B08 - Attachment 01 - PWS_Ferrets mAbs_rev 04.13.2023.docx

PERFORMANCE WORK STATEMENT (PWS)

FOR

THE GENERATION OF MONOCLONAL ANTIBODIES (mAbs)

FOR

U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES (USAMRIID)

SECTION 1 PURPOSE

1.1. Introduction

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

1.2. Mission

USAMRIID works closely with other USAMRDC organizations, DoD, the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health.

USAMRIID conducts basic and applied research to develop products, information, procedures, strategies, and training programs for medical defense against biological threats and naturally occurring infectious diseases of military significance that require biocontainment.

1.3. Background

The ferret is a model of interest for many pathogens of concern to the public health, as well as high priority pathogens including the Ebolaviruses and henipaviruses. The interest is particularly high due to its capacity to recapitulate human disease for many agents in a small animal model using wild type (not adapted) viruses. Successful establishment of such animal model for Ebolavirus would ultimately allow for the reduction in the number of NHPs and NHP studies required for countermeasure or vaccine evaluation. Although the physical capability to utilize ferrets at BSL-4 exists at USAMRIID, this model has not been fully utilized or developed at the institute for many of the pathogens of interest. Unfortunately, the lack of reagents and standardized procedures has made the study of humoral and cell-mediated immunity challenging in this model. Currently, the capability to do single cell analysis or isolation of specific lymphocytes for further characterization is problematic. Even when flow cytometry or ELISPOTs assays were attempted in ferrets the resource to fully address the humoral and cellular responses in ferrets are still limited. Before bench top in vitro or in vivo studies of the ferret’s immune system can be initiated, critical antibody reagents and molecular assays will need to be generated. In contrast to mice for which detection and characterization reagents are readily available, there are almost no reagents available for the ferret animal model. For some applications (FACS, microscopy, histopathology, or cell population depletion studies in vivo) monoclonal antibodies will be required. Generation of monoclonal antibodies will follow standard hybridoma techniques and obtained commercial companies. These monoclonal antibodies will be used to be able to do basic FACS analysis and eventually flow cytometry cell sorting for these cells and further characterize them by transcriptomic expression profiling.

1.4. Scope

The scope of this requirement is to provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services to USAMRIID wherein The Center for Genome Sciences (CGS) require the generation of monoclonal antibodies targeting the ferret immunoglobulin M and immunoglobulin G. The CGS will provide the target and the contractor will generate the monoclonal antibodies and deliver the final product for screening. The Contractor shall have all necessary knowledge, skills, equipment, and facilities within the team structure to conduct all required support functions within the scope of the contract.

1.5. Organizational Conflicts of Interest (OCI)

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a contractor’s judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses –

(1) Proprietary information that was obtained from a government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract. Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

1.5.1. OCI Certification (Deliverable 1, Attachment 02). This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category 3 – Product Support, which falls within the scope of the PWS. The contractor shall provide an OCI certification of OCI status from all sub-Contractors (if applicable), teaming partners or consultants prior to tasking any such party under the contract. In addition, the contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets.

1.5.2. NDS (Deliverable 2, Attachment 03). The contractor shall sign the NDS and ensure that all staff including all employees, subcontractors, and consultants, assigned to or performing under the contract, execute, sign and adhere to the terms of the NDS. Assignment of staff who have not executed this statement or failure to adhere to this statement may constitute default on the part of the contractor. A completed NDS is required for each employee assigned under the contract, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. Place of Performance

Services shall be provided at the contractor’s facility.

2.2. DUTY HOURS

2.2.1. USAMRIID’s core hours of operation are generally Monday through Friday, 0900 to 1500, daily except U.S. Federal Holidays.

