definiens: shall mean any and all medi cal indications of the Product other than the First Indication ; 1.2 shall mean, with respect to either Part y, any corporation, company, partnership, joint ven ture or any other entity which, directly or indirectly, controls or is controlled by, or is under common co ntrol with such Party . For the purposes of this definitio n, shall mean direct or indirect ownershi p of fifty percent ( 50 % ) or more of the stock or shares entitled to vote for the election of directors ; 1.3 shall mean this Exclusive Licence, Deve lopment and Supply Agreement and its Schedules, as may be updated or amended from time t o time ; 1.4 shall mean EMEA`s Committee for Medicinal Pr oducts for Human Use ; * * * Confidential Treatment Requested * * * 1.5 or sha ll mean the current good manufacturing guidelines set out in the United States Code of Fed eral Regulations Parts 210 and 211, United States 21CFR Part 820 Quality System Requirements and in E U Directive 2003/94 / EC and ISO 13485 so far as the same are relevant in each case as amended an d updated from time to time ; 1.6 or shall me an the current guidelines for the principles of goo d clinical practice in the conduct of clinical trials on medicinal products for human use as set out in EU Directive 2001/20 / EC and US Guidance for Industry E 6 Good Clinical Practice so far as the same are relevant in each case as amended and updated from t ime to time ; 1.7 or shall mean the current guidelines for the principles of good laboratory practice as set out in the EU Direc tives 2004/9 / EC and 2004/10 / EC and the related OECD principles and FDA 's GLP regulations so far as the same are relevant in each case as amended and updated from time to time ; 1.8 shall mean information w hich is transferred between the Parties by written or other tangible form and clearly marked as being confidential by the disclosing Party . In the case o f information which is disclosed orally, Confidential Information includes such information which is confirmed thereafter within thirty ( 30 ) days in wri ting or other tangible form by the disclosing Party as confidential . The term Confidential Information sha ll include but not be limited to, all Product Specifications and manufacturing specifications, an d information relating to the market or technology or either Party 's business provided by it in connec tion with this Agreement ; Know - How revealed shall be deemed to be Confidential Information, regardles s of its marking as confidential or not ; The term Confidential Information shall also includ e information disclosed by JANSSEN and LAB International Inc. under the agreement of July 28, 2005 which shall also be applicable for the Parties of the present Agreement ; The term Confidential Information shall not mean an y information which is previously known to the receiving Party without obligation of confidence to the disclosing Party, as shown by its written reco rds, or which, without breach of this Agreement, is publ icly disclosed either prior or subsequent to receip t by the receiving Party of such Confidential Informa tion, or which is subsequently received by the receiving Party from a Third Party not under an obl igation of confidence to the disclosing Party, or which is independently developed by a Party without violation of any confidentiality requirements or intellectual property rights hereunder, or disclosu re of which is required by subpoena or other legal or administrative process or by law, provided that, wi th respect to the latter, the Parties shall closely collaborate in order to obtain a protective order o r other appropriate remedy concerning any such disclosure ; if any such order or other remedy does not fully preclude disclosure Parties shall make su ch disclosure only to the extent that such disclosure is legally required ; 1.9 shall mean the plan, as agreed b y the Parties and set out in Schedule A as amended from time to time, specifying all the development w ork, including goals, directions, activities, due d ates for the non - clinical and clinical program, the clin ical trial program for the development of the First Indication, the implementation of agreed upon addit ional features into the Product, and regulatory preparations, to be performed mainly by LAB includi ng completion of the regulatory file for the Product in a form suitable for submission to the Re gulatory Authority and as requested by JANSSEN, with the objective of obtaining a Marketing Authori sation for the First Indication in the European Union ; 1.10 shall mean the period until th e First Marketing Authorization has been obtained ; * * * Confidential Treatment Requested * * * 2 1.11 shall mean a reservoir metered dose dry po wder inhaler for the pulmonary delivery of multiple doses of a dry powder formulation of certa in compounds ; 1.12 shall mean costs in accordance with GAAP ( Generally Accepted Accounting Principles ), which are reasonable and ne cessary, in each case linked to a commercial sale and comprise : * * * * * * Confidential Treatment Requested * * * 3 * * * 1.13 shall mean the last date of execut ion of this Agreement ; 1.14 shall mean the European Medicines Evaluation Agency and any successor entity ; 1.15 shall mean the US Food and Drug Administratio n and any successor entity ; 1.16 shall mean the pulmonary administration to humans of fentanyl, alfentanil, sufentanil or remifentanil in base or salt form, in particular fe ntanyl citrate, or the stereoisomers, solvates, non -covalent complexes, chelates, polymorphs or amorpho us forms thereof ; 1.17 shall mean the first sale o f the Product by JANSSEN or its designees in any country in the Territory following receipt of the M arketing Authorisation ; Any sales made prior to the receipt of the Marketin g Authorization, such as so - called, sales and the like, sha ll not be deemed First Commercial Sales ; 1.18 shall mean the first medical use for the Product approved in a European Marketing Authorisation for the management of breakthrough pa in in cancer patients who are already receiving and who are tolerant to opioid therapy for their ca ncer pain ; 1.19 shall mean causes beyond a pa rty 's control, including, without limitation the following which, for the purposes of this Agreement, shall be regarded as beyond the control of the Party in question ; act of God, acts or omissions of any government or any rules, regulations or orders of any govermnental authority or any officer, departme nt, agency or instrument thereof ; fire, storm, floo d, earthquake, accident, acts of the public enemy, war, rebellion, insurrection, riot, invasion, strikes or lockouts ; * * * Confidential Treatment