Herd_Farm__RFP-_15-100-SOL-00007_12_12_2014.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

PAGES

(Date) (Hour)

SEC. PAGE(S) SEC. PAGE(S)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

15A. NAME

AND

ADDRESS

OF

OFFEROR

(Type or Print)

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 77

2. CONTRACT NO.

N/A

3. SOLICITATION NO.

RFP- 15-100-SOL-00007

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

December 12,

6. REQUISITION/PURCHASE

NO.

7. ISSUED BY CODE 8. ADDRESS OFFER TO (If other than Item 7)

HHS/OS/ASPR/AMCG

330 Independence Ave, SW, RM G-640 Washington, DC 20201

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 3 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in See SECTION L.1. of the RFP until 3:00 PM local time 01/13/15

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

Matthew Rose a. TELEPHONE (NO COLLECT CALLS)

202) 205-2901

b. E-MAIL ADDRESS

Matthew.Rose@hhs.gov

11. TABLE OF CONTENTS

((x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 33

X B SUPPLIES OR SERVICES AND PRICES/COSTS 3 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 5 X J LIST OF ATTACHMENTS 37

X D PACKAGING AND MARKING 12 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 13 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 14 X OTHER STATEMENTS OF OFFERORS 38

X G CONTRACT ADMINISTRATION DATA 23 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 39

X H SPECIAL CONTRACT REQUIREMENTS 26 X M EVALUATION FACTORS FOR AWARD 54

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within 180 calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

FAR (48 CFR) 53.214©

K mailto:Matthew.Rose@hhs.gov

NOTE TO OFFERORS

The information in SECTION A - Solicitation/Contract Form, contains important information for any offeror interested in responding to this solicitation. Any contract resulting from this solicitation will include in its SECTION A - Solicitation/ Contract Form, accounting, appropriation and general information applicable to the contract award.

The contract schedule, set forth in Sections B through H, contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that will be awarded as a result of this solicitation. The contract cost or price and other contractual provisions unique to the offeror's proposal may be included in the resultant contract.

The contract schedule is intended to provide the offeror with information to aid in understanding the likely terms and conditions of any resultant contract.

SECTION B – SUPPLIES OR SERVICE AND PRICE / COST

ANIMAL HUSBANDRY AND VETERINARY CARE SERVICES

B. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

B.1. BACKGROUND

This acquisition will provide animal husbandry and veterinary care services for a USG horse herd that is used in the supply of medical countermeasures.

This contract will provide the United States Government (USG) with services and supplies in support of a key MCM essential for an effective medical response to an attack using botulinum toxins.

Although progress has been made on botulism MCM preparedness over the past ten years, it is critical to maintain the manufacturing capability for MCMs for botulism. In order to maintain a capability to respond to botulism attack, the USG needs to maintain a horse herd used in the production of new doses of botulism antitoxins.

B.2. SPECIFIC TECHNICAL REQUIREMENTS

The Offeror shall provide the necessary qualified personnel, facilities, material, equipment (except Government property), and services to provide maintenance and veterinary care for a horse herd used in the production of the Botulism heptavalent botulism antitoxin immunotherapeutic.

B. 3. CONTRACT TYPE

This is a Firm Fixed Price contract for the services related to the maintenance and veterinary care for a horse herd used in the production of the heptavalent botulism antitoxin immunotherapeutic.

B.4 PRICES/COST:

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

It is anticipated that any contract awarded under this solicitation shall contain a base period of three years (36 months). It is further anticipated that any resulting contract will include two consecutive one year (12 months) contract options. Contract options are exercised at the discretion of the government. Exercise of these options could increase the total period of performance to five years (60 months).

B.4.1. In consideration for completion of the work to the Contractor shall be paid as stated in this

RFP.

B.5. PRICE SCHEDULE

BASE PERIOD

Category

Base Year One

Base Year Two

Base Year Three

Total for all Years

Herd – Maintenance

Price - Transportation

Total Price

OPTION PERIOD

Category

Option Year One

Option Year Two

Total for all Years

Price – Herd Maintenance

Price - Transportation

Total Price

SECTION C – STATEMENT OF WORK (SOW)

C.1 INTRODUCTION

The Office of the Assistant Secretary for Preparedness and Response (“ASPR”) within the U.S.

