A02 DRAFT Performance Work Statement - RFI Post for Patent License Agreement Audit Services.docx

PERFORMANCE WORK STATEMENT

Title: Patent License Agreement Audit for the Office of Research and Technology Applications (ORTA)

Requiring Activity Name: Defense Health Agency Medical Research & Development Command (DHAMRDC) Office of Research and Technology Applications (ORTA)

1.0 SCOPE

This Performance Work Statement (PWS) describes contract support needed for the Defense Health Agency Medical Research and Development (DHAMR&D), Office of Research Technology Applications (ORTA) to audit 1-2 patent license agreements with company partners each year. The ORTA conducts technology transfer for the DHAMR&D and negotiates all license agreements as well as select Cooperative Research And Development Agreements (CRADAs).

This award will facilitate an important component of technology transfer which is monitoring company partner compliance with the negotiated terms and conditions of the negotiated patent license agreement. These agreements establish partnerships that enable the development of commercial products by the private sector from early-stage DHAMRDC inventions. The sale of such products provides revenue back to DHAMR&D and its subordinate laboratories.

This PWS will provide the ORTA with specific deliverables that will enable the ORTA to determine whether or not the company licensee is properly calculating the net sales on all products that are covered by the licensed technology. This contract support will improve ORTA effectiveness and management of active DHAMR&D license agreements. In general, the Contractor shall:

(1) Provide Patent License Agreement Audit Services professionally and efficiently in accordance with applicable laws, policies and regulations and as stated in this PWS.

(2) Perform the requirements of this contract independently and not as an agent of the Government.

(3) Have access to ORTA personnel who are knowledgeable of the DHAMR&D licensing requirements, background information on active license agreements, and understand the licensed DHAMR&D technologies.

1.0.1 Background

The DHAMR&D Office of Research and Technology Applications (ORTA) is responsible for Technology Transfer involving a broad range of technologies and organizations within the Defense Health Agency. These technologies reflect the breadth of the military medical mission, which includes medical research, development and acquisition, for the U.S. Army, Navy, Air Force and Marines. The ORTA negotiates all license agreements, select Cooperative Research and Development Agreements (CRADAs) and attendant agreements for Defense Health Agency research laboratories and medical treatment facilities. Additionally, the ORTA conducts Technology Transfer analysis and agreement formation support functions.

Technology transfer (T2) activities are an integral element of the DoD national security mission and are to be given a high-priority role in all DoD acquisition programs per DoD Instruction 5535.8 and DoD Directive 5535.3. Through effective use of T2 agreements, technological advancements can be fielded at a cost savings to the government and often faster than conventional procurement means by leveraging the value of the government’s intellectual property (IP). The U.S. industrial base, and by extension the U.S. economy, also benefit from these T2 collaborations given the access to valuable IP and other government resources made available to industry through such collaborations. The economic catalyst of T2 was the topic of a 2011 Presidential Memorandum challenging federal agencies to improve T2 programs in order to spur economic development in the United States while advancing agency missions.

The license agreements, CRADAs, and attendant agreements establish partnerships that enable the development of commercial products by the private sector from early-stage military medical inventions. The sale of such products provides revenue back to the Defense Health Agency and the laboratories. Developing and maintaining these agreements by the DHAMR&D/ORTA requires a broad range of specialized skills to include budget management and license agreement compliance.

ORTA/MTT currently has 88 active license agreements that it manages.

As ORTA/MTT pursues revised standard operating procedures for monitoring license agreement compliance, as set forth by the U.S. Army Auditing Agency recommendations, the use of an outside, neutral, third party with expertise in conducting patent license agreement financial audits is essential to success. ORTA/MTT is seeking to engage a partner to develop a Licensee Audit Plan (LAP). The proposed LAP will ensure that DHAMR&D collects its full compensation from patent licensees. Additionally, the LAP will provide ORTA/MTT leadership with an internal control system in place to better manage its license portfolio to its maximum effectiveness.

1.0.2 Objectives

The ORTA/MTT requires the services of a licensee royalty auditing firm (“Contractor”) to audit the sales and financial records related to licensed products of DHAMR&D technology licensees (“Licensee”) at their places of business in order to determine if DHAMR&D has received the proper amount of royalty payments specified under their license agreement for use of DHAMR&D intellectual property rights granted under the license agreement. In addition, the Contractor will help ensure that the Licensee is in compliance with other terms of the license agreement including the application of royalty payments creditable against earned royalties due.

