CELEX: 32015M7583
Language: en
Date: 2015-07-17 00:00:00
Title: Commission Decision of 17/07/2015 declaring a concentration to be compatible with the common market (Case No COMP/M.7583 - CSL / NOVARTIS INFLUENZA VACCINES BUSINESS) according to Council Regulation (EC) No 139/2004 (Only the English text is authentic)

|[pic]                             |EUROPEAN COMMISSION                                                                                      |

Brussels, 17.07.2015
C(2015) 5106 final

                                        [pic]

To the notifying party:

Dear Sir/Madam,

Subject:    Case M.7583 - CSL/ NOVARTIS INFLUENZA VACCINES BUSINESS
Commission decision pursuant to Article 6(1)(b) of Council Regulation No 139/2004[1] and Article 57 of the Agreement  on  the  European  Economic
Area[2]

   1) On 12 June 2015, the European Commission received notification of a proposed concentration pursuant to Article 4 of the  Merger  Regulation
      by which CSL Limited ("CSL" or the "Notifying Party", Australia) will acquire sole control of Novartis AG's ("Novartis", Switzerland) human
      influenza vaccines business ("the Target"), by way of purchase of shares and assets (the "Transaction").[3]

   2) CSL and the Target are designated hereinafter as the "Parties".

       THE PARTIES

   3) CSL is an Australia-based pharmaceutical company active worldwide in research, development, manufacturing and  marketing  of  biotherapies,
      vaccines (via its subsidiary bioCSL) and other pharmaceuticals.

   4) Novartis is a Switzerland-based global pharmaceutical company active in research, development, manufacturing and  marketing  of  originator
      pharmaceuticals and generic pharmaceuticals. In  Europe,  the  Novartis  business  includes:  Novartis  Pharmaceuticals,  Alcon  (eye  care
      pharmaceuticals) and Sandoz (generic pharmaceuticals).

   5) The Transaction follows Novartis' sale of its vaccines business (excluding influenza) to GlaxoSmithKline plc ("GSK"), which was approved by
      the Commission in January 2015.[4] The Target consists of Novartis' influenza  vaccines  business,  which  is  held  by  Novartis  Vaccines
      Holdings Limited and a subsidiary thereof, and comprises in particular of three  manufacturing  sites  (Liverpool,  United  Kingdom,  Holly
      Springs, United States, and […] production lines in Marburg, Germany).

       THE OPERATION and the concentration

   6) On 26 October 2014, CSL and Novartis entered into a Share and Business Sale Agreement ("SAPA"),  pursuant  to  which  the  Target  will  be
      indirectly solely controlled by CSL.

   7) The acquisition will be effected by way of the purchase of shares and assets within the conditions of the SAPA. CSL will acquire all of the
      shares in Novartis Vaccines Holdings Limited and its subsidiary and any new entity, should such be created, which is incorporated  to  hold
      Novartis' Human Influenza Vaccines Business and the assets of the Flu Group Businesses.

   8) The Transaction therefore constitutes a concentration within the meaning of Article 3(1)(b) of the Merger Regulation.

       UNION DIMENSION

   9) The operation does not have Union dimension within the meaning of Article 1 of the Merger Regulation. Since the Parties' combined worldwide
      turnover is below EUR 5,000 million (CSL: EUR 4,088 million, the Target: EUR […] million), the thresholds of Article  1(2)  of  the  Merger
      Regulation are not met. Similarly, the transaction does not have Union dimension pursuant to the threshold set out in Article 1(3)  of  the
      Merger Regulation as the aggregate Community-wide turnover of the Target is below EUR 100 million (EUR […]  million).

  10) On 9 April 2015 the Commission received, by means of a reasoned submission, a referral request pursuant  to  Article  4(5)  of  the  Merger
      Regulation whereby CSL requested the Commission to take jurisdiction. According to CSL, the  transaction  would  be  reviewable  under  the
      national merger control laws of three Member States, namely Austria, Germany and the UK. A copy of this submission was promptly transmitted
      to Member States on the same day.

