Royalty Report: Drugs, nucleic acid, Assay – Collection: 289237

License Grant

Licensor hereby grants to Licensee under the Licensed Patents a non-exclusive license, without the right to grant sublicenses, to research and develop, to make, have made (with prior notification to Orchid), sell, offer for sale or otherwise dispose of Licensed Products in the Territory solely for use in the Licensed Field.

Under this license, Licensee may use the Licensed Product only to the extent necessary to perform research and development on Licensed Products for sale hereunder and/or quality control functions on lots of the Licensed Products, but under no circumstances may Licensee use the Licensed Products for Research Purposes or for any other purpose within or outside the Licensed Field.

Licensor additionally grants to Licensee, under the Licensed Patents, a non-exclusive license, without the right to grant sublicenses, to research and develop, to make, have made (with prior notification to Licensor), sell, offer for sale or otherwise dispose of Kits in the Territory to a Third Party Licensee for use in the Licensed Field or otherwise consistent with such Third Party Licensees license from Licensor.

License Property

Licensed Product means a Kit and an End User License.

Kit means a product designed for performing Primer Extension comprising one or more Reagents, the sale or offer for sale of which, without the licenses granted herein, would infringe or contribute to the infringement of at least one claim of a Licensed Patent.

Licensed Patents means US Patent No. 5,888,819 and 6,004,744 and any divisionals, continuations, reissues, and foreign counterparts thereof.  To date foreign patents include the Australian Patent No. 660,173.
5,888,819 – Method for determining nucleotide identity through primer extension
6,004,744 – Method for determining nucleotide identity through extension of immobilized primer

Genotype means the detection or quantification of an individual SNP within a single sample.

Reagent means an enzyme, buffer, primer extension chain-terminating compound or other composition useful for Primer Extension.

Field of Use

This agreement pertains to methods for determining nucleotide identity.

Licensed Field means the use of a Licensed Product on an Approved Instrument for Research Purposes only.

License Grant

Licensor hereby grants to Licensee under the Licensed Patents a non-exclusive license, without the right to grant sublicenses, to make, sell, offer for sale or otherwise dispose of Licensed Products in the Territory solely for use in the Licensed Field. Under this license, Licensee may use the Licensed Products only to the extent necessary for Licensee to perform quality control functions on lots of the Licensed Products, but under no circumstances may Licensee use the Licensed Products for Research Purposes or for any other purpose within or outside the License Field.

License Property

Licensed Product means a Kit and an End User License.

Licensed Patents means US Patent No. 5,888,819 and 6,004,744 and any divisionals, continuations, reissues, and foreign counterparts thereof.

5,888,819 – Method for determining nucleotide identity through primer extension
6,004,744 – Method for determining nucleotide identity through extension of immobilized primer

Instruments' mean automated electrophoresis nucleotide sequencing

'Genotype' means the detection or quantification of an individual SNP within a single sample (whether or not the genome of the sample is heterozygous for the given SNP).

Kit means a product designed for performing Primer Extension comprising one or more Reagents, the sale or offer for sale of which, without the licenses granted herein, would infringe or contribute to the infringement of at least one claim of a Licensed Patent.

Primer Extension means a nucleic acid template-dependent primer extension reaction to determine the identity of a single nucleotide base at a specific position in a nucleic acid of interest in which the reaction is performed in the presence of two or more terminators and in the absence of extendable nucleotides.

Reagent means an enzyme, buffer, primer extension chain-terminating compound or other composition useful for Primer Extension.

Field of Use

Licensed Field means the use of a Licensed Product on Approved Instruments for Research Purposes only. Practical applications of these techniques include genetic disease diagnoses, infectious disease diagnoses, forensic techniques, paternity determinations, and genome mapping.

License Grant

Licensor hereby grants Licensee a, worldwide, non-transferable, non-exclusive license under Licensor Licensed Technology, to, (1) develop Generic Kits and Standard Kits as authorized in this Agreement, (2) make, have made, and use (which use includes the right to modify) Licensor OEM Kits and (3) distribute, market and sell such Licensor OEM Kits (OEM License) pursuant to the license granted to Licensee as set forth in this Agreement. Licensee agrees to forbear from the use and exercise of the OEM License otherwise a royalty payment will be due.  If Licensee grants any Third Party a license to exploit the TAG Improvements, Licensee shall pay Licensor a royalty.

The purpose of the Collaboration is to develop, manufacture, market and sell (i) Products, and (ii) software applications for Approved Instruments all as set forth in this agreement. The purpose of the Collaboration may be modified and/or extended upon mutual agreement of the Parties in writing.

