Royalty Report: Drugs, Delivery, Therapeutic – Collection: 203450

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Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 9

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: 9

Primary Industries

  • Drugs
  • Delivery
  • Therapeutic
  • Hormones
  • 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: 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: 4414

License Grant
The Swiss Company has granted Licensee an exclusive license, with the right to grant sublicenses for the licensing of E2/T Combi-Gel.E2/T Combi-Gel covers four hormone products for the treatment of hormone deficiencies in men and women.

This modification of the royalties does not apply for the products Estradiol single gel, Testosterone single gel and the combination product Estradiol plus Testosteron” but only and exclusive for E2-NETA Combi Gel.

License Property
Patents
5,891,462 – A Novel Composition for transdermal administration of an Estrogen, a Progestin or a mixture thereof (Combi Gel)
08/058,517 – Administration System for Estradiol (Estradiol Patch)

Products
Gel E2 where estradiol is the sole active ingredient, and where the gel is applied to the skin Gel Testosterone where testosterone is the sole active ingredient and where the gel is applied to the skin
Patch E2 where estradiol is the sole active ingredient and where the patch is applied to the skin
E2-**** Combi Gel where estradiol and *********** are the two active ingredients and where the gel is applied to the skin
Option regarding E2-T Combi gel
E2-T Combi Gel where Estradiol and Testosterone are the two active ingredients and where the gel is applied to the skin

Products shall mean the four pharmaceutical products either dermal gel or patch, for application on the skin, intended for pharmaceutical use with humans for any indication now known or known in the future, and with defined active compounds.

IPSCIO Record ID: 27099

License Grant
The Swiss Company has granted Licensee an exclusive license, with the right to grant sublicenses for the licensing of E2/T Combi-Gel.E2/T Combi-Gel covers four hormone products for the treatment of hormone deficiencies in men and women.
License Property
Patents
5,891,462 – A Novel Composition for transdermal administration of an Estrogen, a Progestin or a mixture thereof (Combi Gel)
08/058,517 – Administration System for Estradiol (Estradiol Patch)

Products
Gel E2 (where Estradiol is the sole active ingredient, and where the gel is applied to the skin) Gel Testosterone (where testosterone is the sole active ingredient and where the gel is applied to the skin)
Patch E2 (where Estradiol is the sole active ingredient and where the patch is applied to the skin)
E2-**** Combi Gel (where Estradiol and *********** are the two active ingredients and where the gel is applied to the skin)
Option regarding E2-T Combi gel
E2-T Combi Gel (where Estradiol and Testosterone are the two active ingredients and where the gel is applied to the skin)

Field of Use
The rights granted apply to the Products which shall mean the four pharmaceutical products either dermal gel or patch, for application on the skin, intended for pharmaceutical use with humans for any indication now known or known in the future, and with defined active compounds.

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: 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: 282938

License Grant
Licensor shall grant to Licensee a non-exclusive license to make, have made, use, sell and have sold such CombiPatch Product under Confidential Information relating to the CombiPatch Product, including Licensors  Technology, Licensors Patent Rights and any other patents, know-how, improvements, development studies and other information, and any trademarks related to the CombiPatch Product and owned by Licensor, for a royalty of Licensees Net Revenues from sales of the CombiPatch Product so manufactured, in addition to other terms and condition as reasonably agreed between the parties.

Licensor shall supply to Licensee, and Licensee shall purchase from Licensor all of Licensees requirements for the CombiPatch Product for sale in the Territory subject to the terms and conditions set forth herein.  Licensor shall also exclusively supply Licensee, and Licensee shall purchase from Licensor all of Licensees requirements for Licensed Products other than the CombiPatch Product for sale in the Territory.

License Property
The term CombiPatch Product shall mean the transdermal estrogen/progestin patch product which has and is being developed by Licensor solely or jointly with another party and its Affiliates and is marketed under the trademark CombiPatch(TM) in the Territory.

CombiPatch Product, at Licensees option, shall be supplied in finished, packaged and labeled form or in bulk rolls.

The term Licensed Product shall have the meaning set forth in the Licensor License Agreement, as amended. The term Licensed Product or shall mean individually and collectively any Estrogen Transdermal Drug Delivery System or any Combination Estrogen/Progestin Drug Delivery System. A Licensed Product relating to the Estrogen Transdermal Drug Delivery System shall be referred to as an 'Estrogen Product' and a Licensed Product relating to the Combination Estrogen/Progestin Drug Delivery System shall be referred to as a 'Combination Product.'

The term Licensors Technology' shall have the meaning set forth in the Licensor License Agreement in so far as it relates to any combination estrogen/progestin in a polymer adapted for transdermal delivery by application to the epidermis, other than combinations indicated for contraceptive use.

CombiPatch(TM) is a transdermal combination estrogen/progestin delivery system.

Field of Use
This agreement pertains to the drug industry relating to any combination estrogen/progestin in a polymer adapted for transdermal delivery by application to the epidermis, other than combinations indicated for contraceptive use.

CombiPatch (estradiol, norethindrone acetate transdermal system) is a combination of female hormones used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ('hot flashes' or 'hot flushes'); to treat vulvar and vaginal changes.

