Royalty Report: Drugs, Disease, Cancer – Collection: 203461

License Grant

Licensor hereby grants to Licensee an exclusive (even as to Licensor), royalty free (except as otherwise expressly set forth herein)  license under the Patent Rights and the Licensed Know-How, solely in the Territory, to make, have made, develop, import, market, offer for sale, use, obtain Regulatory Approval for, and sell the Product.

License Property

Product means the intranasally-administered formulation of the calcitonin product (that is the subject of existing ANDA No. 76-979 filed by Licensor and accepted by the FDA, or any ANDA incorporating the elements thereof, or any amendment, supplement or successor thereto.

Patent Application: 60/4S6,921; March 21, 2003  (TITLE: NASAL CALCITONIN FORMULATIONS CONTAINING CHLOROBUT ANOL)

Patent Rights means (i) the patents and patent applications listed; (ii) all continuation, divisional, continuation-in-part, continued prosecution, re-examination, reissue, utility model, petty, and other patent applications claiming subject matter therein or claiming priority from any of the foregoing and all patents that issue therefrom; (iii) all counterparts, substitutions, restorations, extensions (including, without limitation, patent term extensions), supplementary protection certificates, registrations, confirmations, validations and renewals of any of the foregoing; and (iv) all other U.S. patents, patent applications (provisional and non-provisional), utility models, invention certificates, and other grants for the protection of inventions or industrial designs, in each case that are Controlled by Licensor or its Affiliates now or in the future and that cover or are useful for the Product or the making (including development, testing, packaging, and Manufacturing), preparation, importation, use, or sale of the Product.

Field of Use

This agreement pertains to the drug industry.

License Grant

The purpose of this contract is to acknowledge the assignment by French Assignor, and individual and Assignee's co-founder, Chairman and Chief Executive Officer, to French Assignee of all his rights to and under the Existing Patents and Current Patent Applications, and to organize the assignment and transfer by Assignor to Assignee and/or its Affiliates of his rights on and to any and all Current Results for the agreed price.

The Parties also agree hereby on the financial compensation for the assignment by Assignor to Assignee and/or its Affiliates of any rights on and to Future Results including any rights as a co-inventor of patentable inventions to be covered by Future Patent Applications.

The provisions of this Agreement shall only apply to Results generated by Assignor during the period ending on the earlier of (i) the term of this Agreement and (ii) the Employment Period.

License Property

Current Patent Applications means:

No. 1. The French patent application n°FR1753775 filed on April, 28th 2017 and entitled “20-Hydroecdysone extract of pharmaceutical grade, its use and its preparation”.
No. 2. The French patent application n°FR1758071 filed on May, 31st 2017 and entitled “Use of 20-hydroxyecdysone and the derivatives thereof in the treatment of myopathies”.
No. 3. The French patent application n°FR1851778 filed on February, 28th 2018 and entitled “Phytoecdysones for their use in the prevention of the loss of muscular strength during an immobilisation” .
No. 4. The French patent application n°FR 1902726, entitled “Phytoecdysones and their derivatives for their use in the treatment of neuromuscular diseases “.
No. 5. The French patent application n°FR 1902727, entitled “Phytoecdysones and their derivatives for their use in the treatment of alterations of the respiratory function”.
As well as any and all (I) provisional and non-provisional applications, foreign patent application, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals of the above describe patent applications, (ii) all patents granted thereon, and (iii) all reissues, re-examinations and extensions or restorations, including supplementary protection certificates or the equivalent thereof, granted thereon and corresponding priority rights.

Existing Patents means the patent applications filed by Licensee before July 13, 2015 as well as any and all (I) provisional and non-provisional applications, foreign patent application, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals of such patent applications, (ii) all patents granted thereon, and (iii) all reissues, re-examinations and extensions or restorations, including supplementary protection certificates or the equivalent thereof, granted thereon and corresponding priority rights.

