definiens: means all existing and available technical inform ation, know - how and data, including inventions ( whether patentable or not ), discoveries, trade secrets, specifications, instructions, proc esses and formulae, including all biological, chemical, p harmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data ; means the agreement for the production of ready t o fill formulation on the declaration of a pandemic entere d into by LEK 10 Pharmaceuticals d.d ., [COMPANY] AG and [COMPANY] Vaccin es and Diagnostics AG on or about 23 October 2014 ; means all liabilities, claims, damages, proceedin gs, demands, orders, suits, costs, losses and expenses of every description, whether deriving from contract, common law, statute or otherwise, whether present or future, actual or contingent, as certained or unascertained or disputed and whether owed or incurred severally or jointly or as princip al or surety ; means the Properties located in Liverpool at whic h the Business undertakes Manufacturing activities ; has the meaning given to it in Clause 2.6.1 ; has the meaning given to it in Clause 4.4 ; means all losses, liabilities, costs ( including l egal costs and experts ’ and consultants ’ fees ), charges, expenses, actions, proceedings, claims and demands ;, or means the planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehous ing, quality control testing, waste disposal, quality re lease, sample retention and stability testing of pr oducts ; means any packed inventory of Products that is : ( i ) in finished form ; ( ii ) beneficially owned by any member of the Seller ’s Group ; ( iii ) held at a Property or outside of a Property where secondary packaging is undertaken ; a nd ( iv ) not yet released by a qualified person of t he Seller ’s Group ; and excluding in each case, for the avoidance of doubt, any In - Market Inventory and Manufacturing Stocks ; means, as at Closing, all stocks of raw materials, active pharmaceutical ingredients, ingredients, adjuvants, drug substance s, intermediates, packaging materials, components, devices and other production and pre - production con sumables and work - in - progress that are beneficially owned by any member of the Seller ’s Group for use i n the Manufacture of Products, Products Under Registration or Pipeline Products ; means the premises leased by the Seller, a member of the Seller ’s Group or a member of the Flu Group and which are located in Marburg ( Germany ) in which the Flu Group undertakes the manufacture of MF59 ® adjuvant ; means the existing dossiers in the Seller ’s Group possession or control containing the relevant Know - How used by th e Seller and/or its Affiliates to obtain and mainta in the Marketing Authorisations ; means the manufacturing, supply and distribution agreement pending transfer of the Marketing Authori sations to be entered into at Closing in the Agreed Terms ; means the marketing authorisations issued or appl ications for marketing authorisations with respect to the Products, Pipeli ne Products and Products Under Registration and all supplements, amendments and revisions thereto ; means any event, occurrence, fact, condition, cha nge or effect that has had or would have a materially adverse effect on the bu siness, financial condition 11 or results of operations of the Flu Group taken as a whole ( other than on a short term, cyclical or temporary basis ), except to the extent caused by : ( i ) the transactions contemplated by this Agreement and the Ancillary Agreements and the announcement a nd consummation thereof ; ( ii ) changes in law, regulation or accounting standards, principles or i nterpretations thereof applicable to the Business ; ( iii ) changes generally applicable to financial, ec onomic, political or similar conditions ( including acts of war, declared or undeclared, armed hostilities a nd terrorism ) or to financial, securities, commodit ies or other market conditions or prevailing interest r ates ; ( iv ) changes generally applicable in the indu stry in which the Business operates ; or ( v ) any matters disclosed in this Agreement, the Ancillary Agreements, the Disclosure Letter or the Data Room ( other than any such matters which would not as at the date of this Agreement have constituted a Mater ial Adverse Effect but which subsequently develop in such a manner as to constitute a Material Advers e Effect as a result of an event or occurrence afte r the date of this Agreement which could not reasonably h ave been anticipated at the date of this Agreement ) ; means the United Kingdom, the United States of Am erica, Italy and Switzerland ; means information relating to clinical and techni cal matters, such as therapeutic uses for the approved indications, drug - disease inf ormation, and other product characteristics Exclusively Related to the Business ( including the Products, Pipeline Products and Products Under Registration ) which is owned or in the possession o f the Seller and/or its Affiliates as of the Closin