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June - August 2004
offeree company; (ii) sufficient time and European Parliament and Council Directive sufficient information provided to the 2004/25/EC of 21 April 2004 on takeover bids addressees of the bid; (iii) the board of the offeree company acting in the interests of Directive 2004/25/EC of 21 April 2004 on the company as a whole; (iv) preventing takeover bids (13th directive) was adopted creation of false markets (i.e. where the rise in the context of the Financial Services or fall in the prices of the securities becomes Action Plan adopted in 1999, stipulating artificial and the normal functioning of the policy objectives and specific measures for market is distorted); (v) ensuring that an improving the single market in financial offeror can fulfil in full any cash or other services. After refusal by the European consideration offered; (vi) minimum possible Parliament of the previous proposal for a hindering of an offeree company's activities directive on takeover bids in July 2001, the present Directive takes into account the remarks of members of the European For the regulation of bids, Member States Parliament, as well as the recommendations may lay down additional conditions and made by the Group of High-Level Company provisions more stringent than those of the Law Experts set up by the Commission.
Directive. Member States are to designate the authority or authorities competent to Pursuant to the Directive, the "takeover bid" supervise bids, and inform the Commission or "bid" means a "public offer (other than by of those designations. The Directive further the offeree company itself) made to the lays down rules for deciding the applicable holders of the securities of a company to law and the competent supervisory acquire all or some of those securities, whether mandatory or voluntary, which follows or has as its objective the acquisition For the purposes of protection of minority of control of the offeree company in shareholders, the Directive provides for a accordance with national law" Article 2 (1) (a).
mandatory bid, which must be executed by a person holding securities of a company The Directive applies to "takeover bids for which give him a specified percentage of the securities of companies governed by the voting rights, giving him control of that laws of Member States, where all or some of company. Such a bid must be addressed at those securities are admitted to trading on a the earliest opportunity to all the holders of regulated market (within the meaning of those securities for all their holdings at the Directive 93/22/EEC of 10 May 1993 on equitable price, i.e. the highest price paid for investment services in the securities field) in the same securities by the offeror, or by one or more Member States" Article 1 (1).
persons acting in concert with him, over The Directive does not apply to takeover a period, to be determined by the Member bids for securities issued by collective States, of not less than six months and not investment companies, or to takeover bids more than twelve before the bid. The for securities issued by the Member States' obligation to launch a bid does not apply central banks.
where control has been acquired following Hurbanovo nám. 5 a voluntary bid to all the holders of securities 811 03 Bratislava, Slovak Republic The Directive sets forth the following general for all their holdings.
tel.: (421-2) 54 41 44 41 principles for the conduct of takeover bids, fax: (421-2) 54 43 45 98 e-mail: [email protected] with which the legal regulation of the The Directive further stipulates the main Member States must comply: (i) equal rules concerning the provision of information treatment for all holders of securities of the on takeover bids to the supervisory branch: Avenue d'Auderghem 36 B-1040, Brussels, Belgium Tel.: +32 (0) 2 230 32 15 fax: +32 (0) 2 230 33 47 e-mail: [email protected]

