A08-Solicitation_19Q0276.docx

W81XWH19Q0276

Section SF 1449 - CONTINUATION SHEET

PWS

PERFORMANCE WORK STATEMENT (PWS)

Good Clinical Practice (GCP) Training to Study Staff located in Maryland, Hawaii, North Carolina, Alaska, Washington, and Texas as outlined in this PWS

1. GENERAL. The Division of Medicine conducts on-site and off-site Clinical Trials and clinical research on Biological Defense (BD) as well as Infectious Diseases (ID) of military significance, offers investigational vaccines to at-risk employees through its Special Immunizations Program (SIP), conducts a variety of educational programs on biological defense for civilian and military healthcare providers, provides clinical laboratory support for human and animal studies, and provides a variety of administrative and management support functions to the institute.

2. The Department of Clinical Research (DCR). The DCR consists of three major sections: Special Immunizations, Clinical Studies (MVCRC and CRU) and Field Studies. The DCR conducts classic Clinical trials and Field studies in support of developing medical countermeasures for the war fighter. The Department designs/prepares original proposals and protocols to study investigational devices, new drugs, vaccines and other countermeasures for biologic threats, infectious and toxic agents of military significance. It operates within Continental United States (CONUS) & Outside the Continental United States (OCONUS) to assess USAMRIID products and other biodefense products developed to aid in biodefense of the war fighter and as prophylaxis for USAMRIID personnel working with select agents. The Department supports DHA/IHB (MILVAX Agency)/ Military Vaccine Clinical Research Center (MVCRC) in its role to ensure that licensed vaccines for the war fighter continue to meet safety and immunologic readiness by using cutting edge technology to study these requirements. Field Studies section operates OCONUS in cooperation with the Defense Threat Reduction Agency and other Department of Defense (DOD) agencies in support of research, countermeasures development, and training involving deadly select agents important to the mission of USAMRIID and for the war fighter.

3. SCOPE. The primary objective is to deliver Regulated Training (Good Clinical Practice – GCP Training) to US Government active duty and civilian employees as well as contractor employees who are members of a Study Team conducting a Phase IV clinical trial at several different sites within CONUS and Hawaii, the sites and the fiscal year that the study will be accomplished are listed in this PWS below.

a. All training will be delivered to the selected community as described within this PWS.

b. The Fort Detrick USAMRIID Contracting Officer Representative (USAMRIID COR) at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is the focal point for this requirement.

4. CONTRACTOR RESPONSIBILITY.

a. The Contractor shall provide a four-day regulated training scheduled for September 2019 (Exact date TBD) to include training CDs (including relevant FDA and GCP educational material) for 20 – 25 personnel; the training schedule will consist of:

DAY ONE AND TWO: On the first and second day of training the trainer shall propose a two day intensive, interactive GCP training program to cover the regulations governing the practical aspects of executing a successful clinical trial as the Government has outlined above. Actual case studies relevant to this mission shall be presented and discussions will follow in order to ensure everyone understands practical applications of the regulations governing clinical research.

DAY THREE: On the third day of training attendees will be performing their normal functions as the trainer performs a “mock” audit in order to work together with the team to improve team cohesion and to look for areas which can be improved. This is provided as a Quality Improvement tool and team building exercise.

DAY FOUR: On the fourth and final day of training the contractor shall review areas of improvement noted during the audit and discuss with the team the best way forward towards ongoing quality improvement and the role each of team member plays in the ongoing process of continuing quality improvement. During this session, the contractor shall discuss how risk management can be used as a tool to mitigate and manage risk and improve outcomes.

The training will be located at the following Government sites and in the given fiscal year starting in late 2019. Other sites will be as follows:

Location of Site Fiscal Year Number per class

4.1 The Contractor shall Provide a qualified trainer for GCP training that would be familiar with Investigational New Drugs (IND) (catered to vaccines and US government medical facilities) and the Code of Federal Regulations (CFR), Title 21, Parts 11, 50, 54, 56, 312, and 314; FDA Guidance for Industry ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6); ICH Guideline for Clinical Safety Data.

