CELEX: 32015M7559
Language: en
Date: 2015-08-04 00:00:00
Title: Commission Decision of 04/08/2015 declaring a concentration to be compatible with the common market (Case No COMP/M.7559 - PFIZER / HOSPIRA) according to Council Regulation (EC) No 139/2004 (Only the English text is authentic)

|[pic]                             |EUROPEAN COMMISSION                                                                                      |

Brussels, 04.08.2015
C(2015) 5639 final

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To the notifying party:

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

Subject:    Case M.7559 - PFIZER/ HOSPIRA
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 15 June 2015, the European Commission received notification of a proposed concentration pursuant to Article 4 of the Merger Regulation by
    which the undertaking Pfizer Inc. of the United States (“Pfizer” or “the Notifying Party”) acquires within the meaning of Article 3(1)(b) of
    the Merger Regulation control of the whole of the undertaking Hospira Inc. (“Hospira”), of the United States.

 2) Pfizer and Hospira are collectively referred to as “the Parties”.

       The Parties AND THE OPERATION

 3) Pfizer is a global research based biomedical and pharmaceutical company active in discovering,  developing,  manufacturing,  marketing,  and
    selling innovative medicines for humans.

 4) Hospira is a global provider of injectable drugs and infusion technologies, with a  broad  portfolio  of  generic,  branded  and  biosimilar
    medicines for humans.

 5) On 5 February 2015, Pfizer and Hospira entered into an Agreement by which Hospira will become a wholly owned subsidiary  of  Pfizer.  Pfizer
    will therefore acquire sole control over Hospira 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[3]  (Pfizer:  EUR  37  339  million,
    Hospira EUR 3 360 million). Each of them has an EU-wide turnover in excess of EUR 250 million (Pfizer:
    EUR [5000-10000] million, Hospira: EUR [250-500] million), and they do not achieve more than two-thirds of their aggregate EU-wide  turnover
    within one and the same Member State. The notified operation therefore has Union dimension within the meaning of Article 1(2) of the  Merger
    Regulation.

       RELEVANT MARKETS AND COMPETITIVE ASSESSMENT

 7) The Parties’ activities overlap with respect to human health pharmaceuticals, in  two  main  areas:  (i)  biosimilars  and  (ii)  speciality
    injectable pharmaceuticals (“sterile injectables”).

 8) The Parties both supply Active Pharmaceutical Ingredients ("API") to third parties and undertake contract manufacturing for  third  parties.
    However, there is no vertical relationship between the Parties where the downstream share (finished dose-level) is above  30%,  irrespective
    of the upstream share (API-level), and vice-versa.

1 Biosimilars

1 Introduction

 9) Biological medicines have an active substance made by or derived from living  organisms.  Biosimilars  aim  to  have  the  same  therapeutic
    mechanism as original patented medicines, but, unlike small molecule generics, are not exact copies of the originator  drugs.  According  to
    the guidelines of the European Medicines Agency (“EMA”), in order to obtain a marketing authorisation for  a  biosimilar,  its  manufacturer
    needs to demonstrate similarity (in terms of quality, safety and efficacy) to a reference biological product. The  clinical  trials  may  be
    performed for only one indication for which the originator drug had been approved, and on that basis the approval may be granted for all the
    indications of the originator drug (the “extrapolation principle”).

10) The biosimilar segment of the pharmaceutical sector is relatively new. The first-generation biosimilars launched in Europe since  2006  have
    been relative simple proteins such as erythropoietin. The second-generation biosimilars, which are at the core of this transaction, are more
    complex monoclonal antibodies (“mAb”).[4] The first mAb biosimilar, a copy of J&J's Remicade (infliximab), was approved in Europe in 2013.

11) Given that biological drugs are also some of the most expensive therapies available, the entry of biosimilars is  expected  to  allow  wider
    access by patients to biological drugs. Furthermore, as the entry of the first biosimilar products have led to price decreases  compared  to
    the originator product, there are significant expectations across the EEA that biosimilars will be an  important  factor  in  relieving  the
    financial pressure on healthcare systems.

12) The Notifying Party submits that the development of a biosimilar can be divided in a number of steps:

        a. Analysis and characterisation of the reference biologic product – Such an analysis focuses on both the structural attributes and  the
           functions of the reference biological product and is carried out on several samples from multiple lots of the reference product  over
           the lifetime of that product. This analysis should lead to a comprehensive physicochemical and  biological  characterisation  of  the
           reference biological product.

        b. Non-clinical studies and development of the manufacturing process – In this phase, manufacturers carry out in-vitro studies to assess
           any difference between the biosimilar product being developed and the reference biological  product.  In  addition,  a  manufacturing
           process that guarantees consistent quality of the biosimilar molecule is developed.

        c. Phase I (pharmacokinetics-PK/pharmacodynamics-PD) clinical trials – PK studies appraise the  way  the  body  affects  the  biosimilar
           product, e.g. in terms of absorption, while PD studies appraise the way the product affects the body, e.g. through its  mechanism  of
           action. The purpose is to show comparability with the reference biological product, in particular as regards safety. Phase  I  trials
           are normally carried out in healthy volunteers.

        d. Phase III (efficacy) clinical trials – As phase II clinical  trials  are  not  required  for  biosimilars,  the  final  step  of  the
           development of a biosimilar consist of the demonstration of  comparable  clinical  efficacy  of  the  biosimilar  and  the  reference
           biological product. Phase III trials are carried out for one approved therapeutic indication of the reference product, as data can be
           extrapolated to other indications if non-clinical and PK/PD studies demonstrate biosimilarity.

13) The Parties’ activities overlap in the development of mAb biosimilars, for which they have three common molecules marketed  or  in  clinical
    trials (phase I or phase III).

    Table 1 – The Parties’ overlapping biosimilars

|Molecule            |Loss of Exclusivity|Indications              |Development stage                |
|                    |                   |                         |Hospira         |Pfizer          |
|rituximab           |2013               |Oncology                 |Phase III       |Phase III       |
|                    |                   |Immunology               |                |                |
|trastuzumab         |2014               |Oncology                 |Phase III       |Phase III       |

14) While Pfizer develops and markets its mAb biosimilars in-house, Hospira markets (or will market, once new biosimilars have  been  developed)
    biosimilars developed by Celltrion of South Korea. This cooperation envisages […].

2 Market definition

1 Product market

15) When defining relevant markets in past decisions  dealing  with  pharmaceutical  products,  the  Commission  has  established  a  number  of
    principles.[5] 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).[6]

16) 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. 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.

17) 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.[7] The overlap in therapeutic uses does not necessarily imply any particular economic substitution patterns between
    products.

18) In its previous decisions, the Commission recognised that the market for biosimilars should be treated differently than the market for small
    molecule generics.[8] However, the Commission did not previously assess the markets for infliximab, rituximab and trastuzumab biosimilars.

1 infliximab

19) infliximab is an anti-TNF (anti-tumor necrosis factor) agent used in autoimmune diseases (such  as  rheumatoid  arthritis).  The  originator
    product, Remicade, was developed by Johnson & Johnson[9] and is marketed by MSD (Merck, Sharp & Dohme, hereinafter referred to  as  “Merck”)
    in Europe. Its annual 2014 sales exceeded USD 10 billion globally (#3 best-selling pharmaceutical). infliximab is currently the only mAb for
    which a biosimilar version (by Hospira and Celltrion) has been approved by the European Commission based on the opinion of  EMA  (in  2013),
    and which has already been prescribed to patients for example in Norway, the UK, Hungary and Finland.

20) There are currently a number of anti-TNF agents  approved  by  the  EMA,  including  monoclonal  antibodies  such  as  adalimumab  (Humira),
    certolizumab pegol (Cimzia), infliximab (Remicade) and golimumab (Simponi), as well as etanercept (Enbrel), a fusion protein. The  Notifying
    Party submits that some anti-TNF agents may substitute for others in certain indications, while different ones, such as infliximab, may not.

21) As to the substitutability between infliximab and other anti-TNF agents, the majority of respondents to the market  investigation  from  the
    demand side indicated that they purchase infliximab pharmaceuticals (Remicade and the biosimilars) through  competitive  tenders,[10]  which
    are typically organised per molecule (for instance infliximab).[11] The majority of leading medical professionals in  the  field  (i.e.  Key
    Opinion Leaders) that responded to the Commission's investigation confirmed that none of their patients on other anti-TNF  agents  (such  as
    adalimumab or etanercept) had been switched to a biosimilar version of infliximab in the past 12 months, while for the rest of  Key  Opinion
    Leaders only a very small minority of such patients were switched to a biosimilar version of infliximab (the maximum amount being 5%).[12]

22) The Notifying Party's views are further confirmed by one key competitor noting in  particular  that  it  "observed  only  little  impact  of
    infliximab biosimilars on other TNF-inhibitors [anti-TNF agents]". Indeed, as opposed to other anti-TNF agents  which  have  a  subcutaneous
    formulation, infliximab has to be administered intravenously and "normally patients used to subcutaneous medicines would not  switch  to  an
    intravenous one".[13] Accordingly, only a minority of respondents from the supply side expect the  introduction  of  a  biosimilar  anti-TNF
    agent to exert downward pressure on prices of the originator products of other molecules sharing the same  indications  with  the  reference
    product.[14]

23) In light of the above, the Commission takes the view that infliximab belongs to a separate product market from other anti-TNF agents.

24) As to the substitutability between Remicade and infliximab biosimilars, it should be noted that both are approved by the EMA  for  the  same
    indications (by virtue of the principle of extrapolation), and that they compete for the same tenders related to infliximab. In practice, in
    a number of situations (more than half of the analysed tenders),[15] Remicade is co-awarded the tender along with one infliximab biosimilar.

25) In light of the above, for the purpose of the present Decision, as regards  the  molecule  concerned  the  relevant  product  market  should
    comprise infliximab pharmaceuticals, including both the originator infliximab (Remicade) and infliximab biosimilars.

2 rituximab

26) rituximab is a humanised monoclonal antibody that binds to the CD20 protein, used in autoimmune diseases (such as rheumatoid arthritis)  and
    oncology (such as for certain types of leukaemia and lymphoma). The originator product, MabThera, was developed by Roche.  Its  annual  2014
    sales were USD 7.4 billion globally (#6 best-selling pharmaceutical).

27) For the purpose of the present Decision, it is not necessary to delineate the precise product market definition in relation to rituximab, as
    no competitive concerns arise on a hypothetical market for rituximab pharmaceuticals, as well as under any wider market definition.

3 trastuzumab

28) trastuzumab is a humanised monoclonal antibody that binds to the HER2 protein, used primarily for treatment of early and  metastatic  breast
    cancer. The originator product, Herceptin, was developed by Roche. Its annual 2014 sales were USD  6.7  billion  globally  (#9  best-selling
    pharmaceutical).

29) For the purpose of the present Decision, it is not necessary to delineate the precise product market definition in relation to  trastuzumab,
    as no competitive concerns arise on a hypothetical market for trastuzumab pharmaceuticals, as well as under any wider market definition.

2 Geographic market

30) The Commission has consistently considered that the markets for  finished  dose  pharmaceutical  products  are  national.[16]  For  pipeline
    products, the Commission previously considered that the geographic scope of the relevant market is at least EEA-wide.[17]

31) There appears to be no reason to depart from this conclusion in the present case. Since all overlaps related to biosimilars concern pipeline
    products, the relevant geographic scope for the assessment of biosimilars in the present Transaction is at least EEA-wide.

3 Competitive assessment

1 The competitive dynamics of biosimilar markets differ from those of generics

32) As part of its analysis in the present case, the Commission considered, on the basis of the evidence of this case, the  differences  between
    competition in markets for biologic drugs on the one hand and competition in markets for small-molecule drugs and generics versions of  such
    drugs on the other hand. In particular, the Commission considered (as part of its analysis  of  the  transaction)  the  differences  between
    generics and biosimilars in terms of product differentiation, interchangeability, regulatory  framework,  cost  structure  and  barriers  to
    entry, all of which are key for the competitive assessment of the proposed transaction.

33) Small-molecule originator products and generic products based on the same active principle can generally be considered homogeneous  products
    that compete mainly on price, especially in the case of hospital drugs procured through competitive tenders. While manufacturers, especially
    originators, may try to differentiate their product as a strategy to soften the intensity of price competition, measures have been taken  in
    European countries to constrain their ability to do so. Such measures include  for  example  incentives  for  physicians  to  write  generic
    prescriptions (i.e. financial incentives based on targets of generic prescriptions), generic substitution by the  pharmacist  regardless  of
    the brand name used by the prescriber, incentives for pharmacists to dispense the cheapest available versions  of  a  given  medicine  (e.g.
    regressive margins, obligation to stock and dispense the cheapest generic), and incentives for patients to ask for  the  cheapest  available
    versions of their medicines (i.e. differentiated patient co-payments based on relative prices). These measures  are  designed  to  encourage
    generic uptake by making prescribers, pharmacists and patients more sensitive  to  price  differences.  Evidence  shows  that  they  can  be
    effective at fostering price competition.[18]

34) Biological products are intrinsically differentiated due to their complex molecular structure. As discussed above, no biosimilar product  is
    identical either to the original biologic product on which it is based, or  to  any  other  biosimilar  product.  Despite  their  similarity
    stemming from pre-clinical bioequivalence studies, regulatory authorities consider their differences  sufficiently  significant  to  request
    clinical trials to prove the clinical equivalence between every new biosimilar and the original biologic product on which it is  based,  for
    at least one major indication. In particular, the EMA establishes for every family of biological medicines[19] a specific  set  of  clinical
    evidence required for the regulatory approval of new biosimilars. As a consequence, not  only  the  regulatory  approval  and  the  clinical
    evidence available for biosimilar products differ from that of generic products, but such clinical evidence also differs  between  different
    families of biological medicines.

35) Originator biological products and biosimilar products are therefore not identical in terms of molecular structure, and  moreover  they  are
    distinct in terms of clinical evidence available on their efficacy and safety. According to the EMA,  "it  is  for  each  national  (health)
    authority to decide on the interchangeability and substitution of the originator  and  the  biosimilar  based  on  the  scientific  evidence
    submitted to the EMA and other available data and information (…) the EMA is not involved in this second decision-making process at national
    level and there is no common European legal framework regarding interchangeability".[20] Accordingly,  physicians  and  pharmacists  do  not
    necessarily consider originator and biosimilars based on the same biologic molecule to be fully interchangeable. This applies equally to the
    interchangeability amongst biosimilars based on the same molecule, which are also not identical in their  chemical  structure  and  clinical
    evidence. In practice, the situation varies from Member State to Member State and from indication to indication, depending in particular  on
    the perception of the clinical risks for the patient associated to product switches. Competition  between  original  biologic  products  and
    biosimilar products, as  well  as  between  any  pair  of  biosimilar  products,  is  therefore  characterised  by  the  limited  degree  of
    substitutability for patients already undergoing treatment. Hence biosimilars differ from small-molecule generics,  which  being  chemically
    identical show a much higher degree of substitutability for all patients. Biosimilars of the same molecule, by contrast, show  lower  degree
    of substitutability for patients already in treatment, while still showing a high degree of substitutability for new patients.

36) This lower degree of substitutability for a segment of patients has an impact both on commercial strategies and  market  outcomes.  Original
    biologic products have the chance of building a stock of potentially locked-in patients during the period of market exclusivity,  especially
    for chronic treatments (e.g. for immunological disorders). Upon loss of market exclusivity, if the perceived clinical risks of switching are
    not negligible, new biosimilar entrants for a given monoclonal antibody are less likely to attract  patients  that  have  already  initiated
    treatment with the original product. In this case, biosimilar competition takes place mainly for newly diagnosed patients that are about  to
    initiate treatment so have not received a therapeutic drug yet. The commercial strategy of new biosimilar entrants can consist both of price
    undercutting and product differentiation, for instance through investment on the development of superior clinical evidence.  The  originator
    firm may have an incentive to exploit its stock of locked-in patients through price premiums,  while  still  competing  for  treatment-naive
    patients via product differentiation, leveraging on brand and product recognition acquired during the period of market exclusivity.

37) This results in the segmentation of patients by product and implies that not the entire market is contestable at any point in time. In terms
    of market outcomes, it results in slower market penetration by biosimilar products, compared to what is typically observed  in  markets  for
    small-molecule generics, even though price  discounts  offered  by  biosimilar  manufacturers  can  be  of  similar  magnitude.  The  market
    investigation has in fact shown that payers typically need to procure both the  original  product  and  biosimilar  products,  to  guarantee
    treatment continuity to all their patients. Hence, price differentials do not automatically translate into shifts in market shares in favour
    of biosimilars.

38) To the extent that new biosimilar entrants manage to attract treatment-naive patients and build their own stock of locked-in patients,  they
    face the trade-off between continuing to price low to attract additional patients and increasing prices to exploit their stock of  locked-in
    patients. Given their inability to price discriminate between new and  locked-in  patients,  this  trade-off  weakens  their  incentives  to
    aggressively compete in price for new patients. Therefore, while biosimilar competitors have an  incentive  to  price  low  at  entry,  such
    incentive diminishes as they establish their position in the market, resulting in less intense price competition.

2 infliximab

39) The competitive landscape in relation to infliximab pharmaceuticals in the EEA is as follows:

        a. the originator drug Remicade (off-patent since 2014) is exclusively marketed by Merck in the EEA;

        b. there is one approved biosimilar, marketed co-exclusively between Celltrion (the developer  of  the  product,  marketing  it  through
           distributors under the brand name Remsima) and Hospira (marketing it under the brand name Inflectra) based on a  duplicate  marketing
           authorisation;

        c. two companies have infliximab biosimilars in phase III clinical trials: Pfizer and Samsung Bioepis of South Korea; and

        d. a number of other companies (such as Epirus, Amgen/Actavis and Dr. Reddy's) are at earlier stages in the  development  of  infliximab
           biosimilars.

40) The Notifying Party submits that the Transaction will not have a significant  impact  on  competition  with  respect  to  infliximab.  Post-
    transaction Remicade would remain on the market as an active competitor, there would be two infliximab biosimilars on the market  (one  from
    Celltrion, and one from the merged entity), and at least one short  term  potential  entrant,  who  already  is  seeking  approval  (Samsung
    Bioepis). According to the Notifying Party, Samsung Bioepis appears as a credible potential competitor that will be the third to  enter  the
    market, well before the next potential entrant (Epirus or Pfizer). Given that Pfizer is not the next entrant on the market (and in  fact  is
    over […] years away from possibly entering the market) and that the originator biologic remains a strong  competitor,  the  Notifying  Party
    submits that it is not the only credible competitor to Hospira and Celltrion.  In  addition,  existing  competition  between  Celltrion  and
    Hospira, as well as potential competition from the next entrants, would preclude the  emergence  of  any  anti-competitive  effects  on  the
    infliximab market. According to the Notifying Party, by the time that Pfizer's product will be ready for market launch there will be four if
    not five infliximab on the market from Merck (Remicade), Hospira, Celltrion, Samsung Bioepis and potentially Epirus.

    Nature of competition in the market

41) The market for infliximab is characterised by three types of competitive interactions, each of  a  different  nature:  (i)  the  competition
    between the originator biologic and biosimilars; (ii) the actual price competition between Hospira and Celltrion, which both market the same
    biosimilar in the EEA, and (iii) the future competition between  three  differentiated  biosimilar  products  (Hospira/Celltrion’s,  Samsung
    Bioepis’ and Pfizer’s).

42) Regarding competition between the originator biologic and  biosimilars,  this  competition  manifests  itself  mainly  in  a  one-way  price
    constraint form biosimilars on the originator drug. Indeed, the market entry of Inflectra and Remsima at a lower price than Remicade led  to
    Merck reducing the price of Remicade in order to mitigate the loss of market share.[21] However, given that  it  is  still  early  days  for
    biosimilars and given that biosimilars are only "similar" to the originator, the price levels of Remicade generally remain higher than those
    of Inflectra and Remsima.[22] This is consistent with Merck having an incentive to maintain a relatively higher price to benefit from locked-
    in patients. The fact that Remicade is co-awarded the tender along with one biosimilar in a number of situations  illustrates  that  it  has
    differentiating features that still allow Merck to charge a premium compared to the biosimilar suppliers and that biosimilars are not  fully
    replacing the originator. This is consistent with the need of guaranteeing treatment continuity to patients already initiated  on  Remicade,
    avoiding any clinical risks associated to changing the prescribed product.  Customers  and  Key  Opinion  Leaders  confirmed  that  not  all
    infliximab patients, in particular patients already on Remicade, are prescribed Remsima or Inflectra,[23] which highlights  the  absence  of
    full interchangeability of biosimilars, as a result of which the hospitals continue purchasing Remicade  in  spite  of  higher  prices.  The
    availability of Remicade is also of importance for patients with indications for which biosimilars were not tested in  clinical  trials  (in
    relation to which physicians tend to be more sceptical). One competitor indeed highlighted that it "has  noticed  a  certain  reluctance  of
    gastroenterologists to prescribe biosimilars and is aware of an ECCO [European Crohn´s and Colitis Organisation] position paper published 18
    months ago which raises doubts on extrapolation of biosimilars in gastroenterological diseases  without  significant  clinical  trials",[24]
    while a Key Opinion Leader confirmed that "once studies on switching patients to biosimilars have been published, also  gastroenterologists'
    reluctance will be countered. Current reluctance mainly exists due to biosimilar infliximab having  been  tested  only  for  RA  [Rheumatoid
    Arthritis], while the application for the gastroenterological  indications  was  only  extrapolated  from  the  efficacy  in  RA".[25]  This
    highlights that the competition between infliximab biosimilars and the originator  may  be  weaker  for  extrapolated  indications  such  as
    gastroenterological diseases.

43) Therefore, Remicade can be considered a distant competitor to infliximab biosimilars.

44) Regarding actual competition between Hospira and Celltrion, respondents to the market investigation  indicated  that  they  are  aware  that
    Inflectra and Remsima are the same product, and that they generally select only one  of  the  two  (typically  the  cheapest).[26]  This  is
    confirmed by the analysis of tender data across the EEA which shows that Inflectra and Remsima almost never win the same tender (whereas, as
    explained above, Remicade and one biosimilar often do).[27] This is a unique feature of  the  market,  specific  to  infliximab,  where  two
    commercially distinct biosimilar products are in fact identical in  their  molecular  structure  and  clinical  evidence.  They  compete  as
    homogeneous products, with brand differentiation being consciously disregarded by customers, leading to intense downward pricing pressure in
    infliximab tenders since the entry of Hospira and Celltrion's biosimilars in 2013.

45) Finally, the importance of future  competition  between  differentiated  biosimilar  products  (Hospira/Celltrion’s,  Samsung  Bioepis’  and
    Pfizer’s) also stems from the lack of full interchangeability between Remicade and infliximab biosimilars, as well as between the infliximab
    biosimilars. Provided that they all reach the market, each of them will show some degree of differentiation  from each other, with  its  own
    clinical evidence being evaluated by the EMA for the purpose of regulatory approval. Indeed, the potential for market  success  of  each  of
    these biosimilars will depend on the degree of prescribers’ acceptance across therapeutic indications, which itself depends in particular on
    the robustness of the clinical data (as well as real-world experience) provided by each manufacturer. Therefore, contrary to generics, there
    is room for differentiation strategies and non-price competition between these three distinct biosimilars, with the likely  result  of  less
    intense price competition than what has been observed so far between Hospira and Celltrion. In such circumstances, it is  less  likely  that
    few biosimilar competitors can deliver significant price reductions than typically observed for small-molecule generics. The  importance  of
    the number of differentiated biosimilars for price competition is illustrated by the internal pricing forecasts of the Parties’, […].[28]

46) Given the limited experience so far with biosimilar products in general, it is difficult to assess at this stage  the  potential  commercial
    success of each of these products (Hospira/Celltrion's, Samsung Bioepis', Pfizer's and the next entrants). However, the market investigation
    provided insights on the expectations of market participants (including the Parties).

