Royalty Report: Drugs, Disease, Hormones – Collection: 349382

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 11

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: 11

Primary Industries

  • Drugs
  • Disease
  • Hormones
  • Diagnostic
  • Therapeutic
  • Pharmaceuticals
  • Vaccine
  • Biotechnology

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: 349382

License Grant
LIcensee obtained from Licensor a worldwide, non-exclusive, sublicensable (subject to Licensor’s consent in the United States, specified major European countries and Japan, such consent not to be unreasonably withheld) license under the specified patents and know-how that are the subject of Licensee’s exclusive license to develop, manufacture and commercialize LUM-201 for diagnostic purposes, excluding Autism Spectrum Disorders.
License Property
LUM-201, which is a growth hormone (“GH”) secretagogue, also called ibutamoren, for rare endocrine disorders where injectable recombinant human growth hormone (“rhGH”) is currently approved. LUM-201 is a tablet formulation that will be administered once daily.  LUM-201, a potential oral therapy for pediatric growth hormone deficiency (PGHD) and other rare endocrine disorders.

LUM-201 stimulates GH via the GH secretagogue receptor, also known as the ghrelin receptor, thus providing a differentiated mechanism of action to treat some rare endocrine disorders (involving a deficiency of GH) by increasing the amplitude of endogenous, pulsatile GH secretion. LUM-201’s stimulatory effect is regulated by both circulating levels of GH and its down-stream mediator insulin-like growth factor which at supraphysiological levels feedback or negatively regulate additional release of GH from the pituitary, hence protecting against hyperstimulation of GH release. LUM-201 has been observed to stimulate endogenous GH secretion in patients who have a functional but reduced hypothalamic pituitary GH axis.

The therapeutic goal in PGHD is to restore growth, enabling short children to achieve normal height and prevent complications that could involve metabolic abnormalities, cognitive deficiencies and reduced quality of life.

Field of Use
Field of use is for the treatment of PGHD and other rare endocrine disorders.  Its diagnostic purposes is for any and all indications, excluding Autism Spectrum Disorders.

PGHD is a rare endocrine disorder occurring in approximately one in 3,500 persons aged birth to 17 years. Causes of PGHD can be congenital (children are born with the condition), acquired (brain tumor, head injuries or other causes), iatrogenic (induced by medical treatment) or idiopathic (of unknown cause). Children with untreated PGHD will have significant growth failure (potential adult heights significantly less than five feet and may have abnormal body composition with decreased bone mineralization, decreased lean body mass and increased fat mass).

IPSCIO Record ID: 287545

License Grant
The Company acquired assets that primarily comprised of a license from another party.
License Property
The assets in this Asset Purchase agreement included but not limited to the License with another party.  This license has related patents, intellectual property and related product inventory to the products below.

LUM-201 is a potential oral therapy for pediatric growth hormone deficiency (“PGHD”) and other rare endocrine disorders.

To develop and potentially commercialize our Ebola vaccine V920 product candidate and other aspects of our vaccine technology. The Ebola vaccine V920 product candidate was originally developed by the Public Health Agency of Canada and is designed to utilize the rVSV vector to induce immunity against the Ebola virus when replacing the VSV glycoprotein with corresponding glycoproteins from filoviruses.

Field of Use
This agreement pertains to the drug industry.

IPSCIO Record ID: 264695

License Grant
This Agreement governs the Development and Commercialization of Combination Products for all Indications in the Field in the Territory.

The parties previously entered agreements to develop and commercialize IGF-1 in the United States and in all foreign countries.  The IGF-1 Agreements contain restrictions on each Partys ability to develop a combination product containing both human growth hormone and IGF-1.  This Agreement will collaborate in the development and commercialization of products containing both human growth hormone and IGF-1.

For the Exclusive/Co-Exclusive License, in the event of a Licensee Opt-In,  Licensor grants to a license, under the Licensor Patents and Licensor Know-How and Licensors interest in the Joint Patents and Joint Know-How, in all cases, to use, offer for sale, sell and import Combination Products in the Field in the Territory and otherwise perform its obligations and exercise its rights under this Agreement.