IPSCIO Record ID: 230786

License Grant
Licensor grants to Licensee of the Netherlands and Licensees Affiliates an exclusive, even as to Licensor, license right, with the right to grant sublicenses, to use and exploit Licensor IP Rights to import, market, sell and distribute the Product, in the Territory, in the Field.

Licensor also grants to Licensee the right to file Marketing Authorization Applications outside EU countries and to seek pricing and reimbursement approvals where required.

Licensor also grants to Licensee an exclusive, license right, with the right to grant sublicenses, to use the Trademark on and solely in connection with the commercialization of the Product throughout the Territory, in the Field.

License Property
Product means a pharmaceutical composition containing testosterone as the single active drug ingredient and CPE 215 which fall within the scope of any composition, method or claim of Licensor IP Rights and which is intended to be applied topically, including TESTIM 1% testosterone gel.

Trademark means TESTIM.

Field of Use
Field means the use of Product for testosterone replacement therapy to restore serum testosterone in adult males with primary and secondary hypogonadism or such equivalent or similar indication as authorized on a country-by-country basis, and any additional indications based on the existing dossier which do not require extra development work (to the exclusion of regulatory work); such additional indications, if initiated by Licensee, are subject to approval by Licensor.

Competing Product means all transdermal products containing testosterone as an active ingredient used for testosterone replacement therapy to restore serum testosterone in adult males with primary and secondary hypogonadism or such equivalent or similar indication.

IPSCIO Record ID: 222559

License Grant
Australian Licensors grant to Licensee the sole and exclusive (including with respect to Licensor, except as otherwise provided) license, under the Licensed Intellectual Property, solely to exploit, import, export, make, have made, develop, use, market, offer for sale and sell Products for use in the Field in the Territory.
License Property
The Metered Dose Transdermal Spray (MDTS) drug formulations utilize proprietary skin penetration enhancers commonly found in sunscreens. The once-per-day dosing has demonstrated a sustained plasma level of drug over a 24-hour period.

'Licensed Intellectual Property' means the (i) Licensors Patents, and (ii) the Licensed Know-How. 'Licensed Know-How' means the Know-How that is Controlled by Licensor or any Controlled Affiliate and relates to or is useful for MDTS products in the Field.

MDTS means the Licensor metered dose transdermal spray system as described, and including all improvements, derivatives and modifications of such system developed by or under authority of Licensor or its Affiliate. For clarity, it is understood that 'improvements,' as used under this paragraph, would include modified or improved versions of the Licensor metered dose transdermal spray system, and novel enhancers, formulations, methods, and mechanical components relating to or useful for the MDTS system, that are not used in the MDTS as of the Effective Date, but that would improve the safety, effectiveness, or other qualities of such a spray system for use in delivery of testosterone, or any other Androgen added to the Field.

US Patent #6,299,900 –  Dermal penetration enhancers and drug delivery systems involving same

Licensor Patents means (a) the Patents set out in agreement, which shall include all existing Patents licensed under the Monash License or the Licensor DDS License, (b) all continuing patent applications in the Territory based on any Patent in clause (a) above (including any divisionals, continuations, and continuations-in-part); (c) all Patents that issue based on any Patent in clause (a) or (b) above, and including all re-issues, extensions, substitutions, confirmations, re-registrations, re-validations, patents of addition, and supplementary certificates (or equivalents thereof) of any such Patent; and (d) all additional Patents in the Territory that are Controlled by Licensors or Controlled Affiliate, or any other Affiliate of Licensor at any time during the term of this Agreement and that claim or cover an MDTS product, or any portion thereof, or the manufacture or use of an MDTS product or portion thereof, in the Field.

Field of Use
Field means delivery of testosterone (and/or any other Androgen that is added to the Field pursuant to this agreement) to human females using an MDTS, excluding only the Excluded Applications.
Testosterone MDTS® for treating women with low sexual desire.

IPSCIO Record ID: 245874

License Grant
The French Licensor hereby grants to Licensee, and Licensee hereby accepts, an exclusive, unrestricted, irrevocable (except as provided in agreement hereof) license, without the right to grant sublicenses (except with the prior written consent of Licensor), to market, use, distribute and sell Product in the Territory.  

Licensor hereby grants to Licensee and Licensee hereby accepts, an exclusive, unrestricted, irrevocable (except as provided in agreement hereof) license, without the right to grant sublicenses (except with the prior written consent of Licensor), to use the trademark 'Esclim(TM)' (the 'Trademark'), in connection with the Product in the Territory. Licensor covenants that it will not use or license any trademarks confusingly similar to the Trademark in the Territory during the term of this Agreement.

License Property
Product(s) shall mean the Esclim(TM) estrogen transdermal system, consisting of a twice weekly patch in strengths of 25(mu)g/24h, 37.5(mu)g/24h, 50(mu)g/24h, 75(mu)g/24h and 100(mu)g/24h, as currently approved by the FDA, together with any new dosage form thereof and a seven-day Esclim(TM) patch (provided that Licensor makes no representation and gives no warranty that such new forms or seven-day patch will be developed and FDA-approved), but excluding any  combination ·transdermal system.
Field of Use
Esclim(TM) is a female hormone (estrogen) medication. It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness).
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