    Pfizer and Hospira/Celltrion are considered to be strong players in the field of biosimilars

47) The majority of physicians and Key Opinion Leaders confirmed that the reputation of an individual biosimilar supplier plays a role (half  of
    them "to some extent", the other half "to a large extent").[29] In this context, Pfizer and Hospira are generally considered in  the  market
    to be very strong players in the field of biosimilars. Accordingly, they are often quoted by  competitors,  customers,  physicians  and  Key
    Opinion Leaders alike as two of the five most important manufacturers/developers of biosimilars).[30]

48) In particular, despite limited information available so far about the clinical evidence of Pfizer's biosimilars such as infliximab (none  of
    which having being approved yet), customers perceive Pfizer's products as a strong potential competitor with the following strengths  "brand
    name", "experience in biosimilars", "great manufacturer of biologicals", "experienced in rheumatology" and  "marketing  infrastructure".[31]
    Such advantages seem consistent with Pfizer's internal documents showing […].[32]

49) Celltrion, on the other hand, is still working, in particular through partnerships, to gain market  presence  and  reputation  in  the  EEA.
    Leveraging on Hospira’s expertise and reputation in the EEA was indeed a key rationale for Celltrion to enter into a co-exclusive  marketing
    agreement with Hospira for infliximab (and a number of other biosimilars). As evidenced by Celltrion,  "for  distributing  its  biosimilars,
    Celltrion Healthcare pursues a "dual channel" strategy, whereby each European country has  two  appointed  distributors.  For  a  number  of
    biosimilars, including infliximab, Celltrion Healthcare manages one channel  (and  uses  local  distributors),  and  the  other  channel  is
    Hospira".[33] This lack of reputation is evidenced by customers  which  rarely  identify  Celltrion  as  one  of  the  five  most  important
    manufacturers/developers of biosimilars.[34]

    A future entrant still facing challenges: Samsung Bioepis

50) Apart from Pfizer, Samsung Bioepis is the only other company with an infliximab biosimilar in phase III  clinical  trials.  It  submitted  a
    marketing authorisation application to the EMA in March 2015.[35] While it cannot be excluded that Samsung  Bioepis'  infliximab  biosimilar
    will be marketed in Europe before Pfizer's, internal documents from the Parties suggest that […].[36] Furthermore, Samsung Bioepis does  not
    have a marketing presence in the EEA and is partnering with Merck and Biogen Idec for the  commercialisation  of  its  biosimilars.  Samsung
    Bioepis has a partnership with Merck to market its biosimilars in a number of countries (in particular in Europe). However, for  infliximab,
    because Merck is marketing the originator drug Remicade in Europe, it was necessary for Samsung Bioepis to find another partner (it  entered
    into a partnership with Biogen Idec in December 2013). […].[37]

    The other competitors are not expected to become a competitive constraint in the EEA in the foreseeable future

51) Finally, the other competitors identified by the Notifying Party such as Epirus, Amgen/Actavis and Dr. Reddy's, do not  have  an  infliximab
    biosimilar in advanced stages of development, and are therefore not  expected  to  become  a  competitive  constraint  in  the  EEA  in  the
    foreseeable future.

52) While Epirus has an infliximab biosimilar approved in India,[38] it cannot readily use the same data to seek a  marketing  authorisation  in
    the EEA. Indeed, it "plans to initiate a global [phase III] clinical program in late 2015/early 2016".[39] This is  confirmed  by  the  EMA,
    which indicated that "side-by-side analysis of the biosimilar product (from commercial scale and site) with  the  EEA  authorised  reference
    product must be conducted". A comparative trial with a non-EEA authorised reference medicinal product would suppose  that  such  product  be
    approved by "a regulatory authority with similar scientific and regulatory standards as EMA (e.g. ICH countries)". [40],[41]

53) Finally, Dr. Reddy's did not indicate having an infliximab biosimilar in its portfolio,[42] and the Notifying Party highlights in its recent
    internal documents that […].[43]

    Barriers to entry

54) Clinical trials required to provide the necessary evidence for regulatory approval are costly both in terms of financial resources and time,
    and require also certain R&D capabilities. Consequently, barriers to entry for biosimilars are typically higher than for  generics  and  the
    pool of potential entrants upon patent expiry is typically smaller for biological drugs than for small-molecule chemical drugs. According to
    the Notifying Party, the development of a new biosimilar product takes on average between six and  eight  years  of  development,  to  which
    should be added on average one and a half year for regulatory approval.[44]  Small-molecule  generic  products,  on  the  contrary,  can  be
    prepared for launch much faster.

55) This has at least two consequences for the assessment of potential competition in markets of biologic drugs. On the  one  hand,  the  higher
    barriers to entry are likely to result in fewer successful entrants in the market. The larger sunk costs an entrant needs  to  incur  (which
    range from USD [100-200] million to USD [300-400] million according to the Notifying Party) weaken the competitive  constraints  imposed  by
    potential entrants.  On the other hand, the length of the clinical development implies that the set of  potential  entrants  can  be  easily
    identified, as the stage of development of each potential entrant can be observed early on.

    Conclusion on the competitive landscape

56) In light of the above, the Commission takes the view that the competitive landscape for the infliximab market in the foreseeable  future  is
    composed of one biosimilar co-marketed by Hospira and Celltrion (which are subject to intense price competition from each  other),  and  two
    future differentiated biosimilar competitors from Samsung Bioepis and Pfizer, while the originator infliximab is a distant competitor to its
    biosimilars.

    Effects of the proposed Transaction

57) The proposed Transaction will therefore bring two  infliximab  biosimilars  under  the  same  ownership  (Inflectra  and  Pfizer’s  pipeline
    biosimilar). This situation will reduce the Parties’ pre-merger incentives to compete in one of the two alternatives ways:

 a)      Pfizer will either delay or discontinue its pipeline biosimilar in order to focus on Inflectra, leading to the net loss of one of  only
    three differentiated biosimilars marketed or in advanced stages of development. Pfizer’s internal documents […];[45] or

 b)      [Analysis of elements that could lead Pfizer to],[46] hand back Hospira’s Inflectra rights to Celltrion, leading to the loss  of  price
    competition between Hospira and Celltrion.

58) On the one hand, the reduced incentives to continue developing Pfizer's biosimilar translate into a  lessening  of  innovation  competition.
    Indeed, the delay or even cancellation of Pfizer's development program would deprive patients from timely access to a differentiated product
    that is currently assessed positively by market participants on the basis of available clinical evidence. It would lessen price  competition
    for new patients in a market where, due to the presence of switching costs, every new entrant has an incentive to  behave  as  an  important
    competitive force , pricing low to gain market share.

59) On the other hand, the return of Hospira's commercial rights to Inflectra to  Celltrion  would  eliminate  the  particularly  intense  price
    competition currently observed between Hospira and Celltrion, which is a specific feature of these two biosimilar products due to  the  fact
    that they are the very same compound, and are perceived as homogeneous products fully  interchangeable  in  clinical  practice.  The  likely
    result of this would be higher prices at least for Hospira's and Celltrion's customers.

60) The reduction of the Parties' pre-merger incentives to compete on the infliximab market was  confirmed  by  competitors  responding  to  the
    market investigation which indicated that a biosimilar company does not  have  any  incentive  to  pursue  the  development  of  a  pipeline
    biosimilar if it already markets a biosimilar for the same molecule.[47] Customers and Key Opinion Leaders expressed concerns regarding  the
    Transaction's effects on infliximab, leading either to “reduced price cuts” or to “Pfizer’s infliximab, which is a very good  molecule,  not
    becoming available”.[48]

61) Therefore, based on all available evidence, the Commission concludes that the analysis of the proposed  Transaction  indicates  that  it  is
    likely to significantly impede effective  competition  by  either  eliminating  an  important  future  competitive  constrain  (three-to-two
    differentiated biosimilars) or reducing the competitive pressure on the remaining competitors (loss of price competition), and  thus  raises
    serious doubts as to its compatibility with the internal market in relation to infliximab.

3 rituximab

62) The Notifying Party submits that the competitive landscape in relation to rituximab pharmaceuticals in the EEA is as follows:

        a. the originator drug MabThera is marketed by Roche in the EEA;

        b. there is no approved biosimilar;

        c. seven companies have differentiated rituximab biosimilars in phase III clinical trials: each of the Parties (Hospira  in  partnership
           with Celltrion), Sandoz (Novartis), Boehringer Ingelheim, Mabion, Amgen/Actavis and Merck Serono/Dr Reddy's; and

        d. a number of other companies (such as Merck) are at earlier stages in the development of rituximab biosimilars.

63) The market investigation broadly confirmed the competitive landscape in relation to rituximab biosimilars.[49]

64) Furthermore, Pfizer's internal documents highlighted its intention to […].[50] Contrary to infliximab, which is already marketed by  Hospira
    and Celltrion's distributors, Celltrion's rituximab biosimilar is still in development and estimated to enter the EEA in […], and it is more
    likely than not that Celltrion would be able to find an alternative distributor in Europe (or  distribute  the  product  itself)  should  it
    obtain marketing authorisation.

65) Excluding Mabion,[51] none of the six companies appear to have a significant competitive advantage with respect to the development of  their
    differentiated rituximab biosimilar. Internal documents from Pfizer highlight that […].[52] In any event, a number of future competitors  of
    the merged entity will remain after the Transaction.

66) Therefore, based on all available evidence, the Commission concludes that the proposed Transaction does not raise serious doubts as  to  its
    compatibility with the internal market in relation to rituximab.

4 trastuzumab

67) The Notifying Party submits that the competitive landscape in relation to rituximab pharmaceuticals in the EEA is as follows:

        a. the originator drug Herceptin is marketed by Roche in the EEA;

        b. there is no approved biosimilar;

        c. five companies have differentiated trastuzumab biosimilars in phase III clinical trials: each of the Parties (Hospira in  partnership
           with Celltrion), Amgen/Actavis, Mylan/Biocon and Samsung Bioepis; and

        d. a number of other companies (such as BioXpress  and  Nippon  Kayaku)  are  at  earlier  stages  in  the  development  of  trastuzumab
           biosimilars.

68) The market investigation broadly confirmed the competitive landscape in relation to trastuzumab biosimilars.[53]

69) Furthermore, Pfizer's internal documents highlighted […].[54] Contrary to infliximab, which is already marketed by Hospira  and  Celltrion's
    distributors, Celltrion's trastuzumab biosimilar is still in development and estimated to enter the EEA in […], and it is more  likely  than
    not that Celltrion would be able to find an alternative distributor in Europe (or distribute the product itself) should it obtain  marketing
    authorisation.

70) None of the five companies appear to have a significant competitive advantage with  respect  to  the  development  of  their  differentiated
    trastuzumab biosimilar. Internal documents from Pfizer highlight that […].[55] In any event, a number of future competitors  of  the  merged
    entity will remain after the Transaction.

71) Therefore, based on all available evidence, the Commission concludes that the proposed Transaction does not raise serious doubts as  to  its
    compatibility with the internal market in relation to trastuzumab.

2 Sterile injectables

1 General characteristics of sterile injectables markets

72) The Parties are both active in the supply of generic sterile injectables.  Even  though  Pfizer  focuses  its  business  activities  on  the
    development of new drugs, and is thus mainly active in originator drugs, it also markets generic  drugs.  Upon  patent  expiry  (or  shortly
    before), Pfizer's products are transferred to  its  Global  Established  Pharmaceuticals  business  ("GEP").  GEP  is  responsible  for  the
    commercialisation of the products that have lost or are about to lose patent protection and of generics.  Approximately  […]%  of  Hospira's
    total sales in the EEA are accounted for by the sale of its generic sterile injectables.

73) The term "sterile injectables" refers to a large group of medicines that are administered by the same route, i.e. with a hollow needle which
    is pierced through the skin. As such, sterile injectables do not correspond to a single  relevant  market  within  the  meaning  of  the  EU
    competition rules, but encompass a heterogeneous set of entirely different molecules which are not substitutable to  one  another.  However,
    some characteristics relevant for the competitive assessment of the present merger apply to  all  the  sterile  injectables  markets.  These
    characteristics are described below.

    Barriers to entry and to expansion

74) The Notifying Party submits that the markets for sterile injectables within the EEA are fragmented with a significant  number  of  suppliers
    present across different geographic areas. According to the Notifying Party there are  no  suppliers  that  hold  a  strong  position  in  a
    particular molecule across different EEA countries. In that regard, the Notifying Party notes that geographic barriers to entry are low, and
    that a supplier active in one country could easily enter another geographic market (and even more so if it already provides  other  products
    in that geographic market) should prices increase post-Transaction.

75) As regards the barriers to entry in sterile injectables, the Commission retained that the average duration  to  develop  a  generic  sterile
    injectable is of four to six years, before the product reached the market. This implies two stages: development and the regulatory approval.
    The development of a generic drug typically takes from ten months (for companies specialising in generics) up  to  four  and  a  half  years
    depending on the complexity and sophistication of the originator drug, as well as on the process, formulation and method of use patents held
    by the originator. Each presentation will need to be developed, tested and (new) release methods or (new) analytics methods might have to be
    developed. Production batches would need to be made in order to see if the product under normal production  capacity  still  tests  out  and
    meets specifications.

76) Once the development of the drug has been finalised,  a  certain  time  is  required  for  the  administrative  procedure.  Development  and
    administrative procedure may add up (depending on the product at hand) to more than one year and it might in individual cases  take  several
    years depending on the product. In addition to that, the Notifying Party submits that in general, API manufacturing leading times are of the
    order of […] months, and fill and finish times are approximately […] months. They are followed by freight  and  European  re-testing  (where
    appropriate) and release. This adds another […] months to the time from the decision to manufacture a product to putting it on the market.

77) As regards the barriers to enter into a geographically neighbouring market, the market investigation  has  revealed  that  once  a  supplier
    already markets a generic sterile injectable in certain countries, entry is only possible if a marketing authorisation has been granted. The
    supplier would also need a commercial organisation in that particular country.[56] Even in case a marketing authorisation has  already  been
    obtained for a country where the supplier previously was not active, suppliers would still need to have a commercial organisation  in  order
    to be able to start selling and become a credible competitor in a new country.[57]

78) In addition to the existence of a marketing authorisation and a local commercial  organisation,  suppliers  take  into  consideration  other
    factors as well when deciding to enter a new country, such as potential market size, prices of their competitors, tendering  system,  number
    of competitors.[58]

79) In sum, entry can play a role in exerting competitive pressure for the supply of sterile injectables. However, barriers to entry  cannot  be
    qualified as low in an abstract and general way. The competitive constraint that entry can exert must be assessed on a case by  case  basis,
    taking into account in particular whether potential entrants supply the  product  in  question  in  neighbouring  countries,  can  scale  up
    production to expand to a new geographic market, possess a marketing authorisation and a commercial organisation in the  country  concerned,
    and whether an hypothetical price increase would provide the financial incentive to enter such market.

    Criteria for the selection of suppliers

80) The Notifying Party submits that for generic sterile injectables, competition in most markets primarily takes place  through  tenders  (with
    few exceptions), organised by individual hospitals, groups of hospitals or public authorities, depending on  the  country.  Whilst  in  some
    countries tenders are organized for a number of products, suppliers are selected separately for each molecule (and sometimes even separately
    for particular presentations). Other criteria are qualitative and include, inter alia, type of packaging, packaging  differentiation,  shelf
    life, and ability to supply during the weekend or in the evenings.

81) Price is an important criterion for the allocation of tenders. Each hospital chooses the  exact  importance  attributed  to  price,  but  it
    usually accounts for an important part of the decision in the tender, which are in the vast majority of cases organised by the hospitals  or
    purchasing groups.[59] The replies to the market investigation have shown that indeed price is the main  criterion  taken  into  account  by
    customers when choosing their sterile injectable suppliers, together with security of  supply  and  range  of  strengths/concentrations.[60]
    Other criteria mentioned as important, but not essential, were range of vials, capacity and long shelf life.

    Switching

82) For all the markets analysed in this case, the market investigation showed it is relatively easy for customers to change their  supplier  at
    the end of the contract.[61]  Moreover, the contracts with suppliers do not usually contain commitments to purchase minimum quantities of  a
    given product.[62] There are thus no legal barriers to switch.

83) As regards the duration of the contracts, customers mentioned that in most of the cases these are between one and two years, sometimes  also
    up to one year,[63] therefore showing that in a relative short period of time they could have the possibility  of  switching  their  sterile
    injectable suppliers.

1 General approach to the product market definition

    Therapeutic classes versus molecule approach

84) As is explained above in paragraph 15 the Commission has in its previous decisions in the pharmaceutical sector referred to the third  level
    (ATC3) as the starting point for defining the relevant product market.[64] 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

    Galenic form

85) As the Commission has acknowledged in its previous decisions[65] 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.[66]

86) For the purpose of the present decision the question of  whether  the  relevant  markets  would  comprise  also  other  galenic  forms  than
    injectables can be left open, as the competitive assessment of individual markets would not change irrespective of galenic  form  concerned.
    Alternative candidate product market definitions would lead to fewer overlaps and less affected markets. Consequently,  the  Commission  has
    focused its assessment of the competitive effects for injectable products at the molecule level.

Generics versus originator drugs

87) 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.

88) In previous cases, 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.

89) Also during the present market investigation, the large majority  of  respondents  expressed  that  they  thought  of  generics  as  a  full
    alternative to originator products.

90) Therefore, in line with the precedents and for the purposes of the present decision, the  Commission  considers  that  in  relation  to  the
    overlapping molecules the product market includes both generic and originator versions.

    Prescribed drugs versus over the counter ("OTC") drugs

91) 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[67] 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.

92) This case only involves prescription drugs. Therefore the question as to whether separate relevant product markets for prescribed drugs  and
    OTC drugs should be defined for the purpose of the present decision can be left open.

2  Relevant geographic market

93) The Notifying Party has, in line with the Commissions prior decisions, submitted an overview  of  its  activities  on  a  country-by-country
    basis. The Commission has consistently considered that the markets for finished dose pharmaceutical products[68] were 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 purchasing practices, the national regulatory and reimbursement schemes and the fact that competition between pharmaceutical firms still
    predominantly takes place at a national level

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

3 General approach to the competitive assessment

95) In line with the past decisions,[69] 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.

96) Based on this filter, pharmaceutical markets are analysed according to three categories:

  • 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 less than 1%;

  • Group 3: The Parties’ combined market share is between 20% and 35%.

97) The Notifying Party has based its analysis mainly on the IMS data, measured by Standard Units (e.g., 1 vial), submitting that market  shares
    by volume are the most relevant in this case. However, the Commission observed that these products are sold in  different  dosages  (vials),
    which are all equally calculated as one unit, no matter the number or quantity that they comprise. Therefore, the Commission considers  that
    the market shares in value are the most relevant in this case  and  show  a  better  image  of  the  market  positioning  of  the  different
    competitors.

98) Based on this methodology, the Commission has identified all Group 1 markets under the narrowest plausible market definition,  i.e.  at  the
    molecule  level,  in  the  following  marketed  molecules:  carboplatin,  cisplatin,  cytarabine,  epirubicin,   fluorouracil,   irinotecan,
    nitroglycerin, piperacillin/tazobactam, vancomycin and vincristine, a total number of 30 overlaps. Besides these ones, a total of 13 Group 2
    and Group 3 affected markets were also examined.

99) The markets which fall within Group 2 because the Parties' combined market shares exceeded 35% and the increment does not exceed 1% are  the
    following: docetaxel in Spain, fluorouracil in Denmark, irinotecan in Spain, methotrexate in Italy and piperacillin/tazobactam  in  Belgium.
    Given the small increment, the fact that no concerns have been raised by customers or competitors in the course of the market investigation,
    and that respondents did not highlight any particular advantage of  the  Parties  on  these  markets,  the  Commission  concludes  that  the
    Transaction does not raise serious doubts as to its compatibility with the internal market in respect of these possible markets.

100) The markets which fall within Group 3 because the Parties' combined market shares were between  20%  and  35%  are  the  following:  calcium
    folinate in Norway, cisatracurium besilate in Spain, cisplatin in Italy, methotrexate in Portugal, piperacillin/tazobactam  in  Finland  and
    the Netherlands, and vancomycin in the Netherlands and Spain. Given the moderate combined market shares in these markets, the fact that  the
    combined entity will still face significant competition from a number of other competitors such as Teva, Intas, Fresenius, Mylan,  Aurobindo
    or Novartis, and that no substantiated concerns have been raised by customers or competitors in the course of the market investigation,  the
    Commission concludes that the Transaction does not raise serious doubts as to its compatibility with the internal market in respect of these
    possible markets.

101) The remainder of the decision deals with the markets that fall within Group 1.

    4 Product specific assessment

1 Carboplatin

    Product market definition

102) Carboplatin is a platinum compound used as a chemotherapy drug in the treatment of a number of  different  cancers  (ovarian  cancer,  small
    cell lung cancer, head and neck cancer). The first platinum based drug that was developed was cisplatin. Carboplatin is a second  generation
    drug that is administered intravenously as a short term infusion. Generic versions  of  carboplatin  became  available  from  2004  onwards.
    Carboplatin belongs to the ATC3 class of platinum antineoplastics.

103) The Commission, in its decision Teva/Barr, defined the relevant product market for carboplatin at the  molecule  level  as  the  indications
    were only partially overlapping with other molecules in the same ATC class.[70] Hospitals indicated that switching between  molecules  would
    be limited during the treatment of the serious illnesses that these medicines are aimed  for.  In  another  decision,  Teva/Ratiopharm,  the
    Commission left the market definition open, since under any alternative product market definition (ATC 3 class, ATC4 class or defined on the
    level of molecule) the transaction would not give rise to competition concerns.[71]

104) The Notifying Party submits that in the present case the assessment should be carried out at the molecule level, since the  substitutability
    between different types of platinum antineoplastics is limited and tendering procedures are  very  often  organised  on  the  level  of  the
    molecule only. The Notifying Party also submits that the product market definition could be ultimately  left  open,  since  the  transaction
    would not significantly impede effective competition regardless of the product market definition.

105) In the market investigation, the limited  substitutability  for  carboplatin  was  confirmed.  The  indications  for  which  carboplatin  is
    prescribed only partially overlap with those of other molecules in the same ATC class. Moreover purchasing takes place on the level  of  the
    molecule, predominantly through molecule-specific tenders.

106) On the basis of the above, the Commission concludes that for the purpose  of  the  present  decision  the  relevant  product  market  should
    comprise sterile injectable carboplatin.

    Competitive assessment

107) In carboplatin, the Transaction give raise to two affected Group 1 markets in Belgium and Italy.

    Belgium

108) According to the Notifying Party, the market size of the carboplatin in Belgium was EUR [1-5] million in 2014. The  combined  market  shares
    of the Parties reached [50-60]% in value in 2014, with an increment of [10-20]% brought by Pfizer.

109) The Notifying Party submits that on the Belgian market there are a number of other competitors, the main ones being Teva  and  Accord/Intas.
    The Notifying Party considers Teva as the strongest competitor with a market share of [30-40]%. In addition, Accord/Intas  has  entered  the
    market and achieved a market share of almost [0-5]% in 2014, according  to  the  Notifying  Party.[72]  The  Notifying  Party  expects  that
    Accord/Intas' market share will grow, because the Notifying Party expects a growing number of tenders in the  future  due  to  a  regulatory
    change in Belgium.[73]

110) The Notifying Party submits that Hospira's market share has been significantly higher mainly due to the fact that it was the  first  generic
    on the market. However, between 2012 and 2014 its market share declined (in volume). The Notifying Party also submits that  Pfizer's  market
    share is relatively low, due to the fact that it does not have the [...] vials in its portfolio.  According  to  the  Notifying  Party  this
    weakens its competitive position, because hospitals typically choose one supplier for the  whole  range  of  dosages.  The  Notifying  Party
    considers that request for this particular dosage will increase in the future and argues that Pfizer's competitive force on the  market  may
    therefore be decreasing.

111) An analysis of the market share evolution over the last three years shows a relatively stable market size. As  regards  the  positioning  of
    the Parties, market shares in value which, as explained above provide a more appropriate picture of the situation  in  this  case,  show   a
    slight increase in Pfizer's and a slight decrease in Hospira's position.

112) The Commission also investigated whether there are enough alternative suppliers to the merged entity, taking  into  account  that  switching
    suppliers in this market appears to be relatively easy. The replies received during the market investigation have confirmed  Teva  as  being
    the main challenger.[74] However, even though the other competitor Accord/Intas confirmed its presence, it is considering withdrawal due  to
    the fact that "the procurement decisions are opaque  with  a  high  degree  of  protectionism,  local  distribution  is  expensive  and  the
    unpredictable claw back tax regime".[75] No other competitor amongst the respondent ones has confirmed presence, or intention to enter  this
    market in near future.[76] [77]

113) The range of vials sold in Belgium is: 5ml, 15 ml, 45ml and 60ml, with a concentration of 10mg/ml.[78] Competitors  answering  to  questions
    posed during the market investigation did not identify the range of vials/products offered as a particular advantage  of  either  Pfizer  or
    Hospira. Nor did the market investigation confirm the decreasing importance of Pfizer for the Belgium market for carboplatin as a result  of
    the current inability to provide the […] vials. Moreover, an overview of the sales for the last five years did  not  reveal  a  decrease  in
    volume, which would have been a plausible consequence of the preference of hospitals to buy bigger vials, as  the  Notifying  Party  claims.
    There are no other indications to show that Pfizer's lack of the […] vial in Belgium represents a competitive disadvantage.

