Royalty Report: Drugs, cardiac, Disease – Collection: 322362

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 17

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: 17

Primary Industries

  • Drugs
  • cardiac
  • Disease
  • Therapeutic
  • Proteins
  • Drug Discovery
  • Biotechnology
  • Diagnostic
  • Pharmaceuticals

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: 322362

License Grant
Licensor grants an exclusive, worldwide license to develop, manufacture and commercialize PCSK9.
License Property
PCSK9 is a RNAi therapeutics targeting proprotein convertase subtilisin/kexin type 9.

PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that regulates low-density lipoprotein (LDL) receptor levels on hepatocytes; gain-of-function human mutations in PCSK9 are associated with hypercholesterolemia while loss-of-function mutations are associated with lower levels of LDL cholesterol and a reduced risk of cardiovascular disease.

Field of Use
PCSK9 is for the treatment of hypercholesterolemia and other human diseases, including inclisiran.

Hypercholesterolemia, also called high cholesterol, is the presence of high levels of cholesterol in the blood. It is a form of hyperlipidemia, high blood lipids, and hyperlipoproteinemia (elevated levels of lipoproteins in the blood).

Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood which is known to increase the risk of coronary artery disease, the leading cause of death in the U.S. Some forms of hypercholesterolemia can be treated through dietary restrictions, lifestyle modifications (e.g., exercise and smoking cessation) and medicines such as statins.

Inclisiran is an experimental drug for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH). It is a small interfering RNA that inhibits translation of the protein PCSK9.

IPSCIO Record ID: 301197

License Grant
Licensor grants the Licensee of Japan exclusive rights to NEXLETOL and NEXLIZET tablet development and commercialization in Japan.
License Property
NEXLETOL and NEXLIZE are cost-effective, oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicines.
Field of Use
The field of use is for hypercholesterolemia patients in Japan.  Hypercholesterolemia, also called high cholesterol, is the presence of high levels of cholesterol in the blood. It is a form of hyperlipidemia, high blood lipids, and hyperlipoproteinemia (elevated levels of lipoproteins in the blood).  High cholesterol can limit blood flow, increasing risk of heart attack or stroke.

IPSCIO Record ID: 257032

License Grant
The Company will grant Japanese Licensee exclusive commercialization rights to bempedoic acid and the bempedoic acid / ezetimibe combination pill in the European Economic Area and Switzerland (the Territory).   The parties will establish a joint collaboration committee (the “JCC”) to, among other powers and responsibilities, review and guide the implementation and management of development plans of the licensed products in the Territory, review the status of licensed products, approve of Licensee’s request of certain clinical activities, address certain development and manufacturing matters of the licensed products in accordance with the terms of the Agreement, and perform other activities mutually agreed by the Company and Licensee from time to time.
License Property
The bempedoic acid / ezetimibe combination pill, are targeted therapies that have been shown to significantly lower elevated LDL-C levels in patients with hypercholesterolemia, including patients inadequately treated with current lipid-modifying therapies.

Through the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe combination pill is our lead, non-statin, orally available, once-daily, LDL-C lowering therapy.   Inhibition of ATP Citrate Lyase by bempedoic acid reduces cholesterol biosynthesis.

Field of Use
This agreement pertains to the drug for hypercholesterolemia.  Hypercholesterolemia, also called high cholesterol, is the presence of high levels of cholesterol in the blood. It is a form of hyperlipidemia, high blood lipids, and hyperlipoproteinemia (elevated levels of lipoproteins in the blood).

IPSCIO Record ID: 249742

License Grant
The University grants an exclusive, even as to the University, world-wide license to research, develop, commercialize, make, have made, use, import, offer for sale and sell under the University Existing Patents and New Patents, Licensed Products and Materials in all fields during the Term, and under the Assigned Bristol-Myers Squibb Patents and Assigned BMS Technical Information, the Designated Compounds and University Materials in the Field of Use during the Term.
License Property
The patents include Composition Patents, Combination Patents, and, Universitys Existing and New Patents.

Designated Compound means BMS-201,038;  prodrugs or metabolites of BMS-201,038, to the extent any such prodrug or metabolite is covered by a composition claim in a Composition Patent; and  stereoisomers, hydrates, anhydrides, solvates, salt forms, or polymorphs of BMS-201,038 or any compounds; furthermore, in the case of a prodrug or metabolite as referred to above, the compound in question will constitute a Designated Compound hereunder only if the making, use or sale of such compound is necessary for or results from the making, use and sale of BMS-210,038 within the Field of Use.

