Royalty Report: Drugs, Central Nervous System, Delivery – Collection: 315667

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 16

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: 16

Primary Industries

  • Drugs
  • Central Nervous System
  • Delivery
  • Drug Discovery
  • Therapeutic
  • Disease
  • Pharmaceuticals
  • Cancer
  • Addiction
  • Alzheimer’s disease

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: 315667

License Grant
The Swiss Licensee obtained a worldwide, sub-licensable license from the Licensor covering four different compounds, which included Mazindol (the “Licensed Compounds”). Under the Second Amendment it was agreed to include sales realized upon the commercialization of products developed on the basis of the Licensed Compounds during the terms of their respective patents.  The Licensee’s majority shareholders are also majority shareholders in the Licensor and as such are considered to be related parties.
License Property
Licensed Compound, Mazindol, is an active molecule in a proprietary controlled release formulation. The controlled-release formulations are being designed to optimize their pharmacokinetic and pharmacodynamic properties with a rapid onset of action and prolonged controlled therapeutic effect, allowing for a daily oral dose that effectively provides consistent and long acting symptom control and designed to uniquely meet the needs of patients.

Licensor is primarily focusing on the repurposing of safe and (cost-)effective compounds to treat Attention Deficit/HyperActivity Disorder (ADHD), sleep disorders and cognitive impairment.

Field of Use
Licensee will utilize Mazindol, an active substance, to cover a range of areas including the therapeutic use of mazindol for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and combination therapies containing mazindol (add-ons with iron or stimulants) as well as sleep disorders such as narcolepsy or idiopathic hypersomnia.  Attention Deficit Hyperactivity Disorder (ADHD) is a group of behavioral symptoms that include inattentiveness, hyperactivity and impulsiveness.

Licensee is an innovative biotechnology company engaged in the discovery and development of life-improving drug therapies to treat rare and complex central nervous system, or CNS, disorders, including narcolepsy, idiopathic hypersomnia and other rare sleep disorders, and of neurodevelopmental disorders, such as Attention Deficit Hyperactivity Disorder, or ADHD. CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance use disorders.

IPSCIO Record ID: 287024

License Grant
Licensor has the right to receive a royalty generated by KP415, KP484 or KP879, and any product candidates arising therefrom, including royalty payments on any license of KP415, KP484 or KP879, the sale of KP415, KP484 or KP879 to a third party, the commercialization of KP415, KP484 or KP879.
License Property
The products for the treatment of ADHD include KP415 and KP484, and the Companys preclinical product candidate for the treatment of SUD includes KP879.
Field of Use
KP415 is Licensee’s prodrug product candidate being developed for the treatment of ADHD. KP415 consists of serdexmethylphenidate (SDX), Licensee’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. KP415 is designed to address unmet needs with the most prescribed methylphenidate ADHD treatments, including earlier onset of action and longer duration of therapy. In addition, the results from the Human Abuses Potential program for the SDX component of KP415 suggest that the prodrug may have lower abuse potential than relevant d-MPH comparators.

KP484 is Licensee’s co-lead clinical development candidate being developed for the treatment of ADHD in patients that respond best when a very long duration of therapy is required. Similar to KP415, KP484 consists of SDX, Licensee’s prodrug of d-MPH. Preclinical and clinical studies of KP484 have demonstrated that the prodrug may produce a longer duration release of d-MPH compared to the most prescribed methylphenidate products. KP484 has the potential to be the first new methylphenidate-based product being developed with the intent to address the specific needs of the adult ADHD population.
Attention deficit hyperactivity disorder (ADHD) is a mental disorder of the neurodevelopmental type. It is characterized by difficulty paying attention, excessive activity and acting without regards to consequences, which are otherwise not appropriate for a person's age.

KP879 is an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder, or SUD.
A substance use disorder (SUD), also known as a drug use disorder, is a medical condition in which the use of one or more substances leads to a clinically significant impairment or distress.

IPSCIO Record ID: 308166

License Grant
The agreement provided Licensee and its affiliates exclusive worldwide rights to develop, manufacture and, if approved, commercialize product candidates containing SDX and d-MPH, including KP415 and KP484.   Further, the KP415/KP484 License Agreement provides Licensee the option to license two additional prodrug candidates from Licensor  KP879 for the treatment of Stimulant Use Disorder, and KP922, a prodrug of amphetamine for the treatment of ADHD.
License Property
Licensor implements its LATâ„¢ technology to create prodrugs that are new molecules by chemically attaching ligand (s) to the parent drug.

KP415 consists of serdexmethylphenidate (SDX), Licensor’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.

KP484 is Licensor’s co-lead clinical development candidate being developed for the treatment of ADHD in patients that respond best when a very long duration of therapy is required.  Similar to KP415, KP484 also consists of serdexmethylphenidate (SDX), Licensor’s prodrug of d-methylphenidate (d-MPH).

serdexmethylphenidate (SDX), is the major active pharmaceutical ingredient in KP415 and KP484, Licensor’s co-lead clinical development product candidates.

d-MPH is d-methylphenidate.

SUDs include those products marked by abuse/misuse of cocaine, methamphetamines, prescription stimulant products that contain methylphenidate or amphetamine, and numerous designer stimulants.

Licensor is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).  KP879 utilizes serdexmethylphenidate (SDX),

KP922 is Licensors prodrug of amphetamine.

Field of Use
KP415 and KP484, Licensor’s co-lead clinical development product candidates intended for the treatment of attention-deficit/hyperactivity disorder (ADHD).  KP415 is a prodrug product candidate being developed for the treatment of ADHD.  In addition, the SDX component of KP415 may offer the possibility of a lower abuse potential.   KP415 is designed to address unmet needs with currently marketed methylphenidate ADHD treatments, including earlier onset of therapy, longer duration of therapy and consistency of the therapeutic effect.  KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).  KP922 is Licensors prodrug of amphetamine which is intended for the treatment of ADHD.

The lead candidate will be developed for the treatment of ADHD, although these prodrugs may also be amenable for the development of products with indications in other therapeutic areas for which stimulant-like effects are desirable.  Licensor believes that SDX has pharmacokinetic properties that are desirable as an agonist replacement therapy for the treatment of SUD.

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.

IPSCIO Record ID: 240440

License Grant
The Taiwan Licensee obtained from the Taiwan Licensor the exclusive global rights to PDC-1421, an API, and its surrounding proprietary information to develop, manufacture, distribute and sell pharmaceutical products for potential use in major depressive disorders.
License Property
PDC-1421, an API for possible use in major depressive disorder with Montgomery-Asberg Depression Rating Scale.
Field of Use
With PDC-1421 as the API, the Licensee is developing two new drug candidates, BLI-1005 to treat MDD and BLI-1008 for ADHD.

Major depressive disorder (MDD), also known simply as depression, is a mental disorder characterized by at least two weeks of low mood that is present across most situations. It is often accompanied by low self-esteem, loss of interest in normally enjoyable activities, low energy, and pain without a clear cause.

Attention deficit hyperactivity disorder (ADHD) is a mental health disorder that can cause above-normal levels of hyperactive and impulsive behaviors. People with ADHD may also have trouble focusing their attention on a single task or sitting still for long periods of time. Both adults and children can have ADHD.

IPSCIO Record ID: 343142

License Grant
Licensor grants  German Licensee an exclusive license, with the right to grant sublicenses, to develop, use, manufacture, market and sell ADAIR throughout Europe.
License Property
ADAIR (Abuse-Deterrent Amphetamine Immediate-Release) is a proprietary, abuse-deterrent oral formulation of immediate-release (short-acting) dextroamphetamine.

ADAIR is an oral, semi-solid, liquid-filled, hard gelatin capsule of dextroamphetamine sulfate, the active ingredient. This formulation resists manipulation and preparation for snorting, and provides meaningful barriers to injection.

Field of Use
Field of use is for the treatment of attention-deficit/hyperactivity disorder (ADHD), and narcolepsy.

ADHD is defined as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. ADHD causes significant impairment during a patient’s childhood, and throughout the patient’s lifespan, as well as increased morbidity, mortality and psychosocial adversity.

Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. People with narcolepsy often find it difficult to stay awake for long periods of time, regardless of the circumstances. Narcolepsy can cause serious disruptions in your daily routine.

IPSCIO Record ID: 26053

License Grant
Licensor hereby grants to Swiss Licensee, and Licensee hereby accepts, an exclusive royalty-bearing license (with the right to sublicense with the consent of Licensor, which consent shall not be unreasonably withheld or delayed), to make, have made, use, import, sell and offer to sell the Methylphenidate Products in the Field in the Territory under the Licensor Technology.
License Property
ADHD shall mean Attention Deficit Hyperactivity Disorder.
d-MPH IR shall mean d-methylphenidate immediate release form.
d-MPH PR shall mean d-methylphenidate pulsed release form.

