistry, Biosensors, Biotechnology, Detection Spectrometry, Biomanufacturing, Bioproduction, Engineering Total Overall Experience Required (Min): 10 Years

Technical Support-Level II

Position requires at least a BS in Science, Technology or Engineering in one or more of the following specific technical focus areas: Chemistry, Molecular Biology, Microbiology, Biodefense, Biochemistry, Biosensors, Biotechnology, Detection Spectrometry, Biomanufacturing, Bioproduction, Engineering Total Overall Experience Required (Min): 5 Years

Technical Support-Level I

Position requires at least a BS in Science, Technology or Engineering in one or more of the following specific technical focus areas: Chemistry, Molecular Biology, Microbiology, Biodefense, Biochemistry, Biosensors, Biotechnology, Detection Spectrometry, Biomanufacturing, Bioproduction, Engineering No Experience Required

*For all positions listed above:

A combination of years in any combination of the various technical areas provided is allowed in order to meet the minimum years of experience required. For example, If a Tech Support Level III has three years of experience in Biodefense and two years in Biochemistry, it would count as five years of total experience in that specific labor category.

C.3.1.1 The contractor shall conduct a Start of Work Meeting within 14 calendar days after contract award.

C.3.1.1.1 The start of work meeting shall include a verbal “walk-through” of this Performance Work Statement (PWS) to summarize its understanding of the specific tasks to be completed, ask and answer questions, and serve as a venue for all parties to make introductions.

C.3.1.1.2 The contractor shall provide start of work meeting minutes to the Government No later than (NLT) forty eight (48) hours after the scheduled start of work meeting in accordance with (IAW) Exhibit Line Item Number (ELIN) A001.

C.3.2 Biomanufacturing and Technical Subject Matter Expertise (SME) Support

C.3.2.1 The contractor shall provide hands on support for biomanufacturing efforts at DEVCOM CBC. The Contractor shall conduct hands on bioproduction, technical interpretations and laboratory test support to the Government on matters dealing with the use and development of laboratory testing approaches and methodologies, laboratory instrumentation, analyses and proper waste disposal procedures cited in Standard Operating Procedures (SOPs).

C.3.2.1.1 The contractor shall design and optimize processes for the scale-up production of materials that can be synthesized and produced in gram to kilogram quantities using batch fermentation of genetically engineered cell lines.

C.3.2.1.2 The contractor shall design and optimize downstream production processes to separate, purify and preserve materials produced.

C.3.2.1.3 The contractor shall provide a subject matter expert (SME) in the development processes for fermentation, downstream processing, and characterization of microbial products, including specialty chemicals, biological polymers, proteins, and phage-based products.

C.3.2.1.4 The contractor shall design and implement processes for the production of military-relevant products using DEVCOM CBC fermentation and down-stream processing equipment under overall guidance of the Biomanufacturing program manager. The contractor shall provide technical expertise to ongoing biomanufacturing operations, and shall work with the Program Manger and other DEVCOM CBC personnel to ensure timely execution of projects within budget.

C.3.2.1.5 The contractor shall make recommendations to DEVCOM CBC for additional downstream processing capabilities as needed for new production methods and will assist DEVCOM staff in the identification, evaluation, acquisition, and implementation of new equipment and procedures.

C.3.2.1.6 The contractor shall operate the fermentation, downstream processing equipment, and/or analytical equipment in accordance with established IOP’s, SOP’s, and with project-specific production and test plans.

C.3.2.1.7 The contractor shall provide expertise in downstream processing for Biomanufacturing and facilities design for Biomanufacturing.

C.3.2.1.8 The contractor shall have experience with downstream purification from the standpoint of purity, yield and efficiency and is responsible for the general strategies employed to achieve these goals.

C.3.2.1.9 The contractor shall define the specific methods and in-process tools and materials used in the downstream process to include filtration and centrifugation, chromatography, ultrafiltration and final polishing chromatography steps.

