Royalty Report: Diagnostic, Drugs, Medical – Collection: 4174

License Grant

University hereby grants to Company and Company hereby accepts from University i. Exclusive right under the Patent Rights to make have made use, import, export, put into use, distribute, subLicense, sell and have sold Licensed Products in the Field in the territory during the term of this Agreement; and ii. Non-exclusive right under the Patent Rights to make, have made, use, import, export, put into use, distribute, sell and have sold Licensed Products for Gene Therapy in the Field and in the territory during the term of this Agreement.

License Property

Company shall be entitled to grant subLicenses to the exclusive License described in this section 2.a.i. under the License on terms and conditions not inconsistent with this Agreement (except that the rate of royalty may be at higher rates than those set forth in this Agreement).

The License shall be subject to i. a non-exclusive license in favor of the U.S. Government to the extent required by Title 35 U.S.C.A. § 200 et seq., or as otherwise required by virtue of use of federal funding in support of inventions claimed within the Patent Rights and ii. a right and license retained by University on behalf of itself and its faculty, students and academic collaborators to practice the Patent Rights for its own bona fide research, including sponsored research and collaborations. The retained rights granted in this Section 2e shall not give University the right to offer or grant rights in the Field under the Patent Rights to third parties.

Patent Rights shall mean any issued patent or any patent to be issued pursuant to any United States or foreign patent application owned, by University, listed in this subclause 1.k. together with any continuations in whole, divisional or substitute patents, any reissues or re-examinations of any such application or patents, and any extension of the term of any such patent in the Field. The issued patents and patent applications referred to in the preceding sentence are

i. US Provisional patent application 60/381.617 filed 05/17/02
ii. US Provisional patent application 60/444,851 filed 02/04/03
iii. PCT application PCT/US03/15658 filed 05/19/03

Licensed Product(s) shall mean any material or product or kit, or any service, process, or procedure that  i. Either is covered by the Patent Rights or whose discovery, development, registration manufacture, use or sale would constitute, but for the license granted to Company pursuant to this Agreement, an infringement of any pending or issued claim within the Patent Rights or  ii. Is discovered, developed, made, sold, registered or practiced using Licensed Method or which may be used to practice the Licensed Method, in whole or in part or  iii. Is a kit, reagent or material which comprises, contains or makes use of Biological Material in its manufacture, testing use or sale.

Gene Therapy shall mean the introduction of genes into cells to modify the behavior of such cells.

Field of Use

Field shall mean the use of the Patent Rights for in vitro drug screening assays, predictive toxicology and efficacy assays, drug-related pharmacology assays, genomics and proteomics studies, and developing human and animal therapeutic and diagnostic products. Field shall not mean Cell-Based Therapy.

License Grant

University hereby grants and Licensee hereby accepts an Exclusive license under the Licensed Patents and Licensed Materials to make, have made, import, use, lease, sell and offer for sale and otherwise commercialize and exploit Licensed Products in the Licensed Territory, and practice any method process or procedure within the Licensed Patents in the Licensed Territory.  Said license is Exclusive, including the right to sublicense  in the Licensed Field of Use for a term commencing as of July 1, 1997 and ending on the expiration of the last to expire of the Licensed Patent(s).  University shall have the right to practice the Invention(s) and use the Technology for its own bona fide research, including sponsored research and collaborations. University shall have the right to publish any information included in Licensed Materials and Licensed Patent(s).

License Property

Licensed Product(s) means any product or part thereof in the Licensed Field of Use, the manufacture, use, or sale of which

(a)I s covered by a valid claim of an issued, unexpired Licensed Patent(s) directed to the Invention(s). A claim of an issued, unexpired Licensed Patent(s) shall be presumed to be valid unless and until it has been held to be invalid or unenforceable by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken or is disclaimed, or rejected or found invalid or unenforceable in a reissue application or re- examination proceeding or otherwise;
  
(b) Is covered by any claim being prosecuted in a pending application directed to the Invention(s); or

(c) Incorporates any of the Licensed Materials.

Licensed Patent(s) means any (i) U.S. patent application Serial Number 270,631 filed July 1, 1994 (issued on July 22, 1997 as U.S. Patent Number 5,650,135), (ii) all divisions, substitutions, and continuations in whole or part of any of the preceding, (iii) all foreign patent applications corresponding to or claiming priority from (including International Application Number PCT/US95/15040 and all national applications claiming priority therefrom), and (iv) all U.S. and foreign patents issuing on any of the preceding, including patents of addition, reexaminations, reissues and extensions.