Department of Health and Human Services (HHS), identified the requirement for medical countermeasures to protect civilians from a potentially lethal exposure to Clostridium botulinum toxins that could occur as the result of an accidental exposure or deliberate act of terrorism directed at the US civilian population. The USG identified the need for medical countermeasures against seven serotypes (A, B, C, D, E, F, G) of Clostridium botulinum toxins (Botulism) and developed a single heptavalent FDA- licensed, intravenous product for use as a post exposure treatment. The product is equine derived, plasma-based heptavalent botulinum antitoxin (H-BAT), maintaining this herd, is a critical component of our national preparedness against an intentional contamination event with botulinum toxin. The primary purpose of this Request for Proposal (RFP) is to provide care and maintenance service 24 hours a day, 7 days a week (24/7) for the horse herd used in the production of botulism antitoxins.

C.2 BACKGROUND

HHS is the lead agency for public health and medical response to manmade or natural disasters and has the responsibility of maintaining a definitive supply of medical countermeasures- or the forward deployment of same- for use in national medical emergencies declared by the secretary of HHS. This acquisition will provide animal husbandry and veterinary care services for a USG horse herd that is used in the supply of medical countermeasures. This product is currently licensed by the Food and Drug Administration (FDA) for the treatment of confirmed or suspected cases of botulism intoxication and is acquired under a Project BioShield contract administered by BARDA with storage, maintenance and deployment of product overseen by the Division of the Strategic National Stockpile at the Centers for Disease Control and Prevention (CDC).

C.3 OBJECTIVE

The US government (USG) has a requirement to acquire, hold, and distribute medical countermeasures that will mitigate injuries caused by exposure to chemical, biological threat agents, and physical radiologic and nuclear exposures. BARDA has a specific need for botulinum antitoxin products to treat individuals with symptomatic botulism resulting from exposure to one or more of the seven identified serotypes of botulinum toxins. BARDA seeks to provide a contract mechanism through which husbandry and veterinary care services can be obtained for the maintenance of a herd of USG-owned horses that were used in the manufacture of the FDA-approved heptavalent Botulinum Antitoxin (hBAT).

C.4 ABBREVIATIONS AND DEFINITIONS

Botulism - a serious illness that causes flaccid paralysis of muscles. It is caused by the botulinum neurotoxin (BoNT), produced by the bacterium Clostridium botulinum. There are seven distinct neurotoxins (types A-G) that Clostridium botulinum produces, but types A, B, and E are the most common and account for more than 99% of cases. The toxin enters the body in one of three ways: 1) by bacterial colonization of the digestive tract in children (infant botulism) or adults (adult intestinal toxemia), 2) by ingestion of toxin from foods (food borne botulism), or 3) by contamination of a wound by the bacterium (wound botulism). Adult intestinal colonization and iatrogenic botulism rarely occur. Inhalational botulism does not occur naturally, but can be caused by inhalation of aerosolized botulinum neurotoxins.

In the United States an average of 145 cases of botulism are reported each year. Of these, approximately 15% are food borne, 65% are infant botulism, and 20% are wound. The current cornerstone of treatment for botulism is botulism antitoxin and mechanical ventilation. If diagnosed early, food borne and wound botulism can be treated with an equine antitoxin which blocks the action of toxin circulating in the blood. Antitoxin does not reverse paralysis but arrests its progression; therefore, it should be administered as soon as possible.

C.5 SCOPE OF REQUIREMENTS

Independently and not as an agent of the USG, the contractor shall furnish all the necessary services, qualified personnel, material, supplies, equipment, facilities, transportation and travel not otherwise provided by the USG to meet Contract requirements.

C.5.1. Scope

1. TASK AREA 0001 The contractor will provide veterinary care (including emergency transportation), husbandry, feeding, security, and maintenance of a US Government herd of up to 100 horses.

2. TASK AREA 0002 Provide transportation to relocate the horses from their current location to the proposed site.

C.6 TASK REQUIREMENTS

The deliverable under this contract is husbandry and veterinary care services to maintain a herd of USG-owned draft horses that were used in the manufacture of the FDA-approved heptavalent Botulinum Antitoxin (hBAT) 24 hours a day, 7 days a week (24/7). Maintenance of these draft horses will be at a secure location with at least 150 attached acres. All draft horses shall be maintained by the contractor, as an independent organization and not as an agent of the USG, shall furnish all necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation, and travel. In the event of an adverse event that results in the sickness or death of the draft horse, the contractor shall notify the CO, COR and and/or other officials as designated by the CO, within 24 hours and provide a plan for horse maintenance. If planned course of action does not meet the government and contractors initial agreement than the contractor shall notify the CO, COR, and and/or other officials as designated by the CO, of alternate solutions for draft horse maintenance.