  11) The Commission took a view in favour of the referral request so that the Parties  could benefit from the one-stop-shop  procedure  and  the
      costs and burdens associated of multiple filings be reduced. Moreover, the Commission's recent experience in  reviewing  cases  related  to
      human vaccines[5] was considered to be an additional argument in favour of the referral request.[6]

  12) None of the Member States that would have jurisdiction to review the transaction objected to the request within the deadline of 15  working
      days. Therefore, the transaction is deemed to have Union dimension in terms of Article 4(5) of the Merger Regulation. This was communicated
      to the Parties on 4 May 2015.

       COMMISSION'S ASSESSMENT

1 Product market definition

  13) Influenza is an acute illness mainly affecting the respiratory system and caused by an infection with an influenza virus,  of  which  there
      are three broad groups: A, B and C. All marketed influenza vaccines are intended to protect against A and B group virus  infections,  which
      present more serious health concerns.

  14) Influenza viruses mutate regularly, rendering the body's immune system ineffective against the mutated form. Influenza outbreaks caused  by
      such mutations can be seasonal epidemics (caused by a slow, gradual genetic drift in the genetic makeup of the virus) or  pandemic  (caused
      by a sudden, drastic genetic shift in the genetic makeup of the virus).

  15) Influenza vaccines may be segmented depending in particular on their end-use, age indication, composition, way  of  preparation,  route  of
      administration and viral coverage.

  16) First, depending on the end-use (which relates to the type of the virus), influenza vaccines can be divided into three types (seasonal, pre-
      pandemic, and pandemic):

a. Seasonal flu vaccines are sold and administered every year. Because circulating influenza viruses evolve continuously,  the  strains  included
   in the vaccine have to be updated frequently (annually) based on a recommendation from the World Health Organisation ("WHO").

b. Pre-pandemic flu vaccines are monovalent vaccines intended to protect against a potential drift in an existing  influenza  strain  that  could
   cause a future pandemic. The objective of a pre-pandemic vaccine is to provide some background level of immunity in the event a pandemic virus
   emerges, even if the immunity is not fully effective.

c. Pandemic flu vaccines can only be prepared once a pandemic virus has been identified by means of  an  official  declaration  of  an  influenza
   pandemic emergency by the WHO. To ensure swift supply of a pandemic vaccine, there are specific procedures in place in Europe based on a "mock-
   up" (prototype) vaccine, which has to be authorised by the Commission on the basis of the scientific  assessment  by  the  European  Medicines
   Agency ("EMA") in advance of the pandemics.

  17) Second, regarding influenza vaccines, the marketing authorisation issued by the Commission should, when appropriate, define as part of  the
      Summary of Product Characteristics for which age group the product is indicated. It may also contain specific  information,  conditions  or
      restrictions for use in special patient populations such as the paediatric (below a certain age threshold) and elderly (above a certain age
      threshold) population.

  18) Third, the difference between egg-based and cell-based flu vaccines refers to the production  process  of  these  vaccines.  Egg-based  flu
      vaccines are grown and incubated in fertilized chicken eggs, whereas cell-based flu vaccines are produced using mammalian cells instead  of
      eggs.

  19) Fourth, certain vaccines contain a substance, separate from the underlying virus antigen, which has  been  added  to  increase  the  body's
      immune response to the vaccine. This substance is referred to as the adjuvant, and vaccines containing such substance are  referred  to  as
      adjuvanted vaccines.

  20) Fifth, seasonal flu vaccines are administered via different delivery systems: needle (intramuscular and intradermal), nasal spray or needle-
      free (using a needle-free injection device). There is currently also ongoing research of a possibility to use micro-needle  patches  as  an
      alternative route of administration.

  21) Finally, most seasonal flu vaccines currently marketed are trivalent (“TIV”): they contain three strains of the influenza virus,  two  sub-
      type A strains, and one type B strain. Recently, some manufacturers started offering  quadrivalent  flu  vaccines  (“QIV”)  which  immunize
      recipients against four strains of influenza virus, the three listed above plus an additional type-B strain.

