CELEX: 32015M7379
Language: en
Date: 2015-01-28 00:00:00
Title: Commission Decision of 28/01/2015 declaring a concentration to be compatible with the common market (Case No COMP/M.7379 - MYLAN / ABBOTT EPD-DM) according to Council Regulation (EC) No 139/2004 (Only the English text is authentic)

|[pic]                             |EUROPEAN COMMISSION                                                                                      |

Brussels, 28.1.2015
C(2015) 543 final

                                        [pic]

|To the notifying party:                                            |

Dear Madam(s) and/or Sir(s),

Subject:    Case M.7379 – MYLAN/ ABBOTT EPD-DM
Commission decision pursuant to Article 6(1)(b) in conjunction with Article 6(2) of Council Regulation  No 139/2004[1]  and  Article  57  of  the
Agreement on the European Economic Area[2]

   1) On 28 November 2014, the European Commission received notification of a  proposed  concentration  pursuant  to  Article  4  of  the  Merger
      Regulation by which the undertaking Mylan, Inc. ("Mylan" or "the Notifying Party", US) acquires within the meaning of  Article  3(1)(b)  of
      the Merger Regulation control of the whole of the undertaking Abbott EPD-DM ("Abbott EPD-DM", Switzerland) by way of purchase of shares.

       The Parties

   2) Mylan is a U.S.-based global pharmaceutical company which develops,  licenses,  manufactures,  markets  and  distributes  generic,  branded
      generic and specialty pharmaceuticals. Mylan offers a broad product portfolio, including more than 1,300 marketed products, to customers in
      approximately 140  countries.  Mylan  operates  a  global  vertically-integrated  manufacturing  platform,  which  includes  more  than  35
      manufacturing facilities around the world. It has extensive active pharmaceutical ingredient ("API") operations.

   3) Abbott EPD-DM is the Non-U.S. Developed Markets Specialty and Branded Generics Business of Abbott Laboratories. Abbott EPD-DM is focused on
      distributing branded ex-originator products whose patents expired.[3] Its  portfolio  includes  approximately  100  products  in  different
      therapeutic areas. Products are sourced from both internal and third  party  manufacturing  facilities.  Internal  production  capabilities
      include plants in Europe, Canada and Japan. The proposed concentration includes the transfer of the finished  dose  pharmaceutical  ("FDP")
      manufacturing facilities in France and Japan.

       The OperatIon

   4) Pursuant to the business transfer agreement signed on 4 November 2014, Abbott EPD-DM will be merged with and into Mylan. Mylan shareholders
      will hold around 78% of shares of new Mylan. The remaining 22% of shares of the new Mylan will be  held  by  the  current  shareholders  of
      Abbott EPD-DM, who will not have decisive influence over Mylan.

   5) The transaction thus constitutes an acquisition of sole control by Mylan over Abbott EPD-DM and  a  concentration  within  the  meaning  of
      Article 3(1)(b) of the Merger Regulation.

       UNION DIMENSION

   6) The undertakings concerned have a combined aggregate world-wide turnover of more than EUR 5 000 million[4] (Mylan: EUR 5.2 billion;  Abbott
      EPD-DM: EUR 1.6 billion). Each of them has an EU-wide turnover in excess of EUR 250 million (Mylan: EUR […]; Abbott EPD-DM: EUR  […]),  but
      each does not achieve more than two-thirds of its aggregate EU-wide turnover within one and the same Member State. The  notified  operation
      therefore has a Union dimension.

       RELEVANT MARKETS AND COMPETITIVE ASSESSMENT

1 Overall context

   7) In contrast to precedents, the proposed transaction involves a merger between a producer of branded ex-originator drugs (Abbott EPD-DM) and
      a producer of generics (Mylan). Although all Abbott EPD-DM's ex-originator drugs affected by this transaction  lost  their  exclusivity  at
      least two years ago, Abbott EPD-DM's products remain branded and often command a price premium over their generic  equivalents.  Mylan,  on
      the other hand is a typical generic supplier, selling mostly non-branded generics. Given the difference in the business model, i.e. branded
      v. generics, Mylan and Abbott EPD-DM focus on different distribution channels. As the originator, Abbott EPD-DM principally aims its  sales
      efforts at prescribers. By contrast, as a typical generic company, Mylan mainly focuses its sales efforts on pharmacies and wholesalers.

   8) The rationale of the transaction is for Mylan to diversify its business outside of  the  U.S.  by  adding  a  differentiated  portfolio  of
      specialty and branded generic products, to provide entry into the over-the-counter (“OTC”) market, to penetrate new markets, in  particular
      Eastern Europe, and to enhance Mylan's reach to physicians as part  of  the  sales  channel.  For  the  seller,  Abbott  Laboratories,  the
      transaction rationale is based on its strategic decision to focus its branded generics business on emerging markets.[5]

   9) The activities of Mylan and Abbott EPD-DM overlap in five therapeutic areas (cardio-metabolic, gastro, anti-infective/respiratory, CNS/pain
      and women's and men's health) in the production and marketing of generic FDPs (section IV.2). In addition, both Parties develop products in
      their pipelines (section IV.3). Finally, both Parties are involved in activities in relation to APIs (section IV.4), contract manufacturing
      (section IV.5) and outlicensing (section IV.6).

2 Finished Dose Pharmaceuticals

1 General approach to the product market definition

      Analysis based on ATC classification

  10) When defining relevant markets in past decisions dealing  with  pharmaceutical  products,  the  Commission  has  established  a  number  of
      principles.[6] In those decisions it noted that medicines may be subdivided into  therapeutic  classes  by  reference  to  the  "Anatomical
      Therapeutic Classification" (ATC), devised by the European Pharmaceutical Marketing Research Association (EphMRA) and maintained by  EphMRA
      and Intercontinental Medical Statistics (IMS).[7]

  11) The ATC system is a hierarchical and coded four-level system which classifies medicinal products according to their indication, therapeutic
      use, composition and mode of action. In the first and broadest level (ATC1), medicinal products are divided into  the  16  anatomical  main
      groups. The second level (ATC2) is either a pharmacological or therapeutic group. The third level (ATC3) further groups medicinal  products
      by their specific therapeutic indications, i.e. their intended use (e.g. S1K - Artificial tears and ocular lubricants). Finally,  the  ATC4
      level is the most detailed one (not available for all ATC3) and refers for instance to the mode of action (e.g. distinction  of  some  ATC3
      classes into topical and systemic depending on their way of action) or any other subdivision of the group.

  12) In its past merger decisions in the pharmaceutical sector, the Commission has referred to the third level (ATC3) 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 within the meaning of the Commission Notice on the Definition of the Relevant Market. As a result,  where
      appropriate and based on the factual evidence collected during the market investigation, the Commission has 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.[8] The overlap in therapeutic uses does not necessarily imply  any  particular  economic  substitution
      patterns between products.

  13) In the present case, given the nature of the markets, i.e. mature genericized markets, the Commission took as a starting point the molecule
      level and assessed, on a case-by-case basis, whether the market should be expanded by including other molecules within the class having the
      same indication. In those cases in which the substitutability with other molecules was evidenced, the  Commission  took  into  account  the
      closeness of substitution between them, while generally considering the generic molecule  as  being  the  closest  substitute  to  the  ex-
      originator drug based on the same molecule.

      Originator pharmaceuticals and generic pharmaceuticals

  14) Generics are in general less expensive, bioequivalent versions of originator drugs. In  regulatory  approval  procedures,  a  generic  drug
      manufacturer has to demonstrate that the generic version of the originator drug has the same qualitative and  quantitative  composition  in
      terms of active substance and the same pharmaceutical form and is bioequivalent to the originator drug.

  15) In previous cases,[9] the market investigation has often suggested that there may be  differences  in  the  demand  for  originator  versus
      generic drugs, even when they are bioequivalent. This is the case more particularly in countries where the penetration of generics is lower
      and the importance of the brand is higher. On the other hand, the growing trend of  regulatory  pushes  in  some  countries  in  favour  of
      generics, such as for instance, mandatory substitution at the pharmacy  level,  mandatory  INN  prescription  etc.  increases  the  generic
      substitution. Finally, generic versions of originator medicines are specifically designed to compete  with  those  medicines  and  normally
      represent the closest substitute to them.[10]

  16) In addition, the present case specifically concerns the combination of an ex-originator with a generic producer competing  head-to-head  in
      many markets. Therefore, in line with the precedents, the Commission considers that in relation to the overlapping  molecules  the  product
      market includes both generic and originator versions.

      Prescription drugs v. Over-the-counter ("OTC") drugs

  17) In certain cases, pharmaceutical products may be further subdivided into various segments on the basis of a variety  of  criteria,  and  in
      particular demand-related criteria. The Commission has in the past[11] defined separate markets for medicines, which can be issued only  on
      prescription and those, which can be sold over the counter (OTC). Medical indications, side  effects,  legal  framework,  distribution  and
      marketing tend to differ between these drug categories, even if the active ingredients are sometimes identical.

  18) OTC products may be advertised to the public at large. Doctors do not need to intervene in the purchase of these products. In  most  cases,
      consumers choose OTC pharmaceuticals themselves and purchases are not reimbursed. By contrast,  prescription  pharmaceuticals  need  to  be
      prescribed by a doctor, whose intervention is thus essential in the choice of the product. Pricing for prescription products is  influenced
      by the public health care system, who pays  (part  of)  the  purchase  price  via  reimbursement.  Marketing,  therefore,  is  targeted  at
      prescribers, that is, doctors and hospitals.[12]

  19) Notwithstanding such differences, it has been outlined in previous decisions[13] that in certain cases, products which  are  available  OTC
      are still reimbursable if bought on prescription.

  20) Furthermore, in some specific circumstances it may not be excluded that these products compete with each other, especially in  cases  where
      the status of the drug is not clearly limited to either OTC or prescription.[14]

  21) In the case at hand, most drugs are only prescription drugs. For those drugs that are both available on prescription and  OTC,  the  market
      investigation did not provide any indications that the market should be sub-divided according to this criterion.

      Galenic form

  22) As the Commission has acknowledged in its previous decisions,[15] medicines are differentiated not only by their active ingredient(s),  but
      also, in particular, as recognized by the European regulatory framework for medicines for human use, by their dosage,  pharmaceutical  form
      and route of administration and this may limit their substitutability.[16]

  23) For the purposes of this decision, the Commission has looked at "galenic form" with reference to the first letter of the typology  of  form
      codes (the so-called "New Form Code" or NFC) used by IMS/EphMRA. In general, the first letter differentiates between forms for systemic and
      topical effect, site of application, and also between long-acting and ordinary forms.

  24) The market investigation in the present case has shown, for some of the  products  considered  in  this  case,  that  different  routes  of
      administration and the pharmaceutical form of a medicine may be designed to serve the needs of different patient groups and  are  therefore
      not interchangeable. This was shown to be the case for the liquid form of certain drugs (such as syrups), which  are  mainly  designed  for
      paediatric patients.

  25) In any event, the question of whether the relevant markets should be further subdivided according to the galenic form can be left open  for
      the purpose of this decision as competitive assessment of individual markets would not change irrespective of galenic form concerned.

3 Relevant geographic market

  26) The Commission has previously defined the  geographic  markets  for  pharmaceutical  products  as  being  national  in  scope.  The  market
      investigation in this case did not provide any indications that such market definition should be revisited, in particular in  view  of  the
      national regulatory and reimbursement schemes and the fact that competition between pharmaceutical firms still predominantly takes place at
      a national level.

  27) Therefore, for the purpose of this decision the Commission concludes that the scope of the geographic markets in relation to  all  assessed
      FDPs markets is national.

4 Product-specific assessment

  28) The Commission conducted a far reaching market investigation in this case. In total, the Commission sent more than  800  questionnaires  to
      five different categories of market participants: prescribers, competitors, wholesalers and distributors, pharmacies  and  national  health
      authorities. In addition to this, the Commission conducted more than 30 conference calls with various market  participants,  including  the
      leading medical specialists in the relevant areas ("key opinion leaders").

  29) The Commission also analysed the information provided by the Parties, including a considerable number of internal documents.

  30) The findings in this decision are based on the overall assessment of all available evidence.

1 Methodology used in the assessment of affected markets

  31) In the sections concerning the competitive assessment in each affected market below, the Commission  provides  a  detailed  and  individual
      assessment of a number of affected markets in each of the five main therapeutic  areas  where  the  Parties'  activities  overlap:  cardio-
      metabolic, gastro, anti-infective/respiratory, CNS/pain and women's and men's health.

  32) In line with the past decisions, given a large number of affected markets  in  pharmaceutical  mergers  (numerous  product  and  geographic
      markets), the Commission has applied a system of filters aimed at determining the group of markets where concerns are most  likely  and  on
      which its focused its analysis.

  33) Specifically, the markets were grouped in four groups:

    • Group 1: where the Parties' combined market share exceeds 35% AND the increment exceeds 1%.

    • Group 2: where the Parties' combined market share exceeds 35% but the increment is below 1%.

    • Group 3: where the Parties' combined market share is between 20%[17] and 35%.

    • Group 1 "plus":[18] there are two scenarios of non-Group 1 markets, which deserve a closer attention: (1)  the  combined  market  share  is
      below 35% BUT only one other competitor remains on the market, and (2) the combined market share exceeds 35% and the increment is below  1%
      BUT the party with the small increment is a recent entrant.[19]

  34) Therefore, as a starting point the Commission assessed in detail all Group 1 markets under the narrowest plausible market definition,  i.e.
      at the molecule level. Specifically, the market investigation focused on a number of molecules belonging to these five  therapeutic  areas,
      giving rise to 68 Group 1 overlaps at the molecule level, 13 Group 1 overlaps at the ATC4 level and 26 Group 1 overlaps at the ATC3  level.
      A total number of 107 Group 1 overlaps were examined by the Commission.

  35) Depending on the results of the market investigation on the scope of the relevant market in relation to  these  molecules,  the  Commission
      assessed these markets on three different alternative levels: (i) at the narrowest market definition, i.e. the molecule, which in any case,
      as explained above (see paragraph (13)), was taken as the starting point of the  assessment,  (ii)  at  a  combination  of  interchangeable
      molecules within the same ATC4 or ATC3 class, and finally (iii)  at the broader ATC4 or ATC3 level. In some  instances,  in  particular  in
      relation to the markets where serious doubts arise, the market investigation provided clear indications that the markets are limited to the
      molecule based on the specificities of those molecules pointing to the lack of alternatives providing therapeutically equal outcome.

  36) Besides, a total of 198 Group 2 and Group 3 affected markets were also examined. Affected markets which fell within these  categories  have
      been considered within their therapeutic area. The Commission in particular assessed the competitive situation on these  markets  analysing
      the nature and the number of existing competitors. In this decision, these markets are  not  considered  in  detail  individually  and  are
      covered by the general conclusions in relation to markets where no serious doubts as to the  compatibility  of  the  transaction  with  the
      internal market arise.

2 Assessment of the markets by therapeutic area

       CARDIO AREA

  37) This therapeutic area includes a range of drugs that are used to treat various forms of heart and blood vessel diseases and to control  the
      various risk factors that arise from heart disease, such as hypertension, high blood lipid levels and irregular heart rhythms. Both Parties
      are present in this therapeutic area with numerous marketed molecules, which belong  to  various  ATC3  classes.  In  particular,  Group  1
      overlaps    were    identified    (at    the    molecule    level)    in    relation    to     the     molecules     set     out     below.

      1 Propafenone and amiodarone hydrochloride (C1B)

      Product market definition

  38) Abbott EPD-DM markets propafenone and Mylan markets amiodarone, two drugs that both belong to the ATC3 class C1B  which  comprises  of  all
      products recommended for use for irregularities with the rate or rhythm of the heartbeat (arrhythmia),  disorders  of  cardiac  rhythm  and
      tachycardia (heart rate that exceeds the normal range).

  39) In its precedent decisions, the Commission has considered whether the ATC3 class C1B was appropriate to define the product market for  this
      type of products. It concluded from the results of the market investigation that applying the Vaughan-Williams classification, rather  than
      the ATC classification is more appropriate.[20]

  40) The Vaughan-Williams classification system was developed in an attempt to classify the numerous antiarrhythmic drugs on the basis of  their
      mechanism. This system re-classifies the drugs included in ATC3 class C1B in four different classes:

   i. Class I: includes the main molecules that affect the conduction  velocity  (i.e.  the  speed  with  which  an  electrical  impulse  can  be
      transmitted through excitable tissue);

  ii. Class II: includes beta blockers (anti-hypertensives that act by way of beta-adrenergic blocking) for the treatment of hypertension;

 iii. Class III: includes two products that slow down the ventricular repolarization and affect sodium channels: amiodarone and sotalol;

  iv. Class IV: includes the calcium antagonists used for the treatment of hypertension or cardiac ischemia.

  41) Although in past cases the Commission considered that Classes I (containing  propafenone)  and  III  (containing  amiodarone)  may  not  be
      substitutable when used in the treatment of ventricular arrhythmias, it left the exact market definition open.[21]

  42) The Notifying Party submits that the Parties market two  different  molecules,  propafenone  and  amiodarone.  With  regard  to  these  two
      molecules, there is an overlap of the Parties' products at the level of the ATC3 class C1B, but no overlap according to the  classification
      by Vaughan-Williams, because propafenone belongs to Vaughan-Williams Class I and amiodarone to Vaughan-Williams Class III.

  43) However, Abbott EPD-DM markets also solatol, a beta-blocking agent, which belongs to ATC3 class C7A and is used  to  treat  arrhythmia  and
      hypertension. Solatol belongs to Vaughan-Williams Class II and III at the same time; given that it has both  beta-blockade  and  potassium-
      channel blockade effects. Accordingly, the Parties' products overlap in relation to Class III of the Vaughan-Williams classification.

  44) The market investigation provided indications that the  products  for  the  treatment  of  arrhythmia,  disorders  of  cardiac  rhythm  and
      tachycardia may be classified according to the classification of Vaughan-Williams. In this context, the prescribers indicated that  sotalol
      and amiodarone are generally substitutable to each other.

  45) Therefore, for the purposes of this decision, the Commission concludes that the relevant product  market  in  relation  to  drugs  treating
      arrhythmias, and in particular propafenone and amiodarone, should be defined according to the Vaughan-Williams classification.

Competitive assessment

  46) On the basis of the market definition set out about, the proposed transaction gives rise to one Group 1 affected market, Portugal.

      Portugal

  47) In Vaughan-Williams Class III, the Parties market the following molecules: Abbott EPD-DM markets solatol under the brand name Darob.  Mylan
      markets amiodarone as branded generic Amioda.

  48) The Parties' combined market share reaches [30-40]% (value) and [30-40]% (volume) with an increment (Abbott EPD-DM) of [10-20]% (value) and
      [10-20]% (volume). There is a number of branded and generic competitors active, namely the market leader Sanofi having a  market  share  of
      [40-50]% (in value) and [30-40]% (in volume), followed by Generis Farma with a market share of [5-10]% in value and [5-10]% in  volume.  In
      addition, Hikma Pharma is active and has a [0-5]% market share (value and volume) as well as Alter Pharma with a market share of [0-5]% (in
      value and volume).

  49) The size of the Portuguese market (2013) is EUR 2.9 million and has been declining from  EUR  3.3  million  in  2011.  Sanofi  as  the  ex-
      originator markets its branded product Cordarone based on amiodarone. Generis Farma and Fresenius together market three un-branded  generic
      products based on amiodarone. Hikma Pharma and Alter Pharma each offer an amiodarone-based un-branded generic product.

  50) In addition, four competitors (BioPortugal, Bluepharma Genéricos, Labesfal Genéricos and Ibigen) hold dormant marketing authorisations  for
      different dosages of amiodarone in the Portuguese market, which can be used to enter the market within a short period of time.

  51) Except for one Fresenius product, all drugs in the Vaughan-Williams Class III of the Parties and their main  competitors  in  Portugal  are
      reimbursed by the national health authorities. The Portuguese health authorities establish a maximum ex-factory price. This price is  based
      on an international reference system considering the average wholesale price in three other EU member states which have a comparable  gross
      domestic product to Portugal. Since wholesale and pharmacy margins are also regulated, this results therefore in a capped outpatient  price
      at pharmacy level (public price paid by patients in the pharmacy). Price increases of  pharmaceutical  products  are  possible  up  to  the
      maximum price set by the authority. In addition, each pharmaceutical company may submit an application for a price increase, which  however
      needs to be motivated. It follows that the ability of pharmaceutical companies to increase prices for these drugs is generally limited.

  52) Moreover, competing products based on the same molecule are typically closer substitutes than products based on different  molecules,  even
      if they belong to same Vaughan-Williams class. This is due to the different clinical and safety profile of each  molecule.  The  regulatory
      framework in Portugal also facilitates  substitutability  across  products  based  on  the  same  molecule  at  pharmacy  level,[22]  while
      substitution across molecules can only happen at the level of physician's prescription. In the case at hand, the  overlap  is  observed  in
      products based on different molecules, which therefore are unlikely to be closest competitors.

  53) Finally, given that solatol also belongs to Williams-Vaughan Class II, it is likely to be simultaneously  constrained  by  the  competitive
      dynamics between products in this other class, where the Parties do not overlap.

      Conclusion

  54) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to the products belonging  to
      the Vaughan-Williams Class III in Portugal.

2 Moxonidine (C2A)

      Product market definition

  55) Both Mylan and Abbott EPD-DM sell moxonidine which belongs to the ATC3 class C2A – Antihypertensives (of non-herbal origin), plain. The C2A
      class includes a group of substances used primarily for the treatment of hypertension. It comprises  plain  antihypertensives  and  various
      fixed dose combinations other than those with diuretics. The C2A class is further subdivided into  ATC4  classes  whereby  the  class  C2A1
      includes products which are mainly centrally-acting (e.g. moxonidine), while products which are mainly peripherally-acting are included  in
      the ATC4 class C2A2.

  56) Although the Commission has not dealt specifically with moxonidine in a past decision  concerning  antihypertensives,[23]  the  Commission,
      analysing the effects of the transaction on the molecule level in relation to three molecules namely methyldopa,  prasozin  and  terasozin,
      ultimately left the exact market definition open and in particular the question of whether the relevant market should  be  defined  on  the
      basis of ATC3, ATC4 or even molecule level.

  57) The Notifying Party submits that its products based on moxonidine compete with other centrally-acting antihypertensives, as they  have  the
      same mode of action, serve the same patient group and the therapeutical results are similar for all centrally-acting antihypertensives.  In
      addition, in the countries where relevant overlaps occur (see below), moxonidine and its other centrally-acting alternatives are subject to
      the same reimbursement rate. Therefore, Notifying Party submits that the relevant market for moxonidine would comprise all centrally-acting
      antihypertensives, i.e. the entire ATC4 class C2A1.

  58) Based on the results of the market investigation many hypertension conditions that are treated by moxonidine could also be treated by  some
      other centrally-acting antihypertension drugs. However, this does not  necessarily  imply  substitution  patterns  across  centrally-acting
      antihypertension drugs.

  59) Moreover, competing products based on the same molecule are typically closer competitors than products based on different  molecules,  even
      if they belong to the same ATC class. This is due to the fact  that,  despite  the  shared  indications,  different  molecules  still  show
      different clinical and safety profiles. The regulatory framework also typically facilitates substitutability across products based  on  the
      same molecule at pharmacy level, while substitution across molecules can only happen at the level of physician's prescription.

  60) The degree of product differentiation between the several calcium antagonist products available in the market is  sufficient  to  have  led
      Mylan to develop and commercialise two centrally-acting hypertensive products based on different molecules  (moxonidine  and  rilmenidine).
      This evidence suggests a degree of economic differentiation across centrally-acting hypertensives, and that having an additional centrally-
      acting hypertensive based on a different molecule in the firm's portfolio brings enough additional sales as to justify the sunk  investment
      needed to develop and launch it in the first place.

  61) In any event, the exact product market definition for moxonidine can be left open for the purpose of this decision  as  no  serious  doubts
      arise in relation to moxonidine under any alternative market definition.

      Competitive assessment

  62) On the basis of a narrowest molecule based market, the proposed transaction gives rise to three  Group  1  markets,  namely  France,  Czech
      Republic and Italy.

      France

  63) On the molecule level, the combined market share of the Parties reaches [50-60]% (value) and [50-60]% (volume). Abbott  EPD-DM's  has  been
      steadily decreasing (halved) in last years. The size of the French moxonidine market is around  EUR  5.2  million  in  2013  and  has  been
      declining from EUR 7.6 million in 2011.

  64) There is a number of branded and generic competitors active, namely the market leader Servier having a market share of [20-30]% (in  value)
      and [20-30]% (in volume) with its branded generic product Moxonidine Biogaran, followed by Teva ([10-20]% in value and [20-30]% in volume),
      and Stada ([5-10]% in value and [5-10]% in volume). Both Servier and Teva have increased their market shares by some [5-10]%  each  between
      2011 and 2013 and have significant marketing and distribution footprints as well as customer relationships in France. In  parallel,  Abbott
      EPD-DM has been consistently losing market share.

  65) Moxonidine is a reimbursed drug in France. The prices of all reimbursed drugs in France are regulated throughout the chain given that  they
      are all part of the so-called positive lists for hospitals and for community pharmacies.[24] As a result,  the  ability  of  pharmaceutical
      companies to increase prices for these drugs is generally limited.[25]

  66) Finally, the market investigation did not raise concerns in relation to moxonidine in France.

      Conclusion

  67) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to the moxonidine  market  in
      France.

      Czech Republic

  68) On the molecule level, the combined market share of the Parties' reaches [50-60]% (value) and  [40-50]%  (volume)  with  a  rather  limited
      increment of [5-10]% (value) and [5-10]% (volume). The size of the Czech moxonidine market is around EUR 5.4 million in 2013 and  has  been
      declining from EUR 6.6 million in 2011.

  69) Abbott EPD-DM's market share has been steadily decreasing in the last years. There is a number of branded and generic  competitors  active,
      namely Stada holding a market share of [20-30]% (value) and [30-40]% (volume), Actavis with a market share of [10-20]% and Worevag  with  a
      comparable share to the increment brought by Mylan, i.e. [5-10]%. Actavis seems to be a competitor gaining significant market share from [5-
      10]% in 2012 when it entered to above [10-20]% in the year thereafter.

  70) Moxonidine is a reimbursed drug in the Czech Republic. Reimbursable pharmaceutical products are subject to a maximum ex-factory price and a
      maximum distribution margin based on external reference pricing derived from a basket of several EU countries. As a result, the ability  of
      pharmaceutical companies to increase prices for these drugs is generally limited.

  71) Finally, the market investigation did not raise concerns in relation to moxonidine in the Czech Republic.

      Conclusion

  72) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to moxonidine  in  the  Czech
      Republic.

      Italy

  73) On the molecule level, the combined market share of the Parties' reaches [70-80]% (value) and  [70-80]%  (volume)  with  a  rather  limited
      increment of [0-5]% (value) and [0-5]% (volume). The size of the Italian moxonidine market is around EUR 1.8 million in 2013 and  has  been
      declining from EUR 2.4 million in 2011.

  74) Abbott EPD-DM is active with its ex-originator branded product Fisiotens and its share of the market has been steadily decreasing since the
      loss of exclusivity. Stada is the strongest competitor holding a market share of  [20-30]%  (value)  and  [20-30]%  (volume),  consistently
      gaining share from Abbott EPD-DM in the last years. Stada's entry had a significant impact on moxonodine  price  which,  according  to  the
      Parties' internal documents have been declining.

  75) Moxonidine is a reimbursed drug in Italy. The prices of the reimbursed drugs are set through negotiation between the relevant  manufacturer
      and the Italian Medicines Agency ("AIFA"). The regulatory framework does  not  generally  allow  for  price  increases  where  it  concerns
      reimbursed products. As a result, the ability of pharmaceutical companies to increase prices for these drugs is generally limited.

  76) One competitor holds a dormant marketing authorisation for three different dosages of moxonidine in Italy, which can be re-activated within
      a short period of time.

  77) Finally, the market investigation did not raise concerns in relation to moxonidine in Italy.

      Conclusion

  78) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to moxonidine in Italy.

