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TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - SC 13D (Activist Investment)

SecurityTGXSF / Tigenix Sa
Form TypeSC 13D
File Date2018-01-12

Document List

TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - SC 13D (Activist Investment)
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.1
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.2
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.3
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.4
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.5
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.6
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.7
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.8
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.9
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.10
TGXSF / Tigenix Sa / TAKEDA PHARMACEUTICAL CO LTD - EX-99.11
SC 13D

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

SCHEDULE 13D

Under the Securities Exchange Act of 1934

(Amendment No.     )*

 

 

TiGenix

(Name of Issuer)

Ordinary shares, no nominal value (“Shares”)

American Depositary Shares (“ADSs”), each representing 20 Shares

(Title of Class of Securities)

ISIN BE0003864817 (Shares)

CUSIP 88675R109 (ADSs)

(CUSIP Number)

James Kehoe

Takeda Pharmaceutical Company Limited

12-10, Nihonbashi 2-Chome, Chuo-ku, Tokyo 103-8668

Tel: +81 3 3278-2111

(Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications)

With a copy to:

Gregory W. Hayes

Sanjay Shirodkar

DLA Piper LLP (US)

444 West Lake Street, Suite 900

Chicago, Illinois 60606

United States

(312) 368-4000

January 4, 2018

(Date of Event Which Requires Filing of this Statement)

 

 

If the filing person has previously filed a statement on Schedule 13G to report the acquisition which is the subject of this Schedule 13D, and is filing this schedule because of Rule 13d-1(e), 13d-1(f) or 13d-1(g) check the following box:  ☐

 

 

Note: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See Rule 13d-7 for other parties to whom copies are to be sent.

 

 

* The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page.

The information required on the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

 

 

 


SCHEDULE 13D

ISIN BE0003864817 (Shares)

CUSIP 88675R109 (ADSs)

 

 

  1   

NAME OF REPORTING PERSON:

 

Takeda Pharmaceutical Company Limited

  2  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP*

(a)  ☐        (b)  ☐

 

  3  

SEC USE ONLY

 

  4  

SOURCE OF FUNDS

 

OO (See Item 3)

  5  

CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)  ☐

 

  6  

CITIZENSHIP OR PLACE OF ORGANIZATION

 

Japan

NUMBER OF

SHARES

BENEFICIALLY

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

SOLE VOTING POWER

 

-0-

     8   

SHARED VOTING POWER

 

56,336,422

     9   

SOLE DISPOSITIVE POWER

 

-0-

   10   

SHARED DISPOSITIVE POWER

 

56,336,422

11  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

56,336,422

12  

CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES  ☐

 

13  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)*

 

20.2% (See Item 5)

14  

TYPE OF REPORTING PERSON

 

CO


* Beneficial ownership of the ordinary shares, no nominal value (“Shares”) of TiGenix (“TiGenix”), is being reported hereunder solely because Takeda Pharmaceutical Company Limited (“Takeda”) may be deemed to have beneficial ownership of 44,684,644 Shares by virtue of the Irrevocable Undertakings described in Item 3, Item 4 and Item 5 of this Schedule 13D (collectively, the “Irrevocable Undertakings”). Neither the filing of this Schedule 13D nor any of its contents shall be deemed to constitute an admission by the Reporting Persons that they are the beneficial owners of any Shares covered by the Irrevocable Undertakings for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Act”), or for any other purpose, and such beneficial ownership thereof is expressly disclaimed.

In addition to the Shares subject to the Irrevocable Undertakings, the Reporting Persons (as defined below) may share beneficial ownership of 11,651,778 Shares held by Takeda Pharmaceuticals International AG (“Takeda International”). Percentage ownership of Takeda is based on 278,614,206 Shares, comprised of (i) 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement (as defined below)) and (ii) 4,327,016 Shares issuable upon exercise of currently exercisable warrants, which Shares are covered by the Irrevocable Undertakings).


SCHEDULE 13D

ISIN BE0003864817 (Shares)

CUSIP 88675R109 (ADSs)

 

  1   

NAME OF REPORTING PERSON:

 

Takeda Pharmaceuticals International AG

  2  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP*

(a)  ☐        (b)  ☐

 

  3  

SEC USE ONLY

 

  4  

SOURCE OF FUNDS

 

WC

  5  

CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)  ☐

 

  6  

CITIZENSHIP OR PLACE OF ORGANIZATION

 

Switzerland

NUMBER OF

SHARES

BENEFICIALLY

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

SOLE VOTING POWER

 

-0-

     8   

SHARED VOTING POWER

 

11,651,778

     9   

SOLE DISPOSITIVE POWER

 

-0-

   10   

SHARED DISPOSITIVE POWER

 

11,651,778

11  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

11,651,778

12  

CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES  ☐

 

13  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)*

 

4.3% (See Item 5)

14  

TYPE OF REPORTING PERSON

 

CO


* Beneficial ownership of Shares is being reported hereunder solely because Takeda may be deemed to have beneficial ownership of 44,684,644 Shares by virtue of the Irrevocable Undertakings. Neither the filing of this Schedule 13D nor any of its contents shall be deemed to constitute an admission by the Reporting Persons that they are the beneficial owners of any Shares covered by the Irrevocable Undertakings for purposes of Section 13(d) of the Act, or for any other purpose, and such beneficial ownership thereof is expressly disclaimed.

In addition to the Shares subject to the Irrevocable Undertakings, the Reporting Persons (as defined below) may share beneficial ownership of 11,651,778 Shares held by Takeda International. Percentage ownership of Takeda International is based on 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement (as defined below)).


SCHEDULE 13D

ISIN BE0003864817 (Shares)

CUSIP 88675R109 (ADSs)

 

  1   

NAME OF REPORTING PERSON:

 

Takeda Pharma A/S

  2  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP*

(a)  ☐        (b)  ☐

 

  3  

SEC USE ONLY

 

  4  

SOURCE OF FUNDS

 

WC

  5  

CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)  ☐

 

  6  

CITIZENSHIP OR PLACE OF ORGANIZATION

 

Denmark

NUMBER OF

SHARES

BENEFICIALLY

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

SOLE VOTING POWER

 

-0-

     8   

SHARED VOTING POWER

 

11,651,778

     9   

SOLE DISPOSITIVE POWER

 

-0-

   10   

SHARED DISPOSITIVE POWER

 

11,651,778

11  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

11,651,778

12  

CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES  ☐

 

13  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)*

 

4.3% (See Item 5)

14  

TYPE OF REPORTING PERSON

 

CO


* Beneficial ownership of Shares is being reported hereunder solely because Takeda may be deemed to have beneficial ownership of 44,684,644 Shares by virtue of the Irrevocable Undertakings. Neither the filing of this Schedule 13D nor any of its contents shall be deemed to constitute an admission by the Reporting Persons that they are the beneficial owners of any Shares covered by the Irrevocable Undertakings for purposes of Section 13(d) of the Act, or for any other purpose, and such beneficial ownership thereof is expressly disclaimed.

In addition to the Shares subject to the Irrevocable Undertakings, the Reporting Persons (as defined below) may share beneficial ownership of 11,651,778 Shares held by Takeda International. Percentage ownership of Takeda Pharma A/S is based on 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement (as defined below)).


SCHEDULE 13D

ISIN BE0003864817 (Shares)

CUSIP 88675R109 (ADSs)

 

  1   

NAME OF REPORTING PERSON:

 

Takeda A/S

  2  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP*

(a)  ☐        (b)  ☐

 

  3  

SEC USE ONLY

 

  4  

SOURCE OF FUNDS

 

WC

  5  

CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)  ☐

 

  6  

CITIZENSHIP OR PLACE OF ORGANIZATION

 

Denmark

NUMBER OF

SHARES

BENEFICIALLY

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

SOLE VOTING POWER

 

-0-

     8   

SHARED VOTING POWER

 

11,651,778

     9   

SOLE DISPOSITIVE POWER

 

-0-

   10   

SHARED DISPOSITIVE POWER

 

11,651,778

11  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

11,651,778

12  

CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES  ☐

 

13  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)*

 

4.3% (See Item 5)

14  

TYPE OF REPORTING PERSON

 

CO


* Beneficial ownership of Shares is being reported hereunder solely because Takeda may be deemed to have beneficial ownership of 44,684,644 Shares by virtue of the Irrevocable Undertakings. Neither the filing of this Schedule 13D nor any of its contents shall be deemed to constitute an admission by the Reporting Persons that they are the beneficial owners of any Shares covered by the Irrevocable Undertakings for purposes of Section 13(d) of the Act, or for any other purpose, and such beneficial ownership thereof is expressly disclaimed.

In addition to the Shares subject to the Irrevocable Undertakings, the Reporting Persons (as defined below) may share beneficial ownership of 11,651,778 Shares held by Takeda International. Percentage ownership of Takeda A/S is based on 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement (as defined below)).


SCHEDULE 13D

ISIN BE0003864817 (Shares)

CUSIP 88675R109 (ADSs)

 

  1   

NAME OF REPORTING PERSON:

 

Takeda Europe Holdings B.V.

  2  

CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP*

(a)  ☐        (b)  ☐

 

  3  

SEC USE ONLY

 

  4  

SOURCE OF FUNDS

 

WC

  5  

CHECK BOX IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)  ☐

 

  6  

CITIZENSHIP OR PLACE OF ORGANIZATION

 

Netherlands

NUMBER OF

SHARES

BENEFICIALLY

OWNED BY

EACH

REPORTING

PERSON

WITH

 

     7    

SOLE VOTING POWER

 

-0-

     8   

SHARED VOTING POWER

 

11,651,778

     9   

SOLE DISPOSITIVE POWER

 

-0-

   10   

SHARED DISPOSITIVE POWER

 

11,651,778

11  

AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

 

11,651,778

12  

CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES  ☐

 

13  

PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)*

 

4.3% (See Item 5)

14  

TYPE OF REPORTING PERSON

 

CO


* Beneficial ownership of Shares is being reported hereunder solely because Takeda may be deemed to have beneficial ownership of 44,684,644 Shares by virtue of the Irrevocable Undertakings. Neither the filing of this Schedule 13D nor any of its contents shall be deemed to constitute an admission by the Reporting Persons that they are the beneficial owners of any Shares covered by the Irrevocable Undertakings for purposes of Section 13(d) of the Act, or for any other purpose, and such beneficial ownership thereof is expressly disclaimed.

In addition to the Shares subject to the Irrevocable Undertakings, the Reporting Persons (as defined below) may share beneficial ownership of 11,651,778 Shares held by Takeda International. Percentage ownership of Takeda Europe Holdings B.V. is based on 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement (as defined below)).


Item 1. Security and Issuer.

This Schedule 13D (the “Schedule 13D”) relates to the ordinary shares, no nominal value, of TiGenix, a limited liability company (naamloze vennootschap / société anonyme) under the laws of Belgium (“TiGenix”) (such shares, the “Shares”), including Shares represented by American Depositary Shares (“ADSs”). The principal executive offices of TiGenix are located at Romeinse straat 12 box 2, 3001 Leuven, Belgium.

Item 2. Identity and Background.

This Schedule 13D is being jointly filed on behalf of: (i) Takeda Pharmaceutical Company Limited, a corporation organized under the laws of Japan (“Takeda”); (ii) Takeda Pharmaceuticals International AG, a Swiss joint stock corporation (“Takeda International”); (iii) Takeda Pharma A/S, a Danish stock limited company (“Takeda Denmark”); (iv) Takeda A/S, a Danish stock limited company (“Takeda A/S”); and (v) Takeda Europe Holdings B.V., a Dutch private limited company (“Takeda Europe”) (each of Takeda, Takeda International, Takeda Denmark, Takeda A/S and Takeda Europe, a “Reporting Person” and collectively, the “Reporting Persons”).

Takeda Denmark owns 86.83% of Takeda International, and Takeda Europe owns 13.17% of Takeda International. Takeda Denmark is a wholly-owned direct subsidiary of Takeda A/S. Takeda owns 76.09% of Takeda A/S, and Takeda Europe owns 23.91% of Takeda A/S. Takeda Europe is a wholly-owned direct subsidiary of Takeda. A Joint Filing Agreement among the Reporting Persons is attached as Exhibit 6 to this Schedule 13D.

The principal business address of Takeda is 12-10, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-8668. The principal address of Takeda International is Thurgauerstrasse 130, 8152 Glattpark – Opfikon (Zurich), Switzerland. The principal address of Takeda Denmark is Langebjerg 1, 4000 Roskilde, Denmark. The principal address of Takeda A/S is Dybendal Alle 10, DK-2630 Taastrup, Denmark. The principal address of Takeda Europe is Jupiterstraat 250, 2132 HK Hoofddorp, Netherlands.

Takeda’s principal business is operating as a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines, focusing its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda International is principally engaged in the business of conducting commercial and financial functions of Takeda. Takeda Denmark is principally engaged in the business of conducting marketing, manufacturing and development functions of Takeda. Each of Takeda Europe and Takeda A/S is principally engaged in the business of being an intermediate holding company of Takeda.

The name, business address, present principal occupation or employment and citizenship of each director and executive officer of each Reporting Person is set forth on Schedule A hereto.

During the last five years, none of the Reporting Persons or, to the knowledge of each of the Reporting Persons, any of the persons listed on Schedule A attached hereto has (i) been convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors) or (ii) been a party to a civil proceeding of a judicial or administrative body of competent jurisdiction and as a result of such proceeding was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws.

Item 3. Source and Amount of Funds or Other Consideration.

The Irrevocable Undertakings described in Item 4 of this Schedule 13D (the terms of which are hereby incorporated by reference) were entered into by and among Takeda and the Supporting Shareholders (as defined below in Item 4). The Supporting Shareholders entered into the Irrevocable Undertakings as an inducement to Takeda’s willingness to enter into the Offer and Support Agreement described in Item 4 of this Schedule 13D (the terms of which are hereby incorporated by reference). The Shares covered by the Irrevocable Undertakings have not been purchased by any Reporting Person and no payments were made by or on behalf of any Reporting Person in connection with the execution of the Irrevocable Undertakings.

Takeda International purchased the 11,651,778 Shares held by it with working capital of Takeda International.


Item 4. Purpose of Transaction.

Offer and Support Agreement.

On January 5, 2018, Takeda and TiGenix entered into an Offer and Support Agreement (the “Offer and Support Agreement”). Pursuant to the Offer and Support Agreement and upon the terms and subject to the conditions set forth therein, Takeda will commence an all cash voluntary and conditional public takeover bid for 100% of the securities with voting rights or giving access to voting rights of TiGenix that are not already owned by Takeda or its affiliates, at a price of EUR 1.78 per Share in cash and an equivalent price for the ADSs, warrants to acquire Shares (“Warrants”) and 9% senior unsecured convertible bonds due March 6, 2018 (the “Convertible Bonds”) of TiGenix (the “Offer”).

The obligation of Takeda to purchase the TiGenix securities pursuant to the Offer is subject to the following conditions : (i) the tender into the Offer, in aggregate, of a number of securities that, together with all securities owned by Takeda and its affiliates, represents or gives access to 85% or more of the voting rights represented or given access to by all of the outstanding securities on a fully diluted basis as of the end of the first acceptance period under the Offer, which shall end no earlier than twenty (20) business days after the commencement of the Offer (the “First Acceptance Period”), (ii) the absence of a material adverse effect occurring at any time after January 5, 2018, (iii) Cx601 (the leading investigational therapy in TiGenix’s pipeline) obtaining marketing authorization in the E.U. from the European Medicines Agency (EMA) and (iv) the expiration, lapse or termination as appropriate of any applicable waiting periods (including any extensions thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in respect of the Offer.

Unless Takeda withdraws the Offer due to a failure of one or more conditions, Takeda has agreed to re-open the Offer for a period of ten (10) business days (the “Second Acceptance Period”) on the tenth business day after publication of the results of the First Acceptance Period, in order for certain Warrant holders to exercise their Warrants under a special exercise period (the “Exceptional Exercise Period”) and tender the Shares obtained as a result of the exercise of such Warrants, which is conditioned on and will commence following the date of payment of the securities tendered in the Offer following closing of the First Acceptance Period (the “Completion of the Bid”), provided that Takeda shall have acquired control of TiGenix upon Completion of the Bid. Following the closing of the Second Acceptance Period, Takeda intends to launch a squeeze-out if the applicable conditions for such squeeze-out are met, to delist the shares of TiGenix from Euronext Brussels and ADSs from NASDAQ. After the squeeze-out, TiGenix would become a wholly-owned subsidiary of Takeda.

Until the earlier of the termination of the Offer and Support Agreement and the date of Completion of the Bid (the “Interim Period”), TiGenix has agreed to operate its business and the business of its subsidiaries in the ordinary course, consistent with past practice, and has agreed to certain other operating covenants, as set forth more fully in the Offer and Support Agreement. Subject to the terms and conditions of the Offer and Support Agreement, TiGenix has agreed to support the Offer and also agreed not to solicit or initiate discussions with any third party regarding acquisition proposals.

The Offer and Support Agreement includes termination provisions under which either Takeda or TiGenix may terminate the Offer and Support Agreement under a number of conditions. Depending on the specific circumstances of the termination of the Offer and Support Agreement, the agreement provides for a break-up fee payable by either party to the other, or a potential equity investment by Takeda in TiGenix.

The foregoing description of the Offer and Support Agreement and the transactions contemplated thereby do not purport to be complete and is qualified in its entirety by reference to the Offer and Support Agreement, which is filed as Exhibit 1 to this Schedule 13D and incorporated herein by reference.

Irrevocable Undertakings.

In connection with the Offer, on January 5, 2018, Gri-Cel S.A. (“Gri-Cel”) and Grifols Worldwide Operations Ltd. (“Grifols Worldwide”) entered into an irrevocable undertaking with Takeda (the “Grifols Irrevocable Undertaking”). Pursuant to the terms of the Grifols Irrevocable Undertaking, Gri-Cel and Grifols Worldwide have irrevocably agreed to tender their Shares to Takeda in the Offer. The Grifols Irrevocable Undertaking applies to 39,427,978 Shares (including Shares represented by ADSs).


Additionally, pursuant to the terms of the Grifols Irrevocable Undertaking, Gri-Cel and Grifols Worldwide will, in each case until the Offer is unconditional or it lapses or is withdrawn (i) provide reasonable support to Takeda in completing the Offer and refrain from any actions that could adversely affect the success of the Offer, (ii) not, without the prior written consent of Takeda, deal in any securities of TiGenix (including but not limited to any sales, transfers, or encumbrances of such securities), and (iii) exercise or procure the exercise by proxy or in person of the votes of the Shares in respect of any resolution proposed at any general shareholders’ meeting of TiGenix in favor of any resolution the passing of which is necessary to fulfil any condition of the Offer and against any resolution whose passing is required in connection with any offer for TiGenix securities by any person other than Takeda or which, if passed, might result in any condition of the Offer not being fulfilled or which might impede or frustrate the Offer in any way.

In connection with the Offer, on January 4, 2018, certain officers and directors of TiGenix (such officers and directors, the “TiGenix Supporting Shareholders,” and. together with Gri-Cel and Grifols Worldwide, the “Supporting Shareholders”) each entered into an irrevocable undertaking with Takeda (the “Additional Irrevocable Undertakings,” and, together with the Grifols Irrevocable Undertaking, the “Irrevocable Undertakings”). Pursuant to the terms of the Additional Irrevocable Undertakings, the TiGenix Supporting Shareholders have irrevocably agreed to tender their Shares to Takeda in the Offer, subject to certain conditions set forth in the Additional Irrevocable Undertakings. The Additional Irrevocable Undertakings collectively apply to 5,614,329 Shares, consisting of (i) 929,650 outstanding Shares and (ii) 4,684,679 Shares issuable upon exercise of Warrants; provided, however, because Warrants exercisable for 357,663 of such Shares will not be exercisable until the Exceptional Exercise Period, only 4,327,016 of such Shares are deemed potentially beneficially owned by Takeda, as set forth in Item 5.

Additionally, pursuant to the terms of the Additional Irrevocable Undertakings, the TiGenix Supporting Shareholders will, in each case until the Offer is unconditional or it lapses or is withdrawn (i) not, without the prior written consent of Takeda, deal in any securities of TiGenix (including but not limited to any sales, transfers, or encumbrances of such securities), and (ii) exercise or procure the exercise by proxy or in person of the votes of the Shares in respect of any resolution proposed at any general shareholders’ meeting of TiGenix in favor of any resolution the passing of which is necessary to fulfil any condition of the Offer and against any resolution whose passing is required in connection with any offer for TiGenix securities by any person other than Takeda or which, if passed, might result in any condition of the Offer not being fulfilled or which might impede or frustrate the Offer in any way.

The foregoing description of the Irrevocable Undertakings and the transactions contemplated thereby does not purport to be complete and is qualified in its entirety by reference to the Grifols Irrevocable Undertaking and forms of Additional Irrevocable Undertaking, which are filed as Exhibit 3, Exhibit 4 and Exhibit 5 to this Schedule 13D, respectively, and incorporated herein by reference.

Confidentiality Agreement.

On June 30, 2017, Takeda International and an affiliate of TiGenix entered into a customary confidential disclosure agreement in connection with a possible transaction between Takeda and TiGenix (as amended on November 17, 2017, the “Confidentiality Agreement”). The Confidentiality Agreement includes customary standstill and non-solicitation provisions for the benefit of TiGenix as well as a customary no-shop provision for the benefit of Takeda, in each case as further described in and subject to the exceptions set forth in the Confidentiality Agreement.

The foregoing description of the Confidentiality Agreement does not purport to be complete and is qualified in its entirety by reference to the Confidentiality Agreement, which is filed as Exhibit 2 to this Schedule 13D and incorporated herein by reference.

Shares Owned by Takeda International.

Takeda International purchased the 11,651,778 Shares owned by it on December 29, 2016 pursuant to a Subscription Agreement between Takeda International and TiGenix (the terms of which have expired) in connection with a pre-existing License Agreement between Takeda and an affiliate of TiGenix. As of the date of this filing there are no agreements between the Reporting Persons and TiGenix relating to such Shares.


Additional Information.

The voluntary public takeover bid described herein has not yet commenced. This communication is for informational purposes only and is neither a recommendation, an offer to purchase nor a solicitation of an offer to sell any securities of TiGenix. At the time the voluntary public takeover bid is commenced, security holders of TiGenix are urged to read the offer documents which will be available at www.sec.gov.

At the time the voluntary public takeover bid is commenced, it shall be comprised of two separate offers – (i) an offer for all Shares, Warrants and Convertible Bonds (the “Securities”) in accordance with the applicable law in Belgium and (ii) an offer to holders of ADSs, and to holders of Securities who are resident in the U.S. in accordance with applicable U.S. law (the “U.S. Offer”). The U.S. Offer will only be made pursuant to an offer to purchase and related materials. At the time the U.S. Offer is commenced, Takeda will file, or cause to be filed, a tender offer statement on Schedule TO with the SEC and thereafter, TiGenix will file a solicitation/recommendation statement on Schedule 14D-9, in each case with respect to the U.S. Offer. Holders of the ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are urged to carefully review the documents relating to the U.S. Offer that will be filed by Takeda with the SEC since these documents will contain important information, including the terms and conditions of the U.S. Offer.

Holders of the ADSs and Securities subject to the U.S. Offer who wish to participate in the U.S. Offer, are also urged to read the related solicitation/recommendation statement on Schedule 14D-9 that will be filed with the SEC by TiGenix relating to the U.S. Offer. You may obtain a free copy of these documents after they have been filed with the SEC, and other documents filed by TiGenix and Takeda with the SEC, at the SEC’s website at www.sec.gov. In addition to the offer and certain other tender offer documents, as well as the solicitation/recommendation statement, TiGenix files reports and other information with the SEC. You may read and copy any reports or other information filed by TiGenix at the SEC Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the Public Reference Room. TiGenix’s filings at the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

Item 5. Interest in Securities of the Issuer.

