id_contract
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| definiendum
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1
| 2,004
|
Affiliate
|
means any company, corporation or other business entity that is controlled by, controlling, or under common control with Licensee . For this purpose means direct or indirect beneficial ownership of at least fifty percent ( 50 % ) interest in the voting stock ( or the equivalent ) of the company, corporation or other business or having the right to direct, appoint or remove a majority of members of its board of directors ( or their equivalents ) or having the power to control the general manage ment of the company, corporation or other business, by law or contract
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1
| 2,004
|
First Commercial Sale
|
means the initial transfer of a Licensed Product or first delivery of a Licensed Service, as the case may be, by or on behalf of Licensee, an Affiliate or Sublicensee for cash or non -cash consideration to which a fair market value can be assigned for purposes of determining Net Sales
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1
| 2,004
|
Licensed Service
|
means a service provided according to a Licensed Process
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1
| 2,004
|
Field of Use
|
means all fields except research reagents
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1
| 2,004
|
Sublicensee
|
means any natural person or legal entity, which is not an Affiliate, to which Licensee grants a sublicense of some or all of the rights granted to Licensee under this Agreement
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1
| 2,004
|
Licensed Intellectual Property
|
means, collectively, the Patent Rights and the Biological Materials
|
1
| 2,004
|
Patent Rights
|
means the issued United States patents listed in Schedule 1 and any reissues, reexaminations or extensions of such patents and any foreign counterparts of such patents
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1
| 2,004
|
fair market value
|
shall mean : ( a ) if Licensee ’s Common Stock is publicly traded, the value of such equity using a per share price equal to the average of the reported closing prices of such stock on the exchange for the twenty ( 20 ) trading days prior to such purchase ; or ( b ) otherwise, the value of such equity using the per share purchase price of Licensee ’s most recent equity financing
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1
| 2,004
|
Licensed Product
|
means any product covered in whole or in part by an issued, unexpired claim or a pending claim in the Patent Rights or products manufactured according to a Licensed Process or products that incorporate or use Biological Materials in whol e or in part . A Licensed Product shall not include any product for which Biological Materials are used in connection with the research, development or testing of such product, but into which no Biological Materials are incorporated and the manufacture or s ale of which would not, without the License granted herein, infringe the Patent Rights
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1
| 2,004
|
Net Sales
|
means the gross income derived by an entity licensed under thi s Agreement from the Sales of Licensed Products or Licensed Services to independent third party customers in bona -fide arms -length transactions less the following deductions, which may not exceed reasonable and customary amounts in the country in which the transaction occurs : ( a ) Transportation charges or allowances actually paid or granted ; ( b ) Trade, quantity, cash or other discounts and brokers ’ or agents ’ commissions, if any, actually allowed and taken ; ( c ) Credits or allowances made or given on account of rejects, returns or retroactive price reductions for any amount not collected that are specifically identifiable to Licensed Products ; and ( d ) Any tax or governmental charge directly on sale or transpo rtation, use or delivery of products paid by a licensed entity and not recovered from the purchaser
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1
| 2,004
|
Territory
|
means worldwide
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1
| 2,004
|
Sale
|
or means an y grant, sale, lease, assignment, transfer, conveyance or other disposition of Licensed Products or Licensed Services for value by or on behalf of Licensee, any Affiliate(s ) or Sublicensee(s )
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1
| 2,004
|
Licensed Process
|
means any process covered in whole or in part by an issued, unexpired claim or a pending claim in Patent Rights or which incorp orates or uses Biological Materials in whole or in part
|
1
| 2,004
|
Agreement
|
means this Exclusive License Agreement, including all attached schedules, which are incorporated herein by reference
|
2
| 2,000
|
Third Party
|
for this subsection i ) means an entity other than the entity having a preexisting relationship with either party or an entity that provides a product or tools for which LION has no reasonable alternative or comparable product
|
2
| 2,000
|
Third Party
|
for this subsection means an entity other than the entity having a preexisting relationship with either party or an entity that provides a product or tools for which PGI has no reasonable alternative or comparable product
|
2
| 2,000
|
FIELD '' ) . For the purposes of this Agreement,
|
Functional GenomicsCrop Production '' ), nutrition, industrial products and foods for human health ; means any business activity resulting in the production or enhanced production of crops, food, animal feed or industrial feed stocks . means database architecture, information storage and retrieval, software, data analysis and query tools and data display and user interface
|
2
| 2,000
|
Affiliated Company
|
