definiens: or means, with respect to any party, any entity, dir ectly or indirectly, controlling, controlled by or under common control with such party, for only so long as such control exists . For purposes of this definition, means ( i ) in the case of an entity that is a corporate entity, direct or indirect ownership of more than fifty percent ( 50 % ) of the stock or shares having the right to vote ( or such lesser percentage which is the max imum allowed to be owned by a foreign corporation in a particular juri sdiction ) for the election of directors of such entity, or ( ii ) in the case of a person or an entit y that is not a corporate entity, t he possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of vo ting securities, by contract or otherwise ; and the terms, or shall have the meanings correlative to the foregoing ; 1.1.2 means the announcement in agreed form between the Seller and the Buyer as set out in SCHEDULE 11 ; 1.1.3 means all laws, ordinances, rules and regulations applicable to the development, manufacture, placing on the market of the Product and the obligations of the Seller or the Buyer, as the context requires under this Ag reement, including, without limitation, ( i ) all applicab le federal, state and local laws and regulations ; ( ii ) the U.S. Federal Food, Drug and Cosmetic Act ; ( iii ) the EU Commission Directive 200 1/83 / EC of 6 November 2001 ( as amended ) on the Community Code Relating to Medicinal Product s for Human Use, as well as national laws of European Member States implementing such aforeme ntioned Community Code ; ( iv ) cGMPs ; and ( v ) any other requirements by any other Health Authority, government or governmental agency ; PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 5 OF 70 CONFIDENTIAL 1.1.4 means both : ( a ) the asset purchase agreement entered into between ( 1 ) EpiCept, ( 2 ) Maxim Pharmaceuticals, Inc. and ( 3 ) the Seller dated 18 J une 2012 relating to the purchase of the Purchased Assets ( as defined in the Asset Purchase Agreement ) ; and ( b ) the asset purchase agreement entered into between ( 1 ) EpiCept, ( 2 ) EpiCept GmbH and ( 3 ) the [COMPANY] AB dated 18 June 2012 relating to the purchase of the Purchased Assets ( as defined in the Asset Purchase Agreement ) ; 1.1.5 means the members of the Seller Group that own an y of the Assets immediately prior to Completion, or for the purposes of the Sel ler Warranties, the members of the Seller Group that own any of the Assets as at Completion ; 1.1.6 means the assets, rights, and license rights of t he Business held by the Seller Group Companies, including the Business Intellectual Prop erty, the Goodwill, the Documentation, the Domain Names, the [COMPANY] Know -How and the [COMPANY] Improvements ; 1.1.7 means the form of notice to be sent to the third parties who are parties to the Contracts as set out in SCHEDULE 13 ; 1.1.8 means the business of the respective Asset Seller s as carried on by those Asset Sellers on the date of this Agreement, comprising or relati ng to the development, manufacture, distribution, marketing and/or commercialisation of Ceplene and / or the Product in the Territory ; 1.1.9 means any day which is not a Saturday, a Sunday or a bank or public holiday in England, Luxembourg or Sweden ; 1.1.10 means all of the information relating to customer s and suppliers including price lists, in each case to the extent t hat such information rela tes to the Business and/or Assets, together with all documents material to the Business Intellectual Property and all documented Know- How which is material to the Business and/or the As sets, including any related regulatory files and/or regulatory informat ion, but excluding the Retained Information ; 1.1.11 means the Intellectual Property concerning the Pr oduct and/or the Business which is owned by an Asset Seller, and which is used and/or exploited or intended to be used or exploited by or on behalf of an Asset Seller in or in connection with the Product and / or the Business ( including the Registered Int ellectual Property ) ; 1.1.12 means all the obligations and Liabilities that re late to or arise in respect of or are connected to the Business or the Assets o r use or ownership of the Assets or acts or omission in relation thereto, whether derived from contract, law or otherwise, and arising after Completion and means any of them ; 1.1.13 means information in any form exclusively relatin g to the Business, ( including future plans and business deve lopment ), but does not include information which : PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 6 OF 70 CONFIDENTIAL ( a ) is publicly known at the Completion Date or which s ubsequently becomes publicly known ( other than in either case as a result of a b reach of the provisions of the Confidentiality Agreement, Clause 19 ( Confidentiality ) of this Agreement or a Transaction Document by a Seller Group Company ) . A compilation of otherwise public information in a form not publicly known is to be r egarded as not publicly known ; ( b ) the Seller can show was made known to it after the Completion Date by a person unconnected with a Buyer Group Company who was enti