Royalty Report: Medical, Device, Surgical – Collection: 316774

License Grant

This agreement is an exclusive, worldwide license to the porcine tissue.  Along with this license agreement, the Parties entered into a supply agreement, whereby Licensor would be the exclusive supplier to Licensee of the licensed porcine tissue.

License Property

This agreement is an exclusive, worldwide license to the porcine tissue for use in the Licensee’s Cardiac Patch and CanGaroo products, subject to certain co-exclusive rights retained by Licensor.

The SIS ECM biomaterial used in the medical device products are manufactured by Licensor.  CanGaroo is soft and pliable and is designed to conform to the implantable device for easy handling and implantation.  The SIS ECM is designed to mitigate the biologic foreign body response that normally occurs around the electronic device.

The CanGaroo envelope is constructed from perforated, multi-laminate sheets of decellularized, non-crosslinked, lyophilized small intestine submucosa (SIS) extracellular matrix (ECM), derived from porcine small intestinal submucosa, a natural biomaterial, which is rich in natural growth factors, structural proteins and collagens.

Field of Use

Specifically, the field of use is with neuromodulation devices in addition to cardiovascular devices; for use in the Licensee’s Cardiac Patch and CanGaroo products.

CanGaroo was designed to mitigate complications deriving from implantable electronic devices and the shortcomings of synthetic envelopes. We believe that CanGaroo is the only biological product that forms a natural, systemically vascularized pocket that conforms to and securely holds implantable electronic devices. CanGaroo is cleared for use with pacemaker pulse generators, defibrillators and other cardiac implantable electronic devices as well as vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

License Grant

The Company and an executive of the Company entered into a Royalty Agreement wherein the Company agreed to pay the executive a royalty on a product-by-product basis for certain proprietary information and inventions that were patented during his employment with the Company.

License Property

Proprietary information and inventions include but not limited to the products such as Lucent Lateral Interbody Implant System, the Lucent XP Expandable Interbody Device System, the Clutch ISP Posterior Fixation System, the Karma Fixation System, the Vertu Anterior Stand-Alone System and Mosaic devices.

The product portfolio addresses a broad spectrum of spine surgery procedures and consists of innovative spinal fixation systems (implantable hardware systems that are mechanically attached to the spine and provide stability), interbody implants (devices implanted between the vertebral bodies of the spine), surgical instruments (instruments used to prepare the spine and implant our devices) and biologics (allograft or synthetic biomaterials intended to augment or replace the normal capacity of such tissue in the body).

“Product Line” shall mean each of the following product categories, with each understood to specifically contain and be solely composed of the individual products and parts set forth on Schedule A (i) Mosaic, (ii) Vertu, (iii) Lucent Lateral, (iv) Lucent Expandable, (v) ISP (Clutch), and (vi) Zip Tie (Karma).

Field of Use

The field of use is for the procedures used in surgery with reduced trauma to the muscles and soft tissues, less blood loss, smaller incisions, shorter procedure time, reduced hospitalization, lower post-operative medication use, faster patient recovery and other benefits for patients and surgeons.

The Company is a medical device company focused on the design, development and commercialization of a comprehensive portfolio of systems, products and technologies for spine surgery procedures, with a strategic focus on minimally invasive surgery (“MIS”) procedures.

License Grant

Sub-licensor grants to sub-licensee, a not-for-profit cardiology and heart surgery center, an exclusive, even as to sub-licensor, non-transferrable, non-sub-licensable, worldwide license under the sub-licensor Patents for performance of research in the Product Area and the development of Products in accordance with the terms and conditions hereinafter set forth. The Parties agree that the foregoing license to sub-licensee includes the right to research and develop parts of the heart, including, but not limited to, heart valves, cardiac patches, blood vessels, AV node, and the like, provided sub-licensee is conducting such research and development of parts of the heart solely in furtherance of  sub-licensees research and development of Products; provided, that this shall not be construed as a license to conduct clinical trials of, or sell, offer to sell, have sold, supply or import or otherwise commercialize or have commercialized, parts of the heart (including, without limitation, heart valves, cardiac patches, blood vessels, AV node and the like). The foregoing license shall be retroactive to the first publication date of a patent application falling within the sub-licensor Patents. Sub-licensor represents and warrants that it possesses all rights to bring demands, claims, and causes of action against the sub-licensee, and sub-licensees representatives, officers, shareholders, directors, employees, subsidiaries, affiliates, divisions, successors and assigns (collectively the “Released Parties”) for infringement of the sub-licensor Patents, and that such demands, claims, and causes of action are within the scope of the license set forth in this agreement.

