1. 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), more specifically, the Strategic Medical Countermeasures Program (SMCP) on behalf of the Canadian Forces Health Services Group (CF H Svcs Gp), has a requirement for Fentanyl Citrate Oral Transmucosal lozenges for the treatment of Canadian Armed Forces (CAF) members injured in the course of military training or operations.
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:
3.1 The Supplier must provide evidence that their proposed Fentanyl Citrate Oral Transmucosal lozenges holds a valid Health Canada issued Notice of Compliance in accordance with Division 8 or be authorized for sale through Division 11 of the Canadian Food and Drug Regulations. The Division 11 application will be filed by DND. The Supplier will be responsible for any associated export requirements.
A copy of the most recently approved prescribing information must be provided as part of their bid.
3.2 The Supplier must demonstrate that their proposed Fentanyl Citrate Oral Transmucosal lozenges has the following information included on its primary package label:
• Product name
• Strength
• Lot or batch number
• Expiry date or date of manufacture
A photo or design mock-up of the primary package label must be provided as part of their bid.
3.3 The Supplier must demonstrate that their proposed Fentanyl Citrate Oral Transmucosal lozenges has a minimum shelf-life of 30 months from date of manufacture.
Real-time stability data for a minimum of 36 months at 15 - 25°C must be provided as part of their bid.
4. Applicability of the trade agreements to the procurement
This procurement is subject to the following trade agreements:
a. Canadian Free Trade Agreement (CFTA);
b. Revised World Trade Organization - Agreement on Government Procurement (WTO-AGP);
c. Canada-European Union Comprehensive Economic and Trade Agreement (CETA);
d. Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP);
e. Canada-Chile Free Trade Agreement (CCFTA);
f. Canada-Colombia Free Trade Agreement;
g. Canada-Honduras Free Trade Agreement;
h. Canada-Korea Free Trade Agreement;
i. Canada-Panama Free Trade Agreement;
j. Canada-Peru Free Trade Agreement (CPFTA);
k. Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA); and
l. Canada-Ukraine Free Trade Agreement (CUFTA).
5. Justification for the Pre-Identified Supplier
Fontus Health Ltd., c/o Northumbria Pharma Ltd., the pre-identified supplier, is the only known eligible supplier that can provide the Cynril Compressed Lozenges (Fentanyl Citrate) for Oral administration.
6. Government Contracts Regulations Exception
The following exception to the 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.
7. Exclusions and/or Limited Tendering Reasons
The following exclusions and/or limited tendering reasons are invoked under the following trade agreements:
a) Canadian Free Trade Agreement (CFTA) – Article 513 (1) (b) (ii): the protection of patents, copyrights or other exclusive rights;
b) World Trade Organization - Agreement on Government Procurement (WTO-AGP) – Article XIII (b) (ii): the protection of patents, copyrights or other exclusive rights;
c) Canada-European Union Comprehensive Economic and Trade Agreement (CETA) – Article 19.12 (1)(b) (ii): the protection of patents, copyrights or other exclusive rights;
d) Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) – refer to CETA as the provisions of CETA are incorporated by reference into and made part of this Agreement. (CETA) Article 19.12 (b) (ii);
e) Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) – Article 15.10 (2) (b) (ii): the protection of patents, copyrights or other exclusive rights;
f) Canada-Chile Free Trade Agreement (CCFTA) – Article Kbis-09 (1) (b): where, for works of art, or for reasons connected with the protection of patents, copyrights or other exclusive rights, or proprietary information or where there is an absence of competition for technical reasons, the goods or services can be supplied only by a particular supplier and no reasonable alternative or substitute exists;
g) Canada-Colombia Free Trade Agreement – Article 1409 (1) (b) (ii): the protection of patents, copyrights or other exclusive rights;
h) Canada-Honduras Free Trade Agreement – Article 17.11 (2) (b) (ii): the protection of patents, copyrights or other exclusive rights;
i) Canada-Korea Free Trade Agreement – Article 14.3:Scope;
j) Canada-Panama Free Trade Agreement – Article 16.10 (1) (b) (ii): a good or service being procured is protected by a patent, copyright or another exclusive right;
k) Canada-Peru Free Trade Agreement (CPFTA) – Article 1409 (1) (b) (ii): the protection of patents, copyrights or other exclusive rights; and
l) Canada-Ukraine Free Trade Agreement (CUFTA) – Annex 10.13 (1) (b) (ii): the protection of patents, copyrights or other exclusive rights.
8. Ownership of Intellectual Property
No intellectual property ownership is required.
9. Period of the proposed contract or delivery date
The proposed contract period is from Contract Award to 31 March 2029. Requested delivery date for the initial requirement is for 498 QTY of Cynril Fentanyl Citrate oral transmucosal lozenges, 800 mcg, to be delivered as soon as possible but no later than 01 March 2025.
Optional requirements of an additional 4,000 QTY Cynril Fentanyl Citrate Oral Transmucosal lozenges, 800 mcg will be required on an "as and when requested basis" and must be delivered before 31 March 2029.
10. Cost estimate of the proposed contract
The estimated value of the Contract, including option(s), is $238,000.00 CAD, excluding taxes.
11. Name and address of the pre-identified supplier
Name: Fontus Health Ltd., c/o Northumbria Pharma Ltd.
Address: Discovery 1, William Armstrong Way, Sedgefield,
County Durham, TS21 3FD, United Kingdom
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 requirements.
13. Closing date for a submission of a statement of capabilities
The closing date and time for accepting statements of capabilities is 12 September 2024 at 02:00 P.M. EST.
14. Inquiries and submission of statements of capabilities
All inquiries must be submitted in writing to the Contracting Authority no later than five (5) calendar days before the closing date of the ACAN. Inquiries received after that time may not be answered.
Inquiries and statements of capabilities are to be directed to:
Name: Natalie Provost, D Svcs C 3-4
Title: Procurement and Contracting Officer
Email: natalie.provost@forces.gc.ca