June - August 2004
authorities, to the public, as well as to medicine authorization and the UK licensing employees representatives of the offeree company or its employees.
We informed you in the last ECLN issue The Directive also contains the requirement (ECLN 01 - 05/2004) of the amended EC that the board of the offeree company must rules on medicinal products, including obtain the prior authorisation of its Directive 2004/27/EC of the European shareholders before taking any defensive Parliament and of the Council amending action, or the requirement to freeze Directive 2001/83/EC on the Community members' extraordinary rights (such as Code relating to medicinal products for multiple voting rights, appointment rights and restrictions on the transfer of securities)during the bid, however, it leaves it up to New provisions inserted in Directive Member States whether or not to apply 2001/83, specifically its Articles 6 and 10, them. In case a Member State decides not extend the possibility of abridged to apply these provisions generally, it must applications for generic medicines. In give to the companies themselves particular, Directive 2001/83 now providesa possibility to decide whether they want to that "when a medicinal product has been apply these rules. granted an initial marketing authorization[…] any additional strengths, pharma- The Directive lays down a "squeeze-out ceutical forms, administration routes, right" enabling a majority shareholder to presentations, as well as any variations and require the remaining minority shareholders extensions shall also be granted an to sell their securities, which is combined authorization […] or be included in the initial with a "sell-out right" enabling minority marketing authorization. All these marketing shareholders to require the majority authorizations shall be considered as shareholder to buy their securities following belonging to the same global marketing a takeover bid.
authorization, in particular for the purpose ofthe application of Article 10 (1) [abridged More detailed rules governing the conduct application for generic medicines]" (Article 6 of bids, especially the lapsing of bids, the (1) subparagraph 2).
revision of bids, competing bids, thedisclosure of the results of bids, the In other words, this new provision effectively irrevocability of bids and the conditions limits the data protection period applicable permitted must be laid down by the to the contents of the file of a particular medicine and its later developments to tenyears from the date of first marketing in the The Directive entered into force on 20 May 2004 and Community. As a result, new versions of the Member States are required to transpose the Directive medicine, based on the initial application file, no later than 20 May 2006.
are subject to the data protection period Official Journal of the European Union, 2004, L 142 initially granted. The data protection periodinitially granted is extended "to a maximum of eleven years only if, during the first eightyears of those ten years, the marketing PHARMACEUTICALS - ABRIDGED
authorization holder obtains an authorization REGISTRATION OF GENERIC
for one or more therapeutic indications which during the scientific evaluation prior to Opinion of Advocate General Jacobs in Approved their authorization, are held to bring a Prescription Services Ltd (C-36/03) of 8 July 2004 significant client benefit in comparison toexisting therapies" (Article 10 (1) The Advocate General Jacobs rendered an subparagraph 4).
opinion on 8 July 2004, in the case C-36/03)between the applicant for a generic In the present case before the High Court of

June - August 2004
England and Wales the generic medicine is Sidel in 2001, Tetra Laval had failed to fully fluoxetine, also the name of the active disclose relevant research & development ingredient, in a liquid pharmaceutical form data and intellectual property rights by not (product C). The abridged application made providing information about the Tetra Fast in 1999, refers to Product B, the medicine technology. This failure happened both in Prozac, containing the same active the Form CO and in response to a letter in ingredient, also manufactured in liquid form.
which the Commission asked for Although the marketing authorization of information, which should have led to the product B was granted in 1992 (less than disclosure of the Tetra Fast technology. The the ten year data protection period with existence of the Tetra Fast technology was regard to the application of product C) the revealed only after the adoption of the application of product B was made in Commission's decision of October 2001. reference to Product A, also Prozac but intablet form which was authorized in 1988 The Commission imposed a fine of EUR (i.e. more than ten years data protection 90,000 for the infringements. It should be noted, however, that the fines in questionwere imposed under the old merger The question asked by the High Court of regulation. The new Merger Regulation (see England and Wales to the Court of Justice is ECLN 12/2003 - 1/2004) in force since 1 whether the relevant Community rules May 2004, companies can be fined up to should be interpreted as allowing an 1% of their aggregate turnover for supplying application for product C to refer to product incorrect or misleading information.
B authorized for less than ten years, andtake into account product A, reference medicine of product B and authorized formore than ten years. REDUCTION OF FINE FOR CARTEL OF

The conclusions of Advocate General Judgments of the Court of First Instance in Steel Tube Jacobs which, essentially, build on the Producers (Cases T-44/00, T-48/00, T-50/00 andJointed Cases T-67/00, T-68/00, T-71/00 and T-78/00) provision decisions of the Court in cases of Generics (C-368/96) and Novartis (C-106/01), and recommends that the generic In December 1999, the Commission marketing application of product C should adopted a decision concluding that eight be accepted as submitted, are followed by companies (four European and four the Court of Justice, the result may be Japanese) producing certain types of equivalent to an early application of the new seamless carbon-steel pipes and tubes provisions of Directive 2001/83.
used in the oil industry had participated inthe period of 1990 - 1995 in a cartel agreement. The agreement, which wasconcluded at meetings known as the COMPETITION - FINES FOR
"Europe-Japan Club", consisted of a division of the markets so that each of the INFORMATION IN MERGER CONTROL
companies undertook not to sell the pipes and tubes in question on the domesticmarket of any other company that was a In June 2004, the European Commission party to that agreement. Given the general decided, for the fifth time in the history only, prohibition of cartel agreements set forth in to impose a fine to a company for providing Article 81 of the EC Treaty, the Commission incorrect or misleading information in imposed on all eight producers fines of a merger proceedings. The company fined is total amount of EUR 99 millions.
the carton packaging company Tetra LavalB.V. Seven out of eight convicted producerssubsequently filed an action for annulment The Commission discovered that during its of the Commission's decision before the examination of Tetra Laval's acquisition of Court of First Instance (the "Court"). The