The primary requirements are listed below.

C.6.1 MAINTENANCE (TASKS AREA 0001)

C.6.1.1. Within 15 calendar days of the signing of this contract, the Contractor shall provide a listing of the names, titles and telephone numbers (non-emergency and emergency) of its key personnel who should be contacted for USG visits, horse(s) (USG Furnished Property) status, and access to horse(s), during normal and after business hours. The Contractor shall notify by telephone and provide the CO and COR in writing any future updates or changes to the listing within 24 hours of making the update or change.

C.6.1.2.Within 30 calendar days of the signing of this contract, the CO will identify to the Contractor those representatives authorized by the Government as requiring access to the Contractor’s maintenance facility for inspection of facilities. The CO shall then notify the Contractor via telephone and in writing of any updates or changes to that list within 24 hours of any such updates/changes.

C.6.1.3.The Contractor shall allow announced and unannounced visits to its maintenance facility by Government personnel for the purpose of inspection and the review of horses. Quality assessments of

Contractor’s facility and equipment shall undergo an initial qualification audit. The CO will provide the Contractor with a minimum of a 24-hour advance notice of any announced visits. A Quality Assessment agenda shall be provided prior to the assessment date. Upon completion of the assessment, the Government shall provide to the Contractor a written Quality Assessment Report summarizing all findings and recommendations. The Contractor shall provide a written response addressing each finding/recommendation within 30 calendar days from the date report is received by the Contractor. The Contractor shall provide additional information and/or clarification regarding the assessment findings as requested by the Government. All visits, announced and unannounced, will be limited to normal business hours.

C.6.1.4.The Contractor shall be responsible to notify the CO and COR immediately of any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., State Veterinarian Office, OSHA, OLAW & USDA, local, state, and federal law enforcement agencies), and third party Contractors that may involve and/or impact Government-owned property. The Government shall be permitted to delegate at least two persons to observe the inspection. The notifications should be sent electronically to the CO, COR or other officials as designated by the CO.

C.6.1.5.The Contractor shall provide the USG with a plan of proposed corrective actions no later than fifteen (15) calendar days from the USG’s identification of problems regarding maintenance, inventory management, or other discrepancies identified through scheduled or non-scheduled storage sites visits. Contractor shall make all mutually agreed upon changes pursuant to such agreements as soon as possible.

C.6.2 ADDITIONAL MAINTENANCE TASKS

C.6.2.1 The USG will provide the Contractor up to 100 pre-immunized horses (USG Furnished Property) with veterinary and immunization records from calendar year 2013 to be used solely for the maintenance of the draft horses under this contract. The Contractor shall be responsible for the re-immunization of the horses with botulinum toxins, toxoids, and/or adjuvants as necessary and for monitoring the levels of anti-toxin antibodies at which time the Contractor shall initiate plasmapheresis under appropriate cGMP conditions. The Contractor shall include in its monthly report to the CO and COR a summary of anti-toxin titers.

C.6.2.2 The Contractor shall be responsible for all appropriate security measures to ensure that the herd is protected in a secure location for up to 100 horses with a minimum of 150 aggregate acres.

The location shall have buildings, fences, and facilities to maintain the herd.

C.6.2.3 Within 15 calendar days of the signing of this contract, the Contractor shall provide a listing of the names, titles and telephone numbers (non-emergency and emergency) of its key personnel who should be contacted for USG visits.

C.6.2.4 The contractor must provide a location within the continental United States that meets the meets the following criteria:

1. Provide farm staff commensurate to the size of the herd for routine maintenance that includes but not limited to: daily feeding, water, visual inspections twice per day, and herd management services;

2. Provide a single parcel of land that is not shared with other livestock;

3. Provide a metal security fence that is at least five feet high with an electrified wire near the top of the fence;

4. Provide a location that is located within 10 miles of an equine referral hospital with access to board certified surgeons, anesthesiologists, radiologists, internal medicine specialists, pathologists;

5. Provide a designated quarantine area separate from the herd that can house at least two horses undergoing treatment or returning from treatment in conditions that are suitable for draft horses;