The information contained in rows 7, 8, 9, 10, 11 and 13 on each of the cover pages of this Schedule 13D and the information set forth or incorporated in Items 2 and 4 is incorporated by reference in its entirety into this Item 5.

Takeda International owns 11,651,778 Shares. Because of the relationship between the Reporting Persons as described in Item 2, each Reporting Person may be deemed to beneficially own such Shares. The 11,651,778 Shares over which the Reporting Persons may be deemed to have shared voting and dispositive power constitute approximately 4.3% of the Shares outstanding, based on 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement).

Other than the 11,651,778 Shares over which each Reporting Person may be deemed to beneficially own as described above, the Reporting Persons do not beneficially own any Shares except for those Shares that may be deemed to be beneficially owned by Takeda by operation of the Irrevocable Undertakings. For purposes of Rule 13d-3Rule 13d-3”) under the Act, as a result of entering into the Irrevocable Undertakings, Takeda may be deemed to possess shared voting power and shared dispositive power over, and therefore beneficially own for purposes of Rule 13d-3, the 44,684,644 Shares beneficially owned by the Supporting Shareholders as described in Item 4 of this Schedule 13D (the terms of which are hereby incorporated by reference). As a result, Takeda could be deemed to have shared voting and dispositive power over 56,336,422 Shares, comprised of (i) the 11,651,778 Shares described above, and (ii) the 44,684,644 Shares beneficially owned by the Supporting Shareholders, which constitutes approximately 20.2% of the Shares outstanding (based on 278,614,206 Shares, comprised of (i) 274,287,190 Shares outstanding as of January 5, 2018 (based on information provided by TiGenix in the Offer and Support Agreement) and (ii) 4,327,016 Shares issuable upon exercise of currently exercisable warrants, which Shares are covered by the Irrevocable Undertakings). Notwithstanding the preceding, the Reporting Persons hereby disclaim beneficial ownership of such 44,684,644 Shares and this Schedule 13D shall not be construed as an admission that the Reporting Persons are, for any or all purposes, the beneficial owners of such securities.


Except as described in this Schedule 13D, there have been no transactions in the Shares effected by the Reporting Persons, or, to the best of the Reporting Persons’ knowledge, any person identified on Schedule A hereto, during the last 60 days.

Item 6. Contracts, Arrangements, Understandings or Relationships with Respect to Securities of the Issuer.

The information set forth under Items 3, 4 and 5 and the agreements set forth on the Exhibits attached hereto are incorporated herein by reference. Other than the Offer and Sale Agreement, Confidentiality Agreement and the Irrevocable Undertakings described above, to the best of the Reporting Persons’ knowledge, there are no contracts, arrangements, understandings or relationships (legal or otherwise) among the persons named in Item 2, or between such persons and any person, with respect to the securities of TiGenix, including, but not limited to, transfer or voting of any of the securities, finder’s fees, joint ventures, loan or option arrangements, puts or calls, guarantees of profits, division of profits or loss, or the giving or withholding of proxies, including any securities pledged or otherwise subject to a contingency the occurrence of which would give another person voting power or investment power over such securities.

Item 7. Material to Be Filed as Exhibits.

 

Exhibit 1 —    Offer and Support Agreement, dated as of January 5, 2018, by and between Takeda and TiGenix.
Exhibit 2 —    Confidential Disclosure Agreement, dated as of June 30, 2017, by and among TiGenix SAU (an affiliate of TiGenix) and Takeda International, as amended by the addendum thereto dated as of November 17, 2017, by and among TiGenix SAU, TiGenix, Takeda International and Takeda.
Exhibit 3 —    Irrevocable Undertaking, dated as of January 5, 2018, by and among Gri-Cel, S.A., Grifols Worldwide Operations Ltd. and Takeda.
Exhibit 4 —    Form of Irrevocable Undertaking, dated as of January 4, 2018, by and among Takeda and each of Eduardo Bravo and Claudia D’Augusta.
Exhibit 5 —    Form of Irrevocable Undertaking, dated as of January 4, 2018, by and among Takeda and each of Greig Biotechnology Global Consulting, Inc., Innoste SA, Willy Duron and June Almenoff.
Exhibit 6 —    Joint Filing Agreement, dated as of January 12, 2018, by and among Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals International AG, Takeda Pharma A/S, Takeda A/S and Takeda Europe Holdings B.V.
Exhibit 7 —    Power of Attorney (Takeda)
Exhibit 8 —    Power of Attorney (Takeda International)
Exhibit 9 —    Power of Attorney (Takeda Denmark)
Exhibit 10 —    Power of Attorney (Takeda A/S)
Exhibit 11 —    Power of Attorney (Takeda Europe)


SIGNATURE

After reasonable inquiry and to the best of its knowledge and belief, the undersigned certifies that the information set forth in this statement is true, complete and correct.

Dated: January 12, 2018

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED
By:   /s/ Paul Sundberg
Name:   Paul Sundberg
Title:   VP and Deputy General Counsel
TAKEDA PHARMACEUTICALS INTERNATIONAL AG
By:   /s/ Paul Sundberg
Name:   Paul Sundberg
Title:   VP and Deputy General Counsel
TAKEDA PHARMA A/S
By:   /s/ Paul Sundberg
Name:   Paul Sundberg
Title:   VP and Deputy General Counsel
TAKEDA A/S
By:   /s/ Paul Sundberg
Name:   Paul Sundberg
Title:   VP and Deputy General Counsel
TAKEDA EUROPE HOLDINGS B.V.
By:   /s/ Paul Sundberg
Name:   Paul Sundberg
Title:   VP and Deputy General Counsel


EXHIBIT INDEX

 

Exhibit 1 —    Offer and Support Agreement, dated as of January 5, 2018, by and between Takeda and TiGenix.
Exhibit 2 —    Confidential Disclosure Agreement, dated as of June 30, 2017, by and among TiGenix SAU (an affiliate of TiGenix) and Takeda International, as amended by the addendum thereto dated as of November 17, 2017, by and among TiGenix SAU, TiGenix, Takeda International and Takeda.
Exhibit 3 —    Irrevocable Undertaking, dated as of January 5, 2018, by and among Gri-Cel, S.A., Grifols Worldwide Operations Ltd. and Takeda.
Exhibit 4 —    Form of Irrevocable Undertaking, dated as of January 4, 2018, by and among Takeda and each of Eduardo Bravo and Claudia D’Augusta.
Exhibit 5 —    Form of Irrevocable Undertaking, dated as of January 4, 2018, by and among Takeda and each of Greig Biotechnology Global Consulting, Inc., Innoste SA, Willy Duron and June Almenoff.
Exhibit 6 —    Joint Filing Agreement, dated as of January 12, 2018, by and among Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals International AG, Takeda Pharma A/S, Takeda A/S and Takeda Europe Holdings B.V.
Exhibit 7 —    Power of Attorney (Takeda)
Exhibit 8 —    Power of Attorney (Takeda International)
Exhibit 9 —    Power of Attorney (Takeda Denmark)
Exhibit 10 —    Power of Attorney (Takeda A/S)
Exhibit 11 —    Power of Attorney (Takeda Europe)


SCHEDULE A

DIRECTORS AND EXECUTIVE OFFICERS OF THE REPORTING PERSONS

Takeda Pharmaceutical Company Limited

The name, business address, title and present principal occupation or employment of each of the directors and executive officers of Takeda Pharmaceutical Company Limited (“Takeda”) are set forth below. If no address is given, the business address is 12-10, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-8668.

 

Name

  

Principal Occupation

  

Citizenship

Christophe Weber    Director and President and Chief Executive Officer of Takeda    France
James Kehoe    Director and Chief Financial Officer of Takeda    Ireland
Masato Iwasaki, Ph.D.    Director and President of Japan Pharma Business Unit of Takeda    Japan

Andrew S. Plump,

M.D., Ph.D.

   Director and Chief Medical and Scientific Officer of Takeda    United States
Yoshiaki Fujimori    Outside Director of Takeda    Japan
Emiko Higashi   

Outside Director of Takeda and Managing Director of Tomon Partners, LLC

 

1430 O’Brien Drive,

Menlo Park, California 94025

   Japan
Michel Orsinger    Outside Director of Takeda    Switzerland
Masahiro Sakane    Outside Director and Chair of the Board Meeting of Takeda    Japan
Toshiyuki Shiga    Outside Director of Takeda    Japan
Yasuhiko Yamanaka    Director of Takeda    Japan
Shiro Kuniya   

Outside Director of Takeda and Managing Partner of Oh-Ebashi LPC & Partners

 

Kishimoto Building 2F, 2-2-1 Marunouchi, Tokyo 100-0005, Japan

   Japan
Jean-Luc Butel   

Outside Director of Takeda and President of K8 Global Pte. Ltd

 

21 Biopolis Road

Nucleos South Tower

# 04-24/28

Singapore 138567

   France
Koji Hatsukawa    Outside Director of Takeda    Japan
Christophe Bianchi    President of Global Oncology Business Unit of Takeda    United States
Gerard Greco    Global Quality Officer of Takeda    United States


Haruhiko Hirate    Corporate Communications and Public Affairs Officer of Takeda    Japan
Ricardo Marek    President, Emerging Markets Business Unit of Takeda    Brazil
Yoshihiro Nakagawa    Global General Counsel of Takeda    Japan
David Osborne    Global Human Resources Officer of Takeda    United States
Giles Platford    President, Europe and Canada Business Unit of Takeda    United Kingdom
Ramona Sequeira    President, United States Business Unit of Takeda    Canada
Rajeev Venkayya    President, Global Vaccine Business Unit of Takeda    United States
Thomas Wozniewski    Global Manufacturing and Supply Officer of Takeda    Germany

Takeda Pharmaceuticals International AG

The name, business address, title and present principal occupation or employment of each of the directors and executive officers of Takeda Pharmaceuticals International AG (“Takeda International”) are set forth below. If no address is given, the business address is Thurgauerstrasse 130, 8152 Glattpark – Opfikon (Zurich), Switzerland.

 

Name

  

Principal Occupation

  

Citizenship

Thomas Wozniewski    Director of Takeda International and Global Manufacturing and Supply Officer of Takeda    Germany
Costa Saroukos    Director of Takeda International and Chief Financial Officer of Europe and Canada Business Unit of Takeda    Australia
Nils Kjaersgaard    Director of Takeda International and Vice President and General Counsel of Europe and Canada Business Unit of Takeda    Denmark
Marcello Agosti    Director of Takeda International and Head of Global Business Development and Global Commercial of Takeda    Italy
Giles Platford    Director of Takeda International and President of Europe and Canada Business Unit of Takeda    United Kingdom

Takeda Pharma A/S

The name, business address, title and present principal occupation or employment of each of the directors and executive officers of Takeda Pharma A/S (“Takeda Denmark”) are set forth below. If no address is given, the business address is Dybendal Allé 10, DK-2630 Taastrup, Denmark.

 

Name

  

Principal Occupation

  

Citizenship

Ingeborg Borgheim    Director of Takeda Denmark and Head of Nordics and Baltics    Norway
Bjarne Lange    Director of Takeda Denmark and Engineer of Takeda    Denmark


Marianne Hauge    Director of Takeda Denmark and Associate Director, European Regulatory Affairs LOC liaison of Takeda    Denmark
Niels Hansen    Director of Takeda Denmark and Senior Director, Head of Supply Chain Coordination Europe and Canada Business Unit of Takeda    Denmark
Efthymis Giannoulis    Director of Takeda Denmark and Regional Finance Director Nordics & Baltics, EUCAN Finance    Greek
Patrik Forsell    General Manager of Takeda Denmark and Manager Denmark, Commercial Operations    Swedish

Takeda A/S

The name, business address, title and present principal occupation or employment of each of the directors and executive officers of Takeda A/S (“Takeda A/S”) are set forth below. If no address is given, the business address is Dybendal Alle 10, 2630 Taastrup, Denmark.

 

Name

  

Principal Occupation

  

Citizenship

Ingebrog Borgheim    Director of Takeda A/S, Head of Nordics and Baltics    Norway
Nils Kjaersgaard    Director of Takeda A/S and Vice President and General Counsel of Europe and Canada Business Unit of Takeda    Denmark
Efthymis Giannoulis    Regional Finance Director Nordics & Baltics, EUCAN Finance    Greek
Bjarne Lange    Director of Takeda A/S and Engineer of Takeda    Denmark
Marianne Hauge    Director of Takeda Denmark and Associate Director, European Regulatory Affairs LOC Liaison of Takeda    Denmark
Patrik Forsell    General Manager of Takeda A/S and Manager Denmark, Commercial Operations    Swedish

Takeda Europe Holdings B.V.

The name, business address, title and present principal occupation or employment of each of the directors and executive officers of Takeda Europe Holdings B.V. (“Takeda Europe”) are set forth below. If no address is given, the business address is Jupiterstraat 250, 2132 HK Hoofddorp, Netherlands.

 

Name

  

Principal Occupation

  

Citizenship

Remco van Rhoon    Director and Financial Controller of Takeda Europe    Netherlands
Herman Timmermans    Director and Finance Director of Takeda Europe    Netherlands
EX-99.1
LOGO    Exhibit 1

OFFER AND SUPPORT AGREEMENT

BETWEEN

 

1. Takeda Pharmaceutical Company Limited, a company under the laws of Japan, having its registered office at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka, Japan,

hereby validly represented by Misako Hirose, in her capacity as Authorised Representative,

hereinafter referred to as the “Bidder” or “Takeda”;

ON THE ONE HAND

AND

 

2. TiGenix NV, a limited liability company (naamloze vennootschap / société anonyme) under the laws of Belgium, having its registered office at Romeinse straat 12 box 2, 3001 Leuven, Belgium, registered with the Crossroads Bank of Enterprises under number 0471.340.123 (Register of Legal Entities Leuven),

hereby validly represented by Eduardo Bravo, in his capacity as Authorised Representative,

hereinafter referred to as the “Target”,

ON THE OTHER HAND

The Bidder and the Target are hereinafter jointly referred to as the “Parties” and each individually as a “Party”.

WHEREAS:

 

(A) The Target is a dual-listed (Euronext Brussels and Nasdaq:TIG) biopharmaceutical company focused on exploiting the anti-inflammatory properties of stem cells to develop novel therapies for serious medical conditions in areas of high unmet medical need.

 

(B) The Bidder has been considering launching and, subject to the terms and conditions contained herein, shall launch, a voluntary public takeover bid (vrijwillig openbaar overnamebod / offre publique d’acquisition volontaire) within the meaning of the Belgian Law of 1 April 2007 on public takeover bids (Wet op de openbare overnamebiedingen / Loi relative aux offres publiques d’acquisition) (hereinafter referred to as the “Law on Public Takeover Bids”) with respect to 100% of the Securities (as defined below), by way of a Belgian Offer (as defined below) and a US Offer (as defined below) on the terms and subject to the conditions set forth in this Agreement (as defined below) (hereinafter referred to as the “Bid”).

 

(C) On 10 November 2017, Takeda sent a letter to the Target setting forth its non-binding expression of interest in making the Bid and the Target confirmed its agreement with the terms of the letter on 13 November 2017.

 

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(D) On 15 December 2017, the Target’s product, Cx601, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as part of the Parties’ joint application for marketing authorisation in the E.U.

 

(E) The board of directors of the Target (the “Board of Directors”) has reviewed the terms and conditions of the Bid set out in this offer and support agreement (the “Agreement”). On the basis of the information as at the date of this Agreement, having considered the future prospects of the Target as a standalone company and subject to further information to be provided in the US Offer Documents and the Prospectus (each as defined below), the Board of Directors acknowledges the potential value of the Bid for the Target from a strategic, commercial and business perspective and for the holders of the Securities.

 

(F) The Belgian legislator has reserved the right not to require companies which have their registered office within Belgium to apply article 9(2) and (3) (“passivity rule”) and article 11 (“breakthrough”) of the Directive 2004/25/EC of the European Parliament and of the Council of 21 April 2004 on takeover bids. The Target has not included any of the provisions set out in article 46 of the Law on Public Takeover Bids in its Articles of Association.

 

(G) The Parties wish to set out the terms upon which the Bidder shall make the Bid and the conditions subject to which the Target shall provide the support set forth in this Agreement.

THEREFORE IT HAS BEEN AGREED AS FOLLOWS:

 

1 Definitions and interpretation

 

1.1 Definitions

The following terms and expressions have the following meaning in the Agreement:

“Addendum to the Confidentiality Agreement” means the addendum to the Confidentiality Agreement dated 17 November 2017 by and among (i) TiGenix SAU (an Affiliate of the Target), (ii) Takeda Pharmaceuticals International AG (an Affiliate of the Bidder), (iii) the Target and (iv) the Bidder;

“ADSs” has the meaning set out in Clause 2.1(ii);

“Affiliate” means an affiliated company (verbonden vennootschappen / société liée) as defined in article 11 of the Belgian Company Code (Wetboek van vennootschappen / Code des sociétés);

“Agreement” has the meaning set out in Preamble (E);

“Applicable Law” means, with respect to any Party, any federal, state or local law (statutory, common or otherwise), constitution, treaty, convention, ordinance, code, rule, regulation, order, injunction, judgment, decree, ruling or other similar requirement enacted, adopted, promulgated or applied by a Governmental Entity, or stock exchange or similar body, that is binding upon such Party, as amended unless expressly specified otherwise;

“Applicable Warrant Prices” has the meaning set out in Clause 2.2(iii);

“Belgian Offer” has the meaning set out in Clause 2.3;

 

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“Belgian Takeover Rules” means the Law on Public Takeover Bids and the Royal Decree on Public Takeover Bids, as well as any implementing laws, regulations and regulatory guidance in this respect;

“Bid” has the meaning set out in Preamble (B), and shall, for the avoidance of doubt, refer to both the Belgian Offer and the US Offer, unless otherwise stated;

“Board of Directors” has the meaning set out in Preamble (E);

“Break Payment” has the meaning set out in Clause 9.1;

“Business Day” means a day, other than a Saturday, Sunday or public or bank holiday, when banks are open for business in Brussels, New York and Tokyo;

“Change of Recommendation” has the meaning set out in Clause 5.1.3;

“Commencement Date” has the meaning set out in Clause 4.4;

“Completion of the Bid” means payment of the Securities tendered in the Bid following closing of the First Acceptance Period;

“Completion Date” means the date of the Completion of the Bid;

“Conditions” has the meaning set out in Clause 3.2;

“Confidentiality Agreement” means the confidentiality agreement dated 30 June 2017 by and among (i) TiGenix SAU (an Affiliate of the Target) and (ii) Takeda Pharmaceuticals International AG (an Affiliate of the Bidder);

“Convertible Bonds” has the meaning set out in Clause 2.1(iv);

“Effect” means any state of facts, circumstance, condition, event, change, development, occurrence, result or effect;

“Equity Investment” has the meaning set out in Clause 9.2.1;

“Equity Investment Substitute” has the meaning set out in Clause 9.2.3;

“Exceptional Exercise Period” has the meaning set out in Clause 7.1.2;

“Exchange Act” means the U.S. Securities Exchange Act of 1934, as amended;

“Extended Completion Date” means the date of payment for the Securities tendered in the Bid following closing of the Second Acceptance Period;

“First Acceptance Period” has the meaning set out in Clause 4.5;

“Formal Notification” has the meaning set out in Clause 4.2;

“FSMA” means the Belgian financial services and markets authority (Autoriteit voor financiële diensten en markten / Autorité des services et marchés financiers);

 

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“GAAP” means generally accepted accounting principles in Belgium, Spain or the United States, as applicable;

“Governmental Entity” means any foreign, domestic, federal, territorial, state or local governmental authority, quasi-governmental authority, instrumentality, court, government or self-regulatory organization, commission, tribunal or organization or any regulatory, administrative or other authority, body or agency, or any political or other subdivision, department or branch of any of the foregoing which has or claims to have competent jurisdiction over the relevant persons or its business, property, assets or operations;

“HSR Act” means the Hart Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules promulgated thereunder;

“IFRS” means International Financial Reporting Standards, as issued by the International Accounting Standards Board;

“Initial Announcement” has the meaning set out in Clause 4.1;

“Interim Period” means the period between the date of signing of this Agreement and the earlier of (i) the Completion Date and (ii) the date of termination of this Agreement;

“Key Employees” means the key employees of the Target Group listed in Schedule 1;

“Law on Public Takeover Bids” has the meaning set out in Preamble (B);

“Long Stop Date” means 30 April 2018, it being understood that either Party shall have the right to extend the Long Stop Date one (1) time (but not more than one time) for a period of 45 calendar days (and all references to the Long Stop Date herein shall also be extended) by giving notice in writing to the other Party prior to 30 April 2018;

“Material Adverse Effect” means any Effect that, individually or in the aggregate with any one or more other Effects, has resulted or would reasonably be expected to result (in the latter case, insofar as this probability is confirmed by an independent expert) in a loss or liability for the Target Group, taken as a whole, having a negative impact of more than fifteen million euro (EUR 15,000,000) (after taxes) on the Target’s consolidated net assets (whether before, on or after the Long Stop Date), excluding any Effect resulting from:

 

(A) changes in IFRS, GAAP or any other applicable accounting standards or the official interpretation thereof;

 

(B) changes in the financial or securities markets or general economic, regulatory or political conditions in Belgium, Spain, the United States or Japan;

 

(C) changes of Applicable Law or the official interpretation thereof affecting the existing business operations of the Target Group or changes of conditions affecting the geographical markets in which the members of the Target Group operate;

 

(D) acts of war, sabotage or terrorism, hurricanes, floods, wildfires, tornados, earthquakes or other natural disasters or acts of God involving Belgium, Spain, the United States or Japan;

 

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(E) the announcement of the Transaction or the Completion of the Bid, including the impact thereof on relationships, contractual or otherwise, with customers, suppliers, vendors, lenders, investors, licensors, licensees, venture partners or employees (excluding Key Employees, other than any Key Employee who voluntarily terminates his/her employment relationship with any member of the Target Group) of the Target Group (otherwise than through a breach of this Agreement by any member of the Target Group);

 

(F) any failure by any member of the Target Group to meet any internal or published budgets, projections, forecasts or predictions of financial performance for any period, including any decline in the price of, or variation in the trading volume of, any securities issued by any member of the Target Group (otherwise than through a breach of this Agreement by any member of the Target Group);

 

(G) any action taken (or omitted to be taken) at the written request of the Bidder;

 

(H) any action omitted to be taken by the Target that requires the written consent of the Bidder pursuant to this Agreement to the extent that the Bidder fails to give its reasonable consent thereto after a written request therefor pursuant to the terms of this Agreement;

 

(I) any action taken by any member of the Target Group that is required pursuant to this Agreement;

 

(J) any change, event, occurrence or development relating to the products or product candidates of the Target Group (without prejudice to the requirement to satisfy the Condition in Clause 3.2(iii) (marketing authorization), unless waived by the Bidder); and

 

(K) any breach of this Agreement by the Bidder;

provided, however, that the Bidder and the Target shall negotiate in good faith any modification to this definition of “Material Adverse Effect” as shall reasonably be requested by the FSMA.

