id_contract int64 1 12.5k | year int64 1.98k 2.02k | definiendum stringlengths 1 119 | definiens stringlengths 5 43.5k |
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6 | 2,002 | Reportable Result | means a result obtained through the use of a BloodScreening Assay and Blood Screening System from which it is determinedto release for use or hold and not use ( a ) a blood donation intended fortransfusion or for further processing for other administration to humans or(b ) a product derived from such donation |
6 | 2,002 | Damages | means any liability ( whether arising out of fault, strict liabilityor otherwise ) in the form of an obligation, loss, fine, judgment fordamages, arbitration award, settlement amount, penalty or claim, and allreasonable costs and expenses related thereto ( including reasonablecosts of investigation, fees and expenses p... |
6 | 2,002 | Nonconformity | or shall have the meaning set forthin Section 6.6(a ) |
6 | 2,002 | Package Insert | shall mean the package insert approved by the FDA forthe applicable Blood Screening Assay and attached to this Agreement asan Exhibit to Schedule 2.0, as the same may be amended from time totime |
6 | 2,002 | [COMPANY] Fiscal Year | shall mean each July 1 to June 30 |
6 | 2,002 | Medical Device Reporting Systems | , as defined under the Act, incompliance with the requirements of FDA 's Medical DeviceReporting regulation ( 21 CFR Part 803 ) are established andmaintained by [COMPANY], Gen - Probe or its subcontractors, asapplicable, for the Products . [COMPANY] shall provide, and request thatGen - Probe and its subcontractors prov... |
6 | 2,002 | Upgrades | means ( i ) changes to a Product that are made available tocorrect design faults, discrepancies or defects ( so called ), ( ii)alterations to a Product that do not significantly change the functionality oroperation of the Product, but accomplish incidental, structural, functionaland / or performance improvements, inclu... |
6 | 2,002 | HCV | means the Hepatitis C virus |
6 | 2,002 | Single Unit Testing | means screening of blood donations consisting of(i ) screening a sample from each individual blood donation using a BloodScreening Assay, and ( ii ) follow up discriminatory testing of positiveresults for HIV-1 or HCV |
6 | 2,002 | Act | shall mean the United States Food, Drug and Cosmetic Act, asamended, and all regulations thereunder |
6 | 2,002 | Blood Screening Field | shall mean the nucleic acid probe - basedscreening of ( i ) human blood, recovered and voluntary source plasma, platelets or other blood products intended for transfusion or otheradministration to humans, including autologous donors and ( ii ) recoveredand voluntary source plasma for further manufacture, but specifical... |
6 | 2,002 | Regulations | shall mean all applicable and then current laws, requirements, regulations, standards, specifications, and directives, including without limitation cGMP, promulgated by the FDA or any otherstate or federal authorities |
6 | 2,002 | Products | shall mean Blood Screening Assays, Blood ScreeningSystems and Software |
6 | 2,002 | New Product | means a Product that offers additional functionality overexisting Products ( e.g., additional virus detection such as the Ultrio ™ assay, or a new automated instrumentation platform ) |
6 | 2,002 | Affiliate | shall mean, with respect to any specified Person, any otherPerson which directly or indirectly controls, is controlled by, or is undercommon control with, the specified Person . For purposes of thisdefinition, the term shall mean ( i ) ownership interestsrepresenting more than fifty percent ( 50.0 % ) of the equity or ... |
6 | 2,002 | Pooled Testing | means the conduct of screening of pools of samplesfrom blood donations, generally consisting of:(a ) screening using a Blood Screening Assay of pools of one samplefrom each of 16 donors;(b ) follow up discriminatory testing of positive results ; and(c ) screening using a Blood Screening Assay of allogeneic samples ofle... |