C.3.2.1.10 The contractor shall participate in the ongoing operation and maintenance of the downstream unit operations within a facility.

C.3.2.2 The contractor shall use material handling equipment (e.g., pallet jack, fork lift, compressed gas cylinder cart) as needed to move, position, or set-up equipment or supplies required for testing. As needed, the contractor will ensure personnel have training prior to operating government materials handling equipment.

C.3.2.2.1 The contractor shall provide technical expertise, prepare Internal Operating Procedures (IOPs), update laboratory notebooks based on process development procedures and conduct hands on analyses for Government customer programs using, but not limited to, the following instrumentation and equipment:

• 5-1500 L Fermenters

• Alfa Laval Centrifuge

• Continuous Flow Centrifuge

• Distillation Column

• Filter Press

• Ion Exchange Chromatography

• KARR or Scheible Column

• Lyophilizer

• Millipore Ultrafiltration Unit

• Spray Dryer

• Tangential Flow Filtration Unit

• Rotary Evaporator

• Thin Layer Chromatography Tanks

• Miller

• Tube Furnace

C.3.2.3 The contractor shall write project proposals, test plans, SOWs, production documentation, SOPs, IOPs, technical reports, research publications, and other documents as needed to support incoming projects.

C.3.2.4 The contractor shall communicate the progress of research and development efforts clearly and succinctly with DEVCOM personnel, customers, external program managers and stakeholders, as needed.

C.3.2.5 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.2.6 The contractor shall participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.2.7 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP’s, SOP’s, production and test plans, and data management procedures.

C.3.2.8 The contractor shall communicate project progress, results, and issues in accordance with ELIN A002.

C.3.2.9 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.3 Chemical Surety and Biological Select Agent and Toxins (BSAT/BSL3) Laboratory Support

C.3.3.1 On day one of contract award, the contractor shall have an active PRP program with DEVCOM CBC in accordance with AR50-6, and provide personnel certified in the PRP. New personnel must be capable of being made PRP certified within two months of contract award.

C.3.3.2 The contractor shall conduct hands on chemical and biological surety laboratory testing, analyses of chemical and biological surety agent materials, emerging threat compounds, experimental agents, and toxic industrial chemicals (TICs) or other unique compounds of military relevance and materials and must stay current in the Personnel Reliability Program (PRP).

C.3.3.3 The contractor shall meet all requirements for a respirator medical clearance and proper mask fit as part of being Chemical Personnel Reliability Program (CPRP) capable. Individuals failing to meet all medical and fit requirements will be prohibited from performing operations in a chemical agent or hazardous work environment that requires respiratory protection.

C.3.3.4 The contractor shall examine prior to use and make use of proper personal protection equipment (PPE) as needed per SOP testing.

C.3.3.5 The contractor shall participate in test report preparation, peer reviewed journal articles and technical report writing support to include statistical test design, data analysis, experimental procedures, evaluations, interpretations and conclusions to capture lessons learned to provide improvement and expansion of capabilities to complete customer programs. This effort shall include literature searches, networking with government agencies, academia, and commercial clients.

C.3.4 Non-Surety Chemical and Biological Laboratory Support

C.3.4.1 The contractor shall develop, test, optimize, improve, and evaluate various immunochemical and nucleic acid-based assay technologies - both for specific sensors and for new assay concepts (e.g. new reagent types, new maintenance purchased for assay methods), for bacteria, viruses, toxins, and proteins.

C.3.4.2 The contractor shall participate in test report preparation, peer reviewed journal articles and technical report writing support to include statistical test design, data analysis, experimental procedures, evaluations, interpretations and conclusions to capture lessons learned to provide improvement and expansion of capabilities to complete customer programs. This effort shall include literature searches, networking with government agencies, academia, and commercial clients.