114) Some customers in Belgium responding to the market investigation mentioned that they would expect lesser competition and price increases  as
    a result of the transaction. Suppliers mentioned that Pfizer and Hospira's current main competitive advantage in carboplatin in  Belgium  is
    their pricing.[79]

115) Customers in Belgium also pointed out that they feared that supply security would become  an  increasingly  worrying  issue.  One  important
    customer explained that with such a small number of credible players on the market it would be more difficult  to  negotiate  guarantees  on
    security of supply. The transaction would thus, according to those customers affect competition negatively.[80]

116) According to well-established case law, very large market shares — 50 % or more — may in themselves  be  evidence  of  the  existence  of  a
    dominant market position.[81] It has been pointed out that in Belgium  tendering  procedures  are  not  yet  commonly  adopted  for  sterile
    injectables.[82] Therefore the market shares in Belgium reflect a  strong  market  position  that  would  stem  from  the  transaction.  The
    transaction would remove a competitive restraint from the market, in particular as Teva appears to be the only credible  competitor  to  the
    merged entity. Moreover, a majority of Belgian based customers that responded to the questions posed to them during the market investigation
    expressed their substantiated concerns over the change in market structure as to the security of supply and pricing in the market concerned.

117) Therefore, the analysis of the proposed concentration suggests that it would likely  significantly  impede  effective  competition,  in  the
    Belgian market for carboplatin, in particular as a result of the creation or strengthening of a dominant position. The Commission  concludes
    that the transaction therefore raises serious doubts as to its compatibility with the internal market in relation to carboplatin in Belgium.

    Italy

118) According to the Notifying Party, its combined market shares only reached the level of a Group 1 market in 2012, with a share  of  [40-50]%.
    Since then, both Pfizer's and Hospira's market shares have been constantly decreasing to  [30-40]%  combined  market  share  in  2013..  The
    combined market shares of the Parties reached only [10-20]% in value in 2014, with an increment of [5-10]% brought by  Hospira.  The  market
    size of carboplatin in Italy was EUR [10-20] million in 2014.

119) The other competitors on the market are Teva, Accord/Intas and Sun Pharma. The positioning on the market for carboplatin  in  Italy  of  all
    these suppliers has been strengthened since 2012. Teva increased its market share form [50-60]% in 2012 to [60-70]% in 2014, confirming  its
    market leader position and Intas from [0-5]% in 2012 to [5-10]% in 2014. Finally, Sun Pharma, a new entrant in 2013, reached [10-20]% market
    share in the next year. Post Transaction, the merged entity is expected to continue  facing  strong  competition  from  a  range  first  and
    foremost Teva, but also from Sun Pharma and Accord/Intas. These competitors are likely to increase their supply substantially should  prices
    of the merged entity increase after the Transaction.[83]

120) The range of vials sold in Italy is: 5ml, 15 ml, 45ml and 60ml, with a concentration of 10mg/ml.[84] Pfizer  is  offering  5,  15  and  45ml
    vials and Hospira the whole range. Both Accord and Teva are offering the full range of vial as well.

121) 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  carboplatin  in  Italy,
    because the proposed concentration would not significantly impede effective competition, in the Italian market for carboplatin.

    2 Cisplatin

    Product market definition

122) Cisplatin is the predecessor of carboplatin. It is used for the treatment of cancers including sarcomas, a number of carcinomas,  lymphomas,
    bladder cancer, cervical cancer and germ cell tumours.

123) The Commission previously investigated cisplatin in the same cases as carboplatin. The Commission did not need to  conclude  on  the  market
    definition in one case and defined the relevant product market at the molecule level in the other case.[85]

124) The Notifying Party tables the same arguments to assess the cisplatin market on the molecule level, but suggests leaving open  the  relevant
    product market definition.[86]

125) In the market investigation the limited substitutability between  cisplatin  and  carboplatin  was  confirmed.  The  indications  for  which
    cisplatin is prescribed are only partially overlapping with those for other molecules in the same ATC class, including carboplatin. Moreover
    purchasing takes place at the level of the molecule, predominantly through molecule-specific tenders.

126) On the basis of the above, the Commission concludes that for the purpose  of  the  present  decision  the  relevant  product  market  should
    comprise sterile injectable cisplatin.

    Competitive assessment

127) In cisplatin, the Transaction give raise to two affected Group 1 markets in Finland and Greece.

128) In Finland, the market size of the cisplatin was only EUR [0-1] million in 2014 and,  according  to  the  Notifying  Party,  has  constantly
    decreased since 2012. The combined market shares of the Parties reached [40-50]% in value in 2014, with a small  increment  of  only  [0-5]%
    brought by Pfizer. Accord/Intas is also present in Finland and has reinforced its market position over the last two years from only [10-20]%
    in 2013 to over [50-60]% in 2014.[87]

129) Pfizer's market share has been declining since 2012, when it had a market share of [20-30]%. Pfizer offers cisplatin in  vials  of  100,  10
    and 50ml. Hospira has a narrower range of only 100 and 50 ml vials. The main challenger Accord/Intas seems to have  the  broadest  range  of
    vials, comprising 10, 25, 50 and 100 ml. All suppliers offer the same concentration of 1mg/ml.

130) In Greece, the market size of cisplatin was only EUR [0-1] million in 2014 according to the Notifying Party. The combined market  shares  of
    the Parties reached [50-60]% in value in 2014, with a small increment of [0-5]% brought by Pfizer. The other competitors are Teva ([40-50]%)
    and Medicus (less than [0-5]%). Novartis was also present until 2013, with a market share of [10-20]% in 2012 and [0-5]% in 2013.

131) The Notifying Party submits that they base their submission on IMS data, which for Greece only tracks sales to pharmacies.  Hospira  […][88]
    […] sells cisplatin in Greece in a 100 mg vial. Hospira is unable to participate in tenders where the two most widely used vials  (10mg  and
    50mg) are required. Thus, in a recent national tender, initiated in December  2014,  Hospira  was  not  able  to  submit  an  offer  as  the
    specifications included 10mg and 50mg vials only. Equally, in a tender organised in January 2015, Hospira was unable to submit any offer  as
    it requested 50mg vials only.

132) Nevertheless, Hospira's share has increased from [10-20]% to [50-60]% over the  same  period,  showing  significant  variability  in  market
    shares. Pfizer's market share has drastically decreased since 2012 from [50-60]% to only [0-05]% in 2014. The fluctuations in market  shares
    reflect the fact that Greece is a tendering market with a very small market size. In such a market variations in market shares occur  rather
    often and market shares may overstate the actual market power.

133) During the market investigation customers did not express concerns regarding the  competitive  effects  of  the  proposed  transaction.  The
    competitors to the merged entity such as Teva, Medicus and Novartis are likely to increase their supply substantially should prices  of  the
    merged entity increase after the Transaction.[89]These competitors would constrain the merged entity sufficiently, should the merged  entity
    try to increase its prices.

134) In view of the above, the Commission concludes that the transaction does not give rise to serious doubts as to its  compatibility  with  the
    internal market in relation to cisplatin in Finland and Greece, because the proposed concentration would not significantly impede  effective
    competition, in the Finnish and Greek markets for cisplatin.

    3 Cytarabine

    Product market definition

135) Cytarabine belongs to the ATC3  class  of  antimetabolites,  including  agents  which  prevent  cells  from  multiplying.  Cytarabine  is  a
    chemotherapy agent used for different types of cancer treatment affecting blood cells (leukaemia)  and  is  also  used  to  treat  meningeal
    leukemia and lymphoma. Its patent protection ended in the 1980s.

136) There are no prior Commission decisions involving cytarabine.

137) The Notifying Party submits that the relevant product market should be defined  at  the  molecule  level,  mainly  because  of  the  limited
    substitutability with other agents that prevent cells from multiplying  for  cancer  treatment  and  because  of  the  fact  that  tendering
    procedures are very often geared towards cytarabine only. The Notifying Party argues that the relevant product market definition can in  any
    event be left open as no competition concerns would raise as a result of the transaction.

138) In the present market investigation the limited substitutability for cytarabine was confirmed.  The  indications  for  which  cytarabine  is
    prescribed are only partially overlapping with those of other molecules in the same ATC class. Moreover purchasing takes place on the  level
    of the molecule, predominantly through molecule-specific tenders.

139) On the basis of the above, the Commission concludes that for the purpose  of  the  present  decision  the  relevant  product  market  should
    comprise sterile injectable cytarabine.

    Competitive assessment

140) Cytarabine was originally launched by Upjohn (i.e. Pfizer) in  the  1970s,  under  the  brand  name  Cytostar.  Pfizer  acquired  cytarabine
    following the Pfizer/Pharmacia deal in 2003.[90] From 2005 onwards, generic versions of the drug became available, first one being Hospira's
    (Cytarabine Hospira).

141) The Transaction gives rise to five affected Group 1 markets for cytarabine in Belgium, Denmark, Italy, Portugal and Sweden.

    Belgium, Italy, Portugal and Sweden

142) In Belgium, the market size of the cytarabine was EUR [0-1] million in 2014, according to the Notifying Party. The  combined  market  shares
    of the Parties reached [60-70]% in value in 2014, with an increment of [10-20]% brought by Hospira.

143) The only other competitor on the market is Mundipharma International, an UK based innovator drugs developer, with a  market  share  of  [30-
    40]% in 2014. The Notifying Party submits that IMS data is incomplete as, according to their own competitive intelligence, other competitors
    are present on the market, namely Accord/Intas and Fresenius. As Accord/Intas won recent tenders, the Parties' combined market  share  is  –
    according to the Notifying party – likely to be significantly lower. Moreover, the Notifying Party estimates that, the number of tenders  in
    the future will increase in 2015, therefore the level of competition will increase as well. In addition, the Parties note that Strides holds
    a marketing authorisation in Belgium. While it is currently not active, the  Parties  believe  that  it  could  start  supplying  cytarabine
    effectively and immediately, should it take a business decision to do so.

144) The market investigation did not confirm the market structure advocated by the parties, revealing that Mundipharma is the  only  established
    competitor. Recently Accord/Intas also entered the market. Furthermore, the offers of those competitors do not seem to equal Pfizer's  range
    of products, especially as regards the concentration offered.

145) As regards the products offered, both Pfizer and Hospira offer the 100mg/ml concentration in 10ml and 20ml vials.  On  top  of  this  Pfizer
    also has a concentration of 20mg/ml (which it offers in 5ml and 25ml vials). According to the Notifying Party, hospitals typically require a
    full range of products from the same supplier, and therefore Hospira would be at a  competitive  disadvantage.  Accord/Intas  only  recently
    started supplying the 100mg/ml strength in vials of 1, 5, 10, 20, 40 and 50, while Mundipharma offers only 50 mg  suspension  for  injection
    10mg/ml in 5 ml vials.

146) According to well-established case law, very large market shares — 50% or more — may themselves be evidence of the existence of  a  dominant
    market position.[91] The market shares are rather stable and consistently high. The market investigation did not confirm the presence  of  a
    number of other credible competitors that are likely to increase their supply substantially, should prices of  the  merged  entity  increase
    after the Transaction.[92]

147) Therefore, the Commission considers that the analysis of the proposed transaction would likely significantly impede  effective  competition,
    in the market for cytarabine in Belgium. The  Commission  concludes  therefore  that  the  transaction  raises  serious  doubts  as  to  its
    compatibility with the internal market for cytarabine in Belgium.

148) In Italy, the market size for cytarabine was EUR [1-5] million in 2014, according to the Notifying Party. The combined market shares of  the
    Parties were [40-50]%, with an increment of [5-10]% brought about by Hospira. In 2012 the combined market share was [50-60]% and in 2013  it
    was [70-80]%. The main competitor is Mundipharma International with a market share of  [40-50]%  in  2014.[93]  The  other  competitors  are
    Fresenius and new entrant Accord/Intas, both with [0-5]% market share in 2014. Fresenius has not registered sales since 2013, when it had  a
    market share lower than [0-5]%.

149) Apart from the merged entity, Mundipharma International seems to offer as well a suspension cytarabine presentation in  a  concentration  of
    10mg/ml[94] and they seem to have a well-established positioning on the Italian market, therefore proving that the dry presentation form  is
    not at all a disadvantage in this market. However, MundiPharma International had problems with the supply, due to product recall  caused  by
    quality issues at third party manufacturer plant identified by the regulatory authorities.[95]

150) As regards the presence of the other competitors, the market investigation  did  not  confirm  their  positioning  according  to  IMS  data.
    Mundipharma International remains the main competitor of the merged entity, but with a much weaker position that the one  indicated  by  the
    Notifying Party. The absence of a number of other credible competitors that may be likely to increase  their  supply  substantially,  should
    prices of the merged entity increase after the Transaction, together with the high combined market  shares  would  lead  the  Commission  to
    conclude that the proposed transaction raises serious doubts as to its compatibility with the internal market in relation to  cytarabine  in
    Italy.

151) In Portugal, the market size for cytarabine was EUR [0-1] million in 2014, according to the Notifying Party. The combined market  shares  of
    the Parties reached almost [90-100]% in 2014, with an increment of [5-10]% brought about by Pfizer. The Notifying Party  only  mentions  Lab
    Unknown[96] as being present with a market share of less than [0-5]% in 2014.

152) The Notifying Party submits that, […].[97] The Notifying party argued that […]However, Pfizer failed to submit credible evidence […].

153) Because of the very high combined market share customers would have no alternative to turn to.[98] The market investigation did not  confirm
    any potential entrants from neighbouring markets, nor indicated that such entry has occurred in the  recent  past.  This  would  enable  the
    merging parties to increase prices to the detriment of the customers in Portugal.

154) In view of the above the Commission concludes that the proposed transaction would significantly impede effective competition, in the  market
    for cytarabine in Portugal. The Commission concludes therefore that the transaction raises serious doubts as to its compatibility  with  the
    internal market.

155) In Sweden, the size of the market for cytarabine was EUR [0-1] million in 2014, according  to  the  Notifying  Party.  The  combined  market
    shares of the Parties reached almost [60-70]% in 2014, with an increment of [20-30]%.  The  other  competitors  present  are  SkyePharma,  a
    generic drug delivery specialist, with a market share of [20-30]% in 2014, Fresenius with [10-20]% and new  entrant  Accord/Intas  with  [0-
    05]%.

156) The Notifying Party submits that in addition, two other companies submitted offers in recent tenders,  namely  Farmaplus  and  PharmaCoDane,
    thereby increasing the level of competition, despite the fact that they did not win any contracts. The market investigation did however  not
    confirm the existence of any other additional competitor except  for  Accord/Intas,  and  to  a  lesser  extent  Fresenius  and  SkyePharma.
    Accord/Intas has had a small market share and SkyePharma has consistently had a very minor share for the last 5 years, in spite of the  fact
    that the Swedish market can be characterised as a tendering market.  In the markets described above, the proposed transaction would lead  to
    very high market shares. The market investigation showed that some competitors were very small and remained very small throughout the years,
    thereby indicating that they have not been able to effectively win tenders. In these cases  the  Commission  cannot  dispel  serious  doubts
    purely based on the fact that the markets involved have some tendering  characteristics.  On  the  contrary,  the  fact  that  the  proposed
    transaction would result in high and sometimes very high market shares would illustrate the strengthening of a  dominant  position  and  the
    loss of competitive pressure. In this situation, the competitors that are consistently small would not  be  able  to  constrain  the  merged
    entity.

157) Moreover, a majority of customers in these markets that responded to the market investigation questionnaires expressed their concerns  about
    the proposed transaction, fearing in particular the loss of competition to the detriment  of  their  ability  to  negotiate  the  supply  of
    cyterabine. Customers also pointed out that too few (credible) competitors in a tender would lead to suboptimal outcomes  of  the  tendering
    procedure. Some of these customers described that the prices of cytarabine may increase as a result of the proposed transaction.[99]

158) Taking into consideration all of the above, the Commission considers that the proposed concentration would  significantly  impede  effective
    competition, in the market for cytarabine in Sweden, in particular as a result of the creation or strengthening of a dominant position.  The
    Commission concludes therefore that on this market, the transaction raises serious doubts as to its compatibility with the internal market.

    Denmark

159) According to the Notifying Party, the market size of the cytarabine in Denmark was only EUR [0-1] million in 2014. Denmark  was  a  Group  1
    market in 2012 and 2013, where the combined market share of the Parties reached [60-70]% and [60-70]% respectively. In  2014,  there  was  a
    significant drop in both Parties' position, therefore reaching only [10-20]% in value in 2014, with  an  increment  of  [5-10]%  brought  by
    Pfizer.

160) The other competitors on the market are Pacira Pharmaceuticals, a US-based generic company, with a constant strong presence during the  last
    three years of more than [30-40]% of the market. The other main challenger proves to be Fresenius. Since its entry in 2013,  it  immediately
    succeeded to gain a [5-10]% market share in the same year and a much stronger one in 2014. Therefore, after merger,  there  will  be  enough
    alternative suppliers that could

161) The Notifying Party submits that in Denmark there is one national tender covering all the public hospitals in the country which is  held  on
    a yearly basis organised by Amgros I/S (the hospital purchasing agency). The Notifying Party estimates  that  the  Parties  combined  market
    share will […].

162) All competitors, including the Parties, offer the 100mg/ml concentration in 10ml and 20ml dosages. In addition, Pfizer offers a  20mg/ml  in
    5ml dosage which other suppliers do not offer. However, the Notifying Party submits that this presentation was not included  in  the  tender
    specifications and is sold solely outside the tender processes.

163) An analysis of the market share fluctuations shows that in 2014 the drop in sales of both Parties was compensated by the increase  in  sales
    of both of their rivals, mainly to the recent entry of Fresenius. Accord/Intas has also confirmed its recent entry. However, they  have  not
    recorded any sales in 2014. Given the recent drop in the Parties' combined market share due to successful entrance of  further  competitors,
    the Commission considers that, post-merger, there will be enough alternative suppliers that could constraint the merged entity.

164) 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  cytarabine  in  Denmark,
    because the proposed concentration would not significantly impede effective competition.

4 Epirubicin

    Product market definition

165) Epirubicin is a medicine used for the treatment of various cancers, such as ovarian cancer, stomach cancer, lung cancer,  bowel  cancer  and
    myeloma. It is also used to treat some types of lymphoma and leukemia. It belongs to the ATC3 class of antineoplastic  antibiotics  and  has
    been off patent since 2007.

166) The Commission has investigated a merger involving epirubicin in one case, Novartis/Ebewe,  without  needing  to  conclude  on  the  product
    market definition.[100]

167) The Notifying Party submits that the market investigation in the present case should be carried out at the level of the molecule,  but  that
    the relevant product market definition ultimately can be left open.

168) The market investigation showed however limited substitutability for epirubicin. Moreover  purchasing  takes  place  on  the  level  of  the
    molecule, predominantly through molecule-specific tenders.

169) On the basis of the above, the Commission concludes that for the purpose  of  the  present  decision  the  relevant  product  market  should
    comprise sterile injectable epirubicin.

    Competitive assessment

170) In the market for epirubicin, the Transaction give raise to five affected Group 1 markets in Austria, Belgium, Italy,  the  Netherlands  and
    Spain.

171) In Austria, the market size of the epirubicin was EUR [5-10] million in 2014, according to the Notifying Party. The combined  market  shares
    of the Parties reached [50-60]% in 2014, with an increment of [5-10]% brought by Hospira. In 2012 and 2013 the combined market  shares  were
    [50-60]% and [70-80]% respectively. The other present competitors are Actavis, with a market share of [20-30]% in 2014, Novartis  with  [10-
    20]% and a new entrant Accord/Intas with [5-10]% in 2014.

172) In Belgium, the market size of epirubicin was EUR [1-5] million in 2014. The combined market shares  of  the  Parties  reached  [70-80]%  in
    2014, with an increment of [0-5]% brought by Hospira. In 2012 and 2013 the combined market shares were [70-80]% and  [70-80]%  respectively.
    The other present competitors are Teva, with a market share of [10-20]%, Aurobindo with [10-20]% and a new entrant Accord/Intas with [0-05]%
    in 2014. The Notifying Party submits that Novartis is also present with a market share of less than [0-5]%.

173) In Italy, the market size of the epirubicin was EUR [10-15] million in 2014. In 2012 and 2013 the combined market shares were  [80-90]%  and
    [80-90]% respectively. The combined market shares of the Parties reached [60-70]% in 2014, with an increment of [20-30]% brought by Hospira.
    The other present competitors are Teva, with a market share of [20-30]% and  the  new  entrant  Accord/Intas  with  [10-20]%  in  2014.  The
    Notifying Party submits that Novartis is also present with a market share of less than [0-5]%.

174)  In Netherlands the market size of the epirubicin was EUR [1-5] million in 2014. The combined market shares of the Parties reached  [40-50]%
    in 2014, with an increment of [10-20]% brought by Hospira. In  2012  and  2013  the  combined  market  shares  were  [60-70]%  and  [40-50]%
    respectively. The other present competitors are the new entrant Accord/Intas with [50-60]% and Teva with a smaller market share of[5-10]% in
    2014. The Notifying Party submits that Novartis was also present in 2013with a market share of less than [0-5]%.

175) In Spain the market size of the epirubicin was EUR [1-5] million in 2014. The combined market shares of  the  Parties  reached  [40-50]%  in
    2014, with an increment of [10-20]% brought by Pfizer. In 2012 and 2013 the combined market shares were [70-80]% and [70-80]%  respectively.
    The other present competitors are Teva with [30-40]%, Accord/Intas with [10-20]% market share, Aurobindo with [5-10]% and Ferrer  with  less
    than [0-5]% in 2014.

176) However, in all these markets, the market investigation did not confirm the positioning or presence  of  all  these  alternative  suppliers,
    revealing a weaker positioning of some of them. In addition, there seem to be capacity constraints for some of  the  competitors[101]  in  a
    market that security of supply is seen as a very important aspect by customers.[102] Moreover, no other supplier has confirmed the intention
    to enter any of these markets.[103] Therefore, after the merger, there will be only a reduced number of alternative suppliers.

177) During the market investigation a minority of customers in the markets concerned expressed concerns about the proposed transaction,  fearing
    a loss of competition. These customers indicated that the possibility to negotiate good prices would significantly decrease as a  result  of
    the transaction.[104]

178) The Notifying Party submits that […].[105] The Notifying Party argued that […] However, Pfizer failed to submit credible evidence […].

179) The Commission, taking into consideration the concerns expressed by customers, the high combined market shares and the lack  of  competitive
    constraints by competitors placed on them and especially the fact that the Notifying Party was not able to proof  […],  concludes  that  the
    proposed concentration would significantly impede effective competition, in the markets for  epirubicin  in  Austria,  Belgium,  Italy,  the
    Netherlands and Spain, in particular as a result of the creation  or  strengthening  of  a  dominant  position.  Therefore,  the  Commission
    concludes that on these markets the transaction gives rise to serious doubts as to its compatibility with the internal market.

5 Fluorouracil

    Product market definition

180) Fluorouracil is also an agent that prevents cells from multiplying and is thus used for the treatment of various cancers such as  colorectal
    cancer and breast cancer.

181) The Commission has previously considered that fluorouracil should  be  considered  a  separate  relevant  product  market  because  it  only
    partially overlaps with other agents within the same class and because of the buying patterns of the hospitals.[106]

182) The Notifying Party proposes that the assessment should be at the level of  the  molecule,  but  argue  that  the  relevant  product  market
    definition could be left open, since according to the Parties the transaction would not lead to competitive concerns.

183) The market investigation yielded some evidence pointing towards a relevant product market definition at the molecule  level,  for  the  same
    reasons as the other sterile injectable products that were investigated. However, in the present case the relevant product market definition
    can be left open as the transaction would not raise serious doubts as to a significant lessening of competition,  regardless  of  the  exact
    relevant market delineation.

    Competitive assessment

184) In fluoruracil, the Transaction give raise only to one affected Group 1 market in Norway.

185) According to the Notifying Party, the market size of the fluoruracil in Norway was only EUR [0-1]  million  in  2014.  The  combined  market
    shares of the Parties reached [60-70]% in 2014, with an increment of [5-10]% brought by  Hospira.  Accord/Intas,  a  new  entrant,  is  also
    present in this market with a considerable market share of [30-40]%.

186) Hospira's market share has been declining since 2012 from [20-30]% to [5-10]% in 2014. The Notifying Party argues that […].[107]

187) Pfizer is offering 50mg/ml strength in 10 and 20ml vials, while  Hospira  is  offering  the  same  strength  in  10,  50  and  100ml  vials.
    Accord/Intas, the main challenger, is offering a much wider range of vials, covering vials from 5 to 100ml. Therefore, it was very easy  for
    Accord/Intas to gain rapidly market share and a good position on the market because of its wide range of products. Also, from  the  analysis
    of the market share evolution over the last three years it can be easily observed that the loss of sale of both Parties has  been  reflected
    in the increase in the market position of Accord/Intas. The latter, together with the size of this  market,  suggest  that  the  competitive
    dynamics between the existent participants were strong enough to give raise to a very different and changing positioning of the suppliers in
    this market.

188) The market investigation showed that there will be sufficient competitive pressure from  potential  entrants  in  the  future  to  constrain
    higher pricing by the merged entity. The market investigation indicated that this is indeed the case.[108]  Fluoruracil  is  produced  by  a
    number of competitors who have marketing authorisations in other countries which would have no capacity constraint to  serve  the  Norwegian
    market and which offer other drugs in Norway, thus have sales organisation there. For fluoruracil in Norway the market  investigation  hence
    did confirm the existence of a number of credible competitors that are likely to increase their supply substantially, should prices  of  the
    merged entity increase after the Transaction.[109]

189) 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. because the proposed concentration  would
    not significantly impede effective competition, in the market for fluorouracil in Norway.