6 | 2,002 | Enhancement | means an alteration or addition to a Product thatsignificantly changes the functionality or operation of the Product ( e.g.,robotic sample handling, automated reagent addition, etc . ), for which aseparate fee will be imposed |
6 | 2,002 | FDA | shall mean the United States Food and Drug Administration, orany successor entity thereto |
6 | 2,002 | Gen - Probe | shall mean Gen - Probe Incorporated, a Delawarecorporation |
6 | 2,002 | Blood Screening Assays | shall mean the nucleic acid probe assayspurchased by [COMPANY] from [COMPANY] under this Agreement, which shall beused by [COMPANY] in the Blood Screening Field |
6 | 2,002 | Territory | means the United States of America, including Puerto Rico, Guam and all other protectorates of the United States |
6 | 2,002 | Reagent Utilization Factor | means, with respect to a specified timeperiod, the quantity of Blood Screening Assay tests consumed by ARCduring such period divided by the number of Reportable Results duringsuch period |
6 | 2,002 | Party | or means [COMPANY], [COMPANY] or [COMPANY] and [COMPANY], respectively |
6 | 2,002 | Person | shall mean an individual, corporation, partnership, limited liabilitycompany, trust, business trust, association, joint stock company, jointventure, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listedherein |
6 | 2,002 | NTLs | means [COMPANY] 's national testing laboratories identified on Schedule1.36 |
6 | 2,002 | Third Party | shall mean any Person other than [COMPANY], and [COMPANY] |
7 | 2,020 | Phase 1 Clinical Study | means a human clinical trial of a product in any country, the principal pur pose of which is a preliminary determination of safety in patients, that would satisfy the requi rements of 21 C.F.R. 312.21(a ), or a similar clinical study prescribed by the relevant R egulatory Authorities in a country other than the United ... |
7 | 2,020 | Major Indication | means ( a ) each type of cancer for which Regulatory Approval for a Licensed Product is being sought or has been obtained by [COMPANY], its Affiliates, or their Sublicensees that is [ * * * ] or ( b ) a [ * * * ] |
7 | 2,020 | [ * * * ] | means any and all [ * * * ] payments made by GS K or its Affiliates to any Third Party with respect to [ * * * ] by Third Parties that [COMPANY] reasonably determines, af ter [ * * * ] of performing Commercial Manufacture or o ther Commercialization of a Licensed Product in the Prof it - Sharing Territory |
7 | 2,020 | Manufacturing Cost | means, with respect to a Licensed Product, [COMPANY] ’s reasonable and necessary FTE Costs and Third Party invoiced cost, determined in accordance with IFRS, and the terms and conditions of this Agreement, incurred in Manufacturing or acquisition of such Licensed Prod uct, in each case to the extent [ * * * ], which sh... |
7 | 2,020 | Marketing Approval Application | or means an NDA or any corresponding application in the applica ble country or jurisdiction outside of the United States, including, with respe ct to the European Union, an application for Regulatory Approva l filed with the EMA pursuant to the centralized approval procedure, or with the applicable national Regulatory ... |
7 | 2,020 | MHLW | means the Ministry for Health, Labor and Welfare of Japan, or the Pharmaceutical and Medical Devices Agency ( the ), or any successor to either of them, as the case may be |
7 | 2,020 | United States | or means the United States and its territories and possessions |
7 | 2,020 | [ * * * ] | means the annual fee paid to the [ * * * ] as d efined in the [ * * * ] and similar [ * * * ] in the Profit -Sharing Territory to the extent directly attributable and r easonably allocable to the applicable Licensed Prod uct and not included as a [ * * * ] |
7 | 2,020 | Collaboration Plan | means a plan for each Collaboration Program, setting out the preclinical Development ac tivities ( and solely with respect to the MAT2A Program, the limited clinical Development activities ) to be conducted by or on behalf of the Parties, including the Party responsible for each a ctivity and any other matters pertinen... |
