Royalty Report: Drugs, Pain, Pharmaceuticals – Collection: 221493

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts, a perpetual, worldwide, exclusive license, exclusive even as to Licensor, under the Licensed IP and Related Licensed IP to make and have made, to use and have used, to sell and have sold, to offer for sale and have offered for sale, and to import and have imported Licensed Products, to practice and have practiced Licensed Methods, and to otherwise use and have used the Licensed IP and Related Licensed IP (including, but not limited to, the Patent Rights and the Technology), in any and all ways and respects in any and all fields (the “License”). To the extent that aspects of the Technology not covered by Patent Rights may be used outside of the context of d-Methadone, Licensor reserves the right to use and to license or assign to third parties such aspects of the Technology outside of the context of d-Methadone.

License Property

Licensor jointly and collectively developed certain inventions regarding d-Methadone in the context of analgesic use.

Licensor jointly and collectively developed certain inventions regarding d-Methadone in the context of psychiatric use (the “Existing Invention”).

Licensor jointly and collectively developed certain further inventions regarding d-Methadone in the context of neurological and other uses (the “New Invention”).

This agreement is in regards to d-Methadone in the context of analgesic use, psychiatric use, neurological and other uses.

Licensed IP shall mean Licensor’s right, title, and interest in and to (a) the Licensed Inventions (including, without limitation, all existing work relating to the Licensed Inventions) and (b) any and all Future Inventions.

Related Licensed IP shall mean all of Licensor’s intellectual property related to the Licensed IP. For the avoidance of doubt, the Licensed IP and the Related Licensed IP collectively include, but are not limited to, Licensor’s right, title and interest in and to the Patent Rights, Technology, and Licensed Intangible Assets.

Licensed Product shall mean any service, composition, or product (a) that uses Technology; or (b) that is claimed in Patent Rights; or (c) that is produced or enabled by a Licensed Method; or (d) the manufacture, use, sale, offer for sale, or importation of which would constitute, but for the license granted to Licensee under this Agreement, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within the Patent Rights.

Patent shall mean any and all patents, pending patents, patent applications (whether registered or unregistered) (and equivalents of any of the foregoing including certificates of invention, and any and all divisions, continuations, provisional applications, continuations-in-part, continued prosecution applications, requests for continued examinations, additions, renewals, extension, re-examinations, reissues, supplementary protection certificates, and all United States and foreign counterparts of any the foregoing.

Patent Rights shall mean all of Licensor’s right, title, and interest in and to the Patents set forth (which may be updated from time to time to reflect new Patents including without limitation from Future Inventions) and any other Patent related to any of the Licensed IP and/or the Related Licensed IP, including its development manufacture, packaging, use, marketing, promotion, distribution, licensing, offer for sale, or importation. For the avoidance of doubt, the Patent Rights shall include any Patent relating to any of the Licensed IP and/or the Related Licensed IP licensed to Licensee herein, including, without limitation, Patents relating to any and all of Licensor’s right, title and interest in and to Future Inventions (including the development manufacture, packaging, use, marketing, promotion, distribution, licensing, offer for sale, or importation of any of the Licensed IP and/or the Related Licensed IP), filed, requested, and/or issued after the Effective Date regardless of whether the information updated to reflect such Patent.

Technology shall mean all right, title, and interest of Licensor in and to the Technical Information related to any of the Licensed Products, Licensed Inventions, Licensed IP, and/or the Related Licensed IP, including any of their development, manufacture, packaging, use, marketing, promotion, distribution, licensing, offer for sale, or importation.

d-methadone (dextromethadone), is a novel, N-methyl-D-aspartate (NMDA) receptor antagonist being developed for the treatment of depression and neuropathic pain, and/or other potential indications. As a single isomer of racemic methadone, d-Methadone has been shown to possess NMDA antagonist properties with virtually no opioid activity or ketamine-like toxicities at the expected therapeutic doses. The activation of NMDA receptors has been associated with depression and neuropathic pain and it is expected that d-Methadone will have a therapeutic role by blocking this activity. In contrast, racemic methadone is a long-acting narcotic producing typical opioid side effects used in the treatment of various pain states and as a substitution therapy in opioid addiction.

A relative of methadone, a widely known synthetic opioid medication, d-Methadone represents half of methadone’s chemical structure with profoundly different activity on the mu opioid receptor, considered a “gateway for addiction.”  Methadone is an opioid used for opioid maintenance therapy in opioid dependence, and for pain.