Future Patent Application means (I) any patent or patent application based on Current Results for which Assignor is designated as an inventor or co-inventor and/or (ii) a patent application filed on the basis of Future Results and for which Licensor is designated as an inventor or co-inventor, as well as any and all (x) provisional and non-provisional applications, foreign patent application, patent cooperation treaty (PCT) applications, substitutions, continuations, continuations-in-part, divisions and renewals of such patent applications described in (I) and (ii), (y) all patents granted thereon, and (z) all reissues, re-examinations and extensions or restorations, including supplementary protection certificates or the equivalent thereof, granted thereon and corresponding priority rights.

The myopathies are neuromuscular disorders in which the primary symptom is muscle weakness due to dysfunction of muscle fiber.

Field of Use

This agreement pertains to the drug industry.  Assignee is a biotechnology company that develops drug candidates to treat age-related and genetic degenerative diseases, especially those affecting muscular and visual functions.

License Grant

Licensor hereby grants to Licensee and its Affiliates an exclusive license, with the right to sublicense, under the Licensor Technology to make, have made, use, sell, offer for sale, import, and export Products in the Field in the Territory.

License Property

Licensor has developed and owns or controls certain intellectual property rights with respect to a controlled release formulation of anagrelide.

Licensor Patents means (a) those Patents set forth hereto (the Initial Licensor Patents); (b) any other Patents owned, licensed, or controlled by Licensor or any Affiliate thereof, or subject to an obligation of assignment to Licensor or any Affiliate thereof, Covering or relating to any portion of the Technology; (c) any additions, divisionals, continuations, continuations-in-part, conversion, supplemental examinations, extensions, term restorations, registrations, re-instatements, amendments, reissuances, corrections, substitutions, re-examinations, registrations, revalidations, supplementary protection certificates, renewals, and foreign counterparts of the Initial Licensor Patents or the Patents described in (b) above, and any other Patents owned, controlled, or licensed by Licensor claiming priority to any of the foregoing or any of the Patents referenced in clause (a) or (b) above; and (d) all patents issuing from any of the Patents mentioned in clause (a), (b), or (c) above and any foreign counterparts of any such Patents, and which shall include, in any case, patents surviving post grant review and inter partes review.

US patent 6,585,995  Methods and compositions for treating platelet-related disorders
US Patent Application 20130022671

Product means a product that is Covered by one or more Licensor Patents in any country in which such product or any part thereof is made, used, or sold.

Licensor Technology means the Licensor Know-How and the Licensor Patents.

Patent(s) means any granted or issued patents and pending patent applications, together with all additions, divisionals, continuations, continuations-in-part, substitutions, reissues, re-examinations, supplemental examinations, patents reviewed under post grant review or inter partes review, extensions, registrations, patent term extensions, revalidations, supplementary protection certificates, and renewals of any of the foregoing, and all foreign applications and patents corresponding to or claiming priority from any of the foregoing.

Field of Use

GALE-401 contains the active ingredient anagrelide, an FDA-approved product, which has been in use since the late 1990s for the treatment of essential thrombocythemia (ET).

Essential thrombocythemia (ET) is a rare chronic blood cancer (myeloproliferative neoplasm) characterised by the overproduction of platelets (thrombocytes) by megakaryocytes in the bone marrow.

Cardiovascular Field means the direct prevention, treatment, diagnosis of myocardial infarction, strokes and peripheral arterial disease in humans or other animals. For sake of clarity the Cardiovascular Field will not include the prevention, treatment or diagnosis of conditions that may ultimately lead to a decrease in the risk of thrombotic events, such as Myeloproliferative Disorders and other hematological indications.

License Grant

Collaborator hereby grants to Licensee of Ireland an exclusive license (exclusive even as to Collaborator), with the right to sublicense, under the Collaborator Technology, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize and have Commercialized Antibodies and Products in the Territory.

License Property

Product means any pharmaceutical product containing one or more Antibodies whose manufacture, use, sale, offer for sale or importation by Licensee in a given country in the Territory is covered by a Valid Claim under a Collaborator Patent Right or Sponsored Research Patent Right in such country.

Collaborator Patent Right means any Patent Right that (a) is Controlled by Collaborator or any of its Affiliates as of the Effective Date (including the Collaborator Patent Rights that comes into the Control of Collaborator or any of its Affiliates during the Term (other than through the grant of a license by Licensee) and (b) claims or discloses any (i) Antibody or Product (including the composition of matter thereof), (ii) method of making any Antibody or Product or materials used in any method of making any Antibody or Product, or (iii) methods of using any Antibody or Product.

