Commission européenne, DG COMP MERGER REGISTRY, 1049 Bruxelles, BELGIQUE  
Europese Commissie, DG COMP MERGER REGISTRY, 1049 Brussel,  BELGIË  
 
Tel: +32 229 -91111. Fax: +32 229 -64301. E -mail: COMP -MERGER -REGISTRY@ec.europa.eu .  EUROPEAN COMMISSION  
Brussels, 15.10.2020  
C(2020 ) 7163 final  
PUBLIC VERSION  
 
To the notifying party  
Subject : Case M. 9962  – MYLAN / ASPEN’S EU THROMBOSIS BUSINESS  
Commission decision pursuant to Article 6(1)(b) of Council Regulation 
No 139/20041 and Article 57 of the Agreement on the European Economic 
Area2 
Dear Sir or Madam,  
(1) On 17 September 2020 , the European Commission received notification of a 
concentration pursuant to Article 4 of the Merger Regulation which  would resu lt 
from a proposed transaction by which  Mylan N.V.  (“Mylan”, Netherlan ds), through 
its subsidiary  Mylan Ireland Limited (Ireland)  intends to acquire  sole control within 
the meaning of Article 3(1)(b) of the Merger Regulation of the whole of Aspen’s EU 
Thro mbosis Business  (“Aspen’s Target Business” , Mauritius ), a subset  of Aspen 
Global Incorporated (“AGI” , Mauritius ), owned and indirectly controlled by Aspen 
Pharmacare Holdings Limited  (“Aspen” , Mauritius ) by way o f purchase of assets  
(‘the Transaction’)3. Mylan is designated hereinafter as the “Notifying Party” and 
together with Aspen’s Target Business , as the “Parties ” to the Transaction . The 
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the “Merger Regulation ”). With effect from 1 December 2009,  the Treaty on the 
Functioning of the European Union ( “TFEU ”) has introduced certain changes, such as the replacement of  
“Community ” by “Union ” and “common market ” by “internal market ”. The terminology of the TFEU will 
be used throughout this decision.  
2  OJ L 1, 3.1.1994, p . 3 (the “EEA Agreement”).  
3  Publication in the Official Journal of the European Union No C 317, 25.9.2020 , p. 24. 
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information omitted has been replaced by 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.  
 
 
2 undertaking that would resu lt from the Transaction is referred to as the ‘merged 
entity ’. 
1. THE PARTIES  
(2) Mylan is a global pharmaceutical company that develops, licenses, manufactures, 
markets and distributes generic, branded generic and specialty pharmaceuticals  
through a vertically integrated global supply chain that includes over 40 
manufacturing facilities. Its port folio includes more than 1 500 products.  
(3) Aspen’s Target Business consists of certain intellectual property, assets and rights 
relating to the unincorporated business of manufacture, distribution and marketing of 
four AGI antithrombotic products in the EEA , namely Nadroparin (brand names 
Fraxiparine and Fraxodi), Fondaparinux (brand name Arixtra), Certoparin (brand 
name Mono Embolex) and Danaparoid (brand name Orgaran). These assets 
constitute a business with market presence to which a turnover can be clear ly 
attributed.4 
2. THE OPERATION  AND THE CONCENTRATION  
(4) Pursuant to an asset purchase agreement dated 7 September 2020, between Mylan 
Ireland Limited  and AGI, Mylan agreed to acquire sole control of all assets of  
Aspen’s Target Business and each right attached  to these5.  
(5) As a result of this Transaction, Mylan will obtain sole control over Aspen’s Target 
Business  within the meaning of Article 3(1)(b) of the Merger Regulation.  
3. UNION  DIMENSION  
(6) The Parties  have a combined aggregate worldwide  turnover of more than  EUR 5 000 
million6 (Mylan EUR 10 156 million, Aspen’s Target Business EUR […] million) . 
Each of them has a Union-wide turnover in excess of EUR 250 million  (Mylan EUR 
[…] million, Aspen’s Target Business EUR […] million) , but they do not achieve 
more than  two-thirds of their aggregate Union-wide turnover within one and the 
same Member State. The notified operation therefore has a U nion dimension  
pursuant to Article 1(2) of the Merger Regulation.  
                                                 
4  See Commission  Consolidated Jurisdictional Notice under Council Regulation (EC) No 139/2004 on the  
control of concentrations between unde rtaking s, OJ C95 of 16.04.2008 , in particular p. 24  
5  Including the (i) de-commercialized products (See Form CO  footnotes 2 and 4), (ii) Pending Registration 
Products ( See Form CO footnote 5) and (ii) Orgaran New Business Opportunity products ( See Form CO, 
footnote 6) , which may be transferred to Mylan at a later date . All of these products have been included  in 
the substantive assessment of the concentration  by the Notifying Party.  
6  Turnover calculated in accordance with Article 5 of the Merg er Regulation . 
 