June - August 2004
Court rejected all arguments of the steel The Japanese companies also contested producers except for arguments relating to the date on which the infringement imputed the duration of the infringement concerned on them had ended. The Court held that it and, consequently, on the size of the fines had not been established, in the case of the Japanese undertakings, that theinfringement had continued beyond 1st July Given that between 1977 and 1990, certain 1994 and, therefore, considered it voluntary agreements between the necessary to reduce the duration of the European Community and Japan on infringement by an additional six months.
restraint of imports have been in force, theCommission concluded that although it Consequently, the Court partially annulled could have set the start-date of the the Commission's decision and slightly infringement as 1977, the infringement reduced respective fines to a total amount started, for the purpose of the proceedings, of EUR 86 million.
only in 1990. The Court noted that itsexamination must not relate to the legality or appropriateness of that concession of theCommission, but only to the question FINANCING OF PROMOTIONAL
whether the Commission correctly applied it ACTIVITIES AS STATE AID
in this case.
Judgment of the Court of Justice in Pearle and Others(C-345/02) of 15 July 2004 The Japanese producers, however, claimedthat the voluntary agreements between the Dutch law provides for the establishment of EC and Japan have lasted till the end of industry associations and entrusts to them a 1991 (not 1990). They, however, were not certain scope of internal autonomy. The able to produce any direct evidence to that case concerns a Dutch chamber of traders end and nor was the Commission able to active on the market of optic products demonstrate the opposite, although it was which, by virtue of its internal bye-laws, the Commission who represented the EC in imposed specific charges on its members.
negotiations with Japan on the voluntary These charges were used solely to finance agreements. The Court recalled that advertising activity designed to promote although, in general, an applicant (the optical products for the benefit of the Japanese producers) cannot transfer the Chamber' members.
burden of proof to the defendant, theconcept of burden of proof couldn't be The dispute arose between the chamber applied for the benefit of the Commission in and three of its members, private this case. Consequently, the Court corporations active in the optic industry, considered, by way of exception, that it was which contested the levy of the charge by incumbent on the Commission to produce the chamber. The plaintiffs argued that the evidence of when such voluntary charge shall be qualified as state aid within agreements had ceased to exist. The Court the meaning of applicable Community law.
finally concluded, also on the basis of Since the alleged state aid had not been certain indirect evidence produced by the notified to the Commission, as is normally Japanese producers, that for the purposes required under Community law, the plaintiff of these proceedings, and having regard to argued that the decision of the chamber to the burden of proof falling upon the levy the charge was invalid and that the Commission regarding the existence of an charges already collected were subject to infringement, the voluntary restraint agreements concluded between theCommission and the Japanese authorities The Court has ruled in favour of the remained in force during 1990. In view of Chamber. It noted that state aid is defined that finding of fact the Court decided that as any support granted directly or indirectly the duration of the infringement was from public funds, which may be attributed reduced by one year.
to the activity of public authorities.

