Atropine 2mg/Obidoxime 220mg AutoInjectors

Trade Agreement: Canadian Free Trade Agreement (CFTA) 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: ChemProtect SK sro Cukrovarnicka 1071/62 Czech Republic 16200 Nature of Requirements:

Atropine Obidoxime

W6369-21A022/A Duplin-Vu(ph870), Kim André Telephone No. - (819) 956-7335 ( ) Fax No. - ( ) - ( )

ATROPINE 2mg/OBIDOXIME 220MG IN AUTOINJECTOR FORM Purpose of ACAN:

Public Services and Procurement Canada proposes to negotiate a contract with ChemProtect SK sro, on behalf of the Department of National Defence for the purchase of Atropine 2mg/Obidoxime 220mg in AutoInjector (AI) form.

Definition of Requirement: Atropine/Obidoxime auto injectors are required as part of the Medical Counter Measure (MCM) stockpile. Atropine 2mg/Obidoxime 220mg is an antidote used against nerve agent intoxication and is administered rapidly during an emergency situation.

Quantities

The estimated quantity for the firm delivery is 28,000 Auto Injectors, with 32,000 Auto Injectors in optional quantities.

Term of Contract

The period of the contract will be from contract award to March 31, 2023.

Evaluation Criteria

1) The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg Autoinjectors has the following Certification and Compliance:

- Must be manufactured in accordance with Good Manufacturing Practices (GMP) as set out in the Food and Drugs Act - Food and Drug Regulations (FDR) - Division 2 - Good Manufacturing Practices, website http://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-108.html#h-186 and Health Canada’s Good Manufacturing Practices (GMP) Guidelines - 2009 Edition, Version 2 (GUI-0001), website https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/good-manufacturing-practices-guidelines-2009-edition-version-2-0001.html

Proof of GMP must be included in the statement of capabilities.

2) The Vendor must demonstrate that their proposed Atropine/Obidoxime autoinjector contains the following drug type and potency:

Drug Product (Obidoxime) Active ingredient: Obidoxime dichloride in water for injection Dose: 220 mg Volume: 2.0 mL (+/- 0.2 mL) pH: 2.0 - 6.0 Primary packaging: Pharmaceutical grade glass, rubber, stainless steel Physical characteristics:Free from undissolved materials or particulates Sterility: Sterile

Drug Product (Atropine) Active ingredient: Atropine sulfate monohydrate in water for injection Dose: 2 mg Volume: 2.0 mL (+/- 0.2 mL) pH: 2.0 - 6.0 Primary packaging: Pharmaceutical grade glass, rubber, stainless steel Physical characteristics:Free from undissolved materials or particulates Sterility: Sterile

The Vendor must include an executed Certificate of Analysis in the statement of capabilities.

3) The Vendor must demonstrate that their proposed Atropine/Obidoxime 2mg/220mg has the following configuration and drug administration method: Requirement/Specification Device: (Autoinjector) Maximum dimensions(Length x Width):Length 150 mm +/- 15 mm; Width 25 mm +/- 5 mm Materials: Approved for medical device use Robustness: Operational after stability and environmental tests conducted in accordance with applicable International Conference on Harmonization (ICH) standards and MIL-STD-810, respectively. Needle Gauge: 20 - 23 Needle Length: 19 - 22 mm Weight: 75 g +/- 25g Ease of Use: Less than 3 steps and be operated while wearing gloves Maximum delivery time: 10 seconds Safety Mechanisms: Mechanism to prevent accidental firing Injection of air: