Royalty Report: Drugs, Genome, Therapeutic – Collection: 227277

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 6

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: 6

Primary Industries

  • Drugs
  • Genome
  • Therapeutic
  • Diagnostic
  • Disease
  • Pharmaceuticals
  • cardiac

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: 227277

License Grant
Pursuant to the attached term sheet between the Swiss Licensor and the Licensee, the agreement is for the exclusive manufacturing of prespecified amounts of API for commercial sales and distribution in Licensees Field of Use.
License Property
The API or Product means (6R)-5,6,7,8-Tetrahydro-L-biopterin dihydrochloride (Tetrahydrobiopterin, BH4) intended for use as an active pharmaceutical ingredient.

Phenoptinâ„¢ is a proprietary oral form of tetrahydrobiopterin (6R-BH4), for the treatment of moderate to mild forms of phenylketonuria (PKU). PKU is a genetic disorder caused by a deficiency of an enzyme, phenylalanine hydroxylase (PAH), which is required for the metabolism of phenylalanine (Phe), an amino acid found in most protein-containing foods.

Field of Use
Licensees Field of Use means use of the Product in the field of single gene disorders, including the indication of phenylketonuria (PKU). Specifically excluded is any single-gene disorder based on mutation or deletion of the nitric oxide synthase gene.

Phenylketonuria (commonly known as PKU) is a rare inherited disorder that increases the levels of a substance called phenylalanine in the blood. Phenylalanine is a building block of proteins (an amino acid) that is obtained through the diet. It is found in all proteins and in some artificial sweeteners.  PKU is caused by a defect in the gene that helps create the enzyme needed to break down phenylalanine.

IPSCIO Record ID: 203325

License Grant
Japanese Licensor grants an exclusive right, exclusive even as to Licensor, with the right to sublicense, under the Licensor Information
– to develop the Drug Product in the Territory for the Other Field, including conducting any development necessary to obtain Regulatory Approval in any of the countries in the Territory for Other Field;
– to manufacture and/or have manufactured the Drug Substance and the Drug Product; and
– to use, promote, offer to sell, sell, have sold, distribute, import, and export the Drug Product in the Territory for the Other Field.

It is expressly understood that Licensees right to sublicense shall be subject to Licensors prior written consent.

License Property
Drug Substance means the chemical substance identified as 6R-BH4 in its code name (generic name Sapropterin) and (6R)-2-amino-6-[(1R,2S)-l,2-dihydroxypropyl]-5,6, 7,8-tetrahydro-4-(3H)-pteridinone dihydrochloride in its chemical name and also known as (6R)-L-erythro-5,6,7,8-tetrahydrobiopterin dihydrochloride, for use in the Drug Product.

Phenoptin (sapropterin hydrochloride) is an investigational oral enzyme co-factor for the treatment of the genetic condition phenylketonuria.
Phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. Phenylalanine is a building block of proteins (an amino acid) that is obtained through the diet.  It is found in all proteins and in some artificial sweeteners. If PKU is not treated, phenylalanine can build up to harmful levels in the body, causing intellectual disability and other serious health problems.

The most severe form of this disorder is known as classic PKU. Infants with classic PKU appear normal until they are a few months old. Without treatment, these children develop permanent intellectual disability. Seizures, delayed development, behavioral problems, and psychiatric disorders are also common.

Patent No. 4,713,454; 6,410,535; 6,288,067l 4,778,794; 5,753,656

Field of Use
The Field means all Indications for all biochemical genetic disorders that are caused by single gene defects, but only to the extent that such biochemical genetic disorder also meets the Orphan Drug regulation requirements.

The Other Field means all therapeutic, diagnostic and preventative uses of Drug Product or Drug Substance that are not Orphan Drugs applied to biochemical single gene defects (i.e., everything other than the Field as defined in a prior license agreement).

IPSCIO Record ID: 203326

License Grant
Licensor grants to the Swiss Licensee a license under the Licensors IP and Licensor’s interest in Joint Project Technology to use, sell, offer to sell, and import each Licensed Product for each Indication solely within the Field and the Territory during the Royalty Term.

Licensee expressly acknowledges that the license granted includes a sublicense of certain rights licensed to Licensor pursuant to the Existing Third Party Agreements, and any sublicense of such rights must comply with the requirements set forth in the respective Existing Third Party Agreements regarding sublicenses granted pursuant to such Existing Third Party Agreement.

License Property
Licensor has developed, licensed or acquired certain intellectual property relating to those certain investigational therapies currently referred to by Licensor as Phenoptin and Phenylase.

The Licensed Product means any product incorporating Phenoptin or Phenylase as an active pharmaceutical ingredient, either alone or with one or more other pharmaceutical ingredients, including all additions, mutations, post-translational modifications (e.g., PEGylation), rearrangements, and other modifications thereto and any other pharmaceutical product that the manufacture, use, sale, offer to sell or import thereof, would infringe one or more Patent Claims under any Patents in or to any Licensor IP; or the research, development, formulation, composition or manufacture of which was performed with the use of or incorporates any Licensor IP; or the development of which was in part funded by Licensor under this Agreement. The term Licensed Product shall include Supplied Product.

Phenoptin means tetrahydrobiopterin (6R-BH4).  Phenylase means phenylalanine ammonia lyase.

Licensors IP includes patents for Methods and Compositions for the Treatment of Phenylketonuria, Crystalline Forms of (6R)-L-erythro-tetrahydrtobiopterin dihydrochloride  and Methods for Preparing Tetrahydrobiopterin, and others.

Phenylketonuria also called PKU, is a rare inherited disorder that causes an amino acid called phenylalanine to build up in the body. PKU is caused by a defect in the gene that helps create the enzyme needed to break down phenylalanine.