For the Non-Exclusive License,  in the event of a Licensee Manufacturing Opt-In,  Licensor automatically grants a non-exclusive, sublicensable (without any need for consent) license, under the Licensor Patents and Licensor Know-How;  Licensors interest in the Joint Patents and Joint Know-How;  the license granted to Licensee by Licensor under the previous agreements to Manufacture and import Combination Products;  Manufacture and import IGF-1 alone, BP3 alone, ALS alone and/or IGF-1 combined with BP3 and/or ALS, for use in the Manufacture of Combination Products; and perform research and development activities related to the Manufacture of Combination Products or the Manufacture of those compounds, in all cases, for use and sale within the scope of the license granted to Licensee.

For Joint Trademarks, Licensor automatically grants an exclusive license, under Licensors interest in the Joint Trademarks for Combination Products for such Indication, to use such Joint Trademarks for purposes of Developing and Commercializing Combination Products for such Indication in the Field in the Territory.

License Property
The Combination Product means a pharmaceutical formulation or product for use in the Field that contains GH and IGF-1 (including, without limitation, formulations and products containing GH and IGF-1 combined with BP3, IGF-1 combined with ALS or IGF-1 combined with BP3 and ALS) and that, in all cases, except for the purposes of the definitions of Phase I Clinical Trial and Phase II Clinical Trial, is administered either as a Pre-Mixed Formulation or single injection from a pre-filled, dual-chamber container-closure system (e.g., a syringe or vial). Combination Products include Short Stature Products and Non-Short Stature Products.

IGF-1 means native-sequence insulin-like growth factor-1 from any species with or without an N-terminal methionine, allelic variants thereof, and sequence variants thereof wherein substitutions and/or deletions are made in the region from 1 to 5 amino acids from the N-terminus of the mature native-sequence IGF-1 of any species, including des-IGF-1 and variants wherein at least the glutamic acid residue is absent at position 3 from the N-terminus of native-sequence human IGF-1.

There will be at least one Combination Product for Short Stature Indications (a Short Stature Product) and at least one Combination Product for the AGHD Indication and Other Indications (a Non-Short Stature Product).

A short Stature Product means a Combination Product for a Short Stature Indication.

Non-Short Stature Product means a Combination Product developed for an Indication other than a Short Stature Indication (i.e., for the AGHD Indication or an Other Indication) that contains a different concentration of GH and/or IGF-1 relative to the concentration of GH and/or IGF-1, respectively, in any Short Stature Product and/or a different ratio of GH to IGF-1 relative to the ratio of GH to IGF-1 in any Short Stature Product.

AGHD Indication means the Indication in which an adult patient has growth hormone deficiency as measured by a generally accepted growth hormone stimulation test, where such adult patient either has growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy or trauma; or was growth hormone deficient during childhood as a result of congenital, genetic, acquired or idiopathic causes.

Licensor Patents means the rights granted by a Patent Office under a Patent Controlled by Licensor during the term of this Agreement (excluding Licensors interest in any Joint Patents), which Patent is necessary or used by Licensor for the Development, Manufacture or Commercialization of any Combination Product in the Field.

Licensor Know-How,, means Know-How (or, with reference to tangible substances, samples of Know-How) Controlled by Licensor during the term of this Agreement (excluding Licensors interest in any Joint Know-How) that is necessary or used by Licensor for the Development, Manufacture or Commercialization of any Combination Product in the Field.

Field of Use
The Field means all prophylactic, diagnostic and therapeutic uses in humans for any Indication. For clarity, Field does not include the Excluded Indications.  'Excluded Indications means any human disease, disorder or condition of the central nervous system (CNS) including, without limitation, CNS diseases and conditions arising out of Closed traumatic injury to head; Open traumatic injury to head; Traumatic or crush injury to spinal cord; Birth asphyxia; Perinatal asphyxia; In utero asphyxia; Toxic injury to brain; Near drowning; Acute meningitis (viral or bacterial); Post cardiac bypass surgery; Post extra corporeal membrane oxygenation; Anaesthetic maladventure; Carbon monoxide poisoning; Status epilepticus; Apparent life threatening event of infancy ( near miss cot death); Asphyxiation; Acute Encephalomyelitis; or, Multiple Sclerosis.

IPSCIO Record ID: 324330

License Grant
The purpose of this amendment is to reflect the updated supply agreement between the Parties relating to the supply of the API Macimorelin acetate;  grant the Licensee of Ireland a joint ownership interest in the German Licensor Patent Rights and Licensor Trademarks; amend responsibility between the Parties for the pediatric clinical trial for the Pediatric Indication; make a payment to Licensor; and,  modify the future payment obligations.  Pediatric Indication means assessing GHD in Children.

