Royalty Report: Drugs, Delivery, Hormones – Collection: 356972

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 12

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: 12

Primary Industries

  • Drugs
  • Delivery
  • Hormones
  • Therapeutic
  • Disease
  • Medical
  • Osteoarthritis
  • Proteins

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: 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: 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: 203450

License Grant
Licensor grants an exclusive license in the Territory, and, the right to grant sub licenses, to rights under
(a) the Licensor Patents and Technology; and
(b) Licensors rights in any Joint Developments in the Field;
in each case to develop, use, make, have made, sell or otherwise dispose of the Products in the Field; provided, however, that notwithstanding the foregoing, Licensee shall not have the right to make or have made the Products other than as expressly contemplated by or provided in the Manufacturing and Supply Agreement, or to modify in any way the structure or composition of the Products, without the prior written consent of Licensor.
License Property
The patents cover the T-Patch and/or the TE Patch.

Products means the TE Patch and the T-Patch. For the avoidance of doubt, Products does not include Intrinsa.

The Once A Week T Patch means the transdermal patch drug delivery system to be developed by Licensor that will contain testosterone as the single active ingredient at a dosage in vitro of testosterone to be determined, that is intended to be worn for seven consecutive days, which shall be evidenced by either an NDA or a supplement to the NDA for the T Patch or lntrinsa.

The T-Patch means the transdermal patch drug delivery system developed by Licensor that contains testosterone as the single active ingredient at an in vivo dosage bio-equivalent to Intrinsa which is worn for three to four consecutive days, which shall be evidenced by either an NDA, a supplement thereto, or a supplement to the NDA, for Intrinsa, and shall include any minor improvements or modifications to such product that do not require additional development work.

The TE Patch means the transdermal patch drug delivery system to be developed by Licensor that will contain as the active ingredients a combination of testosterone and estrogen at a single dosage in vivo of testosterone to be determined, which dosage shall be in the range of about 50 to about 600 meg/day and which shall he evidenced by an NDA or a supplement thereto.

Field of Use
The Field means transdermal patches that contain testosterone ( or androgen derivatives of testosterone or androgens that convert to testosterone in the body) as the single active ingredient, and transdermal patches that contain the combination of testosterone (or androgen derivatives of testosterone or androgens that convert to testosterone in the body) plus estrogen or other related hormones (e.g. progestin), in each case at dosages of testosterone, androgen derivatives of testosterone or androgens that convert to testosterone in the body (in vivo) in the range of about 50 to about 600 meg/day, for use by women for any indication.

IPSCIO Record ID: 260368

License Grant
Licensor grants
—  an exclusive license, even as to Licensor, under the Licensed Patents to make, have made, import, use, sell, offer for sale and have sold Products in the Field in the Territory, subject to rights already granted to a Third Party under the Development Agreement between Licensor and and the Third Party; and,
—  a non-exclusive royalty-free license under the Future Licensor Patents to make, have made, import, use, sell, offer for sale and have sold Products in the Field in the Territory.

Licensor will assign to Licensee the Trademarks.

License Property
The inventions and know-how are regarding transdermal drug delivery systems and technologies.

The Trademark means the trademark applications and registrations for the mark MACROFLUX.

Microprojection System means a microprojection array having a plurality of microprojections which pierce at least through the outmost layer, i.e., the stratum comeum layer, of the skin.

Macroflux® transdermal microprojection delivery system provides unique benefits including convenient needle-free administration with room temperature stability for various therapeutic peptides, proteins, small molecules and vaccines.

Macroflux
skin patch technology provides rapid and reproducible intracutaneous administration of dry-coated antigen. The depth of skin penetration targets skin immune cells; the quantity of antigen delivered can be controlled by formulation, patch wearing time, and system size. This novel needle-free patch technology may ultimately have broad applications for a wide variety of therapeutic vaccines to improve efficacy and convenience of use.

Field of Use
The Field means passive, diffusion-mediated delivery of one or more therapeutic or prophylactic agents into or through the skin from a Microprojection System, which Microprojection System is coated with such therapeutic or prophylactic agents; or (b) diffusionmediated delivery of one or more therapeutic or prophylactic agents into or through the skin by way of pathways formed by a Microprojection System.

