Description
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 5
Primary Industries
- Drugs
- Skin care
- Drug Discovery
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: 319194
The parties hereto agree to the amendment as follows
Licensor has granted Third Parties certain rights under the Distribution Agreements (as such term has been amended based on changes pursuant to this Second Amendment) with respect to research and development of the Products for uses within the Development Field (the “Pre-existing Rightsâ€) and that Licensee’s exclusive license is subject to such Pre-existing Rights.
During the Development Term, Licensee shall have the right to conduct research and development activities outside of the United States in support of Licensee’s efforts to obtain Regulatory Approval in the United States, except in those jurisdictions where such research and development efforts would conflict with the rights granted to Third Parties pursuant to the Pre-existing Rights.
Triglycerides are a type of fat (lipid) found in your blood. When you eat, your body converts any calories it doesnt need to use right away into triglycerides. The triglycerides are stored in your fat cells. Later, hormones release triglycerides for energy between meals.
Development Field means the treatment of any human disease, disorder or condition, including but not limited to UCD, HE or Hyperammonemia.
'GT4P' for the treatment of Urea Cycle Disorder ('UCD'), Hepatic Encephalopathies ('HE') and other indications, and additional indications for AMMONUL(R) (sodium phenylacetate/sodium benzoate) (collectively, the 'Research Projects').
UCD is an inherited, inborn error of metabolism. Patients with UCD lack one of the key enzymes that comprise the urea cycle, which can result in the life-threatening condition of hyperammonemia, i.e., dangerously heightened levels of ammonia in the bloodstream. HE results from a complication of liver failure. Patients with HE experience an accumulation of toxic substances in the bloodstream typically removed by the liver, impairing the function of brain cells to the point of coma or death in severe cases.
A urea cycle disorder (UCD) is an inherited disease that affects how the body removes the waste that is made from breaking down protein.
Hyperammonemia is a metabolic disturbance characterised by an excess of ammonia in the blood. It is a dangerous condition that may lead to brain injury and death. It may be primary or secondary. Ammonia is a substance that contains nitrogen. It is a product of the catabolism of protein.
Licensee is a biopharmaceutical company focused on creating treatments for urea cycle disorders and other rare diseases.
IPSCIO Record ID: 372547
For the Promotion Rights and License
Licensor grants an exclusive, even as to Licensor, nontransferable, non-sublicenseable license to Promote during the Development Term for use in the On-Market Field.
For the Exclusive Commercialization Rights, Licensee shall have the sole and exclusive rights to Commercialize all Products for any and all indications, including any and all indications in the field of Hyperammonemia, which rights shall include the worldwide manufacture and supply of Products for use in all such Commercialization activities.
For the Product Technology and Developed Technology, Licensor grants an exclusive, non-transferable, nonsublicenseable, except as necessary to conduct research and development activities outside of the United States license under the Product Technology and the Developed Technology to research, develop, make, have made, import and use the Development Products to
— perform the activities under the Development and Regulatory Program in the Development Field in the Development Territory;
— perform research and development activities of such Development Products outside the Development Field in the Development Territory; and
— perform research and development activities of such Development Products outside the Development Territory.
For the Manufacturing Technology; Drug Master Files
— During the Development Term, subject to the terms and conditions of the Agreement, Ucyclyd hereby grants to Hyperion an exclusive, non-transferable, nonsublicenseable license under the Manufacturing Technology to make or have
– clinical supplies for GT4P; and,
– commercial supply of Ammonul HE, provided that each such supply, clinical and commercial, is subject to the other terms and conditions of this Agreement regarding manufacture and supply of Products.
For the Licensed Marks, Hyperion Marks, Domain Names and 1-888 Phone Number, Licensor grants an exclusive, except to the extent used by Licensor to exercise its rights and perform its obligations under the Agreement including continuing Promotion and sale of the Marketed Products, nontransferable, non-sublicenseable license to use the Licensed Marks, including the Domain Names and the 1-888 Phone Number, to the extent each contain a Licensed Mark, solely for the purpose of preparing Promotional Materials for the Marketed Products in the On-Market Field in the Promotion Territory; and on and following Closing, for use solely in connection with the Products and Promotional Materials relating thereto, in each case in accordance with the terms and conditions of the Agreement.
Licensor is engaged in the research and development of the product currently referred to as GT4P for use in the treatments of urea cycle disorder and hepatic encephalopathies; and Ammonul for use in the treatment of hepatic encephalopathies.
Ammonul means the pharmaceutical product marketed by Licensor in the Promotion Territory pursuant to NDA 20-645 and any supplements thereto.
Ammonul HE means any products containing sodium phenylacetate and sodium benzoate, including any salts, analogs, metabolites, prodrugs and other physical forms or derivatives of sodium phenylacetate or sodium benzoate, and all Improvements thereto.