5,650,135 – Non-invasive localization of a light-emitting conjugate in a mammal

Licensed Materials means those biological materials listed, and such other agreed materials as University may provide to Licensee during the term of this Agreement, which shall be added.
– Individual components of light systems (Vectors, genes and gene fragments)
– Bacteria
– Tumor cells
– Indicator cells for HIV
– Transgenic mouse lines

Field of Use

Licensed Field of Use means all uses.

License Grant

University hereby grants to Israel Corporation and Corporation hereby accepts from University the License. License shall mean the exclusive worldwide license to practice University’s share in the University Research Technology (as hereinafter defined) for the development, manufacture, use and sale of the Licensed Products (as hereinafter defined). At the initiative of Corporation or University, the parties shall consult with each other regarding the prosecution of all patent applications with respect to the University Research Technology. University and Corporation shall assist, and cause their respective employees and consultants to assist, each other in assembling inventorship information and data for the filing and prosecution of patent applications on inventions pertaining to the Research Technology. Corporation shall be entitled to grant sublicenses under the License on terms and conditions in compliance and not inconsistent with the terms and conditions of this Agreement (except that the rate of royalty may be at higher rates than those set forth in this Agreement) (i) to a Corporation Entity or (ii) to other third parties for consideration and in an arms-length transaction.

License Property

Licensed Products shall mean all products, drugs, diagnostic reagents, diagnostic methods, therapeutic agents and therapeutic methods covered by a claim of any unexpired University Patents (as hereinafter defined) which has not been disclaimed or held invalid by a court of competent jurisdiction from which no appeal has been or can be taken.

University Research Technology shall mean all University Patents and all University Know-How.

University Patents shall mean all United States and foreign patents and patent applications, and any divisions, continuations, in whole or in part, reissues, renewals and extensions thereof, and pending applications therefor
(1)  
which claim Pre-Existing Inventions and which are identified hereto; or
(2)  
which claim inventions that are made, in whole or in part, by students or employees of SAMSF during the term and in the course of the Research Project;  
with the exception of all such patents which are Corporation Patents as hereinafter defined.
U.S. Patent Application Serial No. 08/801,301, filed February 18, 1997 entitled Use if Nekatibub To Prevent Cytotoxic effects of Amyloid Protein by Pappolla.
U.S. Provisional Patent Application Serial No. 60/075,555 filed February 23, 1998 entitled Use of 3-Indol-Proprionic acid by Pappolla
U.S. Provisional Patent Application Serial No. 60/079,349 filed March 25, 1998 entitled Inhibition of Alzheimer of Alzheimer Beta-Fibrillogenesis by Mela Tonm by Pappolla.

Corporation Patents shall mean all United States and foreign patents and patent applications, and any divisions, continuations, in whole or in part, reissues, renewals and extensions thereof, and pending applications therefor which claim inventions that are made, in whole or in part, by students or employees of Corporation.

Research Technology shall mean all University Patents, University Know-How, Corporation Patents and Corporation Know-How.

Field of Use

Field shall mean research, development and testing within pharmaceutical, biotechnological and diagnostic development programs in the field of Alzheimer’s Disease and other central nervous system and neurodegenerative diseases, and in the field of all other possible utilities for melatonin analogs.

License Grant

Licensor hereby grants to Licensee, subject to all the terms and conditions of this Agreement, a worldwide, nonexclusive right and license (without the right to grant sublicenses) under the Patent Rights to (a) use, offer to sell, sell and practice Diagnostic Services in the Field; (b) make, have made, use, offer to sell, sell and import Licensed Reagents in the Field; and (c) make, have made, use, offer to sell, sell and import Kits in the Field. Notwithstanding the foregoing, Licensor hereby grants to Licensee the worldwide, non-exclusive right to convey to the end-user (purchaser) of FDA (U.S. Food and Drug Administration) Approved Kits manufactured by Licensee the right to perform Diagnostic Services solely in conjunction with the use of FDA Approved Kits manufactured by or on behalf of Licensee (without the right to grant sublicenses).

License Property

Patent Rights shall mean collectively the Gene Patent Rights and the Methodology Patent Rights.

Diagnostic Service(s) shall mean the performance of laboratory-based assays covered in whole or in part by a Valid Claim of the Patent Rights.

Gene Patent Rights shall mean the United States and foreign patents and patent applications relating to the APC (Adenomamus polyposis coli) gene and/or the p53 gene and licensed (with the right to grant sublicenses) to Licensor pursuant to the JHU (Johns Hopkins University) License Agreement together with patents arising therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent applications listed hereto (which may be updated from time to time to include such additional patents and patent application that may arise therefrom); provided, however, that Gene Patent Rights expressly excludes any claims of such patents and patent applications that fall outside of the Field, including, without limitation, claims to antibodies, to the treatment, prevention or remedying of a gene deficiency, to purified proteins, or to DNA (Deoxyribonucleic acid) sequences other than those sequences that correspond to the p53 gene and the APC (Adenomatous polyposis coli) gene; provided further that DNA sequences which are (i) immediately adjacent to the p53 or APC genes and (ii) necessary to the use of the p53 or APC genes, respectively, in the Field shall be considered within the Gene Patent Rights.

