Applied DNA Sciences, Inc. has signed a license and cooperation agreement and a related supply agreement, effective March 31, 2018, with Colorcon, Inc. for the use of Applied DNA’s SigNature molecular tags in Colorcon’s product offerings and access to the company’s associated authentication technologies. The 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.
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.
“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,” Dr. James Hayward, president and CEO of Applied DNA, said in a statement.
Colorcon has experience in global regulatory compliance, while Applied DNA has scaled to supply large, global commercial ecosystems. Its molecular tags have been included in more than 200 million pounds of cotton, over 15 million pounds of synthetic fibers, and in excess of 800,000 microcircuits for the Department of Defense. Applied DNA’s data portals, supporting hundreds of thousands of data transactions per day, have stored more than 300,000 sample testing reports, and are now exchanging data with multiple third-party platforms, according to the company.
(Source: Applied DNA Sciences, Inc.)
Filed Under: Drug Discovery