The Contractor shall design and execute an audit to ensure that DHAMR&D is collecting full Royalty compensation as agreed upon in Appendix G of the signed License Agreement.

ORTA/MTT will audit one to two license agreements per calendar year (CY).

Each calendar year, ORTA/MTT will submit to Contractor a list of 1-2 proposed license agreements to be audited.

1.1 Non-Personal Services

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

1.2 Severable / Non-Severable Services

This award identifies services that are severable in nature.

1.3 Inherently Governmental Functions

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

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

1.5 Organizational Conflict of Interest (OCI) Category

DHAMR&D has categorized all its non-purchased care requirements into three broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories are defined as follows:

-Category 1: DHAMR&D Internal Support: Services which, by their very nature, give the Contractor access to potential requirements and extensive data about Category 2 and Category 3 contractors.

-Category 2: Program Management Support: Services which assist DHAMR&D in planning and managing its activities and programs. This includes, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support.

-Category 3: Product Support. Services or end items required to meet the mission requirements of DHAMR&D’s non-purchased care activities and programs. This includes, for example: concept exploration and development; system design; system development and integration; Commercial Off-The- Shelf (COTS) procurement and integration; internal development testing; deployment; installation; operations; and maintenance.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that DHAMR&D presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in DHAMR&D requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all DHAMR&D requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding and / or mitigating against OCIs, DHAMR&D will examine all its non- purchased care requirements and acquisitions regardless of the cognizant contracting activity or the type of contract vehicle used.

Each DHAMR&D non-purchased care solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract / order has been determined by DHAMR&D to fall within the following non-purchased care OCI category:

Category 2: Program Management Support

2.0 STATEMENT OF WORK (SOW)

The Contractor shall provide license agreement audit reports for the ORTA/MTT.

2.1 Task Management

The Contractor shall provide sufficient management to ensure that this task is performed efficiently, accurately, on- time, and in compliance with the requirements of this document. Specifically, the Contractor shall designate a single manager to oversee this task and supervise staff assigned to this task. The Contractor shall ensure that a Biweekly Progress Report (Deliverable 2) is submitted outlining the expenditures, billings, progress, status, and any problems/ issues encountered in the performance of this task.

2.1.2 Outgoing Transition Plan (Optional)

The Contractor shall provide a plan for 7 business days to transition work from an active task order to a follow-on contract/order or Government entity (Deliverable 9) not later than 90 days prior to the end of the contract period of performance. This transition may be to a Government entity, another Contractor, or to incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract and/or orders issued under this Contract to a successful provider. This shall include formal coordination with Government staff and successor staff and management. It shall also include delivery of copies of existing policies and procedures, and delivery of required metrics and statistics. This transition plan shall include, but is not limited to:

-Coordination with Government representatives, -Review, evaluation and transition of current support services, -Transition of historic data to new Contractor system, -Government-approved training and certification process, -Transfer of hardware warranties and software licenses (if applicable), -Transfer of all necessary business and/or technical documentation, -Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc., -Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance, -Turn-in of all government keys, ID/access cards, and security codes.

2.1.3 Program Management Plan (PMP)

The Contractor shall write a PMP describing the Contractor’s management steps planned to ensure that all activities are managed in a sound, reasonable way, using Generally Acceptable Accounting Principles (GAAP) to achieve the Government’s objectives (Deliverable 7). The PMP shall consist of control policies and procedures in accordance with standard industry practices for project administration, execution, and tracking.

The Contractor shall include the following in the PMP:

-Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities;

-An Integrated Master Management Plan (IMMP) describing the Contractor’s overall management approaches, policies and procedures including project metrics;

-A detailed staffing plan including actions to be taken to ensure continuity of service throughout the period of performance; and, -A detailed subcontractor management plan.

The Offeror shall submit the PMP with the Offeror’s proposal. The Contractor shall review and revise the PMP within 30 days of contract award. The Contractor shall review and revise the PMP within 30 days of award of any subsequent contract options or if the Contractor makes a significant change to management steps, policies, or procedures. The PMP will be reviewed and approved by the Government and the Contractor shall respond to all Government comments.

2.1.5 Quality Control Plan (QCP)

The Contractor shall prepare and adhere to a QCP (Deliverable 8). A QCP shall initially be submitted no later than fifteen (15) business days after award. A final plan shall be submitted no later than 25 calendar days after contract award. The Contractor shall review and revise the QCP within 30 days of award of any contract options or if the Contractor makes a significant change to plans, policies, or procedures documented in the QCP. The QCP will be reviewed and approved by the Government and the Contractor shall respond to all Government comments. The QCP shall document how the Contractor will meet and comply with the quality standards established in this Performance Work Statement and that all deliverables produced are acceptable prior to delivery to the Government. The QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this contract. The QCP will be reviewed and approved by the Government and the Contractor shall respond to all Government comments.

