definiens: of an entity means beneficial ownership, directly or i ndirectly, of fifty percent ( 50 % ) or more of the outstanding voting shares or securities or the ability otherwise to elect or appoint a majority of the board of directors or other managin g authority of such entity . [ * * * ] Certain information in this document has been omitted and f iled separately with the Securities and Exchange Commission Confidential treatment has been requested with respect to portions of this agreement . 1 1.2 means ( a ) all laws, ordinances, rules, directives and regulations applicable to the Produc ts, the Project or this Agreement, including without limitation applicable local laws and regula tions in each country in the Territory ; ( b ) applicable regulations and guidelines of the FDA an d other Regulatory Authorities and the International Conference on Harmonization ( ICH ) gui delines ; ( c ) as applicable to the particular activities performed, Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other Regulatory Authorities or the ICH ; and ( d ) all applicable industry and trade stan dards, including the applicable standards of the International Organization for Standardization ( ISO ), including at least the ISO 9001/9002 quality standards . 1.3 means those commercially reasonable efforts customarily used by companies in the biopharmaceutical industry for carrying out in a sustained manner a particular tas k or obligation, and at least equivalent to those level of efforts applied by a Party for its [ * * * ] . 1.4 means the confidential or proprietary scientific, technic al or business information, materials and technologies of a Party disclosed or learned under this Agreement, including the Work Plans and any information exchanged prior to the Effectiv e Date, whether in written, oral, electronic, photographic, magnetic or other form . F or clarity, the Project Results and Intellectual Property owned by a Party pursuant to this Agreement shall be deemed the Confidential Information of such Party . Confidentia l Information shall exclude any portion of such information which : ( a ) was known to the receiv ing Party prior to its receipt from the disclosing Party as evidenced by the receiving Part y ’s written records existing prior to such receipt ; ( b ) is or becomes part of the public domai n, through no fault of the receiving Party ; ( c ) is disclosed to the receiving Party by a third party who has a legal right to make such disclosure ; or ( d ) is independently developed or di scovered by the receiving Party without resort to any Confidential Information of the discl osing Party, as evidenced by documentation contemporaneous with such independent development o r discovery . 1.5 means with respect to an item of information or intellectual p roperty rights, possession by a Party of the power and authority, whether arising by ownership, license, or other authorization, to disclose such item as required by this Agreement, and/or to grant and authorize licenses or sublicenses under such items that are within the scope granted to the other Party under this Agreement, without violating the terms of any written agreemen t with any non - Affiliate third party under which such Party first acquired such rights to such item of information or intellectual property . 1.6 means with respect to a pro duct by certain Intellectual Property means that ( a ) such product or its manufacture, use or sale would infringe a Valid Claim of a Patent Right within such Intellectual Property, in the country of such manufacture, use or sale, or ( b ) such product incorporates or is made using m aterial Know - how within such Intellectual Property . 1.7 means all data, data sets, tes t data, pre - clinical and clinical trial data, analyses, reports, regulatory filings and approvals and the information therein or associated therewith ( including drug master files and device m aster files, supporting data, regulatory correspondence and meeting minutes ) and rights to r eference the same, in each case : ( a ) that are generated by either Party in the course of perf orming the Work Plan ( ) ; or ( b ) that are owned or Controlled by [COMPANY] prior to t he Effective Date, or generated by [COMPANY] during the term of this Agreement outside of perfor ming the Work Plans, and are necessary or useful for the efforts of Mpex, its Affiliates or S ublicensees in obtaining Marketing Approval for the Products ( ) . [ * * * ] Cert ain information in this document has been omitted and filed separately with the Securities an d Exchange Commission Confidential treatment has been requested with respect to portio ns of this agreement . 