means a corporation or other entity which controls, is controlled by, or is under common control with a party to this Agreement . A corporation or other entity shall be deemed to control another corporation or entity if it owns, directly or indirectly, more than fifty percent ( 50 % ) of the voting shares or other interest, or has the power to elect more than half the directors, of such other corporation or entity
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2
| 2,000
|
Development Data
|
for the purposes ofthis Agreement means data that is useful in the Development Plan to develop New Software Products and the Metabolic Profiling Database
|
3
| 2,014
|
Legal and Litigation
|
shall mean the expenses associated with general, worldwide administrative legal andlitigation expenses for Product including Losses from any Third Party Claims relating to the Manufacturing orCommercializing of the Product and costs associated with recall or withdrawal of Product other than, in each case, expenses, Losses and costs subject to indemnification under Section 11.1 or 11.2 of the Supply Agreement or underSection 11.1 or 11.2 of this Agreement, or relating to or arising from a Party ’s gross negligence or willful misconduct;and real losses on receivables ( other than Net Sales ) that have become irrecoverable ; insurance liabilities for Product;and license fees, royalties and other payments under licenses to the extent attributable to, and based on, theDevelopment, Manufacture or Commercialization of Product
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3
| 2,014
|
[ … * * * … ] Milestone
|
shall mean [ … * * * … ]
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3
| 2,014
|
Governmental Authority
|
shall mean any national, international, federal, state, provincial or localgovernment, or political subdivision thereof, or any multinational organization or any authority, agency or commissionentitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal ( or any department, bureau or division thereof, or any governmental arbitrator or arbitral body )
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3
| 2,014
|
Commercially Reasonable Efforts
|
shall mean:(a ) With respect to efforts of [COMPANY] as measured on a country by country basis : that measure of efforts andresources consistent with [COMPANY] ’s and its Affiliates ’ own efforts and resources applied to its and their owncompounds, devices and products of a similar value, stage of development, life cycle and commercial potential, taking into account all relevant factors including issues of safety and efficacy, product profile, difficulty in developingor manufacturing the applicable Product or sourcing raw materials necessary therefor, competitiveness of alternativethird party products in the marketplace, regulatory approvals ( including pricing approvals ), pricing and reimbursement, the patent or other proprietary position of the applicable Product, the regulatory requirements involved and thepotential profitability of the applicable Product for [COMPANY] and its Affiliates as compared to the expected profitability ofother products of its then current or in development product portfolios ; and(b ) With respect to efforts of the Licensors : the use of reasonable efforts and resources, in good faith, consistent with the efforts and resources that a pharmaceutical or biotechnology company of similar size and situationto the Licensors, in the exercise of prudent legal, medical, scientific and business judgment, would commonly applyto its own compounds, devices and products of a similar value, stage of development, life cycle and commercialpotential to the applicable Product
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3
| 2,014
|
[COMPANY] Technology
|
shall mean all [COMPANY] Know - How, [COMPANY] Patents and [COMPANY] ’s or its Affiliate’sinterest in Joint Patents and Joint Inventions
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3
| 2,014
|
Education
|
shall mean expenses associated with professional education with respect to Product in theTerritory through any means, including, but not limited to, articles appearing in journals, newspapers, magazines orother media ; seminars, and scientific exhibits ; symposia, advisory boards and opinion leader development activities;peer - to - peer activities ; speakers programs, including training of such speakers ; transporting, housing and maintainingsales representatives for training and the costs of all training materials used for such purpose ; medical managementand support ; the coordination of medical information requests and field based medical scientific liaisons with respectto Product, including activities of medical scientific liaisons and the provision of medical information services
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3
| 2,014
|
Calendar Year
|
shall mean a period of 12 consecutive months beginning on and including January 1st
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3
| 2,014
|
Diabetes
|
shall mean diabetes mellitus, regardless of type
|
3
| 2,014
|
Advertising
|
shall mean all media costs associated with Product advertising in the Territory including, but notlimited to production expense / artwork including set up ; design and art work for an advertisement ; consumer andprofessional internet and digital media spending ; social media spending ; the cost of securing print space, air time, etc
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3
| 2,014
|
Joint Inventions
|
shall mean any and all Inventions invented by one or more employees or contractors ofSanofi or any of its Affiliates and one or more employees or contractors of the Licensors or any [COMPANY] Affiliate
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3
| 2,014
|
Regulatory Expenses
|