 
3 4. MARKET DEFINITIONS  
4.1. Fixed Dose Pharmaceuticals  
(7) Mylan and Aspen ’s Target Business  produce and sell Fixed Dose Pharmaceuticals 
(“FDPs”). FDPs are pharmaceutical products that have undergone all stages of 
production, including packaging in the final container and labelling. Production and 
sale of FDPs is one of the most  common activity of pharmaceutical companies.   
(8) As regards the product market, the Commission found in a past decision ,7 that 
antithrombotic FDPs falling into ATC4 classes B1B1 (heparin) and B1B2  
(antithrombin III) , along with those falling into ATC3 class B1X (other 
antithrombotic agents) that have the same applications as heparins, belong to the 
same product market as they have the same mode of action (injectable) and range of 
indications. In a subsequent case,8 the Commission did not specify whether  the 
market should be defined as if each of the above ATC4 classes constitute a different 
market, or if ATC3 class B1B  (of which classes B1B1 and B1B2 are part) also 
constitutes a market in itself.   
(9) The Notifying Party provides market shares for all of tho se possible product market 
definitions, including plausible affected markets at molecule level , namely a subset 
of generic products at ATC4 level that are based on the same molecule .  
(10) In any event, for the purposes of this Decision, it is not necessary to conclude on the 
exact product market definition for antithrombotic FDPs , that is (i) whether classes 
B1B1 and B1B2 are each a separate product marke t or if together they constitute a 
product market (under class B1B) , and (ii) whether class B1X is a separat e market or 
it should be considered together with class B1B,  as the Transaction does not give 
rise to serious doubts  as to its compatibility with the internal market or the 
functioning of the EEA agreement  under any of those  plausible market definitions .  
(11) As regards the geographic market, i n line with numerous  Commission precedents9, 
the relevant market for a ntithrombotic FDPs is national . 
4.2. Contract manufacturing organisation (“CMO”)  
(12) CMO is an arrangement under which a  manufacturer provides upstream 
manufac turing services of FDPs under contract on behalf of third party 
pharmaceutical companies.  
(13) As regards the product market definition, a number of contract manufacturing 
markets may be defined, corresponding in each case to the pharmaceutical form  of 
the spe cific product that  is manufactured . In some cases , contract -manufacturing 
markets can be further subdivided by  the conditions in which the manufactur ing 
                                                 
7  Case M. 3354 - Sanofi -Synthelabo/Aventis (2004).  
8  Case M.5253 - Sanofi -Aventis/Zentiva (2009).  
9  Case M.5295 - Teva/Barr (2008), Case M.5479 - Teva/Lonza (2009), Case M.5530 - Glaxo Smith 
Kline/Stiefel Laboratories (2009), Case M.6162 - Pfizer/Ferrosan Consumer Healthcare Business (2011).  
 
 
4 process takes place  (types of active pharmaceutical ingredient (“ API”) involved in 
the process, toxicit y, sterile environment, etc.).10  
(14) In past decisions ,11 the Commission left open whether the CMO market should be 
defined as an overall market, or whether it could be further segmented into four 
product markets,  namely  contract manufacturing of : (i) solid dose and powder 
pharmaceuticals;  (ii) liquids and semi -solid pharmaceuticals; (iii) sterile liquid 
pharmaceuticals;  and (iv) medicated confectionary  pharmaceuticals.   
(15) For the purpose of the assessment of the Transaction,  the relevant segment of the 
upstrea m CMO product market is the one of s terile  liquid pharmaceuti cals, as 
Aspen’s Target Business produ ces downstream injectable FDPs.  In any event, for 
the purpose of this Decision,  the precise product market definition of CMO  can be 
left open as, regardless of the market definition considered  (an overall market for 
CMO, or a market for CMO services for sterile liquid pharmaceuticals ), the 
Transaction does not give rise to serious doubt s as to i ts compatibility with the 
internal market and the functioning of t he EEA Agreement.  
(16) With regard to the geographic market, i n line with past decisions  of the 
Commission12, the precise market definition  for CMO services can be considered to 
be worldwide , or at least EEA -wide . No further elaboration is necessary, since the 
transaction does not give rise to serious doubts  under either of the above possible 
geographic market definitions.  
5. COMPETITIVE ASSESSMEN T 
5.1. Analytical Framework  
(17) Under Articles 2(2) and 2(3) of the Merger Regulation, the Commission must assess 
whether a proposed concentration would significantly impede effective competition 
in the internal market or in a substantial part of it, in particular through the creation 
or strengthening of a dominant position.  
(18) Frequently, a merger can entail horizontal effects. I n this respect, in addition to the 
creation or strengthening of a dominant position, the Commission Guidelines on the 
assessment of horizontal mergers under the Merger Regulation (“the Hor izontal 
Merger Guidelines”)13 distinguish between two main ways in wh ich mergers 
between actual or potential competitors on the same relevant market may 
significantly impede ef fective competition, namely (a) by eliminating important 
competitive constraints on one or more firms, which consequently would have 
increased market  power,  without resorting to coordinated behaviour (non -
coordinated effects); and (b) by changing the nature of competition in such a way 
that firms that previously were not coordinating their behaviour are now 
significantly more likely to coordinate and r aise prices or otherwise harm effective 
                                                 
