Royalty Report: Medical, Device, Therapeutic – Collection: 279319

License Grant

The Parties will undertake a Drug-Device testing program using Licensee’s Drug (including specific and necessary formulations of the Drug) in a Licensor Device to permit the parties’ evaluation of potential further testing and development of a Drug/Device combination therapy.  Licensor will provide Mini-Med® Paradigm Insulin Pumps and Sertable® Infusion Sets as further specified in the Work Plan.  Licensor shall retain ownership of the Pumps and Licensee shall return the Pumps to Licensor upon completion of the Clinical Study.

License Property

Product means any Drug, Device, or Drug/Device combination developed pursuant to the Agreement.

Drug means the hybrid natriuretic peptides (CD-NP) known as cenderitide as defined in US Patent Number(s) 6,407,211 owned or licensed or otherwise acquired by or assigned to Nile, which exist at the Effective Date.

Cenderitide, our lead product candidate, is a chimeric natriuretic peptide that we are developing for the treatment of heart failure.

6,407,211 – Chimeric natriuretic peptides

Licensee Patents focus on the use of hybrid natriuretic peptides, including but not limited to CD-NP, as defined.
Licensee Patents means the following Intellectual Property
6,818,619 – Chimeric natriuretic peptides
7,384,917 – Chimeric natriuretic peptides

Intellectual Property means all forms of intellectual property in any jurisdiction and under any law, whether now or hereafter existing, including (a) inventions, discoveries, patent applications, patents (including letters patent, industrial designs, and inventor’s certificates), design registrations, invention disclosures, and applications to register industrial designs, and any and all rights to any of the foregoing anywhere in the world, including any provisionals, substitutions, extensions, supplementary patent certificates, reissues, re-exams, renewals, divisions, continuations, continuations in part, continued prosecution applications, and other similar filings or notices provided for under the laws of the United States, or of any other country; (b) trade secrets and other confidential or non-public business information, including ideas, formulas, compositions, inventor’s notes, discoveries, improvements, concepts, know-how, manufacturing and production processes and techniques, testing information, research and development information, data resulting or derived from research activities, inventions, invention disclosures, unpatented blue prints, drawings, specifications designs, plans, proposals and technical data, business and marketing plans, market surveys, market know-how and customer lists and related information; (c) copyrights, whether or not registered, and any non-registered copyright to any writings and other copyrightable works of authorship, including source code, object code, documentation (whether or not released), and databases; (d) features of shape, configuration, pattern or ornament; and (e) registrations of, and applications to register, any of the foregoing with any governmental entity and any renewals or extensions thereof and all other rights to any of the foregoing.

Clinical Study means the Phase IIa feasibility study designed by Nile to be conducted hereunder as further set forth in this agreement.

Field of Use

Licensor will provide the equipment necessary for the Licensee to conduct its planned Phase I clinical trial to assess the pharmacokinetics and pharmacodynamics of cenderitide when delivered to heart failure patients through continuous subcutaneous infusion using Licensor’s diabetes pump technology.

License Grant

The Israel Licensor and Licensee intend to jointly develop one or more Devices to be commercially sold for use in the field (the “Project”). The Parties’ shall, promptly upon execution of this Joint Development and Supply Framework Agreement (JDSA), agree on a plan for the Project (the Project plan). Each Party shall perform the duties and obligations assigned to it under the Project plan, on the timeline set forth therein.

Each Party agrees to fully cooperate with the other Party and hereby assigns to the other Party the Project patents and Project know-how to the extent necessary to achieve the ownership and other rights set forth in this Agreement. This includes, but is not limited to, reviewing patent applications and providing comments to the same, providing comments to facilitate prosecution or opposition of the other Party’s patent application or a joint patent application, providing data or evidence of patentability required for prosecution or opposition and executing assignment documents and instruments reasonably necessary to evidence or record such assignment or to enforce rights in the assigned intellectual property.

License Property

Device Devices that utilize RF alone or a combination of RF energy plus optical radiation and or other types of energy sources, to achieve one or more Benefits.

Project Patent  Any Patent claiming a Project invention.

Project patent – Device Any Project patent wherein (a) each of the claims covers at least one of the following, or covers a combination of any of the following any Device, Device component, RF and/or optical radiation or other types of energy sources, or method of making or using any of the same; and (b) no such claims cover, or include limitations directed specifically to, any of the following, or a combination of any of the following any Personal Care Composition, ingredient(s) thereof, or a method of making or using any of same, or Licensee Device technology. None of the individual items listed in clause (a) shall be used to interpret or limit the scope of other items listed in such clause (there is overlap among categories).

Project invention Any invention conceived and/or reduced to practice (a) by Licensor employees or other agents (whether solely or jointly with another), (b) by Licensee employees or other agents (whether solely or jointly with another), or (c) by at least one of each of the foregoing in (a) and (b), in each case (x) pursuant to their conduct of the Project, or (y) using the other Party’s materials that are (or were prior to the effective date) received in connection with (or in preparation for) the Project or otherwise pursuant to this JDSA.

