PWS.docx

PERFORMANCE WORK STATEMENT (PWS)

Title: EBOV GP AND CD40L/EBOV GP VACCINE PRODUCTION

1.0. Introduction

U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Virology Division, Pathogenesis and Immunology Branch have a requirement for two adenovirus-5 vectored-vaccines. One vaccine will express the glycoprotein (GP) of Ebola Virus (EBOV) and the other will express a multimerized CD40L/EBOV GP antigen.

1.1. Mission

USAMRIID, Virology Division, Pathogenesis and Immunology Branch has been tasked by the Defense Threat Reduction Agency (DTRA) to investigate a potential for enhanced efficacy of a CD40L/EBOV GP immunogenic compared to EBOV GP alone.

1.2. Background

The immune system uses many different soluble and cell membrane-bound messengers to communicate. One such protein, CD40 Ligand (CD40L), functions in a role that provides crucial information between cell types to generate productive immune responses. The cognate receptor for CD40L and CD40 is expressed by antigen-presenting cells. CD40L, therefore, can be utilized to direct an antigen of interest to a specific cell type (i.e. antigen-presenting cells). As antigen-presenting cells are pivotal initiators of immune responses, targeting an antigen of interest specifically to them – by virtue of CD40L – presents a means of efficient antigen delivery that can elicit robust immune responses. Furthermore, the biology behind CD40L and CD40 interactions results in a phenomenon known as cross-presentation, which increases the breadth of T cell responses that can be derived from vaccination. Multimerized formulations of CD40L-EBOV GP are essential as CD40 expression on antigen-presenting cells is best engaged by multiple CD40L molecules. Current Ebola EBOV vaccines utilize the GP of EBOV to elicit immune responses. Our goal is to evaluate the relative potency of EBOV GP vaccination in an Adenovirus-5 (Ad5) vector compared to an identically vectored EBOV GP that utilizes CD40L targeting.

1.3. Scope

The contractor shall provide two batches of vaccine in an Ad5 vector. One shall express EBOV GP and the other shall express a multimerized construct of CD40L/EBOV GP. Each batch will need to be sufficient to vaccinate 300 mice at a dose of 1x108 infectious units (IU) per mouse.

03 July 2017- 02 June 2018 (tentative) + 4 Option Periods, for a total of five years. The period of performance is for a twelve (12) months Base Years and four (4) twelve (12) months option years, for a total of five (5) years. The place of performance is at the contractor location.

2.2 Non-Personal Services

This award identifies services that are strictly non-personal in nature.

2.3 Severable / Non-Severable Services

This award identifies services that are non-severable in nature.

2.4 Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

2.5 Acquisition Functions Closely Associated with Inherently Governmental Not applicable for this task.

2.6. Business Relations

2.6.1. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

2.6.2. Reports and documents delivered by the contractor in the performance of this contract shall be considered “Technical Data” as defined in the applicable FAR clause 52.227-14, Rights in Data. 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 the 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 topics addressed in the performance work statement (PWS).

2.7. Contract Management Activities

2.7.1. The Contracting Officer’s Representative (COR) for this contract will be appointed by the contracting officer (KO) and will serve as the primary point of contact for all activities and issues that occur under this contract . The COR is responsible for all duties included in the COR Appointment Letter, but not limited to the following:

2.7.1.1. Serving as the primary technical point-of-contact for this contract, as required, and interfacing with other identified technical points of contact.

2.7.1.2. Identifying the need for and sending contract modification requirements to the KO and Contract Specialist, as required.

2.7.1.3. Reviewing and accepting or rejecting all Contractor technical deliverables provided under this contract.

2.7.1.4. Serving as the approval and disapproval authority for receiving reports and invoices.

2.7.1.5. Assuring that Government furnished property, equipment, information, and materials are properly managed by the Contractor.

2.7.1.6. Conducting contract surveillance activities (see PWS Section 6.0).

2.7.1.7. Conducting other activities as specified in the COR appointment memorandum.

2.7.2. The COR shall ensure that all tasks are performed efficiently, accurately, on time, and in compliance with the PWS requirements. The COR shall coordinate as necessary with the Contractor Program Manager to ensure the tasks are managed consistently with overall contract requirements. The COR shall ensure timely and accurate submission of invoices. The following deliverables are required:

2.7.2.1. Non-Disclosure Statement ( Deliverable 1). The Contractor shall sign the Non-Disclosure Statement to ensure that all contractor employees, subcontractors, and consultants assigned performed under this contract execute, sign, and adhere to the terms of the Non-Disclosure Statement. Contractor employees who have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor. Each Offeror shall provide one (1) Non-Disclosure statement with their proposal, which indicates that all contractor employees, subcontractors, and consultants assigned to perform under this contract have executed, signed, and adheres to the terms of the Non-Disclosure Statement.