“Price per ADS” has the meaning set out in Clause 2.2(ii);

“Price per Convertible Bond” has the meaning set out in Clause 2.2(iv);

“Prices per Security” means any of the following (i) Price per ADS, (ii) Price per Convertible Bond, (iii) Price per Share and (iv) Applicable Warrant Prices;

“Price per Share” has the meaning set out in Clause 2.2(i);

“Prospectus” means the tender offer memorandum (prospectus) that the Bidder is to prepare and issue in connection with the Bid pursuant to the Belgian Takeover Rules and subject to the terms and conditions set out herein;

“Response Memorandum” means the response memorandum (memorie van antwoord / mémoire en réponse) that the Board of Directors is to prepare and issue in connection with the Bid pursuant to the Belgian Takeover Rules and subject to the terms and conditions set out herein;

“Reverse Break Payment” has the meaning set out in Clause 9.3;

 

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“Royal Decree on Public Takeover Bids” means the Belgian Royal Decree of 27 April 2007 on public takeover bids (Koninklijk Besluit op de openbare overnamebiedingen / Arrêté Royal relatif aux offres publiques d’acquisition);

“Schedule 14D-9 Response” has the meaning set out in Clause 5.1.2(iii);

“SEC” means the US Securities and Exchange Commission;

“Second Acceptance Period” has the meaning set out in Clause 4.5;

“Securities” has the meaning set out in Clause 2.1;

“Shares” has the meaning set out in Clause 2.1(i);

“Subscription Agreement” has the meaning set out in Clause 9.2.1;

“Superior Target Takeover Proposal” has the meaning set out in Clause 5.1.2(iv);

“Target Group” means the Target and its subsidiaries;

“Tax” means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature (including any related fine, penalty, surcharge or interest) imposed by, or payable to, any government, state or municipality, or any local, state, federal or other fiscal, revenue, customs, or excise authority, body or official;

“Transaction” means the transaction contemplated by the Bid;

“Transaction Value” means the total consideration, in cash, offered by the Bidder for the Securities;

“US Anti-trust Clearance” means any applicable waiting periods (including any extensions thereof) under the HSR Act shall have expired, lapsed or been terminated as appropriate in each case in respect of the Bid;

“US Offer” has the meaning set out in Clause 2.3;

“US Offer Documents” has the meaning set out in Clause 4.6;

“US Persons” shall mean holders of Shares, ADSs, Warrants or Convertible Bonds who are resident in the United States of America, including holders who are U.S. holders within the meaning of Rule 14d-1(d) of the Exchange Act;

“US Securities Laws” means the U.S. federal securities laws;

“VAT” means, within the E.U., such Tax as may be levied in accordance with (but subject to derogations from) Directive 2006/112/EC and, outside the E.U., value added tax or any form of consumption tax levied by a relevant tax authority, as well as all other forms of consumption taxes levied by the relevant tax authority on the purchase of a good or a service, including but not limited to sales tax and good and service tax; and

“Warrants” has the meaning set out in Clause 2.1(iii).

 

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1.2 Interpretation

 

1.2.1 In the event of any difficulty of interpretation, the rules contained in articles 1156 to 1161 and 1163 to 1164 of the Belgian Civil Code shall apply, it being understood that the application of article 1162 of the Belgian Civil Code is expressly excluded.

 

1.2.2 The Schedules form part of this Agreement and shall have the same force and effect as if set out in the body of this Agreement and any reference to this Agreement shall include the Schedules.

 

1.2.3 The headings in this Agreement are for convenience only and shall not affect the interpretation of this Agreement.

 

1.2.4 In this Agreement, except where the context otherwise requires:

 

(i) a reference to a Preamble, Clause or Schedule (other than to a schedule to a statutory provision) shall be a reference to a preamble, clause or schedule (as the case may be) to this Agreement.

 

(ii) references to writing shall include any modes of reproducing words in any legible form and shall include email except where otherwise expressly stated.

 

(iii) a reference to “includes” or “including” shall mean “includes without limitation” or “including without limitation” respectively.

 

(iv) references to times are to Brussels time.

 

(v) any reference to a day (including within the phrase Business Day) shall mean a period of 24 hours running from midnight to midnight.

 

2 Scope and structure of the Bid

 

2.1 The Bidder agrees and undertakes that, subject to Clause 2.3, the Bid shall extend to 100% of the securities with voting rights or giving access to voting rights of the Target that are not yet owned by the Bidder or its Affiliates (the “Securities”):

 

(i) all 262,635,412 currently outstanding ordinary shares of the Target (listed on Euronext Brussels under ISIN-code BE0003864817), which amount shall be deemed to include such additional ordinary shares of the Target as may be issued from time to time as a result of the exercise of Warrants or conversion of Convertible Bonds, but to exclude any ordinary shares of the Target as are represented by ADSs (the “Shares”);

 

(ii) all 1,096,259 outstanding American Depositary Shares as of December 31, 2017, with each ADS representing 20 Shares (listed on the Nasdaq Global Select Market under ISIN-code US88675R1095), which amount shall be deemed to include such additional American Depositary Shares as may be issued from time to time as a result of deposits of underlying Shares, but to exclude such American Depositary Shares as may be exchanged from time to time for underlying Shares (“ADSs”);

 

(iii) all 14,534,956 outstanding warrants to acquire ordinary shares of the Target which amount shall be deemed to exclude any such warrants as may be exercised or lapse from time to time (the “Warrants”); and

 

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(iv) all 180 outstanding 9% senior unsecured convertible bonds due 6 March 2018 (ISIN-code BE6276591128) which amount shall be deemed to exclude any such convertible bonds as may be converted or redeemed from time to time (the “Convertible Bonds”).

 

2.2 The Bidder shall offer a price in cash in both the Belgian Offer and US Offer, as applicable, for the Securities as follows:

 

(i) EUR 1.78 for each Share (the “Price per Share”);

 

(ii) an amount in Euro (EUR) (payable in United States Dollars (USD)) or United States Dollars (USD) equivalent to the Price per Share (as decided by the Bidder in its sole discretion), adjusted for the ratio of the number of Shares underlying each ADS of 20:1 (the “Price per ADS”);

 

(iii) depending on the strike price and maturity of the Warrant, and subject to any comments that the FSMA may have on the assumptions used by the Bidder for its Black-Scholes valuation methodology, the offer price for each category of outstanding Warrants is as set out in Schedule 2 (the “Applicable Warrant Prices”); and

 

(iv) EUR 198,152 for each Convertible Bond (the “Price per Convertible Bond”).

 

2.3 Subject to the terms and conditions of this Agreement, the Bidder shall launch the Bid simultaneously by way of (i) an offer in Belgium (pursuant to Chapter II of the Royal Decree on Public Takeover Bids) for all Securities (except ADSs) not yet owned by the Bidder or its Affiliates (the “Belgian Offer”) and, (ii) an offer in the U.S. relating to (A) all ADSs and (B) subject to exemptions that may be available in the U.S., all other Securities held by US Persons, unless otherwise required by US Securities Laws or other Applicable Law (the “US Offer”); provided, however, that any Securities held by US Persons excluded from the US Offer pursuant to exemptions available in the U.S. shall be included in the Belgian Offer.

 

2.4 The terms and conditions of the Bid set forth in this Agreement shall apply, in all material respects, to the Belgian Offer and the US Offer; it being understood, however, that the requirements of US Securities Laws and the Belgian Takeover Rules may require adjustments to the terms and timelines of the Belgian Offer and/or the US Offer and other terms and conditions not specifically addressed in this Agreement. Without limitation to, and subject to, the foregoing, the Parties acknowledge and agree that they will cooperate, acting reasonably, to agree with the SEC and the FSMA on timelines in these respects, to permit the Belgian Offer and the US Offer to run simultaneously (to the extent permitted by Applicable Law).

 

3 Conditions of the Bid

 

3.1 The Bidder agrees and undertakes that the commencement of the Bid shall not be subject to any conditions precedent other than receipt of the approval of the Prospectus and the Response Memorandum by the FSMA.

 

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3.2 The Bidder agrees and undertakes that Completion of the Bid shall not be subject to any conditions, other than the following (the “Conditions”):

 

(i) there shall have been validly tendered in accordance with the Bid, and not withdrawn, into the US Offer and the Belgian Offer, in aggregate, a number of Securities that, together with all Securities owned by the Bidder and its Affiliates, represents or gives access to 85% or more of the voting rights represented or given access to by all of the outstanding Securities on a fully diluted basis as of the end of the First Acceptance Period;

 

(ii) the absence of a Material Adverse Effect occurring at any time after the Initial Announcement;

 

(iii) the Target’s product Cx601 shall have received marketing authorisation in the E.U. from the European Medicines Agency (EMA); and

 

(iv) receipt of US Anti-trust Clearance.

 

4 Undertakings in relation to timing

 

4.1 Immediately following the signing of this Agreement, the Bidder shall announce via press release its intention to launch the Belgian Offer in accordance with article 8 of the Royal Decree on Public Takeover Bids, and the US Offer, in the form as set out in Schedule 3 (the “Initial Announcement”). The Target shall simultaneously publish a press release to acknowledge the Bidder’s announcement in the form as set out in Schedule 4.

 

4.2 As soon as reasonably possible, and no later than 16 February 2018, the Bidder will formally notify the Belgian Offer (including the draft Prospectus) to the FSMA in accordance with article 5 of the Royal Decree on Public Takeover Bids (the “Formal Notification”). The Bidder shall provide the Target and its counsel with a reasonable opportunity to review the draft Prospectus before such document is filed with the FSMA. The Bidder shall address any comments from the FSMA on the draft Prospectus, and respond to any requests in connection with the FSMA’s review thereof, as promptly as practicable in order to commence the Bid as soon as possible following Formal Notification.

 

4.3 The Bidder shall make any other required filings under the US Securities Laws in a timely manner, including, but not limited to, any required Schedule TO pre-commencement, commencement or post-commencement communications in connection with the Bid.

 

4.4 The Bidder shall commence the Bid following the FSMA having approved the Prospectus and the Response Memorandum in accordance with article 30, second paragraph of the Royal Decree on Public Takeover Bids (the date of such commencement, the “Commencement Date”).

 

4.5 Without prejudice to its obligations under article 35 of the Royal Decree on Public Takeover Bids, and unless the Bidder decides to withdraw its Bid upon announcement of the results of the first acceptance period (the “First Acceptance Period”) (due to non-satisfaction of any of the Conditions), the Bidder undertakes to voluntary reopen its Bid for a period of 10 Business Days (the “Second Acceptance Period”) on the tenth Business Day after publication of the results of the First Acceptance Period, to allow the holders of Warrants to exercise their Warrants during the Exceptional Exercise Period and tender the Shares received as a result of such exercise in the Bid as set out in Clause 7.1.

 

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4.6 On the Commencement Date, the Bidder shall commence (within the meaning of Rule 14d-2 under the Exchange Act) the US Offer and (i) file with the SEC a tender offer statement on Schedule TO with respect to the US Offer (together with all amendments and supplements thereto and including exhibits thereto, the “Schedule TO”) that shall include the summary term sheet required thereby and, as exhibits, the offer to purchase and a form of letter of transmittal and summary advertisement (collectively, together with any amendments or supplements thereto, the “US Offer Documents”) and (ii) cause the US Offer Documents to be disseminated to holders of ADSs and the US Persons that hold Securities to the extent required by applicable US Securities Laws. The Bidder agrees to promptly correct any information provided by it for use in the Schedule TO or Schedule 14D-9 Response if and to the extent that such information shall have become (or shall have become known to be) false or misleading in any material respect. In the event of any correction to the Schedule TO, the Bidder shall use its reasonable best efforts to cause the Schedule TO as so corrected to be filed with the SEC and the US Offer Documents as so corrected to be disseminated to holders of ADSs and the US Persons that hold Securities, in each case to the extent required by US Securities Laws. The Target and its counsel shall be given a reasonable opportunity to review and comment on the Schedule TO and the US Offer Documents each time before any such document is filed with the SEC, and the Bidder shall give reasonable and good faith consideration to any comments made by the Target and its counsel. The Bidder shall provide the Target and its counsel with (i) any material comments or other communications, whether written or oral, that the Bidder or its counsel may receive from time to time from the SEC or its staff with respect to the Schedule TO or US Offer Documents promptly after receipt of those comments or other communications and (ii) a reasonable opportunity to participate in the response of the Bidder to those comments and to provide comments on that response (to which reasonable and good faith consideration shall be given).

 

4.7 The Bidder undertakes that the First Acceptance Period shall close no earlier than 20 Business Days after the Commencement Date. The Bidder undertakes to open and close the First Acceptance Period, Second Acceptance Period and any other acceptance periods of the Belgian Offer and the US Offer simultaneously (to the extent permitted by Applicable Law).

 

4.8 Following the Extended Completion Date, the Bidder shall launch a squeeze-out in accordance with article 42 of the Royal Decree on Public Takeover Bids at the applicable Prices per Security of the Belgian Offer and US Offer, if the conditions for such a squeeze-out are met, with a view to acquiring the Securities that were not acquired by the Bidder during the course of the First Acceptance Period or Second Acceptance Period.

 

4.9 In connection to the Bidder’s Affiliate (Takeda Pharmaceuticals International AG) and the Target’s Affiliate’s (TiGenix S.A.U) licence agreement dated 4 July 2016, the Bidder undertakes to provide (whether itself or through one of its Affiliates) a duly completed orphan drug appeal dossier to the Target by 30 January 2018. Subject to the receipt of such dossier, the Target undertakes to file the orphan drug appeal based on such dossier by 2 February 2018 (close of business CET).

 

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5 Undertakings during the Interim Period

 

5.1 Obligations during the Interim Period

 

5.1.1 Upon the terms and subject to the conditions of this Agreement, the Bidder agrees and undertakes that it will, during the Interim Period:

 

(i) subject to Clause 5.1.2(i), use its reasonable best efforts to secure the approval of the Prospectus by the FSMA, the US Anti-trust Clearance and any other required regulatory or other approvals from any Governmental Entity as promptly as possible, provided, however, that nothing in this Agreement obligates the Bidder (i) to agree or implement an agreement to divest, hold separate, license, or otherwise dispose of any assets, businesses, entities, or operations; or (ii) to agree to or accept any restrictions upon the ability of the Bidder, its subsidiaries or Affiliates to own, operate, or conduct any assets, businesses, entities, or operations of the Bidder, the Target, or their respective subsidiaries or Affiliates;

 

(ii) in furtherance, and not in limitation of the foregoing, make an appropriate filing of a Notification and Report Form pursuant to the HSR Act with respect to the Bid as promptly as practicable following the date of this Agreement, and respond as promptly as practicable to any requests for additional information and documentary material from a Governmental Entity in connection with such filing; and

 

(iii) agree on a common communications strategy regarding the Bid in close cooperation with the Target, and not issue any press releases or any other form of public statement in relation to the Bid, or having directly or indirectly a negative impact on the Bid, without the prior written approval of the Target which shall not be unreasonably withheld, conditioned or delayed, and subject always to applicable disclosure obligations under Applicable Law or stock exchange regulations.

 

5.1.2 Upon the terms and subject to the conditions of this Agreement, the Target agrees and undertakes that it will, during the Interim Period:

 

(i) make an appropriate filing of a Notification and Report Form pursuant to the HSR Act with respect to the Bid as promptly as practicable following the date of this Agreement, and respond as promptly as practicable to any requests for additional information and documentary material from a Governmental Entity in connection with such filing;

 

(ii) except to the extent that to do so is prohibited by Applicable Law, timely provide to the Bidder such information and assistance as may reasonably be required to prepare (a) the Prospectus, (b) the US Offer Documents and (c) the regulatory filings in connection with the US Anti-trust Clearance and any other required regulatory or other approvals as promptly as possible;

 

(iii) support the Bid, subject to compliance with the requirements of the HSR Act and without prejudice to the fiduciary duties of the Board of Directors as provided for by Applicable Law and the corporate interest (vennootschapsbelang / intérêt social) of the Target, including, without limitation, procuring that the Board of Directors will:

 

  •   not take any action which it knows or reasonably should know could materially prejudice, prevent or delay the successful outcome of the Bid;

 

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  •   subject to review of the Prospectus (provided that the price per security and the conditions as set forth therein are consistent with the Prices per Security and the Conditions), render a positive advice in the Response Memorandum with respect to the Bid and with respect to the other matters that are to be addressed in the Response Memorandum. Once the draft Response Memorandum has been filed with the FSMA, the Target shall provide the Bidder and its counsel with a reasonable opportunity to review the Response Memorandum before the final draft is filed with the FSMA for approval;

 

  •   subject to review of the US Offer Documents, which shall be completed prior to the Commencement Date, file with the SEC contemporaneously with the commencement of the Bid, or as promptly as practicable thereafter, and disseminate to holders of ADSs and US Persons that hold Securities to the extent required by applicable US Securities Laws, a solicitation/recommendation statement on Schedule 14D-9 (the “Schedule 14D-9 Response”), that shall reflect the recommendation of the Board of Directors and shall otherwise comply with all US Securities Laws applicable to the Target with respect to the Bid; and

 

  •   provide the Bidder with all reasonable assistance to implement the Bid and any related procedures (e.g., re-opening of the Bid, squeeze-out and delisting), including, but not limited to, in dealings with the FSMA, the SEC, Euronext Brussels, Nasdaq and any other relevant authorities;

 

(iv) subject to Clause 5.1.3, procure that the Board of Directors and the boards of directors of its Affiliates shall not solicit or assist any third party to analyse, organise or otherwise initiate a potential public takeover bid, merger, or any other transaction by such third party that would relate to a transfer of all or a significant part of the securities or assets of any member of the Target Group, except that the Target and any member of the Target Group shall not be restricted from (A) engaging in contacts and discussions for the sole purpose of providing access to the Ethos virtual data room as provided to the Bidder (with the exception of the Q&A) following a bona fide written unsolicited proposal for a competing bid under articles 37 to 41 of the Royal Decree on Public Takeover Bids from a third party (a “Target Takeover Proposal”) (i) which the Board of Directors reasonably believes (taking financial, regulatory and timing aspects into account and based on advice from reputable independent financial advisors as well as advice from professional legal counsel regarding compliance of such competing bid with the Belgian Takeover Rules) to be a serious potential bidder that is capable (from a financial perspective) of launching such competing bid and (ii) which the Board of Directors determines in good faith to be more favourable to the holders of Securities than the Bid contemplated by this Agreement (a “Superior Target Takeover Proposal”), provided that in such case the Target will not provide any assistance to the third party (whether through Q&A process or otherwise) other than providing access to the Ethos virtual data room or (B) transferring any goods or providing services in or by the Target or any other member of the Target Group in the ordinary course of business and consistent with past practice (which shall, for the avoidance of doubt, not extend to the licensing, assigning or transferring of any intellectual property rights of any member of the Target Group), to the extent not prohibited herein. This Clause 5.1.2(iv) replaces Clause 4.1 of the Addendum to the Confidentiality Agreement and from and including the date of this Agreement, Clause 4.1 of the Addendum to the Confidentiality Agreement shall no longer apply as between the Parties (who shall each also procure that such Clause 4.1 of the Addendum to the Confidentiality Agreement is no longer applied by their respective applicable Affiliate from and including the date of this Agreement);

 

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(v) procure that the members of the Board of Directors will enter into an irrevocable undertaking providing, among other matters, that the members of the Board of Directors will, subject to the terms and conditions of such irrevocable undertaking, tender their Securities to the Bidder under the Bid and not acquire any further Securities in the Target;

 

(vi) not acquire any Securities in the Target;

 

(vii) procure that the Board of Directors will not increase the share capital of the Target by application of article 6 (Authorised share capital) of the Articles of Association of the Target, it being understood for the avoidance of doubt that this will not prevent any increase in the share capital of the Target resulting from the exercise of the outstanding Warrants and/or the conversion of the Convertible Bonds;

 

(viii) agree on a common communications strategy regarding the Bid in close cooperation with the Bidder, and not issue any press releases or any other form of public statement in relation to the Bid, or having directly or indirectly a negative impact on the Bid, without the prior written approval of the Bidder which shall not be unreasonably withheld, conditioned or delayed, and subject always to applicable disclosure obligations under Applicable Law or stock exchange regulations;

 

(ix) following the release of the Initial Announcement, use reasonable best efforts to assist the Bidder in identifying and contacting the holders of the Securities (including the beneficial holders of the Securities), subject to compliance with US Securities Laws;

 

(x) following the release of the Initial Announcement, use reasonable best efforts to assist the Bidder in (i) approaching any third party that is a party to any material agreement or arrangement with any member of the Target Group which is, or is likely to be, affected materially by the Transaction, and (ii) obtaining, to the extent possible, any waiver, consent or other confirmation from such third party that may be deemed reasonably necessary or appropriate by the Parties for the purpose of the Transaction. For the avoidance of doubt, no such waiver, consent or other confirmation shall be a Condition. If the Target or any other member of the Target Group is contacted by such third party regarding the Bid or the Transaction, the Target shall consult and collaborate in good faith with the Bidder in dealing with such third party; and

 

(xi) not disclose (whether directly or indirectly) any material information with respect to the Target or any members of the Target Group to any person (other than the Target’s own advisors, it being understood that such advisors shall not have the right to disclose any such information to any third party in the context of a potential Target Takeover Proposal), unless it discloses the same information simultaneously to the Bidder, subject to compliance with Applicable Law.

 

5.1.3 The undertakings of the Target set out in Clause 5.1.2 are subject to compliance with any fiduciary duties that the Board of Directors and the boards of directors of the applicable Affiliates of the Target may have. In the event of a Superior Target Takeover Proposal, the Board of Directors expressly reserves the right to (x) no longer recommend and support the Bid, and (y) express a preference for the Superior Target Takeover Proposal, or otherwise recommend it to the holders of the Securities, in accordance with its fiduciary duties (a “Change of Recommendation”).

 

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5.1.4 The Parties confirm that they are not, and do not intend to be, acting in concert (in onderling overleg handelend/agissant de concert) within the meaning of article 3 §1, 5° of the Law on Public Takeover Bids prior to the Completion Date and the Parties agree that any provisions of this Agreement should be interpreted accordingly.

 

5.1.5 The Bidder acknowledges and agrees that any information and/or assistance provided by the Target or any member of the Target Group to assist the Bidder in (x) satisfying the Conditions, (y) preparing the Prospectus or (z) preparing the US Offer Documents (or any other filings required by US Securities Laws), in each case, in connection with the Bid, shall be provided on the basis that neither the Target nor any members of the Target Group nor any of their respective officers, directors or employees shall incur any liability in respect of any loss or damage that the Bidder may suffer as a result of the provision of any such information and/or assistance, other than in case of gross negligence or willful misconduct.

 

5.2 Conduct of business operations in the ordinary course of business

Upon the terms and subject to the conditions of this Agreement, the Target agrees and undertakes that it will, during the Interim Period, conduct its business operations as a going concern in the ordinary course of business, subject to the limitations set out in Clause 5.3 and that, in particular but without limitation, the Target shall, except with the prior written consent of the Bidder, which consent shall not be unreasonably withheld, conditioned or delayed:

 

(i) duly perform the material agreements the Target Group is party to with respect to its business operations;

 

(ii) use reasonable best efforts to maintain all material licenses, permits, authorisations and approvals required for the business operations of the Target Group;

 

(iii) use reasonable best efforts to maintain all material insurance policies that were entered into in relation to the business operations of the Target Group;

 

(iv) use reasonable best efforts to renew all material insurance policies required to continue the business operations of the Target Group;

 

(v) maintain the corporate structure (e.g., not incorporate subsidiaries or open branch offices) and domicile, board and (executive) management structure, operational structure, working capital and/or equity capital structure of the Target Group existing at the date of signing of this Agreement, subject to (A) such changes as required by Applicable Law, (B) such changes in the equity capital structure of the Target that would result from the exercise of the Warrants and/or the conversion of the Convertible Bonds and (C) such changes in working capital arising in the ordinary course of business or as a result of the taking of any action not prohibited by this Agreement;

 

(vi) retain the Key Employees on their existing terms and conditions or as provided for under the terms of this Agreement (without prejudice to the right of each Key Employee to voluntarily terminate his/her employment relationship with any member of the Target Group, for which the Target shall not be held to be in breach of this Clause 5.2(vi)); and

 

(vii) maintain, to the extent reasonably practicable, the relations and goodwill of the Target’s key customers, suppliers, credit providers and any other persons or companies with which the Target Group has material commercial relations at the date of signing of this Agreement.

