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.