Without the enzyme necessary to process phenylalanine, a dangerous buildup can develop when a person with PKU eats foods that contain protein or eats aspartame, an artificial sweetener. This can eventually lead to serious health problems.

Field of Use
The Field means all therapeutic, diagnostic or preventative uses, and these ingredients have been developed for the treatment of genetic disorders that are characterized by an inability of the body to metabolize the essential amino acid, phenylalanine (PKU), including, without limitation, phenylketonuria, and also for the treatment of other disorders.

IPSCIO Record ID: 3467

License Grant
The Licensor receives royalties from the Licensee on 6R-BH4 product sold in Japan. Additionally in 2008, 6R-BH4 royalty revenues included a $1.5 million milestone payment related to the Japanese approval of biopterin, which contains the same active ingredient as Kuvan, for the treatment of patients with PKU.  Phenylketonuria (PKU) is a rare condition in which a baby is born without the ability to properly break down an amino acid called phenylalanine.
License Property
6R-BH4, commonly known as BH4 or tetrahydrobiopterin, is a naturally occurring enzyme cofactor that is required for numerous biochemical and physiologic processes, including the synthesis of nitric oxide (NO). NO has been shown to play a key protective role throughout the cardiovascular system and produces multiple positive effects, such as relaxing smooth muscle, reducing blood pressure, controlling inflammation and reducing platelet aggregation.

Researchers have demonstrated that a deficiency of BH4 can disrupt NO synthesis, resulting in a loss of normal endothelial NO production. This loss of endothelial NO production, commonly referred to as endothelial dysfunction, has been associated with many cardiovascular diseases, including hypertension, diabetic vascular disease, peripheral arterial disease, coronary arterial disease and pulmonary hypertension, and has been shown to be a strong predictor of cardiovascular adverse events in a number of clinical studies.

Field of Use
The rights granted apply to the healthcare industry.

IPSCIO Record ID: 260419

License Grant
The Licensor of France grants to the Licensee of the Netherlands an exclusive license right under the Patents to develop, use, make, have made, sell or offer to sell Product in the Field of Use and in the Territory.
License Property
The patents are relating to the preparation and use of recombinant viruses in gene therapy.

The Product shall mean a gene therapy product containing a recombinant virus with a nucleic acid coding for a lipoprotein lipase (LPL) developed, used and/or commercialized by or for Licensee or its affiliates where the activity in relation to such product occurs in one of the countries of the Territory and is covered in whole or in part by a Valid Claim within the Patents in that country.

Field of Use
The Field of Use shall mean indications of Lipoprotein Lipase (LPL) deficiency also referred to as Type I or V hyperlipoproteinernia.

Lipoprotein lipase deficiency (LPLD) is a rare monogenic disorder of triglyceride metabolism. Deficiency of the enzyme lipoprotein lipase results in pronounced accumulation of triglycerides in the plasma. Specifically, the clearance of chylomicrons is impaired. Chylomicrons, fatty droplets that transport fat in the form of triglyceride, appear in the bloodstream shortly after the ingestion of dietary fat. Chylomicrons are normally cleared from the body after a period of fasting. Lipoprotein lipase recognizes a protein in chylomicrons called apolipoprotein C2, and is then activated to metabolize and clear out triglycerides. However, deficiency or lack of lipoprotein lipase results in the accumulation of chylomicrons and triglycerides in the body. High triglyceride levels are present from infancy and childhood, and various associated symptoms may occur. Some patients remain undiagnosed until adulthood. LPLD is caused by mutations in the LPL gene and is inherited in an autosomal recessive manner.

IPSCIO Record ID: 261354

License Grant
This amendment between the French Licensor and the Licensee of the Netherlands will modify the financial terms associated with royalty payments and create reporting obligations regarding pricing and reimbursement of Licensees gene therapy product Glybera® and its development milestones, and add a Right of First Negotiation for Licensor.  The original agreement was exclusive.
License Property
The original agreement identifies the patents are relating to the preparation and use of recombinant viruses in gene therapy.

The Product shall mean a gene therapy product containing a recombinant virus with a nucleic acid coding for a lipoprotein lipase (LPL) developed, used and/or commercialized by or for Licensee or its affiliates where the activity in relation to such product occurs in one of the countries of the Territory and is covered in whole or in part by a Valid Claim within the Patents in that country.

Field of Use
The Field of Use shall mean indications of Lipoprotein Lipase (LPL) deficiency also referred to as Type I or V hyperlipoproteinernia.

Lipoprotein lipase deficiency (LPLD) is a rare monogenic disorder of triglyceride metabolism. Deficiency of the enzyme lipoprotein lipase results in pronounced accumulation of triglycerides in the plasma. Specifically, the clearance of chylomicrons is impaired. Chylomicrons, fatty droplets that transport fat in the form of triglyceride, appear in the bloodstream shortly after the ingestion of dietary fat. Chylomicrons are normally cleared from the body after a period of fasting. Lipoprotein lipase recognizes a protein in chylomicrons called apolipoprotein C2, and is then activated to metabolize and clear out triglycerides. However, deficiency or lack of lipoprotein lipase results in the accumulation of chylomicrons and triglycerides in the body. High triglyceride levels are present from infancy and childhood, and various associated symptoms may occur. Some patients remain undiagnosed until adulthood. LPLD is caused by mutations in the LPL gene and is inherited in an autosomal recessive manner.

Glybera is used to treat adults with lipoprotein lipase deficiency who have severe or multiple attacks of pancreatitis (inflammation of the pancreas) despite maintaining a low-fat diet.  This is a type of medicine that works by delivering genes into the body.

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