The University completed a Phase II clinical trial of lomitapide for the treatment of patients with called homozygous familial hypercholesterolemia, or HoFH.

Field of Use
Field of Use means  monotherapy or in combination with other dyslipidemic therapies for treatment of patients with homozygous familial hypercholesterolemia; monotherapy or in combination with other dyslipidemic therapies for treatment of patients with severe hypercholesterolemia of any etiology unable to come within 15% of NCEP LDL cholesterol goal on maximal tolerated oral therapy, as determined by the patient’s prescribing physician; (c) monotherapy or in combination with other dyslipidemic therapies for treatment of patients with severe combined hyperlipidemia of any etiology unable to come within 15% of NCEP non-HDL cholesterol goal on maximal tolerated oral therapy, as determined by the patient’s prescribing physician; and (d) monotherapy or in combination with other dyslipidemic therapies for treatment of patients with severe hypertriglyceridemia unable to reduce TG<1000 on maximal tolerated therapy.

Licensee's lead compound, lomitapide, is a microsomal triglyceride transfer protein inhibitor, or MTP-I, which limits secretion of cholesterol and triglycerides from the intestines and the liver, the main sources of lipids in the body. Licensee is initially developing lomitapide as an oral, once-a-day treatment for patients with a rare genetic lipid disorder called homozygous familial hypercholesterolemia, or HoFH.  These patients are at very high risk of experiencing life threatening events at an early age as a result of extremely elevated cholesterol levels in the blood. Licensee believe that lomitapide, either on a stand-alone basis or in combination with other drugs, has the potential to help these patients achieve recommended target levels of low-density lipoprotein cholesterol, or LDL-C.

IPSCIO Record ID: 291117

License Grant
The Canadian Licensor grants
—  an exclusive license for the Field in the Territory under the Licensed Patents; and
—  an exclusive license for the Field to use the Know-How in the Territory; for the sole and exclusive purpose of developing, making, having made, importing, using and selling Licensed Products in the Territory, including the right to grant sublicenses.
License Property
Licensed Products means human and veterinary therapeutic compositions and methods.

Licensed Patents are titled and related to Liposome Compositions and Methods for the Treatment of Atherosclerosis.

The European patents claim methods for treatment of atherosclerosis using liposomes. The U.S. patent applications claim liposome compositions and methods for treatment of disease, including atherosclerosis. The European patents expires in 2011.

Atherosclerosis refers to the buildup of fats, cholesterol and other substances in and on your artery walls (plaque), which can restrict blood flow. The plaque can burst, triggering a blood clot. Although atherosclerosis is often considered a heart problem, it can affect arteries anywhere in your body.

Field of Use
Together, the Basic Field, Improvements Field and Know-How Field comprise the Field.   Field means human and veterinary therapeutics, the Basic Field;
—  For Improvements, human and veterinary therapeutics, but limited to products that use or include Large Unilammelar Vesicles (LUVS) as a therapeutic agent which are not associated with any other therapeutic agent other than an apoprotein, the Improvements Field;
—  For Know-How, human and veterinary therapeutics, but limited to products that use or include Large Unilammelar Vesicles (LUVS) as a therapeutic agent which are not associated with any other therapeutic agent other than an apoprotein, the Know-How Field;

IPSCIO Record ID: 153529

License Grant
Licensor grants the exclusive right and license to market, promote, sell and distribute the Products listed in the Territories.
License Property
Licensor products are Metformin Extended Release, Lovastatin Extended Release and Omeprazole Delayed Release Capsules.

Lovastatin Extended Release is used along with a proper diet to help lower 'bad' cholesterol and fats? (such as LDL, triglycerides) and raise 'good' cholesterol (HDL?) in the blood.

Metformin and extended release metformin are used in type 2 diabetes to improve glycemic control in combination with diet and exercise.

Omeprazole Delayed-Release Capsules is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.

Field of Use
Lovastatin is a statin drug, used for lowering cholesterol in those with hypercholesterolemia to reduce risk of cardiovascular disease.

