Royalty Report: Drugs, Therapeutic, Bacterial Infection – Collection: 211833

License Grant

The Licensor of Ireland grants an exclusive license, with the right to grant sublicenses, to manufacture, have made, use and sell Products in the Territory, using the Licensors Know-How and under the Patent Rights.

License Property

Licensor owns Know-How and Patent Rights relating to Compound and/or ophthalmic pharmaceutical compositions containing Compound.

The Compound shall mean any recombinant human bactericidal/permeability increasing protein (BPI), that is rBPI21, other BPI analog proteins, N-terminal fragment proteins, BPI variant proteins or the holoprotein containing amino acid residues 1 to 456 of BPI.

BPI, bactericidal/permeability-increasing protein, is a naturally occurring human host-defense protein with multiple anti-infective properties.

Field of Use

The Field shall mean the mitigation, treatment or prevention of ophthalmic bacterial infection in humans and other mammals.

rBPI in combination with Licensee's anti-infectives may offer an important new approach to developing products that meet the clinical need for novel weapons against ophthalmic infections.

License Grant

The Licensor of Ireland grants an exclusive license, except as to the Licensor in cases where the Licensor provides development, manufacturing or other services to the Company,  in the Field of Use to practice under the Technology and to utilize the Know-how and Improvements in the Territory, and to make, have made, use, lease, sell or offer to sell the Licensed Products and to practice and have practiced the Licensed Processes.

The Licensor grants to the Company the right to grant sublicenses to third parties under the license granted hereunder in its sole discretion.

The Licensor grants to the Company an exclusive sublicense in the Field of Use to all rights granted under the NYU License Agreement, known as the NYU Sublicense.

The Licensor grants to the Company an exclusive sublicense in the Field of Use under the Incyte License Agreement.

The Licensor grants to the Company an exclusive sublicense in the Field of Use under the Joslin License Agreement.

The Licensor grants to the Company for the term of this Agreement a non-exclusive license to use any United States and/or foreign trademarks or trademark applications filed by or on behalf of the Licensor related to the Technology, the Patent Rights, Licensed Products or Licensed Processes, including NEUPREX®.

License Property

Technology shall mean all Know-how and Patent Rights, as well as all other rights that the Licensor has in BPI Cell Lines, BPI or its use or manufacture, unless expressly excepted or retained by the Licensor in this Agreement.

Licensed Process(es) shall mean any process, use or method to which any of the Patent Rights or Know-how are directed, in whole or in part, in the country in which the process or method is used.

Licensed Product(s) shall mean
– any product containing BPI which is covered in whole or in part by Patent Rights or Know-how in the country in which the product is made, used, leased or sold;
– any product containing BPI which is manufactured using a process which is covered in whole or in part by Patent Rights or Know-how in the country in which the process is used; or
– any product containing BPI which is used according to a method or use which is covered in whole or in part by Patent Rights or Know-how in the country in which the method is used.

Field of Use

Field of Use shall mean all uses of BPI.  BPI means a bactcricidal/penneability-increasing protein molecule, and includes naturally an recombinantly produced bactericidal/permeability-increasmg protein; natural, synthetic and recombinant fragments of bactericidal/permeability-increasing protein; variants; and analogs of bactericidal/penneability-increasing protein or fragments there including cysteine-substituted analogs and specifically includes rBPI21, opebacan a/k/a NEUPREX®.

The indications include Sepsis (including, but not limited to, any and all subsets of sepsis), Bum, Surgical Infection, Pneumonia, Graft vs. Host Disease, Inflammatory Diseases of the Bowel, Infectious Diseases of the Bowel, Ocular Diseases, Bone and Joint Diseases, Cystic Fibrosis

Neuprex® is an orphan drug for treating life-threatening infections–eg, meningococcemia–aka meningococcal septicemia, gram-negative bacteria, and N meningitidis infection in Pts with partial hepatectomy. See Meningococcemia.