2 As used herein, the term alone refers to both Project Data and E xisting [COMPANY] Data . 1.8 means a pharmaceutical preparation that is formulat ed for [ * * * ], alone or in addition to one or more other active or inactive substances, chemicals or ingredients . 1.9 means the electronic nebulizer device(s ) being sold by [COMPANY] as of the Effective Date and improvements thereto made by [COMPANY] during the term o f this Agreement outside the Project and without use of Mpex Intellectual Property, Proj ect Results or Project Intellectual Property, in each case that includes [ * * * ] . 1.10 means [COMPANY] ’s proprietary component of the Project Nebulizer that is specific to the Dr ug Product and separable from the Project Nebulizer, which component [ * * * ] . It is understood that the [ * * * ] may be sold together or apart from the Project Nebulizer or Drug Product an d may or may not be consumable . 1.11 means compounds that speci fically interfere with the ability of an efflux pump to export its normal substrate, or othe r substrate such as an antibiotic, from the cytoplasm, membrane compartment or periplasmic spac e. The inhibitor may have intrinsic antimicrobial ( e.g., antibacterial ) activity of its own, but at least a significant portion of the relevant activity is due to the efflux pump inhibit ing activity . Efflux Pump Inhibitors shall include without limitation Pentamidine . 1.12 means the United States Food and Drug Administration or any successor to that agency . 1.1 3 shall mean the first commercial sale of a product subject to royal ties under Article 6, by or under authority of Mpex, its Affiliates and/or their Sublicensees in a country in the Mpex Territory, after Marketing Approval in such country has been obtaine d. 1.14 means any of a group of antibiotics that are fluorinated derivat ives of quinolone compounds, including without limitation Levofloxacin . 1.15 means generally accepted accounting principles in the United States or Germany, or the International Accounting Standard, consistently applied by a Party throughout its ente rprise . 1.16 or means all good manufacturing p ractices as promulgated by the FDA and other Regulatory Authorities or the ICH, in the form of laws or regulations or guidance documents, for the manufacturing of pharmaceutical products including 21 CFR § § 210 - 211, and medical devices, including 21 CFR § 820 – Quali ty System Regulation . 1.17 means all processes and activities t ypically engaged in by a person or entity in the pharmaceutical or medical device industry fo r the GMP manufacture of a product or component thereof, including procuring raw material s, manufacturing, quality control and assurance testing, GMP record keeping, packaging an d labeling . 1.18 means ( a ) all right, title and interest in all pate nt applications and patents including, without limitation divisions, continuations, continuations- in - part, renewals, [ * * * ] Certain information in this document has been omitted and filed separat ely with the Securities and Exchange Commission Confidential treatment has been requeste d with respect to portions of this agreement . 3 re - examination certificates, reissues, continued prosecution applications, extensions, substitutions, nationalizations and for eign counterparts of such patent applications and patents and all patents which issue from the fo regoing ( collectively, ), and ( b ) all Data, know - how and technical information, i ncluding, without limitation, concepts, inventions ( whether or not patentable ), trade secre ts, discoveries, formulas, systems, methods, techniques, designs, drawings, sketches, theories, descriptions, instructional materials, computer programs, computer files, images, videos a nd works of authorship ( collectively, ) . It is understood, however, that Know - h ow does not include information that falls within exceptions ( a ) through ( d ) of the defi nition of in Section 1.4 . 1.19 means ( -)-(S)-9 - fl uoro-2,3 - dihydro-3 - methyl-10-(4 - methyl - l - piperazinyl)-7 - oxo-7H - pyrido[1,2,3 - de ] -1, 4 - benz oxazine-6 - carboxylic acid hemihydrate, and all solid and liquid forms thereof . 