2.2.2. Federal Holidays. Federal holidays are an exception to the regular duty hours. Any of the listed below federal holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

New Year’s Day, 1 January Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, last Monday in May Juneteenth, 19 June Independence Day, 4 July Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, 11 November Thanksgiving Day, 4th Thursday in November Christmas Day, 25 December

2.3. NON-PERSONAL SERVICES

2.3.1. This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the Contractor’s responsibility to notify the Contractor Officer (KO) immediately.

2.3.2. Severable/Non-Severable Services. This PWS identifies services that are non-severable in nature.

2.3.3. Inherently Governmental Functions. This PWS has been reviewed and contains no services that are inherently governmental functions, as defined in FAR Part 2.1.

2.3.4. Acquisition Functions Closely Associated with Inherently Governmental Functions. This PWS has been reviewed and contains no acquisition functions closely associated with inherently government functions.

2.4. CONTRACT MANAGEMENT

2.4.1. Government Management. The Contracting Officer’s Representative (COR) for this requirement will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under the contract.

2.4.2. The COR has specific technical, functional and oversight responsibilities. The assigned COR will serve as the official point of contact for coordination for the contract; approve or disapprove contractor invoices; review and accept or reject all contractor technical deliverables; monitor funds obligated and disbursed; conduct surveillance by uploading a monthly report in the Procurement Integrated Enterprise Environment (PIEE), Surveillance and Performance Monitoring (SPM); and conduct other activities as may be specified by the COR appointment letter.

2.4.3. Contractor Management. The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO, Contract Specialist and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills. The name of the PM and an alternate (who shall act for the Contractor when the manager is absent) shall be designated in writing to the KO. The Manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Manager or alternate shall be available (in-person or virtually) as required.

2.4.3.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.5. REPORTS

2.5.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable “Rights in Data” clause (i.e., DFARS clause 252.227-7015). All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS.

2.5.1.1. Monthly Status Reports (Deliverable 3). The contractor shall provide monthly reports detailing all work completed within seven (7) calendar days after each end of month. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next two (2) months, those items which required Government approval during the previous month and whether approval has been given or is still pending, a list of documentation which was due and not delivered, the status of delinquent data deliveries to include impact statements for each delinquency, and all ODC expenses bill for the month. It shall be submitted with a transmittal letter that highlight major events in the reporting period. The report shall also include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, inventories, and any problems/issues encountered as applicable. The format for the report shall be agreed upon by the Government and Contractor.

2.5.1.2. Summary Reports (Deliverable 4). The Contractor shall provide a Summary Report of the process, testing and characteristics of the six hybridomas produced and selected (Deliverables 5 and 6) for delivery to the Principal Investigator (PI) USAMRIID. The report shall be submitted upon delivery of the material, 14 business days prior to the end of the contract.

2.6. OTHER DIRECT COSTS (ODC’S)

2.6.1. ODC’s shall be billed for all actual costs incurred and submitted on a monthly basis. Costs are defined as the purchase price of materials plus General and Administrative (G&A) charges or material and handling (M&H) charges.

2.6.2. All ODCs shall be fully supported in compliance with all competition requirements of the FAR PART 6.

2.6.3. All ODCs shall be reported as stated in the Monthly Status Report (Deliverable 3).

2.6.4. Estimated ODCs are up to the maximum value specified in Section B material expenses as approved and allowed in the terms of the contract.

2.7. Maintain Safety, Security, and Biosecurity Standards

2.7.1. General

Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom—no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work. Other personal protective equipment may be required, depending on the tasks to be performed and biosafety level.

In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites. Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety and biosecurity procedures. Personnel may be required to demonstrate initial and continuous task proficiency with strict adherence to biosafety principles in order to conduct work in BSL-2 through BSL-4. Adherence to the USAMRIID Biosafety Program; Biosafety Plan, standard operating procedures, biocontainment suite specific manuals, biosafety training program and biosafety mentorship program will be ensured through a compliance program. As a part of this compliance program, all personnel are required to self-report any deviation to standard procedures and designated personnel may be required to observe work of others in the suites and document observations and adherence to the biosafety plan. Lack of adherence to any component of the Biosafety Program or lack of skill proficiency will be grounds for revocation of biocontainment access.