License Property

Intellectual property related to the transplantation of the heart organ in human beings, whereby perfusion decellularization and/or perfusion recellularization has been utilized in any portion of the creation or manufacture of such whole heart organ.

Sub-licensor is engaged in the research, development, manufacture and marketing of perfusion decellularization and recellularization technology and the products that are created utilizing such technology.

Decellularization. The anatomical structure of organs is highly complex and enormously challenging to reproduce synthetically. We utilize porcine organs as the scaffold for creating human organs because significant anatomical and vascular similarities exist between the two species’ scaffolding. Using our proprietary perfusion decellularization process we remove the porcine cells from harvested porcine organs leaving behind a scaffold of extracellular matrix (“ECM”) that retains the architecture, mechanical properties, and vascular network of the original organ structure. Porcine ECM is estimated to be over 93% homologous to human ECM which significantly reduces potential for antibody formation and adverse reaction. In addition, we have generated human clinical data demonstrating the safety of our decellularized porcine liver scaffold in clinical trials of two products we previously developed, commercialized and spun out, Miromesh® and Miroderm®.

Recellularization. Recellularization is the process of growing new functional organs starting with the ECM that remains after the decellularization process is completed. We currently use living human cells harvested from organ donors to re-seed the ECM, and in the future intend to develop new techniques using patient-derived stem cells. Living human cells are adaptive, and when introduced into the decellularized ECM display unique regenerative, plasticity, and adhesion properties. The process of recellularization occurs in a bioreactor where media and living human cells are perfused into the ECM in the appropriate sequence in order to facilitate cellular regeneration and organ functionality.

Field of Use

Field of use is for the prevention and treatment of cardiovascular disease.

License Grant

The Licensor grants to Licensee an exclusive right and license, with the right to grant sublicenses , under the Licensed Rights, for all human uses of self expanding tissue expanders, to develop, make, have made, use, offer for sale, sell, have sold, import and export Products in the Application Areas in the Territory.

License Property

The Licensor owns or controls certain Patent Rights and Know How related to the use self inflating tissue expanders for therapeutic purposes as a result of an assignment from the inventors of the Patent Rights.

U.S. provisional patent application no. 60/612,018 – Tissue expanders and methods of use

One method of correcting skin deficit is to stimulate creation of new skin. Implantation of a device that expands and stretches the existing skin causes a growth response in which new skin is created. While the exact physiologic mechanism of this response is not fully understood, clinical success has been reported for many years.

One aspect of the disclosure is a tissue expansion system, including an implantable device adapted to be implanted within a patient, wherein the implantable device has an anterior portion, a posterior portion, an inferior portion, and a superior portion, and wherein the implantable device comprises a communication component secured in the superior and anterior portions, and an external device adapted to be disposed external to the patient to wirelessly communicate with the communication component to control the expansion of the implantable device.

Field of Use

Tissue expanders are used in breast reconstruction procedures following mastectomy to expand and stretch the skin and underlying muscle prior to the placement of a permanent breast implant.

License Grant

If, and only if, Licensor exercises its option for a license under the CIC Patents pursuant to this agreement, Licensor shall grant (and will cause its Affiliates to grant) to Licensee and its Affiliates the right and option until the expiration of thirty (30) months from the Effective Date or ninety (90) days from the date Licensor exercises its option, whichever is later in time, to obtain a non-exclusive, worldwide, non-transferable, royalty-bearing license under the Savacor Patents.

License Property

Savacor Patents shall mean those patents and patent applications, and all patents and patent applications claiming priority therefrom, that Licensor or its Affiliates acquired from Savacor, Ind. as set forth.  The Savacor Patents shall include the sublicensable patents and patent applications of Cedars Sinai Medical Center listed.