      Notifying Party's views

  22) The Notifying Party submits that flu vaccines should be grouped into seasonal, pandemic and pre-pandemic flu vaccines, and argues  that  in
      this case overlaps occur only with respect to seasonal flu vaccines.

  23) Indeed, the Notifying Party is of the view that any further segmentation[7] of the seasonal flu vaccine market would be inappropriate given
      the high degree of demand-side substitutability between seasonal influenza vaccines.  Therefore,  the  Notifying  Party  submits  that  the
      relevant product market for the purpose of this decision is the one for the supply of seasonal flu vaccines, in relation  to  which  actual
      overlaps would occur in Germany and the United Kingdom (and potential overlaps in Italy and Spain due to CSL being a future competitor).

      Past Commission decisions

      ATC classification for pharmaceuticals

  24) In its past merger decisions in the pharmaceutical  sector,   the  Commission  referred  to  the  third  level  ("ATC3")  of  the  European
      Pharmaceutical Market Research Association ("EphMRA") classification as the starting  point  for  defining  the  relevant  product  market.
      However, in a number of cases, the Commission found that the ATC3 level classification did not yield the appropriate market definition.  As
      a result, where appropriate and based on the factual evidence collected  during  the  market  investigation,  the  Commission  defined  the
      relevant product market at the ATC4 level or at a level of molecule or a group of molecules that are considered interchangeable  so  as  to
      exercise competitive pressure on one another. The  overlap  in  therapeutic  uses  does  not  necessarily  imply  any  particular  economic
      substitution patterns between products.[8]

  25) In relation to vaccines, the Commission recently assessed mergers in markets for human vaccines where it  took  as  a  starting  point  the
      disease for which the vaccines were intended, but did not specifically analyse  influenza  vaccines.[9]  Similarly,  in  a  past  decisions
      dealing with flu vaccines, namely, Novartis/Chiron, the Commission noted that  "vaccines  intended  for  other  diseases  are  clearly  not
      therapeutically substitutable to flu vaccines", while ultimately leaving the market for flu vaccines open.[10]

      The Commission's assessment

      Distinction between seasonal, pandemic and pre-pandemic influenza vaccines

  26) The market investigation confirmed that the seasonal influenza vaccines have a number of characteristics distinguishing them from  pandemic
      and pre-pandemic influenza vaccines.

  27) On the supply-side, respondents to the market investigation indicate that a  manufacturer  currently  only  active  in  seasonal  influenza
      vaccines would incur high costs and face regulatory barriers to enter the (pre-)pandemic flu vaccines business.[11] Pandemic vaccines  have
      a particular authorization process (for which, for example, development of a mock-up vaccine may be required). They are only produced  when
      a pandemics is officially declared by the WHO and aim at addressing the specific (pandemic) strain of virus.

  28) Similarly, demand-side substitution is limited as only suppliers who have an approved mock-up vaccine in the EEA can enter into a  contract
      with governments whereby they reserve production capacity in case of a pandemic outbreak.[12] Therefore, vaccines approved and marketed  as
      seasonal flu vaccines cannot be used as pandemic or pre-pandemic flu vaccines in a straightforward way.

  29) In light of the above, the Commission concludes that seasonal influenza  vaccines  constitute  a  separate  market  from  pre-pandemic  and
      pandemic influenza vaccines.