4.1.2. The Contractor shall plan the training to include Management: Definitions and Standards for Expedited Reporting (E2A); ICH Guideline on General Considerations for Clinical Trials (E8) prepare and set up for the class (i.e.: CDs that would be needed in order to provide the training), ideally this would include reference materials that will be given to each participant for future use..

4.1.3. The Contractor shall make arrangements for transportation and/or housing for trainer.

4.1.4.. The contractor shall provide USAMRIID with invoices in agreement with instructions provided in the contract award

1.4. PERFORMANCE QUALITY.

1.5.1. CONTRACTOR QUALITY CONTROL (QC) PROGRAM. The Contractor shall implement and sustain, through-out the life of the contract, an industry acceptable quality control program for Reference Laboratory Services in accordance with (IAW) commercial industry standards, and as required by 21 CFR Part 58, GLP Regulations for Nonclinical Laboratories and CLIA (42 USC 263a.The Contractor shall provide a copy of its existing Quality Control System to the USAMRIID/COR within 15 days after award.

1.5.1.5. The Contractor shall notify the Contracting Officer immediately, in writing, upon its loss of any required certification, accreditation, or licensure. The Contractor shall submit to the USAMRIID COR notification of completion of corrective action.

1.6. SAFETY REQUIREMENTS.

1.6.1. The Contractor shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

1.6.2. The Contractor shall submit a written property damage report to the USAMRIID COR, within 72 hours, for any accident caused by any contractor which results in damage to Government property.

1.7. Computer Security. Computer system processing is sensitive, but unclassified information, and shall have the appropriate security features in accordance with requirements in DoDD 8500.01E, Information Assurance, U.S. Army’s or other Government Agency basic policy of initial and periodic security training and the need for physical controls to protect hardware and data.

1.8. A progress meeting shall be held within 60 days after the contract start date between the USAMRIID/COR and the Contractor to discuss any issues; throughout the life of the contract, the contractor shall be available to meet with the TO/COR or USAMRIID/COR upon request, thereafter.

2. GOVERNMENT INFORMATION

2.1. RESPONSIBILITIES. The Government will:

2.1.1. The Government will provide access to Military base, essential class room space, office equipment and supplies necessary to conduct training.

2.2. GOVERNMENT-FURNISHED ITEMS.

2.2.1. See above paragraph 3.1.1.

3. CONTRACTOR -FURNISHED ITEMS. Not applicable

4. DESCRIPTION OF WORK: The primary objective is to deliver Regulated Training (Good Clinical Practice – GCP Training) to US Government active duty and civilian employees as well as contractor employees who are members of a Study Team conducting a Phase IV clinical trial at several different sites within CONUS, the sites and the fiscal year that the study will be accomplished described in paragraph 1.3.1 above.

5. DELIVERABLES.

5.1. Monthly SA Reports. The Contractor shall provide separate monthly data summary reports of tests performed for each SA under this contract. The printed reports shall be delivered to the USAMRIID, Fort Detrick, MD, the contracting officer, and the COR as identified on this task order, by the tenth calendar day of the month after the end of each monthly reporting period. Contractor shall provide reports to the Lab Manager upon request for the SA listed in this contract.