6 Irinotecan

    Product market definition

190) Irinotecan is an alkaloid molecule derived from plants. It interferes with the enzymes that control the manipulation of DNA  structure  that
    is necessary for cell replication. Blocking these enzymes leads to breaks in the DNA structure which in turn leads  to  cell  death.  It  is
    primarily used for colorectal cancer. Irinotecan has been off patent since 2009.

191) In a previous decision, Sanofi-Synthelabo/Aventis, the  Commission  concluded  that  there  was  a  separate  relevant  product  market  for
    pharmaceutical products for the treatment of colorectal cancer.[110] However, this decision did not specifically refer to irinotecan.

192) For the purpose of the present case the Notifying Party argues that the assessment should take place at the level of the molecule, but  that
    the market can be left open because do transaction would not give rise to anti-competitive effects.

193) The market investigation showed limited substitutability for irinotecan Moreover purchasing takes  place  at  the  level  of  the  molecule,
    predominantly through molecule-specific tenders.

194) On the basis of the above, the Commission concludes that for the purpose  of  the  present  decision  the  relevant  product  market  should
    comprise sterile injectable irinotecan.

    Competitive assessment

195) In irinotecan, the Transaction give raise to six affected Group 1 markets in Belgium, the Czech Republic, Finland, Greece, Italy and Spain.

    Belgium, the Czech Republic and Italy

196) In Belgium, the market size for irinotecan was EUR [5-10] million in 2014. The combined market shares of the  Parties  reached  [70-80]%  in
    2014, with an increment of [5-10]% brought by Hospira. The Notifying Party submits that there are also other suppliers active on this market
    like Fresenius ([10-20]%), Aurobindo ([5-10]%), Teva ([0-5]%) and Mylan ([0-5]%).

197) In the Czech Republic, the market size of the irinotecan was EUR [1-5] million in 2014. The combined market shares of  the  Parties  reached
    [50-60]% in 2014, with an increment of [10-20]% brought by Hospira. The Notifying Party submits that there are also other  suppliers  active
    on this market like Mylan ([30-40]%) and Teva ([5-10]%), and some smaller ones like Servier, Fresenius and Accord/Intas, all with  a  market
    share of less than [0-5]%.

198) In Italy, the market size of the irinotecan was EUR [20-25] million in 2014. The combined market shares of the Parties reached  [50-60]%  in
    2014, with an increment of [10-20]% brought by Pfizer. The Notifying Party submits that there are also other suppliers active on this market
    like Fresenius ([30-40]%), Molteni ([10-20]%), a pharmaceutical company that focuses on pain therapy and drug  addiction,  Mylan  ([5-10]%),
    Teva and Novartis, both with a market share of less than [0-5]% in 2014.

199) However, in all these markets, the market investigation did not entirely confirm the  positioning  or  presence  of  all  these  alternative
    suppliers, revealing a weaker positioning for some competitors with respect to what represented by the Parties. In addition, there  seem  to
    be capacity constraints for some of the competitors[111] in a market where security of  supply  is  seen  as  a  very  important  aspect  by
    customers;[112] additionally, one competitor is exiting the market. Moreover, no other supplier has confirmed the intention to enter any  of
    these markets.[113] Therefore, after the merger, there will be only a reduced number of alternative suppliers.

200) A majority of customers responding to the Commissions market queries in these markets expressed their concerns with regard to  the  proposed
    transaction during the market investigation. A number of those customers described that the prices of irinotecan may go up as  a  result  of
    the proposed transaction. A number of customers had voiced concerns over the security of  supply  as  a  result  of  the  fewer  alternative
    suppliers stemming from the proposed transaction.[114]

201) In light of the high market shares and the limited number of credible alternative  supply  options  that  the  customers  would  have  post-
    transaction, the fact that the market investigation did not entirely confirm the presence of  all  alternative  suppliers,  showed  capacity
    constraints of competitors and revealed concerns by a majority of customers, the Commission concludes that the proposed concentration  would
    significantly impede effective competition, in the markets for irinotecan in Belgium, the Czech Republic and Italy in particular as a result
    of the creation or strengthening of a dominant position. Therefore, the Commission concludes that on those  markets  the  transaction  gives
    rise to serious doubts as to its compatibility with the internal market.

    Finland and Spain

202) In Finland, the market size of the irinotecan was EUR [0-1] million in 2014. The combined market shares of the Parties reached [90-100]%  in
    2014, but there was no overlap in 2014 (as in 2012), because Pfizer did not realise any sales. However,  in  the  previous  year  2013,  the
    Parties reached [60-70]% combined market share, with an almost equal share of each Party. The Notifying Party submits that  in  2013,  there
    were also other competitors active like Novartis ([10-20]%), Fresenius ([5-10]%) and Teva  ([5-10]%).  Therefore,  Finland  was  a  Group  1
    country exceptionally only in 2013.

203) The fluctuations in market shares reflect the fact that Finland is a tendering market with a small market size. In such a market  variations
    in market shares occur rather often and market shares may overstate the actual market power.

204) During the market investigation customers did not express concerns as to negative competitive  effects  of  the  proposed  transaction.  The
    competitors to the merged entity such as Teva, Fresenius and Novartis are likely to increase their supply substantially should prices of the
    merged entity increase after the Transaction. These competitors would constrain the merged entity sufficiently, should the merged entity try
    to increase its prices.

205) In Spain, the market size of the irinotecan was EUR [5-10] million in 2014. The combined market shares of the Parties  reached  [40-50]%  in
    2014, but the increment was less than [0-5]% brought by Pfizer. However, Spain was Group 1 market in 2012, when the combined  market  shares
    reached [60-70]% and the increment of [0-5]% of Pfizer. The Notifying Party submits that in 2012 there are also other  suppliers  active  on
    this market like Accord/Intas ([10-20]%), GP Pharm ([10-20]%), a local pharmaceutical company, Fresenius ([5-10]%), Teva ([0-5]%),  Aurobino
    ([0-5]%), Mylan and Novartis, both with a market share of less than [0-5]%.

206) The Notifying Party further submits that in 2014, it started the official process of withdrawing the  marketing  authorisation  in  Finland.
    Equally, Pfizer submitted evidence that in Spain the official withdrawal, approved by the Medicines  Agency,  took  place  on  23  September
    2014.[115]

207) During the course of the investigation, Pfizer submitted documents showing that in Finland, it is  not able to effectively  compete  on  the
    market and therefore Pfizer initiated the marketing  authorisation  withdrawal  procedure.[116]  Equally  for  Spain,  the  Notifying  Party
    submitted documents concerning the withdrawal of marketing authorisation for irinotecan in Spain.

208) The Commission, taking into consideration all of the above, including the documents submitted showing clear exiting  of  Pfizer  from  Spain
    and Finland, concludes that the transaction does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  in
    relation to irinotecan in Finland and Spain. because the proposed concentration would not significantly impede effective competition, in the
    markets for irinotecan in Finland and Spain.

    Greece

209) In Greece, the market size of the irinotecan was only EUR [0-1] million in 2014. The combined market  shares  of  the  Parties  reached  the
    level of a Group 1 market only in 2012, with a combined market share of [30-40]% and  an  increment  of  [5-10]%  brought  by  Hospira.  The
    Notifying Party submits that in 2012, there were also other competitors active like Mylan ([40-50]%) and Teva ([10-20]%).

210) Mylan was clearly the market leader for the last three years, reaching to [50-60]% in 2014. Hospira did not record any  sales  in  2013  and
    2014.

211) The Notifying Party submits that the IMS data is incomplete. They estimate the total value of the market (public and  private)  in  2014  at
    approximately EUR [1-5]million. This estimate is based on the last national  tender  for  public  hospitals,  which  covers  almost  95%  of
    government hospitals. This last tender has been won by Mylan (Generics Pharma) and has been executed form spring 2014 to spring  2015  at  a
    total value of EUR [0-1] million. Based on the Parties' actual sales, their estimated individual market shares would be [10-20]% for Pfizer,
    and [5-10]% for Hospira in 2015.

212) 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  irinotecan  in  Greece,
    because the proposed concentration would not significantly impede effective competition, in the markets for irinotecan in Greece.

    7 Methotrexate

    Product market definition

213) Methotrexate is an antimetabolite and antifolate drug which acts by inhibiting the metabolism of folic acid. It  is  used  in  treatment  of
    cancer, autoimmune diseases, ectopic pregnancy, and for the induction of medical abortions.

214) The market investigation yielded some evidence pointing towards a relevant product market definition at the molecule  level,  for  the  same
    reasons as the other sterile injectable products that were investigated. However, in the present case the relevant product market definition
    can be left open as the transaction would not raise serious doubts as to a significant lessening of effective competition, regardless of the
    exact relevant market delineation.

    Competitive assessment

215) In methotrexate, the Transaction give raise to two affected Group 1 markets in Italy and Portugal.

216) In Italy the market size for methotrexate was EUR [30-40] million in 2014. The combined market shares of the Parties reached the level of  a
    Group 1 market only in 2012, with [60-70]% and an increment of only [0-5]% brought by Hospira. The Notifying Party  submits  that  in  2012,
    there were also other competitors active like Alpha Wassermann ([30-40]%), an Italian based pharmaceutical group, and Teva ([0-5]%).

217) Due mainly to decreasing sales of both Parties in 2013 and 2014, Italy was only a Group  2  market  in  these  two  years.  Hospira's  share
    decreased from [0-5]% in 2012 to a mere [0-5]% in 2014. Pfizer's market share dropped from [60-70]% in 2012 to [50-60]% in 2014.

218) An analysis of the market shares evolution during the last three years, shows that the main winner of the Parties' loss  of  sales  was  the
    main rival Alpha Wassermann, constantly improving its share up to [40-50]% of the market in 2014.

219) In Portugal, the market size of the methotrexate was EUR [1-5] million in 2014. The combined market shares of the Parties reached the  level
    of a Group 1 market only in 2012, with [30-40]% and an increment of [10-20]% brought by Hospira. The Notifying Party submits that  in  2012,
    there were also other competitors active like Medac ([60-70]%) and Teva ([5-10]%).  However,  due  to  decreasing  sales  of  both  Parties,
    Portugal was only a Group 3 market in 2013 and 2014.

220) The market leader has been Medac, consolidating its position from [60-70]% in 2012 to [60-70]% in 2014, taking  advantage  of  the  Parties'
    loss in sales. Hospira's share decreased from [10-20]% in 2012 to [5-10]% in 2014. Pfizer's positioning was rather constant, with  a  market
    share around [20-30]% during the 2012-2014 period.

221) 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, because the proposed concentration  would
    not significantly impede effective competition, in the markets for methothrexate in Italy and Portugal.

    8 Nitroglycerin

    Product market definition

222) Nitroglycerin belongs to a group of drugs called nitrates, which includes many  other  nitrates  like  isosorbide  dinitrate  (Isordil)  and
    isosorbide mononitrate (Imdur, Ismo, Monoket). These agents all exert their effect by being converted into nitric oxide,  a  potent  natural
    vasodilator, in the body.

223) In medicine, nitroglycerin is used as a medicine for angina pectoris, a symptom of ischemic heart  disease  caused  by  inadequate  flow  of
    blood and oxygen to the heart. Nitroglycerin corrects the imbalance between the flow of oxygen and blood to the heart. It is also  a  potent
    antihypertensive agent. In cardiac treatment, the lowering of pressure in the arteries reduces the pressure against  which  the  heart  must
    pump.

224) Irrespective of the exact product market definition the transaction would not  raise  serious  doubts  as  to  a  significant  lessening  of
    effective competition.

    Competitive assessment

225) Regarding nitroglycerin, the Transaction gives rise to only one affected Group 1 market, namely in Portugal.

226) Here, the market size was EUR [1-5] million in 2014. The combined market shares of the Parties reached [40-50]% in 2014, but  the  increment
    was only [0-5]% brought by Hospira. The Notifying Party submits that in 2014 there were also other  competitors  present  like  Medac  ([20-
    30]%), Merk&CO ([5-10]%), Novartis ([5-10]%), UCB ([5-10]%), a global biopharmaceutical company with headquarters in Belgium, Quilaban  ([5-
    10]%), a local distributor and finally Faes Farma ([5-10]%), a Spanish distributor.

227) Hospira's sales have been decreasing during the last three years from [0-05]% in 2012 to [0-5]% in 2014.  The  same  stands  valid  for  the
    market size, which seems to be shrinking from 2012 onwards from EUR [1-5] million in 2012 to EUR [1-5] million in 2014. The market  position
    of the Parties' competitors proved relatively stable during the period analysed, with only very small variations, showing that there will be
    several active suppliers post-merger that will continue to compete with the merged entity exerting competitive constraint over it.

228) The Commission, taking into consideration all of the above, concludes that the transaction does not give rise to serious doubts  as  to  its
    compatibility with the internal market, because the proposed concentration would not significantly  impede  effective  competition,  in  the
    market for nitroglycerin in Portugal.

    9 Piperacillin/Tazobactam

    Product market definition

229) Piperacillin/Tazobactam is an extended-spectrum beta-lactam antibiotic of the ureidopenicillin class. It is normally used  together  with  a
    beta-lactamase inhibitor, notably in the combination piperacillin/tazobactam. It is used  for  preventing  infections  that  are  proven  or
    strongly suspected to be caused by bacteria.

230) The market investigation yielded some evidence pointing towards a relevant product market definition at the molecule  level,  for  the  same
    reasons as the other sterile injectable products that were investigated. However, in the present case the relevant product market definition
    can be left open as the transaction would not raise serious doubts as to a significant lessening of competition,  regardless  of  the  exact
    relevant market delineation.

    Competitive assessment

231) In piperacillin/tazobactam, the Transaction gives raise to three affected Group 1 market in Ireland, Italy, the Netherlands.

232) In Ireland the market size of the piperacillin/tazobactam was EUR [10-15] million in  2014.  The  combined  market  shares  of  the  Parties
    reached the level of a Group 1 market only in 2013, with [40-50]% and an increment of only [0-5]% brought by  Pfizer.  The  Notifying  Party
    submits that in 2012, there were also other competitors active like Wockhardt ([10-20]%), a global generic pharmaceutical company and an API
    producer, Teva ([10-20]%), Stada ([10-20]%), Fresenius ([10-20]%) and Mylan ([5-10]%).

233) The market share data shows that since 2012 Pfizer's sales have been drastically decreasing from  [5-10]%  to  less  than  [0-5]%  in  2014.
    Hospira's market share in 2012 was of [10-20]% and [10-20]% in 2014. In addition, there are several suppliers that will remain on the market
    post-transaction and that will impose competitive constraints on the merged entity.

234) In Italy, the market size of the piperacillin/tazobactam was EUR [70-80] million in 2014. The combined market shares of the Parties  reached
    the level of a Group 1 market only in 2012, with [60-70]% and an increment of just [0-5]% brought by Hospira. The  Notifying  Party  submits
    that in 2012, there were also other competitors active like Magis Farmaceutici ([10-20]%), an Italian distributor, Teva ([5-10]%), Fresenius
    ([5-10]%), and several others like IBI, a local pharmaceutical producer, Bioton Group, Mylan and several small other ones.

235) Both Parties' sales have drastically decreased since 2012. Pfizer was the market leader in 2012 with a market share of [60-70]%, whereas  in
    2014 it accounted for only [5-10]% of the market. Equally, Hospira's market share dropped from [0-5]% in 2012 to [0-5]% in  2014,  remaining
    an insignificant player on this market.

236) In the Netherlands, the market size of the piperacillin/tazobactam was EUR [1-5] million in 2014. The combined market shares of the  Parties
    reached the level of a Group 1 market only in 2012, with [50-60]% and an increment of [20-30]%  brought  by  Hospira  and  in  2013  with  a
    combined market share of [30-40]% and a much smaller increment of Hospira's of [0-5]%. The Notifying Party submits that in 2013, there  were
    also other competitors active like Fresenius ([40-50]%), Teva ([10-20]%), Mylan ([0-5]%) and Novartis (less than [0-5]%).

237) The Notifying Party submits that […] In addition to that, one competitor mentioned that during a  supply  disruption  of  one  of  the  main
    suppliers on this market, the other participants were able to supply sufficient volume to cove this shortage.[117]

238) 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 piperacillin/tazobactam  in
    Ireland, Italy and the Netherlands.

10 Vancomycin

    Product market definition

239) Vancomycin is classified in an ATC3 catch all class, 'other  antibacterials'.   Such  a  class  does  not  group  interchangeable  molecules
    together. Vancomycin is a natural occurring antibiotic made by a bacterium in the soil. It has been  off  patent  since  the  early  1980's.
    Vancomycin is primarily used for the first line of treatment for MRSA (Methicillin-resistant Staphylococcus aureus).

240) The Commission dealt with vancomycin in its Pfizer/Wyeth decision[118], where  it  considered  that  generic  vancomycin  was  not  a  close
    substitute for two other branded MRSA antibiotics, because those were reserve antibiotics. Vancomycin was  considered  to  be  the  leading,
    first line treatment.

241) For this reason and because tenders are often organised per molecule, the Notifying Party argues that the assessment should  take  place  at
    the level of the molecule.  The Parties submit that the relevant product market definition ultimately can be left open.

242) In the present market investigation the limited substitutability for vancomycin was confirmed. The  indications  for  which  carboplatin  is
    prescribed are only partially overlapping with those of other molecules in the same ATC class. Moreover purchasing takes place predominantly
    through molecule-specific tenders.

243) On the basis of the above, the Commission concludes that for the purpose of the present decision the relevant product market definition  can
    be left open as the transaction would not raise serious doubts as to a  significant  lessening  of  competition,  regardless  of  the  exact
    relevant market delineation.

    Competitive assessment

244) In vancomycin, the Transaction give raise to two affected Group 1 markets in Ireland and Norway.

    Ireland

245) In Ireland, the market size of vancomycin was EUR [1-5] million in 2014. The combined market shares of the Parties reached [50-6]% in  2014,
    with an increment of [0-5]% brought by Pfizer. The Notifying Party notes that there would be another competitor present in the market,  with
    a share of [5-10]%. The Parties have submitted that the market share accounted for under the title of "Lab Unknown" is in reality compounded
    vancomycin, sold directly to hospitals from Fannin and Baxter. The other suppliers are Flynn Pharma ([10-20]%) and Actavis ([5-10]%).

246) The Notifying Party submits that Pfizer launched vancomycin in Ireland in 2011, but its sales were first recorded  by  IMS  in  2014.  Thus,
    while Pfizer does not have estimates of its market share for the period between 2011 and 2014, it believes that its market share  has  risen
    gradually since 2011.

247) In addition, while Pfizer is a new entrant in this market, Hospira's market share has been increasing too since 2012 onwards, from only [10-
    20]% in 2012 to [50-60]% in 2014, taking market share mainly from Lab  Unknown.  Therefore,  the  Transaction  would  even  further  enforce
    Hospira's recently consolidated leading position in this market.

248) Moreover, no other supplier has confirmed its intention to enter this market in the near future.[119]  Therefore, after  the  merger,  there
    will be only a reduced number of alternative suppliers.

249) The Commission, taking into consideration all of the  above,  including  the  results  of  the  market  investigation,  concludes  that  the
    transaction gives rise to serious doubts as to its compatibility with the internal market, because  the  proposed  concentration  would  not
    significantly impede effective competition, in the market for vancomycin in Ireland.

    Norway

250) In Norway, the market size for vancomycin was only EUR [0-1] million in 2014. The combined market shares of the  Parties  reached  [90-100]%
    in 2014, with an increment of [40-50]% brought by Hospira. The other suppliers are Mip Group ([0-5]%) and Fresenius ([0-5]%). The  Notifying
    Party submits that Xellia, a primarily generic company which has its headquarters in Denmark, has a market share of less than 1% in 2014.

251) The Notifying Party estimates the Parties' combined market share to be significantly lower in 2015, as […]. Pfizer estimates  that  in  2015
    […] will have a market share of [40-50]%, […] a market share of [30-40]% and that its own market share will be [10-20]%.

252) The Parties consider that their high market share results from the low prices they  offer.  Should  Pfizer  try  to  increase  prices  post-
    Transaction, it would lose market share to other competitors present on the market. This could be easily observed by the  evolution  of  the
    bid prices […] its market share:

    Table 2: Correlation between Pfizer's bid price and market share in Norway

|                                          |Bid price (NOK)                           |Market share (%)                           |
|2013                                      |[…]                                       |[20-30]%                                   |
|2014                                      |[…]                                       |[50-60]%                                   |
|2015                                      |[…]                                       |[…]%(estimate)                             |

    Source: The Notifying Party.

253) This proves that although the combined market shares of the Parties are high, in a small value market with a lumpy demand, it does not  give
    Pfizer a degree of market power that would allow it to impose higher prices after the Transaction. As is  the  case  with  vincristine  (see
    below), there are a number of potential suppliers constraining Pfizer and Hospira already now and they will continue to do so.

254) 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, because the proposed concentration  would
    not significantly impede effective competition, in the market for vancomycin in Norway.

11 Vincristine

    Product market definition

255) Vincristine is an alkaloid microtubule agent derived from the periwinkle plant. Microtubules are parts of human cells that are ensuring  the
    replication of the cells. Inhibiting the microtubule cells leads to cell death and is therefore used as a treatment  for  various  forms  of
    cancer, such as head and neck cancers, brain tumours, soft tissue sarcoma and many others. Vincristine has been off-patent for a  number  of
    years.

256) There has not been a prior case with the Commission where it has looked at vincristine.

257) For the purpose of the present case the Parties argue that the assessment should take place at the molecule level, but that in any even  the
    market definition can be left open because the transaction would not give rise  to  anti-competitive  effects  under  any  plausible  market
    definition.

258) The market investigation yielded some evidence pointing towards a relevant product market definition at the molecule  level,  for  the  same
    reasons as the other sterile injectable products that were investigated. However, in the present case the relevant product market definition
    can be left open as the transaction would not raise serious doubts as to a significant lessening of competition,  regardless  of  the  exact
    relevant market delineation.

    Competitive assessment

259)  For vincristine, the Transaction give raise to only one affected Group 1 market in Norway.

260) Here, the combined market shares of the Parties reached [90-100]% in 2014, with an increment of [20-30]% brought  by  Pfizer.  In  2013  and
    2012, Pfizer accounted for the totality of the market. The size of the market in value accounted to only EUR [0-1 million] in 2014,  and  to
    similar amounts in previous years.

261) The Notifying Party submits that Vincristine is purchased in Norway  exclusively  by  hospitals  through  tenders  held  every  three  years
    (instead of the more common yearly tenders) because of the extremely small amounts involved. Until 2014, Pfizer  […].  Hospira  entered  the
    market in […] and immediately gained significant market share by winning tenders on the basis of a lower price than Pfizer.

262) The Notifying Party submits that it will have no incentives to increase prices post Transaction, as gains would be necessary very  small  in
    monetary terms, while such behaviour would seriously damage its reputation with Norwegian hospitals as a reliable supplier of a  vast  array
    of drugs.

263) The Commission finds no merit in the reputational argument proposed by the Notifying Party. As tenders are organised by molecule, the  price
    of each molecule is set individually. Hospitals rely on competition between bidders to obtain favourable price, while there is  no  evidence
    that reputational factors play a role in the determination of price.

264) The relevant question is therefore whether there will be sufficient competitive pressure from potential entrants in the future to  constrain
    higher pricing by the merged entity. The market investigation indicated that this is indeed the case[120].  First,  the  limited  amount  of
    suppliers for vincristine in Norway is due to the small market size and not to other factors. Vincristine indeed is produced by a number  of
    competitors, including e,g. Stada, Teva and Novartis, which would have no capacity constraint to serve  the  Norwegian  market.  Whether  to
    enter or not the market will be based on economic considerations of its  attractiveness.  Were  the  merged  entity  to  raise  prices  post
    Transaction, it would provide the necessary incentives to new entrants. Second, entry is certainly feasible, as  demonstrated  by  the  fact
    that Hospira gained a large portion of the market within one year of entry. This strategy can be replicated by other companies (for example,
    Stada sells vincristine in neighbouring Denmark, Finland and Sweden). Finally, the market investigation did not  evidence  concerns  on  the
    side of customers for the procurement of vincristine post Transaction.

265) 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, because the proposed concentration  would
    not significantly impede effective competition, in the market for vincristine in Norway.

    2 Pipeline products

    Product market definition

266) The Parties also have overlapping pipeline activities for voriconazole (commercial name Vfend) and linezolid (Zyvox), where  Pfizer  is  the
    originator company and Hospira is developing a generic alternative.[121]

267) Voriconazole is generally used to treat serious, invasive fungal infections in immunocompromised patients. While there is some  substitution
    at the individual level between molecules sharing the same indications, competition primarily takes place at  the  level  of  the  molecule.
    According to the Notifying Party hospitals typically tender or purchase  voriconazole  at  the  molecule  level.  The  Commission  considers
    moreover that the fact that voriconazole is a broad spectrum antifungal agent sets it apart from other more narrow antifungal agents with  a
    narrower spectrum. Therefore the Commission considers that for the purpose of the present assessment the competitive assessment should  take
    place at the molecule level.