7 | 2,020 | [ * * * ] | means, to the extent not included in Develo pment Costs and not covered in the applicable Devel opment Plan, costs incurred in the [ * * * ] of the applicable Licensed Product for sale in the Profit - Sharing Te rritory, and related [ * * * ], including, in each case to the exten t directly attributable and reasonably ... |
7 | 2,020 | Generic Product | means, with respect to a Licensed Product, any pharmaceutical product that has the sa me active pharmaceutical ingredient as a Licensed Product 10 [ * * * ] Certain information in this document has been excluded pursuant to Regulation S - K, Item 601(b)(1 0 ) |
7 | 2,020 | [ * * * ] | means, with respect to the applicable Licensed Prod uct in the Profit - Sharing Territory : ( 1 ) [ * * * ] |
7 | 2,020 | MAT2A Compound | means any compound that modulates the MAT2A Target [ * * * ] that is Controlled by IDEAYA as of the Execution Date or otherwise discovered by either Party in the course of performing its activities under this Agreement, including any [ * * * ], metabolites, p rodrugs, isomers, enantiomers, esters, salts, hydrates, solv... |
7 | 2,020 | Arising Technology | means all Patents and Know- How invented, discovered, created or developed by or on behalf of a Party solely or the Parties jointly in conn ection with the exercise of its or their rights or performance of its or their obligations under this Agreement |
7 | 2,020 | Licensed Product | means ( a ) solely if the O ption Closing Date occurs, a MAT2A Product, ( b ) a WRN Product, or ( c ) a POLQ Product . For clarity, if a given Licensed Product contains ( i ) [ * * * ] or ( ii ) [ * * * ], such Licensed Product shall be considered to be multiple Licensed Products for the purposes of this Agreement, [ *... |
7 | 2,020 | Net Sales | means, with respect to a Licensed Product during a stated time period, the gross invoiced sales amou nts for such Licensed Product sold by or on behalf of [COMPANY], its Affiliates or Sublicens ees in arm ’s length transactions to Third Parties ( but not including sales relating to transactions by and between [COMPANY]... |
7 | 2,020 | FDA | means the U.S. Food and Drug Administration, or a ny successor entity thereto performing similar functio ns in the United States |
7 | 2,020 | GAAP | means generally acceptable accounting standards, principles, and procedures as issued by the Financi al Accounting Standards Board ( FASB ) |
7 | 2,020 | final determination | as defined in Section 1313 of the United States Internal Revenue Code |
7 | 2,020 | Senior Manager | has the meaning set forth on Section 15.1.1 |
7 | 2,020 | Commercially Reasonable Efforts | means such efforts that are consistent with the efforts and resources norma lly used by [COMPANY] ( in the case of [COMPANY] ) or IDEAYA ( in the case of IDEAYA ) in the exerc ise of its reasonable business discretion relating to discovery, Development and C ommercializati on of a compound or product owned by it or to ... |
7 | 2,020 | Business Day | means a day that is not ( a ) a Saturday, Sunday or a day on which banking institutions in New York, New York or London, United Kingdom are required by Applicable Law to remain cl osed, or ( b ) the nine ( 9 ) consecutive calendar days beginning on December 24 through and i ncluding January 1 of each Calendar Year to t... |
7 | 2,020 | MAT2A Combination Study | means a Phase 1 Clinical Study combining a MAT2A Product with any pharmaceut ical preparation, substance, formulation or dosage which is comprised of or cont ains a [COMPANY] PRMT Product |
7 | 2,020 | [ * * * ] | means, to the extent not subject to [COMPANY] ’s o r IDEAYA ’s [ * * * ] under this Agreement, amounts paid to Third Parties by [COMPANY] or its Affiliates ( including [ * * * ], excluding any such amounts attributable to [ * * * ], which amounts will be borne solely by [COMPANY] |
7 | 2,020 | Government Official | ( where means all levels and subdivisions of governments, i.e. local, regional, national, administrative, legislative, executive, or judicial, and royal or r uling families ) means ( a ) any officer or employee of a government or any department, agen cy or instrumentality of a government ( which includes public enterpr... |