3 Verapamil and Diltiazem (C8A)

      Product market definition

  79) Both Mylan and Abbott EPD-DM market verapamil, which is a calcium channel blocker derived from phylalkylamine. It belongs to the ATC3 class
      C8A which is comprised of plain calcium antagonists that are primarily used for the treatment of high blood pressure  and  angina.  Calcium
      antagonists, or calcium channel blockers, are a type of anti-hypertensives that inhibit movement of calcium ions across  a  cell  membrane.
      They include dihydropyridines ("DHPs") like nifedipine and non-DHPs such as verapamil and diltiazem.

  80) The Commission has so far assessed this type of molecules twice.[26] First, it concluded that combining multiple ATC2 classes consisting of
      numerous hypertension drugs would be too wide for market definition purposes. In a subsequent case, the Commission assessed ATC3 class  C8A
      and concluded that DHPs and non-DHPs compete. It also found that various types of antihypertensive drugs including beta  blockers,  calcium
      antagonists, ACE inhibitors form separate markets.[27]

  81) The Notifying Party submits that the product market should be defined in line with the Commission's precedents as ATC3 class  C8A,  because
      DHPs and non-DHPs (such as verapamil and diltiazem) compete with one another.

  82) It can be derived from the results of the market investigation that there  are  several  molecules  that  share  mechanism  of  action  and
      indications with verapamil, such as amlodipine, diltiazem, felodipine, gallopamil, nifedipine, and which can therefore in  some  cases  and
      for some patients be prescribed alternatively by physicians. This overlap in  therapeutic  uses  does  not  however  imply  any  particular
      economic substitution patterns across calcium antagonist drugs. The market investigation did not provide any indications that the market in
      this case should be further segmented depending on the galenic form or on whether the drug is sold against a prescription or OTC.

  83) Moreover, competing products based on the same molecule are typically closer substitutes than products based on different  molecules,  even
      if they belong to same ATC class. This is due to the fact that, despite the shared indications, different molecules  still  show  different
      clinical and safety profiles. The regulatory framework also typically facilitates  substitutability  across  products  based  on  the  same
      molecule at pharmacy level, while substitution across molecules can only happen at the level of physician's prescription.

  84) The degree of product differentiation between the several calcium antagonist products available in the market is  sufficient  to  have  led
      Mylan to develop and commercialise not less than 6 calcium  antagonist  products  based  on  different  molecules  (amlodipine;  diltiazem;
      lercanidipine; manidipine; nifedipine and nitrendipine). This evidence suggests a degree of differentiation  between  calcium  antagonists,
      and that having an additional calcium antagonist based on a different molecule in the firm's portfolio brings enough additional sales as to
      justify the sunk investment needed to develop and launch it in the first place. In any event,  the  exact  product  market  definition  for
      verapamil and diltiazem can be left open for the purpose of this decision as no serious doubts arise in relation to verapamil and diltiazem
      under any alternative market definition.

      Competitive assessment

  85) On the basis of the narrowest molecule based market definition, the proposed transaction gives rise to three Group 1 affected  markets  for
      verapamil, namely in France, Ireland and Sweden, as well as one Group 1 affected market in relation to diltiazem, namely in Portugal.

      France

  86) On the molecule level for verapamil, the combined market shares of the Parties reach [60-70]% (value) and [60-70]%  (volume).  Abbott  EPD-
      DM's shares have been steadily decreasing in the last years. The size of the French verapamil market is around EUR 21.5 million in 2013.

  87) There are a number of branded and generic competitors active, namely Teva with a market share of [10-20]% (value)  and  [20-30]%  (volume),
      Servier with [5-10]% (value) and [5-10]% (volume), Stada with [5-10]%  and  Novartis  with  [0-5]%.  All  these  four  competitors  have  a
      significant marketing and distribution footprint as well as customer relations in France. Therefore, they will be in a  position  to  exert
      competitive pressure on the merged entity post-merger.

  88) The prices of all drugs in the class in France are regulated throughout the chain given that they are all part of  the  so-called  positive
      lists for hospital and for community pharmacies. As a result, the ability of pharmaceutical companies to increase prices for these drugs is
      generally limited.[28]

  89) Finally, the market investigation did not raise concerns in relation to verapamil in France.

      Conclusion

  90) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to verapamil in France.

      Ireland

  91) On the molecule level for verapamil, the combined market share of the Parties in Ireland reaches [60-70]%  (value)  and  [60-70]%  (volume)
      with the increment of Mylan being limited reaching only [0-5]% in value and [5-10]% in volume. Abbott EPD-DM is present  with  its  branded
      products Isoptin and Securon, albeit its market share has been decreasing from [60-70]% in volume and [60-70]% in value in 2011. The  Irish
      verapamil market is very small with a turnover of EUR 339,000 in 2013 and has been declining from EUR 660,000 in 2011.

  92) [Mylan's information on phasing out activities and the lack of future  plans  with  regard  to  re-entering  the  market  of  verapamil  in
      Ireland].. The degree of competitive constraint exercised by Mylan can already be  considered  as  negligible  as  it  does  not  have  any
      prospects of re-entry in the short term.

  93) In addition, the other competitors, Novartis/Rowa/Wagner and Orion have increased their market share from [10-20]% and [5-10]%  (in  value)
      in 2011 to [20-30]% and [10-20]% in 2013 respectively.

  94) Finally, the market investigation did not raise concerns in relation to verapamil in Ireland.

      Conclusion

  95) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to verapamil in Ireland.

      Sweden

  96) On the molecule level for verapamil, the combined market share of the Parties in Sweden reaches  [50-60]%  (value)  and  [60-70]%  (volume)
      going down from [90-100]% (value) and [90-100]% (volume) as a consequence of parallel imports by 2Care4 and  Orifarm  that  reached  market
      shares of [20-30]% and [10-20]% (value) and [10-20]% and [10-20]% (volume).

  97) Procurement procedures for verapamil in Sweden are characterised by the use of tenders which occur every month and typically exert downward
      pressure on pricing. Tenders are used to appoint preferred suppliers on the basis of a competitive  process  based  on  price  competition.
      Therefore, competition takes place for the market (as opposed to "in the market"). In such a system, high market shares for  verapamil  are
      not necessarily indicative of the Parties' ability to affect the conditions of sale pre- or post-merger.

  98) Moreover, the size of the Swedish verapamil market is relatively small with a turnover of around EUR 1.28 million  in  2013  and  has  been
      declining from EUR 1.45 million in 2011. In these particular circumstances, namely where tenders are frequent  and  the  market  is  small,
      importing capacity of parallel importers may be significant.  The ability of parallel importers to quote lower prices when participating in
      tender procedures triggers downward pressure on prices, obliging suppliers with an established local presence to undercut prices  to  avoid
      being excluded from the set of appointed preferred suppliers. The high frequency of tenders in Sweden (i.e. on a monthly basis) facilitates
      the participation of parallel importers despite their general lack of security of long-term supply. As a  consequence,  parallel  importers
      can exert a pricing constraint in the rather unique setting observed in Sweden.

  99) Finally, the market investigation did not raise concerns in relation to verapamil in Sweden.

      Conclusion

 100) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to verapamil in Sweden.

 Portugal

 101) On the diltiazem molecule level, the combined market share of the Parties in Portugal reaches [20-30]% (value) and [30-40]%  (volume)  with
      an increment of [0-5]% for Abbott EPD-DM's product. The market leader is Rottapharm Madaus with a [40-50]% market share (value and volume).
      Sanofi has a market share of [20-30]% in value and [10-20]% in volume. The size of the  Portuguese  diltiazem  market  is  around  EUR  4.5
      million in 2013 and has been declining from EUR 6 million in 2011.

 102) The Portuguese health authorities establish a maximum  ex-factory  price.  This  price  is  based  on  an  international  reference  system
      considering the average wholesale price in three other EU Member States which have a comparable gross domestic product to  Portugal.  Since
      wholesale and pharmacy margins are also regulated, this results therefore in a capped outpatient price at pharmacy level (public price paid
      by patients in the pharmacy). Price increases of pharmaceutical products are possible up to the maximum price  set  by  the  authority.  In
      addition, each pharmaceutical company may submit an application for a price increase, which however needs to be motivated. It follows  that
      the ability of pharmaceutical companies to increase prices for these drugs is generally limited.

 103) Finally, the market investigation did not raise concerns in relation to diltiazem in Portugal.

      Conclusion

 104) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to diltiazem in Portugal.

4 Hydrochlorothiazide/verapamil and mefruside/nifedipine (C8B1)

      Product market definition

 105) The ATC3 class C8B includes calcium antagonists combined with other active ingredients. Calcium  antagonists  are  used  to  treat  various
      conditions of the heart and blood vessels including hypertension. The ATC4 class C8B1 relates to combinations of calcium  antagonists  with
      other antihypertensives and/or diuretics.

 106) The Commission has so far twice assessed this type of molecules.[29] First, it concluded that combining multiple ATC2 classes consisting of
      numerous hypertension drugs would be too wide for market definition purposes. In the subsequent case, the Commission  assessed  ATC3  class
      C8A and concluded that DHPs and non-DHPs compete. It also held that various  types  of  antihypertensive  drugs  including  beta  blockers,
      calcium antagonists, ACE inhibitors form separate markets.[30] However, the Commission has not yet considered a product  market  definition
      for ATC4 class C8B1 combination products.

 107) The Notifying Party submits that due to the fact that it discontinued its product in ATC4 class C8B1 in  mid-2013  and  re-entry  will  not
      occur in the short to medium term there is no need to reach any conclusions on market definition for this segment.

 108) Mylan stopped the marketing of its product (sold under the brand name Duranifin Sali),  [Mylan's  information  on  discontinuation  of  its
      product].

 109) [Mylan's information on market share development of its product]. Therefore, Mylan sold the last batch into the market in August  2013  and
      it confirms that there are no stocks left. Accordingly, Mylan has no commercial incentive to-enter this market segment.

 110) Finally, Mylan's product has officially been set “AV” (i.e. sales officially terminated) in the German public price list “Lauertaxe” on  15
      September 2013.

      Conclusion

 111) Based on the above, the Commission considers that the discontinuation of Mylan's ATC4 C8B1 product Duranifin Sali  was  an  autonomous  and
      definitive business decision by Mylan and that production and marketing of this product was  unlikely  to  resume.  As  a  result,  Mylan's
      decision to exit the relevant markets constitutes the relevant counterfactual  and  therefore  overlaps  in  these  markets  do  not  arise
      irrespective of the market definition.

5 Trandolapril (C9A)

      Product market definition

 112) Both Mylan and Abbott EPD-DM market trandolapril, an anti-hypertension product. Trandolapril is an angiotensin-converting-enzyme  inhibitor
      ("ACE inhibitor"),  which  reduces  peripheral  arterial  resistance  by  inactivating  an  enzyme  that  converts  angiotensin  I  to  the
      vasoconstrictor angiotensin II. It belongs to the ATC3 class C9A which is comprised of plain ACE inhibitors that are primarily used for the
      treatment of high blood pressure and congestive heart failure.

 113) In its latest decision dealing with ACE-inhibitors, the Commission defined the market at  the  molecule  level.  In  its  investigation  on
      perindopril, an ACE inhibitor in the C9A class, the Commission concluded that no antihypertensive medicine other than the generic  versions
      of perindopril was able to meaningfully constrain branded perindopril sales and prices.[31] In previous merger  decisions,  the  Commission
      had left the product market definition open in relation to ACE inhibitors.[32]

 114) The Notifying Party submits that the product market should be defined to include at least ATC3 class C9A and possibly also ATC3 class  C9B,
      as all ACE inhibitor drugs have comparable efficacy in terms of their blood pressure lowering ability.

 115) The market investigation indicated that although ACE inhibitors share mechanism of action and indications, they  cannot  always  substitute
      each other. The market investigation provided evidence that each molecule has its specificities and that in some cases trandolapril is even
      the only ACE inhibitor that can be used. Indeed, the  overlap  in  some  indications  does  not  imply  substitution  patterns  across  ACE
      inhibitors.

 116) Moreover, products based on the same molecule are typically closer substitutes than products based on different  molecules,  even  if  they
      belong to same ATC class. This is due to the fact that, despite the shared indications, different molecules still show  different  clinical
      and safety profiles. The regulatory framework also typically facilitates substitutability across products based on  the  same  molecule  at
      pharmacy level, while substitution across molecules can only happen at the level of physician's prescription.

 117) The degree of product differentiation between the several calcium antagonist products available in the market is  sufficient  to  have  led
      both Abbott EPD-DM and Mylan to develop and commercialise several ACE inhibitors based on different molecules in  parallel.  Abbott  EPD-DM
      commercialises three ACE inhibitors (cilazapril, imidapril and trandolapril), while  Mylan  commercialises  ten  different  ACE  inhibitors
      (benazepril, captopril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril and  zofenopril).  This  evidence
      suggests a degree of differentiation between ACE inhibitors, and that having an additional ACE inhibitor based on a different  molecule  in
      the firm's portfolio brings enough additional sales as to justify the sunk investment needed to develop and launch it in the first place.

 118) The market investigation also indicated that trandolapril is not a widely used ACE inhibitor and its  share  has  been  declining  as  more
      modern therapies, including combination drugs, gain traction in the market.

 119) In any event, the product market definition in relation to trandolapril can be left open for the purpose of this case as no serious  doubts
      arise in relation to trandolapril irrespective of the market definition.

      Competitive assessment

 120) On the basis of the narrowest molecule based market definition, the proposed transaction gives rise to Group 1 affected markets in  Poland,
      Czech Republic, France, Italy, Portugal and Slovakia.

 Poland

 121) The combined market share of the Parties at molecule level in Poland reaches [90-100]%  (value)  and  [90-100]%  (volume)  with  a  limited
      increment of less than [0-5]% (value) and [0-5]% (volume) brought by Mylan. Abbott EPD-DM is active with its branded product  Gopten  while
      Mylan sells generic. Since 2013 Actavis is also active with a share of around [5-10]% which it gained in the first year.

 122) The size of the Polish trandolapril market is rather small of around EUR 3.6 million in 2013 and has been declining from EUR 4.1 million in
      2011. This seems to be in line with the finding that trandolapril is a rarely used molecule in Poland and more generally in Eastern Europe.
      According to the market investigation, trandolapril in Poland is typically used only as a third line of treatment, in rare situations where
      ramipril and perindopril would not produce satisfying effects.

 123) In addition, none of trandolapril based drugs are reimbursed in Poland, which also explains its low penetration. Although pricing  of  non-
      reimbursed drugs is free, the prices have been decreasing in Poland irrespective of the concentrated  nature  of  the  Polish  trandolapril
      market. The rapid gain of trandolapril sales share by Actavis, compared to the decrease in Mylan's share between 2012  and  2013,  suggests
      that Actavis currently exerts the strongest competitive pressure on Abbott EPD-DM for trandolapril in Poland. This  competitive  constraint
      will remain active post transaction.

 124) Moreover, three competitors hold dormant marketing authorisations to sell trandolapril in several dosages in the Polish market,  which  can
      be re-activated within a short period of time. One of these marketing authorisations is held by Galex, with an established presence in  the
      Polish market through a portfolio of drugs, including several cardiologic therapies like ramipril, lisinopril and valsartan amongst others.
      Galex is present with trandolapril in a number of other European markets, including Slovenia, Denmark, Czech Republic,  Hungary,  Slovakia,
      Bulgaria, Estonia, Latvia, Lithuania and Romania. Alvogen, a generic multinational company that acquired the Romanian Labormed  Pharma,  is
      the current holder of another market authorisation for trandolapril in Poland. Alvogen has a portfolio  of  more  than  350  pharmaceutical
      products and an established presence in Poland as well as most Eastern and Central European Countries, including Bulgaria,  Croatia,  Czech
      Republic, Estonia, Hungary, Latvia, Lithuania and Slovakia.

 125) Finally, the market investigation did not raise concerns in relation to trandolapril in Poland.

      Conclusion

 126) Taking into consideration all of the above, including the results of the market investigation and the minimal increment resulting from  the
      transaction, the Commission, concludes that the transaction does not give rise to serious doubts as to its compatibility with the  internal
      market in relation to trandolapril in Poland.

 Czech Republic

 127) The combined market share of the Parties at molecule level in the Czech Republic reaches [90-100]% (value) and [90-100]%  (volume)  with  a
      limited increment of [0-5]% (value) and [0-5]% (volume) brought by Mylan. Abbott EPD-DM is active with its  branded  product  Gopten  while
      Mylan sells a generic product. Since 2013 Teva has also been active with a share of around [5-10]% which it gained in the first year.

 128) The size of the Czech trandolapril market is rather small of less than EUR 3 million in 2013 and has been declining from EUR 3.7 million in
      2011. Similarly to Poland, trandorapril is a rarely used molecule in the Czech Republic, relative to other ACE inhibitors.

 129) The rapid gain of trandolapril sales share by Teva, compared to the relatively flat evolution of Mylan's share since  2011,  suggests  that
      Teva currently exerts the strongest competitive pressure on Abbott EPD-DM for trandolapril in the Czech Republic.

 130) Moreover, at least one competitor, Galex, holds a dormant marketing authorisation to sell trandolapril in  several  dosages  in  the  Czech
      Republic, which can be re-activated within a short period of time. Galex has  an  established  presence  in  the  Czech  market  through  a
      portfolio of drugs, including several cardiologic therapies like ramipril and valsartan. Galex is present with trandolapril in a number  of
      other European markets, including Slovenia, Denmark, Czech Republic, Hungary, Slovakia, Bulgaria, Estonia, Latvia, Lithuania and Romania.

 131) Trandolapril-based products are reimbursed in the Czech Republic. Reimbursable pharmaceutical products are subject to a maximum  ex-factory
      price and a maximum distribution margin based on external reference pricing derived from a basket of several EU countries. As a result, the
      ability of pharmaceutical companies to increase prices for these drugs is generally limited.

 132) Finally, the market investigation did not raise concerns in relation to trandolapril in the Czech Republic.

      Conclusion

 133) Taking into consideration all of the above, and in particular the minimal increment resulting  from  the  transaction,  together  with  the
      rising constraint exerted by Teva and the presence of relevant potential competition, the Commission concludes that  the  transaction  does
      not give rise to serious doubts as to its compatibility with the internal market in relation to trandolapril in the Czech Republic.

      France

 134) The combined market share of the Parties at molecule level in France reaches [60-70]% (both in value and volume). Abbott EPD-DM  is  active
      with its branded product Odrik while Mylan sells a generic product. Servier, Actavis and Stada are also present holding  market  shares  of
      [20-30]%, [5-10]% and [0-5]% respectively. Moreover, [EPD-DM's information on lack of promotion of trandolapril in France].   Between  2011
      and 2013, its market share dropped from [50-60]% to [30-40]%.

 135) The size of the French trandolapril market is limited amounting to less than EUR 6 million in 2013 and has  been  declining  from  EUR  7.3
      million in 2011. In addition, given its strong network of prescribers in the cardio-metabolic area and French historical franchise, Servier
      is a particularly vigorous competitor in the French market consistently gaining market share. Specifically, between 2011 and  2013  Servier
      gained [10-20]% market share while Abbott EPD-DM lost around [10-20]% of its sales. This  evidence  suggests  that  Servier's  trandolapril
      currently exerts the strongest competitive pressure on the merging Parties for trandolapril in France.

 136) Trandolapril-based products are reimbursed in France. The prices of all reimbursed drugs in France are regulated throughout the chain given
      that they are all part of the so-called  positive  lists  for  hospital  and  for  community  pharmacies.  As  a  result,  the  ability  of
      pharmaceutical companies to increase prices for these drugs is generally limited.[33]

 137) Finally, the market investigation did not raise concerns in relation to trandolapril in France.

      Conclusion

 138) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to trandolapril in France.

      Italy

 139) The combined market share of the Parties at molecule level in Italy reaches [90-100]%. Abbott EPD-DM is active  with  its  branded  product
      Gopten while Mylan sells a generic product.

 140) Two competitors hold dormant marketing authorizations  for  various  strengths  of  trandolapril  in  Italy.  One  of  them  is  Mediolanum
      Farmaceutici, an Italian-based company with established R&D, manufacturing and commercialisation  footprint  in  Italy.  Its  portfolio  of
      products includes other cardio-metabolic drugs, like lisinopril and ticlopidine. This makes it an experienced potential competitor  in  the
      area. The other marketing authorisation is held by Actavis, since it acquired Arrow,  the  previous  holder.  Actavis  is  a  multinational
      pharmaceutical company, with an established manufacturing and commercial presence in Italy. Moreover,  Actavis  has  recently  entered  the
      trandolapril market in other countries, like Poland, where it has been a vigorous competitor rapidly gaining market share.

 141) The size of the Italian trandolapril market is very limited amounting to EUR 409,000 in 2013 and has been declining  from  EUR  578,000  in
      2011. Moreover, both relative market shares and unit prices for trandolapril in Italy have remained broadly stable over the last years. The
      latter, together with the declining size of an already very small market by size, suggests that the competitive dynamics were  unlikely  to
      deliver any further price reductions absent the proposed transaction.

 142) In addition, trandolapril is a reimbursed drug in Italy. The prices of the  reimbursed  drugs  are  set  through  negotiation  between  the
      relevant manufacturer and AIFA. The regulatory framework does not  generally  allow  for  price  increases  where  it  concerns  reimbursed
      products. As a result, the ability of pharmaceutical companies to increase prices for these drugs is generally limited.

 143) Finally, the market investigation did not raise concerns in relation to trandolapril in Italy.

      Conclusion

 144) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to trandolapril in Italy.

      Portugal

 145) The combined market share of the Parties at molecule level in Portugal reaches [30-40]% (value) and [30-40]%  (volume).  Abbott  EPD-DM  is
      active with its branded product Gopten while Mylan sells a generic product. Faes and Generis Farma are also present holding  significant  –
      higher than Mylan - market shares of [40-50]% and [20-30]% respectively.

 146) The size of the Portugese trandolapril market is very limited amounting to EUR 414,000 in 2013 and has been declining from EUR 1 million in
      2011. Generis Farma's market share was steadily rising since 2011 from [10-20]% to [20-30]%.

 147) The trandolapril-based products of the Parties and their competitors in Portugal are reimbursed by the  national  health  authorities.  The
      Portuguese health authorities establish a maximum ex-factory price. This price is based on an international  reference  system  considering
      the average wholesale price in three other EU member states which have a comparable gross domestic product to Portugal. Since wholesale and
      pharmacy margins are also regulated, this results therefore in a capped outpatient price at pharmacy level (public price paid  by  patients
      in the pharmacy). Price increases of pharmaceutical products are possible up to the maximum price set by the authority. In  addition,  each
      pharmaceutical company may submit an application for a price increase, which however needs to be motivated. It follows that the ability  of
      pharmaceutical companies to increase prices for these drugs is generally limited.

 148) Finally, the market investigation did not raise concerns in relation to trandolapril in Portugal.

      Conclusion

 149) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to trandolapril in Portugal.

      Slovakia

 150) The combined market share of the Parties at molecule level in Slovakia reaches [80-90]%  (value)  and  [80-90]%  (volume)  with  a  limited
      increment of [0-5]% (both in value and [0-5]% (volume) brought by Mylan. Abbott EPD-DM is active with  its  branded  product  Gopten  while
      Mylan sells a generic product. Teva is also active holding a market share of [10-20]% (value) and [10-20]% (volume), as well as Actavis ([0-
      5]% market share in value and volume). The size of the Slovak trandolapril market is around EUR 4.5 million in 2013 and has been  declining
      from EUR 5.4 million in 2011.

 151) The Notifying Party submits that in view of its marginal  market  share  and  [Mylan's  commercial  information  concerning  its  sales  of
      trandolapril in Slovakia], Mylan has decided to discontinue its trandolapril activities in Slovakia. Mylan's stock which is  still  in  the
      market will be exhausted in the course of […].

 152) Finally, the market investigation did not raise concerns in relation to trandolapril in Slovakia.

      Conclusion

 153) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to trandolapril in Slovakia.

6 Fenofibrate (C10A)

      Product market definition

 154) Fenofibrate is a broad spectrum lipid-lowering agent belonging to the ATC3 class C10A comprising various  products  used  for  a  range  of
      metabolic disorders, mainly cholesterol and trigyceride regulating preparations. They operate by reducing the amount of fats in blood.

 155) In its past decision, the Commission has considered that the market definition encompasses  all  cholesterol  and  tryglyceride  regulating
      preparations (the ATC3 class C10A).[34]

 156) The Notifying Party submits that the product market should be defined in line with the precedent at ATC3 class C10A, as substitution  takes
      place, for example, between fibrates (ATC4 class C10A2) and statins (ATC4 class C10A1).

 157) Based on the results of the market investigation, fenofibrate shares therapeutic  indications  with  other  agents,  such  as  bezafibrate,
      ciprofibrate or fluvastatin, atorvastatin, and simvastatin. This overlap in indications does not imply any particular economic substitution
      patterns across angiotensin-II receptor antagonists. In addition, the market investigation did not provide any indications that the  market
      in this case should be further segmented depending on the galenic form or on whether the drug is sold against a prescription or OTC.

 158) Moreover, competing products based on the same molecule are typically closer substitutes than products based on different  molecules,  even
      if they belong to same ATC class. This is due to the fact that, despite the shared indications, different molecules  still  show  different
      clinical and safety profiles.

 159) The degree of product differentiation between the several cholesterol and tryglyceride regulating  products  available  in  the  market  is
      sufficient to have led Mylan  to  develop  four  different  cholesterol  and  tryglyceride  regulating  drugs  (bezafibrate,  ciprofibrate,
      fenofibrate and gemfibrozil). This evidence suggests a degree of differentiation between cholesterol and tryglyceride regulating drugs, and
      that having an additional cholesterol and tryglyceride regulating drug based on a different molecule in the firm's portfolio brings  enough
      additional sales as to justify the sunk investment needed to develop and launch it in the first place.

 160) In any event, the product market definition in relation to fenofibrate can be left open for the purpose of this case as no  serious  doubts
      arise in relation to fenofibrate irrespective of the market definition.

      Competitive assessment

 161) On the basis of the narrowest molecule based market definition, the proposed transaction gives rise to  three  Group  1  affected  markets,
      namely France, Germany and Belgium.

 France

 162) The combined market share of the Parties at molecule level in France reaches [40-50]% (value) and [40-50]% (volume) with  an  increment  of
      [20-30]% (value) and [10-20]% (volume) brought by Abbott EPD-DM. A number of other competitors are present in the  market,  namely  Servier
      with a market share of [20-30]% (value) and [20-30]% (volume), Teva with [10-20]% (value) and [10-20]% (volume), as well as  Novartis  with
      [5-10]% (value) and [10-20]% (volume). All three competitors are well established firms, whose market shares  increased  both  jointly  and
      individually over the last years, showing that they represent a significant competitive constraint to the merging Parties.

 163) The size of the French fenofibrate market is around EUR 55 million in 2013 and has been declining from EUR 70 million in 2011.

 164)  Fenofibrate-based products are reimbursed in France. The prices of all reimbursed drugs in France are regulated throughout the chain given
      that they are all part of the so-called  positive  lists  for  hospital  and  for  community  pharmacies.  As  a  result,  the  ability  of
      pharmaceutical companies to increase prices for these drugs is generally limited.[35]

 165) Finally, the market investigation did not raise concerns in relation to fenofibrate in France.

      Conclusion

 166) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to fenofibrate in France.

 Germany

 167) The combined market share of the Parties at molecule level in Germany reaches [30-40]% (value) and [20-30]% (volume) with an  increment  of
      [10-20]% (value) and [10-20]% (volume) brought by Mylan. The size of the German fenofibrate market is around EUR 9.4 million  in  2013  and
      has been declining from EUR 12.3 million in 2011.

 168) A number of other competitors are present in the market, namely Torrent with a market share of  [30-40]%  (value)  and  [30-40]%  (volume),
      Sanofi with [20-30]% (value) and [20-30]% (volume), Novartis with [5-10]% (value) and [5-10]%  (volume),  as  well  as  Teva  with  [5-10]%
      (volume). All the competitors are well established firms. The market share of the leading competitor is higher  than  the  combined  market
      share of the merging Parties, while the second largest competitor has market share well above the increment  resulting  from  the  proposed
      transaction.