FOCALIN® and FOCALIN XR® are the long-acting drug formulation for attention deficit disorder, or ADD, and attention deficit hyperactivity disorder, or ADHD.

The Licensor has retained the exclusive commercial rights to FOCALIN® and FOCALIN XR® for oncology-related disorders, such as chronic fatigue associated with chemotherapy. The Licensor also granted  rights to all of its related intellectual property and patents, including formulations of the currently marketed RITALIN LA®.

U.S. Patent 5,733,756 Process for Biocatalytic Resolution
U.S. Patent 5,936,091 Process for Optical Resolution of Amide (Threo) intermediate
U.S. Patent 5,837,284 Delivery of Multiple of Multiple doses of Methylphenidate
U.S. Patent 5,908,850 Method of treating Attention Deficit Disorders with  D-Threo- Methylphenidate
U.S. Patent 5,922,736 Chronic Bolus Administration OF D-Threo-Methylphenidate
U.S. Patent 5,965,734 Process for Optical Resolution of Amide (Erythro) intermediates
U.S. Divisional Application (CELG-0085, the Divisional from CELG-0008); Serial No. 038470, filed March 11,1998.

Field of Use
Field shall mean administration of methylphenidate for the treatment of ADD and ADHD, and all other human disease indications other than disease indications in the field of oncology.

IPSCIO Record ID: 369272

License Grant
University hereby grants to Licensee the world-wide right and license to the Patent Rights set forth to the full end of the term of each patent included therein unless sooner terminated as hereinafter provided. This grant is expressly subject to the rights of the U.S. Government, if any.

In order to establish a period of exclusivity for Licensee, University hereby agrees that it shall not grant any other license to make, have made, use, lease and sell the Patent Rights during the period of time commencing with the Effective Date of this Agreement and terminating with the full end of the term of this Agreement, unless sooner terminated as hereinafter provided.

Licensee shall have the right to sublicense worldwide any of the rights, privileges and license granted hereunder.

License Property
Patent Rights' shall mean

5,616,707 – Compounds which are useful for prevention and treatment of central nervous system disorders

5,726,316 – Pharmaceutical compositions for prevention and treatment of central nervous system disorders

Field of Use
Ispronicline (TC-1734). Ispronicline is a novel small molecule that we are developing as an oral treatment for conditions marked by cognitive impairment that afflict elderly persons, including Alzheimer’s disease and age associated memory impairment, commonly referred to as AAMI

Field of use is for nicotinic compounds for use in therapeutic applications, including for prevention and treatment of central nervous system disorders.

IPSCIO Record ID: 5732

License Grant
We entered into an exclusive Licensing Agreement to develop a series of methylphenidate analogs or Ritalin-like compounds targeting the clinical development of enhanced pharmaceuticals for the treatment of drug addiction, attention deficit hyperactivity disorder (ADHD), and depression.
License Property
The licensed compounds are analogs of Ritalin, a well-known drug used for treatment of ADHD.  The analogs are designed specifically to have a slow onset and increased half-life in the bloodstream, thus reducing a patient's required daily dosage and the potential for drug abuse.  We have the exclusive right to develop, use, market and sell products derived from the licensed compounds.

The Licensed compounds are analogs of Ritalin, a well-known drug used for treatment of ADHD. The analogs are designed specifically to have a slow onset and increased half-life in the bloodstream, thus reducing a patient's required daily dosage and the potential for drug.

Field of Use
Field means all uses or potential uses of the Compounds, including all therapeutic, diagnostic, and prophylactic uses.

IPSCIO Record ID: 239026

License Grant
For selected targets, Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive right and license, without any right to sublicense, except as set forth below,  under Licensors rights in the Licensor Background Materials and the Licensor Background Technology and a co-exclusive right and license, without any right to sublicense, except as set forth below, under Licensors rights in the Program Intellectual Property to identify and validate Selected Targets, other than Selected Targets that have become Licensee Inactive Selected Targets, Licensor Inactive Selected Targets, Licensee Targets or Licensor Targets, for the identification, evaluation and optimization of Small Molecule Compounds that are active against such Selected Targets for use in the CNS Field,  identify Small Molecule Compounds that are active against such Selected Targets through the use of such Selected Targets and undertake preclinical research and evaluation of Program Compounds, in each case in the conduct of the Research Program.