US Patent No.  5,352,775 – APC gene and nucleic acid probes derived therefrom
US Patent No.  5,527,676 – Detection of loss of the wild-type P53 gene and kits therefor

Methodology Patent Rights shall mean the United States and foreign patents and patent applications relating to methods of detecting mammalian nucleic acids isolated from stool specimens and reagents therefor and licensed (with the right to grant sublicenses) to Licensor pursuant to the JHU (Johns Hopkins University) License Agreement together with patents resulting therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent application listed hereto (which may be updated from time to time to include such additional patents and patent applications that may arise therefrom).

US Patent Application No. W093/20235 and 08/861,910 (detecting mammalian nucleic acids from stool)

Licensed Reagent shall mean any Reagent covered in whole or in part by a Valid Claim of the Patent Rights.

Kit shall mean a collection of one or more Reagents, including at least one Licensed Reagent, packaged in the form of a kit (including an FDA Approved kit).

Field of Use

Field shall mean (a) stool-based detection of any disease or condition (including pre-cancers, staging and monitoring of the foregoing, and therapeutic response) for research and development, Clinical Laboratory Improvement Amendments (CLIA) testing services (and their foreign equivalents), and FDA Approved Kits; and (b) a screening assay (regardless of other uses to which such assay is put) for colorectal cancer in any type of patient samples, excluding tests solely for staging and/or monitoring of colorectal cancer which do not obsolete or adversely impact such screening assay.

License Grant

The Research Foundations for the universities grant the right to Licensee.
Licensee shall, in the Field, in the Territory and during the Term, have
(a)
an exclusive license under Patent Rights; and
(b)
a nonexclusive license to use Know-How;
to make, manufacture, use, sell, have sold, lease, have leased, and offer for sale Licensed Products, including the right to grant Sublicenses as set forth in agreement. This license shall include the right to have Licensed Product made, manufactured or imported by Third Parties solely and exclusively for sale or use by Licensee, Sublicensees, Designees, and Affiliates of any of the foregoing. This license may be subject to the overriding obligations to the U.S. Government set forth and any future amendments thereto, and applicable governmental implementing regulations, including but not limited to those described herein.

License Property

Licensed Products means Patented Products and/or Other Products.

Patented Product means any products or service (or component thereof) that (i) if made, manufactured, used, offered for sale, sold, imported, leased or otherwise transferred within the Territory, but for the license granted herein, would infringe Patent Rights, or (ii) are made by using a Licensed Service, or (iii) when used, practice a Licensed Service. As used within this Agreement, the term 'Patented Products' includes 'Licensed Services'.

Other Products means any product or service (or component thereof), specifically excluding any product or service that is a Patented Product, the discovery, development, manufacture, use, sale, offering for sale, importation, exportation, distribution, rental or lease of which involves the use or incorporation, in whole or in part, of Know-How.

Inventions means any and all patentable inventions described in the provisional patent applications listed or in the invention disclosures NTD 2031-110 and NTD 2032-110, whether such Inventions are owned by one or both Licensors, or such Inventions are owned jointly by Licensee and one or both Licensors.

NTD 2031-110 means Foundation New Technology Disclosure 110-2031, entitled 'Method of normalizing epigenetic sequencing data to account for temporal variations,' and the counterpart disclosure to PSRF, Invention Disclosure 2017- 4601.

NTD 2032-110 means Foundation New Technology Disclosure 110-2032, entitled 'Method of identifying brain injuries and symptom duration through epigenetic analysis,' and the counterpart disclosure to PSRF, Invention Disclosure 4571, entitled 'Salivary microRNA Diagnostic/Prognostic Concussion Test'.

Patent Rights means Licensors rights to any subject matter that is claimed in, could be claimed in, or is otherwise Covered By one or more Valid Claims in any Licensed Patent.

Licensed Service means (i) any method, process, procedure or service that, but for the license granted herein, would infringe Patent Rights or is otherwise Covered By a Valid Claim in Patent Rights or (ii) any method, process, procedure, or service that results in the manufacture of a Patented Product.

Licensed Patents means any patent application filed claiming Inventions, including the patent applications, and continuing applications thereof including divisions, substitutions, and continuations-in-part (but only to extent a claim thereof is enabled by disclosure of the parent application), and any patents issuing on said applications including reissues, reexaminations and extensions, and any corresponding foreign applications and issued patents.

Field of Use

Field means diagnostic methods, services and devices for traumatic brain injury.