 169) Finally, the market investigation did not raise concerns in relation to fenofibrate in Germany.

      Conclusion

 170) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to fenofibrate in Germany.

 Belgium

 171) The combined market share of the Parties at molecule level in Belgium reaches [80-90]% (value)  and  [70-80]%  (volume)  with  a  very  low
      increment of [0-5]% (value) and [0-5]% (volume) brought by Mylan, which entered the market in 2003 as a first generic company. The size  of
      the Belgian fenofibrate market is around EUR 6.6 million in 2013 and has been declining from EUR 7.2 million in 2011.

 172) Other competitors, with much higher market share than Mylan, are present in the market, namely SMB with a market share of [10-20]%  (value)
      and [10-20]% (volume), as well as Stada with [5-10]% (value) and [5-10]% (volume). Both competitors  have  a  well-established  and  stable
      presence in the Belgian market and have market share several times higher than the  increment  resulting  from  the  proposed  transaction.
      Therefore, the main competitive constraints to Abbott EPD-DM will remain active post-transaction.

 173) Finally, the market investigation did not raise concerns in relation to fenofibrate in Belgium.

      Conclusion

 174) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to fenofibrate in Belgium.

7 Eprosartan (C9C)

      Product market definition

 175) Eprosartan belongs to the ATC3 class C9C including plain angiotensin II receptor antagonists. This group  of  pharmaceuticals  is  used  to
      treat hypertension, diabetic nephropathy (kidney damage due to diabetes) and congestive heart failure.

 176) So far, the Commission has not assessed the molecule eprosartan  specifically.  With  regard  to  anti-hypertensives,  the  Commission  has
      considered in its past decisions that anti-hypertensives belonging to ATC3 classes C7A/B (plain  and  combined  betablockers),  ATC3  class
      C8A/B (plain and combined calcium antagonists), ATC3 class C9A/B (plain and combined ACE  inhibitors)  and  ATC3  class  C9C/D  (plain  and
      combined angiotensin II inhibitors) are not part of the same product market.[36]

 177) The Notifying Party submits that its products based on eprosartan, which fall under ATC3  class  C9C  compete  with  other  angiotensin  II
      antagonists, including candesartan, irbesartan, losartan, olmesartan, telmisartan and valsartan. In its  submission,  the  Notifying  Party
      relies on comparable efficacy and safety of different angiotensin II antagonists and the lack of clear clinical benefit  as  compared  from
      one angiotensin II antagonist to another.

 178) Based on the results of the market investigation, eprosartan shares therapeutic indications with other angiotensin-II receptor antagonists,
      including losartan, valsartan, candesartan and irbesartan. The overlap in indications does not imply any particular  economic  substitution
      patterns across angiotensin-II receptor antagonists.

 179) Moreover, competing products based on the same molecule are typically closer substitutes than products based on different  molecules,  even
      if they belong to the same ATC class. This is due to the fact  that,  despite  the  shared  indications,  different  molecules  still  show
      different interactions and secondary effects. The regulatory framework also often facilitates substitutability across products based on the
      same molecule at pharmacy level, while substitution across molecules can only happen at the level of physician's prescription.

 180) The degree of product differentiation between the several angiotensin-II receptor antagonists available in the market is sufficient to have
      led Mylan to develop no less than seven different angiotensin-II  receptor  antagonists  (candesartan  cilexetil,  eprosartan,  irbesartan,
      losartan, telmisartan and valsartan). This evidence suggests a degree of differentiation between angiotensin-II receptor  antagonists,  and
      that having an additional angiotensin-II receptor antagonist based on a different molecule in the firm's portfolio brings enough additional
      sales as to justify the sunk investment needed to develop and launch it in the first place.

 181) In any event, the product market definition in relation to eprosartan can be left open for the purpose of this case as  no  serious  doubts
      arise in relation to eprosartan irrespective of the market definition.

      Competitive assessment

 182) On the basis of the narrowest molecule-based market definition, the proposed transaction gives rise to one Group  1  affected  market,  the
      Netherlands.

 The Netherlands

 183) The combined market share of the Parties at molecule level in the Netherlands reaches  [60-70]%  (value)  and  [60-70]%  (volume)  with  an
      increment of [10-20]% (value) and [10-20]% (volume) brought by Mylan. Abbott EPD-DM is active with its branded product Teveten while  Mylan
      sells generic.

 184) There is a strong activity of parallel importers supplying the remaining quantities of eprosartan. In 2011  and  2012,  parallel  importers
      provided up to 70% of the overall supplies, after being appointed as preferred suppliers by regulatory authorities  following  the  tenders
      organised in the framework of the "preference policy" mechanism.

 185) The size of the Dutch eprosartan molecule market is very small with a turnover of around EUR 0.89 million in 2013. The limited size of  the
      market, as compared with Abbott EPD-DM's significant EEA-wide sales of Teveten of […] million, allows parallel importers to find sufficient
      sources of supply to participate in Dutch tenders. This is evidenced by the approximately 70% market share held by  parallel  importers  in
      2011 and 2012. As a consequence, parallel importers exert a pricing constraint in this rather unique setting observed in the Netherlands.

 186) Eprosartan-based products are reimbursed in the Netherlands, and the regulatory framework includes the "preference policy"  mechanism  that
      exerts strong downward pressures on pricing through tenders, significantly constraining firms' commercial behaviour. The system enables  in
      fact the use national tenders for generic medicines such as eprosartan  to  decide  which  suppliers  are  preferred  on  the  basis  of  a
      competitive process, based on price. Given the size of the market and the frequency of the tenders,  parallel  importers  also  compete  in
      tenders. In such a system, high market shares for generic products are not necessarily indicative of the Parties'  ability  to  affect  the
      conditions of sales. Benefits of competition are rather achieved through effective use  of  competition  for  the  market  (as  opposed  to
      competition "in the market").

 187) Finally, the market investigation did not raise concerns in relation to eprosartan in the Netherlands

      Conclusion

 188) Taking into consideration all of the above, including the results of the market investigation and in particular the regulatory  environment
      and the rather unique "preference policy" implemented in the Netherlands, the Commission concludes that the transaction does not give  rise
      to serious doubts as to its compatibility with the internal market in relation to eprosartan in the Netherlands.

8 Other Group 2 and Group 3 markets in the cardio therapeutic area

 189) In addition to the Group 1 markets analysed above, there is a number of  Group  2  and  Group  3  affected  markets  in  the  cardio  area,
      specifically:

      • ATC3 class C1B in Belgium, the Czech Republic, France, Italy, and the UK.

      • ATC3 class C2A in the Czech Republic, Finland, France, Italy, Belgium, Slovakia and Spain.

      • ATC3 class C7A in Italy

      • ATC3 class C8A in France, Italy and Portugal

      • ATC3 class C9A in France and Slovakia

      • ATC3 class C9B in France

      • ATC3 class C9C in France

      • ATC3 class C10A in Belgium, Czech Republic, France, Germany and the UK

 190) Within these ATC classes several galenic  forms  are  marketed  and  give  rise  to  technically  affected  markets.  However,  the  market
      investigation did not provide any indications that the markets in this case should be further segmented depending on the galenic form or on
      whether the drug is sold against a prescription or OTC.

 191) On these markets the combined market share of the Parties are moderate to low and / or the increment is below 1%. In all cases there are  a
      number of strong competitors active on these markets with a wide portfolio of products, including branded medicines but  also  branded  and
      non-branded generic products, such as Servier, Sanofi, Novartis, Stada, Teva, Actavis, Pfizer, Takeda, Sigma  Tau,  Bristol  Myers  Squibb,
      Böhringer Ingelheim.

 192) The market investigation did not provide any indication that competition issues would arise in these markets. On this basis the  Commission
      concludes that the transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to any  of
      these markets.

GASTRO AREA

 193) This therapeutic area concerns products that are prescribed for gastrointestinal indications. The relevant products in this segment for the
      envisaged transaction are prescribed for treatment of disorders concerning the acid secretion by the  stomach,  obstipation  and  irritable
      bowel syndrome. Both Parties are present in this therapeutic area with several marketed products, which belong to various ATC3 classes.  In
      particular, they compete in the relation to the molecules as set out below.

1 Ranitidine (A2B)

      Product market definition

 194) Ranitidine belongs to the ATC3 class A2B which includes antiulcerants. The anti-peptic ulcer category encompasses a variety of  drugs  used
      to treat a range of common disorders considered to be related to acid secretion by the stomach. The ATC3 class A2B is further divided  into
      several ATC4 classes depending on the mode of action. For instance, ATC4 class A2B1 contains  the  H2  antagonists  (e.g.  ranitidine-based
      products) and ATC4 class A2B2 includes acid (or proton) pump inhibitors (e.g. lansoprazole-based products).

 195) In past decisions, the Commission has analysed this market both at the ATC3 (A2B – antiulcerants) and ATC4 level (A2B1 - H2 antagonists and
      A2B2 - acid pump inhibitors).[37] In case COMP/37.507 (AstraZeneca), the Commission defined a separate market at the ATC4 level for  proton
      pump inhibitors which did not include H2 blockers.

 196) The Notifying Party supports a market definition at the ATC4 level leading to a relevant market for the A2B1 class of H2 antagonists, which
      would include molecules such as ranitidine, cimetidine, famotidine, nizatidine, and roxatidine.

 197) The market investigation indicated that various molecules within the category of H2 antagonists are substitutable and ranitidine is  by  no
      means specific. In addition, the results of the market investigation revealed that within the  family  of  antiulcerants  A2B2,  acid  pump
      inhibitors such as omeprazole, are a more recent and effective generation  of  products  compared  to  H2  antagonists.  Hence,  acid  pump
      inhibitors, appear to be preferred by doctors. For example, it was submitted that in France doctors prescribe acid pump inhibitors  instead
      of H2 antagonists in more than 95% of cases. Also, switching patients who are already taking H2 antagonists to acid pump inhibitors is  not
      problematic. Therefore, H2 antagonists appear to be substitutable by acid pump inhibitors, which seem to be more  effective  (although  the
      reverse substitution may not occur).

 198) Given the one-way substitutability of H2 antagonists (including ranitidine) by acid pump inhibitors, for the  purposes  of  this  case  the
      Commission concludes that the relevant product market in relation to ranitidine-based products is wider than  the  molecule,  but  narrower
      than the ATC3 class, likely comprising ATC4 classes A2B1 and A2B2.

      Conclusion

 199) On the basis of the market definition set out above, no Group 1 affected markets arise and the transaction does not raise serious doubts in
      relation to ranitidine.

2 Lactulose (A6A)

      Product market definition

 200) Lactulose belongs to the ATC3 class A6A which includes OTC and prescription products used for the treatment of constipation. ATC3 class A6A
      is further subdivided into several ATC4 classes on the basis of the drugs' mode of action. Lactulose-based products are  categorised  under
      the A6A6 class of osmotic laxatives without electrolytes.[38]

 201) In the past, the Commission examined all A6A products within one market.[39] Similarly, in another  case  where  the  ATC3  class  A6A  was
      considered the Commission found that products categorized in the various ATC4 classes belonging to the ATC3 class A6A  are  interchangeable
      to some degree, but it ultimately left open the market definition.[40]

 202) The results of the market investigation suggest that other molecules may be substitutable  to  lactulose.  According  to  the  respondents,
      lactulose is a relatively old molecule which had popularity in the past. Since then, newer and more effective products have appeared on the
      market treating the same condition, in particular Polyethylene Glycol ("PEG"), also known  under  the  International  Non-proprietary  Name
      ("INN") macrogol, which belongs to the same ATC4 class A6A6 as lactulose. PEG products appear  to  have  lower  side  effects  compared  to
      lactulose. Given their substitutability, PEG products are prescribed more often  compared  to  lactulose  based-products,  for  example  in
      France. [Internal Mylan documents concerning relationship PEG/Macrogol versus lactulose.]

 203) Based on the above, for the purposes of this decision, the Commission concludes that the relevant product market for  lactulose  should  be
      defined at least as comprising other products in the ATC4 class A6A6.

      Competitive assessment

 204) On the basis of the market definition set out above, a Group 1 market arises in France.

      France

 205) Both Parties market lactulose-based products in France, which are primarily sold OTC. Abbott EPD-DM markets its  product  under  the  brand
      name Duphalac while Mylan markets a generic lactulose product. Lactulose products  are  reimbursed  in  France.  The  size  of  the  French
      lactulose market is around EUR 19.5 million in 2013.

 206) The Parties' combined market share at the ATC4 level is [40-50]% by value (Abbott EPD-DM: [10-20]%; Mylan: [20-30]%) and [40-50]% by volume
      (Abbott EPD-DM: [10-20]%; Mylan: [20-30]%).

 207) Post-merger, a number of strong competitors would remain in the market, including a market leader,  Servier,  with  its  generic  lactulose
      product holding a market share of [20-30]% (value) and [20-30]% (volume), as well as Ipsen with a market share of [10-20]% (value) and [10-
      20]% volume, and Novartis with a market share of [5-10]% (value) and [10-20]% (volume).

 208) In addition, eight competitors (including Teva, Fresenius and Ranbaxy) hold dormant  marketing  authorisations  for  different  dosages  of
      lactulose in the French market, which can be used to enter the market within a short period of time.

 209) The prices of all reimbursed drugs in France are regulated throughout the chain given that they are all  part  of  the  so-called  positive
      lists for hospital and for community pharmacies. As a result, the ability of pharmaceutical companies to increase prices for these drugs is
      generally limited.[41]

      Conclusion

 210) Taking into consideration all of the above, including the results of the market investigation and in particular the presence of significant
      competitors, the Commission concludes that the transaction does not give rise to serious doubts as to its compatibility with  the  internal
      market in relation to lactulose in France.

3 Mebeverine (A3A)

      Product market definition

 211) Mebeverine belongs to the ATC3 class A3A covering all plain synthetic and natural antispasmodics and anticholinergics which are part of the
      wider ATC2 class A3 covering functional gastro-intestinal disorder drugs. Amongst other things, anticholinergic or antispasmodic drugs  are
      used to relieve cramps or spasms of the stomach, intestines and bladder.

 212) The Notifying Party submits that the relevant market for mebeverine should be defined at ATC3 level, encompassesing all plain synthetic and
      natural antispasmodics and anticholinergics.

 213) The Commission analysed the A3A class in the past[42] adopting a market definition approach based on the ATC3 level,  although  there  were
      indications that in some cases the products might not be entirely substitutable. The Commission  also  identified  a  possible  distinction
      between the OTC and prescription segments.

 214) In the present case, the feedback received from respondents to the market  investigation  suggests  that,  while  it  may  be  possible  to
      substitute mebeverine by some other products in some specific cases, mebeverine is unlikely to be fully replaceable in the treatment of its
      main indications, in particular irritable bowel syndrome. The results of the market investigation indicate that  mebeverine  has  a  longer
      action which is unique compared to other molecules on the market. Alternative products, such as Buscopan (based on  butylscopolamine),  are
      characterised by short targeted action and are usually prescribed in case of acute cramps. By contrast, mebeverine  provides  a  long  term
      retarded effect and is particularly useful in chronic conditions. Moreover, some of the alternative products tend  to  cause  greater  side
      effects than mebeverine

 215) Based on the above, for the purposes of this decision, the Commission concludes that the relevant product market for mebeverine  should  be
      defined at the molecule level.

      Competitive assessment

 216) On the basis of the market definition set out above, Group 1 markets arise in relation to Germany and the UK.

      Germany

 217) Abbott EPD-DM markets its product under the brand Duspatal. Mylan's generic version of mebeverine is non-branded and is marketed under  the
      name of the active ingredient. The total size of the market in Germany in terms of sales is approximately EUR 6 million.

 218) The Parties' combined market share for mebeverine-based products in Germany at the molecule level is [60-70]% by volume (Abbott EPD-DM: [20-
      30]%; Mylan: [40-50]%) and [60-70]% by value (Abbott EPD-DM: [30-40]%; Mylan: [30-40]%).

 219) The only competitors to the Parties for mebeverine in Germany are parallel importers, which buy branded mebeverine-based products, in  this
      case Abbott EPD-DM's, in other Member States and import them to Germany. According to the market investigation, the competitive  constraint
      imposed by parallel importers in Germany is limited since they: (i) do not control the availability of product and are dependent on  supply
      from the branded manufacturers in other countries; (ii) benchmark their pricing against the branded product (namely, Abbott EPD-DM's);  and
      (iii) rarely participate in tenders run by insurance companies in Germany given the lack of ability of parallel importers to commit to long-
      term supply. The difficulties of parallel importers to ensure supply of mebeverine is  explained  by  the  relatively  large  size  of  the
      mebeverine market in Germany (i.e. EUR 6 million) as compared with the relatively limited source base (i.e. Abbott EPD-DM's total  EAA-wide
      sales of mebeverine of […] million). This is in line with the evidence that the share of parallel importers in German mebeverine market  is
      relatively limited, below 30% in the last three years.[43]

 220) In addition, a large part of pharmaceuticals in the German market is sold pursuant to public tenders  organised  by  health  insurers.  The
      Notifying Party estimates that 70% of the generic volume in the German market is tender driven. Mebeverine  is  also  a  tendered  molecule
      albeit not for the full volume. Price undercutting between tender participants occurs in Germany in the context of the "rebate  agreements"
      which are awarded as a result of tenders. Given the limited role played by parallel importers in  tenders  for  mebeverine  (see  paragraph
      (219)), the transaction effectively leads a merger from two to one, which may result  in  increase  in  prices.  In  this  context,  market
      investigation revealed concerns about the lack of competition and the available participants in tenders for mebeverine.

 221) Furthermore, Germany operates a reference price system for pharmaceuticals. The amount of reimbursement is computed based on the  reference
      price set by the Joint Federal Committee of Physicians and Health Funds ("GBA"). A price increase by a pharmaceutical company is  possible,
      which could lead to a greater co-payment by patients, as well as a risk of loss of market share. For example, currently Mylan's  price  for
      mebeverine is set below the reference price and there is no co-payment for patients. Following the merger, the merged entity is  likely  to
      be able to increase its prices leading to greater co-payment by patients without the threat  of  losing  market  share  given  the  limited
      remaining competition.

 222) Dormant marketing authorisations for mebeverine-based products in Germany are held only by parallel importers. Their potential entry,  even
      if it were to occur, would have only a limited countervailing effect on the merged entity, for the reasons explained in paragraph (219).

      Conclusion

 223) The Commission concludes that serious doubts arise as regards the compatibility of the transaction with the internal market in relation  to
      mebeverine in Germany, because the transaction would create a dominant position of the merged entity on this market, in particular  leading
      to a merger from two to one in relation to tenders for mebeverine.

      The United Kingdom

 224) Abbott EPD-DM markets its mebeverine-based product under the brand Colofac in the UK. Mylan's generic version of mebeverine is  non-branded
      and is marketed under the name of the active ingredient. The Notifying Party estimates the total size of the market in the UK in  terms  of
      sales to be approximately EUR 7 million.

 225) The Parties' combined market share for mebeverine-based products in the UK at the molecule level is [60-70]% by volume (Abbott EPD-DM: [30-
      40]%; Mylan: [20-30]%).[44]

 226) The only important competitor to the Parties is Teva which markets a generic mebeverine product. In 2013,  Teva  experienced  shortages  of
      supply due to operational and administrative reasons, which lasted for almost a year. These problems did not lead  to  any  product  recall
      from the market, but the market investigation  revealed  that  during  that  time  the  price  for  mebeverine  in  the  UK  has  increased
      substantially. This is illustrated by the following graph:

                 Figure 1

                                                                      [pic]

                  Source: Response to the 7th RFI of 11 December 2014, question 1b

 227) Teva confirmed that there were some price increases for mebeverine in the UK following the supply shortages it had experienced.[45]

 228) The increase of price for mebeverine during Teva's shortages provides an indication of possible effects stemming from the disappearance  of
      one of the competitors, as would be a result of the merger.

 229) Furthermore, there are no potential competitors which could enter the mebeverine market in the  UK  sufficiently  quickly  to  counter  the
      potential negative effects of the merger.

 230) Finally, the UK regulatory system provides for free pricing whereby  the  price  is  a  function  of  competition  in  the  market.[46]  In
      particular, there are no regulatory price ceilings. Generics prices are freely determined by pharmaceutical suppliers  in  accordance  with
      market forces. Consequently, the merged entity would be able to raise prices, as was evidenced in  a  market  situation  with  two  players
      during Teva's shortage.

      Conclusion

 231) The Commission concludes that serious doubts arise as regards the compatibility of the transaction with the internal market in relation  to
      mebeverine in the UK, because the transaction would create a dominant position of the merged entity on this market.

      4 Pinaverium Bromide (A3A)

      Product market definition

 232) Like mebeverine, pinaverium bromide belongs to the ATC3 class A3A of all plain synthetic and natural  antispasmodics  and  anticholinergics
      which are part of the wider ATC2 class A3 covering functional gastro-intestinal disorder drugs. Amongst other  things,  anticholinergic  or
      antispasmodic drugs are used to relieve cramps or spasms of the stomach, intestines and bladder.

 233) As mentioned in paragraph (213), in the past the Commission assessed the relevant A3A products under the ATC3 market  definition  approach,
      although there were indications that in some cases the products might not be entirely substitutable.[47]

 234) The Notifying Party submits that the appropriate market definition for pinaverium bromide is the ATC3 level, which  encompasses  all  plain
      synthetic and natural antispasmodics and anticholinergics.

 235) The market investigation has not revealed any specificities of pinaverium bromide compared to other molecules within the ATC3 class, except
      mebeverine which, as described in section IV.2.3.2.k, constitutes a separate product market.

 236) In any event, for the purposes of the present case, it can be left open whether the relevant product market for pinaverium  bromide  should
      be defined at the ATC3 level or narrower since no serious doubts arise under any plausible alternative market definition.

 France

      Competitive assessment

 237) Both Parties sell their pinaverium bromide-based products in France. On the ATC3 level, no  Group  1  market  arises  given  a  substantial
      position of competitors which excludes serious doubts.[48] However, a Group 1 market would  arise  if  the  relevant  product  market  were
      defined at the molecule level. The latter conservative approach is applied in the analysis below.

 238) The size of the French market for pinaverium bromide at the molecule level is around EUR 7.1 million in 2013 and has  been  declining  from
      EUR 9.2 million in 2011.

 239) The Parties' combined market share for pinaverium bromide-based products at the molecule level in France is [50-60]% by value (Abbott  EPD-
      DM: [30-40]%; Mylan: [20-30]%) and [50-60]% by volume (Abbott EPD-DM: [20-30]%; Mylan: [20-30]%).

 240) Post-merger, a number of competitors selling generic pinaverium bromide products would remain in the market: Servier with a market share of
      [10-20]% (value) and [20-30]% (volume), Novartis with a market share of [10-20]% (value) and [10-20]% (volume), Teva with a market share of
      [5-10]% (value) and [5-10]% (volume) and Actavis with a market share of [0-5]% (value) and  [5-10]%  (volume).  These  parties  are  strong
      competitors with substantial financial and manufacturing capabilities and market presence in France.

 241) In addition, two competitors (Teva and Arrow) hold dormant marketing authorisations to sell pinaverium bromide in the French market,  which
      can be used to enter the market within a short period of time.

 242) Pinaverium bromide-based products are reimbursed in France. The prices of all reimbursed drugs in France are regulated throughout the chain
      given that they are all part of the so-called positive lists for hospital and for  community  pharmacies.  As  a  result,  the  ability  of
      pharmaceutical companies to increase prices for these drugs is generally limited.[49]

      Conclusion

 243) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in  relation  to  pinaverium  bromide  in
      France.

5 Other Group 2 and Group 3 markets in the gastro therapeutic area

 244) In addition to the Group 1 markets analysed above, there is a number of  Group  2  and  Group  3  affected  markets  in  the  gastro  area,
      specifically:

      • ATC3 class A2B in France

      • ATC3 class A3A in Germany and the UK

      • ATC3 class A6A in France, Germany and Italy

      • ATC3 class A9A in the Netherlands

 245) Within these ATC classes several galenic  forms  are  marketed  and  give  rise  to  technically  affected  markets.  However,  the  market
      investigation did not provide any indications that the markets in this case should be further segmented depending on the galenic form or on
      whether the drug is sold against a prescription or OTC.

 246) On these markets the combined market share of the Parties are moderate to low and / or the increment is below 1%. In all cases there  is  a
      number of strong competitors active on these markets with a wide portfolio of products, including branded medicines but  also  branded  and
      non-branded generic products, such as Servier, Novartis, Teva, GlaxoSmithKline, AstraZeneca and Takeda.

 247) The market investigation did not provide any indication that competition issues would arise in these markets. On this basis the  Commission
      concludes that the transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to any  of
      these markets.

       ANTI-INFECTIVE / RESPIRATORY AREA

 248) This therapeutic area includes products that are prescribed for the treatment of various kinds of infections, asthma and  bronchitis.  More
      particularly, the relevant products in this therapeutic area for the purposes of the proposed transaction are prescribed for the  treatment
      of bacterial infection and infections caused by methicillin-resistant staphylococcal ("MRS") strains.

 249) Both Parties are active in this therapeutic area with marketed products belonging to the ATC3 class J1F (macrolides and similar types). The
      Parties compete in relation to some molecules in this therapeutic area. In particular, Group 1 overlaps were identified  (at  the  molecule
      level) in relation to clarithromycin.

1 Clarithromycin (J1F)

      Product market definition

 250) Both Mylan and Abbott EPD-DM sell clarithromycin-based products. Clarithromycin is a leading macrolide anti-infective belonging to the ATC3
      class J1F – Macrolides and similar types. Macrolide antibiotics are used in the treatment of several types of infections, such as lower and
      upper respiratory tract infections, skin infections, etc. These products are a subcategory of antibacterials generally  reserved  to  treat
      those specific bacteria resistant to penicillin and for patients oversensitive to penicillin.

 251) In previous decisions where macrolides were assessed, the Commission considered the ATC3 class J1F as the  appropriate  definition  of  the
      relevant product market.[50] However, in one case where the Commission examined more particularly the  molecule  azithromycin,  the  market
      investigation raised some arguments in favour of defining the market at the molecule level although the market  definition  was  ultimately
      left open.[51]

 252) According to the Notifying Party, the relevant market for clarithromycin should comprise all macrolides.

 253) While the results of the market investigation in this case indicated that the market definition at molecule level would be  unduly  narrow,
      the market investigation also confirmed that the relevant market is not as wide as the entire ATC3 class. Specifically,  according  to  the
      market participants, azithromycin seems to be a close substitute to clarithromycin and in some cases it is even the preferred treatment. To
      a lesser extent, other macrolides such as roxithromycin and spiramycin, were also indicated to be possible alternatives  to  clarithromycin
      in some cases. One of the main reasons why the prescribers indicated that clarithromycin and azithromycin are the closest substitutes  were
      relatively more severe side effects (e.g. diarrhoea) of the other macrolides.

 254) On the basis of the above, the Commission concludes for the purpose of this decision that the relevant  market  should  comprise  at  least
      clarithromycin and azithromycin, regardless of the galenic form.

      Competitive assessment

 255) On the basis of the market definition set out above, the proposed transaction gives rise to a number of Group 1 affected markets, which are
      examined in turn below.

      Italy

 256) Macrolide antibiotics are prescription drugs which are reimbursable in Italy.

 257) The relevant overlap in Italy occurs between products available in oral solid ordinary form (galenic form NFC1-A).  The  Parties'  products
      marketed under this form are Abbott EPD-DM's product sold under the brand  name  Klacid  and  Mylan's  generic  products  Azitromicina  and
      Claritromicina. Abbott EPD-DM is the former originator of  clarithromycin-based  products  in  these  markets.  The  size  of  the  Italian
      clarithromycin market is around EUR 58 million in 2013 and has been declining from EUR 72.6 million in 2011.

 258) The Parties' combined market share at this level reaches [20-30]% (value) with an increment (Mylan) of [0-5]% (value) and [20-30]% (volume)
      with an increment of [0-5]% (volume).