      Sub-segmentation of the seasonal influenza vaccines market

  30) As to the question of whether the seasonal influenza vaccines should be further sub-divided, results of the  market  investigation  broadly
      confirm that the customers perceive different seasonal flu vaccines available on the market as substitutable.

      a) Age indication

  31) The majority of respondents from the demand-side indicate that the most important criterion in vaccine selection is the age indication  and
      most of the influenza vaccines currently marketed in Europe have broad age indications.[13] There are a few exceptions  including  vaccines
      with age indication only for children or only for  elderly  (above  65  years  old),  which  are  not  suitable  for  use  in  the  general
      population.[14]

      b) Egg- and cell- based vaccines

  32) As to the potential sub-segmentation between egg-based and cell-based  vaccines,  only  the  minority  of  respondents  confirm  that  they
      regularly purchase cell-based flu vaccines and the majority of those customers indicate that it is a niche product purchased in very  small
      quantities and used only for patients suffering from egg allergy.[15] Only one respondent indicated purchasing cell-based vaccines for  the
      general population. Opinions of Key Opinion Leaders are also mixed. While some confirm that cell-based vaccines  slightly  increase  safety
      for patients with egg allergies,[16] others indicate that there is no general recommendation to use cell-based vaccines for  patients  with
      egg-allergies and that the decision is mostly taken on a case-by-case basis, and therefore  that  egg-based  and  cell-based  vaccines  are
      substitutable.[17]

      c) Adjuvanted and non-adjuvanted vaccines

  33) As to the potential sub-segmentation between adjuvanted and non-adjuvanted  vaccines,  the  market  investigation  yielded  mixed  results.
      Adjuvanted vaccines are not currently marketed in the UK. In Germany, Italy and Spain, the majority  of  respondents  purchased  adjuvanted
      vaccines in the last flu season to administer them to the elderly population and partly to adult risk patients.[18] There  seems  to  be  a
      preference to purchase adjuvanted vaccines in Spain and Italy, whereas in Germany there appear  to  be  no  clear  recommendations  and  no
      practice to purchase adjuvanted vaccines for any specific groups of population.[19]

      d) Mode of administration

  34) As to the potential sub-segmentation according to the mode of administration, the majority of respondents do not qualify it as an important
      criterion.[20]

      e) TIV and QIV vaccines

  35) Finally, as to the potential sub-segmentation between TIV and QIV, only a minority of respondents use  QIV  vaccines,  mostly  for  use  in
      specific risk groups. Only a few customers use QIV vaccines for the general population.[21] With respect to the future of the QIV vaccines,
      roughly half of the respondents expect that QIV will replace TIV in the future.[22] Key Opinion Leaders expect a shift  from  TIV  to  QIV,
      even though opinions about QIV's effectiveness differ. One Key Opinion Leader stated for instance that "there is currently no  sufficiently
      robust scientific evidence that would point to a significantly higher medical efficacy".[23]

      Conclusion

  36) The market investigation confirmed furthermore that seasonal flu vaccines are to a large extent commoditised products, with the majority of
      respondents to the market investigation confirming that price is the most important factor  when  selecting  seasonal  flu  vaccines.  Most
      customers further indicate that brand is the least important factor in the selection of seasonal influenza vaccines.[24]

  37) In light of the above, the Commission considers that the question whether seasonal  influenza  vaccines  should  be  further  segmented  by
      different criteria can be left open for the purpose of this decision, as no serious doubts arise in relation to seasonal influenza vaccines
      irrespective of the market definition.

3 Geographic market definition

  38) The Commission has previously analysed the vaccine markets at national level. More specifically,  the  Commission  considered  that,  while
      vaccine manufacturers typically produce vaccines for the whole EEA, the supply of vaccines to wholesalers is affected by different national
      regulations and reimbursement systems in each Member State, which confer to those markets a national dimension. Furthermore, it noted  that
      market characteristics, distribution channels, sales patterns, vaccines schedules and price setting for  flu  vaccines  vary  significantly
      among countries.[25]

  39) Responses to the market investigation in this case also point to  the  national  scope  of  the  seasonal  influenza  vaccine  markets,  in
      particular in light of national regulatory frameworks, prices and reimbursement. All of  the  competitors  confirm  that  their  commercial
      relations with customers typically take place at least at the national level (a small proportion indicate to have commercial relations at a
      regional (infra-national) level).[26]

  40) In light of the above, the seasonal influenza vaccine markets are analysed at the national level.

