Exhibit 1- Sample Task Order 1- Animal Husbandry Colony Maintenance.docx

Initial Task Order

Task Order Performance-Based Work Statement for WRAIR Non-human Primate Colony Maintenance

2.0 Tasks

2.1 Task Management

The Contractor shall provide all services, including preparation for shipping as necessary, in accordance with DoD, federal, state, and local regulations and industry standards to include Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), Public Health Service policy, Animal Welfare Act and standards described in The Guide for the Care and Use of Laboratory Animals, 8th edition. Additionally, the Contractor shall designate a single manager to oversee this task and supervise staff assigned to this task.

Period of Performance. The Initial Task Order may potentially include a base period of 12 months and 4 12-month options. However, the Government reserves the right to award the base period only, or any combination.

Optional Transition In period- Date of award through 2 months, and/or Base period: Date of award through 12 months;

Option Period 1: End of base period through 12 months;

Option Period 2: End of option period 1 through 12 months;

Option Period 3: End of option period 2 through 12 months;

Option Period 4: End of option period 3 through 9 months.

Option Period 5: End of option period 4 through 3 months.

2.1.1 Monthly Financial Progress Report (MPR) – Deliverable 1

The Contractor shall ensure that a MPR (Deliverable 1) is submitted outlining the financial expenditures, billings, progress, status, and any problems/risks or issues encountered in the performance of this task. The MPR shall provide sufficient detail to enable the COR to monitor financial performance as well as monitor cost expenditures to ensure projects are in compliance with allotted funds.

The Contractor shall ensure that any Contractor projected travel and other direct costs are within the spending plan; coordinating for COR approval prior to travel or ODC expenditures.

The Contractor shall also require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and Contractor.

2.2 Transition and Shipping Services

The Contractor shall ensure all responsibilities are transferred without any degradation in service. Cages shall be in accordance with the United States Department of Agriculture (USDA) and International Air Transport Association (IATA) guidelines (if applicable). Each compartmentalized, properly ventilated, and escape-proof cage shall have separate water and feed containers for each compartment. Each shipment of NHPs shall be held separately while under quarantine following local Standard Operation Procedure (SOP). If possible, a representative for the Government will be available on site to inspect NHPs during receipt at final destination.

2.2.1 Animal Delivery

Transition includes those services and the action that transfers responsibility of the animal colony and all associated administrative actions to include shipment of NHPs, diagnostics in preparation for transition, quarantine efforts and transfer of records.

Shipping includes those services and the action to ship a specified number of NHPs in support of research protocols. Services shall include, but are not limited to, shipment of NHPs, diagnostics in preparation for transition, quarantine efforts and transfer of records. Each shipment of NHPs shall be held separately while under quarantine for a minimum of 10 days before transportation unless waived by the Government. During quarantine, NHPs will be tuberculin tested twice, and receive a broad spectrum antihelmintic as agreed upon by COR and the Contractor. All NHPs will have serology submitted for Herpes B virus, measles, Simian Retrovirus Type D (SRV), Simian T-cell Leukemia Virus (STLV), Simian Immunodeficiency Virus (SIV) within three (3) months of delivery. Only seronegative NHPs will be shipped to the Government, unless the COR otherwise approves.

The Contractor shall establish procedures to ensure a smooth transition of all management and functional responsibilities identified in this PWS as coordinated with and approved by the COR. The Contractor shall ensure all responsibilities are transferred without any degradation in service. The Contractor shall provide the expertise and the mechanisms of shipment.

2.2.1.2 All animal health records, current medical condition, diagnostic test results, breeding records, and colony history, to include digital and any paper records, will be transferred to the gaining Contractor prior to animal shipment. The COR will determine the time and site of delivery and coordinate the mechanisms of shipment with the Contractor.

2.2.2 Transition Services

2.2.2.1 Transition In - Deliverable 2a

In accordance with this solicitation, the Contractor shall provide a Transition In Plan for 60-days incoming transition from contract to contract with the proposal (Deliverable 2a). The Government will designate a transition period for the incoming Contractor to coordinate and work with the outgoing Contractor. The transition in plan shall include target completion dates for each task. The Transition In Plan shall include, but is not limited to:

required.

Information (GFI), and GFE inventory management assistance.

2.2.2.2 Transition Out Plan – Optional Task – Deliverable 2b

Contractor will provide a detailed 90-day transition out plan (Deliverable 2b) with the proposal outlining all aspects of successful transition to include animal quarantine, diagnostic testing, animal transportation and delivery and necessary administrative tasks. A Cull Report identifying NHPs that may not be suitable for transport due to illness, age, etc., must be provided to the Contracting Officer Representative (COR) prior to final transport. The Transition Out Plan shall include, but is not limited to:

2.3 Contingency Operations Plan and Emergency Operations

2.3.1 Contingency Operations Plan– Deliverable 3

The Contractor shall develop a Contingency Operations Plan (Deliverable 3). A draft plan shall be provided with proposal submission. The Contingency Operations Plan shall document Contractor plans and procedures to maintain WRAIR support during an emergency. The draft Contingency Operations Plan shall be due with the proposal. The Contingency Operations Plan shall document Contractor plans and procedures to maintain WRAIR support during an emergency. This plan shall specifically address the risks inherent to the particular facility while also demonstrating the flexibility to address less likely scenarios.

