Royalty Report: Drugs, Hormones, Disease – Collection: 274910

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 10

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: 10

Primary Industries

  • Drugs
  • Hormones
  • Disease
  • Therapeutic
  • Delivery
  • Diagnostic
  • 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: 274910

License Grant
Licensee shall have the exclusive option to include the Option Territory.

For the Exclusive License, Licensor grants an exclusive right and license, with the right to grant sublicenses under the Licensor Technology and Licensors interest in and to the Joint Collaboration Technology to make, and have made, use, and import Formulations and Products in the Field in the Licensed Territory and sell and offer for sale Products in the Field in the Licensed Territory.

For the Non-Exclusive License, as applicable prior to the expiration of the Option Period or if Licensee does not exercise the Option, Licensor further grants a non-exclusive right and license, with the right to grant sublicenses, under the Licensor Technology to make, and have made, Formulations and Products in the Field in the Option Territory, and to use, and import, but not sell or offer for sale, Formulations and Products in the Field in the Option Territory; in each case solely for the purpose of developing Formulations and Products and commercializing Products in the Field in the Licensed Territory.

License Property
Licensor is engaged in the development and commercialization of protein therapeutics for patients with chronic gastrointestinal and metabolic diseases and is currently developing a drug product candidate, known as ALTU-238, for the treatment of patients with growth hormone disorders.

ALTU-238 means any pharmaceutical product containing a polyarginine-Complexed crystal formulation,
including the formula designated by the internal Licensor Compound code ALTU-238.

Compound means synthetic, natural or recombinant human growth hormone or any of its active fragments, analogues derivatives or other variants.

Formulation means any composition containing a polycation-Complexed crystallized Compound.

Product means any pharmaceutical product containing a Formulation, and not any other active pharmaceutical ingredient that is not a Compound which active pharmaceutical ingredient is Covered by a Valid Claim within the Licensor Technology or that uses or embodies Licensor Know-How.

ALTU-238 is a long-acting subcutaneous formulation of recombinant human growth hormone, in a ready-to-use liquid suspension formulation, that employs Licensor's proprietary protein crystallization and formulation technology. Altus' technology preserves the structure of the human growth hormone molecule without the need for polymers or encapsulation and enables administration through a fine gauge needle. Recombinant human growth hormone is approved for treating multiple growth disorders in children and adolescents and for growth hormone replacement in adults.

Field of Use
ALTU-238 is a subcutaneously administered, once-per-week formulation of human growth hormone, which employs Licensor's proprietary protein crystallization and formulation technology, for patients with growth hormone deficiencies.

IPSCIO Record ID: 275008

License Grant
For the Conduct of Development Plan, Licensor grants a non-exclusive, non-transferable, non-sublicenseable right and license under the Licensor Technology, Licensor Collaboration Technology, Licensee Technology and Joint Collaboration Technology; in each case to make and use, but not sell, offer for sale or import, Products in the Field in the North American Territory solely to the extent necessary for Licensee to perform those development activities with respect to a Formulation or Product to be performed by Licensee, and, to conduct certain other activities approved in advance by Licensor.

For the Co-Promotion, Licensor grants a non-exclusive, non-transferable, non-sublicenseable, right and license under the Licensor Technology, Licensor Collaboration Technology, Licensee Technology and Joint Collaboration Technology; in each case solely to the extent necessary, to Co-Promote Products in the Co-Promote Territory in the Field.

For the Polycation Collaboration Technology, Licensor grants a non-exclusive, non-transferable right and license under the Polycation Collaboration Technology to make, use, sell, offer for sale or import any product that is not a Formulation or Product in the Licensed Territory, and any product outside of the Licensed Territory.

For the Licensor Housemarks, Licensor grants a non-exclusive, non-transferable, non-sublicenseable, right and license to use the Licensor Housemarks and Product Trademarks solely in connection with Licensees Co-Promotion of Products in the Co-Promote Territory in the Field.

This agreement also includes exclusive grants back to Licensor from Licensee.

License Property
Licensor has significant experience in the development and commercialization of drug products, particularly growth hormone products,

Compound means synthetic, natural or recombinant human growth hormone or any of its active fragments, analogues derivatives or other variants.

Formulation means any composition containing a polycation-Complexed crystallized Compound.

Product means any pharmaceutical product containing a Formulation, and not any other active pharmaceutical ingredient that is not a Compound which active pharmaceutical ingredient is Covered by a Valid Claim within the Licensor Technology or that uses or embodies Licensor Know-How.

Field of Use
ALTU-238 product candidate, is a crystallized formulation of Human Growth Hormone (HGH) that is designed to be administered once-weekly through a fine gauge needle for the treatment of HGH disorders.

