FiloIP_JandA_Posted.pdf

Justiflcatlon and Approval For Other than Full and Open Competition

, _N-ll-02 I,og Number

1. Contracting Activity: United Søtes Army Research, Development and Engineering Command (RDECOM) on-site contracting team supporting rhe Chemical Biological Mäical systems (CBMS)-JPM, 64 Thomas Johnson Drive, Frederick, MDzl7o2-san.

2. Description of Action: Approval is requested for a new contract with AlphaVax, Inc., Research Triangle Park, North Carolina, 27709 ('AlphaVax') in support of tire JointVaccine Acquisition Program (JVAP) Filovirus Vaccine Program on the baslJ of other than full and open competition. A fïrm fixed-price contract is contemplated. Fiscal Year 2010 Research, Development, Test, and Evaluation (RDT&E) frrnds are available for this procurement of intellectual property data.

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This acquisition supports ttre DoD requirement for a filovirus vaccine capability to protect against aerosol exposure ûo Ebola and Marburg viruses. Development of filovirus vãccine(s) fills an essential capability gap for protecting the rWarfîghter against the threat of an aerosolized filovirus Biological Warfare (BW) attack. The DoD's ultimate goal is the development of a dual use FDA licensed filovirus trivalent vacoine for pre-exposure prophylactic appliiations and as a post-exposure prophylactic following a filovirus BW attack or endemic outbreak. The use of filoviruses (Ebola and Marburg viruses) by an adversary or terrorist group as biological weapons could cause great hann to U.S. Forces and impede our ability to conduct military oþerations.

This vaccine will increase the survivability and minimize inðapacitation of Warhghters required to operate in potential Chemical, Biological, Radiological, and Nuclear (CBRN) environments.

The Chemical Biological Medical Systems Joint Vaccine Acquisition program (CUUS-fVef¡ it the requiringactivity with the goal of developing a filovirus trivalent vuccin" containing of components for the Ebola sudan, Ebola z.afte, andMarburg vi¡uses in a single vial.

Vaccination is the DoD's prefened approach to CBRN preparedness, because it reduces the logistics burden associated with treannent and evacuàtion and maintains combat force effectiveness by preventing illness and death resulting from exposure to biological weapons.

The patents owned or those to which Alphavax has an exclusive license that are needed in developing and producing a trivalent filovin¡s vaccine employing on the AlphaVax's propriety alphavirus replicon vector syst€or are listed in Table l.

Title Ownership' U;S. Patent No./Publ or Appl. No.2

Government Purpose Rights Exist

Attenuating mutations in VEE Virus

EL us 5,505,947 Yes

Alphavirus RNA Replicon Systems

EL US 5,792,462; US

6,541,010;

US 6,156,558; US

6,521235;

US 6,531,135; US

7.235-23;5

Yes

Improved Alphavirus Replicon Vector Systems o us 7,045,335;

us7.42s.337

No

Improved Alphavirus Replicons and Helper Constructs o 1J57,442,397 No

Alphavirus Particles and Methods for Preoaration o us 7,078,218 No

TC-83 Replicon System o US Publ. No. 2009- 0266550

Yes

Alphavinrs and Alphavirus Replicon Particle Formulations and Methods o US Publ. No. 2009-047255 No

Promotorless Cassettes for Expression of Alphavirus Sfuctural Proteins o US Publ. No. 2009- 0075384;

US Publ. No. 2010- 01 83665

Yes

Use ofMicroRNAs to Control Virus Helper Nucleic Acids o PCTruS2009/065900 No

Any other AlphaVax patent, know how or other IP rights incorporated into or employed to achieve the above described AlphaVax VRP modifications.

o N/A N/A

Table l. AlphaVax Patents.

EL= exclusively licensed to AlphaVax; O:owned by AlphaVax;'Bold Numbers indicate isiued patent

4. Authority Cited: The statutory authority permitting acquisition of these itemVservices by other than full and open competition is 10 U.S.C. 2304(c)(l), Only one responsible source and no other supplies or services will satisfy agency requirements as implemented by FAR 6.302-1.