6. Provide horse barn(s)with stalls and horse retention stocks suitable for draft horses;

7. Provide a secure location that limits access to authorized personnel only 24 hours, 7 days a week;

8. Provide at least two separate treatment paddocks that are at least 25 ft. x 25 ft. with at least four inches of sand for comfortable footing to accommodate hoof-related treatment;

C.6.3 VETERINARY SERVICES

C.6.3.1 The Contractor shall be responsible for the maintenance and control of the horses as GFP, and provide all necessary veterinary care and vaccinations. In the event of an illness, the Contractor shall notify the COR within 1 hour and in consultation with a USG veterinarian will determine the fate of the horse. In the event of a sudden death, the Contractor shall notify the CO and COR within 24 hours and initiate an investigation. If the cause of death is the result of Contractor negligence, the Contractor shall be liable for all replacement costs for the horse including costs for a) procurement of the horse, b) immunization of the horse to produce usable, immune titers, including supplies of toxoid and toxin, c) husbandry (food, water, routine veterinary care and vaccinations) for the period of time necessary to develop a usable titer. The USG reserves the right to conduct an investigation at its discretion.

The contractor shall establish, maintain, and adhere to a schedule that provides routine and emergency care that includes but is not limited to: health monitoring, immunizations, deworming, colic, internal and external infections, hoof care, ophthalmic, and dental exams and routine dental care every 6 months.

a. Provide immunizations based on the proposed location. At a minimum provide:

Equine Influenza, Equine Rhinopneumonitis, Equine Eastern Encephalomyelitis, Equine Western Encephalomyelitis, tetanus toxoid, West Nile vaccine, Strangles (Streptococcus equi.), Rabies vaccine, Potomac Horse Fever.

b. Complete Blood Count (CBC) and chemistry panel testing on each horse in the herd every six months by an accredited laboratory.

c. The Contractor shall be responsible for having the proper equipment available to properly diagnose and treat horses. At a minimum the following equipment is required:

• Tracker Microchip reader

• Portable X ray machine (100 kVP or larger)

• Digital X ray processor and cassettes (CR or DR)

• Diagnostic ultrasound equipment with either multi-frequency probe or separate rectal or external probes.

• Video endoscopes including gastroscopes, bronchoscope, and colonscope

• Equine veterinary dental equipment including electric or hydraulic power

• Floats, dental speculum and light source.

• Retention stocks (large enough for up to 2500 lb. draft horses)

• Microscope, refractometer, centrifuge, validated digital rectal thermometer

C.6.4 TRANSPORTATION (TASK AREA 0002)

C.6.4.1 Provide transportation for the relocation of the USG herd from its current location in Auburn, AL, to new location. The transportation plan must meet all USDA requirements for horse transportation. The contractor shall be responsible for obtaining all required legal and medical documentation necessary for the transportation of horses across US state lines. The contractor shall also be responsible for obtaining all necessary permits required to transport equine sera to its facility.

a. The contractor must provide a plan for approval to the CO and COR that includes proposed locations for stops and lay-overs and will ensure horse (s) are transported in the most humane manner.

b. The contractor must provide air conditioned trailers for trips that exceed 100 miles.

c. The contractor must identify the type of trailer to be used, the number of draft horses it can hold, and how many trips are necessary to relocate a herd of 100 horses.

C.6.5 SECURITY

C.6.5.1 The contractor shall be responsible for all security measures to ensure that the herd is protected and access is controlled 24 hours a day, 7 days a week. In the event that horses are transferred to another facility, the Contractor shall be responsible for the safe and humane transport to the specified location. The contractor shall be responsible for obtaining all required legal and medical documentation necessary for the transportation of horses across US state lines. The contractor shall also be responsible for obtaining all necessary permits required to transport equine sera to its facility.

C.6.5.2 The contractor shall restrict access to the horses by ensuring access to the location is controlled by cards and security cameras/recording equipment sufficient to provide full coverage of the fences and gates.

C.6.5.3 The contractor shall provide a security plan consistent with the requirements specified under Attachment # 7 in the technical part of the proposal. That plan shall be incorporated into any resultant contract subsequent to the approval of the Contracting Officer. Performance of work under this contract shall be in accordance with this approved written security plan.

C.6.6 PROGRAM MANAGEMENT

C.6.6.1 The contractor shall provide a program management plan that in the technical part of the proposal and that plan shall be incorporated into any resultant contract subject to the approval of the Contracting Officer. Performance of work under this contract shall be in accordance with this approved written program management plan. This plan shall be consistent with the Contractor’s staffing and retention of personnel, continuity of services, and the transition. Contractor must provide key contractor personnel who have worked as a team on projects of similar size and relevance.

