Royalty Report: Drugs, Medical, Therapeutic – Collection: 26284

License Grant

The University granted an exclusive license to several of its patents covering, among other things, enhanced Nell-1 bone mineralization. Under the license, the Licensee is permitted to make, have made, use, sell, offer for sale and import any products covered by the licensed patents in a certain field of use.

License Property

The Licensee is targeting spinal fusion as the first clinical indication and is currently in the pre-investigational device exemption (IDE) phase. The lead product, purified Nell-1 recombinant protein, is expected to be dried onto ß-tricalcium phosphate (TC”) bone void filler to produce a medical device, known as Nell-1/TCP (Nell/TCP Fusion Device). This device will be mixed with 510(k) cleared DBX® Demineralized Bone Putty recommended for use in conjunction with a cleared intervertebral body fusion device. The Nell-1/TCP Fusion Device is intended for use in lumbar spinal fusion and may have a variety of other applications such as cervical spinal fusion.

Field of Use

By a subsequent Seventh Amendment entered into on August 7, 2012, the parties modified the applicable field of use that Licensee is permitted to use the patents in, which generally comprises musculoskeletal repair and regeneration, plus some related methods of manufacture. The Nell-1/TCP Fusion Device will be comprised of a single dose vial of NELL-1 recombinant protein freeze dried onto TCP. A vial of Nell-1/TCP will be sold in a convenience kit with a diluent and a syringe of 510(k) cleared demineralized bone (“DBX® Putty”), produced by MTF. A delivery device will allow the surgeon to mix the reconstituted Nell 1/TCP with the appropriate quantity of DBX® Putty just prior to implantation.

License Grant

The Company assumed an exclusive license agreement with an undisclosed Licensee for bioactive bone graft putty.

License Property

Bioactive bone graft putty is an FDA cleared bioactive synthetic bone graft substitute comprised of a mixture of calcium phosphate granules and bioglass granules suspended in a resorbable polymer carrier that facilitates handling and delivery of the granule components to fill spaces of missing bone. The product is indicated as a bone void filler for standalone use in posterolateral spine fusion procedures without the aid of autologous extenders or enhancers to meet the needs of the surgeon and effectively facilitate structural fusion of the spine. The ratio of certain components in Signafuse’s composition is similar to ratios found to promote attachment and bone formation to produce a stable scaffold that allows sustained bioactivity and osteoconductivity during the healing process. The patented bioactive component is designed for a faster rate of bone fill than bioglass particles with a broader size range. In vitro studies have demonstrated the product’s effective phosphate layer formation on the surface of the implant as early as seven days after application.

License Grant

The University hereby grants to Licensee an exclusive license under University 's Patent Rights, in jurisdictions where University's Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law.

License Property

University's Patent Rights means The University interest in any of the patent applications listed in this Agreement and assigned to The University (Case Nos. 1999-560, 2004-331, 2006-369, 2009-271, 2009-569, 2011-416, 2015-573, 2016-631, and 2016-99D).

Patent No. 8,048,646 from US Application No. 12/400,715 – NELL Peptide Expression Systems And Bone Formation Activity Of Nell Peptide
Patent No. 7,807,787 from US Application No. 12/400,714 – NELL Peptide Expression Systems And Bone Formation Activity Of Nell Peptide
Application No. 09/412,297 – NELL-1 Enhanced Bone Mineralization
Application No. 11/392,294 – NELL -1 Enhanced Bone Mineralization
Application No. 11/713,366 – NELL-1 Enhanced Bone Mineralization

Field of Use

Field of Use means use in spinal fusion by local administration, Osteoporosis, and long bones/extremities (trauma), and excludes use in cartilage and all other indications.  Osteoporosis means thinning of the bones, with reduction in bone mass, due to depletion of calcium and bone protein.

License Grant

The University hereby grants to Licensee an exclusive license under Patent Rights, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods under Licensor Patent Rights, in jurisdictions where Licensor's Patent Rights exist, in the Field of Use to the extent permitted by law.

License Property

Licensed property is generally characterized as

NELL-1 Enhanced Bone Mineralization”“NELL-1 Enhanced Bone Mineralization”

“NELL1 Expresion Systems and Neuroprotective Activity of NELL2”

“Recombinant NELL-1 & 2 Protein Production”

Field of Use

The Field of Use means modulation of neuroectodermal, mesenchymal cell or mesoderm derivatives, including musculoskeletal and cardiovascular system growth, formation, replacement, remodeling, regeneration, or repair.

The Licensee manufactures orthobiologic products. The Licensee's protein-based technologies deliver outcomes in the surgical specialties of spinal, orthopedic, general orthopedic, plastic reconstruction, neurosurgery, interventional radiology, and sports medicine.

License Grant

The University hereby grants to Licensee an exclusive license under Regents Patent Rights, in jurisdictions where Regents Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law.

License Property

Patent Rights means The Regents interest in any of the patent applications listed to this Agreement and assigned to The Regents (Case Nos. 1999-560, 2004-331, 2006-369, 2009-271, 2009-569, and 2011-416); any continuing applications thereof including divisions; but excluding continuations-in-part except to the extent of claims entirely supported in the specification and entitled to the priority date of the parent application; any patents issuing on these applications including reissues and reexaminations; and any corresponding foreign patents or patent applications; all of which will be automatically incorporated in and added to a part of this Agreement.