g Date other than information which the Seller and/or its Affiliate is required by Applicable Law to ret ain ; means the Intellectual Property Rights owned by the Seller ’s Group comprised within the MF59 ® Right s that are Exclusively Related to the Business ; means the Contracts held by the Seller ’s Group relating to the Intellectual Propert y Rights comprised within the MF59 ® Rights that are Exclusively Related to the Business ; means the manufacturing and supply agreement for the supply of MF59 ® adjuvant to the Seller and/or i ts Affiliates to be entered into at Closing in the Agreed Terms ; means the Intellectual Property Rights owned by t he Seller ’s Group comprised within the MF59 ® Rights ex cluding the MF59 ® Flu Specific Intellectual Property Rights, including the Intellectual Propert y Rights set out in Schedule 23 ; means the Contracts held by the Seller ’s Group relating to the Intellectual Property Rights comprised within the MF59 ® Rights excluding the MF59 ® Flu Specific Intellectual Property Rights Con tracts ; means all rights in the MF59 ® adjuvant owned by o r licensed to the Seller ’s Group including : ( i ) all stocks of the adjuvant and mater ials used in its production ; ( ii ) all Intellectual Property Rights in and relating to the MF59 ® adjuvant ; and ( iii ) all Intellectual Property Rights in and relati ng to the manufacture and production or fill finish proce ss relating to the MF59 ® adjuvant ; 12 has the meaning given to it in the Netherlands Of fer Letter ; means the Assumed Liabilities to the extent they relate to the Netherlands Business, excluding always the Excluded Liabilities ; means that part of the Flu Group, comprising : ( i ) the Flu Group Businesses as conducted in the Nether lands ; ( ii ) the Netherlands Assumed Liabilities ; ( iii ) the Netherlands Employees ; and ( iv ) any other assets that are exclusively related to th e Flu Group Business as conducted in the Netherlands ; has the meaning given to it in the Netherlands AP A ; means the Employees employed in the Netherlands B usiness ; means the letter from the Purchaser to the Seller in respect of the binding offer from the Purchaser to acquire the Netherlands Business dated on or around the date hereof ; has the meaning given to it in the Netherlands Of fer Letter ; has the meaning given to it in paragraph 2.21.4 o f Schedule 16 ; has the meaning given to it in Clause 15.11.1 ; means all Information Technology of any Flu Group Company to the extent Exclusively Related to the Business ; means the Contracts Exclusively Related to the Bu siness which relate to Intellectual Property Rights and th at are held by the Flu Group Companies ; means the Intellectual Property Rights of any Flu Group Company to the extent Exclusively Related to the Bu siness ; means patents, design patents, patent application s and any reissues, re - examinations, divisionals, continuations, continuations - in - part, provisionals, and extensions thereof or any counterparts to any of the foregoing ( including rig hts resulting from any post - grant proceedings relat ing to any of the foregoing ) ; means, in relation to a Product Approval or Produ ct Application, the date upon which the relevant Governmental Entity approves and notifies the Product Approval or Product Application ( as applicable ) naming the Purchaser or the relevant Affiliate of the Purchaser ( or design ee thereof ) as the holder of such Product Approval or Product Application in the relevant country or territory covered by that Product Approval or Produ ct Application ; means the Chiron UK Pension Scheme ; has the meaning given to it in paragraph 4.15.1 o f Schedule 16 ; means : 13 ( i ) Encumbrances for Taxes, assessments and charges or levies of any Governmental Entity not yet delinquent or for which adequate reserves are maint ained on any financial statements ( including management accounts ) relating to the Business, wher e such financial statements have been made available to the Purchaser ; ( ii ) Encumbrances imposed by Applicable Law ; ( iii ) Encumbrances imposed in the ordinary course of busi ness which are not yet due and payable or which are being contested in good faith ; ( iv ) Encumbrances which are listed in Schedule 6 ; ( v ) except with respect to the Transferred Real Propert y, pledges or deposits to secure obligations under Applicable Law relating to workers ’ compensat ion, unemployment insurance or to secure public or statutory obligations ; and ( vi ) except with respect to the Transferred Real Propert y, liens, title retention arrangements or deposits to secure the performance of bids, trade c ontracts ( other than for borrowed money ), conditional sales contracts, leases, statutory obli gations, surety and appeal bonds, performance bonds and other obligations of a like nature incurr ed in the ordinary course of the Business ; means : ( i ) each product in development by the Business set out under the heading in Paragraph C of Part 2 of Schedule 7 ; and ( ii ) any other product in development which is Exclusive ly Related to the Business ; means all permits, licences, certificates, cleara nces, registration or other authorisations or consents issued by any Government al Entity to the Seller or one of its Affiliates in relation to the research and development of Pipelin e Products ; means exclusively or predominantly related to, or used or held for use exclusively or predominantly in connec tion with, the Business ; means all applications for Product Approval filed with respect to Products Under Registration, with each individual applicatio n being a ; means all permits, licences, certificates, cleara nces, registrations or other authorisations or consents, including any Marketing Authorisations, issued by any Governmental Entity to the Seller or one of its Affiliates with respect to the Products or the use, research, development, marketing, distribution or sale thereof ; means : ( i ) the products set out under the heading i n paragraph A of Part 2 of Schedule 7 ; and ( ii ) any other products Exclusively Related to the Busin ess ; means : ( i ) the products set out under the heading in paragraph B of Part 2 of Schedule 7 ; and 14 ( ii ) any other product under registration Exclusively Re lated to the Business ; means the Company Real Properties, the Transferre d Real Properties and the Marburg MF59 ® Premises and means any one of them ; means all confidential and proprietary informatio n of the Seller or its Affiliates that is Exclusively Related to the Busin ess, including confidential Medical Information, confidential Know How and confidential Commercial I nformation ; means the preparation, filing, prosecution and ma intenance of the Flu Group Intellectual Property Rights, and any re - exam inations, re - issues, interference actions, oppositi ons or other similar proceedings before national or sup ranational patent offices . For the avoidance of dou bt, Prosecution and Maintenance shall exclude the enfor cement or defence of Flu Group Intellectual Property Rights in any U.S. federal court or any fo reign counterpart thereof or before any internation al trade commission panel ; has the meaning given to it in Clause 3.1 ; means the account notified by the Seller to the P urchaser no later than 5 Business Days prior to the Closing Date ; means the agreement between the Seller and/or one or more of its Affiliates and the Purcha ser and/or one or more of its Affiliates in the Agr eed Terms, to be entered into on Closing, in respect of the grant of licences from the Seller ’s Group ( oth er than a Flu Group Company ) to the Purchaser ’s Group of certain Intellectual Property Rights ; means the Purchaser and its Affiliates from time to time ; means Xxxxx & XxXxxxxx LLP, of 000 Xxx Xxxxxx Xxx xxx, Xxxxxx, XX0X 0XX, Xxxxxx Xxxxxxx ; means Intellectual Property Rights that are regis tered, issued, filed, or applied for under the authority o f any Governmental Entity ; means all Flu Group Intellectual Property Rights that are Registered Intellectual Property Ri ghts ; means the Business Sellers and such other members of the Seller ’s Group who employ the Relevant Flu Business Employees ; has the meaning given to it in paragraph 5.1 of S chedule 9 ; means the relevant part of the Shared Business Co ntracts which relates exclusively to the Business ( or the relevant part of the Business that is transferred to the Purchaser at Closing ) ; means : ( i ) any Liabilities assumed by the Purchas er or a member of the Purchaser ’s Group as contemplate d by Schedule 9 ; and ( ii ) any Transferred Employee Benefit Liabilities which the Purchaser ag rees to assume in accordance with Schedule 10 ; has the meaning given to it in Clause 8.4.2 ; 15 means the Flu Business Employees immediately prio r to the Closing Date and means any one of them ; means the Flu Group Company Employees immediately prior to the Closing Date and means any one of them ; means any loss, relief, allowance or credit in re spect of any Tax and any deduction in computing Income, Profits or Gains for the purposes of any Tax ; has the meaning given to it in Clause 2.3.4 ; means an internationally recognised and independe nt firm of accountants who does not act as auditor to the Seller or the Pu rchaser, to be agreed by the Seller and the Purchas er within seven days of a notice by one to the other r equiring such agreement or, failing such agreement, to be nominated on the application of either of them b y or on behalf of the Institute of Chartered Accountants of England and Wales ; has the meaning given to it in Clause 4.1.1 ; has the meaning given to it in paragraph 2.16.6 o f Schedule 16 ; means any of the Trademarks ( including in either or both logo and local script form ),, and use d either alone or in combination with other words or marks ; means any counterparty to a development, contract research, commercialisation, manufacturing, distribution, sales, marketing, supp ly, consulting or other collaboration