This plan should consider natural, national, and localized disaster related events requiring preplanning and execution; and shall address these circumstances. The Contingency Operations Plan shall include the following:

· Telephone numbers, E-mail addresses

2.4 Quality Control Plan (QCP) – Deliverable 4

The Contractor shall develop a Quality Control Plan (Deliverable 4). A draft QCP will initially be submitted with the Offeror’s proposal. The QCP shall document how the Contractor will meet and comply with the quality standards established in this Performance Work Statement (PWS). At a minimum, the QCP must include the Contractor’s objectives for animal care (health and psychological well-being); management of the reproductive NHPs and for providing for the number of progeny necessary to meet the needs of the Government. Additionally, 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, data management, customer satisfaction, and any other requirements set forth in this solicitation.

2.5 KEY PERSONNEL (June 2015) (USAMRAA)

a. The Contractor agrees to utilize the following Key Personnel on this contract:

Veterinarian: The veterinarian shall possess a DVM, or equivalent doctoral degree, obtained from a college accredited with AVMA; be licensed to practice veterinary medicine in at least one state in the USA; and must have experience providing medical care and breeding management for nonhuman primates. Comment by Miller, Lynn J MAJ USARMY WRAIR (USA): What happened to all of the additional specifics about what the veterinarian must have (licensure, ect) that was listed in the QASP originally? Does that information not go here? I put it back in.

b. The above Key Personnel shall be utilized as necessary to fulfill the requirements of this contract.

c. The contractor must provide thorough and detailed documentation of the experience, abilities, and background for Key Personnel under this contract in the form of resumes or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience.

d. The contractor agrees that during the contract performance period substitution for Key Personnel shall not be permitted unless such substitution is necessitated by sudden illness, death, or termination of employment. In any of these events, the contractor shall promptly notify the Contracting Officer and provide the information required by paragraph (e) below.

e. All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for the proposed substitute(s), and any other information requested by the Contracting Officer needed to approve or disapprove the proposed substitution(s). All proposed substitutes shall have qualifications that are equal to or higher than the qualifications of the person to be replaced. The Contracting Officer or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof.

f. 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.

2.6 Animal Husbandry and Veterinary Care Services

The Contractor shall provide qualified trained personnel to provide husbandry and veterinary care for the primates 7 days a week, 365 days a year. Personnel must have experience in the operation and management of a non-human primate breeding colony.

2.6.1 Animal Health Maintenance

The Contractor will provide on-site veterinary care to include, but not limited to, twice daily health observations, 24 hour emergency care, clinical pathology, diagnostic pathology, hospital care and surgical treatment of NHPs. The Contractor will make every effort to maintain a colony that is SPF for Herpes B Virus, measles, SRV, SIV and STLV-1.

Contractor will provide NHPs with treatment against endoparasites and ectoparasites in accordance with current accepted standards of veterinary care and using a product approved by COR. All primates dying unexpectedly must receive an examination and necropsy to determine the cause of death. NHPs shall be vaccinated against measles at the discretion of the Government.

The contractor will test all NHPs for Herpes B virus, measles, Simian Retrovirus Type D (SRV), Simian T-cell Leukemia Virus (STLV), and Simian Immunodeficiency Virus (SIV) by serology and/or polymerase chain reaction (PCR) as appropriate. These tests will be done annually on all NHPs greater than 12 months of age. NHP’s will be tuberculin tested every 6 months. The cost for these colony diagnostics will be included in the daily per diem charge for the NHPs and not billed separately. The Government may change the testing frequency as necessary.

2.6.2 Animal Breeding- Deliverable 5

The Contractor is expected to provide at least 450 research naïve (RN) 2.5-3 year old, >3.05 Kg SPF IO rhesus macaques per year. Table 2 demonstrates the WRAIR’s recent colony production rates employing a breeding method of out-door, gang-caged harems consisting of one male and up to 8 females. Based on historical production rates, our current needs and current literature (see Table –1-4 below), the Contractor shall provide a draft Animal Breeding Plan Report (Deliverable 5) with proposal submission detailing its plan to achieve the required numbers of NHPs. The subsequent report shall detail the status discussing progress made and/or possible causes of the lack of progress along with recommended courses of action. The plan shall include ways to improve breeding efficiency to the following objectives: a production rate (defined as the # of young weaned/ # documented pregnancies) of ≥70%, an infant loss rate ≤8%, and an adult mortality rate ≤ 4%. A reasonable rate of progress towards improving breeding efficiency is an increase of 5-7% per year. If Contractor does not make reasonable strides towards reaching a 70% production rate, or if infant loss rate/adult mortality rate rises or exceeds the contract standard, the Contractor shall promptly notify COR. Any changes in husbandry and/or breeding practices must be approved by COR prior to implementation.

