Royalty Report: Drugs, Disease, Biotechnology – Collection: 7033

License Grant

The Licensor, a nonprofit American academic medical center, hereby grants to the Company the exclusive worldwide right and license under the Licensed Technology to develop, make, have made, use, import, export, lease, offer to sell, sell, have sold and otherwise exploit Licensed Products for use in the Field in the Territory, and to grant, offer for sale and authorize sublicenses with respect to the right and license granted under this Agreement to other third parties.

License Property

Licensed Patents shall mean, collectively  United States Patent No.  5,591,629, (formerly Application S.N.  08/236,520, filed April 29, 1994), entitled Monoclonal Antibodies Which Promote Central Nervous System Remyelination, the inventions described and claimed therein, and any substitutions, extensions, renewals, divisions, patents-of-addition, continuations, continuations-in-part to the extent the claims are directed to subject matter specifically described in such patent (including, but not limited to, all of those continuations-in-part specifically listed in this Agreement), patents issuing thereon or reissues, extensions or supplementary protection certificates thereof, and any and all patents and patent applications throughout the Territory corresponding thereto; and all patents and patent applications, and any substitutions, extensions, renewals, divisions, patents-of-addition, continuations, continuations-in-part to the extent the claims are directed to subject matter specifically described in such patent or patent application, patents issuing thereon or reissues, re-examinations, extensions or supplementary protection certificates thereof, and any and all foreign counterparts thereto concerning any invention, technology or other intellectual property owned in whole or in part by Licensor and made, first reduced to practice or otherwise developed in connection with the Programs, whether before or after the date of this Agreement, or derivatives or analogs thereof, including any and all technology which may be subject to either of the Option Agreements.

Field of Use

Field shall mean the prevention, mitigation or treatment of nervous system disorders, diseases or injuries including, without limitation, pain, and any and all other diagnostic, therapeutic, pharmaceutical, cosmetic, medical or health care related applications.

License Grant

Licensor hereby grant to Licensee an exclusive (even to Licensor), royalty-bearing, freely sublicenseable license in the Territory under the Licensed Patents and Information for  all purposes, including without limitation, to develop, use, make, have made, import, have imported, export, have exported, offer for sale, have sold and sell Licensed Products.

License Property

Licensed Product means a product that utilizes or incorporates a Valid Claim for the therapeutic treatment of a specific fibrotic human disease, which product has been approved after the Effective Date for the therapeutic treatment of such specific fibrotic human disese by the United States Food and Drug Administration (FDA) and/or any Regulatory Agenciies through the granting of a New Drug Application (NDA) or equivalent foreign approval document.

Licensed Patents means that certain U.S. Patent No. 5,310,562; and all corresponding foreign patent applications and patents throughout the Territory, including any and all divisions, re-issues, re-examinations, renewals, continuations and substitutes in whole or in part of such patents and patent applications in the Territory with respect to the anti-fibrotic  uses of Pirfenidone; and all Patents defined. The Licensed Patents shall specifically exclude U.S. Patent No. 5,962,478 titled Tumor Necrosis Factor Alpha.
5,310,562 – Composition and method for reparation and prevention of fibrotic lesions

Patents means all of Licensors (a) anti-fibrotic, Pirfenidone patent applications heretofore or hereafter filed or having legal force in any country including without limitation divisionals, continuations, continuation-in-part and provisional applications; (b) issued, unexpired anti-fibrotic Pirfenidone patents in any country, including utility, model and design patents and certificates of invention; and (c) substitutions, extensions, reissues, renewals, and supplementary protection certificates with respect to any such issued patents. For clarity, such patent applications and patents shall include those owned, as well as those controlled with the right to grant licenses, by any of Licensors. The Patents shall not include patent applications and patents to the extent claiming uses of Pirfenidone other than for anti-fibrotic uses, nor uses of compounds for anti-fibrotic applications other than Pirfenidone.

Field of Use

This agreement pertains to the drug industry relating to products potentially useful in the prevention, mitigation and treatment of fibrotic and other diseases.