Collaborator Technology means the Collaborator Patent Rights and Collaborator Know-How.

Patent Rights means any and all (a) issued patents, (b) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions and renewals, and all patents granted thereon, (c) patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, patent term extensions, supplementary protection certificates or the equivalent thereof, (d) inventor’s certificates, (e) other forms of government-issued rights substantially similar to any of the foregoing and (f) United States and foreign counterparts of any of the foregoing.

Field of Use

This agreement pertains to the drug industry.

License Grant

Israelis University hereby grants to Israelis Licensee an exclusive, worldwide, non-transferrable, royalty-bearing, license under Licensors interest in the Patent Rights for the sole purpose of developing, manufacturing, using, offering for sale and selling Licensed Products; provided that Licensor reserve the right, for itself, Licensor and other not-for-profit research organizations to practice and use the Patent Rights within the scope of the license set forth above solely for research, teaching and other educational purposes.

License Property

Patent Applications:
Title: Sonochemical coating of textiles with Metal Oxide Nanoparticles for Antimicrobial Fabrics
PCT no.: PCT/IL2009/000645
National Phase:
IL – appl. no. 209908, filed 29-06-2009
US – appl. no. 12/997,276, filed on 10-Dec-2010
EU – appl. no. 09773041.0, 06-01-2011
Title: Doped Metal Oxide Nanoparticles of and uses thereof
PCT/IL2014/050406, filed on 05-May-2014

Patent Rights means, in each case to the extent owned and controlled by Licensor: (a) the patent applications listed in Exhibit B; (b) any patent or patent application that claims priority to and is a divisional, continuation, reissue, renewal, reexamination, substitution or extension of any patent application identified in (a); (c) any patents issuing on any patent application identified in (a) or (b), including any reissues, renewals, reexaminations, substitutions or extensions thereof; (d) any claim of a continuation-in-part application or patent (including any reissues, renewals, reexaminations, substitutions or extensions thereof) that is entitled to the priority date of, and is directed specifically to subject matter specifically described in, at least one of the patents or patent applications identified in (a), (b) or (c); (e) any foreign counterpart (including PCTs) of any patent or patent application identified in (a), (b) or (c) or of the claims identified in (d); and (f) any supplementary protection certificates, pediatric exclusivity periods, any other patent term extensions and exclusivity periods and the like of any patents and patent applications identified in (a) through (e).

Field of Use

This agreement pertains to the chemical coatings and textile industry.

Licensed Product means any bed linen, drapery, upholstery, home textile and/or clothing that contains Covered Textile.

License Grant

Licensor hereby grant to Licensee an exclusive (even to Licensor), royalty-bearing, freely sublicenseable license in the Territory under the Licensed Patents and Information for  all purposes, including without limitation, to develop, use, make, have made, import, have imported, export, have exported, offer for sale, have sold and sell Licensed Products.

License Property

Licensed Product means a product that utilizes or incorporates a Valid Claim for the therapeutic treatment of a specific fibrotic human disease, which product has been approved after the Effective Date for the therapeutic treatment of such specific fibrotic human disese by the United States Food and Drug Administration (FDA) and/or any Regulatory Agenciies through the granting of a New Drug Application (NDA) or equivalent foreign approval document.

Licensed Patents means that certain U.S. Patent No. 5,310,562; and all corresponding foreign patent applications and patents throughout the Territory, including any and all divisions, re-issues, re-examinations, renewals, continuations and substitutes in whole or in part of such patents and patent applications in the Territory with respect to the anti-fibrotic  uses of Pirfenidone; and all Patents defined. The Licensed Patents shall specifically exclude U.S. Patent No. 5,962,478 titled Tumor Necrosis Factor Alpha.
5,310,562 – Composition and method for reparation and prevention of fibrotic lesions