1.20 means both : ( a ) Drug Product for delivery through the Project Nebulizer ( ), and/or ( b ) if Mpex deems, acting in good faith as described in Section 4.4, that the Project Nebulizer is not commercially feasible, or otherwise elects to [ * * * ], the configu ration of a Drug Product delivered through an [ * * * ], provided that such Drug Product, [ * * * ] or combination thereof is Covered by [COMPANY] Intellectual Property . For clarity, [COMPANY] acknowledg es that prior to the Effective Date, Mpex has investigated on its own formulations of Drug Pr oducts and [ * * * ], and accordingly the combination of Drug Product delivered through an [ * * * ], where neither the Drug Product nor the inhalation delivery device ( nor the combination thereof ) is [ * * * ] . Notwithstanding the foregoing, the Parties agree that if the Project Ne bulizer is based upon [ * * * ], the same shall not be deemed a [ * * * ], but will instead be consider ed an [ * * * ] . 1.21 means a fully completed marketing authorization application ( file d with the FDA, if in the United States, or to the counterpart of the FDA, if outside the Unite d States ), including all supporting documentation and data required for such applicatio n to be accepted for substantive review, filed with a Regulatory Authority to seek Marketing Approval for a particular indication in a particular country . It is understood that MAA does not include applications for pricing or reimbursement approval . 1.22 m eans all approvals, registrations or authorizations of any governmental entity that are necessary for the manufacture, use, storage, import, transport and sale of products in a regulat ory jurisdiction . For countries where governmental approval is required for pricing or re imbursement for Products to be reimbursed by national health insurance, Marketing Approval sh all not be deemed to occur until such pricing or reimbursement approval is obtained . 1.23 means any one of [ * * * ] or [ * * * ] . 1.24 means the pulmonary adm inistration of either clause ( a ) or ( b ) below, alone or any combination involving clause ( a ) or ( b ) below as an active pharmaceutical ingredient, for the treatment, prophylaxis or manag ement of any disease or condition : ( a ) Levofloxacin or one backup Fluoroquinolone selected or substituted pursuant to Section 2.5 ; and/or ( b ) Pentamidine and/or any Efflux Pump Inhib itors Covered by those Patent Rights owned or Controlled by Mpex as of the Effective Dat e listed on Exhibit 1.24, or any divisions, continuations, continuations - in - part, renewals, re- examination certificates, reissues, continued prosecution applications, extensions, substitutions, or the like, or any nationalizations and foreign counterparts of such patent applications an d patents and all patents which issue from the foregoing . [ * * * ] Certain information in this do cument has been omitted and filed separately with the Securities and Exchange Commiss ion Confidential treatment has been requested with respect to portions of this agreemen t. 4 1.25 means all Intellectual Property owned or Controlled by Mpex and its Affiliates, as of the Effective Date or during the term of this Agreement, that is reasonably necessary for [COMPANY] to perform the Work Plans . 1.26 means the entire world . 1.27 means those types of accessories sold by [COMPANY] as of the Effective Date or during the term of this Agreement for use with eFlo w ® Devices, which are not specific to the drug substance being delivered by such devices, inc luding e.g., power adapters, carrying cases, face masks, and when adapted for use with a Project Nebulizer, may be desirable for the commercialization of such Project Nebulizer . 1 . 28 means the amounts received by Mpex, its Affiliates and its Sublicense es for their sales of Drug Product for use in a Licensed Configuration to non - Affiliate third par ties less the following deductions : ( a ) trade, wholesale, quantity, cash or other discounts, refun ds, returns, credits, allowances, commissions and wholesaler charge backs allowed and taken ; ( b ) import, export, excise, sales or use taxes, value added taxes, and other taxes, t ariffs and duties imposed on such sales and actually paid by Mpex, its Affiliates or Sublicense es, as applicable ; ( c ) out - bound packaging, handling, transportation, freight, freight insuranc e, and other insurance relating to such sales ; and ( d ) amounts allowed or credited on the sale for retroactive price reductions or rebates including, but not limited to, Medicaid rebates . Sa les between or among a Party, its Affiliates or Sublicensees shall be excluded from the computat ion of Net Sales if such Party, Affiliate or Sublicensee is not an end - user, but Net Sales shall include the subsequent re - sale of the Drug Product for use in a Licensed Configuration to a no n - Affiliate third party . Net Sales shall not include amounts in respect of Drug Product sold or used for development applications ( including for clinical trials ) or as commercial sa mples . 1.29 means [ * * * ]