Field of Use

This agreement pertains to the drug industry relating to d-Methadone and its use as a therapeutic, or its effects on patients and animals as well as in the context of analgesic, psychiatric use, neurological and other uses.

License Grant

University hereby grants to Licensee an exclusive license, with right to grant sublicenses, under the Patent Rights and Know-How to make, have made, use, sell, offer for sale and import Licensed Products in the territory.  Territory is defined as the entire world.

License Property

Licensed Product means any and all formulations for human pharmaceutical or animal health use, the manufacture, importation use or sale of which would (a) infringe a Valid Patent Claim but for the license provided under Article II hereof or (b) involve the use of Know-How.  Patent Rights means the patents and patent applications listed and any and all divisions, continuations, continuations-in-part, reissues, renewals, extensions or the like of any such patents and patent applications and all foreign equivalents thereof and any and all patents and patent applications owned by University which contain one or more claims directed to compositions or methods for the attenuation of opioid tolerance and dependence and the enhancement of opioid analgesic potency and which result from the research funding provided by Licensee to University pursuant to this Agreement, and any and all divisions, continuations, continuations-in-part, reissues, renewals, extensions or the like of any such patents and patent applications and all foreign equivalents thereof.  Technology relates to reformulate existing opioid pain killers into new drugs, which we believe offer enhanced pain relief, fewer adverse side effects and reduced tolerance and addiction compared to existing opioid pain killers.

Field of Use

The rights granted apply for human or animal health.

License Grant

The University granted the Licensee an exclusive license to  make, have made, use, sell, offer to sell, import, have imported, and otherwise exploit Licensed Products and to practice Licensed Methods.  The inventions, generally characterized as High Dose Capsaicin Relieves Neuropathic Pain (or High Dose Capsaicin for Neuropathic Pain) UCSF Case No. SF00-056.

License Property

Patent Rights means the Regents’ interest in any subject matter claimed in or covered by any of the following Pending U.S. Patent Application Serial No. 08/746,207 entitled Therapeutic Method with Capsaicin and Capsaicin Analogs filed November 6, 1996, the continuation-in-part U.S. Patent Application Serial No. 08/990,633 entitled Transdermal Therapeutic Device and Method with Capsaicin and Capsaicin Analogs filed December 15, 1997 and assigned to The Regents; pending PCT Patent Application Serial No. PCT/US98/25794 of the same title, filed December 8, 1998 and assigned to The Regents; and continuing applications thereof including divisions, substitutions, continuation-in-part applications (but only to the extent however, that claims in the continuation-in-part applications are entitled to the priority filing date of the foregoing applications); any patents issuing on said applications including reissues, reexaminations and extensions; and any corresponding foreign applications or patents based on said applications.

Field of Use

The rights granted apply to the healthcare industry.  Field of Use means all fields and uses.

License Grant

Licensor grants an exclusive, except as to Licensor for internal research purposes only and not for clinical development, license under Know How, the Licensed Patents arid the Process Licensed Patents, to develop, obtain Regulatory Approval for, use, make, have made, import, sell, and offer for sale New Compounds and New Products in the Territory.

License Property

The patents, related foreign equivalents and know-how relate to peripherally selective opioid antagonists.

The New Compound shall mean a chemical entity (including salts and solvates thereof, which shall be considered the same New Compound for purposes of this Agreement) covered by any valid and unexpired claim of Licensed Patents, but shall exclude in all cases the Roberts Agreement Compound.

The New Product means a finished, formulated pharmaceutical product containing a New Compound, together with all improvements and line extensions thereon which may be included in any supplement, modification or addition to the relevant Regulatory Approval to the extent that any such improvements or line extensions contain a New Compound.

Field of Use

The Field of Use means all uses as a Peripherally Selective Opioid Receptor Antagonist, where the term Peripherally Selective Opioid Receptor Antagonist shall mean a chemical entity that has a selectivity ratio of greater than 20 upon parenteral administration as measured by the ED-50 for antagonism of analgesia in the mouse writhing test in morphine-naive mice divided by the ED-50 for precipitation of diarrhea in the morphine-dependent mice test.

Licensee is developing  alvimopan, a peripherally selective mu opioid antagonist for management of postoperative ileus, opioid induced bowel dysfunction and certain other indications.  Alvimopan is in a class of medications called peripherally acting mu-opioid receptor antagonists. It works by protecting the bowel from the constipation effects of opioid (narcotic) medications that are used to treat pain after surgery.