Patents means all of Licensors (a) anti-fibrotic, Pirfenidone patent applications heretofore or hereafter filed or having legal force in any country including without limitation divisionals, continuations, continuation-in-part and provisional applications; (b) issued, unexpired anti-fibrotic Pirfenidone patents in any country, including utility, model and design patents and certificates of invention; and (c) substitutions, extensions, reissues, renewals, and supplementary protection certificates with respect to any such issued patents. For clarity, such patent applications and patents shall include those owned, as well as those controlled with the right to grant licenses, by any of Licensors. The Patents shall not include patent applications and patents to the extent claiming uses of Pirfenidone other than for anti-fibrotic uses, nor uses of compounds for anti-fibrotic applications other than Pirfenidone.

Field of Use

This agreement pertains to the drug industry relating to products potentially useful in the prevention, mitigation and treatment of fibrotic and other diseases.

Fibrosis, also known as Fibrotic scarring, is a pathological wound healing in which connective tissue replaces normal parenchymal tissue to the extent that goes unchecked, leading to considerable tissue remodelling and the formation of permanent scar tissue.

License Grant

On the Commencement Date, the Swiss Licensor shall assign to Licensee all right, title and interest in the Patents by executing an assignment of the Patents.  With effect from the Commencement Date, Licensor assigns to Licensee all right, title and interest in the Know How.  Licensee and its Personnel shall have the full unfettered and exclusive worldwide right to disclose and use the Know How for any purpose whatsoever.

Within 15 days of the Commencement Date, Licensor shall transfer and deliver to Licensee in good order the Documentation.

With effect from the Commencement Date, all right, title and interest in the Documentation and the Ancillary Rights shall vest in Licensee.  Licensor shall at the request of Licensee promptly do all acts and execute all documents as may be necessary or desirable to vest in Licensee all right, title and interest in the Documentation and the Ancillary Rights.

In the event the development, making, having made, use, or sale of Products by Licensee, its Affiliates or Licensees would infringe any other intellectual property which Licensor owns at the Commencement Date or has the rights to license (other than the Patents, Know How, Documentation and Ancillary Rights), Licensor hereby grants to Licensee, a non-exclusive, world-wide, royalty-free, sub-licensable license under such other intellectual property solely for Licensee, and its Affiliates and Licensees to develop, make, have made, use and sell Products.

License Property

Patents means:  (a)  the patents and patent applications listed in Schedule 1 as LÃœCH-1 and E11-1;   (b)  any and all foreign counterparts, and any patents and patent applications anywhere in the world claiming, or entitled to claim, priority from any of the patents and patent applications listed in Schedule 1, and any patents issued or issuing on any of such applications;  (c)  any provisional and non-provisional applications anywhere in the world, including certificates of invention and applications for certificates of invention, claiming Inventions and any patents issued or issuing on any such applications,  (d)  any continuations, divisions, continuations-in-part, re-examinations, renewals, supplementary protection certificates, patents of addition, utility models of any of the foregoing and any patents issued or issuing thereon, and  (e)  any reissues and extensions of any of the foregoing

US Patent:  6,583,265 – Cyclosporins
Ciclosporin, also spelled cyclosporine and cyclosporin, is an immunosuppressant medication and natural product.

Products means any product containing a Compound.

Compound means a Compound ELL-1 or a Compound LUCH-1.
Compound ELL-1 any compound, whose manufacture, sale or use falls within the scope of a Valid Claim of ELL-1. Included are any and all compounds whose manufacture passes the Intermediate as defined in Claim 1, formula VI of US 6,583,265 (hereinafter called Cation);
Compound LUCH-1 any compound, whose manufacture, sale or use falls within the scope of a Valid Claim of LUCH-1.  Included are any and all compounds, whose manufacture passes the Intermediate Polyanion of 4-(gamma-hydroxy)-N-methylleueineuyclosporin (hereafter called Polyanion), namely the compound 3-alpha-(2-N,N-dimethylamino)-ethylthio-4-(gamma-hydroxy-Me-Lue)-cyclosporin or a salf thereof.

Field of Use

This agreement pertains to the drug industry.