IPSCIO Record ID: 347182

License Grant
Licensor will grant Licensee exclusive development and commercialization rights to bempedoic acid and the bempedoic acid /ezetimibe combination tablet for purposes of treating hyperlipidemia in humans (the Field) in the following territories South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, Macao, Cambodia and Myanmar (the Daiichi Territory).
License Property
Bempedoic acid and the bempedoic acid /ezetimibe combination tablet is a oral, small molecule in fixed-dose combination developed to lower elevated LDL-C (low-density lipoprotein cholesterol) to help patients who still need additional lipid lowering despite taking maximally tolerated statin therapy.
Field of Use
Field of use is for purposes of treating hyperlipidemia in humans.

Hyperlipidemia is an abnormally high concentration of fats or lipids in the blood commonly known as high cholesterol.

IPSCIO Record ID: 300431

License Grant
Each of the Company and Licensee will obtain an exclusive license under certain intellectual property rights of the other party to commercialize Praluent in the United States and outside the United States, respectively.
Licensee of France will transfer to the Company certain assets relating to the commercialization of Praluent in the United States.  The Company, at its sole cost, is solely responsible for the development and commercialization of Praluent in the United States, and Licensee, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States.
License Property
PRALUENT® (alirocumab) is indicated
– to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

– as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C).

Field of Use
Praluent® (alirocumab) used in the treatment of high cholesterol.

IPSCIO Record ID: 383599

License Grant
For the Product License, Licensor grants an exclusive license, with the limited right to sublicense, under the Licensed IP to research, develop, make, have made, use, sell, offer for sale, have sold, import and export Products in the Territory for therapeutic purposes.

For the Limited Right to Sublicense, the Product License is sublicensable only in connection with a sublicense of a Product to any Affiliate of Licensee or to any Third Party,

License Property
Licensor has intellectual property to advance mipomersen and related compounds targeting apoB.

Mipomersen means mipomersen sodium, including all pharmaceutically acceptable salts, solvates, hydrates, hemihydrates, metabolites, pro-drug forms, stereoisomers, enantiomers, racemates and all optically active forms thereof.

apoB means apolipoprotein B.

Product means all pharmaceutical compositions, formulations, dosage forms, delivery systems and presentations that contain Mipomersen or any Follow-On Compound as an active ingredient.

ASO Product any preparation in final form for sale by prescription, over-the-counter or any other method for any indication, including human or animal use, which contains one or more oligonucleotides or an analog thereof that  selectively modulates protein synthesis at the nucleic acid level through the binding of such oligonucleotide to a complementary sequence.

FH means familial hypercholesterolemia.

Licensed Product Patents means the Shortmer Patent, and any Patent Controlled by Isis during the Term, including any Licensor Program Patents and Joint Patents, claiming nucleic acids that hybridize to a nucleic acid molecule encoding apoB, the sequence of apoB. the specific composition of matter of a Product, or methods of using Product as a therapeutic, methods of using Product to modulate apoB, and methods of using the Product to inhibit expression of apoB- and also claiming or describing (x) nucleic acids that hybridize to a nucleic acid molecule encoding a gene target other than apoB or ( y) methods of using such nucleic acids as a therapeutic or to modulate a gene target other than apoB.

Field of Use
The field of use is to treat homozygous familial hypercholesterolemia.  Homozygous familial hypercholesterolemia is a disorder where it is hard for your body to remove LDL 'bad' cholesterol from your blood. The disease raises your chances of a heart attack at an early age, but drugs and other treatments can lower your risk.

Licensee will develop and commercialize mipomersen, Isis' lipid-lowering treatment for high risk cardiovascular patients that utilizes novel antisense technology.  Mipomersen, formerly ISIS 301012, is a lipid-lowering drug targeting apolipoprotein B-100. Currently in phase 3 development, mipomersen has been shown in phase 2 trials to reduce cholesterol and other atherogenic lipids more than 40 percent beyond reductions achieved with current standard lipid-lowering drugs, enabling more patients to achieve lipid targets.

IPSCIO Record ID: 258520

License Grant
The Company granted to Licensee an exclusive license in Japan, with the right to grant sub-licenses, to manufacture and commercialize the Company’s current product.
License Property
The current product is JUXTAPID, a product that contains lomitapide as the sole active ingredient.   Lomitapide is a drug used as a lipid-lowering agent .
Field of Use
The field of use is for the current marketed indication for homozygous familial hypercholesterolemia (HoFH).  Familial hypercholesterolemia is a genetic disorder. It is caused by a defect on chromosome 19. The defect makes the body unable to remove low density lipoprotein (LDL, or bad) cholesterol from the blood.