Personal Care Composition Topical formulations and compositions for application to keratinous tissue (including skin, hair, and nails) marketed to consumers for using either during operation of the Device or within a treatment regimen(s) using the Device. Such a regimen includes pre-and post treatment lotions, but excludes cleansers, daily use lotions or other general use lotions.

Device technology All technology solely developed by Licensee pertaining to delivery, distribution and/or application of compositions from a device, aesthetic or ergonomic aspects of devices, consumables other than consumables utilized for the administration of energy or cooling of the skin or otherwise retro-fitted components for use with devices other than components utilized for the administration of energy or cooling of the skin, discoveries and inventions related to the marketing of devices, discoveries and inventions related to the consumer use or consumer interface that’s associated with the use of the device by the consumer, methods of use of devices within the field, business methods associated with marketing devices within the field, discoveries and inventions related to safety aspects of devices.

Intellectual property or IP Inventions, discoveries and technology, whether patentable or not, and all patents, registrations, invention disclosures and applications therefore, including divisions, continuations, continuations-in-part, and renewal applications, and including renewals, extensions, re-examinations and reissues; (ii) Confidential Information, trade secrets and know-how, including processes, schematics, business methods, formulae, drawings, prototypes, models, designs, customer lists and supplier lists (collectively, “Trade Secrets”); (iii) published and unpublished works of authorship, whether copyrightable or not (including, without limitation, databases and other compilations of Information), copyrights therein and thereto, and registrations and applications therefore, and all renewals, extensions, restorations and reversions; and (iv) all other intellectual property or proprietary rights.

Benefit Enhancement of skin appearance with respect to preventative and therapeutic treatment of, the following conditions fine lines, wrinkles, hyperpigmentation, superficial and benign vascular and pigmented lesions, such as telangiectasias, rosacea, poikiloderma, cellulite and angioma, but not including (and explicitly excluding) the following conditions and applications adipose tissue, skin recontouring or reshaping, fat reduction, lypolysis, acne, leg veins, hair removal, and the inhibition, prevention, reduction, or slowing of hair growth.

Field of Use

Field In-home use to obtain one or more Benefits using the Device. The Field shall not include (and explicitly excludes) use in clinical settings, use in spa settings, and use by Professionals in treating patients or clients.

This agreement pertains to the medical industry relating to in-home personal use that utilize radio frequency (“RF”) alone or a combination of RF and optical radiation and/or other types of energy sources, alone or when in conjunction with Personal Care Compositions, to enhance an individual’s skin appearance.

License Grant

Licensor, a nonprofit American academic medical center, grants to Licensee an exclusive, world-wide, royalty-bearing license, with the right to sublicense pursuant to this Agreement, under the Patents and Improvements, and a nonexclusive right under the Know-How to develop, make, have made, use, sell, import, offer to sell and commercialize Products within the Territory and within the Field.

License Property

US Patent granted June 2002, #6,407,211 – Chimeric natriuretic peptides
US Patent granted November 2004, #6,818,619 – Chimeric natriuretic peptides

CD-NP is a rationally-designed synthetic peptide developed to incorporate the optimal components of naturally occurring natriuretic peptides.  CD-NP is a selective NPRB agonist that has shown potent renal enhancement and cardiac unloading properties in vivo. Importantly, however, CD-NP appears to do so with minimal hypotensive effects as compared with competitive products. In multiple preclinical studies, including a large animal model of congestive heart failure, CD-NP demonstrated potent therapeutic activity.

Field of Use

CD-NP may be useful in several cardiovascular and renal indications, and is initially being developed as a treatment for heart failure.

License Grant

Seller hereby agrees to sell, convey, transfer, assign, grant and deliver to Purchaser, and Purchaser hereby agrees to purchase, acquire and accept from Seller at the Closing (as hereinafter defined) all of Seller’s right, title and interest in and to the Intellectual Property, free and clear of all liabilities, obligations, pledges, security interests, liens, defenses, contractual commitments, claims, setoffs, equities or other encumbrances or charges (collectively, the Encumbrances) other than as expressly set forth herein.

License Property

Intellectual Property shall mean all of Seller’s right, title, and interest in and to a certain software, technology and data developed and owned by Seller relating to products and services for the gathering and sequencing of human genome DNA, alignment and processing of such DNA through Seller’s proprietary Artificial Inteligence (“AI”) in order to provide reports and analysis to customers (the Licensor Technology).

