Royalty Report: Drugs, Delivery, Pain – Collection: 294017

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 9

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 9

Primary Industries

  • Drugs
  • Delivery
  • Pain
  • Disease
  • Therapeutic
  • Respiratory

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 294017

License Grant
The English Licensor hereby grants, on behalf of itself and its Affiliates, to the English Licensee, effective on the Effective Date, a royalty-bearing, exclusive (even as to Licensor (except to the extent necessary for Licensor to perform the Licensor Development Activities)) worldwide license, with the right to sublicense, under the Licensor Technology to Manufacture, Develop and Commercialize the Products in the Field in the Territory.

Licensee hereby grants, on behalf of itself and its Affiliates, to Licensor, effective on the Effective Date, a royalty-free, non-exclusive license, with the right to sublicense, (i) under the Licensee Technology to the extent necessary for Licensor to perform the Licensor Development Activities and (ii) under any Licensee Improvement Manufacturing Patent Rights for use other than for the Manufacture, Development and/or Commercialization of the Products in the Field in the Territory.

License Property
Xodol means the product currently marketed under the brand name 'Xodol', which is a combination of 5, 7.5 or 10 milligrams (mg) ofhydrocodone, in each case, combined with 300 mg of acetaminophen (it being understood that (x) Licensors existing sublicensee currently markets such product under a different name and (y) such product, whether marketed under such different name or any other name in the future, shall be deemed to be 'Xodol' for the purposes of this Agreement).

Product means any Hydrocodone Product or Combination Product.

Hydrocodone Product means any pharmaceutical product containing Hydrocodone as its sole Active Ingredient that is in a formulation containing the Licensee Technology and which is Developed, Manufactured and Commercialized pursuant to, and in accordance with, this Agreement.

Combination Product means any pharmaceutical product comprised of Hydrocodone and any non-opioid agonist drug as the Active Ingredients.  For purposes of clarity, S-297995 (also known as Naldemedine) is a non-opioid agonist drug.

S-297995 means (5R, 14S)-17-(Cyclopropylmethyl)-6, 7-didehydro-4,5-epoxy-3 ,6, 14-trihydroxy-N-[1-methyl-l-(3-phenyl-1,2,4-oxadiazol-5-yl)ethyl]morphinan-7-carboxamide Monotosylate including any metabolites, prodrugs, solvates (including hydrates), esters, salts, stereoisomers, racemates, tautomers and polymorphs (including crystal forms), of such compound.

Licensor Technology means the (a) Licensor Know-How and the Licensor Patent Rights, including Licensor Core Technology (b) the Licensor Core Technology Improvements, and (c) all intellectual property rights therein.

Licensor Patent Rights means any Patent Right that Licensor or its Affiliates Controls on the Effective Date or that comes into the Control of Licensor or its Affiliates during the Term (other than any Patent Rights which are Licensee Patent Rights), to the extent that such Patent Right is necessary or useful to Develop, Manufacture, or Commercialize in the Territory, the Products in the Field, including any method of making the Products, any composition or formulations of the Products, or any method of using or administering the Products provided that Licensee Patent Rights excludes any Patent Rights to the extent relating to an Licensee API.  The Licensor Patent Rights existing on the Effective Date are set forth.
8,298,581 – Matrix compositions for controlled delivery of drug substances
8,563,038 – Formulations and methods for the controlled release of active drug substances

Licensor Core Technology means, to the extent covered by any Licensor Patent Rights or Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date,  (i) any abuse-deterrent drug delivery system, (ii) the formulation of products for which any such abuse-deterrent drug delivery system is used and/or (iii) manufacturing of products containing any such abuse-deterrent drug delivery system.  

Licensor Core Technology includes the Licensor Patent Rights and Licensor Know-How, in each case, Controlled by Licensor and its Affiliates as of the Effective Date to the extent covered by clause (i), (ii) and/or (iii) above.  Notwithstanding anything herein to the contrary, in the event there is a dispute as to whether anything in clause (i), (ii) and/or (iii) above was covered by any such Licensor Know-How as of the Effective Date, Licensor shall have the burden of proof with respect to establishing that it was so covered.

Generic Product means, on a country-by-country basis, any pharmaceutical product that (a) is sold by a Third Party that is not an Affiliate or Sublicensee of Licensee under a marketing authorization granted by a Regulatory Authority to a Third Party and (b) results from (i) an abbreviated new drug application including any amended or successor abbreviated route of approval thereof in the United States (ANDA) or (ii) abbreviated routes of approval in any other countries in the Territory that are comparable to ANDA, which in the case of clause (i) and/or (ii), references the applicable Product, provided that (x) such pharmaceutical product has the same Active Ingredient as the Product and an abuse deterrent system or (y) the Product is the primary basis for the approval of such pharmaceutical product.