Pipeline products

  41) In its previous practice, the Commission assessed the potential for products in research & development to enter into competition with other
      products which are either on the market or at the development stage by reference to their characteristics, intended  therapeutic  use,  and
      expected therapeutic and economic substitutability.[27]

  42) As regards the geographic dimension of pipeline pharmaceuticals, in line with its previous practice, the Commission  considers  that  since
      pipeline products need to be assessed with reference to the R&D in a given area and to the extent that R&D for  the  relevant  products  is
      normally global, the geographic scope of the market should be global or at least be EEA-wide.[28]

4 Competitive assessment – seasonal influenza vaccines

  43) The Parties' activities give rise to affected markets regarding seasonal  influenza  vaccines,  where  the  Parties  supply  the  following
      products in the EEA:

a. CSL markets Afluria (age 5+ years, egg-based, TIV, non-adjuvanted) and a non-branded vaccine (age 5+ years, egg-based, TIV, non-adjuvanted);

b. the Target markets Agrippal/Begripal (age 6+ months, egg-based, TIV, non-adjuvanted), Fluad  (age  65+  years,  egg-based,  TIV,  adjuvanted),
   Optaflu (age 18+ years, cell-based, TIV, non-adjuvanted) and Fluvirin (age 4+ years, egg-based, TIV, non-adjuvanted).

  44) For the purposes of this decision, the effects of the proposed transaction are  assessed  on  an  overall  market  for  seasonal  influenza
      vaccines. The assessment is not materially affected if one were to consider each of the segmentations contemplated above.

      a) Age indication

  45) Since CSL's vaccine is a multi-purpose vaccine covering all ages above 5 years, there is no overlap below this age group.  As  regards  age
      groups above 5 years, the Parties' main competitors cover all age groups and the structure of the market is  not  materially  different  to
      that of the overall market.

      b) Egg- and cell-based vaccines

  46) Only the Target supplies cell-based vaccines and therefore there is no overlap in this category. Regarding egg-based vaccines, the Parties'
      main competitors supply such vaccines and the structure of the market is not materially different to that of the overall market.

      c) Adjuvanted and non-adjuvanted vaccines

  47) Only the Target supplies the former category (therefore  there  is  no  overlap  regarding  adjuvanted  vaccines)  and  the  Parties'  main
      competitors supply non-adjuvanted vaccines and the structure of the market is not materially different to that of the overall market.

      d) Route of administration

  48) Whilst all the Parties' vaccines marketed in the EEA are intramusucular vaccines,[29] the structure  of  this  particular  segment  is  not
      materially different to that of the overall market.

      e) TIV and QIV vaccines

  49) While the Parties only market TIV, they both have QIV in development stage.  This  pipeline  to  pipeline  overlap  is  analysed  below  at
      paragraphs (62) through (65).

  50) Regarding the overall market for seasonal flu vaccines, the Parties' activities overlap in  two  Member  States:  Germany  and  the  United
      Kingdom (both affected markets). For two additional Member States, Italy and Spain, the Target has a market share greater than 20% and  CSL
      intends to start selling its flu vaccine as of the […]  flu season.

  51) The Transaction follows a trend of consolidation in the market for seasonal flu vaccines over the last few years. Out  of  the  seven  main
      suppliers in the EEA (Abbott respectively Mylan,[30] Baxter, Crucell, CSL, GSK, Novartis, Sanofi-Pasteur MSD),  two  (Baxter  and  Crucell)
      have exited the market in Germany, the United Kingdom, Italy and Spain in the 2012/13 and 2013/14 flu seasons.

