Anthrax Vaccine

Trade Agreement: Agreement on Internal Trade (AIT) Tendering Procedures: Generally only one firm has been invited to bid Non-Competitive Procurement Strategy: Exclusive Rights Comprehensive Land Claim Agreement: No Vendor Name and Address: Emergent BioDefense Operations Lansing LLC 3500 N Martin Luther King Jr Blvd Lansing Michigan United States 48906 Nature of Requirements:

Contract Award Notice (ACAN)

1. Definition of the requirement

The Public Health Agency of Canada (PHAC) has a requirement for the supply of a firm quantity of 15,600 doses of Anthrax Vaccine Adsorbed (AVA) and optional quantity of up to a maximum 28,570 doses to be delivered over a 5 year period from date of contract award.

2.Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements)

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

a. Vaccine offered must be approved by a credible regulatory agency (i.e., FDA, EMEA, MHRA) for protection against Anthrax as general use prophylaxis and as postexposure prophylaxis.

b. Vaccine must offer protection as post-exposure prophylaxis within 30 days of initial dose with no more than a 3 dose primary series.

c. Publications or unpublished reports supporting the efficacy of the vaccine as post-exposure prophylaxis

d. If blood products are used in the production of the offered vaccine, it must be manufactured using only North American sourced blood products (e.g. plasma, albumin) so as to ensure the vaccine is Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE) free

e. Supplier/manufacturer must demonstrate that they meet and are compliant with current Good Manufacturing Practices (cGMP)

f. Vaccine must have a shelf life of at least 40 months upon delivery

3. Applicability of the trade agreement(s) to the procurement This procurement is subject to the Agreement of Internal Trade (AIT).

4.Justification for the Pre-Identified Supplier This requirement is being negotiated with Emergent BiodefenseOperations Ltd as they are the only known supplier capable of providing Anthrax Vaccine that meets PHAC’s requirement for anthrax vaccine that offers prophylactic and post exposure protection.

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

5. Period of the proposed contract and delivery date

The proposed contract is for a period of 5 years contract award. Delivery of the firm quantity is for March 31 2017

6. Name and address of the pre-identified supplier Emergent BioDefense Operations Lansing LLC 3500 N Martin Luther King Jr Blvd Lansing, Michigan, USA 48906

7.The closing date and time for acceptingstatements of capabilities is November 1,2016 .

8. Inquiries and statements of capabilities are to be directed to

TPSGC.Vaccin-Vaccine.PWGSC@tpsgc-pwgsc.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.