2.1.6 Contingency Operations Plan Not applicable for this task.

2.1.7 Operations During Emergency Situations Not applicable for this task.

2.1.8 Reserved

2.1.9 Key Personnel

Key Personnel identified for this requirement are as follows:

-Project Manager/Director -Senior Consultant Contractor shall provide all personnel, subject matter experts, facilities, material, state-of-the-art computer equipment, computer and graphics output devices and administrative capability necessary to perform any or all of the work. No government furnished equipment or work space will be provided.

2.1.10 Contractor Personnel Performance/Replacement

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have qualification equal to or greater than the individuals proposed. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance. If any of the listed Key Personnel are subcontractor personnel, the Contractor shall include the substance of this clause in any subcontract which he awards under this contract.

2.1.11 Identification of Contractor Employees

All contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

2.1.12 Contracting Officer Representative (COR)

The Contracting Officer’s Representative (COR) will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

2.2 Specific Tasks

The Contractor shall provide license agreement audit support to the ORTA as follows. The following will be provided in the form of a Category A, B, C, or D audit (depending on the size and scope required) as defined in the “License Agreement Categories” Attachment to the PWS, as specified by the program office, and in accordance with the corresponding CLIN structure in this contract.

Agreement – “Desk Audit”

materials One patent (United States) or one licensed biological material Not a full audit but brief review to identify potential issues

combination with one other product

control) Single licensee

few additional ones

possibly a few additional ones

<50% of the required reports

2.2.1 License Compliance Review Preparation: Prior to each audit of sales and financial records, the Contractor, under a confidential nondisclosure agreement, will be provided background information by the ORTA/MTT Director and Staff (“ORTA”). The ORTA will prepare and send an audit confirmation letter to the Licensee and assist in coordinating the scheduling of the audit. The Contractor will determine from the Licensee and Sublicensee(s) the type(s) of accounting system and data availability for the period to be audited. A briefing of the Contractor will be conducted by the ORTA. A compliance review plan will be formulated by the Contractor as an outcome of the briefing [Deliverable 3]. Background information provided by the ORTA to the Contractor will include a copy of the license and sublicense agreements and any amendments, copies of sales and earned royalty reports submitted by the Licensee for the period to be audited, the Licensee’s payment history, the results of an internal audit, and copies of any other pertinent information about Licensed Products and their sales obtained from other sources. Contractor will provide a timeline of the proposed audit [Deliverable 4] based upon the compliance review plan.

2.2.2 Site Visits to Licensee Places of Business: Based on the information obtained during the compliance review preparation and briefing, the Contractor will visit the sites where Licensed Product sales records are kept, to conduct the on-site audit and compliance review. The compliance review plan will be executed during each site visit.

*Due to COVID-19 outbreak, during the base period of performance, on-site reviews will be replaced by virtual reviews. The Contractor will provide the COR a plan to conduct virtual reviews.

The Contractor will review the available sales records of the Licensee and its Sublicensee(s) to test the gross sales figures for all areas where Licensed Product was sold and to verify that the Licensee and Sublicensee(s) have accounted for all the Licensed Product sales when reporting net sales and earned royalties due for the period covered by the audit. Contractor will also review Licensee records and documentation to include notification, reporting, milestone dates, and License terms compliance.

Contractor will work with DHAR&D Patent Counsel in the event the Licensee has claimed overpayment of earned royalties on product sales or Licensee claims product sales are not covered by the licensed patents. Contractor will examine formulation records for such products to determine validity of such assertions and credits taken. A detailed calculation of royalties owed on net sales of Licensed Product in accordance with the subject license agreement will be performed by the Contractor. Specifically, using appropriate accounting and auditing procedures, the Contractor will perform an audit that includes at least the following elements set forth in Task 2.2.4 below.

See the “Travel” section below for information relating to approval requirements prior to travel being performed. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract.

2.2.3 Exit Interviews: Upon completion of the audit, an exit interview and briefing will be conducted by the Contractor with the Licensee to present the audit findings for the site and to provide an opportunity to explain and/or correct any deficiencies found during the interview. The Exit Interviews will be virtual meetings with the Licensee.