C.6.6.1.1 The contractor shall have a staff experienced with the maintenance of draft horses.

C.6.6.1.2 The Contractor shall provide documentation that records the management of the herd, maintenance, including procurement of feed, daily observation of the herd, maintenance of records, and communication with BARDA.

C.6.6.1.3 The Contractor shall develop, provide, and maintain a management plan that clearly outlines a plan to maintain records of daily observations, staff, maintenance, dietary needs, immunizations, transition and emergency care.

C.6.6.1.4 The contractor shall provide and maintain a plan that outlines 24 hours a day, 7 days a week, (including weekends and holidays) security and access to equine veterinary medical care.

C.6.6.1.5 The contractor shall provide and maintain a communication plan for urgent care of horse.

C.6.6.1.6 The contractor shall provide and maintain a transportation plan for emergency cases to a veterinary referral hospital to include:

1) a plan to provide and maintain Institutional Animal Use and Care Committee IACUC review of all care and emergency issues

2) provide a plan for the disposal of deceased horses

C.6.7 GOVERNMENT FURNISHED PROPERTY AND EQUIPMENT

The horses that are the subject of this contract are US Government property and will be provided.

All other property and equipment needed to provide the services identified above in Task Requirements must be provided by the Contractor.

C.6.8 TRAVEL REQUIREMENTS

The Contractor is required to travel once per year for the duration of the contract to the BARDA offices in Washington, DC, for a program review meeting. Travel for two individuals to Washington, along with two nights in a hotel there, must be included in the proposal.

C.6.9 MEETINGS

The Contractor and HHS shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, site visits to the Contractor’s facilities.

Quarterly meetings between the HHS team and Contractor will occur at a pre-determined site. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and Government-contracted subject matter experts as required by the CO/COR to facilitate review of activities.

C. 6.10 REPORTING REQUIREMENTS

C.6.10.1 Performance of the contract will be monitored by the CO/COR on a regular basis via teleconference monthly, monthly reports, and on a quarterly basis via site visits. The Contracting Officer will be responsible for inspection and acceptance of product and services.

C.6.10.2 Monitoring of the contract will be based on periodic reporting by the Contractor. Reporting requirements and deliverables will be supplemented by quarterly visits to the location. The first “kick-off” site visit will be convened within 30 days of contract award to review HHS procedures, processes and expectations, as well as Contractor’s development plans. Program assessment will be performed by qualified subject matter experts.

SECTION D – PACKAGING, MARKING AND SHIPPING

D.1. METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, delivery of all deliverable items described in to be furnished to the government under this contract (including invoices) shall be delivered primarily electronically to the Contracting Officer (CO) and secondarily through the US Mail or other postal services or email as described in SECTION F.3.

SECTION E – INSPECTION AND ACCEPTANCE

Applicable FAR clauses for Inspection and Acceptance are in SECTION I.

E.1. INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by the Contracting Officer or a duly authorized representative at the destination of the product, services or documents.

E.2. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/FAR/ . HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html .

FAR Clause Title and Date

FAR 52.246-4 Inspection of Services - Fixed Price (August 1996)

FAR 52.246-16 Responsibility for Supplies (April 1984)

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PERIOD OF PERFORMANCE

https://www.acquisition.gov/FAR/ http://www.hhs.gov/policies/hhsar/subpart352.html

The period of performance for the base period shall be three years (36 months) after the contract start date. If one or both of the option periods are exercised by the Government, the contract could be extended for an additional 12 to 24 months. If all option periods are exercised the contract shall not exceed 5 years.

F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work in SECTION C of this contract, and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule as detailed in Section F.3.2. 9.

F.3. CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

F.3.1. Submission of Contract Deliverables

Documents should be delivered primarily electronically to the Contracting Officer (CO) and secondarily through the US Mail or other postal services. These reports are subject to the technical inspection and requests for clarification by the Contracting Officer Representative (COR).

Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W., Room G640 Washington, DC 20201 Email: To be identified at the time of award of contract

Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Avenue, S.W., Room G640 Washington, DC 20201 Email: To be identified at the time of award of contract

F.3.2. Reporting Requirements

In addition to those reports required by other terms of this contract, the Contractor(s) shall submit to the CO and the COR technical progress reports as identified in the contract. These reports shall be subject to the technical inspection and requests for clarification by the COR. These reports shall be brief and factual and prepared in accordance with the following format:

F.3.2.1. Monthly Progress Reports

The Contractor shall submit Monthly Progress Reports on the status of the project. Reports are due on the fifteenth (15th) calendar day of each month for the previous calendar month or within fifteen

(15) days past the achievement of project milestones, the Contractor shall submit a report to the COR and the CO. This is inclusive of updates on staffing, regulatory notifications and communications, facilities issues, etc. The Contractor shall submit the progress reports via e-mail of less than 20 pages in length. Reports shall be in narrative form, informal, and may include additional graphics, if needed. The final form must be approved by the CO. The Monthly Report shall contain brief descriptions of what was accomplished since the last reporting, what is planned for the next month, and what are the current or anticipated impediments, technical or otherwise, to accomplishing the planned activities.

The Monthly Report is not required in months that an Annual Report or Final Report are required The report shall be submitted in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project or compatible, editable formats. Technical Progress reports shall, at a minimum, include the following information:

Title Page: The Technical Progress Report title page shall include the contract number and title, the period of performance or milestone being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission.

Distribution List: A list of persons receiving the Technical Progress report.

Introduction/ Background: An introduction covering the purpose and scope of the report.

Summary: A table summarizing:

Summary table will include health issues that have arisen amongst herd.

Summarize routine and emergency veterinary care provided during the period

Identify each horse that has received care

Progress: The report shall detail, document and summarize, the results of work performed, and milestones achieved during the period covered. Progress should be represented as % of total project plan completed, as well as % completed for the month based on forecasted for the month. Information supporting the summary shall also be provided.

A summary of work and travel planned for the next reporting period shall be included.

Issues: Issues resolved, new issues and outstanding issues shall be enumerated with options and recommendations for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if project activity is delinquent, then what corrective steps are planned.

Invoices: Summary of any invoices submitted during the reporting period.

Action Items: Summary table of activities or tasks to be accomplished by a certain date and by whom.

Attachments: Each report will include an attachment with an up to date contract history including invoice submission/acceptance dates, and modifications. Results on the project are provided as attachments where appropriate

F.3.2.2. Executive Summary

The Executive Summary shall accompany each Technical Progress Report, be formatted as a Microsoft PowerPoint presentation, and include the following:

Title page: Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor's name and the date of submission.

Project Progress: Presented as milestone events, test results, tasks and other activities achieved during the reporting period as talking point bullets.

Project Issues: Presented headings and each item as a talking point bullet..

F.3.2.3. Annual Program Progress Report (APPR)

The Contractor shall submit an Annual Program Progress Report in lieu of a Monthly Report following each anniversary month from the contract effective date. The APPR shall summarize all of the work completed during the previous year and be suitable for publication. The APPR shall follow the same format as the Monthly Report with the inclusion of an Executive Summary. An APPR is not required for the period when the Final Report is required.

F.3.2.4. Final Report

The contractor shall be required to submit a final report upon final completion of the contract (with a requirement for a draft final report). This report is to include summation of work performed, and the results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. Additional elements to be included in the Annual Report will be discussed, and approved by the Contracting Officer and/or the Contracting Officer Representative. The report shall contain but not be limited to:

• Executive summary

• Details of each of the tasks

• Conclusions

F.3.2.5. Meetings/Teleconferences and Site Visits/Audits

A) Contract Initiation Meeting

The contractor shall attend a Kickoff meeting within a month of the contract award.

B) Monthly Meetings/Teleconferences (or as needed)

The following types of meetings should be expected, and the frequency will be specified in the award.

The Contractor shall perform the following tasks:

1. Within 30 calendar days of the effective date of the award, participate in a kick of Meeting with the Contracting Officer Representative, the Contracting Officer, and other HHS/BARDA personnel designated by the Contracting Officer Representative to be held at a location determined by the COR. The purpose of the Kick off Meeting will be to orient the Contractor to HHS/BARDA contract procedures, review contract requirements, and to plan implementation of award activities.

2. Plan and conduct meetings of the Contractor’s Program Director, Program Team, Contracting Officer Representative and Contracting Officer. This will include other BARDA personnel deemed appropriate by the Contracting Officer Representative, at a minimum of monthly intervals, either in person or via teleconference, to review protocols, the status of approved work assignments, discuss any matters relevant to the scientific and financial administration of the contract and future activities. The schedule for those meetings will be established by the Contracting Officer Representative and Contracting Officer after contract award. The Contractor shall prepare and distribute the agenda as well as meeting/teleconference materials to all participants, provide a summary of all meetings, and teleconferences in the Annual Progress Reports.

