JOFOC_17-100-SOL-00004_Redacted_2017-03.pdf

Justification for Other than Full and Open Competition

"Source Selection Information- see FAR 2.101 and 3.104"

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS/OS/ ASPR

Acquisition Management Contracts and Grants (AMCG)

b. Sponsoring organization.

Biomedical Advanced Research and Development Authority (BARDA)

c. Project Officer/Contracting Officer's Representative.

• Contracting Officer's Representative Name.

Dr. Mark Craven

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

CDC and Evolva have already entered into and executed a Cooperative Research and Development Agreement (CRADA) and a Commercial Licensing Agreement with the goals to achieve EPA registration of the biotoxicant Nootkatone as a killing agent (toxicant) and repellent against mosquitoes. The requirement of this contract, detailed in the contract tasks/deliverables is to conduct all safety and efficacy trials required for such EPA registration.

b. Project background.

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.

BARDA manages Project BioShield (PBS), which includes the procurement and advanced development of medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA is a member of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which includes other departments and agencies such as the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Department of Defense (DoD).

The BARD A Division of Chemical, Biological, Radiological, and Nuclear Threats in partnership with the Regulatory and Quality Affairs Division is responsible ensuring procured MCMs delivered to the United States Strategic National Stockpile meet current Good Manufacturing Practice ( cGMP) standards for shipment and long term storage.

The ongoing Zika virus epidemic is severely impacting the public health in Latin America and the Caribbean and appears to be spreading into Southeast Asia. In addition, Zika virus is an imminent threat to the southern part of the continental U.S., where the primary mosquito vectors, Aedes aegypti (the predominant vector) and Aedes albopictus, are widespread and abundant. While the virus produces a range of outcomes in infected individuals, the most dire and long lasting effects of infection are seen with fetuses exposed to the virus in early to mid-stages of a pregnancy.

In the absence of a Zika virus vaccine or treatment, preventing infected mosquitoes from biting is the main method of controlling the disease.

However, public perceptions about the health and environmental risks of synthetic chemical toxicants and chemical repellents, as well as increasing insecticide resistance among mosquito vectors, severely hinder these disease prevention and control efforts. New toxicants (insecticides) with modes of action that allow them to kill mosquitoes that are resistant to pyrethroids and other commonly used toxicant active ingredients are urgently needed to ensure effective emergency control of adult mosquitoes in the short term and improved management of insecticide resistance through toxicant rotations or mosaics in the long term.

Nootkatone, a plant-derived compound, has demonstrated a great deal of potential for use as a killing agent (toxicant) and repellent against the Aedes mosquito vectors that transmit Zika, yellow fever, dengue, and chikungunya viruses (1-2). Nootkatone appears to have a mode of action distinct from that of currently used toxicants and therefore may overcome the resistance issues hampering current emergency control efforts and be valuable to mitigate toxicant resistance in mosquito vectors in the longer term (3-4). Nootkatone presently is used in the flavor and fragrance industry and is considered "food grade" and therefore safe for human consumption and topical application.

N ootkatone and other compounds extracted from Alaska yellow cedar and common to citrus products are patented by Scientists at the Centers for Disease Control and Prevention-Division of Vector-Borne Diseases (CDC/DVBD) for use to control arthropod vectors of disease agents.

Evolva (Reinach, Switzerland, Larkspur, CA, and Lexington, KY) has a patented yeast fermentation process for producing high-purity, food-grade Nootkatone. This process allows for high-yield, high-quality product at a reduced cost compared to other synthetically derived methods of Nootkatone production. CDC is currently working with Evolva to evaluate formulated test products and Evolva holds a Commercial Licensing Agreement for the CDC/DVBD patents. However, CDC/DVBD lacks the formally certified laboratory facilities required to conduct the efficacy trials needed for EPA registration ofNootkatone as a mosquito toxicant and repellent.

This contract will overcome the hurdles internal to BARDA and its PHEMCE partners through engaging external expertise to rapidly conduct all safety and efficacy trials required for EPA registration of the biotoxicant Nootkatone as a killing agent (toxicant) and repellent against mosquitoes of public health importance.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

a. Project title.

Novel Toxicant and Repellent for Arthropod-borne Virus Vectors

(NTRAVV)

b. Project description.