Requested * * * 4 1.20 ( ) shall mean the dat abase containing all Adverse Events and pregnancy reports for the Product that will be used for regulatory reporting and responses to safety queries from Regulatory Authorities . Adverse Event ( AE ) shall have the official meanings or definitions as provided by and as further defined o r modified by the applicable law and Regulatory Authorities ; 1.21 shall mean * * * 1.22 shall mean any trademark, comme rcial name, logo and/or other distinctive sign owned by JANSSEN or a JANSSEN Affiliate and chosen by JANSSEN for use with the Product ; 1.23 shall mean Improvements that i nclude at least one inventor with an obligation to assign rights to LAB and at least one inventor with an obligation to assign rights JANSSEN ; 1.24 shall mean any and all unpatented or unp ublished inventions, discoveries, trade secrets, information, data, analysis, formulae, procedures, methods, processes and results, or any other know - how in the possession of LAB which relates to or is useful in connection with the development, approval and eventual commercialization of the Prod uct or developed by LAB in the performance of this Agreement, including clinical, pre - clinical, a nd regulatory information concerning the Product ; 1.25 shall mean any trademark, commercia l name, logo and/or other distinctive sign owned by LAB ( as listed in Schedule K ) and chosen by JANSSEN or an Affiliate for use with the Product ; 1.26 shall mean all steps leading to and including the preparation of the powder formulation, filling of the formulation in the suba ssembly of the Device, the final assembly of the Device post filling, secondary packaging of the Pro duct, all Product testing required for quality cont rol, quality, assurance and warehousing ; 1.27 shall mean the single and multi - cavity production injection moulding tools and assembly / testing modules, filling and packaging equipment for Manufacturing the Product and all equipment and fixtures necessary for control of Pro duct quality ; 1.28 shall mean the plan set out in Schedule F as amended from time to time, specifying all activities and associated due dates for the design, establishment, validation and opera tion of the manufacturing facilities and procedures for the Manufacturing of the Product for the supply of the Product to JANSSEN ; 1.29 or shall mean any ap proval of the Product and/or establishment license, registration or authorization of any agenc y, department or other governmental entity having regulatory jurisdiction, required for the manufactu re, storage, import, export, transport or commercia l sale or use of the Product for use in the Field in any country of the Territory ; * * * Confidential Treatment Requested * * * 5 1.30 or shal l mean the application for a Marketing Authorization ; 1.31 shall mean, commencing with the First C ommercial Sale of the Product in any country in the Territory, the aggregate of the gross invoiced sales price for the Product sold by JANSSEN or its designees to Third Parties, after deduction of the following amounts according to standard method of accounting and to the extent included in the gross invoice amount : * * * 1.32 shall mean the patents listed in Schedule K and any patents ( including all additions, division s, continuations, continuations - in - part, substitutions, national patent rights, extensions, patent term extensions, supplementary protection certificates a nd renewals thereof ), utility models and patent applications ( including patents issued thereon ) der iving or claiming priority from any of the patents and patent applications that are or become owned or lic ensed by LAB and that would be infringed ( or, in th e case of patent applications, contain claims which, if allowed in an issued patent, would be infringed ) by the development, use or sale of the Product in the absence of the licences granted herein ; 1.33 shall mean the price charged by LAB SRL to JANSSEN for the Product, net of VAT, as set out in Schedule I and Section 15.3 ; 1.34 shall mean the Device containing 30 doses of powder formulation of fentanyl citrate in two separate strengths of 100 and 200 micrograms per do se developed and owned by LAB as specified in Schedule B, and any Improvements thereto ; 1.35 shall mean the voluntary or forced recall of the Product from the market and shall mean Product which is the subject of a Recall ; 1.36 shall mean EMEA, the CHMP, the MHRA and other national regulatory authorities responsible for granting MAs for pharma ceutical products in or outside the Territory and t he FDA with respect to the Manufacturing and supply of the Product from the United States of America ; 1.37 shall have the meaning set out in Schedul e I ; 1.38 shall mean the plan set out in Schedule G ; as amended from time to time, specifying all activities and associated due dates for scale - up of the LAB manufacturing facilities to a commercial scale operation with capacity to meet the forecaste d demand for the Product ; * * * Confidential Treatment Requested * * * 6 1.39 shall mean Scientific Advice fr om CHMP concerning the requirements for a MA for the Product for the First Indication within the EU ; 1.40 * * * 1.41 shall mean a Third Party performing a Manufacturing step for the Product under contract to LAB ; 1.42 shall mean a Third Party, other than a S ubcontractor, supplying API, excipients, raw materials ; Devices, primary and secondary packaging components, equipment or services for Manufacturing the Product ; 1.43 shall mean the longest of ( a ) ten ( 10 ) years from the date of the First Commercial Sale of the Product in the Territory or ( b ) the expiration of t he longest lasting LAB Patent related to the Produc t or ( c ) the expiration of longest lasting regulatory ex clusivity for the Product in the Territory ; 1.44 shall mean European Union 's current 27 member states plus Switzerland, Norway, Iceland, Liechtenstein, Russia, CIS ( Armenia, Azerbaijan, Be larus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Ukraine, Uzbekistan and as associate me mber Turkmenistan ), Croatia, the former Yugoslav Republic of Macedonia ( FYROM ), Bosnia - Herzegovina, Serbia, Montenegro, Turkey, Andorra, San Marino, Monaco, all the countries of the African co ntinent, all the Middle East countries * * * Sri Lanka and Pakis tan ; 1.45 shall mean any person, corporation, o r other entity other than JANSSEN, LAB and their respective Affiliates ; 1.46 shall mean a version of the Produ ct not containing any active pharmaceutical ingredient designed and provided for demonstration purposes, education and training of health care professionals, patients and others in the use of th e Product