shall mean, with respect to the applicable Calendar Quarter, the costs and expensesincurred by a Party or any of its Affiliates after the Execution Date in connection with filing, revising, obtaining ormaintaining Regulatory Filings with respect to Product in the Field in the Territory in such Calendar Quarter inaccordance with the Development Budget, excluding the Cost of Goods for Product used in conducting or performingsuch activities, calculated on a fully burdened basis ( i.e
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3
| 2,014
|
Field
|
shall mean the prevention or treatment of diseases and other conditions in all indications in humansand animals
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3
| 2,014
|
Development Plan
|
shall mean the written plan setting forth the studies and other activities to beperformed by the Parties with respect to the Development of Product in the Field in the Territory, established bySanofi and reviewed and approved by the JAC, as may be amended . A summary of the initial Development Plan hasbeen separately delivered by letter as of the Execution Date
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3
| 2,014
|
Commercialization Budget
|
shall mean the budget for activities within the Commercialization Plan forconducting Commercialization activities with respect to Product in the Field in the Territory established on a CalendarYear basis by [COMPANY] for review and approval by the JAC
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3
| 2,014
|
Development Budget
|
shall mean the budget, established on a Calendar Year basis and reviewed andapproved by the JAC, for activities within the Development Plan for conducting Development activities with respect toProduct in the Field in the Territory, established on a Calendar Year basis by [COMPANY] for review and approval by theJAC
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3
| 2,014
|
FDA
|
shall mean the United States Food and Drug Administration, or any agency that is responsible forapproving the sale of pharmaceutical products in the United States
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3
| 2,014
|
[COMPANY] Trademarks
|
) . All capitalized terms usedand not otherwise defined in this Exhibit will have the meaning given such terms in this Agreement . References in thisEXHIBIT A to [COMPANY] shall refer to TICV or BV as applicable outside the United States
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3
| 2,014
|
Service Provider
|
shall mean any Third Party service provider such as a contract research organization, clinical research organization, contract manufacturing organization, consultant, subcontractor or other independentcontractor performing on behalf of a Party such Party ’s obligations under this Agreement, but excluding any ThirdParty to whom a sublicense or license under any [COMPANY] Technology, [COMPANY] Trademarks or [COMPANY] Technologyis granted
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3
| 2,014
|
Manufacture
|
or shall mean all activities related to the manufacturing, packaging andsupply of a pharmaceutical product, or any component thereof, including manufacturing product, components thereofor supplies for Development, clinical trials, and/or commercial sale ; in - process and semi - finished product testing;release of product or any components thereof ; quality assurance activities related to manufacturing and release ofproduct ; ongoing stability tests and regulatory activities related to any of the foregoing, and packaging of productsready for distribution and sale
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3
| 2,014
|
Distribution
|
shall mean the sales commissions payable to distributors and the portion of distribution costsrelating to moving Product in the Territory from the manufacturing point to a warehouse to the customer as follows : landing costs and duties ( in - house or subcontracted ), handling and transportation to fulfill orders includingexport / import taxes, insurance and transit running costs, etc . ( excluding such costs, if any, treated as a deduction inthe definition of Net Sales ) ; customer services, including order entry, billing and adjustments, inquiry and credit, collection, and litigation with customers concerning orders / deliveries ; order administration ; and departmentscoordinating sales forecasts and supply management ; physical distribution centers and other direct cost of storageand distribution of the Products, including distribution and storage subcontracted to third parties ; distribution servicesbetween physical distribution centers and commercial activities ; local supply chain department ; transportationpackaging modifications as a result of marketing decisions or regulatory requirements ; and the costs of the trafficdepartment where there is a separate department that has responsibility for administration of freight costs
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3
| 2,014
|
First Commercial Sale
|
shall mean, on a Competing Product - by - Competing Product and country - by - country basis, the first bona fide, arm ’s length sale by, on behalf of or under the authority of [COMPANY], its Affiliates orsublicensees to a Third Party, of Competing Product in a country in the Field in the Territory following receipt ofMarketing Approval in such country . Sales of a Competing Product for registration samples, clinical trials, compassionate use, named patient use and inter - company transfers to Affiliates of a Party will not constitute a FirstCommercial Sale
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3
| 2,014
|
Applicable Laws
|
shall mean the applicable provisions of any and all national, supranational, regional, stateand local laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits ( including Marketing Approvals ) of or from any court, arbitrator, RegulatoryAuthority or governmental agency or authority having jurisdiction over or related to the subject item
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3