268) Linezolid is an antibiotic used for the treatment of serious infections. Although for linezolid there is a number  of  partial  alternatives
    (depending on the exact indication and the patient's reaction to the antibiotic), purchasing typically takes place at  the  molecule  level.
    Moreover for serious infection it is understood that there is a need to maintain the highest number of available product options to  address
    potential resistance. Even if alternatives exist, it was reported that linezolid is a reserve antibiotic that would be purchased separately.
    Linezolid is also much more expensive than other antibiotics used for the same indications. As such linozelid is not a close  substitute  to
    other antibiotics that are used for the same indications. For these reasons the Commission considers that for the  purpose  of  the  present
    assessment the competitive assessment should take place on a molecule level.

    Competitive assessment

269) Generic companies usually develop a number of pipeline generic drugs which are intended to compete with originators which go 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.[122]

1 Linezolid

270)  Pfizer is the originator in this market. It markets linezolid under the brand name Zyvox (or Zyvoxid). According to the Notifying Party  it
    will lose patent protection in the EU in January 2016. Pfizer's Zyvox (linezolid)  is  marketed  in  a  dextrose  formulation  and  an  oral
    formulation. Pfizer […].

271) Hospira is developing a generic equivalent to Zyvox. Hospira has developed two presentations of linezolid: one in dextrose  solution  (which
    matches the Pfizer product), and a second in saline solution.

272) The dextrose and saline formulations are largely substitutable except for the small population of patients (approximately  1%  of  patients)
    with specific conditions that make one or the other preferable (e.g., saline is not preferred for patients with heart condition, or dextrose
    not preferred for a patient with diabetes). The Notifying Party submits that pricing of the two formulations is […].

273) Hospira […] and was expecting to enter the market in […]. An internal document[123] of Hospira shows that […]. Another internal document  of
    Hospira shown that […]. [124]

274) According to the Notifying Party, Hospira is currently exploring the options of […]. Further on, the Parties state that they  are  aware  of
    numerous players that are currently developing generic linezolid with launch in the EU expected around patent expiry. These players  include
    major generic companies such as Teva, Sandoz, Stada and Fresenius, but also many other players  including  Alvogen,  Helm,  Hameln,  Hetero,
    Polpharma, and Synthon. They also submit that Teva, Sandoz and Fresenius have received approval for their generic products in the EU through
    a decentralised procedure.

275) Internal documents of the Parties show that […].[125] Teva has already launched its generic version of linezolid in the US.

276) In any case, the market investigation replies have confirmed that a sufficient number of competitors intend to enter into EEA  markets  with
    a generic version of linezolid, in either an IV form or oral form. Therefore, at least four strong competing pharmaceutical  companies  will
    remain post-merger for linezolid, even more in some countries. The Proposed Transaction will  therefore  not  lead  to  the  removal  of  an
    important competitive constraint on Pfizer. First and foremost because […]. But also, and  more  importantly,  because  a  large  number  of
    equally suitable competitors such as Teva that has its generic version of linezolid already on the market in  the  US,  will  constrain  the
    merged entity.

277) Taking into consideration all of the above, the Commission concludes that the transaction does not give rise to serious  doubts  as  to  its
    compatibility with the internal market, because the proposed concentration would not significantly impede effective competition, in relation
    to linezolid.

2 Voriconazole

278) Pfizer is the originator in this market. It markets voriconazole under the brand name Vfend. According to the Notifying Party,  voriconazole
    will go off patent in the EU in between January and July 2016 (varying by country), but the intravenous (IV) formulations only in June 2018.
    Vfend is available in the EU as tablets, as an oral suspension and as a powder to be made up into a  solution  for  infusion.  Each  of  the
    galenic forms can be used for all approved indications. Choice of formulation is a decision made by the practitioner and generally based  on
    severity of disease and of patient's age (for example oral solution is useful especially for children).

279) Hospira has just developed a generic voriconazole product. It only developed it  as  powder  for  infusion  formulation.  According  to  the
    Notifying Party, on 26 March 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive  opinion,  recommending  the
    granting of a marketing authorisation to Hospira for its medicinal product Voriconazole Hospira. Hospira planned to launch  its  product  in
    […] for the patent free markets only, e.g., CEE.  On 27 May 2015, Hospira was granted  the  marketing  authorisation  valid  throughout  the
    EU.[126]

280) Internal documents from the file have revealed that Hospira intended to […].

281) Pfizer submitted that […].

282) The Transaction will eliminate any such incentive and therefore Pfizer will lose one patent challenger, resulting in a likely delayed  entry
    of generic versions for voriconazole. This is also shown in an internal document showing that […].[127]

283) In addition to that, Pfizer holds a patent as regards the process of making an excipient present in an IV formulation, which will expire  in
    […]. According to the Notifying Party, voriconazole has some complexities given that  the  injectable  formulation  contains  a  specialized
    solubilizer ([…]) for which pharmaceutical grade is not readily available  and  is  expected  to  limit  competition.  Pfizer  sources  this
    excipient ([…]) from […]. Hospira also executed an agreement in […] with […] for a co-exclusive right to obtain  […].  Therefore,  following
    the merger, Pfizer will have exclusive right to an important input for the IV formulation  of  voriconazole,  which  according  to  its  own
    declaration would limit competition.

284) The above elements indicate that Hospira was in a privileged position to successfully enter the EEA markets  for  voriconazole.  The  market
    investigation did not provide indications that other companies took comparable steps to Hospira, in terms of securing of necessary ancillary
    inputs ([…]) that would allow them to exert a similar competitive pressure on Pfizer before or upon loss of  exclusivity  for  voriconazole.
    The Transaction will therefore eliminate Hospira as a uniquely placed new entrant in the EEA markets for voriconazole.

285) Consequently, the Commission concludes that the transaction gives rise to serious doubts as to its compatibility with  the  internal  market
    in relation to voriconazole in the EEA.

3 Conclusion

286) The transaction gives rise to serious doubts as to its compatibility with the internal market in relation to:

        a. with respect to biosimilars, the market for infliximab in the EEA (or wider);

        b. with respect to sterile injectables, the markets for carboplatin in Belgium; cytarabine  in  Belgium,  Italy,  Portugal  and  Sweden;
           epirubicin in Austria, Belgium, Italy, the Netherlands and Spain; irinotecan in Belgium, the Czech Republic and Italy; vancomycin  in
           Ireland and voriconazole in the EEA.

       COMMITMENTS

1 Framework for the assessment of the Commitments

287) Where a concentration raises serious doubts as regards its compatibility with the internal market, the Parties may undertake to  modify  the
    concentration so as to remove the grounds for the serious doubts identified by the Commission.  Pursuant  to  article  6(2)  of  the  Merger
    Regulation, where the Commission finds that, following modification by the undertakings concerned, a notified concentration no longer raises
    serious doubts, it shall declare the concentration compatible with the common market pursuant to article 6(1)(b) of the Merger Regulation.

288) As set out in the Commission’s Remedies Notice,[128] the commitments have to eliminate the competition concerns entirely,  and  have  to  be
    comprehensive and effective from all points of view.[129]

289) In assessing whether commitments will maintain effective competition, the Commission considers all relevant  factors,  including  the  type,
    scale and scope of the proposed commitments, with reference to the structure and particular characteristics  of  the  market  in  which  the
    Transaction is likely to significantly impede effective competition, including the position of the Parties and  other  participants  on  the
    market.[130]

290) In order for the commitments to comply with those principles, they must be capable of being implemented effectively within  a  short  period
    of time. Concerning the form of acceptable commitments, the Merger Regulation gives discretion to the Commission as long as the  commitments
    meet the requisite standard. Structural commitments will meet the conditions set out above only in so far  as  the  Commission  is  able  to
    conclude with the requisite degree of certainty, at the time of its Decision, that it will be possible to implement them and that it will be
    likely that the new commercial structures resulting from them will be sufficiently workable and lasting to ensure that effective competition
    will be maintained.[131] Divestiture commitments are normally the best way to  eliminate  competition  concerns  resulting  from  horizontal
    overlaps.

2 Commitments submitted by the Parties

291) In order to ensure that effective competition will be maintained, the Parties submitted a set of  commitments  under  Article  6(2)  of  the
    Merger Regulation on 13 July 2015 ("Initial Commitments"). The Commission market tested the Initial Commitments in order to  assess  whether
    they are sufficient and suitable to remedy serious doubts identified in the markets for infliximab in the EEA  (or  wider);  carboplatin  in
    Belgium; cytarabine in Belgium, Italy, Portugal and Sweden; epirubicin in Austria, Belgium, Italy, the Netherlands and Spain; irinotecan  in
    Belgium, the Czech Republic and Italy; vancomycin in Ireland and voriconazole in the EEA. Following the feedback received during the  market
    test, the Initial Commitments were refined and improved, and amended commitments were submitted on 28 July 2015 ("Final Commitments"). These
    Final Commitments are annexed to this Decision and form an integral part thereof.

1 Initial Commitments

1 infliximab

292) In order to dispel the serious doubts arising in relation to infliximab, Pfizer submitted commitments consisting of a  full  divestiture  of
    the development, manufacturing and marketing rights of its infliximab pipeline biosimilar (the "Product"), with a reverse carve-out  of  ex-
    EEA marketing rights back to Pfizer (together, the "infliximab Divestment Business").

293) Pfizer notes that the Product is now undergoing a phase III clinical trial, which is conducted […] on a global basis. It further notes  that
    the manufacturing of the Product is outsourced to […] and that the manufacturing process incorporates certain intellectual  property  rights
    of […].

294) The commitments package includes in particular appropriate books and records, marketing plans and forecasts, contracts  with  third  parties
    (such as correspondence with regulators), and personnel in relation to the Product.

295) The personnel provided consists of all Pfizer's employees which provide substantial support to the infliximab Divestment Business and  which
    is necessary to continue to develop, manufacture, have manufactured and market the Product, including the following Key Personnel:

        a. Global infliximab Asset Lead

        b. Global infliximab Medical Affairs Lead

        c. Global infliximab Clinical Lead

        d. Global infliximab Project Manager

        e. Global infliximab Study Clinician

        f. Global infliximab Commercial Lead

        g. Global infliximab Regulatory Lead

296) It further includes patents, copyrights, data and know-how relating exclusively to the clinical development,  manufacture  of  sale  of  the
    Product, as well as a royalty-free, perpetual, irrevocable and sub-licensable license to patents, copyrights, data  and  know-how  necessary
    for the development, manufacturing or sale of the Product in the EEA.

297) This package is subject to the purchaser licensing-back to Pfizer the exclusive (including as to the purchaser)  right  to  conduct  non-EEA
    country specific development activities, as well as to manufacture and market the Product outside the EEA. To preserve  Pfizer's  legitimate
    interests in the Product, it will establish a Joint Development Committee (the "JDC") which would have authority over a  certain  number  of
    key decisions. Such decisions, such as changes or delays in the clinical trial protocol and any clinical trial  matter  that  is  likely  to
    adversely impact the development or future commercialisation of the Product in the Pfizer (ex-EEA) markets, would be decided by unanimity.

298) Finally, the Initial Commitments include a transitional agreement between Pfizer and the Purchaser for a period  of  up  to  […],  including
    clinical development assistance for a period of up to […].

299) In terms of Purchaser requirements, besides the standard requirements, the Initial Commitments provided that the Purchaser be in a  position
    to, in a timely manner, take over the existing agreements or conclude direct agreements on commercially reasonable terms with […],  […]  and
    […], to the extent these relate to the infliximab Divestment Business.

2 Sterile injectables

300) Moreover, in order to dispel the serious doubts identified in relation to sterile injectables, Pfizer submitted  commitments  consisting  of
    the rights, title and interests  of one Party in the relevant molecules in the relevant countries covering all  markets  for  which  serious
    doubts were raised (the “sterile injectables Divestment Businesses”), namely:

        a. Pfizer's rights to carboplatin in Belgium and vancomycin in Ireland;

        b. Hospira's rights to cytarabine in Belgium, Italy, Portugal and Sweden; to epirubicin in Austria, Belgium, Italy, the Netherlands  and
           Spain; to irinotecan in Belgium, the Czech Republic and Italy; and to voriconazole in the EEA.

301) The sterile injectables Divestment Businesses fully remove the overlap in all markets were serious doubts were identified.

302) The Divestment Businesses are structured as asset carve-outs; no legal entities are to be  divested.  Specifically,  the  businesses  to  be
    divested include the following assets:

        a. The existing product inventories, sales and promotional materials at the time of the divestment;

        b. Related contracts, commitments and/or records including but not limited to customers  credit  records,  customer  invoices,  purchase
           orders, tender information and contact for the last three years and including tenders won;

        c. Current and pending marketing authorisations including all relevant dossiers and the information contained in the  full  registration
           dossiers;

        d. Licenses (perpetual, irrevocable, royalty free) for all relevant intellectual property rights, data, books,  records,  and  effective
           arrangements for the transfer of all know-how related to the development and manufacture of the relevant products;

        e. Trademarks relevant to the products and markets concerned;

        f. At the option of the purchaser transitory supply agreements and a transitory distribution agreement designed to ensure  a  continuous
           supply of the Divestment businesses and distribution by the Divestment Businesses.

303) 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.

2 Results of the market test and assessment of the Initial Commitments

304) The market test was launched on 13 July 2015 and sought to assess mainly the scope and  effectiveness  of  the  Initial  Commitments,  their
    viability, the attractiveness of the Divestment Businesses as well as the suitability of the Purchaser criteria.

305) While  generally  the  market  test  yielded  positive  results,  in  particular  regarding  the  scope  and  viability  of  the  Divestment
    Businesses,[132] respondents identified certain shortcomings.

306) In relation to infliximab, specifically, the following key issues were raised:

        a. While the JDC decision-making process and scope of action is deemed to provide a  suitable  purchaser  with  sufficient  ability  and
           incentive to develop the infliximab biosimilar and, if successful, market it in the EEA, respondents from the supply side highlighted
           a risk to delay decisions in the absence of "specific binding timelines on decision making and escalation processes to ensure  timely
           decisions", as well as a risk of Pfizer effectively having full control over the clinical  trial  by  its  ability  of  blocking  key
           decisions.[133]

        b. With respect to the clinical trial, the handover of the clinical trial from Pfizer to the purchaser is considered by respondents from
           the supply side as a potential cause of delay, and therefore an implementation risk.[134]

        c. Finally, respondents from the supply side highlighted that registration of biosimilars is not granted based solely  on  the  clinical
           trial results, but on the totality of the evidence available, with analytical, functional and non-clinical data  being  essential  to
           success. Respondents also submitted that consistent manufacturing is essential, as comparability to the previous process  version  as
           well as similarity to the reference product have to be maintained.[135]

307) As to the suitable Purchaser of the infliximab Divestment Business, respondents to the market test indicated that […].[136]

308) As to the suitable Purchaser of the sterile injectables Divestment Business, respondents to the market test  indicated  that  it  should  be
    already marketing a portfolio of sterile injectables in the relevant EEA countries.[137]

3 Final Commitments

309) The Parties were informed of the shortcomings identified during the market test and submitted a final text  of  Commitments  addressing  the
    issues on 28 July 2015.

310) Specifically, the Final Commitments submitted by the Parties provide in particular for the following  additional  improvements  compared  to
    the Initial Commitments with respect to the infliximab Divestment Business:

        a. the key decisions of the JDC which must be adopted by unanimity must not give Pfizer joint control over the clinical trial  and  over
           the development of the Product exclusively in the EEA;

        b. in order to mitigate the implementation risk in relation to the clinical trial and avoid any delay, until it is  transferred  to  the
           purchaser, any deviation from the clinical trial timeline must be agreed between  the  Purchaser  and  Pfizer,  as  overseen  by  the
           Monitoring Trustee and the Commission; […];

        c. finally, to address the concerns regarding analytical, functional and non-clinical data, Pfizer (or an affiliated  undertaking)  will
           provide     reasonable support to the Purchaser in relation to the market approvals and post-authorisation procedures for the Product
           in the EEA, including, but not limited to, demonstration of bioequivalence to the reference product based on pre-clinical data, for a
           period of up to […].

311) Furthermore, […], the Final Commitments include:

        a. a transitory non-exclusive manufacturing or supply agreement for the infliximab DP for up to […];

        b. at the purchaser's request, the technology transfer of the infliximab DP manufacturing to a facility of the Purchaser’s choice.

312) The Final Commitments also require the Purchaser of the infliximab Divestment Business […].

313) Finally, the Commitments now include specific Purchaser criteria with regards to the sterile injectables Divestment Businesses, […].

314) The full description of the assets and obligations of the Final Commitments is contained in the Schedules thereof.

4 Overall assessment of the Final Commitments

315) The Final Commitments remove the entire overlap between the Parties in relation to the markets  for  which  the  Commission  raised  serious
    doubts: infliximab in the EEA (or wider); carboplatin in Belgium; cytarabine in Belgium, Italy, Portugal and Sweden; epirubicin in  Austria,
    Belgium, Italy, the Netherlands and Spain; irinotecan in Belgium, the Czech Republic and Italy; vancomycin in Ireland  and  voriconazole  in
    the EEA.

316) In particular, in relation to infliximab, the Final Commitments include  the  tangible  and  intangible  assets  necessary  to  conduct  and
    complete the global phase III clinical trial for the Product, and, if successful, obtain a marketing authorisation and bring the product  to
    the EEA markets

317) Furthermore, the Final Commitments address the shortcomings of the Initial Commitments as identified by the market test.

318) The attractiveness of the Divestment Businesses was evidenced by the number of potentially interested purchasers,  including  in  particular
    large players in the area of biosimilars for the infliximab Divestment Business,[138] and sterile  injectables  suppliers  for  the  sterile
    injectables Divestment Businesses.[139]

319) The Notifying Party commits to sell […] Divestment Businesses within […] months from  the  date  of  this  decision.  If  unsuccessful,  the
    Divestiture Trustee will receive a mandate to sell the two Divestment Businesses within the following […].

320) Finally, the Final Commitments envisage the appointment of a Monitoring Trustee to ensure that the Final Committments  will  be  implemented
    effectively and within a short period of time.

 321) On this basis, and in particular in view of a number of interested Purchasers, the Commission  considers  that  the  infliximab  Divestment
      Business and the sterile injectables Divestment Businesses are attractive and likely to be acquired by suitable Purchasers.

 322) For the reasons outlined above, and in view of the results of the market  test  and  the  ensuing  improvements  to  the  Commitments,  the
      Commission considers the Final Commitments to be sufficient in scope and suitable to eliminate the serious doubts as to  the  compatibility
      of the Transaction with the internal market in relation to infliximab in the EEA (or wider); carboplatin in Belgium; cytarabine in Belgium,
      Italy, Portugal and Sweden; epirubicin in Austria, Belgium, Italy, the Netherlands and Spain; irinotecan in Belgium, the Czech Republic and
      Italy; vancomycin in Ireland and voriconazole in the EEA given the purpose of Article 6(2) of the Merger Regulation.

3 Conditions and obligations

323) Under 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 a notified concentration compatible with the internal market.

324) 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 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) 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.

325) In accordance with the distinction described above, the Decision in this case is conditioned on the full compliance  with  the  requirements
    set out in section B (including Schedules 1 to 7) of the Final Commitments (conditions), whereas the other sections of the Final Commitments
    constitute obligations on Pfizer.

326) The detailed text of the Final Commitments is annexed to the present Decision. The full text of the  final  Commitments  forms  an  integral
    part to this Decision.

        CONCLUSION

327) 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 section
    B (including Schedules 1 to 7) 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.7559 – PFIZER / HOSPIRA

                                                      COMMITMENTS TO THE EUROPEAN COMMISSION

Pursuant to Article 6(2) of Council Regulation (EC) No 139/2004 (the "Merger Regulation"),  Pfizer  Inc.  (the  "Notifying  Party"  or  "Pfizer")
hereby enter into the following Commitments (the "Commitments") vis-à-vis the European Commission (the "Commission") with  a  view  to  rendering
the acquisition of Hospira, Inc. ("Hospira") (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").

Section A.  Definitions

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

      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, paragraph 5 (a), (b) and (c) and described more in detail in the Schedules.

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

      Closing Period: the period of 3 months 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, other than, as far as the Infliximab Divestment Business is concerned, such information as is or will be licensed
      to Pfizer pursuant to Schedule 1.

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

      Divestment Businesses: Infliximab  Divestment  Business,  Carboplatin  Divestment  Business,  Cytarabine  Divestment  Business,  Epirubicin
      Divestment Business, Irinotecan Divestment Business, Vancomycin Divestment Business and Voriconazole  Divestment  Business  as  defined  in
      Section B and the Schedules which the Notifying Party commits to  divest  (each  individual  business  is  referred  to  as  a  "Divestment
      Business").

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

      Effective Date: the date of adoption of the Decision.

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

      Hold Separate Manager: the person appointed by the Notifying Party for the Divestment Business to manage the day-to-day business under  the
      supervision of the Monitoring Trustee.  It is understood that separate Hold Separate Managers may be appointed, to the extent  needed,  for
      different Divestment Businesses.

      Hospira: Hospira, Inc. and Affiliated Undertakings.

      Key Personnel: all Key Personnel (if any) listed in the Schedule(s), including the Hold Separate Manager(s).

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

      Parties: Pfizer and Hospira.

      Personnel: all personnel necessary to maintain  the  viability  and  competitiveness  of  the  Divestment  Business  as  described  in  the
      Schedule(s).

      Pfizer: Pfizer Inc. and Affiliated Undertakings.

      Purchaser: the entity 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 18 of these Commitments that the Purchaser must fulfil in order to be  approved  by
      the Commission.

      Schedules: the schedules to these Commitments describing more in detail the Divestment Businesses.

      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, Pfizer commits to divest, or procure the divestiture of, the Divestment Businesses by  the  end
      of the Trustee Divestiture Period as a going concern to one or more Purchasers  and  on  terms  of  sale  approved  by  the  Commission  in
      accordance with the procedure described in paragraph 19 of these Commitments. To carry out the divestiture, Pfizer commits to find  one  or
      more Purchasers and to enter into a final binding sale and purchase agreement for the sale of each of the Divestment Businesses within  the
      First Divestiture Period. If Pfizer has not entered into such an agreement at the end of the First Divestiture Period, Pfizer  shall  grant
      the Divestiture Trustee an exclusive mandate to sell the Divestment Business in accordance with the procedure described in paragraph 31  in
      the Trustee Divestiture Period.

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

        a) by the end of the Trustee Divestiture Period, Pfizer 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 19 for each of the Divestment Businesses;

        b) the Closing of the sale of the Divestment Businesses to the Purchaser takes place within the Closing Period; and

        c) the transfer of the development of the Product and the Clinical Trial have been effected as described in Schedule 1.

   4. In order to maintain the structural effect of the Commitments, Pfizer 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  the  Notifying  Party  showing  good
      cause and accompanied by a report from the Monitoring Trustee (as provided in paragraph 45 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 Businesses consist of the Infliximab Divestment Business, Carboplatin Divestment Business, Cytarabine  Divestment  Business,
      Epirubicin Divestment Business, Irinotecan Divestment Business, Vancomycin Divestment Business and Voriconazole  Divestment  Business.  The
      legal and functional structure of each of the Divestment Business as operated to date is  described  in  the  corresponding  Schedule.  The
      Divestment Businesses, described in more detail in the Schedules, include all assets that  contribute  to  the  current  operation  or  are
      necessary to ensure the viability and competitiveness of each of the Divestment Businesses, in particular:

        a) all tangible and intangible assets (including intellectual property rights);

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

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

        d) the Personnel.

   6. For the avoidance of doubt, the Schedules form an integral part of these Commitments.

   7. In addition, the Divestment Businesses include the benefit, for a transitional period  of  up  to  […]  after  Closing  and  on  terms  and
      conditions equivalent to those at present afforded to each of the Divestment Business, of all current arrangements under  which  Pfizer  or
      its Affiliated Undertakings supply products or services to the Divestment Business, as detailed in the Schedules, unless  otherwise  agreed
      with the Purchaser.

   8. Strict firewall procedures will be adopted so as to ensure that any competitively sensitive information related to, or  arising  from  such
      supply arrangements (for example, product roadmaps) will not be shared with, or passed  on  to,  anyone  other  than  for  the  purpose  of
      implementation of these Commitments.