License Property

Licensor Licensed Technology means Technology Controlled by Licensor and its Affiliates as of the Effective Date that is useful in the Field of Use, as listed or described hereto. Licensor represents and warrants that the items listed hereto comprise all of the Licensor Licensed Technology as of the Effective Date of this agreement. As of the Effective Date the Licensor Licensed Technology does not require payment of royalties to third parties. Licensor and its Affiliates will amend this from time to time to keep it current. Licensor and its Affiliates warrant that all Controlled Technology for carrying out the marketing, sale, and other disposition of Products will be included in the Licensor Licensed Technology.
US Patent 5,888,819 – Method for determining nucleotide identity through primer extension

Product means any of a Standard Kit, a Custom Kit and/or a Generic Kit.

Combination Kit means any Custom Kit that contains Primers more than 50% of which are identical to Primers contained in any part of any Standard Kits existing at the time of launch of such Custom Kit, or any combination of Standard Kits existing at the time of launch of such Custom Kit.

Custom Kit means a kit consisting of certain Reagents, certain Primers that have been customized by Licensor or Licensors subcontractors for use in the Field of Use and an End User License, and shall not include use of or refer to any use of TAG Arrays other than for genotyping with GBA.

Standard Kit means a kit consisting of Reagents, CMC Approved Primers for use in the Field of Use and an End User License.

Generic Kit means a kit consisting of Reagents and an End User License.

Primer means GBA primers (a synthetic oligonucleotide of a sequence known to be complementary with the oligonucleotide sequence immediately adjacent, 5, to a SNP) or either PCR primers or information to generate PCR primers.

Reagent means buffers, enzymes and terminators (but not Primers) useful in GBA.

GBA means Genetic Bit Analysis, or single nucleotide primer extension methods designed to detect the identity of a single nucleotide at a predetermined location in the DNA of a sample.

SNP means Single Nucleotide Polymorphism.

Technology means and includes all inventions, discoveries, improvements, trade secrets and proprietary methods and materials, whether or not patentable, including but not limited to, samples of, methods of production or use of, and structural and functional information pertaining to, chemical compounds, proteins or other biological substances; other data; formulations; techniques; and know-how; including any negative results.

TAG Array means a tag array GeneChip probe array. Each set of probes consists of four probes with the following relationship to a defined target sequence — a perfect match to target sequence, a single base mismatch to target sequence, a perfect match to the complement of target sequence, and, a single base mismatch to the complement of target sequence. For the avoidance of doubt, TAG Arrays include no license (express or implied) authorizing use for any purpose except genotyping with GBA.

TAG Assay means any assays for hybridization to a TAG Array.

TAG improvement is any improvements to TAG Assays.

Field of Use

Field of Use means the use of Product to practice GBA in Tag Array format in Approved Instruments for Research Purposes and clinical reference laboratories where work is performed under the Clinical Laboratory Improvements Act and explicitly excludes Products that have received marketing approval from the FDA.

License Grant

Licensor grants to Licensee, for  the term of this Agreement, a non-transferable, non-exclusive license to use the SNP Assay Kits (provided under  this  Agreement) on DNAPrint's SNPstream Instrument solely for research use and only for the detection of genetic polymorphism by SNP-IT.  Licensee may make this use only on its own behalf and in its  provision of Genotyping Services under this Agreement.

License Property

Primer Extension means a nucleic acid template-dependent primer extension reaction to determine the identity of a single nucleotide base at a specific position in a nucleic acid of interest.

SNP Assay Kit means the SNPware(TM) pre-formatted consumable assay kits containing validated and quality controlled reagents or similar kits for genotyping.

Licensor Trademarks means the marks.

Field of Use

The rights granted relates to the Company providing Formatting with its supply of SNP Assay Kits to the Licensee.  Licensee may not order any SNP Assay Kit until the Company completes Formatting for the particular SNP(s) which the SNP Assay Kit is intended to identify.

License Grant

Licensor grants a non-exclusive license under the Licensed Patents in the Field in the Territory during the License Term, to make, have made, use, offer to sell, sell and import Licensed Services.  Licensee shall have the right to sublicense.

License Property

The patents and technology relate to Colorectal Cancer Assay, meaning any colorectal cancer diagnostic or monitoring test including but not limited to screening, diagnosis, staging, monitoring and pharmacogenetic testing.

Licensed Services shall mean services that but for this Agreement would infringe a valid and enforceable claim in the Licensed Patents.

Field of Use

The field shall mean colorectal cancer assays used for specialty testing.