C.3.4.3 The contractor shall provide technical expertise and conduct hands on analyses for Government customer programs using, but not limited to, the following analytical instrumentation and equipment:

• Real Time PCR instrumentation to include

• SeqStudio Genetic Analyzer

• Oligosynthesizer

• Liberty Blue, Automated Peptide Synthesizer

• Ultraviolet Spectrometer (UV VIS)

• Agilent LC/MSD and Associated Accessories

C.3.4.4 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.4.5 Equipment and supplies. The contractor shall provide equipment and supplies as necessary, with government concurrence.

C.3.4.6 The contractor shall provide administrative support to the Contracting Officer’s Representative (COR) to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.4.7 The contractor shall drive or ride in government vehicles as needed to participate in the transport of test equipment or test materials between buildings. As needed, the contractor will ensure personnel have training prior to operating government vehicles.

C.3.4.8 The contractor shall assist the Government with the study of cell processes and shall have an understanding of gene sequencing, cell signaling, and gene expression. The contractor shall participate in laboratory procedures following protocols including DNA sequencing, cloning and extraction, RNA purification, gel electrophoresis and/or protein expression and purification protocols.

C.3.4.8.1 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP, SOP’s, production and test plans and data management procedures.

C.3.4.8.2 The contractor shall communicate project progress, results, and issues in a timely manner to principal investigators.

C.3.4.8.3 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.4.8.4 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.4.8.5 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.3.4.9 The contractor shall assist the Government to grow and study a number of viruses or bacteria at BSL 1 and BSL 2 level. The contractor is responsible for investigating the growth, structure, development and other characteristics of microscopic organisms. Contractor may participate in characterization, detection, identification and decontamination studies using a wide range of analytical and scientific techniques. The Contractor shall provide support in conducting applied research and development in olfactory sciences for the detection and identification of CBE weapons and to enhance current stand-off detection technologies. Test-bed support for MWD and other working animal RDT&E projects will be executed for a variety of the CBE threats and simulants to include the entire threat mitigation spectrum from detection, identification, toxicity assessment, protection and decontamination.

C.3.4.9.1 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP’s, SOP’s, production and test plans, and data management procedures.

C.3.4.9.2 The contractor shall communicate project progress, results, and issues in a timely manner to principal investigators.

C.3.4.9.3 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.4.9.4 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.4.9.5 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as

C.3.5 Information Technology Support

C.3.5.1 The contractor shall provide information technology services, to include support to dedicated software and hardware for biomanufacturing operations, data and information collection, management, analysis, and communication.

C.3.5.2 The contractor shall develop tools to analyze and manage fermentation/production data, metabolomics data, microbiological data, and/or synthetic biology data. The contractor shall develop software pipelines by utilizing combinations of Government off the shelf (GOTS), and Commercial off the shelf (COTS) tools that are adaptable in accordance with contract security requirements. The contractor shall be familiar with current cloud-based laboratory data management and analysis packages and shall make recommendations to DEVCOM CBC principal investigators on systems that would be suitable to the needs of the facility.

C.3.5.3 The contractor shall be familiar with Laboratory Information Management Systems (LIMS) and modern cloud-based notebook and data management solutions, particularly regarding fermentation and downstream processing, product yield and purity analysis, metabolomic characterization of fermentation broth, and strain characterization.

C.3.5.4 The contractor shall be familiar with Agile Development concepts and develop solutions through collaborative effort with CBC Principal Investigators. The contractor shall apply principles of software engineering to the design, maintenance, testing and evaluation of software.

C.3.5.5 The contractor shall build, maintain, and upgrade hardware and software to accomplish data management requirements. The contractor shall provide support during test and evaluation events involving software, software interfaces, hardware, or integration requirements.

C.3.5.6 The contractor shall work closely with other CBC bioinformatics personnel and principal investigators to maximize use of existing hardware infrastructure in the Branch and throughout DEVCOM

CBC.

C.3.5.7 The Contractor shall assist the Government by learning coding software should it be deemed necessary to the success of the project.

