Canadian Market Authorization

Advance Contract Award Notice (ACAN) 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 the requirement The Department of National Defence (DND), Canadian Forces Health Services Group (CFHS) has a requirement for the acquisition and support of an Emergency Use New Drug (EUND) Submission to seek Health Canada regulatory approval of a therapeutic drug for the treatment smallpox infections. 2.1 Requirement:

In accordance with the Health Canada Guidance Document concerning The Management of Drug Submissions and Applications, the Contractor must request and attend a pre-New Drug Submission meeting with Health Canada Therapeutic Products Directorate (TPD) prior to filing the EUND submission. The Contractor must file an EUND submission to the TPD within the Health Products and Food Branch of Health Canada, in accordance with Health Canada regulations, policies, guidelines and notices, in the eCTD format.  The Contractor must provide the TA with a copy of any final decisions issued by Health Canada, including but not limited to the Notice of Compliance, Notice of Deficiency, Notice of Non-compliance, Notice of Deficiency - Withdrawal Letter, or Notice of Non-compliance - Withdrawal Letter.

3. Criteria for assessment of the Statement of Capabilities (Minimum Essential Requirements) Any interested supplier must demonstrate by way of a statement of capabilities that it meets the following requirements:

The Contractor must demonstrate that their therapeutic drug for the treatment of smallpox infections have the current regulatory approval by either the United States Food and Drug Administration (FDA), or the European Medicines Agency (EMA), or the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), or the Health Canada (HC). The contractor must provide a copy of the approval letter from the Regulatory Authority that approved the drug. The Contractor must provide Regulatory Authority's approved documentation including the proof that their drug product is for the treatment of human smallpox disease caused by variola virus, as approved by the FDA, or EMA, or MHRA, or HC.

4. Applicability of the trade agreement(s) to the procurement This procurement is subject to the following trade agreement(s):

Canadian Free Trade Agreement (CFTA); Canada-Colombia Free Trade Agreement; Canada-Honduras Free Trade Agreement; Canada-Panama Free Trade Agreement; Canada-Korea Free Trade Agreement (CKFTA); Canada-Peru Free Trade Agreement; North America Free Trade Agreement (NAFTA); Comprehensive Economic and Trade Agreement (CETA); World Trade Organization Agreement on Government Procurement (WTO-AGP); Canada-Ukraine Free Trade Agreement; and Canada-Chile Free Trade Agreement.

5. Justification for the Pre-Identified Supplier SIGA Technologies Inc.is the developer and has the ownership of the intellectual property of TPOXX®, the smallpox therapeutic drug. TPOXX® is the only drug that has been approved for the treatment of human smallpox disease by a national regulatory authority. Government Contracts Regulations Exception(s) The following exception to Government Contracts Regulations (GCRs) from http://laws-lois.justice.gc.ca/eng/regulations/SOR-87-402/page-2.html#h-6) is applicable: (d) only one person is capable of performing the contract. Exclusions and/or Limited Tendering Reasons

Canadian Free Trade Agreement (CFTA), Article 513 (1) (b) (iii): due to an absence of competition for technical reasons; Canada-Colombia Free Trade Agreement, Article 1409 (1) (b) (iii): due to an absence of competition for technical reasons; Canada-Honduras Free Trade Agreement, Article 17.11 (2) (b) (iii): due to an absence of competition for technical reasons; Canada-Panama Free Trade Agreement, Article 16.10 (1) (b) (iii): because of the absence of competition for technical reasons; Canada-Korea Free Trade Agreement (CKFTA), referencing the WTO Protocol Amending the GPA, Article XIII (1) (b) (iii): due to an absence of competition for technical reasons; Canada-Peru Free Trade Agreement, Article 1409 (1) (b) (iii): due to an absence of competition for technical reasons; North American Free Trade Agreement (NAFTA), Article 1016 (2) (b) : due to an absence of competition for technical reasons; Comprehensive Economic and Trade Agreement (CETA), Article XIII (b) (iii): due to an absence of competition for technical reasons; WTO-AGP Free Trade Agreement, Article XIII (b) (iii): due to an absence of competition for technical reasons; Canada-Ukraine Free Trade Agreement, Annex 10-13 (b) (iii): due to an absence of competition for technical reasons; Canada-Chile Free Trade Agreement, Article Kbis-16 (2) (c): necessary to protect intellectual property.

Period of the proposed contract or delivery date The proposed contract period is from contract award to 31 March 2022. Cost estimate of the proposed contract The estimated value of the contract is $522,988.00, (GST/HST extra). 10. Name and address of the pre-identified supplier SIGA Technologies, Inc. 31 East 62nd Street New York, NY 10065 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 requirements. Closing date for a submission of a statement of capabilities The closing date and time for accepting statements of capabilities is December 02, 2019 at 2:00 p.m. EST. 13. Inquiries and submission of statements of capabilities Name: Marie-Diane PayeurTitle: Senior Procurement OfficerTelephone: 819-939-8469E-mail: Marie-Diane.Payeur@forces.gc.ca