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License Agreements
12 Months Ended
Nov. 30, 2012
License Agreements [Abstract]  
License Agreements [Text Block]

Note 5 – License Agreements

 

Rhode Island Hospital

 

In September 2001, the Company completed the purchase of its cell line business and, as a result, it acquired an exclusive license agreement with Rhode Island Hospital for the use of four patents owned by the hospital related to liver cell lines and liver assist devices. The primary patent acquired and being utilized is for immortalized hepatocytes. As of November 30, 2006, management tested the carrying value of the license agreement for impairment and concluded that it had been impaired and reduced the carrying value to zero. The Company will pay the hospital a 5% royalty on net sales derived from licenses based upon the patented technology, until it has paid a total of $550,000. As of November 30, 2012, no significant payments had been made under this license agreement. After royalties totaling $550,000 have been paid, the Company pays a 2% royalty instead of a 5% royalty for the life of the patent.

 

Amarin Neuroscience Limited

 

On December 31, 2005, the Company entered into a worldwide Exclusive License Agreement (the “License Agreement”) with Amarin Neuroscience Limited (“Amarin”). Among other things, the License Agreement provides that Amarin shall grant to the Company and its affiliates an exclusive worldwide license with respect to therapeutic or commercial uses of certain technology of Amarin, including LAX-202 (to be renamed MCT-125), and the Company shall develop and seek to commercialize products based on such technology. The initial technology to be developed is Amarin’s LAX-202, which is a potential treatment for fatigue in patients diagnosed with multiple sclerosis. The agreement has a term equal to the life of the patents licensed. The License Agreement provides that the Company will pay future royalty milestone payments in accordance with the following:

 

  (a) $500,000 upon first filing of a new drug application with Food and Drug Administration (FDA) or a reasonably similar filing with any regulatory authority for Active Agent Product,

 

  (b) $1,000,000 upon first FDA approval for sale in the USA for Active Agent Product,

 

  (c) $1,500,000 within twelve calendar months after the first sale in the USA for Active Agent Product, and

 

  (d) $1,000,000 within twelve calendar months after the first sale in the European Economic Area for Active Agent Product.

 

None of these milestones have been achieved as of November 30, 2012 and, accordingly, none of these obligations have been paid or recorded. If any milestone payment is not paid when due, and if no payment is received from the Company within thirty days after the date of receipt of a written notice of such nonpayment, Amarin shall have the option to either (i) terminate this agreement or (ii) convert the license under this agreement to a worldwide non-exclusive license with the right to sublicense, which non-exclusive license shall be subject to all of the terms and obligations of the agreement. The Company shall also pay Amarin without set-off or counterclaim a royalty of nine percent on net sales of Active Agent Product sold by the Company, its affiliates, or sublicensees and their affiliates. On November 5, 2008 the License Agreement was amended whereby Amarin granted exclusive worldwide rights to the Company related to the treatment of all chronic fatique and pain in addition to the treatment of fatigue in multiple sclerosis patients.

 

Corning Incorporated

 

On October 9, 2007, the Company executed an exclusive license and purchase agreement (the “Agreement”) with Corning Incorporated (“Corning”) of Corning, New York. Under the terms of the Agreement, Corning has the right to develop, use, manufacture, and sell the Company’s Fa2N-4 cell lines and related cell culture media for use as a drug discovery assay tool, including biomarker identification for the development of drug development assay tools, and for the performance of absorption, distribution, metabolism, elimination and toxicity assays (“ADME/Tox assays”). The Company retained and will continue to support all of its existing licensees. The Company retains the right to use the Fa2N-4 cells for use in applications not related to drug discovery or ADME/Tox assays. The Company also retains rights to use the Fa2N-4 cell lines and other cell lines to further develop its Sybiol® liver assist device, to produce therapeutic proteins using the Company’s BioFactories™ technology, to identify drug targets and for other applications related to the Company’s internal drug development programs. In consideration for the license granted, Corning paid the Company $375,000 upon execution of the Agreement, and an additional $375,000 upon the completion of a transition period. In addition, Corning purchased inventory and equipment from the Company and reimbursed the Company for laboratory costs and other expenses during a transition period. The Company is recognizing the income ratably over a 17 year period. The Company recognized $44,118 in income for each of the years ended November 30, 2012 and 2011. The balance of deferred revenue from this license is $522,059 and $566,177 at November 30, 2012 and 2011, respectively, and will be amortized into revenue through October 2024.

 

Pfizer Inc.

 

The Company has another license agreement with Pfizer Inc., for which revenue is being deferred. During the years ended November 30, 2012 and 2011, the Company recognized $5,200 in each year and the balance of the deferred revenue from this license is $26,000 and $31,200 at November 30, 2012 and 2011, respectively, and will be amortized into revenue through January 2018.

 

University Health Network

 

On July 5, 2011, the Company, entered into a sponsored research agreement with the University Health Network (UHN), a not-for-profit corporation incorporated under the laws of Canada. Under this agreement UHN will evaluate the Company’s product candidates, MCT-465 and MCT-485, in in vitro models for the treatment of primary liver cancer. The mechanism of action of MCT-465 and MCT-485 and their potential selective effect on liver cancer stem cells will also be evaluated. Under the terms of the agreement, the Company will retain exclusive access to the research findings and intellectual property resulting from the research activities preformed by UHN.