Royalty Report: Delivery, Device, Medical – Collection: 248285

License Grant

The Norwegian Licensor hereby grants Licensee an exclusive (even as to Licensor) license to and under the Licensor Know-How, the Licensor Patents, the Licensor Trademarks and the Licensor Additional Intellectual Property (i) to use, sell, offer for sale, have sold and import the Product in the Licensed Territory; and (ii) to make or have made the Product anywhere in the world solely for such permitted use, sale, offer for sale and importation in the Licensed Territory.

License Property

Device means a nasal device used for the delivery of pharmaceutical products in a powder or liquid formulation and that is covered by an Licensor Patent listed below.

6,715,485 – Nasal delivery device
8,327,844 – Nasal delivery method
7,740,014 – Nasal devices

Product(s) means any products or product candidates developed by or under the authority of a Party or any of its Affiliates as of the Effective Date or during the Term consisting of a formulation that contains [as its sole active ingredient] a compound within the class of compounds [known as triptans], including any salt, polymorphic or amorphous form of such a compound, that is delivered in a nasal delivery device; [provided that, the foregoing definition of Product may be amended and expanded by the mutual agreement of the Parties, in each Partys sole discretion, to include a formulation of triptan with one or more other active ingredients]. For purposes of the foregoing, the class of compounds known as [triptans] includes the compounds known as of the Effective Date as the following Sumatriptan[, rizatriptan, naratriptan, zolmitriptan, almotriptan, frovatriptan, avitriptan and eletriptan]. Solely for the purposes of a Product shall also include products or product candidates consisting of [ a formulation that contains a compound within the class of compounds known as triptans (including any salt, polymorphic or amorphous form of such a compound) together with one or more other active ingredients, that is delivered in a nasal delivery device].  

Licensor Trademarks means, any, whether domestic or foreign, trademarks, service marks, and trade names Controlled by Licensor or any of its Affiliates as of the Effective Date or during the Term that are used (or required to be used) in connection with the Device or a Product in the Licensed Territory, including those trademarks, service marks and trade names listed (the 'Existing Licensor Trademarks').  
Service marks and trade names
Optimist, Optimose, Breath Powered, Bi-Directional

Field of Use

The rights granted apply to the healthcare industry relating to pharmaceutical products.

License Grant

Japanese Licensor hereby grants to Licensee an exclusive, royalty-bearing license (with the right to sublicense in accordance with this agreement, under the Licensed Technology to (i) develop, use, sell, offer for sale, import or otherwise commercialize the Product, and (ii), make or have made the Product (using the Device supplied by Licensor or a Third Party permitted under this Agreement); in each case of (i) and (ii) solely for the Field within the Territory.

Licensee has the right to grant sublicenses under the license granted to any Affiliate or Third Party, other than a Licensor Competitor, to commercialize the Product in EU, Japan, Australia, New Zealand, Canada, the United States and/or the Territory in its entirety without Licensor’s prior written approval.

License Property

Licensed Patents
8,337,817 – Preparation for transnasal application

Product means the product consisting of (i) a pharmaceutical product containing the Compound, as the only active pharmaceutical ingredient, formulated using the Formulation Technology and (ii) the Device that contains such pharmaceutical product.

Device means the single-use version of Licensor’s proprietary nasal delivery device (Fit-lizer™).

Compound means the compound known as Dihydroergotamine or DHE, and any complex, chelate, salt, hydrate, polymorph, isomer, diastereomer, prodrug, congener, metabolite or ion pair thereof.

Formulation Technology means Licensor’s proprietary nasal drug delivery formulation technology as further described below, including its powdery drug carrier (µco™ System carrier).
– Licensors proprietary inhalable dry powder pharmaceutical formulations designed to enhance drug absorption, comprising of one or more physiologically active substance and muco-adhesive powder drug carrier (µcoâ„¢ Carrier) including Microcrystalline cellulose Ceolus® PH-F20JP (Manufacturer Asahi Kasei Corporation), microcrystalline cellulose Ceolus® PH-301; (Manufacturer Asahi Kasei Corporation) and tribasic calcium phosphate.

Field of Use

The licensing agreement is for a novel, rapidly absorbed treatment for acute migraine incorporating dihydroergotamine (DHE) as the active drug.

TO-2070 is expected to offer a new and potentially improved approach to the treatment of acute migraine.  Preclinical data suggest that TO-2070 may offer significant migraine treatment benefits beyond those provided by less convenient and more invasive DHE drug delivery methods, such as injection, liquid nasal sprays or pulmonary inhalation.  TO-2070 is designed to provide these benefits at a relatively low cost via a unique and proprietary nasal powder drug delivery system that can be easily self-administered by patients.