License Grant

Licensor hereby grants to Licensee, an exclusive (except as otherwise provided in this agreement) license under the Licensor Technology to Develop, Manufacture and Commercialize Licensed Products, in each case solely for applications in the Field in the Territory. The license granted under this agreement shall not include the right to sublicense (except to a Marketing Partner as provided or to an Affiliate); provided, however, that the use by Licensee of subcontractors shall not be construed as a sublicense. Licensee shall have the right to exercise such license through its Affiliates solely for as long as such entity remains an Affiliate of Licensee, and Licensee shall remain responsible for the compliance of such Affiliate with the applicable terms of this Agreement.

Licensor hereby grants to Licensee a non-exclusive license to make, use and otherwise exploit subject matter within the Licensor Technology to the extent necessary to conduct the activities assigned to Licensee under the Discovery Research Plan or otherwise cooperate with Licensor hereunder. The license granted shall not include the right to sublicense; provided, however, that the use by Licensee of subcontractors or delegation of responsibilities to an Affiliate shall not be construed as a sublicense.

License Property

Licensor Technology shall mean the Licensor Patents and Licensor Know-How, including without limitation any Know-How and Patents covering (i) inventions made by Licensor in the course of performing activities under the Discovery Research Program and any Development Program, and (ii) formulations of Aganocide Compounds developed by Licensor for use outside the Field.

Aganocide Compound shall mean any chemical entity (i) having bactericidal, antibacterial, anti-infective, antimicrobial, antifungal, anti-parasitic, sporicidal, antiviral, immunomodulatory or anti-inflammatory activity, and (ii) consisting of either hypochlorous acid or consisting of a chemical formula outlined in the agreement.

Licensed Compound shall mean any Aganocide Compound that (i) is Controlled by Licensor as of the Effective Date, including NVC-101, NVC-422 and the compounds NVC-521, NVC-524, NVC-530, NVC-539, NVC-546; (ii) is Discovered by Licensor during the Exclusivity Period; or (iii) is Controlled by Licensor during the Exclusivity Period.

Field of Use

The novel Aganocide(TM) compounds can to treat infections of the eye, ear and sinus. Licensee said it believes Licensor;s Aganocide(TM) compounds have the potential to be important in the treatment of such infections because of their broad application to bacterial, viral and fungal infections.

Field shall mean, collectively, the Ophthalmic Sub-Field, Otic Sub-Field and Sinus Sub-Field. The Ophthalmic Sub-Field, Otic Sub-Field and Sinus Sub-Field may each be referred to herein, individually, as a “Sub-Field”.

Ophthalmic Sub-Field shall mean any pharmaceutical product or medical device incorporating a Licensed Compound for applications in or on the eye in humans, including without limitation contact lens solutions and ophthalmic solutions containing a Licensed Compound as a preservative.

Otic Sub-Field shall mean any pharmaceutical product or medical device incorporating a Licensed Compound for the prevention or treatment of infections in the ear in humans and solutions containing a Licensed Compound as a preservative for the ear in humans. For clarity, such pharmaceutical products or medical devices indicated for the treatment of otitis externa, including acute otitis externa (AOE), are considered products for the prevention or treatment of infections in the ear and thus a part of the Otic Sub-Field. (For purposes of this Agreement “infections” shall include any infection, whether bacterial, viral, fungal or any combination thereof; and “treatment” of an infection shall include the reduction or elimination of biofilm associated with such infection.)

Sinus Sub-Field shall mean any pharmaceutical product or medical device incorporating a Licensed Compound for the prevention or treatment of infections in the paranasal sinuses in humans and solutions containing a Licensed Compound as a preservative for the paranasal sinuses in humans, but excluding products for the treatment or prevention of infections of the nares.

Licensor Patents shall mean any and all Patents Controlled by Licensor during the Term claiming the composition or use of a Development Compound or that are otherwise necessary for the Development, Manufacture or Commercialization of Licensed Products incorporating such Development Compound, in each case within the Field in the Territory.