 

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5.3 Limitations during the Interim Period

Upon the terms and subject to the conditions of this Agreement, and always subject to the fiduciary duties of the Board of Directors as provided for by Applicable Law and the corporate interest (vennootschapsbelang / intérêt sociale) of the Target, the Target agrees and undertakes that it will not, during the Interim Period, except (i) with the prior written consent of the Bidder, which consent shall not be unreasonably withheld, conditioned or delayed and (ii) for any such actions contemplated by this Agreement:

Agreements

 

(i) enter into any agreements that impose any material restriction or limitation on the business operations of the Target Group as a whole or materially limit the use, ownership, or exploitation of any material technology or intellectual property rights of the Target Group as a whole, including, but not limited to, non-competition, exclusivity, licensing or similar restrictions or limitations;

 

(ii) enter into, materially amend or terminate any agreements with directors or Key Employees or otherwise materially change the terms and conditions of their contractual relationship with the Target Group;

 

(iii) enter into employment agreements with new employees of the Target Group except that this Clause 5.3(iii) shall not restrict the Target Group from entering into such new agreements with up to the equivalent of 7 additional FTEs in the manufacturing and quality divisions to support the growth of the Target Group and which are entered into in the ordinary course of business by the Target Group on terms and conditions consistent with past practice and not exceeding a total annual cost for the Target Group (including any taxes and/or employer and employee social security contributions) of EUR 600,000;

 

(iv) increase the salary or bonus of any employees of the Target Group, except that this Clause 5.3(iv) shall not restrict the carrying out of the annual remuneration review and normal promotion processes for, and the making of any related performance and other remuneration payments (up to 100% of any person’s target bonus or involving any such salary increase not to exceed 3%) to any employees of any member of the Target Group in the ordinary course of business;

Indebtedness

 

(v) undertake any issuance of new debt securities, including, but not limited to, the issuance of convertible instruments and derivatives;

Tax acceleration

 

(vi) take any action (other than in the ordinary course of business or as required by Applicable Law) that would have the effect for income tax purposes of accelerating taxable income from a date following the Completion Date to a date preceding the Completion Date;

Settlements

 

(vii) settle any claims in such a manner as would have a Material Adverse Effect;

 

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Dividends

 

(viii) declare any new dividends pursuant to articles 617 and 618 of the Belgian Company Code;

Articles of Association

 

(ix) amend the Articles of Association of the Target, other than as the result of an exercise of Warrants or conversion of Convertible Bonds;

Equity

 

(x) issue any new securities or any other rights giving right to acquire any new securities, or undertake to do so or, subject to Clauses 5.1.2(iv) and 5.1.3, enter into any discussions in order to do so (except discussions with the Target’s own financial and legal advisors), other than the issuance of new shares resulting from the exercise of any Warrants and/or the conversion of any Convertible Bonds.

 

6 Undertakings of the Parties following Completion of the Bid

The Target shall be subject to the undertakings and limitations in this Clause 6 solely in the event that the Bidder shall have acquired, as a result of the Bid, in aggregate, a number of Securities that, together with all Securities owned by the Bidder and its Affiliates, represents or gives access to 50% or more of the voting rights represented or given access to by all of the outstanding Securities on a fully diluted basis as of the end of the First Acceptance Period.

 

6.1 Obligations following Completion of the Bid

The Target agrees and undertakes that it will, following Completion of the Bid, support the Bidder, without prejudice to the fiduciary duties of the Board of Directors as provided for by Applicable Law and the corporate interest (vennootschapsbelang / intérêt social) of the Target, including, without limitation, procuring that the Board of Directors will provide the Bidder with all reasonable assistance to further implement the Bid and any related procedures (e.g., re-opening of the Bid, squeeze-out and delisting), including, but not limited to, in dealings with the FSMA, the SEC, Euronext Brussels, Nasdaq and any other relevant authorities.

 

6.2 Conduct of business operations in the ordinary course of business

The Target agrees and undertakes that it will, following Completion of the Bid, conduct its business operations as a going concern in the ordinary course of business, subject to the limitations set out in Clause 6.3 and that, in particular but without limitation, the Target shall:

 

(i) duly perform the material agreements the Target Group is party to with respect to its business operations;

 

(ii) maintain, as far as reasonably possible, all material licenses, permits, authorisations and approvals required for the business operations of the Target Group;

 

(iii) maintain, as far as reasonably possible, all material insurance policies that were entered into in relation to the business operations of the Target Group;

 

(iv) renew, as far as reasonably possible, all material insurance policies required to continue the business operations of the Target Group;

 

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(v) maintain the corporate structure and domicile, board structure, operational structure, working capital and/or equity capital structure of the Target Group existing at the date of signing of this Agreement, subject to (A) such changes as required by Applicable Law, (B) such changes in the equity capital structure of the Target that would result from the exercise of the Warrants and/or the conversion of the Convertible Bonds and (C) such changes in working capital arising in the ordinary course of business or as a result of the taking of any action not prohibited by this Agreement;

 

(vi) retain the Key Employees on their existing terms and conditions or as provided for under the terms of this Agreement (without prejudice to the right of each Key Employee to voluntarily terminate his/her employment relationship with any member of the Target Group, for which the Target shall not be held to be in breach of this Clause 6.2(vi)); and

 

(vii) maintain, to the extent reasonably practicable, the relations and goodwill of the Target’s key customers, suppliers, credit providers and any other persons or companies with which the Target Group has material commercial relations at the date of signing of this Agreement.

 

6.3 Limitations following Completion of the Bid

Subject to the fiduciary duties of the Board of Directors as provided for by Applicable Law and the corporate interest (vennootschapsbelang / intérêt sociale) of the Target, the Target agrees and undertakes that it will not, following Completion of the Bid, except for any such actions contemplated by this Agreement:

Agreements

 

(i) enter into any agreements that impose any material restriction or limitation on the business operations of the Target Group or materially limit the use, ownership, or exploitation of any material technology or intellectual property rights of the Target Group, including, but not limited to, non-competition, exclusivity, licensing, non-disclosure, confidentiality or similar restrictions or limitations;

 

(ii) enter into, materially amend or terminate any agreements with directors or Key Employees or otherwise materially change the terms and conditions of their contractual relationship with the Target Group;

Indebtedness

 

(iii) undertake any issuance of new debt securities, including, but not limited to, the issuance of convertible instruments and derivatives;

Tax acceleration

 

(iv) take any action (other than in the ordinary course of business or as required by Applicable Law) that would have the effect for income tax purposes of accelerating taxable income;

Settlements

 

(v) settle any claims in such a manner as would have a Material Adverse Effect;

 

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Dividends

 

(vi) declare any new dividends pursuant to articles 617 and 618 of the Belgian Company Code;

Articles of Association

 

(vii) amend the Articles of Association of the Target, other than as the result of an exercise of Warrants or conversion of Convertible Bonds;

Equity

 

(viii) issue any new securities or any other rights giving right to acquire any new securities, or undertake to do so or, enter into any discussions in order to do so, other than the issuance of new shares resulting from the exercise of any Warrants and/or the conversion of any Convertible Bonds.

 

6.4 Directors

The Target agrees and undertakes that it will, following Completion of the Bid, use reasonable best efforts to procure that:

 

(i) the directors and the members of the executive management will remain in function at least until the shareholders’ meeting referred to in Clause 6.4(iii) below;

 

(ii) the Board of Directors will in case of any vacancy, appoint a director upon the proposal of the Bidder, subject to Applicable Law; and

 

(iii) the Board of Directors will convene a general shareholders’ meeting of the Target as soon as possible to deliberate and decide on the appointment of one or more additional directors upon the proposal of the Bidder, subject to Applicable Law.

 

6.5 Directors’ and officers’ insurance

 

6.5.1 If and to the extent such obligations are permitted by Applicable Law, for six (6) years after the Completion Date, the Bidder shall procure that the members of the Target Group honour and fulfil their respective obligations (if any) existing as at the date of this Agreement to indemnify their current respective directors and officers and to advance reasonable expenses, in each case with respect to matters existing or occurring at or prior to the Completion Date.

 

6.5.2 With effect from the Completion Date, the Bidder shall procure that the directors and officers of the Target Group as of the Completion Date will benefit from cover under the directors’ and officers’ liability insurance existing within the Bidder at the Completion Date, which shall provide cover, in terms of amount and scope, at least as comprehensive as that provided under the Target Group’s directors and officers insurance as at 4 December 2017 (as tacitly renewed on the same terms and conditions). In addition, the Bidder agrees that, and shall procure that, the Target will extend the directors’ and offers’ liability insurance existing within the Target Group at the Completion Date for a period of six (6) years following the Completion Date. Such insurance cover contemplated by the preceding sentence shall be with one or more reputable insurer(s).

 

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7 Treatment of Warrants, Convertible Bonds and management incentives

 

7.1 Treatment of Warrants

 

7.1.1 The Bidder acknowledges that on 11 October 2017 the Target approved the accelerated vesting of the outstanding unvested Warrants held by all holders of Warrants other than the independent directors in accordance with article 4.2 of the applicable plans for such Warrants (the “Warrant Plans”). Such accelerated vesting is conditional on the start of the First Acceptance Period of the Bid and will allow more holders of Warrants to tender their Warrants (or the Shares received as a result of the exercise thereof) into the Bid. According to the terms and conditions of the Warrant Plans, the transfer restrictions applicable to the Warrants do not apply to tenders of Warrants (or the Shares received as a result of the exercise thereof) into the Bid.

 

7.1.2 The Bidder furthermore acknowledges that on 11 October 2017 the Target approved the creation of an exceptional exercise period (the “Exceptional Exercise Period”) of one (1) month in accordance with article 6.3 of the Warrant Plans for all vested and unvested Warrants held by any holder of a Warrant (including any independent director). The Exceptional Exercise Period shall commence from, and be subject to the occurrence of, the Completion Date provided that the Bidder shall have acquired control of the Target upon Completion of the Bid. To allow the holders of Warrants who decide to exercise their Warrants during this Exceptional Exercise Period sufficient time to tender their Shares (obtained as a result of the exercise of such Warrants) in the Bid, the Bidder undertakes to voluntarily reopen its Bid on the same terms and conditions, as during the First Acceptance Period, for a period of 10 Business Days. The Bidder shall allow the holders of Warrants to tender their Shares (obtained as a result of the exercise of such Warrants) in the Bid pending the effective issue of these Shares.

 

7.2 Treatment of Convertible Bonds

If any holders of the Convertible Bonds do not tender their Convertible Bonds into the Bid, but instead exercise their put option upon the occurrence of a change of control as set out in condition 7.5 of the terms and conditions of the Convertible Bonds, the Bidder agrees and undertakes to provide a secured loan (such loan to be made only once reasonable security documentation has been agreed between the Parties) to the Target on at arm’s length terms and conditions (or otherwise than as a loan, at the sole discretion of the Bidder), so that the Target can meet such payment obligations, in full and on a timely basis, as provided for in the terms and conditions of the Convertible Bonds. The Target shall use such funds exclusively for the payment obligations deriving from the exercise of the relevant put options as provided for in the terms and conditions of the Convertible Bonds.

 

7.3 Incentive Scheme

 

7.3.1 The Bidder acknowledges that, upon closing of the First Acceptance Period with confirmation by the Bidder that it accepts the Securities tendered in the First Acceptance Period, the Target intends to award a one-off payment of an incentive bonus with a total cost for the Target (including any taxes and/or employer and employee social security contributions) of 1% of the Transaction Value (the “Incentive Bonus”) to up to six key employees of the Target listed on, and in accordance with the terms set out in, Schedule 5 (the “Incentive Scheme”) to recognize the significant contribution of such key employees to the Target’s success.

 

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7.3.2 The Board of Directors intends to hold a board meeting that will ultimately confirm the beneficiaries among the abovementioned key employees of, and approve the amount payable to each such beneficiaries out of the applicable cap on, the Incentive Scheme, immediately after the closing of the First Acceptance Period, once the Bidder has announced whether it will accept the Securities tendered in the First Acceptance Period and prior to the Completion Date. The Target will immediately inform the Bidder of the decisions taken in respect of the Incentive Scheme. The actual payment of the Incentive Bonus by the Target will occur as soon as possible thereafter, and in any event prior to the Completion Date.

 

7.3.3 The Bidder acknowledges the intention of the Board of Directors to award such Incentive Bonus to the abovementioned key employees and confirms that the intended Incentive Bonus has no impact on the launch of the Bid or Completion of the Bid and is not perceived by the Bidder as a defensive measure nor a material change in the composition of the assets and liabilities of the Target.

 

8 Term and termination

 

8.1 Term

The Agreement will commence on the date of signing of this Agreement and will continue to be in effect until the earlier of 31 December 2018 and termination in accordance with its terms.

 

8.2 Termination

Unless otherwise agreed by the Parties, this Agreement may be terminated with immediate effect by giving notice in writing to the other Party:

 

(i) by the Bidder, if:

 

  (a) the Target shall have failed to comply with its undertakings under Clauses 5.1.2(vii), 5.3(ix) or 5.3(x);

 

  (b) the Target shall have failed to comply with its undertakings under sections (i) to (iv) of Clause 5.1.2, which failure to comply (A) would prevent the Completion of the Bid and (B)(i) is incapable of being cured so as to enable Completion of the Bid to occur prior to the Long Stop Date or, (ii) if curable, is not cured by the Target within ten (10) Business Days of any of the six key managers listed in Schedule 5 or the General Counsel of the Target having obtained actual knowledge (having made all reasonable enquiries and given appropriate instructions to the employees of the Target and other members of the Target Group promptly following the signing of this Agreement) of the failure, provided that the Target has promptly notified the Bidder in writing of the failure (absent such prompt notification, the Target shall not have the benefit of the cure period);

 

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  (c) the Target shall have failed to comply with its undertakings under Clauses 5.2 or 5.3 (other than Clause 5.3(ix) and Clause 5.3(x)), which failure to comply (A) would have a Material Adverse Effect on the Target Group as a whole and (B)(i) is incapable of being cured or, (ii) if curable, is not cured by the Target within ten (10) Business Days of any of the six key managers listed in Schedule 5 or the General Counsel of the Target having obtained actual knowledge (having made all reasonable enquiries and given appropriate instructions to the employees of the Target and other members of the Target Group promptly following the signing of this Agreement) of the failure, provided that the Target has promptly notified the Bidder in writing of the failure (absent such prompt notification, the Target shall not have the benefit of the cure period;

 

  (d) a Change of Recommendation shall have occurred; or

 

  (e) following the closing of the First Acceptance Period, if at the closing of the First Acceptance Period:

 

  (A) (i) the Condition in Clause 3.2(i) (acceptance threshold) is not satisfied and has not been waived by the Bidder or (ii) the Condition in Clause 3.2(iv) (US Anti-trust Clearance) is not satisfied or (iii) the Condition in Clause 3.2(iii) (marketing authorization) is not satisfied and has not been waived by the Bidder; or

 

  (B) the Condition in Clause 3.2(ii) (Material Adverse Effect) is not satisfied and has not been waived by the Bidder;

 

(ii) by the Target, if:

 

  (a) Completion of the Bid fails to occur prior to the Long Stop Date;

 

  (b) the Bidder shall have breached or failed to comply with its obligations under Clauses 4.1, 4.2 (last sentence only), 4.3, 4.4, 4.5, 4.6, 5.1.1(i) or 5.1.1(ii) of this Agreement, which breach or failure to perform would prevent the Completion of the Bid by the Long Stop Date;

 

  (c) the Formal Notification shall have failed to occur by 16 February 2018, other than for delays directly attributable to the FSMA, the SEC or any other Governmental Entity involved;

 

  (d) the Bidder shall have reduced the Price per Security set forth in Clause 2.2 or the Bidder shall have withdrawn the Bid prior to the start of the First Acceptance Period; or

 

  (e) a Change of Recommendation shall have occurred.

 

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8.3 Effect of termination

 

(i) Termination of this Agreement shall be without prejudice to the rights of any of the Parties which have arisen at or prior to termination. If the Agreement is terminated pursuant to Clause 8.2:

 

  (a) the Break Payment will be payable by the Target if an event described in Clause 8.2(i)(a), (b), (c) or (d) entitling the Bidder to terminate the Agreement, or in Clause 8.2(ii)(e), entitling the Target to terminate the Agreement, has occurred prior to, or occurs simultaneously with, termination of this Agreement;

 

  (b) the Bidder will be subject to the Equity Investment (or the Equity Investment Substitute, as applicable) if an event described in Clause 8.2(i)(e)(A), entitling the Bidder to terminate the Agreement, or in Clause 8.2(ii)(c), entitling the Target to terminate the Agreement, has occurred prior to, or occurs simultaneously with, termination of this Agreement;

 

  (c) the Reverse Break Payment will be payable by the Bidder if an event described in Clause 8.2(ii)(b) or (d), entitling the Target to terminate the Agreement, has occurred prior to, or occurs simultaneously with, termination of this Agreement; and

 

  (d) subject to Applicable Law, the Bidder shall withdraw the Bid as soon as possible if the Target terminates the Agreement pursuant to Clause 8.2(ii)(a); provided, however, that if such withdrawal is prohibited by Applicable Law, the Bidder shall withdraw the Bid promptly after such withdrawal is no longer prohibited by Applicable Law.

 

(ii) In addition, Clause 7 of the Confidentiality Agreement and Clause 3.1 (Standstill) of the Addendum to the Confidentiality Agreement shall no longer apply as between the Parties (who shall each also procure that such Clauses are no longer applied by their respective applicable Affiliate from and including the date of the Change of Recommendation).

 

8.4 Survival

Clauses 8 to 16 (inclusive) shall survive termination of this Agreement. Clause 6 shall survive termination of this Agreement if the Bid is nonetheless completed by the Bidder.

 

9 Break Payment, Equity Investment and Reverse Break Payment

 

9.1 Break Payment

If this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(a), (b), (c) or (d), or by the Target pursuant to Clause 8.2(ii)(e), the Target shall pay to the Bidder a break payment by way of compensation for any loss or damage (including, but not limited to, incurring costs and expenses, lost opportunity costs, business dislocation, reputational harm or adverse market reaction) that may be suffered by the Bidder (the “Break Payment”) equal to:

 

  (a) two million seven hundred thousand euro (EUR 2,700,000) if this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(a), (b) or (c); or

 

  (b) five million four hundred thousand euro (EUR 5,400,000) if this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(d) or by the Target pursuant to Clause 8.2(ii)(e).

 

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9.2 Equity Investment

 

9.2.1 If this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(e)(A) or by the Target pursuant to Clause 8.2(ii)(c), the Target shall have the right to require the Bidder to subscribe, and the Bidder commits to subscribe for, directly and/or indirectly through any Affiliate, ordinary shares (which may be issued to the Bidder and/or any Bidder’s Affiliates in the form of ADSs) of the Target, upon the terms of a subscription agreement to be negotiated in good faith, taking into account market practice in connection with private placements and public offerings (also with reference to representations and warranties of the Target concerning the valid incorporation and existence of the Target and the valid issuance and transfer of title to the shares) and to be agreed upon between the Target and the Bidder and/or any Bidder’s Affiliates (the “Subscription Agreement”). If the Target elects to enforce the abovementioned subscription commitment, the ordinary shares (which may be represented by ADSs) shall be issued by the Target within six (6) months from the date of termination of this Agreement, on a private placement basis (in which case the price per ordinary share or ADS subscribed, as applicable, will be based on the average closing share prices of the Target on Euronext Brussels during the period of 30 (thirty) calendar days immediately prior to the date of the issuance thereof), or as part of a public offering (in which case the price per share or ADS subscribed will be based on the public offering price and such commitment shall be subject to the relevant allocation by the managing underwriters of such offering), as elected by the Target, for an aggregate amount in cash equal to (the “Equity Investment”):

 

  (a) twenty million euro (EUR 20,000,000) if this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(e)(A)(i) (acceptance threshold), provided that there shall have been validly tendered in accordance with the Bid, and not withdrawn, into the US Offer and the Belgian Offer, in aggregate, a number of Securities that, together with all Securities owned by the Bidder and its Affiliates, represents or gives access to 75% or more of the voting rights represented or given access to by all of the outstanding Securities on a fully diluted basis as of the end of the First Acceptance Period;

 

  (b) fifteen million euro (EUR 15,000,000) if this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(e)(A)(ii) (Anti-trust Clearance) or by the Target pursuant to Clause 8.2(ii)(c); and

 

  (c) twenty million euro (EUR 20,000,000) if this Agreement is terminated by the Bidder pursuant to Clause 8.2(i)(e)(A)(iii) (marketing authorization), provided that the marketing authorization has not been received due to the length of the orphan drug appeal process, despite the Target having filed this appeal by 2 February 2018 (close of business CET) as provided for in Clause 4.9.

 

9.2.2 The subscription commitment described in Clause 9.2.1 shall terminate:

 

(i) in case the subscription process has not been initiated by the Target within four (4) months from the date of termination of this Agreement and the relevant capital increase has not been completed within six (6) months from the date of termination of this Agreement (including the signing of the Subscription Agreement);

 

(ii) in case the Equity Investment would breach or is reasonably likely to breach applicable anti-trust regulations; or

 

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(iii) in the event that, on a pro forma basis taking into consideration the receipt of the proceeds of the Equity Investment, (A) the Target is, or is reasonably likely to be, insolvent or declared bankrupt or liquidated or (B) if proceedings to that effect have been initiated or reasonably threatened by the Target or a third party.

 

9.2.3 If the subscription commitment described in Clause 9.2.1 is terminated pursuant to Clause 9.2.2(ii), then the Bidder shall, directly and/or indirectly through any Affiliate, make available to the Target, upon the terms of an agreement to be negotiated in good faith, taking into account market practice, and to be agreed upon between the Target and the Bidder and/or any Bidder’s Affiliates, an amount equal to the euro amount set forth in Clause 9.2.1 for the event pursuant to which the Equity Investment was to be made (the “Equity Investment Substitute”).

 

9.2.4 The Target will request Euronext Brussels to admit the shares to trading on Euronext Brussels. The shares will be subject to a three (3) months lock-up as from their issuance.

 

9.2.5 The Bidder shall be deemed to have terminated this Agreement pursuant to Clause 8.2(i)(e)(A) if the Bid is withdrawn or lapses because any of the Conditions referred to in Clause 8.2(i)(e)(A) are not satisfied or have not been waived.

 

9.3 Reverse Break Payment

If this Agreement is terminated by the Target pursuant to Clause 8.2(ii)(b) or (d), the Bidder shall pay to the Target a break payment by way of compensation for any loss or damage (including, but not limited to, incurring costs and expenses, lost opportunity costs, increased costs for obtaining additional financing, business dislocation, reputational harm or adverse market reaction) that may be suffered by the Target equal to twenty million euro (EUR 20,000,000) (the “Reverse Break Payment”).