License Grant

Licensor, a non-profit biomedical research company, grants to Licensee an exclusive, royalty-bearing license, with the right to grant sublicenses pursuant to Section 2.5, in the Territory under and to use the Licensed Intellectual Property to research, develop, make, have made, use, sell, offer for sale and import Licensed Products in the Field.

License Property

Licensed Patents means (a) the Patents listed below to this Agreement; (b) any and all Patents that claim Licensed Know-How and are Controlled by Licensor on the Effective Date and during the Term, including without limitation Licensors interest in any Joint Patent that claims Licensed Know-How; (c) all divisionals, continuations (in whole or in part, including without limitation conversions of provisional applications into utility patent applications), and substitutions of any of the preceding, and any letters patent and/or registrations (including, without limitation, all reissues, renewals, extensions, confirmations, re-examinations, supplementary protection certificates) that may be granted on any of the foregoing; and ( d) any and all United States and foreign counterparts of any of the foregoing.

Licensed Patents:
U.S. provisional patent application USSN 60/965,135 entitled Therapeutic Compositions for Treatment of Inflammation of Ocular and Adnexal Tissues

PCT/US08/09776 filed on 15.08.2008 claiming priority to Provisional 60/965,135, filed on August 16 2007. Published on February 26, 2009 WO/2009/025763, entitled Therapeutic Compositions for Treatment of Inflammation of Ocular and Adnexal Tissues

Provisional 61/143,561 filed January 09. 2009 entitled Therapeutic Compositions For Treatment of Corneal Disorders

Licensed Product means any product the manufacture, use or sale of which would, but for the licenses granted in this Agreement, infringe a Valid Claim of a Licensed Patent.

An amendment to the license agreement dated 01/01/1990 is amended by deleting it in its entirety the above Licensed Patent Information and replacing it hereto:
Licensed Patents:
U.S. Patent Appln. No. 121685.510
U.S. Patent Appln. No. 13/183,231

Field of Use

The patent applications cover methods of treating diseases of the eye using an inhibitor of the inflammatory cytokine IL-1.

License Grant

Irish Licensor hereby grants to Licensee for the Term an exclusive license to the Licensor Intellectual Property to import, use, offer for sale and sell the Product in the Field in the Territory.

License Property

Product means the once or twice-daily oral tablet or oral capsule formulation(s) incorporating the Licensor Technology and containing the Compound as its sole active combination of ingredients, being developed pursuant to the R&D Program.

Licensor Intellectual Property means the Licensor Know-How, the Licensor Patents, the Licensor Improvements and the Product Patents.

Licensor Patents means any and all Patent Rights now existing, currently pending or hereafter filed by Licensor relating to the Licensor Technology.

Licensor Technology means the SODASâ oral controlled release formulation technology that comprises the formation of 0.5-5mm beads containing an active agent and excipients which can be coated with a product-specific modified release polymer and then formulated into a final formulation such as a sprinkle, a tablet or a capsule, as applied in the Licensor Know-How.

Licensor Trademark means SODAS® or such other trade marks as Licensor may from time to time reasonably specify.

Licensor Improvements means any and all improvements to the Licensor Patents, the Licensor Know-How, the Licensor Technology and/or the Product Patents that have been conceived, created, developed and/or otherwise invented by Licensor and/or Licensee under the R&D Program, or otherwise pursuant to this Agreement.

Patent Rights means any and all rights under any and all patent applications and/or issued or granted patents, now existing, currently pending or hereafter filed, including, but not limited to, provisional applications, substitutions, divisionals, continuations, continuations-in-part, renewals and any foreign counterparts thereof or equivalents thereto, including the right to claim priority from any of the foregoing under the Paris Convention, and all patents issuing or granted on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof, or any other government-issued rights substantially equivalent to the foregoing.

BiDil means the existing immediate release product containing the Compound that is currently marketed in the United States by Licensee.

Compound means the combination of the active drug substances isosorbide dinitrate and hydralazine HCl and/or other salts, bases and isomeric forms of each.

Field of Use

The know-how and technology is to develop a once-a-day version of its BiDil heart drug.