| 2,014
|
ICH
|
shall mean the International Conference on Harmonization ( of Technical Requirements forRegistration of Pharmaceuticals for Human Use )
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3
| 2,014
|
[COMPANY] Technology
|
shall mean all [COMPANY] Know - How, [COMPANY] Patents and [COMPANY] ’s or aMannKind Affiliate ’s interest in Joint Patents and Joint Inventions
|
3
| 2,014
|
Confidentiality Agreement
|
shall mean that certain confidentiality agreement, dated May 31, 2013,between [COMPANY] and [COMPANY], as amended
|
3
| 2,014
|
Promotion
|
shall mean the expenses associated with programs to promote Product in the Territory directly tothe prescriber or end user, including, but not limited to, expenses associated with promoting products directly to theprofessional community such as professional literature ; costs associated with patient assistance programs;promotional material costs ; patient aids and detailing aids ; sales force tools and aids ; managed care programscharged directly to the brand ( including speaker programs, distribution of promotional material, contract administration, etc . ) ; field force meetings and training ; professional agency fees ; direct field funding ; public relations ; pharmacyprograms ; coupons and voucher programs ; advocacy ; sponsorships ; scientific and medical promotion, includingexpenses associated with grants and medical education, conventions, non - certified medical expense medicalactivities, scientific publications, commercial and medical advisory boards, field medical events, evidence - basedmedicine non - research projects ; and Product samples ( which, for the avoidance of doubt, will not be double countedwith associated costs contained in Paid Price or Cumulative COGS ), including associated expenses such as per unitcosts, costs of distributing samples from the warehouse to sales representatives or fulfillment warehouses, and anyother costs related to Product samples such as sample fulfillment, sample optimization programs, and managementfees for sample voucher programs ( i.e., vouchers provided by the physicians to patients in order to obtain free tradeunits at the pharmacy )
|
3
| 2,014
|
Commercial Expenses
|
shall mean, with respect to the applicable Calendar Quarter, the sum of thefollowing costs and expenses ( each of which is specified below ) incurred by the Parties and their Affiliates after theExecution Date, in each case to the extent directly attributable to the Commercialization of Product in the Field in theTerritory in such Calendar Quarter in accordance with the Commercialization Plan and the Commercialization Budget, excluding the Cost of Goods for Product used in conducting or performing such activities, calculated on a fullyburdened basis ( i.e
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3
| 2,014
|
FCPA
|
shall mean the U.S. Foreign Corrupt Practices Act ( 15 U.S.C. § 78dd-1, et seq . ) as amended
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3
| 2,014
|
Bankruptcy Laws ” ), licenses ofrights to “ intellectual property
|
), licenses ofrights to as defined under the Bankruptcy Laws . If a case is commenced during the Term by oragainst a Party under Bankruptcy Laws then, unless and until this Agreement is rejected as provided in suchBankruptcy Laws, such Party ( in any capacity, including debtor - in - possession ) and its successors and assigns(including a trustee ) shall perform all of the obligations provided in this Agreement to be performed by such Party . If acase is commenced during the Term by or against a Party under the Bankruptcy Laws, this Agreement is rejected asprovided in the Bankruptcy Laws and the other Party elects to retain its rights hereunder as provided in theBankruptcy Laws, then the Party subject to such case under the Bankruptcy Laws ( in any capacity, including debtor - in - possession ) and its successors and assigns ( including a Title 11 trustee ), shall provide to the other Party copies ofall Information necessary for such other Party to prosecute, maintain and enjoy its rights under the terms of thisAgreement promptly upon such other Party ’s written request therefor . All rights, powers and remedies of thenon - bankrupt Party as provided herein are in addition to and not in substitution for any and all other rights, powers andremedies now or hereafter existing at law or in equity ( including the Bankruptcy Laws ) in the event of thecommencement of a case by or against a Party under the Bankruptcy Laws
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3
| 2,014
|
Regulatory Filing
|
shall mean all approvals, licenses, registrations, submissions and authorizations madeto or received from a Regulatory Authority necessary for the 12.CONFIDENTIAL Development, Manufacture or Commercialization of the Product, including any INDs, MAAs and Marketing Approvals, excluding Master Files
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3
| 2,014
|
Calendar Quarter
|
shall mean a period of three consecutive months during a Calendar Year beginning onand including January 1st, April 1st, July 1st or October 1st
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3
| 2,014
|
SEC
|
shall mean the U.S. Securities and Exchange Commission, or any successor agency
|
3
| 2,014
|
Export Control Laws
|
shall mean all applicable laws and regulations relating to ( a ) sanctions andembargoes imposed by any governmental authority in the Territory or ( b ) the export or re - export of commodities, technologies, or services, including, but not limited to, the Export Administration Act of 1979, 24 U.S.C. § § 2401 - 2420, the International Emergency Economic Powers Act, 50 U.S.C. § § 1701 - 1706, the Trading with the Enemy Act,50 U.S.C. § § 1 et seq ., the Arms Export Control Act, 22 U.S.C. § § 2778 and 2779, and the International BoycottProvisions of Section 999 of the U.S. Internal Revenue Code of 1986 ( as amended )