 

9.4 Miscellaneous

 

9.4.1 If the Target would be entitled to the Equity Investment (or the Equity Investment Substitute, as applicable) and the Reverse Break Payment, then the Bidder will only be required to make either the Equity Investment (or the Equity Investment Substitute, as applicable) or the Reverse Break Payment. Similarly, if the Target would be entitled to the Equity Investment (or the Equity Investment Substitute, as applicable) or the Reverse Break Payment under several provisions of Clause 9.2 or 9.3 respectively, then the Bidder will only be required to make the Equity Investment (or the Equity Investment Substitute, as applicable) or the Reverse Break Payment once. The Target shall have the right, in its sole discretion, to elect the provision pursuant to which it requires the Equity Investment (or the Equity Investment Substitute, as applicable) or the Reverse Break Payment.

 

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9.4.2 The Parties irrevocably agree, having taken appropriate advice, that the Break Payment, the Equity Investment (or the Equity Investment Substitute, as applicable) and the Reverse Break Payment constitute fair and reasonable amounts payable by the Target and the Bidder, as applicable, on the occurrence of the events described above. The right of the Bidder to receive the Break Payment and the right of the Target to receive the Equity Investment (or the Equity Investment Substitute, as applicable) or Reverse Break Payment are in addition to any other rights or remedies they may have under Applicable Law. If the amount of the Break Payment, the Equity Investment (or the Equity Investment Substitute, as applicable) or the Reverse Break Payment would, at any moment in time, exceed the applicable legal limitations, the Parties will refrain from claiming the nullity, but the amount due will automatically be reduced to the applicable legal limitations.

 

9.4.3 The Target shall pay the Break Payment to the Bidder within twenty (20) Business Days of the day on which the event described in Clause 9.1 occurs. The Bidder shall pay or procure the payment of the Equity Investment Substitute or the Reverse Break Payment to the Target within twenty (20) Business Days of the day on which the event described in Clause 9.2.1 or Clause 9.3, respectively, occurs. The Parties anticipate, and shall use all reasonable endeavours to secure, that each of the Break Payment, the Equity Investment Substitute or the Reverse Break Payment, as applicable, is not and will not be treated as consideration for a taxable supply for VAT purposes. If, however, the Break Payment, the Equity Investment Substitute or the Reverse Break Payment is determined by any tax authority to be consideration in whole or part for a taxable supply for VAT purposes then: (a) the Target with respect to the Break Payment and the Bidder with respect to the Equity Investment Substitute or the Reverse Break Payment, shall provide the other Party with a valid VAT invoice in respect of that supply; and (b) if the Target with respect to the Break Payment and the Bidder with respect to the Equity Investment Substitute or the Reverse Break Payment, is liable to account for VAT in respect of that supply, the amount of the Break Payment, the Equity Investment Substitute or the Reverse Break Payment, as applicable, shall be increased to take account of such recoverable VAT. The Bidder or the Target may assign their creditor rights under the Break Payment, the Equity Investment Substitute or the Reverse Break Payment, as applicable; provided that if as a result of such assignment the other Party would become liable to account for VAT in respect of that supply and would not have been otherwise liable, such Party will not be required to increase the amount of the Break Payment, the Equity Investment Substitute or the Reverse Break Payment, as applicable, to take account of such recoverable VAT. VAT (if any) will only become due and payable upon presentation of a valid VAT invoice (or, where there is no provision in the legislation for the jurisdiction concerned that a VAT invoice is required to be issued, a written demand containing such information as is customary in that jurisdiction).

 

9.4.4 Payments pursuant to this Clause 9 shall be made in immediately available funds (without any deduction or withholding, save only as required by Applicable Law, and without regard to any lien, right of set-off, counterclaim or otherwise) to such bank account of the Target, the Bidder or their respective Affiliates as may be notified by the recipient in writing for such purpose. If any amount is required to be withheld from any such payment, the Bidder or the Target, as applicable, shall pay to the other Party such additional amount so that the amount received by the Bidder or the Target, as applicable, shall be the same as it would have received without such withholding.

 

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10 Severability

 

10.1 If any provision in this Agreement would be held to be illegal, invalid or unenforceable, in whole or in part, under Applicable Law, then that provision will be deemed not to form part of this Agreement, and the legality, validity or enforceability of the remainder of this Agreement will not be affected.

 

10.2 In such case, each Party will use its reasonable best efforts to negotiate in good faith a valid replacement provision having a similar economic effect which is as close as possible to that of the invalid, void or unenforceable provision.

 

11 Costs and expenses

Without prejudice to the Break Payment, the Equity Investment (or the Equity Investment Substitute, as applicable) or the Reverse Break Payment or as otherwise provided in this Agreement, each Party shall pay its own costs and expenses in relation to the negotiation, preparation, execution and carrying into effect of this Agreement and any matter contemplated by it.

 

12 Notices

 

12.1 Any notice in connection with this Agreement must be in writing in English and will be validly given if:

 

(i) delivered by hand (with written confirmation of receipt) to the addressees listed hereinafter;

 

(ii) sent by e-mail (with confirmation sent by registered mail or courier company within three (3) Business Days) to the e-mail addresses set out hereinafter; or

 

(iii) sent by registered mail or courier company (with written confirmation of receipt) to the addresses set out hereinafter,

or to such other addressee, e-mail address or address as a Party may notify to the other Parties in accordance with this Clause 12.1.

 

to the Bidder:   

Takeda Pharmaceutical Company Limited

c/o Takeda Pharmaceuticals International AG

For the attention of EUCAN General Counsel

  

Thurgrauerstrasse 130

Glattpark-Opfikon

Zurich

Switzerland

   Email: [email protected]
with a copy to:    DLA Piper UK LLP
  

For the attention of Erwin Simons

Louizalaan 106

1050 Brussels

+32 2 500 16 94

   Email: [email protected]

 

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to the Target:   

TiGenix NV

For the attention of Eduardo Bravo

  

Romeinse straat 12 box 2

3001 Leuven

Belgium

+ 34 91 804 92 64

Email: [email protected]

with a copy to:   

Osborne Clarke CVBA

For the attention of David Haex

Marnixlaan 23

1000 Brussels

Belgium

+32 2 515 93 22

Email: [email protected]

 

Davis Polk & Wardwell LLP

For the attention of Michael J. Willisch

Paseo de la Castellana, 41

28046 Madrid

Spain

+34 91 768 9600

Email: [email protected]

 

12.2 Any notice will be effective upon receipt and will be considered received:

 

(i) at the moment of delivery, if delivered by hand or sent by courier company;

 

(ii) at the first Business Day following its being sent, if the notice was sent by e-mail (it being understood that, if the confirmation is not received within three (3) Business Days, the notice will only be considered received the date of effective receipt of such confirmation);

 

(iii) at the first Business Day following its being sent, if the notice was sent by registered mail, if the sender and addressee both have their registered office in Belgium; or

 

(iv) at the third Business Day following its being sent, if the notice was sent by registered mail and the sender and addressee do not have their registered office in Belgium.

 

13 Entire agreement

 

13.1 Save for the Addendum to the Confidentiality Agreement, this Agreement constitutes the whole and only agreement between the Parties relating to the Transaction and supersedes any previous agreement whether written or oral between the Parties in relation to the Transaction (including the non-binding expression of interest for the Bid by the Bidder dated 10 November 2017 and acknowledged by the Target on 13 November 2017).

 

13.2 Except in the case of fraud, each Party acknowledges that it is entering into this Agreement in reliance upon only this Agreement and that it is not relying upon any pre-contractual statement that is not set out in this Agreement.

 

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14 Assignment

 

14.1 Neither Party may assign all or part of its rights and obligations under this Agreement to any third party (including through a sale, a capital contribution, a donation or any other transaction, including the sale or contribution of a universality of goods (algemeenheid / universalité), a branch of activity (bedrijfstak / branche d’activité), a merger or (partial) demerger) without the prior written approval of the other Party. As long as such approval has not been obtained, the assigning Party will continue to be liable for all obligations that it intended to assign (without prejudice to any other right or remedy that the other Party may have for breach of this article) and the assignee will not be entitled to exercise any of the rights under this Agreement.

 

14.2 Without prejudice to Clause 14.1, the provisions of this Agreement will inure to the benefit of and will be binding upon the Parties and their assignees.

 

15 Counterparts

This Agreement may be executed in one or more counterparts, each of which when so executed will be deemed to be an original copy of this Agreement, and all of which, when taken together, will be deemed to constitute one and the same instrument.

 

16 Governing law and jurisdiction

 

16.1 This Agreement will be governed by and interpreted in accordance with Belgian Law with the exclusion of the rules of conflict of laws.

 

16.2 Except as otherwise agreed in writing by the Parties, the Courts of Brussels, Dutch section, Belgium, will have the exclusive competence over any disputes that may arise between the Parties in relation to this Agreement.

*                *

*

Done on 5 January 2018, in two (2) originals. Each Party acknowledges receipt of its own original.

 

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FOR THE BIDDER      
/s/ Misako Hirose  

 

 

 

 

 

Name:   Misako Hirose      
Title:   Director, Global Alliances      
  Global Business Development      
  Takeda Pharmaceutical Company Limited (Authorised Representative)

FOR THE TARGET

 

/s/ Eduardo Bravo  

 

   

 

Name:   Eduardo Bravo     Name:  
Title:   CEO     Title:  

FOR ACKNOWLEDGEMENT OF CLAUSES 5.1.2(iv) AND 8.3(ii):

FOR TAKEDA PHARMACEUTICALS INTERNATIONAL AG

 

/s/ Marcello Agosti     /s/ Andrea Ferrari
Name:   Marcello Agosti     Name:   Andrea Ferrari
Title:   Head of Global Business     Title:   Senior Director, Associate General Counsel
    Development & Global Commercial           Business Development & Commercial Law

FOR TIGENIX SAU

 

/s/ Eduardo Bravo      
Name:   Eduardo Bravo     Name:  
Title:   CEO     Title:  

 

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EX-99.2

Exhibit 2

CONFIDENTIAL DISCLOSURE AGREEMENT

This Agreement is made effective as of the date (the “Effective Date”) of the last signature hereto by and between:

TiGenix SAU, with registered office at Calle Marconi 1, Parque Tecnologico de Madrid, Tres Cantos, 28760 Madrid, Spain, registered with the Commercial Registry of Madrid under volume number 20117, page 81, sheet M-355159, and with tax identification number (CIF) A-84008986TiGenix”)

and

Takeda Pharmaceuticals International AG with registered office at Thurgauerstrasse 130, 8152 Glattpark-Opfikon (Zurich), Switzerland (“Takeda”).

TiGenix and Takeda are collectively referred to as the “Parties” and individually as a “Party”.

RECITALS

WHEREAS, TiGenix possesses certain proprietary, economic and business information relating to itself and its Affiliates (as defined below), including in relation to its and its Affiliates’ products (including, but not limited to, pipeline products and Cx601 (the “Product”)) and their respective business capabilities including, but not limited to, general financial and legal affairs;

WHEREAS, Takeda possesses certain proprietary, economic and business information relating to itself and its Affiliates (as defined below) and their respective business capabilities;

WHEREAS, the Parties are currently in partnership regarding the development and upcoming commercialisation of the Product. However, the current partnership regarding the Product does not include, amongst other, a partnership for commercialisation in the United States of America.

WHEREAS, the Parties wish to explore and evaluate a potential more in depth collaboration and business partnership regarding the Product and any other business opportunity the Parties may deem appropriate (including, but not limited to, potentially extending their business relationship in respect of the Product to, amongst other, the United States of America) (the “Purpose”). In order to do so, each of the Parties is willing to disclose to the other certain information which it deems confidential and proprietary in nature.

NOW THEREFORE, the Parties, mutually acknowledging their sufficient legal capacity to enter into and be bound by this Confidentiality Disclosure Agreement (hereinafter, the “Agreement”), agree as follows:

 

1. CONFIDENTIAL INFORMATION

For the purposes of this Agreement, “Affiliate” means in the context of the Recipient (as defined below) or the Disclosing Party (as defined below) any person, corporation, company, partnership, joint venture or other entity controlling, controlled by or under common control with either the Recipient or the Disclosing Party, as the case may be. For such purpose the term “control” means the holding of more than fifty percent (50%) of the common voting stock or ordinary shares in, or the right to appoint more than fifty percent (50%) of the directors of the said corporation, company, partnership, joint venture or other entity.

For the purposes of this Agreement, “Confidential Information” means any non-public information which is disclosed orally, electronically, visually or in a document or other tangible

 

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form and which is by nature confidential or is identified confidential by a Party or by a Party’s Affiliate (hereinafter, “Disclosing Party”) or which, under the circumstances surrounding disclosure ought to be treated as confidential by the Party that receives such information or by such Party’s Affiliate (hereinafter, “Recipient”). Confidential Information includes, without limitation, (a) any and all, customer, product, business plans, commercial, financial, technical, purchasing, specifications, know-how, data, and other information, in any form or medium, concerning a Party or its Affiliates, (whether prepared by or on behalf of each Party, its Affiliates or any of their Representatives (as defined below) and (b) all notes, analyses, studies, interpretations, compilations, memoranda and other documents or reports prepared by a Party or the Party’s Representatives which contain, reflect or are based upon, in whole or in part, the information furnished to the other Party or other Party’s Representatives pursuant hereto. For the sake of clarification, any Confidential Information (other than that disclosed under the confidentiality agreement dated 17th June 2013 entered into between the Parties, which shall remain subject only to this earlier confidentiality agreement) disclosed to, furnished to, or prepared by, the Recipient prior to the Effective Date shall be deemed to have been disclosed, furnished or prepared hereunder and shall be subject to the terms of this Agreement.

For the purposes of this Agreement, “Representatives” means officers, directors, employees, agents, advisors and consultants of each Party and its Affiliates.

 

2. USE OF CONFIDENTIAL INFORMATION

 

2.1 Recipient shall use Confidential Information only for the Purpose.

 

2.2 Recipient agrees to hold in confidence any and all Confidential Information disclosed, and further agrees not to disclose Confidential Information to third parties, not to publish Confidential Information, and not to use Confidential Information, except for the Purpose or with the written permission from an authorized officer of Disclosing Party. In addition neither Party will disclose to any third party the fact that the Confidential Information has been provided to the other Party, the existence of this Agreement, its terms or that discussions are taking place between the Parties.

 

2.3 Recipient undertakes to use its efforts to limit access to Confidential Information under its control solely to Recipient’s and Recipient’s Affiliates’ Representatives whose access to Confidential Information is strictly necessary for the Purpose, provided that such Representatives have been specifically informed of the confidentiality of Confidential Information and have agreed to be bound by the terms of this Agreement or have entered into an agreement of similar scope and obligations with Recipient to protect the proprietary/confidential information of Recipient or the proprietary/confidential information of third parties in the Recipient’s possession. Notwithstanding the above, Recipient shall remain jointly and severally liable for the compliance of the terms and conditions of the present Agreement by its Representatives.

 

2.4 Recipient shall use the same degree of care as Recipient uses to protect its own confidential information of a similar nature, but no less than reasonable care, to prevent the unauthorized use, disclosure or publication of Confidential Information.

 

2.5 In the event that Disclosing Party provides any computer software and/or hardware to Recipient as Confidential Information, Recipient may not directly or indirectly, disassemble, decrypt, decompile or derive source code from such Confidential Information, or otherwise attempt to reverse engineer the design and function of such Confidential Information.

 

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2.6 Recipient shall notify Disclosing Party immediately upon discovery of any unauthorized use, disclosure or publication of Confidential Information or any other breach of this Agreement by Recipient and its or its Affiliates’ Representatives, and cooperate with Disclosing Party in order to help Disclosing Party regain possession of Confidential Information and prevent its further unauthorized use, disclosure or publication.

 

2.7 Recipient shall at any time, at Disclosing Party’s sole request, return all originals, copies, reproductions and summaries of Confidential Information and all other tangible materials and devices provided to the Recipient as Confidential Information, or at Recipient’s option, certify the destruction of the same except for one copy that may preserved for archival purposes. In addition, the Recipient and its Representatives will not be obligated to destroy copies of Confidential Information remaining on their standard computer back-up devices provided such information is not accessible in the ordinary course of business and is not accessed except as required for backup, recovery, contingency planning or business continuity planning purposes. Any Confidential Information so retained will continue to be subject to the terms of this Agreement.

 

3. OWNERSHIP OF CONFIDENTIAL INFORMATION

 

3.1 All Confidential Information is and shall remain the property of Disclosing Party, and Disclosing Party may use such Confidential Information for any purpose without obligation to Recipient. Neither the execution of this Agreement nor the furnishing of any Confidential Information hereunder shall be construed as an express or tacit assignment or transmission of any intellectual and/or industrial property rights currently or hereafter owned by or controlled by Disclosing Party.

 

3.2 Recipient covenants and undertakes not to use under its name (or register), nor shall it collaborate with any third party for said purpose, all or part of any intellectual and/or industrial property rights, currently or hereafter owned by or controlled by Disclosing Party, nor shall it use the Confidential Information other than for the Purpose and as permitted herein.

 

4. DATA PROTECTION

The Parties agree to abide by applicable personal data protection laws. As a result, the Parties agree that, to the extent they are considered as data processor, they shall:

 

  (a) use the data following the instructions of the controller of such data;

 

  (b) only use the data for the purposes of this Agreement;

 

  (c) not disclose to third parties nor copy any personal data, even for conservation purposes;

 

  (d) apply all the reasonable security measures, and in any case those required by applicable data protection law, in order to preserve the integrity, confidentiality and the disposure/traffic of the data;

 

  (e) destroy the personal data, including any documentation or format containing such information, or return it to the other Party, upon request of the other Party; and

 

  (f) be liable vis-à-vis each other for the processing of personal data in breach of this clause 4.

 

5. LIMITATIONS ON CONFIDENTIALITY

Nothing in this Agreement shall be interpreted as placing any obligation of confidentiality, non-use and non-publication by Recipient with respect to any Confidential Information that:

 

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  (a) can be reasonably demonstrated by Recipient to have been in the public domain as of the Effective Date of this Agreement, or legitimately comes into the public domain through no fault of the Recipient; or

 

  (b) can be reasonably demonstrated by Recipient to have been known by the Recipient prior to the Effective Date and was not acquired, directly or indirectly, from Disclosing Party or from a third party under an obligation of confidentiality; or

 

  (c) can be reasonably demonstrated by Recipient to have been independently developed by personnel of the Recipient (or its Affiliates) or advisors or consultants thereof who had no substantive knowledge of any Confidential Information provided by Disclosing Party; or

 

  (d) is required to be disclosed pursuant to law, government agency or court order or regulations (including any regulations and rules of applicable stock exchanges), provided that Recipient provides prompt prior written notice to Disclosing Party (subject to such notice being allowed pursuant to applicable law and regulations) and provides sufficient time to Disclosing Party to assert any exclusions or privileges that may be available by law or applicable regulations. The Recipient shall disclose only that portion of the Confidential Information that it is legally required to disclose.

 

6. LIMITED WARRANTY AND LIABILITY AND NO OBLIGATION

Disclosing Party makes no warranties in respect of Confidential Information and provides all information “as is”, without any express or implied warranty of any kind, including any warranty as to merchantability, fitness for a particular purpose, accuracy, completeness or violation of third party intellectual and/or industrial property rights. In no event shall Disclosing Party be liable for any special, incidental or consequential damages of any kind whatsoever resulting from the disclosure, use or receipt of Confidential Information (subject to any other subsequent agreement between the Parties and/or their Affiliates regarding any liability regime agreed with respect to any transaction based on the Confidential Information disclosed pursuant to this Agreement).

 

7. SHARE TRADING

Takeda’s parent company, Takeda Pharmaceutical Company Limited, and TiGenix’ parent company, TiGenix NV, are each publicly traded companies. Each Party hereby acknowledges that (i) the trading in securities of such publicly traded companies are subject to applicable securities legislation, (ii) as a result of the disclosure of the Confidential Information of the other Party hereunder, it may possess material, non-public information of such other Party, and (iii) any trading by it in the securities of the other Party while in possession of such material, non-public information may entail the violation by it of applicable securities and other legislation and is prohibited.

 

8. REMEDIES

 

8.1 In case of breach by the Recipient or any of Recipient’s Representatives of any of its obligations under this Agreement, the Disclosing Party shall be entitled to immediately cease the disclosure of any further Confidential Information and the Recipient shall be liable for any and all direct damages, costs, liabilities, losses, and/or other expenses suffered by the Disclosing Party as a consequence of or in relation to such breach.

 

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8.2 The Parties acknowledge that monetary damages may not be a sufficient remedy for unauthorized disclosure, use or publication of Confidential Information and that Disclosing Party shall be entitled, without waiving any other rights or remedies, to such injunctive or equitable relief as may be deemed proper by a court of competent jurisdiction. Any and all remedies available to the Disclosing Party shall be cumulative.

 

9. TERM

 

9.1 The term of this Agreement is ten (10) years from the Effective Date.

 

9.2 Upon termination of this Agreement, Recipient will immediately cease any and all disclosures or uses of Confidential Information and, upon request by Disclosing Party, all such information obtained from Disclosing Party and all copies thereof made by Recipient will be destroyed or returned to Disclosing Party in accordance with clause 2.7 within forty (40) days.

 

10. NO ADDITIONAL AGREEMENTS

 

10.1 Neither the holding of discussions nor the exchange of material or information shall be construed as an obligation of either Party to perform any work or enter into any agreement with the other Party. The Parties hereby acknowledge that they are not agents of each other. Nothing in this Agreement shall prohibit a Party from providing its own Confidential Information to third parties and entering into agreements with third parties (other than the fact that the Confidential Information has been provided to the other Party, the existence of this Agreement, its terms or that discussions are taking place between the Parties with respect to the Purpose, which shall not be disclosed other than as between the Parties and their Representatives, pursuant to the terms herein).

 

10.2 Each Party reserves the right, in its sole discretion, to reject any and all proposals made by the other Party or its Affiliates or their Representatives with regard to a transaction (including for the Purpose) between the Parties and to terminate discussions and negotiations at any time. Additional agreements of the Parties, if any, shall be made in writing.

 

10.3 Nothing in this Agreement shall oblige the Disclosing Party to disclose any particular information to the Recipient or its Representatives and the Disclosing Party shall have an absolute discretion as to the nature and extent of the information it chooses to disclose hereunder.

 

11. ASSIGNMENT

Other than as permitted herein, this Agreement, or any right or interest under this Agreement, shall not be assigned, nor shall any obligation to be performed under this Agreement be delegated, voluntarily, by operation of law or otherwise, by either Party without the other Party’s prior written consent.

A Party shall be entitled to assign this Agreement to an Affiliate without the consent of the other Party.

The terms of this Agreement shall be binding upon, inure to the benefit of, and be enforceable by the permitted respective successors and assigns of the Parties hereto.

 

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12. MISCELLANEOUS

 

12.1 Any formal notice required or permitted by this Agreement must be delivered in writing and sent by certified mail, return receipt requested, addressed to the other Party at the address shown at the beginning of this Agreement or at such other address for which such Party gives notice hereunder.

 

12.2 Should any part, article, paragraph, sentence or clause of this Agreement be deemed vague, inapplicable, invalid or unenforceable, such part shall be eliminated and the rest of the Agreement shall remain applicable, valid and in force. The Parties shall enter, in good faith, into negotiations with the aim of replacing the vague, inapplicable, invalid or unenforceable part, article, paragraph, sentence or clause of this Agreement with a similar, albeit applicable, enforceable and valid part, article, paragraph, sentence or clause.

 

12.3 This Agreement may not be changed, modified, or discharged, in whole or in part, except by a subsequent agreement in writing signed by authorized representatives of each Party.