7 | 2,020 | MAT2A Program Costs | means all Development Costs incurred by IDEAYA or its Affiliates in the perform ance of the MAT2A Program in accordance with the applicable Collaboration Plan u p to and until the Option Packag e Delivery Date . For the avoidance of doubt, the cost s of conducting the MAT2A Combination Study shall be borne by [COMPANY]... |
7 | 2,020 | Regulatory Filing | means any filing or regulatory application or submission specifically related to a Licensed Product filed with a Regulatory Authority, including authorizations, app ro vals or clearances arising from the foregoing, and all correspondence with a Regula tory Authority, as well as minutes of any material meetings, telepho... |
7 | 2,020 | Registration Study | means, with respect to a given Licensed Product, any pivotal clinical study of suc h Licensed Product for the purpose of establishing safety and efficacy of such License d Product in patients with the disease or condition being studied for purposes of filing an NDA with the FDA, as described under 21 C.F.R. § 312.21(c ... |
7 | 2,020 | IND | means an Investigational New Drug Application ( including any amendments thereto ) filed with the FDA pursuant to 21 CFR Part 312, or any equivalent filing with any relevant Regulato ry Authority in any jurisdiction |
7 | 2,020 | Patent Costs | means all out - of- pocket expenses ( including reasonable attorneys ’ fees ) incurred in the prepara tion, prosecution, filing and maintenance of the Subject Patents |
7 | 2,020 | Collaboration Program | means the programs described in ARTICLE 3 of this Agreement, conducted by the Parti es in accordance with mutually agreed Collaboration Plans and Collaboration Budget s ( if applicable ) |
7 | 2,020 | [COMPANY] Arising Technology | means [COMPANY] Arising Know- How and [COMPANY] Arising Patents |
7 | 2,020 | Control ” ( including variations such as “ Controlled, | ( including variations such as and the like ) means, with respect to any material, information, or intellectual property, the possession ( whether by o wnership or license, other than the licenses granted hereunder ) of the ability to grant a license or sublicense or other right to exploit, without violating the terms ... |
7 | 2,020 | GLP Toxicology Study | means a pre- clinical toxicity safety study conducted und er GLP with respect to the applicable Licensed Comp ound to generate data to support filing of an IND |
7 | 2,020 | IDEAYA Technology | means ( a ) all IDEAYA Existing Technology, ( b ) all IDEAYA Arising Technology Contr olled by IDEAYA during the Term, and ( c ) IDEAYA ’s joint ownership interest in Joint Arising Technology Controlled by IDEAYA during the Term, in each case, that ar e necessary or reasonably useful for the making, having made, usin g... |
7 | 2,020 | Profit - Sharing Territory | means the United States only with respect to any WRN Product or MAT2A Product fo r which the Parties are then sharing Pre - Tax Profit or Loss |
7 | 2,020 | Manufacture | means all activities related to the synthesis, making, production, processing, purifying, formulat ing, filling, finishing, packaging, serialization, labeling, shipping, and holding of a ny product, or any component or intermediate thereof, including process development, process qualification and validation, scale - up... |
7 | 2,020 | VAT | means any value added, sales, use, purchase, turn over or consumption tax as may be applicable in any rele vant jurisdiction, including but not limited to value added tax chargeable under leg islation implementing EU Cou ncil Directive 2006/112 / EC |
7 | 2,020 | Calendar Quarter | means the respective periods of three ( 3 ) consecutive calendar months ending on March 31, Jun e 30, September 30 and December 31 |
7 | 2,020 | Option Package Delivery Date | means the date on which the Option Data Package is provided by IDEAYA to GS K in accordance with this Agreement |
7 | 2,020 | MAT2A Target | means methionine adenosyltransferase II alpha |