TO-2070 is based on a novel nasal powder drug delivery technology created by SNBL that combines a muco-adhesive drug carrier with a proprietary nasal powder drug delivery device.  This system is the product of a decade-long SNBL internal development program with the objective of unlocking the significant market potential for nasal drug delivery by overcoming many of the obstacles that have limited its application to date.  Unlike previous nasal drug delivery technologies, the SNBL system is able to consistently deliver drug into the nasal cavity with each administration and hold it in place on the nasal mucosa to enable enhanced absorption into the bloodstream. Delivery of the dry powder drug formulation to the nasal mucosa via the specially designed device nozzle is achieved by simply squeezing the device.

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

Licensor hereby grants to Israelis Licensee a non-exclusive, non-sublicensable license, under CareFusion’s interest in the CareFusion Patents, to develop, make, have made, use, have used, sell, offer for sale, have sold, and import Licensed Products throughout the world solely within the Field (the “License”).

License Property

The intellectual property licensed covers devices and methods for delivering nitric oxide (NO) formulations to a patient at steady and alternating concentrations, including intermittent delivery of NO. The license also covers patents relating to devices and methods for delivering alternating concentrations of NO topically, nasally and to an upper respiratory tract.

“NO Gas” means nitric oxide gas.
“NO Gas Container” means a storage vessel for NO Gas.
“NO Gas Delivery Device(s)” means devices used for the delivery of NO Gas that contain Intellectual Property Licensed by CareFusion to Licensee.

Nitric Oxide (NO) possesses broad-spectrum anti-microbial activity acting against bacteria, fungi and viruses. NO is produced at high output as part of the innate immune response. NO and its by-products (for example, Reactive Nitrogen Species, RNS) are responsible for the process of killing microorganisms within white blood cells called macrophages and in organs such as the lungs and other mucolytic tissues.

Field of Use

“Field” means the application of NO Gas for the treatment of diseases or conditions in humans (expressly excluding veterinary applications).

License Grant

The Irish Licensor hereby grants to Licensee for the Term, and Licensor hereby accepts,

(i)  an exclusive license of the Licensor Intellectual Property and the Joint Intellectual Property in connection with the applications or deliveries of compounds listed, except with respect to any Retained Licensor Intellectual Property, as to which Licensee is being granted a non-exclusive license
(ii) a non-exclusive license of the Licensor Intellectual Property and the Joint Intellectual Property in connection with the applications or deliveries of compounds listed on Appendix E, and
(iii) subject to existing contractual rights of third parties, an exclusive license of the Licensor Intellectual Property and the Joint Intellectual Property for use with any other compounds not listed on Appendices D or E and which are not Licensor Compounds.  

In each case for use only as Auto-Injector Technology and in the Field for the Territory to develop, make, have made, manufacture, have manufactured, package, use, import, export, promote, distribute, market, offer for sale, and sell the Devices and Products in the Field for the Territory.

License Property

Device shall mean any device or any parts or components thereof, the manufacture, use, importation or sale of which is covered by or embodies the Auto-Injector Technology, the Licensor Intellectual Property, the Joint Intellectual Property and the Licensee Intellectual Property.

Auto-Injector Technology shall mean any technology incorporated or used in a device (i) constituting a disposable, single use, needle injection system wherein the active ingredient is housed in a vial which is situated in a manner substantially perpendicular to the body surface, (ii) utilizing gas generation achieved via a chemical reaction for delivery of the active ingredient and (iii) having infusion time for delivery of an active ingredient which is less than or equal to 10 seconds. For the  avoidance of doubt, Auto-Injector Technology shall not include any other technology that does not meet the foregoing definition, whether or not similar or containing elements of the Licensor Intellectual Property, including, without limitation, the Medipad(TM) Technology or any other Excluded Technology.

Field of Use

Field shall mean the practice of delivering therapeutic entities utilizing Auto Injector Technology, other than (A) active ingredients used in the treatment of  (i) central nervous system disorders, (ii) pain, (iii) male erectile dysfunction, and (iv) gene therapy and gene delivery and (B) Licensor Compounds, provided, in the case of Licensor Compounds that Licensee has not previously sub- licensed the right to use the Auto-Injector Technology with respect to such compound to an unaffiliated third party on an exclusive basis pursuant to a written agreement and that Licensee has delivered to Licensor prior written notice of same.