IPSCIO Record ID: 123666

License Grant
Licensee exercised the right to enter into an exclusive license agreement.  In December 2015, the parties entered into an option agreement to explore a novel approach to develop a drug in the field of hypercholesterolemia.
License Property
The developed drug would be a spleen tyrosine kinase or Syk inhibitors,  a drug in the field of hypercholesterolemia.
Hypercholesterolemia, also called dyslipidemia, is the presence of high levels of cholesterol in the blood.
Field of Use
Licensee is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis, other hematologic diseases and inflammation for patients who currently have limited or no approved treatment options.

IPSCIO Record ID: 263518

License Grant
Licensee receives from the Israeli Licensor a co-exclusive, sublicenseable license under the technology and collaboration technology to conduct collaborative development of development targets, compounds and products.

If Licensee exercises its option with respect to a development target and the parties enter into a license agreement, Licensee receives an exclusive, sublicenseable, license under our technology and collaboration technology to exploit compound and products with respect to such development target.

Licensee initially selected two development targets, including Glycogen Storage Disease III, and the parties agreed to a list of eight additional reserved targets related to rare diseases for which Licensee has the exclusive right to evaluate for collaborative development. During the reserved target exclusivity period Licensee may substitute a reserved target for a selected target, and/or exercise an expansion option by payment to us, whereby a reserved target will be deemed an additional target (and will preclude an additional reserved target in place of the converted reserved target). Further, during the reserved target exclusivity period, Licensee may replace a reserved target with a proposed new target, subject to certain conditions including whether we have the ability to partner such new target.

The Agreement additionally provides for limitations on our activities with third parties utilizing LUNAR lipid-mediated delivery technology with respect to a development target for a specified period of time. During the reserved target exclusivity period, we have agreed to exclusivity with respect to any product containing mRNA, including modified mRNA, or UNA oligomer with respect to such reserved target, and will first offer Licensee a right of first negotiation for any other RNA product or a product utilizing the LUNAR delivery technology with respect to such reserved target. The reserved target restrictions terminate upon expiration of the reserved target exclusivity period for each target, which may be extended on a reserved target-by-reserved target basis upon payment of an exclusivity extension fee.

On a reserved target-by-reserved target basis, following the target exclusivity period, Licensee receives an exclusive right of first negotiation to obtain an exclusive license to exploit RNA products with respect to such reserved target. Following the reserved target right of first negotiation period, if the parties have not entered into an agreement during a specified time period, the rights of Licensee terminate and we may grant a license or enter into a third-party arrangement with respect to such reserved target.

License Property
The collaboration technology specifically relates to the composition or formulation of a particular compound or product, or any method of using, making or administering a particular compound or product, and, all improvements to LUNAR lipid-mediated delivery technology and/or UNA oligomer chemistry.

The proprietary lipid nanopartical deliver system, LUNAR®, enables multiple nucleic acid medicines.  LUNAR® lipid-mediated delivery technology includes a diverse, growing library of over 150 proprietary lipids that Licensor rationally designed to be versatile, maximizing efficacy and increasing tolerability of a diverse selection of nucleic acids, target cell types and routes of administration. A key feature of our LUNAR lipids is their biodegradability, decreasing the undesired effects caused by lipid accumulation that are associated with tolerability issues present in other lipid-mediated RNA medicine delivery platforms.  LUNAR® and nucleic acid technologies are covered by a patent portfolio of 152 patents and patent applications, issued in the United States, China, Europe, Japan and other countries.