Table 1: WRAIR Colony Production Rates

Table 2: Reproductive Rates Macaques

Source: Nonhuman Primates in Biomedical Research: Biology and Management, pg 209 Table 3: Current Contract NHP Colony Totals

Table 4: Current Contract Breeders

2.7 Data Management

Contractor will maintain a digital system of records to store, analyze and display data on all past and present NHPs of the colony for the duration of the contract. The Contractor shall file and maintain vendor animal health reports, keeping information available for all current research protocols. The animal record shall reflect at a minimum:

· Individual Identification number

· Sire’s and Dam’s Individual Identification Numbers if known

· Birthdate

· Gender

· Offspring, when applicable, to include stillbirths:

a. by Individual Identification Number;

b. gender;

c. date of birth;

d. birth weight;

e. hospitalizations and cause;

f. date of death;

g. sire’s Individual Identification Number

· Health Status (e.g. herpes +, SIV +, in hospital)

· Hospitalizations and cause

· Specific location within facility

· Disposition, when applicable, to include date and cause

· Behavior related incidents including self-injurious behavior (SIB), aggression, and alopecia The Contractor will maintain a digital system of records to store, analyze and display data on all past and present NHPs of the colony for the duration of the contract. The Contractor shall establish and maintain a copy of animal records on the designated WRAIR Animal Management System (AMS) digital record keeping system. Both a primary and secondary individual should be designated and granted access to the WRAIR digital record keeping system. The Contractor identified employees shall be issued a Common Access Card (CAC), undergo a background screening, be required to complete all required training in accordance with the AT/OPSEC requirements (Section 11, IDIQ PWS) to maintain access to the network. Contractor identified employees shall log into the WRAIR network no less than once monthly to maintain access. The Contractor shall file and maintain vendor animal health reports, keeping information available for all current research protocols.

2.7.1 Monthly Activities Report – Deliverable 6

The Contractor shall provide a Monthly Activities Report (Deliverable 6) describing the progress of the animal husbandry/maintenance program to date, noting all technical areas in which effort is being directed and indicating the status of work within these areas will be furnished to the COR for review and acceptance. The COR shall review each monthly activities report to ensure the Contractor is making adequate forward movement toward achieving the stated objectives of the proposal.

2.7.2 Monthly Colony Census Report – Deliverable 7

Contractor shall provide the colony census report (Deliverable 7) on a monthly basis or upon Government’s request. The Contractor shall conduct a Monthly Colony Census to obtain and verify basic demographic data. The system of records shall be updated monthly to reflect the results of the respective census.

2.7.3 Reproductive Cull Report – Deliverable 8

Contractor shall provide a reproductive cull report (Deliverable 8) identifying NHPs not suitable for breeding to the COR on an annual basis or upon Government’s request.

2.7.4 Miscellaneous Data Reports – Deliverable 9

Miscellaneous reports (Deliverable 9) covering colony maintenance, husbandry data, health status, protocol use, or contract administrative reports, not otherwise addressed, may be requested by the Government and must be provided within 20 days. It is expected that no more than 3 miscellaneous reports per quarter will be requested.

2.8 Personnel Training – (Deliverable 10)

The Contractor shall provide personnel trained in a manner that is consistent with AAALAC standards. The Contractor shall maintain a documented training program for its personnel. Evidence of training program and employee documentation of training (Deliverable 10) shall be made available upon Government request. Some general categories of training shall include, but are not limited to, humane care and ethical use of NHPs, animal care and veterinary medicine, animal husbandry techniques, animal handling and restraint, operation of service equipment, and safety.

2.9 Facilities

The Contractor shall provide secure, licensed and accredited NHP facilities which are certified and maintained in accordance with DoD, federal, state, and local regulations and industry standards to include AAALAC, USDA, PHS policy, Animal Welfare Act and standards described in The Guide for the Care and Use of Laboratory Animals, 8th edition. The facility must maintain its accreditation and licensure status for the duration of the contract. The facilities and equipment shall be of sufficient size, strength, safety, durability and ability to be sanitized to house NHPs while providing a psychologically enriching environment to the NHPs. Facilities and equipment shall be maintained in accordance with industry standards. The Contractor shall verify the efficacy of the sanitation and disinfection activities, the feed, bedding, water quality and environmental monitoring, treatment regimes, breeding practices and any other procedure which is suspected to impact colony health in order to ensure that NHPs remain healthy and pathogen free and subclinical disease agents are identified.