Buphenyl means Buphenyl Powder and Buphenyl Tablets.
Buphenyl Powder means the pharmaceutical product marketed by Licensor in the Promotion Territory pursuant to NDA 20-573 and any supplements thereto.
Buphenyl Tablets means the pharmaceutical products marketed by Licensor in the Promotion Territory pursuant to NDA 20-572 and any supplements thereto.
GT4P means any products containing glyceryl tri-(4phenylbutyrate), including any analogs, metabolites, prodrugs, salts, isomers, enantiomers and other physical forms and derivatives thereof, and all improvements thereto.
HE means hepatic encephalopathy or hepatic encephalopathies.
Hyperammonemia means any clinically significant change in blood ammonia concentration, which includes, in any case, each of UCO and HE.
UCD means urea cycle disorder.
The licensed marks are
AMMONUL
BUPHENYL
EXTENDING LIVES FROM INFANCY TO ADULTHOOD
— with respect to GT4P, the treatment of UCD, HE and other forms of Hyperammonemia, individually or collectively, in humans; and
— with respect to Ammonul HE, the treatment of HE in humans.
On-Market Field means
— the treatment of UCD; and
— in the event that Approval of Ammonul HE Prior to Closing applies, with respect to Ammonul
HE, the treatment of HE.
IPSCIO Record ID: 331383
Licensor Know-How means all unpatented inventions, technology, methods, materials, including biological and pharmaceutical materials, know-how, studies, pre-clinical and clinical data, including toxicology, safety data, and bioequivalence studies, tests and assays, reports, manufacturing processes, including manufacturing batch records to support regulatory approvals, regulatory filings and approvals and other information owned or licensed by Licensor as of the Effective Date with the right to license or sublicense without violating the terms of any agreement to which Licensor is party, in each case that relates to Axxx-001 or the subject matter claimed by Licensor Patents or Licensor controlled Patents.
Licensor patents are
Palatable comositions including Sodium Phenylbutyrate and uses thereof, and,
Administration of Sodium Phenylbutyrate in a fasted state to treat urea cycle disorders.
Licensor controlled patent is Methods of modulation of branched chain acids and uses thereof.
Urea cycle disorder (UCD) is an inherited disease that affects how the body removes the waste that is made from breaking down protein. Everyone needs protein, which is found in foods like dairy products, meat and fish.
Infants with a urea cycle disorder appear normal at birth but rapidly develop cerebral edema and the related signs of lethargy, anorexia, hyper- or hypoventilation, hypothermia, seizures, neurologic posturing, and coma.
Classical Maple Syrup Urine Disease (MSUD) is a disease of infancy which is an inherited disorder of metabolism of branched-chain amino acids (BCAA).
Maple syrup urine disease (MSUD) is an autosomal recessive metabolic disorder affecting branched-chain amino acids. It is one type of organic acidemia. The condition gets its name from the distinctive sweet odor of affected infants' urine, particularly prior to diagnosis and during times of acute illness.
IPSCIO Record ID: 336320
Hyperammonemia is a metabolic disturbance characterised by an excess of ammonia in the blood. It is a dangerous condition that may lead to brain injury and death. It may be primary or secondary. Ammonia is a substance that contains nitrogen. It is a product of the catabolism of protein.
Hepatic encephalopathy (HE) is a common neuropsychiatric complication of liver disease.
Field shall mean any and all uses.
IPSCIO Record ID: 340675
Licensor grants Licensee of Switzerland an exclusive, even with respect to Licensor except as necessary or appropriate for Licensor to perform its obligations under the Clinical Supply and Quality Agreement, the Commercial Supply and Quality Agreement, the Pharmacovigilance Agreement and any other agreements or arrangements similar to the foregoing or otherwise providing for the manufacture or supply of Product), nontransferable, sublicensable (with prior written notice to Licensor, license under the Licensor Patents, Licensor Know-How and Development Data for Development and Commercialization in the Field in the Licensee Territory.
Licensor grants a non-sublicensable sublicense to Licensee under the Baylor College of Medicine Patents, to the extent within the Licensee Territory, and Subject Technology for Development and Commercialization in the Field in the Licensee Territory.
The patents include
Palatable compositions including sodium phenylbutyrate and uses thereof;
Administration of sodium phenylbutyrate in a fasted state to treat urea cycle disorders; and,
Methods of modulation of branched chain acids and uses thereof.
Urea cycle disorders (UCDs) are a group of diseases. They make it hard for your child's body to remove waste products as they digests proteins. They are inherited diseases — you pass them down to your child. In most cases, you can manage them with diet and medications.
Maple syrup urine disease (MSUD) is an autosomal recessive metabolic disorder affecting branched-chain amino acids. It is one type of organic acidemia. The condition gets its name from the distinctive sweet odor of affected infants' urine, particularly prior to diagnosis and during times of acute illness.
