definiens: means any company, corporation, firm, individual, t rust or other entity which controls, is controlled by or is under common contr ol with a party to this Agreement, and for the purpose of this definition t he term 2 means the possession, directly or indirectly, of th e power to direct or cause the direction of the management and policies of such fi rm, person, trust or company, whether through the ownership of voting se curities, by contract or otherwise, or the ownership either directly or indi rectly, including the ownership by trusts with substantially the same ben eficial interests, of 50 % or more of the voting securities ( or, in relation to a ny country where ownership of more than 50 % of the voting securities is prohibite d by law, the maximum percentage permitted, provided such percentage is n o less than 30 % ) of such company, corporation, firm, individual, trust or ot her entity ; means all laws, rules, regulations and codes of pra ctice regarding the representation, promotion and marketing of the Fini shed Products in any jurisdiction in the Territory ; means the date of the first commercial sale to a Th ird Party customer for commercial use or onsale of Finished Product in any country within the Territory following Regulatory Approval ; means a product ( other than the Finished Product ) a vailable in a country in the Territory in which the Finished Product is sold by [COMPANY] or its distributors which is indicated for use in the Fiel d ; means all confidential information, data and materi als in whatever form disclosed by one party to the other or received in connection with this Agreement including, without limitation, the terms of this Agreement, [COMPANY] ’s marketing plans and [COMPANY] ’s sal es forecasts, but excluding information : ( a ) which, at the time of disclosure by one pa rty to the other, is in the public domain ; 3 ( b ) which, after disclosure by one party to th e other, becomes part of the public domain by publication, except by breach of a ny obligation of confidentiality ; ( c ) which the receiving party can establish by competent proof was already in its possession at the time of its receipt and wa s not acquired directly or indirectly from the other party ; ( d ) which, after disclosure by one party to th e other, was developed independently of the information received ; or ( e ) received from Third Parties who were lawfu lly entitled to disclose such information ; means the European Economic Area as at the Effectiv e Date, together with any other countries joining the European Economic Area thereafter as from the date of their joining ; means the date of this Agreement ; means the European Medicines Evaluation Agency or a ny successors thereto ; means The Food and Drug Administration of the Unite d States of America or any successor thereto ; means the intrathecal treatment of malignant diseas e ( including without limitation lymphomatous meningitis and, if an appro ved indication, the treatment of neoplastic meningitis ) ; 4 means Product presented in Vials, packaged and labe lled for sale to end users ; means in relation to either party, any cause affect ing the performance of this Agreement or the Supply Agreement arising from or a ttributable to any acts, events, non happenings, omissions or accidents beyo nd the reasonable control of the party to perform and in particular but witho ut limiting the generality thereof shall include strikes, lock outs, industria l action, civil commotion, riot, invasion, war, threat of or preparation for war, te rrorist activity, fire, explosion, storm, flood, earthquake, subsidence, epidemic or o ther natural physical disaster, impossibility of the use of railways, shi pping, aircraft, motor transport, or other means of public or private transport, fail ure or suspension of utilities, and political interference with the normal operatio n of either party ; means any discovery, development, improvement, Know -How or Patent relating to the Product and/or the Field generated, conceived, reduced to practice or otherwise created during the Term by Sk ye ( or any Affiliate or licensee of Skye ) ; means patents, trade marks, service marks, logos, tr ade names, rights in designs, copyright, utility models, rights in Know - How and o ther intellectual property rights, in each case whether registered or unregist ered and including applications for registration, and all rights or fo rms of protection having equivalent or similar effect anywhere in the world ; means all information, procedures, instructions, te chniques, data, technical information, knowledge and experience ( including, w ithout limitation, toxicological, 5 pharmaceutical, clinical, non - clinical and medical data, health registration data and marketing data ), designs, dossiers ( including, without limitation, manufacturing