 259) Post-merger, strong competitors remain in the market, namely the current market leader Pfizer with its azithromycin-based  branded  product
      Zithromax, holding a market share of [20-30]% (value) and [10-20]% (volume), a strong local player Menarini with a market share of [20-30]%
      (value) and [30-40]% (volume), Teva with a market share of [5-10]% (value) and [5-10]% (volume), Stada with   a  market  share  of  [5-10]%
      (volume) and Novartis with a market share of [5-10]% (volume).

 260) Moreover, twenty competitors (including Pfizer) hold dormant marketing authorisations to sell clarithromycin in its  various  forms/formats
      in the Italian market, which can be re-activated within a short period of time.

      Conclusion

 261) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in Italy.

 France

 262) The only overlap at this level occurs between products available in liquid form (galenic form NFC1-D). The Parties'  relevant  products  in
      liquid form are Abbott EPD-DM's product sold under the brand name Zeclar and Mylan's generic  product  Clarithromycin.  The  size  of  this
      market is around EUR 2.7 million in 2013.

 263) The Parties' combined market share reaches [20-30]% (value) and [50-60]% (volume), with an increment (Mylan) of [10-20]% (value)  and  [20-
      30]% (volume).

 264) Post-merger, strong competitors remain in the market: Pfizer with its azithromycin-based product Zithromax,  which  was  confirmed  by  the
      market investigation to be the leading macrolide in France, with a market share of [60-70]% (value) and [20-30]% (volume) and Novartis with
      a market share of [5-10]% (value) and [10-20]% (volume).

 265) Moreover, three competitors (including Pfizer) hold dormant marketing authorisations to sell clarithromycin in the French market, which can
      be re-activated within a short period of time.

 266) The Parties' products and their competitors' products are prescription drugs which are reimbursed in France. The prices of  all  reimbursed
      drugs in France are regulated throughout the chain given that they are all part of the  so-called  positive  lists  for  hospital  and  for
      community pharmacies. As a result, the ability of pharmaceutical companies to increase prices for these drugs is generally limited.[52]

      Conclusion

 267) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in France.

Ireland

 268) Abbott EPD-DM is the former originator of the clarithromycin-based products in Ireland. The Parties' products where  the  relevant  overlap
      occurs are Abbott EPD-DM's branded product Klacid and Mylan's branded generic products sold under the brands Azromax and Klariger. The size
      of the Irish clarithromycin market is around EUR 5 million in 2013.

 269) The Parties' combined market share reaches [30-40]% (value) and [40-50]% (volume), with an increment (Mylan) of [5-10]% (value) and [5-10]%
      (volume).

 270) Post-merger, a number of strong competitors remain in the market: Pfizer with its azithromycin-based product Zithromax, with a market share
      of [10-20]% (value) and [10-20]% (volume), Teva with a market share of [10-20]% (value) and [10-20]% volume), Stada with a market share  of
      [10-20]% (value) and [10-20]% (volume), Novartis with a market share of [10-20]% (value) and [10-20]% (volume) and Actavis  with  a  market
      share of [5-10]% (value) and [5-10]% (volume).

 271) Moreover, four competitors hold dormant marketing authorisations to sell clarithromycin in the Irish  market,  which  can  be  re-activated
      within a short period of time.

 272) The Parties' products and most of their competitors' products[53] are prescription drugs which are reimbursed in Ireland.  The  ability  of
      pharmaceutical companies to increase prices of reimbursed drugs in Ireland is very limited. The only possibility for this  requires  filing
      an application to the relevant authority motivating the reason for the price increase. The market investigation  showed  that  historically
      price increases required evidence of price oppression and the National health Authority's expectation was that  budget  neutral  modulation
      across a portfolio of products was the preferred methodology.

      Conclusion

 273) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in Ireland.

Austria

 274) Abbott EPD-DM is the former originator of the clarithromycin-based products in Austria. The only  overlap  at  this  level  occurs  between
      products available in liquid form. The Parties' relevant products in liquid form are Abbott EPD-DM's branded products Klacid  and  Klaricid
      and Mylan's generic products Azithromycin and Clarithromycin. The size of the clarithromycin market in Austria is around EUR 4.8 million in
      2013.

 275) The Parties' combined market share reaches [40-50]% (value) and [50-60]% (volume), with an increment (Mylan) of [0-5]% (value)  and  [0-5]%
      (volume).

 276) Post-merger, two strong competitors remain in the market: Pfizer with its product Zithromax, which the market investigation confirmed to be
      the leading macrolide in Austria, with a market share of [30-40]% (value) and [10-20]% (volume) and Novartis with a market  share  of  [20-
      30]% (value) and [20-30]% volume.

 277) Moreover, three competitors hold dormant marketing authorisations to sell clarithromycin in the Austrian market, which can be  re-activated
      within a short period of time.

 278) The Parties' products and their competitors' products in this segment are reimbursed in Austria. The ability of pharmaceutical companies to
      increase prices of reimbursed drugs in Austria is limited. The only possibility for this requires filing an  application  to  the  relevant
      authority motivating the reason for the price increase or delisting the product from the reimbursement list (free pricing).

      Conclusion

 279) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in Austria.

Belgium

 280) Abbott EPD-DM is the former originator of the clarithromycin-based products in Belgium. The Parties' products where  the  relevant  overlap
      occurs are Abbott EPD-DM's products Biclar, Clarithromycine, Heliclar and Maclar and  Mylan's  products  Azithromycin  and  Clarithromycin,
      which are reimbursed in Belgium. The size of the clarithromycin market in Belgium is around EUR 6.6 million in 2013.

 281) The Parties' combined market share reaches [30-40]% (value) and [40-50]% (volume), with an increment (Mylan) of [0-5]% (value)  and  [0-5]%
      (volume).

 282) Post-merger, three strong competitors remain in the market: Stada with a market share of [20-30]% (value) and [20-30]%  (volume),  Novartis
      with a market share of [20-30]% (value) and [10-20]% (volume) and Pfizer with a market share of [5-10]% (value) and [10-20]% (volume).

 283) Moreover, one competitor holds a dormant marketing authorisation to sell clarithromycin in the Belgian market, which  can  be  re-activated
      within a short period of time.

 284) The Parties' products and Pfizer's product Zithromax are reimbursed in Belgium. Novartis and Stada's products are not reimbursed.  However,
      this does not change the outcome of the Commission's assessment, since in Belgium the  maximum  ex-factory  prices  of  all  pharmaceutical
      products (reimbursed or not) are set by the competent authorities. The only possibility for pharmaceutical companies to increase the  price
      of pharmaceutical products requires filing an application to the relevant authority motivating the reason for the price increase.

      Conclusion

 285) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in Belgium.

      Czech Republic

 286) Macrolide antibiotics are prescription products which are reimbursable in the Czech Republic.

 287) Abbott EPD-DM is the former originator of clarithromycin-based products in the Czech Republic. The Parties'  products  where  the  relevant
      overlap occurs are Abbott EPD-DM's product Klacid and Mylan's products Azithromycin and Klarithromycin.  The  size  of  the  clarithromycin
      market in the Czech Republic is around EUR 10.4 million in 2013.

 288) The Parties' combined market share reaches [40-50]% (value) and [50-60]% (volume), with an increment (Mylan) of [0-5]% (value)  and  [0-5]%
      (volume).

 289) Post-merger, three strong competitors remain in the market: the strong local player Krka with a market share of [20-30]% (value)  and  [20-
      30]% (volume), Teva with a market share of [10-20]% (value) and [5-10]% (volume) and Novartis with a market share of [5-10]% (value).

 290) Moreover, five competitors hold a dormant marketing authorisation to sell clarithromycin in the Czech market,  which  can  be  re-activated
      within a short period of time.

 291) The Parties' products and their competitors' products in this segment are reimbursed in the Czech Republic. The ability  of  pharmaceutical
      companies to increase prices of reimbursed drugs in the Czech Republic is limited. Some reimbursable pharmaceutical products are subject to
      a maximum ex-factory price, which is the case for azithromycin-based products. The regulatory framework does not allow for price  increases
      of these products above such limit. On the other hand, clarithromycin-based products in the Czech Republic are not subject to a price  cap,
      which means that their prices may be increased each quarter. However, such increase is subject to an application to the relevant  authority
      in the precedent quarter. In any case, the authorities in the Czech Republic set the maximum  reimbursement  amount,  which  pharmaceutical
      companies take into account when determining their prices.

      Conclusion

 292) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in the Czech Republic.

Portugal

 293) Macrolide antibiotics are prescription products which are reimbursable in Portugal.

 294) The only relevant overlap at this level occurs between products available in liquid form. The Parties' relevant products in liquid form are
      Abbott EPD-DM's product Klacid and Mylan's products Azithromycin and Clarithromycin. The size of the clarithromycin market in  Portugal  is
      around EUR 5.4 million in 2013.

 295) The Parties' combined market share reaches [40-50]% (value) and [60-70]% (volume), with an increment (Mylan) of [0-5]% (value)  and  [0-5]%
      (volume).

 296) Post-merger, at least three strong competitors remain in the market: Pfizer with its azithromycin-based product  Zithromax  with  a  market
      share of [30-40]% (value) and [20-30]% (volume), Generis Farma with a market share of [10-20]% (value) and [10-20]% (volume) and Teva  with
      a market share of [5-10]% (value).

 297) Moreover, eleven competitors hold a dormant marketing authorisation to sell clarithromycin in the  Portuguese  market,  which  can  be  re-
      activated within a short period of time.

 298) The Parties' products and Pfizer's products[54] are reimbursed in Portugal. The relevant  authority  sets  the  maximum  public  price  for
      reimbursed drugs, which limits the ability of pharmaceutical companies to increase their prices. The only possibility to increase the price
      of reimbursed pharmaceutical products requires filing an application to the authority motivating the reason for the price increase.

      Conclusion

 299) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in  relation  to  the  macrolides
      clarithromycin and azithromycin in Portugal.

2 Other Group 2 and Group 3 markets in the anti-infective / respiratory therapeutic area

 300) In addition to the Group 1 markets analysed above, there is a number of Group 2 and Group  3  affected  markets  in  the  anti-infective  /
      respiratory area, specifically:

      • ATC3 class J1F in Austria, Belgium, Czech Republic, France,  Germany,  Greece,  Hungary,  Italy,  Ireland,  the  Netherlands,  Portugal,
        Slovakia, Spain and the UK

 301) Within these ATC classes several galenic  forms  are  marketed  and  give  rise  to  technically  affected  markets.  However,  the  market
      investigation did not provide any indications that the markets in this case should be further segmented depending on the galenic form or on
      whether the drug is sold against a prescription or OTC.

 302) On these markets the combined market share of the Parties are moderate to low and / or the increment is below 1%. In all cases there  is  a
      number of strong competitors active on these markets with a wide portfolio of products, including branded medicines but  also  branded  and
      non-branded generic products, such as Pfizer, Novartis, Stada, Sanofi, Servier, Teva, Estallas Pharma,  Daiichi  Sankyo,  Menarini,  Elpen,
      Krka Pharma.

 303) The market investigation did not provide any indication that competition issues would arise in these markets. On this basis the  Commission
      concludes that the transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to any  of
      these markets.

      CNS / PAIN AREA

 304)  This therapeutic area concerns products that are prescribed for the treatment of pain and indications  relating  to  the  central  nervous
      system. The relevant products are prescribed for the treatment of disorders  ranging  from  musculoskeletal  inflammation  to  vertigo  and
      Meniere's disease.

 305) Both Parties are active in this therapeutic area with a number of marketed products belonging to the ATC3 classes N5C  (tranquilisers)  M1A
      (anti-rheumatics, non-steroidal), N5A (anti-psychotics), N6A (antidepressants and mood stabilisers) and  N7C  (antivertigo  products).  The
      Parties compete in relation to a number of molecules in this therapeutic area. In particular, Group 1  overlaps  were  identified  (at  the
      molecule level) in relation to the molecules set out below.

3 Delorazepam (N5C)

      Product market definition

 306) Delorazepam belongs to the ATC3 class N5C-Tranquilizers. This class  includes  minor  tranquillisers,  e.g.  benzodiazepines  (delorazepam,
      lorazepam, etc.), hydroxyzine and meprobamate, used for their sedative, anxiolytic  (anti-anxiety),  anticonvulsant,  and  muscle  relaxant
      properties.

 307) In previous decisions where the ATC3 class N5C was analysed, the Commission has not considered delorazepam specifically.[55]

 308) The Notifying Party submits that delorazepam is substitutable and competes with the other benzodiazepines categorized  in  the  ATC3  class
      N5C, such as bromazepam, alprazolam and lorazepam, in view of the identical mode of action and equivalent anxiolytic therapeutic effects of
      all benzodiazepines. According to the Notifying Party, the closest competitor of Abbott  EPD-DM's  branded  delorazepam-based  drug  EN  is
      Pfizer with its branded originator product Xanax based on alprazolam, another benzodiazepine, and not generics based on delorazepam.

 309) The results of the market investigation indicate that delorazepam is a popular drug for treating anxiety disorders  in  Italy.  The  market
      investigation confirmed that there is some degree of substitutability between delorazepam and other benzodiazepines in the ATC3 class  N5C.
      Indeed, the indications in case of which different benzodiazepines are prescribed by doctors are sometimes overlapping.  Nevertheless,  the
      market investigation also revealed that the molecule of delorazepam has certain specific characteristics, which distinguish it  from  other
      benzodiazepines.

 310) In particular, according to the responses received during the market investigation delorazepam is characterised by longer action  and  less
      sedative effect compared to other benzodiazepines and therefore is often prescribed as first line of treatment. Also,  medical  specialists
      stated that delorazepam is usually prescribed is case of general anxiety disorders, while alprazolam (Pfizer’s Xanax) is  more  suited  for
      treating panic disorders. Therefore, in the view of the respondents, Abbott EPD-DM's delorazepam-based  EN  and  Pfizer's  alprazolam-based
      Xanax are not close competitors, unlike submitted by the Notifying Party.. The market investigation did not provide  any  indications  that
      the market in this case should be further segmented depending on the galenic form or on whether the drug is sold against a prescription  or
      OTC.

 311) Moreover, competing products based on the same molecule are typically closer substitutes than products based on different  molecules,  even
      if they belong to same ATC class. This is due to the fact that, despite the shared indications, different molecules  still  show  different
      clinical and safety profiles. The regulatory framework also typically facilitates  substitutability  across  products  based  on  the  same
      molecule at pharmacy level, while substitution across molecules can only happen at the level of physician's prescription.

 312) To rebut the findings of the Phase 1 market investigation in relation to the market definition, the Notifying  Party  submitted  additional
      evidence. First, the Notifying Party submitted prescription data for the Italian market from the Medical Audit database  developed  by  IMS
      Health. These data provide the total number of prescriptions of several benzodiazepines according to various indications collected  through
      a panel of physicians (both general practitioners and specialists). According to the Notifying Party, these data suggest that for  each  of
      the main listed indications of delorazepam other benzodiazepines are prescribed more often. In  the  view  of  the  Notifying  Party,  this
      confirms that delorazepam is not unique in its action and is substitutable by other benzodiazepines.

 313) The Commission acknowledges that  there  is  a  certain  degree  of  overlap  between  the  indications  in  which  delorazepam  and  other
      benzodiazepines are prescribed. Nevertheless the Commission considers that the provided prescription data does not demonstrate the  absence
      of the specific characteristics of delorazepam which would limit its substitutability with other benzodiazepines, identified  in  paragraph
      (310). For example, in  the  data  provided,  the  largest  proportion  of  prescriptions  of  delorazepam  (22%),  as  well  as  of  other
      benzodiazepines, are categorised under “F419 Anxiety disorder, unspecified”.[56] This category groups prescriptions for  symptoms  that  do
      not clearly fit any single more specific diagnostic category. Thus, this largest category does not provide a granular enough data to  allow
      robust conclusions on the precise indications for delorazepam as compared with other benzodiazepines. For instance, within the general F419
      category, the indications for delorazepam could include symptoms which are closer to generalized anxiety  disorder,  while  for  alprazolam
      those closer to panic disorders, in line with the feedback received from the market investigation (see paragraph (310)). In  addition,  the
      fact that that various drugs may be prescribed for one general indication does not in itself evidence the substitutability of the drug  for
      individual patients; if anything it demonstrates that some patients are better treated with one drug rather than the  other.  Overall,  the
      Commission considers that the prescription data does not convincingly refute the findings that the molecule  of  delorazepam  is  generally
      used for different purposes than other benzodiazepines.

 314) Second, the Notifying Party submitted pricing and volume data in relation to delorazepam. According to these data, the prices  for  generic
      benzodiazepines, including delorazepam, remained stable in recent years. By contrast, the prices for branded benzodiazepine-based products,
      including Abbott EPD-DM's EN (delorazepam), Pfizer's Xanax (alprazolam) and  Pfizer's  Tavor  (lorazepam),  have  increased.  Overall,  the
      Notifying Party concludes that the submitted data confirms that EN competes mainly with branded products based  on  other  benzodiazepines,
      while generic benzodiazepines compete between themselves independently.  The  Notifying  Party  supports  this  conclusion  with  [internal
      documents which analyse a price increase for benzodiazepines].

 315) The Commission notes that some internal documents of the Notifying Party clearly suggest  that  Abbott  EPD-DM’s  delorazepam-based  EN  is
      subject to competitive pressure and is losing market  share  to  generics,  and  in  particular  to  Mylan’s  product,  rather  than  other
      benzodiazepines and Pfizer’s branded products, as indicated in the graph below.

           Figure 2

           Source: [Third party advisor] Report – Project Air Commercial Assessment –
           June 10, 2014, slide 102

 316) The graph above illustrates that the market share of Abbott EPD-DM’s EN declined by [0-10]%, from [60-70]% to [60-70]%,  between  2010  and
      2013 (first line from the top), while Mylan’s share has grown by [0-10]%, from [0-10]% to [10-20]% in the same period (second line from the
      top). The same slide states that […].[57] The slide does not refer to other benzodiazepines, including Pfizer’s Xanax, which suggests  that
      the main competitive constraint for Abbott EPD-DM’s delorazepam-based EN comes from  delorazepam-based  generics  rather  than  from  other
      benzodiazepines.

 317) Moreover, the Commission considers that the presented pricing data and internal documents of the Notifying Party do not evidence that other
      branded benzodiazepines would be closer competitors to Abbott EPD-DM's branded delorazepam than would be generic delorazepam. The fact that
      Abbott EPD-DM follows developments on a wider benzodiazepines market does not in itself mean that the other benzodiazepines belong  to  the
      same relevant market for competition purposes. Indeed, the Notifying Party did not provide any evidence of substitution of  delorazepam  by
      other benzodiazepines in response to a price increase. To the contrary, based on the data in

 318) Figure 2 it can be inferred that Abbott EPD-DM's branded delorazepam lost share to generic delorazepam during the same period  when  Abbott
      EPD-DM was implementing price increases (see paragraph (330)).

 319) Further, the Notifying Party submitted an internal graph tracking the market shares of various  benzodiazepines  purportedly  showing  that
      “[Abbott's information and assessment regarding the relationship between the developments  in  EPD-DM  and  Pfizer  market  shares  in  the
      benzodiazepines market in Italy]”.[58]

      Figure 3

      Source: Parties' response of 14 January 2015, question 5

 320) The basis of the above-mentioned conclusion is unclear. Contrary to the Notifying Party’s statement, the graph  above  shows  very  limited
      fluctuation of the market share of Abbott EPD-DM’s EN (third line from the bottom) in response to much greater  fluctuations  (in  absolute
      terms and in variations of extremes) of market shares of Pfizer’s Xanax and Tavor (first and second lines from the  top,  respectively)  at
      least in the period from April to October. At best, this evidence cannot be considered as conclusive.

 321) Overall, and within the limits of the Phase I investigation, the Commission considers that the information presented by the Notifying Party
      does not disprove the indications received from medical specialists that delorazepam has specific characteristics which distinguish it from
      other benzodiazepines.

 322) Therefore, the Commission concludes for the purpose of this decision that the relevant product market is limited to delorazepam only.

      Competitive assessment

 323) On the basis of the market definition set out above, a Group 1 market arises in Italy.

       Italy

 324) Both Parties market delorazepam-based products in Italy. While delorazepam was never patent-protected in Italy, Abbott EPD-DM's product was
      the first product to be registered in Italy containing that active ingredient. Abbott EPD-DM markets its product under the brand  name  EN,
      while Mylan markets a non-branded generic version of delorazepam. Delorazepam-based products  are  subject  to  prescription  but  are  not
      reimbursed in Italy.

 325) The total size of the market for delorazepam in Italy in terms of sales is approximately EUR 40 million.

 326) The Parties' combined market share at the molecule level is [80-90]% (value) and [80-90]% (volume), with an increment  (Mylan)  of  [5-10]%
      (value) and [10-20]% (volume). Abbott EPD-DM is clearly the market leader although in the last three  years,  its  volume  share  has  been
      consistently declining. As Abbott EPD-DM has been losing sales, Mylan's volume share has been growing,  as  illustrated  by  the  graph  in
      Figure 2.

 327) Also, the Parties' internal documents state in relation to Abbott EPD-DM's product EN that […]".[59] This suggests that EN is subject to  a
      competitive constraint from Mylan's delorazepam-based product. Nevertheless, EN remains a popular product with "[information on the product
      contained in internal document]" for which brand loyalty is high.[60] The price for Abbott EPD-DM's product EN  has  been  rising  steadily
      every two years since 2005.

 328) The only sizeable competitor on the market is Teva, which markets a generic version of delorazepam. Teva holds a market  share  of  [5-10]%
      (value) and [5-10]% (volume). Teva's share has remained largely stable in the last three years, in contrast with Mylan's  share  which  has
      been steadily growing. During the market investigation, Teva stated that overall it considered Italy to be  a  difficult  market  in  which
      demand has to be stimulated at the retail level which requires costs and good distribution network. Furthermore, Teva  has  other  priority
      products than delorazepam in Italy. Therefore, the limited presence of Teva in delorazepam is unlikely to constrain the merged entity.

 329) There are seven dormant marketing authorisations for delorazepam held by third parties in Italy. While these marketing  authorisations  can
      be potentially used for a market entry, by itself this possibility is insufficient to rule out competition concerns, especially in view  of
      the fact that the steady rise in the price of Abbott EPD-DM's delorazepam-based product has not triggered entry.

 330) Based on the above, the Commission considers that Abbott EPD-DM holds a dominant position on the market  for  delorazepam  in  Italy.  This
      dominant position will be further strengthened by the addition of Mylan.

 331) Finally, the regulatory framework in Italy allows for price increases of non-reimbursed pharmaceuticals once every two  years.  While  AIFA
      publishes recommended price increases for all non-reimbursable products in Italy, pharmaceutical companies can increase prices also  beyond
      recommended levels.[61]

      Conclusion

 332) The Commission concludes that serious doubts arise as regards the compatibility of the transaction with the internal market in relation  to
      delorazepam in Italy, because the transaction would strengthen the dominant position which Abbott EPD-DM already holds on this market.

4 Ibuprofen (M1A)

      Product market definition

 333) Ibuprofen is a non-steroidal anti-inflammatory drug derivative of propionic acid belonging to the ATC3  class  M1A  (anti-rheumatics,  non-
      steroidal) and N2B (non-narcotics and anti-pyretics). The ATC3 class  M1A  is  further  subdivided  into  two  ATC4  classes:  M1A1  (anti-
      rheumatics, non-steroidal plain), to which ibuprofen belongs, and  M1A2  (anti-rheumatics,  non-steroidal  combination).  It  is  used  for
      reliving pain and fever as well as reducing inflammation and it can be acquired in the OTC and in the prescription segment.

 334) In a previous decision, the Commission did not consider whether the forms of ibuprofen in which the Parties are active may be substitutable
      with drugs based on different molecules.[62] The market investigation did not provide any indications that the market in this  case  should
      be further segmented depending on the galenic form

 335) The Notifying Party supports a market definition at the ATC4 level, comprising all propionic acid derivatives, such as ibuprofen, naproxen,
      fenoprofen, flurbiprofen and ketoprofen.

 336) In the case at hand, the results of the market investigation generally indicated that ibuprofen is widely substitutable by other  propionic
      acid derivatives belonging to the same ATC4 class, and in particular by molecules naproxen and diclofenac. This  is  because  practitioners
      generally considered that ibuprofen has similar therapeutic profile than other pain relieving drugs both in terms of efficacy, tolerability
      and side effects. The respondents also indicated that should the prices of ibuprofen go up by 5-10% they would switch to other substitutes.

 337) Therefore, the Commission concludes for the purposes of the present decision that the relevant  product  market  for  ibuprofen  should  be
      defined at least at the ATC4 level, comprising all anti-rheumatic drugs belonging to the M1A1 class, or wider. The question of whether  the
      market should be further segmented according to the galenic form or prescription versus OTC can be left open for the purpose of  this  case
      as no serious doubts arise in relation to the M1A1 class irrespective of the market definition.

 338) On the basis of the above, no affected markets arise and the transaction does not raise serious doubts in relation to ibuprofen.

5 Promazine and risperidone (N5A)

      Product market definition

 339) Promazine and risperidone are two antipsychotics belonging to the ATC3 class N5A. Antipsychotics are mainly used to treat psychosis,  which
      is typified by schizophrenia and mania. However, these two molecules belong to two different ATC4  classes:  promazine  is  a  conventional
      antipsychotic (ATC4 N5A1) while risperidone is an atypical antipsychotic (ATC4 N5A9). The overlap between the Parties in  relation  to  N5A
      class arises only at ATC3 level.

 340) In previous decisions, the Commission considered whether conventional and  atypical  anti-psychotics  should  be  considered  two  separate
      product markets, but ultimately left the question open.[63]

 341) The Notifying party supports a market definition at the ATC4 level leading to two separate product markets for conventional anti-psychotics
      (N5A1) and for atypical anti-psychotics (N5A9).

 342) The market investigation indicated that the two molecules are considered to be substitutable by prescribers.  In  any  event,  the  product
      market definition in relation to promazine and risperidone can be left open for the purpose of this case as  no  serious  doubts  arise  in
      relation to promazine and risperidone irrespective of the market definition.

       Competitive assessment

 343) The proposed transaction gives rise to one Group 1 affected market at ATC3 level in Italy.

Italy

 344) The Parties' products in the N5A class are Abbott EPD-DM's branded product Talofen, with promazine as the active  ingredient,  and  Mylan's
      generic product Risperidone. The former originator of risperidone-based products in Italy is J&J, while the former originator of promazine-
      based products is Sanofi-Aventis. The size of the market for the N5A class in Italy (2013) is around EUR 31 million.

 345) The Parties' combined market share at the ATC3 level reaches [50-60]% (value) and [30-40]% (volume), with an increment  (Mylan)  of  [0-5]%
      (value) and [0-5]% (volume).

 346) Post-merger, strong competitors remain in the market: J&J with a market share of [10-20]% (value) and  [30-40]%  (volume),  Otsuka  with  a
      market share of [10-20]% (value), Menarini with a market share of [5-10]% (value) and [10-20]% (volume) and Novartis with a market share of
      [5-10]% (value) and [5-10]% (volume).

 347) Moreover, two competitors hold dormant marketing authorisations for promazine-based products and  twenty  competitors  hold  them  to  sell
      risperidone-based products in the Italian market, which can be re-activated within a short period of time.

 348) Promazine and risperidone are prescription drugs. Mylan's product Risperidone is reimbursed in Italy, while Abbott EPD-DM's product Talofen
      (promazine) and their competitors' products are not. However, pricing restrictions are in place in Italy both  for  reimbursable  and  non-
      reimbursable medicines.

      Conclusion

 349) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to anti-psychotics in Italy.

6 Fluvoxamine and paroxetine (N6A4)

      Product market definition

 350) Fluvoxamine and paroxetine belong to the ATC3 class  N6A,  which  includes  substances  used  in  the  treatment  of  depression  and  mood
      stabilisation. The N6A class is further subdivided into several ATC4 classes with different modes of action: herbal antidepressants (N6A1),
      mood stabilisers (N6A3), selective serotonin re-uptake  inhibitors  ("SSRIs")  antidepressants  (N6A4),  serotonin-noradrenaline  re-uptake
      inhibitors ("SNRIs) antidepressants (N6A5) and other antidepressants (N6A9). Both fluvoxamine and  paroxetine  belong  to  the  N6A4  SSRIs
      antidepressants category.