Investigators in the laboratories study amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks.

Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and BSL-4. As described above, approved work in biocontainment suites and using BSAT requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

2.7.2. Security

USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables USAMRIID to safeguard both the biological materials used in the laboratories as well as the personnel who work here. USAMRIID is frequently inspected by those regulating agencies, and successful completion of those inspections is required for USAMRIID to continue its operation. It is therefore critical that all employees, including Contractor employees, meet standards and maintain compliance with all regulations, policies, and procedures that have been instituted for their protection and the protection of others. Security, training, and other requirements may be subject to change based upon changes in regulations and policies, and the Contractor shall be immediately responsive to those changes.

The Contractor shall not employ, or continue employment, of persons for work on this contract, if such employee is identified to the Contractor by the KO as a potential threat to the health, safety, security, general well-being, or operational mission of the installation or its population. All Contractor employees shall be screened before hiring for active participation in any group that opposes the use of animals in research; such candidates shall not be selected for work on this PWS (all contract employees shall support the humane use of laboratory animals in research). In addition, if it becomes known that an employee is an active member of any group that opposes animal research or in any other way demonstrates a desire to compromise the security or the mission of the Institute, the Contractor employee shall be removed from this requirement immediately.

2.7.3. Security Requirements

The Contractor shall protect all For Official Use Only (FOUO) and unclassified information involved in the performance under this contract.

2.7.4. Installation Access Requirements

2.7.4.1. All visitors must enter through the Nallin Gate which is open 24 hours per day, seven days per week. Contractors are to provide proof of identification to the Fort Detrick security staff at the Visitor Center located at the Nallin Gate. A Criminal History Check will be conducted on all Contractor and subcontractor employees requiring base access. Acceptable forms of Government issued identification include a passport or Driver’s License that complies with the REAL ID ACT. Non-U.S. citizens visiting Fort Detrick will require a federal employee escort onto the Base. Non-U.S. Citizens visiting or working at USAMRIID will require MRDC approval. Vehicles entering the Base will be searched before being allowed to enter the Base. In addition to your vehicle, the trunk, boxes, bags, or other items located in the vehicle is subject to search. Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives and blades over 2 ½ inches, alcoholic beverages and open containers of alcohol. No photographs may be taken while on Fort Derick. Cell phones may be used while driving only if hands free.

2.7.4.2. The Contractor and all associated subcontractors’ employees shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures provided by the Government representative. The Contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the Contract is completed or when a Contractor employee no longer requires access to the installation and facility as defined in the contract.

2.7.4.3. Force Protection Condition (FPCON) impact on work levels. The Contractor employees must comply with all personal identity verification requirements as directed by DoD, and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON change, the Government may require changes in Contractor security matters or process. IAW DoDI 2000.16, the FPCON is defined as follows:

2.7.4.3.1. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher THREATCONS resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

2.7.4.3.2. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

2.7.4.3.3. FPCON CHARLIE. This condition applies when an incident occurs, or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

2.7.4.3.4. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition.

2.7.5. Security Clearance Requirements - RESERVED

2.7.6. Requirements for BPRP Enrollment - RESERVED

2.7.7. Requirements for Escorted Entry to Federal Select Agent Program (FSAP)-Registered Spaces (Visitor) - RESERVED

2.7.8. Workplace Safety - RESERVED

2.7.9. Foreign Nationals Requirements – RESERVED

2.7.10. Requirements for Controlled Substances PRP (CS-PRP) Enrollment - RESERVED

2.7.11. Network Security - RESERVED

2.7.12. Safeguarding Information - RESERVED

2.7.13. Physical Security

2.7.13.1. NOT APPLICABLE - The Contractor shall comply with Force Protection Condition procedures, Random Antiterrorism Measures, and local search/ identification requirements. The Contractor shall safeguard all Government property, including controlled forms, provided for Contractor use. At the close of each work period, Government training equipment, vehicles, facilities, support equipment, and other valuable materials shall be secured.