Contract with the Seller or any Affiliate of the Seller ; means the Seller and its Affiliates from time to time ; means all insurance policies ( whether under polic ies maintained with third party insurers or any member of the Sell er ’s Group ), other than Flu Group Insurance Policie s, maintained by the Seller or any member of the Selle r ’s Group in relation to the Flu Group or under which, immediately prior to Closing, any Flu Group Company or the Seller or member of the Seller ’s Group in relation to the Flu Group Businesses is en titled to any benefit, and means any one of them ; means, from time to time, all businesses of the S eller ’s Group, excluding the Business ; has the meaning given to it in Clause 9.1.4 ; means Linklaters LLP, of Xxx Xxxx Xxxxxx, Xxxxxx, XX0X 0XX, Xxxxxx Xxxxxxx ; means the warranties given by the Seller pursuant to Clause 9 and Schedule 16, and means any one of them ; means the members of the Seller ’s Group ( other th an the Flu Group Companies ) that own any Shares ; means any Contract which relates both : 16 ( i ) to the Business or any part of the Business to be t ransferred to the Purchaser at Closing ; and ( ii ) to any part of the Seller ’s Group Retained Business ( as at the date of this Agreement ), any product other than the Products, Pipeline Products or Products Under Registration, or any Excluded Asset, and to which a member of the Seller ’s Group is a pa rty or in respect of which a member of the Seller ’s Group has any right, liability or obligation at Clo sing, and shall mean any of them ; means the shares in the capital of any Flu Group Company ( other than the Subsidiary ) ; means agreements and arrangements relating to the business and activities of the Sinergium Consortium, including agreements a nd arrangements between : ( i ) any of the Sinergium Consortium Members ; ( ii ) any of the Sinergium Conso rtium Members ( and/or the Sinergium Consortium ) and the Argentinian Ministry of Health ; and ( iii ) any member of the Seller ’s Group and any Sinergium Consortium Member ( and/or the Sinergium C onsortium ) ; means the members of Sinergium Biotech - Consorci o de Cooperación ( taken together, the ), who as at the date of this Agreement are [COMPANY] Argentina, S.A., Biogénesis Bago, S.A., La boratorio ELEA S.A.C.I.F. y A. and Sinergium Biotech, S.A. ; means the statement of net assets as at the State ment of Net Assets Date, as set out in Schedule 20 ; means 31 December 2013 ; means the rules in accordance with which the Stat ement of Net Assets was prepared, as set out in Part 2 of Schedule 20 ; means the unaudited carve out profit and loss acc ount of the Flu Group for the 9 month period ended on 30 September 2014, as contained in the Data Room at 9.1.2.2.5.1 ; means [COMPANY] Vaccines and Diagnostics Limited, details of which are set out in paragraph 2 of Schedule 2 ; means the LEK Filling and Packaging Agreement and any of the other agreements or arrangements referred to in Clause 5 . 2.2 ; or means all forms of taxation ( other than any accou nting for deferred tax ), and statutory, governmental, state, provincial, local g overnmental or municipal impositions, duties, contributions and levies, in each case in the natur e of tax, whether levied by reference to income, pr ofits, gains, net wealth, asset values, turnover, added va lue or otherwise and shall further include payments to a Tax Authority on account of Tax, in each case whe ther of the United Kingdom or elsewhere in the world whenever imposed and whether chargeable direc tly or primarily against or attributable directly o r primarily to a member of the Seller ’s Group or any other person, and including all interest, penalties and additions imposed with respect to such amounts by a ny Tax Authority or with respect to any failure to file any Tax Return ; 17 means the amount by which : ( i ) the aggregate amount of the corporate income taxes payable by the Flu Group Companies, as at the Effective Time and as derived from the Closing Statement, exceeds or is less than ( ii ) the aggregate amount of the corporate income tax re ceivables of the Flu Group Companies as at the Effective Time as derived from the Closing Stat ement, and any such excess amount shall be treated as a po sitive number and any shortfall shall be treated as a negative amount ; means any taxing or other authority competent to impose any liability in respect of Taxation or responsible for the administration and/ or collection of Taxation or enforcement of any law in relation to Taxation ; means the deed of covenant against taxation, in t he Agreed Terms, to be entered into on the Closing Date between the Seller and the Purc haser ; means any return, declaration, claim for refund, information return or statement, including any schedule or attachment thereto, which must be filed or lodged with, or submitted to, any Tax Authority in relation to the assessment, notifi cation, collection or administration of any Tax, or which a taxpayer must prepare