tled to do so ( and not in breach of an obligation of confidence ) and who did not imp ose an obligation of confidence or restricted use ; or ( c ) the Seller or an Asset Seller has retained or acquired exclusive rights in under a Transaction Document ; 1.1.14 means the group of corporate Affiliates comprisin g the Buyer, any person which is from time to time a subsidiary undertaking of th e Buyer, a parent undertaking of the Buyer, any other subsidiary undertaking of Buyer ’s parent undertaking, and the respective Affiliates of any of the aforesaid ; 1.1.15 means any entity included in the Buyer Group ; 1.1.16 means a statement set o ut in SCHEDULE 7 ; 1.1.17 means any chemical composition comprising or cont aining histamine dihydrochloride ( 2 -(3H -imidazol -4 - yl ) ethylnamine dihydrochloride ) ; 1.1.18 means the Ceplene trademarks that are identified in S CHEDULE 2, Part 1 ; 1.1.19 means a claim arising under or in respect of a Tr ansaction Document ; 1.1.20 means the Good Manufacturing Practices as set out in Directive 2003/94 / EC, together with the gu idance for interpretation of the principles and gui delines of good manufacturing practices for medicinal products for human use ; 1.1.21 means the Completion of the sale and purchase of the Business and Assets in accordance with this Agreement ; 1.1.22 means the date of this Agreement ; 1.1.23 means the agreement dated 2 February 2016 between the Buyer and the Seller in which, amongst other things, the Buyer has agreed to keep confide ntial certain information relating to the Business and the Seller ; 1.1.24 means those contracts in SCHEDULE 4 ; 1.1.25 means consent, waiver, authorisation, appeal or n otice ; 1.1.26 means the agreement dated 18 June 2012 between ( 1 ) EpiCept, ( 2 ) EpiCept GMBH and ( 3 ) [COMPANY] AB ; PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 7 OF 70 CONFIDENTIAL 1.1.27 means all personal data ( as defined in the Data P rotection Directive ) of patients and any other individuals which is transfe rred to the Buyer under the terms of this Agreement ; 1.1.28 means the data stick containing the Disclosure Bu ndle documents ; 1.1.29 has the meaning given to it in Clause 6.1.1 ; 1.1.30 has the meaning given to it in Clause 6.1.1 ; 1.1.31 means the documents listed at APPENDIX 1 to the Disclosure Letter ; 1.1.32 means the letter described as such, from the Seller to the Buyer dated the Completion Date ; 1.1.33 means : ( i ) all Regulatory Documentation ; and ( ii ) the Dossier and all material documents, records and files ( including, without li mitation, all computer readable mater ial ) reflecting or incorporating the same, to the extent, in respect of the Business, that the same relates to the Product in the Territory ; 1.1.34 means the internet domain names set out in SCHEDULE 2, PART 3 ; 1.1.35 means in respect of the Product, the registration file required to obtain, support and maintain the respective Marketing Authorisation in the relevant Territory ( comprising modules 1 to 5 according to the Volume 2B of the Notice to Applicants, Medicinal products for human use, or any formats equivalent thereto in any other relevant jurisdiction ) and any variations, notifications or renewal documentation ; 1.1.36 the amount ( if any ) due for payment by the Sellers ( or any of them ) to the Buy er in respect of a Claim that has been Resolved ; 1.1.37 means 00:01 a.m. ( GMT ) on the Completion Date ; 1.1.38 means a charge, debenture, mortgage, pledge, lien, security interest, title retention, assignment, restriction, right of first refusal, option, right of pre- emption or other third party right or interest of any kind, whether grante d for the purpose of security or not ; 1.1.39 means EpiCept Corporation, a corporation organise d under the laws of the State of Delaware, USA having its principal offices at 777 O ld Saw Mill River Road, Tarytown, New York, 10591 USA ; 1.1.40 means the supply agreement dated 29 March 2010 be tween EpiCept and [COMPANY] AB in respect of the Business for the manufacture a nd supply of the Finished Product ( as defined in the EpiCept Supply Agreement ) ; 1.1.41 means $ 5,000,000 ; 1.1.42 has the meaning given in Clause 3.3.1 ; 1.1.43 means all of the goodwill associated with the Bus iness ; 1.1.44 means any government, any state or other politica l subdivision thereof, any entity exercising executive, legislati ve, judicial, regulatory or administrative functions of or pertaining to government or any oth er authority, agency, department, board, commission or instrumentality of any jurisdiction, and any court, tribunal or arbitrator(s ) of competent jurisdiction ; PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 8 OF 70 CONFIDENTIAL 1.1.45 means any officer or employee of a government or any department, agency, or instrumentality thereof, or of a public international organization, or any person acting in an official capacity for or on behalf of any suc h government or department, agency, or instrumentality, or for or on behalf of any such pu blic international organisation ; 1.1.46 means a public authority or government agency res ponsible for exercising autonomous authority in respect of medicines