Royalty Report: Drugs, Delivery, Pharmaceuticals – Collection: 372611

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 20

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: 20

Primary Industries

  • Drugs
  • Delivery
  • Pharmaceuticals
  • Drug Discovery
  • Migraine
  • Coating
  • Disease
  • Pain
  • Time-released

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: 372611

License Grant
Licensor grants
— an exclusive license, or sublicense as the case may be with respect to Know-How and Patent Rights arising under the Kyowa Agreement, with the right to grant sublicenses, under the Licensor Intellectual Property Rights, excluding the Licensor Trademarks, to use, sell, offer for sale, package, and import Product in the Field in the Territory;
— a worldwide, exclusive license, or sublicense as the case may with respect to Know-How and Patent Rights arising under the Kyowa Agreement, with the right to grant sublicenses under the Licensor Intellectual Property Rights, excluding the Licensor Trademarks, in the Field to make and have made Product solely to the extent that Licensee is permitted to make or have made Product under the Clinical Supply Agreement and Commercial Supply Agreement; and,
— a worldwide, exclusive license, or sublicense as the case may be with respect to Know-How and Patent Rights arising under the Kyowa Agreement, with the right to grant sublicenses, under the Licensor Intellectual Property Rights, excluding the Licensor Trademarks, to package Product in any country outside of the territory and to use Product for the purpose of conducting Clinical Studies in any country outside of the territory.

Licensor grants
— an exclusive right, with the right to grant sublicenses, to use the Licensor Trademarks in connection with the using, selling, offering for sale and importing of Product in the Field in the Territory;
— a worldwide, exclusive right to use the Licensor Trademarks in connection with the making and having made of Product solely to the extent that Licensee is permitted to make or have made Product under the Clinical Supply Agreement and Commercial Supply Agreement; and
— a worldwide, exclusive right to use the Licensor Trademarks in connection with the packaging of Product outside of the Territory and the use of Product for the purpose of conducting Clinical Studies in any country outside of the Territory.

License Property
Licensor is the owner or licensee of the Licensor Intellectual Property Rights relating to the ODT Technology.

Product means an immediate-release, i.e., lacking any substantial sustained or controlled release component to the drug release, pharmaceutical composition containing the Compound, as the sole active ingredient and regardless of presentation or dosage, which is developed by or on behalf of the Parties pursuant to this Agreement, and which uses the Formulation and incorporates the ODT Technology.

ODT Technology means the proprietary oral dissolve dmg delivery and related technology Controlled by Licensor and/or its Affiliates as of the Effective Date or during the Term, including, without limitation, the Microcaps® taste masking microencapsulation technology and the AdvaTab® oral disintegrating tablet technology and, in each case, any manufacturing processes relating thereto.

Compound means 3,5-diantino-6-(2,3-dichlorophenyl)-1 ,2,4-triazine, the compound that is known by the generic name lamotrigine and its prodrugs, metabolites, isomers, esters, salts, hydrates, solvates and polymorphs, Lamotrigine IR Orally Disintegrating Tablets (25, 50, 100 & 200 mg).

Licensor Trademarks means MICROCAPS, and, ADVATAB.

EUR-1048 is a tastemasked orally disintegrating tablet developed using our AdvaTab® and Microcaps® technologies,

Field of Use
AdvaTab is an advanced orally-disintegrating tablet technology that creates tablets that disintegrate rapidly in the mouth, in less than 30 seconds, with or without water. … Together, these technologies may enhance compliance by providing patients with a convenient, easy-to-swallow product with a pleasant taste.

Microcaps taste-masking. The ability to mask the bitter or irritant characteristics of many drugs with flavors and sugars is limited, and coating of the drug is generally required to achieve maximum taste-masking effectiveness. Our Microcaps technology deposits a polymer layer around the drug particles to form a complete and continuous barrier. Fluid-bed layering techniques, in which a solution of the polymer is sprayed onto particles that are 'fluidized' by blowing air through a bed of drug particles, are typically unable to match this level of coating integrity and hence performance.