*Due to COVID-19 outbreak, during the base period of performance, fact-to-face Exit Interviews will be replaced by virtual Exit Interviews. The Contractor will provide the COR a plan to conduct virtual Exit Interviews.

2.2.4 Preliminary License Agreement Audit Report and Debriefing with ORTA/MTT Director and Staff: A preliminary written report [Deliverable #5] will be prepared by the Contractor and delivered to the ORTA within three weeks of completing the audit. A debriefing meeting or phone conference with the Contractor will be scheduled by the ORTA within three weeks of receiving the preliminary report. The written report will contain all relevant raw data, auditing procedures, findings, analyses of reported findings, and conclusions. At a minimum, the report will address the following highlights:

-Review of relevant records for compliance with GAAP (or, for foreign records, IFRS) standards for accounting and reporting;

-Comparison of data submitted to Agency against internal records;

-Comparison of all products potentially related to the licensed patents against the patent claims to ensure all Licensed Products are being reported;

-Comparison of inventory with reported production of Licensed Product;

-Review of records of deductions from gross receipts (e.g., shipping/receiving costs, taxes) to the extent claimed on any report of sales;

-Determination of methods used and analysis of Licensee’s calculations of earned royalties for each Licensed Product, including, if and when applicable, whether substantiated overpayments made to Agency have been properly credited in calculating earned royalties;

-Determination of the methods used for the analysis of sales data for each Licensed Product;

-Correlation of locations of Licensee’s and Sublicensee’s actual sales force – specifically, those in each territory included in the license who are promoting Licensed Products – with the locations of reporting offices and reported sales;

-Analysis of periodic sales fluctuation over period relative to season or period of Licensee’s fiscal year;

-Analysis of true currency-exchange valuation versus Licensee’s reporting for sales in foreign currencies;

-Comparison of sales volume of products that are sold together with or are complementary to each Licensed Product against sales of that Licensed Product for the same reporting period.

2.2.5 Final License Agreement Audit Report: Within 30 days of the debriefing meeting or phone conference, a final Audit Report [Deliverable #6] will be delivered by the Contractor to the ORTA. The report will include financial information and summary data in an appendix sufficient to ensure the audit was calculated accurately, however, confidential records of the Licensee and/or Sublicensee(s) will not be included.

3.0 RESERVED

4.0 DELIVERABLES

4.1 Delivery Address

All deliverables shall be submitted to the COR designated in the COR appointment letter.

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), 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 the U.S. Postal Service standard delivery for delivery of materials, equipment, or required hardcopy documents. The COR must approve all exceptions to this requirement.

4.4 Government Acceptance Period

The COR will have ten (10) workdays to review draft deliverables and make comments. The Contractor shall have five (5) workdays 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) work 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 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) workdays to correct the rejected deliverable and return it per delivery instructions.

4.5 Delivery Schedule Abbreviations

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

4.6 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). For deliverables indicated below as requiring both electronic and hard copy delivery, you may confirm with the COR if he/she would like to receive a hard copy in addition to the electronic delivery, as it may not always be necessary, on a case by case basis.

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

ORTA

Director

ORTA

Director

ORTA

Director

ORTA

Director

after award of any option years or significant changes are made to policies and procedures

after award of any option years or significant changes are made to policies and procedures

5.0 CONTRACT ADMINISTRATION DATA

5.1 Contract Administration

5.1.1 Place of Performance

The work will be performed at Contractor’s facilities.

5.1.2 Duty Hours

Contractor personnel shall perform services during regular duty hours 8:00 AM to 5:00 PM, Monday through Friday, excluding Federal Holidays as listed in paragraph 5.1.2.3 below. Contractor shall implement a system that accurately records hours worked and that is available to the COR. Some mission requirements may require work before or after established core hours.

5.1.2.1 Contractor shall not perform services on those days designated as a Federal Holiday by Federal Statute, Executive Order, Presidential Proclamation, or Installation Commander.

5.1.2.2 Contractor shall not perform services or report to work on those days the Government or installation is closed due to local determination relating to inclement weather conditions, national emergencies, energy conversation, requiring the closures. During these periods of closure, the contractor personnel that are not designated as essential shall not report for work nor will they be compensated for those days. Government will not pay for such closures.

5.1.2.3 The following is a list of legal federal holidays that services shall not be performed. Services shall not be performed on any other day declared a federal holiday:

-New Year’s Day, January 1st -Martin Luther King's Birthday, 3rd Monday in January -President’s Day, 3rd Monday in February -Memorial Day, Last Monday in May -Juneteenth Day, June 19th -Independence Day, July 4th -Labor Day, 1st Monday in September -Columbus Day, 2nd Monday in October -Veteran's Day, November 11th -Thanksgiving Day, 4th Thursday in November -Christmas Day, December 25th NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

5.1.2.4 The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor’s employees may be required to sign specific nondisclosure agreements as required by contract.