and retain ; means the Seller ’s Warranties set out in paragrap h 2.18 of Schedule 16 ; has the meaning given to it in Clause 11.4 ; means all consents, licences, approvals, permits, authorisations or waivers required from third parties for the assignment or t ransfer to the Purchaser of any of the Transferred Contracts, Transferred Intellectual Property Contra cts, Shared Business Contracts, Co - Owned Flu Group Intellectual Property Rights or Transferred P lant and Equipment and means any one of them ; means the aggregate amount as at the Effective Ti me of all outstanding Indebtedness owed by the Flu Group Companies to any third party less any Indebtedness owed by any third party to any Flu Group Company as derived fro m the Closing Statement ( but excluding any item included in respect of any Flu Group Companies ’ Cas h Balances ), and, for the purposes of this definition, third party shall exclude any member of the Seller ’s Group ; means trademarks, service marks, trade names, cer tification marks, service names, industrial designs, brand names, brand marks, trade dress rights, identifying symbols, logos, emblems, and signs or insignia and all goodwill of the busin ess in relation to which any of the foregoing are u sed ( but no other or greater goodwill ) ; means the proposed acquisition of all or any of t he Shares or Flu Group Businesses pursuant to this Agreement ; means the relevant national measure by which the employment of a Relevant Flu Business Employee automatically transfers to th e Purchaser or a relevant member of the Purchaser ’s Group ; means all trade accounts and notes receivable ari sing in the ordinary course of the business of the Seller ’s Gro up ( other than any Flu 18 Group Company ) after the Closing Date to the extent related to the Business, and outstanding at the Effective Time, together with any unpaid financing charges accrued thereon ; means copies of all books, ledgers, files, report s, plans, records, manuals and other materials ( in any form or medium ) to the extent relating to, or maintained exclusive ly for, the Business by the Seller ’s Group ( excluding the Flu Group Companies ) ( other than emails ), but excluding : ( i ) any such items to the extent that : ( A ) they are rel ated to any Excluded Assets ; ( B ) they are related to any corporate, Tax, human resources or s tockholders matters of the Seller or its Affiliates ( other than the Flu Group Companies ) ; ( C ) any Applicable Law prohibits their transfer ; or ( D ) any transfer thereof otherwise wou ld subject the Seller or any of its Affiliates to any material liability ( unless such items are requi red by Applicable Laws to be held by the Purchaser ) ; and ( ii ) any laboratory notebooks to the extent containing r esearch and development information unrelated to the Business ; means : ( i ) the Contracts, other than Transferred Intellectual Property Contracts and the US Government Contracts, that are Predominantly Related to the Bu siness between a member of the Seller ’s Group ( excluding the Flu Group Companies ), on the o ne hand, and any person who is not a member of the Seller ’s Group, on the other hand ( ot her than this Agreement and any Ancillary Agreement ), but excluding any Excluded Contract ; an d ( ii ) the Relevant Part of the Shared Business Contracts ; has the meaning given to it in Schedule 10 ; means : ( i ) the Flu Business Employees to whom the Purchaser ( o r a member of the Purchaser ’s Group ) offers employment and who accept such employment an d become employed by the Purchaser ( or a member of the Purchaser ’s Group ) in accordanc e with Schedule 9 ; ( ii ) any Relevant Flu Business Employees who transfer to the Purchaser ( or a member of the Purchaser ’s Group ) by operation of the Transfer Reg ulations and do not object to such transfer ( to the extent permitted by the Transfer Regulation s ) in accordance with Schedule 9 ; and ( iii ) the Relevant Flu Group Company Employees, and means the employees in ( i ) and ( ii ), means the employees in ( iii ) and, and respectively means any one of them ; means all Information Technology of any member of the Seller ’s Group ( other than a Flu Group Company ) to the extent Exclusively Related to the Business ; 19 means Contracts Exclusively Related to the Busine ss which relate to Intellectual Property Rights ( but e xcluding the rights under any such Contracts that a re held by the Flu Group Companies ) including the MF59 ® Flu Specific Intellectual Property Rights Contracts, but excluding the MF59 ® Platform Intelle ctual Property Rights Contracts ; means the Intellectual Property Rights of any mem ber of the Seller ’s Group ( other than a Flu Group Company ) Exclusively Related to the Business including the MF59 ® Flu Specific Intellectual Property Rights, bu t excluding the MF59 ® Platform Intellectual Property Rights ; means all inventories ( including Manufacturing In ventory and Manufacturing Stocks and In - Market Inventory ), including all