definiens: means the direct or indirectownership of more than fifty percent ( 50 % ) of the voting stock orother voting interests or interest in the profits of the Party;Agreementmeans this Agreement;Alliance Managermeans the individual appointed by each Party as the principalpoint of contact for communication between the Parties under thisAgreement and appointed in accordance with Clause 2.1.3;Alpine Background IPmeans all Intellectual Property Rights that ( a ) are Controlled byAlpine or its Affiliates as of the Effective Date, or ( b ) created ordeveloped by Alpine or its Affiliates during the Term other than inthe performance of this Agreement;Alpine Foreground IPis defined in Clause 10.1.2(b);Alpine Indemniteesis defined in Clause 14.1;Alpine Licensed IPmeans any of the Alpine Background IP, Alpine Foreground IP orJoint Foreground IP co - owned by Alpine, subject to Clause 6.6,which either ( a ) [ * * * ] ; or ( b ) [ * * * ] ; Alpine Patentsmeans the Patents set out in Exhibit 6;Alpine Platform Technologymeans the platform technology created or developed by Alpineoutside of the performance of this Agreement, whether prior to orafter the Effective Date, including its [ * * * ] ; Anticorruption Lawsis defined in Clause 17.1.1;Applicable Lawsmeans all applicable international, multinational, national, regional, state, provincial and local laws, rules, regulations, ordinances, declarations, requirements, directives, guidance, policies and guidelines which are in force during the Term and inany jurisdiction in which any Clinical Trial or other activity underthis Agreement is performed or in which any Product ismanufactured, sold or supplied to the extent in each caseapplicable to any Party to this Agreement, including, asapplicable to activities hereunder, the regulations and2CONFIDENTIAL – FINAL regulatory guidance promulgated by the FDA, the ConsolidatedGuidance E6 on Good Clinical Practice adopted by theInternational Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for HumanUse, as ratified by the FDA and the Clinical Trials Directive(Directive 2001/20 / EC of 4th April 2001 ) and the respectiveimplementing legislation, the conditions and requirementsimposed by the related ethics committee and any of the foregoingwhich relate to ethical business conduct, the import or export ofgoods, technical data or other items, and data protection andprivacy rules, as any of the foregoing may be amended from timeto time;Background IPmeans, as applicable, the Alpine Background IP and theAdaptimmune Background IP;Biosimilarmeans any drug or biological product that is subject to reviewunder an abbreviated approval pathway as a biosimilar, follow - onbiologic or generic biological product, as those terms arecommonly understood under the FD&C Act or the PHS Act andrelated rules and regulations, or the corresponding or similar laws, rules and regulations of any other jurisdiction and where suchdrug or biological product obtains Regulatory Approval based on, or in part on, reference to any data or Regulatory Approvalapplicable to a Product hereunder;Bona Fide Internal Programis defined in Clause 3.1.3;Change of Controlmeans with respect to a Party, ( a ) the sale or disposition to aThird Party of all or substantially all of the business or assets ofsuch Party to which the subject matter of this Agreement relates, including all of or substantially all of the Licensed IP under whichsuch Party has granted rights to the other Party under thisAgreement ; or ( b ) ( i ) the acquisition by a Third Party of more thanfifty percent ( 50 % ) of the issued voting shares or stock in suchParty, or ( ii ) the acquisition, merger or consolidation of such Partywith or into a Third Party