Section C.  Related commitments

Preservation of viability, marketability and competitiveness

   9. From the Effective Date until Closing, Pfizer 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 Pfizer undertakes:

        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; and

        c) to take all reasonable steps, or procure that all reasonable steps are being taken, including appropriate incentive schemes (based on
           industry practice), to encourage all Key Personnel to remain with the Divestment Business, and not to solicit or move  any  Personnel
           to Pfizer's remaining business. Where, nevertheless, individual members of the  Key  Personnel  exceptionally  leave  the  Divestment
           Business, Pfizer shall provide a reasoned proposal to replace the person or persons concerned to the Commission  and  the  Monitoring
           Trustee. Pfizer must be able to demonstrate to the Commission that the  replacement  is  well  suited  to  carry  out  the  functions
           exercised by those individual members of the Key Personnel. The replacement shall take place under the supervision of the  Monitoring
           Trustee, who shall report to the Commission.

      Hold-separate obligations

  10. Pfizer commits, from the Effective Date until Closing, to the extent reasonably practical, to keep the Divestment  Business  separate  from
      the business(es) it is retaining and to ensure that unless explicitly permitted under these Commitments: (i)  management and staff  of  the
      business(es) retained by Pfizer have no involvement in the Divestment Business; (ii) the Key Personnel  and  Personnel  of  the  Divestment
      Business have no involvement in any business retained by Pfizer and do not report to any individual outside the Divestment Business.

  11. Until Closing, Pfizer shall assist the Monitoring Trustee in ensuring that the Divestment Business is managed as a  distinct  and  saleable
      entity separate from the business(es) which Pfizer is retaining and in accordance with provision 10 above. Immediately after  the  adoption
      of the Decision:

        a) Pfizer shall appoint a specific Hold Separate Manager for the Infliximab Divestment Business, upon consultation with  the  Monitoring
           Trustee and the Commission;

        b) By way of a derogation from the provision  11  above,  for  the  Cytarabine  Divestment  Business,  Epirubicin  Divestment  Business,
           Irinotecan Divestment Business and Voriconazole Divestment Business, Pfizer shall  appoint  one  or  more  Hold  Separate  Manager(s)
           immediately after the closing date of the acquisition of Hospira by Pfizer;

        c) For the avoidance of doubt, a Hold Separate Manager(s) for the Carboplatin Divestment Business and the Vancomycin Divestment Business
           will be appointed by Pfizer immediately after the adoption of the Decision.

  12. The Hold Separate Manager(s), who shall be part of the Key Personnel, shall manage the Divestment Business independently and  in  the  best
      interest of the business with a view to ensuring its continued economic viability, marketability and competitiveness and  its  independence
      from the businesses retained by Pfizer. The Hold Separate Manager shall closely cooperate with, and report to, the Monitoring Trustee  and,
      if applicable, the Divestiture Trustee. Any replacement of the Hold Separate Manager shall  be  subject  to  the  procedure  laid  down  in
      paragraph 9(c) of these Commitments. The Commission may, after having heard Pfizer, require Pfizer to replace the Hold Separate Manager. To
      preserve Pfizer's legitimate interest in the Infliximab Divestment Business post Closing date, Pfizer shall continue to have  authority  to
      decide together with the Hold Separate Manager, under the supervision of the Monitoring Trustee, on the Key Decisions listed in Schedule 1.

Ring-fencing

  13. Pfizer shall implement, or procure to implement, all necessary measures to ensure that it does not, after the Effective  Date,  obtain  any
      Confidential Information relating to the Divestment Business and that any such Confidential  Information  obtained  by  Pfizer  before  the
      Effective Date will be eliminated and not be used by Pfizer. This includes measures vis-à-vis Pfizer's appointees on the supervisory  board
      and/or board of directors of the Divestment Business.  In  particular,  the  participation  of  the  Divestment  Business  in  any  central
      information technology network shall be severed to the extent possible, without compromising the  viability  of  the  Divestment  Business.
      Pfizer may obtain or keep information relating to the Divestment Business  which  is  reasonably  necessary  for  the  divestiture  of  the
      Divestment Business, or the disclosure of which to Pfizer is required by law.

Non-solicitation clause

  14. The Parties undertake, subject to customary limitations, not to solicit, and to procure that Affiliated Undertakings do  not  solicit,  the
      Key Personnel transferred with the Divestment Business for a period of […] after Closing.

Due diligence

  15. In order to enable potential purchasers to carry out a reasonable due diligence of  the  Divestment  Business,  Pfizer  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; and

        b) provide to potential purchasers sufficient information relating to the Personnel and allow them reasonable access to the Personnel.

Reporting

  16. Pfizer 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 working days after the end of every month following
      the Effective Date (or otherwise at the Commission's request). Pfizer 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 working days of their receipt.

  17. Pfizer 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

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

        i) For each of the Divestment Businesses,

   a) The Purchaser shall be independent of, and unconnected to, the Notifying Party and its Affiliated Undertakings (this being assessed  having
      regard to the situation following the divestiture);

   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; and

   c) 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.

       ii) As far as the Infliximab Divestment Business is concerned, the Purchaser, […].

      iii) The Purchaser should, to the extent related to, respectively, the Carboplatin Divestment Business,  Cytarabine  Divestment  Business,
           Epirubicin Divestment Business, Irinotecan Divestment Business and Vancomycin Divestment Business, […].

  19. The final binding sale and purchase agreement (as well as ancillary agreements) relating to  the  divestment  of  each  of  the  Divestment
      Businesses shall be conditional on the Commission's approval. When Pfizer 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. Pfizer must be able to demonstrate to the Commission that the purchaser fulfils the  Purchaser  Criteria  and  that  each  of  the
      Divestment Businesses 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 each of the Divestment Businesses 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 each the Divestment Businesses without one or more Assets or parts of the Personnel, or by substituting one or more
      Assets or parts of the Personnel with one or more different assets or different personnel, 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

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

  21. If Pfizer 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 Pfizer at that time or thereafter, Pfizer shall  appoint
      a Divestiture Trustee. The appointment of the Divestiture Trustee shall take effect  upon  the  commencement  of  the  Trustee  Divestiture
      Period.

  22. The Trustee shall:

      (i)   at the time of appointment, be independent of Pfizer and its 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.

  23. The Trustee shall be remunerated by the Pfizer 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 Pfizer

  24. No later than two weeks after the Effective Date, Pfizer shall submit the name or names of one or more natural or legal persons whom Pfizer
      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, Pfizer shall submit a list of one or more persons whom Pfizer 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 set out in paragraph 22 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; and

   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

  25. 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. The Commission shall approve or reject the proposed  Trustee(s)
      within one week of the proposal by Pfizer. If only one name is approved, Pfizer 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, Pfizer 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 Pfizer

  26. If all the proposed Trustees are rejected, Pfizer 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 20 and 25 of these Commitments.

Trustee nominated by the Commission

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

II.   Functions of the Trustee

  28. 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 Pfizer, 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

  29. 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 Pfizer 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 business retained by the Parties, in accordance with paragraphs 9 and 10 of these Commitments;

   b) supervise the management of the Divestment Business as  a  distinct  and  saleable  entity,  in  accordance  with  paragraph  11  of  these
      Commitments;

   c) with respect to Confidential Information, in consultation with Pfizer and the Hold Separate Manager(s):

    – determine all necessary measures to ensure that Pfizer does not after the Effective Date obtain any Confidential  Information  relating  to
      the Divestment Business, in accordance with paragraph 13 of these Commitments,

    – 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 Pfizer before the Effective Date is  eliminated
      and will not be used by Pfizer, and

    – decide whether such information may be disclosed to or kept by Pfizer as the disclosure is reasonably necessary to allow  Pfizer  to  carry
      out the divestiture or as the disclosure is required by law;

   d) monitor the splitting of assets and the allocation of Personnel between the Divestment Business and Pfizer or Affiliated Undertakings;

      iii) propose to Pfizer such measures as the Monitoring Trustee considers necessary to ensure Pfizer'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  and  the  non-disclosure  of  competitively  sensitive
           information;

       iv) 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 reasonable access to the Personnel.

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

       vi) provide to the Commission, sending Pfizer 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;

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

     viii) within one week after receipt of the documented proposal referred to in paragraph 19 of these Commitments, submit to the  Commission,
           sending Pfizer 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;

       ix) assume the other functions assigned to the Monitoring Trustee under the Schedules; and

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

  30. 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

  31. 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 18 and 19 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 Pfizer, subject to Pfizer's unconditional obligation to  divest  at
      no minimum price in the Trustee Divestiture Period.

  32. 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 Pfizer.

III.  Duties and obligations of the Parties

  33.  Pfizer 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 Pfizer's or  the  Divestment
      Business' books, records, documents, management or other personnel, facilities, sites and technical information  necessary  for  fulfilling
      its duties under the Commitments and Pfizer and the Divestment Business shall provide the Trustee upon request with copies of any document.
      Pfizer 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.

  34. Pfizer 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. Pfizer 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. Pfizer 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.

  35. Pfizer 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, Pfizer shall cause the documents required for effecting the sale and the Closing to be duly executed.

  36. Pfizer 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 Pfizer 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.

  37. At the expense of Pfizer, the Trustee may appoint advisors (in particular for corporate finance  or  legal  advice),  subject  to  Pfizer'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 Pfizer refuse to approve the advisors proposed by the Trustee the Commission may approve the appointment  of
      such advisors instead, after having heard Pfizer. Only the Trustee shall be entitled to issue instructions to the advisors. Paragraph 33 of
      these Commitments shall apply mutatis mutandis. In the Trustee Divestiture Period, the Divestiture Trustee  may  use  advisors  who  served
      Pfizer during the Divestiture Period if the Divestiture Trustee considers this in the best interest of an expedient sale.

  38. Pfizer agrees that the Commission may share Confidential Information proprietary to  Hospira  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.

  39. Pfizer 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.

  40. 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

  41. 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 Pfizer, require Pfizer to replace the Trustee; or

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

  42. If the Trustee is removed according to paragraph 38 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 20-27 of these Commitments.

  43. Unless removed according to paragraph 41 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

  44. The Commission may extend the time periods foreseen in the Commitments in response to a request from Pfizer or, in  appropriate  cases,  on
      its own initiative. Where Pfizer 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
      Pfizer be entitled to request an extension within the last month of any period.

  45. The Commission may further, in response to a reasoned request from Pfizer 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 the Pfizer. 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

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

      ……………………………………
      duly authorised for and on behalf of
      Pfizer Inc.
                                                                    SCHEDULE 1

                                                                    INFLIXIMAB

   1. The Divestment Business as operated to date has the following legal and functional structure:

      (a)   The infliximab biosimilar pipeline product (the "Product") is under development by Pfizer and is now undergoing a  Phase  3  clinical
           trial (the "Clinical Trial");

      (b)   The manufacturing process of the Product incorporates certain intellectual property rights of […]; Pfizer has obtained a license from
           […] to use […] system to manufacture and sell the Product and multiple other products;

      (c)   The manufacturing of the Product was outsourced by Pfizer to […];

      (d)   The Clinical Trial is conducted for Pfizer by […] as a single clinical trial on a global basis;

      (e)   Since the Product is not approved for marketing, there are no sales or marketing teams for the Product  and  there  is  only  limited
           stock of the product;

      (e)   The development of the Product is part of Pfizer's broader biosimilars development program and is currently supported within Pfizer's
           organisation by […].

   2. In accordance with Section B paragraph 5 of these Commitments, the Divestment Business includes, but is not limited to:

      (a)   the following main tangible assets (together with the intangible assets listed below the "Transferred Assets"):

               i)      All relevant Clinical Trial reports
              ii)      Inventories of Product for use in the ongoing Clinical Trial of the Product
             iii)      As far as the EEA regulatory files for the Product are concerned: the current investigator brochure,  the  investigational
                  medicinal product dossier (the IMPD) and the protocol for the Clinical Trial; the Statistical Analysis Plan (SAP); minutes  and
                  correspondence regarding interactions with the EEA regulators regarding the Product, including the scientific advice  from  EEA
                  regulators;
              iv)      As far as the regulatory files outside the EEA for the Products are concerned: an option for the  Purchaser  to  obtain  a
                  transfer of the investigator brochure, the application documents and minutes and correspondence regarding interactions with the
                  non-EEA regulators regarding the Products, including scientific advice from the non-EEA regulators, subject  to  the  Purchaser
                  granting (i) continuing control over all interactions with non-EEA regulators to Pfizer and (ii) an exclusive (including as  to
                  Purchaser), royalty-free, perpetual, irrevocable and sub-licensable license to Pfizer to use the non-EEA regulatory  files  for
                  any regulatory approvals for the Product for any non-EEA markets (it being understood that the Purchaser shall be able  to  use
                  the non-EEA regulatory files for any regulatory approvals for the Product for the EEA markets);
               v)      All relevant books and records relating exclusively  to  the  Product,  save  for  the  books  and  records  which  relate
                  exclusively to the clinical development or manufacture of the Product in or for any non-EEA  markets;  the  books  and  records
                  relating to the Product that also relate to other products developed or to be developed by Pfizer or its affiliates, shall only
                  be transferred to the extent that they relate to the Product, it being understood that the other  sections  shall  be  redacted
                  prior to the transfer to the Purchaser;
              vi)      An option for the Purchaser to obtain a transfer of  the books and  records  which  relate  exclusively  to  the  clinical
                  development or manufacture of the Product in or for any  non-EEA  market,  subject  to  the  Purchaser  granting  an  exclusive
                  (including as to Purchaser), royalty-free, perpetual, irrevocable and sub-licensable license to Pfizer to use the non-EEA books
                  and records to conduct non-EEA country specific development activities, manufacture, have manufactured or market the Product in
                  or for any countries other than the EEA countries (it being understood that the Purchaser shall be  able  to  use  the  non-EEA
                  books and records for EEA country specific development activities, and to manufacture, have manufactured or market the  Product
                  in or for any EEA countries);
             vii) Marketing plans and forecasts which are specific for the Product; the marketing plans and forecasts that also relate  to  other
                  products developed or to be developed by Pfizer or its affiliates, shall only be transferred to the extent that they relate  to
                  the Product, it being understood that the other sections shall be redacted prior to the transfer to the Purchaser;
            viii)  Any other assets identified by the Purchaser and Pfizer in the asset purchase agreement as overseen by the Monitoring Trustee.

       (b)  the following main intangible assets:

               i)      Right to conduct the Clinical Trial and rights to develop the Product globally, subject to an exclusive (including  as  to
                  Purchaser), royalty-free, perpetual, irrevocable and sub-licensable license to  Pfizer  to  conduct  non-EEA  country  specific
                  development activities (it being understood that the Purchaser and Pfizer shall (i) provide mutual support  to  each  other  in
                  relation to the market approvals for the Product in relation to their respective  markets  and  (ii)  exchange  information  in
                  relation to any country specific development activities for the Product which are relevant for the other party's market);
              ii)      Right to manufacture, have manufactured and market the  Product  globally,  subject  to  an  exclusive  (including  as  to
                  Purchaser), royalty-free, perpetual, irrevocable and sub-licensable license to Pfizer to  manufacture,  have  manufactured  and
                  market the Product in or for any countries other than the EEA member states;
             iii)      Sponsorship of any and all current Clinical Trial Authorisations or other regulatory filings for the Product in the EEA;
              iv)      Patents, copyrights, data and know-how existing  as  of  the  Closing  date  and  relating  exclusively  to  the  clinical
                  development, manufacture or sale of the Product (the "In-Scope IP"), as set out in further detail in these Commitments; for the
                  avoidance of doubt, the In-Scope IP does not include any patents, copyrights, data and know-how  that  also  relates  to  other
                  products developed or to be developed by Pfizer or its affiliates;
               v)      A royalty-free, perpetual, irrevocable and sub-licensable license to patents, copyrights, data and know-how existing as of
                  the Closing date necessary for the development, manufacturing or sale of the Product in the EEA other than In-scope IP,  to  be
                  used solely by the Purchaser to perform development activities in relation to the Product and to seek and  maintain  regulatory
                  approval for, manufacture, have manufactured and sell the Product in the EEA and  in  a  manner  which  ensures  that  Pfizer's
                  proprietary rights in relation to these patents, copyrights, data and know-how are adequately  protected  as  overseen  by  the
                  Monitoring Trustee; furthermore, Pfizer will, at the request of the Purchaser, assist the Purchaser in  transferring  technical
                  information and know-how to a manufacturer selected after consultation among  Purchaser,  Pfizer  and  the  Monitoring  Trustee
                  (during which consultation the reasonable comments and concerns of all three parties will be considered and addressed  in  good
                  faith), in a manner which ensures that Pfizer's proprietary rights in relation to the manufacturing Process of the Product  are
                  adequately protected as overseen by the Monitoring Trustee;
              vi)      Subject to having obtained all required regulatory and data protection consents, the Clinical Trial database,  which  will
                  be transferred at a date to be mutually agreed by the Purchaser and Pfizer, as overseen by the Monitoring Trustee.

      (c)   the following main licences, permits and authorisations:

               i)      To the extent that Pfizer has obtained rights to any of the Transferred Assets through a license or other agreement with a
                  third party, Pfizer will assign its rights there under or grant a sublicense there under, as the case may  be,  to  the  extent
                  Pfizer is permitted to do so in accordance with the terms of such license  agreements,  and  if  consent  of  any  third  party
                  licensor is needed, Pfizer will use its best efforts to obtain any required consents;
              ii) All licences, permits and authorisations issued by any governmental organisation for the benefit of  the  Divestment  Business,
                  unless excluded under these Commitments. Since the Product is still in the clinical trial phase, no  permits  or  authorisation
                  have been granted yet in relation to the Product, other than the authorizations with respect to the Clinical Trial referred  to
                  in Section 2(a) above and in the Section 4 below.

      (d)   the following main contracts, agreements, leases, commitments and understandings

           Contracts with third parties existing as of the Closing date to the extent relating exclusively to the clinical  development  of  the
           Product.  If any such contracts cannot be assigned to the Purchaser pursuant to their terms or because  the  scope  of  the  contract
           includes products or services not related to the Product (as is the case for the contract with […], with […] and  with  […]),  Pfizer
           will use its best efforts to assist Purchaser in putting in place  appropriate  alternative  arrangements  with  the  relevant  third
           parties or obtaining consents or waivers from such third parties as appropriate.

      (e)   the following customer, credit and other records:

               i)      Since the Product is still in clinical trial phase, it is not yet being supplied for commercial use to customers;
              ii)      Pfizer will provide the full list of Key Opinion Leaders for the Product on the date of Closing to the Purchaser.

      (f)   the following Personnel:

       All personnel of Pfizer which at the time of Closing provides substantial support to the  Infliximab  Divestment  Business  and  which  is
           necessary to continue to develop, manufacture, have manufactured and market the Product as determined by  the  Purchaser  and  Pfizer
           overseen by the Monitoring Trustee, taking into account (i) the identity of the Purchaser, (ii) the transitional services provided by
           Pfizer to the Purchaser referred to under section 2(h) of this Schedule; and (iii) the rights granted to Pfizer for non-EEA countries
           in accordance with this Schedule. For the avoidance of doubt,  the  Purchaser's  requests  in  relation  to  Personnel  shall  remain
           reasonable at all times.

      (g)   the following Key Personnel:

       Key Personnel are the persons holding the functions below:

           i)    Global Infliximab Asset Lead (US based)
           ii)   Global Infliximab Medical Affairs Lead (US based)
           iii)  Global Infliximab Clinical Lead (US based)
           iv)   Global Infliximab Project Manager (US based)
           v)    Global Infliximab Study Clinician (US based)
           vi)   Global Infliximab Commercial Lead (US based)
           vii)  Global Infliximab Regulatory Lead (US based)

      (h)   the arrangements for the supply with the following products or services by Pfizer or Affiliated Undertakings:

               i)      At the option of the Purchaser, Pfizer (or an affiliated undertaking) will provide:
                    • reasonable clinical development assistance to the Purchaser in connection with the completion of the Clinical Trial, and
                    • reasonable support to the Purchaser in relation to the market approvals and post-authorisation procedures for the  Product
                      in the EEA, including, but not limited to, demonstration of bioequivalence to the reference product based on  pre-clinical
                      data
            such assistance to be provided for up to a period of […] unless an extension has been mutually agreed between Pfizer and  Purchaser,
                  at a reasonable negotiated rate to be agreed with the Purchaser as overseen by the Monitoring Trustee.

              ii)      At the option of the Purchaser, Pfizer shall enter into a transitory non-exclusive manufacturing and/or  supply  agreement
                  for the infliximab drug product (DP) for up to […]. Such transitory arrangement shall include appropriate  provisions  designed
                  to ensure the continued supply by Pfizer to the Purchaser. It shall not contain provisions requiring the delivery of minimum or
                  maximum supply volumes or batches.

             iii)      In addition, at the request of the Purchaser, Pfizer will undertake the technology transfer of infliximab DP manufacturing
                  to a facility of the Purchaser's choice in order to  enable  the  Purchaser  to  manufacture  the  infliximab  DP  or  have  it
                  manufactured at launch of the Product at the latest.

              iv)      The Purchaser will grant to Pfizer an exclusive (including as to  Purchaser),  royalty-free,  perpetual,  irrevocable  and
                  sublicensable license to use the Transferred Assets to perform development activities in relation to the Product  and  to  seek
                  and maintain regulatory approval for, manufacture, have manufactured and sell the Product in or for the non EEA markets.

               v)      Pfizer and the Purchaser may, under the supervision of the Monitoring Trustee and the Commission, enter into the necessary
                  arrangements to ensure that the Infliximab Divestment Business is viable and competitive. […]

   3. Preservation of legitimate rights of Pfizer

        a) The parties will put in place appropriate arrangements so that both parties will have access to the clinical database such  that  any
           data from the Clinical Trial will be readily accessible to both Parties at all times, and both  Parties  will  be  permitted  to  use
           Clinical Trial data to seek, obtain and maintain regulatory approvals for the Product in their  respective  markets  and  to  further
           develop the Product or other products.  The parties will put in place a specific Pharmacovigilance agreement to ensure fulfilment  of
           safety reporting responsibilities.

        b) The Purchaser will assume responsibility and authority for completion of the Clinical Trial in accordance with the existing  clinical
           trial design, protocol, timeline, budget and in accordance with the clinical trial term agreed upon with […].  The  timeline  of  the
           Clinical Trial is attached to this Schedule. Until the Clinical Trial is transferred  to  the  Purchaser,  any  deviation  from  this
           timeline must be agreed between the Purchaser and Pfizer, as overseen by the Monitoring Trustee  and  the  Commission.   The  Parties
           acknowledge that the Clinical Trial design and the protocol have already been approved by the EMA and the FDA.   The  Purchaser  will
           have sole authority to conduct the Clinical Trial, provided Pfizer's legitimate interests in the Product are preserved.  To that end,
           Pfizer and the Purchaser will establish a joint development committee ("JDC"). The JDC would be  made  up  of  three  representatives
           appointed by Purchaser and two representatives appointed by Pfizer.  The Purchaser will be responsible for  the  marketing  approvals
           for the Product for the EEA countries; Pfizer will be responsible for the marketing  approvals  for  the  Product  for  the  non  EEA
           countries.

        c) The JDC shall have authority for "Key Decisions" in relation to the Clinical Trial. The list of Key Decisions will be mutually agreed
           upon between the Purchaser and Pfizer in the asset transfer agreement for the Divestment  Business  as  overseen  by  the  Monitoring
           Trustee so as to preserve Pfizer's legitimate interests in the Product for the non-EEA markets. In particular,  Pfizer  will  have  a
           veto right over all decisions that could negatively affect the development or future commercialisation of the Product in the  non-EEA
           markets including the rights as set forth below provided these rights do not give Pfizer joint control over the  clinical  trial  and
           over the development and marketing of the Product exclusively in the EEA:
              • Orderly completion of the Clinical Trial;
              • Continuity of the Clinical Trial / (early) termination of the Clinical Trial
              • Global consistency of regulatory strategies and adoption of the statistical analysis plan  (after  consultation  with  regulatory
                agencies);
              • Changes to the Clinical Trial protocol;
              • Delays in the Clinical Trial timeline or temporary halt in the Clinical Trial process;
              • Changes to the Clinical Trial budget;
              • Any Clinical Trial matter that is likely to adversely impact the development or future commercialization of the  Product  in  the
                Pfizer markets;
              • Responses to regulatory queries that are likely to negatively impact regulatory submissions outside EEA, including communications
                on any significant safety issue arising in the Clinical Trial;
              • Any other decision mutually agreed upon between the Purchaser and Pfizer in the  asset  transfer  agreement  for  the  Divestment
                Business as overseen by the Monitoring Trustee.

        d) The Key Decisions shall be adopted by unanimity. Pfizer's or the Purchaser's consent should not be unreasonably withheld.

        e) If the JDC cannot reach a unanimous decision on a Key Decision within the time period  to  be  mutually  agreed  by  Pfizer  and  the
           Purchaser before it, the matter will be submitted to a senior executive of the  Purchaser  and  a  senior  executive  of  Pfizer  for
           resolution.  If such senior executives are not able to resolve such matter within the time period to be mutually agreed by Pfizer and
           the Purchaser, the matter shall be referred to the dispute resolution mechanism agreed upon by the Purchaser and Pfizer in the  asset
           transfer agreement for the Divestment Business.