6,970,742 – Method for detecting, diagnosing, and treating cardiovascular disease
6,328,699 – Permanently implantable system and method for detecting, diagnosing and treating congestive heart failure

Field of Use

“CRM Products” means devices for monitoring or electrically stimulating or shocking the heart which are suitable for chronic implantation, in whole or in part, by or with human patients. The term “CRM Products” includes, without limitation cardiac pacemakers, antitachycardia pacemakers, cardiac resynchronization therapy systems, cardioverters, and defibrillators, including combinations thereof; loop recording systems, implantable cardiac monitoring systems, implantable hemodynamic monitoring systems, pulse generators and other waveform generators for such devices; cardiac lead implant catheters and associated tools; leads, electrodes, sensors, capacitors, batteries, power sources, and all other components for such devices; mechanisms for coupling such generators in a stimulating, shocking, sensing, or monitoring relationship to the heart; and data dispensing, processing, and gathering systems for such devices, including programmers, pacing system analyzers, defibrillation system analyzers, testers, encoders, decoders, transtelephonic and other remote monitoring systems and services for use with implantable devices, transmitters, receivers, and computer software-controlled systems, and including the software. The term “CRM Products” excludes, by way of example and not limitation, nerve stimulators (unless used for cardiac therapy), bone growth stimulators, drug release pumps, cardiac pumps, artificial hearts, prosthetic heart valves, catheter ablation devices, imaging systems, catheter location systems, apparatus for revascularization or correction of other physical defects in heart tissue, arrhythmia mapping devices (except as part of an implantable cardiac therapy or monitoring device), angioplasty devices and EKG monitors (other than cardiac stimulation device programmers or other telemetry devices for use with implantable pulse generators or cardiac monitors) which are standalone, non-ambulatory and not intended for transtelephonic or other remote monitoring.

License Grant

The Licensor hereby grants to the Licensee, and the Swiss Licensee hereby accepts, a non-exclusive, royalty-bearing right and license under the Licensed IP to use, make, have made, sell, offer to sell, distribute and import Licensed Products in the Territory during the Term for applications within the Field of Use; provided, however, that upon the occurrence of a License Conversion Event, the portion of the non-exclusive license consisting of the non-exclusive, royalty-bearing license to sell, offer to sell, distribute and import Licensed Products in the Territory during the Term for applications within the Field of Use (the Non-Exclusive Distribution License) shall immediately, and without the need for any action on the part of either party, convert into an exclusive, royalty-bearing license to sell, offer to sell, distribute and import Licensed Products in the Territory during the Term for applications within the Field of Use (Exclusive Distribution License); provided, however, that the exclusivity of such Exclusive Distribution License shall be subject to, and shall not impact, any license rights previously granted in favor of Greatbatch pursuant to the Greatbatch License Agreement; provided, further, however, that if the Licensee fails to obtain FDA Approval for the Licensed Products within six (6) years after the License Conversion Date, the Exclusive Distribution License shall become convertible by the Licensor, at its sole discretion, back into a Non-Exclusive Distribution License. For the avoidance of doubt, during the Term, the non-exclusive, royalty-bearing license to use, make and have made Licensed Products in the Territory during the Term for applications within the Field of Use shall continuously remain a non-exclusive license.  License Conversion Event means the first to occur of (i) receipt of a Conformité Européenne (CE) mark for the Licensed Products that permits sale of such Licensed Products within the European Economic Area for application within the Field of Use; (ii) receipt of FDA Approval or (iii) completion by the Licensee of a human clinical study demonstrating safety and efficacy required to obtain (A) a Conformité Européenne (CE) mark for the Licensed Products that permits sale of such Licensed Products within the European Economic Area for applications within the Field of Use, or (B) FDA Approval.

