Development of Trivalent Vaccine

Trade Agreement: Agreement on Internal Trade (AIT) Tendering Procedures: Generally only one firm has been invited to bid Attachment: None Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address: Defyrus Incorporated 2627 Conc. 2 Chute-a-Blondeau Ontario Canada K0B1B0 Nature of Requirements: Title: Preclinical Development of a Trivalent Vaccine Against Venequelan, Eastern and Western Equine Encephalitis Viruses

1. Advance Contract Award Notice

An ACAN is a public notice indicating to the supplier community that a department or agency intends to award a contract for goods, services or construction to a pre-identified supplier, thereby allowing other suppliers to signal their interest in bidding, by submitting a statement of capabilities. If no supplier submits a statement of capabilities that meets the requirements set out in the ACAN, on or before the closing date stated in the ACAN, the contracting officer may then proceed with the award to the pre-identified supplier.

2. Definition of Requirement

The Department of National Defence, Defence Research and Development Canada - Suffield, (DRDC-S) Ralston, AB has a requirement to demonstrate the safety, immunogenicity and efficacy of an adenovirus-vectored trivalent vaccine against western equine encephalitis virus (WEEV), eastern equine encephalitis virus (EEEV) and Venezuelan equine encephalitis virus (VEEE) in animal models. The goal of the contract is to complete the pre-clinical studies required for filing a Clinical Trial Application (CTA) in Canada and an Investigational New Drug (IND) application in the United States. Upon completion of this contract, a data package containing reports of the results in animal toxicity, immongenicity and efficacy of the trivalent vaccine will be required.

Due to the nature of this work follow-on work may result.

3. Criteria for assessment of the Statement of Capabilities

Any interested supplier must demonstrate by way of a statement of capabilities that it meets the following requirements:

Education: Must have a Ph.D. in a field directly related to the project, such as Molecular Biology, Microbiology, Physiology, Biophysics, Virology, and/or Immunology

Experience: Must have extensive experience managing advanced R&D programs developing medical countermeasures for chemical and/or biological threats

Must have published at least 5 peer-reviewed scientific papers, abstracts and/or book chapters related to medical countermeasures for chemical and/or biological threats

Must have issued at least 3 domestic and international patents directly related to medical countermeasures for chemical and/or biological threats

Must have at least 5 years of experience in attracting and retaining technical expertise and accessing manufacturing and testing facilities for the development of medical countermeasures

Must demonstrate that they have a working adenovirus vaccine delivery system

Must have clear access to the gene sequences for the three alpha viruses related to this project

Must demonstrate a freedom-to-operate with respect to the right to make, use and sell the proposed trivalent vaccine product

Must have access to a cGMP manufacturing capability and all cells lines required for production of the trivalent vaccine

4. Applicability of Trade Agreements

This procurement is subject to the following trade agreements: Agreement on Internal Trade (AIT),.

5. Justification for Pre-Identified Supplier

The proposed contract is linked to an ongoing strategic relationship between DRDC and Defyrus Inc.

Defyrus holds IP rights to all of the key components required to produce the trivalent alphavirus vaccine proposed in this Statement of Wrok. Specifically, adenovirus vector technology specific for alphaviruses. The IP is summarized in the following table: Technology IP Status Ad5 virus vector, expression plasmid (pDC316) Production Cell lines 293 and AC2 Multiple US patents EU-EP00912186 CA-765,093 AUS-2,366,914 Licensed from AdVec Inc. by Defyrus Use of Ad5 vector for vaccines against infectious diseases US 6,565,853 & 6,936,257 also in AUS, CA and EU Licensed from Porton-Down by Defyrus Ad5 viral vectored EE vaccines DEF 104-Trivalent EE vaccine DEF 101-VEEV Def 102-WEEV DEF 103-EEEV 24 issued patents 4 pending patents Licensed from Porton-Down by Defyrus

Only Defyrus, through its IP portfolio has the legal right to make, use and sell trivalent alpha virus vaccines. 6. Government Contracts Regulations Exception

The following exception to the Government Contracts Regulations is invoked for this procurement under subsection 6(d) - "only one person is capable of performing the work".

7 Exclusions and/or Limited Tendering Reasons

The following exclusions and/or limited tendering reasons are invoked under the section of the trade agreement specified:

North Ameriican Free Trade Agreement (NAFTA) - Excluded under Annex 1001.1b-2 Services WTO-AGP not applicable, as per Services in Appendix I, Canada - Annex 4.

8. Ownership of Intellectual Property

Contractor owned

9. The Period of the Proposed Contract

The proposed contract is for a period of approximately 4 years from date of award.

10. The Estimated Cost of the Proposed Contract

The estimated value of the contract is $4,375,000.00, GST extra.

11. Name and Address of the Pre-Identified Supplier

Defyrus Inc. 2 Bloor Street West, Suite 2602 Toronto, ON M4W 3E2

12. Suppliers' Right to Submit a Statement of Capabilities

Suppliers who consider themselves fully qualified and available to provide the goods, services or construction services described in the ACAN, may submit a statement of capabilities in writing to the contact person identified in this notice on or before the closing date of this notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirement.

13. Under the Code of Conduct and Certification provisions, 2003 (2012-07-11) Standard Instructions - Goods or Services - Competitive Requirements, Bidders must submit the following as part of their bid:

1. a complete list of names of all individuals who are currently directors of the Bidder; 2. a properly completed and signed Consent Form, for each individual named in the aforementioned list.

14. The Closing Date and Time for Accepting Statements of Capabilities

2:00 MDST August 10, 2012

15. Inquiries and Submission of Statement of Capabilities

Inquiries and statements of capabilities are to be directed to

Elaine Barton, Supply Specialist Public Works and Government Services Canada Telus Plaza North 5th Floor 10025 Jasper Avenue Edmonton, AB T1J 1S5

Telephone:780-497-3519 Facsimile: 780-497-3510 E-mail: elaine.barton@pwgsc-tpsgc.gc.ca

Delivery Date: Above-mentioned

You are hereby notified that the government intends to negotiate with one firm only as identified above. Should you have any questions concerning this requirement, contact the contracting officer identified above.

An Advance Contract Award Notice (ACAN) allows departments and agencies to post a notice, for no less than fifteen (15) calendar days, indicating to the supplier community that it intends to award a good, service or construction contract to a pre-identified contractor. If no other supplier submits, on or before the closing date, a Statement of Capabilities that meets the requirements set out in the ACAN, the contracting authority may then proceed with the award. However, should a Statement of Capabilities be found to meet the requirements set out in the ACAN, then the contracting authority will proceed to a full tendering process.

Suppliers who consider themselves fully qualified and available to provide the services/goods described herein, may submit a statement of capabilities in writing to the contact person identified in this Notice on or before the closing date of this Notice. The statement of capabilities must clearly demonstrate how the supplier meets the advertised requirements.

The PWGSC file number, the contracting officer's name and the closing date of the ACAN must appear on the outside of the envelope in block letters or, in the case of a facsimile transmission, on the covering page.

The Crown retains the right to negotiate with suppliers on any procurement.

Documents may be submitted in either official language of Canada.