5.2. CONTRACTOR MANPOWER REPORT (CMR). “ACCOUNTING FOR CONTRACT SERVICES-The Office of the Assistant Secretary of the Army (Manpower & Reserve Affairs) operates and maintains a secure Army data collection site where the Contractor shall report ALL Contractor manpower (including subcontractor manpower) required for performance of this contract. The Contractor is required to completely fill in all the information in the format using the following web address https://cmra.army.mil. The required information includes: (1) Contracting Office, Contracting Officer, Contracting Officer’s Technical Representative; (2) Contract number, including task and delivery order number; (3) Beginning and ending dates covered by reporting period; (4) Contractor name, address, phone number, e-mail address, identity of CSP entering data; (5) Estimated direct labor hours (including sub-Contractor); (6) Estimated direct labor dollars paid this reporting period (including sub-Contractor); (7) Total payments (including sub-Contractor); (8) Predominant Federal Service Code (FSC) reflecting services provided by Contractor (and separate predominant FSC for each sub-Contractor if different); (9) Organizational title associated with the Unit Identification Code (UIC) for the Army Requiring Activity (the Army Requiring Activity is responsible for providing the Contractor with its UIC for the purposes of reporting this information); (10) Locations where Contractor and sub-Contractors perform the work (specified by zip code in the United States and nearest City, Country, when in an overseas location, using standardized nomenclature provided on website); (11) Presence of deployment or contingency contract language; (12) Number of Contractor and sub-CSP deployed in theater this reporting period (by country) and (13) As part of its submission, the Contractor shall also provide the estimated total cost (if any) incurred to comply with this reporting requirement. Reporting period will be the period of performance not to exceed 12 months ending September 30 of each government fiscal year and must be reported by 31 October of each calendar year. The Contractor shall notify the Contracting Officer’s Representative (COR) by the 5th working day of November whether or not they have completed this report. If the COR is unavailable, the Contractor shall notify the Contracting Officer.

5.3. The Contractor shall designate and submit, in writing, within 10 working days after award, the name, telephone number, pager, cell phone number, facsimile number and e-mail address of a full-time Contractor representative and alternate. The written designation shall be submitted to the COR at the USAMRIID, Fort Detrick, MD and the contracting officer.

6. Obligations of the Government

Provisions for the Government to Inform the Contractor of Privacy Practices and Restrictions

(a) The Government shall provide the Contractor with the notice of privacy practices that the Government produces in accordance with 45 CFR 164.520.

(b) The Government shall provide the Contractor with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect the Contractor’s permitted or required uses and disclosures.

(c) The Government shall notify the Contractor of any restriction to the use or disclosure of Protected Health Information that the Government has agreed to in accordance with 45 CFR 164.522.

7. Permissible Requests by the Government

The Government shall not request the Contractor to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Privacy Rule, the HIPAA Security Rule, or any applicable Government regulations (including without limitation, DoD 6025.18-R and DoD 8580.02-R) if done by the Government, except for providing Data Aggregation services to the Government and for management and administrative activities of the Contractor as otherwise permitted by this clause.

7.1. Termination

(a) Termination. A breach by the Contractor of this clause, may subject the Contractor to termination under any applicable default or termination provision of this Contract.

(b) Effect of Termination.

8. Period of Performance –

9. POINTS OF CONTACT: The points of contact for this task order are:

1. Contracting Officer: Philip Huff, philip.h.huff.civ@mail.mil

1. Contracting Specialist: Michael Baughman, michael.e.baughman.civ@mail.mil

1. Contracting Officer Representative (COR): TBD

10. DEFINITIONS/ACRONYMS.

a. CONTRACTOR. The term as used in this contract refers to both the prime and subcontractors.

b. CONTRACTING OFFICER is a person with authority to enter into, administer, or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government. The basic contract will be administered by the Center for Health Care Contracting/Contracting Officer.

c. CONTRACTING OFFICER'S REPRESENTATIVE (COR) is an employee of the U.S. Government appointed by the Contracting Officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

1. QUALITY ASSURANCE. The procedures used to verify that services being performed by the Contractor are performed according to acceptable standards.

1. QUALITY ASSURANCE PROGRAM (QAP). All necessary measures taken to assure that the quality of an end product or service shall meet contract requirements.

1. SUBMITTING ACTIVITY is any Government activity submitting specimens under this contract.

1. TASK ORDER CONTRACTING OFFICER. Contracting Officer who issues an individual task order against the basic contract, other than the CO

ACRONYMS.