raw materials, work in progress, finished Products and packaging and labelling material in respect of the Products and otherwise Exclusively Related to the Business ( but excluding any such items held by the Flu Group Companies ) whether held at any location or facility of a member of the Seller ’s Group or in transit to a member of the Seller ’s Group, in each case as of the Effective Time ; has the meaning given to it in paragraph 1.1 of P art 4A of Schedule 3 ; has the meaning given to it in paragraph 1.1 of P art 4A of Schedule 3 ; means : ( i ) the Transferred Information Technology ; ( ii ) all plant, furniture, furnishings, vehicles, equipm ent, tools and other tangible personal property ( other than Transferred Inventory or Transferred In formation Technology ) of the Seller ’s Group that are Exclusively Related to the Business ( but e xcluding : ( a ) any such items owned by the Flu Group Companies ; and ( b ) any such items situate d at or otherwise used in relation to the Xxxxx Springs Site ) ; and ( iii ) all plant, furniture, furnishings, vehicles, equipm ent, tools and other tangible personal property ( other than Transferred Inventory or Transferred In formation Technology ) of the Seller ’s Group that are Predominantly Related to the Business and are situated at or otherwise used in relation to the Xxxxx Springs Site ; means : ( i ) the Transferred Owned Real Properties ; and ( ii ) the Transferred Leased Real Properties ; and means any one of them ; means the transitional services agreement between the Seller and/or one or more of its Affiliates and the Purcha ser and/or one or more of its Affiliates which shal l be entered into at Closing in the Agreed Terms ; means the agreement for the reservation of manufa cturing capacity and production and supply of vaccine during a pandemic entered into between the 20 Secretary of State for Health ( acting through the C ommercial Medicines Unit ) and [COMPANY] Vaccines and Diagnostics Limited dated 1 June 2012 ; means all benefit and compensation plans, contrac ts, policies or agreements, including but not limited to ( within the meaning of section 3(3 ) of ERISA ), deferred compensation, severance, change in control or employment, vacation, incentive, bonus, stock option, stock purchase, or restricted stock plans, benefiting United States Flu Business Employees in respect of which any Flu Group Company or Business Seller contributes or under which any Flu Group Company or Business Seller is subject to continuing financial obligations or liabilities ( whether actu al or contingent ) ; means : ( i ) the Contracts of [COMPANY] Vaccines & D iagnostics, Inc. set out in Part 1 of Schedule 15 ; and ( ii ) any other Contra cts that are Predominantly Related to the Business between a member of the Seller ’s Group ( excluding t he Flu Group Companies ), on the one hand, and a Governmental Entity in the United States of America on the other hand, but excluding any Excluded Contract ; has the meaning given to it in paragraph 5.1 of S chedule 9 ; means the London interbank offered rate, being th e interest rate offered in the London inter - bank market for three month US dollar deposit s as displayed on pages LIBOR01 or LIBOR02 of the Reuters screen at 11 a.m. ( London ) on the secon d Business Day prior to the Closing Date ; means a preparation comprising : ( i ) an antigen ; ( ii ) an epitope of an antigen ; or ( iii ) a polynucleotide encoding an antigen derived directly or indirectly from, or mimicking, an agent ( including, but not limited to, a compound, a toxin, a microbe including a pathogen or component thereof ), wherein such preparation may further comp rise a composition capable of modulating an immune response, including preparations intended to improve a human ’s immune response to a microbe that has been linked to cancer, wherein said prepar ation is intended for purposes of inducing an immun e response in a human, including, but not limited to, a functional immune response or immunological memory to the particular or related antigen or agen t, thereby causing or improving an immune response to a challenge by the particular or related agent . shall not include preparations intended to improve a human ’s immune response to or to treat ot her non - infectious conditions, whether or not related to pathogens, such as certain autoimmune di seases, Alzheimer ’s disease and certain cancers, or non - antigen preparations comprising immune system c omponents intended to function analogous to corresponding native components within the patient, such as antibodies or white blood cells ( both unmodified or modified to better treat disease ) ; means within the European Union such Taxation as may be levied in accordance with ( but subject to derogations from ) Council Directive 2006 /112 / EC and outside the European Union any Taxation levied by reference to added value or sale s ; and means the Worker Adjustment and Retraining Notifi cation Act of 1988 of the United States