Royalty Report: Drugs, Delivery, Respiratory – Collection: 291110

License Grant

Canadian Licensor hereby grants to Licensee an exclusive license for the Field in the Territory under the Licensed Patents; and an exclusive license for the Field in the Territory under the Know-How; for the sole purpose of developing, making, having made, importing, using, offering for sale and selling Licensed Product in the Territory, including the right to grant sublicenses under these rights as set out in this Agreement.

License Property

Licensed Product means Ciprofloxacin encapsulated in the Licensor Liposome Technology and which is intended for pulmonary delivery.

Ciprofloxacin means the chemical compound known as ciprofloxacin, whose more specified chemical name is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid and all pharmaceutically active salts thereof.

AERx Device means the durable hand-held device developed by Licensee for the delivery of Ciprofloxacin by inhalation and known as the AERx Device, as such device may be modified pursuant to the Agreement.

Loading Patents means the patents owned by University and exclusively licensed to Licensor and set out in Agreement.
5,800,833 – Method for loading lipid vesicles
5,785,987 – Method for loading lipid vesicles

Sphingosome Patents means the Patents owned by Licensor and set out in this Agreement.
5,543,152 – Sphingosomes for enhanced drug delivery

Licensed Patents means the Loading Patents and the Sphingosome Patents.

Patent means (a) all patent applications filed or having legal force in any country owned or controlled by Licensor as of the Effective Date; (b) all patents that have issued or in the future issue therefrom owned or controlled by Licensor as of the Effective Date, including without limitation utility, model and design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions (including supplemental protection certificates), additions, registrations or confirmations to or of any such patent applications and patents.

Licensor Liposome Technology means Licensor’s proprietary liposomal drug delivery system that encapsulates drugs in sphingomyelin/cholesterol liposomes using a proton gradient generated by either an ionophore or methylammonium sulfate.

Field of Use

This agreement pertains to patented liposomal formulation technology for the pulmonary delivery of ciprofloxacin

Ciprofloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. It is used to treat different types of bacterial infections, including skin infections, bone and joint infections, respiratory or sinus infections, urinary tract infections, and certain types of diarrhea.

License Grant

Australia Licensor hereby grants Licensee an exclusive license to the Licensor Intellectual Property and the Third Party Patents in relation to the Field in the Territory, with the right to grant sublicense, to develop, use, make (subject to the terms and conditions of this Agreement and any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates), sell, offer for sale, export and import the Products. In no event shall Licensee use the Licensor Intellectual Property or the Third Party Patents for purposes not related to Licensee obligations to Licensor under this Agreement or any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates.

License Property

Licensor Intellectual Property shall mean the Licensor Know-How, the Licensor Patents and the Licensor Developed Technology. Licensor Intellectual Property excludes (a) technologies solely relating to the Compound, Formulation, or the Product; and (b) products, processes, methods, technologies and other inventions in the public domain or that are owned or made by Third Parties (other than on behalf of Licensor or its Affiliates) and not Controlled by Licensor or its Affiliates.

Licensor Developed Technology shall mean improvements to the Licesor Know-How and Licensor Patents conceived, created, developed or otherwise invented or acquired solely by an employee or agent of Licensor or one of its Affiliates or a Third Party (under contract with Licensor or one of its Affiliates) as a direct result of fulfilling obligations or exercising rights, including the sharing of Confidential Information, under this Agreement or any other agreement between the Parties.

Licensor Patents shall mean any and all rights under the Patent Applications and/or Patents as set forth as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof. In the event any additional Licensor Patent or Patent Application is necessary or useful to allow Licensee to practice the rights granted to it by Licensor herein, Licensor shall include such Patent or Patent Application as applicable.
US application 10/497715 – Method of Particle Formation
US application 10/017135 – Synthesis of small particles.