 351) The Commission has assessed this segment in a number of previous decisions, but ultimately left the market definition  open.  Firstly,  the
      Commission left open whether the market ought to be defined on the basis of the ATC3 class, the ATC3 class excluding certain  ATC4  classes
      or the ATC4 class N6A9.[64] In a subsequent case, the Commission analysed several molecules on potentially narrower markets, while  leaving
      the market definition ultimately open.[65]

 352) The Notifying Party supports a market definition at the ATC4 level, comprising all the SSRIs, due to their similar scope of action and same
      level of reimbursement in the affected markets.

 353) The results of the market investigation indicated that while both being SSRIs, fluvoxamine and paroxetine are not  perfect  substitutes  as
      paroxetine is considered the first line of treatment while fluvoxamine would typically be used in the second line.

 354) In any event, the precise market definition in relation to fluvoxamine and paroxetine can be left open for the purpose of this case  as  no
      serious doubts arise in relation to these products irrespective of the market definition.

      Competitive assessment

 355) At the molecule level, the proposed transaction gives rise to two Group 1 affected markets, namely fluvoxamine in France and paroxetine  in
      Italy.

      Fluvoxamine in France

 356) The combined market share of the Parties at molecule level in France reaches [60-70]% (value) and [60-70]% (volume) with  an  increment  of
      [10-20]% (Abbott-EPD-DM). Abbott EPD-DM is active as ex-originator with several branded products: Fluoxetin (based on fluoxetine), Dumirox,
      Faverin, Floxyfra and; Maveral (based on fluvoxamine) and Casbol and Sereupin (based on paroxetine), while Mylan  sells  generic  products.
      Several other competitors are also active, namely Teva ([10-20]%), Novartis ([10-20]%) and Stada  ([5-10]%),  all  marketing  an  unbranded
      generic product. All these competitors have an established presence and customer relationships in France.

 357) Despite the fact that Abbott EPD-DM is the ex-originator, its market share has for the last three years  been  significantly  smaller  than
      Mylan's market share. Both Mylan's and Abbott EDP-DM's market shares decreased since 2011, while Novartis' market share increased  steadily
      and Stada and Teva preserved their market shares. Accordingly, with regard to fluvoxamine, Mylan and Abbott EDP-DM appear  not  to  be  the
      closest competitors and competition appears to occur mainly among the generic products.

 358) The size of the French fluvoxamine market is relatively limited, amounting to less than EUR 1.5 million and has been declining from EUR 1.8
      million in 2011. Fluvoxamine is a highly genericized market with Abbott EPD-DM holding less than [5-10]% market share in  volume  and  [10-
      20]% in value.

 359) Two competitors hold dormant marketing authorizations for fluvoxamine in France.

 360) Fluvoxamine is a reimbursed drug in France. The prices of all reimbursed drugs in France are regulated throughout the chain given that they
      are all part of the so-called positive lists for hospital and for  community  pharmacies.  As  a  result,  the  ability  of  pharmaceutical
      companies to increase prices for these drugs is generally limited.[66]

 361) In addition, the market investigation did not reveal any concerns in relation to flvoxamine market in France.

      Conclusion

 362) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to fluvoxamine in France.

Paroxetine in Italy

 363) The combined market share of the Parties at molecule level in Italy reaches [40-50]% (value) and [40-50]% (volume), with  an  increment  by
      Mylan of [5-10]% (value) and [10-20]% (volume). Abbott EPD-DM is active with its branded product  Sereupin  while  Mylan  sells  a  generic
      product. Several other competitors, all holding a share higher than Mylan - namely Angelini ([20-30]%), Italfarmaco ([10-20]%) and GSK ([5-
      10]%) – are also active.

 364) The size of the Italian paroxetine market is around EUR 61.5 million in 2013.

 365) Paroxetine-based products are reimbursed in Italy. The prices of the reimbursed drugs are set  through  negotiation  between  the  relevant
      manufacturer and AIFA. The regulatory framework does not generally allow for price increases where it concerns reimbursed  products.  As  a
      result, the ability of pharmaceutical companies to increase prices for these drugs is generally limited.

 366) In addition, the market investigation did not reveal any concerns in relation to paroxetine market in Italy.

      Conclusion

 367) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market  in  relation  to  paroxetine  market  in
      Italy.

7 Betahistine (N7C)

      Product market definition

 368) Betahistine belongs to the ATC3 class N7C (antivertigo products), which includes  molecules  betahistine,  cinnarizine,  acetylleucine  and
      flunarizine when indicated for vertigo and Menière's disease. Betahistine stimulates the H1-receptors in the inner ear and acts by reducing
      the asymmetrical functioning of sensory vestibular organs and by increasing vestibulocochlear  blood  flow,  which  decreases  symptoms  of
      vertigo and balance disorders.

 369) The Notifying Party submits that the appropriate market definition for betahistine would comprise all the antivertigo  products,  i.e.  the
      entire ATC3 class N7C.

 370) The Commission has not examined the appropriate market definition for the N7C class in the past.[67]

 371) The market investigation in this case provided indications that betahistine may be a unique molecule, not interchangeable  with  the  other
      molecules within the ATC3 class N7C. In any event the market definition for betahistine can be left open for the purpose of this case as in
      Ireland serious doubts arise in relation to betahistine irrespective of the market definition while in other countries  no  serious  doubts
      arise under any plausible market definition.

      Competitive assessment

 372) On the basis of the market definition set out above, the proposed transaction gives rise to eight  Group  1  affected  markets  in  France,
      Ireland, Austria, Belgium, the Czech Republic, Hungary, Portugal and the UK. Abbott EPD-DM is the former  originator  of  betahistine-based
      drugs in these markets.

 France

 373) The Parties' products where the relevant overlap occurs at the molecule level are Abbott  EPD-DM's  branded  products  Betahistine  Biphar,
      Betaserc and Serc, and Mylan's generic product Betahistine.  The size of the market for betahistine in France (2013) is EUR 20.6 million.

 374) The Parties' combined market share for betahistine-based products in France at the molecule level reaches [30-40]% by value (Abbott EPD-DM:
      [10-20]%; Mylan: [20-30]%) and [40-50]% by volume (Abbott EPD-DM: [10-20]%; Mylan: [20-30]%).

 375) Post-merger, three strong competitors remain in the French market for betahistine: Recordati with a market share of  [20-30]%  (value)  and
      [10-20]% (volume), Servier with a market share of [10-20]% (value) and [10-20]% (volume) and Teva with a market share  of  [5-10]%  (value)
      and [0-5]% (volume).

 376) Moreover, seven competitors hold dormant marketing authorisations to sell betahistine-based products in the French market, which can be re-
      activated within a short period of time.

 377) Betahistine can be acquired both at the prescription and at the OTC segment in France. The Parties' products are reimbursed if  prescribed.
      In France, OTC products that are allowed into the reimbursement system are subject to the same  pricing  restrictions,  if  prescribed,  as
      prescription products that are reimbursed. A price increase of reimbursed drugs is only possible through an  application  to  the  HAS  and
      requires either robust clinical data demonstrating a clinical added-value or completely delisting the product from the  reimbursement  list
      (free pricing).

      Conclusion

 378) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in France.

 Austria

 379) The Parties' products where the relevant overlap occurs at the molecule level are Abbott EPD-DM's products Betaserc,  and  Mylan's  product
      Betahistine – Arca. The size of the market for betahistine in Austria (2013) is EUR 1.8 million.

 380) The Parties' combined market share for betahistine-based products in Austria at the molecule level reaches [40-50]% (value) with  a  [0-5]%
      increment (Mylan) and [40-50]% (volume) with a [0-5]% increment (Mylan).

 381) Post-merger, two strong generic players remain in the Austrian market for betahistine: Teva with a market share of [30-40]% (value) and [30-
      40]% (volume) and Actavis with a market share of [10-20]% (value) and [10-20]% (volume).

 382) Moreover, two competitors hold dormant marketing authorisations to sell betahistine-based products in the Austrian market, which can be re-
      activated within a short period of time.

 383) Betahistine is sold as a prescription drug in Austria. Mylan's product Betahistine is reimbursed in Austria, while Abbott EPD-DM's  product
      is not. The ability of pharmaceutical companies to increase prices of reimbursed drugs in Austria is limited. The only possibility for this
      requires filing an application to the relevant authority motivating the reason for the price increase or delisting  the  product  from  the
      reimbursement list (free pricing).

      Conclusion

 384) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in Austria.

 Belgium

 385) The Parties' products where the relevant overlap occurs at the molecule level are Abbott EPD-DM's  branded  product  Betaserc  and  Mylan's
      products Betahistine and Docbetahi. The size of the market for betahistine in Belgium (2013) is EUR 6.2 million.

 386) The Parties' combined market share for betahistine-based products in Belgium at the molecule level reaches [40-50]% by value  (Abbott  EPD-
      DM: [20-30]%; Mylan: [10-20]%) and [30-40]% by volume (Abbott EPD-DM: [10-20]%; Mylan: [10-20]%).

 387) Post-merger, the market leader Stada remains in the Belgian market with a market share of [50-60]% (value) and [50-60]%  (volume).  Stada's
      betahistine-based products are not reimbursed in Belgium; the products of the Parties and their other competitors are reimbursed.  However,
      this does not change the outcome of the Commission's assessment, since in Belgium the  maximum  ex-factory  prices  of  all  pharmaceutical
      products (reimbursed or not) are set by the competent authorities. The only possibility for pharmaceutical companies to increase the  price
      of pharmaceutical products requires filing an application to the relevant authority motivating the reason for the price increase.

 388) Moreover, two competitors hold dormant marketing authorisations to sell betahistine-based products in the Belgian market, which can be  re-
      activated within a short period of time.

      Conclusion

 389) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in Belgium.

 The Czech Republic

 390) The Parties' products where the relevant overlap occurs at the molecule level are Abbott EPD-DM's  branded  product  Betaserc  and  Mylan's
      generic product Betahistin. The size of the market for betahistine in the Czech Republic (2013) is EUR 3.7 million.

 391) The Parties' combined market share for betahistine-based products in the Czech Republic at the molecule level reaches [30-40]% (value) with
      a [0-5]% increment (Mylan) and [30-40]% (volume) with a [0-5]% increment (Mylan).

 392) Post-merger, three strong players remain in the Czech market: Actavis with a market share of [20-30]% (value) and [30-40]%  (volume),  Teva
      with a market share of [10-20]% (value) and [20-30]% (volume) and Avefarm with a market share of [5-10]% (value) and [10-20]% (volume).

 393) Moreover, three competitors hold dormant marketing authorisations to sell betahistine-based products in the Belgian market, which can be re-
      activated within a short period of time.

 394) Betahistine is sold as a prescription drug in the Czech Republic. The product of the Parties and their competitors are  reimbursed  in  the
      Czech Republic. The ability of pharmaceutical companies to increase prices of reimbursed drugs in  the  Czech  Republic  is  limited.  Some
      reimbursable pharmaceutical products are subject to a maximum ex-factory price, in which case the regulatory framework does not  allow  for
      price increases of these products above such limit. For products that are not subject to a price cap, their prices may  be  increased  each
      quarter. However, such increase is subject to an application to the  relevant  authority  in  the  precedent  quarter.  In  any  case,  the
      authorities in the Czech Republic set the maximum reimbursement amount, which pharmaceutical companies take into account  when  determining
      their prices

      Conclusion

 395) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in  the  Czech
      Republic.

 Hungary

 396) The Parties' products where the relevant overlap occurs at the molecule level are Abbott EPD-DM's branded  product  Betaserc,  and  Mylan's
      product Betagen. The size of the market for betahistine in Hungary (2013) is EUR 5.6 million.

 397) The Parties' combined market share for betahistine-based products in Hungary at the molecule level reaches [60-70]% by value  (Abbott  EPD-
      DM: [30-40]%; Mylan: [20-30]%) and [50-60]% by volume (Abbott EPD-DM: [30-40]%, Mylan: [20-30]%).

 398) Post-merger, three strong players remain in the Hungarian market: Teva with a market share of [20-30]% (value) and [20-30]% (volume), Sager
      Pharma with a market share of [10-20]% (value) and [5-10]% (volume) and Actavis  with  a  market  share  of  [5-10]%  (value)  and  [5-10]%
      (volume).

 399) Moreover, eight competitors hold dormant marketing authorisations to sell betahistine-based products in the Hungarian market, which can  be
      re-activated within a short period of time.

 400) Betahistine is sold as a prescription drug in Hungary. Mylan's product Betagen is reimbursed in  Hungary,  while  Abbott  EPD-DM's  product
      Betaserc and SagerPharma's product Betaverin are not. In Hungary,  the  regulatory  framework  does  not  allow  for  price  increases  for
      reimbursed products. Moreover, in Hungary, there is a bi-annual "blind-price" bidding system put in place by the  reimbursement  authority.
      As a result of this price bidding system the average price on the betahistine market has decreased by 22% in the last four years.[68]

      Conclusion

 401) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in Hungary.

 Portugal

 402) The Parties' products where the relevant overlap occurs at the molecule level are Abbott EPD-DM's  branded  product  Betaserc  and  Mylan's
      product Betahistina. The size of the market for betahistine in Portugal (2013) is EUR 9.6 million.

 403) The Parties' combined market share for betahistine-based products in Portugal at the  molecule  level  reaches  [50-60]%  (value)  with  an
      increment of [0-5]% (Mylan) and [40-50]% (volume) with an increment of [0-5]% (Mylan).

 404) Post-merger, three players remain in the Portuguese market: Generis Farma with a market share of [20-30]% (value)  and  [30-40]%  (volume),
      Actavis with a market share of [5-10]% (value) and [10-20]% (volume) and Aurobindo with a market share of [5-10]% by volume.

 405) Moreover, four competitors hold dormant marketing authorisations to sell betahistine-based products in the Portuguese market, which can  be
      re-activated within a short period of time.

 406) Betahistine is sold as a prescription drug in Portugal. The products of the Parties and their competitors are reimbursed  in  Portugal.  In
      Portugal, the relevant authority sets the maximum public price for reimbursed drugs, which limits the ability of  pharmaceutical  companies
      to increase their prices. The only possibility to increase the price of reimbursed pharmaceutical products requires filing  an  application
      to the authority motivating the reason for the price increase.

      Conclusion

 407) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in Portugal.

 The United Kingdom

 408) Abbott EPD-DM is active in the UK with its betahistine-based branded product Serc while Mylan sells a generic Betahistine.

 409) The Parties' combined market share for betahistine-based products in the UK at the molecule level reaches [40-50]% by volume  (Abbott  EPD-
      DM: [30-40]%; Mylan: [10-20]%).

 410) Post-merger, three generic players remain in the UK market: Teva, Actavis and Sandoz.[69] Moreover, at least four competitors hold  dormant
      marketing authorisations to sell betahistine-based products in the UK. In addition to this, the UK market has a very high rate  of  generic
      penetration, confirmed by the presence of three of the strongest  generic  suppliers  across  Europe,  and  Abbott  EPD-DM's  market  share
      decreased by [0-10]% between years 2012 and 2013 at every plausible market definition.

 411) Abbott EPD-DM's products based on betahistine are sold in the prescription segment, while Mylan's products are sold both under prescription
      and OTC. In the UK, the prices of generics are determined freely by the pharmaceutical companies and therefore price  increases  and  price
      decreases occur. However, the reimbursement level is set by the authorities for different categories of pharmaceutical  products  depending
      on how valuable each product is (according to their cost and how commonly they are prescribed). The market investigation revealed  that  in
      cases of shortages and in particular where there is only one supplier in the market, there are concessions and the drugs can be sold  at  a
      higher price and reimbursed at this higher level. However, in a competitive scenario such as the one at hand, in which  the  merged  entity
      would face competitive constraint from three strong generic players, such possibility can be excluded.

      Conclusion

 412) The Commission, taking into consideration all of the above,  including  the  results  of  the  market  investigation,  concludes  that  the
      transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to betahistine in the UK.

 Ireland

 413) Abbott EPD-DM is active in Ireland with its branded product Serc while Mylan sells a branded generic  Vertigon.  The  size  of  the  market
      (2013) is EUR 1.5 million.

 414) The Parties' combined market share for betahistine-based products in Ireland at the molecule level reaches [80-90]% by value (Abbott EPD-DM
      [60-70]%; Mylan [10-20]%) and [80-90]% by volume (Abbott EPD-DM: [60-70]%; Mylan: [10-20]%), which makes them the only sizeable players  in
      this market. High market shares are equally reached at the broader ATC3 N7C class, where the Parties' combined market  share  reaches  [70-
      80]% by value (Abbott EPD-DM: [50-60]%; Mylan: [10-20]%) and [70-80]% by volume (Abbott EPD-DM: [50-60]%; Mylan: [10-20]%).

 415) The only competitors to the Parties at the molecule level are two small players with a generic profile, namely  Fannin  and  Accord,  which
      entered the market in 2013. Fannin, which has taken the place of Erga Healthcare (Helsinn Corp.) by obtaining its  marketing  authorisation
      for the branded generic product "By Vertin" in August 2013, has a market share of [10-20]% (value) and [10-20]% (volume).  Accord's  market
      share is negligible (far below [0-5]%).[70] At the broader ATC3 level, the Parties' main competitor is J&J[71]  with  its  branded  product
      Stugeron, based on a different molecule, cinnarizine which is reimbursed in Ireland.

 416) The market investigation showed that the brand plays a very important role in this market. Indeed, the market for betahistine in Ireland is
      driven by prescribers acting as the ultimate gatekeepers as there is no pharmacy  substitution  for  betahistine  in  Ireland.  Doctors  in
      Ireland seem to be particularly attached to brands and unwilling to switch. In this context it is noted that both Abbott EPD-DM  and  Mylan
      sell betahistine in Ireland under very strong brands, while the brands from other producers such as Fannin's product By-Vertin have only  a
      limited take-up in the market.

 417) Only one competitor holds a dormant marketing authorisation to enter this market while his plans remain unclear.  In  addition,  given  the
      strong branded nature of this particular market, any potential entrant would have to create a brand and overcome the barrier stemming  from
      the strong position of the Parties' established brands benefitting from strong prescribers' loyalty.

 418) Moreover, there are a number of additional barriers to enter this market, given that betahistine is an old  molecule  which  would  require
      engaging in a lengthy and costly procedure in order to update the marketing dossier. Such barriers, in combination with the small  size  of
      the market (EUR 1.5 million), strong brand of Abbott EPD-DM and the fact that there is  no  pharmacy  substitution  for  this  molecule  in
      Ireland, make entry in the market very unlikely.

 419) Based on the above, the Commission considers that Abbott EPD-DM holds a dominant position on the market for betahistine  in  Ireland.  This
      dominant position will be further strengthened by the addition of Mylan.

 420) Finally, the Commission considered the regulatory framework in Ireland. Betahistine is sold as a prescription drug in Ireland. The  product
      of the Parties and their competitors are reimbursed in Ireland. The ability of pharmaceutical companies to increase  prices  of  reimbursed
      drugs in Ireland is limited. The only possibility for this requires filing an application to the relevant authority motivating  the  reason
      for the price increase. However, the market investigation in relation to Ireland revealed that in highly concentrated markets with  limited
      competition (as in the present case), price increases are possible and are more likely to be granted than  in  markets  with  a  number  of
      established players.

      Conclusion

 421) The Commission concludes that serious doubts arise as regards the compatibility of the transaction with the internal market in relation  to
      betahistine in Ireland, because the transaction would strengthen the dominant position which Abbott EPD-DM already holds on this market.

8 Other Group 2 and Group 3 markets in the CNS / pain therapeutic area

 422) In addition to the Group 1 markets analysed above, there is a number of Group 2 and Group 3 affected  markets  in  the  CNS  /  pain  area,
      specifically:

      • ATC3 class M1A in the Czech Republic, France, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden

      • ATC3 class N2B in France

      • ATC3 class N2C in Italy

      • ATC3 class N5C in Italy

      • ATC3 class N6A in France, Germany and Italy

      • ATC3 class N7C in France, Italy, Luxembourg and Poland

 423) Within these ATC classes several galenic  forms  are  marketed  and  give  rise  to  technically  affected  markets.  However,  the  market
      investigation did not provide any indications that the markets in this case should be further segmented depending on the galenic form or on
      whether the drug is sold against a prescription or OTC.

 424) On these markets the combined market share of the Parties are moderate to low and / or the increment is below 1%. In all cases there  is  a
      number of strong competitors active on these markets with a wide portfolio of products, including branded medicines but  also  branded  and
      non-branded generic products, such as Sanofi,  Servier,  Teva,  Pfizer,  Novartis,  Johnson  &  Johnson,  Roche,  Daiichi  Sankyo,  Actavis
      Gruenenthal, Recordati, Polifarma.

 425) The market investigation did not provide any indication that competition issues would arise in these markets. On this basis the  Commission
      concludes that the transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to any  of
      these markets.

       WOMEN'S AND MEN'S HEALTH AREA

1 Pygeum africanum (G4C9)

      Product market definition

 426) Pygeum africanum is a product of herbal origin derived from the bark of a tree called pygeum africanum, belonging  to  the  Prunus  family.
      Pygeum africanum belongs to the ATC3 class G4C, which includes benign prostatic hypertrophy ("BPH") products, which  treat  the  growth  of
      individual prostatic stromal and epithelial cells. The ATC3 class G4C is further split in seven ATC4 classes depending  on  their  mode  of
      action or the origin of the products, two of which are out of use. The Parties' pygeum africanum-based  products  fall  under  class  G4C9.
      Class G4C9 includes also other products of herbal or animal origin, as well as homeopathic products, improving prostatic health.

 427) The Notifying Party submits that the relevant product market for pygeum africanum comprises at least all products within  the  class  G4C9,
      including serenoa repens.

 428) There are no Commission precedents analysing specifically pygeum africanum-based products.

 429) The results of the market investigation suggest that pygeum africanum is used as an effective treatment for patients with BPH. According to
      respondents, while other products, for example serenoa repens, can be prescribed for the same condition, their action is not the same since
      natural extracts all have their specificities. Given its natural origin, pygeum arfricanum cannot be reproduced in its exact action.

 430) Therefore, for the purposes of this decision, the Commission concludes that the relevant product market  for  pygeum  africanum  should  be
      defined at the molecule level.

      Competitive assessment

 431) On the basis of the market definition set out about, the proposed transaction gives rise to one Group 1 market, namely France.

France

 432) The Parties both market their pygeum africanum-based products in France.[72] Abbott EPD-DM sells its product under the brand name  Tadenan,
      whereas Mylan uses a non-registered name Prunier d'Afrique. The products of both Parties are sold OTC.

 433) The total size of the market for pygeum africanum in France in terms of sales is approximately EUR 23 million.

 434) The Parties' combined market share for pygeum africanum-based products in France at the molecule level is [90-100]%, with an increment from
      Mylan of [0-5]% (value) and [0-5]% (volume) in 2013. While Mylan's increment was small in 2013, its market position  was  stronger  in  the
      preceding years, achieving up to [20-30]% (volume) in 2011.

 435) The decrease in Mylan's market share is explained by [Mylan's commercial information regarding the product]. Therefore, the limited  market
      share of Mylan in 2013 does not reflect its full marketing potential and is likely to underestimate its  future  market  position  [Mylan's
      commercial information regarding the product].

 436) In addition, despite the relatively significant size of the market in France (EUR 23 million), there are  no  other  competitors  currently
      present nor does any other competitor hold a marketing authorization. This suggests that the Parties have certain advantages  (e.g.  access
      to scarce supply sources, know-how, etc.) and that entry is likely to be difficult.

 437) Based on the above, the Commission considers that Abbott EPD-DM holds a dominant position on the market for  pygeum  africanum  in  France.
      This dominant position will be further strengthened by the addition of Mylan.

 438) Finally, the Parties' pygeum africanum-based products are sold OTC, which means they are subject to free  pricing  in  France.  Hence,  the
      merged entity would not face any regulatory constraints to increase prices.

      Conclusion

 439) The Commission concludes that serious doubts arise as regards the compatibility of the transaction with the internal market in relation  to
      pygeum africanum in France, because the transaction would strengthen the dominant position  which  Abbott  EPD-DM  already  holds  on  this
      market.

2 Oxybutynin (G4D)

      Product market definition

 440) Oxybutynin belongs to the ATC3 class G4D which includes urinary incontinence products and is further divided in two ATC4 classes  depending
      on the origin of the products. ATC4 class contains urinary incontinence products (e.g.  oxybutynin-based  products)  and  ATC4  Class  G4D8
      contains products of herbal or animal origin, as well as homeopathic products. Oxybutynin  is  an  urinary  antispasmodic  that  serves  as
      anticholinergic agent that inhibits involuntary detrusor contractions.

 441) The Commission has not assessed oxybutynin or the ATC3 class G4D in its previous decisions.

 442) The Notifying Party submits that the appropriate market definition for oxybutynin should include all anticholinergics covered in class G4D,
      although it may potentially exclude some drugs with other modes of action also included in this class.

 443) The results of the market investigation suggest that there are more modern alternatives available to oxybutynin,  which  cause  fewer  side
      effects. In particular, the respondents mentioned general substitutability of oxybutynin with various anticholinergic agents  belonging  to
      the ATC3 class G4D including propiverine, trospium, tolterodine, solifenacine, trospium, darifenacine, and fesoterodine.

 444) Based on the above, for the purposes of this case the Commission concludes that the relevant product market in relation to oxybutynin-based
      products is wider than the molecule, but narrower than the ATC3 class, likely comprising ATC4 classes A2B1 and A2B2.

 445) Therefore, for the purposes of this decision, the Commission concludes that the relevant product market for oxybutynin should be defined at
      the ATC3 level. It may be left open whether some specific G4D class products are not substitutable  with  oxybutynin,  since  it  will  not
      change the assessment in the present case.

      Conclusion

 446) On the basis of the market definition set out above, no Group 1 markets arise and the transaction does not raise serious doubts in relation
      to oxybutynin.

3 Other Group 2 and Group 3 markets in the women's and men's health therapeutic area

 447) In addition to the Group 1 markets analysed above, there is a number of Group 2 and Group 3 affected  markets  in  the  women's  and  men's
      health area, specifically:

      • ATC3 class G3D in France

      • ATC3 class G4C in France

      • ATC3 class G4D in France

 448) Within these ATC classes several galenic  forms  are  marketed  and  give  rise  to  technically  affected  markets.  However,  the  market
      investigation did not provide any indications that the markets in this case should be further segmented depending on the galenic form or on
      whether the drug is sold against a prescription or OTC. On these markets the combined market share of the Parties are moderate to low and /
      or the increment is below 1%. In all cases there is a number of strong competitors active  on  these  markets  with  a  wide  portfolio  of
      products, including branded medicines but also branded and non-branded generic products, such as Teva, Servier, Sanofi, Urgo, Zambon Group,
      and Pierre Fabre.

 449) The market investigation did not provide any indication that competition issues would arise in these markets. On this basis the  Commission
      concludes that the transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to any  of
      these markets.

3 Pipeline products

 450) In addition to drugs already on the market, generic companies are usually developing a number of pipeline generic drugs which are  intended
      to compete with originators which come off-patent. In assessing pipeline competition, the Commission has previously  focused  on  instances
      where one party is planning to enter a market with a new product within a period of two years and the other party (or the parties combined)
      has a market share of 35% or more on any possible market definition where the pipeline products and existing products overlap.[73]

 451) Both Abbott EPD-DM and Mylan invest in the development of new products. [Parties' information on pipeline products].

 452) Based on the above, the Parties have identified in the Form CO [Parties' information on  pipeline  products]  products  in  a  sufficiently
      advanced stage of development (i.e. around two years till launch) where the other Party has an existing market share of at least 35%  based
      on all plausible market definitions and the other party is planning to enter. These [Parties' information on  pipeline  products]  relevant
      pipeline products of the Parties are the following:

    − [Parties' information on pipeline products];

    − [Parties' information on pipeline products].