Fibrosis, also known as Fibrotic scarring, is a pathological wound healing in which connective tissue replaces normal parenchymal tissue to the extent that goes unchecked, leading to considerable tissue remodelling and the formation of permanent scar tissue.

License Grant

College hereby grants to Licensee an exclusive, worldwide, sublicensable license under the Patent Rights to make, have made, use, market, sell, offer to sell, lease and import Licensed Products in the Field.

License Property

Technologies are biomarkers that directly impact the diagnosis of neurodegenerative diseases.   Licensee , in collaboration with College, have applied the latest proteomic techniques to the differential diagnosis of neurodegenerative diseases utilizing blood serum.

The term Patent Rights shall mean United States Patent Application Serial No. TBA, entitled 'Biomarkers for Neurodegenerative Disease,' filed TBA, which was developed by the Inventors, the inventions described and claimed therein, and all other pending United States patent applications or parts thereof and any United States patent which issues from any such pending applications and any and all divisions, reissues, re-examinations, renewals, continuations, continuations-in-part to the extent the claims are directed to subject matter specifically described in the aforementioned patent application and are dominated by the claims of the existing Patent Rights, and extensions thereof, and all other counterpart, pending or issued patents in all other countries.

Re College OTA # 04-107 Entitled 'Serum Proteomic Methods and Biomarkers for Diagnosis of Neurodegenerative Disease and Differential Diagnosis of Alzheimers, Parkinsons Lou Gehrigs (ALS) Diseases, and other Motor Neuron and Neurological Disorders'

The term Licensed Product(s) shall mean any product, process or service that incorporates, utilizes or is made with the use of the Patent Rights.

Field of Use

This agreement pertains to the drug industry relating to Diagnosis of Neurodegenerative Disease and Differential Diagnosis of Alzheimers, Parkinsons Lou Gehrigs (ALS) Diseases, and other Motor Neuron and Neurological Disorders in the Field that shall mean all fields.

License Grant

Licensor hereby grants to Japanese Licensee, under the Licensed Technology, an exclusive, royalty-bearing license, with the right to grant sublicenses, to develop, have developed, make, have made, use, sell, offer for sale and import Licensed Products within the Licensed Field in the Licensee Territory.

License Property

Licensed Product shall mean
          (i)   any Clinical Candidate (as defined in the Collaboration Agreement);
          (ii)  any compound (a) which is identified, developed or discovered by Licensee using Licensed Technology and (b) which acts through activation of the insulin signal transduction pathway for the treatment of diabetes mellitus or insulin resistance in humans; and
          (iii) any compound which is an analog, homolog or chemical modification of a compound described in clause (i) or (ii) and which acts through activation of the insulin signal transduction pathway for the treatment of diabetes mellitus or insulin resistance in humans.

Licensed Technology shall mean the Licensed Patent Rights and the Licensed Know-How.

Licensed Patent Rights shall mean all of (i) Licensors interest in any patents and patent applications (including any divisions, continuations-in-part, reissues, extensions, renewals, supplementary protection certificates and foreign counterparts thereof) covering inventions made in the course of the Research Program (the Research Program Patents) and (ii) other patents and patent applications (including any divisions, continuations-in-part, reissues, extensions, renewals, supplementary protection certificates and foreign counterparts thereof) owned or Controlled by Licensor, but only to the extent such other patents and patent applications are necessary or useful for Licensee for the manufacture, use, sale, offer for sale or import of Licensed Products which are covered by the Research Program Patents.

Field of Use

License is for the development of a Type II diabetes drug.  The molecular fingerprinting is a family of small molecules that have demonstrated they can bind to and activate the insulin receptor to lower blood glucose levels in diabetes patients.

License Grant

The licenses granted include the right of each licensee to use its Affiliates in exercising such rights and carrying out its obligations under this Agreement.

Licensor hereby grants to Licensee the exclusive (except as to Licensor to permit it conduct its Co-Funded Development and/or Co-Commercialization activities and those activities under the ITMN-191 Transition Plan hereunder) license under the Licensor Know-How and Licensor Patent Rights and under Licensor’s rights in Joint Know-How and Joint Patent Rights to develop, make, have made, use, import, export, offer for sale and sell Licensed Compounds and Products in the Territory.