Unlocked Nucleic Acid (UNA) – are RNA analogues in which the C2’-C3’ bond of the ribose ring is absent. UNA chemistry technology can potentially be applied to multiple types of RNA medicines including mRNA, siRNA, microRNA and guide RNAs for gene editing. One or more UNAs can be positioned strategically along a nucleic acid strand to manipulate the chemical properties of the molecule.  UNAs can potentially improve the efficiency and specificity of siRNA-mediated protein suppression. siRNAs are short double-stranded RNA molecules. Once inside the cell, they become part of the RNA-induced silencing complex (RISC) and are split into two single siRNA strands. One of these strands stays with RISC and binds to any mRNA with a complementary sequence. If the wrong siRNA strand stays with RISC, it can bind to different mRNAs than the target mRNA and therefore inhibit translation of other proteins. This is an undesired off-target effect and is one of the major barriers to developing effective siRNA medicines. Incorporating a single UNA into siRNA molecules can make one of the strands preferentially bind to RISC improving specificity. Additionally, incorporation of UNA modifications can reduce susceptibility of the siRNA to nuclease degradation, improving the efficiency of siRNA-mediated protein suppression.  The comprehensive suite of UNA technology patents for therapeutic and reagent use, enabling Licensor to operate freely and to independently pursue nucleic acid therapeutic candidates incorporating this technology.

The Agreement provides that each party owns their respective collaboration know-how and collaboration patents and jointly own all joint collaboration know-how and joint collaboration patents.

Field of Use
This partnering is to develop up to ten mRNA therapeutic candidates for certain rare disease targets.  Target means any single protein (i.e., a protein designated by a unique NCBI reference sequence but including all of its naturally-occurring mutations and variants) that could be used as a potential treatment for a rare or ultra rare disease and that is expressed in the liver, including  Glycogen Storage Disease Type 3 (GSD), caused by genetic mutations in the glycogen debranching enzyme, known as  AGL, which leads to glycogen accumulation in liver and muscle.  There are approximately 10,000 patients worldwide with this type of GSD, who experience enlarged liver, increased fats in the blood, low blood sugar, decreased stature and late-onset muscle weakness.

The Licensed Field is for the diagnosis, prevention or treatment of human diseases.

IPSCIO Record ID: 300

License Grant
The University grants the Licensee an exclusive right and license to practice, commercialize and otherwise exploit the Licensed Patents and grants the exclusive right and license to make, have made, research, develop, use, lease, offer to sell, sell, import and export Licensed Products, within the Licensed Field of Use in the Licensed Territory during the term.
The Licensee has the right to grant sublicenses.
License Property
The licensee covers AEM-28 and certain analogs.

U.S. Patent No. 6,156,727. Anti-atherosclerotic peptides and a transgenic mouse model of atherosclerosis.
U.S. Patent No 6,506,880. Synthetic peptides that enhance atherogenic lipoprotein uptake and lower plasma cholesterol.
U.S. Patent No. 7,653,771. Synthetic single domain polypeptides mimicking apolipoprotien F, Anantharamaiah.

Apolipoprotein E (Apo E) is a 299 amino acid protein that plays an important role in lipoprotein metabolism. AEM-28 is a 28 amino acid mimetic of Apo E that contains a domain that anchors into a lipoprotein surface while also providing the Apo E binding domain that is removed by heparin sulfate receptors in the liver. AEM-28 as an Apo E mimetic has the potential to restore the ability of atherogenic lipoproteins to be cleared from the plasma, completing the reverse cholesterol transport pathway, and thereby reducing cardiovascular risk. This is an important mechanism of action for AEM-28. For patients that lack LDL receptors (Homozygous Familial Hypercholesterolemia or HoFH), have Severe Refractory Hypercholesterolemia, or have acute coronary syndrome, AEM-28 may provide a therapeutic solution.

Field of Use
Licensed Field of Use means any and all diagnostic, therapeutic and prophylactic uses in all fields of use, and for all indications except diseases of the eye.

IPSCIO Record ID: 233152

License Grant
The Licensor grants to the Cayman Island Licensee and its Affiliates a sole and exclusive  royalty-bearing license, with the right to sublicense, under the Licensor IP and rights in the Product IP, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize and have Commercialized Compounds and Products in the Field in the Territory.  The License provides exclusive rights to and use of the Licensors patent portfolio of Apo E mimetic peptides and formulations, which have anti-inflammatory properties, in the territory.
License Property
Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides.

Apolipoprotein E (Apo E) is in a class of protein that occurs throughout the body. Apo E is essential for the normal metabolism of cholesterol and triglycerides. After a meal, the postprandial (or post-meal) lipid load is packaged in lipoproteins and secreted into the blood stream. Apo E targets cholesterol and triglyceride rich lipoproteins to specific receptors in the liver, decreasing the levels in the blood. Elevated plasma cholesterol and triglycerides are independent risk factors for atherosclerosis, the buildup of cholesterol rich lesions and plaques in the arteries. Atherosclerosis is the major cause of cardiovascular disease, peripheral artery disease and cerebral artery disease, and can cause heart attack, loss of limbs and stroke. Defective lipid metabolism also plays an important role in the development of adult onset diabetes mellitus (Type 2 diabetes), and diabetics are particularly vulnerable to atherosclerosis, heart and peripheral artery diseases.