License Property

United States (U.S.) Licensed Patents
8,954,148  Key Fob controller for an implantable neurostimulator  
8,483,836  Automated search to identify a location for electrical stimulation to treat a patient
8,515,545  Current steering neurostimulator device with unidirectional current sources
8,571,667  Active current control using the enclosure of an implanted pulse generator
8,738,153  Implantable lead with braided conductors
8,757,485  System and method for using clinician programmer and clinician programming data for inventory and manufacturing prediction and control
8,761,892  Active current control using the enclosure of an implanted pulse generator
8,761,897  Method and system of graphical representation of lead connector block and implantable pulse generators on a clinician programmer
8,781,592  Identifying an area for electrical stimulation to treat a patient
8,812,125  Systems and methods for the identification and association of medical devices
8,868,199  System and method of compressing medical maps for pulse generator or database storage
8,874,219  Arbitrary waveform generator and neural stimulation application
8,903,496  Clinician programming system and method
8,983,616  Method and system for associating patient records with pulse generators
8,996,115  Charge balancing for arbitrary waveform generator and neural stimulation application
8,996,117  Arbitrary waveform generator and neural stimulation application with scalable waveform feature
8,700,175  Devices and methods for visually indicating the alignment of a transcutaneous energy transfer device over an implanted medical device
9,002,466  Diversity antennas for neurostimulator programming devices
9,031,664  Current steering neurostimulator device with unidirectional current sources
9,031,666  Devices and methods for visually indicating the alignment of a transcutaneous energy transfer device over an implanted medical device
9,067,074  Automated search to identify a location for electrical stimulation to treat a patient
9,072,903  System and method of establishing a protocol for providing electrical stimulation with a stimulation system to treat a patient
9,098,610  Communication for implantable medical devices
9,101,767  Measuring load impedance with active stimulation pulses in an mplanted pulse generator
9,126,043  Patient handheld device for use with a spinal cord stimulation system
D663,035  Two-port implantable medical device
D665,086  Three-port implantable medical device
D665,087  Multi-port implantable medical device
D671,900  Pocket controller for implantable neurostimulator
D698,779  Clinician programmer for implantable neurostimulator

Field of Use

Field of Use means deep brain stimulation for movement disorders (i.e. Parkinson’s disease and/or essential tremor).

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, upon the terms and conditions herein after specified, the exclusive, worldwide right and license under the Licensed Patents and Technology to further test and develop the Technology, to make, to have made, to use, to sell, to lease, to implant, and to have implanted and otherwise dispose of Products and to sublicense the rights created hereby pursuant to the terms.

License Property

Technology relates to a patent for Neurocyberenetic Prosthesis Technology.  This license agreement covers the method and devices of the neurocybernetic prosthesis ('NCP') System for vagus nerve and other cranial nerve stimulation for the control of epilepsy and other movement disorders.  The NCP system is an implantable, multiprogrammable pulse generator that delivers constant current electrical signals to the vagus nerve for the purpose of reducing the frequency and severity of epileptic seizures. The signals are delivered on a predetermined schedule, or may be initiated by the patient with an external magnet. The device is implanted in a subcutaneous pocket in the chest just below the clavicle, similar to pacemaker placement. The stimulation signal is transmitted from the prosthesis to the vagus nerve through a lead connected to an electrode which is a multi-turn silicone helix, with a platinum band on the inner turn of one helix. The prosthesis can be programmed with any IBM- compatible personal computer using NCP software and a programming wand.

Licensor owns a patent relating to Neurocyberenetic Prosthesis Technology (U.S. Patent No. 4,702,254) and other pending patent applications and know-how, and technology relating thereto (collectively referred to as the “Technology”).

4,702,254

US

NeuroCybernetic Prosthesis

Oct. 27, 1987

4,867,164

US

NeuroCybernetic Prosthesis

Sept. 19, 1989

50,258,807

US

NeuroCybernetic Prosthesis

June 25, 1991

577,549

Australia

NeuroCybernetic Prosthesis

March 3, 1989
1,259,379

Canada

NeuroCybernetic Prosthesis

September 12, 1989
0,156,854

Eurpoean

NeuroCybernetic Prosthesis

September 5, 1990

Austria, Belgium, Switzerland, Germany, France, United

Kingdom, Liechtenstein, Luxembourg, Netherlands, Sweden

503,504/84

Japan

Application Number

September 11, 1984

Field of Use

NCP System is an implantable medical device for the treatment of epilepsy.