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3
| 2,014
|
Government Health Care Program Contract
|
shall mean, with respect to Product, any agreements thatare necessary to give effect to any Government Health Care Program ( whether or not such agreements constitute as such term is used in connection with government procurement, e.g. 340B PharmaceuticalPricing Agreements and Medicaid Drug Rebate Agreements )
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3
| 2,014
|
Third Party
|
shall mean any Person other than the Licensors, [COMPANY] and their respective Affiliates
|
3
| 2,014
|
Territory
|
shall mean all countries of the world, excluding any Terminated Country
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3
| 2,014
|
United States
|
or shall mean the United States of America, including its territories and possessionsand the District of Columbia
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3
| 2,014
|
IFRS
|
shall mean the international financial reporting standards
|
3
| 2,014
|
Net Sales
|
shall mean, with respect to a Product for any period, the gross amount billed or invoiced bySanofi or its Affiliates for the sale of a Product to Third Parties, less the following deductions from such grossamounts, solely to the extent allocable to such Product and actually incurred, allowed or accrued ( and not previouslydeducted in calculating the amount invoiced):(a ) normal and customary trade, quantity and prompt settlement discounts ( including chargebacks andallowances ) actually allowed;(b ) amounts repaid or credited by reason of rejection, return or recall of Product;(c ) rebates or bona fide retroactive price reductions;(d ) freight, postage, shipping and insurance expenses to the extent that such items are included in the grossamount invoiced;(e ) customs and excise duties and other taxes or duties related to the sales to the extent that such itemsare included in the gross amount invoiced;(f ) rebates and similar payments made with respect to sales paid for by any governmental or regulatoryauthority such as, by way of illustration, federal or state Medicaid, Medicare or similar state program or equivalentforeign governmental program;(g ) the portion of administrative fees paid during the relevant time period to group purchasing organizationsor pharmaceutical benefit managers relating to such product ; and(h ) bad debts and uncollectable invoiced amounts relating to sales of Product that are actually written off inaccordance with IFRS, consistently applied throughout [COMPANY] and its Affiliates, provided that any such amountssubsequently collected will be included in Net Sales
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3
| 2,014
|
Regulatory Authority
|
shall mean any Governmental Authority whose review or approval is necessary forthe Manufacture, packaging, use, storage and Commercialization of Product in a given country in the Territory . Wheregovernmental approval is required for pricing or reimbursement for Product to be reimbursed by national healthinsurance ( or its local equivalent ), shall also include any Governmental Authority whose reviewor approval of pricing or reimbursement is required
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3
| 2,014
|
[COMPANY] Know - How
|
shall mean all Information that ( a ) is Controlled by [COMPANY] or any of its Affiliates as ofthe Effective Date or during the Term and ( b ) is necessary or useful for the Development, Manufacture, use orCommercialization of Product in the Field, expressly excluding any Know - How pertaining to the Manufacture ofInsulin
|
3
| 2,014
|
Profit
|
shall have the meaning set forth on EXHIBIT B hereto
|
3
| 2,014
|
Patent(s )
|
shall mean ( a ) all patents, certificates of invention, applications for certificates of invention, priority patent filings and patent applications, and ( b ) any renewal, division, continuation ( in whole or in part ), orrequest for continued examination of any of such patents, certificates of invention and patent applications, and any allpatents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of theforegoing
|
3
| 2,014
|
Data
|
shall mean any and all scientific, technical or test data pertaining to Product that is generated by oron behalf of [COMPANY] or its Affiliates or by or on behalf of [COMPANY] or a [COMPANY] Affiliate in the course ofperformance of studies or activities contemplated by the Development Plan or this Agreement, including researchdata, clinical pharmacology data, CMC data ( including analytical and quality control data and stability data ), 4.CONFIDENTIAL pre - clinical data, clinical data and pharmacoeconomic data, including any and all such data in publications, presentations or submissions made in association with a Regulatory Filing with respect to Product
|
3
| 2,014
|
Marketing Approval
|
shall mean all approvals, licenses, registrations or authorizations of RegulatoryAuthorities in a country necessary for the Manufacture, use, storage and Commercialization of Product in suchcountry . For countries where governmental approval is required for pricing or reimbursement for Product to bereimbursed by national health insurance ( or its local equivalent ), shall not be deemed to occuruntil such pricing or reimbursement approval is obtained
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3
| 2,014
|
Commercialize ” ( including any variations such as “ Commercialization
|
( including any variations such as or ) shallmean, with respect to a Product, to promote, market, distribute, sell ( and offer for sale or contract to sell ), import, orotherwise commercially exploit or provide product support for such Product
|
3
| 2,014
|
Business Day
|
shall mean a day other than a Saturday or Sunday or any public holiday in the UnitedStates, France or Germany
|
3
| 2,014
|
Master Files
|