  52) While the structure of demand for seasonal flu vaccines varies across the  four  abovementioned  countries,  these  markets  are  typically
      markets within which purchasing is done via tenders or where there is a degree of regulatory oversight on pricing:

a. In Germany, in the 2015/16 flu season, most of the federal states will have introduced tenders for purchasing flu vaccines. German  non-profit
   insurance collectives known as "sickness funds" negotiate prices on behalf of their beneficiaries  collectively  via  these  tenders.  In  the
   remaining federal states, the sickness funds negotiate a maximum  "fixed"  reimbursement  price  for  influenza  vaccines  with  the  pharmacy
   association for that region.

b. In the United Kingdom, the public GP channel (for which Drug Tariff prices are set by regulators), is by far the  most  significant,  followed
   by a public tender channel, and then a comparatively small pharmacy/private channel (which in turn supplies to self-pay patients).

c. In Italy and Spain, the public tender segment accounts for the great majority of the market (about [90-100]% in Italy and more than  [90-100]%
   in Spain).

Germany and the United Kingdom

  53) In Germany and the United Kingdom, the Notifying Party submits there are five main suppliers  of  seasonal  flu  vaccines  (Mylan,  Sanofi-
      Pasteur MSD, GSK, CSL and the Target), with the following information on the Parties' and their main competitors market shares:

|Season        |Volume (doses)                             |Value (EUR)                                  |
|                                                                                                        |
|2014/15                                                                                                 |
|2014/15       |[10-20]%                                    |[0-5]%                                       |
|                                                                                                         |
|2014/15                                                                                                  |

  2014/15 |– |[30-40]% |[30-40]% |– |[40-50]% |[40-50]% | |2013/14 |– |[20-30]% |[20-30]% |– |[20-30]% |[20-30]% | |2012/13 |– |[5-10]% |[5-10]%
   |– |[5-10]% |[5-10]% | |Source: Parties' estimates. Due to the seasonal nature of flu vaccines, yearly market shares are provided by influenza
      season.

  54) The Notifying Party submits that CSL obtained national approval for its seasonal flu vaccine in 2014 in Italy and February 2015  in  Spain,
      and expects to be able to launch it in both countries in the […] flu season. It further claims that, even assuming that  CSL  were  not  to
      enter the seasonal flu vaccines markets in Spain and Italy, four suppliers would remain after the Transaction.

  55) Respondents to the market investigation from the demand side in Italy and Spain confirmed that they purchase vaccines from  Sanofi-Pasteur,
      GSK and Mylan (Johnson & Johnson is also mentioned), as well as from the Target.[36] In  particular,  Sanofi-Pasteur  MSD  is  the  largest
      supplier in Italy and Spain with a volume market share of [50-60]% (Italy) and [40-50]% (Spain), in the flu season  2014/15,  and  in  both
      countries, one additional strong competitor – GSK and Mylan, respectively – is also present. Finally, the majority of  respondents  to  the
      market investigation in Italy and Spain indicated that they do not expect any impact from the Transaction on the  price  of  the  influenza
      vaccines currently offered on the market.[37]

  56) In view of the above, the Commission concludes that the proposed transaction does not raise serious doubts as to its compatibility with the
      internal market in relation to the market for seasonal flu vaccines in Italy and Spain.

Quadrivalent influenza vaccines (QIV)

  57) The proposed Transaction gives rise to a pipeline overlap regarding the hypothetical narrower  market  for  QIV.  Indeed,  CSL  has  a  QIV
      currently undergoing clinical trials,[38] while the Target has three QIV pipeline products.[39]

  58) The Notifying Party submits that, to the extent that QIV vaccines are considered in isolation, CSL and the Target will be  late  comers  in
      the supply of QIV vaccines in Europe compared to some of their key competitors. It  further  notes  that  there  will  likely  be  as  many
      competitors as are currently supplying TIV influenza vaccines in Europe given that the other main TIV suppliers market QIV or  have  it  in
      their pipeline.