License Grant

The Canadian Licensor hereby grants to Licensee an exclusive, worldwide, royalty-bearing license, including the right to grant sublicenses (which themselves may include the right to grant further sublicenses), under the Licensor Patent Rights, the Licensor Know-How and Licensor’s interest in the Joint Patents, to research, develop, make and have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import and export Products in the Field.

License Property

Product means any member of the class of substituted 4-H chromenes, analogs and derivatives thereof and any compound encompassed by the generic chemical formulae included in those Joint Patent Rights specifically set forth below, including all formulations and modes of administration thereof.

Licensor Patent Rights means all Patents in any country within the Territory which are owned or Controlled by Licensor as of the Effective Date or during the term of this License Agreement that claim the manufacture, use or sale of a Product (including, without limitation, any formulation, process of manufacture, or method of use of such Product).  

Joint Patent Rights shall mean those Patents claiming inventions made jointly by one (1) or more employees or consultants of each Party or otherwise listed hereto.  Joint Patent Rights as they exist as of the Effective Date are set forth hereto.
Application Patents:
10/146,138 – SUBSTITUTED 4H-CHROMENES AND ANALOGS AS ACTIVATORS OF CASPASES AND INDUCERS OF APOPTOSIS AND THE USE THEREOF
10/146,136 – Substituted  COUMARINS AND QUINOLINES AND ANALOGS AS ACTIVATORS OF CASPASES AND INDUCERS OF APOPTOSIS AND THE USE THEREOF

Patent (which term may be used either in the singular or plural form) means any patent and patent applications, and all additions, divisions, continuations, continuations in-part, pipeline protection, substitutions, reissues, extensions, registrations, patent term extensions, supplementary protection certificates and renewals of any of the above.

Field of Use

Patent relate to the MX2105 series of vascular targeting agent cancer drug candidates.

License Grant

The Israeli Licensor, the technology transfer company of the University, hereby grants to the Company an exclusive or non-exclusive license, in accordance with the Agreement terms, in the Territory, with the right to grant sublicenses as provided, to practice and utilize the Licensed Patent Rights, and the Licensed Know-how to (a) research and develop products and services solely in the Field of Use, and (b) to register, make, have made, lease, use, import, market, have marketed, and/or sell or have sold products and services solely in the Field of Use.

License Property

Product(s) shall mean any products, product component, production supplement and/or process covered by a valid claim of the Licensed Patent Rights in the country where the product is sold and/or that embodies any Licensed Know-How.

Licensed Patent Rights shall mean the Patent Rights, the Non-exclusive Patent Rights and Research Patent Rights.  

Research Patent Rights shall mean any United States and/or non-United States patent or patent applications and all substitutions, divisions,  continuations, continuations-in-part, reissues, reexaminations and extensions  thereof that are owned or otherwise controlled by the Licensor and that cover the Know-how and/or Research Know-how developed prior to or during the course of the Research Program.

Patent Rights shall mean:  The patent application set forth, designated as exclusive; Any non-United States patent applications claiming  priority from the patent application referred to; Claims of United States continuation-in-part applications, and of the resulting patents; and Any reissues, divisionals, amendments or extensions of the United States or non-United States patents.

Exclusive Patent Rights:  New Heterocyclic compounds, method of developing new drug leads and combinatorial libraries used in such method.
Non-exclusive Patent Rights:  A general procedure for the preperative scale systhesis of protected Ca (functionalysed alkyl) amino acids suitable for solid phase synthesis.

Exclusive Know-How: All new developments, now in existence or to be developed pursuant to the Research Program.

Non-Exclusive Know-How: The novel building units described in Agreement and a process for the preparation of compounds described in the Agreement consisting of a multistep reaction procedure.

Non-Exclusive Patent Rights shall mean the provisional patent application set forth in this Agreement designated as non-exclusive; Any United States  utility patent application and non-United States patent applications based, in whole or in part, on the provisional patent application set forth; The United States and non-United States patents issued from the applications referred to; Claims of United States continuation-in-part applications, and of the resulting patents, which are based on the subject matter specifically described; and Any reissues, divisionals, amendments or extensions of the United States or non-United States patents described.

Field of Use

This invention is in the field of using combinatorial chemistry to develop new drugs.