Solicitation Amendment Three 20210806.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

All changes incorporated to this solicitation amendment number three, w ill be reflected in green text. PLEASE NOTE THAT THE SOLICITATION RESPONSE DATE HAS BEEN EXTENDED UNTIL 12:00PM (Noon) EDT ON 07 SEPTEMBER 2021.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 38

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 06-Aug-2021

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street , County, State and Zip Code) X W911SR21RBMRC

X 9B. DATED (SEE ITEM 11)

14-Jul-2021

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

06-Aug-2021

CODE

USA CONTRACTING CMD-APG. - W911SR

EDGEWOOD CONTRACTING DIVISION

8456 BRIGADE STREET

BLDG E4215

ABERDEEN PROVING GROUND MD 21010-5401

W911SR 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W911SR21RBMRC

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION A - SOLICITATION/CONTRACT FORM

The following have been modified:

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 applied and basic research services, and applied and basic research support services. 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 20 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 at award of the base IDIQ 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 from the Contracting Officer ONLY.

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 12:00 P.M (Noon). (EDT) on 07 September 2021, per instructions listed in this solicitation.

A.11 All proposals from responsible sources will be fully considered, unless the proposal is deemed non-responsive. Offerors that are not registered in the System for Award Management (SAM) database at the time of proposal submission will be considered non-responsive. Offerors may register with SAM online at the following website: www.sam.gov.

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

C.2.22 29 CFR 1910.134 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134

C.2.23 Radiation Safety Program for DEVCOM CBC

C.2.24 DOD 8570.01 (Certification Requirements) https://public.cyber.mil/cw/cwmp/dod-approved-8570-baseline-certifications/

C.2.25 DOD 8570.01M (Information Assurance Workforce Improvement Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf

C.2.26 Army Conference Policy (see Army Regulation AR 1-50)

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 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 RDT&E 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 RDT&E 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 at least 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) of the above mentioned fields when combined: 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 Government 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 applied and basic research support services to coordinate the acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. The Contractor shall not provide services in this task without PRIOR approval from the COR or Contracting Officer. 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, subject to approvals stated in the Army Conference Policy AR 1-50, 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 Government provided 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

• 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 applied and basic research support services to coordinate the acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. The Contractor shall not provide services in this task without PRIOR approval from the COR or Contracting Officer. 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 applied and basic research support services to coordinate the acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. The Contractor shall not provide services in this task without PRIOR approval from the COR or Contracting Officer. 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 an interface at scientific/Collaborator meetings.

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 research and recommend potential 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 become familiar with 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 an interface at scientific/Collaborator meetings.

C.3.6 Applied and Basic Research, 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 RESERVED

C.3.6.4 The contractor shall maintain a supply room to ensure that routine supplies are on hand for support of operations after approval from the COR. The COR will provide 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 not related to this contract 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) as a “Timekeeper” only. Under no circumstances can a timekeeper be assigned certification authority in ATAAPS. The Contractor shall also enter data into 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 recommendations to 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 will conduct, and contractor personnel are subject to, respirator fit testing IAW the current versions of 29 CFR

1910.134 and AR 11-34 (The Army Respiratory Protection Program). The contractor shall meet all requirements for a respirator medical clearance and proper fit prior to contract start of work. Individuals failing to meet all medical and fit requirements will be prohibited from performing operations in a chemical agent and/or hazardous work environment that requires respiratory protection.

C.3.10 Security. This contract requires access to classified materials. The highest clearance required shall be SECRET. The DD Form 254 for this contract governs access and use of classified materials. The contractor and subcontractor personnel shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified "Confidential," "Secret," and requires contractors to comply with the Security Agreement (DD Form 441) and the most recent version of the National Industrial Security Program Operating Manual (DoD 5220.22-M). The DD Form 254 for this task governs access and use of classified information.

C.3.10.1 AT Level I training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website:

http://jko.jten.mil.

C.10.2 iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the CO. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

C.10.3 Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to government information systems. All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DoD Information Assurance Awareness prior to access to the IS and then annually thereafter.

C.10.4 For contracts that require a formal OPSEC program. The contractor shall develop an OPSEC Standing Operating Procedure (SOP)/Plan with 90 calendar days of contract award, to be reviewed and approved by the responsible government OPSEC officer. This plan will include a process to identify critical information, where it is located, who is responsible for it, how to protect it and why it needs to be protected. The contractor shall implement OPSEC measures as ordered by the commander.