  59) In addition the market investigation confirmed that GSK is currently marketing a QIV  vaccine  in  Europe  since  the  2013/14  flu  season
      (Fluarix/Influsplit Tetra),[40] while Sanofi-Pasteur MSD has a pipeline QIV in phase III (Vaxigrip Tetra), which has already been  launched
      in the US,[41] and Mylan has a pipeline QIV in phase III.[42] Furthermore, the majority of respondents to the market investigation from the
      demand side indicated that they do not expect any impact from the Transaction on the prices of QIV,[43] as well as on innovation  regarding
      influenza vaccines.[44]

  60) In view of the above, the Commission therefore  concludes  that  the  proposed  Transaction  does  not  raise  serious  doubts  as  to  its
      compatibility with the common market in relation to the pipeline overlap in quadrivalent seasonal flu vaccines.

       CONCLUSION

  61) For the above reasons, the European Commission has decided not to oppose the notified operation and  to  declare  it  compatible  with  the
      internal market and with the EEA Agreement. This decision is adopted in application of Article 6(1)(b) of the Merger Regulation and Article
      57 of the EEA Agreement.

For the Commission
(Signed)
Margrethe VESTAGER
Member of the Commission

-----------------------
[1]   OJ L 24, 29.1.2004, p. 1 ('the Merger Regulation'). With effect from 1 December 2009, the Treaty on the Functioning of the  European  Union
("TFEU") has introduced certain changes, such as the replacement of "Community"  by  "Union"  and  "common  market"  by  "internal  market".  The
terminology of the TFEU will be used throughout this decision.
[2]   OJ L 1, 3.1.1994, p.3 ("the EEA Agreement").
[3]   Publication in the Official Journal of the European Union No C 206, 23.06.2015, p. 11.
[4]   See case M.7276 – GlaxoSmithKline / Novartis vaccines business (excl. influenza) / Novartis Consumer Health business.
[5]   In particular GlaxoSmithKline/Novartis Vaccines Business (excl. influenza), which covered the  sale  of  the  rest  of  Novartis'  vaccines
business and is therefore closely related to the case at hand.
[6]   Commission Notice on Case Referral in respect of concentrations OJ 2005/C 56/02, paragraph 31.
[7]   E.g. distinguishing by age indication, between egg-based and cell-based vaccines, adjuvanted and non-adjuvanted, TIV and QIV, or  by  route
of administration.
[8]   See e.g. cases M.7480 – Actavis/Allergan; M.7279  –  Mylan/Abbott  EPD-DM;  M.7276  –  GlaxoSmithKline/Novartis  vaccines  business  (excl.
influenza)/Novartis Consumer Health business; M.7275 – Novartis/GlaxoSmithKline Oncology Business and M.5253 – Sanofi-Aventis/Zentiva.
[9]   See e.g. cases M.7276 – GlaxoSmithKline/Novartis vaccines business (excl. influenza)/Novartis Consumer Health business.
[10]  See case M.4049 – Novartis/Chiron.
[11]  See replies to question 24 – Phase I questionnaire to competitors.
[12]  See agreed minutes of a call with a customer dated 19 May 2015.
[13]        See replies to question 8 – Phase I questionnaire to customers.
[14]  Those vaccines include among others MedImmune's Fluenz and Fluenz Tetra recommended  for  children  below  18  years  and  Novartis'  Fluad
recommended for the elderly above 65 years. See replies to question 8 – Phase I questionnaire to customers.
[15]  See replies to question 11 – Phase I questionnaire to customers.
[16]  See agreed minutes of a call with a Key Opinion Leader dated 22 May 2015.
[17]  See agreed minutes of a call with Key Opinion Leaders dated 19 May 2015 and 22 May 2015.
[18]  See replies to question 12 – Phase I questionnaire to customers.
[19]  See agreed minutes of a call with a competitor dated 22 May 2015.
[20]  See replies to question 9 – Phase I questionnaire to customers.
[21]  See replies to question 13 – Phase I questionnaire to customers.
[22]  See replies to question 14 – Phase I questionnaire to customers.
[23]  See agreed minutes of a call with a competitor dated 22 May 2015.