5. Reason for Authority Cited:

a. Backeround

There are no FDA approved medical prophylactic or therapeutic countermeasures against any of the filoviruses. Protective equipment is the only available protection from the threat of filoviruses, and is only effective when used prior to exposure.

The Govemment has detemrined that further development of a Filovirus Vaccine using the VRP system is in the best interest of the Government. AlphaVax has utilized the VRP vaccine platform for a variety of human use applications. These include everything from null VRPs (no antigen insert) used as an adjuvant platform to VRP expressing antigens for infectious agents and cancer antigens. AlphaVax is the full owner and exclusive licensee for the following licensed product, AVX Patents, A\lX Know-How, and AVX Vecüor Systems.

b. Alternatives

The Joint Science and Technology Office funded the USAMRIID to develop and evaluate filovirus vaccine candidates for advanced development. This effort resulted in fwo USAMRIID developed candidates for which the Government retains access to portions of the IP:

1. Venezuelan Equine Encephalitis (VEE) RNA repliconparticle (VRP)

2. Virus-like particle (VLP)

The Government conducted a resource allocation decision to determine the best candidate to allocate resources to achieve the program goals. After a thorough analysis of technical data and risk, the Government decided it was in the Govemment's best interest to develop the VRP candidate; however, as a matter of risk mitigation data for the VLP will continue to be developed under studies and tests for approximately one year.

Following the August 10, 2009 Materíel development Decision Review for the filovirus vaccine, the Joint Program Executive Officer for Chemical and Biological defensg the Milestone Decision Authority (MDA) for the Chemical and Biological Defense program, formally designated the Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)) as the lead in developing the Analysis of Material Approaches (AMA) Study Plan and conducting an AMA. The MDA approved the study plan on November 17,2009. On April 28,201A, the OASD(HA) completed the independent assessment of alternative materiel solutions to frrlfill the filovirus vaccine capability. The overall ranking of the altematives evaluated was based on combined scores of schedule, and risk factors.

cost, not as technically mature. To attain the level of development required to support Food and Drug Administration (FDA) licensure, the VLP would need additional research and development efforæ and require additional ñrnding and cause a significant delay in initiating the program (approximately 3 yean).

c. Justification

The VRP candidate was developed by AlphaVax with Government and private funds;

therefore, the Government has Government Purpose Rights to a portion of the IP, but no rights to development performed with private frrnding, nor exclusive rights to technologies developed with Govemment funds. AlphaVax is the only known sor¡rce that has improved the existing US Govemment owned VRP technology. AlphaVax is the product developer and, as suct¡ is the onlycompany that has developed and qualified the small-scale manufacturing process and product release assays for ttris vaccine product.

The AlphaVax patents revolve around novel modifications made to an existing VRP vector invented by the United States Army Medical Research Institute for lnfectious Diseases (USAMRIID). These modifications were necessary to support eventual FDA licensure of a VRP vaccine, specifically addressing the following:

o safetl ofthe vector . antigenexpression o increase virus yields

These irnprovements are critical to ensuring that the capability meets the key performance parameter in DoD requirements for medical countermeasures, FDA approval. The FDA will base approval decisions on safety, effrcacy, and manufacturability of the vaccine. The improvement in virus yrelds wilM cost of ownership for this vaccine system.

Lawrence.Mize Rectangle d.Imnact

Approval of the J&A for the procurement of the IP for AlphaVax's proprieøry VRP system expedites the delivery of an FDA approved Filovirus Vaccine to the Warfighter and the failure to approve would deny the rüarfighter the ability to be protected by the vaccine candidate found to be most viable..

6. Efforts to Obtain Competition: AlphaVax developed the VRP candidate with Govemment and private funds therefore, the Governnent has Govemment Purpose Rights to a portion of the IP, but no rights to development performed \¡/ith private funding, nor exclusive rights to technologies developed with Govemme¡rt ñ¡nds. AlphaVax is the only source for the VRP candidate IP, see section 8.

7. Actions to Increase Competition; AlphaVax is the only IP source firr the modified Government invented VRP. Once the Govemrnentprocures the IP forAlphaVax's proprietary VRP system, the Govemment will compete for a contractor to develop and manufacture the Filovirus vaccine using this technology.