IPSCIO Record ID: 282823

License Grant
Licensor hereby grants to Swiss Licensee (a) an exclusive license under the Know-How and the Licensor-Patents regarding the Product, during the term of this Agreement, to use, sell, offer to sell or otherwise distribute the Product in the Territory and (b) an exclusive license under the Manufacturing Know-How and the Licensee-Patents to make a Product, have the Product made, solely under Licensees right to the extent permitted to self-supply in the Toll Manufacturing Agreement and (c) a non-exclusive license under US Patent 5,225,197 and corresponding patents in foreign countries to make, have made, sell, use, or offer for sale or otherwise distribute the Product in the Territory.

Licensee has the right to sub-license the rights granted to an Affiliated Company of Licensee and/or a Non Affiliated Company of Licensee for the purposes of marketing or distributing the Product.

License Property
The term Product shall mean a tablet for the treatment of depression manufactured using the technology of Licensor commonly known as Orasolv(R) as patented by the Patents as described hereof, containing the Substance as the active ingredient and adapted to disperse in the mouth of a human adult, which tablet incorporates the Substance together with a matrix or coating in microparticles or microcapsules which provide essentially complete release of the Substance into the gastrointestinal tract in a period of less than one hour after dissolution of the tablet.
5,178,878 – Effervescent dosage form with microparticles
5,225,197 – Pharmaceutical formulation

The term Licensor-Patents shall mean the Patents excluding US patent no. 5,225,197 d.d. July 6, 1993, and corresponding patents in other countries.

OraSolv(R) is a drug delivery technology. OraSolv(R) ODT formulation dissolves quickly in the mouth without chewing or the need for water.

Field of Use
Remeron SolTab, an antidepressant that incorporates Licensor's OraSolv(R) fast-dissolve drug delivery system with Licensee's active drug ingredient, mirtazapine.

IPSCIO Record ID: 248396

License Grant
Licensor grants to Licensee an exclusive license, even as to Licensor, with the right to grant sublicenses, under the Licensor Licensed Technology to use, make, have made, develop, have developed, offer to sell, sell, have sold, distribute, import or otherwise dispose of Licensed Products in the Field in the Territory.

Licensor grants to Licensee and its permitted sublicensees and Affiliates a non-exclusive license to the Licensor Trademarks identified during the term of this Agreement for the purpose of performing its obligations under this Agreement.  The Trademarks are to be used in labeling of Licensed Product as requested as well as use name and derivations thereof in promoting, marketing and selling of Licensed Product in the Territory.

License Property
Licensed Product shall mean oral disintegrating tablets containing prednisolone sodium phosphate, prednisolone, or any salt or base thereof and all improvements and line extensions thereof.

Oral Disintegrating Tablets shall mean a solid tablet dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds when taken orally.

Trademarks shall mean the trademarks, tradenames (and registrations and applications therefor) controlled by each of the parties and used on Licensed Product, (Oral Disintegrating Tablets) including, initially the applicable Licensor Trademarks listed hereto and the applicable Ascent Trademarks listed hereto.
CIMA
CIMA LABS INC.
OraSolv®
PakSolv®
DuraSolv®
CIMA
ORA.FRED®

Licensor Technical Information shall mean (a) techniques and data, including ideas, inventions (including patentable inventions, but excluding inventions covered by Licensor Licensed  Patents), practices methods, knowledge, know-how, trade secrets, skill, experience, documents, apparatus, test data, including pharmacological, toxicological and clinical test data, analytical and quality control data, manufacturing, patent data or descriptions relating to Licensed Product, including, but not limited to, those that relate to DuraSolv(R)Technology, PakSolv(R)Technology and/or OraSolv(R)Technology, owned or Controlled by Licensor and/or its Affiliates and (b) chemical formulations, compositions of matter, product samples and assays relating to Licensed Product, including, but not limited to, those that relate to DuraSolv(R)Technology, PakSolv(R)Technology and/or OraSolv(R)Technology, owned or Controlled by Licensor and/or its Affiliates. Licensor Technical Information shall include Developed Intellectual Property. Licensor Technical Information shall not include any Work Product.

