ITEM 126-1001-R0305 Submission




1.�� Nature of the Intellectual Property covered under this joint venture, including sources of funding for this research.


The lack of effective treatment for many forms of acquired and inherited hearing disorders has prompted interest in the potential application of gene delivery techniques to restore normal cochlear function.� It was found that Adeno-associated virus (AAV) could target gene expression to cochlear hair cells and support cells.� New AAV production and purification methods were developed, which lead to increased titers and to new AAV serotypes.� These AAV could be genetically engineered to deliver candidate genes that can potentially restore normal auditory function.� A provisional patent was filed by the University on June 18, 2004 to protect these inventions, and preparation of the full application is in under way.� Appropriate forms have been filed with the federal granting agency so that UM can retain title to the invention under Bayh-Dole.


2.�� a.��� Names of the University employees involved:

David Poulsen, Ph.D.

Peter Von Dorsten, M.D.

Diana Lurie, Ph.D.


b.�� Name of business involved:

Big Sky Biotechnology, LLC


3.�������� The University and employees are seeking approval to establish licensing and other contractual relationships between the University and a company in which the employees have significant financial interests.


4.�� a.��� Relationships between the University and the business entity:


The University will negotiate with the business a worldwide exclusive license to the business for patent(s) covering these technologies.� As part of this license the University will receive fees, royalties, and reimbursement of patent expenses.� Also, the University may negotiate agreements with the business to rent laboratory space and certain scientific equipment, under terms and conditions that are consistent with University policy and State law.


b.��� Duration of the agreements:


Licenses for the patent rights will be for the life of the patent(s) - 20 years after filing.� Agreements for use of University facilities are expected not to exceed one year.


c.       Conditions under which the agreements may be terminated:


Failure of the business to comply with provisions in the licensing or other agreements.


5.�� How the University and the State of Montana will benefit from these agreements:


The University may receive significant royalties from commercial exploitation of these Intellectual Properties.� The market for drugs to treating schizophrenia alone exceeds one billion dollars per year.� A new company will be created in Montana with new jobs and contributions to the tax base.


6.�� Summarize the possible financial terms of the agreement:


UM is seeking approval before entering in to negotiations on a licensing agreement with the business.� If the proposed relationships are approved, it is anticipated that the negotiated license will include fees, royalties, and reimbursement for relevant University patent expenses.� If successful products are developed under these licenses, income to the University could exceed $100,000 per year.


a.��� The University�s contributions:


UM managed the grant, provided facilities and equipment, and certain personnel for the research project.� Patent advice, filings, Bayh-Dole compliance and other contributions were made by the University�s Technology Transfer Office.� The University may lease facilities, on a short-term basis to help the company get started.

b.��� Employees� contributions:


The UM employees wrote the grand application that funded the research, carried out the research, conceived and reduced to practice the ideas, which resulted in the patent applications.


c.��� Time line for anticipated revenues:


Gene therapy technologies will require long development and clinical testing procedures before they get to market, so the potential $100,000 + per year revenues to UM would not occur for more than a decade.� However, if the business granted any sublicenses under this agreement, sublicense fees would be shared with the University at the time they were received by the business.


d.��� Sharing of revenues and expenses between the University and the business:


As part of the terms f the license agreement, the business will reimburse the University for patent expenses; the University is not expected to incur any other direct expenses in these arrangements.� Sharing of fees and royalties will be negotiated with the business as part of the license agreement and will be consistent with the standards established for license agreements on products like these.


e.��� Nature of each party�s equity interest in the project.


As part owners in the company, certain University employees will own equity in the business.� The University does not intend to acquire equity in the company.