2.7.2.2. Quality Control Plan (QCP) (Deliverable 2). The Contractor shall prepare and adhere to a QCP describing how the Contractor intends to manage the contract to achieve the established standards set forth in the Performance-Standards Summary Matrix and Quality Assurance Surveillance Plan (QASP) provided with their proposal.

2.7.2.3. Monthly Task Status Report (Deliverable 3, Attachment 3). Contractor shall submit a Monthly Report for this contract.

2.7.2.4. Contract Manpower Reporting (Deliverable 4). This is a mandatory requirement in accordance with Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the EBOV GP AND CD40L/EBOV GP VACCINE production via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at: http://www.ecmra.mil/.

2.8. Labor Categories and Descriptions. The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work or task with a minimum of under or over employment of resources. Labor rates, and man-hours utilized in the performance of this contract issued hereunder will be the minimum necessary to accomplish the task. The contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

2.9. Hours of Work.

All services under this contract shall be performed at the contractor location. Contractor shall be available to the Government during normal business Monday through Friday from 0600 to 1700 hours.

2.10. Travel / Temporary Duty (TDY).

None required for this contract.

2.11 Security and Workplace Safety:

2.11.1 General. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s biological surety program is governed by a broad set of Federal, Department of Defense(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.

2.11.2. Security Requirements - No requirements.

2.11.3. Foreign Nationals Requirements - No requirements.

2.11.4. Requirements for BPRP Enrollment - No requirements.

2.11.5. Services for Contractors Enrolled in the Biological Personnel reliability Program (BPRP)

2.11.5.1. Government Furnished Services - No requirements.

2.11.5.1. Contractor Furnished Services - No requirements.

2.11.6. Requirements for Escorted Visitor Entry to CDC-registered Spaces - Contractor shall comply with USAMRIID’s Visitor Policy 11-24, Escorted Entry to CDC Registered Areas when onsite.

2.11.7. Services for Contractors Not Enrolled in the BPRP

2.11.7.1. Government Furnished Services - No requirements.

2.11.7.2. Contractor Furnished Services - No requirements.

2.11.8. Network Security – No requirements.

2.11.9. Safeguarding Information

The Contractor shall properly and adequately safeguard sensitive (FOR OFFICIAL USE ONLY) or classified government materials in accordance with Department of Defense Directive (DoDD) 5230.09, Clearance of DoD Information for Public Release; DoDD 5200.1-R, Security and Policy Review of DoD Information for Public Release; DoDD 5200.1-PH, Classified Information Nondisclosure Agreement; AR 380-5, Department of the Army Information Security Program; and AR 380-40, Safeguarding and Controlling communications Security Material. Work shall not be performed in classified areas unless appropriate clearances are received in accordance with DoDM 5220.22-M,National Industrial Security Program Operating Manual (NISPOM) .

2.11.10. Physical Security

2.11.10.1. DFARS Clause 252.225-7043, Antiterrorism (AT)/Force Protection for Defense Contractors Outside the United States shall be applicable to this contract requirement if 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.

2.11.10.2. 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 DoD, Headquarter Department of the Army (HQDA) and local policy. In addition to the changes otherwise authorized by the change 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.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

2.11.11. Workplace Safety

The contractor employee must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations. Contractor employees are required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR immediately.

2.11.12. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training. This training is IAW USAMRAA Policy 17-01, Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Guidance.

2.11.12.1. The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Responses Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

2.11.12.2. The contractor shall require all contractor personnel with knowledge to an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government’s COR or Contracting Officer. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

2.11.12.3. Government Unique Training. The contractor shall ensure all services providers receive SHARP Training no later than 60 calendar days after contractor personnel begin performance under this contract and annually thereafter. Training can be self-study using the provided slides, obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or in person. In-person training through USAMRAA can be scheduled by contacting (301) 619-8937 for class date/time and availability. If the employee has an AKO account, they can access training online at Army AKO: https://www.us.army.mil/. (Deliverable 8)

2.12. Contractor Attendance at Government Training Opportunities. The Government may require contractor attendance at Government provided or Government sponsored training offered by the Research, Development and Acquisition Support Office, or as outlined in the current version of USAMRMC Command Policy Memorandums “US Army Medical Research and Materiel Command (USAMRMC) Decision Gate (DG) Training Requirements” and “Requirement for Training of Personnel Involved in Food and Drug Administration (FDA)-Regulated Activities”. These training opportunities will be provided via web-based offerings, at on-site classroom settings or at local venues that will not otherwise incur travel expenses by the attendee. The Government determination for contractor attendance at one or more of the aforementioned training opportunities will be based on the applicability of the specific training opportunity to tasks being performed in this PWS and the above referenced USAMRMC Command Policy Memorandums. The COR will document all government training determinations made for each contractor employee performing under this contract as well as training opportunity attendance/completion.

