Royalty Report: Drugs, Cancer, Diagnostic – Collection: 209521

License Grant

For the Alliance Field, Licensor grants to Abbott and its Affiliates a worldwide, nonexclusive license, with no right to grant sublicenses, under Licensor – Independent Patent Rights, Independent Technology, Alliance Patent Rights and Alliance Technology –  in the Exclusive Areas (the fields of use) solely to the extent necessary for Licensee to perform its obligations expressly set forth in this Agreement; and to Commercialize Alliance Products during the term of this Agreement.

Licensor grants a worldwide, nonexclusive license, with no right to grant sublicenses, under Licensor Alliance Patent Rights and Licensor’s Deliverable Alliance Technology solely to the extent necessary to permit Licensee and its Affiliates to Commercialize Non-Alliance Products.

Licensor grants a worldwide, nonexclusive license, with no right to grant sublicenses, under Licensor Independent Patent Rights and under Independent Technology that was previously used by Licensee or its Affiliates in Commercialization of an Alliance Product, solely to the extent necessary to permit Licensee and its Affiliates to Commercialize Non-Alliance Products that had been subject to rejected NPCDs (New Product Concept Document) in the Conditionally Exclusive Areas.

For Outside the Alliance Field, for products, other than therapeutic products, Licensor grants a nonexclusive license under Licensor’s Deliverable Alliance Technology and any Licensors Alliance Patent Rights, to manufacture, use, sale, offer for sale or import of which is covered by a Valid Claim of the Licensors Alliance Patent Rights

The Licensor grants licenses of the scope granted under the corresponding Independent Technology and Alliance Technology Copyrighted Works that are part of Joint Alliance Technology.

License Property

Licensors Existing Products means ViroSeq HIV Genotyping Kit and associated software; HLA Sequencing based typing Kits (HLA-DRB, Codon 86 for HLA-DRB, HLA-A, HLA-B) and associated software; and Cystic Fibrosis mutation screening system available as Analyte Specific Reagents and General Purpose Reagents.

Copyrighted Works means original works of authorship, including, without limitation, computer programs (in source code, object code or other form), notes, sketches, drawings and reports.

Field of Use

The field of use, or exclusive area of use, means the products and services that are used or distributed for use in the Alliance Field in detecting, classifying or quantifying nucleic acid sequences for HIV, HBV,HCV, HPV, CT and NG viruses;  cystic fibrosis; fragile X syndrome; only human Factor II, Factor V and Methylene Tetrahydrofolate Reductase (MTHFR); deep vein thrombosis risk);  breast cancer prognosis, and hormone therapy responsiveness in breast cancer; myocardial infarction (or coronary heart disease) risk; and infectious agent or any human gene or genetic variation.  Instruments are specifically excluded for the exclusive area, except for Alliance products.

License Grant

For the Alliance Field, Licensor grants a worldwide, nonexclusive license, with no right to grant sublicenses, under Licensor – Independent Patent rights, Independent Technology,  Alliance Patent Rights and Alliance Technology in the Exclusive Areas (the field of use) solely to the extent necessary for Licensee to perform its  obligations expressly set forth in this Agreement; and to Commercialize Alliance Products during the term of this Agreement.

Licensor grants to a worldwide, nonexclusive license, with no right to grant sublicenses, under Licensor Alliance Patent Rights and Deliverable Alliance Technology solely to the extent necessary to permit Licensee and its Affiliates to Commercialize Non-Alliance Products.

Licensor grants a worldwide, nonexclusive license, with no right to grant sublicenses, under Licensor Independent Patent Rights and under Independent Technology that was previously used by Licensee or its Affiliates in Commercialization of an Alliance Product, solely to the extent necessary to permit Licensee and its Affiliates to Commercialize Non-Alliance Products that had been subject to rejected NPCDs (New Product Concept Document) in the Conditionally Exclusive Areas.  The license granted in this Section will survive expiration or termination of this Agreement.

For Outside the Alliance Field, for products, other than therapeutic products, Licensor grants a nonexclusive license, under Licensors Deliverable Alliance Technology and any Licensor Alliance Patent Rights.

License Property

Licensors Existing Product means the LCx instrument system and uniquely associated accessories and consumables (System) and the LCx HIV and HCV assays (collectively Viral Assays).

Field of Use

The field of use, or exclusive area of use, means the products and services that are used or distributed for use in the Alliance Field in detecting, classifying or quantifying nucleic acid sequences for HIV, HBV,HCV, HPV, CT and NG viruses;  cystic fibrosis; fragile X syndrome; only human Factor II, Factor V and Methylene Tetrahydrofolate Reductase (MTHFR); deep vein thrombosis risk);  breast cancer prognosis, and hormone therapy responsiveness in breast cancer; myocardial infarction (or coronary heart disease) risk; and infectious agent or any human gene or genetic variation.  Instruments are specifically excluded for the exclusive area, unless they are alliance products.

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.