 

12.4 This Agreement may be signed in counterparts, which together shall constitute one agreement. Signatures to this Agreement transmitted by facsimile transmission, by electronic mail in Portable Document Format (.pdf) form, or by any other electronic means intended to preserve the original graphic and pictorial appearance of a document, will have the same effect as physical delivery of the paper document bearing the original.

 

12.5 None of the provisions of this Agreement shall be deemed to have been waived by any act, omission, or acquiescence on the part of the Disclosing Party without a written instrument signed by the Disclosing Party. No waiver by a Party of any breach shall be effective unless in writing, and no waiver shall be construed as a waiver of any succeeding breach, whether or not of the same or a different term or condition.

 

12.6 This Agreement shall be construed according to Belgian law, to the exception for its provisions on conflict of laws. Any dispute arising from the interpretation and/or implementation of this Agreement, which cannot be settled amicably within 30 days of such dispute having been notified by one Party to the other, shall be brought before a competent court of the City of Leuven.

 

12.7 This document contains the entire agreement between the Parties with respect to the subject matter hereof, and neither Party shall have any obligation, express or implied by law, except as set forth herein.

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.

 

For and on behalf of TiGenix SAU
/s/ Eduardo Bravo
Name:   Eduardo Bravo
Title:   CEO
Date:   30/06/2017

For and on behalf of Takeda Pharmaceuticals International AG

 

/s/ Nils Kjaersgaard
Name:   Nils Kjaersgaard
Title:   General Counsel, EUCAN
Date:   30/06/2017
/s/ Jeremy Impey
Name:   Jeremy Impey
Title:   Legal Counsel
Date:   30/06/2017


ADDENDUM TO CONFIDENTIAL DISCLOSURE AGREEMENT

This addendum (the “Addendum”) is made effective as of the date (the “Effective Date”) of the last signature hereto by and between:

 

1. TiGenix SAU, with registered office at Calle Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spain, registered with the Commercial Registry of Madrid under volume number 20117, page 81, sheet M-355159, and with tax number (CIF) A-84008986TiGenix Spain”);

and

 

2. Takeda Pharmaceuticals International AG, with registered office at Thurgrauerstraße 130, Glattpark-Opfikon (Zurich), Switzerland (“Takeda International”);

and

 

3. TiGenix NV, with registered office at Romeinse straat 12 box 2, 3001 Leuven, Belgium, registered with the Crossroads Bank of Enterprises under number 0471.340.123 (Register of Legal Entities Leuven) (“TiGenix Belgium” and together with TiGenix Spain referred to as “TiGenix”);

and

 

4. Takeda Pharmaceutical Company Limited, with office at 12-10, Nihonbashi 2-chome, Chuo-ku, Tokyo 103-8668, Japan (“TPC” and together with Takeda International referred to as “Takeda”);

TiGenix and Takeda are collectively referred to as the “Parties” and individually as a “Party”.

All used but not defined terms in this Addendum shall have the meaning given to it in the CDA (as defined below).

RECITALS

On 30 June 2017, TiGenix Spain and Takeda International entered into a confidential disclosure agreement (the “CDA”). In the CDA, TiGenix Spain and Takeda International explored and evaluated a potential more in depth collaboration and business partnership regarding the Product and any other business opportunity they may deem appropriate. In relation thereto, each of TiGenix Spain and Takeda International agreed to disclose to the other certain information which it deems confidential and proprietary in nature.

TPC (an affiliate of Takeda International) is now considering launching either directly and/or through any person affiliated with it a voluntary public takeover bid (vrijwillig openbaar overnamebod / offre publique d’acquisition volontaire) within the meaning of the Belgian Law of 1 April 2007 on public takeover bids (Wet op de openbare overnamebiedingen / Loi relative aux offres publiques d’acquisition) with respect to the securities with voting rights or giving access to voting rights, issued by TiGenix Belgium (an affiliate of TiGenix Spain), that are not yet owned by TPC (the “Proposed Transaction”). In connection with the Proposed Transaction, the Parties are prepared to make certain additional Confidential Information available to each other.

In this respect, TiGenix Belgium and TPC hereby agree to accede to the CDA and the Parties hereby agree to extend the scope and purpose of the CDA in order to include the Proposed Transaction.


NOW THEREFORE, the Parties, mutually acknowledging their sufficient legal capacity to enter into and be bound by this Addendum, agree as follows:

 

1. Accession of TiGenix Belgium and TPC

TiGenix Belgium and TPC agree to accede to the CDA and accept to be bound by its terms as if each of them had entered into the CDA and was a signatory to it.

 

2. Extension of the Purpose

In accordance with clause 12.3 of the CDA, the Parties hereby agree to extend the Purpose of the CDA to the Proposed Transaction.

 

3. Standstill

 

3.1 Without prejudice to the obligations set out in clause 7 of the CDA and its obligations under such laws and regulations, Takeda agrees that it shall not, and shall procure and guarantee that none of its Representatives and its Affiliates shall, whether directly or indirectly through intermediaries, persons or entities acting in concert, or otherwise, for a period ending the earlier of (i) the day following the public announcement of the FY2017 results by TiGenix Belgium and (ii) 30 April 2018 (the “Standstill Period”), except with the prior written consent of TiGenix Belgium:

 

  (a) purchase, offer to purchase (through a tender offer or otherwise), agree to purchase, or otherwise acquire, offer to acquire (through a tender offer or otherwise) or agree to acquire, or in any way assist any other person in acquiring, directly or indirectly, any shares, securities or other financial instruments of TiGenix Belgium otherwise than pursuant to the Proposed Transaction;

 

  (b) acquire, offer to acquire or agree to acquire, in any manner whatsoever, any assets of TiGenix Belgium otherwise than pursuant to the Proposed Transaction;

 

  (c) enter into, agree to enter into, propose or offer to enter into or facilitate any merger, business combination, recapitalisation, restructuring or other similar transaction with respect to TiGenix Belgium otherwise than pursuant to the Proposed Transaction;

 

  (d) otherwise seek to control or influence the board of directors or the management of TiGenix Belgium; or

 

  (e) advise, assist or encourage, or enter into any discussions, negotiations, agreements or arrangements with, any other person with respect to any of the foregoing otherwise than pursuant to the Proposed Transaction.

 

3.2 Notwithstanding the restrictions contained in the foregoing clause 3.1:

 

  (a) Takeda, its Representatives and its Affiliates shall not be prohibited from entering into an agreement and having discussions with their legal, accounting, financial or tax advisors for the limited purposes of evaluating any of the transactions contemplated in clause 3.1(a) through (c), subject always to clause 2.3 of the CDA;

 

  (b) so long as Takeda has not violated the provisions of clause 3.1, Takeda may inform TiGenix Belgium privately that Takeda (acting itself or through an Affiliate) would be interested in engaging in discussions with TiGenix Belgium that could result in a negotiated transaction described in clause 3.1(a), (b) or (c), so long as:

 

  (i) Takeda does not propose any such transaction unless TiGenix Belgium requests Takeda to make such a proposal, and

 

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  (ii) Takeda does not take any action that would reasonably be expected to require TiGenix Belgium to make any public announcement.

 

3.3 The restrictions contained in the foregoing clause 3.1 shall not apply to:

 

  (a) the exercise by Takeda of any of its rights under the CDA;

 

  (b) the exercise by Takeda or its Affiliates as a TiGenix Belgium shareholder, if applicable, of any voting rights available to TiGenix Belgium shareholders generally pursuant to any transaction described in clause 3.1 above, provided that Takeda (or any of its Affiliates) has not then either directly or indirectly, made, effected, initiated or caused such transaction to occur;

 

  (c) any activity by Takeda or its Affiliates after TiGenix Belgium or any third party unrelated to Takeda has made any public announcement of its intent to solicit or engage in any transaction which would result in a change of control of TiGenix Belgium, or after any such change of control of TiGenix Belgium shall have occurred; or

 

  (d) any investment by Takeda or an Affiliate in third party mutual funds or other similar passive investment vehicles that hold interests in securities of TiGenix Belgium.

 

3.4 Clause 3.1 shall no longer be applicable in the event of any of the following:

 

  (a) the acquisition by any third party of beneficial ownership of more than ten percent (10%) of the outstanding TiGenix Belgium share capital;

 

  (b) the announcement or commencement by any third party individual or entity of a tender offer or exchange offer to acquire securities of TiGenix Belgium which, if successful, would result in such third party owning, when combined with any other securities owned by such individual or entity, fifty percent (50%) or more of the then outstanding TiGenix Belgium share capital;

 

  (c) TiGenix Belgium entering into a definitive written merger, sale or other business combination agreement pursuant to which fifty percent (50%) or more of the TiGenix Belgium share capital would be converted into cash or securities of another third party individual or entity or, immediately after the consummation of such transaction, fifty percent (50%) or more of the then TiGenix Belgium share capital would be owned by third party individual or entity other than the holders of TiGenix Belgium shares immediately prior to the consummation of such transaction, or which would result in all or substantially all of TiGenix Belgium’s assets being sold to any third party entity or individual;

 

  (d) TiGenix Belgium or any of its Affiliates becoming the subject of any bankruptcy, insolvency or similar proceeding (except for any involuntary proceeding that is dismissed within sixty (60) days); or

 

  (e) TiGenix Belgium engaging in the solicitation of one (1) or more third party bids for any transaction which would result in a change of control of TiGenix Belgium.

 

3.5 Parties acknowledge that the provisions of Clauses 3.2, 3.3 and 3.4 are without prejudice to applicable restrictions under Belgian law and other applicable laws and regulations governing insider trading and use of non-public information.

 

3


4. No Shop and Non-solicitation of Employees

 

4.1 TiGenix agrees, and shall procure that its Affiliates agree and undertake, that beginning on the date of this Addendum and continuing until the earlier of (i) ninety (90) days after the date of this Addendum and (ii) ten (10) days after announcement of the opinion from the Committee for Medicinal Products for Human Use (CHMP) on the application for marketing authorization for cx601 in the E.U., to procure that the boards of directors of TiGenix and its Affiliates (the “Boards of Directors”) shall not solicit or assist any third party to analyse, organise or otherwise initiate a potential public takeover bid, merger, or any other transaction that would relate to a transfer (in the broadest sense possible) of all or a significant part of the securities or assets of TiGenix or any of its Affiliates.

The undertakings set out in this clause 4.1 are subject to any fiduciary duties that the Boards of Directors may have (including in the case of a third party which has not been solicited by TiGenix, but has at its own initiative informed TiGenix of its interest to acquire all securities of TiGenix) and excluding the transfer of goods or provision of services in TiGenix’s and its Affiliates’ ordinary course of business consistent with past practice.

The undertakings set out in this clause 4.1 shall automatically terminate if TPC notifies TiGenix Belgium in writing of a reduction of the proposed Price Per Share as set out in its non-binding expression of interest dated 10 November 2017 during the negotiation of the Proposed Transaction.

 

4.2 Takeda agrees that it shall not, and procures that none of its Affiliates shall, beginning on the date of this Addendum until the earlier of (i) completion of the Proposed Transaction, or (ii) two (2) years from the date of this Addendum, directly or indirectly, knowingly, as a result of knowledge obtained in connection with the Proposed Transaction, solicit, endeavour to entice away, employ or offer to employ (whether as an employee, a consultant or in any other capacity):

 

  (a) any person who is on the date of this Addendum (or shall become at any time during the negotiation of the Proposed Transaction) employed by TiGenix or any of its Affiliates; or

 

  (b) any director or member of management of TiGenix or any of its Affiliates who has entered into on the date of this Addendum (or shall enter into at any time during the negotiation of the Proposed Transaction), either directly or through a management company or otherwise, any consultancy agreement, management agreement or other service contract with TiGenix or its Affiliates,

whether or not such person would commit any breach of his or her employment contract or service contact in leaving such employment or terminating such contract.

The foregoing provision shall not prevent Takeda or its Affiliates from soliciting, employing or offering to employ any person (either directly or through a management company or otherwise) (i) who contacts Takeda or its Affiliates on his or her own initiative without any direct or indirect solicitation from Takeda or its Affiliates, (ii) following termination of such person’s employment, consultancy, management or other service contract with TiGenix or its Affiliates or (iii) following the use of an independent employment agency (so long as it is not directed to solicit such person), advertisements in publications or other general solicitations for employment not directed at such person and (iv) in accordance with the terms of the license agreement entered into between TiGenix Spain and Takeda International on 4 July 2016.

 

5. Governing law

This Addendum shall be governed by and construed in accordance with Belgian law.

 

4


6. Dispute resolution

Any dispute arising from the interpretation and/or implementation of this Addendum; which cannot be settled amicably within 30 days of such dispute having been notified by one Party to the other, shall be brought before the competent courts of Brussels, Dutch section.

[Signature page follows]

 

5


IN WITNESS WHEREOF, the Parties have caused this Addendum to be executed by their duly authorised representatives.

 

For and on behalf of TiGenix SAU
/s/ Eduardo Bravo
Name:   Eduardo Bravo
Title:   CEO
Date:   17/Nov/2017

For and on behalf of Takeda Pharmaceuticals International AG

 

/s/ Marcello Agosti  

 

  /s/ Andrea Ferrari
Name:   Marcello Agosti     Name:   Andrea Ferrari
Title:   Head of Global BD & Commercial     Title:   Snr Direct, Associate General Counsel
Date:   17th November 2017     Date:   17th November 2017

 

For and on behalf of TiGenix NV
/s/ Eduardo Bravo
Name:   Eduardo Bravo
Title:   CEO
Date:   17/Nov/2017

 

6


For and on behalf of Takeda Pharmaceutical Company Limited

 

/s/ John Bathery (under PoA)  

 

  /s/ Jeremy Impey (under PoA)
Name:   John Bathery     Name:   Jeremy Impey
Title:   VP, USBU Business Dev.     Title:   Senior Corporate Counsel
Date:   17th November 2017     Date:   17th November 2017

 

7

EX-99.3

Exhibit 3

IRREVOCABLE UNDERTAKING

The undersigned,

 

1. Gri-Cel, S.A., a company under the laws of Spain, having its registered office at Avenida de la Generalitat 152, 08174 Sant Cugat del Vallès, Barcelona, Spain,

here validly represented by Alfredo Arroyo Guerra, acting in his capacity of Chief Financial Officer,

hereinafter referred to as “Gri-Cel”;

and

 

2. Grifols Worldwide Operations Ltd., a company under the laws of Ireland, having its registered office at Grange Castle Business Park, Grange Castle, Clondalkin, Dublin 22, Ireland,

here validly represented by Alfredo Arroyo Guerra, acting in his capacity of Chief Financial Officer,

hereinafter referred to as “Grifols” and, together with Gri-Cel, as the “Undersigned”;

 

1. Ownership

The Undersigned represent and warrant as follows on the date of this irrevocable undertaking (hereinafter referred to as the “Undertaking”):

 

  (a) Gri-Cel owns 32,238,178 shares in TiGenix NV (hereinafter referred to as the “Shares”), a limited liability company (naamloze vennootschap / société anonyme) under the laws of Belgium, having its registered office at Romeinse straat 12 box 2, 3001 Leuven, Belgium, registered with the Crossroads Bank of Enterprises under number 0471.340.123 (Register of Legal Entities Leuven) (hereinafter referred to as “TiGenix”);

 

  (b) Grifols owns 7,189,800 shares in TiGenix held in the form of American Depositary Shares (hereinafter referred to as the “American Depositary Shares”);

 

  (c) the Undersigned do not have an interest in any securities issued by TiGenix other than those respectively set out under (a) and (b) above;

 

  (d) the Undersigned have the capacity and authority to transfer the Shares and the American Depositary Shares (hereinafter referred to as the “Relevant Securities”) (i) free from any security, lien (including voorrecht / privilège), charge, pledge, option, equity, guarantee, usufruct, retention right, priority right, right of first refusal, pre-emption right, seizure, claim, attachment, transfer restriction or, in general, any third party rights and interests of any nature, as well as any power of attorney granted in view of creating such right or interest and any agreement, commitment, undertaking, obligation or other arrangement that has similar consequences, being, among others, limiting or prohibiting a transfer of the Relevant Securities and (ii) together with all rights and benefits now or hereafter attaching thereto, including the right to all dividends and other distributions (if any) declared, made or paid hereafter.

 

1


2. Undertakings

 

2.1 The Undersigned irrevocably undertake to tender the Relevant Securities to Takeda Pharmaceutical Company Limited (hereinafter jointly referred to as “Takeda”) in the context of a voluntary public takeover bid (vrijwilig openbaar overnamebod / offre publique d’acquisition volontaire) within the meaning of the Belgian Law of 1 April 2007 on public takeover bids (Wet op de openbare overnamebiedingen / Loi relative aux offres publiques d’acquisition) (hereinafter referred to as the “Offer”) that Takeda is considering launching with respect to the securities with voting rights or giving access to voting rights, issued by TiGenix, that are not yet owned by Takeda or its affiliates, under the terms and subject to the conditions thereof, provided that the bid price would not be below EUR 1.30 per Share.

 

2.2 The Undersigned agree that they will fulfil the undertaking set out in Clause 2.1 above as soon as possible and in any event by no later than 3:00 pm on the fifth (5th) Business Day (i.e. a day, other than a Saturday, Sunday or public holiday, when banks are open for business in Belgium) after publication of the formal document containing the Offer (hereinafter referred to as the “Prospectus”).

 

2.3 The Undersigned irrevocably undertake, in general, to provide reasonable support to Takeda in completing the Offer and to refrain from any actions that could adversely affect the success of the Offer (including, but not limited to, soliciting any third party to analyse, organise or otherwise initiate a potential public takeover bid, merger, or any other transaction that would relate to a transfer (in the broadest sense possible) of all or a significant part of the securities or assets of any members of the group of companies to which TiGenix pertains (hereinafter referred to as the “Target Group”), excluding the transfer of goods or provision or services in the Target Group’s ordinary course of business consistent with past practice).

 

2.4 The undertakings set out in this Clause 2 are subject to, and will only enter into force upon, publication by Takeda of a press release to announce its intention to launch the Offer. As a result, prior to such publication, none of the Undersigned shall (i) be obliged to support the Offer or (ii) otherwise be deemed to be acting in concert with Takeda.

 

3. Withdrawal Rights

For the avoidance of doubt, notwithstanding any provisions set out in the terms of the Prospectus or the right of withdrawal from accepting the Offer conferred by article 25 of the Belgian Royal Decree of 27 April 2007 on public takeover bids (Koninklijk besluit op de openbare overnamebiedingen / Arrête royal relatif aux offres publiques d’acquisition) (to the extent applicable), the Undersigned undertake that they will not withdraw their acceptance of the Offer in respect of the Relevant Securities and undertake that they will procure that no rights to withdraw any acceptance of the Offer in respect of the Relevant Securities are exercised during the period of the Offer.

 

4. Dealings in Relevant Securities

The Undersigned undertake that they will not, prior to the Offer becoming unconditional in all respects, its withdrawal or lapsing (whichever is earlier) without the prior written consent of Takeda, in any manner, deal in any securities of TiGenix, including, without limitation:

 

  (a) sell, transfer, charge, encumber, grant any option over or otherwise dispose of or permit the sale, transfer, charging or other disposition or creation or grant of any other encumbrance or option of or over all or any of the Relevant Securities except pursuant to the Offer and this Undertaking, or accept any other offer in respect of all or any Relevant Securities, either in the context of a counter bid or otherwise;

 

2


  (b) purchase or otherwise acquire (or encourage any other person to so purchase or acquire) any other securities of TiGenix or rights to acquire or subscribe for securities of TiGenix (including any options or derivatives), other than in accordance with the terms of the Offer;

 

  (c) other than pursuant to the Offer and this Undertaking, enter into any agreement or arrangement or permit any agreement or arrangement to be entered into or incur any obligation or permit any obligation to arise:

 

  (i) to do all or any of the acts referred to in Clauses 4(a) and 4(b) (inclusive) above; or

 

  (ii) which would or might restrict or impede acceptance of, or be otherwise prejudicial to, the success of the Offer in respect of the Relevant Securities,

and for the avoidance of doubt, references in this Clause to any agreement, arrangement or obligation shall include any such agreement, arrangement or obligation whether or not subject to any conditions, or which is to take effect upon or following withdrawal, closing or lapsing of the Offer, or upon or following this Undertaking ceasing to be binding, or upon or following any other event.

 

5. General shareholders’ meeting of TiGenix

 

5.1 Until such time as the Offer becomes unconditional in all respects or lapses or is withdrawn (whichever is earlier), the Undersigned will exercise or procure the exercise by proxy or in person of the votes attaching to the Relevant Securities in respect of any resolution proposed at any general shareholders’ meeting of TiGenix, or at any adjournment thereof (hereinafter referred to as a “Relevant Resolution”):

 

  (a) in favour of any such resolution the passing of which is necessary to fulfil any condition of the Offer;

 

  (b) against any such resolution whose passing is required in connection with any offer for TiGenix’ securities that is made by a person other than Takeda; and

 

  (c) against any such resolution which, if passed, might result in any condition of the Offer not being fulfilled or which might impede or frustrate the Offer in any way.

 

5.2 The Undersigned acknowledge and accept that any resolution to adjourn a general shareholders’ meeting of TiGenix whose agenda includes the consideration of a Relevant Resolution, and a resolution to amend a Relevant Resolution, is also a Relevant Resolution.

 

6. Disclosure

 

6.1 The Undersigned consent to the issue of a press release incorporating references to them and to this Undertaking. The Undersigned understand and accept that, if the Offer is made, this Undertaking will be made available for inspection during the period of the Offer and that particulars of it will be contained in the Prospectus.

 

3


6.2 The Undersigned undertake to provide Takeda on its request with all such further information at their disposal in relation to their interests, and those of any person connected with them, in securities of TiGenix as Takeda may reasonably require in order to comply with the requirements of any legal or regulatory requirements for inclusion in the Prospectus (or any other document required in connection with the Offer), and they will immediately notify Takeda in writing of any material change in the accuracy or import of any information previously supplied to Takeda by them.

 

7. Lapse of Undertaking

This Undertaking shall lapse and, without any prejudice to any existing breaches of the obligations of the Undersigned, shall cease to have any effect if:

 

  (a) Takeda has not published a press release to announce the intended Offer by 12 January 2018;

 

  (b) the Offer is not made (by the posting of the Prospectus) by 30 March 2018 or such later time or date as Takeda and TiGenix agree;

 

  (c) the Offer lapses or is withdrawn without becoming unconditional in all respects; or

 

  (d) upon completion of the Offer following tender of the Relevant Securities by the Undersigned.

 

8. Confidentiality

The Undersigned understand that the information provided to them by Takeda in relation to the Offer must be kept confidential until the Prospectus is published or the information has otherwise become public. Before this time, they will not, on the basis of this information, enter into a transaction, place an order to trade, cancel or amend an order which has already been made or engage in any other activity or behaviour which would amount to market manipulation for the purposes Regulation (EU) no 596/2014 on market abuse (Verordening betreffende marktmisbruik / Règlement sur les abus de marché) (hereinafter referred to as “MAR”) nor attempt to engage in market manipulation, and they acknowledge and agree to comply with their respective obligations under applicable securities laws, including, but not limited to, obligations pursuant to MAR.

 

9. Governing law and jurisdiction

 

9.1 This Undertaking will be governed by and be interpreted in accordance with Belgian Law, with the exclusion of the rules of conflict of laws.

 

9.2 Except as otherwise agreed in writing by the Undersigned and Takeda, the Courts of Brussels, Dutch section, Belgium, will have the exclusive competence over any disputes that may arise between the Undersigned and Takeda in relation to this Undertaking.