3.0. Performance Requirements

3.1. Objective 1 – Provision of EBOV GP/Ad5 vaccine – The contractor shall produce an Ad5 vaccine expressing EBOV GP. The contractor shall provide a titer for the vaccine defined by the number of infectious units per mL (IU/mL).

Performance standard: The titer must be equal to or greater than 1x1010 IU/mL and have endotoxin levels below 1 endotoxin unit (EU)/mL.

UIC for USAMRIID is W4GPAA Deliverable 5: EBOV GP/Ad5 vaccine at a titer ≥1x1010 IU/mL with an endotoxin content below 1 EU/mL.

3.2. Objective 2 - Provision of CD40L-EBOV GP/Ad5 vaccine – The contractor shall produce an Ad5 vaccine expressing a CD40L-EBOV GP multimer construct. The contractor shall provide a titer for the vaccine defined by the number of infectious units per mL (IU/mL).

Performance standard: The titer must be equal to or greater than 1x1010 IU/mL and have endotoxin levels below 1 endotoxin unit (EU)/mL.

Deliverables 6: CD40L-EBOV GP/Ad5 vaccine at a titer ≥1x1010 IU/mL with an endotoxin content below 1 EU/mL.

4.0. Special Requirements

4.1. Transition

4.1.1. Transition-in – No requirements.

4.1.2. Option Item: Transition-out - No requirements.

4.2. Contingency Operations Plan –Deliverable 8

The Contractor shall prepare and submit a Contingency Operations Plan to the Government. The Contingency Operations Plan shall be due thirty (30) calendar days after the award of the order, and shall be updated on a semi-annual basis (Deliverable 8). The Contingency Operations Plan shall document Contractor plans and procedures to maintain USAMRIID support during an emergency. The Contingency Operations Plan shall include the following:

4.2.1. A description of the Contractor’s emergency management procedures and policy.

4.2.2. Planned temporary work locations or alternate facilities.

4.2.3. How the Contractor will communicate with USAMRIID during emergencies.

4.2.4. A list of primary and alternate Contractor points of contact, each with primary and alternate:

4.2.4.1. Telephone numbers

4.2.4.2. E-mail addresses

4.3. Contractor Personnel Performance/Replacement - No requirement.

4.4. Contractor Identification - No requirements.

4.5. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their Contractor status known during introductions.

4.6. Use of Military Rank by Contractor Personnel

Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contract under which they provide services.

4. 7. Other Special Considerations – No requirements.

5.0. DELIVERABLES

5.1 Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter, and others listed below.

5.2 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.

5.3 Shipping

The Contractor shall use appropriate, Good Manufacturing Practices (GMP) - 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 COR must approve the selected shipping method and any exceptions to these requirements.

5.4 Government Acceptance Period

5.4.1. 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.

5.4.2. 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.

5.5 Delivery Schedule Abbreviations

The following abbreviations are used in the delivery/deliverable schedule:

5.6 Deliverable/Delivery Schedule

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).

TOCOR

Signed statements are due, from each employee assigned, prior to performing ANY work on this task.

TOCOR

TOCOR

TOCOR

TOCOR

TOCOR

TOCOR

TOCOR

6.0 CONTRACT ADMINISTRATION DATA

6.1. Government Facility – No requirements.

6.2 Other Direct Costs (ODCs)

6.2.1. ODCs shall be billed on a cost reimbursable basis. Costs are defined as the purchase price of materials or service plus General and Administrative charges (G&A) or material and handling charges (M&H).

6.2.2. All ODCs shall be fully supported in compliance with all competition requirements of the FAR 6, Competition Requirements.

6.2.3. All ODCs shall be reported as stated in the Monthly Progress Report paragraph 2.7.2.3.

6.2.4. Estimated ODCs are as follows:

Total ODC

6.3. Quality Assurance

The Government will review Monthly Progress Reports and will attend regular task performance review meetings with the Contractor to survey quality of products and services.

6.3.1 Quality Assurance Surveillance Plan (QASP)

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight provided for in the order and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.

6.4. Government Furnished Equipment (GFE)/ Information (GFI)/Property(GFP) No requirements.

7.0 APPLICABLE DOCUMENTS AND DEFINITIONS

EXHIBIT 1: GLOSSARY OF ACRONYMS