License Property

ITMN-191 shall mean that Macrocycle identified within Licensee as ITMN-191, together with its salts and esters, which is hereby designated a Licensed Compound.

Macrocycle shall mean any cyclic macromolecule in the Field containing a substituted proline moiety and optional Pl and P3 groups as part of the backbone ring and supporting the attachment of Pl and P4 groups.

Licensee Patent Rights shall mean any and all patents and patent applications in the Field in the Territory which are Controlled by Licensor during the term of this Agreement which Cover any activity permitted under this Agreement, all to the extent that the subject matter claimed therein is used in the course of performing any activity permitted under this Agreement, including, but not limited to, the making, using, selling, offering to sell, exporting or importing Lead Compound, Licensed Compounds, Products, Passed Compounds or Reverted Compounds. For the purposes of this Agreement, “patents and patent applications” shall be deemed to include certificates of invention and applications for certificates of invention, as well as divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

Joint Patent Rights shall mean any and all patents and patent applications in the Field in the Territory which are invented jointly during the term of this Agreement by employees of both Parties according to the U.S. laws pertaining to joint inventorship. For the purposes of this Agreement, “patents and patent applications” shall be deemed to include certificates of invention and applications for certificates of invention, as well as divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

Licensed Compound shall mean (a) ITMN-191 and (b) Collaboration Compounds properly included by Licensee as Licensed Compounds; provided however, Licensee may substitute a Lead Compound for an existing Licensed Compound as set forth in this Agreement; provided further there shall not be more than two (2) Licensed Compounds at any time during the Term unless Licensee shall have exercised its option to expand the number of Licensed Compounds pursuant to this agreement.

Product(s) shall mean any pharmaceutical preparation containing a Licensed Compound for any and all uses in humans, including any Combination Product.

Field of Use

Field shall mean the treatment and/or prevention of acute or chronic HCV infection in humans by administering a compound whose mechanism of clinical activity results solely from  binding to and inhibiting the serine protease active site of HCV NS3/4A.

Hepatitis C virus (HCV) is a viral infection that causes liver inflammation, sometimes leading to serious liver damage.

License Grant

Canadian Licensor hereby grants to Israeli Licensee an exclusive license to exploit the Licensor solely as necessary to develop, manufacture, market, use, sell, offer for sale, import, export, commercialize and distribute the Licensed Products (the License).

License Property

Licensed Product relates to an orally dissolved film containing CBD, as an active material, for medical treatment.

Licensed Product shall mean Licensor’s patch described below hereto in combination with Cannabidiol (CBD) for medical or recreational cannabis, where latter permitted for the transmucosal delivery of medicinal or recreational cannabis, where latter permitted (other than in the field of oral care) or any other product exploiting the Licensee Cannabis IP for the transmucosal delivery of medicinal or recreational cannabis, where latter permitted.

Description of Patch – A “Eluting Transmucosal Patch Platform (ETP)” for non-invasive drug delivery.

Licensor Patents shall mean those patents and patent applications listed below, as well as patents issuing therefrom, and any substitutions, divisions, continuations, continuations-in-part (but only to the extent that they cover the same invention claimed in the foregoing), reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and any provisional applications, of any such patents or patent applications.

Patent(s)/Patent Application(s)
1. WO 2012/104834 A1
New oral dissolving films for insulin administration, for treating diabetes.
filed on December 2011. National Phase at Israel and the USA.
2. WO 2010/135053 A2
Dual and single layer dosage forms.
Issued USA patent on April 28, 2015.
3. PCT/IL 2017/050845
Adhesive Oral dissolved Films in Managing Oral Care.
PCT on 31 July 2017.

Field of Use

This agreement pertains to the drug industry relating to Cannabis.

License Grant

The University Foundation grants to Licensee the exclusive right and license to make, have made, use, import, offer for sale, and sell in the Territory, Licensed Products during the term of this Agreement including Licensee’s right to grant sublicenses.