*                *

*

 

4


Date: 5 January 2018

 

FOR GRI-CEL:
/s/ Alfredo Arroyo Guerra
Name:   Alfredo Arroyo Guerra
Title:   CFO

 

FOR ACCEPTANCE BY TAKEDA:
/s/ Misako Hirose
Name:   Misako Hirose
Capacity:   Director, Global Alliances
  Global Business Development
  Takeda Pharmaceutical Company Limited
  (Authorised Signatory)

 

5


FOR GRIFOLS:
/s/ Alfredo Arroyo Guerra
Name:   Alfredo Arroyo Guerra
Title:   CFO

 

6

EX-99.4

Exhibit 4

IRREVOCABLE UNDERTAKING

The undersigned,

                                                          (the “Director”);

 

1. Ownership

The Director represents and warrants as follows on the date of this irrevocable undertaking (hereinafter referred to as the “Undertaking”):

 

  (a) The Director owns                      shares in TiGenix NV (hereinafter referred to as the “Shares”, as such number may increase from time to time as the result of any exercises of Warrants), a limited liability company (naamloze vennootschap / société anonyme) under the laws of Belgium, having its registered office at Romeinse straat 12 box 2, 3001 Leuven, Belgium, registered with the Crossroads Bank of Enterprises under number 0471.340.123 (Register of Legal Entities Leuven) (hereinafter referred to as “TiGenix”);

 

  (b) The Director owns                      warrants in TiGenix (hereinafter referred to as the “Warrants”, as such number may decrease from time to time as the result of any exercises of Warrants), which will become fully vested at the start of the first acceptance period as mentioned in Clause 1(e) below;

 

  (c) The Director does not have an interest in any securities issued by TiGenix other than those respectively set out under Clauses 1(a) and (b) above;

 

  (d) Takeda Pharmaceutical Company Limited (hereinafter referred to as “Takeda”) intends to launch a voluntary public takeover bid (vrijwillig openbaar overnamebod / offre publique d’acquisition volontaire) within the meaning of the Belgian Law of 1 April 2007 on public takeover bids (Wet op de openbare overnamebiedingen / Loi relative aux offres publiques d’acquisition) with respect to 100% of the securities with voting rights or giving access to voting rights of TiGenix, that are not yet owned by Takeda or its affiliates (hereinafter referred to as the “Offer”).

 

  (e) On 11 October 2017, TiGenix approved the accelerated vesting of the outstanding unvested warrants held by all warrant holders other than the independent directors in accordance with article 4.2 of the warrant plans, such acceleration being subject to the start of the first acceptance period of any future takeover bid.

 

  (f) The Director has the capacity and authority to transfer the Shares and any Warrants tendered during the first acceptance period (hereinafter referred to as the “Relevant Securities”) (i) free from any security, lien (including voorrecht / privilège), charge, pledge, option, guarantee, usufruct, retention right, priority right, right of first refusal, pre-emption right, seizure, claim, attachment, transfer restriction or, in general, any third party rights and interests of any nature, as well as any power of attorney granted in view of creating such right or interest and any agreement, commitment, undertaking, obligation or other arrangement that has similar consequences, being, among others, limiting or prohibiting a transfer of the Relevant Securities, except for such transfer restriction set out in the terms and conditions of the Warrants and (ii) together with all rights and benefits now or hereafter attaching thereto, including the right to all dividends and other distributions (if any) declared, made or paid hereafter.


2. Undertakings

 

2.1 The Director irrevocably undertakes to tender the Relevant Securities to Takeda in the context of the Offer, under the terms and subject to the conditions thereof, provided that the bid price would not be below EUR 1.78 per share and at the price per Warrant that is not lower than as set out in Schedule 1.

For the avoidance of doubt, Takeda confirms and undertakes that the Director shall be entitled to the highest price payable at any time by Takeda to the holders of shares and warrants of TiGenix who tendered their securities in the Offer, in accordance with article 25, 2° of the Belgian Royal Decree of 27 April 2007 on public takeover bids (Koninklijk besluit op de openbare overnamebiedingen / Arrête royal relatif aux offres publiques d’acquisition) (the “Royal Decree on Public Takeover Bids”).

 

2.2 The Director agrees that it will fulfil the undertaking set out in Clause 2.11 above as soon as possible and in any event by no later than 3:00 pm on the tenth (10th) Business Day (i.e. a day, other than a Saturday, Sunday or public holiday, when banks are open for business in Belgium) after publication of the formal document containing the Offer (hereinafter referred to as the “Prospectus”) and opening of the first acceptance period.

 

3. Withdrawal Rights

Notwithstanding any provisions set out in the terms of the Prospectus or the right of withdrawal from accepting the Offer conferred by article 25, 1° of the Royal Decree on Public Takeover Bids (to the extent applicable), the Director undertakes that it will not withdraw its acceptance of the Offer in respect of the Relevant Securities during the period of the Offer, provided that (i) the bid price does not go below EUR 1.78 per share and the price per Warrant as set out in Schedule 1, (ii) the Director shall be entitled to the highest price payable at any time by Takeda to the holders of shares and warrants of TiGenix who tendered their securities in the Offer and (iii) the undertaking set out in this Clause 3 is without prejudice to Clause 6.

 

4. Dealings in Relevant Securities

The Director undertakes that it will not, prior to the Offer becoming unconditional in all respects, its withdrawal or lapsing (whichever is earlier) without the prior written consent of Takeda, in any manner, deal in any securities of TiGenix, including, without limitation:

 

  (a) sell, transfer, charge, encumber, grant any option over or otherwise dispose of or permit the sale, transfer, charging or other disposition or creation or grant of any other encumbrance or option of or over all or any of the Relevant Securities except pursuant to the Offer and this Undertaking, or accept any other offer in respect of all or any Relevant Securities except in the circumstances described in Clause 6.1(d);

 

  (b) purchase or otherwise acquire (or encourage any other person to so purchase or acquire) any other securities of TiGenix or rights to acquire or subscribe for securities of TiGenix (including any options or derivatives), other than in accordance with the terms of this Undertaking;

 

  (c) other than pursuant to the Offer and this Undertaking, enter into any agreement or arrangement or permit any agreement or arrangement to be entered into or incur any obligation or permit any obligation to arise to do all or any of the acts referred to in Clauses 4(a) and 4(b) (inclusive) above,


and for the avoidance of doubt, references in this Clause to any agreement, arrangement or obligation shall include any such agreement, arrangement or obligation whether or not subject to any conditions, or which is to take effect upon or following withdrawal, closing or lapsing of the Offer, or upon or following this Undertaking ceasing to be binding, or upon or following any other event.

Parties acknowledge, for the avoidance of doubt, that the restrictions set out in this Clause 4 do not prevent the Director from exercising any of the Warrants.

 

5. General shareholders’ meeting of TiGenix

 

5.1 Until such time as the Offer becomes unconditional in all respects or lapses or is withdrawn (whichever is earlier), the Director will exercise or procure the exercise by proxy or in person of the votes attaching to the Shares in respect of any resolution proposed at any general shareholders’ meeting of TiGenix, or at any adjournment thereof (hereinafter referred to as a “Relevant Resolution”):

 

  (a) in favour of any such resolution the passing of which is necessary to fulfil any condition of the Offer;

 

  (b) against any such resolution whose passing is required in connection with any offer for TiGenix’ securities that is made by a person other than Takeda; and

 

  (c) against any such resolution which, if passed, might result in any condition of the Offer not being fulfilled or which might impede or frustrate the Offer in any way.

 

5.2 The Director acknowledges and accepts that any resolution to adjourn a general shareholders’ meeting of TiGenix whose agenda includes the consideration of a Relevant Resolution, and a resolution to amend a Relevant Resolution, is also a Relevant Resolution.

 

6. Lapse of Undertaking

 

6.1 This Undertaking shall automatically lapse and shall be of no further force or effect if:

 

  (a) Takeda has not announced its intention to Offer via press release in accordance with article 8, §1 of the Royal Decree on Public Takeover Bids by Takeda by 8 January 2018;

 

  (b) the Offer is not made (by the posting of the Prospectus) by 16 February 2018 or such later time or date as Takeda and TiGenix agree;

 

  (c) the Offer lapses or is withdrawn without becoming unconditional in all respects; or

 

  (d) a third party launches a competing bid under articles 37 to 41 of the Royal Decree on Public Takeover Bids that the board of directors of TiGenix determines in good faith to be more favourable to the holders of securities in TiGenix than the Offer (a “Superior Target Takeover Proposal”) and (x) no longer recommends and supports the Offer, and (y) expresses a preference for the Superior Target Takeover Proposal, or otherwise recommends it to the holders of the securities in TiGenix, in accordance with its fiduciary duties.

 

6.2 Lapse of this Undertaking shall be without prejudice to the rights of any party in respect of any breach of this Undertaking by the other party prior to such lapse.


7. Confidentiality & Miscellaneous

 

7.1 The content of this Undertaking is confidential. However, the Director consents to the issue of a press release incorporating references to this Undertaking under applicable securities laws. The Director further understands and accepts that, if the Offer is made, this Undertaking will be made available for inspection during the period of the Offer and that particulars of it will be contained in the Prospectus or the response memorandum prepared by the board of directors of TiGenix or may need to be filed as part of the Prospectus, other offer documents or Schedule 14D-9.

 

7.2 The Director understands that the information provided to it by Takeda in relation to the Offer must be kept confidential until the Prospectus is published or the information has otherwise become public (including such information announced by Takeda in accordance with article 8, §1 of the Royal Decree on Public Takeover Bids). Before this time, it will not, on the basis of this information, enter into a transaction, place an order to trade, cancel or amend an order which has already been made or engage in any other activity or behaviour which would amount to market manipulation for the purposes Regulation (EU) no 596/2014 on market abuse (Verordening betreffende marktmisbruik / Règlement sur les abus de marché) (hereinafter referred to as “MAR”) nor attempt to engage in market manipulation, and it acknowledges and agrees to comply with its respective obligations under applicable securities laws, including, but not limited to, obligations pursuant to MAR.

 

7.3 The Director and Takeda hereby acknowledge and agree that:

 

  7.3.1 the Director’s rights and obligations hereunder are as a shareholder of TiGenix and not as a member of the board of directors of TiGenix; and

 

  7.3.2 the Director’s fiduciary duties as a member of the board of directors of TiGenix shall not be affected by the provisions of this Undertaking.

 

8. Severability

 

8.1 If any provision in this Undertaking would be held to be illegal, invalid or unenforceable, in whole or in part, under any applicable law, then that provision (or part thereof) will be deemed not to form part of this Undertaking, and the legality, validity or enforceability of the remainder of this Undertaking will not be affected.

 

8.2 In such case, each party will use its reasonable best efforts to negotiate in good faith a valid replacement provision having a similar economic effect which is as close as possible to that of the invalid, void or unenforceable provision.

 

9. Governing law and jurisdiction

 

9.1 This Undertaking will be governed by and be interpreted in accordance with Belgian Law, with the exclusion of the rules of conflict of laws.

 

9.2 Except as otherwise agreed in writing by the parties, the Courts of Brussels, Dutch section, Belgium, will have the exclusive competence over any disputes that may arise between the parties in relation to this Undertaking.

*                *

*


Date:

 

THE DIRECTOR

 
Name:  

FOR ACCEPTANCE BY

TAKEDA PHARMACEUTICAL COMPANY LIMITED:

 

 
Name:  
Capacity:  
EX-99.5

Exhibit 5

IRREVOCABLE UNDERTAKING

The undersigned,

                                                          (the “Director”);

 

1. Ownership

The Director represents and warrants as follows on the date of this irrevocable undertaking (hereinafter referred to as the “Undertaking”):

 

  (a) The Director owns                      shares in TiGenix NV (hereinafter referred to as the “Shares”, as such number may increase from time to time as the result of any exercises of Warrants), a limited liability company (naamloze vennootschap / société anonyme) under the laws of Belgium, having its registered office at Romeinse straat 12 box 2, 3001 Leuven, Belgium, registered with the Crossroads Bank of Enterprises under number 0471.340.123 (Register of Legal Entities Leuven) (hereinafter referred to as “TiGenix”);

 

  (b) The Director owns                      warrants in TiGenix (hereinafter referred to as the “Warrants”, as such number may decrease from time to time as the result of any exercises of Warrants);

 

  (c) The Director does not have an interest in any securities issued by TiGenix other than those respectively set out under Clauses 1(a) and (b) above;

 

  (d) Takeda Pharmaceutical Company Limited (hereinafter referred to as “Takeda”) intends to launch a voluntary public takeover bid (vrijwillig openbaar overnamebod / offre publique d’acquisition volontaire) within the meaning of the Belgian Law of 1 April 2007 on public takeover bids (Wet op de openbare overnamebiedingen / Loi relative aux offres publiques d’acquisition) with respect to 100% of the securities with voting rights or giving access to voting rights of TiGenix, that are not yet owned by Takeda or its affiliates (hereinafter referred to as the “Offer”).

 

  (e) On 11 October 2017, TiGenix approved the creation of an exceptional exercise period (hereinafter referred to as the “Exceptional Exercise Period”) of one (1) month in accordance with article 6.3 of the warrant plans for all vested and unvested warrants held by any holder of a warrant. The Exceptional Exercise Period shall commence from, and be subject to the occurrence of, the date of payment of the securities tendered in the Offer following closing of the first acceptance period, provided that Takeda shall have acquired control of TiGenix upon payment of the securities tendered in the Offer following closing of the first acceptance period. To allow the holders of warrants who decide to exercise their warrants during this Exceptional Exercise Period sufficient time to tender the shares obtained as a result of the exercise of such warrants in the Offer, Takeda undertakes to voluntarily reopen its Offer on the same terms and conditions for a period of 10 Business Days (as defined hereinafter). Takeda shall allow the holders of warrants to tender the shares obtained as a result of the exercise of such warrants in the Offer pending the effective issue of these shares.

 

  (f)

The Director has the capacity and authority to transfer the Shares, any vested Warrants tendered during the first acceptance period and the shares obtained as a result of the exercise of the Warrants during the Exceptional Exercise Period (hereinafter referred to as the “Relevant Securities”) (i) free from any security, lien (including voorrecht / privilège), charge, pledge, option, guarantee, usufruct,


  retention right, priority right, right of first refusal, pre-emption right, seizure, claim, attachment, transfer restriction or, in general, any third party rights and interests of any nature, as well as any power of attorney granted in view of creating such right or interest and any agreement, commitment, undertaking, obligation or other arrangement that has similar consequences, being, among others, limiting or prohibiting a transfer of the Relevant Securities, except for such transfer restriction set out in the terms and conditions of the Warrants and (ii) together with all rights and benefits now or hereafter attaching thereto, including the right to all dividends and other distributions (if any) declared, made or paid hereafter.

 

2. Undertakings

 

2.1 Provided that Takeda shall have acquired control over TiGenix upon payment of the securities tendered in the Offer following closing of the first acceptance period, the Director irrevocably undertakes to exercise any Warrants not tendered to Takeda during the first acceptance period during the Exceptional Exercise Period within one (1) week following the date of payment of the securities tendered in the Offer following closing of the first acceptance period.

 

2.2 The Director irrevocably undertakes to tender the Relevant Securities to Takeda in the context of the Offer, under the terms and subject to the conditions thereof, provided that the bid price would not be below EUR 1.78 per share. Parties agree that the Director has the option to either tender its vested Warrants to Takeda during the first acceptance period at the price per Warrant that is not lower than as set out in Schedule 1 or to exercise such vested Warrants (together with its unvested Warrants) during the Exceptional Exercise Period.

For the avoidance of doubt, Takeda confirms and undertakes that the Director shall be entitled to the highest price payable at any time by Takeda to the holders of shares and warrants of TiGenix who tendered their securities in the Offer, in accordance with article 25, 2° of the Belgian Royal Decree of 27 April 2007 on public takeover bids (Koninklijk besluit op de openbare overnamebiedingen / Arrête royal relatif aux offres publiques d’acquisition) (the “Royal Decree on Public Takeover Bids”).

 

2.3 The Director agrees that it will fulfil the undertaking set out in Clause 2.2 above (i) in respect of the Shares, or if the Director elects to do so in respect of the vested Warrants, as soon as possible and in any event by no later than 3:00 pm on the tenth (10th) Business Day (i.e. a day, other than a Saturday, Sunday or public holiday, when banks are open for business in Belgium) after publication of the formal document containing the Offer (hereinafter referred to as the “Prospectus”) and opening of the first acceptance period and (ii) in respect of the shares obtained as a result of the exercise of the Warrants during the Exceptional Exercise Period, as soon as possible and in any event by no later than 3:00 pm on the eighth (8th) Business Day after the opening of the second acceptance period.

 

3. Withdrawal Rights

Notwithstanding any provisions set out in the terms of the Prospectus or the right of withdrawal from accepting the Offer conferred by article 25, 1° of the Royal Decree on Public Takeover Bids (to the extent applicable), the Director undertakes that it will not withdraw its acceptance of the Offer in respect of the Relevant Securities during the period of the Offer, provided that (i) the bid price does not go below EUR 1.78 per share and the price per Warrant as set out in Schedule 1, (ii) the Director shall be entitled to the highest price payable at any time by Takeda to the holders of shares and warrants of TiGenix who tendered their securities in the Offer and (iii) the undertaking set out in this Clause 3 is without prejudice to Clause 6.


4. Dealings in Relevant Securities

The Director undertakes that it will not, prior to the Offer becoming unconditional in all respects, its withdrawal or lapsing (whichever is earlier) without the prior written consent of Takeda, in any manner, deal in any securities of TiGenix, including, without limitation:

 

  (a) sell, transfer, charge, encumber, grant any option over or otherwise dispose of or permit the sale, transfer, charging or other disposition or creation or grant of any other encumbrance or option of or over all or any of the Relevant Securities except pursuant to the Offer and this Undertaking, or accept any other offer in respect of all or any Relevant Securities except in the circumstances described in Clause 6(d);

 

  (b) purchase or otherwise acquire (or encourage any other person to so purchase or acquire) any other securities of TiGenix or rights to acquire or subscribe for securities of TiGenix (including any options or derivatives), other than in accordance with the terms of this Undertaking;

 

  (c) other than pursuant to the Offer and this Undertaking, enter into any agreement or arrangement or permit any agreement or arrangement to be entered into or incur any obligation or permit any obligation to arise to do all or any of the acts referred to in Clauses 4(a) and 4(b) (inclusive) above,

and for the avoidance of doubt, references in this Clause to any agreement, arrangement or obligation shall include any such agreement, arrangement or obligation whether or not subject to any conditions, or which is to take effect upon or following withdrawal, closing or lapsing of the Offer, or upon or following this Undertaking ceasing to be binding, or upon or following any other event.

Parties acknowledge, for the avoidance of doubt, that the restrictions set out in this Clause 4 do not prevent the Director from exercising any of the Warrants.

 

5. General shareholders’ meeting of TiGenix

 

5.1 Until such time as the Offer becomes unconditional in all respects or lapses or is withdrawn (whichever is earlier), the Director will exercise or procure the exercise by proxy or in person of the votes attaching to the Shares in respect of any resolution proposed at any general shareholders’ meeting of TiGenix, or at any adjournment thereof (hereinafter referred to as a “Relevant Resolution”):

 

  (a) in favour of any such resolution the passing of which is necessary to fulfil any condition of the Offer;

 

  (b) against any such resolution whose passing is required in connection with any offer for TiGenix’ securities that is made by a person other than Takeda; and

 

  (c) against any such resolution which, if passed, might result in any condition of the Offer not being fulfilled or which might impede or frustrate the Offer in any way.

 

5.2 The Director acknowledges and accepts that any resolution to adjourn a general shareholders’ meeting of TiGenix whose agenda includes the consideration of a Relevant Resolution, and a resolution to amend a Relevant Resolution, is also a Relevant Resolution.


6. Lapse of Undertaking

 

6.1 This Undertaking shall automatically lapse and shall be of no further force or effect if:

 

  (a) Takeda has not announced its intention to Offer via press release in accordance with article 8, §1 of the Royal Decree on Public Takeover Bids by Takeda by 8 January 2018;

 

  (b) the Offer is not made (by the posting of the Prospectus) by 16 February 2018 or such later time or date as Takeda and TiGenix agree;

 

  (c) the Offer lapses or is withdrawn without becoming unconditional in all respects; or

 

  (d) a third party launches a competing bid under articles 37 to 41 of the Royal Decree on Public Takeover Bids that the board of directors of TiGenix determines in good faith to be more favourable to the holders of securities in TiGenix than the Offer (a “Superior Target Takeover Proposal”) and (x) no longer recommends and supports the Offer, and (y) expresses a preference for the Superior Target Takeover Proposal, or otherwise recommends it to the holders of the securities in TiGenix, in accordance with its fiduciary duties.

 

6.2 Lapse of this Undertaking shall be without prejudice to the rights of any party in respect of any breach of this Undertaking by the other party prior to such lapse.

 

7. Confidentiality & Miscellaneous

 

7.1 The content of this Undertaking is confidential. However, the Director consents to the issue of a press release incorporating references to this Undertaking under applicable securities laws. The Director further understands and accepts that, if the Offer is made, this Undertaking will be made available for inspection during the period of the Offer and that particulars of it will be contained in the Prospectus or the response memorandum prepared by the board of directors of TiGenix or may need to be filed as part of the Prospectus, other offer documents or Schedule 14D-9.

 

7.2 The Director understands that the information provided to it by Takeda in relation to the Offer must be kept confidential until the Prospectus is published or the information has otherwise become public (including such information announced by Takeda in accordance with article 8, §1 of the Royal Decree on Public Takeover Bids). Before this time, it will not, on the basis of this information, enter into a transaction, place an order to trade, cancel or amend an order which has already been made or engage in any other activity or behaviour which would amount to market manipulation for the purposes Regulation (EU) no 596/2014 on market abuse (Verordening betreffende marktmisbruik / Règlement sur les abus de marché) (hereinafter referred to as “MAR”) nor attempt to engage in market manipulation, and it acknowledges and agrees to comply with its respective obligations under applicable securities laws, including, but not limited to, obligations pursuant to MAR.

 

7.3 The Director and Takeda hereby acknowledge and agree that:

 

  7.3.1 the Director’s rights and obligations hereunder are as a shareholder of TiGenix and not as a member of the board of directors of TiGenix; and

 

  7.3.2 the Director’s fiduciary duties as a member of the board of directors of TiGenix shall not be affected by the provisions of this Undertaking.


8. Severability

 

8.1 If any provision in this Undertaking would be held to be illegal, invalid or unenforceable, in whole or in part, under any applicable law, then that provision (or part thereof) will be deemed not to form part of this Undertaking, and the legality, validity or enforceability of the remainder of this Undertaking will not be affected.

 

8.2 In such case, each party will use its reasonable best efforts to negotiate in good faith a valid replacement provision having a similar economic effect which is as close as possible to that of the invalid, void or unenforceable provision.

 

9. Governing law and jurisdiction

 

9.1 This Undertaking will be governed by and be interpreted in accordance with Belgian Law, with the exclusion of the rules of conflict of laws.

 

9.2 Except as otherwise agreed in writing by the parties, the Courts of Brussels, Dutch section, Belgium, will have the exclusive competence over any disputes that may arise between the parties in relation to this Undertaking.

*                *

*


Date:

 

THE DIRECTOR

 
Name:  

FOR ACCEPTANCE BY

TAKEDA PHARMACEUTICAL COMPANY LIMITED:

 

 
Name:  
Capacity:  
EX-99.6

Exhibit 6

AGREEMENT OF JOINT FILING

This joint filing agreement (this “Agreement”) is made and entered into as of this 12th day of January, 2018, by and among Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals International AG, Takeda Pharma A/S, Takeda A/S and Takeda Europe Holdings B.V.