 453) The market investigation confirmed that sufficient competition is likely to remain in relation  to  the  above-mentioned  products  in  the
      relevant Member States post-merger. This is due to the fact that the relevant product markets are wider than the ones where the other Party
      would have a market share of at least 35% ([Parties' information on pipeline products]) and/or a number of strong competing  pharmaceutical
      companies remaining post-merger ([Parties' information on pipeline products]).

 454) In addition to the [Parties' information on pipeline  products]  above-mentioned  pipeline  products,  [Parties'  information  on  pipeline
      products].

 455) Consequently, the Commission concludes that serious doubts do not arise in relation to the Parties' pipeline products.

4 Active pharmaceutical ingredients

 456) An API is the substance in a drug that is pharmaceutically active, as opposed to the  excipient  (inert  substance  in  which  the  API  is
      suspended).

 457) APIs are produced from chemical and biological products and may be manufactured internally or sourced from external manufacturers. In  past
      cases, the Commission considered that APIs form separate product markets upstream from the markets for FDPs. Geographically, the latter are
      considered to be national markets, due to national regulation, while API markets are at least EEA-wide and possible global in scope.

 458) With respect to horizontal analysis, while Mylan has extensive active  pharmaceutical  ingredient  ("API")  operations,  Abbott  EPD-DM  is
      essentially not active in the production of APIs for sale to third parties (it only sells limited excess inventory). Hence,  any  increment
      to the combined market share would be limited.

 459) Also, there are no actual vertical relationships between Mylan and Abbott EPD-DM since none of the APIs manufactured by Mylan  is  used  by
      Abbott EPD-DM in the downstream FDPs, and vice versa. The transaction however gives rise to several potential vertical  links  due  to  the
      upstream API manufacturing by Mylan and downstream activities of Abbott EPD-DM in FDPs.

 460) For all potential vertically affected links the API produced by Mylan is a different molecule than the API used by Abbott EPD-DM to produce
      its corresponding FDP. This suggests that the producer upstream is unlikely to successfully engage in input foreclosure  and  the  producer
      downstream is unlikely to successfully engage in customer foreclosure.

 461) There is only one vertically affected link downstream where Abbott EPD-DM's competitors produce FDPs using the  same  API  as  produced  by
      Mylan. However, this API is produced also by several other API producers. Therefore, API purchasers would have several alternative  sources
      post-merger.

 462) Accordingly, the Commission concludes that serious doubts do not arise in relation to the Parties' API activities.

5 Contract manufacturing

 463) Contract manufacturing of FDPs consists of the manufacturing under contract of FDPs on behalf of third party pharmaceutical companies.  The
      third party then commercializes the FDPs under its own label or brand. In its previous decisions, the Commission found that the  geographic
      market for contract manufacturing to be worldwide or at least EEA-wide.[74]

 464) Both Abbott EPD-DM and Mylan have contract manufacturing activities. All Abbott EPD-DM's contract manufacturing sales are generated by  its
      plant in Japan and none was in the EEA. None of the Parties is a  major  player  in  contract  manufacturing  activities  given  their  low
      estimated market shares in various segments. Sufficient alternative contract manufacturers are likely to remain post-merger.

 465) Accordingly, the Commission concludes that serious doubts do not arise in relation to the Parties' contract manufacturing activities.

6 Outlicensing

 466) Outlicensing in the pharmaceutical industry refers to a licensor licensing to a licensee rights to use a  dossier  to  obtain  a  marketing
      authorization for a product in one or more countries. Based on Commission’s  practice,  outlicensing  may  result  in  vertically  affected
      markets where (i) one party is active on a downstream FDPs market, (ii) the other party is active  upstream  as  a  licensor  and  contract
      manufacturer of a downstream competitor and where (iii) the combined share of the Parties and the licensee on the downstream market are  in
      excess of 25%.

 467) Mylan and Abbott EPD-DM are both active in the market of outlicensing market authorization dossiers  to  third  parties.  Three  vertically
      affected markets have been identified. The Notifying Party submits that no competition concerns arise given (i) the lack of  incentive  for
      the merged entity to discontinue its licensing arrangements given the Parties' small market shares downstream; and (ii)  ample  alternative
      sources of supply. The market investigation has confirmed these statements.

 468) Accordingly, the Commission concludes that serious doubts do not arise in relation to the Parties' outlicensing activities.

       PROPOSED commitments

 469) In order to render the concentration compatible with the internal market, the Parties have modified the notified concentration by  entering
      into the following Commitments, which the Notifying Party submitted on 7 January 2015. The Commitments  were  subsequently  modified  on  8
      January 2015. The final version of the Commitments including the adaptations made following the results of the market test was submitted on
      21 January 2015. These Committments are annexed to this decision and form an integral part thereof.

      Description of the Commitments

 470) Specifically, Mylan offered to divest its local businesses in the product markets where serious doubts were identified following the  phase
      I market investigation to one or more suitable third party purchasers ("the Purchasers").

 471) The businesses to be divested (hereafter referred to as "the Divestment Businesses") include the following:

            - Mylan's mebeverine business in Germany;

            - Mylan's mebeverine business in the United Kingdom;

            - Mylan's pygeum africanum business in France;

            - Mylan's betahistine business in Ireland;

            - Mylan's delorazepam business in Italy.

 472) The Divestment Businesses are structured as an asset carve-out; no legal entity of Mylan is to be divested. Specifically, the businesses to
      be divested include the following assets:

   i. the relevant marketing authorizations under which the Divestment Businesses operate, including  all  relevant  dossiers,  and  without  any
      limitation as to the use of the information contained in the dossiers;

  ii. all licenses, permits and authorisations issued by any governmental organisation for the benefit of the Divestment Business;

 iii. customer contacts and historical information of orders;

  iv. to the extent such contracts exist, assignment of contracts or a best efforts obligation to obtain the  assignment  of  the  supply  and/or
      customer contracts or entered into by Mylan;

   v. all advertising, marketing, sales, publicity and presentational materials related to the Divestment Businesses, as applicable.

  vi. the benefit for a period of up to 2 years after Closing, on a reasonable cost-plus basis to be agreed with the Purchaser  and  overseen  by
      the Monitoring Trustee, of an non-exclusive and transitory manufacturing or supply arrangement relating to the existing forms of product in
      the country of the Divestment Business, and/or  reasonable  technical  assistance  to  the  Purchaser  to  assume  responsibility  for  the
      manufacture, sale and marketing of the relevant Divestiture Business, as detailed in the Schedules;

 vii. an option for the Purchaser to hire one or more Personnel, who work for the relevant  Divestment  Business  and  who  would  reasonably  be
      considered necessary to maintain the viability, marketability and competitiveness of that Divestment Business,  to  be  supervised  by  the
      Monitoring Trustee. This option is to be exercised within a period of one year after signing the Transfer Agreement.

 473) In addition the undertakings concerned have entered into  related  commitments,  inter  alia  regarding  the  separation  of  the  divested
      businesses from their retained businesses, the preservation of the viability, marketability and competitiveness of the divested businesses,
      including the appointment of a monitoring trustee and, if necessary, a divestiture trustee.

 474) The Commitments also include specific Purchaser requirements in particular the need for the Purchaser(s) to have an existing  footprint  in
      the sale of generics in the relevant country.

       ASSESSMENT OF THE PROPOSED commitments

475) The Commission analysed the suitability of the Commitments to remedy serious doubts in this  case  against  the  standard  set  out  in  the
    Commission Notice on Remedies.[75]

1 Framework for the Commission's assessment of the Commitments

476) Where a notified concentration raises serious doubts as to its compatibility with the internal market, the parties may modify  the  notified
    concentration so as to remove the grounds for the serious doubts identified by the Commission with a view to having it  declared  compatible
    with the internal market pursuant to Article 6(1)(b) in conjunction with Article 6(2) of the Merger Regulation.

477) As set out in the Commission Notice on Remedies, commitments have to eliminate the Commission's serious doubts entirely,  they  have  to  be
    comprehensive and effective from all points of view and they must be capable of being implemented effectively within a short period of time,
    as the conditions of competition on the market will not be maintained until the commitments have been fulfilled.[76]

478) In assessing whether or not commitments will restore effective competition,  the  Commission  considers  their  type,  scale  and  scope  by
    reference to the structure and the particular characteristics of the market in which the Commission has identified serious doubts as to  the
    compatibility of the notified concentration with the internal market.[77]

479) Divestiture commitments are the best  way  to  eliminate  serious  doubts  resulting  from  horizontal  overlaps  of  the  merging  parties'
    activities.[78] Other commitments (such as licensing) may be suitable to resolve serious doubts  if  those  commitments  are  equivalent  to
    divestitures in their effects. The divested activities must consist of a viable business that, if operated  by  a  suitable  purchaser,  can
    compete effectively with the merged entity on a lasting basis and that is divested as a going concern.[79]

480) The business to be divested must include all the assets which contribute to its current operation or  which  are  necessary  to  ensure  its
    viability and competitiveness and all personnel which are currently employed or which are necessary to ensure the  business'  viability  and
    competitiveness. Personnel and assets which are currently shared between the business to be divested and other businesses  of  the  parties,
    but which contribute to the operation of the business or which are necessary to ensure its  viability  and  competitiveness,  must  also  be
    included.[80] Otherwise, the viability and competitiveness of the business to be divested would be endangered.

481) Furthermore, the intended effect of the divestiture will only be achieved if and once the business is transferred to  a  suitable  purchaser
    with proven relevant expertise and ability to maintain and develop  the  business  to  be  divested  as  a  viable  and  active  competitive
    undertaking. This may imply some specific purchaser requirements are included in the commitments to ensure  that  the  transferred  business
    remains viable.

482) Even though normally the divestiture of an existing viable stand-alone business  is  required,  the  Commission,  taking  into  account  the
    principle of proportionality, may also consider the divestiture of businesses which have existing strong links or are  partially  integrated
    with businesses retained by the parties and therefore need to be ‘carved out’ in those respects.[81] Commitments including a carve-out of  a
    business can only be accepted by the Commission if it can be certain that, at least at the time when the  business  is  transferred  to  the
    purchaser, a viable business on a stand-alone basis will be divested and the risks for the viability and competitiveness caused by the carve-
    out will thereby be reduced to a minimum.[82]

    Suitability for removing serious doubts

483) In order to assess the suitability of the Commitments to remove serious doubts in this case, the Commission launched  a  market  test  on  9
    January 2015. The market test of the Commitments, which was addressed to competitors, customers and  wholesalers,  distributors  and  German
    Health Funds, was generally positive and confirmed that the Commitments are suitable to eliminate the competition concerns identified by the
    Commission. In particular, the majority of respondents considered  that,  subject  to  them  being  divested  to  suitable  Purchasers,  the
    Divestment Businesses include all the necessary assets to successfully market the specific molecules in the  markets  where  the  Commission
    identified competition concerns and to subsequently compete effectively with the merged entity on these markets.

484) Specifically, the Commitments consist of businesses evolving around marketing authorisations  issued  by  national  health  authorities  and
    providing the access to the national pharmaceutical products' markets where competition concerns were identified.  Given  the  economies  of
    scale associated with the sale of generic products, companies are  typically  active  in  several  countries.  Therefore,  the  market  test
    indicated that to preserve the attractiveness of the Divestment Businesses the use  of  information  contained  in  the  divested  marketing
    authorisations should not be limited. The revised Commitments of 21 January 2015 do not include any limitation with regard to the  scope  of
    the use of the marketing authorisations to be divested.

485) Since it is a common practice in the pharmaceutical sector to cooperate with third-party producers of API or FDP, the market test  confirmed
    that it is necessary to ensure that the Purchasers have access to all third parties, such as contract manufacturers,  in  the  same  way  as
    Mylan has had. This also holds true for all customer contracts and any other customer related information.  To  that  end,  the  Commitments
    package includes the transfer of all such contracts and in the absence of such, a commitment of Mylan's best efforts for the transfer of the
    relationship.

486) In addition, to ensure that the divested products will be swiftly marketed by the Purchaser(s) and to the extent  required  by  the  latter,
    the Commitments include an option to hire some of Mylan's personnel as needed.

2 Purchaser criteria

487) Besides the standard criteria for a suitable purchaser contained in section D of the Commitments, the results of the market  test  indicated
    the need for a suitable Purchaser to be an established player in the business of marketing generic pharmaceutical products.

488) This is because, according to the market test, companies marketing generic pharmaceutical  products  tend  to  compete  using  their  entire
    portfolio rather than on a single product basis. In addition, there are economies of scale associated with the entire generic supply  chain.
    Therefore, for the divestment businesses to remain viable there is a need for the Purchaser to have  the  ability  to  swiftly  include  the
    acquired business into its own product portfolio which should have a sufficient breadth to appeal to pharmacy and  wholesale  customers.  It
    follows that for the Purchaser to be able to establish a competitive position in the problematic markets, it should therefore be  a  company
    which markets a broad product portfolio, such as Mylan's.

489)  In addition, the respondents to the market test confirmed that a suitable Purchaser needs to have an existing and strong  distribution  and
    sales footprint in the affected markets in order to guarantee a successful and prompt commercialisation of the divested products.

3 Interest in the Commitments

490) The market test revealed an interest of a sufficient number of potentially suitable Purchasers as a result of what it can be concluded  that
    the Commitments are likely to be implemented in practice.

4 Conclusion on the Commitments

491) On the basis of the above the Commission concludes that the Divestment Businesses are viable businesses  and  the  modalities  foreseen  for
    their transfer will enable their operation by the corresponding Purchaser(s) in a competitive and viable manner.

492)  The Commitments will permit to address the competition concerns identified in the present decision  as  they  remove  the  overlap  between
    Mylan and Abbott APD-DM in problematic markets and provide grounds for a new player to emerge.

493) In particular, the Commitments are suitable and sufficient to remedy the serious doubts raised by the transaction in relation  to  the  five
    markets where serious doubts were identified, namely

   i. Mebeverine in Germany,

  ii. Mebeverine in the UK,

 iii. Delorazepam in Italy,

  iv. Betahistine in Ireland and

   v. Pygeum africanum in France.

494) Moreover, the Commitments are comprehensive and effective from all points of view, and are capable of being implemented  effectively  within
    a short period of time.

495)  The Commission therefore considers that the Commitments, as submitted including the adaptations made following the results  of  the  market
    test, are sufficient to eliminate all serious doubts as to the compatibility of the  transaction  with  the  internal  market  and  the  EEA
    Agreement.

       CONDITIONS AND OBLIGATIONS

496) Pursuant to the first sentence of the second subparagraph of Article 6(2) of the  Merger  Regulation,  the  Commission  may  attach  to  its
    decision conditions and obligations intended to ensure that the undertakings concerned comply with the commitments they  have  entered  into
    vis-à-vis the Commission with a view to rendering the concentration compatible with the internal market.

497) The achievement of the measure that gives rise to the structural change of the market is a condition, whereas the implementing  steps  which
    are necessary to achieve this result are generally obligations on the parties. Where a condition is not fulfilled, the Commission's decision
    declaring the concentration compatible with the internal market and the EEA Agreement no longer stands.  Where  the  undertakings  concerned
    commit a breach of an obligation, the Commission may revoke the clearance  decision  in  accordance  with  Article  8(6)(b)  of  the  Merger
    Regulation. The undertakings concerned may also be subject to fines and periodic penalty payments under Articles  14(2)  and  15(1)  of  the
    Merger Regulation.

498) In accordance with the basic distinction between conditions and obligations, the decision in this case is  conditional  on  full  compliance
    with the requirements set out in Section B of the final Commitments, which constitute conditions. The remaining requirements set out in  the
    other Sections of the said Commitments are considered to constitute obligations.

499) The full text of the final Commitments is annexed to this Decision as Annex I and forms an integral part thereof.

       CONCLUSION

500) For the above reasons, the Commission has decided not to oppose the notified operation as modified by the  Commitments  and  to  declare  it
    compatible with the internal market and with the functioning of the EEA Agreement,  subject  to  full  compliance  with  the  conditions  in
    sections B and C of the Commitments annexed to the present decision and with the obligations contained in the other  sections  of  the  said
    commitments. This decision is adopted in application of Article 6(1)(b) in conjunction with  Article  6(2)  of  the  Merger  Regulation  and
    Article 57 of the EEA Agreement.

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

                                                                                                             Case M. 7379 – Mylan / Abbott EPD-DM

                                                      COMMITMENTS TO THE EUROPEAN COMMISSION

Pursuant to Article 6(2) of Council Regulation (EC) No 139/2004 (the “Merger Regulation”),  New  Moon  B.V.  (“Mylan”)  hereby  enters  into  the
following Commitments (the “Commitments”) vis-à-vis the European Commission (the “Commission”) with a view to rendering the acquisition  of  sole
control by Mylan over Abbott EPD-DM (the “Concentration”) compatible with the internal market and the functioning of the EEA Agreement.

This text shall be interpreted in light of the Commission’s decision pursuant to  Article  6(1)(b)  of  the  Merger  Regulation  to  declare  the
Concentration compatible with the internal market and the functioning of the  EEA  Agreement  (the  “Decision”),  in  the  general  framework  of
European Union law, in particular in light of the Merger Regulation, and by reference to the  Commission  Notice  on  remedies  acceptable  under
Council Regulation (EC) No 139/2004 and under Commission Regulation (EC) No 802/2004 (the “Remedies Notice”).

                                                                TABLE OF CONTENTS

Section A.  Definitions      3

Section B.  The commitment to divest and the divestment business    4

Section C.  Related commitments   6

Section D.  The Purchaser    8

Section E.  Trustee    9

Section F.  The review clause     15

Section G.  Entry into force 15

Section A.  Definitions

1. For the purpose of the Commitments, the following terms shall have the following meaning:

   Abbott EPD-DM: Abbott Laboratories' Non-U.S. Developed Markets Speciality and Branded Generics Business.

   Affiliated Undertakings: undertakings controlled by the Parties and/or by the ultimate parents of the Parties, whereby the notion  of  control
   shall be interpreted pursuant to Article 3 of the Merger Regulation and in light of the Commission Consolidated  Jurisdictional  Notice  under
   Council Regulation (EC) No 139/2004 on the control of concentrations between undertakings (the "Consolidated Jurisdictional Notice").

   Assets: the assets that contribute to the current operation or are necessary to ensure the viability and  competitiveness  of  the  Divestment
   Business as indicated in Section B and described more in detail in the Schedule.

   Closing: the transfer of the legal title to the Divestment Business to the Purchaser.

   Closing Period: the period of [*] from the approval of the Purchaser and the terms of sale by the Commission

   Confidential Information: any business secrets, know-how, commercial information, or any other information of a proprietary nature that is not
   in the public domain.

   Conflict of Interest: any conflict of interest that impairs the Trustee's objectivity and independence in discharging  its  duties  under  the
   Commitments.

   Divestiture Trustee: one or more natural or legal person(s) who is/are approved by the Commission and appointed  by  Mylan  and  who  has/have
   received from Mylan the exclusive Trustee Mandate to sell the Divestment Business to a Purchaser at no minimum price.

   Divestment Business: the businesses as defined in Section B and in the Schedules which Mylan commits to divest.

   Effective Date: the date of adoption of the Commission Decision declaring the  acquisition  of  sole  control  by  Mylan  over  Abbott  EPD-DM
   compatible with the internal market and the functioning of the EEA Agreement.

   First Divestiture Period: the period of [*] from the Effective Date.

   Hold Separate Manager: the person appointed by Mylan for the Divestment Business to manage the day-to-day business under  the  supervision  of
   the Monitoring Trustee.

   Monitoring Trustee: one or more natural or legal person(s) who is/are approved by the Commission and appointed by Mylan, and who has/have  the
   duty to monitor Mylan's compliance with the conditions and obligations attached to the Decision.

   Mylan: New Moon B.V. a private limited liability company organized and existing under the laws of the Netherlands, with its corporate seat  in
   Amsterdam, the Netherlands and registered at the Dutch chamber of commerce (Kamer van Koophandel) under number 61036137. After the closing  of
   the acquisition of Abbott EPD-DM, New Moon B.V. will be converted to Mylan N.V. a limited liability company organized and existing  under  the
   law of the Netherlands, with its corporate seat in Amsterdam.

   Parties: Mylan and Abbott EPD-DM.

   Personnel: all staff currently employed by the legal entity or entities of which the Divestment Businesses form part.

   Purchaser: the entity or entities approved by the Commission as acquirer of the Divestment Business in accordance with the criteria set out in
   Section D.

   Purchaser Criteria: the criteria laid down in paragraph 16 of these Commitments that the Purchaser must fulfil in order to be approved by  the
   Commission.

   Schedule: the schedule to these Commitments describing more in detail the Divestment Business.

   Transfer Agreement: the agreement by virtue of which the Divestment Business is transferred to the Purchaser.

   Trustee(s): the Monitoring Trustee and/or the Divestiture Trustee as the case may be.

   Trustee Divestiture Period: the period of [*] from the end of the First Divestiture Period.

   Section B.    The commitment to divest and the Divestment Business

      Commitment to divest

2. In order to maintain effective competition, Mylan commits to divest, or procure the divestiture of the Divestment Businesses  by  the  end  of
   the Trustee Divestiture Period to a purchaser and on terms of sale approved by the Commission in accordance with the  procedure  described  in
   paragraph 17 of these Commitments. To carry out the divestiture, Mylan commits to find a purchaser and to enter into a final binding sale  and
   purchase agreement for the sale of the Divestment Business within the First Divestiture  Period.  If  Mylan  has  not  entered  into  such  an
   agreement at the end of the First Divestiture Period, Mylan shall grant the Divestiture Trustee an exclusive mandate to  sell  the  Divestment
   Business in accordance with the procedure described in paragraph 29 in the Trustee Divestiture Period.

3. Mylan shall be deemed to have complied with this commitment if:

      (a)   by the end of the Trustee Divestiture Period, Mylan or the Divestiture Trustee has entered into a final  binding  sale  and  purchase
           agreement and the Commission approves the proposed purchaser and the terms of sale  as  being  consistent  with  the  Commitments  in
           accordance with the procedure described in paragraph 17; and

      (b)   the Closing of the sale of the Divestment Businesses to the Purchaser takes place within the Closing Period.

4. In order to maintain the structural effect of the Commitments, Mylan shall, for a period of 10  years  after  Closing,  not  acquire,  whether
   directly or indirectly, the possibility of exercising influence (as defined in paragraph 43 of the Remedies Notice, footnote 3) over the whole
   or part of the Divestment Business, unless, following the submission of a reasoned request from Mylan showing good cause and accompanied by  a
   report from the Monitoring Trustee (as provided in paragraph 43 of these Commitments), the Commission finds that the structure of  the  market
   has changed to such an extent that the absence of influence over the Divestment Business  is  no  longer  necessary  to  render  the  proposed
   concentration compatible with the internal market.

      Structure and definition of the Divestment Business

5. The Divestment Business consists of

     i. Mylan's mebeverine business in Germany;

    ii. Mylan's mebeverine business in the United Kingdom;

   iii. Mylan's pygeum africanum business in France;

    iv. Mylan's betahistine business in Ireland; and

     v. Mylan's delorazepam business in Italy.

6. Each of these Divestment Businesses, described in more detail in the Schedules, shall include, as applicable:

   a) all tangible and intangible assets (including intellectual property rights, which contribute to the current operation and are necessary  to
      ensure the viability, marketability and competitiveness of the Divestment Business);

   b) all licences, permits and authorisations issued by any governmental organisation for the benefit of the Divestment Business;

   c) all contracts, commitments and customer orders of the Divestment Business; all  customer,  credit  and  other  records  of  the  Divestment
      Business;

   d) all advertising, marketing, sales, publicity and presentational materials related to the Divestment Business, as applicable (items referred
      to under (a)-(d) hereinafter collectively referred to as "Assets");

   e) if such contract exists, a best efforts obligation
   f) [83] to obtain the assignment of the contract manufacturing arrangement entered into by Mylan and/or the active  pharmaceutical  ingredient
      ("API") supply arrangement entered into by Mylan;

   g)  the benefit for a period of up to 2 years after Closing, on a reasonable cost-plus basis to be agreed with the Purchaser and  overseen  by
      the Monitoring Trustee in accordance with paragraph 27(iii), of  an  non-exclusive  and  transitory  manufacturing  or  supply  arrangement
      relating to the existing forms of product in the Member State of the Divestment Business, and/or reasonable  technical  assistance  to  the
      Purchaser to assume responsibility for the manufacture, sale and marketing of  the  relevant  Divestiture  Business,  as  detailed  in  the
      Schedules;

   h) in relation to the Divestment Businesses set out in the Schedules, subject to applicable local employment legislation, an  option  for  the
      Purchaser to hire one or more Personnel, who work for the relevant Divestment Business and who would reasonably be considered necessary  to
      maintain the viability, marketability and competitiveness of that Divestment Business to be supervised  by  the  Monitoring  Trustee.  This
      option is to be exercised within a period of one year after signing the Transfer Agreement.

7. The Divestment Business is structured as an asset carve-out; no legal entity of Mylan is to be divested.

   Section C.     Related commitments

      Preservation of viability, marketability and competitiveness

8. From the Effective Date until Closing, Mylan shall preserve  or  procure  the  preservation  of  the  economic  viability,  marketability  and
   competitiveness of the Divestment Business, in accordance with good business practice, and shall minimise as far as possible any risk of  loss
   of competitive potential of the Divestment Business. In particular the Parties undertake:

    (a)    not to carry out any action that might have a significant  adverse  impact  on  the  value,  management  or  competitiveness  of  the
           Divestment Business or that might alter the nature and scope of activity, or the industrial or commercial strategy or the  investment
           policy of the Divestment Business;

    (b)    to make available, or procure to make available, sufficient resources for the development of the Divestment Business,  on  the  basis
           and continuation of the existing business plans.

      Hold-separate obligations

9. Mylan commits, from the Effective Date until Closing, to the extent reasonably practical, to keep the Divestment Businesses separate from  the
   EPD-DM business covering the same molecules as will be transferred to Mylan after the Effective Date. Mylan also commits to  ensure  that  the
   Personnel of the Divestment Businesses – including the Hold Separate Manager – will have no involvement in the EPD-DM  business  covering  the
   same molecules as will be transferred to Mylan after  the  Effective  Date  and  vice  versa,  to  the  extent  reasonably  practical  without
   compromising the viability of Divestment Businesses or the businesses retained by the Parties.

10. Until closing, Mylan shall assist the Monitoring Trustee in ensuring that the Divestment Business  is  managed  separately  from  the  EPD-DM
   business covering the same molecules as will be transferred to Mylan after the Effective Date. Immediately after the adoption of the Decision,
   Mylan shall appoint a Hold Separate Manager. The Hold Separate Manager shall manage the Divestment  Business  independently  from  the  EPD-DM
   business covering the same molecules as will be transferred to Mylan after the Effective Date and in the best interest of the business with  a
   view to ensuring its continued economic viability, marketability and competitiveness. The Hold Separate Manager shall closely  cooperate  with
   and report to the Monitoring Trustee and, if applicable, the Divestiture Trustee. In case of any replacement of  the  Hold  Separate  Manager,
   Mylan shall provide a reasoned proposal to replace the person or persons concerned to the Commission and the Monitoring Trustee. Mylan must be
   able to demonstrate to the Commission that the replacement is well suited to carry out the functions exercised by the Hold  Separate  Manager.
   The replacement shall take place under the supervision of the Monitoring Trustee, who shall report to  the  Commission.  The  Commission  may,
   after having heard Mylan, require Mylan to replace the Hold Separate Manager.

      Ring-fencing

11. Mylan shall implement, or procure to implement, all necessary measures to ensure that its personnel that manages  the  Divestment  Businesses
   shall not, after the Effective Date and Until Closing, obtain any Confidential Information relating to the EPD-DM business covering  the  same
   molecules as will be transferred to Mylan after the Effective Date, and vice versa.

      Non-solicitation clause

12. In the instance that the Purchaser exercises the option as described in paragraph 6(g), Mylan undertakes, subject to  customary  limitations,
   not to solicit, and to procure that Affiliated Undertakings do not solicit Personnel hired by (as opposed to seconded to) the Purchaser for  a
   period of 24 months after Closing.