shall mean all drug master files and device master files relating to Product filed or that maybe filed with any Regulatory Authority in any country or jurisdiction in the Territory
|
3
| 2,014
|
Allocable Overhead
|
means ( for any particular cost item ) a Party ’s internal allocation ( determined inaccordance with the last two ( 2 ) sentences of this Section 5.1 ), based on direct project headcount or other generallyaccepted activity - based accounting methods, of indirect overhead costs incurred by a Party or any of its operatingunits to support and carry out the activities of the specific business function, such as Development, obtaining ormaintaining Regulatory Filings, Manufacturing ( which, for the avoidance of doubt, shall be included solely as Cost ofGoods under the Supply Agreement ) and Commercialization, with respect to Product for the Territory, which indirectcosts may include but are not limited to : indirect labor costs ; 3.occupancy costs ; repair and maintenance costs ; office supplies and service costs ; equipment costs ; insurancecosts ; outside professional and other service costs ; and excise taxes and other taxes including those related to theU.S. Affordable Care Act . Such overhead will exclude any indirect costs associated with any excess or unusedcapacity . Except as provided herein, overhead costs of a Party or operating units that are not engaged in theDevelopment, obtaining or maintaining Regulatory Filings, Manufacturing or Commercialization of Product in theTerritory, including, by way of example only, executive management, investor relations, business development, legalaffairs, human resources and finance, will not be recoverable as Allocable Overhead or otherwise . The Partiesacknowledge and agree that each Party ’s Allocable Overhead for all applicable cost items shall be determined bymutual agreement of the Parties on an annual basis prior to each Calendar Year and such agreed - upon annualAllocable Overhead amount shall be the amount used for such Calendar Year for all calculations of AllowableExpenses hereunder . For the sake of clarity, neither Party shall be entitled to any reimbursement for AllocableOverhead that exceed such mutually agreed - upon annual Allocable Overhead amount
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3
| 2,014
|
Selling Expenses
|
shall mean the following costs directly associated with the efforts of field salesrepresentatives with respect to Product in the Territory : field sales force ; field 6.medical liaisons, field sales offices ; home offices ; staffs directly involved in the management of and the performanceof the selling functions ; and payments to Third Parties under contract sales and marketing agreements . The costs ofdetailing sales calls will be allocated at an accounting charge rate consistently applied within and across Sanofi’soperating units consistent with the internal charge rate used by [COMPANY] for its own internal cost accounting purposesfor products other than the Product ( excluding internal profit margins and markups ) . Selling Expenses may beallocated differently on a country - by - country basis but in any event shall be determined consistently with the mannerin which [COMPANY] prepares its internal financial statements
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3
| 2,014
|
including ” shall be deemed to be followed by the phrase “ without limitation
|
shall be deemed to be followed by the phrase or likeexpression ; ( b ) the word means unless the context dictates otherwise because the subject of theconjunction are mutually exclusive ; ( c ) the words and and other words of similar importrefer to this Agreement as a whole and not to any particular Article or Section or other subdivision ; ( d ) references inthis Agreement to shall mean calendar days ; ( e ) the singular shall include the plural and vice versa ; and(f ) masculine, feminine and neuter pronouns and expressions shall be interchangeable . Each accounting term usedherein that is not specifically defined herein shall have the meaning given to it under IFRS, or if not defined by IFRS, the meaning applied to it by [COMPANY] in preparing its publicly reported financial statements, in each case, consistentlyapplied, but only to the extent consistent with its usage and the other definitions in this Agreement
|
3
| 2,014
|
Market Research
|
shall mean expenses for primary and secondary market and consumer research personneland payments to Third Parties related to conducting and monitoring professional and consumer appraisals of Productin the Territory, such as primary and secondary market share services ( e.g., IMS data ), special research testing andfocus groups
|
3
| 2,014
|
[COMPANY] Patents
|
shall mean all Patents Controlled by [COMPANY] or any of its Affiliates as of the EffectiveDate or during the Term that are necessary for, or useful for and actually used in, the Development, Manufacture, useor Commercialization of Product in the Field, but excluding any Joint Patents
|
3
| 2,014
|
Development Term
|
shall mean the period during which the Parties are conducting studies and activitieswith respect to Product in the Field in the Territory under the Development Plan, commencing on the Effective Dateand ending upon the completion of all studies and activities specified in the Development Plan or earlier termination ofthis Agreement
|
3
| 2,014
|
Product
|
shall mean any product in a form suitable for human applications consisting of ( a ) a Formulationthat contains Insulin as the sole active pharmaceutical ingredient, without any other active ingredients, for use in aDevice, ( b ) a Device, but only to the extent that it is sold ( or intended to be sold ) for use with such a Formulationdescribed in clause ( a ), or ( c ) both a Device and such a Formulation described in clause ( a ) for use together, in eachcase, including all improvements thereof . For clarification, Product shall not include a Device to the extent that it issold ( or intended to be sold ) for administration of a Formulation that contains an active pharmaceutical ingredient otherthan solely Insulin
