SUPPLEMENTARY INFORMATION:

The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to Inversago Pharma Inc.:

The patent rights in these inventions have been assigned to the Government of the United States of America.

The prospective exclusive patent license territory may be worldwide and a field of use limited to human therapeutics for Hermansky-Pudlak syndrome and idiopathic pulmonary fibrosis.The invention covered by the patents and patent applications pertaining to HHS Ref. No. E-282-2012 relates to cannabinoid receptor 1 (CB₁ R) inverse agonists. CB₁ R activation plays a key role in appetitive behavior, metabolism, and tissue fibrosis. Of importance as a therapeutic target here is that the receptor is expressed in both peripheral tissue as well as the central nervous system. The invention is a class of pyrazole compounds that act as CB1 receptor inverse agonists and have been shown effective at reducing obesity and its associated metabolic consequences while having no experimentally discernable neuropsychotropic side effects that are considered adverse, unlike the earlier antagonists rimonabant. These CB₁ R receptor compounds were developed with the goals of limiting their brain penetrance without losing their metabolic efficacy due to CB1 inverse agonism, and having a primary metabolite directly targeting enzymes involved in inflammatory and fibrotic processes associated with metabolic and other disorders. The patents are both compositions of matter and methods of use.

The inventions covered by HHS Ref. E-140-2014-0 also pertain to pyrazole CB₁ R receptor inverse agonists. In addition, some of these compounds also have a direct inhibitory effect on inducible nitric oxide synthase (iNOS), whereas another group of the compounds directly activates AMP kinase. There is evidence that the metabolic effects of endocannabinoids are mediated by CB1 receptors in peripheral tissues. These dual-target compounds may be useful for treating metabolic disease and related conditions such as obesity and diabetes and their complications, including various forms of tissue fibrosis, without the dangerous side effects. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent license will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, NHGRI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license.

Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act,5 U.S.C. 552.