10  Case M.6613 - Watson/Actavis (2012)  
11  Case M.5953 - Reckitt Benc kister/SSL (2010), paragraphs 59 and 62 , and Case M.7480 - Actavis/Allergan 
(2015).  
12  Cases M.5953 - Reckitt Benckiser/SSL (2010) and Case M.6613 - Watson/Actavis (2012).  
13  Guidelines on the assessment of horizontal mergers under the Council Regulation on the control of 
concentrations between undertakings, OJ C 31, 5.2.2004 p.5  
 
 
5 competition. A merger may also make coordination easier, more stable or more 
effective for firms which were coordinating prior to the merger (coordinated effects).   
(19) Furthermore, a  merger can entail vertical effects. The Commission Guidelines on the 
assessment of non -horizontal mergers under the Merger Regulation (“the non -
horizontal Merger Guidelines”)14 also distinguish between two main ways in which 
non-horizontal mergers may significantly impede effective competitio n: (a) when 
they give rise to input and/or customer foreclosure (non -coordinated effects); and (b) 
when the merger changes the nature of competition in such a way that firms that 
previously were not coordinating their behaviour, are now more likely to coor dinate 
to raise prices or otherwise harm effective competition (coordinated effects). The 
non-horizontal Merger Guidelines distinguish two types of foreclosure: (a) where the 
merger is likely to raise the costs of downstream rivals by restricting their acc ess to 
an impo rtant input (input foreclosure)  and (b) where the merger is likely to foreclose 
upstream rivals by restricting their access to a sufficient customer base (customer 
foreclosure).  
5.2. Competitive assessment  
5.2.1.  Horizontal Overlap in the market for ant ithrombotic FDPs.  
(20) According to the Notifying Party’s submission, t he Parties’ activities hori zontally 
overlap in the FDP market for antithrombotic products  only in F rance. The 
combined market shares of the Parties post-Transaction would be  [10-20]% at most  
under every possible market definition,15 with very low increment , [0-5]% at most .  
(21) In view of the low combined market shares and very limited overlap , the 
Commission concludes that the Transaction  does not raise serious doubts as to its 
compatibility with  the internal market  or the functioning of the EEA agreement , as 
regards  this horizontal overlap  in the market for antithrombotic FDPs .  
5.2.2.  Vertical Relationship between Contract Manufacturing Organisation (upstream) and 
the sale and production of FDPs (downs tream)  
(22) In the present case, Mylan’s upstream participation in CMO for FDPs in markets 
where the Target is present downstream with market shares exceeding 30% in 
several national markets, gives rise to vertically affected markets.16 
(23) The Notifying Party agree s to the market definitions drawn from the Commission’s 
precedence and provides Mylan’s total market share and its market share per 
segment in the worldwide and EEA -wide market. Mylan’s upstream market shares in 
the CMO market are [0-5]% at most  (see table  1). 
                                                 
14  Guidelines on the assessment of non -horizontal mergers under the Council Regulation on the control of 
concentrations between undertakings, OJ C256, 18.1.2008, p.6.  
15  For complet eness, the Parties consider alternative market definitions for FDPs for antithrombotic 
products, based on both the third (ATC3) and the fourth (ATC4) levels of classification. The Parties also 
provide overall market shares of ATC3 classes B1B and B1X toget her. In addition to the above, the 
Parties also consider plausible affected markets at molecule level namely a subset of generic products at 
ATC4 level that are based on the same molecule.   
16  For completeness, the target does not include any CMO contracts or infrastructure.  

