Description
Created On: 2020-07-15
Record Count: 9
Primary Industries
- Drugs
- Disease
- Hormones
- Therapeutic
- Pharmaceuticals
- Delivery
- 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: 256257
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.
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.
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
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.
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.
IPSCIO Record ID: 263941
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.
“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).
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: 3580
IPSCIO Record ID: 274910
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.
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.
IPSCIO Record ID: 275008
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.
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.
IPSCIO Record ID: 29098
IPSCIO Record ID: 6985
This Sublicense includes the rights to distribute the L-glutamine treatment for the treatment of Short Bowel Syndrome under the trademark NutreStore® in the U.S., and commercially launched NutreStore® in June 2008.
IPSCIO Record ID: 265296