      Due diligence

13. In order to enable potential purchasers to carry out a reasonable due diligence  of  the  Divestment  Businesses,  Mylan  shall,  subject  to
   customary confidentiality assurances and dependent on the stage of the divestiture process:
   a) provide to potential purchasers sufficient information as regards the Divestment Business;
   b) provide to potential purchasers sufficient information relating to the Personnel.

      Reporting

14. Mylan shall submit written reports in English on potential purchasers of the Divestment Business and developments in  the  negotiations  with
   such potential purchasers to the Commission and the Monitoring Trustee no later than 10 days after  the  end  of  every  month  following  the
   Effective Date (or otherwise at the Commission’s request). Mylan shall submit a list of all potential purchasers having expressed interest  in
   acquiring the Divestment Business to the Commission at each and every stage of the divestiture process, as well as a copy of  all  the  offers
   made by potential purchasers within five days of their receipt.

15. The Parties shall inform the Commission and the Monitoring Trustee on the preparation of the data room documentation and  the  due  diligence
   procedure and shall submit a copy of any information memorandum to the Commission and the Monitoring Trustee before sending the memorandum out
   to potential purchasers.

   Section D.    The Purchaser

16. In order to be approved by the Commission, the Purchaser must fulfil the following criteria:

    a) The Purchaser shall be independent of and unconnected to the Parties;

    b) The Purchaser shall have the financial resources, proven expertise and incentive to maintain and develop the  Divestment  Business  as  a
       viable and active competitive force in competition with the Parties and other competitors;

    c) The Purchaser shall have an existing marketing and distribution footprint in generics in the relevant countries in which  the  Divestment
       Business is currently active;

    d) The acquisition of the Divestment Business by the Purchaser must neither be likely to create, in light of the  information  available  to
       the Commission, prima facie competition concerns nor give rise to a risk that the implementation of the Commitments will be  delayed.  In
       particular, the Purchaser must reasonably be expected to obtain all necessary approvals from the relevant regulatory authorities for  the
       acquisition of the Divestment Business.

17. The final binding sale and purchase agreement (as well as ancillary agreements) relating to the divestment of the Divestment  Business  shall
   be conditional on the Commission’s approval. When Mylan has reached an agreement with a purchaser, it shall  submit  a  fully  documented  and
   reasoned proposal, including a copy of the final agreement(s), within one week to the Commission and the Monitoring  Trustee.  Mylan  must  be
   able to demonstrate to the Commission that the purchaser fulfils the Purchaser Criteria and that the Divestment Business is being  sold  in  a
   manner consistent with the Commission's Decision and the Commitments. For the approval, the Commission shall verify that the purchaser fulfils
   the Purchaser Criteria and that the Divestment Business is being sold in a manner consistent with the Commitments including their objective to
   bring about a lasting structural change in the market. The Commission may approve the sale of the Divestment  Business  without  one  or  more
   Assets, or by substituting one or more Assets with one or more different assets, if this does not affect the viability and competitiveness  of
   the Divestment Business after the sale, taking account of the proposed purchaser.

   Section E.    Trustee

      I.    Appointment procedure

18. Mylan shall appoint a Monitoring Trustee to carry out the functions specified in these Commitments for a Monitoring  Trustee.  Mylan  commits
   not to close the Concentration before the appointment of a Monitoring Trustee.

19. If Mylan has not entered into a binding sale and purchase agreement regarding the Divestment Business one month before the end of  the  First
   Divestiture Period or if the Commission has rejected a purchaser proposed by  Mylan  at  that  time  or  thereafter,  Mylan  shall  appoint  a
   Divestiture Trustee. The appointment of the Divestiture Trustee shall take effect upon the commencement of the Trustee Divestiture Period.

20. The Trustee shall:

    (i) at the time of appointment, be independent of the Parties and their Affiliated Undertakings;

    (ii) possess the necessary qualifications to carry out its mandate, for example have sufficient relevant experience as an investment  banker
    or consultant or auditor; and

    (iii) neither have nor become exposed to a Conflict of Interest.

21. The Trustee shall be remunerated by Mylan in a way that does not  impede  the  independent  and  effective  fulfilment  of  its  mandate.  In
   particular, where the remuneration package of a Divestiture Trustee includes a  success  premium  linked  to  the  final  sale  value  of  the
   Divestment Business, such success premium may only be earned if the divestiture takes place within the Trustee Divestiture Period.

Proposal by Mylan

22. No later than two weeks after the Effective Date, Mylan shall submit the names of three or more natural or legal persons whom Mylan  proposes
   to appoint as the Monitoring Trustee to the Commission for approval. No later than one month before the end of the First Divestiture Period or
   on request by the Commission, Mylan shall submit a list of one or more persons whom Mylan proposes to appoint as Divestiture  Trustee  to  the
   Commission for approval. The proposal shall contain sufficient information for the Commission to verify that the person or persons proposed as
   Trustee fulfil the requirements as set out above and shall include:

    (a)    the full terms of the proposed mandate, which shall include all provisions necessary to enable the Trustee to fulfil its duties under
           these Commitments;

    (b)    the outline of a work plan which describes how the Trustee intends to carry out its assigned tasks;

    (c)    an indication whether the proposed Trustee is to act as both Monitoring Trustee and Divestiture Trustee or whether different trustees
           are proposed for the two functions.

Approval or rejection by the Commission

23. The Commission shall have the discretion to approve or reject the proposed Trustee(s) and to approve the  proposed  mandate  subject  to  any
   modifications it deems necessary for the Trustee to fulfil its obligations. If only one name is approved, Mylan shall appoint or cause  to  be
   appointed the person or persons concerned as Trustee, in accordance with the mandate approved by the Commission. If  more  than  one  name  is
   approved, Mylan shall be free to choose the Trustee to be appointed from among the names approved. The Trustee shall be appointed  within  one
   week of the Commission’s approval, in accordance with the mandate approved by the Commission.

New proposal by Mylan

24. If all the proposed Trustees are rejected, Mylan shall submit the names of at least two more natural or legal  persons  within  one  week  of
   being informed of the rejection, in accordance with paragraphs 18 and 23 of these Commitments.

Trustee nominated by the Commission

25. If all further proposed Trustees are rejected by the Commission, the Commission shall nominate a Trustee, whom Mylan shall appoint, or  cause
   to be appointed, in accordance with a trustee mandate approved by the Commission.

      II.   Functions of the Trustee

26. The Trustee shall assume its specified duties and obligations in order to ensure compliance with the Commitments. The Commission may, on  its
   own initiative or at the request of the Trustee or Mylan, give any orders or instructions to the Trustee in order to  ensure  compliance  with
   the conditions and obligations attached to the Decision.

Duties and obligations of the Monitoring Trustee

27. The Monitoring Trustee shall:

     i)    propose in its first report to the Commission a detailed work  plan  describing  how  it  intends  to  monitor  compliance  with  the
        obligations and conditions attached to the Decision;

    ii) oversee, in close co-operation with the Hold Separate Manager, the on-going management  of  the  Divestment  Business  with  a  view  to
        ensuring its continued economic viability, marketability and competitiveness and monitor compliance by Mylan  with  the  conditions  and
        obligations attached to the Decision. To that end the Monitoring Trustee shall:

            (a)   monitor the preservation of the economic viability, marketability and competitiveness  of  the  Divestment  Business,  and  the
             keeping separate of the Divestment Business from the EPD-DM business covering the same molecules as will be  transferred  to  Mylan
             after the Effective Date, in accordance with paragraphs 9 and 10 of these Commitments;

            (b)   supervise the management of the Divestment Business, in accordance with paragraph 9 of these Commitments;

            (c)   with respect to Confidential Information:

               – determine all necessary measures to ensure that Mylan does not after the Effective Date  obtain  any  Confidential  Information
                 relating to the EPD-DM business covering the same molecules as will be transferred to Mylan after the Effective Date;
               – in particular strive for the severing of the Divestment Business’ participation in a central information technology network  to
                 the extent possible, without compromising the viability of the Divestment Business;
               – make sure that any Confidential Information relating to the Divestment Business obtained by Mylan before the Effective Date  is
                 eliminated and will not be used by Mylan; and
               – decide whether such information may be disclosed to or kept by Mylan as the disclosure is reasonably necessary to  allow  Mylan
                 to carry out the divestiture or as the disclosure is required by law;

            (d)   monitor the splitting of assets between the Divestment Business and the Parties or Affiliated Undertakings;

   iii) oversee the determination of the reasonable cost-plus basis for the transitory manufacturing or  supply  arrangements  that  Mylan  will
        offer to the Purchaser (see paragraph 6(f) above);

    iv) propose to Mylan such measures as the Monitoring Trustee considers necessary to  ensure  Mylan’s  compliance  with  the  conditions  and
        obligations attached to the Decision, in particular the maintenance of the full economic viability, marketability or competitiveness  of
        the Divestment Business, the holding separate of the Divestment Business from the EPD-DM business covering the same molecules as will be
        transferred to Mylan after the Effective Date and the non-disclosure of competitively sensitive information;

     v) review and assess potential purchasers as well as the progress of the divestiture process and verify that, dependent on the stage of the
        divestiture process:

            (a)   potential purchasers receive sufficient and correct information relating to  the  Divestment  Business  and  the  Personnel  in
             particular by reviewing, if available, the data room documentation, the information memorandum and the due diligence process; and

            (b)   potential purchasers are granted sufficient access to the Personnel;

    vi) act as a contact point for any requests by third parties, in particular potential purchasers, in relation to the Commitments;

   vii) provide to the Commission, sending Mylan a non-confidential copy at the same time, a written report within 15  days  after  the  end  of
        every month that shall cover the operation and management of the Divestment Business  as  well  as  the  splitting  of  assets  and  the
        allocation of Personnel so that the Commission can assess whether the business is held in a manner consistent with the  Commitments  and
        the progress of the divestiture process as well as potential purchasers;

  viii) promptly report in writing to the Commission, sending Mylan a non-confidential copy at the same time,  if  it  concludes  on  reasonable
        grounds that Mylan is failing to comply with these Commitments;

    ix) within one week after receipt of the documented proposal referred to in paragraph 14 of these Commitments,  submit  to  the  Commission,
        sending Mylan a non-confidential copy at the same time, a reasoned opinion as to  the  suitability  and  independence  of  the  proposed
        purchaser and the viability of the Divestment Business after the Sale and as to whether the Divestment Business  is  sold  in  a  manner
        consistent with the conditions and obligations attached to the Decision, in particular, if relevant, whether the Sale of the  Divestment
        Business without one or more Assets or not all of the Personnel affects the viability of the Divestment Business after the sale,  taking
        account of the proposed purchaser;

     x) assume the other functions assigned to the Monitoring Trustee under the conditions and obligations attached to the Decision.

28. If the Monitoring and Divestiture Trustee are not the same legal or natural persons, the  Monitoring  Trustee  and  the  Divestiture  Trustee
   shall cooperate closely with each other during and for the purpose of the preparation of the Trustee Divestiture Period in order to facilitate
   each other's tasks.

Duties and obligations of the Divestiture Trustee

29. Within the Trustee Divestiture Period, the Divestiture Trustee shall sell at no  minimum  price  the  Divestment  Business  to  a  purchaser,
   provided that the Commission has approved both the purchaser and the final binding sale and purchase agreement (and ancillary  agreements)  as
   in line with the Commission's Decision and the Commitments in accordance with paragraphs 14 and  15  of  these  Commitments.  The  Divestiture
   Trustee shall include in the sale and purchase agreement (as well as in any ancillary agreements) such terms and conditions  as  it  considers
   appropriate for an expedient sale in the Trustee Divestiture Period. In particular, the Divestiture  Trustee  may  include  in  the  sale  and
   purchase agreement such customary representations and warranties  and  indemnities  as  are  reasonably  required  to  effect  the  sale.  The
   Divestiture Trustee shall protect the legitimate financial interests of Mylan, subject to the Parties’ unconditional obligation to  divest  at
   no minimum price in the Trustee Divestiture Period.

30. In the Trustee Divestiture Period (or otherwise at the Commission’s request), the Divestiture Trustee shall provide  the  Commission  with  a
   comprehensive monthly report written in English on the progress of the divestiture process. Such reports shall be  submitted  within  15  days
   after the end of every month with a simultaneous copy to the Monitoring Trustee and a non-confidential copy to the Parties.

      III.  Duties and obligations of Mylan

31.  Mylan shall provide and shall cause its advisors to provide the Trustee with all  such  co-operation,  assistance  and  information  as  the
   Trustee may reasonably require to perform its tasks. The Trustee shall have full and complete access to  any  of  Mylan's  or  the  Divestment
   Business’ books, records (including the information reasonably necessary for the Trustee's  task  as  defined  in  paragraph  27(iii)  above),
   documents, management or other personnel, facilities,  sites  and  technical  information  necessary  for  fulfilling  its  duties  under  the
   Commitments and Mylan and the Divestment Business shall provide the Trustee upon request with copies of any document. Mylan and the Divestment
   Business shall make available to the Trustee one or more offices on their premises and shall be available for meetings in order to provide the
   Trustee with all information necessary for the performance of its tasks.

32. Mylan shall provide the Monitoring Trustee with all managerial and administrative support that it may reasonably request  on  behalf  of  the
   management of the Divestment Business. This shall include all administrative support functions relating to the Divestment Business  which  are
   currently carried out at headquarters level. Mylan shall provide and shall cause its advisors to provide the Monitoring Trustee,  on  request,
   with the information submitted to potential purchasers, in particular give the Monitoring Trustee access to the data  room  documentation  and
   all other information granted to potential purchasers in the due diligence procedure. Mylan shall inform the Monitoring  Trustee  on  possible
   purchasers, submit lists of potential purchasers at each stage of the selection process, including the offers made by potential purchasers  at
   those stages, and keep the Monitoring Trustee informed of all developments in the divestiture process.

33. Mylan shall grant or procure Affiliated Undertakings to grant comprehensive powers of attorney, duly executed, to the Divestiture Trustee  to
   effect the sale (including ancillary agreements), the Closing and all  actions  and  declarations  which  the  Divestiture  Trustee  considers
   necessary or appropriate to achieve the sale and the Closing, including the appointment of advisors to assist  with  the  sale  process.  Upon
   request of the Divestiture Trustee, Mylan shall cause the documents required for effecting the sale and the Closing to be duly executed.

34. Mylan shall indemnify the Trustee and its employees and agents (each an  “Indemnified  Party”)  and  hold  each  Indemnified  Party  harmless
   against, and hereby agrees that an Indemnified Party shall have no liability to Mylan for, any liabilities arising out of the  performance  of
   the Trustee’s duties under the Commitments, except to the extent that such liabilities result from the  wilful  default,  recklessness,  gross
   negligence or bad faith of the Trustee, its employees, agents or advisors.

35. At the expense of Mylan, the Trustee may appoint advisors (in particular for corporate finance or legal  advice,  the  determination  of  the
   cost plus of supply agreements or any other expert in  the  pharmaceutical  industry  reasonably  necessary  for  the  implementation  of  the
   Commitments), subject to Mylan's approval (this approval not to be unreasonably withheld or delayed) if the Trustee considers the  appointment
   of such advisors necessary or appropriate for the performance of its duties and obligations under the Mandate,  provided  that  any  fees  and
   other expenses incurred by the Trustee are reasonable. Should Mylan refuse to approve the advisors proposed by the Trustee the Commission  may
   approve the appointment of such advisors instead, after having heard Mylan. Only the Trustee shall be entitled to issue  instructions  to  the
   advisors. Paragraph 32 of these Commitments shall apply mutatis mutandis. In the Trustee Divestiture Period, the Divestiture Trustee  may  use
   advisors who served Mylan during the Divestiture Period if the Divestiture Trustee considers this in the best interest of an expedient sale.

36. Mylan agrees that the Commission may share Confidential Information proprietary to Mylan with the Trustee. The  Trustee  shall  not  disclose
   such information and the principles contained in Article 17 (1) and (2) of the Merger Regulation apply mutatis mutandis.

37. Mylan agrees that the contact details of the Monitoring Trustee are published on the website  of  the  Commission's  Directorate-General  for
   Competition and they shall inform interested third parties, in particular any potential purchasers, of the  identity  and  the  tasks  of  the
   Monitoring Trustee.

38. For a period of 10 years from the Effective Date the Commission may request all information
   from the Parties that is reasonably necessary to monitor the effective implementation of these Commitments.

      IV.   Replacement, discharge and reappointment of the Trustee

39. If the Trustee ceases to perform its functions under the Commitments or for any other good cause, including the exposure of the Trustee to  a
   Conflict of Interest:

   (a)      the Commission may, after hearing the Trustee and Mylan, require Mylan to replace the Trustee; or

   (b)      Mylan may, with the prior approval of the Commission, replace the Trustee.

40. If the Trustee is removed according to paragraph 39 of these Commitments, the Trustee may be required to continue in  its  function  until  a
   new Trustee is in place to whom the Trustee has effected a full hand over of all relevant information. The new Trustee shall be  appointed  in
   accordance with the procedure referred to in paragraphs 18-25 of these Commitments.

41. Unless removed according to paragraph 39 of these Commitments, the Trustee shall cease to act  as  Trustee  only  after  the  Commission  has
   discharged it from its duties after all the Commitments with which the  Trustee  has  been  entrusted  have  been  implemented.  However,  the
   Commission may at any time require the reappointment of the Monitoring Trustee if it subsequently appears that the relevant remedies might not
   have been fully and properly implemented.

   Section F.    The review clause

42. The Commission may extend the time periods foreseen in the Commitments in response to a request from Mylan or, in appropriate cases,  on  its
   own initiative. Where Mylan requests an extension of a time period, it shall submit a reasoned request to the Commission  no  later  than  one
   month before the expiry of that period, showing good cause. This request shall be accompanied by a report from  the  Monitoring  Trustee,  who
   shall, at the same time send a non-confidential copy of the report to the Notifying Party. Only in exceptional circumstances  shall  Mylan  be
   entitled to request an extension within the last month of any period.

43. The Commission may further, in response to a reasoned  request  from  the  Parties  showing  good  cause  waive,  modify  or  substitute,  in
   exceptional circumstances, one or more of the undertakings in these Commitments. This request shall  be  accompanied  by  a  report  from  the
   Monitoring Trustee, who shall, at the same time send a non-confidential copy of the report to Mylan. The request shall not have the effect  of
   suspending the application of the undertaking and, in particular, of suspending the expiry of any time period in which the undertaking has  to
   be complied with.

    Section G.    Entry into force

44. The Commitments shall take effect upon the date of adoption of the Decision.

      [Signed]
      ……………………………………
      duly authorised for and on behalf of     Mylan

                                                                    SCHEDULE I

                                                       Product: Mylan's mebeverine products
                                                                Territory: Germany

        1. The Divestment Business consists of Mylan's rights, title and interests in mebeverine in Germany (currently marketed under  the  name
           Mebeverine Dura) including the right to develop, manufacture and use mebeverine with a view to its sale and marketing in any form and
           for any indication whatsoever in Germany. Mebeverine is used for the treatment of irritable bowel syndrome and related symptoms.  For
           the avoidance of doubt, this Divestment Business does not include any rights to sell mebeverine outside of Germany.

        2. The Divestment Business includes:

      (a)   the sale of existing mebeverine product inventory, sales and promotional material in Germany, as far as available;

      (b)   all mebeverine-related contracts, commitments and customer records meaning customers  credit  records,  customer  invoices,  purchase
           orders and contact details, whilst only the information related to mebeverine specifically will be provided;[84]

      (c)   the transfer of the marketing authorisation for mebeverine in Germany including all relevant dossiers, as  well  as  the  information
           contained in the relevant full registration dossier(s), relating to the current and/or pending marketing authorisations available  to
           Mylan; and

      (d)   an irrevocable, assignable, sub-licensable, and royalty free license for all relevant  intellectual  property  rights,  data,  books,
           records and effective arrangements for the transfer of all know-how to  the  extent  that  these  are  related  to  the  development,
           manufacture, use of Divestment Business with a view to its sale in Germany, including in particular the information contained in  the
           registration dossier.

       (items referred to under (a)-(d) hereinafter collectively referred to as "Assets of the Divestment Business").

      3.    If and to the extent that the know-how listed in paragraph 2 (d) above of this Schedule  is  not  exclusively  related  to,  and  not
           exclusively used in respect of, the manufacture, use and sale of mebeverine in Germany, Mylan shall have  the  right  to  retain  the
           ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive and perpetual right to use  such  asset
           for the manufacture, use and sale of mebeverine in Germany.

        4. At the option of the Purchaser, Mylan shall enter into a transitory non-exclusive manufacturing and/or supply agreement  relating  to
           the existing forms of product in Germany for up to two years.  Such  transitory  arrangement  shall  include  appropriate  provisions
           designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain provisions requiring the delivery of  minimum
           supply volumes or batches.

        5. Mylan commits to make its best efforts to facilitate the assignment of the relevant health fund contracts to the Purchaser in as  far
           as the contracts concern mebeverine.

        6. At the option of the Purchaser, and to the extent required by law in Germany or necessary with a view to  assigning  or  transferring
           the relevant contracts with the German health funds pertaining to mebeverine to the Purchaser, Mylan will enter into  a  transitional
           distribution arrangement related to the Divestment Business lasting until the relevant marketing authorisation  is  transferred  into
           the name of the Purchaser on a reasonable cost-plus basis which determination is overseen by the Monitoring Trustee. Mylan commits to
           make its best efforts to ensure that no supply disruption will occur or any other supply issue that might lead to the termination  of
           the contract with the relevant German health funds.

        7. If Mylan were to win any tenders pertaining to mebeverine before Closing, Mylan commits to make its best efforts  to  facilitate  the
           assignment of the relationship or the contract as the case may be with the relevant German health funds to the Purchaser in line with
           the provisions contained in this Schedule concerning existing contracts with the relevant German health funds.

        8. Mylan will transfer all historical information (orders; price; etc.) concerning its relationship regarding mebeverine in Germany with
           API supplier [*] to the Purchaser in accordance with applicable law. Mylan commits to make  its  best  efforts  to  ensure  that  the
           Purchaser can continue the existing relationship with [*] with respect to Germany.

        9. Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the transfer of the Divestment Business  and  to
           undertake all regulatory changes that would be required as a result of such transfer.

       10. At the option of the Purchaser, Mylan shall provide reasonable technical assistance to the Purchaser to assume responsibility for the
           manufacture, sale and marketing of mebeverine in Germany for a period of up to two years to be agreed with the  Purchaser  and  which
           determination is overseen by the Monitoring Trustee. The  transitional  technical  assistance  agreement  shall  include  appropriate
           provisions to ensure that Mylan provides technical assistance to the Purchaser expeditiously.

       11. The Purchaser will be given an option (to be exercised within one year after signing the relevant Transfer Agreement) to hire one  or
           more Personnel, subject to applicable local employment legislation, who would reasonably be  considered  necessary  to  maintain  the
           viability, marketability and competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.

       12. The Divestment Business shall not include:

        a. Any manufacturing facility;
        b. Raw materials;
        c. Any research and development, clinical data and studies or intellectual property relating to mebeverine after Closing;
        d. All marketing authorizations currently held by the Parties outside of Germany for mebeverine;
        e. The right to use the information  contained  in  the  registration  dossiers  underlying  the  marketing  authorization(s)  that  are
           transferred as part of the Divestment Business to obtain marketing authorizations outside of Germany;

        f. The "Mylan" name or the name of any Mylan subsidiaries;
        g. Monies owed to the Parties by customers for the purchase of mebeverine, and monies owed by the Parties  to  suppliers  for  materials
           used in the production of mebeverine.

       13. If there is any asset or personnel which is not be covered by paragraph 2 of this Schedule but which is  both  used  (exclusively  or
           not) in the Divestment Business and
           necessary for the continued viability and competitiveness of the Divestment Business,
           that asset or adequate substitute will be offered to the Purchaser.

                       *****

                                                                   SCHEDULE II

                                                       Product: Mylan's mebeverine products
                                                          Territory: United Kingdom (UK)

        1. The Divestment Business consists of Mylan's rights, title and interests in mebeverine in the UK (currently marketed  under  the  name
           Mebeverine) including the right to develop, manufacture and use mebeverine with a view to its sale and marketing in any form and  for
           any indication whatsoever in the UK. Mebeverine is used for the treatment of irritable bowel syndrome and related symptoms.  For  the
           avoidance of doubt, this Divestment Business does not include any rights to sell mebeverine outside of the UK.

        2. The Divestment Business includes:

      (a)   the sale of existing mebeverine product inventory, sales and promotional material in the UK, as far as available;

      (b)   all mebeverine-related contracts, commitments and customer records meaning customers  credit  records,  customer  invoices,  purchase
           orders and contact details, whilst only the information related to mebeverine specifically will be provided;[85]

      (c)   the transfer of the marketing authorisation for mebeverine in the UK including all relevant dossiers,  as  well  as  the  information
           contained in the relevant full registration dossier(s),  relating to the current and/or pending marketing authorisations available to
           Mylan; and

        d) an irrevocable, assignable, sub-licensable, and royalty free license for all relevant  intellectual  property  rights,  data,  books,
           records and effective arrangements for the transfer of all know-how to  the  extent  that  these  are  related  to  the  development,
           manufacture, use of Divestment Business with a view to its sale in the UK, including in particular the information contained  in  the
           registration dossier.

       (items referred to under (a)-(d) hereinafter collectively referred to as "Assets of the Divestment Business").

      3.    If and to the extent that the know-how listed in paragraph 2 (d) above of this Schedule  is  not  exclusively  related  to,  and  not
           exclusively used in respect of, the manufacture, use and sale of mebeverine in the UK, the Parties shall have the right to retain the
           ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive and perpetual right to use  such  asset
           for the manufacture, use and sale of mebeverine in the UK.

        4. At the option of the Purchaser, Mylan shall enter into a transitory non-exclusive manufacturing and/or supply agreement  relating  to
           the existing forms of product in the UK for up to two  years.  Such  transitory  arrangement  shall  include  appropriate  provisions
           designed to ensure the continued supply by Mylan to the Purchaser. It shall not contain provisions requiring the delivery of  minimum
           supply volumes or batches.

        5. At the option of the Purchaser and to the extent required by law in the  UK,  Mylan  will  enter  into  a  transitional  distribution
           arrangement related to the Divestment Business lasting until the relevant marketing authorisation is transferred into the name of the
           Purchaser on a reasonable cost-plus basis which determination is overseen by the Monitoring Trustee.

        6. Mylan will transfer all historical information (orders; price; etc.) concerning its relationship regarding mebeverine in the UK  with
           API supplier [*] to the Purchaser in accordance with applicable law. Mylan commits to make  its  best  efforts  to  ensure  that  the
           Purchaser can continue the existing relationship with [*] with respect to mebeverine.

        7. Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the transfer of the Divestment Business  and  to
           undertake all regulatory changes that would be required as a result of such transfer.

        8. Mylan commits to make its best efforts to obtain the licensor's consent to assign to the Purchaser the full contract in  relation  to
           its right concerning [*]. In addition, Mylan will provide the Purchaser with all the relevant information concerning the steps  taken
           by Mylan to obtain the aforementioned contract.

        9. At the option of the Purchaser, Mylan shall provide reasonable technical assistance to the Purchaser to assume responsibility for the
           manufacture, sale and marketing of mebeverine in the UK for a period of up to two years to be agreed with  the  Purchaser  and  which
           determination is overseen by the Monitoring Trustee. The  transitional  technical  assistance  agreement  shall  include  appropriate
           provisions to ensure that Mylan provides technical assistance to the Purchaser expeditiously.

       10. The Purchaser will be given an option (to be exercised within one year after signing the relevant Transfer Agreement) to hire one  or
           more Personnel, subject to applicable local employment legislation, who would reasonably be  considered  necessary  to  maintain  the
           viability, marketability and competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.

       11. The Divestment Business shall not include:

        a. Any manufacturing facility;
        b. Raw materials;
        c. Any research and development, clinical data and studies or intellectual property relating to mebeverine after Closing;
        d. All marketing authorizations currently held by the Parties outside of the UK for mebeverine;
        e. The right to use the information  contained  in  the  registration  dossiers  underlying  the  marketing  authorization(s)  that  are
           transferred as part of the Divestment Business to obtain marketing authorizations outside of the UK;

        f. The "Mylan" name or the name of any Mylan subsidiaries;
        g. Monies owed to the Parties by customers for the purchase of mebeverine, and monies owed by the Parties  to  suppliers  for  materials
           used in the production of mebeverine.

