Revive Therapeutics Ltd. ("Revive" or the "Company") (CSE: RVV, US: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that it has signed a Memorandum of Understanding ("MOU") with Attwill Medical Solutions Sterilflow, LP ("AMS") to establish AMS as a resource for clinical packaging and distribution for the Company's Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19.
"We are pleased to engage in formal discussions with Attwill Medical to assist us in the clinical packaging and distribution for our Phase 3 clinical study in COVID-19, as they have the resources and capabilities to execute on a number of activities that are critical to large-scale clinical studies," said Michael Frank, CEO of Revive.
Based in Lodi, Wisconsin, AMS is one of the largest contract Lyophilization services facilities in the USA and recently announced a MOU with Vaxart, Inc. affirming the parties' intent to establish AMS as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart's oral COVID-19 vaccine. AMS operates an FDA compliant facility with ISO 13485 2016 certification and operates under cGMP and specializes in the lyophilization and related processing of pharmaceutical intermediates, medical devices, nutraceuticals and nutritional ingredients and supplements.
The MOU outlines a proposed scope of work with the intention to form a collaboration between Revive and AMS in the area of clinical packaging. The primary activities that AMS may perform for the Phase 3 clinical study in COVID-19 are analytical and stability studies, clinical supply chain management, storage, distribution and project management.
As AMS is a related party to the Company due to the fact that Bill Jackson, a director of Revive, is an insider of AMS, the MOU is deemed to be a "related party transaction" as defined under Multilateral Instrument 61-101--Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction with AMS is exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 (pursuant to subsections 5.5(a) and 5.7(a)) as the fair market value of the consideration to be paid to AMS will not exceed 25% of the Company's market capitalization.
Revive would also like to announce that it has commenced the process to have the Company's common shares upgraded and quoted on the OTCQB Market exchange in the United States. Commencement of trading through the facilities of the OTCQB is subject to the fulfilment of the various regulatory requirements and completion of due diligence.
Moving to the OTCQB in the United States will provide existing shareholders with an additional trading platform to the Canadian Securities Exchange in addition to introducing the Company to a broader range of retail and institutional investors that a U.S. listing provides.