The German Licensor grants to the Licensee of Ireland a joint ownership interest in the Licensor Patent Rights and Trademarks (Joint Ownership Interest) and a non-assignable right and license to use the Licensor IPR Package (Licensors know-how and Intellectual Property rights)
a)
to Commercialize the Product in the Territory;
b)
to Manufacture in any country the quantities of Product required for Commercialization in the Territory; and
c)
to Develop the Product for Commercialization in the Territory.

With this amendment, Licensee now has a joint ownership interest under the Licensor Patent Rights and the Licensor Trademarks to carry out development, manufacturing, registration and commercialization of the Product in the Territory.

License Property
Licensor owns or has the exclusive right to certain technology, intellectual property rights, regulatory files and confidential and/or proprietary information relating to the Product macimorelin acetate.

Patents are or relate to Growth Hormone Secretagogues;  Methods and kits to diagnose Growth Hormone Deficiency;  Method of Assessing Growth Hormone Deficiency Comprising Oral Administration of a Macimorelin Containing Composition and Collecting One or Two Post-administration Samples;  Use of Macimorelin in Assessing Growth Hormone Deficiency in Children;  A novel peptide-mimetic GH secretagogue with potent and selective GH-releasing activity in man by Broglio et al; Targeting the Ghrelin Receptor; and, GH-releasing hormone and GH-releasing peptide-6 for diagnostic testing in GH-deficient adults.

API means the active pharmaceutical ingredient macimorelin acetate, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.

Trademark means the Macrilen trademark registered in the Territory and any accompanying logos, trade names, trade dress and/or other indicia relating to the Product Controlled by Licensor.

Macimorelin (INN), or Macrilen (trade name) is a drug being developed for use in the diagnosis of adult growth hormone deficiency.

Field of Use
Macrilen works by stimulating the release of growth hormone (GH) in the body. Macrilen is used as part of a medical test to measure growth hormone (GH).

IPSCIO Record ID: 27528

License Grant
The Company hereby grants to a Swiss company a sole and exclusive right and license including the right to sublicense others to register, use, sell and market Canada Products in Canada.
License Property
The term Canadian products shall mean the pharmaceutical products Activase, registered trademark, tissue plasminogen activator, Protropin, registered trademark, and Nutropin, registered trademark, human growth hormone, Actimmune, registered trademark, interferon gamma and Pulmozyme, registered trademark, dornase alpha each as sold in Canada.

Protropin® (somatrem for injection), is a polypeptide hormone produced by recombinant DNA technology. Protropin® (somatrem for injection) is indicated only for the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion. Skeletal Growth Protropin stimulates skeletal growth in children with growth failure due to a lack of adequate secretion of endogenous growth hormone. Skeletal growth is accomplished at the epiphyseal plates at the ends of a growing bone. Growth and metabolism of epiphyseal plate cells are directly stimulated by growth hormone and one of its mediators, insulin-like growth factor-l. Serum levels of insulin-like growth factor-l are low in children and adolescents who are growth hormone deficient, but increase during treatment with Protropin. New bone is formed at the epiphyses in response to growth hormone. This results in linear growth until these growth plates fuse at the end of puberty.  Cell Growth Treatment with pituitary-derived human growth hormone results in an increase in both the number and the size of skeletal muscle cells.

IPSCIO Record ID: 29098

License Grant
The European Commission granted marketing authorization for Increlex® in the European Union for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor deficiency. Under the Increlex License, the Licensee paid the Licensor a milestone payment for receiving marketing authorization of Increlex® in the European Union for the targeted product label set forth in the Increlex License. Increlex® was launched in the Licensee's territory in November 2007.
License Property
Increlex is used to treat growth failure in children whose bodies do not make enough IGF-1 or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

IPSCIO Record ID: 263941

License Grant
The parties previously entered agreements to develop and commercialize IGF-1 in the United States and in all foreign countries.  The IGF-1 Agreements contain restrictions on each Partys ability to develop a combination product containing both human growth hormone and IGF-1.  This Agreement will collaborate in the development and commercialization of products containing both human growth hormone and IGF-1.

For the Exclusive/Co-Exclusive License,  Licensor grants a license, under the Licensor Patents and Licensor Know-How; Licensors interest in the Joint Patents and Joint Know-How; the GNE Patents and GNE Know-how as identified in the previous agreements,  to use, offer for sale, sell and import Combination Products in the Field in the Territory and otherwise perform its obligations and exercise its rights under this Agreement.