C.3.5.8 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors should calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.5.9 The contractor may participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as

C.3.6 Administrative, Program and Project Support

C.3.6.1 The contractor shall perform a variety of administrative tasks and responsibilities as detailed below, to ensure continuity and efficiency of the administrative office operations and procedures.

C.3.6.2 The contractor shall answer phones, prepare correspondence and reports that are required to maintain client relations.

C.3.6.3 The contractor shall collect and maintain time sheets from personnel to provide for Government use in time keeping duties.

C.3.6.4 The contractor shall maintain a supply room to ensure that routine supplies are on hand for support of operations. The Government will select the vendors and input the purchase requests to support the contractor in the maintenance of the supply room.

C.3.6.5 The contractor shall inspect all incoming supplies for conformance to the purchase request and report any deficiencies to the appropriate Branch member.

C.3.6.6 The contractor shall have experience in budgeting, procurement, purchasing supplies and services, and constructing financial reports through the General Fund Enterprise Business Systems (GFEBs).

C.3.6.7 The contractor shall be responsible for entering data in the Army’s Automated Time Attendance and Production System (ATAAPS), the Defense Travel System (DTS) and other government portals that are deemed necessary for efficient management of project, personnel and financial tasks.

C.3.6.8 The contractor shall provide management, personnel, training, contract and procurement records in accordance with Department of Defense (DoD), Defense Finance and Accounting Service (DFAS) and Office of Personnel Management (OPM) requirements.

C.3.6.7 The contractor shall provide the government with financial data to be used for transfers of funding, to include Military Interdepartmental Purchase Requests (MIPR), Internal Funds Transfers, Purchase Orders, and Purchase Requests.

C.3.6.8 The contractor shall be familiar with the Chemical and Biological Center SharePoint system and maintain non-conflicting calendar schedules for the daily activities of the managers and the shared conference rooms. The contractor shall perform these duties on-site at Aberdeen Proving Ground.

C.3.7 Administration.

C.3.7.1 On-Site Workers: The Government will coordinate with the contractor’s program manager for assignment of work tasks to on-site contractor personnel. The contractor support personnel working on-site shall:

C.3.7.2 Implicitly consent to Government searches, monitoring and surveillance, including audio and video recording of actions and conversations while entering and working on the Government facility.

C.3.7.3 Wear a Common Access Card (CAC) or a DA Form 1602, Contractor Identification Card, attached above the waist or on a lanyard around the neck at all times while in any DEVCOM CBC owned or controlled building or facility.

C.3.7.4 Label workstations and offices with employee and company name.

C.3.7.5 Identify themselves as a contractor when answering government telephones.

C.3.7.6 Have an auto-generated caveat in the name field on all emails that distinctly identifies the employee as a contractor.

C.3.7.7 Not sign memoranda or any other documents which will imply that they are making a decision on behalf of the Government.

C.3.7.8 Not attend meetings as the sole representative of DEVCOM CBC with the Department of the Army (DA), Department of Defense (DOD), or other Governmental agencies.

C.3.7.9 Identify themselves as a contractor employee at the start of any meetings.

C. 3.8 Deliverables. The following items shall be delivered by the contractor. All data shall be delivered in accordance with the attached DD Form(s) 1423. The contractor may obtain a copy of Data Item Descriptions listed in block 4 from: http://assist1.daps.dla.mil/quicksearch/.

C.3.8.1 ELINA001; Start of Work Meeting Minutes. The contractor shall deliver minutes from the start of work meeting.

C.3.8.2 ELINA002; Contract Status Report. The contractor shall prepare monthly progress reports

C.3.8.3 ELIN A003; Annual Report. The contractor shall prepare and provide an annual report at the end of each period of performance (base year, option year 1, option year 2).

C.3.8.4 ELIN A004; Final Comprehensive Report. The contractor shall prepare and provide a final comprehensive report at the end of the total effort.

C.3.8.5 ELIN A005; Government Property Inventory Report. If applicable, the contractor shall conduct initial and annual inventory on all Contractor Acquired Property (CAP) during the performance of the contract.