Certain invention (the Inventions), generally characterized as

1)
UCLA Case No. 1999-560 “NELL-1 Enhanced Bone Mineralization”;

2)
UCLA Case No. 2004-331 “NELL1 Expression Systems and Neuroprotective Activity of NELL2”;

3)
UCLA Case No. 2006-369 “Recombinant NELL-1 & 2 Protein Production”;

4)
UCLA Case Number 2009-271 “Recombinant NELL Protein Production”;

5)
UCLA Case No. 2009-569 “NELL-1 Isoform”, and

6)
UCLA Case No. 2011-416 “Using NELL-1 to Inhibit Osteoclasts and to Prevent, Treat Osteoporosis”

Licensed Product means any article, composition, apparatus, substance, chemical, or any other material whose manufacture, use or sale would constitute an infringement of any Valid Claim within Regents Patent Rights, or any service, article, composition, apparatus, chemical, substance, or any other material made, used, or sold by or utilizing or practicing a Licensed Method. This definition of Licensed Product also includes a service either used by Licensee, an Affiliate, or Sublicensee or provided by Licensee, an Affiliate or Sublicensee to its customers when such service requires the use of Licensed Product or performance of Licensed Method.

Licensed Method means any process or method whose use or practice would constitute an infringement of any Valid Claim within Regents Patent Rights.

Regents Patent Rights

1999-560-1
NELL-1 Enhanced Bone Mineralization

United States Of America

09/412,297
1999-560-2
NELL -1 Enhanced Bone Mineralization

United States Of America

11/392,294
1999-560-3
Composition for Promoting Cartilage Formation or Repair Comprising a NELL Gene Product and Method of Treating …

United States Of America

11/594,510
1999-560-3
Composition for Promoting Cartilage Formation or Repair Comprising a NELL Gene Product and Method of Treating …

European Patent Office

7871373.2
1999-560-3
Composition for Promoting Cartilage Formation or Repair Comprising a NELL Gene Product and Method of Treating …

Canada

2668375
1999-560-4
NELL-1 Enhanced Bone Mineralization

United States Of America

11/713,366
1999-560-4
NELL-1 Enhanced Bone Mineralization

Canada

2679723
1999-560-6
Composition for Promoting Cartilage Formation or Repair Comprising a NELL Gene Product and Method of Treating …

United States Of America

12/700,644
1999-560-8
NELL-1 Enhanced Bone Mineralization

United States Of America

13/011,736
2004-331-2
NELL Peptide Expression Systems And Bone Formation Activity Of Nell Peptide

United States Of America

10/544,553
2004-331-2
NELL Peptide Expression Systems and Bone Formation Activity of Nell Peptide

United Kingdom

4709500.5
2004-331-2
NELL Peptide Expression Systems and Bone Formation Activity of Nell Peptide

Spain

4709500.5
2004-331-2
NELL Peptide Expression Systems and Bone Formation Activity of NELL Peptide

Germany

4709500.5
2004-331-3
Expression System of NELL Peptide

United States Of America

11/601,529
2004-331-3
Expression System of NELL Peptide

European Patent Office

7868700.1
2004-331-7
Expression System of NELL Peptide

United States Of America

12/700,630
2006-369-2
Pharmaceutical Compositions for Treating or Preventing Bone Conditions

United States Of America

11/884,525
2006-369-3
Pharmaceutical Compositions for Treating or Preventing Bone Conditions

United States Of America

12/897,397
2009-271-2
Recombinant NELL Protein Production

United States Of America

13/121,394
2009-271-2
Recombinant NELL Protein Production

United Kingdom

9819839.3
2009-271-2
Recombinant NELL Protein Production

Spain

9819839.3
2009-271-2
Recombinant NELL Protein Production

Germany

9819839.3
2009-271-2
Recombinant NELL Protein Production

France

9819839.3
2009-569-2
Isoform NELL-1 Peptide

United States Of America

13/256,931
2009-569-2
Isoform NELL-1 Peptide

European Patent Office

10756811.5
2009-569-2
Isoform NELL-1 Peptide

Canada

2756168
2009-569-3
Isoform NELL-1 Peptide

United States Of America

15/265,680

Field of Use

This agreement pertains to the drug industry.  Field of use means use in spinal fusion by local administration, osteoporosis, and long bones/extremities (trauma), and excludes use in cartilage and all other indications.

License Grant

Under the terms of the Restated License Agreement, the University have continued to grant the Company exclusive rights to develop and commercialize NELL-1 (the Licensed Product) for spinal fusion applications.

License Property

The Licensed Product is a recombinant human protein growth factor that is essential for normal bone development.

NELL-1’s powerful specific bone and cartilage forming properties are derived from the ability of NELL-1 to only target cells that exhibit an activated “master switch” to develop into bone or cartilage. NELL-1 is a function specific recombinant human protein that has been proven in laboratory bench models to recapitulate normal human growth and development to provide control over bone and cartilage regeneration.

Field of Use

Licensee has expanded its Field of Use definition beyond spine fusion within the NELL-1 license agreement with Regents. Consistent with that expansion, Licensee has entered into an exclusive license agreement with Regents for the worldwide application of the NELL-1 protein for both osteoporosis and trauma through a technology transfer. This agreement pertains to the drug industry.

License Grant

Licensor, an individual, grants to the Licensee a worldwide nontransferable license, royalty bearing right and license under the licensed Patents to evaluate, develop, test, conduct clinical, trials, obtaining government approvals, make, have made, use, practice manufacture, have manufactured, sell, transfer or commercialize products with the understanding that such rights to certain products are exclusive, whereas certain rights are non-exclusive with respect to certain products. Products means mechanical or inflatable expandable interbody implants covered by a Licensed Patent or Assigned Patent.

License Property

The present disclosure relates generally to devices and methods for treating spinal conditions, and in particular, to expandable spinal implants configured for positioning within an intervertebral space.

Field of Use

The Licensee is a spine device company in the field of orthopedic & neurologic spine issues using surgical implants & devices.