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Applied DNA signs agreement with Colorcon for molecular tagging


06/04/2018

Applied DNA Sciences has signed an agreement with Colorcon for the use of Applied DNA's SigNature molecular tags in Colorcon's product offerings and access to the Company's associated authentication technologies. These Agreements follow the memorandum of understanding (MOU) announced on December 18, 2017.
 
Under the terms of the Agreements, Applied DNA grants Colorcon exclusive worldwide right to use the Company's molecular tags and associated authentication technologies in film coatings for solid oral dosage form ("SOD") applications, for which Colorcon is the largest global supplier, and non-exclusive rights to use the Company's technologies in inks and colorants for SOD applications. Pursuant to the Agreements, Applied DNA will supply taggant and authentication materials to Colorcon in exchange for long-term royalties on the sale of Colorcon products incorporating the Company's molecular tags and on the sale of authentication services related thereto. Further, the first of two milestone payments is payable to Applied DNA with the signing of the Agreements. The Company will receive the second milestone payment upon initial approval by a regulatory authority for application in a SOD pharmaceutical or nutraceutical product application. The Agreements generally expire on the later of October 1, 2032 or the last expiration date of any patent licensed pursuant to the Agreements.
 
"With the signing of these definitive agreements and Colorcon's industry-leading role, we demonstrate our continuing ability to monetize our DNA molecular taggant platform and associated services to drive revenue growth. The seamless solution integrating our molecular tag with Colorcon's film coatings puts us on a path to adoption by Colorcon's current and prospective pharmaceutical customers," stated Dr. James Hayward, President and CEO of Applied DNA. Dr. Hayward added that: "Molecular tags will provide traceability for audits and law enforcement and, perhaps most importantly, forensic confirmation of the authenticity of the drug product to the patient and all those in the supply chain, including the pharmacist, the drug distributors and manufacturers.  We are gratified to be working with a world leader whose sales channel greatly amplifies our combined access to the market."  
 
"Our teams are already actively engaged in discussions with potential customers," stated Kelly Boyer, General Manager Film Coatings Business Unit for Colorcon. "Colorcon has an established reputation for innovation and service.  Applied DNA's SigNature molecular tags and authentication technologies provide value-addition at a time when regulators are demanding that the industry implement serialization in order to track packaging."
 
Colorcon has extensive experience in global regulatory compliance, while Applied DNA has the benefit of several of its management team with experience in the pharmaceutical industry, and the Company has already scaled to supply large, global commercial ecosystems. Applied DNA's Molecular Tags have been included in over 200 million pounds of cotton, over 15 million pounds of synthetic fibres, and over 800,000 microcircuits for the Department of Defense. The Company's data portals, supporting hundreds of thousands of data transactions per day, have stored over 300,000 sample testing reports, and are now exchanging data with multiple third-party platforms.