2.7.13.2. NOT APPLICABLE - This contract includes activities that may require Contractor travel to destinations outside of the United States. These activities will be defined at the contract level. The Contractor shall ensure that assigned participants allow sufficient lead-time to obtain valid passports, country clearances, visas, and immunizations to support project activities. Contractors shall be responsible for providing their own security and coordinate with State Department and local authorities as required at the contract level.

2.7.13.3. NOT APPLICABLE - DFARS Clause 252.225-7043, “Antiterrorism (AT)/Force Protection for Defense Contractors Outside the United States” shall be applicable to Contractors that require performance and delivery in a foreign county. This clause applies to both contingency and non-contingency support. The key AT requirement is for non-local national Contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the Contractor’s compliance with combatant commander and subordinate task force commander policies and directives.

2.7.13.4. CORs will be required to complete Contract Requirements Package Antiterrorism/Operations Security Review Cover Sheet (AT/OPSEC) to document the review of the requirements package statement of work (SOW) quality assurance surveillance plan and any applicable source selection evaluation criteria for antiterrorism (AT) and other related protection matters, including AT, operations security (OPSEC), information assurance (IA)/cyber security, physical security, law enforcement, intelligence, and foreign disclosure. A signed AT/OPSEC cover sheet must be included in all requirements packages except for supply contracts under the simplified acquisition level threshold, field ordering officer actions, and Government purchase card purchases. Command policy may require this form for supply contracts under the simplified acquisition level threshold. The organizational antiterrorism officer (ATO) must review each requirements package prior to submission to the supporting contracting activity, including coordination with other staff elements for review as appropriate. If the requiring activity does not have an ATO, the first ATO in the chain of command will review the contract for considerations. An OPSEC officer review is also mandatory. Upon completion of this AT/OPSEC cover sheet, a Standard Contract Language Provision/Contract Clause Text Applicability and/or Additional PWS Language will be created. This language shall be included in the PWS. If this language is not applicable, then it should be noted.

a. NOT APPLICABLE - 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 Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30calendar 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 KO, 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.

b. NOT APPLICABLE - Access and general protection/security policy and procedures. This standard language is for Contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-Contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by Do D, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

c. NOT APPLICABLE - For Contractors requiring Common Access Card (CAC). Before CAC issuance, the Contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation IAW Army Directive 2014-05. The Contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

d. NOT APPLICABLE - AT Awareness Training for Contractor Personnel Traveling Overseas. This standard language required US based Contractor employees and associated sub-Contractor employees to make available and to receive government provided AOR specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander with the unit ATO being the local point of contact.

e. NOT APPLICABLE - 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 sub-Contractors 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 COR. 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.

f. NOT APPLICABLE - 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 info 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.

g. NOT APPLICABLE - For contracts that require OPSEC Training. Per AR 530-1 Operations Security, the Contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

h. NOT APPLICABLE - For Contract Requiring Performance or Delivery in a Foreign Country, DFARS Clause 252.225-7043, Antiterrorism/Force Protection for Defense Contractors Outside the US. The clause shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non-contingency support. The key AT requirement is for non-local national Contractor personnel to comply with theater clearance requirements and allows the combatant commander to exercise oversight to ensure the Contractor’s compliance with combatant commander and subordinate task force commander policies and directives.

i. NOT APPLICABLE - For contracts that require handling or access to classified information. Contractor shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified “Confidential,” “Secret,” or “Top Secret” and requires Contractors to comply with— (1) The Security Agreement (DD Form 441), including the National Industrial Security Program Operating Manual (DoD 5220.22-M); (2) any revisions to DoD 5220.22-M, notice of which has been furnished to the Contractor.

j. NOT APPLICABLE - Threat Awareness Reporting Program. For all Contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. Task 1 (Milestone 1) - Three hybridomas for Ferret IgM (Deliverable 5). The Contractor shall conduct/accomplish three different hybridomas generated on rats and selected based on Ferret IgM specific reactivity.