C) Annual Meeting

BARDA shall meet with the contractor in Washington, DC, once a year to discuss the contract. The initial meeting shall take place within 30 days of the first anniversary of the contract award date, and on an annual basis thereafter. The Contractor shall also arrange periodic site visits for BARDA contract and program staff to review and discuss the following items: project progress; problems, obstacles, and approaches to overcoming identified problems and obstacles; recommendations for modifications.

These site visits shall be attended by the Principal Investigator, the Contractor’s business representative, and all key personnel. The Contractor shall be responsible for the following activities:

1. Planning and submitting the agenda to the Contracting Officer Representative for approval

2. Developing written and oral presentation materials of contracting activities

3. Present summary of all contracting activities

D) Periodic Site Visits

The Contractor shall accommodate periodic site visits by BARDA on an ad hoc basis, to include, if applicable, subcontractor facilities.

E) Security and Quality Systems Audits

BARDA shall perform a pre-award security and QA audit, in addition to periodic security, and QA audits during the performance of the contract on an ad hoc basis. A summary of these audits will be provided within 25 business days to the contractor.

The Contractor shall take the necessary corrective action within a timely manner.

F.3.2.6. Plan Updates

Any updates or revisions of the plans for herd maintenance required by this contract shall be a required deliverable.

F.3.2.7. Subcontracting Reports (Ref FAR 52.219-9 July 2013)

Submit Standard Form 294, Subcontracting Report for Individual Contracts, and Standard Form 295, Summary Subcontractor Report using the Electronic Subcontract Reporting System (eSRS). Access to eSRS can be found at: http://www.esrs.gov/

F.3.2.8. Deliverable Schedule

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work in SECTION C of this contract, and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

Below is a summary of deliverables, reporting procedures and the deliverable schedule:

The items specified below in the REPORTING REQUIREMENTS in Attachment 2 of this contract will be required to be delivered FOB Destination as set forth in FAR 52.247-35, FOB DESTINATION WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below:

Deliverable Description Due Date 1.0

Kickoff Meeting/Status Update Meetings

The Contractor shall complete a Kickoff meeting after contract award and shall hold recurring Program Review Meetings.

Within a month of contract award, but after submission of a draft Project Plan, for Kick Off meeting.

Program Review Meetings shall occur at least annually during contract period of performance.

2.0

The Contractor shall participate in biweekly teleconferences with

Biweekly or as negotiated by all parties http://www.esrs.gov/

Biweekly Teleconference

BARDA to discuss the performance of the contract. The Contractor shall record, maintain and provide draft meeting minutes to the COR for approval within three days after teleconference. The COR will approve the draft version. The Contractor shall distribute the final approved version duly marked as final within 3 business days after receipt of BARDA approval.

3.0

Monthly and Annual Contract Performance Reports

The Contractor shall provide weekly progress and annual summary reports to BARDA that address each of the items identified in the Task Requirements.

1. Annual Coggins test (EIA) through ALAC approved lab

2. CBC and Chemistry panel every 6 months on each U.S. government horse

3. Maintain veterinary medical records on each horse that list the immunization information (vaccine name and manufacturer, date of immunization, batch number, lot number, date of expiration)

4. Veterinary care including medical treatment of colics, foot abscesses, sub-solar bruises, cuts, scrapes, lacerations, skin problems, respiratory problems, dental and sinus conditions, opthalmic exams and routine treatments, neurological exams, Reports shall be submitted on the 15th day of each month for the previous calendar month with an Annual Report submitted on the 15th day of the final month of each contract year for the previous twelve calendar months. Progress reports are not required for the periods when the Annual Report(s) and Final Report are due. The Annual Report should be a summary of the monthly reports, highlighting trends or conclusions related to issues that span several months.

lameness exams and treatments and diagnostic radiology and ultrasound.

All veterinary procedures must be clearly documented in individualized horse records

4.0

Technical Documents

The Contractor shall make final technical documents and data available for BARDA review during on-site HHS quality inspections.

Contractor shall submit all final technical documents within 10 business days of completion or as mutually agreed to during the program execution with the Project Officer.

5.0

Standard Operating Procedures

The Contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) that are material to the contract work available for review electronically.