   4. The Divestment Business shall not include:

        a) Any manufacturing facility, physical property (other than the specific Product inventories described above) or equipment;

        b) Any right to manufacture, market or sell any product other than the Product or any license to use any asset of Pfizer  in  connection
           with any product other than the Product;

        c) Any asset that is not a Transferred Asset and any asset that does not relate to the clinical development, manufacture or sale of  the
           Product;

        d) Marketing plans and forecasts for any territories outside the EEA;

        e) Sponsorship of any and all Clinical Trial Authorisations or other regulatory filings for the Product outside the EEA, such as the  US
           IND;

        f) Any trade names or trademarks used or intended to be used by Pfizer in relation to the Product; and

        g) Any cash, accounts receivable or other similar current assets.

   5. If there is any asset or personnel which is not 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 transferred to potential purchasers by transfer or license, as appropriate as overseen the Monitoring Trustee.
                                                       ANNEX 1: TIMELINE OF CLINICAL TRIAL

|Key progress points                                                                              |Date                                 |
|Date Protocol Approved                                                                           |[…]                                  |
|FSFV                                                                                             |[…]                                  |
|First Subject Dosed (Baseline)                                                                   |[…]                                  |
|50% Patients Enrolled                                                                            |[…]                                  |
|LSFV or Enrollment Complete                                                                      |[…]                                  |
|Primary Completion Date (PCD) […]                                                                |[…]                                  |
|Database Release (for PCD)                                                                       |[…]                                  |
|Top Line Report (TLR) Date (for PCD)                                                             |[…]                                  |
|Final Clinical Study Report  (for PCD)                                                           |[…]                                  |
|LSLV […]                                                                                         |[…]                                  |
|Database Lock                                                                                    |[…]                                  |
|Database Release                                                                                 |[…]                                  |
|Top Line Report (TLR) Date                                                                       |[…]                                  |
|Delivery of final TLFs                                                                           |[…]                                  |
|Final Clinical Study Report                                                                      |[…]                                  |
|All Study Documentation to Sponsor                                                               |[…]                                  |
|Overall - Study Completion                                                                       |[…]                                  |

                                                                    SCHEDULE 2

                                                                   CARBOPLATIN

                                                      Product: Pfizer's carboplatin products
                                                                Territory: Belgium

   1. The Divestment Business consists of Pfizer's rights, title and interests in carboplatin in  Belgium  (currently  marketed  under  the  name
      Carboplatinum Pfizer) including the right to develop, manufacture and use carboplatin with a view to its sale and marketing in any form and
      for any indication whatsoever in Belgium. Carboplatin is used to treat various types of cancers, including ovarian cancer, small cell  lung
      cancer, head and neck cancer. For the avoidance of doubt, this Divestment Business does not include any rights to sell carboplatin  outside
      of Belgium.

   2. The Divestment Business includes:

        a) the sale of existing carboplatin product inventory, sales and promotional material in Belgium, at the time of the divestment  and  as
           far as available;

        b) the transfer of all carboplatin-related contracts, commitments and customer contracts and/or records including  but  not  limited  to
           customers credit records, customer invoices, purchase orders, tender information and contact  for  the  last  three  years  preceding
           Closing, whilst only the information related to carboplatin specifically will be provided;

        c) the full transfer of all current and pending marketing authorisations for carboplatin in Belgium 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 Pfizer;

        d) an irrevocable, assignable, sub-licensable, perpetual 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 Belgium, including in particular the information contained in  the
           registration dossier; and

        e) full transfer of all national trademarks of Pfizer specifically related to carboplatin in Belgium (if any) or, in the case of a wider
           than national specific carboplatin trademark, an irrevocable, assignable, sub-licensable, perpetual and royalty free license  to  use
           that trademark for the Divestment Business.

           (items referred to under (a)-(e) 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 carboplatin in Belgium, Pfizer 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 carboplatin in Belgium.

   4. At the option of the Purchaser, Pfizer shall enter into a transitory non-exclusive manufacturing and/or supply agreement  relating  to  the
      existing forms of product in Belgium for up to […]. Such transitory arrangement shall include appropriate provisions designed to ensure the
      continued supply by Pfizer to the Purchaser. To the extent a supply disruption would occur, Pfizer commits to, for as long  as  the  supply
      disruption continues to occur, treat Purchaser equally to other parties (including Pfizer's own businesses) it supplies at  that  time.  It
      shall not contain provisions requiring the delivery of minimum or maximum supply volumes or batches.

   5. At the option of the Purchaser, and to the extent required by law in Belgium or necessary with a view  to  assigning  or  transferring  the
      relevant contracts with the customers in Belgium pertaining to carboplatin  to  the  Purchaser,  Pfizer  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. Pfizer 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 customers.

   6. If Pfizer were to win any tenders pertaining to carboplatin before Closing, Pfizer commits to make  its  best  efforts  to  facilitate  the
      assignment of the relationship or the contract as the case may be with the relevant customers to the Purchaser in line with the  provisions
      contained in this Schedule concerning existing contracts with the relevant customers.

   7. Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship regarding carboplatin in Belgium with API
      supplier […] to the Purchaser in accordance with applicable law. Pfizer commits to make its best efforts to ensure that the  Purchaser  can
      continue the existing relationship with […] with respect to carboplatin.

   8. Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship with […] regarding the finishing, filling
      and packaging of carboplatin in Belgium to the Purchaser in accordance with applicable law. Pfizer commits to  make  its  best  efforts  to
      ensure that the Purchaser can continue the existing relationship with  […]  with  respect  to  the  finishing,  filling  and  packaging  of
      carboplatin.

   9. At the option of the Purchaser, Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship with  […]
      regarding the shipping of carboplatin in Belgium to the Purchaser in accordance with applicable  law.  Pfizer  commits  to  make  its  best
      efforts to ensure that the Purchaser can continue the existing  relationship  with  […]  for  Belgium  with  respect  to  the  shipping  of
      carboplatin to Belgium.

  10. Pfizer 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.

  11. At the option of the Purchaser, Pfizer shall provide reasonable technical assistance to the Purchaser  to  assume  responsibility  for  the
      manufacture, sale and marketing of carboplatin in Belgium for a period of up to […] 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
      Pfizer provides technical assistance to the Purchaser expeditiously.

  12. The Divestment Business shall not include:

        a) Any manufacturing facility;

        b) Raw materials, other than the raw materials in stock used to produce the carboplatin in Belgium;

        c) Any research and development, clinical data and studies or intellectual property relating to carboplatin after Closing;

        d) All marketing authorizations currently held by the Parties outside of Belgium for carboplatin;

        e) Any other asset not part of the Carboplatin Divestment Business or which is used in relation to a business of the Parties other  than
           the Carboplatin Divestment Business;

        f) The "Pfizer" name or the name of any Pfizer subsidiaries;

        g) Monies owed to the Parties by customers for the purchase of carboplatin, and monies owed by the Parties to  suppliers  for  materials
           used in the production of carboplatin.

  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 3

                                                                    CYTARABINE

                                                      Product: Hospira's cytarabine products
                                                  Territory: Belgium, Italy, Portugal and Sweden

   1. The Divestment Business consists of Hospira's rights, title and interests in cytarabine in Belgium, Italy, Portugal and  Sweden  (currently
      marketed under the name Cytosar, Alexan, Aracytin and/or Cytarabine Hospira) including the right to develop, manufacture and use cytarabine
      with a view to its sale and marketing in any form and for any indication whatsoever in Belgium, Italy, Portugal and Sweden. Cytarabine is a
      chemotherapy agent used for the treatment of different types of cancer affecting white blood cells (leukaemia), including acute and chronic
      myelogenous and acute lymphocytic leukaemia. It is also used to treat meningeal leukemia and lymphoma (cancers found in the lining  of  the
      brain and spinal cord). For the avoidance of doubt, this Divestment Business does not include any rights  to  sell  cytarabine  outside  of
      Belgium, Italy, Portugal and Sweden.

  14. The Divestment Business includes:

        a) the sale of existing cytarabine product inventory, sales and promotional material in Belgium, Italy, Portugal and Sweden, at the time
           of the divestment and as far as available;

        b) the transfer of all cytarabine-related contracts, commitments and customer contracts and/or records  including  but  not  limited  to
           customers credit records, customer invoices, purchase orders, tender information  and  contact  details  for  the  last  three  years
           preceding Closing, whilst only the information related to cytarabine specifically will be provided;

        c) the full transfer of all current and pending marketing authorisations for cytarabine in Belgium, Italy, Portugal and Sweden including
           all relevant dossiers, as well as the information contained in the relevant full registration dossier(s) and  all  relevant  clinical
           reports relating to  the  Divestment  Business  existing  prior  to  Closing,  relating  to  the  current  and/or  pending  marketing
           authorisations available to Hospira;

        d) an irrevocable, assignable, sub-licensable, perpetual 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 Belgium, Italy, Portugal and Sweden, including in  particular  the
           information contained in the registration dossier; and

        e) full transfer of all national trademarks of Hospira specifically related to cytarabine in Belgium, Italy,  Portugal  and  Sweden  (if
           any) or, in the case of a wider than national specific cytarabine trademark, an irrevocable,  assignable,  sub-licensable,  perpetual
           and royalty free license to use that trademark for the Divestment Business.

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

  15. 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 cytarabine in Belgium, Italy, Portugal and Sweden, Hospira 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 cytarabine in Belgium, Italy, Portugal and Sweden.

  16. At the option of the Purchaser, Hospira shall enter into a transitory non-exclusive manufacturing and/or supply agreement relating  to  the
      existing forms of product in Belgium, Italy, Portugal and Sweden for up to […].  Such  transitory  arrangement  shall  include  appropriate
      provisions designed to ensure the continued supply by Hospira to the Purchaser. To the extent  a  supply  disruption  would  occur,  Pfizer
      commits to, for as long as the supply disruption continues to occur, treat Purchaser equally  to  other  parties  (including  Pfizer's  own
      businesses) it supplies at that time. It shall not contain provisions requiring the delivery  of  minimum  or  maximum  supply  volumes  or
      batches.

  17. At the option of the Purchaser, and to the extent required by law in Belgium, Italy, Portugal and  Sweden  or  necessary  with  a  view  to
      assigning or transferring the relevant contracts with the customers in Belgium, Italy, Portugal and Sweden pertaining to cytarabine to  the
      Purchaser, Hospira 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. Hospira 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 customers.

  18. If Hospira were to win any tenders pertaining to cytarabine before Closing, Hospira commits to make its  best  efforts  to  facilitate  the
      assignment of the relationship or the contract as the case may be with the relevant customers to the Purchaser in line with the  provisions
      contained in this Schedule concerning existing contracts with the relevant customers.

  19. Hospira will transfer all historical information (orders; price; etc.) concerning its relationship regarding cytarabine in Belgium,  Italy,
      Portugal and Sweden with API supplier […] to the Purchaser in accordance with applicable law. Hospira commits to make its best  efforts  to
      ensure that the Purchaser can continue the existing relationship with […] with respect to cytarabine.

  20. Hospira will transfer all historical information (orders; price; etc.) concerning  its  relationship  with  […]  regarding  the  finishing,
      filling and packaging of cytarabine in Belgium, Italy, Portugal and Sweden to the Purchaser in  accordance  with  applicable  law.  Hospira
      commits to make its best efforts to ensure that the Purchaser can  continue  the  existing  relationship  with  […]  with  respect  to  the
      finishing, filling and packaging of cytarabine.

  21. At the option of the Purchaser, Hospira will transfer all historical information (orders; price; etc.) concerning its relationship  with  a
      distributor ([…] for Belgium (Hospira considers them a customer), […] for Sweden (Hospira considers them a customer), […]  for  Italy,  […]
      and […] for Portugal) regarding the shipping of cytarabine in Belgium, Italy, Portugal and Sweden  to  the  Purchaser  in  accordance  with
      applicable law. Hospira commits to make its best efforts to ensure that the  Purchaser  can  continue  the  existing  relationship  with  a
      distributor ([…]) for Belgium, Italy, Portugal and Sweden with respect to the shipping  of  cytarabine  to  Belgium,  Italy,  Portugal  and
      Sweden.

  22. Hospira 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.

  23. At the option of the Purchaser, Hospira shall provide reasonable technical assistance to the Purchaser to  assume  responsibility  for  the
      manufacture, sale and marketing of cytarabine in Belgium, Italy, Portugal and Sweden for a period of up  to  […]  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 Hospira provides technical assistance to the Purchaser expeditiously.

  24. The Divestment Business shall not include:

        a) Any manufacturing facility;

        b) Raw materials, other than the raw materials in stock used to produce the cytarabine in Belgium, Italy, Portugal and Sweden;

        c) Any research and development, clinical data and studies or intellectual property relating to cytarabine after Closing;

        d) All marketing authorizations currently held by the Parties outside of Belgium, Italy, Portugal and Sweden for cytarabine;

        e) The "Hospira" name or the name of any Hospira subsidiaries;

        f) Monies owed to the Parties by customers for the purchase of cytarabine, and monies owed by the Parties  to  suppliers  for  materials
           used in the production of cytarabine.

  25. 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 4

                                                                    EPIRUBICIN

                                                      Product: Hospira's epirubicin products
                                          Territory: Austria, Belgium, Italy, the Netherlands and Spain

   1. The Divestment Business consists of Hospira's rights, title and interests in epirubicin in Austria, Belgium,  Italy,  the  Netherlands  and
      Spain including the right to develop, manufacture and use epirubicin with a view to its  sale  and  marketing  in  any  form  and  for  any
      indication whatsoever in Austria, Belgium, Italy, the Netherlands and Spain. Epirubicin is used for the  treatment  of  breast  cancer  and
      other types of cancer including ovarian cancer, stomach cancer, lung cancer, bowel cancer and myeloma.  It is also used to treat some types
      of lymphoma and leukaemia. For the avoidance of doubt, this Divestment Business does not include any rights to sell epirubicin  outside  of
      Austria, Belgium, Italy, the Netherlands and Spain.

  26. The Divestment Business includes:

        a) the sale of existing epirubicin product inventory, sales and promotional material in Austria, Belgium,  Italy,  the  Netherlands  and
           Spain, at the time of the divestment and as far as available;

        b) the transfer of all epirubicin-related contracts, commitments and customer contracts and/or records  including  but  not  limited  to
           customers credit records, customer invoices, purchase orders, tender information and contact  for  the  last  three  years  preceding
           Closing, whilst only the information related to epirubicin specifically will be provided;

        c) the full transfer of all current and pending marketing authorisations for epirubicin in Austria, Belgium, Italy, the Netherlands  and
           Spain 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 Hospira;

        d) an irrevocable, assignable, sub-licensable, perpetual 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 Austria, Belgium, Italy, the Netherlands and Spain,  including  in
           particular the information contained in the registration dossier; and

        e) full transfer of all national trademarks of Hospira specifically related to epirubicin in Austria, Belgium,  Italy,  the  Netherlands
           and Spain (if any) or, in the case of a  wider  than  national  specific  epirubicin  trademark,  an  irrevocable,  assignable,  sub-
           licensable, perpetual and royalty free license to use that trademark for the Divestment Business.

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

  27. 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 epirubicin in Austria, Belgium, Italy, the Netherlands and Spain, Hospira  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 epirubicin in Austria, Belgium, Italy, the Netherlands and Spain.

  28. At the option of the Purchaser, Hospira shall enter into a transitory non-exclusive manufacturing and/or supply agreement relating  to  the
      existing forms of product in Austria, Belgium, Italy, the Netherlands and Spain for up to […]. Such transitory  arrangement  shall  include
      appropriate provisions designed to ensure the continued supply by Hospira to the Purchaser. To the extent a supply disruption would  occur,
      Pfizer commits to, for as long as the supply disruption continues to occur, treat Purchaser equally to other  parties  (including  Pfizer's
      own businesses) it supplies at that time. It shall not contain provisions requiring the delivery of minimum or maximum  supply  volumes  or
      batches.

  29. At the option of the Purchaser, and to the extent required by law in Austria, Belgium, Italy, the Netherlands and Spain or necessary with a
      view to assigning or transferring the relevant contracts with  the  customers  in  Austria,  Belgium,  Italy,  the  Netherlands  and  Spain
      pertaining to epirubicin to the Purchaser, Hospira 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. Hospira 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 customers.

  30. If Hospira were to win any tenders pertaining to epirubicin before Closing, Hospira commits to make its  best  efforts  to  facilitate  the
      assignment of the relationship or the contract as the case may be with the relevant customers to the Purchaser in line with the  provisions
      contained in this Schedule concerning existing contracts with the relevant customers.

  31. Hospira will transfer all historical information (orders; price;  etc.)  concerning  its  relationship  regarding  epirubicin  in  Austria,
      Belgium, Italy, the Netherlands and Spain with API supplier […] to the Purchaser in accordance with applicable law. Pfizer commits to  make
      its best efforts to ensure that the Purchaser can continue the existing relationship with […] with respect to epirubicin.

  32. Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship with […] regarding the finishing, filling
      and packaging of epirubicin in Austria, Belgium, Italy, the Netherlands and Spain to the  Purchaser  in  accordance  with  applicable  law.
      Pfizer commits to make its best efforts to ensure that the Purchaser can continue the existing relationship with […] with  respect  to  the
      finishing, filling and packaging of epirubicin.

  33. At the option of the Purchaser, Pfizer will transfer all historical information (orders; price; etc.) concerning its  relationship  with  a
      distributor ([…] for Austria ([…]) and Belgium ([…]), […] for Spain ([…]) and Netherlands) regarding the shipping of epirubicin in Austria,
      Belgium, Italy, the Netherlands and Spain to the Purchaser in accordance with applicable law. Pfizer commits to make its  best  efforts  to
      ensure that the Purchaser can continue the existing relationship with the distributors mentioned above for  Austria,  Belgium,  Italy,  the
      Netherlands and Spain with respect to the shipping of epirubicin to Austria, Belgium, Italy, the Netherlands and Spain.

  34. Hospira commits to use its best efforts to assist the Purchaser with obtaining the consent, waiver or alternative arrangements, as the case
      may, be in connection with the replacement of Hospira with the Purchaser for the purposes of the joint venture agreement  with  […]  as  of
      Closing to the extent such agreement sees upon the manufacture of epirubicin products for Austria,  Belgium,  Italy,  the  Netherlands  and
      Spain.

  35. Pfizer commits to use 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.

  36. At the option of the Purchaser, Pfizer shall provide reasonable technical assistance to the Purchaser  to  assume  responsibility  for  the
      manufacture, sale and marketing of epirubicin in Austria, Belgium, Italy, the Netherlands and Spain for a period of up to […] 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 Pfizer provides technical assistance to the Purchaser expeditiously.

  37. The Divestment Business shall not include:

        a) Any manufacturing facility;

        b) Raw materials, other than the raw materials in stock used to produce the epirubicin in Austria, Belgium, Italy, the  Netherlands  and
           Spain;

        c) Any research and development, clinical data and studies or intellectual property relating to epirubicin after Closing;

        d) All marketing authorizations currently held by the Parties outside  of  Austria,  Belgium,  Italy,  the  Netherlands  and  Spain  for
           epirubicin;

        e) The "Hospira" name or the name of any Hospira subsidiaries;

        f) Monies owed to the Parties by customers for the purchase of epirubicin, and monies owed by the Parties  to  suppliers  for  materials
           used in the production of epirubicin.

  38. 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 5

                                                                    IRINOTECAN

                                                      Product: Hospira's irinotecan products
                                                 Territory: Belgium, the Czech Republic and Italy

   1. The Divestment Business consists of Hospira's rights, title and interests in irinotecan in Belgium, the Czech Republic and Italy  including
      the right to develop, manufacture and use irinotecan with a view to its sale and marketing in any form and for any indication whatsoever in
      Belgium, the Czech Republic and Italy. Irinotecan is used primarily  for  the  treatment  of  colorectal  cancer  and,  in  particular,  in
      combination with other chemotherapy agents. For the avoidance of doubt, this Divestment Business  does  not  include  any  rights  to  sell
      irinotecan outside of Belgium, the Czech Republic and Italy.

  39. The Divestment Business includes:

        a) the sale of existing irinotecan product inventory, sales and promotional material in Belgium, the Czech Republic and  Italy,  at  the
           time of the divestment and as far as available;

        b) the transfer of all irinotecan-related contracts, commitments and customer contracts and/or records  including  but  not  limited  to
           customers credit records, customer invoices, purchase orders, tender information  and  contact  details  for  the  last  three  years
           preceding Closing, whilst only the information related to irinotecan specifically will be provided;

        c) the full transfer of all current and pending marketing authorisations for  irinotecan  in  Belgium,  the  Czech  Republic  and  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 Hospira;

        d) an irrevocable, assignable, sub-licensable, perpetual 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 Belgium, the Czech Republic and Italy, including in particular the
           information contained in the registration dossier; and

        e) full transfer of all national trademarks of Hospira specifically related to epirubicin in Belgium, the Czech Republic and  Italy  (if
           any) or, in the case of a wider than national specific irinotecan trademark, an irrevocable,  assignable,  sub-licensable,  perpetual
           and royalty free license to use that trademark for the Divestment Business.

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

  40. 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 irinotecan in Belgium, the Czech Republic and Italy, Hospira 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 irinotecan in Belgium, the Czech Republic and Italy.

  41. At the option of the Purchaser, Hospira shall enter into a transitory non-exclusive manufacturing and/or supply agreement relating  to  the
      existing forms of product in Belgium, the Czech Republic and Italy for up to […]. Such transitory  arrangement  shall  include  appropriate
      provisions designed to ensure the continued supply by Hospira to the Purchaser. To the extent  a  supply  disruption  would  occur,  Pfizer
      commits to, for as long as the supply disruption continues to occur, treat Purchaser equally  to  other  parties  (including  Pfizer's  own
      businesses) it supplies at that time. It shall not contain provisions requiring the delivery  of  minimum  or  maximum  supply  volumes  or
      batches.

  42. At the option of the Purchaser, and to the extent required by law in Belgium, the Czech Republic and Italy or  necessary  with  a  view  to
      assigning or transferring the relevant contracts with the customers in Belgium, the Czech Republic and Italy pertaining  to  irinotecan  to
      the Purchaser, Hospira 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. Hospira 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 customers.

  43. If Hospira were to win any tenders pertaining to irinotecan before Closing, Hospira commits to make its  best  efforts  to  facilitate  the
      assignment of the relationship or the contract as the case may be with the relevant customers to the Purchaser in line with the  provisions
      contained in this Schedule concerning existing contracts with the relevant customers.

  44. Hospira will transfer all historical information (orders; price; etc.) concerning its relationship regarding  irinotecan  in  Belgium,  the
      Czech Republic and Italy with API supplier […] to the Purchaser in accordance with applicable law. Hospira commits to make its best efforts
      to ensure that the Purchaser can continue the existing relationship with […] with respect to irinotecan.

  45. Hospira will transfer all historical information (orders; price; etc.) concerning  its  relationship  with  […]  regarding  the  finishing,
      filling and packaging of irinotecan in Belgium, the Czech Republic and Italy to the Purchaser in accordance with  applicable  law.  Hospira
      commits to make its best efforts to ensure that the Purchaser can  continue  the  existing  relationship  with  […]  with  respect  to  the
      finishing, filling and packaging of irinotecan.

  46. At the option of the Purchaser, Hospira will transfer all historical information (orders; price; etc.) concerning its relationship with […]
      for Belgium (Hospira considers them a customer), […] for the Czech Republic and […] for Italy  regarding  the  shipping  of  irinotecan  in
      Belgium, the Czech Republic and Italy to the Purchaser in accordance with applicable law. Hospira commits  to  make  its  best  efforts  to
      ensure that the Purchaser can continue the existing relationship with […] for Belgium, […] for the Czech Republic and […]  for  Italy  with
      respect to the shipping of irinotecan to Belgium, the Czech Republic and Italy.

  47. Hospira commits to use its best efforts to assist the Purchaser with obtaining the consent, waiver or alternative arrangements, as the case
      may, be in connection with the replacement of Hospira with the Purchaser for the purposes of the joint venture agreement  with  […]  as  of
      Closing to the extent such agreement sees upon the manufacture of irinotecan products for Belgium, the Czech Republic and Italy.

  48. Hospira 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.

  49. At the option of the Purchaser, Hospira shall provide reasonable technical assistance to the Purchaser to  assume  responsibility  for  the
      manufacture, sale and marketing of irinotecan in Belgium, the Czech Republic and Italy for a period of up to […]  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 Hospira provides technical assistance to the Purchaser expeditiously.

  50. The Purchaser will be given an option (to be exercised within one year after signing the relevant Transfer Agreement) to request Hospira  –
      whose acceptance thereof would not be unreasonably withheld – to make  available  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.