The parties to this Agreement hereby agree to prepare jointly and file timely (and otherwise to deliver as appropriate) all filings of any Schedule 13D, and any and all amendments thereto and any other document relating thereto (collectively, the “Filings”) required to be filed by them pursuant to the Securities Exchange Act of 1934, as amended. Each party to this Agreement further agrees and covenants to the other parties that it will fully cooperate with such other parties in the preparation and timely filing (and other delivery) of all such Filings.

This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one and the same instrument.

[Signature Page Follows]


IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED
By:       /s/ Paul Sundberg
Name:       Paul Sundberg
Title:       Vice President and Deputy General Counsel

TAKEDA PHARMACEUTICALS

INTERNATIONAL AG

By:       /s/ Paul Sundberg
Name:       Paul Sundberg
Title:       Vice President and Deputy General Counsel
TAKEDA PHARMA A/S
By:       /s/ Paul Sundberg
Name:       Paul Sundberg
Title:       Vice President and Deputy General Counsel
TAKEDA A/S
By:       /s/ Paul Sundberg
Name:       Paul Sundberg
Title:       Vice President and Deputy General Counsel
TAKEDA EUROPE HOLDINGS B.V.
By:       /s/ Paul Sundberg
Name:       Paul Sundberg
Title:       Vice President and Deputy General Counsel
EX-99.7

Exhibit 7

POWER OF ATTORNEY

Know all by these present, that Takeda Pharmaceutical Company Limited (the “Reporting Person”) hereby constitutes and appoints each of Paul Sundberg, Chad Diehl and Brett Budzinski, signing singly, as the Reporting Person’s true and lawful attorney-in-fact to:

 

  (1) prepare, execute in the Reporting Person’s name and on the Reporting Person’s behalf, and submit to the U.S. Securities and Exchange Commission (the “SEC”) a Form ID, including amendments thereto, and any other documents necessary or appropriate to obtain codes and passwords enabling the Reporting Person to make electronic filings with the SEC of Reports required by Sections 13 and 16(a) of the Securities Exchange Act of 1934 or any rule or regulation of the SEC;

 

  (2) prepare and file on behalf of the Reporting Person any and all reports, notices, communications and other documents (including, but not limited to, reports on Schedule 13D, Schedule 13G, Form 3, Form 4 and Form 5) that the Reporting Person may be required to file with the SEC pursuant to the Securities Act of 1933, as amended (together with the implementing regulations thereto, the “Act”) and the Securities Exchange Act of 1934, as amended (together with the implementing regulations thereto, the “Exchange Act”) (collectively, the “Reports”) with respect to the Reporting Person’s ownership of, or transactions in, the securities of any entity whose securities are beneficially owned (directly or indirectly) by the Reporting Person (“Portfolio Companies”);

 

  (3) do and perform any and all acts for and on behalf of the Reporting Person which may be necessary or desirable to complete and execute any such Reports, complete and execute any amendment or amendments thereto, and timely file such form with the SEC and any stock exchange or similar authority;

 

  (4) complete for and on behalf of the Reporting Person, execute in the Reporting Person’s name and on the Reporting Person’s behalf, and submit to the requestor thereof, any questionnaires, documents or other materials that are requested in connection with any (i) equity or debt offering by a Portfolio Company and (ii) exercise by the Reporting Person of voting or proxy rights in connection with the Reporting Person’s equity ownership of any Portfolio Company; and

 

  (5) take any other action of any type whatsoever in connection with the foregoing which, in the opinion of such attorney-in-fact, may be of benefit to, in the best interest of, or legally required by, the Reporting Person, it being understood that the documents executed by such attorney-in-fact on behalf of the Reporting Person pursuant to this Power of Attorney shall be in such form and shall contain such terms and conditions as such attorney-in-fact may approve in such attorney-in-fact’s discretion.


The Reporting Person hereby grants to each such attorney-in-fact full power and authority to do and perform any and every act and thing whatsoever requisite, necessary, or proper to be done in the exercise of any of the rights and powers herein granted, as fully to all intents and purposes as the Reporting Person might or could do if the legal representatives of the Reporting Person were personally present, hereby ratifying and confirming all that such attorney-in-fact shall lawfully do or cause to be done by virtue of this power of attorney and the rights and powers herein granted. The Reporting Person acknowledges that the foregoing attorneys-in-fact, in serving in such capacity at the request of the Reporting Person, are not assuming nor relieving any of the Reporting Person’s responsibilities to comply with Section 13 or Section 16 of the Exchange Act. The Reporting Person acknowledges that none of the foregoing attorneys-in-fact assume (i) any liability for the Reporting Person’s responsibility to comply with the requirements of the Act or the Exchange Act, (ii) any liability of the Reporting Person for any failure to comply with such requirements or (iii) any obligation or liability of the Reporting Person for profit disgorgement under Section 16(b) of the Exchange Act.

This Power of Attorney shall remain in full force and effect until the Reporting Person is no longer required to file any Reports with respect to the Reporting Person’s ownership of, or transactions in, the securities of Portfolio Companies, unless earlier revoked by the Reporting Person at any time at its sole discretion. This Power of Attorney shall expire as to any individual attorney-in-fact if such attorney-in-fact ceases to serve as an employee of a subsidiary of the Reporting Person.

[Signature page follows]


IN WITNESS WHEREOF, the Reporting Person has caused this Power of Attorney to become effective as of the date set forth below.

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED
By:   /s/ James Kehoe
Name:   James Kehoe
Title:   Chief Financial Officer
Date:   November 27, 2017

[Signature Page to Power of Attorney]

EX-99.8

Exhibit 8

POWER OF ATTORNEY

Know all by these present, that Takeda Pharmaceuticals International AG, a public limited company incorporated under the laws of Switzerland, registered with the commercial register of Canton Zurich under CHE-113.444.401 and with business address at Thurgauerstrasse 130, 8152 Glattpark - Opfikon (Zurich) (“TPIZ”) hereby constitutes and appoints each of Paul Sundberg, Chad Diehl and Brett Budzinski, signing singly, as the TPIZ’s true and lawful attorney-in-fact to:

 

  (1) prepare, execute in TPIZ’s name and on TPIZ’s behalf, and submit to the U.S. Securities and Exchange Commission (the “SEC”) a Form ID, including amendments thereto, and any other documents necessary or appropriate to obtain codes and passwords enabling TPIZ to make electronic filings with the SEC of Reports required by Sections 13 and 16(a) of the Securities Exchange Act of 1934 or any rule or regulation of the SEC;

 

  (2) prepare and file on behalf of TPIZ any and all reports, notices, communications and other documents (including, but not limited to, reports on Schedule 13D, Schedule 13G, Form 3, Form 4 and Form 5) that TPIZ may be required to file with the SEC pursuant to the Securities Act of 1933, as amended (together with the implementing regulations thereto, the “Act”) and the Securities Exchange Act of 1934, as amended (together with the implementing regulations thereto, the “Exchange Act”) (collectively, the “Reports”) with respect to TPIZ’s ownership of, or transactions in, the securities of any entity whose securities are beneficially owned (directly or indirectly) by TPIZ (each an “Portfolio Company” and collectively “Portfolio Companies”);

 

  (3) do and perform any and all acts for and on behalf of TPIZ which may be necessary or desirable to complete and execute any such Reports, complete and execute any amendment or amendments thereto, and timely file such form with the SEC and any stock exchange or similar authority;

 

  (4) complete for and on behalf of TPIZ, execute in TPIZ’s name and on TPIZ’s behalf, and submit to the requestor thereof, any questionnaires, documents or other materials that are requested in connection with any (i) equity or debt offering by a Portfolio Company and (ii) exercise by TPIZ of voting or proxy rights in connection with TPIZ’s equity ownership of any Portfolio Company; and

 

  (5) take any other action of any type whatsoever in connection with the foregoing which, in the opinion of such attorney-in-fact, may be of benefit to, in the best interest of, or legally required by, TPIZ, it being understood that the documents executed by such attorney-in-fact on behalf of TPIZ pursuant to this Power of Attorney shall be in such form and shall contain such terms and conditions as such attorney-in-fact may approve in such attorney-in-fact’s discretion.


TPIZ hereby grants to each such attorney-in-fact full power and authority to do and perform any and every act and thing whatsoever requisite, necessary, or proper to be done in the exercise of any of the rights and powers herein granted, as fully to all intents and purposes as TPIZ might or could do if the legal representatives of TPIZ were personally present, hereby ratifying and confirming all that such attorney-in-fact shall lawfully do or cause to be done by virtue of this power of attorney and the rights and powers herein granted. TPIZ acknowledges that the foregoing attorneys-in-fact, in serving in such capacity at the request of TPIZ, are not assuming nor relieving any of TPIZ‘ s responsibilities to comply with Section 13 or Section 16 of the Exchange Act. TPIZ acknowledges that none of the foregoing attorneys-in-fact assume (i) any liability for TPIZ’ s responsibility to comply with the requirements of the Act or the Exchange Act, (ii) any liability of TPIZ for any failure to comply with such requirements or (iii) any obligation or liability of TPIZ for profit disgorgement under Section 16(b) of the Exchange Act.

This Power of Attorney shall remain in full force and effect until TPIZ is no longer required to file any Reports with respect to TPIZ’s ownership of, or transactions in, the securities of Portfolio Companies, unless earlier revoked by TPIZ at any time at its sole discretion. This Power of Attorney shall expire as to any individual attorney-in-fact if such attorney-in-fact ceases to serve as an employee of Takeda Pharmaceutical Company Limited (Japan) or one of its subsidiaries.

[Signature page follows]


IN WITNESS WHEREOF, TPIZ has caused this Power of Attorney to become effective as of the date set forth below.

 

TAKEDA PHARMACEUTICALS INTERNATIONAL AG
By:   /s/ Nils Kjaergaard
Name:   Nils Kjaergaard
Title:   VP, General Counsel Europe and Canada
Date:    

 

TAKEDA PHARMACEUTICALS INTERNATIONAL AG
By:   /s/ Mirjam von Zedtwitz
Name:   Mirjam von Zedtwitz
Title:   Associate General Counsel Corporate
Date:    

[Signature Page to Power of Attorney]

EX-99.9

Exhibit 9

POWER OF ATTORNEY

Know all by these present, that Takeda Pharma A/S, a stock limited company incorporated under the laws of Denmark, and with business address at Dybendal Alle 10, 2630 Taastrup, Denmark (“Takeda Pharma A/S”) hereby constitutes and appoints each of Paul Sundberg, Chad Diehl and Brett Budzinski, signing singly, as Takeda Pharma A/S’s true and lawful attorney-in-fact to:

 

  (1) prepare, execute in Takeda Pharma A/S’s name and on Takeda Pharma A/S’s behalf, and submit to the U.S. Securities and Exchange Commission (the “SEC”) a Form ID, including amendments thereto, and any other documents necessary or appropriate to obtain codes and passwords enabling Takeda Pharma A/S to make electronic filings with the SEC of Reports required by Sections 13 and 16(a) of the Securities Exchange Act of 1934 or any rule or regulation of the SEC;

 

  (2) prepare and file on behalf of Takeda Pharma A/S any and all reports, notices, communications and other documents (including, but not limited to, reports on Schedule 13D, Schedule 13G, Form 3, Form 4 and Form 5) that Takeda Pharma A/S may be required to file with the SEC pursuant to the Securities Act of 1933, as amended (together with the implementing regulations thereto, the “Act”) and the Securities Exchange Act of 1934, as amended (together with the implementing regulations thereto, the “Exchange Act”) (collectively, the “Reports”) with respect to Takeda Pharma A/S’s ownership of, or transactions in, the securities of any entity whose securities are beneficially owned (directly or indirectly) by Takeda Pharma A/S (each an “Portfolio Company” and collectively “Portfolio Companies”);

 

  (3) do and perform any and all acts for and on behalf of Takeda Pharma A/S which may be necessary or desirable to complete and execute any such Reports, complete and execute any amendment or amendments thereto, and timely file such form with the SEC and any stock exchange or similar authority;

 

  (4) complete for and on behalf of Takeda Pharma A/S, execute in Takeda Pharma A/S’s name and on Takeda Pharma A/S’s behalf, and submit to the requestor thereof, any questionnaires, documents or other materials that are requested in connection with any (i) equity or debt offering by a Portfolio Company and (ii) exercise by Takeda Pharma A/S of voting or proxy rights in connection with Takeda Pharma A/S’s equity ownership of any Portfolio Company; and

 

  (5) take any other action of any type whatsoever in connection with the foregoing which, in the opinion of such attorney-in-fact, may be of benefit to, in the best interest of, or legally required by, Takeda Pharma A/S, it being understood that the documents executed by such attorney-in-fact on behalf of Takeda Pharma A/S pursuant to this Power of Attorney shall be in such form and shall contain such terms and conditions as such attorney-in-fact may approve in such attorney-in-fact’s discretion.


Takeda Pharma A/S hereby grants to each such attorney-in-fact full power and authority to do and perform any and every act and thing whatsoever requisite, necessary, or proper to be done in the exercise of any of the rights and powers herein granted, as fully to all intents and purposes as Takeda Pharma A/S might or could do if the legal representatives of Takeda Pharma A/S were personally present, hereby ratifying and confirming all that such attorney-in-fact shall lawfully do or cause to be done by virtue of this power of attorney and the rights and powers herein granted. Takeda Pharma A/S acknowledges that the foregoing attorneys-in-fact, in serving in such capacity at the request of Takeda Pharma A/S, are not assuming nor relieving any of Takeda Pharma A/S’s responsibilities to comply with Section 13 or Section 16 of the Exchange Act. Takeda Pharma A/S acknowledges that none of the foregoing attorneys-in-fact assume (i) any liability for Takeda Pharma A/S’s responsibility to comply with the requirements of the Act or the Exchange Act, (ii) any liability of Takeda Pharma A/S for any failure to comply with such requirements or (iii) any obligation or liability of Takeda Pharma A/S for profit disgorgement under Section 16(b) of the Exchange Act.

This Power of Attorney shall remain in full force and effect until Takeda Pharma A/S is no longer required to file any Reports with respect to Takeda Pharma A/S’s ownership of, or transactions in, the securities of Portfolio Companies, unless earlier revoked by Takeda Pharma A/S at any time at its sole discretion. This Power of Attorney shall expire as to any individual attorney-in-fact if such attorney-in-fact ceases to serve as an employee of Takeda Pharmaceutical Company Limited (Japan) or one of its subsidiaries.

[Signature page follows]


IN WITNESS WHEREOF, Takeda Pharma A/S has caused this Power of Attorney to become effective as of the date set forth below.

 

TAKEDA PHARM A/S
By:   /s/ Patrik Forsell
Name:   Patrik Forsell
Title:   Managing Director
Date:   12/12-2017

[Signature Page to Power of Attorney]

EX-99.10

Exhibit 10

POWER OF ATTORNEY

Know all by these present, that Takeda A/S, a stock limited company incorporated under the laws of Denmark, and with business address at Dybendal Alle 10, 2630 Taastrup, Denmark (“Takeda A/S”) hereby constitutes and appoints each of Paul Sundberg, Chad Diehl and Brett Budzinski, signing singly, as Takeda A/S’s true and lawful attorney-in-fact to:

 

  (1) prepare, execute in Takeda A/S’s name and on Takeda A/S’s behalf, and submit to the U.S. Securities and Exchange Commission (the “SEC”) a Form ID, including amendments thereto, and any other documents necessary or appropriate to obtain codes and passwords enabling Takeda A/S to make electronic filings with the SEC of Reports required by Sections 13 and 16(a) of the Securities Exchange Act of 1934 or any rule or regulation of the SEC;

 

  (2) prepare and file on behalf of Takeda A/S any and all reports, notices, communications and other documents (including, but not limited to, reports on Schedule 13D, Schedule 13G, Form 3, Form 4 and Form 5) that Takeda A/S may be required to file with the SEC pursuant to the Securities Act of 1933, as amended (together with the implementing regulations thereto, the “Act”) and the Securities Exchange Act of 1934, as amended (together with the implementing regulations thereto, the “Exchange Act”) (collectively, the “Reports”) with respect to Takeda A/S’s ownership of, or transactions in, the securities of any entity whose securities are beneficially owned (directly or indirectly) by Takeda A/S (each an “Portfolio Company” and collectively “Portfolio Companies”);

 

  (3) do and perform any and all acts for and on behalf of Takeda A/S which may be necessary or desirable to complete and execute any such Reports, complete and execute any amendment or amendments thereto, and timely file such form with the SEC and any stock exchange or similar authority;

 

  (4) complete for and on behalf of Takeda A/S, execute in Takeda A/S’s name and on Takeda A/S’s behalf, and submit to the requestor thereof, any questionnaires, documents or other materials that are requested in connection with any (i) equity or debt offering by a Portfolio Company and (ii) exercise by Takeda A/S of voting or proxy rights in connection with Takeda A/S’s equity ownership of any Portfolio Company; and

 

  (5) take any other action of any type whatsoever in connection with the foregoing which, in the opinion of such attorney-in-fact, may be of benefit to, in the best interest of, or legally required by, Takeda A/S, it being understood that the documents executed by such attorney-in-fact on behalf of Takeda A/S pursuant to this Power of Attorney shall be in such form and shall contain such terms and conditions as such attorney-in-fact may approve in such attorney-in-fact’s discretion.


Takeda A/S hereby grants to each such attorney-in-fact full power and authority to do and perform any and every act and thing whatsoever requisite, necessary, or proper to be done in the exercise of any of the rights and powers herein granted, as fully to all intents and purposes as Takeda A/S might or could do if the legal representatives of Takeda A/S were personally present, hereby ratifying and confirming all that such attorney-in-fact shall lawfully do or cause to be done by virtue of this power of attorney and the rights and powers herein granted. Takeda A/S acknowledges that the foregoing attorneys-in-fact, in serving in such capacity at the request of Takeda A/S, are not assuming nor relieving any of Takeda A/S’s responsibilities to comply with Section 13 or Section 16 of the Exchange Act. Takeda A/S acknowledges that none of the foregoing attorneys-in-fact assume (i) any liability for Takeda A/S’s responsibility to comply with the requirements of the Act or the Exchange Act, (ii) any liability of Takeda A/S for any failure to comply with such requirements or (iii) any obligation or liability of Takeda A/S for profit disgorgement under Section 16(b) of the Exchange Act.

This Power of Attorney shall remain in full force and effect until Takeda A/S is no longer required to file any Reports with respect to Takeda A/S’s ownership of, or transactions in, the securities of Portfolio Companies, unless earlier revoked by Takeda A/S at any time at its sole discretion. This Power of Attorney shall expire as to any individual attorney-in-fact if such attorney-in-fact ceases to serve as an employee of Takeda Pharmaceutical Company Limited (Japan) or one of its subsidiaries.

[Signature page follows]


IN WITNESS WHEREOF, Takeda A/S has caused this Power of Attorney to become effective as of the date set forth below.

 

TAKEDA A/S
By:   /s/ Patrik Forsell
Name:   Patrik Forsell
Title:   Managing Director
Date:   12/12-2017

[Signature Page to Power of Attorney]

EX-99.11

Exhibit 11

POWER OF ATTORNEY

Know all by these present, that Takeda Europe Holdings B.V., a private limited liability company incorporated under the laws of the Netherlands, and with a business address at Jupiterstraat 250, 2132 HK Hoofddorp, Netherlands (“Takeda Europe”) hereby constitutes and appoints each of Paul Sundberg, Chad Diehl and Brett Budzinski, signing singly, as Takeda Europe’s true and lawful attorney-in-fact to:

 

  (1) prepare, execute in Takeda Europe’s name and on Takeda Europe’s behalf, and submit to the U.S. Securities and Exchange Commission (the “SEC”) a Form ID, including amendments thereto, and any other documents necessary or appropriate to obtain codes and passwords enabling Takeda Europe to make electronic filings with the SEC of Reports required by Sections 13 and 16(a) of the Securities Exchange Act of 1934 or any rule or regulation of the SEC;

 

  (2) prepare and file on behalf of Takeda Europe any and all reports, notices, communications and other documents (including, but not limited to, reports on Schedule 13D, Schedule 13G, Form 3, Form 4 and Form 5) that Takeda Europe may be required to file with the SEC pursuant to the Securities Act of 1933, as amended (together with the implementing regulations thereto, the “Act”) and the Securities Exchange Act of 1934, as amended (together with the implementing regulations thereto, the “Exchange Act”) (collectively, the “Reports”) with respect to Takeda Europe’s ownership of, or transactions in, the securities of any entity whose securities are beneficially owned (directly or indirectly) by Takeda Europe (each an “Portfolio Company” and collectively “Portfolio Companies”);

 

  (3) do and perform any and all acts for and on behalf of Takeda Europe which may be necessary or desirable to complete and execute any such Reports, complete and execute any amendment or amendments thereto, and timely file such form with the SEC and any stock exchange or similar authority;

 

  (4) complete for and on behalf of Takeda Europe, execute in Takeda Europe’s name and on Takeda Europe’s behalf, and submit to the requestor thereof, any questionnaires, documents or other materials that are requested in connection with any (i) equity or debt offering by a Portfolio Company and (ii) exercise by Takeda Europe of voting or proxy rights in connection with Takeda Europe’s equity ownership of any Portfolio Company; and

 

  (5) take any other action of any type whatsoever in connection with the foregoing which, in the opinion of such attorney-in-fact, may be of benefit to, in the best interest of, or legally required by, Takeda Europe, it being understood that the documents executed by such attorney-in-fact on behalf of Takeda Europe pursuant to this Power of Attorney shall be in such form and shall contain such terms and conditions as such attorney-in-fact may approve in such attorney-in-fact’s discretion.


Takeda Europe hereby grants to each such attorney-in-fact full power and authority to do and perform any and every act and thing whatsoever requisite, necessary, or proper to be done in the exercise of any of the rights and powers herein granted, as fully to all intents and purposes as Takeda Europe might or could do if the legal representatives of Takeda Europe were personally present, hereby ratifying and confirming all that such attorney-in-fact shall lawfully do or cause to be done by virtue of this power of attorney and the rights and powers herein granted. Takeda Europe acknowledges that the foregoing attorneys-in-fact, in serving in such capacity at the request of Takeda Europe, are not assuming nor relieving any of Takeda Europe’s responsibilities to comply with Section 13 or Section 16 of the Exchange Act. Takeda Europe acknowledges that none of the foregoing attorneys-in-fact assume (i) any liability for Takeda Europe’s responsibility to comply with the requirements of the Act or the Exchange Act, (ii) any liability of Takeda Europe for any failure to comply with such requirements or (iii) any obligation or liability of Takeda Europe for profit disgorgement under Section 16(b) of the Exchange Act.

This Power of Attorney shall remain in full force and effect until Takeda Europe is no longer required to file any Reports with respect to Takeda Europe’s ownership of, or transactions in, the securities of Portfolio Companies, unless earlier revoked by Takeda Europe at any time at its sole discretion. This Power of Attorney shall expire as to any individual attorney-in-fact if such attorney-in-fact ceases to serve as an employee of Takeda Pharmaceutical Company Limited (Japan) or one of its subsidiaries.

[Signature page follows]


IN WITNESS WHEREOF, Takeda Europe has caused this Power of Attorney to become effective as of the date set forth below.

 

TAKEDA EUROPE HOLDINGS B.V.
By:   /s/ Remco van Rhoon
Name: Remco van Rhoon
Title: Managing Director
Date:   29 November 2017
TAKEDA EUROPE HOLDINGS B.V.
By:   /s/ Manoj Bhojwani
Name: Manoj Bhojwani
Title: Managing Director
Date:   4 / Dec / 2017

[Signature Page to Power of Attorney]