Upon request from the COR and

CO/CS

6.0

USDA Audits

The Contractor shall notify the COR and CO/CS within 24 hours of and USDA or OLAW audits, site- visits, and inspections related to the subject horse herd.

In the event of an USDA inspection which occurs as a result of this contract, or for any other USDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the USG with a copy of the forms and memos that are related to the inspection or site-visit. The Contractor shall provide the COR and CO/CS copies of the plan for addressing any observations or findings made in USDA forms and memos that are related to the audit or site-visit. The Contractor shall make arrangements for BARDA representative(s) to be present at any follow up meetings.

The Contractor shall notify the COR and CO/CS within 24 hours of receipt.

7.0 The Contractor shall inform the The Contractor shall inform the

Contractor Audit/Site Visits

COR and CO/CS in advance of upcoming audits/site visits of subcontractors as part of the bi-weekly communications, including goals and agenda.

Upon completion of the audit/site visit the Contractor shall provide a report capturing the material findings, results and next steps. If action is requested, details and concerns for addressing areas must be provided to BARDA.

The Contractor shall provide responses from all parties concerned to address these concerns and plans for corrective action execution

COR and CO/CS within 7 business days of report completion.

8.0

Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to BARDA for review prior to submission

30 calendar days for USG review of manuscripts and 15 calendar days for abstracts allowed

9.0

Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases

The Contractor shall ensure that the Contracting Officer has received, and approved an advanced copy of any press release pertaining to this contract; not less than 5 business days prior to the issuance of the press release

10.0

Security Reporting

The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products

The Contractor shall report within 24 hours after occurrence of activity or incident

F.4. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address:

http://www.acquisition.gov/comp/far/index.html.

Clause Title and Date

FAR 52.242-15 Stop Work Order (August 1989)

FAR 52.242-15 Stop Work Order (August 1989), Alternate 1 (April 1984)

SECTION G – CONTRACT ADMINISTRATION

G.1. CONTRACTING OFFICER (CO/CS)

1) The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract.

2) The CO is the only person with authority to act as agent of the Government under this contract.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) obligate or deobligate funds into the contract; or (6) otherwise change any terms and conditions of this contract.

3) No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The Government's Contracting Officer’s Representative (COR) is:

To be identified at the time of award of contract

As delegated by the CO, the COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) assisting the CO in interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

G.3. CONTRACTOR’S POINTS OF CONTACT

The Contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

G.4. PAYMENT BY ELECTRONIC FUNDS TRANSFER

The Government shall use Electronic Funds Transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer–Central Contractor Registration, in Section I, requires the Contractor to designate in writing a financial institution for receipt of Electronic Funds Transfer payments.

G.6. INVOICE SUBMISSION

(a) The Contractor shall submit invoices to the Contracting Officer at the address provided in SECTION F.3. Unless otherwise specified by the Contracting Officer, two hard copies of the invoice shall be delivered by first class mail to the CO with a courtesy copy to be sent by electronic mail.

The invoice shall be deemed as ‘received’ upon receipt of the hard copy of the invoice at the address provided. A sample invoice form is provided in SECTION J – Attachment 4.

(b) The Contractor agrees to include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Contract Number

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Total Amount of Invoice

(10) Name, title and telephone number of person to be notified in the event of a defective invoice

(11) Payment Address, if different from the information in (b) (1).

G.7. PAYMENT CONDITIONS

G.7.1. The Contractor shall not submit an invoice prior to delivery of product or services.

G.8. GOVERNMENT PROPERTY

If this Contract will result in the acquisition or use of Government Property provided by the contracting agency, or if the Contracting Officer authorizes, in the pre-award negotiation process, the acquisition of property (other than real property), this section will include applicable provisions and incorporate the HHS Publication, entitled, "Contractor's Guide for Control of Government Property."

G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

G.10. EVALUATION OF CONTRACTOR PERFORMANCE

a) Purpose: In accordance with FAR 42.1502 - Policy, the contractor’s performance will be periodically evaluated by the government in order to provide current information for source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

b) Performance Evaluation Period: The contractor’s performance will be evaluated at least annually.

c) Evaluators: The performance evaluation will be completed jointly by the Contracting

Officer’s Representative and the Contracting Officer.

d) Performance Evaluation Factors: The contractor's performance will be evaluated in accordance with the attachment listed in Section J titled Contractor Performance…