7 | 2,020 | Clinical Dose Expansion | means the first person dosed in an expansion cohort of the applicable Phase 1 Clinical Study for the relev ant Licensed Product being conducted by a Party utilizing the re commended dose for expansion for such Licensed Product |
7 | 2,020 | [ * * * ] | means any payment, income, or other conside ration ( other than Net Sales ) received by [COMPANY] or it s Affiliates from a Third Party [ * * * ], and any payment, income, or other consideration received pursuant to [ * * * ] o f the Agreement consistent with [ * * * ] of the Agreement |
7 | 2,020 | [ * * * ] | means amounts [ * * * ] to the extent consisten t with [COMPANY] ’s or its Affiliate ’s business practices for its other products, if not deducted [ * * * ], and provided that any amounts actually [ * * * ] shall be deducted from A llowable Expenses |
7 | 2,020 | [ * * * ] | means, to the extent not subject to [COMPANY] ’s i ndemnification obligations under this Agreement, ex penses directly attributable and reasonably allocable to t he v a Licensed Product in the Profit - Sharing Terri tory, v Licensed Product, [ * * * ] Licensed Product and [ * * * ] Licensed Product, in each case incurr... |
7 | 2,020 | Development Budget | means the budget for conducting the corresponding portion of the Development Plan for a given Licensed Compound or Licensed Product as presented by [COMPANY] to the applica ble JDC pursuant to Section 6.2.2, and as updated on an annual basis by [COMPANY] |
7 | 2,020 | Institutional Review Board | means an institutional review board ( ) or independent ethics committee ( ) that reviews the methods proposed for research and development activities to ensure s uch methods satisfy ethical requirements |
7 | 2,020 | Know - How | means proprietary and confidential trade secrets, models, discoveries, ideas, Data and other types of data, databases, results, assays, instructions, processes, techniques, formul as, algorithms, Materials, inventions, computational models, human - relevant disease models, computer software ( including source code ), p... |
7 | 2,020 | [ * * * ] | means, with respect to a Licensed Product f or which Regulatory Approval has been obtained in t he Profit - Sharing Territory, [ * * * ] to the extent directly att ributable and reasonably allocable to such Licensed Product in the Profit - Sharing Territory, including Third Party invoiced costs and Commercial FTE Costs... |
7 | 2,020 | v | means costs and expenses incurred by or on behalf of [COMPANY] that are directly attributable and reasonab ly allocable to the [ * * * ] for sale in the Profit - Shari ng Territory, including : ( a ) [ * * * ] ; ( b ) [ * * * ] ; ( c ) reasonable and customary [ * * * ] ; and ( d ) to the extent not paid for by custome... |
7 | 2,020 | CDA | means that certain Mutual Confidential Disclosure Agreement between [COMPANY] LLC and IDEAYA ef fective June 4, 2019, as amended on April 23, 2020 |
7 | 2,020 | or | will be interpreted to mean, ( f ) all references herein to Articles, Sections, or Exhibits, unless otherwise specifically provided, w ill be construed to refer to Articles, Sections, and Exhibits of this Agreement, and ( g ) the words and will be interpreted to mean and respectively |
7 | 2,020 | POLQ Product | means any pharmaceutical preparation, substance, formulation or dosage which is comprised of or contains a POLQ Compound ( whether or not such POLQ Compound is the sole active ingredient ) . For clarity and without limitation, [ * * * ] |
7 | 2,020 | Data Sharing Initiative | means [COMPANY] ’s policy initiative ( as may be amended from time to time ), known at th e Execution Date as the, to provide researchers with access to clinical trial and study information, including anonymized patient level data |
7 | 2,020 | Currency Gains and Losses | means the gain or loss resulting from changes in exchange rates between th e U.S. dollar and the foreign currency in which the transaction is denominated, t o the extent directly attributable or reasonably allocable to a Licensed Compound or Lice nsed Produ ct, and shall only include the currency gains and losses reali... |