June - August 2004
That definition does not seem, in the Court's system. The plaintiff submitted that certain opinion, to cover the charge collected by of the Community safety requirements were the chamber. The revenues so acquired not complied with in one waste water were used only in the interest of the treatment plant.
members, which benefited from thepromotional activities. Thus, the benefits The Commission wrote to the Italian enjoyed by the members were not related to authorities in August 2000 requesting any allocation or transfer of public funds information regarding the matters raised in since any advantages which the members the complaint, in order to examine the might have obtained were financed by situation in greater detail. The Italian means of the charge collected from them.
authorities did not reply to that request, norto a subsequent one of March 2001.
The Court also set aside, as irrelevant to thiscase, the argument that both the activities Considering that the silence of the Italian and authority of the Chamber, including the authorities constituted an absence of right to impose charges, were based on the genuine cooperation on their part, for the provisions of Dutch public laws on purposes of Article 10 EC, the Commission entrepreneurship. The Court also pointed instituted a procedure under Article 226 EC.
out that the decision of the chamber to After putting the Italian Republic on notice to impose the charge was taken at the request submit its observations, the Commission of some of its members. As such, the issued a reasoned opinion in July 2002 in charge was not a part of the general policy which it called on the Italian authorities to of the Dutch public authorities and could not adopt the measures necessary for have been attributed to them.
compliance within two months of itsnotification. As the Italian authorities failed to OBLIGATION OF LOYALTY
respond, the Commission brought the Judgement of the Court of Justice in Commission of present action against the Italian Republic the European Communities v Italian Republic (C-82-03) before the Court in February 2003. The Italian Republic claimed that the lack of By this judgement, the Court of Justice information on the name and location of the confirmed its case law concerning Article 10 plant created an objective difficulty for the of EC Treaty, in particular its judgement in Italian authorities to identify the supervisory Case 192/84, Commission v Greece, and bodies responsible to conduct targeted Case C-478/01, Commission inspections and provide the requested v Luxembourg. Article 10 EC requires information. The Court decided that the Member States to take all appropriate place, which was the subject of the measures to ensure fulfilment of their complaint, was sufficiently clearly identified obligations arising out of the EC Treaty or in the letters of the Commission sent before resulting from action taken by Community the pre-litigation procedure, and, therefore, institutions. According to the Court, Article the Italian Republic had failed to fulfil its 10 EC creates an obligation for Member obligations under Article 10 EC.
States to cooperate in good faith with theenquiries of the Commission pursuant to Article 226 EC, and provide it with all theinformation requested for that purpose.

In 2000, the Commission received Regulation no. 805/2004 of the European Parliament a complaint regarding the application of and of the Council of 21 April 2004 creating a European Council Directive 89/655/EEC of 30 Enforcement Order for uncontested claims November 1989 concerning the minimumsafety and health requirements for the use of The Regulation represents an important work equipment within the Italian legal step for the proper functioning of the internal

June - August 2004
market in the field of judicial cooperation in A judgement that has been certified as a civil matters as it provides for free circulation European Enforcement Order by the court of judgements, court settlements and of origin is recognised and enforced in the authentic instruments for uncontested other Member States without the need for a claims throughout the Member States declaration of enforceability and without any (except Denmark).
possibility of opposing its recognition. Itmust be treated as if it had been delivered in At present, a judgement issued in one the Member State in which enforcement is Member State can be enforced in another Member State after it has been recognisedas an enforceable title by the Member State The Regulation comes into force on 1 January 2005 where the enforcement of such judgement and shall apply from 21 October 2005.
has been sought. Such procedure is Official Journal of the European Union, 2004, L 143, p 15 governed by the Council Regulation44/2001 on jurisdiction and the recognition and enforcement of judgements in civil andcommercial matters. This intermediate COMPENSATION TO CRIME VICTIMS
procedure, however, still involves delays and Council Directive No. 2004/80/EC relating to expenses for the person seeking the compensation to crime victims Directive 2004/80/EC aims to abolish Under the Regulation, such requirement of obstacles to the free movement of services a prior declaration of enforceability is by drawing up minimum standards for the abolished in respect of judgements, court protection of crime victims. Such protection settlements and authentic instruments (such is considered corollary of that freedom of as enforceable notarial records) provided movement and Member States are obliged they concern uncontested claims in civil and to implement the Directive by 1 January commercial matters and that certain specific conditions stipulated in the Regulation aremet.
The Directive sets up a system ofcooperation in order to facilitate the access An uncontested claim is a claim to which the to compensation for victims of violent debtor has expressly agreed or to which the intentional crimes in cross-border situations.
debtor has never objected in the course of It will enable access to compensation in the court proceedings or a claim where the cases where the crime was committed in a debtor has not appeared at a court hearing Member state different from the state of that claim. As the Regulation seeks to victim's residence. Each Member State is promote the fundamental rights, more thus obliged to ensure that, where a violent particularly the right to a fair trial, certain intentional crime has been committed in a minimum procedural standards must be Member State different from the Member met in the (court) proceedings in the State where the victim has habitual Member States of origin. Consequently, a residence, the victim shall have the right to certificate is issued only provided the submit the application for compensation in documents instituting the proceedings have the Member State where the crime took been properly served on the debtor, that the debtor has been properly informed aboutthe claim in question and about procedural The compensation system under the steps necessary to contest the claim. Directive will operate on the basis of thecompensation schemes existing of the A certificate of a European Enforcement Order is issued by the court of origin uponapplication.
For the purpose of the Directive, eachMember State shall appoint a central