Patent Right means any and all (a) patent applications filed in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon; (b) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof; and (c) any other form of government-issued right substantially similar to any of the foregoing, including certificates of invention and applications for certificates of invention.

Field of Use
The collaboration is for the development and commercialization of abuse-deterrent hydrocodone-based product candidates.  Abuse-deterrent is for the treatment of pain and in other indications.

IPSCIO Record ID: 266811

License Grant
Licensor grants a license, under the Adderall XR Intellectual Property and under any and all statutory and regulatory exclusivities issued by any Governmental Authority to import, Manufacture, have Manufactured and Market Licensee Product in the Territory on and after the License Effective Date. Notwithstanding the foregoing, Licensee shall have the limited right to Manufacture and/or import reasonable quantities of Licensee Product prior to the License Effective Date for the sole purpose of launching and selling such Product in the Territory under the foregoing license on and after the License Effective Date.

In the event a Third Party, without any cooperation or assistance from Licensee, markets a Generic Equivalent in the Territory prior to the License Effective Date, and Licensor elects, in its sole discretion, to market or have marketed a Generic Product to compete with such Third Party prior to the License Effective Date, then Licensor shall appoint Licensee as the exclusive, even as to Licensor, but except as to the Third Party Licensee.

License Property
Licensor is the owner of a New Drug Application, No. 21-303, which was approved by the Food and Drug Administration for the manufacture and sale of a pharmaceutical composition containing mixed amphetamine salts for the treatment of Attention Deficit Hyperactivity Disorder, all strengths of which Licensor sells under the trade name Adderall XR.

Adderall XR Intellectual Property shall mean U.S. Patent Nos. 6,322,819, 6,605,300, and 6,913,768 and any patent that issues as a result of a reexamination or reissue thereof; any patent that issues from, or any continuation, continuation-in-part or divisional application relating to, U.S. Patent Application Serial Nos. 09/176,542, 10/353,073, 10/758,417, 10/774,697, and 11/030,174; and any other present or future U S. patent owned or controlled by Licensor and its Affiliates which may be infringed by the making, using, selling or importing of the Generic Product.

Compound shall mean mixed amphetamine salts, as further defined in the NDA.

Field of Use
The field of  use is as a pulsed dose delivery system for amphetamine salts and mixtures.

Licensor has settled all pending litigation with Licensee in connection with Barr's Abbreviated New Drug Application ('ANDA') and its attempt to market generic versions of Licensor's ADDERALL XR (extended-release mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder ('ADHD').

IPSCIO Record ID: 319167

License Grant
By this amended and restated agreement, the Parties are modifying their current relationship as of the Effective Date and have agreed to amend and restate the Original License and Distribution Agreement as set forth herein.

Licensor grants a limited license, under the Adderall XR Intellectual Property and under any and all statutory and regulatory exclusivities to Manufacture, have Manufactured and Market Impax Product in the Territory on and after the License Effective Date.

Licensor authorizes Licensee to Market Licensees AG Product in the Territory from and after the License Effective Date. In connection with and solely for purposes of such authorization,  Licensor grants a limited license under the Adderall XR Intellectual Property and under any and all statutory and regulatory exclusivities to Market such Licensee AG Product in the Territory from and after the License Effective Date.

The Authorization and License shall be on an Exclusive basis.

License Property
Adderall XR shall mean the pharmaceutical product that contains the Compound as its sole active ingredient which is approved for Marketing in the Territory pursuant to Shires NDA and sold under the trade name Adderall XR.

Adderall XR Intellectual Property shall mean
(i) U. S. Patent Nos. 6,322,819, 6,605,300, and 6,913,768 and any patent that issues as a result of a reexamination or reissue thereof;
(ii) any patent that issues from, or from any continuation, continuation-in-part or divisional application relating to, U.S. Patent Application Serial Nos. 09/176,542, 10/353,073, 10/758,417, 10/774,697, and 11/030,174; and
(iii) any other present or future U.S. patent owned or controlled by Licensor which may read upon the making, using, selling or importing of a Generic Product.

AG Product shall mean generically Labeled Adderall XR, commonly called an authorized generic product, approved for sale by the FDA pursuant to a labeling supplement to Licensors NDA.

Compound shall mean mixed amphetamine salts.