7 | 2,020 | Big Four Accounting Firm | means one of the following : ( i ) Deloitte, ( ii ) Ernst & Young, ( iii ) KPMG, or ( iv ) P ricewaterhouseCoopers |
7 | 2,020 | European Union | means the economic, scientific and political organization of member states in Europe, as it may be constituted from time to time, including Switzerland and the United Kingd om |
7 | 2,020 | int ellectual property | as defined in Section 101 of th e U.S. Bankruptcy Code, shall be deemed to be for the purpos es of Section 365(n ) or any analogous provisions in any other country or jurisd iction |
7 | 2,020 | [COMPANY] Termination Technology | means ( a ) all [COMPANY] Existing Technology, ( b ) all [COMPANY] Arising Technology Controll ed by [COMPANY], ( c ) [COMPANY] ’s joint ownership interest in Joint Arising Technology Cont rolled by [COMPANY] and ( d ) subject to [ * * * ], in each case that are ( i ) [ * * * ] or ( ii ) othe rwise [ * * * ] |
7 | 2,020 | [COMPANY] Technology | means ( a ) all [COMPANY] Existing Technology, ( b ) all [COMPANY] Arising Technology Controlled by [COMPANY] du ring the Term, and ( c ) [COMPANY] ’s joint ownership interest in Joint Arising T echnology Controlled by [COMPANY] during the Term, in each case that are necessary or reasonably useful for IDEAYA ’s conduct... |
7 | 2,020 | NDA | means a New Drug Application ( as more fully defined in 21 C.F.R. 314.5 et seq . or its successor regulation ) and all amend ments and supplements thereto filed with the FDA |
7 | 2,020 | Companion Diagnostic | means a product designed for use in a diagnostic biomarker assay tailored or optimiz ed for use with a Licensed Product, for predicting or monitoring the suitability of suc h Licensed Product for prophylactic or therapeutic use in human patients or defined subpopulations thereof . A Companion Diagnostic shall be intend... |
7 | 2,020 | Material Receiving Party | means the Party receiving Materials from the other Party as contemplated in S ection 3.2.5(a ) |
7 | 2,020 | [ * * * ] | means a [ * * * ] that is subject to sharing of Pre - Tax Profit or Loss for which IDEAYA has not ex ercised the IDEAYA Opt - Out, [ * * * ] |
7 | 2,020 | Calendar Year | means each successive period of twelve ( 12 ) months commencing on January 1 and ending on D ecember 31 |
7 | 2,020 | [COMPANY] PRMT Product | means a compound that is a Type 1 protein arginine methyl transferase inhibitor that is Controlled by [COMPANY] |
7 | 2,020 | Option Data Package | means that certain Data generated from and to support the conduct of the Phase 1 MAT2 A Monotherapy Study by IDEAYA pursuant to the MAT2A Program and as specifi cally set forth on Schedule 1.152 |
7 | 2,020 | POLQ Target | means DNA polymerase theta |
7 | 2,020 | Manufacturing FTE Costs | means, as applicable with respect to any period, the FTE Rate(s ) for Manufacturing activities, multiplied by the number of FTEs perfor ming such Manufacturing activities under this Agree ment, respectively, during such period |
7 | 2,020 | any | will mean unless other wise clearly indicated by context |
7 | 2,020 | Collaboration Budget | means the budget for conducting the corresponding Collaboration Plan as agreed by the P arties and approved by the applicable JDC and the JSC, as updated from time to time |
7 | 2,020 | [ * * * ] | means [ * * * ] |
7 | 2,020 | HSR Clearance Date | means the earlier of ( i ) the date on which the FTC or DOJ shall notify the Parties of early termin ation of the waiting period under the HSR Act or ( ii ) the date on which the applicable waiting period und er the HSR Act expires ; provided that, if the FTC or DOJ commences any investigation by means of a second requ... |
7 | 2,020 | Commercial Manufacturing | means Manufacture of a Licensed Product ( including the cost of API ) or acq uisition of such Licensed Product, in each case, for Commercialization of such License d Product in the Profit- Sharing Territory |
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