5.1.2.5 The contractor shall ensure that all contractor personnel are advised of their supervisor and who they should contact if they have questions. The Contractor POC will serve as the supervisor for contractor personnel.

5.1.3 Continuity of Services

If routine services are disrupted for more than three (3) consecutive days, the Government reserves the right to procure such services from another source, until routine services are restored by the Contractor. When the Government exercises it right to procure these services from another source, the Government will reduce the Contractor’s invoice at an equivalent amount to that incurred. A copy of the other source’s service ticket will be used as the basis for this reduction. The Government will furnish the Contractor a copy of this ticket upon the Contractor’s request.

5.1.4 Relationship of the Parties

This is a non-personal service contract. Contractor personnel are not subject to the supervision and control of a Government officer or employee IAW FAR 37.104(a)(1)(ii). Rather, contractor personnel perform their duties IAW specific tasks outlined in the PWS. Supervisory functions such as hiring, directing, counseling, and firing of contractor personnel are not performed by the Government. The contractor personnel who furnish services under this contract are subject to Government technical oversight of the services provided. The Government retains the right to reject services for contractual nonperformance.

5.1.5 English Language Requirement

Contractor personnel shall be fluent and communicate in the English language, in both written and oral communication.

5.1.6 Citizenship Requirement

Contractor personnel shall be a U.S. Citizen.

5.1.7 Conflict of Interest

The Contractor shall not employ any person who is an employee of the United States Government, if the employment of that person would create a conflict of interest.

5.1.8 Contractor Personnel Appearance

Contractor personnel working in the government location shall report for work in suitable business attire, and present a neat and professional appearance.

5.1.9 Records

The contractor shall be responsible for creating, maintaining, and disposing of only those Government required records which are specifically cited in this PWS or as may be required by the DA. If requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such records within five working days of receipt of the request.

5.1.10 Communication

The contractor shall ensure a contract employee under his/her supervision maintains an open and professional communication with the staff at the DA facilities. Complaints validated by the COR or DA staff shall be reported in writing to the contract administrator and the contractor for action. If the contractor fails to correct validated complaints raised by the COR and Contracting Officer (KO), it will be considered a failure in performance.

5.1.11 Performance Evaluation Meetings

The contractor or his representative shall meet with the on-site team lead, COR, and other Government personnel as required at least quarterly, but may meet more frequently if required. The contractor may request a meeting with the KO when deemed necessary. Meeting will be documented in the contract file with written minutes signed by the contract administrator and the KO. If the contractor does not concur with the minutes, such nonoccurrence shall be provided in writing to the KO within ten (10) calendar days of receipt of the minutes.

6.0 OTHER TERMS, CONDITIONS, AND PROVISIONS

6.1 Non-Disclosure /Non-Use Agreement

The Contractor shall ensure that the Non-Disclosure/Non-Use Agreement (Attachment to PWS) (Deliverable 1) is signed by all staff assigned to or performing on this Task order before performing any work, including all subcontractors and consultants. The Non-Disclosure/Non-Use Agreement shall be cosigned by a corporate official (Contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of staff who have not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. Requiring activity must ensure the NDA has been approved by its supporting Staff Judge Advocate.

6.2 Security Requirements

All contract employees require a minimum of a National Agency Check with Local Agency Check and Credit (NACLC) an active DoD Security Clearance prior to starting work on this contract. In accordance with the Federal Investigative Standards (FIS), what was formerly called a NACLC is now a Tier 3 (T3) investigation.

For contractors that do not require CAC, but require access to a DoD facility or installation. 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.

6.2.1 AT Level I Training

All contractor employees, to include subcontractor employees, requiring access Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 10 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 10 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

6.2.2 Access and general protection/security policy and procedures Contractor, Contractor employees, and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the 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, 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.

6.2.3 Information Security

6.2.3.1 The Contractor shall retain all data in strictest confidence and prevent the unauthorized duplication, use and disclosure of information. The contractor shall follow DoD, Fort Detrick, MRDC, and PCO security regulations and procedures. The Contractor shall ensure that all personnel exposed to data that is subject to the Privacy Act of 1974 and Health Insurance Portability and Accountability Act (HIPAA) take appropriate action to prevent disclosure of this information.