3.1.1. The Contractor shall synthesize and clone the Ferret IgM Fc region based on the sequenced provided by the USAMRIID PI.

3.1.2. The Contractor shall perform the genetic immunization of rodents with the Ferret IgM Fc region (from task 3.1.1). Immunization of rats is preferred; however, other rodents including mice would also be acceptable.

3.1.3. The Contractor shall perform the fusion of rat lymphocytes from the immunized rodents to generate the hybridomas and perform the screening for positive hybridomas (antibodies targeting the ferret IgM Fc region).

3.1.4. The Contractor shall scale each selected (task 3.1.3) hybridomas to minimum of 24 ml (1,000,000 cells per ml), and via cryopreservation, obtain a minimum of 24 vials at 1ml each of the three different hybridomas.

3.1.5. The Contractor shall subclone the selected rat hybridomas (task 3.1.4).

3.1.6. The Contractor shall deliver a minimum of 24 vials, at 1ml each, of the three hybridomas to the USAMRIID PI, 14 business days prior to the end of the contract.

3.2. Task 2 (Milestone 2) - Three hybridomas for Ferret IgG (Deliverable 6). The Contractor shall conduct/accomplish three different hybridomas generated on rats and selected based on Ferret IgG specific reactivity.

3.2.1. The Contractor shall synthesize and clone the Ferret IgG Fc region based on the sequenced provided by the USAMRIID PI.

3.2.2. The Contractor shall perform the genetic immunization of rodents with the Ferret IgG Fc region (from task 3.2.1). Immunization of rats is preferred; however, other rodents including mice would also be acceptable.

3.2.3. The Contractor shall perform the fusion of rat lymphocytes from the immunized rodents to generate the hybridomas and perform the screening for positive hybridomas (antibodies targeting the ferret IgG Fc region).

3.2.4. The Contractor shall scale each selected (task 3.2.3) hybridomas to minimum of 24 ml (1,000,000 cells per ml), and via cryopreservation, obtain a minimum of 24 vials at 1ml each of the three different hybridomas.

3.3.5. The Contractor shall subclone the selected rat hybridomas (task 3.2.4).

3.2.6. The Contractor shall deliver a minimum of 24 vials, at 1ml each, of the three hybridomas to the USAMRIID PI, 14 business days prior to the end of the contract.

3.3. Task 3: Timely receipt of Summary Reports (Deliverable 4): The Contractor shall provide/accomplish a summary report of the process, testing and characteristics of the six hybridomas produced and selected (Deliverables 5 and 6) and provide upon delivery of the material. This is a one-time activity. Summary report shall be provided when the Contractor delivers the products to USAMRIID, 14 business days prior to the end of the contract.

SECTION 4 DELIVERABLES

4.1. Delivery Address: All deliverables shall be submitted to the USAMRIID PI and appointed COR.

4.2. Method of Delivery: Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

4.3. Shipping: The Contractor shall use appropriate, current Good Manufacturing Practice (cGMP) compliant refrigerated shipping carriers for drug product shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the Contractor shall use the US Postal Service standard delivery for delivery of all such shipments. The Government will be responsible for paying the shipping and handling costs, and the COR must approve the selected shipping method and any exceptions to these requirements.

4.4. Government Acceptance Period: The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions at no additional cost to the Government.

4.5. Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E) unless otherwise stated.

(Attachment 02)

(Attachment 03)

5. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

5.1 The Government intends to utilize a QASP to monitor the quality of the Contractor’s performance. The oversight provided for in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract period of performance. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required monthly COR status reports. The QASP is a living document and may be updated by the Government as necessary. The QASP has been included as Attachment 04.

6. ACRONYMS

The acronyms listed below will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.