Compound shall mean (i) any beta-agonist in combination with any steroid; (ii) any steroid; and (iii) insulin, as well as any salts, isomorphs, polymorphs, cogeners or isomers of the preceding. Initial specifications for each Compound will be agreed to by the parties and after such agreement shall be considered an original part of this Agreement.

Product shall mean the Formulation comprising the Product Intermediate and, to the extent required to effect delivery to a patient, a delivery device for use in the Field.

Formulation shall mean a composition of Product Intermediate suitable for administration by inhalation via pulmonary or nasal delivery, as applicable. A Formulation may comprise a mixture, blend or solution of the Product Intermediate combined with excipients and/or adjuvants or neat Product Intermediate and a single Product Intermediate may be covered by more than one Formulation. Specifications for each Formulation will be developed by MAP and after such development shall be considered an original part of this Agreement.

Beta-agonist shall mean any short-acting beta-agonist or any long-acting beta agonist as those terms may be further defined from time to time in a generally accepted pharmacology textbook.

Field of Use

Field shall mean the administration of a Product by inhalation as follows (i) for a Product containing any Beta-agonists and any steroid, the Field shall be limited to administration via pulmonary delivery; (ii) for a Product containing a steroid as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery; and (iii) for any Product containing Insulin as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery. The parties may add additional fields to the definition of Field as the parties may mutually agree from time to time, under the terms of this Agreement.

Licensee is engaged in the research and development of proprietary drug delivery systems for inhalation therapy by pulmonary or nasal delivery, including devices and formulations suitable for those devices.

License Grant

The Canadian Licensor hereby grants to Licensee and Licensee hereby accepts an exclusive sublicense under the Technology to make, have made, use, sell, offer for sale, sublicense, distribute, import, and have imported Product in the Licensee Field in the Territory.

License Property

US Patent Number 5,837,282 – Ionophore-Mediated Liposome Loading

Product means any one or more of Sphingosomal Vinorelbine and Sphingosomal Topotecan.

Sphingosomal Vinorelbine means a liposome that includes sphingomyelin and cholesterol and contains encapsulated vinorelbine, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Sphingosomal Topotecan means a liposome that includes sphingomyelin and cholesterol and contains encapsulated topotecan, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Field of Use

Marqibo (sphingosomal vincristine), INX-0125 (sphingosomal vinorelbine) and INX-0076 (sphingosomal topotecan) are proprietary drugs using INEX's proprietary sphingosomal drug delivery technology. This technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness while reducing the side effects of the encapsulated drug.
Marqibo has completed phase 2 clinical trials and is ready to enter phase 3 clinical trials in first-line aggressive non-Hodgkin's lymphoma and acute lymphoblastic leukemia. An Investigational New Drug (IND) application has been approved for the commencement of phase 1 clinical trials for INX-0125 in both the US and Canada and preclinical development is being completed for INX-0076.

License Grant

Licensor grants an exclusive license for the Licensor Technology in the Territory to research, Develop, Commercialize, use, import, register, sell, have sold, and distribute Products in the Field within the Territory.

Licensor grants a non-exclusive license for the Licensor Technology in the Territory to make and have made Products in the Field in the Territory.

This agreement includes a non-exclusive grant back from Licensee to Licensor.

License Property

Licensor has certain proprietary rights related to a pulmonary drug delivery technology known as AERx® technology, as well as expertise and know-how relating to the use and manufacture of such technology.

The licensed Technology means, only if it relates to the AERx pulmonary drug delivery system and collectively, the Licensor Patents, Licensor Know-How, Licensor New Intellectual Property, all Information relating to the Licensor Patents, Know-How, and New Intellectual Property in the course of any work conducted pursuant to this Agreement, and Licensor Improvements.

The patents include, but are not limited to, Disposable package for intrapulmonary delivery of aerosolized formulations; Methos of fabricating porous membrane with unique pore structure for aerosolized delivery of drugs;  Aerosol-forming porous membrane with certain pore structure;  Device and method of creating aerosolized mist of respiratory drug; Lockout device for controlled release of drug from patient-activated dispenser; and, Method of administration of insulin.

