Bioneer : Other Management Information(Voluntary Disclosure) (Development Agreement with FIND for development/licensing/production/supply of POC Molecular Diagnostics (Iron-qPCR) in LMIC)
December 17, 2021 at 03:59 am EST
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Other Management Information(Voluntary Disclosure)
1. Title
Development Agreement with FIND for development/licensing/production/supply of POC Molecular Diagnostics (Iron-qPCR) in LMIC
2. Details
1. Counterparty
International Molecular Diagnosis Evaluation and Supply Organization FIND (Foundation for Innovative New Diagnostics).
2. Scope of Agreement
- Agreement to collaborate on development, certification, large-scale production, and supply of molecular diagnostics equipment related to COVID-19 and RSV for LMIC
- Supply of the products with the contract price to LMIC
- Registration on WHO's EUL, and PQ approval
- Support for clinical trials and approval of other developed countries
3. Products
- IRON-qPCR equipment
- RV Multiplex Kit (Product name to be confirmed later)
4. Each Party's Responsibility
- FIND: Support and monitoring over the development, validation, certification, production, and sales activities of equipment(Iron-qPCR) and related kits
- BIONEER : Development, validation, certification, production, and sales of equipment(Iron-qPCR) and related kits, in accordance with Global Access requirements
5. Period of Agreement
- Effective date: December 1st, 2021.
- Expiration date: The later date between,
1) The expiration date of the product sales in the selected region
2) 10 years from the effective date of the agreement
3. Decision(Confirmation) Date
2021-12-16
4. Other references concerning investment decisions
- The agreement's execution date is December 16, 2021, but its effective date is December 1, 2021.
- According to the confidentiality clauses, specific contract terms and prices are not stated.
- FIND is a global non-profit to ensure equitable access to diagnostics that collaborates with WHO, CDC, USAID, UNITAID, CEPI, and other global partners. FIND's independent evaluation of new diagnostics technologies is recognized for transparency and credibility.
※ Title and date of other disclosure related to this one
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Bioneer Corporation published this content on 17 December 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 December 2021 08:58:14 UTC.
Bioneer Corp is a Korea-based company engaged in the biotechnology business. The Company mainly operates genetic research, molecular diagnostics, probiotics, and RNA interference (RNAi) new drug development businesses. The Company mainly provides services such as gene analysis and synthesis, gene expression, and protein expression and purification. The Companyâs products include body fat-reducing lactic acid bacteria in probiotics field, and basic materials, reagents, kits, gene extraction, amplification, quantitative analysis equipment, molecular diagnosis equipment for genetic research and molecular diagnosis used in molecular diagnosis field. The company also provides laboratory equipment, single products, and laboratory consumables used in biotech research.
Bioneer : Other Management Information(Voluntary Disclosure) (Development Agreement with FIND for development/licensing/production/supply of POC Molecular Diagnostics (Iron-qPCR) in LMIC)