Field of Use
Field means all diagnostic, therapeutic and prophylactic uses for all indications, except for the diseases of the eye.

IPSCIO Record ID: 7419

License Grant
The Licensee, as part of a strategic alliance, entered into an agreement with the Belgium Licensor.

The Licensor granted the Licensee an exclusive, worldwide, royalty-bearing license to MBX-8025 and certain other PPAR compounds (the PPAR Products) with the right to grant sublicenses to third parties to make, use and sell such PPAR Products.

License Property
PPAR – Peroxisome proliferator-activated receptors form a family of nuclear hormone receptors involved in energy hemostasis and lipid metabolism.

MBX-8025 is a selective agonist (a substance that stimulates a response by binding to a receptor) for the peroxisome proliferator-activated receptor delta (PPARd), a nuclear receptor that regulates genes involved in lipid storage and transport (particularly in fatty acid oxidation) and insulin signaling and sensitivity. In preclinical studies in rodents, dogs and primates, MBX-8025 demonstrated a variety of beneficial effects on the lipid profile and other metabolic parameters. MBX-8025 treatment increased peripheral oxidation of fatty acids leading to reduced levels of triglycerides (TGs) and low-density lipoprotein (LDL), while raising high-density lipoprotein (HDL). MBX-8025 inhibited fat mass accumulation, resulting in attenuation of body weight gain in rodent models of obesity.

MBX-8025 has potential therapeutic application for disorders linked to deficits in lipid storage, handling and utilization, many of which result in metabolic disorders. To date, it has been in development as a first-in-class treatment that effectively addresses all three lipid disorders associated with mixed dyslipidemia (abnormal lipid levels in the blood) as well as a majority of the cardiovascular risk factors that define metabolic syndrome. The future development program will focus on high unmet need indications in dyslipidemia as well as in high unmet need specialty and orphan diseases.

The 8-week Phase 2 study investigated MBX-8025 at doses of 50 or 100 mg/day in moderately obese patients with mixed dyslipidemia. The study demonstrated that treatment with MBX-8025 led to significant reductions in total LDL (~20%) and selective depletion of the small dense atherogenic (promotion of arterial plaque formation) LDL particles, resulting in an exceptional improvement in the LDL particle size profile. It also decreased TGs (~30%) and raised HDL (~12%). This unique combination of effects significantly decreased the atherogenic risk of patients’ lipid profile. When administered in combination with atorvastatin (Lipitor®), MBX-8025 provided a comprehensive improvement in all lipid and cardiovascular risk parameters without side effects seen in other combination lipid therapies.

In addition, MBX-8025 addressed other aspects of metabolic syndrome, including improvements in insulin sensitivity and trends toward decreased waist circumference and body fat. Over half of the patients that entered the Phase 2 study meeting the criteria for metabolic syndrome no longer met the criteria at the end of the study.

The product seladelpar is for the treatment of primary biliary cholangitis (PBC), an autoimmune disease that causes progressive destruction of the bile ducts in the liver. Seladelpar is a potent and selective agonist of PPARd, a nuclear receptor that regulates genes important for lipid, bile acid/sterol and glucose metabolism and for inflammation in liver and muscle.

Field of Use
This agreement pertains to the drug industry relating to treatment of an autoimmune disease.

Under the terms of the agreement, the Licensee has full control and responsibility over the research, development and registration of any PPAR Products and is required to use diligent efforts to conduct all such activities.

The Licensee shall grant the Licensor a worldwide, exclusive, irrevocable license under the agreement in all information that is controlled, developed or acquired by the Licensee which relates to a PPAR compound or PPAR product and in all patents that are filed.

IPSCIO Record ID: 362449

License Grant
University hereby grants to Corporation and Corporation hereby accepts from University the License. License shall mean the exclusive worldwide license to practice the University Patents (as hereinafter defined) for the development, manufacture, use and sale of the Licensed Products (as hereinafter defined) in the Field.