2.9.1 Visitation Program Policy – Deliverable 11

Contractor shall establish and maintain a written health certification program and policy concerning all COR approved visitors, staff, and guest investigators working at or visiting the breeding colony, and maintain updated records on all such individuals. Visitors shall wear dedicated shoes and clothing, as provided by the Contractor, while on the premises. Contractor shall maintain a registry of all visitors to the colony. The registry shall contain the visitor’s name, dates and time of visit and business address. The Contractor shall provide the register to the COR upon request (Deliverable 11). This program shall be in effect for the duration of the contract. Enforcement and maintenance of the health certification policy for visitors and staff is the responsibility of the Contractor.

2.9.2 Security

The Contractor shall provide adequate and appropriate physical, cyber and informational security to protect the facility, its NHPs, its employees and its information from entities with intent to damage or disrupt colony operations.

2.9.3 Computer and Network Security

All Contractor employees with access to a Government information system must be registered in the Army Training and Certification Tracking System (ATCTS) at commencement of services and must successfully complete the DoD Information Assurance (IA) Awareness training prior to access to the information system and annually thereafter. The Contractor shall insure unauthorized access to, and protection of, issued Government property to include laptop and CAC card issued for use in the performance of the contract.

2.10 Animal Delivery

The Contractor shall, under a separately awarded task order, provide biological samples for pre-screening of NHPs prior to shipment. Each shipment of NHPs shall be held separately while under quarantine for a minimum of 10 days before transportation unless waived by the Government. During quarantine, NHPs will be tuberculin tested twice, and receive a broad spectrum antihelmintic as agreed upon by COR and the Contractor. All NHPs will have serology submitted for Herpes B virus, measles, Simian Retrovirus Type D (SRV), Simian T-cell Leukemia Virus (STLV), Simian Immunodeficiency Virus (SIV) within three (3) months of delivery. Average diagnostic information is available in Table 1of Section 2.3.1 for viral profile and SRV testing. Only seronegative NHPs will be shipped to the Government, unless the COR otherwise approves.

2.11 PLACEHOLDER RESERVED

2.12 Animal Acquisition (Purchase) and Disposition (Sale) -Optional Task Upon Government request, the Contractor shall purchase of IO rhesus macaques, Chinese origin rhesus macaques and cynomolgus macaques, or the sale of NHPs from the Government-owned colony. An amount up to $700,0001 million per year shall be provided for the purchase of new NHPs to the colony on a separately issued task order for purchase. Additional costs due to specific research requirements would be included in the purchase price of the animal. The Contractor shall also provide the Government an option to sell excess NHPs from both the Contractor maintained colony and the WRAIR in-house colony. The COR will identify any excess NHPs eligible for sale following fulfillment of research and breeding needs. The Government must approve the purchaser following review of requested documentation described below. The Contractor will receive a portion of total receipts following the sale. The portion of sales provided to the Contractor will be based on current market purchasing fees and mutually agreed upon by both the Government and Contractor. The Government will also have the option to apply/offset its portion of receipts toward the cost of the husbandry/maintenance contract.

2.12.1 Market Value Report - Deliverable 13

The Contractor shall provide a report detailing market value (Deliverable 13) for IO rhesus macaques, Chinese origin rhesus macaques and cynomolgus macaques. The COR will review this report and utilize information provided in the event NHPs need to be purchased.

2.12.2 Animal Source Information

The Contractor will provide supplier information to COR if requested prior to animal purchase. This information may include but is not limited to: copy of any licensing (USDA) and or accreditation status (AAALAC) documentation, description of animal housing and husbandry to include veterinary care, animal health records.

2.12.3 Report of Interested Buyers

Once potential buyers are identified, Contractor shall provide COR with buyer information to include but not limited to: accreditation status, licensing (USDA), animal housing, and proposed use of animal. Contractor shall also include a quote detailing a breakdown of all costs associated with the sale to include any shipping costs and diagnostics charges. The Government retains the right to have final authority for sale of any identified NHPs.

2.12.4 Sale Documentation – Deliverable 14

Following approval of sale by COR, Contractor shall provide a copy of all final sale documentation (Deliverable 14), transfer of ownership documentation, and confirm final shipment and receipt of NHPs.

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

3.2 Method of Delivery

Reports shall be created using Microsoft Office suite of tools (i.e. 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.

3.3 Deliverables 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.

3.4 Government Acceptance Period

The COR will have ten (10) workdays to review 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.

3.5 Delivery Schedule Abbreviations

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

3.6 Deliverable/Delivery Schedule

Deliverable 12

RESERVED

4. Other Direct Costs The following amounts are provided as “plug” amounts for ODCs.