June - August 2004
contact point, which will provide applicants whenever the transmission would contain with necessary information and assistance.
indirect advertising of alcohol beverages.
Furthermore, the Member States mustestablish standard forms, which will be used However, the Court pointed out that for applications for compensation. The restrictions to the free movement of services compensation will be paid by the authority introduced by the Member States may be of the Member State on the territory of justified on the grounds of public health which the crime was committed.
considerations. The Court found Frenchprovisions proportionate to that aim. The Official Journal of the European Union, 2004, L 261, p 15 measures at issue were designed to limit thenumber of events available on television where the public might have viewedadvertisements of alcohol and thus might RESTRICTIONS ON ALCOHOL
have been encouraged to consume alcohol. ADVERTISING IN BROADCASTS OF

According to the Court, in line with well Judgment of the Court of Justice in Commission established case law, the fact that it is lawful v France (C-262/02) of 13 July 2004 to show advertisements of tobaccoproducts during television broadcasts of French laws prohibit advertising of alcohol sports events, is not relevant. Member on television under the pain of prosecution States are free to define objectives of their and administrative sanctions. Furthermore, public health policy and correspondingly under established practice, French choose implementing measures. Therefore, television broadcasters might have been total prohibition in France of television precluded from broadcasting sports events alcohol advertisements may be deemed where alcohol was indirectly advertised on proportionate, regardless of measures banners, billboards, T-shirts of the teams applied by other Member States.
etc. That applied, in particular, to bilateralsports events addressed directly to the French public. In such cases, Frenchbroadcasters were required to refrain from LABELING OF FOODSTUFFS
broadcasting should the organisers provide Judgment of the Court of Justice in the case Douwe advertising facilities concerning alcohol Egberts (C-239/02) of 15 July 2004 The Court of Justice has issued a decision The Commission enforced proceedings regarding claims which may be inserted on against France under Article 226 EC the labeling of foodstuffs. A brand of ground claiming infringement of the free movement coffee marketed in Belgium and carrying of services, particularly of advertising and slimming and weight control claims was broadcasting services. The Court has, challenged in court by a competitor arguing, however, rejected charges against France.
among others, a breach of severalprovisions of national and Community law The Court admitted that an infringement of regarding the labeling and the advertising of free movement of services was involved.
The Court noted that, for instance, theequipment owners were required to reject The interpretation of relevant Community advertisements of alcohol products rules and the compatibility of applicable whenever a sports event was to be national rules with Community law were broadcasted in France. Furthermore, French referred to the European Court of Justice.
broadcasters were precluded frombroadcasting those games where alcohol While Directive 1999/4/EC harmonizes the advertisements were displayed. Organisers definition of coffee extract and chicory were in turn prevented from selling extracts, the main relevant Community broadcasting rights to French operators provisions are contained in Directive

