Royalty Report: Medical, Surgical, Wound Care – Collection: 332218

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts
(a) an exclusive license under the Licensed Technology, CoStasis Ingredient Improvements and CoStasis Ingredient Improvement Patents to make, have made, sell, have sold, offer for sale, export, have exported, import and have imported CoStasis Products in the Orthopedic Hemostat Field in the Territory;
(b) until such time as Licensor elects to distribute, promote, market and/or sell one or more Licensor-Branded CoStasis Products, an exclusive license under the Licensed Technology, CoStasis Ingredient Improvements and CoStasis Ingredient Improvement Patents to make, have made, sell, have sold, offer for sale, export, have exported, import and have imported CoStasis Products in the Non-Orthopedic Hemostat Field in the Territory;
(c) from and after such time as Licensor elects to distribute, promote, market and/or sell one or more Licensor-Branded CoStasis Products, a co-exclusive (meaning that only Licensee and Licensor can act in each country of the Territory) license under the Licensed Technology, CoStasis Ingredient Improvements and CoStasis Ingredient Improvement Patents to make, have made, sell, have sold, offer for sale, export, have exported, import and have imported CoStasis Products in the Non-Orthopedic Hemostat Field in the Territory;
(d) a non-exclusive license under the Licensed Technology to make, have made, use, sell, have sold, offer for sale, export, have exported, import and have imported CellPaker Products and Accessories in the CellPaker Field in the Territory; and
(e) a non-exclusive license under the Licensed Technology and CoStasis Ingredient Improvements and CoStasis Ingredient Improvement Patents to use (including, without limitation, to research, have researched, develop and have developed) CoStasis Ingredients and Formulated CoStasis Ingredients (but only for uses directly related to Licensee’s Product licenses and rights hereunder), Products (other than Licensor-Branded CoStasis Products) and Accessories in the Licensed Field in the Territory.

Solely for purposes of fulfilling Licensee’s obligations under this Agreement with respect to the Licensor Trademarks ANGIOTECHKNOWLEDGY® and CELLPAKER® (or other Licensor Trademark(s) that Licensor may wish to substitute therefor during the Term), Licensor grants to Licensee a non-exclusive right and license to use such Licensor Trademarks for this limited purpose.

License Property

Products means CoStasis Products and CellPaker Products, collectively or individually, as the context requires.

CoStasis Product(s) means a product(s) containing the Formulated CoStasis Ingredients in a syringe that is manufactured by or for Licensee or by or for Licensor (and/or Licensor’s Affiliates) for use and exploitation in the Licensed Field in accordance with this Agreement. The current formulation of the CoStasis Product is described in Exhibit A hereto. The term “CoStasis Products” includes Licensor-Branded CoStasis Products. The term CoStasis Products shall expressly exclude Drug-Loaded Products. However, Licensee may add one or more additional ingredients to the CoStasis Ingredients to make a CoStasis Product; provided that no such additional ingredient is an active pharmaceutical ingredient or a drug.
Description A sterile suspension of bovine collagen and bovine thrombin in calcium chloride.

CoStasis Ingredients means collagen and thrombin.

Licensor-Branded CoStasis Product(s) means a CoStasis Product(s) for use and exploitation in the Non-Orthopedic Hemostat Field that is distributed, promoted, marketed and/or sold by or on behalf of Licensor and/or its Affiliates under one or more Licensor Trademarks selected by Licensor; provided that if Licensee loses its exclusive (or co-exclusive, as applicable) rights with respect to CoStasis Products in the Orthopedic Hemostat Field, then the term Licensor-Branded CoStasis Product(s) shall also include use and exploitation in the Orthopedic Hemostat Field.

CellPaker Product(s) means a CellPaker® Plasma Collection System product(s) for use with CoStasis Products, as  described hereto.
Description A needle-less syringe device for drawing blood from a human for direct placement into a centrifuge for centrifuging to separate plasma from red and white blood cells.
“Licensed Patents” means
5,290,552 – Surgical adhesive material
6,096,309 – Compositions containing thrombin and microfibrillar nanometer collagen, and methods for preparation and use thereof
5,968,018 – Cell separation device and in-line orifice mixer system

LicensorTrademark(s) means a Trademark(s) owned or Controlled by Licensor. Licensor shall select one or more Licensor Trademarks for use in conjunction with an Licensor-Branded CoStasis Product(s), and these Licensor Trademark(s) shall be different from Licensee Trademark(s) used in conjunction with CoStasis Product(s). Licensor Trademark(s) shall expressly include ANGIOTECHKNOWLEDGY® and CELLPAKER®.