Licensor Licensed Patents shall mean the patents and patent applications owned or Controlled by Licensor and/or its Affiliates that claim Licensed Product, the DuraSolv(R) Technology, the PakSolv(R) Technology and/or the OraSolv(R) Technology as related to Licensed Product, and its manufacture, its packaging, or its use, its import or its sale and including any extension, reissue, renewal, reexamination or continuation-in-part of such patents or patent applications. Licensor Licensed Patents shall include Developed Intellectual Property. Licensor Licensed Patents shall not include any Work Product. The initial list of Licensor Licensed Patents is set forth.

U.S. Pat. No. 5,178,878 – Effervescent dosage form with microparticles
U.S. Pat. No. 6,155,423 – Blister package and packaged tablet
U.S. Pat. No. 6,024,981 – Rapidly dissolving robust dosage form
U.S. Pat. No. 6,221,392 – Rapidly dissolving robust dosage form

DuraSolv(R)Technology shall mean the fast-dissolving drug delivery system generally described in U.S. Patents 6,024,981 and 6,221,392 and PCT Published Application No. WO 98/46215.

PakSolv(R)Technology shall mean the packaging system generally described in U.S. Patents 6,155,423; 6,269,615 and 6,311,462.

OraSolv(R)Technology shall mean the fast-dissolving drug delivery system generally described in U.S. Patent 5,178,878 and U.S. Patent Application 08/468,913.

Field of Use
Field shall mean the treatment of all human conditions.  Exclusive Field shall mean any product containing prednisolone sodium phosphate, prednisolone, or any salt or base thereof.

IPSCIO Record ID: 203479

License Grant
Licensor hereby grants to Licensee, as of the Effective Date, an exclusive license, exclusive even as to Licensor, in the Territory under the Licensed Patent Rights, and to use Licensor Know-How to develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell Licensed Product(s). Any Improvements shall be included in Licensor Know-How or Licensed Patent Rights, as the case may be, for all purposes of this Agreement. Without limiting the foregoing, Licensor hereby grants Licensee an irrevocable, worldwide, paid-up, exclusive license to use Licensor Know-How or other intellectual property rights relating to the Development Program and  Manufacture of Licensed Product that are necessary for Licensees filings for the purpose of obtaining and maintaining the Health Registrations in the Territory for the Licensed Product, including but not limited to the Manufacturing of Licensed Product as provided in the Health Registrations. Notwithstanding the foregoing, Licensee has granted certain rights to Manufacture Licensed Product to Licensor.
License Property
The term Licensed Product shall mean any dosage form utilizing any material elements of the Licensor Know-How, and/or the Licensed Patent Rights, in its Manufacture or use, and which contains the Active Ingredient as a pharmaceutically active ingredient.

5,178,878 – Effervescent dosage form with microparticles
6, 155,423 – Blister Package and Packaged Tablet

The term OraSolv Technology shall mean the fast-dissolving drug delivery system described in U.S. Patent 5,178,878 and U.S. Patent Application 08/468,913 including, formulations, materials, methods and other technologies which are owned by Licensor or licensed to Licensor with the right to grant sublicenses.

OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water.

Field of Use
This agreement pertains to the drug industry.

IPSCIO Record ID: 7576

License Grant
Canadian Licensor hereby grants to the Canadian Licensee, an exclusive worldwide, perpetual license under the Patents and the Licensed Know-How, with such exclusivity being limited to the right to and for the sole purpose the Licensed Application ('License').  The Oral Dissolving Technology is exclusively available to the Canadian Licensee through the License Agreement.
License Property
'Product' shall mean Sildenafil Citrate.

An orally disintegrating tablet or orodispersible tablet (ODT) is a drug dosage form available for a limited range of over-the-counter and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed whole.

'Licensed Patents' shall mean Intellectual Property solely relating to the Product and US Patent Application 2007/01.90144 (Novel formulation for sublingual drug delivery and use thereof) and all corresponding know-how, patents, patent applications, continuation applications, continuation, etc.

Field of Use
'Field of Use' shall mean oral dissolving technology (sublingual) delivery of the Product.