for hu man use in a regulatory or supervisory capacity in any jurisdiction ; 1.1.47 shall mean tangible and intangible data, techniqu es, processes, technology, practices, trade secret, inventions ( whether patent able or not ), methods, knowledge, Know- How, skil l, experience, test data and results ( including, wi thout limitation, pharmacological, toxicological and clinical test data and results ), analytical and quality control data, results, descriptions and compositions of matter ; 1.1.48 means all intellectual property rights in any par t of the world including : ( a ) patents, utility models, rights in inventions, regi stered and unregistered trade and service marks, supplementary protection certificates rights in business and trade names and get -up, rights in domain names, registered designs, unr egistered rights in desi gns, copyrights and neighbouring rights, database rights, rights in Know- How, and, in each case, rights of a similar or corresponding character ; and ( b ) all applications and rights to apply for the protec tion of any of the rights referred to in paragra ph ( a ) above ; 1.1.49 means all Product, consisting of any raw material s, works in progress, goods consigned by an Asset Seller, finished goods, packa ging, supplies and labels ( including any of the foregoing held for the benefit of the Busin ess in the possession of third party manufacturers, suppliers, dealers, distributors or others in trans it ) held anywhere in the world for resale or licens e by the Business in the Territory or incorporated in to or consumed in connection with such goods and materials ; 1.1.50 means the amount allocated for the value of Inven tory for the Business ; 1.1.51 means each licence, permission, consent, undertak ing, settlement, agreement, restriction and arrangement relating to the Business Intellectual Property or relevant to its use or exploitation in, or in connection wit h, the Business ; 1.1.52 means the deeds of assignment conveying the Ceple ne Trademarks and the [COMPANY] Patents to the Buyer as set out in SCHEDULE 12 ; 1.1.53 means trade secrets, confidential information, kn ow - how, technical or commercial knowledge and manufacturing or business processes, methods and procedures ; PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 9 OF 70 CONFIDENTIAL 1.1.54 means any and all debts, liabilities, guarantees, assurances, commitments, costs, expenses and obligations, whether accrued or not ac crued, fixed, known or unknown, absolute or contingent, asserted or unasserted, mature d or unmatured, liquidated or unliquidated, due or to become due, or determined or determinable, whene ver or however arising ( including whether arising out of any contract or tort, other Applicab le Law or related to taxes payable by a person ) ; 1.1.55 means all losses, damages costs ( including proper ly and reasonably incurred legal costs and expenses ), charges, expenses, actions, proceedi ngs, claims, interest, fines, penalties, awards, judgments, settlements and demands whether or not r easonably foreseeable or avoidable ; 1.1.56 or means the approval, registration, license or auth orisation issued by the competent Health Authority for the pu rpose of permitting the placing on the market and marketing of a Product i n a specific territory after evaluation for safety, efficacy and quality, being Marketing Authorisation No . EU/1/08/477/001 ; 1.1.57 means a Solna Municipality company organised and existing under the laws of Sweden, registered at the Swedish Companies Registr ation Office under number 556529- 4773 having its principal offices at Box 906, SE -170 09, Solna, Sweden ; 1.1.58 means any and all developments, inven tions discoveries, information and/or data relating to the [COMPANY] Patents, the Produ cts or the [COMPANY] Know- How developed or acquired by the Seller or any of its Affiliates ; 1.1.59 means all Information owned by the Seller, or any of its Aff iliates and/or any Asset Seller that is necessary and/or useful fo r the registration, regulatory approval, development, manufacturing, promotion, marketing, s ale and/or distribution of the Product in the Territory ; 1.1.60 means the patents set out in Schedule 2 Part 2 an d any patents owned by the Seller or any of its Affiliates and/or any Asset Se ller that, in the absence of a licence thereunder, would be infringed by the development, use, sale, o ffer for sale or import o f the Product in the Territory ; 1.1.61 means a member state of the European Union ; 1.1.62 means the designation by a competent authority of the Product for diagnosis, prevention or treatment of life - threaten ing or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the Eur opean Union ( EU ), being the Orphan Drug Designation No . EU/3/05/272 ; 1.1.63 has the meaning given to it in Clause 6.2.2 ; 1.1.64 means a Fixed Payment Date or the date that an Ea rn Out Payment is due in accordance with SCHEDULE 10 ; 1.1.65 means Cytovia Inc., a company incorporated under the laws of Delaware ( reg . no . 