C.3.8.5 DoD Computer Network Access. All Contractor employees, subcontractors, and suppliers at the applicable installation or facility shall comply with governing policies for gaining network access and for securing and using email accounts. All Contractor employees, subcontractors, and suppliers shall comply with DOD and agency- specific regulations and policies pertaining to Government-owned websites and databases. The contractor shall coordinate with the Government to obtain approval from the agencies’ security and public affairs officials.

3.9 Safety/Hazards Information. This contract requires the contractor to perform surety operations with the chemical agents GA, GB, GD, GF, VX, L, HD, HN1, HN3, HL, AC, CK, EA Compounds, stimulants, non-agent compounds, TICs, BSL2 and BSL3 agents and various solvents in accordance with Biosciences Standing Operating Procedures (SOPs), written procedures, DEV COM CBC requirements, local guidelines and material safety data sheets. The contractor shall also handle chemical agent contaminated items in accordance with DB SOPs, DB written procedures, CBC requirements, and local guidelines to minimize hazards. The contractor shall follow the requirements of the SOP and local guidelines to minimize hazards and shall comply with the applicable SOPs. The contractor shall follow the SOP that pertains to the agent and operation per evaluation.

C.9.1 CHEMICAL: When using Chemical agents on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor shall comply with the current versions of: AR 385-10 (The Army Safety Program);

DA PAM 385-61 (Toxic Chemical Agent Safety Standards); DA PAM 385-10 (Army Safety Program); AR 190-59 (Chemical Agent Security Program); Interim Guidance on Occupational Health Practices for the Evaluation and Control of Occupational Exposures to Nerve Agents GB, GA, GD, GF, VX, and Mustard Agents H, HD, and HT; AR 50-6 (Chemical Surety); and all local policies and procedures (available upon request) for operations involving military unique chemical agents or other chemicals which fall into the same range of toxicity as chemical agents (such as agent degradation products and/or precursors). Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.2 BIOLOGICAL AND TOXINS: When using biological select agents and toxins on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor shall comply with the current versions of: AR 50-1 (Biological Surety); AR 385-10 (The Army Safety Program); DA PAM 385-10 (Army Safety Program);

DA PAM 385-69 (Safety Standards for Microbiological and Biomedical Laboratories); AR 190-17 (Biological Select Agents and Toxins Security Program); 7 C.F.R. 331 (Possession, Use, and Transfer of Select Agents and Toxins); 9 C.F.R. 121 (Possession, Use and Transfer of Biological Agents and Toxins), and 42 C.F.R. 73 (Select Agents and Toxins). Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. In addition, the contractor shall comply with all local biological safety, security, or surety policies and procedures (available upon request).

The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.3 The contractor shall comply with the current versions of: AR 385-10 (The Army Safety Program; DA PAM 385-10 (Army Safety Program); and DA PAM 385-69 (Safety Standards for Microbiological and Biomedical Laboratories) when working with infectious agents and toxins. Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. In addition, the contractor shall comply with all local policies and procedures concerning infectious agents and toxins (available upon request). The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.4 RAD/ LASER: The contractor shall comply with the current versions of the CBC Radiation Safety Program for all operations involving lasers or non-ionizing radiation.

C.9.5 Onsite contractors shall not bring or use radioactive material or equipment which generates ionizing radiation unless approved by the CCDC CBC Radiation Safety Officer ((410) 436-4411).

C.9.6 GENERAL: When working on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor will operate under an approved Standard Operating Procedure (SOP) for all hazardous operations to include, but not limited to: toxic chemicals, microbiologicals (pathogenic and non-pathogenic), toxins, radioactive materials, explosives/pyrotechnics, lasers, x-rays devices or any other substance or equipment which is hazardous. It the contractor must prepare an SOP, it shall do so IAW the latest version of Preparation of Standing Operating Procedure (SOP). The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.7 When working on-site at the Edgewood Area of Aberdeen Proving Ground, the Government…