The first product the Licensee will develop with this technology is sublingual sildenafil. This therapy is used for erectile disfuction.

The Licensee is to complete the required studies and regulatory tasks to commercialize products using the oral dissolving technology and is responsible for any all clinical trials related to the development of products using ODT technology.

IPSCIO Record ID: 227284

License Grant
Licensor hereby grants to Licensee an exclusive license for the term of this Agreement under the following assets to market, distribute and sell the Products, for all indications and for all agreed upon Product line extensions, in the Territory.

Licensor grants to Licensee an exclusive, royalty bearing license to use the Licensor Trademarks to market, distribute and sell the Products, during the term of this Agreement, for all indications and for all agreed upon Product line extensions in the Territory.

License Property
Product shall mean any of the pharmaceutical products described, it being understood that additional products may be added after the date hereof in accordance with this agreement.

Product (API)
                                                Strengths
                                   LicensorTarget Completion Date
#1metoclopramide HCl
                        5mg 10mg
                                   December 01, 2002
#2 carbidopallevodopa
                        10m!V100mg
                                                                        25m!V 100mg
                                                                        2Smg/250mg

#3 baclofen
                                                10mg
                                                                        20mg

#4 alprazolam
                                        HCI 0.25 mg
                                                                        0.5mg
                                                                        1mg
                                                                         2mg
                                           March 31, 2003
#5 selegiline HCI
5mg

#6 diphenoxylate HCVatropine sulfate
2.5 mw0.025 mg

#7 dicyclomine HCI
                                10mg
                                                                        20mg

Licensor Patents shall mean United States patent nos. 6,024,981 and 6,221,392 (Rapidly Dissolving Robust Dosage Form) and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application. To the extent that the OraSolv(R) and PakSolv(TM) technology is used with respect to any Product pursuant, the term 'Licensor Patents' shall, with respect to such Product, be deemed to include United States patent nos. 5,178,878, 6,155,423, 6,269,615 and 6,311,462 and any patents and patent applications resulting therefrom, including any extension, reissue, renewal, reexamination or continuation-in-part of such patent or patent application.

Licensor Trademarks shall mean the Licensor(R), DuraSolv(R), PakSolv(TM), OraSolv(R) and Meltabs(R) trademarks.

Licensor Technology shall mean all of the Licensor Patents and all of Licensors trade secrets, technology, know-how and all other information necessary for the manufacture of the Products including, without limitation, that relate to Licensors DuraSolv(R), PakSolv(TM) and OraSolv(R) technologies.

OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water.

Field of Use
This agreement pertains to the drug industry relating to pharmaceutical products through proprietary drug delivery technologies.  DuraSolv(R)Technology shall mean the fast-dissolving drug delivery system.

IPSCIO Record ID: 299234

License Grant
Licensor grants under the Licensed  Patents, the non-exclusive, except the Pediatric exclusivity, license and right to  make, have made, use and sell each Licensed Product in the Licensed Field and in the Territory.

For the Pediatric exclusivity, until May 15, 1998, the license granted shall be an exclusive license with respect to Licensed Products in the Pediatric Market in the United States and Canada and including Puerto Rico.

License Property
Licensor is the owner or licensee of certain patent rights pertaining to an effervescent, fast-dissolving, oral drug-delivery tablet technology;

Licensed Product means a product comprised of an effervescent agent together with micro-particles of either
—  where a Licensed Product is, by active ingredient, any active ingredient listed for the relevant country or region in the Territory which, as of the Effective Date, is approved by the appropriate regulatory agency for sale in the OTC market in such country or region of the Territory; and
—  where a Licensed Product is, by product category, such as cough/cold, one or more active ingredients used or useful in such product category, such as Pseudoephrine HC1, provided that, as of the Effective Date, all such active ingredients are approved by the appropriate regulatory agency for sale in the OTC market in the relevant country or region of the Territory, coated by a rupturable or non-rupturable coating material, such product being adapted to dissolve in the mouth of a human being and to provide a distinct sensation of effervescence on dissolution, the manufacture, use or sale of which would, but for this Agreement, constitute infringement of Licensed Patents.