QASP

QUALITY ASSURANCE SURVEILLANCE PLAN

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

1. What will be monitored?

1. How monitoring will take place.

1. Who will conduct the monitoring?

1. How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

FAR 52.246-4 Inspection of Services- Fixed Price

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: Philip H, Huff Organization or Agency: USAMRAA Email: philip.h.huff.civ@mail.mil

b. Contract Specialist (KS) -

Assigned KS: Michael E. Baughman Telephone: 301-619-2315 Email: michael.e.baughman.civ@mail.mil

c. Contracting Officer Representative (COR) – The COR is responsible for technical administration of the contract and assures proper Government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any changes on the Government’s behalf. Any changes that the contractor deems may affect contract price, terms or conditions shall be referred to the Contracting Officer for action.

Assigned COR: TBD Telephone: 301-619-1 Email:

3. CONTRACTOR REPRESENTATIVES:

4. Methods of QA Surveillance

a. Contractor Performance Assessment Report System (CPARS) – The Government for this procurement will address the Quality of Service; Schedule; Business relations, Management of Key Personnel, and other important areas. As this information may affect future source selections throughout DoD, the annual Government will be used appropriately as a complementary performance oversight and communication tool with the QASP.

b. QASP - The below listed method of surveillance shall be used by the COR in the technical administration of this QASP.

5. PERFORMANCE STANDARDS.

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Work Statement (PWS) for this contract has been submitted separately.

The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

The Performance Requirements Summary Matrix, paragraph in the Performance Work Statement includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Performance Requirement Paragraph Acceptable Quality Level Surveillance Method

Provide a four-day regulated training scheduled for September 2019 and various other dates as specified in the PWS (Exact dates TBD) to include training computer discs (CDs) and reference materials for 20 – 25 personnel at Government sites in Hawaii, North Carolina, Alaska, Washington, and Texas

90% acceptable on first submission to Government

100% acceptable on subsequent submission to Government Reviewed and accepted by Contracting Officer Representative (COR)

Provide a qualified trainer with FDA and GCP educational material that will be delivered to medical personnel at the training sites as outlined in the PWS in Hawaii, North Carolina, Alaska, Washington, and Texas.

90% acceptable on first submission to Government

100% acceptable on subsequent submission to Government Reviewed and accepted by Contracting Officer Representative (COR)

Prepare and set up for the class.

90% acceptable on first submission to Government

100% acceptable on subsequent submission to Government Reviewed and accepted by Contracting Officer Representative (COR)

Make arrangements for transportation and/or housing for trainer.

90% acceptable on first submission to Government

100% acceptable on subsequent submission to Government Reviewed and accepted by Contracting Officer Representative (COR)

METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

1. Feedback from Government Users or on site contractor personnel

1. Direct Observation

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

1. DIRECT OBSERVATION. (Can be performed by Feedback from Government Users or on site contractor personnel)

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

6. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Example 1:

7. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

CONTRACTOR MANPOWER REPT

CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)

The contractor shall report ALL contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the USAARL via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: 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.

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at www.ecmra.mil.

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new eCMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website will ask for the “Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code (UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this contract is W4GPAA.

(End of Instruction)

CONTRACTOR IDENTFICATION

CONTRACTOR IDENTIFICATION (USAMRAA) (May 2015)

When contractor personnel perform the services required in this contract (on a Government installation, facility and/or government leased site), they are required to possess and wear an identification badge that displays his or her name and the name of the Company. 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.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

OCI

ORGANIZATIONAL CONFLICT OF INTEREST

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.

Offerors are encouraged to present their best strategy for mitigation of any potential OCI under this requirement. Offerors 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. 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, for purposes of this clause, to be 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.

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

· Does the Offeror or any intended Subcontractors, teaming partners, proposed employees, or affiliates have? Would award to the Offeror result in the Offeror having the opportunity Unequal Access to Information to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract? Specifically, will the Offeror/Contractor have access to any of the following information:

· Budget(s), or Budget Information?

· Acquisition Sensitive Information related to the procurement process to include, but not limited to Acquisition Plans, Requirements, Statements of Work, or Evaluation Criteria?

· Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have “impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

· Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a Government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself?

· Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

NON-DISCLOSURE

Non-Disclosure Agreement for Contractor Employees and Subcontractors I, __________, am an employee of or a subcontractor to [Company Name] , a Contractor acting under contract to the USAMRIID under Prime Contract No. W81XWH-19-?-????/TBD . I understand that in the performance of this task, I may have access to sensitive or proprietary business, technical, financial, and/or source selection information belonging to the Government or other Contractors. This information includes, but is not limited to, cost/ pricing data; Government spend plan data; Planning, Programming, Budgeting and Execution (PPBE) documents and information, as defined in DoD Directive 7045.14; Contractor technical proposal data; independent government cost estimates; negotiation strategies and Contractor data presented in negotiations; contracting plans and statements of work. I agree not to use, discuss, divulge, or disclose any such information or data to any person or entity except those persons directly concerned with the use or performance of this delivery order. I have been advised that the unauthorized disclosure, use or negligent handling of the information by me could cause irreparable injury to the owner of the information. The injury could be source sensitive procurement information of the government or proprietary/trade secret information of another company.

I understand that the United States Government may seek any remedy available to it to enforce this Agreement, including, but not limited to, application for a court order prohibiting disclosure of information in breach of this agreement. Court costs and reasonable attorney fees incurred by the United States Government may be assessed against me if I lose such action. I understand that another company might file a separate claim against me if I have misused its proprietary information.

In the event that I seek other employment, I will reveal to any prospective employer the continuing obligation in this agreement prior to accepting any employment offer.

The obligations imposed herein do not extend to information/data which is:

a. in the public domain at the time of receipt or it came into the public domain thereafter through no act of mine;

b. disclosed with the prior written approval of the USAARL designated Contracting Officer;

c. demonstrated to have been developed by [Company Name] , or me independently of disclosures made hereunder;

d. disclosed pursuant to court order, after notification to the USAARL designated Contracting Officer;

e. disclosed inadvertently despite the exercise of the same reasonable degree of care a party normally uses to protect its own proprietary information.

I have read this agreement carefully and my questions, if any, have been answered to my satisfaction.

(Signature)

Organization

(Printed Name of Corporate Official) (Printed Title –Task Manager or higher)

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NET AMT

FFP

SEE INSTRUCTIONS

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

14-SEP-2020

W4GP USA MD RES INST OF DISEAS

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

210-221-7877

W23MYC

14-SEP-2020

W23MYC

14-SEP-2020

W23MYC

14-SEP-2021

W4GP USA MD RES INST OF DISEAS

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

210-221-7877

W23MYC

14-SEP-2021

W23MYC

14-SEP-2021

W23MYC

14-SEP-2022

W4GP USA MD RES INST OF DISEAS

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

210-221-7877

W23MYC

14-SEP-2022

W23MYC

14-SEP-2022

W23MYC

14-SEP-2023

W4GP USA MD RES INST OF DISEAS

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

210-221-7877

W23MYC

14-SEP-2023

W23MYC

14-SEP-2023

W23MYC

14-SEP-2024

W4GP USA MD RES INST OF DISEAS

BLDG 1425 PORTER STREET

FORT DETRICK MD 21702-5711

210-221-7877

W23MYC

14-SEP-2024

W23MYC

14-SEP-2024

W23MYC

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will the Lowest Price Technically Acceptable (LPTA) to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Lowest Price Technically Acceptable

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

BASIS FOR AWARD

The Government intends to make a Single Firm-Fixed Price (FFP) Award using the LOWEST PRICE TECHNICALLY ACCEPTABLE (LPTA) process. Award will be made based on the Offeror with the Lowest Price Technically Acceptable offer. Technically Acceptable means that the offer meets all of the stated minimum requirements. Incomplete or unreasonable offers shall not be considered. The Government will evaluate information based on the following evaluation criteria: Technical Approach, Past Performance, and Price. All quotations received on or before the quotation due date will be evaluated by a Source Selection Team (SST). It is the Offeror’s burden to ensure that their quotation is submitted on or before the due date and time.