Licensee Trademark(s) means a Trademark(s) owned or Controlled by Licensee. Licensee shall select one or more Licensee Trademarks for use in conjunction with CoStasis Product(s) (other than Licensor-Branded CoStasis Product(s)), and these Licensee Trademark(s) shall be different from Licensor Trademark(s) used in conjunction with Licensor-Branded CoStasis Product(s).

CoStasis Ingredient Improvementis defined as  With respect to an Improvement to the CoStasis Ingredients and/or the Formulated CoStasis Ingredients (including, without limitation, any Improvement constituting a composition, method of making and/or method of using any of the foregoing) that is conceived, reduced to practice, discovered, derived or developed by or on behalf of Licensee or its Affiliates (each, a CoStasis Ingredient Improvement), Licensee and its Affiliates agree to assign, and hereby do assign, their right, title and interest in and to each such CoStasis Ingredient Improvement to Licensor.

CoStasis Ingredient Improvement Patents is defined as  Licensor shall file, prosecute and maintain in force (a) any and all patents and patent applications included in the Licensed Patents, (b) any and all patent and patent applications related to any CoStasis Ingredient Improvement.

Field of Use

Licensed Field means, collectively or individually, as the context requires, (a) the Orthopedic Hemostat Field; (b) the Non-Orthopedic Hemostat Field; and (c) the CellPaker Field. The terms “Licensed Field,” “Orthopedic Hemostat Field” and “Non-Orthopedic Hemostat Field” are expressly inapplicable to Drug-Loaded Products, even if a Drug-Loaded Product is approved for human use in the Licensed Field.

Orthopedic Hemostat Field means, with respect to a CoStasis Product, human medical uses of the CoStasis Product as a Hemostat for all indications treated by an orthopedic surgeon or other surgeon relating to the surgical repair of diseases or injuries of the spine, bone or related soft tissue, such as ligaments or cartilage.

Non-Orthopedic Hemostat Field means, with respect to a CoStasis Product, human medical uses of the CoStasis Product as a Hemostat for all indications, other than indications within the Orthopedic Hemostat Field.

Hemostat means a product, the primary purpose of which is to stop bleeding through an activation of the coagulation cascade.

CellPaker Field means human medical uses of the CellPaker Products and/or Accessories in connection with CoStasis Products.

License Grant

Licensor grants
—  an exclusive license under the Licensed Technology, CoStasis Ingredient Improvements and CoStasis Ingredient Improvement Patents to make, have made, sell, have sold, offer for sale, export, have exported, import and have imported CoStasis Products in the Orthopedic Hemostat Field in the Territory;

—  until such time as Licensor elects to distribute, promote, market and/or sell one or more Licensor Branded CoStasis Products, an exclusive license under the Licensed Technology, CoStasis Ingredient Improvements and CoStasis Ingredient improvement Patents to make, have made, sell, have sold, offer for sale, export, have exported, import and have imported CoStasis Products in the Non-Orthopedic Hemostat Field in the Territory,

—  from and after such time as Licensor elects to distribute, promote, market and/or sell one or more Licensor Branded CoStasis Products, a coexclusive, meaning that only the Parties can act in each country of the Territory, license under the Licensed Technology, CoStasis Ingredient Improvements and CoStasis Ingredient Improvement Patents to make, have made, sell, have sold, offer for sale, export, have exported, import and have imported CoStasis Products in the Non-Orthopedic Hemostat Field in the Territory;

—  a non-exclusive license under the Licensed Technology to make, have made, use, sell, have sold, offer for sale, export, have exported, import and have imported CellPaker Products and Accessories in the CellPaker Field in the Territory; and

—  a non-exclusjve license under the Licensed Technology and CoStasis Ingredient improvements and CoStasis Ingredient Improvement Patents to use, including, without limitation, to research, have researched, develop and have developed) CoStasis Ingredients and Formulated CoStasis Ingredients, but only for uses directly related to Licensees Product licenses and rights hereunder, Products, other than Licensor Branded CoStasis Products, and Accessories in the Licensed Field in the Territory.

License Property

CoStasis Ingredients means collagen and thrombin.

CoStasis® Surgical Hemostat product is a sterile suspension of bovine collagen and bovine thrombin in calcium chloride.

