Department of Health and Human Services July 25, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
National Institute of Allergy and Infectious Diseases (NIAID); Notice of Workshop
The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health; the Food and Drug Administration (FDA); the Transformational Medical Technologies (TMT); and Biomedical Advanced Research and Development Authority (BARDA) are holding an Animal Model Development Workshop to explore the scientific and regulatory challenges of developing medical countermeasures (MCM) under the ``Animal Rule'' (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products). The goals of this workshop are to highlight the significant progress made in animal model development for MCMs, review recent case studies of products under development using animal models, and capture lessons learned to inform future animal model development efforts. In addition, the workshop will provide a forum to discuss current challenges and identify potential solutions or mitigation strategies.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive License: Use of Glucocerebrosidase Activators for the Treatment of Gaucher Disease and Central Nervous System Proteinopathies, Including Parkinson's Disease
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to Lysosomal Therapeutics, Inc., a company having a place of business in Boston, Massachusetts, to practice the inventions embodied in U.S. Provisional Patent Application No. 61/420,946, filed December 8, 2010 (HHS Ref. No. E-257-2010/0-US- 01) and PCT Patent Application No. PCT/US2011/063928, filed December 8, 2011 (HHS Ref. No. E-257-2010/0-PCT-02), both entitled ``Substituted Pyrazolopyrimidines as Glucocerebrosidase Activators.'' The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``Treatment of Gaucher disease and human central nervous system proteinopathies, including without limitation Parkinson's disease.'' Upon the expiration or termination of the exclusive evaluation option license, Lysosomal Therapeutics, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.
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