 
 
7 Table 2 Market shares of Aspen’s Target Business ’ downstream (only if above 30%, 
“-” means no prese nce or below 30%)  
 
 B1B (B1B1 + 
B1B2)  B1B2  B1X B1B + 
B1X 
Austria  -  -  [50-60]%  -  
Bulgaria  [70-80]%  [80-90]%  [90-100]%  [70-80]%  
Belgium  - - [90-100]%  - 
Croatia  - - [90-100]%  - 
Chechia [40-50]%  [50-60]%  [90-100]%  [40-50]%  
Estonia  - - [90-100]%  - 
Finland  - - [90-100]%  - 
France  - - [90-100]%  - 
Germany  - - [90-100]%  - 
Greece  - - [90-100]%  - 
Italy - - [90-100] %  - 
Latvia  [40-50]%  [40-50]%  [90-100]%  [40-50]%  
Lithuania  [70-80]%  [70-80]%  [90-100]%  [70-80]%  
Netherlands  [40-50]%  [40-50]%  [90-100]%  [40-50]%  
Norway  - - [90-100]%  - 
Poland  - - [70-80]%  - 
Portugal  - - [90-100]%  - 
Romania  [40-50]%  [40-50]%   [90-100]%  [50-60]%  
Slovakia  [60-70]%  [70-80]%  [90-100]%  [60-70]%  
Slovenia  [40-50]%  [40-50]%  [90-100]%  [40-50]%  
Spain  - - [90-100]%  - 
UK - - [90-100]%  - 
 
(26) Notwithstanding the high market shares in national markets downstream , customer 
foreclosure can be excluded , for the following reasons :  
(27) Firstly, Aspen’s T arget Business ’ CMO needs for antithrombotic FDPs pre-
Transaction are covered in -house by Aspen .17 Therefore, even if post -Transaction  
the merged entity were to source all of its CMO needs for antithrombotic FDPs  
internally, there  would be no change to the pre -Transaction situation and no rival 
CMO supplier would be affected .  
(28) Second ly, Aspen’s Target Business’  high market shares in some countries for some 
injectable FDPs would in any event not give the merged entity sufficient market  
power  to harm rival upstream  CMO providers . This is  because CMO providers  offer 
the same services for all sterile liquid pharmaceuticals, and  do not differentiate if 
their downstream customers manufacture  specific  injectable FDPs  such as 
antithrombotic injectables . The potential oppo rtunity for the CMO services linked to 
Aspen’s Target Business  needs for antithrombotic FDPs is only a fraction of around 
[0-5]% of the market for CMO services for sterile liquid pharmaceuticals  in the 
EEA.18 
                                                 
17  See Form CO, paragraph 8 8 and footnote 74.  
18  See Form CO, paragraph 87.  
 
 
8 (29) Consequently , this limited potential demand for CMO services for sterile liquid 
pharmaceuticals would in any event  not allow the merged entity to foreclose 
Mylan’ s rival CMO providers upstream, from accessing downstream markets for 
injectable FDPs by withholding or reducing Aspen’s Target Business  purch ases 
(which are only limited to antithrombotic injectable FDPs).  
(30) Thirdly, according to information provided by the Notifying Party, CMO services do 
not represent a substantial part of the total final costs of injectable antithrombotic 
FDPs (below [0-5]% on  average).19 
(31) Finally, the Notifying Party submits that in past Decisions20 the Commission has 
used as a reference to assess the foreclosure risk, the combined downstream market 
share of the merged entity and any of its downstream competitors for which the 
merged entity potentially provides CMO services in order to evaluate the potential 
harm of similar vertical relationships.  
(32) On this basis, the only country in which Mylan provides CMO services to any of 
Aspen’s Target Business ’ downstream competitors is the U.K. More specifically, 
Mylan provides CMO services for the molecule heparin (B1B1) to [company name ], 
through a  production  site in [country ].21 The combined market share of the Target 
and [company name ] under any possible market definition is below [5-10]%.22 
Consequently , the aggregated market shares of the two competitors do not raise 
competitive concerns as a result of customer foreclosure.  
(33) Therefore , the merged entity cannot foreclose its upstream competitors in the 
provision of CMO services by denying access to the downstream market for 
antithrombotic FDPs . 
(34) In light of the above , the Commission concludes that the Transaction does not raise 
serious doubts as to its compatibility with the internal market  or the functioning of 
the EEA Agreement  with regard to  the vertical link between the upstream CMO 
market the downstream market for FDP antithrombotic  product s.  
                                                 
19  See e -mail of 25/09/2020 . 
20  For instance, see: Case M.5253 - Sanofi-Aventis/Zentiva (2009) , Case M.5661 - Abbott/Solvay 
Pharmaceuticals (2010), Case  M.6278 - Takeda/Nycomed (2011) and Case M.6613 - Watson/Actavis 
(2012 ). 
21  Additionally, the Notifying Party submits that [information concerning Mylan’s CMO activities ]. See 
Form CO, footnote 6 1. 
22  See Form CO, paragraph 80.  
 
 
9 6. CONCLUSION  
(35) For the above reasons, the European Commission has decided not to oppose the 
notified operation and to declare it compatible  with the internal  market and with the 
EEA Agreement. This decision is adopted in application of Article 6(1)(b) of the 
Merger Regulation and Article 57 of the EEA Agreement .  
For the Commission  
 
 
(Signed)  
Margrethe VESTAGER  
Executive Vice-President