The license granted is subject to a reserved, non-exclusive license of Foundation, transferable to University and its not-for-profit academic collaborators, to practice the Licensed Patents in the Field, only for the purpose of non-commercial scientific inquiry, academic research, and education.

License Property

Licensed Product means any compound, product, service, or process in the Field, the manufacture, use, or sale of which, but for the license granted herein, would infringe at least one Valid Claim.

Licensed Patents means (i) the patent applications listed, (ii) the United States patents that may issue from the patent applications listed and from divisionals and continuations and continuations-in-part of such United States patents and patent applications, (iii) all foreign counterparts of such patent applications, and all patents that issue thereon anywhere in the world, including reexamined and reissued patents. Licensed Patents shall also mean any patent application having claims in the Field directed to an invention made in the laboratory of Dr. Vasu Nair six months or less prior to the Effective date, and (iv) with respect to the matters described in clauses (i), (ii) and (iii) above, all provisionals, renewals, re-examinations, patents of addition, supplementary protection certificates, extensions, restorations of patent terms, letters of patent, registration or confirmation patents and reissues of such patents or patent applications.

7,250,421 – Diketo acids with nucleobase scaffolds anti-HIV replication inhibitors targeted at HIV integrase

Indication shall mean the prevention, treatment or diagnosis of a condition, infection or disease caused by or associated with a specific virus in the Field. For example HIV Indication means the prevention, treatment or diagnosis of a condition, infection or disease caused by or associated with Human Immunodeficiency Virus (HIV) and HCV Indication means prevention, treatment or diagnosis of a condition, infection or a disease caused by or associated with Hepatitis C Virus (HCV).

Field of Use

Field means any and all anti-viral uses, including but not limited to prophylaxis, diagnosis or treatment of a condition, infection or disease associated with a virus, except the Field specifically excludes any anti-viral use associated with (a) the following DNA virus families  poxviridae, polyomaviridae, papillomaviridae, adenoviridae, and parvoviridae; and (b) all RNA viruses except for the following RNA virus families, which are specifically included in the Field  retroviridiae (for example HIV as defined below), flaviviridae (for example HCV as defined below), orthomyxoviridae, paramyxoviridae, and coronaviridae. In the event that Licensee terminates the Sponsored Research Agreement (“SRA”), a copy of which is attached as Appendix J, pursuant to paragraph 16(d) of the SRA, the Field of this License Agreement shall automatically be amended to exclude HCV.

License Grant

Licensor granted a worldwide exclusive, sublicensable license to certain Licensor owned provisional patent applications and any patents issuing therefrom, including all continuations, continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations, and any applications and all patents issuing from any applications and patents that claim domestic benefit or foreign priority to the provisional patent applications.

The Agreement also grants a contingent right to License certain other University licensed Patent Rights, to negotiate with Licensor, to obtain a nonexclusive sublicense in the field of cancer and treating cancer, including neuroinflammatory diseases occurring in any patient diagnosed with cancer.

License Property

The licensed patents relate to the use of psilocybin in cancer treatment, and any patents issuing therefrom, including all continuations, continuations-in-part, divisions, extensions, substitutions, reissues, re-examinations, and any applications and all patents issuing from any applications and patents that claim domestic benefit or foreign priority to the provisional patent applications.

Psilocybin is a naturally occurring psychedelic prodrug compound.

U.S. Provisional Patent Application No. 63/060,573, titled “Central Nervous System Delivery of Psilocybin”

U.S. Provisional Patent Application No. 63/060,569, titled “Central Nervous System Delivery of Nonsteroidal Anti-Inflammatory Drugs and Psilocybin”

U.S. Provisional Patent Application No. 63/060,577, titled “Central Nervous System Delivery of Nonsteroidal Anti-Inflammatory Drugs and Psilocybin”

U.S. Provisional Patent Application No. 63/24,827, titled “Use of Psilocybin in Cancer Treatment”

Field of Use

“Field of Use” means treatment of cancer and symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures, confusion, dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type. For the sake of clarity, the Field of Use does not include any potential applications of the Licensed Products and Licensed Processes other than those used in treating cancers and the symptoms caused by the cancers.