6.2.3.2 All data received, processed, evaluated, loaded and created as a result of this award shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the Contracting Officer grants specific exception.

6.2.3.3 Proprietary Information. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

6.2.3.4 All products including files, software and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government expressly grants the Contractor permission to retain the materials for continued development or publication.

6.2.3.5 Non-disclosure Agreements shall be signed by all Contractor employees proposed under this requirement before any work is performed.

6.2.5 Privacy and Confidentiality

6.2.5.1 The contractor shall abide by FAR clauses 52.224-1, Privacy Act Notification and 52.224-2, Privacy Act.

6.2.5.2 The contractor shall abide by FAR clause 52.239-1, Privacy or Security Safeguards.

6.2.5.3 The Contractor shall not publish or disclose in any manner, without the Contracting Officer’s written consent, the details of any safeguards either designed or developed by the Contractor under this contract or otherwise provided by the Government.

6.2.5.4 To the extent required to carry out a program of inspection to safeguard against threats and hazards to the security, integrity, and confidentiality of Government data, the Contractor shall afford the Government access to the Contractor’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

6.2.5.5 If new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party.

6.2.6. Initial and Annual Refresher Controlled Unclassified Information (CUI) Training In accordance with DoD Instruction 5200.48, Controlled Unclassified Information (CUI), all personnel within a DoD organization -- i.e., military members, DoD civilians, and on-site support contractors -- must complete CUI training initially within thirty (30) calendar days of reporting for duty and thereafter once every 365 calendar days. The training is located at https://securityhub.usalearning.gov/index.html.

6.3 Enterprise Architecture (EA) Not Applicable for this task.

6.4 Protection of Information

6.4.1 Public Releases

The Contractor shall coordinate and discuss with the COR all corporate publications (e.g., news releases, abstracts from meetings, etc.) that contain references to this contract. Additionally, prior to releasing any of the above, the Contractor shall provide a copy of the release to the Contracting Officer for comments and approval to release.

6.4.2 Contractor Employees

6.4.2.1. The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

6.4.2.2. 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 make their Contractor status known during introductions.

6.4.2.3. 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.

6.4.3 Personally Identifiable Information (PII) and Protected Health Information (PHI) Not applicable for this task.

6.4.4 Protection of Human Subjects and Adherence to Ethical Standards in Department of Defense (DoD)-Supported Research Not applicable for this task.

6.4.5 Business Associates Not applicable for this task.

6.4.6 Public Key Infrastructure Authentication and Encryption.

Contractors shall follow the DoD standards, policies, and procedures related to the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication including authentication to DoD private web servers or applications. Where interoperable PKI is required for the exchange of unclassified information, including the encryption of e-mail containing sensitive information, between DoD and its Contractors, industry partners shall obtain all necessary certificates if they are not eligible for a DoD Common Access Card. (Refer to http://iase.disa.mil/pki/eca/ and http://www.cac.mil/)

6.5 Access Requirements

6.5.1 Contractor access to HA/TMA Network/DoD Systems Not applicable for this task.

6.5.2 Contractor access to classified information Not applicable for this task.

6.5.3 Contractor access to Planning Programming, Budgeting, and Execution (PPBE) Documents and Data Not applicable for this task.

6.6 Data Rights

The Government will retain rights to all data produced in the course of developing, deploying, training, using and supporting USAMRDC or other federal agencies that utilize this order.

6.7 Quality Assurance

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

6.7.1 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.

6.7.2 Performance Requirements Summary Matrix

By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level columns.

information specified in the PWS.

Inspection Positive Past Performance Rating

of the PWS 90% of time.

100% Inspection Positive Past Performance Rating

acceptance by COR.

100% Inspection Positive Past Performance Rating

licensee site visit.

Inspection Positive Past Performance Rating

the PWS 90% of the time.

100% Inspection Positive Past Performance Rating

management policies or procedures.

PMP delivered on time including all of the required information 90% of the time.

The Contractor adheres to the steps documented in the PMP 90% of the time.

100% Inspection of PMP; periodic surveillance of adherence to approved plan Positive Past Performance Rating

policies or procedures.

QCP delivered on time including all of the required information 90% of the time.

The Contractor adheres to the requirements in the QCP 90% of the time.

100% Inspection of QCP; periodic surveillance of adherence to approved plan Positive Past Performance Rating

6.7.3 Performance Evaluation Process Not applicable for this task.

6.8 Section 508 Requirement

The Contractor shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Specifically, the procurement, development, maintenance, or integration of electronic and information technology (EIT) under this contract must comply…