For the Inactive Selective Targets, Licensor grants to Licensee and its Affiliates, within the Territory,  a non-exclusive right and license, without any right to sublicense, except as set forth below,  under Licensors rights in the Licensor Background Materials and the Licensor Background Technology and an exclusive right and license, without any right to sublicense, except as set forth below, under Licensors rights in the Program Intellectual Property to validate Licensee Inactive Selected Targets for the identification, evaluation and optimization of Small Molecule Compounds that are active against such Selected Targets for use in the CNS Field,  identify Small Molecule Compounds that are active against such Licensee Inactive Selected Targets through the use of such Licensee Inactive Selected Targets and undertake preclinical research and evaluation of Small Molecule Compounds that are active against such Licensee Inactive Selected Targets.

For the Licensee targets, Licensor grants to Licensee and its Affiliates, within the Territory,  a non-exclusive right and license, without any right to sublicense, except as set forth below, under Licensors rights in the Licensor Background Materials and the Licensor Background Technology and an exclusive right and license, without any right to sublicense, except as set forth below, under Licensors rights in the Program Intellectual Property to identify Small Molecule Compounds that are active against Licensee Targets through the use of such Licensee Targets and undertake preclinical research and evaluation of Small Molecule Compounds that are active against such Licensee Targets.

For the Grants of Development and Commercialization Licenses, Licensor grants to Licensee and its Affiliates, within the Territory, an exclusive right and license, with the right to sublicense, under Licensors rights in the Program Intellectual Property to develop, make, have made, import, use, have used, offer for sale, sell and have sold Licensee Development Compounds and Licensee Products.

License Property
Licensor is engaged in the identification and validation of targets for use in the discovery of compounds potentially useful to prevent or treat diseases and conditions of the central nervous system.

Small Molecule Compound means a chemical compound having a molecular weight of less than 1,000 Daltons, as well as conjugates of such chemical compounds to larger molecules to improve the delivery bioavailability and/or pharmacokinetic properties of such chemical compound.

Licensors Product means a pharmaceutical product containing a Licensor Development Compound as an active ingredient.

Selected Target means any Target that is selected for research by the Joint Management Committee.

Field of Use
Both Parties are each in the business of discovering, developing and commercializing pharmaceutical products.

CNS Field means the prevention, palliation, control or treatment in humans of depression, schizophrenia, bipolar disease, dementia, anxiety, attention deficit hyperactivity disorder, anorexia nervosa and other affective disorders, Alzheimers disease and other cognitive disorders, Parkinsons disease, amyotrophic lateral sclerosis and other neurodegenerative disorders, pain, epilepsy, insomnia, narcolepsy and other sleep disorders, substance abuse and migraine.

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: 367292

License Grant
Licensor hereby grants to Licensee and its Affiliates an exclusive license, with the right to grant sub-licenses solely pursuant to Agreement, in the Licensor Intellectual Property Rights and the Licensor Licensed Product identified in the Notice Letter dated March 14, 2007 to develop, have developed, make, have made, use, have used, sell, have sold and offer for sale the Licensor Licensed Product in the Field anywhere in the Territory.
License Property
Licensed Product as used herein shall mean molindone and it salts, racemic mixtures, isomers, derivatives, and analogues thereof as licensed to Licensee in accordance with the terms and conditions of this Agreement.

Patent Rights
6,897,212 – Treatment of oppositional defiant disorder and conduct disorder with 5-aminoalkyl-4,5,6,7-tetrahydro-4-oxyindolones
6,613,763 – Use of molindone to treat oppositional defiant disorder and conduct disorder

Field of Use
Field shall mean for the treatment, diagnosis or prevention of central nervous system related diseases and indications in humans and animals.

IPSCIO Record ID: 310660

License Grant
For the Exclusive Licenses, the French Licensor grants to Licensee exclusive licenses, with the right to grant sublicenses, to the Product and the Licensed Assets to Commercialize the Product, including, to package and/or have packaged the Product, as supplied by Licensor under the Supply Agreement, solely in the Field in the Licensee Territory. It is understood and agreed that the licenses exclude the right to manufacture or have manufactured the API contained in the Product, except to the extent set forth hereunder or in the Supply Agreement.

