definiens: means a transfer of intellectual property or information from an Independent Third Partyto [COMPANY] or [COMPANY], as the case may be, to the extent to which there are noobligations or restrictions in respect of that intellectual property or information whichprohibit use by or disclosure to [COMPANY] or [COMPANY], as appropriate ; [ * * * * * ] means any corporation or business entity which [COMPANY] or [COMPANY], directly orindirectly, owns or controls, is under common ownership with, or which owns one of theParties to this Agreement . Ownership or control shall exist when an entity owns 50 % ormore of the capital or business assets of another entity ; has the power to exercise 50 % ormore of the voting rights or to appoint 50 % or more of the Board of Directors of anotherentity ; or has the right to control the affairs of another entity, it being understood that thedirect or indirect ownership of a lesser percentage of such shares shall not necessarilypreclude the existence of control ; means this license agreement ( which expression shall be deemed to include the Recitalsand Schedule hereto, and any other document(s ) incorporated herein by reference ) ; means various proprietary synthetic compounds described by the [COMPANY] Technologythat are used to facilitate transport through membranes via a number of different Routesof Administration to deliver the Compound ; means calcitonin, specified by [COMPANY] herein, [ * * * * * ] [ * * * * * ] means the date when [COMPANY] exercises the Option and makes the payment foreseen inthe Option Agreement under Article 2.3 thereof ; 2 means [COMPANY] Technologies, Inc., its Affiliates, successors and permitted assignees ; means all existing proprietary trade secrets, confidential scientific, technical and medicalinformation and expertise from time to time developed, produced, created or Acquired byor on behalf of [COMPANY], on or before the Effective Date, including, but not limited to, unpatented inventions, discoveries, theories, plans, ideas or designs relating to theresearch and development, registration for marketing, use or sale of the Carriers orformulations of Compounds and Carriers, needed relevant data on the Carriers, preclinicaltoxicity and manufacturing data for the Carriers and prototype Compound / Carrierformulation(s ), and toxicological, pharmacological, analytical and clinical data, bioavailability studies, other formulations, control assays and specifications, methods ofpreparation and stability data with respect to Carriers and prototype Compound / Carrierformulation(s ) ; [ * * * * * ] means all and any existing patents, utility models and any applications therefor in theTerritory ( other than the [COMPANY] Program Patents or Joint Patents ) that are orsubsequently may be owned or Acquired by, or assigned or licensed to, Emisphere(including any and all divisions, continuations, continuations - in - part, extensions, additions, registrations, confirmations, reexaminations, Supplementary ProtectionCertificates, renewals or reissues thereto or thereof ) as of the Effective Date and thatwould be infringed by the development, manufacture, use, disposal, sale, offer of disposalor sale, or importation of the Product(s ) in the Territory and/or relate to the Field ; theEmisphere Patents as of the effective date are included in the Schedule I hereto ; means all trade secrets, confidential scientific, technical and medical information andexpertise developed, produced, created or Acquired by or on behalf of Emispherepursuant to the Research and Development Program ( other than [COMPANY] Know - Howand Joint Know - How ), including, but not limited to, unpatented inventions, discoveries, theories, plans, ideas or designs ( whether or not reduced to practice ), and relating to theresearch and development, registration for marketing, use or sale of the Carriers or theProduct(s ), needed relevant data on 3 the Carriers, preclinical toxicity and manufacturing data for the Carriers and prototypeProduct(s ), and toxicological, pharmacological, analytical and clinical data, bioavailability studies, formulations, control assays and specifications, methods ofpreparation and stability data with respect to the Carriers and prototype Product(s ) ; means all and any patents, utility models and applications therefor in the Territory(including any and all divisions, continuations, continuations - in - part, extensions, additions, registrations, confirmations, reexaminations, Supplementary ProtectionCertificates, renewals or reissues thereto or thereof ) on or for any inventions ordiscoveries that have been or subsequently may be conceived or made by employees oragents of [COMPANY] pursuant to the Research and Development Program ; means the [COMPANY] Program Patents, the [COMPANY] Program Know - How and / orEmisphere ’s share of the Joint Patents and the Joint Know - How, as well as any otherEmisphere intellectual property rights ( such as copyright or data rights ) created or arisingduring the term of this Agreement and relevant to the Field ; means the [COMPANY] Patents and/or the [COMPANY] Know - How, as well as any otherEmisphere intellectual property rights ( such as copyright or data rights ) created or arisingbefore the term of this Agreement and relevant to the Field ; means the research, development and optimization of the Compound and all uses of theCompound utilizing one or more Carriers for all medical ailments or indications for theoral Route of Administration as well as the manufacture, use, promotion, distribution, marketing and sale of the Product(s ) ; means full time equivalent persons employed by one of the Parties as defined in theOption Agreement ; means the following costs : [ * * * * * ] 4 means any relevant regulatory authority the approval of which is necessary to market aproduct in any country of the Territory and which in the United States is the Food andDrug Administration ( FDA ) or any successors or agency the approval of which isnecessary to market a product in the United States of America ; means any intellectual property rights of [COMPANY] relevant to the Field created orarising outside the scope of this Agreement, but during the term of this Agreement ; means any Investigational New Drug Application or similar application in relation to aProduct(s ) filed by [COMPANY] or its approved designee with the relevant Health Authority ; means any person other than [COMPANY], [COMPANY] or any of their Affiliates ; means know - how which is jointly developed by the Parties in pursuance of the Programunder the Option Agreement and during the term of this License Agreement ( i.e., pursuantto the Research and Development Program ) ; means all and any patents, utility models and any applications therefor in the Territory(including any and all divisions, continuations, continuations - in - part, extensions, additions, registrations, confirmations, reexaminations, Supplementary ProtectionCertificates, renewals or reissues thereto or thereof ) on or for any inventions ordiscoveries which are jointly conceived by the Parties in pursuance of the Program underthe Option Agreement and during the term of this License Agreement ( i.e., pursuant to theResearch and Development Program ) ; means the first commercial sale of a Product ; the date thereof shall be determined on acountry - by - country basis ; means milestones as specified in the Appendices to the Option Agreement ; means any New Drug Application or similar application in relation to a Product(s ) filedby [COMPANY] or its approved designee with the relevant Health Authority ; 5 means with respect to the Product(s ) the gross invoice price of Product sold by Novartisand its sublicensees to independent, non - Affiliated third parties in bona fide, arms - lengthtransactions, from which shall be subtracted, if not previously deducted in the amountinvoiced or received, ( i ) quantity and/or cash discounts actually allowed or taken, ( ii)freight, postage and shipping insurance [ * * * * * ], ( iii ) customs duties and taxes, if any, directly related to the sale, ( iv ) amounts repaid or credited by reasons of rejections, returnof goods and retroactive price reductions specifically identifiable as relating to Product,(v ) amounts incurred resulting from government ( or an agency thereof ) mandated rebateprograms, ( vi ) third party rebates and chargebacks related to the sale of Product to theextent actually allowed, ( vii ) amounts that are uncollectible because of, for example, thebankruptcy of a customer, ( viii ) as agreed by the Parties in writing, any specificallyidentified amounts included in the Product ’s gross sales that were or ultimately will becredited and are substantially similar to those listed above