[24]  See replies to question 9 – Phase I questionnaire to customers.
[25]  See e.g. cases M.4049 – Novartis / Chiron and M.7276 – GlaxoSmithKline / Novartis vaccines business (excl. influenza) /  Novartis  Consumer
Health business.
[26]  See replies to question 4 – Phase I questionnaire to competitors.
[27]  See M.7275 – Novartis/GlaxoSmithKline Oncology Business,  Commission  decision  of  28  January  2015;  M.6969  –  Valeant  Pharmaceuticals
International / Bausch & Lomb Holdings, Commission decision of 5 August 2013; M.6278 – Takeda/Nycomed,  Commission  decision  of  29  July  2011;
M.5778 – Novartis/Alcon, Commission decision of 9 August 2010; M.5476 – Pfizer/Wyeth, Commission  decision  of  17  July  2009;  M.1846  –  Glaxo
Wellcome/Smithkline Beecham, Commission decision of 8 May 2000, M.1878 – Pfizer/Warner Lambert, Commission decision of  22  May  2000;  M.1846  –
Glaxo Wellcome/Smithkline Beecham, Commission decision of 8 May 2000; and M.737 – Ciba-Geigy/Sandoz, Commission decision of 04 February 1998..
[28]  See M.7275 – Novartis/GlaxoSmithKline Oncology Business, Commission decision of 28 January 2015; and M.737 – Ciba-Geigy/Sandoz,  Commission
decision of 17 July 1996.
[29]  With the exception of CSL, but not the Target, developing a needle-free injection device which has been approved in the US (but not in  the
EEA).
[30]  On 27 April 2015, Mylan completed its acquisition of Abbott Laboratories'  non-U.S.  developed  markets  speciality  and  branded  generics
business, which includes Abbott's trivalent influenza vaccine (Influvac). See: http://newsroom.mylan.com/index.php?s=2429&item=123282.
[31]  See replies to question 12 – Phase I questionnaire to competitors.
[32]  Pfizer distributes CSL's flu vaccines in the UK but is not a flu vaccine manufacturer in the EEA.
[33]  See replies to questions 5 and 8 – Phase I questionnaire to customers (Germany, the UK).
[34]  See replies to question 25 – Phase I questionnaire to competitors and to question 23 – Phase I questionnaire  to  customers  (Germany,  the
UK).
[35]  See replies to question 23 – Phase I questionnaire to customers (Germany, the UK).
[36]  See replies to questions 5 and 8 – Phase I questionnaire to customers (Italy, Spain).
[37]  See replies to question 25 – Phase I questionnaire to competitors and to question 23 – Phase I questionnaire to customers (Italy, Spain).
[38]  CSL expects to submit its QIV pipeline product for Marketing Authorisation in  Europe  in  […],  using  […].  Assuming  CSL  receives  this
Marketing Authorization, CSL will introduce its QIV vaccine in Europe with an indication of 5 years and over for the […] flu season.
[39]  The Target's QIV pipeline products are (i) an adjuvanted QIV for the paediatric segment 6 months – 6 years which, in the  EU,  is  expected
to be filed in […] and approved / launched in […] (or potentially one year later); (ii) FLUCELVAX QIV, for 4 years and older,  with  an  expected
US launch in […] (although whether to bring this vaccine into the EU remains under consideration); and (iii) an adjuvanted QIV for 65y+, with  an
expected file in […] and launch in the EU in […].
[40]  See replies to question 6 – Phase I questionnaire to competitors.
[41]  See agreed minutes of a call with a competitor dated 22 May 2015.
[42]  See e.g. https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-001042-24/DE
[43]  See replies to question 24 – Phase I questionnaire to customers.
[44]  See replies to question 25 – Phase I questionnaire to customers.

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 In the published version of this decision, some information has been omitted pursuant to Article 17(2) of Council Regulation (EC)  No  139/2004
 concerning non-disclosure of business secrets and other confidential information.  The  omissions  are  shown  thus  […].  Where  possible  the
 information omitted has been replaced by ranges of figures or a general description.

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