The patents relate to effervescent dosage form.

Field of Use
Licensed Field means the OTC market for sale of any Licensed Product in the Adult Market or the Pediatric Market.

The Agreement covers full-scale production of an over-the-counter product in Licensor's OraSolv dosage form.  OraSolv is an oral dosage formulation incorporating microencapsulated active drug ingredients into a tablet which dissolves quickly in the mouth without chewing or water and which effectively masks the taste of the medication being delivered. OraSolv's fast-dissolving capability may enable patients in certain age groups or those with a variety of conditions that limit their ability to swallow conventional tablets to receive medication in a more convenient oral dosage form.

IPSCIO Record ID: 282836

License Grant
Licensor hereby grants to Puerto Rico Licensee and its Affiliates an exclusive (even as to Licensor) worldwide license under the OraSolv® Technology in the Field, during the term of this Agreement, to use, sell, import or otherwise distribute, or to make, have made, or make for others solely under Licensees right to self-supply contained in the Supply Agreement, prescription pharmaceutical products incorporating the OraSolv® Technology containing as active ingredient zolmitriptan or any other 5HT1 agonist compound for the treatment of migraine headaches.

Licensor granted to Licensee the OraSolv-Registered Trademark to utilize for the development, marketing, distribution and sale of a product incorporating zolmitriptan.

License Property
Product means the pharmaceutical dosage form which is formulated using the OraSolv-Registered Trademark- Technology and contains zolmitriptan as its active ingredient, whether taste masked or untreated.

ORASOLV-Registered Trademark- Technology means Licensors effervescent, fast-dissolving, oral drug-delivery tablet technology, including (i) the inventions disclosed in patents and patent applications owned, controlled or licensed (with the right to sublicense) by Licensor during the term of this Agreement, (ii) all know-how, technology, trade secrets, data, processes and methods, or other information owned, controlled or licensed (with the right to sublicense) by Licensor during the term of this Agreement relating to the technology marketed under the trade name OraSolv-Registered Trademark-, including use with either a taste masked or an untreated substance and (iii) all improvements thereto owned, controlled or licensed (with the right to sublicense) by Licensor and made during the term of this Agreement and before December 31, 1020, to the extent that such improvements are useful or necessary to the manufacture of the Product.  OraSolv-Registered Trademark- Technology includes only technology relating to tablets that disintegrate or dissolve in the mouth in 30 seconds or less by either placing on the tongue or by chewing, such disintegration or dissolution time measured in accordance with the in vitro test specification.

OraSolv® Technology does not include any Licensor technology that is specifically designed to increase or enhance the rate or extent of absorption of active drug substances (including 5HT1 agonists for the treatment of migraine headaches), regardless of the in vitro or in vivo disintegration/dissolution time.  This exclusion also extends to enhanced absorption in the oral cavity (sublingual or buccal) or upon ingestion throughout the GI tract (stomach, intestines and colon).  Any New Technology that results in the Product having bioequivalence with standard zolmitriptan tablets shall be included in this definition of OraSolv® Technology, but New Technology that results in the product having better biioavailability than standard zolmitriptan tablets shall be excluded.

OraSolv-Registered Trademark- Technology includes only technology relating to tablets that disintegrate or dissolve in the mouth in 30 seconds or less by either placing on the tongue or by chewing, such disintegration or dissolution time measured in accordance with the in vitro test specification.

Field of Use
Field means prescription pharmaceutical products incorporating the OraSolv® Technology containing as active ingredient, in any formulation or dosage, zolmitritan or any other 5HT1 agonist compound for the treatment of migraine headaches, including cluster headaches or tension headaches, (including, without limitation, the Product) for sale in prescription markets worldwide.

IPSCIO Record ID: 152580

License Grant
Licensor grants an exclusive license for the term of this Agreement to develop, manufacture, market, distribute and sell the Product, for all indications and for all agreed upon product line extensions, in the Territory.

Licensor grants an exclusive license to use the Licensors Trademarks to market, distribute and sell the Product, during the term of this Agreement, for all indications and for all agreed upon product line extensions in the Territory.