For the Non-Exclusive License, Licensor grants a non-exclusive license, under the Licensor Patents and Licensor Know-How; Licensors interest in the Joint Patents and Joint Know-How;  the GNE Patents and GNE Know-how,  as defined in the previous Agreements to Manufacture, but not to have Manufactured,
Combination Products; Manufacture (but not to have Manufactured, and import IGF-l alone, BP3 alone, ALS alone and/or IGF-1 combined with BP3 and/or ALS, for use in the Manufacture of Combination Products; and perform research and development activities related to the Manufacture of Combination Products or the Manufacture of those compounds, for use and sale within the scope of the license granted.

For the Joint Trademarks, Licensor automatically grants exclusive license, under Licensors interest in the Joint Trademarks for Combination Products for such Indication, to use such Joint Trademarks for
purposes of Developing and Commercializing Combination Products for such Indication in the Field in the Territory.

This Agreement governs the Development and Commercialization of Combination Products for all Indications in the Field in the Territory.

License Property
The patents relate to  IGF-1.  IGF-1 means native-sequence insulin-like growth factor-1 from any species with or without an N-terminal methionine, allelic variants thereof, and sequence variants thereof wherein substitutions and/or deletions are made in the region from 1 to 5 amino acids from the N-terminus of the mature native-sequence IGF-1 of any species, including des-IGF-1 and variants wherein at least the glutamic acid residue is absent at position 3 from the N-terminus of native-sequence human IGF-1.

“Joint Trademarks” means any Trademark or pending Trademark application for the identification of a Combination Product that is registered or filed with the United States Patent and Trademark Office or an agency in a foreign country in the Territory, which agency is the foreign equivalent of the United States Patent and Trademark Office.

The Combination Product means a pharmaceutical formulation or product for use in the Field that contains GH and IGF-1 (including, without limitation, formulations and products containing GH and IGF-1 combined with BP3, IGF-1 combined with ALS or IGF-1 combined with BP3 and ALS) and that, in all cases, except for the purposes of the definitions of Phase I Clinical Trial and Phase II Clinical Trial, is administered either as a Pre-Mixed Formulation or single injection from a pre-filled, dual-chamber container-closure system (e.g., a syringe or vial). Combination Products include Short Stature Products and Non-Short Stature Products.

There will be at least one Combination Product for Short Stature Indications (a Short Stature Product) and at least one Combination Product for the AGHD Indication and Other Indications (a Non-Short Stature Product).

Field of Use
The Field means all prophylactic, diagnostic and therapeutic uses in humans for any Indication. For clarity, Field does not include the Excluded Indications.  Excluded Indications means any human disease, disorder or condition of the central nervous system (CNS) including, without limitation, CNS diseases and conditions arising out of Closed traumatic injury to head; Open traumatic injury to head; Traumatic or crush injury to spinal cord; Birth asphyxia; Perinatal asphyxia; In utero asphyxia; Toxic injury to brain; Near drowning; Acute meningitis (viral or bacterial); Post cardiac bypass surgery; Post extra corporeal membrane oxygenation; Anaesthetic maladventure; Carbon monoxide poisoning; Status epilepticus; Apparent life threatening event of infancy ( near miss cot death); Asphyxiation; Acute Encephalomyelitis; or, Multiple Sclerosis.

The collaboration is for the development, manufacture and worldwide commercialization of two products containing Licensor's recombinant human growth hormone Nutropin AQ® [somatropin (rDNA origin)] and Licensee's recombinant insulin-like growth factor-1 Increlex® (mecasermin [rDNA origin] injection) for the treatment of short stature, adult growth hormone deficiency (AGHD), and potentially other metabolic disorders.

IPSCIO Record ID: 221363

License Grant
The Germany Licensor grants to the Irsih Licensee the exclusive, non-assignableright and license to use the Licensor IPR Package

(a) to Commercialize the Product in the Territory;

(b) to Manufacture in any country the quantities of Product required for Commercialization in the Territory; and

(c) to Develop the Product for Commercialization in the Territory.

License Property
“Product” means any pharmaceutical product containing the API
“API” means the active pharmaceutical ingredient macimorelin acetate, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.