IPSCIO Record ID: 385608

License Grant
Licensor grants to Licensee of the Cayman Islands an exclusive, right and license under the Fablyn Technology to make, have made, use, sell, have sold, import and export Products in the Field in the Territory.
License Property
Licensor owns or has rights under certain patent rights and know-how which relate to Fablyn.

Fablyn means lasofoxifene tartrate.  Fablyn (lasofoxifene tartrate) is a selective estrogen receptor modulator (SERM) intended for the treatment of osteoporosis in postmenopausal women.

Field of Use
Fablyn (lasofoxifene) is a selective estrogen receptor modulator (SERM) that was approved in the EU in 2009 for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

IPSCIO Record ID: 256298

License Grant
This agreement is an exclusive license throughout the world to discover, develop, make, have made, market, sell and import certain Licensed Products throughout the world under the Licensor Patent Rights and Licensor Know-How.

Licensor grants an exclusive license, even as to Licensor, under the Licensed Technology, to make, have made, use, sell, offer for sale and import Licensed Product in the Territory in the Field and an exclusive license, even as to Licensor, under the Licensed Technology, to make, have made, use, and import Active Pharmaceutical Ingredient (API) and PTH in the Territory.

License Property
Licensor has certain proprietary technology related to oral PTH, and has patents and know-how relating to pharmaceutical compositions for oral delivery of an active PTH peptide and the manufacture thereof.

PTH means all forms of parathyroid hormone.  Parathyroid hormone (PTH), also called parathormone or parathyrin, is a hormone secreted by the parathyroid glands that is important in bone remodeling, which is an ongoing process in which bone tissue is alternately resorbed and rebuilt over time.

Licensed Product means a drug product in finished pharmaceutical form, in any formulation containing or incorporating PTH, alone or in combination with any pharmacologically active ingredient which is a non-peptide or non-peptidomimetic or proprietary Licensee peptide, which product incorporates Licensor Know-How and/or is covered by Licensor Patent Rights and/or Joint Patent Rights.

Field of Use
The Field means the use of the Licensed Product for the prophylactic and/or therapeutic treatment of human diseases including, but not limited to, osteoporosis.

The licensing agreement is to develop an oral formulation of an analog of PTH currently in clinical development for the treatment of osteoporosis.

IPSCIO Record ID: 256310

License Grant
The Parties previously entered into the Agreement to provide for the license grant of certain Licensed Technology to discover, develop, make, have made, market, sell and import certain Licensed Products throughout the world under the Licensees Patent Rights and Licensees Know-How.

With this amendment, Licensor consents and agrees that Licensee may enter into one or more agreements with a designated Third Party providing for the development, manufacturing, marketing or sale of 1-34 PTH into a drug product in the Field in finished pharmaceutical form in an oral formulation containing or incorporating 1-34 PTH, alone or in combination with a peptide or a small molecule that is not proprietary to Licensor, and which such oral formulation of 1-34 PTH product incorporates Licensee Know-How or is covered by Licensee Patent Rights, a 1-34 PTH Product.

With this amendment, Licensor grants back to Licensee, but only to the extent necessary to effectuate the specific Third Party Agreement, an exclusive license, even as to Licensor, under the Licensed Technology that relates solely to the manufacturing of 1-34 PTH API for use solely in a 1-34 PTH Product for Licensee to make and sell to Third Party, and for Third Party as Licensee’s licensee to subsequently sell, have sold, make, have made and import 1-34 PTH API for use solely in a 1-34 PTH Product in the Territory in the Field. For the avoidance of doubt, the foregoing license back to Licensee shall only apply to Licensed Technology that is solely related to the manufacturing of 1-34 PTH API for use solely in a 1-34 PTH Product and not any other aspects of Licensed Technology such as, but not limited to, Licensed Technology as to the oral delivery method or amidation technology relating to 1-34 PTH API or a 1-34 PTH Product, and Licensor retains all other rights to the Licensed Technology granted to Licensor under the Agreement.

License Property
1-34 PTH means all formulations of PTH 1-34OH including, but not limited to fusion proteins, muteins and chemical modifications of any or all of the aforementioned PTH 1-34OH. For the avoidance of doubt, 1-34 PTH shall not include any other formulations of PTH 1-34 or any other formulations of PTH.
Field of Use
This amendment further defines that the product in the Field may be in the finished pharmaceutical form in an oral formulation.  The original agreement defines the Field as the use of the Licensed Product for the prophylactic and/or therapeutic treatment of human diseases including, but not limited to, osteoporosis.