CoStasis Product means a product containing the Formulated CoStasis Ingredients in a syringe.

CellPaker® Plasma Collection Svstem is a needleless syringe device for drawing blood from a human for direct placement into a centrifuge for centrifuging to separate plasma from red and white blood cells.

CellPaker Product means a CellPaker® Plasma Collection System product for use with CoStasis Products, CoStasis Ingredients' means collagen and thrombin.

Field of Use

Licensed Field means, collectively or individually, as the context requires,
(a) the Orthopedic Hemostat Field;
(b) the Non-Orthopedic Hemostat Field; and
(c) the CellPaker Field.

The terms Licensed Field, Orthopedic Hemostat Field and Non-Orthopedic Hemostat Field are expressly inapplicable to Drug-Loaded Products, even if a Drug-Loaded Product is approved for human use in the Licensed Field.

CellPaker Field means human medical uses of the CellPaker Products and/or Accessories in connection with CoStasis Products.

Non-Orthopedic Hemostat Field means, with respect to a CoStasis Product, human medical uses of the CoStasis Product as a Hemostat for all indications, other than indications within the Orthopedic Hemostat Field.

Orthopedic Hemostat Field means, with respect to a CoStasis Product, human medical uses of the CoStasis Product as a Hemostat for all indications treated by an orthopedic surgeon or other surgeon relating to the surgical repair of diseases or injuries of the spine, bone or related soft tissue, such as ligaments or cartilage.

License Grant

The original agreement is to distribute, market and sell CoStasis®, re-branded as VITAGEL™, a composite liquid hemostat, and the CELLPAKER® plasma collection system, used together with VITAGEL, to surgical customers throughout North America, with an option to expand the territory to include the European Union and the rest of the world.

The Parties are in the process of transitioning manufacturing of Products and Accessories from Licensor to Licensee, and by this Amendment the Parties wish to set forth certain understandings and acknowledgements regarding Licensors supply of Products and Accessories to Licensee before November 1, 2005.  Licensor is closing their manufacturing facility and transfer the process to the Licensee, including manufacturing technology.

License Property

The manufacturing technology process is for the following products
CoStasis Product 4.5 ml unit dose package
CoStasis Product 2.0 ml unit dose package
CellPaker Product Box of 10 CellPaker Product units
Accessory (MEA) Box of 5 MEA units
Accessory (LEA) Box of 10 LEA units

CoStasis Ingredients means collagen and thrombin.

CellPaker® Plasma Collection Svstem is a needleless syringe device for drawing blood from a human for direct placement into a centrifuge for centrifuging to separate plasma from red and white blood cells.  CellPaker Product means a CellPaker® Plasma Collection System product for use with CoStasis Products, CoStasis Ingredients' means collagen and thrombin.

Field of Use

The Licensee is a biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications.

License Grant

The agreement licensed certain bone wax rights to develop products in the field of bone remodeling, based on patent number 7,074,425 for use in the human skeletal system.  The license agreement excludes the fields of (1) a resorbable hemostat (resorbable bone wax), (2) a resorbable orthopedic hemostat (bone wax) and antimicrobial dressing, and (3) veterinary orthopedic applications. In January 2014, Licensee received 510k approval for their first product under the license, a bioactive bone graft putty and bone graft extender.  In February 2014, Licensor granted a Commercial License to Licensee according to the terms of the development and license agreement.

License Property

The Licensor acquired patent 7,074,425 in September 2009.  It is for a resorbable bone wax and delivery system for orthopedic bone void fillers. The patent offers innovative, safe and effective resorbable orthopedic products that are complementary to the already existing Licensor products.  The bone wax and delivery system address issues such as bone wax granuloma and the cost-effective delivery of materials that manage bone wound healing. The resorbable orthopedic products covered by the patent are (a) a resorbable orthopedic hemostat (resorbable bone wax) used to stop blood flow, (b) a delivery system for osteogenic/osteoinductive orthopedic products (bone void fillers), and (c) the formula as a delivery system for bone growth factors.

License Grant

The agreement licensed certain bone wax rights to develop products in the field of bone remodeling, based on patent number 7,074,425 for use in the human skeletal system.

Field of Use

The field of use is bone remodeling in the human skeletal system.  The license agreement excludes the fields of (1) a resorbable hemostat (resorbable bone wax), (2) a resorbable orthopedic hemostat (bone wax) and antimicrobial dressing, and (3) veterinary orthopedic applications.