Macrilen™ (macimorelin) is an orally-active ghrelin agonist that stimulates the secretion of growth hormone. Macrilen™ (macimorelin) has been granted orphan drug designation by the FDA for the evaluation of growth hormone deficiency. On December 20, 2017, the FDA granted Licensor marketing approval for Macrilen™ (macimorelin) to be used in the diagnosis of patients with adult growth hormone deficiency (“AGHD”).

“Adult Indication” means assessing GHD in adults.

“GHD” means growth hormone deficiency.

AGHD reportedly affects approximately 60,000 adults across the U.S. and Canada. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life as well as an increase of cardiovascular risks.

Licensor Trademark” means the Macrilen trademark registered in the Territory and any accompanying logos, trade names, trade dress and/or other indicia relating to the Product Controlled by the Licensor.

Field of Use
This agreement pertains to the drug industry relating the evaluation of growth hormone deficiency to be used in the diagnosis of patients with AGHD.  MACRILEN(macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).

IPSCIO Record ID: 7520

License Grant
The entered into a worldwide, exclusive license agreement entered into a worldwide, exclusive license agreement with the Licensor, a stockholder & affiliates, for patents and know-how related to the XTEN technology.
License Property
The Technology is related to the XTEN technology to develop and commercialize up to four licensed products for human use.

Each licensed product is to consist of a selected target attached to an XTEN polypeptide, to develop and commercialize up to four Licensed products, including VRS-317. The license gives Licensee rights with respect to two targets, namely hGH and another specified human protein.

VRS-317 was engineered using XTEN technology to extend the residence time in the bloodstream by reducing the clearance of rhGH from the body by the two primary mechanisms, kidney filtration and receptor mediated clearance. XTEN technology was developed by Licensor and involves the use of novel sequences of natural hydrophilic amino acids that can be genetically fused to a desired protein, such as rhGH in the case of VRS-317.

Field of Use
VRS-317 is for growth hormone deficiency, or GHD, an orphan disease.

GHD is a chronic disease with multiple causes that affects two distinct patient groups, pediatric patients and adult patients, although rhGH treatment options for the two groups are the same. Children with GHD typically have pathologic degrees of short stature, a tendency toward obesity, delayed and deficient mineralization of the skeleton, impaired growth of skeletal muscle and development of a high risk lipid profile. GHD during adulthood manifests as alterations in body composition, such as decreased lean and increased fat mass with skeletal demineralization, and causes adverse changes in cardiovascular outcome markers. Patients with untreated GHD also face increased mortality.

IPSCIO Record ID: 330165

License Grant
Licensee entered into an in-license agreement in respect of patent rights for metreleptin with the Licensor, the primary agency of the United States government responsible for biomedical and public health research.

Pursuant to the terms of the agreement Licensee was granted an exclusive and worldwide license to the intellectual property.

License Property
The Intellectual Property includes the right to sub-license, the Licensors patent rights for the use of leptin, leptin analogs and derivatives.

Metreleptin for injection is approved in the United States under the trade name MYALEPT as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired GL. It is approved in the European Union under the trade name MYALEPTA for the treatment of leptin deficiency in patients with congenital or acquired GL and familial or acquired PL for whom standard treatments have failed to achieve adequate metabolic control. GL and PL are rare diseases characterized by loss or lack of adipose tissues (fat cells), resulting in the deficiency of the hormone leptin.

Field of Use
The field of use is the diagnosis, prevention and treatment of human lipodystrophy.

Lipodystrophy refers to medical problem where there is an abnormal distribution of fat in the body. This can refer both to fat loss (lipoatrophy) and abnormal accumulation of fat tissue. The disease may be inherited genetically, (for example, familial partial lipodystrophy or FPLD), or acquired.

Metreleptin is for the treatment of generalized lipodystrophy (GL) and partial lipodystrophy (PL),  GL and PL patients experience severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease.

IPSCIO Record ID: 256257

License Grant
The Licensors and Licensee have entered a Settlement, License and Development Agreement that resolves all outstanding litigation between the companies, including the patent infringement suits brought in the United States and United Kingdom.

With this agreement, Licensee will no longer provide IPLEX to patients with severe Primary IGF-1 Deficiency and other short stature indications and will withdraw its IPLEX marketing authorization application for severe Primary IGF-1 Deficiency in the European Union.

With this agreement, Licensors have waived the damages award by the jury in the U.S. patent infringement litigation.