Adderall XR is combination medication used to treat attention deficit hyperactivity disorder – ADHD. It works by changing the amounts of certain natural substances in the brain. Amphetamine/dextroamphetamine belongs to a class of drugs known as stimulants.

Field of Use
Amphetamine/dextroamphetamine belongs to a class of drugs known as stimulants. It can help increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help you to organize your tasks and improve listening skills.

IPSCIO Record ID: 279333

License Grant
Licensor hereby grants to Licensee for the Term of this Agreement an exclusive (even as to Licensor) license in the Field under the Licensor Intellectual Property to develop, make, have made, use, sell, offer for sale and import Licensed Product(s) in the Territory.
License Property
Licensed Product(s) means all finished pharmaceutical oral formulations for commercial sale (or, where the context so indicates, a Formulation Candidate) that (i) contain the Compound alone as a therapeutically active ingredient or in combination with any other pharmaceutically active ingredient, and (ii) utilize Licensor Intellectual Property.

Intellectual Property means the Licensed Patents, the Licensor Know-How and the Licensor Technology.

Licensed Patents means Patents owned or controlled by Licensor or which Licensor, through license or otherwise, has or acquires rights, which are necessary or useful for the manufacture, use or sale of Licensed Product, including, but not limited to, compositions, formulations, methods of their manufacture, or methods of their use, or otherwise relate to Licensor Know-How or Licensor Technology, including (i) any of the Patents set forth hereto that contain claims that cover, or which relate to, any aspect of Licensed Product, (ii) the Development Patents and (iii) such other Patents as the Parties may agree in writing from time to time.

5,447,729 – Multilamellar drug delivery systems
5,484,608 – Sustained-release drug delivery system

Licensor Technology means  Licensor’s bioavailability enhancement and/ or controlled-release delivery, formulation, process and manufacturing technologies, including but not limited to the Licensor Lead Technology and the technologies embodied in the Licensed Patents and the Licensor Know-How.

Licensor Lead Technology means Microtrol® multi particulate technology or, as subsequently agreed between the Parties, one of the Other Licensor Technologies as may be applied to the Compound pursuant to the Development Plan.

Compound means trospium chloride, the chemical compound whose specific chemical name is 3-alpha benziloyJoxynortropane-8-spiro-1-pyrrolidinium; chloride, or any other trospium salt.

Field of Use
Trospium chloride (“trospium”) is  indicated for urinary incontinence. Trospium is currently under evaluation in a Phase III clinical study.

IPSCIO Record ID: 369241

License Grant
Licensor grants to the Licensee of Ireland
– the exclusive right and license to make, have made, use, offer for sale, sell and import the Product in the Territory, including the right to record sales for its own account;
– in each case, solely for use in the Field and Territory and in connection with Licensees development and Commercialization of the Product and to otherwise exercise Licensees rights and perform its obligations under this Agreement
Know-How;
— an exclusive license under the Product Patents Rights and Product
— an exclusive license under the SAIB Patent Rights;
— an exclusive license under the Re-appliable Patent Rights; and
— an exclusive sublicense under Licensors license to the Epicept Intellectual Property; and,
– an exclusive license and right of cross-reference to all Development Data Controlled by Licensor in existence as of the Effective Date solely to exercise its rights and licenses under this Agreement with respect to the Product.

Licensor grants an exclusive license to use the Licensor Trademark in the Territory solely in connection with the Commercialization of Product in the Territory.

License Property
Licensor is the owner of a proprietary product for pain treatment consisting of a bupivacaine transdermal patch as described below and certain patents and know-how relating thereto.

Product means the product under development by Licensor currently known as ELADURâ„¢.

Bupivacaine means 1-butyl-N-(2,6-dimethylphenyl) piperidine-2-carboxamide, including any and all pharmaceutically acceptable salts, solvates, prodrugs, esters, free base forms, enantiomers (and racemic or other mixtures of said enantiomers) thereof.

Topical Bupivacaine Product means any formulation containing Bupivacaine, either alone or in combination with one or more other active ingredients. for use in the Field.

Licensor Trademark means the trademark rights to the mark ELADURâ„¢ and similar rights under the laws of any Governmental Entity, including all goodwill associated therewith, and all applications, registrations, extensions and renewals relating thereto.

Patents rights include Transdermal Delivery System, and, Methods for Transdermal Drug Administration.

Field of Use
ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.

Bupivacaine is a prescription medication used as a local anesthetic (numbing medicine). Bupivacaine blocks the nerve impulses that send pain signals to your brain.  Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work.

The Field means all pharmaceutical applications, including the treatment of pain, for human health.