8. Market Survey: AlphaVax is the only company that has been authorized or otherwise granted rights to continue with deveþment of the iuitial Government funded VRP IP with conhactor funds. Due to this privately funded effort, Alphvax retains ownership for portions of the IP. In September 2010, CBMS-JVAP conducted an online patent search (htþ://www.freepatentsonline.com) to identiftpatents covering the use of Alphavirus replicons, specifically using the Venezuelan Equine Encephalitis virus. The primary patent (5,792,462) describing the Alphavirus replicon system was assigned to the U.S. Secreøry of the Anny and tlte University of North Carolina ([INC) at Chapel Hill. Subsequent patents covering improvements and productíon of the replicon system are assigned to U.S. Secretary of the Army, IINC at Chapel Hill, and Alphavax, Inc. Alphavax has inlicensed all relevant patients for LINC.

The patent search also identified multiple patents for the ebola componenæ; all of these pate,nts are assigned to the U.S. Government

This market search effort identified that AlphaVax, Inc is the only source for the intellectual property to support the development of a filovin¡s vaccine using the VEE replicon system.

9, Interested Sources: AlphaVax retains all rights to the IP for the portion of the modified Government initially funded VRP technology.

10. Other Facts:

The Joint Science and Technology Ofñce has funded USAMRIID develop a filovirus VRP vaccine candidate and to conduct proof of conoept animal efficacy studies. These efforts have demonstated that this candidate can protect animals from a lethal exposure üo Ebola and Marburg viruses.

However, they are still interested in selling the IP, eithervia a license agreefirent or opportunities. As indicated in this J&4, AlphaVax is the only responsible sor¡rce for the IP. Based on the financial status of the company, the Government is in jeopardy of losing the ability to obtain the license due to potential forbanlouptcy or aoquisition of the company. If the Government is unable to obtain the licensg there would be an estimated 3 year delay in the program as tho Govornment would have to develop the less mafiire altemate candidate.

I 1. Technical Certification:

Technical certification is provided in Appendix A.

12. Requiroments Certification:

I certifr that the supporting data under my cognizance which are includecl in the justification a¡e accurate ancl complete to the best of my knowledge and belief.

DATE: 8

STGNATURE:

13. Fair and Reasonap'le Cost Determin¡tion:

I hereby determine that the arrticipatecl price to the Govemment for this contr.act action will be fair ancl reasonable. Certified cost or pricing data will not be required cluc to the exception at FAR 15.403-t(bxl). Price analysis willbe used to demonstrate that the proposecl prióe is reasonat¡le in comparison with cul'rent or recent prices for the same or similãr itcrni, acljustecl to reflest changes relaled to terms and conditions undcr contracts.

NAME: LTC Philip Smith

TITLE: Joint Product ManagerJVAP

NAME: I.,ynn Selfrictge

TITL,E: ContractinqOfÍicer

NAME: Eric Lile

TIII[.,8: L.egalCounsel

NAMF.: [.ary lvfizæ

TITLE: ContractSpecialist

14. Contracting Officer Ccrtification:

I certity that this justihcation is accurate an<l complete to the bestqf rny and belief.

L o/ø

DA'I'E: /),

15. Legal Sufficiency Revierv: I have reviewcd tlre foregoing justiflrcation and approval and deem it legally sufÌicient.

SIGNATU

SIGNATURË:

Concur

Ba$ed on the foregoing justificatio license to the VRP vascirie syst€m

Brigadier General, USA Joint Progranr Executivo Officer for Chemicat and Biologioal Defense

Ihereby conornwith the aequisition of the AlphaVax rough oûer than full andopencompetition

DNTî",& A*æTO

APIßoVAL

Based on tho foregoing justification, I hereby approve the acquisition of the AlphaVær lis€nse ûo the-V\P vaccine_system through other than ñ¡lI and o¡en compaition basis puísuant to the arrthority of t0 U.S.C. 2304(cXl), subject to the availãbility oifunds, and provided rhat rhe senrioes hercin desøibed h¿ve othervise been authorized foracquisition

ApplovedBy: DATB: l8 Oct20t0 Cheryl A. Deluca Speoial CompotitionAdvooate .

Natick Contraoting Divisionr, USA RÐECOMAC