For the Limited License for Non-Permitted Indications in the United States Licensor grants a non-exclusive, non-sublicenseable license or sublicense, as applicable, under Licensors entire right, title and interest in and to the Licensed Patents to make, have made, use, sell, offer for sale, and import Product for sale in the United States for any Non-Permitted Indication solely for the continuing treatment of any Existing Patient, for a period of twelve months from the Effective Date.

For the License for Named Patient Indications in the European Union on Named Patient Basis;  Licensor grants a limited, non-exclusive, nonsublicenseable license, or sublicense, as applicable, under Licensors entire right, title and interest in and to the Licensed Patents to make, have made, use, sell, offer for sale, and import Product for sale in any country in the European Union solely for the treatment of one or more of the Named Patient Indications, on a Named Patient Basis only.

For the License for Permitted Indications in the Territory, Licensor grants a non-exclusive license, or sublicense, as applicable, with the right to sublicense, under Licensors entire right, title and interest in and to the Licensed Patents to make, have made, use, sell, offer for sale, and import Product for sale in all countries in the Territory, solely for use in the treatment of any of the Permitted Indications.

License Property
Product means any product containing IGF-1 and IGFBP-3, in any dosage, formulation or method of administration, or any co-administration of IGF-1 and IGFBP-3, including without limitation the product known as IPLEX (mecasermin rinfabate) that is sold by Licensee as of the Execution Date. Product does not include any combination product containing IGF-1 and IGFBP-3 and any other active ingredient(s).

Adult Primary IGF-1 Deficiency means abnormally low concentrations of IGF-1 in adults that are not secondary to growth hormone deficiency; and not secondary to specific pathophysiological states outside the GH/IGF-1 system.

ALS means Lou Gehrig’s disease.

IGF-1 means native-sequence insulin-like growth factor-1 from any species with or without an N-terminal methionine, allelic variants thereof, and sequence variants thereof wherein substitutions and/deletions are made in the region from 1 to 5 amino acids from the N-terminus of the mature native-sequence IGF-1 of any species, including des-IGF-1 and variants wherein at least the glutamic acid residue is absent at position 3 from the N-terminus of native-sequence human IGF-1.

IGFBP-3 means native-sequence, insulin-like growth factor binding protein-3 as described in WO 89/09268 published October 5, 1989, that binds IGF-1, including allelic variants of, and animal equivalents to, human BP3 as well as human BP3, for example, the bovine, ovine, porcine and equine species, and may be from any source, whether natural, synthetic, or recombinant, provided that it will bind to the appropriate binding domain of IGF-1.

Trademark means IPLEX(TM)

Licensed Patents means the Licensor controlled patents, that claim the manufacture, use, sale or importation of Product and/or that claim the manufacture, use, sale, or importation of any product or process used in Insmed’s production of Product, including, but not limited to recombinant production of IGF-1 or any IGF-1 binding protein, and purification of IGF-1 or any IGF-1 binding protein.

Field of Use
The field of use Permitted Indications means all indications except the Non-Permitted Indications.   The Non-Permitted Indications are primary IGFD; severe primary IGFD; Noonans syndrome; growth hormone deficiency; adult growth hormone deficiency (as approved by the FDA and consisting of two subgroups adult and child onset); Adult Primary IGF-1 Deficiency; idiopathic short stature; any other short stature indications; Larons Syndrome; growth hormone insensitivity (OHIS); any diseases or conditions which are approved for sale by Licensors, as of the Effective Date, for the treatment by growth hormone, and all Excluded Indications, which, for the purpose of this Agreement and with respect to Insmed, includes ALS or Lou Gehrig’s disease.

Through licensing and development rights granted by Licensors, Licensee will have freedom to operate regarding the manufacture, development and commercialization of IPLEX for certain non short stature indications including severe insulin resistance, myotonic muscular dystrophy and HIV associated adipose redistribution syndrome (HARS), subject to opt-in rights and royalty provisions for Licensors.

Disclaimer: The information gathered from RoyaltySource® database was sourced from the U.S. Securities and Exchange Commission EDGAR Filings and other public records. While we believe the sources to be reliable, this does not guarantee the accuracy or completeness of the information provided. Further, the information is supplied as general guidance and is not intended to represent or be a substitute for a detailed analysis or professional judgment. This information is for private use only and may not be resold or reproduced without permission.