IPSCIO Record ID: 203360

License Grant
The Canadian Licensor grants to Licensee of Denmark, the exclusive right and License under the Licensed Technology to market, sell, offer to sell, use, import and distribute, and/or sub-license with Licensor consent, not to be unreasonably withheld, the Product and the Device in accordance with the terms of this Agreement in the Territory, and, the sole license to package and label Product and Devices in accordance with the terms of this Agreement and to carry out such clinical trials with respect to the Product as contemplated under the terms of this Agreement within the Territory, and to file marketing authorization application or MAAs and to amend any MAA in within the Territory.

Licensor grants to Licensee the right of negotiation with respect to any of Licensor’s pipeline products and or new products, which Licensor is offering for license or sale to non-affiliates in the Territory. Licensee shall be provided with the same data, documentation, and other information simultaneously as such information is being submitted to any Third Party.

Licensor hereby grants to the Licensee an exclusive and royalty free license to the Licensor Trademarks in the Territory under the terms of this Agreement in connection with marketing, sale, use, import and distribution, and/or sub-licensing with Licensor consent, which shall not be unreasonably withheld, of the Product and Device.

License Property
The patents are for Essentially Pure Human Para Thyroid Hormone, Para Thyroid Hormone Formulation, Protein Formulation (PTH (multi-dose injection), a Combined Pharmaceutical Preparation Comprising Para thyroid Hormone and a Bone Resorpion Inhibitor, Stabilized Formulation of Parathyroid Hormone,  Method for Treating Bone Loss Using Parathyroid Hormone, Gautvik/Alestrom Patents, and, Excretion of Heterologous Proteins from E. Coli.

Product shall mean Licensor’s formulated dosage form of the recombinant human parathyroid hormone (1-84) for administration by injection, as well as any Improvement(s) thereto.

Device shall mean the drug delivery device.  The injection device includes a generally elongate housing having an end configured to be coupled with a disposable injection needle. The housing is further configured to receive a carpule therein so as to place the contents of carpule in communication with the injection needle.

The trademarks are PREOS,  OSGENIX,  STRUCTOS,  PRITYRA,  QUAROS,  SUPPORA, and PREOT ACT.

PREOS is our brand name for recombinant, full-length human parathyroid hormone that Licensor are developing for the treatment of osteoporosis.

Field of Use
Licensee is a pharmaceutical company possessing substantial expertise in the development and marketing of pharmaceutical products in the Territory.

IPSCIO Record ID: 349158

License Grant
Licensor hereby grants to Chinese Licensee a co-exclusive license, with the right to grant sublicenses, under and to the Licensor Intellectual Property and Licensor Collaboration Intellectual Property to (i) Develop the Products for the US and (ii) Manufacture the Products in the Territory solely for sale of Products to Licensor in the US. Licensor also grants Licensee a non-exclusive license under and to the Pen Intellectual Property to assemble the Pen in the Territory for the Manufacture of the Product for Commercialization in the US.  Notwithstanding the foregoing, Licensee will not conduct any clinical trials for the Product in the Territory without Licensor’s consent.
License Property
Pen means the variable dose, multi-dose disposal injection drug delivery device(s) (including autoinjectors and other needle-based and needle-free devices) customized by a Third Party and assembled by Licensee that are used in the US during the Term to deliver formulated Insulin Aspart in the Product intradermally, transdermally, subcutaneously or intramuscularly, but excluding transdermal patch technology.

Insulin Aspart means the recombinant insulin aspart having a molecular formula and sequence.

Product means the Insulin Aspart as the sole active ingredient and in all forms, presentations, and formulations (including manner of delivery and dosage), which is co-Developed by Licensee and Licensor for US market, manufactured by Licensee in the Territory and Commercialized by Licensor or any of its Affiliates or Licensee Partners in the US pursuant to this Agreement, as sold in combination with the Pen (whether or not co-packaged).

Field of Use
The license and collaboration agreement is for the development of a biosimilar insulin aspart product.

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes.

IPSCIO Record ID: 273586

License Grant
Licensor grants an exclusive license of the Licensor KnowHow to package, use, offer for sale and sell the Product in the Territory.
License Property
Licensor has rights to technology in relation to the development and production of drug specific dosage forms.