2844245 ), whose principal place of business is at 430 East 29 th Street, Suite 940, New York, NY 10016 ; 1.1.66 means a pharmaceutical product that is or contain s Ceplene and line and label extensions thereof, including, without limitation, all composition, formulation, routes of administration and other [COMPANY] Improvements made or acquired by the Seller or its Affiliates and/or any Asset Seller ; PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 10 OF 70 CONFIDENTIAL 1.1.67 means the purchase price for the Assets to be pai d in accordance with Clause 3.3 ; 1.1.68 means all debts ( including, in addition, VAT if a pplicable ) due and payable to a Seller Group Company in respect of the Business up to and including the Completion Date ; 1.1.69 means the [COMPANY] Patents and the Ceplene Trademarks ; 1.1.70 means any and all existing regulatory application s and approvals concerning the Products in the Territory, including MAs, as detailed in S CHEDULE 3 on a country - by- country basis, and all material documents, records and files ( including all computer reada ble material ) relating to their filing, prosecution, issuance, renewal, maintenance, enforcement and/or defense, and all material corres pondence with the Health Authorities in this regard ; 1.1.71 has the meaning given to it in Clause 3.6.1 ; 1.1.72 means copies of the Dossier and the Documentation and all Tax, accounting, financial and other records of a Seller Group Company which relate to the Business and which a Seller Group Company is required by law to retain a fter Completion ; 1.1.73 an arm ’s length sale of the Product to a third pa rty who is not an Affiliate of the Buyer ; 1.1.74 means all packaged Product ; 1.1.75 means information in any form relating to the property, rights and assets of the Business which does not co me within the definition of Assets ( including future plans and business development ), but does no t include information which : ( a ) is publicly known at the Completion Date or which subsequently becomes publicly known ( other than in either case as a result of a b reach of the provisions of the Confidentiality Agreement, Clause 19 ( Confidentiality ) of this Agreement or a Transaction Document by a Buyer Group Company ) . A c ompi lation of otherwise public information in a form not publicly known is to be r egarded as not publicly known ; ( b ) the Buyer can show was made known to it after the C ompletion Date by a person unconnected with a Seller ’s Group Company who was e ntitled to do so ( and not in breach of an obligation of confidence ) and who did not imp ose an obligation of confidence or restricted use ; or ( c ) the Buyer has retained or acquired exclusive rights in under a Transaction Document ; 1.1.76 means the group of corporate Affiliates comprising the Se ller, any person which is from time to time a subsidiary undertaking of th e Seller, a parent undertaking of the Seller, any other subsidiary undertaking of Seller ’s parent undertaking, and the respective A ffiliates of any of the aforesaid ; PROJECT CEPLENE APA ( E XECUTION VERSION ) PAGE 11 OF 70 CONFIDENTIAL 1.1.77 means any entity included in the Seller Group ; 1.1.78 means Hogan Lovells International LLP of Atlantic House, Holborn Viaduct, London, EC1A 2FG ; 1.1.79 means any of the warranties of the Seller set for th in SCHEDULE 6 ; 1.1.80 has the same meaning as in the Transitional Services Agreement ; 1.1.81 means all forms of tax, levy, impost, contributio n, duty, liability and charge in the nature of taxation and all related withholdings or deducti ons of any nature whether of the United Kingdom or elsewhere a nd all related fines, penalties, charges, costs and interest ; 1.1.82 means a taxing or other governmental ( local or ce ntral ), state or municipal authority ( whether within or outside the United Kin gdom ) competent to impose a liability for or to collect Tax ; 1.1.83 means that certain agreement in the form attached hereto as SCHEDULE 15, to be entered into and a duly executed copy there of delivered to Buyer on the date of this Agreement, to terminate the EpiCep t Supply Agreement and the Cooperation Agreement and to bar any parties to the Asset Purchase Agreem ent from bringing any claims under such agreement from the Completion Date and waiving all claims they may have in respect of the period prior to the Comple tion Date ; 1.1.84 means those countries listed in SCHEDULE 1 ; 1.1.85 means a transaction that : ( a ) relates to or is entered into in connection with th e sale by the Seller and the purchase by the Buyer of the Assets in respect of the Business ; and ( b ) is contemplated in a Transaction Document ; 1.1.86 means : ( a ) this Agreement ; ( b ) the Disclosure Letter ; ( c ) the Termination Agreement ; and ( d ) the Transitional Services Agreement ; 1.1.87 means the transitional services agreement of even date herewith between [COMPANY] AB ( Solna ) and the Preferred Guarantor in respect of the Business for the provision of certain distribution services, in th e form attached hereto as SCHEDULE 14 ; 1.1.88 has the meaning ascribed to such term in Clause 18.1 ; 1.1.89 means the period commencing on the Completion Dat e and ending upon the first to occur of ( a ) termination of this Agreement ; or ( b ) completion of the exhaustive transfer of all Assets to the Buyer