License Property
The Product means a pharmaceutical product containing 0.125 mg of the active ingredient hyoscyamine sulfate, in a fast-dissolving tablet using the Licensors Technology.  The patent is for a Rapidly Dissolving Robust Dosage Form.

The trademarks are CIMA®, DuraSolv® and Meltabs®.

DuraSolv, our leading proprietary fast-dissolve technologies, are oral dosage forms incorporating taste-masked active drug ingredients into tablets, which dissolve quickly in the mouth without chewing or water.

Field of Use
Licensee is in the business of marketing and selling of pharmaceutical products.

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: 245879

License Grant
The French Licensor grants to the Licensee in Puerto Rico, an exclusive license, even as to Licensor, with the right to grant sublicenses, under Licensed Technology, to make, have made, use, sell, offer for sale The Parties  have undertaken a feasibility study to develop a Formulation by applying the Licensors Micropump Technology to Carvedilol.
License Property
Licensor has developed certain proprietary technology related to Licensor Micropump Technology.

Carvedilol11 means (l-(9H-carbazol-4-yloxy)-[[2-2(2-methoxyphenoxy)ethyl] amino ]-2-propanol), the compound that is known by the generic name of Carvedilol and including all racemates, chelates, complexes, enantiomers, diastereoisomers, salts, bases, esters, hydrates, solvates, polymorphs, crystal forms, crystal habits, prodrugs, isotopic or radiolabeled equivalents, metabolites, or the like, thereof and all mixtures and any of the foregoing, and compositions comprising Carvedilol.

Licensor Micropump Technology means a multiple-dose system containing a large number of microparticles that may be contained in capsule, tablet, orally dispersible, sachet or suspension formulations. It is expected that the microparticles are released in the stomach and pass into the small intestine, where each microparticle operates as a miniature delivery system, releasing the drug at a controlled rate and over an extended period of time.

Licensor Patent Rights means all patents and patent applications in existence as of the Effective Date or during the Term of this Agreement claiming generically or specifically a product or process using the Licensors Micropump Technology.

Product means any presentation or presentations of Carvedilol that incorporate the Licensed Technology, alone or in combination with other therapeutically active compounds, for the therapeutic or prophylactic treatment of diseases and conditions in humans in any dosage or strength.

Field of Use
The Micropump® technology is a controlled release and taste-masking technology for the oral administration of small molecule drugs.

IPSCIO Record ID: 66659

License Grant
Licensor hereby grants to Licensee and its Affiliates an exclusive royalty-bearing transferable license, under the Licensed Intellectual Property solely to use and sell the Products for use in the Field within the Territory and to manufacture or have Products manufactured by Third Parties solely on behalf of Licensee and its Affiliates for subsequent sale for use in the Field within the Territory as and to the extent permitted herein. Licensee and its Affiliates shall have the right to sublicense any of rights granted in this Section to contract manufacturers, distributors, co-promotion partners, contract sales organizations and other service providers assisting Licensee and its Affiliates in the commercialization of the Product.
License Property
Licensor has developed a phentermine orally disintegrating tablet (ODT) which is the subject of NDA # 20-2088, and holds rights to the Licensed Intellectual Property.

Intellectual Property relates to orally disintegrating tablet formulations of pharmaceutical products.

Certain Licensed Patent Rights
U.S. Patent No. 6,149,938
U.S. Patent Application Serial No. 12/034,928

'Product' or 'Products' means (i) the finished pharmaceutical forms of phentermine hydrochloride orally disintegrating tablets in 15 mg, 30 mg and 37.5 mg dosages and (ii) any Improvements.

'Product NDA' means NDA # 20-2088.

Field of Use
'Field' means the treatment or prevention of diseases or conditions in humans.

IPSCIO Record ID: 211868

License Grant
The Japanese Licensor grants to the Irish Licensee an exclusive license to the Licensor Technology in the field of pharmaceuticals to make, have made, use, market, distribute, sell, have sold, offer for sale, export and import Product in the Territory subject to the Licensors Reserved Rights.
License Property
Licensor is the owner of a fast disintegrating tablet technology which it markets under the trademark SOLBLET  and a tablet forming technology involving an external lubricant which it markets under the trademark EXLUB.