For the Development License, Licensor grants to Licensee a co-exclusive, with Licensor and its Affiliates, license, with the right to grant sublicenses, under the Licensed Assets, to clinically Develop and register with Regulatory Authorities the Product, in the Field, in the Licensee Territory.

For the Trademark, Licensor grants to Licensee an exclusive license to use the Product Trademarks and Licensor’s trade name in the Licensee Territory for the marketing, sale and promotion of the Product in accordance with this Agreement.  

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

License Property
Licensor has developed the Product and owns or controls certain patents, know-how and other intellectual property relating to the Product.  Licensors objective is novel fundamental research work in order to design and develop drugs destined to be forerunners in new therapeutic groups.

Product shall mean that certain product currently known, as of the Signing Date, as Wakix®, that contains the API as its sole active ingredient, as well as other delivery forms or dosages of Wakix that may be developed by the Parties pursuant to this Agreement.

The trademark is  WAKIX or WAKREM.

API, the active pharmaceutical ingredient is pitolisant hydrochloride (INN).

WAKIX® is a histaminergic treatment for patients with excessive daytime sleepiness (EDS) in narcolepsy.  Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep.

Patents relate to Compound BF 2.649, BF 2.649 + olanzapine, BF 2.649 in Epilepsy, BF 2.649 in Parkinson’s disease,
BF 2.649 + modafinil, BF 2.649 Salt, and
BF 2.649 Process.

Generic Product shall mean any prescription pharmaceutical product other than the Product that contains the API and is therapeutically equivalent.

Field of Use
Licensee is a commercial-stage pharmaceutical company focused on developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs. Licensees WAKIX (pitolisant), is a first-in-class molecule with a novel mechanism of action, or MOA, specifically designed to increase histamine signaling in the brain by binding to H3 receptors.  Licensee has experience in marketing and distributing pharmaceutical products in the Licensee Territory, and intends to Commercialize the Product in the Field and the Licensee Territory,

Field shall mean the diagnosis, therapeutic treatment and/or prevention of (a) Narcolepsy (including Type 1 (with Cataplexy) and indication(s) Type 2 and the sleepiness associated therewith), obstructive sleep apnea (OSA), idiopathic hypersomnia, and Parkinson’s disease; and (b) any other indication(s) unanimously agreed upon by the Parties.

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: 295531

License Grant
The Licensor of Switzerland grants to the Licensee of Brazil, an exclusive, non-transferable distribution right of the Licensed Product in the Territory during the Term, an exclusive, non-transferable license to the Licensor’s Patents and Trademarks to register, import, export, store, handle, commercialize, have commercialized, promote, have promoted, distribute, have distributed, sell and have sold the Licensed Product during the Term, without the right to sublicense and an exclusive, non-transferable license to the Intellectual Property and the Developed Intellectual Property and a right to obtain the technology transfer of the Know-How to manufacture the Licensed Product in the Territory during the Term, all to register, import, export, store, handle, commercialize, have commercialized, promote, have promoted, distribute, have distributed, manufacture, have manufactured, sell and have sold the Licensed Product during the Term, without the right to sublicense.
License Property
The product is Nolazol® (Mazindol CR) used in the treatment of ADHD.

The patents are covering multi-layered formulation of Mazindol.

The brand name for the Licensed Product in the Territory shall be Nolazol®, Brazilian trademark.

Field of Use
The field
shall mean the diagnosis, prevention, and treatment of DSM-V Attention Deficit and Hyperactivity Disorder (ADHD) in children, adolescents and adult populations.

IPSCIO Record ID: 303746

License Grant
The parties entered into an exclusive worldwide license agreement to develop and commercialize V158866, a novel oral, selective fatty acid amide hydrolase inhibitor that was discovered using the Vernalis Design Platform.
License Property
V158866 is for post-traumatic stress disorder and other central nervous system diseases.  V158866 is a novel oral, selective fatty acid amide hydrolase inhibitor that was discovered using the Vernalis Design Platform.

Licensor is a biopharmaceutical company focused on developing and acquiring technologies that help pharmaceutical companies discover and develop medicines.

Field of Use
Licensee will utilize the inhibitor, V158866, for post-traumatic stress disorder and other central nervous system diseases.

Licensee is a biopharmaceutical company committed to developing treatments for psychiatric disorders.

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