IPSCIO Record ID: 367299

License Grant
For the Backup License in this Commercial Supply Agreement, Licensor of Germany grants Licensee a world-wide right and license, with the right to grant and authorize sublicenses, under Licensors Technology, to use, make, have made, sell, offer for sale, import, promote, market, develop, obtain regulatory approval for and otherwise commercialize Patches and any derivatives or improvements thereof made by or for Licensee, its Affiliates or Sublicensees, and to practice any methods, processes or procedures described or claimed therein in connection with the foregoing; provided that Licensee, its Affiliates or Sub licensees shall not exercise any rights set forth.

The Parties have previously entered into a Memorandum of Understanding and a Clinical Supply, Development and License Agreement, pursuant to which the Parties cooperated on the development of a Patch as and Licensor supplied Patches to Licensee for clinical trial purposes.

Licensee is engaging the Licensor of Germany to exclusively manufacture and supply Licensees requirements for the Patch, and Licensor shall manufacture and supply Licensee with all of Licensees commercial requirement for up to the Maximum Capacity for each year.

To the extent Licensee authorizes a Sublicensee to purchase directly from Licensor, Licensor agrees to supply the commercial requirements for Patches of such Sublicensee subject to the Maximum Capacity.

License Property
Technology relates to formulate the active ingredient from a powder into a dermal patch.

For inventions relating to the patch which are Licensor Owned, all inventions developed by the Parties or by either Party under this Agreement or the Clinical Supply Agreement solely relating to Licensor’s existing TTS technology, including but not limited to design, formulation, manufacturing, testing and packaging of TTS, shall be the property of Licensor (Licensor IP). Licensor shall not use any Licensor IP for the development of transdermal therapeutic patches or TTS containing VR1-Ligand until May 29, 2006, other than for Licensee. Thereafter, until May 29, 2009, Licensee shall have a right of first refusal in case Licensor commences development of TTS which contain any VR1-Ligand using Licensor IP.

Active Ingredient means the active pharmaceutical ingredient capsaicin.

VRl-Ligand is any vanilloid or related molecule selected from the group consisting of capsaicin, trans-capsaicin, cis-capsaicin, dihydrocapsaicin, nordihydrocapsaicin, homocapsaicin, homodihydrocapsaicin, resiniferatoxin, piperine, zingerone, eugenol, guaiacol, anandamide, arvanil, N-(4-hydroxyphenyl)-arachidonylamide (AM404), terpenoid unsaturated dialdehydes such as warburganol, polygodial, isovelleral, cinnamodial, aframodial, scalaradial, ancistrodial, b-acardial, sesquiterpenes such as cinnamosmolide or cinnamolide, triprenyl phenols such as scutigeral, olvanil, nonivamide, vanillin, vanillyamide, 20-homovanillyl-mezerein or 20-homovanillyl-12-deoxyphorbol-13-phenylacetate.

Kit means the commercial product form sold by Licensee, its Affiliates or Sublicensees of which the Patch is a component.

Patch or Patches means the TTS containing the Active Ingredient developed by the Parties.

Field of Use
The Field of use is an area based content above 0.2 milligrams per square centimeter or that is covered by Licensors patent continuations, continuations-in-part, divisions and foreign counterparts thereof, & patents issuing thereon, including renewals, reissues and extensions, such TTS with capsaicin as.

Qutenzaâ„¢ (formerly NGX-4010) for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

IPSCIO Record ID: 240601

License Grant
The Licensor of Denmark and Licensee are engaged in the development, production, and commercialization of pharmaceutical products and possess information and technology relating to the manufacture, use, and formulation of such products.

The Licensor of Denmark grants to an exclusive, even as to Licensor; in the Field in the Exclusive Territory to use the Licensor Product Deliverables and investigational new drug, or IND, Deliverables to make, have made under contract, use, develop and have developed under contract pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances, in each case during the Option Period solely in connection with the Initial Development Program.

Licensor grants an exclusive option during the Option Period to license the Licensed Technology for the research, development and Commercialization of Licensee Products on the terms set forth in this Agreement.

Licensor grants an exclusive, even as to Licensor, with the right to grant sublicenses, under the Licensed Technology to develop, have developed under contract, use, offer to sell, sell, have sold, distribute and import pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances in the Exclusive Territory in the Field.

Licensor grants an exclusive, except as to Licensor or its licensees or sublicensees, license, with the right to grant sublicenses, under the Licensed Technology to develop, have developed under contract, use, offer to sell, sell, have sold, distribute and import pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances in the Limited Territory in the Field.