The tablets are characterized in dissolving rapidly in the mouth while having approximately the same hardness as ordinary tablets. They are appropriate for use by patients who have difficulty swallowing, such as infants and elderly people, and by people in workplaces or other situations where it is difficult to access or drink water.

“FDT Patent” means patent and patent application on the SOLBLET Technology entitled Intraorally Rapidly Disintegrable Tablet.

Patent 09/147374

Field of Use
This agreement is for the pharmaceutical industry.

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: 319177

License Grant
Licensor grants an exclusive license to its Intellectual Property only to the extent necessary to research, develop, make, have made, offer for sale, sell Products in the United States and its territories.
License Property
Licensor has developed the following extended-release liquid Products to be sold by doctors prescription only containing the following active pharmaceutical ingredients in accordance with the terms hereof using Neos patent-pending Dynamic Time Release Suspension technology.  Products include Chlorpheniramine and Hydrocodone; Promethazine with Hydrocodone; Fexofenadine with Pseudoephedrine combination product; and Guaifenesin with Hydrocodone or Codeine.

Licensor has developed a broad, proprietary modified-release drug delivery technology that enables the manufacture of single and multiple ingredient extended-release (XR) pharmaceuticals in patient- and caregiver-friendly orally disintegrating tablet (ODT) and oral suspension dosage forms.

Field of Use
The field of use is pharmaceutical products in the form of an extended release liquid.

Licensee is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets.

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: 336386

License Grant
Swiss Licensor hereby grants to English Licensee an exclusive license, with the right to grant sublicenses under the patents, SPCs and Licensor-Know-How to make, have made, use and sell product in the territory, subject to the terms and conditions of this agreement. The rights to make, have made, use and sell shall include all activities concerning the subject matter of patents, SPCs and Licensor-Know-How with respect to the making, use and sale of product only, which activities would, but for the license herein granted, infringe Patents, SPCs and/or Licensor-Know-How. In addition, Licensor hereby grants to Licensee an exclusive license, with the right to grant sublicenses subject to this agreement, to make, have made, use and sell any invention or know-how related to Product which arose under the Letter, whether patented and/or patentable or not, for any purpose directly related to any selective serotonin reuptake inhibitor, provided that Licensor shall be allowed to use any such invention or know-how and the patents covering same, if any, for any other purpose not directly related to any selective serotonin reuptake inhibitor.
License Property
Paroxetine shall mean the chemical compound known as paroxetine, the more specific chemical name of which is [(-)-trans-4-(4- fluorophenyl)-3-[3,4-methylene-dioxyphenoxy) methyl] piperidine] and all pharmaceutically active derivatives thereof such as, but not limited to esters, salts (such as, but not limited to, the hydrochloride salt), hydrates, solvates, polymorphs, prodrugs and isomers thereof.

Geomatrix® Technology shall mean Licensors proprietary oral, modified release (i.e., controlled-release, sustained-release, or delayed release) drug delivery and related technology which utilizes a hydrophilic drug-containing matrix tablet which controls the release of the drug through the use of one or more barrier layers, together with all improvements thereon or thereto.

Product shall mean shall mean an oral delivery system for Paroxetine based on or using the Geomatrix® Technology.

Patents shall mean
4,839,177 – System for the controlled-rate release of active substances
5,422,123 – Tablets with controlled-rate release of active substances
5,476,654 – Process for preparing pharmaceutical compositions having an increased active substance dissolution rate, and the compositions obtained

SPC shall mean a right based upon a patent to exclude others from making, using or selling product, such as a Supplementary Protection Certificate.

Field of Use
Licensee will utilize such technology to develop drugs taken orally in tablet form formulated so as to control the amount, timing and location of the release of the drug in the body for pharmaceutical use in human prescriptions.

IPSCIO Record ID: 282865

License Grant
For the Research License, Licensor grants an exclusive license under the Licensor Intellectual Property Rights and the Formulation, in the Territory to use the CTM, or clinical trial material, manufactured by Licensor to conduct the Clinical Studies required to file and maintain the Regulatory Filings.