  51. The Divestment Business shall not include:

        a) Any manufacturing facility;

        b) Raw materials, other than the raw materials in stock used to produce the irinotecan in Belgium, the Czech Republic and Italy;

        c) Any research and development, clinical data and studies or intellectual property relating to irinotecan after Closing;

        d) All marketing authorizations currently held by the Parties outside of Belgium, the Czech Republic and Italy for irinotecan;

        e) The "Hospira" name or the name of any Hospira subsidiaries;

        f) Monies owed to the Parties by customers for the purchase of irinotecan, and monies owed by the Parties  to  suppliers  for  materials
           used in the production of irinotecan.

    52. 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 6

                                                                    VANCOMYCIN

                                                      Product: Pfizer's vancomycin products
                                                                Territory: Ireland

   1. The Divestment Business consists of Pfizer's rights, title and  interests  in  vancomycin  in  Ireland  including  the  right  to  develop,
      manufacture and use vancomycin with a view to its sale and marketing in any form and for any indication whatsoever in  Ireland.  Vancomycin
      is used to treat various types of cancers, including ovarian cancer, small cell lung cancer, head and neck cancer.  For  the  avoidance  of
      doubt, this Divestment Business does not include any rights to sell vancomycin outside of Ireland.

  53. The Divestment Business includes:

        a) the sale of existing vancomycin product inventory, sales and promotional material in Ireland, at the time of the  divestment  and  as
           far as available;

        b) the transfer of all vancomycin-related contracts, commitments and customer contracts and/or records  including  but  not  limited  to
           customers credit records, customer invoices, purchase orders, tender information  and  contact  details  for  the  last  three  years
           preceding Closing, whilst only the information related to vancomycin specifically will be provided;

        c) the full transfer of all current and pending marketing authorisations for vancomycin 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 Pfizer;

        d) an irrevocable, assignable, sub-licensable, perpetual 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 Ireland, including in particular the information contained in  the
           registration dossier; and

        e) full transfer of all national trademarks of Hospira specifically related to vancomycin in Ireland (if any) or, in the case of a wider
           than national specific vancomycin trademark, an irrevocable, assignable, sub-licensable, perpetual and royalty free  license  to  use
           that trademark for the Divestment Business.

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

  54. 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 vancomycin in Ireland, Pfizer 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 vancomycin in Ireland.

  55. At the option of the Purchaser, Pfizer shall enter into a transitory non-exclusive manufacturing and/or supply agreement  relating  to  the
      existing forms of product in Ireland for up to […]. Such transitory arrangement shall include appropriate provisions designed to ensure the
      continued supply by Pfizer to the Purchaser. To the extent a supply disruption would occur, Pfizer commits to, for as long  as  the  supply
      disruption continues to occur, treat Purchaser equally to other parties (including Pfizer's own businesses) it supplies at  that  time.  It
      shall not contain provisions requiring the delivery of minimum or maximum supply volumes or batches.

  56. At the option of the Purchaser, and to the extent required by law in Ireland or necessary with a view  to  assigning  or  transferring  the
      relevant contracts with the customers in Ireland pertaining to  vancomycin  to  the  Purchaser,  Pfizer  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. Pfizer 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 customers.

  57. If Pfizer were to win any tenders pertaining to vancomycin before Closing, Pfizer commits to  make  its  best  efforts  to  facilitate  the
      assignment of the relationship or the contract as the case may be with the relevant customers to the Purchaser in line with the  provisions
      contained in this Schedule concerning existing contracts with the relevant customers.

  58. Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship regarding vancomycin in Ireland with  API
      supplier […] to the Purchaser in accordance with applicable law. Pfizer commits to make its best efforts to ensure that the  Purchaser  can
      continue the existing relationship with […] with respect to vancomycin.

  59. Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship with […] regarding the finishing, filling
      and packaging of vancomycin in Ireland to the Purchaser in accordance with applicable law. Pfizer commits  to  make  its  best  efforts  to
      ensure that the Purchaser can continue the existing relationship with  […]  with  respect  to  the  finishing,  filling  and  packaging  of
      vancomycin.

  60. At the option of the Purchaser, Pfizer will transfer all historical information (orders; price; etc.) concerning its relationship with  […]
      regarding the shipping of vancomycin in Ireland to the Purchaser in accordance with applicable law. Pfizer commits to make its best efforts
      to ensure that the Purchaser can continue the existing relationship with […] for Ireland with respect to  the  shipping  of  vancomycin  to
      Ireland.

  61. Pfizer commits to use 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.

  62. At the option of the Purchaser, Pfizer shall provide reasonable technical assistance to the Purchaser  to  assume  responsibility  for  the
      manufacture, sale and marketing of vancomycin in Ireland for a period of up to […] 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
      Pfizer provides technical assistance to the Purchaser expeditiously.

  63. The Divestment Business shall not include:

        a) Any manufacturing facility;

        b) Raw materials, other than the raw materials in stock used to produce the vancomycin in Ireland;

        c) Any research and development, clinical data and studies or intellectual property relating to vancomycin after Closing;

        d) All marketing authorizations currently held by the Parties outside of Ireland for vancomycin;

        e) The "Pfizer" name or the name of any Pfizer subsidiaries;

        f) Monies owed to the Parties by customers for the purchase of vancomycin, and monies owed by the Parties  to  suppliers  for  materials
           used in the production of vancomycin.

      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 7

                                                                   VORICONAZOLE

                                                     Product: Hospira's voriconazole products
                                                                  Territory: EEA

   1. The Divestment Business consists of Hospira's rights, title and interests in generic voriconazole  in  the  EEA  (currently  not  marketed)
      including the right to develop, manufacture and use voriconazole with a view to its sale and marketing in any form and for  any  indication
      whatsoever in the EEA. Voriconazole a triazole antifungal medication that is generally used to treat serious, invasive  fungal  infections.
      Pfizer holds the originator product (Vfend), which is close to losing patent protection as it will go off patent in the EEA in  2016.   For
      the avoidance of doubt, this Divestment Business does not include any rights to sell voriconazole outside of the EEA.

  64. The Divestment Business includes:

   a) the sale of existing voriconazole product inventory, sales and promotional material in the EEA, at the time of the divestment and as far as
      available;

   b) the transfer of all voriconazole-related contracts, commitments and  customer  contracts  and/or  records  including  but  not  limited  to
      customers credit records, customer invoices, purchase orders, tender information and contact details for the  last  three  years  preceding
      Closing, whilst only the information related to voriconazole specifically will be provided, provided that the Parties may redact from  such
      copies any information that does not relate to the Divestment Business;

   c) the full transfer of all current and pending marketing authorisations for voriconazole in the EEA including all relevant dossiers, as  well
      as the information contained in the relevant full registration dossier(s) and all relevant clinical  reports  relating  to  the  Divestment
      Business existing prior to Closing, relating to the current and/or pending marketing authorisations available to Hospira;

   d) an irrevocable, assignable, sub-licensable, perpetual 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 EEA, including in  particular  the  information  contained  in  the  registration
      dossier;

   e) full transfer of all assets related to a patent litigation concerning voriconazole in any EEA Member State,  including  plans,  strategies,
      and filings (if any);

   f) full transfer of all trademarks of Hospira related to voriconazole in the EEA (if any).

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

  66. 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 voriconazole in the EEA, Hospira 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 voriconazole in the EEA.

  67. At the option of the Purchaser, Hospira shall enter into a transitory non-exclusive manufacturing and/or supply agreement relating  to  the
      existing forms of product in the EEA for up to […]. Such transitory arrangement shall include appropriate provisions designed to ensure the
      continued supply by Hospira to the Purchaser. To the extent a supply disruption would occur, Pfizer commits to, for as long as  the  supply
      disruption continues to occur, treat Purchaser equally to other parties (including Pfizer's own businesses) it supplies at  that  time.  It
      shall not contain provisions requiring the delivery of minimum or maximum supply volumes or batches.

  68. At the option of the Purchaser, and to the extent required by law in the EEA member states  or  necessary  with  a  view  to  assigning  or
      transferring the relevant contracts with the customers in EEA pertaining to voriconazole to  the  Purchaser,  Hospira  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.  Hospira  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 customers.

  69. If Hospira were to win any tenders pertaining to voriconazole before Closing, Hospira commits to make its best efforts  to  facilitate  the
      assignment of the relationship or the contract as the case may be with the relevant customers to the Purchaser in line with the  provisions
      contained in this Schedule concerning existing contracts with the relevant customers.

  70. Hospira will transfer all historical information (orders; price; etc.) concerning its relationship regarding voriconazole in the  EEA  with
      the contract manufacturer […] to the Purchaser in accordance with applicable law. Hospira commits to make its best efforts to  ensure  that
      the Purchaser can continue the existing relationship with […] with respect to voriconazole.

  71. Hospira will transfer all historical information (orders; price; etc.) concerning its relationship regarding […] in the  EEA  with  […]  in
      accordance with applicable law. Pfizer commits to make its best efforts to ensure that the Purchaser can continue the existing relationship
      with […] with respect to voriconazole.

  72. Hospira 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.

  73. At the option of the Purchaser, Hospira shall provide reasonable technical assistance to the Purchaser to  assume  responsibility  for  the
      manufacture, sale and marketing of voriconazole in the EEA for a  period  of  up  to  […]  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 Hospira provides technical assistance to the Purchaser expeditiously.

  74. The Divestment Business shall not include:

   a) Any manufacturing facility;

   a) Raw materials, other than the raw materials in stock used to produce voriconazole in the EEA;

   b) Any research and development, clinical data and studies or intellectual property relating to voriconazole after Closing;

   c) All marketing authorizations currently held by the Parties outside of the EEA;

   d) The "Hospira" name or the name of any Hospira subsidiaries;

   e) Monies owed to the Parties by customers for the purchase of voriconazole, and monies owed by the Parties to suppliers for materials used in
      the production of voriconazole.

  75. 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.

-----------------------
[1]   OJ L 24, 29.1.2004, p. 1 (the "Merger Regulation"). With effect from 1 December 2009, the Treaty on the Functioning of the  European  Union
("TFEU") has introduced certain changes, such as the replacement of 'Community'  by  'Union'  and  'common  market'  by  'internal  market'.  The
terminology of the TFEU will be used throughout this decision.
[2]   OJ L 1, 3.1.1994, p.3 ("the EEA Agreement").
[3]   Turnover calculated in accordance with Article 5 of the Merger Regulation and the Commission Consolidated Jurisdictional  Notice  (OJ  C95,
      16.04.2008, p1).
[4]   Monoclonal antibodies are used for the treatment of  various  cancers  (e.g.  breast  cancer)  and  autoimmune  diseases  (e.g.  rheumatoid
arthritis). mAbs developed for oncology differ from more conventional chemotherapy compounds as they target a unique and  specific  component  of
the disease mechanism or of the tumour cell.
[5]   See cases M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings, M.5778 – Novartis/Alcon, and M.5865 – Teva/Ratiopharm.
[6]   See cases M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings, M.5865 – Teva/Ratiopharm and M.5295 – Teva/Barr.
[7]   See cases M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings, M.6705 – Procter &  Gamble/Teva  Pharmaceuticals  OTC  II,
M.6613 – Watson/Actavis, and M.5865 –Teva/Ratiopharm.
[8]   See cases M.5865 – Teva / Ratiopharm and M.5479 – Lonza / Teva / JV.
[9]   The marketing authorisation holder in the EU is Janssen Biologics B.V (company controlled by Johnson & Johnson).

[10]  See replies to question 10 of questionnaire Q2 – Biosimilars Customers.
[11]  See replies to question 11 of questionnaire Q2 – Biosimilars Customers.
[12]  See replies to question 13 of questionnaire Q3 – Biosimilars Physicians and Key Opinion Leaders.
[13]  See non-confidential minutes of a conference call with a competitor, 2 June 2015.
[14]  See replies to question 13 of questionnaire Q1 – Biosimilars Competitors.
[15]  Remicade was awarded […] infliximab tenders analysed, typically alongside Inflectra  or  Remsima.  Source:  tender  data  provided  by  the
Parties.
[16]  See e.g. cases M.7379 – Mylan / Abbott EPD-DM, M.7276 – GlaxoSmithKline / Novartis Vaccines Business (excl. Influenza) / Novartis  Consumer
Health Business, M.7275 – Novartis / GlaxoSmithKline Oncology Business and M.5253 – Sanofi-Aventis/Zentiva.
[17]  See e.g. cases M.7480 – Actavis / Allergan and M.7275 – Novartis / GlaxoSmithKline Oncology Business.
[18]  The Final Report of the Commission's Pharmaceutical Sector  Inquiry  presents  econometric  analysis  showing  the  effectiveness  of  such
regulations in facilitating faster generic entry upon loss of exclusivity, fostering generic penetration and delivering lower prices.  See  Annex
to Chapter B, Part II, of the Final Report of the Pharmaceutical Sector Inquiry adopted on 8 July 2009.

[19]  For instance, specific EMA guidance documents exist for the manufacture, characterisation and  control  of  the  drug  substance  regarding
monoclonal antibodies, immunotherapy medicinal products for  the  treatment  of  cancer,  biological  active  substances  produced  by  transgene
expression in animals, etc.
[20]  See non-confidential minutes of a conference call with the EMA, 28 April 2015.
[21]  See replies to question 22 of questionnaire Q2 – Biosimilars Customers.
[22]  See replies to question 23 of questionnaire Q2 – Biosimilars Customers.
[23]  See replies to question 25 of questionnaire Q2 – Biosimilars Customers and replies to question 13 of questionnaire Q3 – Physicians and  Key
Opinion Leaders.
[24]  See non-confidential minutes of a conference call with a competitor, 2 June 2015.
[25]  See non-confidential minutes of a conference call with a Key Opinion Leader, 28 May 2015.
[26]  See non-confidential minutes of a conference call with a customer, 28 May 2015.
[27]  Inflectra and Remsima were co-awarded only […] infliximab tenders analysed. Source: tender data provided by the Parties.
[28]  See in particular Pfizer's internal documents, […].
[29]  See replies to question 8 of questionnaire Q3 – Biosimilars Physicians and Key Opinion Leaders.
[30]  See replies to question 17 of questionnaire Q1 – Biosimilars Competitors, question 29 of  questionnaire  Q2  –  Biosimilars  Customers  and
question 8 of questionnaire Q3 – Biosimilars Physicians and Key Opinion Leaders.
[31]  See replies to question 31 of questionnaire Q2 – Biosimilars Customers.
[32]  See Pfizer's internal document, […].
[33]  See non-confidential minutes of a conference call with Celltrion, 13 May 2015.
[34]  See replies to question 29 of questionnaire Q2 – Biosimilars Customers.
[35]    See    http://www.prnewswire.com/news-releases/samsung-bioepis-submits-marketing-authorization-application-for-sb2-a-remicade-infliximab-
biosimilar-candidate-to-the-european-medicines-agency-300048841.html
[36]  See Pfizer's internal document, […].
[37]  See Pfizer's internal document, […].
[38]  See replies to question 4 of questionnaire Q1 – Biosimilars Competitors.
[39]  See replies to question 2 of questionnaire Q1 – Biosimilars Competitors.
[40]  It is noted that India is not an ICH  member.  ICH  is  the  International  Conference  on  Harmonisation  of  Technical  Requirements  for
Registration of Pharmaceuticals for Human Use, which includes the regulatory authorities of Europe, Japan and the United States.
[41]  See email of the EMA to the case team, 10 July 2015.
[42]  See replies to question 4 of questionnaire Q1 – Biosimilars Competitors.
[43]  See Pfizer's internal document, […].
[44]  See non-confidential minutes of a conference call with the EMA, 28 April 2015.
[45]  Appendix II to Pfizer's Memorandum on Infliximab, 7 July 2015.
[46]  […].
[47]  See replies to question 20 of questionnaire Q1 – Biosimilars Competitors.
[48]  See replies to question 22 of questionnaire Q2 – Biosimilars Customers and question 22 of questionnaire Q2  –  Biosimilars  Physicians  and
Key Opinion Leaders.
[49]  See replies to question 4 of questionnaire Q1 – Biosimilars Competitors.
[50]  See Pfizer's internal document, […].
[51]  Mabion appears to be focusing on Easter Europe. […].
[52]  See Pfizer's internal document, […].
[53]  See replies to question 4 of questionnaire Q1 – Biosimilars Competitors.
[54]  See Pfizer's internal document, […].
[55]  See Pfizer's internal document, […].
[56]  See replies to question 9 of questionnaire Q4 – Sterile injectables Competitors,
[57]  See replies to question 11 of questionnaire Q4 – Sterile injectables Competitors,
[58]  See replies to question 10 of questionnaire Q4 – Sterile injectables Competitors,
[59]  See replies to question 16 of questionnaire Q5- Sterile injectables Customers,.
[60]  See replies to question 18 of questionnaire Q5- Sterile injectables Customers, and to question 5 of questionnaire Q4-  Sterile  injectables
Competitors.,.
[61]  See replies to question 10 of questionnaire Q5- Sterile injectables Customers. .
[62]  See replies to question 9 of questionnaire Q5 – Sterile injectables Customers,.
[63]  See replies to question 7 of questionnaire -Q5 – Sterile injectables Customers.,.
[64]  See for example cases M.5778 – Novartis/Alcon, M.5865 – Teva/Ratiopharm, and M.5253 – Sanofi-Aventis/Zentiva.
[65]  See for example cases M.5778 – Novartis/Alcon, M.5865 – Teva/Ratiopharm, and M.5253 – Sanofi-Aventis/Zentiva.
[66]  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.
[67]   See  for  example  cases  M.6969  –  Valeant  Pharmaceuticals  International/Bausch&Lomb  Holdings,  M.5778  –  Novartis/Alcon,  M.5865  –
Teva/Ratiopharm and M.5295 – Teva/Barr.
[68]  Finished dose pharmaceuticals are essentially pharmaceutical products in the form in which they are marketed for use,  typically  involving
a mixture of active drug components and nondrug components (excipients), along with other  non-reusable  material  that  may  not  be  considered
either ingredient or packaging (such as a capsule shell, for example). All products in the present case concern finished dose pharmaceuticals.
[69]  See case M.5476 – Pfizer/Wyeth; M.4691 – Schering Plough/Organon Biosciences; M.2922 – Pfizer/Pharmacia,; and M.1681 – Akzo Nobel/Hoechst.
[70]  See case M.5295 –  Teva/Barr.
[71]  See case M.5865 – Teva/Ratiopharm.
[72]  Market shares may not add up to 100% because of rounding of the percentages.
[73]  The Notifying Party estimates that [above 70]% of purchases were based on contract bilaterial negociation and  only  the  remaining  [below
30]% on tender.
[74]  See replies to question 22 of questionnaire Q4- Sterile injectables Competitors..
[75]        See replies to question 15 of questionnaire Q4- Sterile injectables Competitors.
[76]  See replies to questions 16 and 20 of questionnaire Q4- Sterile injectables Competitors.
[77]  Bristol-Myers SQB was also mentioned to be present, although in 2012 only in which year it achieved insignificant sales.
[78]  See replies to question 16 of questionnaire Q4- Sterile injectables Competitors.
[79]  See replies to question 23 of questionnaire Q4- Sterile injectables Competitors.
[80]  See replies to question 20, 21, 22 and 24 of questionnaire 5 Sterile injectables Customers.
[81]  Guidelines on the assessment of the horizontal mergers under the Council Regulation on the control of concentrations between  undertakings,
2004/C31/03), para.17.
[82]  The Notifying Party submits that in 2014 […] tenders were organized and Parties estimate a further increase to […] tenders.
[83]  Guidelines on the assessment of the horizontal mergers under the Council Regulation on the control of concentrations between  undertakings,
2004/C31/03), para.32.
[84]  See replies to question 16 of questionnaire Q4 – Sterile injectables Competitors.
[85]  See cases M.5295 – Teva/Barr and M.5865 – Teva/Ratiopharm.
[86]  Under a wider product market definition the market shares would not qualify for a Group 1 market.
[87]  The fluctuations in market shares reflect the fact that Finland is a true tendering market  where  market  shares  of  only  one  year  may
overstate the actual market power.
[88]  […].
[89]  Guidelines on the assessment of the horizontal mergers under the Council Regulation on the control of concentrations between  undertakings,
2004/C31/03), para. 32.

[90]  See case M.2922 – Pfizer / Pharmacia.
[91]  Guidelines on the assessment of the horizontal mergers under the Council Regulation on the control of concentrations between  undertakings,
2004/C31/03), para.17.
[92]  Guidelines on the assessment of the horizontal mergers under the Council Regulation on the control of concentrations between  undertakings,
2004/C31/03), para.32.
[93]  The Notifying Party submits that Pfizer currently only offers a lyophilised (dry powder) presentation, which is much  more  expensive  than
the solution presentation, offered by its competitors.
[94]  See replies to question 42 of questionnaire Q4 – Sterile injectables Competitors.
[95]  See replies to question 51 of questionnaire Q4 – Sterile injectables Competitors.
[96]  "Lab unknown" refers to the molecule used/"manufactured" directly by the hospitals in the NHS.
[97]  Annexes to the Form CO RFI-I 3.1 – […].
[98]  Guidelines on the assessment of the horizontal mergers under the Council Regulation on the control of concentrations between  undertakings,
2004/C31/03), para. 17.

[99]  See replies to question 20, 21, 22 and 24 of questionnaire 5 Sterile injectables Customers.

[100]       See case M.5555 – Novartis / Ebewe.
[101]       See replies to question 63 of questionnaire Q4 – Sterile Injectable Competitors.
[102]       See replies to question 18 of questionnaire Q5 – Sterile Injectable Customers.
[103]       See replies to questions 54 and 59 of questionnaire Q4- Sterile injectables Competitors.
[104]       See replies to question 20, 21, 22 and 24 of questionnaire 5 Sterile injectables Customers.
[105]       See Hospira's internal documents, […].
[106]       See case M.5295 – Teva/Barr.
[107]       Moreover the Notifying Party argues that Hospira does not have the 20ml dosage in its portfolio.
[108]       See in particular replies to question 20, 21, 22 and 24 of questionnaire Q5 – Sterile injectables Customers (Norway).
[109]       Guidelines on the assessment of the horizontal mergers under  the  Council  Regulation  on  the  control  of  concentrations  between
undertakings, 2004/C31/03), para. 32.
[110]       See case M.3354 – Sanofi-Synthelabo/Aventis.
[111]       See replies to question 89 of questionnaire Q4 – Sterile Injectable Competitors.
[112]       See replies to question 18 of questionnaire Q5 – Sterile Injectable Customers.
[113]       See replies to questions 54 and 59 of questionnaire Q4 – Sterile injectables Competitors.
[114]       See replies to question 20, 21, 22 and 24 of questionnaire Q5 – Sterile injectables Customers.
[115]       See Pfizer's internal documents, […].
[116]       See Pfizer's internal document […].
[117]       See replies to question 116 of questionnaire Q4 – Sterile injectables Competitors.
[118]       See case M.5476 – Pfizer/Wyeth.
[119]       See replies to questions 119 and 124 of questionnaire Q4 – Sterile injectables Competitors.
[120]       See in particular replies to question 20, 21, 22 and 24 of questionnaire Q5 – Sterile injectables Customers (Norway).
[121]            There are other […] products that both Parties have in their pipeline: […]. While Hospira is already developing a  new  product,
Pfizer is still in the concept phase. […] these […] overlaps will not be further analysed.
[122]       See cases M.6258 – Teva/Cephalon and M.6613 – Watson/Actavis.
[123]       See Hospira's internal document – […].
[124]       See Hospira's internal document, […].
[125]       See Hospira's internal document, […].
[126] See: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003737/human_med_001866.jsp&mid=WC0b01ac058001d124
[127]       See Hospira's internal document […].
[128]       Commission Notice on remedies acceptable under Council Regulation (EC) No 139/2004 and under Commission Regulation (EC)  No  802/2004
(OJ C 267, 22.10.2008, p. 1-27).
[129]       Remedies Notice, paragraphs 9 and 61.
[130]       Remedies Notice, paragraph 12.
[131]       Remedies Notice, paragraph 10.
[132]       See replies to questions 3, 5, 25 and 26 of questionnaire R1  –  Market  Test  of  the  Commitments  –  Competitors,  question  1  of
questionnaire R2 – Market Test of the Commitments – Customers biosimilars and questions 1 and  2  of  questionnaire  R2  –  Market  Test  of  the
Commitments – Customers sterile injectables.
[133]       See replies to question 12 of questionnaire R1 – Market Test of the Commitments – Competitors.
[134]       See replies to questions 19-22 of questionnaire R1 – Market Test of the Commitments – Competitors.
[135]       See replies to question 6 of questionnaire R1 – Market Test of the Commitments – Competitors.
[136]       […].
[137]       See replies to questions 28 and 29 of questionnaire R1 – Market  Test  of  the  Commitments  –  Competitors,  and  questions  4-8  of
questionnaire R3 – Market Test of the Commitments – Customers sterile injectables.
[138]       See replies to question 15 of questionnaire R1 – Market Test of the Commitments – Competitors.
[139]       See replies to question 27 of questionnaire R1 – Market Test of the Commitments – Competitors.

-----------------------
 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