assay and quality control dossiers ) m anufacturing formulae, processing specifications, sales and marketing mate rials and technology relating to or concerned with the Product and/or the Finishe d Product whether in written, electronic or other form including without limitation the Product Data and the Manufacturing Technology ; means all methods, processes, designs, data, proced ures and other information relating to the manufacture of the Product, includi ng without limitation final quality assurance procedures, manufacturing procedu res, product and raw material specifications, formulation data and other technology related thereto ; means the approval by the EMEA numbered EU/1/01/187 /001 permitting the commercial marketing of the Product in the countrie s of the Territory listed in Part A of Schedule VII for the intrathecal treatmen t of lymphomatous meningitis ; means the plan for the marketing, distribution and sale of the Finished Product in the Territory submitted to the Committee in accordance with Claus e 4 ; means the event identified in Schedule III which tr iggers a one - off Milestone Payment ; means each one - off payment by [COMPANY] to Skye i dentified in Schedule III which is triggered by a Milestone Event ; means the use of the Product for the treatment of n eoplastic meningitis ; 6 means total gross sales of Finished Product invoice d by [COMPANY], its Affiliates, sub -distributors and sub -licensees to Third Parties, less : ( a ) transport, freight and insurance costs ; ( b ) sales and excise taxes and duties ; ( c ) normal and customary trade, quantity and cash discounts and rebates ; ( d ) amounts repaid, discounted or credited by reason of ( i ) retroactive price reductions ; ( ii ) discounts ; or ( iii ) rebates which are, in any case, imposed upon [COMPANY], its Affiliates, sub - licensees or sub - distributors by any governmental or non - governmental body with the auth ority to impose such price reductions, discounts or rebates ; ( e ) billing errors ; and ( f ) amounts repaid or credited ( other than in respect of outdated goods ) for rejected, returned or recalled goods ; means any patent and patent application ( including provisional and non - provisional applications ) that may be issued or iss ue in any country, including all additions, divisions, confirmations, continuati ons - in - part, substitutions, re - issues, re - examinations, extensions, registrations, patent terms extensions, supplementary protection certificates and renewals of any of the above ; 7 means the phase IV clinical trial entitled Skye 0101 -010 ; means grant of all necessary pricing and reimbursem ent approvals by a regulatory, governmental or non - governmental author ity in any country of the Territory ; means the Depofoam formulation of cytarabine ( a sustained rel ease formulation of cytarabine ( ara -C ) a pyrimidine analogue ( L01BC01 ) ) ; means all data, information or results generated in the performance of any clinical studies, non - clinical studies ( including p harmacological and toxicological studies ) or chemistry and analytical studies in respect of the Product conducted by or on behalf of either party w hether before or after the Effective Date ; means a three month period ending on the last day o f March, June, September or December in any Year ; means the grant of all necessary regulatory and gov ernmental approvals by a regulatory authority or other governmental body req uired to sell the Finished Product in any country of the Territory including, without limitation, the Marketing Authorisation but excluding Pricing Appro val ; means any competent regulatory authority or other g overnmental body ( for example, but not by way of limitation, the EMEA ) re sponsible for granting Regulatory Approval in the Territory ; means all Intellectual Property owned by or in the possession or control of Skye at any time during the Term relating to the Product or Finished Product ( including any Improvements ) ; 8 means those Patents set out in Schedule I and such other Patents as come into existence during the Term and relate to the Product or Finished Product ( including any Improvements ) ; means the Skye Patents and Skye IP ; means the agreement between Skye and [COMPANY] Me dical Company for the manufacture and supply of the Finished Product by Skye ; means the term of this Agreement as set out in Clause 15 ; means each of the countries and territories listed or referred to in Schedule VII ; means any company, corporation, firm, individual or other entity but excluding a party to this Agreement or an Affiliate ; means those trade marks registered or applied for s et out in Schedule II and such other trade marks as are agreed between the pa rties from time to time ; means a [ * * ] vial containing the Product ; and means a calendar year