For the Commercial License, Licensor grants an exclusive license under the Licensor Intellectual Property Rights in the Territory to use, offer for sale, import and sell the Product. Licensor grants a license under the  Intellectual Property Rights, in the Territory to make, and have made, the Product to the extent permitted under the Commercial Supply Agreement.

Licensor grants a non-exclusive license to use, and sublicense the right to use, the Licensor Trademarks in the sale and marketing of the Product provided the Product has been manufactured by, on behalf of, or under a license from Licensor.

License Property
Licensor is the owner or licensee of certain technology including processes, patents, trade secrets, trademarks and know-how for the development and manufacture of orally administered pharmaceutical formulations, including controlled release technologies.

DIFFUCAPS® Trademarks

This agreement is for the development of a once-a-day controlled release (CR) capsule dosage form containing a combination of dextromethorphan hydrobromide (DM) and quinidine sulfate (Q). The new product, Neurodex CR, is projected to have 60 mg of DM and up to 60 mg of Q and will be based on Licensors proprietary multi-particulate Diffucaps® technology. Diffucaps beads will allow separate adjustment of the DM and Q doses based on the fill volume of beads in the capsules.

The API or active pharmaceutical ingredients are dextromethorphan hydrobromide or quinidine sulfate separately, or dextromethorphan hydrobromide and quinidine sulfate together.

Product means the pharmaceutical dosage form resulting from the Formulation developed by Licensor pursuant to this agreement.

Formulation means both the identification and selection of ingredients, including the Drug Combination, and the Licensor Patent Rights and Know-How solely related to the Product and improvements thereto.

Field of Use
The field of use is orally administered pharmaceutical formulations, including controlled release technologies.  Diffucaps® incorporate release-controlling polymers or protective coatings onto drug-layered cores, granules, or crystals with one or more drugs.

IPSCIO Record ID: 166934

License Grant
Licensors, two individuals, jointly grant to Licensee/Sponsor an exclusive option of any of the Licensed Subject Matter, to acquire an exclusive worldwide license to make, have made, use, sell or offer to sell Licensed Products, with rights to sublicense.

If Sponsor exercises its option, Licensors grant to Sponsor, under their right, title and interest in Technology Rights and Patent rights in the Invention, an exclusive, worldwide license,with the right to sublicense, to make, have made, use, sell, offer for sale and import Licensed Products incorporating or based upon such invention.

License Property
The specific research and patents to be developed is not disclosed.  The Invention means any discovery, concept, or idea, whether or not patentable, conceived by Licensors or others in their laboratories during the Research Program, and arising directly from the performance of the Research Program.

OraSolv technology is an oral dosage form that combines taste masked drug ingredients with a fast dissolving, low-effervescence system. The OraSolv tablet dissolves quickly in the mouth without chewing or the need for water.

Field of Use
The related property is for medical human pharmaceutical use.  Licensee is a drug delivery company focused primarily on the development and manufacture of pharmaceutical products based upon its patented OraSolv technology for marketing by multi-national pharmaceutical companies.

IPSCIO Record ID: 319184

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

Licensor authorizes Licensee to Market such AG Product in the Territory, but only from and after the License Effective Date.

Licensor grants to a limited license under the Adderal- XR Intellectual Property and under any and all statutory and regulatory exclusivities to Market such AG Product in the Territory from and after the applicable License Effective Date.

License Property
Adderall XR Intellectual Property shall mean U.S. Patent Nos. 6,322,819, 6,605,300, and 6,913,768 and any other related patents.

A Licensor Affiliate is the owner of New Drug Application No. 21-303, which was approved by the FDA for the Manufacture and sale of Adderall XR for the treatment of Attention Deficit Hyperactivity Disorder.

Adderall XR shall mean the pharmaceutical product that contains the Compound as its sole active ingredient which is approved for Marketing in the Territory.

Compound shall mean mixed amphetamine salts.

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 Licensor’s NDA.

Field of Use
This combination medication is 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.
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