       12. If there is any asset or personnel which is not be covered by paragraph 2 of this Schedule but which is  both  used  (exclusively  or
           not) in the Divestment Business and
           necessary for the continued viability and competitiveness of the Divestment Business,
           that asset or adequate substitute will be offered to the Purchaser.

                       *****

                                                                   SCHEDULE III

                                                    Product: Mylan's pygeum africanum products
                                                                Territory: France

        1. The Divestment Business consists of Mylan's rights, title and interests in pygeum africanum in France (currently marketed  under  the
           name Prunier d’Afrique Mylan) including the right to develop, manufacture and use pygeum africanum  with  a  view  to  its  sale  and
           marketing in any form and for any indication whatsoever in France. Pygeum africanum  is  used  for  the  treatment  benign  prostatic
           hypertrophy. For the avoidance of doubt, this Divestment Business does not include any rights to sell  pygeum  africanum  outside  of
           France.

        2. The Divestment Business includes:

        a) the sale of existing pygeum africanum product inventory, sales and promotional material in France;

        b) all pygeum africanum-related contracts, commitments and  customer  records  meaning  customers  credit  records,  customer  invoices,
           purchase orders and contact details, whilst only the information related to pygeum africanum specifically will be provided;[86]

        c) the transfer of the marketing authorisation for pygeum  africanum  in  France  including  all  relevant  dossiers,  as  well  as  the
           information contained in the relevant full registration dossier(s),  relating to the current and/or pending marketing  authorisations
           available to Mylan; and

        d) an irrevocable, assignable, sub-licensable, and royalty free licence for all relevant  intellectual  property  rights,  data,  books,
           records and effective arrangements for the transfer of all know-how to  the  extent  that  these  are  related  to  the  development,
           manufacture, use of pygeum africanum with a view to its sale in France; including in particular  the  information  contained  in  the
           registration dossier.

            (items referred to under (a)-(d) hereinafter collectively referred to as "Assets of the Divestment Business")

      3.    If and to the extent that the know-how listed in paragraph 2 (d) above of this Schedule  is  not  exclusively  related  to,  and  not
           exclusively used in respect of, the use and sale of pygeum africanum in France, the Parties  shall  have  the  right  to  retain  the
           ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive and perpetual right to use  such  asset
           for the use and sale of pygeum africanum in France.

        4. At the option of the Purchaser and to the extent required by law  in  France  Mylan  will  enter  into  a  transitional  distribution
           arrangement related to pygeum africanum lasting until the relevant marketing authorisation  is  transferred  into  the  name  of  the
           Purchaser on a reasonable cost-plus basis which determination is overseen by the Monitoring Trustee.

        5. Mylan will transfer all historical information (orders; price; etc.) concerning its relationship on pygeum africanum in  France  with
           API supplier [*] to the Purchaser in accordance with applicable law. Mylan commits to make  its  best  efforts  to  ensure  that  the
           Purchaser can continue the existing relationship with [*] with respect to pygeum africanum.

        6. If such contract would be concluded before the transfer of the Divestment Business and at the option of the Purchaser, Mylan  commits
           to make its best efforts to facilitate the assignment of the contract manufacturing agreement (with [*]) concerning pygeum  africanum
           in France to the Purchaser. Any negotiations related to said agreement after the Closing  will  be  conducted  by  the  hold-separate
           manager.

        7. If the contract manufacturing agreement with [*] has not been concluded before the transfer of the Divestment  Business  and  at  the
           option of the Purchaser, Mylan commits to provide the Purchaser with documents concerning the  negotiation  history  (such  as  draft
           agreements and offers, etc).

        8. Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the transfer of the Divestment Business  and  to
           undertake all regulatory changes that would be required as a result of such transfer.

        9. The Purchaser will be given an option (to be exercised within one year after signing the relevant Transfer Agreement) to hire one  or
           more Personnel, subject to applicable local employment legislation, who would reasonably be  considered  necessary  to  maintain  the
           viability, marketability and competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.

       10. The Divestment Business shall not include:

        a. Any manufacturing facility’
        b. Raw materials;
        c. Any research and development, clinical data and studies or intellectual property relating to pygeum africanum after Closing;
        d. All marketing authorizations currently held by the Parties outside of France for pygeum africanum;
        e. The right to use the information  contained  in  the  registration  dossiers  underlying  the  marketing  authorization(s)  that  are
           transferred as part of the Divestment Business to obtain marketing authorizations outside of France;

        f. The "Mylan" name or the name of any Mylan subsidiaries;
        g. Monies owed to the Parties by customers for the purchase of pygeum africanum, and  monies  owed  by  the  Parties  to  suppliers  for
           materials used in the production of pygeum africanum.

       11. If there is any asset or personnel which is not be covered by paragraph 2 of this Schedule but which is  both  used  (exclusively  or
           not) in the Divestment Business and
           necessary for the continued viability and competitiveness of the Divestment Business,
           that asset or adequate substitute will be offered to the Purchaser.

                       *****

                                                                   SCHEDULE IV

                                                      Product: Mylan's betahistine products
                                                                Territory: Ireland

        1. The Divestment Business consists of Mylan's rights, title and interests in betahistine in Ireland (currently marketed under the brand
           Vertigon) including the right to develop, manufacture and use betahistine with a view to its sale and marketing in any form  and  for
           any indication whatsoever in Ireland. Betahistine is used for the treatment of vertigo and Meniere's disease. For  the  avoidance  of
           doubt, this Divestment Business does not include any rights to sell betahistine outside of Ireland.

        2. The Divestment Business includes:

        a) the sale of existing betahistine product inventory, sales and promotional material in Ireland;

        b) all betahistine-related contracts, commitments and customer records meaning customers credit  records,  customer  invoices,  purchase
           orders and contact details, whilst only the information related to betahistine specifically will be provided;[87]

        c) the transfer of the marketing authorisation for betahistine in Ireland including all relevant dossiers, as well  as  the  information
           contained in the relevant full registration dossier(s),  relating to the current and/or pending marketing authorisations available to
           Mylan; and

        d) an irrevocable, assignable, sub-licensable, and royalty free license for all relevant intellectual  property  rights  (including  the
           "Vertigon" brand), data, books, records and effective arrangements for the transfer of all know-how to  the  extent  that  these  are
           related to the development, manufacture, use of Divestment Business with a view to its sale in Ireland; including in  particular  the
           information contained in the registration dossier.
            (items referred to under (a)-(d) hereinafter collectively referred to as "Assets of the Divestment Business").

      3.    If and to the extent that the know-how listed in paragraph 2 (d) above of this Schedule  is  not  exclusively  related  to,  and  not
           exclusively used in respect of, the manufacture, use and sale of betahistine in Ireland, the Parties shall have the right  to  retain
           the ownership of such asset and shall grant to the Purchaser at no additional charge an exclusive and perpetual  right  to  use  such
           asset for the manufacture, use and sale of betahistine in Ireland.

        4. Mylan commits not to register the Vertigon brand nor to oppose the future registration of the Vertigon brand name by the Purchaser.

        5. At the option of the Purchaser, Mylan shall enter into a transitory non-exclusive manufacturing and/or supply agreement  relating  to
           the existing forms of product in Ireland for up to two years.  Such  transitory  arrangement  shall  include  appropriate  provisions
           designed to ensure the continued supply by the Parties to the Purchaser. It shall not contain provisions requiring  the  delivery  of
           minimum supply volumes or batches.

        6. At the option of the Purchaser and to the extent required by law in Ireland,  Mylan  will  enter  into  a  transitional  distribution
           arrangement related to the Divestment Business lasting until the relevant marketing authorisation is transferred into the name of the
           Purchaser on a reasonable cost-plus basis which determination is overseen by the Monitoring Trustee

        7. If such contract would be concluded before the transfer of the Divestment Business and at the option of the Purchaser, Mylan  commits
           to make its best efforts to facilitate the assignment of the API supply agreement (with [*]) concerning betahistine in Ireland to the
           Purchaser. Any negotiations related to said agreements after the Closing will be conducted by the hold-separate manager.

        8. If the API supply agreement with [*] concerning betahistine has not been concluded before the transfer of the Divestment Business and
           at the option of the Purchaser, Mylan commits to provide the Purchaser with documents concerning  the  negotiation  history  such  as
           draft agreements and offers.

        9. Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the transfer of the Divestment Business  and  to
           undertake all regulatory changes that would be required as a result of such transfer.

       10. At the option of the Purchaser, Mylan shall provide reasonable technical assistance to the Purchaser to assume responsibility for the
           manufacture, sale and marketing of betahistine in Ireland for a period of up to two years to be agreed with the Purchaser  and  which
           determination is overseen by the Monitoring Trustee. The  transitional  technical  assistance  agreement  shall  include  appropriate
           provisions to ensure that Mylan provides technical assistance to the Purchaser expeditiously.

       11. The Purchaser will be given an option (to be exercised within one year after signing the relevant Transfer Agreement) to hire one  or
           more Personnel, subject to applicable local employment legislation, who would reasonably be  considered  necessary  to  maintain  the
           viability, marketability and competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.

       12. The Divestment Business shall not include:

        a. Any manufacturing facility;
        b. Raw materials;
        c. Any research and development, clinical data and studies or intellectual property relating to betahistine after Closing;
        d. All marketing authorizations currently held by the Parties outside of Ireland for betahistine;
        e. The right to use the information  contained  in  the  registration  dossiers  underlying  the  marketing  authorization(s)  that  are
           transferred as part of the Divestment Business to obtain marketing authorizations outside of Ireland;

        f. The "Mylan" name or the name of any Mylan subsidiaries;
        g. Monies owed to the Parties by customers for the purchase of betahistine, and monies owed by the Parties to  suppliers  for  materials
           used in the production of betahistine.

       13. If there is any asset or personnel which is not be covered by paragraph 2 of this Schedule but which is  both  used  (exclusively  or
           not) in the Divestment Business and
           necessary for the continued viability and competitiveness of the Divestment Business,
           that asset or adequate substitute will be offered to the Purchaser.

                       *****

                                                                    SCHEDULE V

                                                      Product: Mylan's delorazepam products
                                                                 Territory: Italy

        1. The Divestment Business consists of Mylan's rights, title and interests in delorazepam in Italy (currently marketed  under  the  name
           Delorazepam) including the right to develop, manufacture and use delorazepam with a view to its sale and marketing in  any  form  and
           for any indication whatsoever in Italy. Delorazepam is used for the treatment of anxiety disorders. For the avoidance of doubt,  this
           Divestment Business does not include any rights to sell delorazepam outside of Italy.

        2. The Divestment Business includes:

        a) the sale of existing delorazepam product inventory, sales and promotional material in Italy;

        b) all delorazepam-related contracts, commitments and customer records meaning customers credit  records,  customer  invoices,  purchase
           orders and contact details, whilst only the information related to delorazepam specifically will be provided;;[88]

        c) the transfer of the marketing authorisation for delorazepam in Italy including all relevant dossiers,  as  well  as  the  information
           contained in the relevant full registration dossier(s),  relating to the current and/or pending marketing authorisations available to
           Mylan; and

        d) an irrevocable, assignable, sub-licensable, and royalty free license for all relevant  intellectual  property  rights,  data,  books,
           records and effective arrangements for the transfer of all know-how to  the  extent  that  these  are  related  to  the  development,
           manufacture, use of Divestment Business with a view to its sale in Italy; including in particular the information  contained  in  the
           registration dossier.

            (Items referred to under (a)-(d) hereinafter collectively referred to as "Assets of the Divestment Business").

      3.    If and to the extent that the know-how listed in paragraph 2 (d) above of this Schedule  is  not  exclusively  related  to,  and  not
           exclusively used in respect of, the use and sale of delorazepam in Italy, the Parties shall have the right to retain the ownership of
           such asset and shall grant to the Purchaser at no additional charge an exclusive and perpetual right to use such asset  for  the  use
           and sale of delorazepam in Italy.

        4. At the option of the Purchaser and to the extent required by law  in  Italy,  Mylan  will  enter  into  a  transitional  distribution
           arrangement related to the Divestment Business lasting until the relevant marketing authorisation is transferred into the name of the
           Purchaser on a reasonable cost-plus basis which determination is overseen by the Monitoring Trustee.

        5. At the option of the Purchaser, Mylan commits to make its best efforts to facilitate the assignment  of  the  contract  manufacturing
           agreement Mylan has in place concerning delorazepam in Italy to the Purchaser.

        6. Mylan commits to make its best efforts to cooperate with the Purchaser to effectuate the transfer of the Divestment Business  and  to
           undertake all regulatory changes that would be required as a result of such transfer.

        7. Mylan will commit to make its best efforts to facilitate the assignment of the contract  manufacturing  agreement  with  [*]  to  the
           Purchaser.

        8. [Contract Manufacturing Agreement with […].

        9. If the contract manufacturing agreement with [*] concerning delorazepam has not been concluded before the transfer of the  Divestment
           Business and at the option of the Purchaser, Mylan commits to provide the Purchaser with documents concerning the negotiation history
           such as draft agreements and offers.

       10. The Purchaser will be given an option (to be exercised within one year after signing the relevant Transfer Agreement) to hire one  or
           more Personnel, subject to applicable local employment legislation, who would reasonably be  considered  necessary  to  maintain  the
           viability, marketability and competitiveness of this Divestment Business to be supervised by the Monitoring Trustee.

       11. The Divestment Business shall not include:

        a. Any manufacturing facility;
        b. Raw materials;
        c. Any research and development, clinical data and studies or intellectual property relating to delorazepam after Closing;
        d. All marketing authorizations currently held by the Parties outside of Italy for delorazepam;
        e. The right to use the information  contained  in  the  registration  dossiers  underlying  the  marketing  authorization(s)  that  are
           transferred as part of the Divestment Business to obtain  marketing authorizations outside of Italy;
        f. The "Mylan" name or the name of any Mylan subsidiaries;
        g. Monies owed to the Parties by customers for the purchase of delorazepam, and monies owed by the Parties to  suppliers  for  materials
           used in the production of delorazepam.

       12. If there is any asset or personnel which is not be covered by paragraph 2 of this Schedule but which is  both  used  (exclusively  or
           not) in the Divestment Business and
           necessary for the continued viability and competitiveness of the Divestment Business,
           that asset or adequate substitute will be offered to the Purchaser.

                       *****

Case COMP M.7379 – Mylan / Abbott EPD-DM

Annex to the Commitments

[Divestment Business Customer Overview]

-----------------------
[1]   OJ L24, 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 L1, 3.1.1994, p.3 ("the EEA Agreement").

[3]   In January 2013, Abbott Laboratories separated its business into two publicly traded  companies:  Abbott  EPD-DM,  focused  on  diversified
medical products, and AbbVie, focused on research-based pharmaceuticals. Only the former, Abbott EPD-DM, is part of the proposed transaction.
[4]   Turnover calculated in accordance with Article 5 of the Merger Regulation and the Commission Consolidated Jurisdictional  Notice  (OJ  C95,
16.04.2008, p.1).
[5]   Form CO, paragraphs 11-17.

[6]   See for example COMP/M.6969 Valeant Pharmaceuticals International/Bausch & Lomb Holdings of 5 August 2013, COMP/M.5778 Novartis/Alcon of  9
August 2010, and COMP/M.5865 Teva/ Ratiopharm of 3 August 2010.

[7]   See for example COMP/M.6969 Valeant Pharmaceuticals International/Bausch & Lomb Holdings of 5 August 2013, COMP/M.5865  Teva/Ratiopharm  of
3 August 2010, and COMP/M.5295 Teva/Barr of 19 December 2008.

[8]    COMP/M.6969  Valeant  Pharmaceuticals  International/Bausch  &  Lomb  Holdings  of  5  August  2013,  COMP/M.6705  Procter  &  Gamble/Teva
Pharmaceuticals OTC II of 9 November 2012, COMP/M.6613 Watson/Actavis of 5 October 2012, and COMP/M.5865 Teva/Ratiopharm of 3 August 2010.

[9]   See for example COMP/M.5865 Teva/Ratiopharm of 3 August 2010, and COMP/M.5295 Teva/Barr of 19 December 2008.

[10]  COMP/M.5253 Sanofi-Aventis/Zentiva of 4 February 2009.

[11]  See for example COMP/M.6969 Valeant Pharmaceuticals International/Bausch & Lomb Holdings of 5 August 2013, COMP/M.5778 Novartis/Alcon of  9
August 2010, COMP/M.5865 Teva/Ratiopharm of 3 August 2010, and COMP/M.5295 Teva/Barr of 19 December 2008.

[12]  COMP/M.5953 Reckitt Benckiser/SSL of 25 October 2010.

[13]  See for example COMP/M.5778 Novartis/Alcon of 9 August 2010,  COMP/M.5253  Sanofi-Aventis/Zentiva  of  4  February  2009,  and  COMP/M.3751
Novartis/Hexal of 27 May 2005.

[14]  COMP/M.5778 Novartis/Alcon of 9 August 2010.

[15]  See for example COMP/M.5778 Novartis/Alcon of 9 August 2010, COMP/M.5865 Teva/  Ratiopharm  of  3  August  2010,  and  COMP/M.5253  Sanofi-
Aventis/Zentiva 4 February 2009.

[16]  See Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on  the  Community  code  relating  to  medicinal
products for human use (OJ L311, 28.11.2001, p.67), as amended by various subsequent acts.

[17]  Initially, this group included markets where the combined market share ranges between 15% and 35%. However, in line with the new Notice  on
Simplified procedure (Commission Notice on a simplified procedure for treatment of  certain  concentrations  under  Council  Regulation  (EC)  No
139/2004) this range was adapted to 20% to 35% to include only affected markets.

[18]  See COMP/M.5778 Novartis/Alcon, paragraph 25.

[19]  No Group 1 "plus" overlaps were identified in this case (Form CO, footnote 31).

[20]  See COMP/M.3354 Sanofi-Synthelabo/Aventis, paragraph 40, and COMP/M.1397 Sanofi/Synthélabo, paragraph 34.

[21]  See COMP/M.3354 Sanofi-Synthelabo/Aventis, paragraph 40.

[22]  In Portugal, INN prescribing is mandatory. When dispensing, the pharmacist must  inform  the  patient  of  the  most  affordable  medicinal
product that complies with the medical prescription and which is reimbursed and available in the pharmacy.

[23]  See COMP/M.5865 Teva/Ratiopharm, paragraph 130 et seq.

[24]  In France, there is a strict regulatory framework concerning the pricing and reimbursement of prescription medicines. Through  its  medical
and economic assessment, the French national health authority (Haute Autorité de Santé – HAS) establishes whether a drug is reimbursable or  not.
It also eventually fixes the level of reimbursement for all drugs which are listed on the positive lists.  The  level  of  reimbursement  of  the
drugs (as % of the price) is decided on the basis of  different  levels  of  actual  benefit  of  the  drug,  such  as  follows:  important  (65%
reimbursed), moderate (30% reimbursed), mild (15% reimbursed) and insufficient (no  reimbursement,  not  listed).  The  French  national  pricing
authority (Comité Economique des Produits de Santé - CEPS) sets the maximum prices (ex-factory) for originator and  generic  medicines  that  are
reimbursed. Medicine lines which are genericized are deemed to be submitted to further regular price reductions (so-called "baisse de prix").  In
addition, wholesale and pharmacy margins for reimbursed products are regulated by law. It can be concluded from the specificities of  the  French
health regulation that the ability to increase prices is limited.

[25]  A change of the regulated outpatient price is only possible through application to  the  HAS  and  requires  either  robust  clinical  data
demonstrating a clinical value-added or by delisting the product from the reimbursement list, which would then result in free pricing. It can  be
concluded from the specificities of the French health regulation that the ability  to  increase  pharmacy  sales  prices  is  limited  as  it  is
constrained by the need to apply for and achieve a positive evaluation from the HAS.

[26]  See COMP/M.1403 Astra/Zeneca, and COMP/M.1878 Pfizer/Warner-Lambert.

[27]  See COMP/M.1878 Pfizer/Warner-Lambert, paragraphs 23-25.

[28]  See footnotes 24 and 25 for the description of the French regulatory system.

[29]  See COMP/M.1403 Astra/Zeneca, and COMP/M.1878 Pfizer/Warner-Lambert.

[30]  See COMP/M.1878 Pfizer/Warner-Lambert, paragraphs 23-25.

[31]  See COMP/39612 Perindopril (Servier) case, press release from July 9, 2014 (http://europa.eu/rapid/press-release_IP-14-799_en.htm).

[32]  See COMP/M.1403 Astra/Zeneca, paragraph 18, COMP/M.1878 Pfizer/Warner-Lambert, paragraph 24,  COMP/M.2517  Bristol  Myers  Squibb/Du  Pont,
paragraph 14, and COMP/M.3354 Sanofi-Synthelabo/Aventis, paragraph 82.

[33]  See footnotes 24 and 25 for the description of the French regulatory system.

[34]  See COMP/M.1878 Pfizer/Warner-Lambert, paragraph 24.

[35]  See footnotes 24 and 25 for the description of the French regulatory system.

[36]  See COMP/M.1403 Astra/Zeneca, paragraph 18, and COMP/M.1878 Pfizer/Warner-Lambert, paragraph 24.

[37]  See COMP/M.1846 Glaxo Wellcome/Smithkline Beecham and COMP/M.3354 Sanofi-Synthelabo/ Aventis.

[38]  For instance, faecal softening laxatives (A6A1),  stimulant  laxatives  (A6A2),  bulk-forming  laxatives  (A6A3),  enemas  (A6A4),  osmotic
laxatives with (A6A7) or without electrolytes (A6A6; e.g. lactulose-based products).

[39]  COMP/M.3853 Solvay/Fournier, paragraphs 16-23.

[40]  COMP/M.6280 Procter&Gamble/Teva, paragraph 19.

[41]  See footnotes 24 and 25 for the description of the French regulatory system.

[42]  COMP/M.5253 Sanofi-Aventis/Zentiva of 4 February 2009.

[43]  Parallel importers in Germany have to comply with the 15/15 rule (paragraph 129 Deutsches Sozialgesetzbuch  5).  According  to  this  rule,
imported pharmaceutical products have to be always at least 15% or EUR 15 cheaper than the price of the reference drug to be cost effective.  See
non-confidential minutes of the conference call with AOK-Bundesverband of 17 December 2014.

[44]  The Notifying Party was unable to provide market shares by value for the UK.

[45]  Non-confidential minutes of a conference call with Teva, 16 December 2014, paragraph 3.

[46]  The reimbursement price is then set taking into account the average of prices to distributors.

[47]  COMP/M.5253 Sanofi-Aventis/Zentiva of 4 February 2009..

[48]  At the ATC3 level A3A, the Parties combined market share in France is [5-10]% in terms of value and [5-10]% in terms of volume.

[49]  See footnotes 24 and 25 for the description of the French regulatory system.

[50]  COMP/M.3354 Sanofi-Synthelabo/Aventis, where the Commission considered defining a  separate  product  market  for  drugs  used  for  dental
infections but the market division did not support making such a distinction.

[51]  COMP/M.5865 Teva/Ratiopharm, paragraph 186.

[52]  See footnotes 24 and 25 for the description of the French regulatory system.

[53]  With the exception of Novartis' product based on clarithromycin, Clorom.

[54]  With the exception of Pfizer's azithromycin-based product, Zithromax IV.

[55]   See for example COMP/ M.5865 Teva/Ratiopharm, and COMP/M.5476 Pfizer/Wyeth.

[56]  For delorazepam, the five highest proportions from total prescriptions of delorazepam  by  indication  are  the  following:  “F419  Anxiety
disorder, unspecified” – 22%; “F341 Dysthymia” – 9%; “F412 Mixed anxiety and depressive disorder” – 6%; “F329 Depressive episode, unspecified”  –
5%; and “F200 Paranoid schizophrenia” – 3%.

[57]  [Third party advisor] Report – Project Air Commercial Assessment – June 10, 2014, slide 102.

[58]  The Parties' response of 14 January 2015, question 5.

[59]  [Third party advisor] Report – Project Air Commercial Assessment – June 10, 2014, slide 102.

[60]  [Third party advisor] Report – Project Air Commercial Assessment – June 10, 2014, slide 102.

[61]  If pharmaceutical companies increase their prices above the maximum levels recommended by the AIFA, they have to  provide  their  rationale
for doing so. Moreover, the AIFA makes it public which companies have exceeded the limits suggested by the AIFA.

[62]  While in COMP/M.5865 Teva/Ratiopharm the Commission found strong indications for the  existence  of  a  separate  market  for  rectal  form
ibuprofen (paragraph 255), the Commission was not able to exclude the existence of a degree of substitutability between  the  high-dosage  rectal
form of ibuprofen and other products, since this has not been tested with third Parties and the characteristics of the remaining products in  the
market have not been investigated The Parties in the present case are not active in rectal ibuprofen; their products are based on a  lower-dosage
oral solid ordinary form.

[63]  COMP/M.3354 Sanofi-Synthelabo/Aventis, paragraph 106, and COMP/M.5865 Teva/Ratiopharm, paragraph 293.

[64]  COMP/M.5295 Teva/Barr, paragraph 164.

[65]  COMP/M.5865 Teva/Ratiopharm, paragraphs 302 et seq.

[66]  See footnotes 24 and 25 for the description of the French regulatory system.

[67]  In COMP/M.5865 Teva/Ratiopharm (paragraph 386), the N7C class was briefly mentioned in the list  of  Group  1  markets  for  which  serious
doubts did not arise.

[68]  Form CO, "Overview of the regulatory landscape in the affected countries", page 54.

[69]  The exact market share information for the Parties' competitors in the UK is not available. As the Parties  indicate  in  their  submission
(Form CO, page 433), the database IMS does not provide a complete set of data for the UK. Therefore, the Parties relied on actual sales data  and
internal estimations to reproduce the best market view possible.

[70]  The market investigation revealed that there were roughly […] orders for Accord's betahistine-based products (16 mg doses)  in  Ireland  in
September 2014, as opposed to […] orders for Abbott EPD-DM's product Serc and […] for Mylan's product Vertigon (same dose).

[71]  J&J's market share at the broader ATC3 level is [10-20]% by value and [10-20]% by volume.

[72]  The Parties have no or limited sales of pygeum africanum-based products outside of France.

[73]  COMP/M.6258 Teva/Cephalon, paragraphs 81 and 129, and COMP/M.6613 Watson/Actavis, paragraphs 110-111.

[74]  COMP/M.5953 Reckitt Benckiser/SSL, paragraph 64, and COMP/M.6613 Watson/Actavis, paragraph 124.

[75]  Commission Notice on remedies acceptable under Council Regulation (EC) No  139/2004  and  under  Commission  Regulation  (EC)  No  802/2004
(2008/C 267/01), (the "Commission Notice on Remedies").

[76]  Commission Notice on Remedies, paragraph 9.

[77]  Commission Notice on Remedies, paragraph 12.

[78]  Commission Notice on Remedies, paragraph 17.

[79]  Commission Notice on Remedies, paragraph 23.

[80]  The need for some of these assets may in some cases also depend on the nature of the Purchaser and therefore is assessed on a  case-by-case
basis.

[81]  Commission Notice on Remedies, paragraph 35.

[82]  Commission Notice on Remedies, paragraph 36.

[83]  Best efforts obligations in this context are in line with the Commission's practice in the context  of  pharmaceutical  mergers.  See,  for
example, the remedies accepted in case M.5253 (Sanofi-Aventis/Zentiva).

[84]  Mylan will include all customer lists and records since 2010 in the Divestment Business.

[85]  Mylan will include all customer lists and records since 2010 in the Divestment Business.

[86]  Mylan will include all customer lists and records since 2010 in the Divestment Business.

[87]  Mylan will include all customer lists and records since 2010 in the Divestment Business.

[88]  Mylan will include all customer lists and records since 2010 in the Divestment Business.

-----------------------
 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.

                                                                  PUBLIC VERSION

                                                                 MERGER PROCEDURE