|
3
| 2,014
|
Wind - down Period
|
shall mean any period after the date of termination of this Agreement during which, pursuant to Section 13.3(a ), [COMPANY] is required to continue to perform certain activities
|
3
| 2,014
|
Change of Control
|
means, with respect to a Party ( or in the case of Licensors and solely for purposes ofthis definition, any of [COMPANY], TICV or BV separately):(a ) ( i ) the acquisition by a Third Party or Group, in one transaction or a series of related transactions, ofdirect or indirect beneficial ownership of more than fifty percent ( 50 % ) of the outstanding voting equity securities of aParty ; ( ii ) a merger or consolidation involving a Party, as a result of which a Third Party or a Group acquires direct orindirect beneficial ownership of more than fifty percent ( 50 % ) of the voting power of the surviving entity immediatelyafter such merger, reorganization or consolidation ; or ( iii ) a sale of all or substantially all of the assets of a Party inone transaction or a series of related transactions to a Third Party or a Group ; or(b ) the acquisition by a [ … * * * … ], in one transaction or a series of related transactions, of : ( i ) majority controlof the board of directors or equivalent governing body of such Party ; or ( ii ) direct or indirect beneficial ownership ofmore than [ … * * * … ] percent ( [ … * * * … ] % ) of the outstanding voting equity securities of a Party ; or ( iii ) the ability tocause the direction of the management or allocation of corporate resources of such Party ( provided that [ … * * * … ], shall not be deemed to be a Change of Control under this sub - clause ( iii ) so long as [ … * * * … ] ; or ( iv ) all orsubstantially all of the assets of such Party related to the transactions contemplated by this Agreement
|
3
| 2,014
|
Major Market
|
shall mean any of the following countries : [ … * * * … ]
|
3
| 2,014
|
[COMPANY] Know - How
|
shall mean all Information not included in the [COMPANY] Patents Controlled by theLicensors or any [COMPANY] Affiliate as of the Effective Date or during the Term that is necessary or useful for theDevelopment, Manufacture, use or Commercialization of Product in the Field, including all such Information related tothe design and utility of the Device and to the creation of a Formulation, and any replication or any part of suchInformation
|
3
| 2,014
|
Inventions
|
shall mean any and all inventions, discoveries, improvements, processes and techniquesinvented in the course of performance of studies or activities contemplated by the Development Plan or thisAgreement, whether or not patentable or included in any claim of Patents and Patent applications, constituting animprovement or line extension associated with Product
|
3
| 2,014
|
[ … * * * … ]
|
shall mean [ … * * * … ] 1.6 shall mean the Clayton Act, as amended, the HSR Act, and all other applicable laws andregulations issued by a Governmental Authority, whether domestic or foreign, that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening ofcompetition
|
3
| 2,014
|
Competing Product
|
shall mean any product ( other than Product ) containing or comprising any formulationof Insulin that is or is intended to be primarily administered in or through the lungs
|
3
| 2,014
|
Replacement Supply Costs
|
shall mean costs and expenses incurred by [COMPANY] in connection withestablishing replacement source(s ) of supply and associated supply chain following a Trigger Event ( as defined in theSupply Agreement ) except to the extent reimbursed by [COMPANY] under the Supply Agreement
|
3
| 2,014
|
MAA
|
shall mean a New Drug Application as defined in Title 21 of the U.S. Code of Federal Regulations, Section 314.80, et seq ., or comparable filing with any Regulatory Authority in any country or jurisdiction in theTerritory other than the United States, and all amendments and supplements thereto, which is filed with the FDA, including all documents, * * * Confidential Treatment Requested8.CONFIDENTIAL data, and other information concerning a pharmaceutical product which are necessary for gaining Marketing Approvalin the Territory
|
3
| 2,014
|
ControllingParty
|
shall mean [COMPANY] for actions commenced during such time that [COMPANY] is the sole licensee of such PlatformMannKind Patent, and shall mean [COMPANY] for all other actions, and shall mean ( i ) anyallegedly infringing activity in the Field in the Territory for the Product, which activity is reasonably expected to reduceNet Sales of Product then being sold by [COMPANY] and its Affiliates and sublicensees in the Territory, or ( ii ) the making, using, selling, offering for sale or importing Product in the Territory
|
3
| 2,014
|
Public Official or Entity
|
shall mean ( a ) any officer, employee ( including physician, hospital administrator, or other healthcare professional ), agent, representative, department, agency, de facto official, representative, corporate entity, instrumentality or subdivision of any government, military or international organization, including, butnot limited to, any ministry or department of health or any state - owned or affiliated company or hospital, or ( b ) anycandidate for political office, any political party or any official of a political party
|
3
| 2,014
|
Party
|
shall mean the Licensors ( considered together as one ) or [COMPANY] individually, and shall mean the Licensors ( considered together as one ) and [COMPANY] collectively
|
3
| 2,014
|
[COMPANY] Trademarks
|
shall have the meaning set forth on EXHIBIT A
|
3
| 2,014
|
[ … * * * … ] Country
|
shall mean any of the following countries : [ … * * * … ]
|
3
| 2,014
|