Licensor grants an exclusive, even as to Licensor, license, with the right to grant sublicenses, under the Licensed Technology to make and have made under contract pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances for the Field in the Exclusive Territory.

Licensor grants a non-exclusive, license under the Licensed Technology, with the right to grant sublicenses, to make and have made under contract pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance and pharmaceutical products containing Lornoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more other active drug substances for the Field outside the Exclusive Territory.

For the Isomer Option, Licensor grants a right of first refusal on an exclusive license, with the right to grant sublicenses, under any applicable Patent, Know-How or intellectual property other than Patents, Controlled by Licensor relating to any Isomer Product to develop, have developed under contract, make, have made under contract, use, offer to sell, sell, have sold, distribute and import such Isomer Product in the Field in the Exclusive Territory.

License Property
Single Entity Product means a pharmaceutical product containing Lornoxicam, or any salts, solvates or polymorphs thereof, as the single active drug substance, and developed or manufactured by or on behalf of Licensee or Sublicensees using or referencing the Licensed Technology or any part thereof, or the use, manufacture or sale of which would, but for the licenses granted herein, infringe any Licensed Patents or intellectual property right other than Patents included in the Licensed Technology.

Combination Product means a pharmaceutical product containing Lomoxicam, or any salts, solvates or polymorphs thereof, as an active drug substance in combination with one or more additional active drug substances, and developed or manufactured by or on behalf of Licensee or Sublicensees using or referencing the Licensed Technology or any part thereof, or the use, manufacture or sale of which would, but for the licenses granted herein, infringe any Licensed Patents or intellectual property right other than Patents included in the Licensed Technology.

Isomer Product means a pharmaceutical product containing an isomer of Lornoxicam as either the single active drug substance or as an active drug substance in combination with one or more other active drug substances, developed solely by Licensor, and for which Licensor files an IND or equivalent filing in the Exclusive Territory within five years of the Effective Date.

Lornoxicam means the active drug substance known as lornoxicam, having the chemical structure set forth in this Agreement.

Lornoxicam, also known as chlortenoxicam, is a nonsteroidal anti-inflammatory drug (NSAID) of the oxicam class with analgesic (pain relieving), anti-inflammatory and antipyretic (fever reducing) properties.

Field of Use
Lornoxicam is a potent analgesic pain reliever, which makes it an attractive candidate for combination therapy.

IPSCIO Record ID: 367578

License Grant
Israeli Licensor hereby grants to the Licensee an exclusive worldwide through multiple tier license, in the Territory, to 1) the Intellectual Property Rights resulting from and/or arising under the Development Plan and/or Development Results including Resulting Patents, and/or the Drug Formulation and/or Product ; and 2) to make, have made, use, have used and/or license the Drug Formulation and/or the Development Results, and 3) to make, have made, sell, have sold, use, have used, license, and/or import Product; and 4) an exclusive license in the Territory to any Patents covering the Drug Formulation and Product to enable the Licensee to make, have made, sell, have sold, and/or use Products. The Licensee shall not use the Drug Formulation and/or the Development Results for any purpose other than exercise of the License. Licensor hereby grants to the Licensee a non-exclusive license, in the Territory under the Licensor Patents, to use the Licensor Formulation Technology to 1) develop, make, have made, and use, the Drug Formulation, and 2) develop, make, have made, sell, have sold, and use, Product.
License Property
Licensor Patents shall mean the patents and/or patent applications covering or disclosing Licensor Formulation Technology; and including but not limited to,  U.S. Patent No. 5,540,934, U.S. Patent No. 5,716,638 and PCT International Application No. PCT/EP95/02397 and any continuations, continuations-in-part, extensions, divisions, substitutions or additions to such applications and all patents which are reissues thereof, re-validations and registrations based thereon, and any and all foreign patents and patent applications corresponding thereto.

5,540,934 – Compositions for applying active substances to or through the skin
5,716,638 – Composition for applying active substances to or through the skin

Product means a pharmaceutical preparation or composition containing the Drug Formulation which is covered by a Valid Patent Claim.

Drug means the Licensees organoselenium drug or materials, as specified in this Agreement, and its racemate, metabolite, derivatives, isomers, polymorphs, crystals.

Drug Formulation means the formulation of the Drug utilizing Licensors Formulation Technology.

Field of Use
Field of use is for Ethosome, a non-invasive, transdermal drug delivery technology.

Ethosomes are phospholipid nanovesicles used for dermal and transdermal delivery of molecules.

IPSCIO Record ID: 294022

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.

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