University reserves the right to use, and to permit other non-profit academic institutions to use, the University Patents for educational and research purposes.

The parties acknowledge that the United States government retains rights in intellectual property funded under any grant or similar contract with a Federal agency. The License is expressly subject to all applicable United States government rights, including, but not limited to, any applicable requirement that products, which result from such intellectual property and are sold in the United States, must be substantially manufactured in the United, States.

Corporation shall be entitled to grant sublicenses under the License on terms and conditions in compliance and not inconsistent with the terms and conditions of this Agreement

License Property
University Scientists have made certain inventions relating to microRNA 33, metabolic disorders, and atherosclerosis, all as more particularly described in U.S. patent applications US provisional patent application number 61/377,789, filed August 27, 2010, and US provisional patent application number 61/412,720, filed November 11, 2010, both titled 'mir33 Inhibitors and Uses Thereof to Raise Plasma High Density Lipoprotein” owned by University (hereinafter the Pre-Existing Patent Applications).
Field of Use
Field shall mean the prophylactic or therapeutic reduction of microRNA 33 levels or activity for the treatment or prevention of metabolic disorders or atherosclerotic plaque in humans.

The patent rights encompassing the use of an anti-miR therapeutic targeting miR-33 for the treatment of atherosclerosis, metabolic syndrome and elevated triglycerides.
Atherosclerosis is the buildup of fats, cholesterol and other substances in and on your artery walls.
Metabolic syndrome is a cluster of conditions that occur together, increasing your risk of heart disease, stroke and type 2 diabetes. Metabolic syndrome includes high blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol levels. The syndrome increases a person's risk for heart attack and stroke.
Aside from a large waist circumference, most of the disorders associated with metabolic syndrome have no symptoms.
Elevated triglycerides is high level of a certain type of fat (triglycerides) in the blood. Elevated triglycerides may contribute to pancreatitis or hardening of the arteries. This increases the risk of stroke, heart attack, and heart disease.

IPSCIO Record ID: 5858

License Grant
The Licensor has granted the Licensee a non-revocable and exclusive worldwide license including the right to sublicense to third parties to the patents necessary to develop and commercialize drug candidates in which Cardio Vascu-Grow is the active ingredient. As a part of that agreement, Licensor will provide technical development services to us for the development and regulatory approvals of our drug candidates, including but not limited to, lab work, testing and production of our drug candidates in which Cardio Vascu-Grow is the active ingredient for clinical trials, all as directed by us.
License Property
We are working closely with an affiliated company, Cardio, pursuant to a joint patent and technology sharing agreement, to manufacture human fibroblast growth factor-1 (Cardio Vascu-Grow) for Cardio’s ongoing clinical trials.

Cardio Vascu-Grow Human Fibroblast Growth Factor-1 treat patients with advanced atherosclerotic disease of their coronary arteries. This treatment, which regenerates new blood vessels in the hearts of these patients.  Atherosclerosis is a disease affecting arterial blood vessels. It is a chronic inflammatory response in the walls of arteries, in large part due to the accumulation of macrophage white blood cells and promoted by low density (especially small particle) lipoproteins (plasma proteins that carry cholesterol and triglycerides) without adequate removal of fats and cholesterol from the macrophages by functional high density lipoproteins (HDL), (see apoA-1 Milano).

Issued US Patents
1. U.S. 6,268,178 entitled “Phage-Dependent Super-Production of Biologically Active Protein and Peptides;” and
2. U.S. 6,642,026 entitled “Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis.”
3. U.S. 6,773,899 entitled “Phage-Dependent Super-Production of Biologically Active Protein and Peptides”;
4. U.S. 6,794,162, entitled “Phage-Dependent Super-Production of Biologically Active Protein and Peptides;”
Pending US Patent Applications 1.. U.S. 10/649,480 entitled “Method of Producing Biologically Active Human Acidic Fibroblast Growth Factor and its Use in Promoting Angiogenesis;” published as US Patent Application No. US 2004/0115769

Field of Use
Cardio Vascu-Grow™ stimulates the growth of new blood vessels, a biological process termed “angiogenesis”. This growth factor is being tested in a wide variety of human diseases that would benefit from increased angiogenesis including coronary artery disease, stroke, and peripheral vascular disease of the legs and wound healing.
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