[COMPANY] Affiliate
|
shall mean any Affiliate of the Licensors that is controlled ( as such term is defined inSection 1.2 ) by any of the Licensors . For clarity, TICV and BV are [COMPANY] Affiliates
|
3
| 2,014
|
Budget(s )
|
shall mean the Development Budget, and the Commercialization Budget
|
3
| 2,014
|
Formulation
|
shall mean a formulation of an active pharmaceutical ingredient suitable for pulmonaryadministration based upon or incorporating the drug delivery technology Controlled by the Licensors that involvesamorphous or crystalline diketopiperazine microparticles
|
3
| 2,014
|
Product - Specific [COMPANY] Patent
|
shall mean a [COMPANY] Patent that claims or covers no other productor product candidate in addition to Product . The Product - Specific [COMPANY] Patents in existence as of the ExecutionDate are identified in EXHIBIT C. The categorization of any future [COMPANY] Patent as a Product - Specific MannKindPatent shall be determined in good faith by mutual agreement of the Parties
|
3
| 2,014
|
[COMPANY] Patents
|
shall mean all Patents Controlled by [COMPANY] or any [COMPANY] Affiliate as of theEffective Date or during the Term that claim or disclose Product or its components, or are necessary or useful for theDevelopment, Manufacture, use or Commercialization of Product in the Field in the Territory, including all suchPatents claiming or covering the design or utility of a Device or a Formulation, but excluding any Joint Patents . TheMannKind Patents existing as of the Execution Date are listed in EXHIBIT C
|
3
| 2,014
|
Joint Patents
|
shall mean all Patents claiming any Joint Invention
|
3
| 2,014
|
Allowable Expenses
|
shall have the meaning set forth on EXHIBIT B hereto
|
3
| 2,014
|
Marketing Management
|
shall mean expenses for product management and sales promotion management, including, but not limited to, costs associated with developing overall sales and marketing strategies at the global andcountry level ( e.g
|
3
| 2,014
|
Information
|
shall mean all technical, scientific, marketing, financial, commercial and other know - how andinformation, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, * * * Confidential Treatment Requested7.CONFIDENTIAL apparatuses, prototypes, specifications, data, including raw data, results, customer lists, marketing materials, andother material, including : drug discovery and development technology ; biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre - clinical, clinical, safety, manufacturing and quality controldata and information, including study designs and protocols ; assays and biological methodology ; manufacturing andquality control procedures and data, including test procedures ; and synthesis, purification and isolation techniques(whether or not confidential, proprietary, patented or patentable ) in written, electronic or any other form now known orhereafter developed
|
3
| 2,014
|
IND
|
shall mean an Investigational New Drug Application ( including any amendments thereto ) filed with theFDA pursuant to 21 C.F.R. § 312 before commencement of clinical trials of a pharmaceutical product, including clinicaltrial applications, or any comparable filing with any Regulatory Authority in any country or jurisdiction in the Territoryother than the United States
|
3
| 2,014
|
Responsible Party
|
shall mean the Party designated as responsible for conducting the applicable clinicalor non - clinical studies or other activities under the Development Plan or designated by the JAC as responsible forfiling and securing Marketing Approval for Product in the Field in the Territory, as applicable
|
3
| 2,014
|
Government Health Care Program
|
shall mean the Medicare Part D Coverage Gap Discount program ( asdefined in 42 U.S.C. 1395w-114A, as amended ), the Medicaid program ( Title XIX of the Social Security Act ), theDepartment of Veterans Affairs FSS Program, TRICARE, and the Public Health Service 340B Program, and anysimilar federal, state, and local governmental health care plans and programs
|
End of preview. Expand
in Data Studio
This dataset offers a comprehensive collection of 380,131 definitions extracted from 12,468 alliance contracts in the biopharmaceutical industry, spanning four decades from 1981 to 2021.
It was created as a companion to the research paper, "Tracing Definitions: Lessons from Alliance Contracts in the Biopharmaceutical Industry" and we encourage you to consult the paper for a detailed analysis of the data.
Dataset Schema
The data is organized into four columns:
id_contract: A unique identifier linking each definition to its source contract.
Note: Due to rights restrictions, the full contract texts are not provided. Access to contract metadata for scientific research may be granted upon specific request.
year: The year the corresponding contract was signed.
definiendum: The term being defined (e.g., "Net Sales").
definiens: The text of the definition that explains the term (e.g., "means the gross amounts invoiced by...").
To reconstruct a full definition, simply concatenate the definiendum and definiens.
If you find this dataset useful for your work, please cite our research paper:
Citation
@inproceedings{kreutner-etal-2025-tracing,
title = "Tracing Definitions: Lessons from Alliance Contracts in the Biopharmaceutical Industry",
author = "Kreutner, Maximilian and
Leusmann, Doerte and
Lemmerich, Florian and
Haeussler, Carolin",
editor = "Aletras, Nikolaos and
Chalkidis, Ilias and
Barrett, Leslie and
Goanț{\u{a}}, C{\u{a}}t{\u{a}}lina and
Preoțiuc-Pietro, Daniel and
Spanakis, Gerasimos",
booktitle = "Proceedings of the Natural Legal Language Processing Workshop 2025",
month = nov,
year = "2025",
address = "Suzhou, China",
publisher = "Association for Computational Linguistics",
url = "https://aclanthology.org/2025.nllp-1.1/",
pages = "1--15",
ISBN = "979-8-89176-338-8"
}
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