Field of Use

Field means pulmonary delivery of prostacyclin drugs for the treatment of pulmonary arterial hypertension and any and all other therapeutic indications and uses other than control of glucose levels in humans.

License Grant

Licensor grants to the Licensee of Denmark and its Affiliates a worldwide, exclusive license, with the right to sublicense, to the Licensed Patents and Licensed Know-How, to research, develop, make, have made, use, import, export, sell, offer for sale, and otherwise transfer the Licensed Product in the Territory.

Licensee desires to obtain, and Licensor is willing to grant, an exclusive, worldwide license to the proprietary DepoFoam® delivery system in order to develop and commercialize  formulations of Liraglutide.

License Property

Licensor is a biopharmaceutical company specializing in the discovery, development and commercialization of DepoFoam® a proprietary injectable sustained-release delivery system (multivesicular liposomes).

Formulation Intellectual Property means all Know-How arising from activities performed under this Agreement regarding formulations of Liraglutide with DepoFoam and/or methods or processes for making or using such formulations.

Liraglutide means Licensees proprietary, human Glucagon-Like Peptide-1 (GLP-1} analogue.
Liraglutide is a medication used to treat diabetes mellitus type 2 and obesity.

Field of Use

DepoFoam is a drug delivery technology which consists of multi-vesicular liposome particles that contain internal chambers for encapsulated drugs. DepoFoam is capable of sustained release of a drug over a period of between one and 30 days. It works with narrow gauge needles and pen systems and offers flexible delivery that can be designed to for an immediate release dose followed by sustained delivery.

License Grant

With this agreement, the Parties are effecting the termination of the license by the Canadian Licensor to the Licensee of certain MD Anderson Patents, and the termination of all rights, responsibilities and obligations of Licensee associated therewith; and, affirming the continuation of the license by the Canadian Licensor to Licensee of the Licensed Patents for use in the Licensee Field, and affirming the continuation of all rights, responsibilities and obligations of Licensee associated therewith; and, effecting the license by Licensee to Licensor of the certain MD Anderson Patents for use outside the Licensee Field; all as contemplated the Transaction Agreement.

With this agreement, the Parties hereby agree
—  to terminate the exclusive license by Licensor to Licensee under the MD Anderson Patents,
—  to affirm Licensors grant to Licensee of an exclusive license under the Licensed Patents to make, have made, use, sell, offer for sale, import, and have imported Products in the Licensee Field within the Territory; and, an exclusive license to the Technology to make, have made, use, sell, offer for sale, import, and have imported Products in the Licensee Field within the Territory; and
—  to the irrevocable and absolute grant, sale,. assignment and conveyance by Licensor to Licensee, Licensors entire right, title end interest in and to the Thomas Patents set forth in the MD Anderson License; and, Licensors entire right, title and interest in and to Licensors joint ownership of the Sarris Patents subject to the terms and conditions set forth in the MD Anderson License.

License Property

Product means any one or more of Sphingosomal Vincristine, Sphingosomal Vinorelbine, and Sphingosomal Topotecan.

British Columbia Cancer Agency (BCCA) Patents means the egg sphingomyelin patents assigned by the BCCA to Licensor.

Marqibo is Licensee’s trade name for Sphingosomal Vincristine.

Sphingosomal Topotecan means a liposome that includes sphingomyelin and cholesterol and contains encapsulated topotecan, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Sphingosomal Vincristine means a liposome that includes sphingomyelin and cholesterol and contains encapsulated vincristine, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Sphingosomal Vinorelbine means a liposome that includes sphingomyelin and cholesterol and contains encapsulated vinorelbine, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Field of Use

The Licensee Field means all uses of the Products.  The original transaction agreement included, but was not necessarily limited to, the pulmonary delivery of Ciprofloxacin.  Marqibo is used in adult patients with relapsed ALL, and  in patients with metastatic malignant uveal melanoma.