License Grant

Under the terms of this agreement, the Company recognizes royalty revenue on sales of products containing the Companys patented resorbable bone hemostasis.

License Property

The Companys products are primarily purchased by hospitals and ambulatory surgical centers for use by surgeons on surgical wounds.

Field of Use

Licensed refers to certain bone wax rights to Licensee to develop products in the field of bone remodeling, based on Resorbable’s patent number 7,074,425 (see Note 9 “Intangible Assets”) for use in the human skeletal system.

The Company’s business is developing, marketing, and distributing wound and skin care products to physicians, hospitals, clinics and post-acute care settings.

License Grant

For the CoSeal Sealant Units Exclusive Distribution, Sales and Marketing Rights,  Licensors of the United States, Switzerland and Canada grant
— a sole and exclusive license, with right to sublicense, under Licensor Patents and Trademarks to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Sealant Units in the Sealant Territory; and
— a non-exclusive license, with right to sublicense, under Licensor Know-How to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Sealant Units in the Sealant Territory during the term of this Distribution and License Agreement.

For the CoSeal Sealant Option, Licensor grants an option (the CoSeal Sealant Option)
— a sole and exclusive license, with right to sublicense, under Licensor Patents and Trademarks to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Sealant Units in Japan; and
— a non-exclusive license, with right to sublicense, under Licensor Know-How to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Sealant Units in Japan.

For the CoSeal Adhesion Prevention Units Exclusive Distribution, Sales and Marketing Rights, Licensor grants
— a sole and exclusive license, with right to sublicense, under Licensor Patents and Trademarks to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Adhesion Prevention Units in the Adhesion Prevention Territory; and
— a non-exclusive license, with right to sublicense, under Licensor Know-How to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Adhesion Prevention Units in the Adhesion Prevention Territory during the term of this Distribution and License Agreement.

For the CoSeal Adhesion Prevention Option, Licensor grants to an option (the CoSeal Adhesion Prevention Option)
— a sole and exclusive license, with right to sublicense, under Licensor Patents and Trademarks to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Adhesion Prevention Units in the United States; and
— a non-exclusive license, with right to sublicense, under Licensor Know-How to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Adhesion Prevention Units in the United States.

For the CoSeal Accessories Exclusive Rights, Licensor grants
— a sole and exclusive license, with right to sublicense, under Licensor Patents and Trademarks to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import CoSeal Accessories in the Field in the Territory; and
— a non-exclusive license, with right to sublicense, under Licensor Know-How to use, have used, market, have marketed, distribute, have distributed, sell, have sold, offer for sale, export and import the CoSeal Accessories in the Field in the Territory.

License Property

The trademarks include COSEAL©, ADHIBIT™, and, ANGIOTECHKNOWLEDGY™.

CoSeal Ingredients shall mean the two derivatized polyethylene glycol ingredients, designated COH102 and COH206

CoSeal Adhesion Prevention Unit shall mean a CoSeal Adhesion Prevention Product sold in combination with a CoSeal Adhesion Prevention Device.

CoSeal Devices shall mean, collectively, as the context requires, both or either of the CoSeal Adhesion Prevention Devices and/or the CoSeal Sealant Devices.

CoSeal Unit shall mean, collectively, as the context requires, both or either of the CoSeal Sealant Unit and/or the CoSeal Adhesion Prevention Unit.

CoSeal Sealant Unit shall mean a CoSeal Sealant Product sold in combination with a CoSeal Sealant Device.

CoSeal Sealant Product shall mean a product containing the CoSeal Ingredients that is the subject matter of a Regulatory Filing for use as a tissue sealant, adhesive or glue, has been or is approved by one or more Regulatory Authorities for use as a tissue sealant, adhesive or glue, or that is in development or sold for use as a tissue sealant, adhesive or glue.

Field of Use

CoSeal is indicated for use in vascular reconstructions to achieve adjunctive ·hemostasis by mechanically sealing areas of leakage.  CoSeal is designed to rapidly seal tissue surfaces, suture lines and synthetic grafts during surgery.

Field shall mean human therapeutic use for any and all tissue sealing, adhesive, glue or adhesion prevention barrier indications but shall specifically exclude any use (i) in Hemostat indications; (ii) for tissue regeneration indications; (iii) as an osteobiologic for skeletal repair an non-pharmacologic devices for osteoarthritis treatment,; (iv) as a urinary incontinence product and for the treatment of urinary incontinence; or (v) as an ostomy product.