The Licensor Technology consists of the following components and the data and configurations which enable them
1. U.S. Provisional Utility Patent Application; Atty. Docket No. 46223-0002P01
2. NAVII – A set of software components which implement AI and other technologies to process, analyze, and extend sequenced human DNA data
3. Core & API – software and data which extend NAVII and manages the workflow and pipelines necessary for NAVII to interact with other Licensor Technology components
4. Integrations – software implemented to allow interaction with systems and data from labs, partners and customers
5. Products – Application software and product meta-data to generate reports and user interactions for commercial use. Products exist in the Licensor Technology in various states for
a. Cannabis – genetic interpretation and dosing for individuals;
b. Genetic Analysis – interpretations, reporting and web-based interactions of more than a dozen additional areas of analysis for individual genetics; and
c. Health & Wellness – interpretation, reporting and web-based interactions for analyzing individual genetics for the applications of diet, nutrition, exercise and nutraceuticals;
1. Executables, Source codes, use codes, or other coding required to utilize and implement Artificial Intelligence pursuant to this Agreement.
2. All “Authored Work” as set forth in the License Agreement relating to certain Artificial Intelligence;
3. The “Licensor Rapid Cannabis Recommendation” as set forth in the License Agreement;
4. Licensor work product and clinical trial data; and
5. Goodwill

Intellectual Property with respect to the above shall include, without limitation (i) all information, intellectual property inventions, patent applications, patents, trademarks, works of authorship, designs, copyrights, copyright applications, copyright registrations, Trade Secrets and Confidential Information, know-how, show-how, substances, recipes, formulas, compositions, equipment, apparatuses, techniques, samples, prototypes, models, methods, practices, processes, processes, process parameters, research and development information, notes, books, writings or other documents, software, algorithms, flow charts, data flow diagrams, state transition diagrams, contact diagrams, technical plans and designs, data, blueprints, technical information, ideas, specifications, strategies, drawings, computer programs, client or third party information, methods of manufacture, distribution, marketing, strategy and sale, and general business operations, including customer lists, pricing data, financial statements, and business plans including, but not limited to, improvements, changes, and modifications to the foregoing, relating to the Intellectual Property, which is not generally known or readily ascertainable and/or not already known to Purchaser, and which is provided to Purchaser by Seller; (ii) any right to use or exploit any of the foregoing, and (iii) any other proprietary right, whether arising under the laws of the United States or any other country.

Trade Secret shall mean Seller’s formula, pattern, compilation, device, method, technique, or process, tangible or intangible, in connection with the Intellectual Property, wherein Seller derives independent economic value, actual or potential from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use, and is the subject of efforts that are reasonable under the circumstances to maintain its secrecy and/or which qualifies as a trade secret within the meaning of the California Uniform Trade Secrets Act and the Defend the Trade Secrets Act.

Field of Use

Field of use is used in the medical industry relating to DNA, wellness, and cannabis.

License Grant

At the Closing, upon and subject to the terms and conditions of this Agreement, (a) Buyer shall purchase and hereby purchases from the British Virgin Islands Seller, and Seller shall sell, transfer, convey, assign and deliver, and hereby sells, transfers, conveys, assigns and delivers to Buyer, all of its right, title and interest in, to and under the Acquired Assets.

License Property

The Acquired Assets of a tangible nature including but not limited to all Miravant medical laser devices and pharmaceutical product (Miravant Medical Technologies).

Acquired Assets shall mean all of the following
(a) Acquired Patents and all laboratory notebooks, reports, correspondence, test materials, records, assignments and data that pertain to the Acquired Patents;
(b) All of Seller’s rights, if any, in the trade names and trademarks Photrex, Purlytin and PhotoPoint, and all goodwill associated therewith including U.S. Trademark Registration No. 3,021,310 for PHOTOPOINT and design.

Acquired Technology means Acquired Patents, Regulatory Documentation, Regulatory Filings, technology rights, personal property, files, records, documentation, inventory, and other assets pertaining to Photrex and all other Photodynamic Therapy Technology and Photodynamic Therapy related rights, programs and perfected assets acquired from Miravant by Seller, or for which Seller has rights to ownership and has not perfected such rights.

Miravant Derived Photodynamic Therapy Products means products derived by Miravant using the Photodynamic Therapy Technology.

Photodynamic Therapy Technology means all patents, trademarks, trademark rights, trade names, trade name rights, service marks, copyrights, registered designs, utility models and similar property rights, and all applications relating to the foregoing, all inventions, trade secrets and know-how, databases, product and marketing information, surveys, data and research supporting all product registrations, transferable rights to software, and all other intellectual property rights and all analytical and validation methods, and all other know-how and information relating to Photodynamic Therapy or otherwise required to formulate, test, manufacture, use and sell any product relating to Photodynamic Therapy, and all improvements and modifications thereof that are hereafter developed.

Photodynamic Therapy means the technique of diagnosis and/or treatment of abnormal or normal biological or medical conditions, either in-vivo or ex-vivo, through the use of chemical entities, drugs or other compositions activated by light or any type of electromagnetic radiation or magnetic field.

Field of Use

This agreement pertains to the medical industry relating to laser devices and pharmaceutical products.