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: 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.

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: 202864

License Grant
The Parties agree to continue their collaboration on research and development programs to research the use of the Licensor's Technology for oral delivery of parathyroid hormone molecule and human growth hormone molecules (excluding calcitonin) and human growth hormone molecules (not to include secretagogues) and mimetics (PTH and HGH), as well as to study the potential for the Licensors Technology to improve non-oral administration routes, including, but not limited to, the injectable (sub-cutaneous, intra-venous, intra-muscular, intra-peritoneal and depot), buccal, nasal, ocular, pulmonary, transdermal and vaginal administration routes (the 'Non-Oral Routes') of proteins all as more specifically set forth in the PTH and HGH Work Plans. Licensor will make available to Lilly access to all Licensor Technology relevant for the Program.
License Property
Licensor is engaged in the research and development of proprietary synthetic chemical compounds that enable the delivery of therapeutic macromolecules and other compounds that are not currently deliverable by oral means or by certain non-oral means.

The strategic alliance is to develop oral formulations of ForTeo (recombinant parathyroid hormone) and Humatrope (human growth hormone (HGH)) utilizing the Licensor's proprietary drug delivery technology.

Field of Use
Licensee is engaged in research to produce, therapeutic macromolecules and other compounds that are not currently deliverable by oral means or by certain non-oral means.

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: 327464

License Grant
Licensor of Germany grants to Licensee of Ireland the exclusive right to use the Licensed Rights and any Improvements during the Term to Commercialize, including marketing, selling and offering to sell, of the Licensed Product in the Field in the Territory and to conduct the necessary actions to obtain and maintain Marketing Authorizations in the Field in the Territory.  Licensee may grant sublicenses in respect of the Licensed Rights and any Improvements to Third Parties.
License Property
Licensed Product shall mean Macimorelin acetate 60 mg granules for oral suspension in sachet, and any and all other forms of administration, pack sizes, and presentations of the Compound for use in the Field.  The Licensed Product is an oral growth hormone secretagogue receptor agonist indicated for the diagnosis of growth hormone deficiency (GHD) in adults and approved by the European Commission.

Compound shall mean the active pharmaceutical ingredient macimorelin acetate.

GHD Test shall mean a growth hormone deficiency test conducted using the Licensed Product.

Field of Use
The Field shall mean the diagnosis of human growth hormone deficiency in adults, the Paediatric Use and any and all further diagnostic uses of the Licensed Product. Field shall not cover any therapeutic uses of the Licensed Product.

Licensee will commercialize the Licensed Product supplied in the Field and in the Territory.

IPSCIO Record ID: 356972

License Grant
Licensor grants a worldwide, exclusive, even as to Licensor, license, with the right to grant sublicenses, under the Licensed Technology, to make, have made, use, sell, offer for sale and import and otherwise Commercialize Licensed Products in the Field in the Territory.
License Property
Licensor is a corporation with proprietary transdermal drug delivery technology, and, has completed a Phase 2 Clinical Trial for a patch utilizing a micro-projection system containing a once-daily formulation of parathyroid hormone (PTH) and a Phase 1 Clinical Trial for such a patch containing a once-weekly formulation of PTH.

Licensed Products means the Daily Product and any Product Patch with a New Dosing Duration.

Daily Product means a Product Patch which is intended to deliver PTH formulations to a patient one time each day.

New Dosing Duration shall be any dosing duration, other than once daily, with respect to a Product Patch or Licensed Product. For example, if a Licensed Product has an administration once daily, then a once weekly administration would be a New Dosing Duration.

Pen means the pre-filled cartridge pen device currently marketed by Licensee to administer via injection once daily formulations of the Licensee’s recombinant human PTH analog (1-34) rhPTH (1-34) or manufactured by Licensee to administer a placebo.

Product Patch means a micro-projection array which pierces through the outmost, the stratum corneum, layer of the skin and either in which the micro-projections are coated with a formulation containing PTH as an active pharmaceutical ingredient, to deliver such active pharmaceutical ingredient into or through the skin, in a passive, diffusion-mediated manner, or to form pathways for diffusion-mediated delivery of PTH as an active pharmaceutical ingredient into or through the skin, in each inclusive of an applicator device, API, patch and packaging. For purposes of clarity, the Product Patch shall include all dosage and timed release formulations of PTH.

Field of Use
Field means all uses of PTH.

Licensee currently markets Forteo®, a once-daily formulation of Licensee’s recombinant human PTH analog (1-34) rhPTH(1-34) administered by subcutaneous injection and approved in the United States for the treatment of severe osteoporosis.

FORTEO is a prescription medicine used to treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis. FORTEO is used to increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO is used to treat both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.

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.

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