The Offeror shall perform required activities according to EPA guidelines for all necessary tests and evaluations ofNootkatone as a mosquito repellent and killing agent (toxicant). The vendor shall furnish all labor, materials, equipment and subcontracting necessary to complete activities required by EPA including and not limited to:

• Nootkatone as a mosquito repellent (formulation of products, product chemistry, acute toxicity, and human efficacy studies)

• Nootkatone as a mosquito pesticide product indoor/outdoor (mode of action, product chemistry, acute and sub-chronic toxicity studies, formulation, efficacy studies, environmental studies, and field studies), and

• Manufacturing ofNootkatone containing mosquito products (scale up and technology transfer, validation of CMO selection, and large scale production demonstration)

(See attached Statement ofWork (SOW)).

c. Requirement type.

X Research & development (R&D) [J R & D support services [J Support services (non~R&D) [J Supplies/equipment [J Information technology (IT) [J Construction [J Architect-engineer (A & E) services [J Design-build [J Other (specify): _______ _

d. Type of action.

X New requirement [J Follow-on [J Other (specify): ________ _

e. Proposed contract/order type.

X Firm-fixed-price [J Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): ____ _ X Cost-plus-fixed-fee [J Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ____ _ [J Time and materials [J Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ____ _ [J Other (specify): ---,----- [J Completion Form [J Term form

f. Acquisition identification number. 17-100-SOL-00004

g. Total estimated dollar value and performance/delivery period.

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1. Only one responsible source and no other supplies or services will satisfy agency requirements.

[J This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

D This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Evolva 80 East Sir Francis Drake Blvd, Suite 2D Larkspur, CA 94939 USA Tel: +1 (415) 448 5451

b. Nature of the acquisition and proposed unique qualifications of the contractor( s ).

Evolva is the only offeror that has the potential to meet all of the government's requirements for the advanced development ofnootkatone for use as a toxicant and repellant. The government issued both a sources sought notice regarding this requirement, and only one vendor, Evolva, responded and was deemed meaningful and posted a notice of intent to award to Evolva, with zero respondents stating they have or can produce/provide a product or technology that is similar or superior to Evolva's nootkatone. Evolva's product nootkatone is unique in that they combine modem genetics with traditional brewing which permits a cost effective method to produce the material at both a desired and ramped-up scale (during a response). In addition Evolva has the technological understanding and ability to perform the testing required to obtain EPA registration. When these factors are considered as a whole, this significantly increases the government's ability to protect American citizens by establishing access to a natural product already deemed safe as a food-additive. All other current products are chemical based (e.g., DEET). The unique nootkatone mosquito toxicant and repellent from Evolva is both desirable and attractive to use, particularly among women of child bearing age or who are pregnant.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

In accordance with FAR 5.202 a presolicitation notice was issued in FedBizOpps on or about December 6, 2016. Only two potential respondents were received.

· One of the potential offerors did not have the required qualifications to meet the Government's needs. In addition, a Notice oflntent to issue a sole source was posted in FedBizOpps on February 1, 2017. We only received one company (Evolva) to respond. Based on the responses from both notices it is the intent of the Government to sole source this solicitation to Evolva.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The Government' s personnel and subject matter experts have substantial technical knowledge and business expertise in performing analytical testing to meet regulatory requirements as well as manufacturing experience to develop a very good independent Government estimate. Certificate cost and pricing will be required to be submitted for this acquisition. This prior knowledge and experience shall be utilized during negotiations to determine if the proposed cost being offered by the contractor is fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Evolva presented to BARDA SME's via its Tech Watch program on June 24th 2016. In addition, the above referenced notices were announced to the public. No qualified responses were received.

9. Any other facts supporting the use of other than full and open competition.

None

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Evolva was the only offeror that submitted information that was determined to be qualified to meet the Government's requirements.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

At this time the Government's only requirement is to further the research and development of this potential product to increase its ability to respond to the current Zika outbreak by ensuring access to food-grade safe toxicant and repellent products that appeal to the most at-risk democratic: females who are pregnant or of childbearing age. These non-chemical based (e.g. DEET based products) are needed to increase use/adoption and therefore increasing public protection and reducing infections and transmission.

12. Program Office Certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Contracting Mark Craven, BARDA

3'~~0/f. Officer's Representative

Project Officer's

Immediate 'JJj 6/ ;I..O{f- Supervisor

Head of the lJ ?!u~l Sponsoring Program

Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Linda Luczak Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature( s ).

Official

Chief of the Contracting

Office

Head of the Contracting

Activity

Name& Title

Linda Luczak

15. Competition Advocate signature.

Official Name& Title

Competition

Signature

Signature

Date

Date

Advocate ,3 .JT,. ok>IJ