Licensor is knowledgeable in the development of drug specific oral and transdermal dosage forms and has developed a unique range of delivery systems designed to provide newer and better formulations of medicaments.

Field of Use
The Licensee entered into a licensing agreement to market a clonidine transdermal patch, a generic version of Catapres TTS®.
Catapres-TTS (clonidine) transdermal therapeutic system is a square, tan adhesive patch containing an active blood-pressure-lowering medication. It is designed to deliver the drug into the body through the skin smoothly and consistently for one full week.

IPSCIO Record ID: 260367

License Grant
Licensor grants the Licensee, of Denmark, a worldwide, exclusive license, with the right to grant sublicenses, under the Licensors Intellectual Property, to research, develop, make, have made, use, import, export, sell, offer for sale, and otherwise transfer the Licensed Products in the Territory.  This agreement includes non-exclusive grants back to Licensor from Licensee.
License Property
The Licensed Product means a therapeutic drug product combining Licensors Patch Technology with any Licensee Proprietary Molecule.

The proprietary transdermal drug delivery technology is known as transdermal microprojection patch technology for use with GLP-1 Receptor Agonist(s).

GLP-1 Receptor Agonist(s) means any substance that binds to the GLP-1 receptor in vitro and activates it, as measured by initiation of an increase in cAMP, with at least 10 fold higher potency than native glucagon. For the avoidance of doubt, native glucagon is not a GLP-1 receptor agonist according to this definition.

Field of Use
Licensee is engaged in the research, development and commercialization of pharmaceutical products.  The technology allows for rapid drug dissolution and release into the skin for rapid microcapillary uptake and systemic bioavailability.

IPSCIO Record ID: 256229

License Grant
Licensee desires to acquire certain assets and rights pertaining to Eladur® and obtain a license to Licensor's proprietary TRANSDUR® transdermal delivery technology and other intellectual property to develop and commercialize Eladur®, and Licensor desires to transfer such assets and grant such a license to Licensee.

For the  License to Product, Licensor grants an exclusive license under the Licensed Technology, other than specific third party patents, solely to make, have made, use, import, sell, offer for sale and otherwise develop and Commercialize Products in the Field in the Territory, and, as permitted, an exclusive sublicense under Licensors license to Licensee Patents solely to make, have made, use, import, sell, offer for sale and otherwise Develop and Commercialize Products that contain bupivacaine, and no other Bupivacaine compound as the sole active ingredient, in the Field in the Territory.

Licensor grants to a limited right to use the trademark 'TRANSDUR®' solely in connection with the sale and marketing of Products in the Field within the Territory in accordance with this Agreement.

License Property
Licensor owns and controls rights in and to its product known as Eladur®, which is a transdermal bupivacaine patch based on Licensors proprietary TRANSDUR® transdermal delivery technology.

Bupivacaine shall mean bupivacaine, or any enantiomer, polymorph, salt form, racemate, isomer, diastereomer, tautomer, solvate, hydrate, or ester of bupivacaine.

Product shall mean any transdermal patch containing Bupivacaine as the sole active ingredient, including Eladur® as further described in IND No. 75,436.

TRANSDUR® Technology is defined as pharmaceutical transdermal patch drug delivery systems for use with a range of pharmaceutical preparations for sustained release of medication into the body, wherein the transdermal patch comprises a backing layer; a pressure-sensitive adhesive layer; and a release liner, wherein the pressure-sensitive adhesive layer comprises active agent, polyisobutylene, and plasticizer.

ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application.
Bupivacaine is an anesthetic (numbing medicine) that blocks nerve impulses in your body. Bupivacaine is used as a local (in only one area) anesthetic. Bupivacaine is given as an epidural injection into the spinal column to produce numbness during labor, surgery, or certain medical procedures.

Field of Use
The agreement is for the rights to develop and commercialize ELADUR®, Licensor's investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN).

Postherpetic neuralgia s the most common complication of shingles. The condition affects nerve fibers and skin, causing burning pain that lasts long after the rash and blisters of shingles disappear. The chickenpox (herpes zoster) virus causes shingles.  Postherpetic neuralgia is a painful condition that affects your nerves and skin. It is a complication of herpes zoster, commonly called shingles. When the pain caused by shingles doesn't go away after the rash and blisters clear up, the condition is called postherpetic neuralgia.

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