Royalty Report: Medical, Device, cardiac – Collection: 353931

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

Licensed Patents License Licensor hereby grants to Licensee during the Term a nontransferable, nonsublicensable, exclusive right and license under the Licensed Patents in the Field of Use to make, use, offer to sell, sell, and import Licensed Products in the Territory.

Know-How License Licensor hereby grants to Licensee during the Term a nontransferable, nonsublicensable, exclusive right and license in the Field of Use under the Licensed Know-How to make, use, offer to sell, sell, and import Licensed Products.

Licensee hereby grants to Licensor a non-exclusive, nonsublicensable, nontransferable, worldwide, royalty-free, license to all Improvements for use by Licensor to make, use, sell, offer for sale and/or import Licensors products solely outside the Field of Use.

License Property

US Patent Applications
1 – METHODS OF DECELLULARIZING BONE Utility – NPREG
United States of America
Issued
13/787,625
2 – U.S. Provisional Patent Application entitled FISTULA FILLER AND DEPLOYMENT SYSTEM, Application No. 62/684,426; Filing Date June 13, 2018, U.S. PROVISIONAL CONVERSION/ PARIS CONVENTION DEADLINE JUNE 13, 2019
3 – U.S. Provisional Patent Application entitled IMPROVED DECELLULARIZATION OF ISOLATED ORGANS, Application No. 62/821,620
4 – U.S. Provisional Patent Application entitled NON-DESTRUCTIVE METHOD OF DEHYDRATION OF EXTRACELLULAR MATRIX OF DECELLULARIZED ORGANS AND PARTICLES FORMED THEREFROM, Application No. 62/789,218

Miromeshâ„¢ and MirodermTM products
and the following products in development or previously considered
Tendon Wrap
Wound Particulate
Nerve Wrap
Void Filler
Fistula

Miromesh is a biological mesh made using perfusion decelluarized porcine liver for hernia repair applications. It is designed to be implanted to boost soft tissue.

MiroDerm® is a non-crosslinked acellular wound matrix, derived from the highly vascularized porcine liver. It is intended for the management of wounds, including partial and full-thickness wounds; pressure ulcers; chronic vascular ulcers; diabetic ulcers; tunneled, undermined wounds; trauma wounds; drainage wounds; and surgical wounds.

Field of Use

Field of Use means acellular extracellular matrix products derived from perfusion decellularization but excluding (i) decellularized Whole Organs; (ii) all non-clinical applications; and (iii) use in three-dimensional printing applications including but not limited to mapping associated therewith. For the avoidance of doubt, under no circumstances does the Field of Use include the addition of cells to the extracellular matrix.

License Grant

Licensor, two individuals from Italy, grants an exclusive, perpetual and irrevocable license to make, use, have made, sell, offer to sell, import, manufacture, market and distribute the Licensed Technology within the Territory. Licensee shall appoint an exclusive distributor of the Licensed Technology in Italy at the conditions to be separately agreed between the parties.

License Property

Licensor is the inventor of certain processes and devices that allow for the migration of organic cells into tissue samples while being incubated in a specialized bioreactor, the Technology.

lmprovements mean any Intellectual Property developed after the Effective Date by the Inventor/Licensor or any third party affiliated with Licensor that constitutes an improvement or enhancement of the functions of the Technology, that is associated to the Technology and that relates to a bioreactor device able to feed and repopulate a rotating tubular structure, with the exclusion of different or new functions relating to generation of electrical fields, pressure fields and fluid dynamic fields.

Field of Use

The intellectual property rights relates to our InBreath Bioreactor.

This bioreactor is the first in a series of products that Licensee is developing to address what we believe is a long-term growth opportunity in the emerging field of regenerative medicine. Regenerative medicine is a new field that uses stem cells to repair damaged organs (e.g., spinal cord and heart) and also to grow tissue (e.g., bladder and bronchus) and organs (e.g., heart and lung) outside the body for transplant.

InBreath hollow organ bioreactor is a device that can be used by a surgeon to seed cells onto a scaffold. The InBreath bioreactor enables the surgeon to
•
secure the scaffold to the bioreactor;
•
seed the patient’s cells on the scaffold under sterile conditions;
•
automatically rotate the scaffold to allow good cell distribution into the pores of the scaffold; and
•
remotely monitor the scaffold during the course of the two to three days incubation period before the transplant.
The InBreath bioreactor has several novel features such as allowing for separate cell seeding conditions on the inside and outside of the scaffold and for pumping cell culture media through the inside of the scaffold without the need for an external pump and tubes. The Licensee believe the InBreath hollow organ bioreactor is the world’s first bioreactor that has been used to perform a human transplant of a regenerated organ.

The Technology has proven beneficial medical uses in organ transplant as well as the potential for use in other areas.

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.