June - August 2004
2000/13/EC on the approximation of the FREE MOVEMENT OF GOODS -
laws of the Member States relating to the labeling, presentation and advertisement of Judgment of the Court of Justice in case Nicolas foodstuffs (the Directive). The Directive Schreiber (C-443/02) of 15 July 2004 harmonizes national rules and prohibitslabeling which, (i) "attributes to any foodstuff The decision of the Court makes the property of preventing, treating or curing a combined application of Community rules a human disease, or refer to such properties", harmonizing national laws (Directive and (ii) "contains misleading references to 98/8/EC concerning the placing of biocidal health". These provisions apply to the labeling products on the market) and of basic and to the advertising of foodstuffs.
provisions of the European CommunityTreaty (EC) on the free movement of goods, In addition, the Directive requires Member Article 28 EC and 30 EC. States to allow the marketing of foodstuffswhich are in compliance with the Directive, The case was referred to the Court of except for national measures regarding Justice after criminal proceedings were labeling (not advertising) justified by the started against Mr. Schreiber following the protection of public health (Article 18 (2) of placing on the market, in Italy, of blocks of the Directive). National measures must red cedar wood having natural anti-moth nevertheless be compatible with the general properties. The product was legally principles of Community law. marketed in Germany where no priormarketing authorization was required. In In the present case, the court decided that contrast, applicable Italian rules require prior national rules (here a Belgian Royal Decree) authorization of such products.
which absolutely prohibit references to"slimming" (as opposed to the prohibition of Under Directive 98/8, biocidal products are misleading references only) do not comply defined as "active substances and with the requirement of proportionality (a preparations containing one or more active general principle of Community law) with substances, put up in the form in which they regard to both Article 18 (2) of the Directive are supplied to the user, intended to destroy, (as to labeling) or to Article 28 EC (as to deter, render harmless, prevent the action advertising) prohibiting restrictions to the of, or otherwise exert a controlling effect on trade of goods between Member States. any harmful organism by chemical orbiological means". While products falling In particular, the Court of Justice considers under the definition of biocidal product are such national provision as not proportionate subject to authorization, the Directive as it does not allow the marketing of creates two further categories, respectively, products carrying slimming claims which are low-risk biocidal products subject only to substantiated, and for which, therefore, the registration and inclusion in annex IA to the slimming claim has an informative function.
Directive and basic substances which may Moreover, the aim of protection public be marketed if listed in annex IB to the health would still be satisfied through a procedure of verification of claims made.
As Directive 98/8 is not fully implemented, Finally, the Court recalls the long standing notably its annexes are still being principle, recently applied in the case Darbo established, the Court considers that the (C-465/98) of 20 April 2000, that it is up to effective harmonization provided by the the national court to decide on the existence Directive is currently limited to the definition of a fraudulent statement, "taking into of biocidal product and that such definition account the presumed expectations of an covers blocks of red cedar wood having average consumer who is reasonably well natural anti-moth properties.
informed and reasonably observant andcircumspect".
Since other rules contained in Directive 98/8are not yet effective, the Court considered that the review of national rules, beyond the

June - August 2004
definition of biocidal product, was subject toArticles 28 EC and 30 EC, regarding the freemovement of goods. Applying itsestablished case law, the Court concludesthat the requirement for authorizationcontained in the Italian legislation is anobstacle to trade between Member States(prohibited by Article 28 EC), but goes on tosay that such requirement is (a) justifiedgiven the qualification of the product as abiocidal product, potentially harmful tohuman health, and (b) proportionate to thelegitimate objective of protecting publichealth (under Article 30 EC). In thisconnection, the Court specifically recallsthat the fact that one Member State has lessstrict rules (here Germany) than another(here Italy), does not mean that the rules ofthe second State are disproportionate withregard to Community law.
The Court decision recalls that untilharmonizing Community rules are fullyimplemented, or the scope of Communityrules in force, Member States may stillmaintain national rules provided such rulesare legitimate under Treaty rules (hereArticle 30EC), (for example the protection ofpublic health) and proportionate. The Courtdoes however refer to ongoing activities forthe implementation of Directive 98/8, inparticular Commission Regulation2032/2003 amending Regulation1896/2000, to determine its position. June - August 2004
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Editor of the European Community Law News: TomበZáreck˘, [email protected] âechová Rakovsk˘. Unauthorised copying not permitted Advokátska kancelária âechová Rakovsk˘ZdruÏenie advokátov: JUDr. Boris Bohunsk˘ (evidenãné ãíslo v zozname advokátov vedenom Slovenskou advokátskou komorou: 1070/318 039 38), JUDr. Katarína âechová (0339/317 831 63) poverená vedením úãtovníctva zdruÏenia pod Iâ DPHSK1020333083, JUDr. Denisa Kubínyiová (1116/318 039 20), Mgr. TomበMaretta(1601/318 172 11), Mgr. Jana Moravãíková (3866/103 515 07 21), Mgr. ZuzanaPetrá‰ová (2157/318 155 96) Hurbanovo nám. 5, 811 03 Bratislava, Slovak Republic, tel: +421 (2) 544 14 441, fax: +421 (2) 544 34 598, Branch Office: Avenue d'Auderghem 36, B-1040 Brussels, Belgium, tel.: +32 (0) 2 230 3215, fax: +32 (0) 2 230 3347,


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